Recombinant DNA research : documents relating to "NIH guidelines for research involving recombinant DNA molecules"

RECOMBINANT DNA RESEARCH

Volume 2

Documents Relating to
“NIH Guidelines for Research
Involving Recombinant DNA Molecules”
June 1976- November 1977

March 1978

U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
Public Health Service National Institutes of Health

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RECOMBINANT DNA RESEARCH
Volume 2

Documents Relating to
"NIH Guidelines for Research Involving
Recombinant DNA Molecules"

June 1976 - November 1977

A Record of Correspondence,

Minutes of Meetings, Analyses, Reports,
Proposed Legislation, Public Announcements, Etc. ,
Documenting the Role of the
National Institutes of Health in the
Development and Promulgation of the
Guidelines of June 23, 1976

Including as a Supplement
The National Institutes of Health
Environmental Impact Statement on NIH Guidelines for
Research Involving Recombinant DNA Molecules , October 19"/ 7

Prepared by the
Office of the Director, NIH

DHEW Publication No. (NIH) 78-1139

U.S. DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE
Public Health Service National Institutes of Health

NAW

v.2

/ <i 7 f

For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C. 20402

Stock No. 017-040-00422-2

PREFACE

This report is the second in a series documenting the activities
of the National Institutes of Health in respect to research involving
recombinant DNA molecules. Volume 1 of the series, prepared in
August 1976, covered events from February 1975--the Asilomar
conference --through June 1976--the issuance of N1H Guidelines.

Volume 2 covers subsequent events culminating with those surrounding
(but not including) the publication of proposed revisions to the Guide-
lines on September 27, 1977.

During the period covered here, NIH undertook an evaluation of
HEW's patent policy, with a view to deciding whether a change was
in order for recombinant DNA inventions made under Departmental
support. The present volume includes an analysis of current policy
by the Director, NIH, and the comments on this analysis by members
of the Recombinant Advisory Committee, the Director's Advisory
Committee, and pharmaceutical companies.

In July 1976 a letter from Senators Javits and Kennedy to President
Ford recommended that the NIH Guidelines be extended to the entire
Nation's research community by appropriate executive or legislative
action. In response, the Secretary of HEW, with the approval of the
President, convened an interagency committee to review and coordinate
the activities of Federal agencies and to conduct other related inquiries.
The Federal Interagency Committee has held eight meetings, and two
subcommittees met to review patent policy and international safety
measures. Included in the present volume are the minutes of the
Committee's meetings and various Committee documents relating to
the above subjects and to recombinant DNA activities in other govern-
ment agencies, the private sector, and abroad. The Committee's
recommendations on the matter of legislation are also reported.

A staff review of congressional action, documented by the major
bills of 1977, is included. Up to February 1978, no law regulating
recombinant DNA activities has been enacted. Compliance with the
NIH Guidelines, however, extends throughout private industry on a
voluntary basis and is compulsory under the far-ranging NIH awards
system .

A bibliography of popular literature on recombinant DNA and a
selection of typical news articles have been included to illustrate the
diverse interests and points of view that have attended this con-
troversial subject.

iii

Finally, the NIH Environmental Impact Statement on "NIH
Guidelines for Research Involving Recombinant DNA Molecules, "
in two parts, supplements this volume. It will accompany the
volume except in our distribution to those who have already received
it.

To ensure wide availability of Volumes 1 and 2 and the Environ-
mental Impact Statement, the Superintendent of Documents has
placed them on sale at the Government Printing Office, Washington,
D. C. 20402, and has deposited them in about 600 public libraries
throughout the country. * For further information, write to the
Office of Recombinant DNA Activities, Room 4A52, Building 31,
National Institutes of Health, Bethesda, Md. 20014.

Donald S. Fredrickson, M. D.
March 1 , 1978

*The Stock Numbers for purchasing Volume 1 and the EIS are
017-040-00398-6 and 017-040-00413-3, respectively.

IV

CONTENTS

Page

DHEW Patent Policy as Related to Recombinant DNA 1

Federal Interagency Committee 156

Establishment and Charter 156

Activities of Voluntary Health Agencies,

Foundations and Societies 184

Research Programs of Government Agencies

and Industry 233

Legislative Events 250

Federal Patent Policies 346

International Activities and Report 361

Review of Federal Legislation (with Copies of Bills) 501

Bibliography of Nontechnical Articles 890

Typical News Articles 895

Environmental Impact Statement on NIH
Guidelines (Supplement)

v

DHEW PATENT POLICY AS RELATED
TO RECOMBINANT DNA

Page

Letter from Donald S. Fredrickson to

Dr. Robert M. Rosenzweig 1A

The Patenting of Recombinant DNA Research
Inventions Developed Under DHEW Support:

An Analysis by the Director, National

Institutes of Health, November 1977 2

Letter from Donald S. Fredrickson to
Recombinant Advisory Committee,

Director's Advisory Committee, and

Representatives of Private Industry 48

List of Correspondents on DHEW Patent

Policy (Alphabetical) 52

Letters on DHEW Patent Policy (Chronological) 56

1

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
BETHESDA. MARYLAND 20014

March 2, 1978

Dr. Robert M. Rosenzweig
Vice President for Public Affairs
Stanford University
Stanford, California 94305

Dear Dr. Rosenzweig:

Shortly after the release of the NIH Guidelines on Recombinant DNA
Research in June 1976, you sent me a letter requesting that the
National Institutes of Health review DHEW policies relating to the
patenting of recombinant DNA research inventions. As you know, your
letter prompted NIH to review current DHEW patent regulations govern-
ing existing institutional patent agreements and to consider how
recombinant DNA research inventions should be handled under the terms
of those agreements. Over the summer and fall of 1976, NIH solicited
comments from a broad range of individuals and institutions on this
matter .

An analysis of the comments received on the question of patenting
recombinant DNA inventions was completed in December 1976, and was
referred for review to the Federal Interagency Committee on Recombi-
nant DNA Research. As you know, this Committee was convened by the
Secretary of HEW, with the approval of the President, to address the
extension of NIH Guidelines beyond NIH to the public and private
sectors .

In an interim report to the Secretary in March 1977, the Committee
recommended that legislation be developed to govern the conduct of
recombinant DNA activities nationally. On the basis of those recom-
mendations, an Administration bill was drafted and was introduced in
Congress by Senator Edward M. Kennedy and Representative Paul G. Rogers.
Congressional hearings were held, but no bills were enacted in the past
session. It appears, however, that new bills will be considered shortly
by the relevant congressional committees.

The Committee reviewed NIH patent policies with respect to recombinant
DNA research in May, and the Public Health Service and the Office of the
General Counsel completed a review of the report in December. The report,
enclosed, provides an analysis of all comments received on this matter
and of the Interagency Committee review of patent policy. On the basis
of the findings contained in the report and my discussions with Dr. Julius
Richmond, the Assistant Secretary for Health, and Peter Libassi, General
Counsel for the Department, it is my recommendation that at least for the
present, recombinant DNA research inventions developed under DHEW-NIH
support should continue to be administered within current DHEW patent

[1A]

Page 2 - Dr . Robert M. Rosenzweig

agreements with the universities. Each agreement, however, will
be amended to permit the institution to grant a license under patents
secured on any such invention only if the licensee provides assurance
of compliance with the physical and biological containment standards
set forth in the Guidelines in any production or use of recombinant
DNA molecules under the license. In my view, the requirements set
for NIH grantees and contractors will thus be honored by licensees
as well.

Accordingly, Stanford may proceed to file recombinant DNA research
patent applications. You should know that Federal patent policies
are under extensive review by the Executive Branch and the Congress,
and that this may lead to actions affecting the administration of
institutional patent agreements generally and other conditions for
recombinant DNA research inventions specifically. For the present,
however, recombinant DNA research inventions should not be handled
differently under current institutional patent agreements, except
for the requirement that licencees agree to comply with containment
standards set forth in the NIH Guidelines.

I regret the long period of time required to review patent policies
involving recombinant DNA research, but the complexity of the issues
necessitated an extended analysis. Your letter stimulated a thorough
and much needed policy review. I appreciate your interest and patience.

Sincerely yours,

Donald S. Fredrickson, M.D.
Director

Enc losure

[IB]

THE PATENTING OF RECOMBINANT DNA RESEARCH INVENTIONS
DEVELOPED UNDER DHEW SUPPORT:

An Analysis by the Director,

National Institutes of Health,

November 1977

Contents

I. Introduction 1

II. Review of Issues and Comments Received in the Patenting

of Recombinant DNA Inventions 3

III. Interagency Committee 10

IV. Summary Review and Analysis 13

APPENDICES 18

[2]

THE PATENTING OF RECOMBINANT DNA RESEARCH INVENTIONS
DEVELOPED UNDER DHEW SUPPORT:

An Analysis by the Director,

National Institutes of Health,

November 1977

I . Introduct ion

The need for the Department of Health, Education, and Welfare
(DHEW) to establish a policy on the patenting of DHEW-supported inventions
involving the use of recombinant DNA molecules has occasioned efforts
to achieve a consensus of views from the public and private sectors.

An account of these efforts, with relevant background and analysis,
is presented here.

On June 23, 1976, the National Institutes of Health (NIH) released
guidelines to govern the conduct of NIH-supported research on recombinant
DNA molecules. In this research, "genes" — that is, deoxyribonucleic
acid (DNA) molecules — from virtually any living organism can be transferred
to single cells from certain completely unrelated organisms. These
experiments depend on the ability to join genetic material of different
sources and then to propagate the resulting hybrid elements in single
bacterial and animal cells. The NIH Guidelines establish carefully
controlled conditions for the conduct of experiments involving the
insertion of such recombinant genes into organisms such as bacteria.

The guidelines were developed by a scientific advisory committee
created by NIH in response to requests by many scientists engaged in
this field of research. These scientists had previously called for
a moratorium on certain kinds of experiments while appropriate guidelines
were devised. In December 1975 the NIH Recombinant DNA Advisory Committee

[3]

2

proposed guidelines to the Director of NIH which were reviewed at a
public hearing in February 1976. As released on June 23, 1976, these
guidelines had been revised in light of a number of suggestions presented
by the public commentators. Accompanying the release was a Director's
Decision document addressing the issues raised at the public hearing and
in subsequent correspondence.

The NIH Guidelines were published in the Federal Register on July 7,
1976, for further public comment. In response to suggestions of public
commentators, NIH also undertook an environmental impact assessment of
recombinant DNA research and filed a Draft Environmental Impact Statement
in the Federal Register on September 9, also for public comment.

In June, shortly before the release of the Guidelines, Dr. Robert
M. Rosenzweig, Vice President for Public Affairs at Stanford University,
sent me a letter asking NIH to review DHEW policies relating to the
patenting of recombinant DNA research inventions. Dr. Rosenzweig noted
that both Stanford and the University of California were applying for
patent protection for recombinant DNA research inventions developed by
their investigators under NIH support. However, in view of the intense
public interest in this research generally, the two universities felt the
need for a formal advisory opinion by NIH on the patenting of recombinant
DNA inventions developed under NIH grants or contracts. A number of other
universities indicated similar interest in obtaining the official views
of NIH.

Prior to making an official pronouncement of DHEW-NIH policy with
respect to patenting of recombinant DNA research inventions, NIH decided
to solicit comments from a broad range of individuals and institutions.

[4]

3

Appendix I lists all individuals and groups whose views were solicited
in the drafting of the present analysis. A copy of the letter soliciting
their coaments is also attached. All correspondence from the commentators
will be published in the second of a series of volumes that document the
public policy issues and the proceedings relating to NIH decisions on
recombinant DNA research.

A review and analysis of comments received on the question of patenting
recombinant DNA inventions was completed in December 1976 and referred
to the Federal Interagency Committee on Recombinant DNA Research for their
attention. Following the Committee review, the report was considered by the
DHEW Office of the General Counsel, the Public Health Service, and the National
Institutes of Health. The review, together with a brief report on related
activities of the Interagency Committee, appears below.

1 1 . Review of Issues and Comments Received in the Patenting of Recom-
binant DNA Inventions

A. Department of Health, Education, and Welfare Patent Policies

Under current DHEW patent regulations, invention rights to dis-
coveries developed under the Department's research support are normally
allocated in either of two ways:

First, the Department may enter into an Institutional Patent Agree-
ment (IPA) with a university or other nonprofit organization that has
instituted mechanisms for administering patents on inventions (see
Appendix II). The IPA provides the institution the first option to own
all inventions made in performance of Department grants or contracts,
subject to a number of conditions deemed necessary to protect the public
interest. Some of the more important conditions are —

m

4

(1) a royalty- free license permitting the Government and those
functioning under Government direction to use the invention,

(2) a limit on the term of any exclusive license granted
("exclusive" = permission to grant only one license for a
limited time),

(3) authority to withdraw specified grants from the Institutional
Patent Agreements,

(4) a right of the Department to regain ownership if the insti-
tution breaches the terms of the IPA or fails to take effec-
tive steps to commercialize the invention, and

(5) a right to disclose the invention to the public after a U.S.
patent application has been filed.

Stanford and the University of California each hold one of the
72 IPAs now being administered by the Department.

For those institutions that have not entered into a patent agree-
ment with the Department, determination of ownership is deferred
until an invention has been made, at which time an institution may
petition the Department for ownership of the invention. In the past,
approximately 90 percent of all such petitions have been granted on
the basis of a satisfactory plan proposed by the institution for
development or licensing.

The IPA provides a mechanism to facilitate the conversion of new
knowledge from the research laboratory to marketable products, by
assuring that the institution where the discovery is made can grant
licenses for continued development of inventions generated with Depart-
ment support. The Department Patent Branch reports that 167 patent

[6]

5

applications were filed from 1969 through the fall of 1974 under
IPAs. Approximately $24 million is committed to the development
of inventions on the basis of licenses granted under these patents.
Meanwhile the Department has reviewed 178 petitions for ownership
from institutions not having IPAs and has granted 162 of them. Ap-
proximately $53 million has been invested or committed to development
under the licenses awarded through this mechanism. The commitment
of private risk capital in these instances may be viewed as evidence
that a licensable patent right is a primary factor in the successful
transfer of results from Department-funded research to the public.

It indeed appears that the incentives provided by Department
patent policy have encouraged the development of new technology and
its transfer to the public — a clear benefit to the United States.

B . The Patenting of Recombinant DNA Research Inventions
1 . Patenting and Disclosure of Information

In reviewing patent policies generally, the effect of the pro-
cessing of patent applications on the rapid dissemination of
scientific and safety information must be considered. Under U.S.
law an inventor has a one-year period of grace after research
results are published in which to file for a patent. In a number
of foreign countries, however, valid protection requires that a
patent application be filed prior to publication. If one publishes
first, valid patent protection cannot be obtained. Thus it could
be anticipated that the effect of allowing patents on recombinant
DNA inventions would be to encourage U.S. inventors to file for

[7]

6

patents before publication in order to protect their interests
abroad. DHEW and Patent Office counsels believe that any neces-
sary patent applications can be handled expeditiously without
undue delays in publication.

The NIH Recombinant DNA Advisory Committee places high
priority on the rapid dissemination of results in recombinant DNA
research. Members of the committee believed, however, that patent-
ing would not create an undue delay or impede the operations of
the committee in disseminating research and safety information.
Other commentators who participated in the public hearing on the
guidelines also concluded that patenting would not create an undue
delay. Commentators from industry stated that patents expedite
the disclosure of research results. Several noted that lack of
patents would discourage the free flow of information because
industry would seek to protect innovations through trade secrets.

One commentator, however, suggested that recombinant DNA
research patents might be specially expedited by the U.S. Patent
Office, as in the case of patents in the field of environmental
protection. This recommendation was forwarded to the U.S. Patent
Office for comment. Another suggestion was that foreign rights
be waived in an emergency, in order to release important safety
information quickly. (In Germany and Japan, there is a grace
period of 6 months after publication in which to file for patent
protection.) This recommendation was forwarded to the U.S. Patent
Office for comment. The Commerce Department did issue an order

[8]

7

for Che expedited processing of patents. The order and its
subsequent review by the Interagency Committee is discussed
in Section 3, devoted to the Interagency Committee review.

2 . Exclusion of DNA Research Inventions from IPAs

The views of commentators were solicited on excluding recom-
binant DNA research inventions from IPAs, so that patents would
be granted only for dedication to the public. Possible approaches
include the following:

Recombinant DNA research inventions could be excluded from
the IPAs. None of the commentators favored this option.

Alternatively, Che IPA could require institutions filing
patent applications for recombinant DNA research inventions
to dedicate all issued patents to the public. No commentator
voiced support for this.

Finally, a condition could be added to the institutional
patent agreement requiring institutions to assign to DHEW all
recombinant DNA research inventions developed under Department
support. The Department, as assignee, could either dedicate
the patent to the public or pursue licensing, with appropriate
conditions attached. Some commentators supported this policy,
including four members of the Recombinant Advisory Committee.

Among the industrial representatives, one commentator found
this option acceptable. Several commentators who attended the
public hearing favored this policy option, and one suggested
that royalties accrued by the Government should be used to

[9]

8

finance more recombinant DNA research. It may be noted, however,
that institutional patent agreements contain clauses defining
rates for royalty return to the investigator and to the insti-
tution (see Appendix II). The conditions set for royalties provide
flexibility for the institution or the inventor to use accrued
royalties in support of continued research.

3 . Extension of the NIH Guidelines Through the Department
Patent System

In light of the control of recombinant DNA research envisioned
by the NIH Guidelines, there is a potential for achieving uniformity
in safety practices through conditions of licensure under patent
agreements. Thus the general views of all commentators were also
solicited on the possibility of incorporating requirements for
adherence to the NIH Guidelines in the IPAs.*

Possible means to accomplish these ends include the following:
Institutions would retain the right to file patent applica-
tions for recombinant DNA research, but all licenses would have
to be reviewed and approved by the Department of Health, Educa-
tion, and Welfare. The Department would be free to set standards,

*This action was proposed prior to the creation of the Interagency
Committee, which recommended in March 1977 that legislation be
passed to regulate all recombinant DNA activities nationally.
Legislation was subsequently proposed by the Administration and
is currently pending before the Congress.

[10]

9

such as compliance with the NIH Guidelines, as a condition for
granting an exclusive or a nonexclusive license.*

The commentators generally supported the inclusion of
requirements in the IPAs which would extend the NIH Guidelines
beyond NIH grantees and contractors to private industry.

Commentators from industry had reservations about mandatory
compliance with the NIH Guidelines as a condition for obtaining
licenses. Most found, however, that the use of the patent system
for requiring compliance with the Guidelines would be acceptable.
It was noted that the Guidelines would need to be modified for
application to industry and that the development of a plan for
their administration through the patent system would require
considerable thought and care. A number of industrial commenta-
tors also pointed out that use of the patent system to achieve
compliance with the Guidelines could only be a temporary measure,
for legislation or some form of administrative regulation would
ultimately be needed to cover recombinant DNA research activity
in both the public and private sectors. The Federal Government,

* A nonexclusive license allows several licenses to be granted
simultaneously for the development and marketing of one patentable
invention. As noted in the relevant section of the patent agreement
included in Appendix II, an institution must attempt to grant
nonexclusive licenses. When the institution is unable to find
a market for nonexclusive licenses, it may then grant an exclusive
license. An exclusive license permits only one license to be granted
for a limited time. A number of conditions are set forth in the
patent agreement governing the granting of an exclusive license
(see Appendix II). In an alternative approach to that mentioned
above, the Department could review and approve exclusive licenses
but not review nonexclusive licenses.

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it was stated, has a broader responsibility for enforcing safety
regulations — and such enforcement should not be limited to NIH
employees and awardees.

Generally, those commentators who had attended the public
hearing in February 1976 also expressed reservations about requiring
compliance through the patent system. A number pointed out the dif-
ficulty in exercising regulatory controls through the patent process.
They urged that regulation might better be carried out by a Govern-
ment agency responsible for all recombinant DNA research. One
commentator noted that the universities do not have the capability
to monitor their licensees for compliance with the Guidelines and
that, necessarily, such responsibility would have to rest with
the Federal Government. Another commentator, however, believed
that the enforcement of compliance by licensees should rest with
the universities holding the patents. The rationale for this view
was that the Government has not assumed the primary role of enforcer
in other patent circumstances and that an exception should not be
created for recombinant DNA research.

Ill . Interagency Committee

A. Mandate of the Interagency Committee

The Secretary of HEW, with the approval of the President, estab-
lished in October 1976 an Interagency Committee on Recombinant DNA
Research chaired by the Director of the NIH. The Committee was chartered
to review the nature and scope of Federal and private-sector activities
related to recombinant DNA research, to determine the applicability

[12]

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of Che NIH Guidelines to govern research in these sectors and, if
necessary, to recommend appropriate legislative or executive action.

The Committee consists of all Federal Departments and agencies that
support and conduct such research and all regulatory agencies that
may have potential authority over it. (The members of the Committee
are listed in Appendix III.)

After several months of work, the Interagency Committee agreed that
legislation was required to ensure uniform standards to govern all
recombinant DNA activities nationally. After detailed deliberations,
the Committee agreed on a set of elements for proposed legislation. The
agreed-upon elements and various alternatives reviewed by the Committee
were presented in an Interim Report transmitted on March 15, 1977, to
HEW Secretary Califano who had legislation developed along the lines
recommended by the Committee. The Administration bill, drafted by the
Department, was introduced into Congress, where it and several other
bills dealing with recombinant DNA activities are pending.

B. Committee Review of Patent Policies
1 . Commerce Department Order

The Department of Commerce published in the Federal Register
on January 13, 1977, an order for the accelerated processing of
patent applications for recombinant DNA inventions. In response to
expressions of concern by members of Congress, HEW Secretary Califano
requested Secretary of Commerce Juanita Kreps to withdraw the order
pending review by the Interagency Committee. In a notice filed in the

[13]

12

Federal Register on March 9, 1977, Commerce announced suspension
of the order (except for applications relating to safety of research
in this field, which would continue to receive expedited processing).

At a meeting held on March 29, the Committee reviewed the order
and documents prepared by the Commerce Department explaining in
detail the underlying policies. The majority of Committee members
were favorably disposed to the reinstatement of the Commerce Depart-
ment order because: (1) accelerated processing involves no change
in patent policies, merely a speeding up of the procedures; (2) it
motivates compliance with the safety standards of the NIH Guidelines
by nongovernmentally funded domestic investigators during the period
while national legislation is being considered; and (3) it encourages
compliance with a set of recognized safety standards by foreign
investigators who may not yet be subject to comparable standards in
their own countries. The views of the Committee were transmitted to
the Secretary for his review in April 1977. The Secretary has taken
no action, pending enactment of legislation.

2 . Institutional Patent Agreements

An analysis of the HEW Institutional Patent Agreements was
referred to the Committee for review. A number of the agency
representatives referred the analysis to their patent counsels.

Among the relevant agencies that commented were the National
Science Foundation, the Defense Department, the Department of
Agriculture, the Energy Research and Development Administration,
and the Department of Justice.

[14]

13

All agencies voiced support for DHEW's policies governing
Institutional Patent Agreements. Further, all except Justice
believe that recombinant DNA research inventions should be handled
no differently from other inventions under the terms of the IPAs.

The Department of Justice believed that, in view of the great public
interest in this research, ownership of any invention stemming from
Government-sponsored research in the recombinant DNA field should
be held by the U. S. Government.

IV. Summary Review and Analysis

From all the comments received, there was general support for Insti-
tutional Patent Agreements between the DHEW and grantee institutions.

The agreements allow, through appropriate conditions, the disposition of
inventions as a result of Department-supported research. Under the terms,
there is a careful delineation of the rights and duties of grantees
and of the Department. Detailed conditions are set forth for institutions
to grant exclusive and nonexclusive licenses, and a set of conditions for
the distribution of royalties is included. Either party may terminate
the agreement upon 30 days notice.

Under the terms of the agreement, institutions must grant the
Government a royalty-free nonexclusive license, under which any grantee
or contractor of the Government operates. Under patent law, the use of
patents for research purposes is not an infringement, and anyone may use
the invention in research without paying royalties. In sum, DHEW Institu-
tional Patent Agreements are perceived to strike a fair and equitable
balance between public rights and private interests.

[15]

14

A number of commentators disagreed with the action of Stanford
and the University of California in seeking to patent such inventions.
Specifically, several commentators believed that those universities were
ill-advised to seek patents when contributions to research advancement in
this area were shared by a number of institutions and investigators. These
are important considerations in the determination of patent rights. How-
ever, the appropriate forums for adjudicating rights to patent inventions
are the U.S. Patent and Trademark Office and the courts. The Patent Office
reviews all patent applications to determine whether the claims for the
new inventions are attributable solely to the claimant. The NIH recognizes
its responsibility to provide the Patent Office with all relevant research
information on recombinant DNA, in order that review of claims can proceed
with full knowledge of prior research results in this area.

The commentators did not believe patents to be an impediment to the
free flow of information. There may be special problems posed by the
Freedom of Information Act which will influence the administration of
patents in the future. For the present, however, it would appear that
the Act and the patent agreement do not necessarily conflict. The
commentators supported the IPAs and urged that recombinant DNA research
inventions not be excluded from them.

When the Guidelines were released in June, a key public issue was
their extension to the rest of the public and private sectors. All com-
mentators whose views were solicited in 1976 agreed that there must be
standards to govern the conduct of recombinant DNA research and that the
NIH Guidelines could provide the standards for such research nationally.

[16]

15

They were divided, however, on whether to achieve that goal through the
use of patent agreements. Several commentators recommended Federal action
to ensure uniform standards with appropriate monitoring. They noted that
the implementation of the NIH Guidelines through licenses granted under
patents is awkward at best and would be only a temporary solution.

The Interagency Committee members voiced strong support for Depart-
ment policies governing Institutional Patent Agreements, and all except
representatives of the Department of Justice believe that recombinant
DNA research inventions should be considered within the existing terms
of the Institutional Patent Agreement. It should be noted that the
Justice Department opinions rested heavily on a draft bill orginally pro-
posed by Senator Kennedy for the regulation of recombinant DNA research
activities. Specifically, Justice referred to the patent sections of
this draft bill that were based on the concept of Government ownership
of recombinant DNA research inventions. In subsequent versions of Senator
Kennedy's bill, however, all sections related to patents were eliminated.

The perceived need for extension of the Guidelines generated support
among the commentators in the summer and fall of 1976 for the use of
patents as a means of obtaining compliance. Legislation to ensure uniform
standards and regulations nationally for all recombinant DNA activities
in both the public and private sectors was considered in the First
Session, 95th Congress. In the current session, legislation once again
is being considered. Use of the Institutional Patent Agreement as a means
of obtaining compliance with the NIH guidelines is not an adequate substitute
for legislation.

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16

However, in the absence of legislation, a condition in the IPAs to require
assurances of compliance with the safety standards in the NIH guidelines
is warranted.

This leaves the residual question whether the subject of the patent-
able processes (recombinant DNA techniques) is of such a peculiar nature
that financial return to the inventors should be denied. This argument,
too, had few advocates among the commentators. There are no compelling
economic, social, or moral reasons to distinguish these inventions from
others involving biological substances or processes that have been patented,
even when partially or wholly developed with public funds. Such inventions
include vaccines for rubella and rabies, treatments for herpes infections
of the eye, treatments for uremia, and prostaglandins — compounds that may
have a number of possible medical uses. The argument that commercial
development based on patent protection has or will assure maximum benefits
of these inventions to the public applies as well to the putative benefits
of recombinant DNA inventions.

It is recognized that Federal patent policies are under extensive
review by the Executive Branch and the Congress. This may lead to actions
that could affect the administration of Institutional Patent Agreements
generally and the conditions for recombinant DNA research inventions
specifically.

It is recommended, however, that recombinant DNA research inventions
developed under DHEW-NIH support should, at least for the present, continue
to be administered within current DHEW patent agreements with the univer-
sities. But each agreement should be amended to ensure that the licensees

[18]

17

will comply with the physical and biological containment standards set
forth in the Guidelines in any production or use of recombinant DNA
molecules under the license. If legislation is passed, these safety
standards will be mandated by the law for all who conduct or support
recombinant DNA research.

[19]

18

Appendices

I.

I

II.

III.

Sample Letter on DHEW Patent Policy as Applied to Recombinant
DNA Inventions; Addressees; Recombinant DNA Advisory Committee

Institutional Patent Agreement Governing Grants and Awards
from the Department of Health, Education, and Welfare

Interagency Committee on Recombinant DNA Research, June 1977

[20]

Appendix I

SAMPLE LETTER ON DHEV PATENT POLICY AS APPLIED TO RECOMBINANT DNA INVENTIONS;
ADDRESSEES; RECOMBINANT DNA ADVISORY COMMITTEE

DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE
PUBLIC HEALTH SCRVICE
NATIONAL INSTITUTES OF HEALTH
BETNC&OA MARYLAND 20014

September 8, 1976

I am writing to solicit your views on the question of patent applications
in the area of recombinant DNA research activity. As you may know,
Stanford University and the University of California have proceeded to
file a patent application on a process for forming recombinant DNA.

This invention was generated in performance of an NIH grant. A number
of other Universities, including the University of Alabama, may also
file patent applications on derivatives of recombinant DNA research.
Notwithstanding Stanford's right to file under the terras of a prior
agreement with the Department, they have solicited NIH's view on an
appropriate plan for administration of this invention.

These patent activities, the certitude that other important inventions
in this field are forthcoming, and the public's apprehension over
control of recombinant DNA research compel inquiry into whether the
Department's normal policy of allocating invention rights is consonant
with the concerns about this research or whether special treatment would
be more appropriate.

Invention rights are normally allocated in either of two ways under
Department patent regulations —

First, if a University or other nonprofit institution seeks to enhance
its technology transfer capability, the Department may enter into an
Institutional Patent Agreement (IPA). This provides to the institution
the first option to ownership in all inventions made in performance of
Department research, subject to a number of conditions deemed necessary
to protect the public interest. Some of the more important conditions
are:

1. a royalty-free license permitting the Government and those functioning
under Government direction to practice the invention,

2. a limit on the term of any exclusive license granted,

3. Department authority to withdraw specified grants from the
agreement, and

1-1

[21]

4. the right of the Department to regain ownership due to public
interest considerations or the institution's failure to take
effective steps to commercialize the invention.

Stanford and the University of Alabama each hold one of the 65 IPA's now
being administered by the Department.

Second, under grants and contracts with institutions having no identified
technology transfer capability, the Department utilizes a provision
deferring determination of ownership until an invention has been made.
Under the deferred determination provision, an innovating institution
may petition the Department for ownership of an invention after it is
identified. In the past, approximately 90 percent of all such petitions
have been granted on the basis of a satisfactory institution plan for
development or licensing, subject, however, the conditions similar to
those contained in the Department's IPA's.

The Department's normal policy of allocating invention rights is designed
to facilitate the transfer of technology from the bench to the market-
place, by assuring that the innovating institution has the right to
convey those intellectual property rights necessary to induce industrial
investment and continued development of inventions generated with
Department support. Only the IPA policy, however, assures a management
focal point in the innovating institution which is trained to solicit
and establish timely rights in intellectual property prior to invention.

We have been advised by the Department Patent Branch that 167 patent
applications were filed from 1969 through the fall of 1974 under IPA's.
Approximately $24 million is committed to the development of inventions
on the basis of licenses granted under these patent applications.
Meanwhile, we are advised that the Department, under the deferred
determination provision, has granted 162 of the institutions' 178
petitions for ownership. Approximately $53 million was invested or
committed to development under the licenses awarded. The commitment of
private risk capital in these instances is viewed as evidence that a
licensable patent right is a primary factor in the successful transfer
of Department research results to industry and the marketplace.

It indeed appears that the incentives provided by Department patent
policy have encouraged the development of new technology in general and
afforded patent protection for some inventions to the economic benefit
of the United States.

The control of DNA research envisioned by the guidelines, however,
requires a delicate balance between need for rapid exchange of informa-
tion unhampered by undue concern for patent rights and a potential for
achieving uniformity in safety practices through conditions of licensure
under patent agreements.

1-2

[22]

As noted, Stanford has indicated some willingness to consider modification
of their IPA as it relates to such research. There are a number of
possible policy options, short of the present allocation of rights under
the IPA, which could be considered for discussion with Stanford and as
possible alternatives to the present allocation of rights made under all
other IPA's. Some of these options are as follows:

1. Institutions could be discouraged from filing patent applications on
inventions arising from recombinant DNA research. If this option were
pursued, publication would be relied on to cut off all possible adverse
patent claims.

2. Institutions could be asked to file patent applications on inventions
arising from recombinant DNA research and to dedicate all issued patents
to the public. This would, to a greater extent than 1., block adverse
patent claims.

3. Institutions could be asked to assign all inventions made in
performance of recombinant DNA research to the Department. The Depart-
ment as assignee of the invention could either pursue the licensing of
whatever patent applications were filed or dedicate issued patents to
the public.

A. The Department could continue to permit institutions to exercise
their first option to ownership under the IPA but require that all
licensing of patented inventions be approved by the Department. The
Department could set certain conditions for approval, such as compliance
with the NIH guidelines on recombinant DNA research.

5. The Department could permit Institutions to retain their first
option as in A., but approve only exclusive licenses. Here, as above,
the Department could set out conditions to account for the special
nature of recombinant DNA research, both in approved exclusive and
nonexclusive licenses.

If it is determined that institutions with IPA's should be permitted to
retain ownership of inventions arising from recombinant DNA research,

I am concerned about the effect of the processing of patent applications
on the dissemination of research information. Under United States law,
an inventor has a one-year period of grace after research results are
published in which to file in order to obtain a valid United States
patent. However, valid protection in a number of foreign countries
requires that a patent application be filed prior to publication. If
one publishes first, valid patent protection cannot be obtained in such
countries. Our patent people believe that any necessary patent
applications can be handled expeditiously without an undue burden on
disclosure. I am especially mindful of the concerns expressed at the

1-3

[23]

Director’s Advisory Committee meeting in February that there be a rapid
dissemination of research and safety results in recombinant DNA research.

I would especially welcome your thoughts on this matter. What experience,
if any, have you or your colleagues or institution had with patent
claims in this regard? I would especially appreciate your views on
Department patent policy as it relates to the suggested policy options I
have outlined above. I intend also to solicit advice on this matter
from other interested parties in the scientific community and public and
private sectors.

Thank you very much for your consideration of this most important matter.
In order that we might be able to respond to Stanford in a timely fashion,
I would appreciate your comments by October 1.

Sincerely yours,

/s/

Donald S. Fredrickson, M.D.

Director

1-4

[24]

ADDRESSEES OF SAMPLE LETTER:

Members of the Advisory Committee to the Director, NIH, Past and Present; and
Other Participants at the February 9-10, 1976, Meeting

Dr. Emmett BARKLEY
Director

Office of Research Safety
National Cancer Institute, NIH
Bethesda, Maryland 20014

Dr. Paul BERG

Department of Biochemistry
School of Medicine
Stanford University
Stanford, California 94305

Dr. Daniel CALLAHAN
Director, Institute of Society,
Ethics, and the Life Sciences
360 Broadway

Hastings-on-Hudson, New York 10706

COMROE, Julius H., Jr., M.D.
Cardiovascular Research Institute
1315-M University of California
San Francisco, California 94143

Dr. Roy CURTISS III
Professor

Department of Microbiology
School of Medicine
University of Alabama
Birmingham, Alabama 35294

DODDS, Joseph J., M.D.

Medical Director
Campbell General Hospital
525 McCallie Avenue
Chattanooga, Tennessee 34702

DUNN, B. Winfield C. , D.D.S.

(former Governor of Tennessee)

12 First American Center
Nashville, Tennessee 37238

CUSTAFS0N, James M., Ph.D.

Professor of Theological Ethics
University of Chicago
Chicago, Illinois 60637

Dr. Philip HANDLER
President

National Academy of Sciences
2101 Constitution Avenue, N.W.
Washington, D.C. 20418

Ms. Margo HAYGOOD

2560 Coventry Road

Shakers Heights, Ohio 44120

Dr. David HOGNESS
Professor

Department of Biochemistry
Stanford University
Stanford, California 94305

HUDSON, Roy D. , Ph.D.

Coordinator for Research Programs
and Drug Development
Parke-Davis and Company
Ann Arbor, Michigan 48105

Mr. Peter Barton HUTT
Covington & Burling
888 16th Street, N.W.

Washington, D.C. 20006

KELLY, James F., J.D.

Executive Vice-Chancellor
State University of New York
99 Washington Avenue
Albany, New York 12210

Dr. Marian KOSHLAND
Professor of Bacteriology
and Immunology

Department of Molecular Biology
University of California
Berkeley, California 94720

Mr. Alan LADWIG

President, Forum for the Advancement of
Students in Science and Technology
1785 Massachusetts Avenue, N.W.
Washington, D.C. 20038

MARTINEZ, Rebecca (Student)

University of New Mexico
School of Medicine
Albuquerque, New Mexico 87131

Dr. Joseph MELNICK
Professor of Virology
Baylor University
Houston, Texas 77025

1-5

[25]

MULLER-EBERHARD, Hans J. , M.D.
Chairman, Department of
Molecular Immunology
Scripps Clinic and Research Foundation
La Jolla, California 92037

NEEL, James V., M.D.

Lee R. Dice University Professor
of Human Genetics
Medical School
University of Michigan
Ann Arbor, Michigan 48104

PETERSDORF, Robert G. , M.D.

Chairman, Department of Medicine
University of Washington
School of Medicine
Seattle, Washington 98103

Mrs. Esther PETERSON
President

The National Consumers League
P.0. Box 1804
Washington, D.C. 20013

ROSENBLITH, Walter A., Professor
Provost

Massachusetts Institute of Technology
Cambridge, Massachusetts 02139

Dr. Margery SHAW

Director, Medical Genetics Center
6420 Lamar Fleming Boulevard
Houston, Texas 77025

SINKFORD, Jeanne, Ph.D., D.D.S.

Dean, College of Dentistry
Department of Restorative Dentistry
Howard University
600 W Street, N.W.

Washington, D.C. 20059

Dr. Maxine SINGER
Director

Office of Research Safety
National Cancer Institute, NIH
Bethesda, Maryland 20014

Dr. Robert SINSHEIMER
Chairman, Division of Biology
California Institute of Technology
Pasadena, California 91109

The Honorable David L. Bazelon
Chief Judge

United States Court of Appeals for
the District of Columbia Circuit
Washington, D.C. 20001

SPRAGUE, Charles C., M.D.

President, Health Science Center
University of Texas
Dallas, Texas 75235

STEVENS, Victoria (student)

The University of Arizona
Arizona Medical Center
Tucson, Arizona 85724

STURGIS, Katharine R., M.D.

349 Wister Road

Wynnewood, Pennsylvania 19096

UDENFRIEND, Sidney, Ph.D.

Director

Roche Institute of Molecular Biology
Nutley, New Jersey 07110

Dr. LeRoy WALTERS
Director, Center for Bioethics
Kennedy Institute
Georgetown University
Washington, D.C. 20007

Dr. Milton ZAITLIN
Professor

Department of Plant Pathology
Cornell University
Ithaca, New York 14853

1-6

[26]

ADDRESSEES FROM PRIVATE INDUSTRY

Dr. Lacy Overby

Director, Experimental Biology
Abbott Laboratories

Dr. Richard Donovick
Director

American Type Culture Collection

Mr. Robert Carov
Association of American Medical
Colleges

Dr. James J. Burchall

Head, Department of Microbiology

Burroughs Wellcome

Ronald Cape, Ph.D.

President
Cetus Corporation

Dr. Karl J. Brunings
Vice President
Pharmaceutical Division
Ciba-Geigy Corporation

Dr. D. J. Kilian
Regional Director
Occupational Health and Medical
Research for Dow, U.S. Area
Dow Chemical Company

Dr. C. C. McDonald
Research Supervisor
Central Research and Development
Department
Dupont Company

Dr. John F. Brown, Jr.

Manager, Life Sciences Branth
GE Corporate Research & Development
General Electric Company

Dr. Louis G. Nlckell
Vice President

BioProducts Research Department
W. R. Grace & Company

W. Vem Hartwell, Ph.D.

Environmental Health Specialist
Office of Environmental Affairs
Department of Commerce 1-7

Dr. Cornelius W. Pettinga
Executive Vice President
Eli Lilly & Company

Mr. T. Milton Freifield
Assistant Technical Director,
Occupational Health
Manufacturing Chemists Assoc., Inc.

Dr. Jerome Birnbaum
Executive Director
Basic Biological Sciences
Merck & Co. , Inc.

Dr. Robert Erickson
Department of Science Information
and Communication Services
Miles Laboratories

Dr. Elena Nightingale
National Academy of Sciences

Dr. Thomas B. Rice and
Mr. Philip Gordon
Agricultural Research Program
Pfizer, Inc.

John G. Adams, Ph.D.

Vice President, Scientific and
Professional Relations
Pharmaceutical Manufacturing Assoc.

Ann-Marie Skalka, Ph.D.

Cell Biology

Roche Institute of Molecular Biology

Harry Green, Ph.D.

Director of Science Liaison
Smith, Kline and French Laboratories

Joe Grady, Ph.D.

The Upjohn Company

Dr. Mark Levner
Biological and Chemical
Development Division
Wyeth Laboratories

[27 J

WITNESSES WHO TESTIFIED AT
MEETING OF FEBRUARY 9-10, 1976, AND
WHO RECEIVED A COPY OF THE SAMPLE LETTER

Dr. David Baltimore
Massachusetts Institute of
Technology

Dr. Donald Brown
Carnegie Institution of
Washington

Dr. Marshall Edgell
University of North Carolina

Dr. Richard Goldstein
Harvard University

Mr. Charles Madansky
Harvard University

Dr. John Sedat
Yale University

Dr. Allen S. Silverstone
Massachusetts Institute of
Technology

Mr. Daniel M. Singer
Fred, Frank, Harris, Shriver
and Kampelman

Dr. Stephen Wiesenfeld
National Jewish Hospital
and Research Center

Dr. Susan Wright
University of Michigan

Dr. Burke Zimmerman
Environmental Defense Fund

1-8

[28]

RE00M3INANT DMA MOLECULE PROGRAM ADVISORY COttUTTEE

CHAIRMAN

1976

VICE CHAIRMAN

STTITEN, DeKitt, Jr., M.D. , Ph.D.
Deputy Director for Science
Office of the Director
National Institutes of Health
Bethcsda, Maryland 20014

JACOBS , Leon, Ph.D.

Associate Director for
Collaborative Research
Office of the Director
National Institutes of Health
Be the sd a , Maryland 20014

EXECUTIVE SECRETARY

CARTLAND, Williao J, Jr., Ph.D.

Director

Office of Recombinant D«A Activities
National Institute of General Medical Sciences
National Institutes of Health
Bethesda, Maryland 20014

ADELBERG, Edward A., Ph.D.

Professor

Department of Hunan Genetics

School of Medicine

Yale University

New Haven, Connecticut 06S10

CURTISS, ROY. Ill, Wi.D.

Professor

Depot Unent of Microbiology
School of Medicine
University of Alabama
Birmingham, Alabama 35294

DWbJEIX, James E., Jr., M.D.

Professor

Department of Molecular Cell Biology
Itockefcllcr University
New York, New York 10021

DAY, Peter R. , Ph.D.

Chief

Division of Genetics
Connecticut Agricultural
Experiment Station
New Haven, Connecticut 06504

BEUNSKI, Donald R. . Ph.D.

Professor

Department of Biology
University of California, San Diego
La Jolla, California 92037

B0CNESS, David S., Ph.D.

Professor

Department of Biochemistry
Stanford University
Stanford, California 94305

LITTLEFIELD, John W. , M.D.

Professor 6 Chairman
Department of Pediatrics
Children's Medical t Surgical Center
Johns Hopkins Hospital
Baltimore, Maryland 21204

REDPDRD, Rr-ette S., Ph.D., LL.D.
Ashbcl Sbith Professor of

Government and Public Affairs
Lyndcn B. Johnson School of
Public Affairs

Univcrirty of Texas at Austin
Austin, Texas 78712

RC*\E, Wallace P. , M.D.

Chief, Laboratory of Viral Diseases
National Institute of Allergy &
Infectious Diseases
National Institutes of Health
Bethesda, Maryland 20014

SETLDW, Jane K. , Ph.D.

Biologist

Brookhavcn National Laboratory
l**on. Long Island, New York 11973

SPIZIZEN, John, Ph.D.

Hotter and Chairman
Department of Microbiology
Scripps Clinic t Research Foundation
La Jolla, California 92037

SZYBALSKJ , Waclaw, D.Sc.

Professor of Oncology
McArdle Laboratory
University of Wisconsin
Madison, Wisconsin 53706
608 262-1259

RHTER, El ixabeth M. , Ph.D.

Member of the Faculty
in Biophysics

The Evergreen State College
Olympia, Washington 98505
206 866-6719

1-9

[29]

RECOMBINANT DNA MOLECULE PROGRAM ADVISORY COMMITTEE
LIAISON REPRESENTATIVES

HEDRICH, Richard, Ph.D.

Coordination Program of Science
Technology & Human Value
National Endowment for the Humanities
Washington, D.C. 20506
202 389-6808

LEWIS , Herman W. , Ph.D.

Division of Biological and
Medical Sciences
National Science Foundation
Washington, D.C. 20418
202 632-4200

NIGOTINGALE, ELENA O. , Ph.D.
Assembly of Life Sciences
National Academy of Sciences
Washington, D.E. 20418
202 389-6807

SHEPHERD, George, R. , Ph.D.
Division of Biomedical and
Environmental Research
Energy Research and Development
Administration
Washington, D.C. 20545
301 973-5037

Appendix II

INSTITUTIONAL PAT2NT AGREEMENT
GOVERNING GRANTS AND AWARDS FROM THE
DEPARTMENT OF HEALTH , EDUCATION, AND WELFARE

This Agreement, made and entered into this day of

, 19 , by and between the United

States of America, as represented by the Assistant Secretary
(Health and Scientific Affairs) of the Department of Health,
Education, and Welfare, hereinafter sometimes referred to as
the Grantor, and

hereinafter referred to as the Grantee.

WITNESSETH:

WHEREAS, the Regulations of the Department of Health,
Education, and welfare, covering inventions resulting from
research grants, fellowship awards, and contracts for research
(45 CFR Parts 6 and 8), provide in Secs. 8.1 through 8.5 that
upon approval by the Assistant Secretary (Health and Scientific
Affairs), the ownership and disposition of domestic and foreign
rights to inventions arising out of activities assisted by
grants and awards may be left to the Grantee pursuant to its
approved established patent policy, with such modifications
as may be agreed upon; and

WHEREAS, the Grantee is desirous of entering into an
agreement whereby it has a first option to retain principal
rights in and to administer inventions made in the course of
or under research supported by grants and awards from the
Department of Health, Education, and Welfare, pursuant to the
aforesaid Regulations; and

WHEREAS, the Assistant Secretary (Health and Scientific
Affairs) has reviewed the patent policy of the Grantee as
set forth in

and its practices thereunder and has found them to be acceptable,
subject to the provisions of this Agreement, and that said

II-l

[31]

policy provides for administration by the Grantee of patents
in the public interest and i3 consistent with the stated ob-
jectives of the president's Statement and Memorandum of
Government Patent Policy, issued October 10, 1963;

NOW, THEREFORE, in consideration of the foregoing, the
parties hereto agree as follows:

I . Scope of Agreement

This Agreement shall define the rights of the parties
hereto regarding disposition of title to inventions made in
the course of or under research supported by grants and awards
from the Department of Health, Education, and welfare, which
are subject to the Department Patent Regulations and are
issued after the date hereof.

II . Definitions

(a) The terra "subject invention" as used in this
Agreement means any process, machine, manuf acture , composition
of matter or design, or any new or useful improvement thereof,
and any variety of plant which is or may be patentable under
the patent Laws of the united States made in the course of or
under research supported by grants and awards from the Depart-
ment of Health, Education, and welfare.

(b) The term "made" when used in relation to any in-
vention or discovery means its conception or first actual
reduction to practice .

III. Disposition of Principal Rights to Subject Inventions

The Grantee shall have the right to elect to file patent
application in the united States and in foreign countries on
any subject invention and to administer such invention pursuant
to the provisions of this Agreement. Grantee shall notify
Grantor at the time each subject invention is reported to
Grantor as required by paragraph V hereof, if it intends to
file patent application ( s) on and to administer the invention.
If Grantee does not elect to file a U.S. patent application on
and to administer a subject invention, it shall notify Grantor
in sufficient time to permit Grantor to file a U.S. patent

II-2

[32]

application thereon. In such event, all rights in and to
such invention, except rights in any foreign patent applica-
tion filed by Grantee, shall be subject to disposition by the
Grantor in accordance with its Regulations then in effect.

IV. Supplementary Patent Agreements

(a) The Gxantee shall obtain patent agreements from all
persons who perform any part of the work under a grant or
award from the Department of Health, Education, and Welfare,
exclusive of clerical and manual labor personnel, requiring
that such persons promptly report and assign all subject in-
ventions to Grantee or its approved patent management organiza-
tion .

(b) The Grantee shall include the following provision
in any contract it enters into involving research and/or
development for which DHEW research grant or award fund3 are
utilized .

“The Contractor hereby agrees to report fully and

promptly to

(Grantee )

any invention conceived or first actually reduced
to practice in performance of this contract (herein
after referred to as "such invention ( s) " , and to
assign all right, title and interest in and to such

invention to

(Grantee )

or its designee.

“In addition, the Contractor agrees to furnish the
following materials, disclosures and reports:

' (i) Upon request, such duly executed instruments

(Prepared by the

(Grantee)

or its designee) and such other papers as are

deemed necessary to vest in the

or its designee the

(Grantee)

rights granted under this clause and to enable the

or its

(Grantee)

II-3

(33)

designee to apply for and prosecute any patent
application, in any country, covering such
invention .

' (ii) Interim reports on the first anniversary of
this contract where extended or renewed and every
year thereafter listing all such inventions made
during the period whether or not previously re-
ported or certifying that no inventions were
conceived or first actually reduced to practice
during the applicable period.

' (iii) Prior to final settlement of this contract,
a final report listing all such inventions, in-
cluding all those previously listed in interim
reports, or certifying that no inventions were
conceived or first actually reduced to practice
under the contract . • "

V. Report of Invention

(a) The Grantee shall submit a written invention report
to the Grantor of each subject invention promptly after con-
ception or first actual reduction to practice.

(b) Such invention report shall be furnished directly
to the Grantor in addition to any other requirement under

any grant or award for the submission of progress or financial
reports, and whether or not reference to subject invention has
been made in any progress or other report furnished to the
Grantor; such report shall include description of such in-
vention, appropriately illustrated by a simple sketch or
diagram, to permit the invention to be understood and evaluated,
and such other information as Grantor may require.

(c) The report shall specify whether or not Grantee
intends to file a U.S. patent application or any foreign
patent application on the invention. Notice of an election
not to file a U.S. patent application shall be given Grantor
not less than ninety (90) days prior to the date a statutory
bar becomes effective.

II-4

[34]

(d) If the Grantee specifies that no U.S. patent
application will be filed (or having specified that it
intends to file, thereafter notifies the Grantor to the
contrary), the Grantee ohall promptly inform the Grantor
of the date and identification of any known publication of
subject invention made by or known to the Grantee or, where
applicable, of any contemplated publication to be made by
or known to the Grantee, and also the date subject invention
or any embodiment thereof was first in public use or on sale
in the united States and shall furnish such other information
(and have executed such documents as provided in VIII (f) as
may be required to enable the Grantor to make disposition of
subject invention rights) .

VI . Administration of Inventions on '^hich the Grantee

Elects to File Patent Applications

(a) The Grantee shall require assignment to it of all
right, title and interest in and to each subject invention
on which it elects to file any patent application for ad-
ministration by it in accordance with and subject to the
terms and conditions herein set forth; Assignments from the
inventor to the Grantee under U.S. patent applications shall
be promptly obtained and recorded by the Grantee in the
United States Patent Office, and copies of the recorded
assignment shall be furnished to the Grantor.

(b) The Grantee shall grant to the Government of the
United States a nonexclusive, irrevocable, royalty-free
license for governmental purposes and on behalf of any foreign
government, pursuant to any existing or future treaty or agree-
ment with the united States under each U.S. or foreign patent
application it elects to file on a subject invention. The
form of the license to be granted shall be as set forth in
Exhibit "A" attached hereto, and by this reference made a

part hereof. Any license issued by Grantee shall be made
expressly subject to the license to the Government of the
United States.

(c) The Grantee shall administer those subject inventions
to which it elects to retain tiile in the public interest and

II-5

[35]

shall, except as provided in paragraph (d) below, make them
available through licensing on a nonexclusive, royalty-free
or reasonable royalty basis to qualified applicants.

(d) The Grantee may license a subject invention on an
exclusive basis if it determines that nonexclusive licensing
will not be effective in bringing such inventions to the
commercial market in a satisfactory manner. Exclusive
licenses should be issued only after reasonable efforts
have been made to license on a nonexclusive basis, or where
the grantee ha3 determined that an exclusive license is
necessary as an incentive for development of the invention
or where market conditions are such as to require licensing
on an exclusive basis. Any exclusive license issued by
Grantee under a U.S. patent or patent application shall be
for a limited period of time and such period shall not,
unless otherwise approved by the Assistant Secretary (Health
and Scientific Affairs) , exceed three years from the date of
the first commercial sale in the united States of America of
a product or process embodying the invention, or eight years
from the date of the exclusive license, whichever occurs
first, provided that the licensee 3hall use all reasonable
effort to effect introduction into the commercial market as
soon as practicable, consistent with sound and reasonable
business practices and judgment. Any extension of the
maximum period of exclusivity shall be subject to approval

of the Grantor. Upon expiration of the period of exclusivity
or any extension thereof, licenses shall be offered to all
qualified applicants at a reasonable royalty rate not in
excess of the exclusive license royalty rate.

(e) Any license granted by the Grantee to other than
the Government of the United States under any patent applica-
tion or patent on a subject invention shall include adequate
safeguards against unreasonable royalty and repressive
practices. Royalties shall not, in any event, be in excess
of normal trade practice. Such license shall also provide
that all sales to the U.S. Government shall be royalty free.

II-6

[36]

(f) If permitted by its patent policies and the terms
of the grant or award under wnich an invention is made, the
Grantee may share royalties received with the inventor (s),
provided that the Grantee 3hall not pay the inventor (s) more
than (1) fifty percent (50%) of the first $3,000 gross
royalty paid under the patent, (2) twenty-five percent (25%)
of the gross royalty income between $3,000 and '$13,000, and
(3) fifteen percent (15%) of the gross royalty in excess of
$13,000. The balance of the royalty income after payment of
expenses incident tc the administration of all inventions
assigned to it pursuant to the provisions of this Agreement
shall be utilized for the support of educational and research
pursuits .

(g) All licenses issued by the Grantee to other than
the Government of the united States under any patent applica-
tion or patent on a subject invention shall be subject to
the conditions of this Agreement and shall specifically
reserve to Grantor those rights specified in paragraph XII
hereof. The Grantee shall, upon request, promptly furnish
copies of any license agreements entered into by it to the
Department.

VII. Patent Management Organizations

The Grantee shall not assign any subject invention to
parties other than the Grantor in circumstances as set forth
in this Agreement except it may assign rights in the invention
to a nonprofit patent management organization, provided that
the patent administration agreement between such organization
and Grantee is approved by the Grantor. Any reference to a
Grantee in this Agreement shall also include a patent manage-
ment organization when applicable and an assignment to such
an organization shall be subject to all the terms and condi-
tions of this Agreement.

VIII. Patent Applications

(a) Grantee shall promptly furnish Grantor with a copy
of each U.S. patent application filed in accordance with this
Agreement specifying the filing date and the serial number.
Grantee shall promptly notify Grantor of each foreign patent
application filed, including filing date and serial number,
and shall furnish a copy of each application upon request.

1 1— 7
[37]

(b) Upon request, Grantee shall fully advise the
Grantor concerning all 3teps and actions taken during the
prosecution of any patent application covering a subject
invention and shall, upon request, furnish copies of any
final actions, amendments, petitions, motions, appeals or
other papers relating to the prosecution of said application.

(c) Upon request, the Grantee shall promptly furnish
to the Grantor an irrevocable power of attorney granting the
right to inspect and make copies of any patent application
covering a subject invention or any of the final actions,
amendments, petitions, motions, appeals, or other papers
relating to the prosecution of said application.

(d) The Grantee shall include the following statement
in the first paragraph of the specification following the
abstract of any patent application filed on a subject
invention;

"The invention described herein was made in the
course of work under a grant or award from the
Department of Health, Education, and welfare."

(e) The Grantee shall not abandon any U.S. patent
application filed on a subject invention without first
offering to transfer all rights oln and to 3uch application
to the Grantor not less than forty- five (45) days prior to
the date a reply to the patent Office action is due. If
the Grantor does not request assignment within thirty (30)
days of receipt of this offer, the Grantee may permit the
application to go abandoned.

(f) If the Grantee elects to file no patent application
or to abandon prosecution of a U.S. patent application on a
subject invention, he shall, upon request, execute instru-
ments or require the execution of instruments (prepared by
the Grantor) and such other papers as are deemed necessary

to vest in the Grantor all right, title and interest in the
subject invention to enable the Grantor to apply for and
prosecute patent applications in any country.

II-8

[38]

IX. Invention Report3 and Certifications

Notwithstanding the provisions of this Agreement, the
Grantee shall provide invention reports and certifications
as may be required by the terms of any grant or award.

X. Disclosure and Publication

The Grantee shall not bar or prohibit publication of
disclosures of inventions on which patent applications have
been filed.

The Grantor shall have the right to publish and make
disclosure of any information relating to any subject in-
vention whenever deemed to be in the public interest, pro-
vided that upon request, reasonable opportunity shall be
afforded the Grantee to file U.S. and foreign patent
applications .

XI . Reports on Development and Commercial Use

The Grantee shall provide a written annual report to the
Department on or before September 30 of each year covering
the preceding year, ending June 30, regarding the development
and commercial use that is being made or intended to be made
of all subject inventions left for administration by the
Grantee. Such reports shall include information regarding
development, the date of first commercial sale, gross sales
by licensees, gross royalties received by the Grantee, and
such other data and information as the Department may specify.

XII. Additional Licenses

(a) The Grantee agrees that if it, or its licensee,
has not taken effective steps within three years after a
United States patent issues on a subject invention left for
administration to the Grantee to bring that invention to the
point of practical application, and has not made such invention
available for licensing royalty-free or on terms that are
reasonable in the circumstances, and cannot show cause why he
should retain all right, title and interest for a further
period of time, the Grantor shall have the right to require

II-9

[39]

(1) assignment of 3aid patent to the united States, as
represented by the Grantor, (2) cancellation of any out-
standing exclusive licenses under said patent; or (3) the
granting of licenses under said patent to an applicant on
a nonexclusive, royalty-free basis or on terms that are
reasonable in the circumstances.

(b) The Grantor reserves the right to license or
to require the licensing of other persons under any U.S.
patent or U.S. patent application filed by the Grantee
on a subject invention on a royalty- free basis or on terns
that are reasonable in the circumstances, upon a deter-
mination by the Assistant Secretary (Health and Scientific
Affairs) that the invention is required for public use by
governmental regulations, that the public health, safety,
or welfare requires the issuance of suen licenee(s), or
that the public interest would otherwise suffer unless
such license (s) ware granted. The Grantee and its
licensees shall be given written notice of any proposed
determination pursuant to this subparagraph not less
than thirty (30) days prior to the effective date of
such determination, and that if requested, shall be
granted a hearing before the determination is issued and
otherwise made effective.

XIII. Inventions by Federal Employees

Notwithstanding any provision contained in this
Agreement, inventions made by Federal employees, or by
Federal employees jointly with others, shall be subject
to disposition under provisions of Executive Orders,
Governmental and Department Regulations applicable to
Federal employees .

XIV. Termination

This Agreement may be terminated by either party
for convenience upon thirty (30) days written notice.
Disposition of rights in, and administration of inventions

11-10

[40]

made under grants or awards entered into during and
subject to thi3 Agreement will not be affected by such
a termination except that in the event the Department
terminates this Agreement because of a failure or re-
fusal by Grantee to comply with its obligations under
Articles V or VI of this Agreement, the Department shall
have the right to require that the Grantee's entire
right, title and interest in and to the particular in-
vention with respect to which the breach occurred be
assigned to the united States of America, as represented
by the Secretary of the Department cf Health, Education,
and welfare.

XV. Limitation

It is agreed and understood that this Agreement
shall not apply to any grants or awards iesued under
statutes containing requirements for disposition of
invention rights with which the provisions of this
Agreement are inconsistent. It is further agreed, that
any constituent agency of the Department of Health,
Education, and welfare may, with the approval of the
Assistant Secretary (Health and Scientific Affairs),
provide as a condition of any grant or award that
this Agreement shall not apply thereto. It is also
agreed that any constituent agency of the Department
of Health, Education, and Welfare may provide, subject
to approval by the Assistant secretary (Health and
Scientific Affairs), that this Agreement shall apply
to specific research contracts.

IN WITNESS WHEREOP, each of the parties hereto

11-11

(41)

has executed this Agreement as of the day and year first
above written.

UNITED STATES OF AMERICA

By

Title

(GRANTEE)

(Corporate Seal) By

Title

CERTIFICATE

I, , certify that I

am the secretary of

named above; that ,

who signed this Agreement on behalf of said corporation was

then of said corporation? and

that this Agreement wa3 duly signed for and in behalf of said
corporation by authority of its governing body and is within
the scope of its corporate powers.

Witness ray hand and the seal of said corporation this
day of , 19 .

(Corporate seal) By

11-12

[42]

EXHIBIT "A

LICENSE TO THE UNITED STATES GOVERNMENT

WHEREAS,

(Inventor)

invented

( Invention)

filed a patent application thereon in

(Country)

bearing Serial No. , filing dato

and

of

, has
, and

+++ >

WHEREAS, the invention waa made in the course of research
supported by grant (o) from the Department of Health, Education,

and Welfare; and

WHEREAS, the United States Government is entitled to certain
rights in and to said invention and application by reason of the
terms of said grant(s); and

WHEREAS, the ,

( Institution)

hereinafter called the "Licensor" hao acquired by assignment
from the inventor the entire right, title, and interest of the
inventor to such invention;

NOW, THEREFORE:

1. The Licensor, in consideration of the premises and other
good and valuable consideration, hereby grants and conveys to
the united States Government a royalty-free, nonexclusive and
irrevocable license for governmental purposes and on behalf
of any foreign government pursuant to any existing or future
treaty or agreement with the united States under the aforesaid
patent application, and any and all divisions or continuations,
and in any and all patents or reissues which may be granted
thereon during the full term or terras thereof. As used herein,
•governmental purpose" means the right of the Government of
the united States (including any agency thereof, state or

11-13

[A3]

EXHIBIT "A

domestic municipal government) to practice and have practiced
(made or have made, used or have used, sold or have sold)
throughout the world by or on behalf of the Government of the
United States.

2. The Licensor covenants and warrants that he has the right
to grant the foregoing license, and that any assignment or
license which he may make of the invention or the said patent
applications or patents thereon, shall expressly be made
subject to this license.

3 . The Licensor agrees that the Government shall not be
estopped at any time to contest the enforceability, validity,
scope of, or title to, any patent or patent application herein
licensed.

(Institution)

(Signature)

(Print or type name)

Date

(Official Title)

CERTIFICATE

I* , certify

that I am the

of the institution named as Licensor herein; that

, who signed this

License on behalf of the institution is

of said Institution; and that said License was duly signed
for and in behalf of said institution by authority of its
governing body, and is within the scope of its corporate powers.

11-14

[44]

Appendix III

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH
JUNE 1977

DEPARTMENT OF AGRICULTURE

Dr. James Nielson

Deputy Assistant Secretary for

Conservation, Research, and Education
U.S. Department of Agriculture
Washington, D.C. 20230

Charles F. Lewis, Ph.D. (Alt.)
Staff Scientist

Plant snd Entomological Sciences
National Program Staff, AVS, USDA
B ARC- Vest

Bcltsville, Maryland 20705

Dr. Clarence 0. Grogan (Alt.)
Principal Agronomist
Conservation, Research, ard Education
U.S. Department of Agri:ulture
Washington, D.C. 202o0

DEPARTMENT OK COMMERCE

Jordan J. Baruch, Sc. I.
Assistant Secretary of Commerce
for Science and Technology
U.S. Department of Comnerce
Washington, D.C. 20’30

DEPARTMENT OF DEFENSE

Dr. Samuel Koslov
Special Assistant fo*" Science
Office of the Assistant Secretary
of Navy (Research and Development)
Room 4E741, Pentagon
Washington, D.C. 2O?50

William R. Beisel, M.D.

Scientific Adviser

U.S. Army Medical Research Institute
of Infectious Diseases
Ft. Detrick

Frederick, Maryland 21701

III-l

DEPARTMENT OF HEALTH, EDUCATION,
AND WELFARE

Ms. Malian Mlay
Director

Office of Policy Development
and Planning, H
Parklavn Building, Room 17A-07
Rockville, Maryland 20852

CENTER FOR DISEASE CONTROL

John H. Richardson, D.V.M.
Director

Office of Biosafety
Center for Disease Control
Atlanta, Georgia 30333

John F. Finklea, M.D.

Director

National Institute for Occupational
Safety and Health
Parklavm Building, Room 3-30
RocJn ille, Maryland 20852

FOOD AN) DRUG ADMINISTRATION

Robert L. Elder, Sc.D.

Deputy Associate Commissioner
for Science

Fooc nnd Drug Administration
Park) aw i Building, Room 14-57
Rockville, Maryland 20852

Rosa M. Gryder, Ph.D. (Alt.)
Staff Science Advisor
Office of Science
Food and Drug Administration
Park avr. T>uilding, Room 7-83
Rockville, Maryland 20852

145]

FOOD AND DRUG ADMINISTRATION (Ccnt'd)

John C. Petricciani, M.D.

Deputy Director
Division of Pathology
Bureau of Biologies, FDA
NIH Building 29, Room 1)14
Bethesda, Maryland 23014

DEPARTMENT OF STATE (Cont’d)

Mr. William J. Walsh III

Science Officer

OES/APT/BMP

Department of State

2201 C Street, N.N1., Room 4333

Washington, D.C. 20520

DEPARTMENT OF INTERIOR

Mariano Pimentel, M.D.

Medical Director

Department of Interior

18th and C Streets, N.N., Room 7045

Washington, D.C. 20240

DEPARTMENT OF TRANSPORTATION

Mr. Douglas A. Crockett
Department of Transportation
Trms Point Building, Room 6222
2100 Second Street, S.W.
Washington, D.C. 20590

DEPARTMENT OF JUSTICE

Mr. Anthony Liotta
Deputy Assistant Attorney General
Land and Natural Resources Division
Department of Justice
Washington, D.C. 20530

DEPARTMENT OF LABOR

Eula Bingham, Ph.D.

Assistant Secretary for

Occupational Safety end Health
Department of Labor
Washington, D.C. 20210

ENERGY RESEARCH AND DEVELOPMENT
ADMINISTRATION

James L. Liverman, Ph.D.
Assistant Administrator for
Environment and Safety
Energy Research and Development
Adminis tration
Washington, D.C. 20545

Charles E. Carter, M.D. (Alt.)
Manager, Biomedical Programs
Division of Biomedical and
Environmental Research
Energy Research and Development
Administration
Washington, D.C. 20545

Oswald H. Ganiev, Ph.D.

Deputy Assistant Secretary for

Advanced and Applied Technology Affairs
Department of State
2201 C Street, N.W , Room 4327
Washington, D.C. 20520

Walter H. Weyzen, M.D. (Alt.)
Manager, Human Health Studies
Program

Division of Biomedical and
Environmental Research
Energy Research and Development
Administration
Washington, D.C. 20545

III-2

[46]

ENVIRONMENTAL PROTECTION AGENCY

Delbert S. Barth, Ph.D.

Deputy Assistant Administrator for
Health and Ecological" Effects
Environmental Protectirn Agency
401 M Street, S.W.

Washington, D.C. 204 SO

Lawrence A. Plumlee, M.D. (Alt.)

Medical Adviser

Office of Principal Science Adviser, ORD
Environmental Protection Agency
Washington, D.C. 204(0

EXECUTIVE OFFICE OF THE PRESIDENT

Gilbert S. Omenn, M.D.. Ph.D.

Assistant Director for Human Resources
Office of Science and Technology Policy
Old Executive Office Building, Room 360
Washington, D.C. 20500

Mr. David A. Katcher (Alt.)

Office of Science and Technology Policy
New Executive Office Bldg., Room 3026
17th St. and Pennsylvania Avenue
Washington, D.C. 205C0

Warren R. Muir, Ph.D.

Senior Staff Member for
Environmental Health
Council on Environmental Quality
722 Jackson Place, N.W.
Washington, D.C. 20006

CHAIRMAN OF THE COMMITTEE

Donald S. Fredrickson, M.D.
Director

National Institutes of Health
Bethesda, Maryland 2U014

III

NATIONAL AERONAUTICS AND SPACE'
ADMINISTRATION

David L. Winter, M.D.

Direr tor for Life Sciences
National Aeronautics and Space
Administration
Washington, D.C. 20546

NATIONAL SCIENCE FOUNDATION

Herman W. Lewis, Ph.D.

Section Head of Cellular Biology-
Division of Physiology, Cellurlar,
and Molecular 3iology
?Iat ioual Science Foundation
Washington, D.C. 20550

Laurence Berlowitz, Ph.D.

Special Assistant to the
Assistant Director for Biological,
Behavioral, and Social Sciences
National Scien« Foundation
Lashing ton, D.C. 20550

U.S. ARMS CONTROL AND DISARMAMENT
AGENCY

Robert Mikulak, Ph.D.

Physical Science Officer
Nonnrof I iferation and Advanced
Technology Bureau, WTD
U.S. Anrs Control and
Disarmament Agency
Wasnington, D.C. 20451

VETERANS ADMINISTRATION

Jane S. Schultz, Ph.D.

Research Service
Veterans Administration
Central Office
810 Vermont Avenue, N.W.

Washington, D.C. 20420

EXECUTIVE SECRETARY OF THE COMMITTEE

Joseph C. Perpich, M.D., J.D.
Associate Director for Program
Planning and Evaluatior
National Institutes of Health
Bethesda, Maryland 20014

[47]

Sample letter to the NIH Recombinant DNA Molecule Program Advisory
Committee.5'

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
BETHESDA. MARYLAND 20014

August 27, 1976

Dear

As you may know, Stanford University and the University of
California have proceeded to file a patent application on a process
for forming recombinant DNA. This invention was generated in perform-
ance of an NIH grant. A number of other Universities, including the
University of Alabama, may also file patent applications on derivatives
of recombinant DNA research. Notwithstanding Stanford’s right to file
under the terms of a prior agreement with the Department, they have
solicited NIH's view on an appropriate plan for administration of this
invention. A copy of their letter on the matter is enclosed.

These patent activities, the certitude that other important
inventions in this field are forthcoming, and the public's apprehension
over control of recombinant DNA research compel inquiry into whether
the Department’s normal policy of allocating invention rights is
consonant with the concerns about this research or whether special
treatment would be more appropriate.

Invention rights are normally allocated in either of two ways
under Department patent regulations:

First, if a University or other nonprofit institution seeks to
enhance its technology transfer capability, the Department may enter
into an Institutional Patent Agreement (IPA) . This provides to the
institution the first option to ownership in all inventions made in
performance of Department research, subject to a number of conditions
deemed necessary to protect the public interest. Some of the more
important conditions are

(1) a royalty-free license permitting the Government and those
functioning under Government direction to practice the invention,

(2) a limit on the term of any exclusive license granted,

(3) Department authority to withdraw specified grants from the
agreement , and

(4) the right of the Department to regain ownership due to public
interest considerations or the institution’s failure to take
effective steps to commercialize the invention.

A more detailed outline of such conditions is enclosed.

* [Editor's note: Essentially the same letter was sent on September 7,

1976, to representatives of private industry and to witnesses who had
testified at the Director's Advisory Committee meeting on February 9-10,
1976.]

[48]

Stanford and the University of Alabama each hold one of the 65
IPA's now being administered by the Department.

Second, under grants and contracts with institutions having no
identified technology transfer capability, the Department utilizes a
provision deferring determination of ownership until an invention has
been made. Under the deferred determination provision, an innovating
institution may petition the Department for ownership of an invention
after it is identified. In the past, approximately 90 percent of all
such petitions have been granted on the basis of a satisfactory insti-
tution plan for development or licensing, subject, however, to conditions
similar to those contained in the Department's IPA's.

The Department's normal policy of allocating invention rights
is designed to facilitate the transfer of technology from the bench
to the marketplace, by assuring that the innovating institution has
the right to convey those intellectual property rights necessary to
induce Industrial Investment and continued development of inventions
generated with Department support. Only the IPA policy, however, assures
a management focal point in the innovating institution which is trained
to solicit and establish timely rights in Intellectual property prior
to invention.

We have been advised by the Department Patent Branch that 167
patent applications were filed from 1969 through the fall of 1974 under
IPA '8. Approximately $24 million is committed to the development of
inventions on the basis of licenses granted under these patent applica-
tions. Meanwhile, we are advised that the Department, under the deferred
determination provision, has granted 162 of the institutions' 178
petitions for ownership. Approximately $53 million was Invested or
committed to development under the licenses awarded. The commitment
of private risk capital in these Instances is viewed as evidence that
a licensable patent right is a primary factor in the successful transfer
of Department research results to Industry and the marketplace.

It indeed appears that the incentives provided by Department patent
policy have encouraged the development of new technology in general
and afforded patent protection for some inventions to the economic
benefit of the United States.

The control of DNA research envisioned by the guidelines, however,
requires a delicate balance between need for rapid exchange of informa-
tion unhampered by undue concern for patent rights and a potential for
achieving uniformity in safety practices through conditions of licensure
under patent agreements.

As noted, Stanford has indicated some willingness to consider
modification of their IPA as it relates to such research. There are a
number of possible policy options, short of the present allocation of
rights under the IPA, which could be considered for discussion with
Stanford and as possible alternatives to the present allocation of
rights made under all other IPA's. Some of these options are as follows:

(1) Institutions could be discouraged from filing patent applications
on inventions arising from recombinant DNA research. If this option
were pursued, publication would be relied on to cut off all possible
adverse patent claims.

(2) Institutions could be asked to file patent applications on inventions
arising from recombinant DNA research and to dedicate all issued patents
to the public. This would, to a greater extent than (1), block adverse
patent claims.

(3) Institutions could be asked to assign all inventions made in
performance of recombinant DNA research to the Department. The
Department as assignee of the invention could either pursue the
licensing of whatever patent applications were filed or dedicate
issued patents to the public.

(4) The Department could continue to permit institutions to exercise
their first option to ownership under the IPA but require that all
licensing of patented inventions be approved by the Department. The
Department could set certain conditions for approval, such as compliance
with the NIH guidelines on recombinant DNA research.

(5) The Department could permit institutions to retain their f j.rst
option as in (4), but approve only exclusive licenses. Here, as above,
the Department could set out conditions to account for the special
nature of recombinant DNA research, both in approved exclusive and non-
exclusive licenses.

If it is determined that institutions with IPA's should be
permitted to retain ownership of inventions arising from recombinant
DNA research, I am concerned about the effect of the processing of
patent applications on the dissemination of research information.

Under United States law, an inventor has a one-year period of grace
after research results are published in which to file in order to
obtain a valid United States patent. However, valid protection in a
number of foreign countries requires that a patent application be
filed prior to publication. If one publishes first, valid patent
protection cannot be obtained in such countries. Our patent people
believe that any necessary patent applications can be handled expedi-
tiously without an undue burden on disclosure. I am especially mindful

[50]

of your Conmittee's concern for the rapid dissemination of research
results in recombinant DNA research and would especially welcome your
thoughts on this matter. For example, would you view patent claims as
an impediment to the operation and functions of your Committee? What
experience, if any, have you or your colleagues or institution had
with patent claims in this regard?

I have asked Bill Gartland to assign about an hour on the agenda
of your meeting to review patent policy, and have asked Joe Perpich
and Norm Latker, the Department Patent Counsel, to attend the meeting
for this discussion.

I would appreciate your views on Department patent policy as
it relates to the conduct of your research, the operations of your
Committee, and the suggested policy options I have outlined above.

I Intend also to solicit advice on this matter from other Interested
parties in the scientific community and in the public and private
sectors .

Thank you very much for your consideration of this most important
matter .

Sincerely yours,

/s/ Donald S. Fredrickson, M.D.

Donald S. Fredrickson, M.D.

Director

3 Enclosures

[51]

LIST OF CORRESPONDENTS
ON DHEW PATENT POLICY

Name, Affiliation page

Baltimore, David

Massachusetts Institute of

Technology 80

Berg, Paul

Stanford University

Medical Center 90

Birnbaum, Jerome
Merck Institute for

Therapeutic Research 129

Bremer, Howard W.

Wisconsin Alumni

Research Foundation 72

Brown, Jr., John F.

General Electric Company 93

Brunings, K. J.

Ciba-Geigy Corporation 102

Callahan, Daniel

Institute of Society, Ethics

and the Life Sciences 135

Cape, Ronald E.

Cetus Corporation 94

Carow, Robert 99

Chernick, Cedric L.

University of Chicago 104

Dann, C. Marshall

Commissioner of Patents
and Trademarks, Department

of Commerce 138

Donovick, Richard

American Type Culture

Collection 75

[52]

Page

Erickson, Robert J.

Miles Laboratories, Inc 87

Fredrickson, Donald S.

Director, National

Institutes of Health 64

Green, Harry

Smith Kline & French

Laboratories 78

Gustafson, James M.

University of Chicago 81

Handler, Philip

President, National

Academy of Sciences 143

Hannaford, Jule M.

Dorsey, Windhorst,

Hannaford, Whitney

and Halladay 140

Hartwell, William V.

Department of Commerce 77

Herr, C. Harold

E.I. duPont de Nemours

and Company 131

Hubbard. Jr., W. N.

Upjohn Company 66

Hudson, R. D.

Parke, Davis and Company 84

Ihler, Garret M.

University of Pittsburgh 62

Kilian, D. J.

Dow Chemical U. S. A 119

LaFalce, The Hon. John J.

U. S. House of

Representatives 68

Larson, Charles F.

Industrial Research

Institute, Inc 147

[53]

Page

Levner, Mark H.

Wyeth Laboratories, Inc 134

Melnick, Joseph L.

Baylor College of

Medicine 86

Neel, James V.

University of Michigan

Medical School 89

Nightingale, Elena 0 105

Overby, L. R.

Abbott Laboratories 98, 149

Perpich, Joseph G.

National Institutes

of Health 69

Petersdorf, Robert G.

University of Washington 122

Peterson, Esther

Giant Food Inc 136

Pettinga, C. W.

Eli Lilly and Company 126

Reimers, Niels J.

Stanford University 71

Rosenzweig, Robert M.

Stanford University 56, 60, 65

Sherman, John F.

Association of American

Medical Colleges 142

Sinsheimer, Robert L.

California Institute

of Technology 74

Sprague, Charles C.

University of Texas Health

Science Center at Dallas 151

[54]

Page

Stetler, C. Joseph
Pharmaceutical
Manufactu rers

Association 106,152

Upham, John D.

American Patent

Law Association 145

Weisblat, D. I.

Upjohn Company 117

Woodrow, Raymond J.

Society of University

Patent Administrators 154

[55]

OFFICE MEMORANDUM • STANFORD UNIVERSITY • OFFICE MEMORANDUM • STANFORD UNIVERSITY • OFFICE MEMORANDUM

To

DatE: June 4, 1976

Those Interested in Recombinant DNA

From

Robert M. Rosenzweig '

Vice President for Public Affairs

Subject: Thoughts on the Patent Question

The proposal to seek patent protection for discoveries arising 3:
from research on recombining DNA has aroused at Stanford a range of 2
emotions that includes enthusiasm, dismay, and most of the stops z

in between. That this is so is not surprising, for Stanford scientists^
have been centrally involved in the research that produced the ability 2
to recombine DNA elements, in the public policy debate over the kinds •
of research that might safely be allowed to proceed and the safeguards ^
for any such research, and in the "invention" for which patent protec- >
tion is being sought. In a situation in which different points of £
view exist among individuals, and in which some individuals are 2

ambivalent or conflicted, it is especially important to define the
issues clearly. Dispute, if there is to be any, should be over real §
differences about real issues. The purpose of this memorandum is to <
state the issues as clearly as I am able to do it. I hope that reader s£
of it will help, by their comments, to add still greater clarity to 3
the discussion.

The Effect of Patents on the Conduct of Science

It is probably the case that most scholars have had a good
deal more experience with the use of copyrights than with
the use of patents. However, both devices are expressions
of a single purpose and are in fact authorized in a single
section of the Constitution:

[The Congress shall have power] . . .

To promote the progress of science and useful arts,
by securing for limited times to authors and inventors
the exclusive right to their respective writings and
discoveries; ... (Article I, Section 8)

An elaborate structure of copyrights, patents, licenses,
litigation, special courts, and so forth, has grown from
that spare statement. I cite it because it seems to me
useful to recall that the purpose of the Founders (and the
English law on which they built) in providing for patents,
was indistinguishable from one of the central purposes of
the university, "to promote the progress of science and the
useful arts."

s

o

JO

>

2

O

c

It is, perhaps, ironic that a major theme in the present
debate is the fear that if scientists are forced to think
about the patentability of their work, there will be an
unhealthy increase in secrecy and that the progress of science^

3

C

X

>

2

c-

c

3

[56]

Those Interested in Recombinant DNA
June 4, 1976
Page Two

which depends on prompt, free, and open communication will be
compromised. While the academic world is not without
experience in the use of patents, it is characteristically
without good evidence of the effects of their use. To state
the matter in the negative, though, I have seen no evidence
that the fairly common expectation of patentable inventions
that characterizes some areas of engineering or chemistry
has inhibited the progress of science in those areas or has
damaged openness and collegiality .

It could, of course, happen, and it is impossible to prove
that it will not happen in the biomedical sciences. It is
fair to observe, however, that other developments in recent
years have posed what night have been thought in prospect
to be serious threats to the openness of science — more
serious in fact than the patent system. For example, the
adoption of research funding based almost exclusively on
competitive applications to government agencies might have
led to the kind of secrecy that characterizes competition
for government contracts in business in industry. That it
has not is encouraging evidence of the strength of the
values that prevail in science and in academic institutions,
and it suggests that it is those values, rather than the
addition or subtraction of particular incentives, that will
determine the way science is conducted in the future

II Commercial Development and Basic Research

The report of the University of Michigan committee that
recommended that recombinant DNA research be permitted
under appropriate controls started by rejecting the notion
"that any and all such research should be permitted because
freedom of inquiry is an absolute freedom that must never
be abridged." Indeed, few people today would argue in
support of so extreme a statement of scientific freedom.

Perhaps the chief limiting factor, the one that is most
likely to generate a demand for controls, is the element
of risk. Some hazards are so great and so imminent as to
render the research that produces them unacceptable —
atmospheric nuclear explosions are such a case. In other
instances judgments must be made that balance the magnitude
and likeliness of risk against the size and probability cf
benefit. Nowhere in recent years has that balancing been
argued so publicly among scientists as in the debate over
the future of recombinant DNA research. To an outsider,
reading the literature of that debate, one fact stands out:
there would be no debate were it not for the enormous pro-
spective benefits that are predicted to accrue from continu-
ation of the research. Were it not for those benefits it
is highly unlikely that funding agencies would find it
politically possible to accept the degree of risk that is

[57]

Those Interested in Recombinant DNA
June 4, 1976
Page Three

inherent in the method. Indeed, public concern aside,
it seems likely that the balance of scientific judgment
would be quite different were not the prospect of benefit
both great and imminent.

If that assessment is correct, or even nearly so, then it
is essential to address squarely the nature of the. links
among research, development, and commercial exploitation.

It is not acceptable to justify taking the risks of pursu-
ing a line of research by pointing to its benefits unless
one is also willing to aid — or at least not inhibit — the
process of bringing those benefits to fruition. The ability
of a company to hold exclusive license for a long enough
period of time to justify the risk of investment in the
development of a product is an important part of that process.
The value of a patent is precisely to make such a license
possible. Those who argue that the patent-license process
has adverse consequences so severe as to bar its use, must
accept the responsibility of proposing feasible alternatives
to assure useful development, or face the prospect of inhib-
iting the very benefits that serve to justify the basic
research. The obligation seems to me inescapable.

Ill The University's Financial Condition

While I do not believe that personal profit is a base or
ignoble motive, it happens that no member of the Stanford
faculty stands to be enriched personally as a result of
this patent. The departments involved, the Medical School,
and the University would be the beneficiaries of success.

It is a fact that the financing of private universities is
more difficult now than at any time in recent memory and
that the most likely prediction for the future is that a
hard struggle will be required to maintain their quality.

I do not want to overstate the weight of this fact on the
matter at hand, but neither should it be ignored. Clearly,
there are things that we would not want Stanford to do ,
even though doing them might be profitable. To put the
point as precisely as I can, we cannot lightly discard the
possibility of significant income that is derived from
activity that is legal, ethical, and not destructive of
the values of the institution.

IV Conflict of Interest and Public Policy

As I indicated at the outset, the special force of the
patent question for Stanford comes from the fact that
Stanford scientists have been leaders both in the science
of recombinant DNA and the public policy of the subject.

A question of special moment, therefore, is whether their
future impact on public policy would be diminished by the

[58]

Those Interested in Recombinant DNA
June 4, 1976
Page Four

fact (or inferences from the fact) that Stanford stands
to gain from the commercial exploitation of the science.

Some of the individuals involved believe that that will
happen. Here, too, it is impossible to prove the negative.

In any event, their concerns must be taken seriously because
their ability to affect policy is a valuable asset to them
and to the University. Let me suggest some ways in which
the appearance of conflict of interest might be mitigated.

1. It is essential that the University be open about the
entire process. We should not try to hide our actions
or disguise our motives.

2. Before the decision is finally taken to press for
patent protection, the leaders of the most relevant
public agencies, e.g., NIH, the President's Science
Advisory Council, should be consulted. We should seek
their agreement that the decision is a proper one and
their willingness to say so publicly.

3. If the conduct of basic research carries safety hazards,
the conduct of commercial development programs will be
many-fold more dangerous. The restraints of government
regulation will be largely absent and the restraints

of peer pressure may well be overwhelmed by the pressure
to produce results. So far as I can tell, no serious
thought has yet been given to the development end of
the safety issue. Here, Stanford could make a genuine
contribution. We might consider, for example, the
establishment of a committee (not unlike the existing
Human Subjects Review Committees) consisting of
scientists and non-scientists and perhaps including
persons from outside the University. This committee
would review licensing proposals to evaluate the hazards
of the proposed line of development compared to the
likely benefits; it might also advise on laboratory
and testing precautions required in the conduct of the
work.

It is within our power, in short, to act to protect our
faculty's important role in public policy deliberations.
Guarantees are not possible, but reasonable assurances are.

We should see if those are obtainable.

This is an incomplete catalog of issues and arguments, but
it includes what seem to me the central ones. If I have missed some
important ones, they should be added; if my analysis of the issues is
defective, it should be corrected. It will be clear to readers by
now that my strong preference is to press for patent protection and a
responsible licensing program. However, if the reaction to our inquiries
suggests that a serious ^nd damaging perception of conflict of interest
would result from that course of action, then I would strongly urge
caution until safer (although undoubtedly less rewarding and effective)
mechanisms can be devised. 1 solicit the views of all who read this.

(59)

STANFORD UNIVERSITY

STANFORD, CALIFORNIA 94305

OFFICE OF THE VICE PRESIDENT
FOR PUBLIC AFFAIRS

June 18, 1976

Dr. Donald S. Frederickson
Director

National Institute of Health
Bethesda, Maryland

Dear Dr. Frederickson:

From Paul Berg and others I know that you are aware of the
discussions taking place at Stanford now over the wisdom of pro-
ceeding (on behalf of Stanford and the University of California)
with an application for patent protection for discoveries in the
area of Recombinant DNA. As you know, we began to move in this
direction with the knowledge and consent of NIH and NSF ; as you
also know, the whole matter of patent protection is now the subject
of lively debate here. The purpose of this letter is to solicit
your views.

As further background to what you already have, you might be
interested in the enclosed memorandum in which I have attempted
to summarize some of the major questions and address them in a way
that makes sense to me, at least. When I wrote this, I was speak-
ing for myself only, and I was not trying to articulate University
policy. From reactions I have received, I would guess that most
of the University's senior officers would agree with my conclusions
(though there is dissent), as do many, though not all, faculty.

One point on which there is substantial unanimity among the officers
of the University is that, if this line of work is to be developed
in a way that provides income to the holder of a patent, there is
no institution or group that has a stronger claim to that income
than Stanford and the University of California — using as the
standard for that judgment, the value of the money earned to the
future progress of scientific research and education.

Let me emphasize that we do not yet have conclusions. We are
proceeding with the necessary steps in the patent application
process and we have had discussions with a prospective licensee.

We have taken no irrevocable steps, but we are rapidly approaching
the stage at which binding decisions will need to be taken. By
that I mean not days, but perhaps a small number of months. Your
contribution to our deliberations would be extremely valuable. I
would especially welcome your views on the suggestions at the end
of my memorandum, but I do not want to limit you to those matters,
alone.

[60]

Dr. 'Donald S. Frederickson
June 18, 1976
Page Two

If you think it would be useful to discuss these questions
at greater length in person, I would be happy to go East, or if
you prefer, arrange a session here at Stanford or in San Francisco.
The issues we are dealing with are complex, interesting and
important, and the way they are resolved is likely to have a last-
ing effect on science and education. I think that is not too strong
a statement. I hope you agree and that we will have the benefit of
your views.

Enel .

cc: R.W. Lyman

W.F. Massy
C.Rich
P.Berg
S. Cohen

Robert M. RosenzweTg-«==J

Vice President £or Public Affairs

[61]

University of Pittsburgh

SCHOOL OF MEDICINE
Department of Biochemistry

June 30, 1976

Dr. Donald S. Fredrickson, Director
National Institutes of Health
Bethesda, Maryland

Dear Sir:

According to Nature magazine of June 24, 1976, a patent is being sought
by the University of California and Stanford University on the procedures
and ideas of genetic manipulation by recombinant DNA. The decisions
of the NIH and the Recombinant DNA Molecule Program Advisory
Committee may thus be short-circuited by placing legal control in the
hands of private rather than public institutions, a prospect which I
find alarming.

According to Nature, ". . . the patent is understood to be worded broadly
enough to cover commercial uses of any method of transporting genes
from one organism into another. 11 While I know very little about the
legal aspects of patents, it is my understanding that if an idea is common
knowledge, it cannot be patented. The idea of recombinant DNA dates
back many years before the 1973 and 1974 experiments of Cohen and
Boyer.

As evidence of this, in late 1967 or early 1968 I submitted a postdoctoral
grant application to the NIH, which was funded as I recall by General
Medical. This application was a proposal to create recombinant DNA
molecules by the use of terminal transferase to add A residues and T
residues to the fragmented half molecules of lambda and to a piece of
foreign DNA, to then anneal the fragments and to close the gaps with
polymerase and ligase to create a new viral DNA molecule containing
the foreign DNA.

This experiment was in fact never done by myself since Dean Rupp and I
became interested in the mechanism of replicative transfer of DNA
(Ihler and Rupp, PNAS 63, 138, 1969) which in turn ultimately led to my
devising a procedure for the isolation of the lactose gene by reverse
orientation (Shapiro jet al. , Nature 224, 768, 1969). This terminal
addition procedure however was successfully done by others several
years later.

[62]

PITTSBURGH, PA. 15261

Dr. DonaldS. Fredrickson
Page 2

June 30, 1976

If NIH should decide to contest the patent application with a view to
reserving for itself the responsibility of determining the appropriate
uses of recombinant DNA, this grant application (which should be
available from GM) should provide legal evidence that the idea of
genetic manipulation was in the common domain for several years
prior to the actual experimental success. I have, moreover, dis-
cussed the possibilities of genetic manipulation with students here
at the University of Pittsburgh every year since 1970, adding further
support to this idea.

Garret M. Ihler, Ph. D. , M. D.
Associate Professor of Biochemistry

[63]

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
BETHESDA. MARYLAND 20014

July 6, 1976

Mr. Robert M. Rosenzweig
Vice President for Public Affairs
Stanford University
Stanford, California 94305

Dear Mr. Rosenzweig:

I am writing in response to your letter of June 18. Dr. Joseph Perpich
has told me of his conversation with you concerning the patent issues
you raised in your letter and the accompanying memorandum. I appreciate
your concern and I recognize the importance of this matter. I have
been receiving letters from a number of interested parties on this
issue. Those who fear most the potential hazards in recombinant DNA
research are concerned about the impact of patents on defining potential
risks and hazards.

In light of the issues raised in your letter and in other letters sent
to me on this matter, I have undertaken a careful review of our patent
policies with respect to recombinant DNA research. I wish to assure
you, however — as Mr. Norman Latker, the patent counsel for the Depart-
ment of Health, Education, and Welfare, may already have told you —
in proceeding to obtain patents, Stanford has acted consistently within
the terms of the institutional agreement Stanford has with the Depart-
ment. I shall keep you informed of my policy review.

Sincerely yours,

/s/ Donald S. Fredrickson, M.D.

Donald S. Fredrickson, M.D.

Director

[64]

STANFORD UNIVERSITY

STANFORD. CALIFORNIA 9005

JFFTCE OF THE VKS P*£2DEVT

XX. IUBUC AFFAXU

July 9, 1976

Dr. Donald S. Fredrickson
Director

Public Health Service

National Institutes of Health

Department of Health, Education and Welfare

Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Thank you for your letter of July 6. I was pleased to know,
as indeed Dr. Perpich had told me, that you have begun a careful
review of patent policies with respect to recombinant DNA.

Everyone here at Stanford agrees with you about the importance
of the issues involved. It is for that reason, of course, that we
have taken some pains to consult fairly widely about the wisdom and
propriety of our proposed course of action and that we have held
off making irrevocable decisions until consultative processes had
a chance to work. Need I add, therefore, that we have a more than
ordinary interest in both the substance and the timing of your delib-
erations at NIH? Let me repeat my earlier offer to participate in
those deliberations, or to arrange for participation by others at
Stanford. Let me also urge that you act with both deliberation and
dispatch. While decisions here are not imminent, they are not all
that far away — in fairness to the people with whom we are dealing.

Finally, I appreciate your offer to keep me informed of the
progress of your policy review. I gladly accept the offer, and I
shall undertake to do the same with respect to developments here.

Robert M. Rosenzweig
Vice President

[65]

THE UPJOHN COMPANY

KALAMAZOO. MICHIGAN 49001
TELEPHONE (616) 382-4000

W N HUBBARD. JR M D
President

July 16, 1976

Dr. Donald S. Fredrickson, Director
National Institutes of Health
Bethesda , Md. 20014

Dear Don:

This letter is in response to your transmittal of June 23rd of the NIH Guide-
lines on work with Recombinant DNA.

The substantive response to your memorandum will be made by Dr. Joseph E.

Grady who was present at the meetings as our representative. As you may
recall, I was traveling in Russia with Marty Cummings and Mary Corning at
the time of the meeting.

It seems to me that both the NIH Guidelines and your decision to release them
are important and valid steps in allowing so-called genetic engineering
research to go forward with a minimized danger. The guidelines for contain-
ment are careful, and, in my view, quite appropriate.

From the particular point of industry, there are really two issues that present
themselves. The first of these is the problem of confidentiality, given the
Freedom of Information Act, of disclosing protocols and research results prior
to the time the patent process has been able to react. This is an important
issue since the patent is the legal documentation of priority of a customer-
oriented effort. There are large numbers of possible accommodations available
which would fulfill the intent of the guidelines you have distributed but at
the same time protect the intentions of the patent system. It would seem to
me that discussion should go ahead quite promptly to identify those accommodat-
ions that would be both feasible and acceptable.

The second concern from industry is a much more general one, but also trouble-
some. Policies and purposes that are unexceptionable at their origin have
a very unhappy tendency to become transformed through mindless application
of regulation into Frankensteins . I realize the nature of the process and
the sense of frustration that every government in the world feels at its
failure to protect its citizenry from the dead hand of self-serving bureau-
cratic regulations. This is a statement not directed at any one country,
since, to my knowledge, there is not a single exception to the problem. Only
recently academic scientists have begun to appreciate that they are also at
peril in their ability to undertake socially beneficial and appropriate
research in the face of regulatory actions which impede, if indeed they do
not totally frustrate, the conduct of such research. It is my impression then

[66]

Dr. D.S. Fredrickson, NIH

-2-

July 16, 1976

that industry will avoid cormitting itself in very formal ways to policy
statements out of a reasonable and deep-seated fear that this is just the
first step of another wave of bureaucratic intervention into individual
endeavor.

This is one for which I have no optimism. All parties to this Greek tragedy
feel fully justified in their positions. I think then that it is highly
probable that a state of sharp contest will continue. If one wishes to be
optimistic, he could imagine this immediate problem in genetic engineering
as being an opportunity to set some new pattern whereby the Greek tradition
of "paideia" could be given priority over the tradition of the Roman lictor
bearing his fasces. I would be delighted to join with any one who seeks this
latter goal.

Best personal wishes.

Cordially yours

W. N. Hubbard, Jr. , M.D.

WNH/nrvj

[67]

JC HN ,1. LAFALjCE
36th District. New York

417 Cannon Building
Washington. D.C. 2031 3
(202) 223-3231

COMMITTEE ON
BANKING. CURRENCY AND
HOUSING

Congress of tfje Hmteb States

Federal Building
Buffalo. New York 14202
(716) 842-2680

COMMITTEE ON
SMALL BUSINESS

%qu it of &epreaentattoe$

®Sa£tf)(ngton, 3B.C. 20515

Main Post Office Building
Niagara Falls. New York 14302
(716) 284-9976

August 9, 1976

Buffalo Office

Public Health Service

Office of the Assistant Secretary of Health
5600 Fishers Lane
Rockville, Maryland 20852

Dear Sir:

I am writing in regard to an inquiry I received from a
constituent. Dr. Joseph Krasner, 60 Snughaven Court,
Tonawanda, New York 14150, concerning studies about gen-
etic manipulation which he read about in the Journal,
NATURE, Vol. 261, page 624, June 24, 1976. Dr. Krasner
said that, according to the journal article, studies have
been done at Stanford University and the University of
California regarding patenting a technique of genetic
manipulation. He believes that, since all the information
has been derived through grants from the Public Health
Service, it is public information and not patentable.

I would appreciate your looking into this and furnishing
me with information regarding this matter. Any details
you can provide which will help to explain the situation
to Dr. Krasner will be appreciated.

Thank you for your interest in this regard.

JOHN J. LaFALCE

Member of Congress

JJL:mf

[68]

DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE

PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
aCTHKSOA. MARYLAND 20014

August 19, 1976

The Honorable John J. LaFalce
Member, United States House of
Representatives
Federal Building
Buffalo, New York 14202

Dear Mr. LaFalce:

I am writing in response to your letter of August 9 requesting
information on the Public Health Service patent policy with respect to
recombinant deoxyribonucleic acid (DNA) research. The article in
Nature , to which Dr. Krasner refers, summarizes the current patent
policies of the Department of Health, Education, and Welfare (DHEW) .
Through the "deferred determination" policy the Department retains
the right to exercise ownership claims on a new invention that was
developed under DHEW grant or contract. However, the inventor or
his Institution may request the Department to waive the right to
ownership so that the inventor can assert patent claims. In
approximately 90 percent of the cases where a request has been filed,
the Department has agreed to waive the right.

In addition to this general policy, there is another departmental
policy which provides for institutional patent agreements between
DHEW and universities or other non-profit organizations. These
agreements described in the Nature article allow the institutions
on their own initiative to assert patent claims for Inventions
developed under DHEW support. The Department currently has agreements
with approximately 65 universities. These agreements set forth a
number of conditions with which the institutions must comply, and
the Department has the right to prescribe new conditions prospectively.

Stanford has an institutional patent agreement with the Department
and has filed patent claims on certain recombinant DNA research
techniques. However, in view of the recent National Institutes of
Health (NIH) guidelines on the conduct of this research, Stanford
has requested the NIH to review its decision to proceed with patent
claims. Dr. Donald S. Fredrickson, Director of the NIH, currently
is conducting such a review. As part of that review. Dr. Fredrickson
has been meeting with Mr. Norman Latker, HEW Patent Counsel, and
Dr. Betsy Ancke r- Johnson , Assistant Secretary for Commerce who is
also chairman of the Committee on Government Patent Policy. Further,
the patent agreement is being reviewed in light of the NIH Recombinant
DNA Research Guidelines that carefully prescribe safety conditions
under which this research will proceed.

[69]

Page 2 - The Honorable John J. LaFalce

I will keep you informed on Dr. Fredrickson's decision. I am
enclosing for your review articles that explain the rationale for
the Department's policy to foster institutional patent agreements.
Enclosed also are the NIH Recombinant DNA Guidelines and the
Decision Paper of Dr. Fredrickson published in the Federal Register
on July 7 for public comment.

-Joseph G. Perpich, M.D. , J.D.
Associate Director for
Program Planning and Evaluation

Enclosures (3)

[70]

STANFORD UNIVERSITY

STANFORD. CALIFORNIA 94305

A«e» Cod* 4IJ A97-iW

oma of

TECHNOLOGY LICENSING
ENCINA «-«J0

September 8, 1976

Mr. Donald S. Frederickson
Director

National Institutes of Health
Building 1, Room 124
Bethesda, Maryland 20014

Subject: Recombinant DNA Advisory Committee Meeting

Dear Mr. Frederickson:

I am the individual at Stanford University responsible for its
licensing program. Your recent letter to members of the Re-
combinant DNA Advisory Committee (soliciting an input from the
Committee regarding Recombinant DNA patent matters) prompted
me to comment directly to you regarding the question of whether
patents inhibit dissemination of research information.

I am not aware of any economic, administrative, or physical
force that will stop or delay a dedicated scientist at a uni-
versity from promptly publishing his or her research findings,
whenever he or she is ready to do so. From a pragmatic point
of view, it would be fatal to the licensing program at this or
any other university if an administrator delayed a scientist's
publication in order to secure a patent position.

We have filed on as little as a week's notice of an impending
publication, but, of course, occasionally do miss patent bars.

This is simply a fact of life in an academic institution. A
case in point is the genetic engineering work of Drs . Cohen
and Boyer which came to our attention only after publication.

In rereading your letter to the Committee, it appeared some
wording possibly may be subject to misinterpretation. My under-
standing of "adverse patent claims," as used in policy options
(1) and (2) , are patent claims adverse to the economic interest
of the U.S. You may find those words misinterpreted by persons
not familiar with patents to mean patent claims adverse to un-
fettered research. Patent claims of course do not impede research
but can be considered "enabling" for development to public use
and benefit by commercial organizations.

Very truly yours

cc: N. Latker, DHEW

R. Rosenzweig, Stanford
NJR : sh

Niels J. Reimers

Manager, Technology Licensing

[71]

WISCONSIN ALUMNI RESEARCH FOUNDATION

POST OFFICE BOX 73S5 • MADISON, WIS. B3707 • TELEPHONE (608) 263-2500

September 9, 1976 263-2831

Waclaw Szybalski, D. Sc.

Professor of Oncology
McArdle Laboratory
University of Wisconsin
Madison, Wisconsin 53706

Dear Dr. Szybalski:

Re: Recombinant DNA Advisory Committee

We have the following comments in reference to Dr. Donald S. Fredrickson's
letter on the above subject and our recent telephone conversation looking
toward the September meeting of the Committee.

Basically we believe that the terms and provisions of the extant Institutional
Patent Agreement between the University of Wisconsin and the Department
of Health, Education, and Welfare (DHEW) are sufficient to protect the public
interest in this situation. In this regard the reporting requirements to DHEW
and the march in rights which that Agency has (Article XII of the Institutional
Patent Agreement) should be particularly emphasized. In addition, and over
and above the protection afforded by such provisions, the Institutional Patent
Agreement and presumably any deferred determination of ownership made by
DHEW has the following provision.

The Grantee shall not bar or prohibit publication of disclosures of
inventions on which patent applications have been filed.

The Grantor shall have the right to publish and make disclosure
of any information relating to any subject invention whenever deemed
to be in the public interest, provided that upon request reasonable
opportunity shall be afforded the Grantee to file U. S. and foreign
patent applications.

[72]

Waclaw Szybalski, D. Sc.

- 2 -

September 9, 1976

As you are aware the dissemination of information from the University
community of the results of research efforts generally occurs rather
promptly. Also, and most importantly, we at WAFF in handling Univer-
sity of Wisconsin inventions as a policy matter have not and do not request
any delay in publication by the investigator of his research results in order
to permit patent actions to be taken. In this regard we agree with the
DHEW people as stated in Dr. Fredrickson's letter that any necessary
patent applications can be handled expeditiously without an undue burden
on disclosure.

Failing agreement amongst the Committee members that the terms and
provisions of the present Institutional Patent Agreement are adequate to
the situation we believe that the approach suggested in item 5 on page 3
of Dr. Fredrickson’s letter, coupled with immediate disclosure to DHEW,
would be the next best alternative.

If you have any questions about any of the foregoing material please call.

Very truly yours

Howard W. Bremer
Patent Counsel

HWB:rw

[73]

CALIFORNIA INSTITUTE OF TECHNOLOGY

PASADENA. CALIFORNIA 01129

DIVISION OF BIOLOGY 190-20

September lU, 1976

Donald S. Fredrickson, M.D. , Director
National Institutes of Health
Bethesda, Maryland 20014

Dear Don:

I am writing in response to your letter of September 8 concerning the
patent situation relating to recombinant DNA research.

I should make clear that I am in no way skilled in the nuances and subtleties
of patent law. Frankly, as a scientist it strikes me as vaguely ludicrous
that one could or would seek or obtain patents concerning recombinant DNA.
Without in any way wishing to denigrate the achievements of the Stanford
scientists (or those elsewhere) it is evident that their contributions here
are a small increment to the great advances in our knowledge of molecular
biology and molecular genetics over the past 25 years that have made
recombinant DNA possible (consider the research upon DNA structure and
function, upon transformation and transinfection , upon E_. coli genetics,
upon plasmids, upon restriction enzymes, upon antibody resistance, etc. etc.).
And it is the NIH that has, very largely, provided the funds for the research
that permitted these advances.

Nevertheless, if patents can and will be obtained then it is indeed a matter
of importance who will own and control them. I would prefer to see ownership
and control vested in the HEW which would then presumably exercise such
control in the public interest. This would reduce the likelihood of adverse
patent claims and would place control in the hands of a public body rather
than in the hands of numerous individual institutions with diverse objectives
and policies.

As you indicate, the rapid dissemination of research and safety results is
indeed important; I hope that the requirements of patent protection will
not necessitate any serious, compromise of this principle.

With best wishes.

Robert L. Sinsheimer
Chairman

[74]

BOARD OF TRUSTEES REPRESENTING

• American Auooation of immunoiognti

• American inttilute or Biological Sciencei

• American Pny topatnoiogicai Society

• American Society ot Biological Cnemuti

• American Society tor Microbiology

• American Society of Parantotognti

• American Society of Zooiogilll

• American Society of Tropical Medicine and Hygiene

• Genetici Society of America

• Inlectioui Oiteaici Society of America

• Mycoiogical Society of America

• National Reiearcn Council-National Academy of Scienct

• Society of Protoaoolognti

• Tinue Culture Aiiociation

• 301-881 261

AMERICAN TYPE CULTURE

COLLECTION

12301 PARKLAWN DRIVE
ROCKVILLE. MARYLAND 2085

September 14, 1976

Dr. Donald S. Fredrickson
Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Doctor Fredrickson:

I am pleased to respond to your letter of September 7, 1976 with regard to
patent applications in the area of recombinant DNA research activity.

Such patent applications will apply to either processes or products. While
the latter inevitably include a process description, the importance of the applica-
tion primarily lies in the product claims. Process patents in microbiological
systems, in my opinion, generally have relatively minor significance since they are
often not too difficult to circumvent. A solid product patent on the other hand
may have great value. Thus process patents may have more nuisance value than
intrinsic value and I would urge the NIH not to encourage them. They may lead to
wasteful research funds in efforts to circumvent an existing process patent.

Despite the above evaluation, process patents probably significantly out-
number product patents in the microbiological area. In reviewing the last 200
patents which have crossed our desk, 68 were product patents and 132 were process
patents. Thus the latter could present a significant problem for NIH without greatly
adding to our know-how.

Therefore, I would recommend the following with regard to patent applications
in the area of recombinant DNA research activity funded by the NIH:

1) Have the NIH retain all patent rights for patents based on
inventions resulting from research funded by NIH and

2) Issue non-exclusive licenses to interested parties to execute
the findings in process patents, and

[75]

Dr. Donald S. Fredrickson
Director, NIH

Page 2

September 14, 1976

3) Issue exclusive license (s) to the inventor (s) for a period
of no less than 5 years for product patents.

I sincerely believe this would encourage the development of worthwhile
patented products and discourage the filing of nuisance and often foolish process
patent applications.

Sincerely yours.

RD : led

Richard Donovick, Ph.D.
Director

[76]

UNITED STATES DEPARTMENT OF COMMERCE
The Assistant Secretary for Science and Technology

Washington, O.C. 20230

September 14, 1976

Dr. Donald S. Fredrickson
Director, National Institutes
of Health

Building 1, Room 124
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Your September 7, 1976 letter requested views on options
for patents and licensing of patents on processes for
inducing recombinant DNA which resulted from studies
conducted under HEW grants. The administration of patents
and licensing of patents is conducted by Mr. C. Marshall
Dann, Commissioner of Patents and Trademarks. Your letter
has been referred to Mr. Dann for consideration and reply.

Thank you for the opportunity to assist in this matter.

Sincerely,

) \yJJL* — D

William V. Hartwell, Ph.D
Environmental Health Specialist
Office of Environmental Affairs

(77]

SK&F

SMITH KLINE SrfRENCH LABORATORIES

1500 Spring Garden St.. P.O. Box 7929, Philadelphia, PA 19101 • 215-854-4000

September 17, 1976

cable SMITHKLINE PHILADELPHIAPA
telex 83-4487

Donald S. Fredrickson, M.D.

Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Dr. Alan D. Lourie, Director, Corporate Patents, SmithKline Corporation, has
read your letter to me of September 7, 1976 and has provided the following
views concerning the questions raised and the various options outlined.

The basic principle underlying his comments is that the benefits of the patent
system are just as appropriate in the field of recombinant ENA as in any other
field and that the special problems inherent in the field can be overcome with-
out sacrificing these benefits. In fact, the more important the field, and this
obviously promises to be one of great significance, the more important it is
that industry have the incentive to invest the capital to develop and bring to
market inventions having practical application. Patent rights should not be
viewed as an "undue" obstacle to achieving other objectives, but as one of the
several important objectives to be considered in any contemplated policy.

Indeed, the benefits achieved in the past by the encouragement of patent
protection of HEW-sponsored inventions are acknowledged in your letter.

The special problems arising out of the field of recombinant ENA research can
be met while retaining the benefits of the patent system by the use of the
Institutional Patent Agreement (IPA) system. The need for early dissemination
of information can generally be met by early filing of patent applications
before any patent-defeating disclosures occur. (You indicate that your present
staff feels that they can accomplish this.) Where this need is so urgent as
to render it impractical or impossible to file before the information must be
disseminated, one can rely on the one-year grace period provided for by U. S.
patent law and the six-month grace period provided for in Germany and Japan.
These are the most important commercial markets and, while loss of other
foreign patent rights would indeed be regrettable, patent protection in these
countries should provide sufficient incentive for most U. S. companies. Okie
must recognize that this problem would usually occur only when dealing with
an emergency situation which required the early dissemination of information.

The need to achieve uniformity in safety practices can perhaps be met by
inclusion of appropriate safety guidelines as conditions for the receipt of
any grant in this field and/or renegotiating any outstanding IPA to include
them. The "march-in" rights possessed by HEM tinder the IPA should provide
sufficient leverage to achieve this, although, as noted, Stanford may be
willing to do this voluntarily.

[78]

Donald S. Fredrickson, M.D.

-2-

September 17, 1976

Therefore, we believe that all of the nonpatent needs in this area can be met
without foregoing the benefits of the patent system and without sacrificing
the IPA which was worked out through the patient and informed efforts of a
number of people, particularly HEW's Patent Counsel, Norman Latker. Ihder the
IPA, HEW has freed itself of a substantial administrative burden by permitting
institutions to make their own licensing arrangements, while retaining adequate
means for reasserting control over any patents which it feels are not being
utilized in the public interest. The various options listed in your letter
seem to be either unnecessary, harmful, or both. Options (1) and (2) would
kill the incentive provided by a patent in order to achieve objectives which
can be met by the less drastic methods discussed above. Option (3), while
perhaps retaining patents, would withdraw licensing responsibility from the
institutions, a step which would appear to be unnecessary and contrary to
recent trends which have proved beneficial. Option (4) is also unnecessary.

The licensing guidelines in the IPA should provide all the control HEW needs
over the terms of the licensing, except for the recombinant research guidelines,
which can be imposed through an amendment to the IPA. In other words, the
licensing agreement should not have to be approved by HEW as long as it is
within the IPA (as amended) guidelines. Finally, while exclusive licenses
are generally necessary to create sufficient incentive for substantial invest-
ment, it is difficult to see why, as in option (5), HEW should prevent the
issuance of nonexclusive licenses where the institution finds such to be
appropriate. Especially in this field, which is susceptible to such a wide
variety of applications, exclusive licensing of. a basic patent might well be
unwise and unnecessary. Che company cannot explore all possible applications
which might be dominated by a basic patent. Once again, the recombinant
guidelines can be imposed through grants or the IPA without precluding non-
exclusive licenses.

I trust that the above views contribute to the Department's policy regarding
patent applications of HEW- funded inventions in the field of recombinant ENA

research.

Sincerely,

Director, "Scientific Liaison

HG:ref

[79]

MASSACHUSETTS INSTITUTE OF TECHNOLOGY

CENTER FOR CANCER RESEARCH
77 MASSACHUSETTS AVENUE, CAMBRIDGE, MASSACHUSETTS 02139

September 20, 1976

Donald S. Fredrickson, M.D.

Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Don,

This letter is a response to your request of 27 August 1976
for my opinion on the patent applications for recombinant DNA
discoveries .

It seems to me that the Institutional Patent Agreement is
meant to stimulate use of new inventions made on grants from
NIH. In the recombinant DNA area, there is hardly need for more
stimulation. The over-riding concern here is that the potentialities
in recombinant DNA research be realized in an orderly and safe
manner. I would therefore opt, I think, for the 3rd alternative
on page 3 of your letter. If I understand the alternatives, this
would best assure openness and speed of publication but would give
the Department at least knowledge of who is using recombinant DNA
methods for what. Any royalties could be used to establish a re-
search award fund for universities and/or to continue work on
safety and ethical aspects of recombinant work.

What I would oppose would be any exclusive licensing scheme
or control of the products by individual universities. Taxes pay
for the work and it should belong to the public.

Sincerely,

DB/mts

[80]

Swift Hall

THE UNIVERSITY OF CHICAGO

THE DIVINITY SCHOOL
1025 EAST 58 T H STRBBT
CHICAGO • ILLINOIS 60637

September 21, 1976

Dr. Donald S. Fredrickson
Director, National Institutes
of Health

Bethesda, Maryland 20014
Dear Dr. Fredrickson:

My competence to make judgments about legal matters involved in
your letter of 8 September 1976 is, of course, minimal. Also,

since I am a humanistic scholar I have not had experience with

patent claims. I am, however, exploring our university's ex-
perience on these matters, and hope to include awareness of this
in a subsecruent letter.

I have to think about these matters in my own way, and what
follows stems from that.

There seems to me to be several general issues involved, some of

which apply to all the research funded by NIH, and to patents

that might be forthcoming. Then I shall have to isolate the re-
combinant DNA matter to designate what special considerations are
involved in this case.

1. Since the research has been funded by the "public," the public
has an interest in and a claim to various benefits (including
financial ones) that are forthcoming. The funding creates an
obligation: the investigators are beneficiaries of the funding;

the results they achieve are "beneficiaries" of the funding
through their work; thus there is a prior and large claim on the
part of agencies representing the public interest to these benefits.

This surely is assumed in the presently operative regulations about
the issuance of patents. I take it that present policies are
efforts to insure a fair distribution of benefits, with a kind of
apportioned regard for the interests of various parties involved.

The contributions of the research institutions, e.g., Stanford,
are attended to as well as those of the public as funding agency.

As I read your letter I perceive that other considerations of
utility are regarded, namely the need to have production of materials
and the required capitalization for this, and the need for con-
trolled dissemination of information.

It appears that the present policies and procedures are satisfac-
tory to all parties if there are no exceptional circumstances
involved as is the case in the recombinant DNA. Since the establish-
ment of policies and procedures is a process of adjudicating
legitimate interests or rights among parties who have them, that

[81]

Dr. Donald S. Fredrickson
Page 2

September 21, 1976

we can "live with " them indicates their viability.

2. From the side of the NIH, I take it that the perennial problem
is that of the extent of authority given to control the results of
investigations and the amount and kinds of power that are to be
exercised in control. The obverse side of this is the concern for
the preservation of the freedom of research and dissemination of
its results^ both as a matter of the rights and interests of the
investigators and a matter of this freedom being a necessary condi-
tion for developing work which will benefit the public interest

(or at least the interests of portions of the public) .

Again, it appears to me that apart from extraordinary cases such as
recombinant DNA research, present policies and procedures are satis-
factory to all parties involved.

3. The matter of whether there is an audible group who insists
that the public interest is threatened in anv case, and the adjudi-
cation of whether it really is threatened are in principle
separable. The fact that the city fathers of Cambridge are now
audible and visible (and/or other groups) is a matter of some prac-
tical political significance, but is not really relevant to the
basic issues involved. Certainly it is not relevant to the patent
question.

4. Whether recombinant DNA is a special case, with special features
of moral and social relevance, is the matter that has been debated,
and for purposes of present discussion is settled. Recombinant

DNA research does involve distinctive features of particular moral
and social relevance, and therefore generally applicable policies
and procedures are to be altered.

5. Special, distinctive policies for patenting with reference to
recombinant DNA must be determined by those features that make this
research an exception to the general policies/ Although I have not
read all the documents you "have sent me about recombinant DNA, I
have been working through those I judge to be most important, and

I have followed (indeed, have a clipping file on) , the discussion
in Science . My perception is that the special features can be put
under a single heading: there are distinctive threats (perhaps it

is a unique threat in the history of biological research) to the
safety of the public involved in this research.

6. If this special feature were the only consideration , then that
patent policy option of the five on page three of your letter which
minimized the possibilities of adverse consequences to the public
would be the proper one to establish. As the discussions of recom-
binant DNA research indicate, the feature which makes it a special
case must always be considered with those aspects which are similar
to all biological research and developments for its practical use.

[82]

Dr. Donald S. Fredrickson
Page 3

September 21, 1^76

Thus a policy which minimized the threat to safety of the public
might unduly sacrifice other features and values in the research.

So here, as in all Dublic policies, some compromise is in order,
though the weight must be on the side of insuring safety.

7. In my limited competence it seems to me that patents have a

double function in this case: to protect the rights of institution

in which the investigation has occurred, and also (intended or
unintended, I am not sure) to provide some controls over the re-
search and its dissemination. The second function, if it is a
function (and I aim prepared to be corrected on this) , is not in-
trinsic to the intention of patents, vet can be supported in this
exceptional case.

8. Within my limited comprehension of the issues, options four
and five are the two which seem to me to best follow as conclusions
from the preceding sections of this letter. Option four, it seems
to me, preserves more of the elements of the general policy to
which recombinant DMA research is a warranted exception, while pro-
viding sufficient basis to protect the safetv of the public, that
which makes recombinant DNA research a special case. Thus I would,
given my present knowledae and reflection, support option four.

I shall take a few words to describe my views of the role of someone
like myself in these matters. Just as the investiaators make
contributions to oolicv, so do those who approach it from some
competence in ethics. Just as invest ioators are often frustrated
because their oolicv recommendations are not accepted without auali
fication by persons responsible for policy, so someone like myself
might be frustrated. I believe, however, I would not be, for if
there is a contribution from mv work it is in lifting out the fea-
tures to be taken into account, and arguing for an outcome. Mv
aspiration is not that policy will be based on my recommendations,
but that, given all the other things you and the staff must take
into account, my argument will be taken seriously in its parts and
its whole.

>r of

Theological Ethics

JMGrch

[83]

Parke, Davis & Company

2800 Plymouth Road
Ann Arbor, Michigan 48106
Telephone (313) 663-7585

PARKE- DAVIS

Research and Development Division

September 22,1976

Donald S. Frederickson, M.D.

Director

National Institutes of Health,

Bldg. 1, Room 124

Dept, of Health, Education and Welfare
Public Health Service
Bethesda, Maryland 20014

Dear Don:

The question which you pose in your recent letter concerning the
development of policies governing patent rights of institutions in the
area of recombinant DNA is indeed difficult. This is especially true
when one considers the need for a continued free flow of information
deriving from this type of research while at the same time recog-
nizing the apprehensions of the public in this regard. There is no
easy answer. It may even be necessary to establish new regulations
which are at best tentative with the idea that these will be reviewed
and evaluated at some specifically designated time.

Hopefully, the final decision will protect the rights of the
scientist while not abridging those of the public. However, because
of the nature of this particular situation, I feel that the Department's
standard approach to patent rights is not sufficient to cover the many
unknowns certain to arise. Therefore, I would support a modification
of the Department's present policy.

In reviewing your recent letter, I would support options four and
three in that order of priority. Granted, there are several other
possibilities .. .yet , option four appears to maintain institutional
privilege while permitting a type of Departmental participation. A
participation which does not appear to encroach in any significant
manner upon institutional privilege.

[84]

I have placed option three in a secondary position primarily
because it deviates somewhat more from the usual practices where
institutions have patent agreements (i.e., it requires the assign-
ment of all inventions to the Department initially).

Although I have suggested options four and three, I hesitate
in this regard because of present budgetary restraints (among other
things). These anticipated regulatory modifications in Department
institution interactions are certain to place an additional burden
on the budget.

Stanford has brought forward a question which was certain to
arise sooner or later. Because it has arisen sooner, we have little
experience upon which to base our judgements. I do hope that you
will get the desired input from the many sources you mentioned prior
to having to make a decision.

I should add that I have made my conments with much trepidation
because of the multifaceted problematic aspects of Stanford's pro-
posal. Sorry I can't be of more help to you in the decision you

must make.

RDH/mec

(85)

■Boy lor College of Medicine

DEPARTMENT OF VIROLOGY AND EPIDEMIOLOGY • 713 790-4443

September 23, 1976

Dr. Donald S. Frederickson
Director

Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Don:

This is in response to your letter of September 8 on patent policy
in the area of Recombinant DNA research.

There must be one overriding principal for the next few years:
safety. This means that at this stage of our ignorance, new infor-
mation must be quickly circulated to all engaged in such research
without any delay because of patent considerations.

As regards the patent options you mention, number (4) is the one
I favor. Even though a formal patent has not been applied for, the
availability of laboratory notebooks recording the details of experi-
ments, of who performed them and when, should be enough to estab-
lish priority for patent purposes. The inventor would have ample
time (one year from the time of dissemination of knowledge of the
invention) to prepare and file the U. S. patent. Although, I am told,
there is some movement towards standardizing international patents,
this will take some time. In any case, I would not let filing of foreign
patents hamper the free and rapid flow of information in this important
area at this crucial time.

Another consideration is to allow the inventor, if he wishes, to
file his application in foreign countries at the same time he disseminates
his material publicly. To do this he and his lawyers would probably
have to burn the midnight oil, but, after all, there is no requirement
that the research findings must be patented.

Sincerely yours,

Joseph L. Melnick

Distinguished Service Professor

[86]

MILES LABORATORIES, INC.

UVJ <A ELKHART. INDIANA 46514

MARSCHALL DIVISION

Phone 219 264-8716
TWX 810 294-2249
Cable MILESLABS ELK

September 24, 1976

Donald S. Fredrickson, M.D.

Department of Health, Education, and Welfare
Public Health Service

National Institutes of Health, Bldg. 1, Rm. 124
Bethesda, MD 20014

Dear Dr. Fredrickson:

I am writing in response to your letter of September 7, 1976, asking for my
views in the area of patents for the recombinant DNA technology. At the out-
set I would like to stress that the views expressed in this letter are per-
sonal and do not reflect, in any manner, a corporate policy statement of my
employer. Miles Laboratories, Inc.

The scientists and their respective institutions appear to have filed a
conventional and valid patent application to cover some very remarkable
discoveries made in their laboratories . Your letter indicates that this
is a normal procedure for NIH funded research, that by prior agreement they
had the right to file for such a patent, and past experience has demonstrated
that inventions covered by such an agreement are transferred quite effi-
ciently to the public sector. I feel that although this is an extremely
significant technological innovation and that certain applications of the
technology must be done with extreme caution, the granting of a patent and
its subsequent licensing should require no special treatment or interfer-
ence by NIH.

The major concerns involved in this issue are, as you stated, the need for
a free and open exchange of information that would aid in insuring compliance
with accepted safety procedures. I feel that this could best be accomplished,
in the present case, by allowing the established U.S. patent system to oper-
ate in its traditional manner. My personal experience has been that concern
for patent rights does not unduly restrict the exchange of sound, reliable
scientific information. On the contrary, I would suggest that the patent
system in our country acts to facilitate the flow of information by publiciz-
ing and detailing an innovation while offering protection for the inventor.

I think that the alternatives to this approach, government ownership or public
dedication of the patent rights, would only serve to confuse and complicate
the utilization of this technology by setting a new and unusual precedent.

[87]

Page 2

Dr. Donald S. Fredrickson
September 22, 1976

I hope these comments aid in the formulation of your response in this important
matter and would like to add my appreciation for the intelligent, open and
judicious manner in which the NIH has approached the problems inherent in the
recombinant DNA technology.

Sincerelv vours

Section Head

Senior Research Scientist

RJE/tlm

[88]

THE UNIVERSITY OF MICHIGAN

MEDICAL SCHOOL

DEPARTMENT OF HUMAN GENETIC*
1137 C CATHERINE STREET
ANN ARBOR. MICHIGAN
4*10*

TELEPHONE!

ANN ARBOR. 7*4 3410

September 24, 1976

Dr. Donald S. Fredrickson
Director, National Institutes of Health
U.S. Public Health Service
Bethesda, Maryland 20014

Dear Don:

This is in response to the recent letter soliciting a
viewpoint on the matter of patenting procedures related to
the production of recombinant DNA.

As you are undoubtedly aware, given the financial
stringencies that are upon us, many universities are
encouraging their faculty to give increased consideration to
the question of whether some of their discoveries have
patentable aspects, with the thought that the university as
well as the investigator might well share in any financial
returns. Given these added pressures plus the present
provisions for patents, so well described in your letter, I
believe that any attempt to exempt the technology of
recombinant DNA research from the accepted procedures would
raise more problems than it would solve.

I agree with the implications of your letter that this
may be a particularly sticky area for patents but see no way
to turn the clock back on this.

Sincerely yours

of Human Genetics

[89]

STANFORD UNIVERSITY MEDICAL CENTER

STANFORD, CALIFORNIA 94305

DEPARTMENT OF BIOCHEMISTRY

PAUL BERG

Willson Professor of Biochemistry

September 27, 1976

Dr. DonaldS. Fredrickson
Dept, of Health, Education
and Welfare

National Institutes of Health
Bethesda, Maryland 20014

Dear Don,

I am very pleased and relieved that you are moving decisively to
examine the Department's patent policy, particularly as it applies to
recombinant DNA research. Continued confusion and uncertainty in
this matter, which is widespread, can only poison the debate on
recombinant DNA matters and lead to regrettable decisions and actions.

The policy establishing IPA's is not only defensible but commend-
able. To encourage the development of new technology based on re-
search progress in University and other non-profit institutional
laboratories is an important way of ensuring that the investment
being made by government in basic research is used for the benefit
of its people. Nevertheless, I have serious concerns and reserva-
tions about the application of current patent policy to recombinant DNA
matters.

Here at Stanford, whenever I've been consulted, I've advocated
caution and even opposition to the University's patent application for
its "recombinant DNA invention". And, I've been particularly
adamant about not entering into negotiations with potential licensees
prior to a resolution of the pending patent application and development
of a national policy by the Government. Nevertheless, in spite of my
reticence and opposition, I've been supportive of the objectives of the
policy establishing the IPA agreements, sympathetic to the University's
need for financial help and totally committed to the notion that commer-
cial exploitation of this basic research development should be accom-
panied by a return of some of that wealth (more or less as a tithe) to
the institutions from whence it came. I am less sympathetic but mind-
ful of those investigators who seek additional personal benefits from
their endeavors.

[90]

p. 2

Letter to Dr. Fredrickson

Department policy carries the proviso that an Institution's
"ownership" in all inventions is conditional. Since one of those
conditions is public interest considerations, I see no difficulty in
placing patent applications on recombinant DNA research in a
special category - one to be dealt with by special procedures.

What should these be and what should they achieve? My proposal,
outlined below, tries to deal with what can be achieved in this
country and with what can be marketed in this country by foreign
concerns.

1. Continue the present policy of encouraging Universities and
other Institutions to apply for patents for inventions stemming from
research carried out in their laboratories by their personnel. Patents
dealing with recombinant DNA methodology (cloning, joining methods,
novel hosts and vectors, etc. , ) must first be cleared through the
Recombinant DNA Advisory Committee or whatever replaces it if

it becomes "federalized".

2. Require that all licensing negotiations, whether for exclusive

or non-exclusive licenses, be carried out jointly between the Institutions,
the potential licensee's and the Committee's designates. During such
negotiations considerations and demands for safety could be examined and
negotiated. This would include Government supervision for compliance
since University licensing group* could never manage the safety issue
on its own.

3. Require that patent application be made only after the relevant
results and procedures have been published in the scientific literature.
Such publication would prevent foreign patent applications from being
filed; moreover, since some proof of priority for the idea and under-
taking of the research leading to the invention is needed to protect a
patent application, I can't see why there should be objection to requiring
publication prior to filing. I suppose one could also consider that where
the publication is accompanied by a statement indicating intention to
file a patent application, that would take precedence for establishing
priority for purposes of the patent application.

4. Develop a formula returning a portion of the royalties from
licensing arrangements to the Institution making the patent applica-
tion. I have no idea what an appropriate fraction of the royalties
should be but it should be enough (20 to 30%? ) to be an incentive and
reward for the Institution's efforts and achievements. The remainder
could then be deposited in some fund to be used for supporting further
research throughout the country or even for contractual arrangements
for investigations on the hazards. In that way the benefits of the re-
search would be distributed to all scientists; this seems appropriate
since the research leading to the invention generally grows out of and
depends upon the work of scientists elsewhere.

[91]

p.3

Letter to Dr. Fredrickson

The proposals are sketchy, possibly impractical or maybe even
faulty but I see in them the following virtues:

1. Universities and investigators can still get some return
although it would be only a small fraction of what's generated. The
bulk of it could be used for the public interest - further research.

2. Licensing responsibility is shared by the private institution

and another group that is interested in an equitable and sensible arrange-
ment as well as with safety.

3. Nothing is secret. Only published material can be reviewed for
a patent. One might even consider that the licensees would be asked to
agree to publishing those of their researches that lead to patentable
developments. (Perhaps this would need modifications of current
patent law or practice.

Please note that my suggestions are made without any sophistication
in patent law or procedures and I'm not sure that those with a stake on
the possible financial benefits will not object violently. But I believe
some features of what I've suggested could be considered in your deci-
sion.

With best regards.

Sincerely yours.

PB:ab

[92]

COR POR ATE

GENERAL

ELECTRIC

RESEARCH AND

GENERAL ELECTRIC COMPANY. RESEARCH AND DEVELOPMENT CENTER. P.O. BOX 8

SCHENECTADY. NEW YORK 12301, Phone (518) 385-2211

DEVELOPMENT

Building K-lf Room 3B35
September 28, 1976

Donald S. Fredrickson, M.D.

Director - National Institutes of Health.

Department of Health, Education and Welfare
Building 1 - Room 124
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

In response to your letter of September 7, 1976, I have con-
sidered the question of recombinant DNA patent licensing policy with
my associates including our Corporate counsel. As a result, it is
our opinion that policy Option 3 set out on page 3 of your letter
would best serve the purposes which you have stated.

As a general proposition, we do not consider it to be in the
public interest for the Government to take title to inventions made
in the performance of work under government contracts. In the very
special circumstances of recombinant DNA research activity, however,
we do believe that, pending enactment of appropriate legislation, the
Government should hold title to all inventions made under NIH grants.

In that way its immediate control purpose can be served through patent
licensing while minimizing potential tie-in provision and alienation
issue problems, and keeping the basic licensing activity as uncompli-
cated as possible.

At best this patent licensing method of providing the desired con-
trol is in our view a poor substitute for specific legislation, and
suitable only for stop-gap use until Congress acts in response to the
recognized necessity for recombinant DNA research regulation.

In regard to the concern that publication of research results
might be unduly delayed because of patent considerations, our general
experience has been to the contrary. Thus, patent application filing
is expedited as necessary to meet management's desire for early publi-
cation without forfeiture of foreign patent rights.

We very much appreciate your affording us the opportunity to be
heard on this important matter.

Sincerely yours,

John F. Brown, Jr.

Manager - Life Sciences Branch

PHYSICAL CHEMISTRY LABORATORY

[93]

September 28, 1976

Dr. Donald S. Fredrickson
Director

National Institutes of Health
Bethesda, Maryland .20Q14

Dear Dr. Fredrickson:

Thank you for requesting our views on the question, of patent applications
in the area of recombinant DNA research activity.

We feel that there are two quite distinct reasons why this matter deserves
the careful attention which you are giving it.

First, the profound and far-reaching nature of the patent claims, as we
understand them, are such that should the patent be granted and be found
valid, it seems that any application of recombinant DNA technology in the
United States will require a license. There are serious questions respecting
both the fairness and practicability of implementation of this kind of control.
There are also public interest issues regarding the policing of this work in
the United States and the effect which the limitation of at least the existing,
far-reaching patent to the United States would have, encouraging nonlicensees
to practise the inventions outside the United States.

The other major issue, again primarily one of public interest, concerns the
environmental and other safety issues addressed by the recently published
guidelines and the extent to which the way in which the patents are handled
impinges on developments in this area.

Let us state our conclusions and follow them with some paragraphs of explana-
tion.

We feel that alternative 4 on page 3 of your letter is the most
sensible way to proceed with two very important stipulations.

First, we believe that any exclusive license, granted to anyone on
any specific application of this technology, no matter how narrowly
defined, and no matter for how short a period of time, would be
extremely unwise. Secondly, using compliance with the NIH guidelines
as a condition for licensing is a splendid idea, but the specific
way in which this is implemented could be either the best or the
worst feature of the program. We feel that the special needs of
industry, which have not yet been properly considered* must be
addressed in a fair and deliberate manner because it is from industry
that the license fees are expected to come. We also have some
concern about the nature of the enforcement of this compliance.

Surely the universities are not set up to do this properly.

* Our strong views on this subject have already been communicated to you.

Cetus Corporation, 600 Bancroft Way, Berkeley, California 94710 Phone: (41 5) 549-3300

[94]

Dr. Donald S. Fredrickson
September 28, 1976
Page 2

In short, Cetus Corporation intends to be active in this area and
is willing to pay fair license fees, on an equal basis with others,
on commercial applications. We would vigorously oppose the granting
to anyone of an exclusive license of any sort whatsoever.

We have previously stated that we endorse and applaud the NIH guide-
lines, and that we have specific ideas about appropriate, somewhat
different guidelines for industrial research and commercial applica-
tion. Regardless of what decisions are made with respect to the
patents, the public interest requires that these decisions be made
openly in some process as yet to be defined.

Now to our reasoning. Probably, you have heard, as have we, that many scien-
tists feel that there is a significant difference between the all-encompassing
nature of the Stanford/UCSF patent and the University of Alabama patent. The
latter, as we understand it, is much more in the way of an application gener-
ated in response to the first discovery. There will undoubtedly be many such
derivative applications. It is the feeling of many that it is inappropriate to
attempt to patent something as fundamental as a way of making recombinant DNA
molecules. This is clearly something for the patent office, not for us, to
decide. In this case, where the patent is restricted to the United States, the
response to its broadness may consist of attempts to circumvent it. Particularly,
if exclusive licenses are granted; those not licensed may feel that they have
little choice but to look to remedies such as practising the invention outside
the United States. That is not in the interests of the United States. Far
better, we feel, to have it clear that HEW and Stanford University and UCSF
have made an investment and facilitated am unprecedented scientific breakthrough
for which they are entitled to a reward, and that nonexclusive fees are a fair
and equitable vehicle for such reward. In the past exclusive licenses may have
been seen as the only way to motivate industry to make the necessary investment
to develop an invention to the point where there would be something to exploit
commercially . This is clearly not the case here. Many companies have already
asserted their intention to become involved in the field - it is difficult to
understand how any significant biologically-based company could do otherwise.

But this brings us to the second major issue, and that involves safety and
the public interest. As I stated in my previous letter to you, dated July 29,
it is vitally important that the industrial community be imbued with the same
concerns and awareness that prompted the academic community to begin the pro-
cess which resulted in the promulgation of the NIH guidelines. Prudence,
restraint, and sophisticated scientific judgment have to be combined in the
determination of what work shall be done, in what sequence, and at what rate.

The very nature of an exclusive license and particularly one with a short
time limit, would encourage speed at the expense of the prudence which in the

[95]

Dr. Donald S. Fredrickson
September 28, 1976
Page 3

public interest is now paramount. The way in which the licensing is imple-
mented, therefore, must encourage this prudence in every possible way. Open
licensing is one such way. Careful consultation with industry prior to
announcement of any particular guidelines is another way.

It is our feeling that the practise of these inventions in the United States
is likely to be more stringent and proper than elsewhere. This will serve no
useful purpose if the corollary is that most of such work is -therefore done
outside the United States.

Another distinction which must be clarified arises from the second paragraph
in the public relations release attached to your letter. It is said that the
patent would cover commercial use of the process, but not academic or indus-
trial research. I think it's clear that some of the nightmares which the
guidelines are intended to obviate, if they were in fact to happen, could
just as easily happen in industrial research (not covered by the patent) as
in subsequent "commercial use." In fact, one could even surmise that the
commercial use would be safer having been extensively tested during the
period of industrial research for safety, among other parameters. How does
one intend to police this industrial research? Could one circumvent the
patent by conducting the industrial research (not covered) in the United
States and then implement the commercial use in some other country? A not
very difficult scenario for a multinational corporation!

So there are certainly some very loose ends and it is probably unreasonable to
expect the granting of a patent to tie them up. It is even more unrealistic
to justify the patent as a means of tying them up.

We feel quite differently about subsequent patents of a narrower nature, of
which we believe the University of Alabama patent to be an example. Whether or
not it is, one last point comes to mind. One can anticipate that a category of
patents which would issue from this work would address the specific industrial
processes (such as those mentioned in the press release to produce insulin and
other hormones) made possible by the development of "new" bacteria. This is
the real commercial payoff, the objective of the industrial research. As is
the case with current microorganism strain development and selection programs
in. the antibiotics industry, the companies can be expected to jealously guard
their unique microorganisms as being integral to the patented commercial pro-
cess. The nature of recombinant DNA research means that these microorganisms
will also have to be vehicles of an EK2 or more stringent type. The present
guidelines insist upon the free availability of all such vehicles within the
scientific community. It is unlikely that industry will want to invest much
money and many years toward the development of such microorganisms if they are
required to make the end result of all this work freely available.

We have probably only scratched the surface. We are carefully studying a wide
variety of possible commercial applications of recombinant DNA technology and
it is clear to us that large scale profitable industrial use is many years

[96]

Dr. Donald S. Fredrickson
September 28, 1976
Page 4

away. This stems largely from our awareness of the public interest considera-
tions. This does not mean that work cannot begin immediately. In fact, it
must if those applications are to materialize in our lifetimes.

In this connection we want to reiterate our position. If a valid patent is
awarded to Stanford University and the University of California, San Francisco,
we will apply for licenses to practise those inventions. We favor the adminis-
tration of such patents in conjunction with the Department of Health, Education,
and Welfare as outlined in your alternative 4. And we urge that a great deal
of careful study, soliciting many inputs, precede any final determination of
any guidelines for recombinant DNA research by industry in the United States.

Yours sincerely,

REC/lmb

CCt

Dr. Stanley Cohen
Dr. Carl Djerassi
Dr. Joshua Lederberg
Hr. Julian Stern
Dr. Julius Tabin

(97]

ABBOTT

Scientific Division

Abbott Laboratories
North Chicago, Illinois 60064

September 28, 1976

Donald S. Fredrickson, M.D.

Director

Dept, of Health, Education and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Doctor Fredrickson:

Thank you kindly for inviting us to submit recommendations on the patent
applications for recombinant DNA procedures by Stanford University and
the University of California. Since receiving your letter we have been
studying and analyzing the possible impacts of various patent options on
the future beneficial development of this technology. We do intend to
submit constructive recommendations but we will not have them in hand by
September 30, because the need for sound and thorough study and in depth
analysis is requiring additional time.

We believe that a sound patent position by the NIH can be a key factor
in the orderly and successful fulfillment of the beneficial potential of
recombinant DNA technology. We trust you will consider our recommenda-
tions which we hope to get to you in the next week or so.

Sincerely yours,

ABBOTT LABORATORIES

Director

Division of Experimental Biology

LRO: nlm

[98]

Robert Carow
4321 Chestnut Street
Bethesda, Maryland 20014

28 September 1976

Donald D. Fredrickson, M.D.

Director

National Institutes of Health
Department of Health, Education
and Welfare

Bethesda, Maryland 20014
Dear Dr. Fredrickson:

This letter is written In response to your solicitation of 7
September 1976 regarding patent policies for certain processes In
recombinant DNA research. I am very pleased to be afforded the oppor-
tunity to comment on this Issue. Please note at the outset that these
comaents are made In my dual roles as citizen and professional econ-
omist and do not necessarily reflect the views or policies of the
Association of American Medical Colleges with which I am associated.

The NIH decision to permit continuation of recombinant DNA
research by its grantees was made after a lengthy period of debate.
Flowing from these debates were lists of risks and opportunities
believed to be Inherent in the recombination process. Tour eval-
uation of the risks and opportunities followed resulting in the de-
cision to permit continuation of the research under the Guidelines.

As you are aware, the absence of actuarial data on the risks
and opportunities inherent In the recombinant experiments has precluded
formal beneflt/rlsk analysis. This has necessitated reliance on an
Informal consensus among experts. I concur in your conclusion that
most researchers In the field believe the opportunities outweigh the
risks. Nonetheless, I would like to emphasize the subjective nature
of this evaluation; a point you have made In this regard during
your testimony before the Subcommittee on Health, Senate Committee
on Labor and Public Welfare, September 22, 1976: "Like many of the

potential benefits, these risks remain speculative, for there is still
scanty evidence that genes from one form of life can be expressed In
any other form." I believe our true state of ignorance regarding the
r lsk/opportunity balance must not be forgotten in the ongoing evaluation
of the research and its ramifications. Including the choice of patent
policies for Inventions resulting from the research.

The lack of actuarial evidence, and the consequent reliance on
expert speculation must lead to the conclusion that the opportunity/
risk ratio, if positive, is nonetheless precarious. Our state of
Ignorance forces this conclusion on us. Patent policy must be viewed
in this context.

[99]

Surely one benefit of permitting the research to proceed will
be our increased knowledge of molecular processes. Increases in
knowledge, however, are conditional on the costs of information.

These costs include actual monetary investments, payments for staff
and equipment, as well as payments necessary to overcome institutional
barriers. Payments for patent rights or extra expenditures on research
to develop techniques circumventing patent coverage fall into this
latter class. If the opportunities inherent in the recombinant techniques
are to be realized in the shortest possible time, barriers (costs) to
information exchange must be minimized.

A patent creates a significant barrier to information exchange.

Its effect is to confer monopoly rights to the patent holder over a
specified time period. Patents provided to scientists for discoveries
of techniques useful only in the furtherance of basic research reduce
the probability of achieving further advances due to the high cost,
both monetary costs and the loss of time, incurred by other scientists
required to purchase rights or to devise other techniques circum-
venting the patent claim. Thus the benefits accruing to the public
in the form of advances in knowledge, and later as useful products
such as medicinals would be postponed and/or made more expensive.

In this way it can be seen that conferring patent rights, at this
stage, would reduce potential benefits making the already precarious
benefit/risk balance even more so.

It may be argued that patent rights induce invention; an argument
which would seem to contradict the foregoing argument. But in act-
uality, patent rights are employed as a mechanism for compensating
risk.* And in this case, because of full ' governmental funding, this
risk is absent. Extra motivation is of course provided by the "will
to know," as well as by the prestige obtained through publication, and
for extraordinary advances by monetary rewards such as the Nobel Prize

Were patents allowed in such govemmentally funded research,
this would permit private interests to capture extra benefits to the
extent the patent was marketable. The patent holder could in effect
charge the public for the discovery. This would result in a welfare
loss to the public who would not only have funded the research effort,
paying salaries and overhead, but would also now pay a rent for the
use of the product. This is double payment. Patents to researchers
operating under government grants could thus harm the public in two
ways: 1) Create barriers to information exchange; 2) Make final

products more expensive.

*K. J. Arrow, "Economic Welfare and the Allocation of Resources For
Invention," in The Rate and Direction of Inventive Activity: Economic
and Social Factors , National Bureau of Economic Research, Princeton
University Press, 1962, pp. 609-626.

[100]

Finally, it may be argued that not permitting governmentally
funded researchers access to patents allows industrial researchers
to employ the "free" information generated at public expense, to create
patentable products. This would negate the benefits derived from
refusing patents to scientists for their discoveries made through the
governmentally funded research. The patent policy must account for this
eventuality. The simplest remedy for this would give the public the
full patent rights arising from innovations derived from the research
performed under its auspices. Then, should private interests require
this knowledge, they could purchase the rights from the public providing
compensation to the public for its expense and for its incursion of risk.
Public retention of patent rights would also privide the most leverage
for enforcement of rules designed to minimize any further risk arising
from the private research efforts.

Based on these considerations I would urge you to adopt either
Options 2 or 3 as outlined on page three of your letter of 7 September,
1976. However, I believe Option 3 is most consistent with the public
Interest as discussed above; it would retain the benefits from publicly
funded research for the public, and would provide the Department the
most leverage in enforcing the Guidelines or any other regulation it
deems necessary.

Thank you for permitting me th e opportunity to comment on this
very important issues.

Sincerely

Robert Carow

[101]

Pharmaceuticals Division

CIBA-GEIGY

CIBA-GEIGY Corporation
Ardsley, NewYork 10502
Telephone914 478 3131

September 28, 1976

Donald S. Fredrickson, M.D.
Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Since CIBA-GEIGY USA does not conduct any form of recombinant

DNA research it is difficult to comment on the question of patent
applications in this area as requested in your letter of September 7.
Molecular biology, including recombinant DNA research, is included in
our research planning and we are studying both the guidelines and the
patent aspects. As we develop firm positions in this area we will
communicate these to you.

Meanwhile, the consensus of the interested parties of our research

and development is that safety in the conduct of recombinant DNA research
and development covered by the guidelines be kept a separate issue from
patent policy. We believe that patent policy in the antibiotics field
sets a useful precedent for formulating patent policy relative to genetically
. transformed micro-organisms and we are much in favor of the liberalization
of government contracts to universities. The Institutional Patent Agree-
ment made with Stanford and the University of Alabama appears to be suitable
for the field of recombinant DNA research. This patent policy would insure
protection to those capable of carrying out such research safely and should
help to implement such regulations as may be devised in the future.

Among the modifications suggested on page 3 of your letter of

September 7, we would favor option number 5 and I am enclosing an opinion
from our Patent Department on this part of your letter. We hope that
these preliminary observations will be of help to the National Institutes
of Health in formulating patent policy relative to recombinant DNA research.

Sincerely,

KJB; jr
Enel.

K. J. Brunings
Senior Vice President

cc: Dr. G. deStevens

Dr. Hansjdrg Heller
Mr. K. Webb

[102]

C/8A-GEIGY

Corporation

Data:

To:

Location:

From:

Location:

Sut>i«ct:

Interoffice

Correspondence

CIBA-GEIGY

September 24, 1976

Dr. Karl J. Brunnings
Pharmaceutical - MR 2

Joseph G. Kolodny
Patent - OB 1

SEPTEMBER 7, 1976 LETTER FROM

DR. FREDRICKSON (HEW) RE. DNA RESEARCH

In connection with a possible response to Dr. Fredrickson
regarding the above-mentioned subject matter, it would
appear, as a matter of basic philosophy, to permit
organizations which carry out research to obtain some
patent rights on that research. If the policy involving
Institutional Patent Agreements is to be changed, however,

I would prefer option (5) found on page 3 of the Fredrickson
letter. This option permits retention of patent rights by
the researcher but gives HEW an opportunity to approve
licenses which the researcher may wish to grant.

If HEW were to modify the IPA procedure according to its
option (1) , again found on page 3 of the Fredrickson
letter, I would propose that, in addition to publication,
the Institution involved actually file a patent application
to be used as a basis for provision of a defensive publication.
By virtue of this modification, the defensive publication
would be effective for a period of five years as a basis
for instituting an interference and preventing a subsequent
filer from obtaining patent protection.

rf

[103]

1

To

From

THE UNIVERSITY OF CHICAGO

date September 28, 1976

Mr. James

Gustafson

Department Divinity School

Cedric L.

Chernick

department Sponsored Programs

IN RE:

I believe that it is improper for PHS to use patents as a means for
"regulating" recombinant DNA research. Two thoughts come to mind:

1) If NIH is interested in rapid dissemination of research
and safety results it should realize that publication is
more likely to be delayed by the time it takes a journal to
review and publish an article than by patent considerations.

2) If NIH is interested in safety and public apprehension then
there should be some form of control over all recombinant
DNA work- - irrespective of the source of the support funds,
and without consideration as to whether or not the work is
patentable .

We have had little experience at Chicago with patents. The University
Statutes forbid faculty and other employees holding patents on work
done on campus. We are experimenting with some variations in this
policy and have not found any problems or conflicts with rapid publication.
The DHEW patent attorney (Norman Latker) and other Federal agency
officials seem willing to allow filing of patent applications prior
to a determination as to who eventually holds patent rights. This
’relaxing' of the requirements is generally based on an assurance that
rights will later be assigned to the government if it is determined
that the government should hold the patent. This procedure allows
early filing and hence early publication, without prejudicing any
rights .

My view, as previously expressed, is that the patents issue is a
red herring. DHEW should decide what, if anything, should be regulated
and then do it. Universities, not this one, with significant patent
programs will oppose encroachment on their perceived patent rights, and
might regard this is the opening shot in a war. DHEW appears to be
trying to finesse a responsibility. We should help them to avoid such
a decision.

[104]

6724 Tovme Lane Court
McLean, Virginia 22101
29 September 1976

Dr. Donald S. Fredrickson
Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

In response to your letter of August 27 on NIH patent policy for
DNA recombinant research, it seems to me that patenting is preferable
to no patenting, especially if the patent policy can be used to broaden
compliance with the NIH guidelines on DNA recombinant research.

Unfortunately, I have no experience with patents, nor do I have
knowledge of patent law, therefore, my comments are necessarily very
limited.

Thank you for the opportunity to convey my thoughts to you on this
most Important matter.

Sincerely ,

Elena 0. Nightingale, M.D., Ph.D.

[105]

PHARMACEUTICAL MANUFACTi/reRS

Jf'W. Vf ///&//

1155 FIFTEENTH STREET, N . W.
WASHI NGTON, D. C. 20005

C. JOSEPH STETLER
PRESIDENT

AREA CODE 202-296-2440

September 29, 1976

Donald S. Fredrickson, M. D.

Director

Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

We appreciate the opportunity to provide our views and comments on
the patent policy considerations regarding DNA research raised in your
September 7, 1976 letter.

The scientific, moral and social responsibilities of the scientific
community in the new field of recombinant DNA research and development have
been the subject of much discussion in recent months. I know that you are
generally familiar with the PMA' s September 22, 1976 testimony before the
Senate Labor and Public Welfare Committee on this subject. Enclosed is a
copy of our statement in which the PMA notes its support of the general
approach of the June 23, 1976 National Institutes of Health "Guidelines for
Research Involving Recombinant DNA Molecules." The pharmaceutical industry
supports the concept of these voluntary guidelines, subject to minor
modifications. The research-based drug industry will undoubtedly have few
problems in achieving full compliance with the spirit of the guidelines.

The PMA, and its member companies, also strongly support the present
system of laws in the United States for protecting intellectual property
rights. The United States patent law is an essential aspect of intellectual
property right protection in this country, and we oppose any attempts to
weaken this system to the detriment of both the public and the research and
development community. Our support of the United States patent laws in
providing an effective incentive to conduct research and to develop research
results to commercial applications encompasses both Government and privately
funded efforts.

[106]

Representing m a n ufa ctu rers of prescri p tio n pharmaceuticals,

In addition, we support the concept developed by the Department
of Health, Education, and Welfare of providing the first option to
ownership of inventions made in the performance of government research to
those nonprofit or educational institutions having demonstrated technology
transfer capabilities. The HEW's Institutional Patent Agreement has
proved to be an effective means of encouraging commercialization of the
results of Government-funded research. Therefore, we believe the IPA con-
cept will assist in recognizing both the incentives of the United States
patent system and the capabilities of the private sector in commercial-
izing the results of Government-funded research. We recommend the continued
full application of this concept to Government-funded activities in the
area of recombinant DNA research. We see no valid reason for instituting a
separate set of rules for such activities. Any potential safety factors
associated with such research can adequately be addressed without alteration
of the basic arrangement of private ownership of incentive subject matter
under the limitations outlined in the IPA.

Your letter raises the concern of whether reliance upon the
United States patent system may discourage the rapid exchange of research
information within the scientific community. In our view, the opposite is
true — that is, elimination of the patent system in this area of research
would serve to discourage rapid dissemination of information, either through
private sector reliance upon trade secret protection or a reluctance by
Government grantees to make full disclosure in reporting research results to
the Government. Continued reliance upon the incentives of the United States
patent system, through the mechanism of the Standard Institutional Patent
Agreement, will encourage prompt reporting and the dissemination of informa-
tion on research activities in the field of recombinant DNA. Therefore, we
agree with the conclusions of your patent experts to the effect that there
will be no undue burden on disclosure due to reliance on patent protection.

In fact, we feel that the greater the reliance on the patent system the
greater will be the incentive for prompt dissemination of private and Govern-
ment-funded research results.

Your letter lists five options which may be appropriate means of
allocating invention rights to Government grantees. In our view, the first
three options are unacceptable in that patent incentives would not be
utilized to an appropriate extent. We recommend that the Department continue
to permit qualifying institutions to exercise the first option to ownership
under the IPA. However, the Department should request that IPA grantees
license only those institutions which are willing to conduct their DNA
research activities in a manner consistent with Federal Government guidelines
governing such research. Thus, we recommend a modification of your options
4 and 5 under which the grantee institution would license only those concerns

U07]

which comply with appropriate Governmental guidelines on DNA research. It
would be objectionable for the Department to "approve" particular licensees
to to "approve" specific terms or conditions in any licensing agreements
with particular licensees.

As to those Government-funded institutions which do not operate
under an IPA, the Department should condition the granting of ownership to
identified inventions on the institution's willingness to (1) abide by
Governmental guidelines and (2) license only those concerns which also comply
with these guidelines.

Again, we appreciate the opportunity to comment on this very important

aspect of DNA research activities. We will be pleased to discuss with you in
greater detail our recommendations of this area if you have any further
questions.

Respectfully submitted.

Enclosure

[108]

Statement on Recombinant DNA Research
on Behalf of the

Pharmaceutical Manufacturers Association
Before the

Senate Labor and Public Welfare Committee

Sepibqer 2 !> 1975

Mr. Chairman and Members of the Committee :

I am C. Joseph StetleR/ President of the Pharmaceutical
Manufacturers Assoc i at ion, an organization composed of 130 members

THAT DISCOVER/ DEVELOP/ MANUFACTURE AND MARKET MOST OF THE PRESCRIPTION
DRUGS AND A LARGE PERCENTAGE OF THE DIAGNOSTIC REAGENTS AND MEDICAL
DEVICES AVAILABLE IN THE UNITED STATES. ACCOMPANYING ME ARE

Dr. John G. Adam S/ PMA Vice President/ Scientific and Professional •
Relations and Dr. Sidney UdenfrienD/ Vice President and Director of
the Roche Institute of Molecular Biology,

Our testimony hill be brief/ but we hope responsive to the
Subcommittee's inquiry into the involvement of PMA member firms in
recombinant DNA research and our views on the Guidelines recently

PUBLISHED BY THE NATIONAL INSTITUTES Or HEALTH.

The subject of todav's hearings is one which is recognized

BY ALL ELEMENTS OF THE BIOMEDICAL RESEARCH COMMUNITY AS A MAJOR
BREAKTHROUGH ALONG THE FRONTIERS OF SCIENCE. As AN INSTITUTION
ENGAGED IN BIOMEDICAL RESEARCH/ THE DRUG INDUSTRY IS ACUTELY AWARE
OF ITS SCIENTIFIC/ MORAL AND SOCIAL RESPONSIBILITIES IN THIS NEW FIELD

[109]

-2-

OF RESEARCH AND DEVELOPMENT. It IS FOR THIS REASON THAT WE ARE
PLEASED TO APPEAR BEFORE YOUR SUBCOMMITTEE AND OFFER COMMENTS IN
SUPPORT OF A DEVELOPING PUBLIC POLICY THAT HOPEFULLY WILL MAXIMIZE
BENEFITS AND MINIMIZE RISKS,

We have ATTEMPTED., IN PREPARING FOR THE HEARINGS, TO ASSESS
THE EXTENT OF THE ACTIVITY OF OUR MEMBER FIRMS IN THIS PIONEERING AREA.
The RESPONSES REVEALED THAT ALL OF THE MAJOR RESEARCH-ORIENTED
PHARMACEUTICAL FIRMS (ABOUT 30) ARE VERY MUCH INTERESTED IN IT BUT
THAT ONLY A FEW ARE NOW ACTIVELY ENGAGED IN RECOMBINANT DNA RESEARCH.

IT ALSO APPEARS THAT SOME OF THESE FIRMS ARE INVOLVED IN SUCH
RESEARCH AS MANUFACTURERS OF OTHER THAN MEDICINAL CHEMICALS.

WE DO NOT KNOW THE EXTENT OF THEIR EFFORTS IN THESE OTHER FIELDS AND
WE MUST, THEREFORE, LIMIT OUR COMMENTS TO THEIR ACTIVITIES IN BIO-
MEDICAL RESEARCH.

IN VIEW OF THE TECHNICAL NATURE OF THIS SUBJECT, I WOULD LIKE TO

have Dr. Adams present the remainder of our statement and for him

AND Dr. UdENFRIEND TO ANSWER YOUR QUESTIONS. I AM SURE IT WILL BE
CLEAR FROM Dr. ADAMS' STATEMENT THAT THE DRUG INDUSTRY ENDORSES THE
SPIRIT AND INTENT OF THE GUIDELINES RECENTLY PROPOSED BY THE NATIONAL

Institutes of Health. With some minor modifications, which Dr. Adams

WILL IDENTIFY, IT IS OUR OPINION THAT THE DRUG INDUSTRY SHOULD AND
WILL ACCEPT THE GUIDELINES AS AN AFFIRMATIVE AND CONSTRUCTIVE APPROACH,

SlAJlMENl-BY PR., J.QHN-Ga-A^AMS

Mr. Chairman:

As YOU AND THE MEMBERS OF THE SUBCOMMITTEE KNOW, THE PRESCRIPTION
PHARMACEUTICAL INDUSTRY IS VERY HEAVILY INVOLVED IN GENERAL AND
BIOMEDICAL RESEARCH, OUR MEMBER FIRMS HAVE DEMONSTRATED A HIGH

[110]

-3-

LEVEL OF SOPHISTICATION IN THEIR RESEARCH AND DEVELOPMENT PROGRAMS
AS THEIR RECORD OF INNOVATION AND ACCOMPLISHMENT CLEARLY SHOWS.

IT IS NOT SURPRISING, THEREFORE, THAT SCIENTISTS IN THE DRUG
INDUSTRY ARE GENERALLY WELL AWARE OF THE PIONEER WORK IN DNA RESEARCH
WHICH LED TO THE DISCOVERY THAT DNA FRAGMENTS BEARING DISSIMILAR BUT
IMPORTANT GENETIC INFORMATION, COULD BE RECOMBINED IN A HOST CELL TO
CREATE HITHERTO UNKNOWN GENETIC SPECIES.

Industry scientists immediately recognized the potential

APPLICATIONS OF THIS NEW TECHNOLOGY TO MANY BIOLOGICAL PROCESSES,
PARTICULARLY IN THE FIELDS OF MEDICINE AND AGRICULTURE, AND MORE
SPECIFICALLY IN THE PRODUCTION OF IMPORTANT DRUGS FROM NATURAL SOURCES.
It IS ALSO WELL RECOGNIZED BY SCIENTISTS IN THE DRUG INDUSTRY AND
ELSEWHERE THAT THERE ARE POTENTIAL RISKS INHERENT IN THIS NEW
TECHNOLOGY AND THAT GREAT CAUTION MUST BE EXERCISED IN SEEKING ITS
BENEFITS FOR MANKIND. We BELIEVE THE DRUG INDUSTRY HAS THE PROVEN
SCIENTIFIC EXPERIENCE AND CAPABILITY TO EXERCISE THAT JUDGMENT.

REC0M3INANT DNA RESEARCH HAS BEEN, AND WILL CONTINUE TO BE,

THE SUBJECT OF MUCH DEBATE ON THE QUESTION OF BALANCING SCIENTIC!C
FREEDOM TO PURSUE NEW AVENUES OF RESEARCH ON THE ONE HAND, AND
THE NEED FOR PEER REVIEW AND COMPLIANCE WITH VOLUNTARY CONTROLS ON
THE OTHER. We 3ELIEVE THAT THESE TWO CONCEPTS ARE COMPATIBLE AND
ARE ACCEPTED 3Y RESPONSIBLE SCIENTISTS AND MANAGEMENT IN THE DRUG
INDUSTRY AND BY OTHER ELEMENTS OF THE SCIENTIFIC COMMUNITY. To THIS
END, IT IS OUR OPINION THAT A GOOD START HAS BEEN MADE IN THE

"Guidelines for Research Involving Recombinant DNA Molecules",

PUBLISHED IN THE FEDERAL REGISTER ON JULY 7 BY THE NATIONAL INSTITUTES

of Health.

uii]

-4-

As YOU MAY BE AWARE,, REPRESENTATIVES OF THE DRUG INDUSTRY TOOK
PART IN A MEETING CALLED BY THE DIRECTOR OF NIH ON JUNE 2 OF THIS
YEAR. ON THAT OCCASION/ AS THE PPiA SPOKESMAN/ I SAID THAT OUR MEMBER
FIRMS WOULD RESPOND TO THE REQUEST FOR CRITICAL REVIEW OF THE GUIDELINES
AND THAT IMMEDIATE STEPPS WOULD EE TA’KEN TO CONVENE A PANEL OF EXPERTS
FOR THAT PURPOSE. THAT PANEL HAS SINCE STUDIED THE QUESTION/ AND /

IN ADDITION/ WE HAVE REQUESTED COMMENTS FROM ALL OF OUR MEMBER FIRMS
FOR SUBMISSION TO THE DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH
BY THE DUE DATE OF NOVEMBER 1,

We commend the NIH for establishing Guidelines and / particularly/

FOR ITS EFFORTS IN SEEKING A CONSENSUS WITHIN THE SCIENTIFIC COMMUNITY
AND FROM THE PUBLIC AND PRIVATE SECTORS, RESEARCH IN THIS FIELD
HOLDS GREAT PROMISE/ AND IT IS FAIR TO EXPECT THAT THE SAME INNOVATIVE
GENIUS WHICH LED TO ITS DISCOVERY CAN ALSO DESIGN SYSTEMS TO CONTROL
IT THROUGH PEER REVIEW AND PHYSICAL AND BIOLOGICAL CONTAINMENT.

It is important to NOTE THAT the DRUG industry is one of THE MOST
SOPHISTICATED SCIENTIFIC INSTITUTIONS ENGAGED IN THE HANDLING OF
BIOHAZARDOUS MATERIALS. SOME PMA MEMBER FIRMS HAVE LONG EXPERIENCE IN
WORKING WITH PATHOGENIC BACTERIA/ VIRUSES/ RICKETTSIAL AND OTHER
PATHOGENIC MICROBIOLOGICAL ORGANISMS. FOR EXAMPLE/ THE ENTIRE TECHNOLOGY
OF VACCINE RESEARCH AND PRODUCTION REQUIRES INTIMATE KNOWLEDGE OF
BACTERIAL AND VIRAL GENETICS AND IS BASED ON RIGID ADHERENCE TO APPROPRIATE
LEVELS OF PHYSICAL AND BIOLOGICAL CONTAINMENT.

Another example ~ the use of drug-resistant organisms to

TEST NEW ANTIBIOTICS AND OTHER CHEMOTHERAPEUTIC AGENTS AGAINST THESE
STRAINS OF PATHOGENIC MICROORGANISMS. SUCH RESEARCH HAS LED TO THE

[112]

-5-

DISCOVERY OF IMPORTANT NEW MEDICINES. It HAS NOT RESULTED IN ANY
PUBLIC HEALTH PROBLEMS.

One further example of industry's experience and capability is

THE PRODUCTION OF MUTANT STRAINS OF BACTERIA AND OTHER MICROORGANISMS
BY X-RAY AND OTHER MUTAGENIC TECHNIQUES IN RESEARCH DESIGNED
TO INCREASE THE YIELD OF ANTIBIOTICS AND OTHER DRUG SUBSTANCES
PRODUCED BY FERMENTATION.

One MUST CONCLUDE from these examples AND from the excellent

SAFETY RECORD OF THE INDUSTRY IN RESEARCH AND PRODUCTION OF OTHER
POTENTIALLY BIOHAZARDOUS MATERIALS THAT IT IS WELL AWARE OF THE
RISKS INVOLVED/ AND THAT IT HAS THE CAPABILITY TO AVOID CONTAMINATION
OR INJURY TO ITS EMPLOYEES AND TO THE ENVIRONMENT. FOR PMA'S PART/

WE WILL EXERT EVERY EFFORT TO KEEP APPRISED OF OUR MEMBER FIRMS'
INVOLVEMENT IN SUCH RESEARCH/ AND WILL ENCOURAGE COOPERATION WITH THE
SCIENTIFIC COMMUNITY AND OTHER PEER GROUPS/ INCLUDING GOVERNMENT
AGENCIES IN ADOPTING NECESSARY CONTROLS.

IT IS TOO EARLY TO KNOW THE ULTIMATE OUTCOME OF MUCH OF THIS
RESEARCH WHICH HAS AND WILL BE UNDERTAKEN. We MIGHT PREDICT/ HOWEVER/
THAT RECOMBINATION OF DMA IN A HOST BACTERIAL CELL COULD PRODUCE
QUANTITIES OF MEDICALLY NEEDED NATURAL PRODUCTS SUCH AS HORMONES AND
OTHER IMPORTANT DRUGS BY FERMENTATION PROCESSES RATHER THAT BY EXTRACTION
OF SUCH RAW MATERIALS AS PANCREAS CR OTHER TISSUES OF ANIMALS AND PLANTS.

Bacterial or other cultures of such recombinant DNA fragments

COULD be MAINTAINED AND PROPAGATED TO SERVE AS A CONSTANT AND
RELIABLE SOURCE FOR PRODUCTION. NEW RECOM3INANT MOLECULES MIGHT
ALSO SERVE AS BASES FOR NEW ANTIBIOTICS OR AS A MEANS TO INCREASE

[113]

-6-

Y I ELDS OF EXISTING ANTIBIOTICS MUCH IN THE SAME WAY NOW EMPLOYED IN
THE USE OF MUTANT STRAINS. THE APPLICATION OF THIS TECHNOLOGY TO
BASIC RESEARCH OF THE DISEASE PROCESS - MORE SPECIFICALLY TO.
GENETICALLY INDUCED OR ASSOCIATED DISEASE - OFFERS GREAT PROMISE,

The potential risks of recombinant BN A research and its commercial

APPLICATION ARE WELL RECOGNIZED. IT IS PERHAPS UNFORTUNATE THAT THE
TERM HAS BECOME SYNONYMOUS WITH "GENETIC ENGINEERING",

A CONCEPT WHICH IS MOST FREQUENTLY ASSOCIATED WITH THE MANIPULATION
OF HUMAN GENETICS OR WITH THE DELIBERATE CREATION OF HIGHLY TOXIC
OR VIRULENT NEW SPECIES OF PLANT AND ANIMAL CELLS. It IS IMPORTANT,

WE BELIEVE, TO EMPHASIZE THAT THE PRESENT STATE OF THE ART AND THE
PROVISIONS OF THE NIH GUIDELINES MILITATE AGAINST RESEARCH AND
DEVELOPMENT THAT WOULD POSE SUCH A THREAT TO SOCIETY.

IN THE CASE OF THE DRUG INDUSTRY, IT IS HIGHLY UNLIKELY THAT
RESEARCH AND DEVELOPMENT WOULD INVOLVE ORGANISMS IN CLASSES 3, 4 AND 5
AS ESTABLISHED BY THE OFFICE OF BIOSAFETY OF THE CENTER FOR

Disease Control of the U. S. Public Health Service in its publication

ENTITLED "CLASSIFICATION OF ETIOLOGIC AGENTS ON THE BASIS OF HAZARD"

OR THAT ADEQUATE BIOLOGICAL CONTAINMENT PROCEDURES WOULD NOT BE
AVAILABLE FOR EK“1 AND EK**2 HOST VECTOR SYSTEMS. MANY OF OUR MEMBER
FIRMS NOW ROUTINELY USE P“i AND P“2 PHYSICAL CONTAINMENT FACILITIES
IN THEIR RESEARCH OPERATIONS AND IT IS NOT UNCOMMON TO FIND FACILITIES
IN THE DRUG INDUSTRY THAT CORRESPOND VERY CLOSELY TO THE SPECIFICATIONS
FOR P-3 LEVELS OF CONTAINMENT. At LEAST ONE OF OUR FIRMS IS NOW
CONSTRUCTING A P"4 FACILITY.

[114]

-7-

There is little doubt then that the drug industry will be able

TO MEET APPROPRIATE STANDARDS FOR PHYSICAL AND BIOLOGICAL
CONTAINMENT LEVELS OF RECOMBINANT DNA RESEARCH AND DEVELOPMENT.

In FACT, A FAIL-SAFE SYSTEM AND A FAVORABLE 3ENEFIT-RISK RATIO HAVE
ALREADY BEEN ESTABLISHED.

The PMA Expert Advisory Committee, which was convened tn July

AGREES THAT THE SPIRIT AND INTENT OF THE NIH GUIDELINES ARE QUITE
ACCEPTABLE. THE PANEL FURTHER AGREES THAT WITH SOME MINOR MODIFICATIONS,
PHARMACEUTICAL FIRMS WOULD HAVE FEW PROBLEMS IN APPLYING THE GUIDELINES
TO THEIR OWN RESEARCH PROGRAMS. BASED ON RESPONSES TO DATE TO OUR
REQUEST FOR COMMENTS AND SUBJECT TO THESE MINOR MODIFICATIONS
WHICH DO NOT INVOLVE ELEMENTS OF RISK OR SAFETY, IT IS FAIR TO ASSUME
THAT PMA MEMBER FIRMS WILL VOLUNTARILY COMPLY WITH THE GUIDELINES.

IN NO INSTANCE WAS THERE ANY INDICATION BY OUR PANEL THAT THE

Guidelines were inadequate to provide the necessary and desirable

SAFEGUARDS. NOR WERE THERE ANY RESERVATIONS ABOUT INDUSTRY'S ABILITY
TO COMPLY WITH THE PROPOSED CONTAINMENT LEVELS. It WAS ALSO THE
CONSENSUS OF THE PANEL THAT THE CREATION OF RECOMBINANT DNA BlOHAZARD
and/or Research Committees to review and approve research projects

WOULD POSE NO SERIOUS PROBLEM TO INDUSTRY AND COULD EE QUICKLY IMPLEMENTED,

Review of the records of the meetings of such Committees present no

SERIOUS DIFFICULTY, EXCEPT INSOFAR AS SUCH MINUTES MIGHT INVOLVE
PROPRIETARY OR TRADE SECRET INFORMATION. SUCH RECORDS SHOULD NOT
NECESSARILY BE MADE PUBLIC, BUT THEY COULD BE MADE AVAILABLE TO
APPROPRIATE AUTHORITIES WHERE CONFIDENTIALITY COULD BE GUARANTEED. We
DO NOT VIEW THOSE FEATURES OF THE GUIDELINES WHICH MIGHT IMPINGE ON SUCH
INTELLECTUAL PROPERTY RIGHTS AS INSURMOUNTABLE AND TRUST THAT SATISFACTORY

MODI F I CT IONS TO THE GUIDELINES COULD BE ACHIEVED.

[115]

-8-

The only other major concern of industry would be the restriction
on volumes of greater than ten liters. Such a restriction would be

UNREALISTIC IN ANY SCALE-UP OPERATION FOR PRODUCTION PURPOSES. We

recognize that the Guidelines are primarily directed to small-scale

RESEARCH BUT PROVISION MUST BE MADE FOR COMMERCIAL APPLICATION AS
TECHNOLOGY EXPANDS AND THE STATE OF THE ART CHANGES. As IN THE
CASE OF TRADE SECRETS AND PROPRIETARY RIGHTS, WE BELIEVE MODIFICATIONS
OR EXCEPTIONS CAN ACCOMMODATE THIS CONCERN.

Thank you, Mr. Chairman. We will be pleased to respond to your

QUESTIONS.

[116]

THE UPJOHN COMPANY

KALAMAZOO. MICHIGAN 40001
TELEPHONE («10* 3g5_7544

September 29, 1976

pharmaceutical research

AND DEVELOPMENT
OUIce of
O. I. WEIS0LAT
Vic9 Fretideof

Donald S. Fredrickson, M.D., Director
Department of Health, Education, and Welfare
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

We appreciate being consulted, by your letter of September 7 to Dr. Joe
Grady, for our views on HEW patent policy and practices as they may relate
to inventions arising from recombinant DNA research. The issues you have
raised are pertinent, timely, and important. We have given them serious
thought, and I am responding not only for Dr. Grady but to offer the ma-
jority opinion of my associates.

As you are aware, current HEW patent policy and practices have been developed,
sometimes quite slowly, over the past two decades toward the difficult objec-
tive of a balanced approach to stimulating the practical development of in-
ventions for the public good, providing appropriate incentive rewards to
inventors, universities, and industry, and protecting the public from the
misuse of the inventions. Many of us in government, academia, and industry
have been involved from time to time in shaping the present arrangement.

While none of us, I suppose, judge it perfect, most of us consider the pres-
ent system reasonably balanced and, as you have indicated in your letter,
fairly effective.

In our opinion, recombinant DNA inventions should not be handled as special
cases, either outside present HEW policy and practices or under some special
modification thereof. We believe the present system will provide the best
balance of considerations necessary to develop the field to the public's
ultimate best good. Notwithstanding our conviction that exclusivity is a
powerful stinulus to development, we regard the universities as well motivated
and capable to decide whether to patent, dedicate, or otherwise disclose inven-
tions and to determine, with HEW advice, various appropriate conditions and
terms for patent licenses in differing situations.

We are sensitive to the need for effective guidelines for recombinant DNA
research and development, and we strongly support the spirit, intent and,
with some exceptions of which you are aware, the substance of the NIH Guide-
lines for that purpose. We believe the Guidelines, modified to some degree.

[117]

Donald S. Fredrickson, M.D.

-2-

September 29, 1976

should be broadly applicable and, consequently, view patent licenses as an
unsuitable mechanism for their wide promulgation and enforcement. The ty-
ing of patent licenses to commitments on Guidelines would create special
responsibilities for licensees in an uneven way, a generally undesirable
result, and possibly could deter potential developers from seeking licenses.
Short of requiring commitment to the Guidelines by licensees, universities
and government properly might call the attention of licensees to the Guide-
lines and suggest compliance.

In summary, we recommend that recombinant DNA patent matters be handled under
current HEW policy and practices and suggest that guidelines can be implemented
more fairly and effectively by means other than tying them to patent licenses.

We hope the views expressed here will be helpful. If further exploration of
them or of other aspects of the problem would be useful, we would be happy
to discuss them with you.

Sincerely yours,

f

D. I, Weisblat

wm

[118]

DOW CHEMICAL U.S.A.

TEXAS DIVISION

FREEPORT TEXAS 77541

September 29, 1976

Donald S. Fredrickson, M. D.

Di rector

Department of Health, Education,
and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Your recent letter requesting an opinion regarding patent applications
in the area of recombinant DNA research activity has been studied by myself
and others. Being a physician almost automatically disqualifies me from
having much expertise in the patent area.

Consequently, I have asked Dr. R. V. Johnston for his advice and a
copy of his letter is enclosed. For many years Dr. Johnston worked in
the Dow agricultural product field and was involved with patent positions
on biological material. If you have any questions, please feel free to call
Dr. Johnston or myself.

Sincerely,

[

Regional Director
Occupational Health and
Medical Research
Dow Chemical U.S.A.

DJK/jm

Enclosure

c.fRAC/^

(119]

AN OPERATING UNIT OF THE DOW CHEMICAL COMPANY

care

DOW CHEMICAL U.S.A.

TEXAS DIVISION
FREEPORT. TEXAS 776*1

September 13, 1976

Dr. D. J. Kilian
Occupational Health
and Medical Research
B-1222 Building

I was very interested to read Dr. Fredrickson's letter about
patent applications in the area of recombinant DNA. I have
several thoughts as follows:

1. It is my understanding that the purposes of the patent

law are to encourage inventors to disclose their inventions
rather than keeping them as trade secrets, and to provide the
inventor with a legal monopoly for a limited period of time
so that he has a chance to recover his costs before it is
copied.

Thus patents are very important to commercial enterprises.

For example, in my experience, the Dow Agricultural Department
would not invest in the development of a pesticide (which
requires several million dollars) unless they had some patent
rights, either through their own efforts or through purchase
of those rights from someone else.

2. There are several kinds of patents, including compound
patents, process patents, and use patents. The most valuable
patent is a compound patent wherein the owner controls all
uses for the compound. However, someone else may discover

a new use for the compound, and then neither one can use the
compound for this use without agreement of the other. A
process patent covers only a particular process, and someone
else may invent an alternate, or even better process.

I judge that at this point, any patent applications in the
recombinant DNA area would be process patents, a way of doing
it. It would not be possible to obtain a patent on insulin
itself, but one could patent a new process for making or
obtaining it. However, new compounds made by the recombinant
process might be patented, or their use might be patented.

,4

lie i

it'

UJ:

K

[120]

Dr. Kili&n

-2-

Septerber 13, 1976

3. It is my understanding that to be patentable an invention
must be unique, unobvious (to one skilled in the art), and
useful. It will be interesting to see if the developments
in the recombinant DNA area provide useful products such as
human insulin.

With these thoughts in mind, I would favor Dr. Fredrickson's
option 4 permitting institutions to own patents. Then they can
negotiate with private industry to commercialize the invention
in return for certain exclusive or partially-exclusive rights.

If the patent is dedicated to the public, who would be willing
to invest in its commercial development?

I would recommend that you consult our Patent Attorneys for their
views .

Finally, as may be noted from the attached program, the Southwest
Science Forum, of which I am a member, is holding a symposium
on November 11 and 12 which includes a session entitled "Genetic
Manipulation May be Patented", by Colin Norman.

R. V. Johnston, D.V.M.
Occupational Health and

Medical Research
B-1222 Building

mhi

attachment

[121]

UNIVERSITY OF WASHINGTON

SEATTLE, WASHINGTON 9819S

September 30, 1976

Department of Medicine
Office of the Chairman

Donald S. Fredrickson, M.D., Director
National Institutes of Health
Bethesda, Maryland 20014

Dear Don:

I submitted your recent inquiry concerning the patenting of recom-
binant DNA research activity to our University's patent officer and I
am enclosing his answer.

I am also asking one of our basic scientists who is very knowledgeable
in the area to comment on your letter and I shall send his answer along
as soon as it becomes available.

Warmest personal regards

Professor and Chairman

RGP : tg

Enc.

[122]

University of Washington Correspondence

INTERDEPARTMENTAL

GOVERNMENT FISCAL RELATIONS AND PATENT OFFICE

iiasg'a: .tt.v.t,:

275 Administration

S?. JB

AC-70

sc:

Sept umber 27, 1976

TO: Dr. Robert G. Petersdorf

Chairman

Department of Medicine RG-20

FROM: Wallace C. Treibel

Government Fiscal Relations and ,
Patent Officer / a

SUBJECT: Patent Problems Related to Recombinant DNA Research Activity

Apparently, Dr. Fredrickson is seeking opinions from several sources, since
earlier this week, I received a copy of an identical letter addressed to
Mr. Carow of AAMC (via the university business officers headquarters).

Dr. Fredrickson is concerned about loss of safety controls and possible publi-
cation delays that may become factors if patents in the DNA research area are
authorized in the normal manner. These are legitimate concerns, it would seem,
in view of the fundamental processes involved. Dr. Fredrickson gives no indi-
cation, however, in his letter that he has discussed this problem with DHEW's
own patent counsel (Mr. Norman Latker), who might have suggested an effective
approach. If he had discussed the matter with Mr. Latker, I doubt that he
would have suggested the several dubious alternatives listed on Page 3 of his
letter:

Item (1) is not practical where DREW has granted patent decision rights
to the University under an Institutional Patent Agreement (IPA).
Furthermore, publication cannot be entirely relied upon to cut off
adverse patent claims, i.e., during the one-year period after publica-
tion when patent applications can be filed.

Item (2) is also impractical, since universities cannot afford to pay
for purely protective patents.

Item (3) assumes that the DHFU Patent Office can handle the job which
cannot be entrusted to the universities. It further assumes that the
universities would be unwilling to apply Governmental safety guidelines
and appropriate publication safeguards in their dealings with licensees.

I see no reason why the universities would not be fully cooperative in
these areas, since they have the same concerns as DHEW. The principal

[123]

Dr. Petersdorf (cont)

9/27/76

Page Two

justification for DHEW's policy of leaving patent rights to respon-
sible universities (i.e., those having IPA agreements) is that the
universities can do a more effective job of transferring technology —
especially since the inventor is located at the university.

If the proposal under Item (3) were implemented, it would be tanta-
mount to admitting that the IPA procedure is not workable. Not so.

In the final analysis, DHEW's IPA agreements already provide that
the Government has "march in" rights (i.e., requiring the universi-
ties to license widely) in cases where DREW declares that the inven-
tion is "required for public use by governmental regulations, that the
public health, safety, or welfare requires the issuance of such
license(s), or that the public interest would otherwise suffer unless
such license (s) were granted."

Item (4) requiring that DHEW approve prospective licenses before they
are granted by the university would introduce a time delay factor in
the license negotiation process that might hamper effective negoti-
ations by the university (or Research Corporation on behalf of the
university). On the other hand, it might be feasible to modify IPA's
to provide for pre-clearance of certain items (e.g., compliance with
NIH safety guidelines), but only in connection with DNA-related inven-
tions, or other sensitive inventions requiring close monitoring. Such
pre-clearance should be initiated as soon as the invention disclosure
is completed, so that the pre-clearance process would not stifle
decisions on committing funds for patent applications and possible
subsequent licensing negotiations.

I do not understand the logic of approving only exclusive licenses, as
suggested under Item (5), unless Dr. Fredrickson means that DHEW would
not be concerned about these problems if the institution licensed on a
non-exclusive basis. That doesn't make sense to me, since the problems
he is concerned about need to be addressed, no matter whether licensing
is exclusive or non-exclusive.

The specific case that brought this matter to Dr. Fredrickson's attention is
the Stanford-Calif ornia invention by Dr. Cohen and Dr. Boyer (see attached
summary). In my opinion, this is a good illustration of the fact that the
universities do act responsibly in their handling of invention rights dele-
gated by DHEW. It may be necessary to implement some additional cross-
checking with DHEW along the lines I suggested above in the handling of the
DNA-related inventions, but I see no justification for disturbing basic

[124]

Dr. Petersdorf (cont)

9/27/76

Page Three

arrangements that have been working well for more than eighL years.

Please let me know if you have any questions regarding the above comments
or opinions.

WCT : mb
ATT.

[125]

ELI LILLY AND COMPANY

INDIANAPOLIS, INDIANA 40100

C. W. PETTINGA
EXECUTIVE VICE PRESIDENT

September 30 , 1976

Donald S. Fredrickson, M.D.

Director, National Institutes of Health
Department of Health, Education,
and Welfare

Bethesda, Maryland 20014
Dear Dr. Fredrickson:

We appreciate your courtesy in asking for our comments on
patent policy in the area of recombinant DNA research
activity. The background information which your letter
provided substantially assisted in our appraisal of this
situation and in the development of our views. We have
carefully considered the points in your letter and have
the following comments.

Stanford University and the University of California
Patent Applications for the Process of Forming
Recombinant DNA and the Appropriate Administration
by NIH of Patent Activity in this Area:

Assuming these applications described patentable
inventions, we feel that the patents should issue
to the universities as would any other patent
under an Institutional Patent Agreement. In our
view, the IPA program as administered by HEW has
fostered and encouraged productive research and
has well served the public interest.

Although the scope of coverage of patents for
inventions in the recombinant DNA field is
potentially broad, we do not feel that NIH should
substantially modify its basic policies as con-
tained in the IPA program for inventions in this
area. The IPA program has encouraged the develop-
ment of new technology and has provided incentives
for industry to invest not only in research but
in production facilities to bring the products of
such research to the public.

[126]

Donald S. Fredrickson, M.D.
Page 2

September 30, 1976

Need for Adherence to the Guidelines:

It appears entirely appropriate for NIH to administer
patents and licenses in the recombinant DNA research
activity area in a manner that will require commit-
ments from patent holders and licensees to observe
appropriate safeguards, including adherence to the
guidelines. As you know, the various pharmaceutical
manufacturers engaged in research in this field have
indicated a willingness to follow appropriate guide-
lines and have offered suggestions with respect to
their further development.

Therefore, we recommend that NIH adopt in principle
option 4 as outlined on page 3 of your letter of
September 7. We suggest, however, that it should
not be necessary for the Department to approve
individual licensees, but that patent holders include
in license requirements that licensees agree to follow
the guidelines.

We feel that the overwhelming public health consider-
ations applicable to research in the recombinant DNA
field should prompt NIH to include this basic require-
ment in its further negotiations with the universities.
In all probability, these universities would have no
objection to including in their license agreements
guideline adherence requirements.

Dissemination of Research Information:

As noted in your letter, the present patent system
provides incentives for research and development in
a manner consistent with the public interest. It
also provides for prompt publication of data involving
new inventions. To forestall inappropriate delays in
the processing of patent applications in the field of
recombinant DNA activity, such applications could
receive "special" treatment in the Patent and Trade-
mark Office. The Office could be requested by HEW
to accord "special" treatment to applications in
this field. A precedent exists for such treatment
in the field of inventions associated with environ-
mental protection.

[127]

Donald S. Fredrickson, M.D.
Page 3

September 30, 1976

We trust the foregoing comments are of assistance to
you in your continuing activities in this field.
Thank you again for your courtesy in soliciting our
views .

Very truly yours.

CWP:rom

[128]

MERCK INSTITUTE

FOR THERAPEUTIC RESEARCH

RAHWAY NSW JERSEY 0706S

it ROME BIRNBAUM P» 0

[•fCv'-vi o «ecto«
l*i>C B^iOC'CAi SC SNCIS

leifpHONe ?ot) 574 ee®2

September 30, 1976

Dr. Donald S. Frederlckson
Director, Public Health Service
Department of Health, Education & Welfare
National Institutes of Health
Bethesda, Maryland 2001A

Dear Dr. Frederlckson:

Thank you for your letter of September 7, 1976, inviting my comments with respect
to patents as they relate to the area of recombinant DNA research.

There can be little dispute that inventions made at public institutions under
Government-sponsored research constitute a valuable national resource. We share
your enthusiasm for DHEW's enlightened patent policy concerning the allocation of
rights to inventions. The incentives provided by the Department's policy have
encouraged the utilization of inventions arising from DHEW-funded research and
have fostered the fullest exploitation of such inventions for the public benefit.

The Institutional Patent Agreement has been particularly effective in the
successful transfer of grant-supported research to industry and ultimately to
the marketplace. The impact the Department's IPA program has made on Government
patent policy is evidenced by a recent announcement by the General Services
Administration. We were pleased to learn that GSA is proposing to amend the Federal
Procurement Regulations concerning patents to provide that educational and non-
profit institutions with an acceptable technology transfer program may retain
title to inventions made in the course of Government contracts. The GSA proposal
is to be implemented by adding to the Procurement Regulations provisions virtually
identical with DHEW's Institutional Patent Agreement. It is apparent that the
Department's IPA should eventually be utilized by all departments and agencies of
the executive.

We should not wish to have the thrust of the Department's IPA program diluted or
compromised. As responsible members of the scientific community, we appreciate
your concern that the development of promising new techniques related to recombinant
DNA technology be safely pursued. However, we believe that the safe conduct of
this research can be achieved without jeopardizing the highly effective IPA
program. Although we are of the opinion that patents are not the appropriate
vehicle to attempt to insure compliance with Government standards or guidelines, we
recognize that recombinant DNA research presents a unique situation. Accordingly,
we propose a modification of Option Number A on page 3 of your letter in order to

[129]

- 2 -

accomplish the desired result. Approval of potential licenses by the Department
would be conditioned on their compliance with the NIH Guidelines. However, it
should be emphasized that the Department's approval or denial of licenses be
precisely limited to a determination of the licensees' ability and intent to
comply with the guidelines. The terms and conditions of the license agreement
must be left to arms-length negotiation by the parties. In this way, the
integrity of the IPA may be maintained, thereby preserving the incentive to
pursue this vital area of technology with the assurance that appropriate condi-
tions of safety shall be exercised in the research effort.

Insofar as the concern you express in your letter regarding patents and the
effect they may have on the dissemination of research information, it has been
our experience that it is the patent right that insures the rapid publication
of technical information. Patents represent the indicia of the Governmental
effort to reward the inventor for the disclosure of his invention by giving him,
for a fixed period, the right to exclude others from its practice. In environ-
ments were patents are denied or the right severely limited, the exchange of
research information is impeded. In those circumstances, one's interest may
often be protected only by resort to the "trade secret" approach whereby informa-
tion is withheld from the public. A viable patent system insures prompt and full
disclosure. In fact, early publication of research information involving
recombinant DNA technology can be best assured under the existing IPA program.

We hope that you find our comments useful. If you should have any questions
concerning this letter or if I may be of further assistance with respect to
this matter, please do not hesitate to call upon me.

[130]

UTAtUtHlO mot

E. I. du Pont de Nemours & Company

MCO«*0«4'CO

Wilmington, Delaware I989Q

LEGAL DEPARTMENT

October 1976

Donald S. Fredrickson, M.D.

Director, Public Health Service
Dept, of Health, Education and Welfare
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Your letter of September 7, 1976, to Dr. C. C. McDonald
of our Central Research and Development Department soliciting
our views on the question of patent activities in the area of
recombinant DMA research activity has been referred to my office.
We in Du Pont welcome the opportunity to present our views on
patenting and licensing in this important research area as well
as on your Department patent policy as it relates to the five
options you have outlined on page 3 of your letter.

As you might expect, we in Du Pont are always interested
in new research horizons and recombinant DMA research is no
exception. In view of our large commitment to R&D activities,
we attach great importance to the patent system as an R&D incen-
tive. Although your letter is primarily concerned with research
efforts stemming from Government (HEW) grants, we visualize
that in this area dealing with the transplanting of genes,
private industry will eventually be playing an important part.

Your Department's normal policy of allocating invention
rights, as we understand it, has our support for we feel that
it is flexible enough to be responsive to both academic and
industry's needs, provides the incentive necessary for widespread
industry participation in NIH programs, and improves the chances
of dissemination of research information. V/e believe that to
stimulate the development of inventions in the recombinant DMA
area, in fact in any field, and to encourage the commercialization
of such inventions, the best policy is one which provides the
historical Incentives of our present patent system. This
clearly encourages participation by companies having technology
transfer capabilities.

We support the position that NIH should continue
to have the authority to negotiate with all contractors and
recipients of grants regarding rights to patents and technical
information resulting from cooperative research efforts with

[131]

Donald S. Fredrickson, M.D.

-2-

governmental agencies and authority to waive such rights if a
waiver is found to be in the best interest of the United States
and the public. Such authority is needed to continue to encourage
wide industry participation in NIH projects and to give NIH
flexibility to deal effectively with situations which cannot
be anticipated. A rigid policy requiring NIH to take title to
all patents resulting from cooperative research or otherwise
denying a private party a reasonable award for its background
rights or its efforts to discover improved technologies
seriously discourages industry's participation

The U.S. patent system offers inven ors and industry
a reasonable incentive to spend the time and money necessary for
the discovery of new and better processes and products. The
incentive is the exclusive right which a patent grants to practice
an invention for 17 years in return for a full disclosure of
the invention to the public. The exclusive right to practice
an invention for 17 years is a valuable incentive for research
and development because it provides a sheltered period during
which research and development expenditures can be recouped.

The disclosure is of benefit since it is available to the public
when the patent issues and thereby acts as a springboard for
further advances by others. Moreover, upon termination of the
patent, the invention can be freely practiced by everybody.

In contrast, without a viable patent system, it would be necessary
to keep inventions secret in order to prevent piracy, and the
advance of technical knowledge would be greatly Impeded.

We believe strongly that mandatory licensing of patents
covering recombinant DNA-related inventions would effectively
deny the benefits of the present patent system to inventors of
such subject matter and eliminate much of the incentive of
industry to participate in such work. Accordingly, we feel that
mandatory licensing of such patents would be counterproductive
to the achievement of NIH's objectives.

Inasmuch as you were kind enough to solicit our views
as to your reply to Stanford on how they might administer
appropriately any patent that they secure on their new genetic
engineering technique we would not cast our vote for any of
your options numbered 1-5- Ownership should remain with the
university but the university might be urged to license such a
patent on a basis which would provide sufficient incentive
for commercialization and encourage responsible companies to pursue
work in the recombinant DNA area and generate subsidiary inven-
tions. We feel, as do your patent people, that your departmental
policy of rapid dissemination of research will not be burdened
by the processing of patent applications.

[132]

Donald S. Fredrickson, M.D.

-3-

In the event that Stanford University would be willing
to publish their findings prior to issuance of their patent,
the sooner, of course, the scientific community would be apprised
of the scope of allowable claims, and could commence taking any
steps deemed appropriate.

There is still another aspect of the matter that is
raised by your letter which we should like to briefly touch upon.
That is whether the U.S. patent system should be employed in
some manner to help protect the public health and insure greater
safety to the American people from any unexpected results of
recombinant DNA research. It is our view that safeguarding
against any such eventualities should be provided by the Federal
Government and by means which are exclusive of patents or patent
license provisions. Merely to place restrictions upon licenses
that NIH might grant as a result of Government subsidies would not
adequately protect the public inasmuch as at least some research
will undoubtedly take place without benefit of Government
funding. Safeguards should be provided by the Federal Government
by means other than our patent system.

We hope the foregoing will aid you in your deliberations
on this important subject. Please call on us if you have any
questions about our comments or if we can further assist you in
any way.

Very truly yours.

C. Harold Herr

CHH : kt

[133]

WYETH LABORATORIES ISC.

P. O Box 8399. Philadelphia. Pennsylvania 19101

Wyeth

RESEARCH AND DEVELOPMENT DEPARTMENT

October 4, 1976

Dr. Donald S. Fredrickson, Director
National Institutes of Health
Department of Health, Education, and V/elfare
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Thank you for your letter of September 7, 1976, regarding patent appli-
cations in the area of recombinant DNA research activity. I apologize for this
belated reply.

I have sought the advice of our legal department, and they feel that
option (4) as set forth on page 3 of your letter is the proper course for NIH
to take. According to our attorneys,

"This would continue the present NIH policy, which
seems to be working pretty well, while giving HEW
the opportunity to control safety precautions. We
are vigorously opposed to any lessening of patent
rights in this area because of the perceived great
importance in rapid dissemination of information.

The patenting process need not slow down disclosure.
Further, and more importantly, i t would be rather
anomalous for HEW to recognize the value of patents
in bringing the fruits of research to the benefit of
the public, and then eliminate the use of the patent
system in a particular area because that area is of
great importance. One could better argue that the more
important the research area, the greater is the need
to use the tools which will bring beneficial discoveries
to publ i c use."

I hope that these comments are helpful.

Sincerely yours,

Mark H. Levner, Ph.D.
Senior Microbiologist

[134]

INSTITUTE OF SOCIETY, ETHICS AND THE LIFE SCIENCES

Hastings Center

DAN I ( l CAllAHAN
Director

October 5, 1976

Dr. Donald S. Fredrickson
Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Somewhat tardily, I am responding to your letter of September 8,
soliciting my views on the question of patent applications in the area
of recombinant DMA research activity.

Wc have discussed the issue here, and agree that it is both an
important and yet difficult one. In general, it seems important to us
that the government have some way of both controlling and monitoring
research on recombinant DNA. For that reason, it does seem to us that
some special provisions are necessary.

Of the various options mentioned in your letter, Option 3 seems to us
to make the most sense. That is, institutions should be asked to assign all
inventions made in performance of recombinant DNA research to the Department
of Health, Education and Welfare. That option, as we understand it, would
allow the greatest possible leeway to the Department. It would not necessarily
stifle the private pursuit of recombinant DNA research, since the Department
could Indeed license various patented inventions, and yet at the same time
it would allow the public to be protected from some of the untoward
possibilities of DNA research--by the mechanism of the selection of those
who would be licensed, and perhaps further conditions concerning the
monitoring of the license.

I would emphasize that I am not speaking here for the Institute, but
rather speaking for myself, after informal consultation with various
people here.

Sincerely,

Daniel Callahan

DC/ern

[135]

360 BROADWAY

HASTINCS-ON-HUDSON, N. Y. 10706

(910 478-0500

GIANT F~ O O D I NO.

BOX 10 0 4 • WASHINGTON. D C 20013

ESTHER PETERSON

VICE PRESIDENT
CONSUMER i'HOGRAMS

October 5, 1976

Dr. Donald S. Fredrickson, Director
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Please pardon my delay in responding to your letter of
September 10 relative to patent applications on a process
for forming recombinant DNA. My delay has been one of trying
to think through this very important, complicated issue as it
relates to the request in your letter.

I must begin by saying I have no competence in the area
of patents, but I am generally disturbed. After reading and
being present at the meetings at NIH, I am aware of the explosive-
ness of this research. I recognize your problems in trying to
set up guidelines. It is such a delicate subject. I do feel
that the primary objective of the entire project must be the
dissemination of results of the research, particularly as
regards public safety. It seems reasonable to encourage rapid
dissemination of information as part of this effort to insure
safety. I would hope that a patent process that best addresses
itself to this end be adopted. I feel that probably the best
would be #4. At some point, however, serious expert review
of the safety implications should be incorporated into the
process .

I am concerned, though, as to why the patent? Is it for
money making? Is it for control of ideas? I do not know, and I
have not been able to do the research to find out. I feel very
strongly about avoiding any confrnercialism in this area, and I
am truly frightened. I think I can speak for most consumers
when I say that we want assurance that no "Andromeda strain"
will occur from the research. Whether any of the patent choices
even touch on this question, I simply cannot tell. Some
approaches seem to provide greater control on the patent than
others by the government or by the institution, but that doesn't
really address the consumer question.

I regret that I cannot be moire constructive. I recognize
the burden of the decision that you have. I do want positive
research that can help mankind to go forward. I do not want
the work commercialized unnecessarily or held back. However,

[136]

-2-

I do want controls so that no scientist will be able to move
into what I call a never-never land where negative results
for all of society might come forth.

Please know I feel the burden of your decision and wish,
beyond all things, that I could be more

Sincerely,

EP/sz

[137]

UNITED STATES DEPARTMENT OF COMMERCE
Patent and Trademark Office

Address : COMMISSIONER OF PATENTS AND TRADEMARKS
Washington, D.C. 20231

October 12, 1976

Dr. Donald S. Fredrickson

Director, Public Health Service

National Institutes of Health

Department of Health, Education, and. Welfare

Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Dr. Hartwell has asked that I write you in connection
with the inquiries contained in your letter of
September 7, 1976. These concerned the patent policies
of the Department of Health, Education, and Welfare
in relation to recombinant DNA research activity.

From your letter and the attachment regarding the patent
application filed by Stanford University and the University
of California, I gather that your principal concerns in
this matter are first, that there be rapid exchange of
information in this important new field, and second, that
there be some degree of control over the type of experi-
ments carried on to avoid possible hazards to humans.
Presumably there is also the desire to make available to
the participating institutions the incentives for
exploitation which patents provide, so long as this does
not interfere unduly with an appropriate resolution of
your other concerns.

It would seem to me that patents offer a very good vehicle
for the sort of control which you would like to maintain.
Either options 3 or 4, of those listed on page 3 of your
letter, would afford your department the opportunity to
set whatever conditions of use or experimentation might
seem appropriate in any licensing of the patents. This
opportunity would not exist if either option 1 or option
2 were selected, and would only partially exist with option
5. Whether this consideration should be the dominant one
of course depends on how vital you consider it to be able
to exercise this sort of control.

[138]

Dr. Donald S. Fredrickson
October 12, 1976
page 2

If it appears that the concern about development of hazard-
ous materials can be satisfied by voluntary compliance
with guidelines and if the patent incentive is not important
in this particular situation (for government - sponsored
research), then I see no problem with use of options 1 or
2. The very promptest publication and communication of
research results probably would occur if no patenting is
attempted. On the other hand, the preparation of patent
applications need not introduce very much delay in disclo-
sure, as your patent people have indicated. It should also
be kept in mind that it is ordinarily much easier to
commercialize patented inventions than those which any
one is free to copy.

You will understand that my judgment in this matter is
based on very limited knowledge of the situation, but all
the circumstances noted above would make me think that
option 4 might be most desirable. This would provide the
institutions encouragement to exploit their developments,
would give your department as much control as you choose
to exert, and should not significantly delay publication
or other dissemination of the results.

Verv trulv vrmre

C. Marshall Dann

Commissioner of Patents and Trademarks

cc: Dr. W. V. Hartwell

(139]

Dorsey. Windhorst, Hannaford, Whitney & Halladay

2 3 0 0 FIRST NATIONAL BANK BUILDING
MINNEAPOLIS, MINNESOTA 55-402
(612) 3-40-2600

cable: dorow
telex: 29-0605
TELECOPIER: (612) 340-2060

October 13, 1976

Dr. Donald S. Fredrickson
Dept, of Health, Education & Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland - 20014

Re: Our File No. 230605-0

Dear Dr. Fredrickson:

This is in response to your September letter
asking for my views on the question of patent applications
in the area of recombinant DNA research. I apologize for
not having answered sooner, but the press of other business
and several out-of-town trips have prevented me from ade-
quately focusing on the questions raised in your very
thoughtful letter. I have at last had time to give the
consideration to the problems raised which your letter
seemed to indicate. As a result, I have come to the con-
clusion that the best policy for the Department to follow
is to continue its current policy which encompasses the use
of an institutional patent agreement of the type set forth
in your letter.

The reasons that I have reached such conclusion
may be summarized somewhat as follows:

1) I am a firm believer in the free enterprise system,
an essential element of which is the U.S. patent system. I
understand that U.S. patents are issuable in connection with
all inventions except those in certain areas primarily in-
volving atomic energy and the space program. I do not know
all of the reasons why patents were prohibited in such areas.
However, to the extent such prohibition was based upon the
desire, through secrecy, to prevent the proliferation of de-
vices extremely dangerous to mankind, such policy has been
signularly unsuccessful. Based upon such experience, I feel
sure that the results of recombinant DNA research will be-
come available to the public and be available for "bad" as
well as "good" purposes. Therefore, I see no reason to
adopt a policy designed to ■ discourage the issuance of pa-
tents resulting from such research.

1460 W-FIRST NATIONAL BANK BUILDING
ST. PAUL. MINNESOTA 55101
(612) 227-0017

116 THIRD STREET SOUTHWEST
ROCHESTER, MINNESOTA 55901
(507) 200-3156

JULE M. HANNAFORD

(612) 340 - 2730

[140]

OORSCT KmOHORST HtNNtrORO WhiTNCT & HallaOAY

Dr. Donald S. Fredrickson 2 October 13, 1976

2) I fully subscribe to the view previously expressed
by the Advisory Committee that knowledge with respect to
indicated safety precautions in recombinant DNA research
should be promptly disseminated. I suspect that a lot of
such knowledge can be disseminated without publishing one

or more inventions resulting from such research. When
such dissemination would result in the publication of an
invention and thus prevent a patent on the invention from
being obtained in one or more countries, I believe that
delay in the dissemination of such knowledge until a U.S.
patent application can be filed should be an option avail-
able to the inventor and would itt be a disaster from the
public interest point of view. In this connection, I under-
stand that publication with respect to an invention, after a
U.S. patent application has been filed but before a foreign
patent application has been filed, for example, in France,
will not prevent the issuance of a patent in France or, for
that matter, in most foreign countries. Such a policy should
not, therefore, result in a long delay of dissemination of
the knowledge.

3) I oppose a requirement that patents resulting
from the research be dedicated to the public or assigned
to HEW and a requirement that patent licenses, whether or
not exlusive, be approved by HEW. I take this position
not only because, as I have indicated above, I am a strong
believer in the patent system, but also because I believe
that the red tape involved in obtaining licenses or ap-
proval of licenses from a government agency would be a sig-
nificant deterrent to research and development activities —
even those financed by HEW.

In conclusion, while I recognize that the list
of horribles which can result from recombinant DNA research
is probably inexhaustible, I am basically a pessimist about
the possibility of preventing the occurrence of any such
horrible through government control of patents and patent
licensing or through government regulation of the research
activities. I suggest that, perhaps, the most defensible
course of action which the Department can take might be to
get out of the business of funding such research and attempt
to control the research process by regulation.

meeting .

I look forward to seeing you again at the December

Very truly yours,

/

Jule M. Hannaford ^

JMH : DAV

[141]

October 14, 1976

Dr. Donald S. Frederickson
Director, National Institutes
of Health

9000 Rockville Pike
Bethesda, Maryland 20014

Dear Don:

Recently you wrote to Mr. Robert Carow, a staff member of the Asso-
ciation of American Medical Colleges, asking for the views of the
Association with respect to the patent policy of the National Insti-
tutes of Health as it might apply to discoveries arising from recom-
binant DNA research. We have reviewed your letter to Mr. Carow to-
gether with other materials relating to recombinant DNA research.
After discussion, we recommend that you continue the present patent
policy of the National Institutes of Health. We understand that
Stanford and the University of California both have entered into
institutional patent agreements with the Department of Health, Edu-
cation and Welfare. Under the Department's normal policy of allo-
cation of invention rights, we understand that the innovating insti-
tution retains the primary right to convey ideas as patented intel-
lectual -property. We see no reason to alter existing department
guidelines on patent policy and believe that some version of the
fourth option, set out on the third page of your letter, is the most
appropriate choice. This option would permit institutions to exer-
cise their option of ownership but require that all licensing of
patented inventions be approved by the Department.

We believe, further, that the NIH guidelines on DNA research should
be extended to industry. In keeping with this belief the course of
action you suggest, i.e., that compliance with the NIH guidelines
on recombinant DNA research should be required of the secondary
licensee, is the best course to follow. However, we hold that the
enforcement of the secondary licensee's compliance with NIH guide-
lines should be the responsibility of the primary patent holder and
not the U.S. government. Our position follows from the fact that
the government would not assume the primary role of enforcer in
other patent circumstances. We hope that our views on this subject
are helpful to you in reaching a decision and would be glad to dis-
cuss the problem further if you desire.

John F. Sherman, Ph.D
Vice President

[142]

Suite 200/ One Dupont Circle, N.W./ Washington, D.C. 20036/(202) 4-66-51 OO

National Academy of Sciences

orncc or tnc ••choc*»t

• •O' CONSTITUTION AVC NUl

waihinqtqn.O C IO+ •

October 18, 1976

Dr. Donald S. Fredrickson
Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Don:

I write in response to your letter of September 8 to express
our appreciation for being kept abreast of the developments within
your Department concerning recombinant DNA research. I also am
responding to your solicitation of views concerning the Department's
patent policy as it relates to policy option for dealing with the
transfer of technology arising from such research. Your communica-
tion was submitted to the Executive Committee of the Assembly of
Life Sciences for their information and review. However, the mem-
bership of that Committee has had rather limited experience with
both governmental patent policy and patent practices in general.
Accordingly, they were understandably reluctant to take a position
or formally comment upon the options suggested in your letter. They
did agree, however, that the overriding consideration was the effec-
tiveness of the adopted approach in insuring compliance with the
research guidelines of the National Institutes of Health. I agree,
and must add that there is certainly no need to provide the incen-
tive of patentability to assure that the potential societal bene-
fits of the technology in question will be vigorously pursued.

After reviewing the conditions as described in your letter and
upon further discussions with staff of the National Research Council,
my own view is that, of the policy options listed in your letter.
Option Four would seem to provide the most useful mechanism for
serving the several policy objectives of the Department, as outlined
in your letter, i.e., facilitating the transfer of technology, pro-
moting the dissemination of research information, and protecting the
public Interest as reflected in the guidelines on DNA research.

[143]

Dr. Donald S. Fredrickson
October 18, 1976
Page Two

It should be noted, however, that the exercise of regulatory
controls through the patent process is, at best, an awkward practice.
While it may be necessary to satisfy immediate concerns , over the
long term, the Federal Government may well wish to consider the
alternative of providing for regulation of the production process
for industrial and commercial uses of recombinant DNA technology in
a similar manner to Federal regulatory practices followed with
respect to the food and drug industries.

I regret that we do not have sufficient experience to comment
in greater detail and more constructively on the Department's patent
policy.

Since

yours ,

Philip Handler
President

[144]

American Patent Law Association

SUITE 20J . 2001 JEFFERSON DAVIS HIGHWAY. ARLINGTON, VA. 22202

Telephone (?03) $21-1680

October 20, 1976

Reply to:

800 N. Lindbergh Blvd.
St. Louis, Missouri 63166

Prnidtat
John D. Uiham

Pniidt*l-EUrl
Donald V. Bannia

III Vi er-Prtiidrnl
Tom Aanolo

2*4 Virt-Prriidrnl
Donald R. Dvnnia

Donald S. Fredrickson, M.D.
Director

Department of Health, Education,
and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Stcrttery

Maagaait M. Uvmnci

T tttnrrr

Fdwaad J. Bmnnii

Re: HEW Patent Policy for

Recombinant DNA Research

Dear Dr. Fredrickson:

Drtrf tit le ABA
Ho uii of Dr U ft In

V. Baovn Moaton. Ja.

Co**eilmo* to NCPLA
Faana L Niuhavaba

Put Prtll4f*l
Edvaad F. MrKrt, J*.

Board of Mtnogtri
The ibott penonj and
Rouit T. Eoill
Maicvi B. Finmican
JimuoN D Gillia
Thomas F. Smical, Ja.
H. Faaoaka Ha mann
Iattno t. Hatton
D. Caal Richaaoa
Haaaiat M ▼olpaon
JcHBAH A. DiGaaNDI
Jambs H. Laucmlin, Ja.
Micmabl N. Mbllia
Thomas E. Smith

Etrnlm Drnclor
Chaalottb E. Gauia

The American Patent Law Association (APLA)
membership, over 4,000, is made up of judges, law
professors, and over one-half of the patent lawyers
in the United States, engaged in private, corporate
and government practice.

After study and recommendations by our Govern-
ment Patent Policy Committee, the Board of Managers of
APLA adopted the following resolution:

Responsive to the request of Donald S.
Fredrickson, M.D., Director, Department
of Health, Education and Welfare, Public
Health Service, National Institutes of
Health, in a letter dated September 7, 1976
to the Manufacturing Chemists Association
and other organizations, concerning patent
applications in the area of recombinant DNA
under Institutional Patent Agreements;

Whereas , the Institutional Patent
Agreements used by the Department of Health,
Education and Welfare provide comprehensive
safeguards for the public interest; and

Whereas , the Institutional Patent Agreements
and the incentives of the patent system do
not unreasonably inhibit the rapid and full
disclosure of research results;

[145]

Donald S. Fredrickson, M.D. -2- October 20, 1976

Resolved , the American Patent Law
Association believes that the Institutional
Patent Agreements used by the Department of
Health, Education and Welfare should be
uniformly applied to all technologies;

Specifically , the American Patent Law
Association believes the Institutional
Patent Agreements should not be abrogated
or modified for recombinant DNA research.

I might add that some members of the Board felt
that patent licensing may not be the best vehicle for
assuring adherence to safety standards. The Board was
in agreement, however, that it would be permissible for
the Department of Health, Education and Welfare to require
that licensees adhere to such standards as may be
approved by the Department.

We hope our views will be of assistance to you
in formulating policy in this important area.

Sincerely

President

nh

[146]

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October 26, 1976

Dr. Donald S. Fredrickson
Director

Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Thank you for the materials on recombinant DNA
molecules recently submitted to us. We are
pleased to learn that you have determined to seek
the advice of the industrial community in this new
and complex field of research.

As you know. Industry has an excellent record of safe
handling of pathogens and other toxic agents. Although
I can not speak for all of industry or even all members
of the Industrial Research Institute, I believe that
I.R.I. member companies engaged in this research effort
will comply with the NIH guidelines relevant to physical
and biological containment.

With respect to your guidelines for DNA recombinant
research, I want to take this opportunity to point out
several problems which are of concern. The first
problem Is one of assuring industry that the con-
fidentiality of its research and development efforts
will be protected. If the guidelines were to be
followed totally, a great deal of information on a
company's research and development plans would have
to be provided to an extramural advisory committee.

Such information might then be subject to disclosure
under the Freedom of Information Act or even through
informal channels. Protection of trade secrets is an
important incentive to research in all areas.

A second problem concerns the limitation on size of
experiment. As currently worded, the specification
is cause for concern among some of our member companies ,
and requires additional discussion before the guidelines
are finalized.

Finally, there is the question of commercial development
of government-funded inventions in this area. We are

[147]

V.

Dr. Donald S. Fredrickson
Page 2

October 26, 1976

concerned that the government continue its policy of providing
an effective incentive to the conduct of research. We believe this
can best be accomplished by continuation of the policy of assigning
ovmership of inventions made in the performance of government
research to those institutions demonstrating appropriate technology
transfer capabilities.

In this regard, we do not believe that the area of recombinant DNA
research should be treated differently than other research. Any
potential safety problems can and should be resolved within the
frame-work for the commercialization of government-funded inventions.

You will be interested to know that the I.R.I. Board of Directors
reviewed these matters at its meeting last week and requested our
Federal Science & Technology Committee to serve as the focal point
for future I.R.I. interaction with NIH.

We trust that these comments and the action of our Board will be
helpful. We would particularly appreciate an opportunity to discuss
with you some possible solutions to the problem of confidential
review referred to above. I shall be in touch soon so that we may
make appropriate arrangements.

Cordially yours,")

Charles F. Larson
Executive Director

CFL :bf

[148]

Abbott Laboratories
North Chicago. Illinois 60064

October 27, 1976

Donald S. Fredrickson, M.D.

Department of Health, Education & Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

We are pleased to offer comments concerning the patent policy
matters in the area of recombinant DNA research activity set
forth in your letter of September 7, 1976.

Because of the potential importance of the field and public
apprehension over its control, there are three primary goals
which should be considered in developing a sound patent policy.

We believe that such a policy should:

1. Provide incentive for expenditure of risk
capital,

2. Encourage the rapid exchange of information
throughout- the scientific community,

3. Provide assurances that guidelines for
conducting recombinant DNA research as set
forth by the Department are adhered to by
researchers .

There are five options listed in your letter concerning treatment
of rights developed out of research funded by the Department.

The first and second options would eliminate licensable patent
rights and provide no commercial incentive for expenditure of
research funds. They would also tend to delay the publication
of information because of the reluctance of researchers to rapidly
submit publications in the absence of proprietary rights. Option
3 also suffers from these deficiencies and would place an additional
burden upon the Department.

Options 4 and 5 would tend to accomplish all three goals. We
believe, however, that some modifications are necessary to
eliminate the troublesome aspects of having the Department involved
in approving specific licensees or specific contract terms. This

[149]

-2-

October 27, 1976

a

Dr. Fredrickson

would be burdensome on the Department and could open it to
criticism. The only condition we recommend that the Depart-
ment should require for granting ownership to either
institutions or licenses to organizations thereunder is
reasonable assurance of an ability and willingness to observe
scientifically reasonable guidelines promolgated by the Depart-
ment .

Thank you for the opportunity to provide comments in this
important area of research.

Very truly yours,

ABI

L. .

Director

Division of Experimental Biology

LRO : em

[150]

THE UNIVERSITY OF TEXAS
HEALTH SCIENCE CENTER AT DALLAS

CHARLES C. SPRAGUE, M.D.

HKSIOtNT

SOUTHWESTERN MEDICAL SCHOOL
GRADUATE SCHOOL OF BIOMEDICAL SCJENI
SCHOOL OF ALUED HEALTH SCIENCES

November 1, 1976

Donald S. Frederickson
Director

National Institutes of Health
Bethesda , MD 20014

Dear Don:

I am very sorry for the long delay in responding to your
letter requesting the opinions and views of a number of
persons as related to the patent applications in the area of
recombinant DNA research.

I have discussed this matter with several of the people
here, and although none of them have the feeling that we are
on solid ground, nonetheless there seems to be remarkable
unanimity of opinion that institutions should be discouraged
from filing patent applications on inventions arising from
recombinant DNA research, and that information regarding
such research should be exchanged as rapidly as possible
among scientists in the field. I question whether the
Department of HEW's present policy of allocating invention
rights is really consonant with the public and scientific
concerns regarding this particular area of research. I
realize this is a most difficult position to arrive at a
totally satisfactory defense, but nonetheless I am giving
the benefit of not only my own opinion, but one that is
shared by the vast majority of the faculty with whom I have
discussed the matter.

Charles C. Sprague, M.D.
President

ccs : db

[151]

5323 HARRY HINES BLVD DALLAS. TEXAS 75235 (214)6883601

PHARMACEUTICAL

C • JOSEPH STETLE ^
£$3 D k. r J T

M AN U FACTl/RE RS

/j-J Or:/ /////*//

1155 FIFTEENTH STREET. N.W
WASHINGTON. D. C. 20005

ARCA CODE 20a - 2S-S -2aa O

November 2, 1976

Donald S. Fredrickson, M. D.

Director

National Institutes of Health
Public Health Service

Department of Health, Education, and Welfare
Bethesda, Md.

Dear Doctor Fredrickson:

The following comments are provided in response to the notice published
on July 7, 197.6, FR (41) 131 entitled "Recombinant DNA Research -
Guidelines" by the Department of Health, Education, and Welfare.

As you know, the Pharmaceutical Manufacturers Association presented
testimony before the Health Subcommittee of the Senate Labor and Public
Welfare Committee on September 22, 1976. A copy of that testimony is
enclosed. Also enclosed is a copy of our letter, dated September 29, 1976,
in response to your request of September 7, 1976, for comments cn patent
policy considerations pertinent to government sponsorship of recombinant
DNA research.

The general purpose of this letter is to reiterate our statement that PMA
member firms support the spirit and intent of the Guidelines. As noted in
our testimony, we believe that in the case of non-government supported
research some modification will be necessary regarding (1 ) protection of
intellectual property rights and (2) volume restrictions. It is our con-
sidered opinion that such modification can be achieved without harm to the
purpose or effectiveness of the Guidelines. Such modification should be
general rather than specific, and should provide for negotiations between
non-government supported sponsors of such research and appropriate offi-
cials of your office.

[152]

Representing manufacturers of prescription pharmeceuticals.
medical devices and diagnostic products

Dr. Fredrickson

- 2 -

11/2/76

The particular provisions of the Guidelines which impact on intellectual
property rights and volume restrictions are those which impose forma-
lized approval and reporting requirements on the principal investigator
as outlined in the chapter entitled "Roles and Responsibilities" FR (41)

131 on page 27920, and related portions of the Guidelines. We believe
that an acceptable mechanism can be worked out for keeping your office
currently advised of the extent of involvement of PMA member firms in
recombinant DNA research without the necessity for such formalized pro-
cedures. Our member firms, which are so engaged, could assure your
office of the existence of institutional biohazards committees, a concept
which the industry has already endorsed. Minutes of the meetings of such
committees could be made available in an edited form which would provide
the safeguards which are considered necessary to protect intellectual
property rights and at the same time provide the necessary assurances of
compliance with the safety provisions of the Guidelines regarding physical
and biological containment levels. Such minutes could be made available
to appropriate officials of your office, provided that the information thus
provided would be protected from public disclosure.

It is suggested that the details concerning allowable exemptions from the
requirements, as published, can best be discussed at a meeting between
representatives of your office, the PMA and affected member firms as sug-
gested earlier by Dr. John G. Adams of our staff. I am confident that such
a meeting will satisfactorily resolve the administrative problems involved
and achieve your purpose in assuring compliance with the Guidelines by the
pharmaceutical industry. We are pleased to offer our cooperation in your
efforts to provide guidance in this new and important field of research and
will look forward to hearing from you in the near future concerning the
above suggestion.

sincerely yours.

Enclosures

[153]

SOCIETY OF UNIVERSITY PATENT ADMINISTRATORS

PRESIDENT
Mr. R.iy Woodrow
Princeton University
P. O. Box 36
Princeton. \. J.

08540

PAST PRESIDENT
Dr. George H. Pickiir
Patents &• I, incensing
University of Miami
P. O. Box 249133
University liranch
Coral Gables, Ha.

33124

VICE PRESIDENT
EASTERN REGION
Mr. Lawrence Gilbert
Patent Administrator
Boston University
Commonwealth Avenue
Boston, Ma.
02215

VICE PRESIDENT
CENTRAL REGION
Dr. Ralph L. Davis
Patent Manager
Purdue Research Kdn.
West Lafavettc, Ind.

47907

VICE PRESIDENT
WESTERN REGION
Mr. Clarence W. Martin
Director
Patent & Product Dev.

University of Utah
' Salt Lake City, Utah
84112

February 11, 1977

Dr. Donald S. Fredrickson

Director

Room 124

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

The Society of University Patent Administrators is a
relatively new organization which has as its most important
objective the advancement of ways and means by which university
inventions and discoveries can be identified, developed and
transferred into public use. Some of the aspects of inventions
and patents in universities are covered in the enclosed copy
of my testimony before Congressman Thornton's Subcommittee
last fall.

In the area of university technology resulting from
Government sponsored research in universities, the Department
of Health, Education and Welfare has had the foresight to
be first in recognizing the need for special arrangements which
are exemplified by its Institutional Patent Agreement which
has been a forerunner for similar agreements from other
agencies. However, HEW's position has not been favorable
with regard to the allowability of costs involved in applying
for patents and licensing users, costs which must be incurred
if the general intent of the Institutional Patent Agreements
is to be fulfilled.

SECRETARY-
TREASURER
Dr. Earl J. I rcisc
Assistant Director
Office of Research Ik-
Sponsored Programs
Northwestern Univ.
Evanston, 111.
60201

We would like to urge that the National Institutes of
Health take a position that these costs be allowable when
university indirect cost rates are computed. We estimate
that the effect would be less than one-half a percentage point
in a university indirect cost rate, a relatively small cost
to provide an incentive for transferring inventions and
discoveries from Government sponsored research into public use.

We urge that the patent costs be prorated in the indirect
cost rate over all organized research of a university, not just
over Government research where the Government has title or
a royalty free license to patents. We urge this for two reasons:
first, it will facilitate a single university patent program
rather than separate programs for government and non-government
research; and second, prorating costs of a patent program over
both non-government and government financed research provides
a strong incentive for an efficient patent program, since
the university will have to pay its fairly allocated share.

All otner university indirect cost functions are prorated in
this way between Government sponsored and other university
activities .

[154]

Dr. Donald S. Fredrickson

-2-

February 11, 1977

We believe that this matter of technology transfer to be
inherently one of great concerns to NIH, the Congress and the public.
We hope that we might meet with you in regard to the matters discussed
in this letter and how technology transfers may be further enhanced
through our joint efforts.

Sincerely yours,
v f V;

Raymond J . Woodrow
President

RJW/dh

Enclosure

cc: Norman J. Latker - Patent Counsel, DHEW

Henry G. Kirschenman - Office of Asst. Secretary Comptroller, DHEW
John J. Lordan - Chief Financial Management Branch, Office of Management

6 Budget

[155]

FEDERAL INTERAGENCY COMMITTEE

Establishment and Charter

Page

Letters exchanged between President

Ford and Senators Javits and Kennedy 157

Summary Minutes of Interagency

Committee, 11/4/76 165

Minutes, 11/4/76 168

Correspondence and Proposed Charter 176

[156]

miimi

HAKKtSOM A. WlLAJAMS. Jtt^ HJ., CHAIRMAN

• MNOOLFM, W. VA.

€ RCIX. RJ.

M. R1NNCOY. MASS.
NCLVM. W1S.

monoali, minn.

lACtnON. MO.
wo«, calif.

D. HATHAWAY. MAINE
URKIM. N.H.

jacoo k. ja vrr*. n.v.

RICHANO S. SCMWCiKCR. PA.

mcmtmr taft. jr.. ohio

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COMMITTEE ON
LABOR AND PUBLIC WELFARE
WASHINGTON. D.C. 20510

July 22, 1976

Donald S. Fredrickson, M.D.

Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Enclosed is a copy of the letter which Senator
Javits and I today sent to the President regarding imple-
mentation of the NIH Recombinant DN'A Research Guidelines in
other Federal agencies and in the private sector.

I want
and statesmanli
the formulation
pleased at your
outside the med
the debate over
tific community
will doubtless
imperative that
refinements and

to offer my congratulations on the thorough
ke job NIH has done thus far with respect to
of these Guidelines. In particular, I am
involvement of knowledgeable people from
ical research and scientific communities. As
the Guidelines continues in both the scien-
and in the public at large, the Guidelines
have to be updated and refined. It will be
NIH remain sensitive to the need for such
responsive to the public's concerns.

In the meantime, we should turn our attent
implementation of the current Guidelines in all sec
the research community. The Health Subcommittee is
to take whatever actions are necessary to this end.

ion to
tors of
prepared

Edward M. Kennedy, Chairman
Senate Health Subcommittee

4

nclosure

[157]

HARRISON A. WILLIAMS. JR., NJ., CHAIRMAN

JENNINGS RANDOLPH. W. VA.
CLAIBORNE PELL. R.l.

EDWARD M. KENNEDY. MASS.
OAYLORO NELSON. WlS.
WALTER P. MONOALE, MINN.
THOMAS F. EAGLE TON. MO.
ALAN CRANSTON. CALIF.
WILLIAM O. HATHAWAY, MAINE
JOHN A. DURKIN, N.H.

ROBERT TAFT, JR., OHIO
J. GLENN BEALL. JR.. MO.
ROBERT T. STAFFORD. VT.
PAUL LAXALT, NEV.

JACOB K. JAVITS. N.V.
RICHARD S. SCHWEIKER, PA.

'UlCwfec* J&ictlas Genetic

COMMITTEE ON
LABOR AND PUBLIC WELFARE
WASHINGTON. D.C. 20310

DONALD EUSBURO. GENERAL COi/NSEL
MARJORIE M. WHITTAKER, CHIEF CLERK

July 19, 1976

The President
The White House
Washington, D.C.

Dear Mr. President:

For several years, the biomedical research community has
been engaged in an extremely important debate over the safety
of certain types of genetic research. The research involves
combining genetic material from different organisms. The
technology that permits this type of genetic experimentation,
called recombinant DNA research, is revolutionary, and holds the
promise of enormous benefits in our understanding of disease
processes, and could lead us to ways of controlling or treating
complex diseases such as cancer and hereditary defects. It could
conceivably lead to improved ways of producing such important
hormones as insulin, clotting factors, and enzymes important
to treatment of many diseases. The technology also has conceivable
applications in agriculture and industry. Clearly, it is a
research area of enormous promise.

However, recombinant DNA research also entails unknown but
potentially enormous risks due to the possibility that micro-
organisms with transplanted genes might prove hazardous to human
and other forms of life--and might escape from the laboratory.
Indeed, scientists engaged in such research declared a voluntary
moratorium on recombinant DNA research in 1974 when they foresaw
the possibility, for example, of creating in the laboratory self-
propagating infectious bacteria that contain genes from cancer-
causing viruses. The moratorium was lifted in 1975, but maintained,
again by the researchers themselves, for the specific types of
experiment which might produce cancer- caus ing bacteria, raise the
resistance of antibiotics of known bacteria, or have other
dangerous results.

On June 23rd of this year, the National Institutes of Health
issued comprehensive guidelines for recombinant DNA research
which specify more stringent safety and containment measures
than are currently required or practiced in many areas. They
specifically prohibit the most potentially dangerous types of
experiments. In addition, the guidelines prohibit the release
into the air or water or environment of any of the genetic
materials created by the research.

[158]

The President
Page Two

We appreciate the great care NIH has taken, in the
formulation of these strict guidelines, in obtaining the
best scientific advice as well as advice from experts in
law and ethics. Opportunity was also given for the public
to comment on the guidelines. The environmental impact
assessment of the guidelines currently being prepared by
NIH will offer further opportunities for such comment.

The guidelines will be widely discussed and debated
with regard to their ultimate adequacy in safeguarding the
public, and they will no doubt further evolve and develop
during this debate and as our understanding of recombinant
DNA advances. Based on the process by which NIH produced
the present guidelines, we are confident they are a respon-
sible and major step forward and reflect a sense of social
responsibility on the part of the research community and
the NIH.

However, we are gravely concerned that these relatively
stringent guidelines may not be implemented in all sectors
of the domestic and international research communities and
that the public will therefore be subjected to undue risks.

The National Institutes of Health has the authority to require
adherence to the guidelines as a condition of their grants
and contracts for research, but they cannot enforce the guide-
lines with respect to other Federal agencies, with respect to
research in the private sector in this country, and with respect
to research done in other nations.

In particular, it is clear that recombinant DNA research
has great potential in the private sector, such as pharma-
ceutical manufacture, the oil industry and agricultural products.
It is also clear that some elements of the guidelines, such
as limitations on the size of experiments, public disclosure,
and non-release of materials into the environment, may be
contrary to the interest and practice of research in private
industry, and may therefore be ignored. In addition, since
private sector research will lead to industrial application,
guidelines must be extended beyond research into application
and production stages. If the NIH guidelines are necessary
to protect the public in Federally funded research, it is
clear they are necessary for privately funded research and
application as well.

[159]

The President
Page Three

Given the high potential risks of this research, it seems
imperative that every possible measure be explored for assuring
that the NIH guidelines are adhered to in all sectors of the
research community. We urge you to implement these guidelines
immediately wherever possible by executive directive and/or
rulemaking, and to explore every possible mechanism to assure
compliance with the guidelines in all sectors of the research
community, including the private sector and the international com-
munity. If legislation is required to these ends, we urge you to
expedite proposals to Congress.

This is an unprecedented issue in the area of biomedical
research. It has been likened in importance to the discovery of
nuclear fission. In the interest of public safety, and in the
interest of permitting this beneficial research to continue with
the blessing of a reassured public, we must act expeditiously on

Public Welfare

[160]

THE WHITE HOUSE
WASHINGTON

September 22, 1976

Dear Senator Javits:

I am writing in response to your and Senator Kennedy's
letter of July 19 concerning the National Institutes
of Health (NIE) Guidelines on Recombinant Deoxyri-
bonucleic Acid (DMA) Research. As you note in your
letter, the Guidelines were developed over an 18-
month period and involved the participation not only
of the scientific community but of the public as
well.

I am advised by the Secretary of Health, Education,
and Welfare that the potential scientific and medi-
cal benefits in this research area are promising
and that support for the research is merited with
appropriate safeguards against possible hazards.

The material accompanying the release of the
Guidelines explained in great detail the care and
consideration given stated public concerns for
safety.

The application of these Guidelines beyond the NIH
to the public and private sectors merits further
consideration. To consider this and other issues
further Secretary Mathews has proposed that an inter-
agency committee be created to review the activities
of all Government agencies conducting or supporting
recombinant DNA research or having regulatory
authority relevant to this scientific field. The
committee could also coordinate activities with non-
Federal institutions. I have written to all
Department Secretaries urging their cooperation and
participation in naming representatives to serve
on this proposed committee.

[161]

2 -

,y this means I believe the concerns you address
in your letter will receive careful attention. I
am asking Secretary Mathews to keep you apprised of
the deliberations of this committee and any
recommendations that may be forthcoming.

Thank you very much for your thoughtful letter.

Sincerely yours.

The Honorable Jacob K. Javits
Ranking Minority Member
Committee on Labor and
Public Welfare
United States Senate
Washington, D.C. 20510

[162]

THE WHITE HOUSE
WASHINGTON

September 22, 1976

Dear Mr. Chaiman:

I am writing in response to your and Senator Javits*
letter of July 19 concerning the National Institutes
of Health (NIH) Guidelines on Recombinant Deoxyri-
bonucleic Acid (DNA) Research. As you note in your
letter, the Guidelines were developed over an 18-
month period and involved the participation not only
of the scientific community but of the public as
well.

I am advised by the Secretary of Health, Education,
and Welfare that the potential scientific and medi-
cal benefits in this research area are promising
and that support for the research is merited with
appropriate safeguards against possible hazards.

The material accompanying the release of the
Guidelines explained in great detail the care and
consideration given stated public concerns for
safety.

The application of these Guidelines beyond the NIH
to the public and private sectors merits further
consideration. To consider this and other issues
further Secretary Mathews has proposed that an inter-
agency committee be created to review -the activities
of all Government agencies conducting or supporting
recombinant DNA research or having regulatory
authority relevant to this scientific field. The
committee could also coordinate activities with non-
Federal institutions . I have written to all
Department Secretaries urging their cooperation and
participation in naming representatives to serve
on this proposed committee.

[163]

2

By this means X believe the concerns you address
in your letter will receive careful attention. I
am asking Secretary Mathews to keep you apprised of
the deliberations of this committee and any
recommendations that may be forthcoming.

Thank you very much for your thoughtful letter.

Sincerely yours.

The Honorable Edward M. Kennedy
Chairman, Subcommittee on Health
Committee on Labor and Public Welfare
United States Senate
Washington, D-C. 20510

[164]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Summary Minutes of Meeting
November 4, 1976
Bethesda, Maryland

The initial meeting of the Interagency Committee on Recombinant
DNA Research was convened at the National Institutes of Health (NIH)
on November fourth and was chaired by Dr. Donald Fredrickson, Director
of the NIH. This was the first in a series of meetings designed to
result in a report to the President by mid or late January.

The first half of the meeting was devoted to a review of the
NIH guidelines on recombinant DNA research by Dr. Fredrickson and his
staff. The topics covered during this review included: the chronology

of events leading to the formulation of the NIH guidelines and the
creation of the Interagency Committee; a brief summary of the substance
of the guidelines; a delineation of the roles and responsibilities of
those involved in recombinant DNA research; the question of patenting
certain inventions resulting from recombinant DNA research; and, a
discussion of recombinant DNA research activities abroad with special
emphasis placed on the guidelines developed in the United Kingdom.

The second half of the meeting was initiated by Dr. Fredrickson
with a review of the mandate of the Committee: to review the nature

and scope of recombinant DNA research in both the public and private
sectors; to determine the applicability of the NIH guidelines to
govern such research; and, to recommend legislative or executive
action needed to insure compliance with the standards as set.

[165]

-2-

Dr. Fredrickson then discussed the functions and processes
required in the regulation of recombinant DNA research (as envisioned
under the NIH guidelines) which the agencies, both regulatory and
performer, need to consider with regard to their respective roles:

• registration of activity

• certification of containment standards

• oversight of investigators and institutions

• formulation of an appellate mechanism to the above

• requirements for safety education and training

• development of safer hosts and vectors

• establishment of a mechanism to provide hosts and vectors

• exchange of information

• establishment of international liaison

• extension of the guidelines throughout the public
and private sector

• placement of ultimate authority

Following this presentation, the NIH General Counsel briefly
reviewed the potential regulatory authorities of the Center for Disease
Control, the Food and Drug Administration, the Department of Transportation,
the Environmental Protection Agency, the Department of Agriculture, and
the Occupational Safety and Health Administration.

The meeting was then open to the floor with ensuing discussions
centering on the following topics: the application of recombinant DNA

research standards to the private sector; the adoption of the NIH guide-
lines by other Federal agencies, especially the Department of Agriculture;

[166]

-3-

the possibility of the Committee reviewing genetic research in
general; and, the immediate approach to be taken by the regulatory
agencies in determining the authority of each agency in the regulation
of recombinant DNA research.

Dr. Fredrickson then brought the meeting to a close by
requesting

• the performer agencies to submit a written statement
analyzing the nature and extent of actual or planned
recombinant DNA research and the role of the agency
vis-a-vis the eleven functions/processes previously
ment loned

• the regulatory agencies to submit a written statement
analyzing the authority and role of the agency in the
regulation of recombinant DNA research

and by announcing his intention to reconvene the Committee within
three weeks. The agenda for this meeting will consist of a discussion
of the two items above plus any other topics suggested by the agency
representatives. Dr. Fredrickson received Committee approval to
create a subcommittee for the purpose of developing future agendas
and Issues for review.

Respectfully submitted,

Associate Director for
Program Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

November 9, 1976

[167]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Minutes of Meeting
November 4, 1976
National Institutes of Health
Bethesda, Maryland

I. NIH Guidelines

The first meeting of the Interagency Committee on Recombinant DNA
Research was convened at the National Institutes of Health on
November 4. The meeting, chaired by Dr. Donald S. Fredrickson,
Director of the National Institutes of Health, was held from
9;30 a.m. to 12:30 p.m. The first half of the meeting was a review of
the development of the NIH guidelines on recombinant DNA research
and activities that were taken by the NIH after the release of the
guidelines in June 1976. The last half of the meeting was devoted
to a review and discussion of the roles and responsibilities of the
Interagency Committee and the Committee’s future agenda.

Dr. DeWitt Stetten, Jr., Deputy Director of the NIH and Chairman
of the NIH Recombinant DNA Molecule Program Advisory Committee ,
reviewed the initial developments and guidelines in this research
area. He briefly discussed the initial call by scientists for a
voluntary moratorium on certain classes of experiments in recombinant
DNA research and the international meeting held at the Asilomar
Conference Center in Pacific Grove, Calif ornia,, in February 1975
where initial guidelines were set pending formal guidelines to be
developed by the NIH. Dr. Stetten also outlined the activities of
the NIH Recombinant Advisory Committee that proposed guidelines on
recombinant DNA research to the Director of the NIH in January 1976.
Dr. Stetten concluded by noting that the Recombinant Advisory
Committee has a number of important functions to perform under the
NIH guidelines and continues to meet regularly to fulfill those
responsibilities .

Following Dr. Stetten's presentation, Dr. Fredrickson reviewed the
events that culminated in the release of NIH guidelines in June.

In order that there be an opportunity for public participation in
the review of the proposed guidelines, a public hearing was held in
February at the NIH that afforded several public interest groups
and scientists an opportunity to comment on the proposed
guidelines. That hearing and the extensive correspondence received
by Dr. Fredrickson provided the basis for his review of the proposed
NIH guidelines. The final guidelines released in June contained a
number of revisions based on issues raised by the public commentators.
Accompanying the release of the guidelines was a decision paper by
Dr. Fredrickson outlining the basis for his decision on each of the

[168]

2

issues raised. Dr. Fredrickson also noted that prior to the release
of the guidelines, meetings were held with representatives from
other government departments and agencies, private industry, and
congressional staff.

Following Dr. Fredrickson's remarks. Dr. William Gartland, Acting
Director, Office of Recombinant DNA Activities, NIH, summarized
the substance of the NIH guidelines and his Off ice 's actions to
implement them. Dr. Gartland defined recombinant DNA research
as that research involving molecules that consist of different
segments of DNA which have been joined together in cell free
systems and which have the capacity to infect and replicate in
some host cell, either autonomously or as an Integrated part of
the host genome. He described the two types of containment
procedures used in the guidelines. The physical containment is a
system to prevent the escape of organisms containing recombinant
DNA molecules. Biological containment, on the other hand, is a
system whereby organisms used in these experiments are crippled so
that in the event of their escape from the laboratory the likelihood
for their survival is minimal. Dr. Gartland then briefly reviewed
the categories of experiments that are forbidden under the guidelines
and those that are permitted under restrictive conditions.

Finally, he summarized the roles and responsibilities of the
investigators, their institutions, and the NIH in ensuring effective
administration of the guidelines.

Following Dr. Gartland's comments Dr. Joseph Perpich, Associate
Director for Program Planning and Evaluation, NIH reviewed NIH
activities after the release of the guidelines in June. These
activities included publication of the guidelines in the Federal
Register on July 7 and publication of the draft environmental impact
statement for this research in the Federal Register on
September 7. Further, the NIH, in August, published a volume
containing the transcript of the public hearing held on the proposed
guidelines, the correspondence received by the Director, NIH, on this
matter and relevant meetings held prior to the release of the
guidelines in June. Dr. Perpich also briefly reviewed •'he creation of
the Interagency Committee. In a letter to President Ford,

Senators Kennedy and Javits recommended executive action to extend
the scope of the NIH guidelines to the rest of the public and
private sectors and in response President Ford recommended the
creation of an Interagency Committee to review these and other
important policy matters pertaining to this research. Following up
on their letters, the Senate Health Subcommittee under the chairman-
ship of Senator Kennedy conducted oversight hearings on September 22
that focused on the need to extend the NIH guidelines to the public
and private sectors with a mechanism to ensure compliance.

Dr. Fredrickson testified for the Administration and agreed that
the Interagency Committee would review these matters and come forth
with appropriate recommendations. In conclusion. Dr. Perpich also
noted that the NIH is reviewing Institutional Patent Agreements
between DHEW and academic institutions to determine an appropriate

U69]

3

policy for recombinant DNA research inventions. Under the patent
agreements, institutions are allowed to patent inventions developed
under DHEW contracts or grants. A number of institutions have
indicated interest in patenting certain recombinant DNA research
inventions and the NIH is currently reviewing what modifications,
if any, are necessary under the terms of the patent agreement to
meet public concerns for safety in this research area. A decision
on this matter should be forthcoming within the next month.

In concluding the review of NIH activities. Dr. Fredrickson discussed
recombinant DNA research activities abroad. He discussed briefly the
recent guidelines developed in the United Kingdom by a scientific
committee known as "The Williams Committee." The NIH and British
guidelines conceptually are similar but Dr. Fredrickson noted that
the U.K. guidelines rely formally on physical containment and their
levels of physical containment differ somewhat from those of the
NIH. To implement these guidelines, the Genetics Manipulation Advisory
Group (GMAG) has been formed to review all recombinant DNA research
protocols to ensure conformity with the standards set in the guidelines.
The responsibility for enforcement of the safety standards will rest
with the Health and Safety Commission that has responsibility in
Britain for ensuring appropriate safety conditions in the work place.

Dr. Fredrickson also reviewed activities in other western European
countries. The European Science Foundation (ESF) and the European
Molecular Biology Organization (EMBO) are responsible for recombinant
DNA research activities collectively in Europe. Each member nation
has a representative that serves on the boards of these organizations
and attempts are being made for a uniform policy to govern the conduct
of this research. ESF has recently recommended that the British
guidelines be adopted for Europe rather than the NIH at the present
time. As Dr. Fredrickson noted, there are a number of important
questions concerning implementation because there is discretion provided
in the British guidelines for classifying experiments. The NIH is
working closely to see where coordination is possible and a commonality
of standards might be achieved. Finally, the NIH is working closely
with Canada which recently has proposed guidelines that differ from
the NIH and the U.K. to try to achieve a consensus on standards. And
the NIH has been working with the World Health Organization and the
International Council of Scientific Unions to reach agreement with
the Communist countries as well.

[170]

4

II. Roles and Responsibilities of the Committee

Following a short break for coffee, the Committee was reconvened to
discuss responsibilities of the Committee. Dr. Fredrickson reviewed
the mandate of the Committee and the prospective scope of inquiry.

The mandate of the Conmittee was described as follows:

1. The Committee shall review the nature and scope of Federal
and private sector activities relating to recombinant DNA
research.

2. The Committee shall determine the applicability of NIH guidelines
to govern research in the public and private sectors.

3. The Committee shall recommend, if appropriate, legislative
or executive actions necessary to ensure compliance with
the standards set for this research.

Dr. Fredrickson then reviewed functions and processes required in
the regulation of recombinant DNA research as envisioned under the
NIH guidelines. He asked that representatives of regulatory and
research agencies consider their respective agencies' roles with
regard to the following functions:

1. Registration of Activity: An accurate record of the
nature and scope of recombinant DNA research nationally
must be determined. The NIH has already under way the
the development of a registry that might possibly serve
for the entire nation.

2. Mechanisms to ensure that the science and safety standards

set in the guidelines reflect the continuing development of
knowledge in the science and safety aspects of this research
area: For example, the NIH guidelines currently prohibit

certain classes of experiments and prohibit the release

of recombinants from the laboratory. Further, there is a
limit on the size of the research experiment that can be
conducted. Further, to ensure the best safety techniques,
there needs to be support for research and development in
testing biohazards and risks and the development of
safer hosts and vectors.

3. There are a number of roles and responsibilities in the
implementation of the guidelines that need to be considered.

They Include the following:

[171]

5

a. Certification for the physical and biological containment
standards in the guidelines. Under the NIH guidelines
local institutional biohazards committees and the appropriate
study sections at the NIH will ensure that the research
protocol meets the standards set in the guidelines. Thus,
the NIH guidelines provide for local review plus independent
national review by NIH study sections. Further, an appellate
mechanism is provided for an appeal from decisions by either
the biohazards committee or study section. Under the NIH
guidelines the Recombinant Advisory Committee will review
such appeals.

b. Oversight of the investigators must be provided to ensure
strict compliance with safety standards, training, and
accidents. In the NIH guidelines, the institutional bio-
hazards committee must certify safety standards, training, and
accidents. Under the NIH guidelines, the institutional
biohazards committee must certify annually that the researcher
is ensuring appropriate attention to required safety
practices, programs, and procedures. Further, there is a
requirement of notification locally and to the NIH of certain
accidents or new safety developments.

c. There must also be oversight of the institution provided.

The NIH study sections are responsible for that function as
well as the Office of Recombinant DNA Activities. The latter
will monitor the operations of the institutional biohazards
committee and the selection of representatives to serve on that
committee.

d. There must be programs for safety education and training for
those who work in the laboratory. The NIH has undertaken to
develop a program under the direction of Dr. W. Emmett Barkley,
Director, Office of Research Safety, NCI, which will be available
to NIH scientists on campus and to those supported by grants

or contracts. Under the guidelines, the NIH also has the
responsibility to certify all maximum physical containment
facilities before research work can proceed.

e. There must be a mechanism to provide hosts,' vectors, and other
materials necessary to conduct the experiments. The NIH has
undertaken to develop support in this area for its grantees
and contractors.

[172]

6

A. Additional responsibilities lie in the area of information
transfer and exchange and international liaison. The NIH
has created a scientific memorandum that will contain the
most recent developments in this research area and will be
distributed to scientists involved. And, as Dr. Fredrickson
has described, the NIH has developed contacts with a number
of international scientific organizations to facilitate
international cooperation.

Following this review of defined responsibilities under the NIH
guidelines. Dr. Fredrickson then asked Mr. Richard Riseberg,

NIH General Counsel, to review briefly potential regulatory roles
to meet some of the responsibilities outlined above. Among potential
regulatory authorities are the following:

1. The Public Health Service in DHEW;

a. DHEW general regulations might serve to regulate such
research supported or conducted under DHEW auspices.

b. The Center for Disease Control has authority to regulate
communicable diseases, but its authority for recombinant
DNA research is not clear.

c. The Food and Drug Administration has authority to regulate
new drugs and devices but, at this point, this research
area may not be at the stage for such regulation.

2. The Department of Transportation:

The Department has the authority to regulate the shipment of
hazardous substances and does have an appropriate role to
play in that regard but its extension to regulation of all
this research is not clear.

3. The Environmental Protection Agency:

The Toxic Substances Control Act confers new authority on
the EPA to regulate chemical substances, but its extension
to this research area needs further exploration.

A. The Occupational Safety and Health Administration:

OSHA has the authority to enforce health and safety standards
and seems to be the most relevant to the needs of recombinant
DNA research.

5. The Department of Agriculture:

The USDA representative suggested that the Animal and Plant
Health Section within the USDA be included as having possible
regulatory authority in this area as well.

[173]

7

Dr. Fredrickson then opened up for discussion the Committee's
future agenda. He first noted that, if possible, the Committee
should have recommendations to the President in mid or late January.
This time frame was suggested at the Senate Health Subcommittee
hearings. There was no disagreement on this tentative time frame
for the Committee's deliberations.

Dr. Fredrickson cited an important responsibility of the Committee
will be to determine the nature and scope of activities in

the private sector and the application of standards to that sector.
To accomplish this, the Committee will need to meet with private
industry and representative unions. Dr. Fredrickson noted that
the Department of Commerce would need to play a most important role
in this regard and Secretary Richardson may undertake to begin
preliminary explorations. Dr. Ancker-Johnson, representing the
Department of Commerce, noted that voluntary compliance by industry
should be no problem and our task would be one to identify the
players and to respect the proprietary nature of the research
conducted by the private sector. Dr. Young, representing NASA,
noted that the private sector is not only industry but a number of
other institutions such as foundations; and Dr. Fredrickson agreed
that the Committee's scope of inquiry should go beyond private
industry.

Dr. Fredrickson asked that those research agencies present, such
as NSF, DOD, USDA, ERDA, and NASA, provide the Committee with
their analyses of recombinant DNA research activity being conducted
or planned and the degree of responsibility each will have for the
various functions required under the NIH guidelines as outlined
before. Dr. Fredrickson noted that the Department of Defense,
the NSF, and ERDA had adopted the NIH guidelines. Dr. Lewis, of
the Department of Agriculture, spoke of recent actions within
his Department relevant to the NIH guidelines. Dr. Lewis reviewed
the activities of certain committees created within the Department
and their recommendations to the Secretary that the NIH guidelines
be endorsed. He also suggested that USDA was considering the
creation of a recombinant advisory committee analogous to the
one at the NIH and that the Department would be willing to accept
a number of responsibilities outlined in the NIH guidelines.

During this discussion there was a question whether the Committee
might review more broadly genetic research. Dr. Fredrickson noted
that given the time constraints, it might be best for the Committee
to act on recombinant HA research, at least for the present.

He noted that the NIH has created a task force to look at other
relevant genetic research areas.

[174]

8

As an additional item on the agenda. Dr. Fredrickson asked that
the regulatory agencies, OSHA, CDC, FDA, EPA, provide an analysis
of their authorities and roles in undertaking functions required
in the regulation of recombinant DNA research. In the ensuing
Committee discussion, it was suggested that perhaps the General
Counsels of each of the Agencies should meet before the next
meeting to reach a consensus on regulatory authorities. It was
alternately suggested that each regulatory agency coordinate with
a research agency to which it is most closely related. A final
suggestion, which was the one adopted, was the Counsel of each
regulatory Agency review that Agency's authority and provide an
analysis that will be presented at the next meeting of the
Interagency Committee. Dr. Kennedy, from the Office of Science and
Technology Policy, noted that the enforcement of the provisions of
the NIH guidelines would depend on the development of detection
systems and he recommended that the Committee review this matter
at a future meeting.

In conclusion, it was agreed that at the next meeting which should
be held within three weeks, two items on the agenda would be a
review of the respective roles and responsibilities of the research
agencies and the regulatory agencies in the conduct and regulation
of recombinant DNA research. Other items for the agenda could be
suggested by other representatives. Dr. Fredrickson recommended and
the Committee approved the creation of a subcommittee to develop
future agendas and Issues for review.

Respectfully submitted.

Joseph C. Perpich, M.D., J.D.
Associate Director for
Program Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

November 9, 1976

f 175]

The Assistant Secretary for Health

Director, NIH

Charter for the Interagency Committee on Recombinant
DNA Research— ACTION

Enclosed is a proposed charter for the Interagency Committee on
Recombinant DNA (deoxyribonucleic acid) Research. Since we have
obtained the names of representatives from most of the Departments
and Agencies and hope to have a meeting in early November, I would
appreciate any help you can give to see that this charter is approved
as expeditiously as possible.

Donald S. Fredrickson, M.D.

Enclosure

Prepared by: NIH/OD, Perpich, 10/19/76, 14-63152

[176]

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH
WASHINGTON. O C 20201

The Secretary
Through: U

Assistant Secretary for Health

Charter for the Interagency Consnittee on Recombinant DNA Research — ACTION

ISSUE

Request to establish the Interagency Comittee on Recombinant DNA
Research.

DISCUSSION

On June 23, 1976, the National Institutes of Health Issued guidelines for
the conduct of research involving the creation of new forms of life used
In studying genetics (recombinant DNA experiments). These guidelines
establish carefully controlled conditions for experiments in which foreign
genes are Inserted into microorganisms, such as bacteria. The objective
of the guidelines la the containment of these possibly dangerous organisms
while permitting research of great potential benefit to mankind.

In an effort to examine the applicability of these guidelines to the
rest of the Pederal Government and to the private sector, the President
has made known that an lnterageocy committee will be established to
review Federal policy on the conduct of research involving recombinant
DNA (See the President's memorandum of September 22 attached at Tab A).
Attached also is a copy of your letter of October 1 (Tab B) to relevant
Department and Agency Heads requesting names of appropriate representatives
to this Comittee.

Attached Is a proposed charter to such a committee.

RECOMMENDATION

That the Secretary, by indicating approval of the attached Charter (Tab C) ,
authorize the establishment of the Interagency Committee on Recombinant
DNA Research.

Theodore Cooper, M.D.

Attachments :

Tab A - President '8 Memorandum of September 22
Tab B - Secretary's Letter of October 1
Tab C - Charter

Prepared by: NIK/OD, Perpich, 10/19/76, 14-63152

U77]

TAB A

THE WHITE HOUSE

WAS H I N GTON

September 22, 1976

MEMORANDUM FOR THE HEADS OF DEPARTMENTS AND AGENCIES

On June 23 the National Institutes of Health released
guidelines for the conduct of research involving the
creation of new forms of life used in studying genetics
(recombinant DNA experiments) . These guidelines establish
carefully controlled conditions for experiments in which
foreign genes are inserted into microorganisms, such as
bacteria. The objective of the guidelines is the containment
of these possibly dangerous organisms while permitting
research of great potential benefit to mankind.

The guidelines extend a moratorium that the scientists
themselves imposed on certain experiments involving re-
combinant DNA. I am advised by the Secretary of Health,
Education, and Welfare that recombinant DNA research has
great potential in medicine as well as in science and
technology generally. There are risks, however. The NIH
guidelines prohibit certain types of experiments and require
special safety conditions for other experiments. The pro-
visions are designed to afford protection with a wide margin
of safety to workers and the environment.

The Department of Health, Education, and Welfare expects
these guidelines to be supported by the largest part of
the scientific community and will use them to govern research
at laboratories of the National Institutes of Health and at
those of its grantees and contractors.

Secretary Mathews will be convening an interagency committee
to review Federal policies on the conduct of research involving
recombinant DNA.

I expect the full cooperation of each department and agency
conducting or supporting recombinant DNA experiments with
Secretary Mathews, who will take the lead in this.

[178]

TAB B

October 1, 1976

Dear (List of Addressees Attached)

On September 22 the President sent you a memorandum concerning the
formation of «n Interagency Comnittee to review Federal policy on the
conduct of research involving the creation of new forms of life used
in studying genetics [recombinant deoxyribonucleic acid (DNA)
experiments). On June 23 the National Institutes of Health (NIH)
released guidelines that establish carefully controlled conditions
for these experiments, in which foreign genes are inserted into
microorvanisms , such as bacteria. The object of the guidelines is
the containment of these possibly dangerous organisms while
permitting research of great potential benefit to mankind.

Tnc NIH guidelines prohibit certain types of experiments — those, for
instance, that might produce disease germs with increased resistance
to antibiotics. Other experiments will go forward under special
safety conditions. The provisions will afford protection with a
wide margin of safety to workers and the environment while permitting
this valuable research to proceed.

Of special concern to the private citizens who commented on the NIH
guidelines was their extension beyond the NIH to the public and
private sectors. Comparable guidelines for those sectors have been
advocated in a considerable volume of correspondence directed to the
NIH and to ny office during the past several months. There has been
emphasis by public commentators on the need for uniformity in
recombinant DNA research.

In light of this public concern, I suggested to the President that a
committee be formed to allow for a policy review of Federal activities
in the conduct, support or regulation of this research area, including
relevant private activities. As a follow-up to the memorandum from the
President, I an requesting that you nominate appropriate representatives
from your Department to serve on such a committee. In my view, this
Interagency Committee will assist in facilitating compliance with a
uniform set of guidelines for the public and possibly private sectors,

[179]

Page 2

and could provide coordination among the several Government agencies
that support and conduct this research. Further, such a committee may
suggest appropriate administrative and legislative proposals where
warranted .

I have asked Dr. Donald S. Fredrickson, Director of the NIH, to serve
as Chairman for this committee. I would very much appreciate your forwarding
your representative's name to Dr. Fredrickson at NIH, Building 1, Room 124,
Bethesda , Maryland 20014, by October 15. If you wish, you may designate
more than one representative from your Department.

At Senate hearings on the NIH guidelines hel-d on September 22, Dr. Fredrickson
stressed that, if possible, a meeting of the Interagency Committee would
be held in October to review application of guidelines to the public and
private sectors. Your prompt attention to this matter will be deeply
appreciated .

The public policy issues that the Interagency Committee will address are
of fundamental importance. Your participation and cooperation in this
policy review are vital. You might wish to contact Dr. Fredrickson on
(301) 496-2433 if you have any questions about the research area, the
NIH guidelines, or the proposed committee.

Thank you very much for your cooperation.

Cordially,

Secretary

[180]

TAB C

CHARTER

INTERAGENCY CO-CriTTEE Oil RECCC SINAI IT DNA RESEARCH

Purporfl

To coordinate Federal program* end activities relating to reconb Inant
deoxyribonucleic ccid (DNA) research, to arslst in facilitating
compliance with a uniform set of guidelines for the conduct of this
research in the public and private uectora and to facilitate communication
and exchange of information auong CovniTJccnt agencies.

Authority

This Committee is established pursuant to a memorandum of September 22
from the President to all Department and Agency Heads and a letter of
October 1 from the Secretary of Health, Education, and Welfare. This
Cocmlttee is excluded from provisions of Public Lav 92-463 vhlch 6eta
forth standards for the formation and use of Advisory Committees.

Function

The Interagency Committee on Recombinant HHA Research shall advise the
Secretary, the Assistant Secretary for Health, and the Director, National
Institutes of Health, on the coordination of those aspects of all Federal
programs and activities relating to recombinant DNA research. The
Committee shall provide for tha full coimunication and exchange of
information necessary to maintain adcouato coordination of such programs
and activities. The Committee shall be responsible for facilitating
compliance vith a uniform oct of guidelines in the conduct of this
research in the public and private sectors and, where warranted, suggest
administrative or legislative proposals.

Structure

The Director of the Notional Institutes of Health shall serve as Chairman
of the Committee and the Coralttee shall include representation from all
Departments and Agencies whose programs involve health functions or
responsibilities as determined by the Secretary.

[181]

2

Departments and Agencies vhich shall have representation on this
Committee are:

Constituent Agencies of HEW:

Office of the Assistant Secretary for Health
Center for Disease Control
Food and Drug Administration
Kational Institutes of Health

Other Departments end Agencies:

Department of Agriculture

Department of Commerce

Department of Defense

Department of Interior

Department of Justice

Department of Labor

Department of State

Department of Transpor ation

Council on Environment il Quality

Energy Research and Development Administration

Environmental Protection Agency

National Aeronautics and Space Administration

Rational Science Foundation

Nuclear Regulatory Commission

Office of Science and Technology Policy

D.S. Arras Control ax. I Disarmament Agency

Meetings

The Committee shall meet at the call of the Chairman but not less often
than four times a year. Meetings shall be conducted and records of
proceedings Rent, as required by applicable laws and departmental
regulations .

Compensation

All members vill be full-time Federal employees who are allowed travel
expenses plus per diem for subsistence while serving away from their
duty stations in accordance with Standard Government Travel Regulations .

Annual Cost Estimate

Estimated cost of operating the Committee excluding staff support is
$lt000. Estimated cost of annual staff support is two man-years at
$40,000.

[182]

3

Reports

The Committee shall prepare a report for the Secretary not later than
sixty days after the end of each fiscal year, which shall include:
a description of the work of the Committee in coordinating DNA research
activities in the public and private sectors, a description of the
work of the Committee in promoting the coordination of Federal programs
and activities relating to recombinant DNA research, and recommendations
for assuring implementation of a standard set of guidelines to govern
the conduct of this research nationally. A copy of the report shall be
provided to the Department Committee Management Officer.

Termination Date

Unless renewed by appropriate action prior to its expiration, the
Interagency Committee on Recombinant DNA Research will terminate two
years from date of establishment.

APPROVED:

Date

Secretary

[183]

FEDERAL INTERAGENCY COMMITTEE

Activities of Voluntary Health Agencies,

~ Foundations, and Societies
Concerning Recombinant DNA Research

Page

Letter from Donald S. Fredrickson

to Voluntary Health Agencies,

Foundations, and Societies,

11/17/76 185

List of Responding Organizations

(Alphabetical) 190

Letters from Organizations

(Chronological) 192

[184]

[Sample letter to voluntary health agencies and foundations.

DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OP HEALTH

]

BETMCSOA MARYLAND 20014

November 17, 1976

Dear

1 am writing to inquire about your organization's role in the support
or conduct of recombinant deoxyribonucleic acid (DNA) research and
the potential application of the National Institutes of Health
guidelines to your research activities in this area. As you may
know, the NIH on June 23 released guidelines that established
strict conditions for these experiments.

Because there is public concern that the NIH guidelines be extended
beyond the NIH to public and private sectors, an Interagency
Committee has been created to address these and other important
public policy issues. A memorandum was sent by the President on
September 22 to all Government Department and Agency Heads
requesting their cooperation in the formation of an interagency
committee. Following that memorandum, Secretary of Health,

Education, and Welfare David Mathews sent a letter to agency heads
requesting that they nominate representatives to serve on this
conxnittee. The conxnittee held its first meeting on November 4.

At Secretary Mathews' request, I am serving as chairman.

The mandate of the committee is to review the nature and scope of
Federal and private-sector activities relating to recombinant DNA
research and to determine the applicability of the NIH guidelines
to govern tnis research in the public and private sectors. Further,
the committee shall recommend whether legislative or executive
action is necessary to ensure compliance to standards. Contacts
have been made and are being pursued to determine the scope of this
activity and the application of the NIH guidelines to private industry.
I am writing to ask your cooperation in providing the committee
such information — namely, the nature and scope of your organization's
research in this area and your possible use of the NIH guidelines.

[185]

Page 2 -

Enclosed is a summary of the Interagency Committee meeting held
on November 4. Here I have listed a number of functions required
in the implementation of the guidelines. At the next meeting of
the Interagency Committee, Federal research agencies will discuss
their activities and their possible role in such implementation.

I would very much appreciate your organization's perspective on
the various functions outlined in the enclosed summary. At the
next meeting of the committee, there will also be reports from
various regulatory agencies concerning their possible role in the
regulation of recombinant DNA research.

Please feel free to call me (496-2433) if you have any questions
concerning this letter. It would be helpful to receive a response
from you as soon as possible so that I can share it with the
committee. As currently planned, the committee is expected to
have recommendations for the President by mid-January.

Sincerely yours,

/s/

Donald S. Fredrickson, M.D.

Director

Enclosure

[186]

ADDRESSEES OF NOVEMBER 17, 1976, LETTER TO VOLUNTARY HEALTH AGENCIES

AND FOUNDATIONS

Voluntary Health Agencies

Mr. Lane W. Adams
Executive Vice President
American Cancer Society
219 East 42nd Street
New York, New York 10017

Ms. Phyllis Hecker
Assistant Director
American Heart Association
7320 Greenville Avenue
Dallas, Texas 75231

Mr. Swen A. Larsen
Executive Director
American Kidney Fund
7515 Wisconsin Avenue
Bethesda, Maryland 20014

Mr. George M. Elsey
President

American National Red Cross
Washington, D.C. 20006

Ms. Dorothy C. Moore
Executive Director
Damon-Runyon Memorial Fund for
Cancer Research
33 West 56th Street
New York, New York 10019

Mrs. Robert Tulcin
President

National Cystic Fibrosis
Research Foundation
3370 Peachtree Road N.E.
Atlanta, Georgia 30326

Mr. Jack H. Vaughn
President

Planned Parenthood Federation
of America
515 Madison Avenue
New York, New York 10022

Ernest M. Frost, Ed.D.

Executive Vice President
American Diabetes Association
1 West 48th Street
New York, New York 10020

Mr. M. Robert Barnett

Executive Director

American Foundation for the Blind

15 West 16th Street

New York, New York 10011

Mr. Gerald R. Riso
Executive Director
American Lung Association
1740 Broadway
New York, New York 10019

Mr. Charles B. Harding
Chairman

Arthritis Foundation
475 Riverside Drive
New York, New York 10027

Edwin M. Lerner, II, M.D.

Presid ent

Leonard Wood Memorial

2430 Pennsylvania Avenue, N.W.

Washington, D.C. 20037

Mr. Meade P. Brown
Executive Director
Leukemia Society of America
211 East 43rd Street
New York, New York 10017

Mr. Gabriel Stickle
Vice President

National Foundation/March of Dimes
Box 2000

White Plains, New York 11502

Ms. Sylvia Lawry
Executive Director

National Multiple Sclerosis Society

205 East 42nd Street

New York, New York 10017

[187]

-2-

Foundations

Mr. McGeorge Bundy
President

The Ford Foundation
320 East 43rd Street
New York, New York 10017

John H. Knowles, M.D.

President

The Rockefeller Foundation

111 W. 50th Street

New York, New York 10020

Ms. Margaret E. Mahoney
Vice President

The Robert Wood Johnson Foundation
The Forres tal Center
P. 0. Box 2316

Princeton, New Jersey 08540

Mr. Harry B. George
President

The Hartford Foundation
405 Lexington Avenue
Suite 5115

New York, New York 10017

Mr. Russell G. Mawby
President

The Kellogg Foundation

400 North Avenue

Battle Creek, Michigan 49016

Carleton B. Chapman, M.D.

President

The Commonwealth Fund
One East 75th Street
New York, New York 10021

Mr. Nils Y. Wessell
President

The Sloan Foundation

630 Fifth Avenue

New York, New York 10020

James S . Coles
President

The Research Corporation
405 Lexington Avenue
New York, New York 10017

Mr. Philip Sapir

Vice President and Director

The Grant Foundation

130 East 59th Street

New York, New York 10022

Mr. James F. Henry
President

The Adna McConnell Clark Foundation
250 Park Avenue
Room 900

New York, New York 10017

Ms. Joan Dunlop
Secretary

The Population Council

245 Park Avenue

New York, New York 10017

Mr. Robert L. Kroc
President

The Kroc Foundation
P. 0. Box 577

Santa Yness, California 93460

Mr. Robert D. Lombard
President

The Kettering Foundation
5335 Far Hills Avenue
Suite 300

Dayton, Ohio 45429

Patrick A, Ongley, M.D.

President

The China Medical Board of New York

420 Lexington Avenue

New York, New York 10017

Mr. Julius Bergen
Chairman

The Fleishman Foundation
P. 0. Box 1871
One East Liberty Street
Reno, Nevada 89505

James A. Moffett
President

The Whitehall Foundation

249 Royal Palm Way

Palm Beach, Florida 33480

[188]

-3-

Foundations (Cont.)

Mr. Robert C. Bates
Vice President

The Rockefeller Brothers Fund
30 Rockefeller Plaza
New York, New York 10020

Mr. William W. Allen
Vice President

The Elsa U. Pardee Foundation
923 West Park Drive
Midland, Michigan 48640

John Z. Bowers, M.D.
President

The Macy Foundation
1 Rockefeller Plaza
New York, N. Y. 10020

Dr. Frederick DeHoffman
President
Salk Institute
P.0. Box 1809

San Diego, California 92112

Mr. Raymond F. Salmen
President

The Schlieder Foundation
One Shell Square
Suite 4424

New Orleans, Louisiana 70139

[189]

LIST OF RESPONDING
VOLUNTARY HEALTH AGENCIES
FOUNDATIONS, AND SOCIETIES

Organization Page

Alza Research, Division of Alza Corporation 212

American Cancer Society, Inc . 22 3

American Heart Association 2 31

American Lung Association 197

American National Red Cross, The 199

American Type Culture Collection 22 7

Childs Memorial Fund for Medical Research, The

Jane Coffin 224

China Medical Board of New York, Inc 193

Clark Foundation, The Edna McConnell 195

Commonwealth Fund, The 196

Fleischmann Foundation, Max C 217

Ford Foundation, The 204

Grant Foundation, Inc., The 215

Hartford Foundation, Inc., The John A 192

Johnson Foundation, The Robert Wood 220

Kellogg Foundation, W. K 198

Kettering Foundation, Charles F 216

Leukemia Society of America, Inc 206

Macy, Jr. Foundation, Josiah 221

[190]

Organization Page

Muscular Dystrophy Association, Inc 222

National Multiple Sclerosis Society 194

Pardee Foundation, Elsa U 205

Planned Parenthood - World Population 226

Research Corporation 202

Rockefeller Brothers Fund 219

Rockefeller Foundation, The 201

Salk Institute, The 218

Sloan Foundation, Alfred P 200

University of North Carolina at Chapel Hill 225

[191]

The John A. Hartford Foun dation . I nc.
Four Hundred Five Lex ngton Avenue
New York, New '•'ork 10017

November 22, 1976

Donald S. Fredrickson, M.D., Director
Department of Health, Education, and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Doctor Fredrickson:

This is in response to your November 17 letter to the
Foundation's President, Harry B. George, inquiring as to this
Foundation's conduct or support of recombinant DNA research.

He has asked me to reply in my role as senior grant program
administrator .

The John A. Hartford Foundation has not supported research
in this area, is not currently supporting any such projects,
and future support is highly unlikely. Its major interests
are in much more clinically-oriented biomedical studies. It
does not conduct intramural research.

In the event that such grant support might be extended
at some future date, I am confident that the Foundation would
insist that any such project be carried out in conformance
with NIH guidelines.

Further, among the terms on which this Foundation's
grants for biomedical research are made which must be accepted
by the grantee institution is this: "That in carrying out the

purposes of the grant, the Grantee shall comply with all applic-
able laws and regulations in force from time to time."

C. G. Coburn
Program Director

CGC :his

[192]

CHINA MEDICAL BOARD OF NEW YORK, INC.

w claake wescoe. m o

CH MAMAS

622 Third Avenue

FIANCES VI HAAAISON

TAE VS LAX A

PATAICA A ONCLEY. M D
PAE5JDENT

Telephone: (212) 682 8000
Caale Adoaess CHIMEDBORD

NEW YORK. N. Y. 10017

J. AOBEAT BUCHANAN, MJ).
CH VALES W. Bl'EK
JOHN A. HOCNESS, MJ).
EDWIN A. LOCKE, JA.
BAYLESS A. MANNINC
PVTAICK A. ONCLEY, MJ).
JAMES E. POTTS
PHILLIPS TALBOT
FAEDEAICK K. TAASK, JA.
JOHN L. WE1NBEAC
W. CLAAKE W E.SCO E . MJ).

November 23, 1976

Dr. Donald S. Fredrickson, Director
Dept, of Health, Education and Welfare
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

This will acknowledge receipt of your letter of November 17, 1976, concerning
the role of China Medical Board in the support or conduct of recombinant
deoxyribonucleic acid research and the potential application of the National
Institutes of Health guidelines to our research in this area.

China Medical Board does not of itself carry out any programs of research either
in this country or overseas. We do support research activities in various
national medical schools in East and Southeast Asia. I do not believe that any
work of this type is being carried out at present, although there is some work
being done with the DNA at the University of Hong Kong, Department of Pathology.
However, I do not believe the work in any way Involves the type of research
referred to above.

I would appreciate it if we could receive one dozen copies of the NIH guide-
lines of June 23, 1976, establishing conditions for experiments of this type
and I will see that they are forwarded to all the schools in East and Southeast
Asia within the Board's program.

I shall also request from the University of Hong Kong details regarding their
experiments with DNA and if they are in any way relevant I will forward them to
you.

Sincerely yours

PAOrmac

President

[193]

National Multiple Sclerosis Society
205 East 42nd Street
New York, N.Y. 10017
Tel. (212) 532-3060

Daniel J. Haughton
Chairman
Palmer Brown
President

Charles W. V. Meares
Senior Vice President
Thacher Longstreth
Vice President

William D. Seybold, M.D.
Vice President
Norman Cohn
Vice President
Mrs. Frederic E. Camp
Vice President
Hollis Harris
Vice President

R. Parker Sullivan
Vice President

John F. McGillicuddy
Treasurer

Nicholas deB. Katzenbach
Secretary
Sylvia Lawry
Executive Director

November 23, 1976

Dr. Donald S. Fredrickson
Di rector

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Thank you for your letter of November 17, 1976 to Miss Sylvia Lawry,
which has been referred to me for reply.

The Society has not supported or conducted any research on recombinant
DNA. Since our programs of grants for research and research training
are focused on research that is directly related to multiple sclerosis,
it seems unlikely that we would be asked to support research involving
recombinant DNA in the foreseeable future.

I am not prepared to comment on the functions outlined in the Summary
of Minutes enclosed with your letter, since I have not yet seen the
NIH guidelines on this subject. I would appreciate receiving a copy
of the guidelines from your office.

S incerely,

William E. Reynolds, M.D.

Deputy Di rector of
Research Programs

WER:jf

cc: Miss Sylvia Lawry

[194]

The Edna McConnell Clark Foundation

250 Park Avenue New York NY 10017 212 986 7050

November 23, 1976

Donald S. Fredrickson, M.D.

Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

To reply to your letter of 17 November regarding this
Foundation’s role in recombinant DNA research: at present

we do not, nor do we plan to support, any research involving
recombinant DNA. If, in the future, we should consider such
an activity, we would in principal agree to use the NIH
guidelines insofar as instructions to our grantees are concerned.

I hope this answers satisfactorily your request.

Very sincerely

/

J. Stauffer Lehman, Jr., M.D
Vice President

JSL/cr

[195]

THE COMMONWEALTH FUND

CARLETON

HARKNESS HOUSE
1 EAST S EVE NTY- FI FTH STREET
NEW YORK. N.Y. 10021

[a I 2 ] 535-0400

B. CHAPMAN, M. D.

IESIDENT

24 November 1976

Dr. Donald S. Fredrickson
Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Don:

Your letter dated 17 November addressed to Quigg Newton came
to me for answer. He retired as President two years ago.

The Commonwealth Fund is not supporting research or recombinant
DNA and has no plans to enter the field. NIH guidelines in
the field will not, therefore, be applicable to us or to our
grantees unless some of them may be doing such work on grants
from other sources. We have no information on this topic one
way or the other.

Yours sincerely,

Carleton B. Chapman, M.D.
President

CBC/bp

[196]

1740 Broadway, New York, N.Y. 10019 (212)245-8000

AMERICAN

f

LUNG ASSOCIATION

The “Christmas Seal" People

November 24, 1976

Donald S. Fredrickson, M.D., Director
Dept, of Health, Education, and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

In regard to your inquiry about support or conduct of support of recombinant
deoxyribonucleic acid, our organization has not been involved in either sup-
port of or conduct of research in this area.

The NIH guidelines have not been applicable to our research activities.

Sincerely,

Doi ig, M.D.

Medical Director

/dc

cc: Mr. G. Riso

Mr. N. Swearingen

[197]

LEONARD L. WHITE

Vice President — Administration

WK.KELLOGG

FOUNDATION

November 2b , 197 6

Dr. Donald S. Fredrickson
Director

Department of Health, Education,
and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

In answer to your November 17 letter, the Kellogg Foundation
does not support research. Therefore, the NIH guidelines on
recombinant deoxyribonucleic acid (DNA) research are of no
concern to us.

LLW:sc

[193]

400 NORTH AVENUE / BATTLE CREEK, MICHIGAN 49016/ PHONE 616 965-1221

+

THE AMERICAN NATIONAL RED CROSS

NATIONAL HEADQUARTERS
WASHINGTON. D. C. 20000

OmCI Or THE PRESIDENT

November 26, 1976

Dear Dr. Fredrickson:

This letter is in response to your letter of November 17, 1976,
regarding the role of the American National Red Cross in the support
or conduct of research involving recombinant deoxyribonucleic acid (DNA) .

All research supported by the American National Red Cross is
reviewed by a Committee on Red Cross Research, the members of which
are Listed on the attached sheet. In addition all research studies are
evaluated by our Committee for the Protection of Human Subjects, member-
ship list also attached . The research and development activities of the
American National Red Cross are all closely related to our mission of
delivering improved blood services to the communities which we serve.

We do not support any research on recombinant DNA at the present time
nor do we contemplate any support in this area in the foreseeable future.
However, we strongly support the strict guidelines released by N.I.H. on
June 23rd and the processes described to insure that organizations
participating in recombinant DNA research meet their responsibilities
under the guidelines.

Donald S. Fredrickson, M.D.
Director

National Institutes of Health
Bethesda, Maryland 20014

Attachments

[199]

Alfred P. Sloan Foundation

630 Fifth Avenue
New York, N. Y. 10020

Program Officer

November 29, 1976

Dr. Donald S. Fredrickson
Director

Department of Health, Education
and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Mr. Wessell has asked me to reply to your letter of
November 17, inquiring about the Sloan Foundation's role
in the support of research on recombinant DNA.

Such research is not within the program interests of
the Foundation, so there are no awards made specifically
for the support of recombinant DNA research. I do under-
stand, however, that at least one recipient of a Sloan
Fellowship for Basic Research has been involved in this
area. These fellowships are awarded to especially out-
standing young scientists in physics, chemistry, mathematics
and neuroscience. Funds are provided through the Fellow's
academic institution to which a grant is made for that pur-
pose. We would expect that institution to be responsible
for applying appropriate guidelines.

I hope I have been responsive to your inquiry and
would be pleased to try to answer any questions you may
have concerning our procedures.

Sincerely

KAK:nyg

[200]

The Rockefeller Foundation

113 3 AVENUE OF THE AMERICAS, NEW YORK. N Y 10036

JOHN H. KNOWLES. M 0.
PRCSIOCNT

CABLE R OC K F 0 U N 0. N E W V 0 R K
TELEPHONE (212) 869-8500

November 29, 1976

Dear Dr. Frederickson

In answer to your letter about The Rockefeller Foundation's

role in the support or conduct of recombinant DNA research, I would
like to inform you that the Foundation, following the redirection of its
programs in 1963, has not supported or otherwise been active in
molecular biological research except insofar as it applies in a limited
way to some of the fundamental research in reproductive biology
supported since 1964 under our current program. The policy will in
all likelihood be continued in the future. Our program definition of
just what constitutes reproductive biology and what areas of reproductive
biology are applicable to the population problem which is our major
program interest has led to certain guidelines. Under those guidelines
there is no possibility that we would support recombinant DNA
research. In the very unlikely event of a change in policy, we would
certainly report such a change to the NIH and would, if necessary,
make use of the NIH guidelines in affect at the time.

Parenthetically, and I am sure you understand my feelings.

I do have substantial reservations as to governmental censorship or
control of research. It would seem that in recent times there have
been increased interest as well as definite steps taken by political
forces to limit fundamental research. The recent action taken in
regard to fetal research is a case in point. Nonetheless, I do under-
stand the public interest in the subject and I salute you for your
efforts in the public interest.

DonaldS. Frederickson, M. D.
Director

Department of Health, Education,
and Welfare

National Institutes of Health
Bethesda, Maryland 20014

JHKraym

Very sincerely yours

[201]

RESEARCH CORPORATION

405 LEXINGTON AVENUE, NEW YORK, NEW YORK 10017

JAMES STACY COLES

PRESIDENT

November 30, 1976

Donald S. Frederickson, M.D.

Director

Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Frederickson:

This is in response to your letter of November 17, 1976,
inquiring about Research Corporation's role in the sup-
port or conduct of recombinant desoxyribonucleic acid (DNA )
research, and the potential application of NIH guidelines
to our research activities in this area.

In response. Research Corporation does not conduct any
research itself. Rather, it supports research on college
and university campuses through a program of grants made
in response to proposals for specific research projects.

Thus, we are conducting no research in this area.

With reference to support of research in this area, we are
at present supporting no such projects.

I note from the summary minutes of the November 4, 1976 meet-
ing of the Interagency Committee on Recombinant DNA Research
that one of the topics covered during your review of the
NIH guidelines was "the question of patenting certain inven-
tions resulting from recombinant DNA research." Recently, at
the explicit request of the Chief of the Patents Branch of
the Office of the Secretary of the Department of Health, Edu-
cation and Welfare, we have undertaken to patent an invention
from the University of Alabama in Birmingham, involving a

[202]

A FOUNDATION FOR THE ADVANCEMENT OF SCIENCE

Donald S. Frederickson, M.D.
November 30, 1976
Page 2

recombinant DNA procedure and organism.

In the discussion of functions and processes required in the
regulation of recombinant DNA research, I believe there
should be an extension of that discussion to the regulation
of the production and use of recombinant DNA organisms, or
other inventions resulting from DNA research. From our
past experience with inventions of processes or compounds
where the maintenance of certain quality levels is required,
we believe that a strong patent, and the careful definition
of terms in the licensing of said patent, provides a very
effective means of controlling quality, production, or use.

I suggest that the use of patents as a means of such regula-
tion be added to the list of issues for review that your
Subcommittee will develop.

Sincerely yours

James S. Coles

JSC :mm

cc: C. H. Schauer

cc: Willard Marcy

[203]

THE FORD FOUNDATION

320 EAST -43B° STREET
NEW YORK, NEW YORK 10017

OFFICE OF THE SECRETARY

November 30, 1976

Dr. Donald S. Fredrickson
Director

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Mr. Bundy has asked me to respond to your letter of November 17,
inquiring about the Ford Foundation's role in the support or conduct
of recombinant deoxyribonucleic acid (DNA) research.

The Foundation neither supports nor conducts research in this scien-
tific field, and the NIH guidelines would have no bearing on our
activities.

Thank you for your interest in writing to the Foundation.

Sincerely yours,

Assistant Secretary

WJHzcpa

[204]

ELSA U. PARDEE FOUNDATION
923 West Park Drive
Midland. Michigan • 48640

November 30,1976

Donald S. Fredrickson , M.D.

Director

Department of Health, education, and Welfare
Public Health Service
National Institute of Health
Bet'nesda, Maryland 20014

Dear Dr. Fredrickson:

Your letter of November 17,1976 concerning the
conduct of (DNA) research and potential application
of the National Institute of Health Guidelines in
this area has been received.

We wish to advise that the £lsa U. Pardee Foundation
is solely a funding body. We carry out no direct
research and are limited by charter to grants for
the cure and control of cancer.

Sincerely,

*y • j ^ * f { / / *

. . * CcCCt

’William W. Allen

Vice President and Secretary

am j

[205]

LEUKEMIA SOCIETY OF AMERICA, Inc.

211 EAST 43RD STREET
NEW YORK, N.Y. 10017
(212)573-8484

December 1 , 1976

Donald S. Fredrickson, M.D.

Director

Department of Health, Education and Welfare
Public Health Service
National Institutes of Health
Bethesda , MD 20014

Dear Doctor Fredrickson:

In answer to your recent letter to Mr. Meade Brown, I am enclosing
a copy of the Policies and Procedures of the Research program of
the Leukemia Society of .America, Inc.

I believe that sections 7 and 8 on page four, as well as other
references to these sections, comply with the NIH guidelines. If
you have any questions, please let me know.

Sincerely,

U- I \ \ Or ■ — (

Claire M. Carroll, Director
Public Education & Information

CMC: It

Enc .

[206]

Insure a Cure — Remember the Leukemia Society of America, Inc. in Your Will

LEUKEMIA SOCIETY OF AMERICA, Inc.

211 EAST 43RD STREET
New YORK. N Y. 10017
(212)573-8484

POLICIES AND PROCEDURES

RESEARCH GRANT PROGRAM

of the

LEUKEMIA SOCIETY OF AMERICA, INC

The LEUKEMIA SOCIETY OF AMERICA, INC. is a national voluntary health agency dedicated
to the conquest of leukemia through medical research. In addition, the Society
supports patient-aid and public and professional education programs through Chapters
throughout the nation.

A fundamental principle of the Society's research program is that all medically sound
avenues of approach toward a cure or control of leukemia should be encouraged on a
world wide basis. To accomplish this, the Society welcomes applications from investi-
gators willing to dedicate their careers to leukemia research. Applicants need not
be American citizens, and there are no restrictions as to age, race, sex or creed.

On recommendation of the Medical and Scientific Advisory Committee of the National
Board of Trustees of the Leukemia Society of America, Inc., only individual investi-
gators having specific research projects are supported. Proposed research projects
must be related directly to the field of leukemia or allied diseases. All applicants
must hold doctoral degrees at the time a grant is to become effective.

The three types of grants are:

SCHOLAR PROGRAM: Five-year grants for a total of $100,000 are awarded to individuals

who have demonstrated distinct ability in the investigation of leukemia and related
disorders. Under special circumstances, the Society may award a reduced Scholar grant
for a shorter period of time.

SPECIAL FELLOW PROGRAM: Two-year grants for a total of $31,000 are awarded to investi-

gators who have demonstrated ability in postdoctoral research and who have become in-
terested in working in the field of leukemia and related disorders. This program has
been tailored to meet the needs of individuals whose qualifications place them between
Fellow and Scholar status. Under special circumstances, the Society may award a re-
duced Special Fellow grant for a shorter period of time.

FELLOW PROGRAM: Two-year grants for a total of $25,000 are awarded to promising younger

investigators to encourage work in leukemia research. Under special circumstances, the
Society may award a reduced Fellow grant for a shorter period of time.

Established investigators, under rare and exceptional circumstances may apply to take
a sabbatical in order for them to gain more information on leukemia and related diseases.
Funding will be given only if such work will greatly add to the knowledge of leukemia
and related disorders. Only two sabbaticals will be given in any one year.

e-m

[207]

Policies and Procedures — Page 2

DESCRIPTION OF PROGRAMS

Through its research support program the Leukemia Society of America, Inc, hopes to
encourage and promote the highest quality of research activity. The administration
of these programs is the responsibility of the National Headquarters of the Society,
with the aid and advice of the Medical and Scientific Advisory Committee which re-
views all applications for research support. The Committee is comprised of experts
in the field of leukemia and allied diseases who serve on a voluntary basis.

Regardless of the type of grant, it is expected that the institution sponsoring the
Grantee will provide adequate facilities and benefits customarily extended to staff
members of equivalent rank, insofar as this is consistent with the regulations of the
institution. The primary purpose of the stipend is to pay for personnel costs, includ-
ing salary, retirement benefits, insurance, social security, and overhead costs of
the institution. Overhead costs will be limited to eight percent of the total budget.
The total budget is not to exceed the amount of the grant. In general, the award will
not be made to an individual with tenure or with a stable salary provided from a de-
partmental budget, if the major effect of the stipend is simply to free the institut-
ion's budgeted funds for other purposes.

Leukemia Society of America awards cannot be used to supplement other special awards
given to an individual; that is, a Leukemia Society of America grant cannot be held
concurrently with another grant which provides a higher level of funding. Leukemia
Society awards may, however, be supplemented from other sources.

SCHOLAR PROGRAM: Scholars of the Leukemia Society of America, Inc. are highly quali-

fied individuals who have demonstrated their ability to conduct original scientific
research bearing on leukemia and related disorders. This program has been designed
to aid the individual rather than the project and to encourage continued investigations
in this field, while assuring the investigator an income for a period of five years.

The proposed research must be relevant to leukemia or related diseases.

The applicant should have shown a capacity for sustained, original investigation in
abnormal growth as it relates to leukmeia and must evince a desire for an investig-
ative career in the field of leukemia and related disorders. It is preferred, how-
ever, that the applicant should not yet have attained the tenured rank of associate
professor.

Awards are almost invariably given to individuals in the clinical or basic science
departments of universities or associated research institutes. The awards, which are
for $20,000 annually, are administered by the sponsoring institution for a period of
five years, for a total grant of $100,000.

The salary budgeted for the Scholar may vary. Some may start below $20,000 per annum,
and in later years may exceed $20,000. This is agreeable so long as the total amount
budgeted for five years, including fringe benefits and eight percent overhead, does not
exceed $100,000. Under special circumstances, the Society may award a reduced Scholar
grant for a shorter period of time. Scholarship awards are not renewable.

Only one Scholar award will be made at any one institution in any one year.

SPECIAL FELLOW PROGRAM: Special Fellows of the Leukemia Society of America, Inc. are

scientists who have completed more basic training and education in the field than the
requirements for a Fellowship, but less than necessary for a full Scholarship. The
proposed research and training must be relevant to leukemia or related diseases.

[208]

r\

Policies ana Procedures — Page 3

Special Fellowships are awarded for two-year periods. Two-year awards will be made up
to $15,000 for the first year and $16,000 for the second year. The total amount of a
Special Fellowship award, including fringe benefits and eight percent overhead, will not
exceed $31,000. Under special circumstances, the Society may award a reduced Special
Fellow grant for a shorter period of time.

Special Fellowships are not renewable, although applications may be made for Scholar-
ship status after at least one year as a Special Fellow.

Only one Special Fellow award will be made at any one institution in any one year.

FELLOW PROGRAM: Fellows of the Leukemia Society of America, Inc. are promising young

investigators assisting and being trained by physicians and other scientists working in
fields relevant to leukemia. Fellows are encouraged to embark on an academic career
involving clinical or fundamental research in or related to leukemia, and should show
evidence of a particular Interest in leukemia or related disorders.

Fellowships are awarded for two-year periods. Two-year awards will be made up to $12,000
for the first year and $13,000 for the second year. The total amount of a Fellowship
award. Including fringe benefits and eight percent overhead, will not exceed $25,000.
Under special circumstances, the Society may award a reduced Fellow grant for a shorter

period of time.

Fellowships are not renewable, although applications may be made for Special Fellowship
status after at least one year as a Fellow.

Only two Fellow awards will be made at any one institution in any one year.

TERMS OF THE GRANTS

1. The funds given pursuant to this grant application shall be used solely for the pur-
poses specified in the application submitted to the Society as executed by the candidate
and sponsor and in strict compliance with the budget annexed to said application. Grant
periods normally run from July 1 to June 30 for each year of the grant. In special cir-
cumstances, the Medical and Scientific Advisory Committee may approve an alternate date

on which funding will start, provided permission has been obtained in advance. All grants
shall be activated within the calendar year for which the application is approved. Other-
wise it must be resubmitted and will have to compete on an equal basis with new grant
applications when they are reviewed by the Committee the following year.

2. The title, "Leukemia Society of America Scholar," (or Special Fellow or Fellow, as
applicable) shall be used in all faculty titles and publications during the periods of the
grant. Identification with the Leukemia Society of America, Inc. shall be made also in
any "news" released about the Grantees by the Public Relations department of the sponsoring
institution.

3. In the event that the Grantee desires to transfer to another institution while the
grant is in effect, continuation of the funding in the new institution will be allowed
only with the written approval of the Medical and Scientific Advisory Committee. To
obtain permission for relocation, the Grantee and Sponsor also shall submit letters to
the Committee at least 90 days prior to the projected move outlining the advantages

of the move and its effect on the progress of the project involved, particularly in its
relationship to the field of leukemia research. An accounting of disbursements of the
grant funds by the original sponsoring institution to the proposed date of transfer must
accompany the request. A letter of recommendation from the new Sponsor who will
supervise the Grantee's on-going work, and a new budget from the administrative office
of that institution will be required. Also, if the proposed work differs from that
originally approved, a complete description of the new project should be included.

Only one transfer per institution per year will be allowed.

[2091

Policies and Procedures — Page 4

4. If a grant is interrupted for valid reasons, written permission must be obtained
from the Medical and Scientific Advisory Committee, so that it may be continued at a
later date. In the event that a grant is not completed due to incapacitating illness
or death of the Grantee, the unexpended balance of the funds must be returned to the
Society.

5. The Grantee must submit a typewritten report of his or her research progress 60
days prior to the grant anniversary date of each year while the grant is in effect.

The report shall be accompanied by an evaluation report from the Sponsor directly re-
sponsible for the Grantee's work. Also, submitted with this report should be documen-
tation of research results keyed to the field of leukemia and allied diseases together
with any and all publications concerning said research. These reports shall be reviewed
by the Society's Medical and Scientific Advisory Committee in order to evaluate the
research progress of each of its Grantees. Although Scholarships are awarded for
five-year period and Fellowships for a two-year period, the Society's Medical and
Scientific Advisory Committee reserves the right to terminate any grant at its descretion.
At the expiration of the grant period the Grantee shall submit a final report of the
research conducted which shall include a recapitulation and summation of the research
activities together with copies of all publications concerning said research written

by the Grantee.

6. The financial officer of the sponsoring institution must submit annual reports
detailing how the grant funds were expended during the year. These reports shall be
submitted within 60 days after each grant anniversary date. The sponsoring institution
also agrees to submit a cumulative final accounting immediately upon completion or
prior termination of the grant. Any unexpended funds must be returned to the Society.

7. The Grantee and Sponsor will obtain approval from the sponsoring institution's
Council on Human Investigation, if the application pertains to human research or the
use of human materials. Those research projects which do not deal with the aforesaid
regulation will furnish a letter signed by the Grantee and the Sponsor stating that:

"The development of the research project at the present time does not involve the use
of human subjects or human materials. Approval of the institution's Council on Human
Investigation will be requested should such use occur and the Leukemia Society of
America, Inc. will be so informed."

8. The Grantee must include in the application a statement about any potential bio-
hazards and a description of the safeguards planned where such hazards to the invest-
igator, other personnel, or any other individuals may be encountered.

The foregoing remarks express the major policies and procedures adopted by the Medical
and Scientific Advisory Committee of the National Board of Trustees of the Leukemia
Society of America3 Inc. The policies as currently stated represent a revision of the
announcement issued on March l3 1963 and are subject to further revision at the dis-
cretion of the Committee. Every effort will be made to cope with the special problems
of investigators within the operational framework of this reseai'ch program.

Revised April 3 1976

[210]

INSTRUCTIONS FOR APPLICANTS

All applications must be signed by the candidate, Sponsor and official authorized
to sign for the sponsoring institution.

All applications pertaining to human research must have the written approval of
the sponsoring institution's Council on Human Investigation and those which do not
deal with human research must so state. (See "Terms of the Grants", paragraph seven
for statement required.)

All applications covering research projects which may involve biohazards for the
investigator, other personnel, or any other individuals must include a description
of the safeguards planned.

Only one application in each category (Scholar, Special Fellow or Fellow) from an
individual Sponsor will be considered.

Leukemia Society of America awards cannot be used to supplement other special awards
given to an individual; that is, a Leukemia Society of America grant cannot be held
concurrently with another grant which provides a higher level of funding. Leukemia
Society awards may, however, be supplemented from other sources.

A statement must be made in the application concerning the relevance of the
proposed work to the field of leukemia and related diseases.

38 copies of the completed application, signed by the applicant and signed and
approved by the Sponsor and authorized official for the sponsoring institution,
together with supporting data and letters of reference as requested in the application
form, plus three copies of all publications pertaining to the proposed research
project, must be sent to the Vice President, Medical and Scientific Affairs,

Leukemia Society of America, Inc., 211 East 43rd Street, New York, New York 10017,
on or before October 1. The Medical and Scientific Advisory Committee, which meets
once during each fiscal year ending June 30 for this purpose, will review all
applications.

Within a month following the review, which usually takes place at a special session
in January, those who have been chosen as Grantees will be so notified, and a contract
of agreement forwarded to them, their Sponsors and their respective sponsoring in-
stitution for signature. Funding will begin on July 1 of the same yaar with payments
made semi-annually (or monthly in the case of foreign Grantees) to the Controller
or other financial officer of the institution. The institution will in turn
disburse the funds to the Grantee during the term of the grant in accordance with
the budget submitted with the application.

Applicants are required to use only the forms supplied by the Leukemia Society of
America, Inc. to apply for a grant. All sections — pages one through six — must
be completed as indicated on the official application blanks.

Incomplete applications as well as those received after the October 1 deadline will
be considered invalid.

[211]

alza research

A DIVISION OF ALZA CORPORATION

1 December 1976

Dr. Donald Frederickson
Director

National Institutes of Health
Bethesda, MD 20014

Dear Dr. Frederickson:

One purpose of this letter is to put ALZA Research on
record as subscribing to the NIH guidelines on recombinant DNA
research, irrespective of the sources of funding for such work.

I attach an internal memorandum that states our current and
foreseeable involvement in this area, the former being nil
and the latter being very substantial. As you probably know
ALZA has pioneered in bringing membrane technology to bear on
achieving both continuity and control of drug entry into the
body through a new class of dosage forms called therapeutic
systems. I anticipate that significant practical applications
of molecular biology will depend heavily upon this technology
and its future extension.

As the attached memorandum states, you and your colleagues
have done an admirable job in responding constructively and con-
fidently to complex and much-debated issues. As an NIH alumnus
(1961-63), I am pleased to see the institution discharge this
responsibility so well.

There is something of a parallel issue in laboratory prac-
tice that the FDA has recently raised. It relates to adequacy
of laboratory procedures in work that bears upon laboratory
testing involved in determining the safety and efficacy of drugs.
Proposed Good Laboratory Practice Regulations were, as you know,
published in the November 19 Federal Register. While these are
nominally directed solely at the pharmaceutical industry, it is
difficult to see how they will not roll out through the entire
biomedical research establishment. I am sure you have antici-
pated being asked whether the intramural research program and
extramural grantees will be expected to adhere to Good Laboratory
Practices. I realize that the proposed regulations have been
written in cognizance of commentary from NIH, NCI, CDC, and other

[212]

Dr. Donald Freder ickson
1 December 1976
Page Two

Federal research institutions. Nevertheless, I hope that the
proposals of November 19 are studied very carefully from multiple
perspectives within NIH to insure that the final regulations will
be productive and cost-effective, rather than the reverse.

JU: sst

[213]

alza resea

MEMORANDUM

23 November 1976

TO:

FROM:

Project Leaders,

Area Directors,
Management Committee

J. Urquhart

_£*y,7.,_ »>*.*.•<

SUBJECT: ALZA's Conformance to the NIH Guidelines on

Recombinant DNA Research*

As you know, v/e currently have neither research nor
development activity in the area of molecular biology, and
thus the NIH guidelines have no immediate impact upon our
work. Yet, in a broader sense they do, in several ways.

They establish a valuable precedent for the intelligent,
informed, responsive, and well-articulated making of public
policy in areas where complex technology intersects with
intense public concern and attention by the mass media. In
particular they represent a valuable model in the area of
laboratory practice for constructive regulation without
obstruction to- innovation. I would hope that other federal
agencies — the FDA, EPA, OHSA, EEOC, SEC, and FTC — whose
actions bear, in one way or another, upon ALZA's work, would
emulate the care, confidence, and skill with which the NIH
has gone about setting these guidelines. They are a model
of enlightened, constructive regulation.

In another sense, one can foresee that practical appli-
cations of molecular biology in medicine will outstrip the
rudimentary technology of drug administration represented in
tablets, capsules, injectables, ointments, and eyedrops.

We can anticipate that, insofar as ALZA continues to lead
the revolution in the technology for controlled continuity
in drug delivery, we shall be very much involved in reducing
to practice the principles of molecular biology.

ALZA therefore will utilize the NIH guidelines on recom-
binant DNA research, irrespective of the sources of funding
for any such. work. Before any such work is undertaken, the
individual in charge must initiate a request for a review
of the type described in the NIH regulation and receive
approval for such work. No capital expenditures or personnel
requisitions are to be made for such work in anticipation
of the results of this review.

*Fed. Reg. , Wed., July 7, 1976. Part II: DHEW , NIH

JU: sst
JU : 1 : B-17

[214]

crfc Grant Foundation «■ ^rw

1 «0 lio-il jO,hSlreel
New York. NY 10022
752 - 0071

December 2, 1976

Dr. Donald S. Fredrickson
Director

Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

In reply to your letter of November 1 7, 1976, I wish to inform
you that the Grant Foundation has never and does not now provide
support for research on recombinant deoxyribonucleic acid (DNA) research.
I was pleased, however, to note the steps that have been taken by the
interagency committee, and certainly believe that you are proceeding
properly.

Sincerely

Philip Sapir
President

PS : 1 p

cc: Dr. Joseph G. Perpich

[215]

CHARLES F. KETTERING FOUNDATION / SUITE 300 / 5335 FAR HILLS AVENUE / DAYTON, 0HI0 45429

E. H. VAUSE, Vice President, Science and Technology

December 2, 1976

Dr. Donald S. Frederickson
Director

Department of Health, Education, and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Frederickson:

Your letter of November 17, 1976 addressed to Mr. Lombard,
our former President, has reached me for reply.

We applaud the leadership tl?e NIH is giving in establishing
guidelines for carrying out recombinant DNA research.

The Interagency Committee is another step in the right
direction.

Our research laboratory is not now engaged in such research,
but we expect to enter this field soon. We are involved
in several aspects of nitrogen fixation research and some
of the activities relate to increasing the yield and pro-
ductivity of soybeans and other legumes. Our investiga-
tors along with other plant scientists and cell biologists
are considering gene amplification as one means for increas-
ing overall nitrogen fixation in such symbiotic systems.

As you know, no guidelines now exist for dealing with plants
or the "beneficial" microorganisms which infect plants.

Such guidelines are urgently needed for scientists who have
already begun preliminary experiments in these areas of
investigation .

Our laboratory will abide by whatever guidelines are promul-
gated whether or not compliance is regulated by the federal
government .

Please write or call if we can assist in any further way
on this important matter.

Sincerely,

E. H. Vause

EHV: jl

[216]

TELEPHONE AREA CODE 702

329 9252

MAILING ADDRESS:

P O. BOX 1871. RENO. NEVADA 89509

MAX C. FLEISCHM ANN FOUNDATION

SUITE 309. SECURITY NATIONAL BANK OF NEVADA BUILDING

ONE EAST LIBERTY STREET

RENO. NEVADA

TRUSTEES:

JULIUS BERGEN. Chairman
FRANCIS R. BREEN
THOMAS L. LITTLE
WALTER ORR ROBERTS
SESSIONS S. WHEELER

Donald S. Fredrickson, M.D.

Director

National Institutes of Health
Public Health Service
U.S. Department of Health, Education
and Welfare

Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Only the volume of our mail has prevented earlier acknowl-
edgment of your letter of November 17th.

Our response to the question raised by you is that this
Foundation has no role in the support or conduct of the re-
search referred to.

December 2, 1976

Sincerely yours

JB/cr

[217]

THE SALK INSTITUTE

POST OFFICE BOX 1809, SAN DIEGO, CALIFORNIA 92112 714: 453-4100

Frederic de Hoffmann

President December 2, 1976

Donald S. Fredrickson, M.D.

D i rector

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Thank you for your letter of November 17 asking about the nature
and scope of work with recombinant DNA at The Salk Institute.

At the present time we are not pursuing any research in this area.

I have discussed your letter with some of the members of our
scientific staff and with the Institute's Biohazards Committee.
Although there are no immediate plans to undertake recombinant DNA
work, we recognize that our plans may change in the future. Any
work in this area would be carefully planned and subject to the
review of our Biohazards Committee, using the NIH guidelines and
any other information that may become available.

With regard to the items mentioned in the minutes of the Interagency
Committee on Recombinant DNA Research included in your letter, we
can offer a few general comments. The Institute has developed
procedures for handling potentially hazardous materials which are
presently used, such as tumor viruses and certain cell lines.

These procedures include registration of materials, review of
activities by our Biohazards Committee, and safety education and
training of our personnel. At the present time we do not anticipate
that we would be involved in developing safer hosts and vectors for
the scientific community, although we would, of course, contribute
in whatever way we could if we became involved in recombinant DNA
work.

We hope that the Interagency Committee will give careful considera-
tion to the means of providing adequate facilities for recombinant
DNA research so that the institutions involved would be able to
comply fully with the NIH guidelines or any other guidelines which
may be developed for such research.

I hope that these brief comments will be helpful to the Interagency
Committee. We will keep you informed about the development of any
plans for recombinant DNA research at The Salk Institute in the
f ut ure .

Yours very sincerely,

[218]

Rockefeller Brothers Fund
30 Rockefeller Plaza
New York. New York 10020

December 3, 1976

Dear Dr. Fredrickson:

I am responding to your letter of November 17, 1976 to Mr. Robert C.
Bates, Vice President of the Fund, with special appreciation for the effort to
extend the NTH guidelines on DNA research to the public and private sectors.

As you can see, we are not directly Involved In the purposes of your survey,
since we are not a research organization and otherwise would have no direct
application of the NTH guidelines.

We are, however, as a private grant-making foundation with special

Interest In environmental Issues and public-interest science, especially con-
cerned with the public policy process and the Issues surrounding the DNA
research. We have presently made two grants to open up and stimulate public
debate on these Issues. The first Is to the Union of Concerned Scientists In
Cambridge, Massachusetts to help them recruit a respected and neutral senior
biochemist who can do a technically competent and yet easily understood an-
alysis of the Issues surrounding the DNA research. We have also made a grant
to the Environmental Defense Fund for a similar analysis under their Toxic
Substances Division.

We appreciate your response to the public concern over these issues,

and we would enter a strong plea and support of even more broad public debate
and Involvement In all future considerations of these Issues.

If your office will be sending out further information In this area,
we would appreciate being added to your mailing list.

Dr. Donald S. Fredrickson
Director

Department of Health, Education, and Welfare
National Institutes of Health
Bethesda , Maryland 20014

Sincerely

[219]

The

Robert Wood Johnson
Foundation

P.O. Box 2316

Princeton, New Jersey 08540
(609) 452-8701

Dr. Donald S. Fredrickson

Public Health Service

Dept, of Health, Education, and Welfare

National Institutes of Health

Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Margaret Mahoney is out of the office, and I am replying to your
November 17 letter to her regarding recombinant deoxyribonucleic
acid research, so that your tabulation of replies will include
The Robert Wood Johnson Foundation. The resources of our Foundation
are directed toward assisting institutions and agencies seeking to
improve health care arrangements in this country. None of our
grantees, or our staff, is involved in research involving re-
combinant DNA.

However, because we are aware of the possible public health hazards
as well as benefits that might result directly or indirectly from such
research, we are watching with interest the work of the Interagency
Committee and other groups involved in this area of science. We
therefore would appreciate anything you might do to keep us informed
of the Committee's deliberations, findings and progress.

With all good wishes.

December 6, 1976

Sincerely yours

Frank Karel ,

Director of Information Services

FK: jms

[220]

J0S1AH MACY. JR. FOUNDATION

ONE ROCKEFELLER PLAZA
NEW YORK, N. Y. 10020
TELEPHONE: (212) 246-8830
CABLE : MACV FOUND, NEW YORK

JOHN Z BOWERS, M O
MUSIOENT

December 7, 1976

Donald S. Fredrickson, M.D.

Director

Department of Health, Education, and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

I have your letter of November 17 in which you inquire
about our role in the support or conduct of recombinant
deoxyriobonucleic acid research and the potential
application of the National Institutes of Health guide-
lines to our research activities in this area. I can
report categorically that we have no relationship to
this field.

Yours sincerely

J ZB/ dh

(221]

JERRY LEWIS

Board of Directors

National Chairman

MRS. GERALD R. FORD

CARL F. AXELROD
LOUIS R. BENZAK
OOROTHY COLLINS
MICHAEL E. DeBAKEY, M.D.
THOMAS R. DONAHUE
MICHAEL T. GAFFNEY
JOHN J. GARDINER
ALVIN HAMPEL
JACK HARRIS
W. HOWARD McCLENNAN
FREDERICK O’NEAL
S. MOUCHLY SMALL, M.D.
HENRY M. WATTS, JR.
SYLVESTER L. WEAVER, JR.
Mrs. JOHN C. WEST

Honorary Chairman

SYLVESTER L. WEAVER, JR.

President

HENRY M. WATTS, JR.

Chairman, Executive Committee

S. MOUCHLY SMALL, M.D.

Chairman,

Scientific Advisory Committee

LEON I. CHARASH, M.D.

Chairman,

MUSCULAR DYSTROPHY ASSOCIATION, INC

Medical Advisory Committee

ROBERT ROSS

Active Member, National Health Council

Vice-President and
Executive Director

December 8, 1976

Donald S. Fredrickson, M.D., Director
National Institutes of Health
Public Health Service

Department of Health, Education and Welfare
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Thank you for your letter of November 26 to Henry M. Watts, Jr., Chairman
of MDA's Executive Committee. Mr. Watts has asked that I reply on his
behalf.

We are grateful to receive from you a copy of the minutes of the November 4
meeting of the Interagency Committee on Recombinant DNA Research. In answer
to your inquiry about this Association's role in support or conduct of re-
search in that area, we have not yet funded such investigations. Although
it seems unlikely that we will be receiving applications for support of
this kind of work in the immediate future, the NIH guidelines will be of
interest to us nevertheless. I hope you will keep us informed of new ad-
visory or regulatory developments pertaining to this area of research.

I trust you won't mind my sharing your present and future communications
with members of our Scientific and Medical Advisory Committees, and I as-
sure you that any grant applications we may receive that deal with re-
combinant DNA will be reviewed for comformity to guidelines and recommenda-
tions of NIH and other appropriate sources, including the institutions where
prospective grantees are working.

Sincerely,

M. L. Moss, Ph.D.
Director of Research

Development

MLM: jsw

[222]'

AMERICAN CANCER SOCIETY, INC.

777 THIRD AVENUE • NEW YORK. N .Y . 10017 • (21 2) 371-2900

RESEARCH

EDUCATION

SERVICE

December 14, 1976

Donald S. Fredrickson, M.D.

Director

Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

Please refer to your letter of November 17, 1976
to fir. Lane Adams, regarding recombinant DNA
research.

The American Cancer Society currently has twelve
grants in effect totaling approximately one
million dollars which deal with recombinant DNA
research. Details are provided in the enclosed
listing .

Also enclosed is a copy of the certification which
will be required from all research grant applicants.
The printed material is at our print shop for
duplication and will constitute page 2 of all future
applications. As you can see, this will cover
research involving both recombinant DNA and human
subjects.

I hope this information will be useful to your
committee

Sincerely,

^r»\ ol/yv o /ovrc'w cv

Stefano Vivona, M.D., M.P.H.
Vice President for Research

Enclosures

The Jane Coffin Childs Memorial Fund for Medical Research

333 Cedar Street • New Haven • Connecticut 06510

December 15, 1976

Dr. Donald S. Fredrickson
Director

Department of Health,

Education and Welfare
National Institutes of Health
Bethesda, Maryland 20014

Dear Doctor Fredrickson:

This note is in response to your letter of
November 29, 1976. The Jane Coffin Childs Memorial Fund
for Medical Research carries out no "in house" research.

Our funds are expended entirely either in the support of
postdoctoral fellowships, or, in a much more limited way,
in small grants to young or recently established investigators
generally in academic institutions.

The research supported by the Fund clearly involves
recombinant DNA experiments in some instances. However, the
monitoring, evaluation and control of this work and the specific
application of the NIH Guidelines is the responsibility of the
host institution where the research is carried on.

Up to this time the Fund has made no inquiries of the
host institutions as to whether or how they apply the Guidelines.

On the surface it does not appear that such a request would serve
any useful function. The Fund has no means of checking on such
aspects of the research that it supports, especially since the
various laboratories are located all over the world. In all
instances academic, governmental or non-profit research
institutions are involved. To the best of our knowledge all
of these are committed to and interested in complying with the
Guidelines .

I am not prepared on short notice to respond in detail
about your proposed list of functions required for implementation.
Since Sal Luria, Paul Berg and Bob Sinsheimer among others are all
members of our Board of Scientific Advisers, I feel that from their
various positions you will have all the multifaceted input to these
questions that this Fund could possibly supply even after long
internal deliberation.

FMRref

Sincerely yours ,

Frederic M. Richards
Director

[224]

THE UNIVERSITY OF NORTH CAROLINA

At

CHAPEL HILL

ifltool ot Moitcioc

The Uiuvemty ot North Carolina *i Chi pel Hill
Old Clinic Building 226 H
Chapel HU1. N.C. 27514

;wcnc«u ot M<d>on«
« u.oo ot Nephrology

December 27, 1976

Ma. E. K. Hatch
Acting Executive Director
American Kidney Fund
Post Office Box 975
Washington, D.C. 20044

Dear Kay:

As Chairman of the Research Crar.ts Committee of the American Kidney
Fund, I am responding tc the inquiry from the Department of Health,
Education and Welfare in regard to whether we arc supporting research
in the area of recombinant deoxyribonucleic acid (DNA).

In reviewing the research which is currently being supported by
the American Kidney Fund, I have not found any projects dealing with
recombinant DNA research. In reviewing the research requests currently
before the American Kidney Fund, I have found that none of these deal
with recombinant DNA research.

I believe these comments about the research which we are currently
supporting and are planning to support should cover the inquiry made by
the Department of Health, Education and Welfare and I would appreciate
your forwarding ay letter to them in reply to their request for information
on this subject.

Sincerely

William D. Kattern, K.D.
Assistant Professor of Medicine

WDM: jc?

[225]

Planned Parenthood -World Population aio seventh avenue, newyork, new york 10019,. (212)541-7900
headquarters of Planned Parenthood Federation of America, Inc.

February 3, 1977

CABLE

PAREN n-iOOD, N Y

Founded by
Margaret Sanger
1879-1966

CHAIRMAN

Mrs. Julian M. Marshall

TREASURER
Roll 1 n M. Dick

SECRETARY

Mrs. Charles P Noyes

EXECUTIVE COMMITTEE
Meacham Hitchcock
Chairman

Mrs. James Bryant, Jr.
Donald S, Buzard
Elizabeth B. Connell, M.D
H. Kimball Faulkner
Mrs. Gordon A, Fox
Beverly W, Gabrio. Ph.D.
Francisco C Gonzalez
Andrew F. Greensfelder
B. T. Hollins, M.D.

Ms. Barbara Johnson
J. L. Kingsley
Joan F. Kraus
Philip R. Lee, M.D.

Rev. Thomas P. Lindsay
Mrs. Marvin Lyons
Jerome K. Nagel
Philip W. Stichter
Warren W. Weaver
Mrs. Richardson White. Jr.
Mrs. Charles F. Whitten
Mrs. William Wimer

PRESIDENT
Jack Hood Vaughn

VICE PRESIDENTS
Hans C. Blaise
Frederick S. Jaffe
Louise B. Tyrer, M.D.

Donald S. Fredrickson, M.D.
Director

Department of Health, Education
and Welfare
Public Health Service
National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Fredrickson:

In regard to your recent letter inquiring about the role of Planned
Parenthood Federation of America in the support or conduct of
recombinant deoxyribonucleic acid (DNA) research, I have checked
this out with our Vice President for Medical Affairs and through
the Research Subcommittee of our National Medical Committee.

They report that our organization through its Affiliate clinics
is not involved in any such research, nor is any contemplated for
the future.

I would, however, appreciate your directing a copy of the June 23rd
guidelines for experimental research in this area to our National
Medical Director, Louise B. Tyrer, M.D. , at this same address.

Thank you for this in advance, and for your interest in maintaining
surveillance in this most significant new area of research.

Sincerely,

(

A

V

/

Jaqk H. Vaughn
Pif^sident

JHV : jh

[226]

PLANNED PARENTHOOD-WORLD POPULATION IS A MEMBER OF THE INTERNATIONAL PLANNED PARENTHOOD FEDERATION

BOA WO OF 1WUSILLS REPRESENTING

• American Association of irnunoio9*sts

• Amci cin institute of Bn •; j Sciences

• American Pny toDJtno'O'j Society

•

•

• American Society of Par jsitoiognti

• American Society of Zooio^ sts

• American Society of T rooic.i Medicine and Hygiene

• Genetics Society of Amei ca

• infectious Diseases Society of America

• Mycoiogica* Society of America

• National Research Counc ■ National Academy of Sciences

• Soc ety of Proto/oofogists

• Tissue Culture Association

• 301-881-2600

AMERICAN TYPE

CULTURE

COLLECTION

12301 PARKLAWN DRIVE
ROCKVILLE. MARYLAND 20852

March 2, 1977

Senator Jacob K. Javitz
and

Senator Edward M. Kennedy
United States Senate
Washington, D. C. 20510

Dear Senators Javitz and Kennedy:

Re: Recombinant DNA Research

Letter of February 14, 1977

In response to your letter of February 14, 1977, it is possible that
the American Type Culture Collection (ATCC) may not fit into the milieu for
which your questionnaire is designed. We are non-profit, non-commercial and
our major raison d'etre is to preserve and provide authenticated strains of
microorganisms, viruses and tissue culture cell lines to the scientific com-
munity. Though we are a private scientific organization we are heavily
involved in NIH grants and contracts and therefore come under the NIH guide-
lines.

At present we are not engaged in recombinant DNA research but it is
conceivable that as new recombinants become available we will be called upon
to develop methods to preserve their, and to make them available to other
scientists and other scientific organizations. Under such circumstances we
certainly would operate under the guidelines. In short then:

1) We are not engaged in recombinant DNA research. We may become
so involved as noted above.

2) If we become involved it is likely to circle around methods for
preserving, reproducing and distributing NIH-approved recombinants.

3) We would certainly be "registered" with the NIH for such research.

4) We would comply with the NIH guidelines.

5) We have not nor do we anticipate obtaining patents on such
recombinants .

[227]

An independent non profit organization incorporated in Washington. D C and devoted to the
preservation of reference cultures and their distribution to the scientific community

Senator Jacob K. Javitz

Page 2

March 2, 19'/ 7

and

Senator Edward M. Kennedy

If I can be of any further service in this connection, please do not
hesitate to ask. It has been my pleasure to have the opportunity to review and
comment on the guidelines before they were issued and certainly the ATCC is in
accord with them.

Sincerely yours

Richard Donovick, Ph.D.
Director

RD : led

cc: Dr. Frederickson

Director - NIH

[223]

QlCrufeb J&enafe

WASHINGTON. DC. 20310

February 14, 1977

Dr. Richard Donovick, Director
American Type Culture Collection
12301 Parklavn Drive
Rockville, Md.

Dear: Dr. Donovick:

As you know, the conduct of recombinant DNA research has become the subject of
increasing debate and concern both within the scientific community and more recently,
in public forums. The Subcommittee on Health has maintained an intense interest in the
issues which have prompted the controversy over such research and has held two public
hearings concerning these issues over the past two years.

At the last hearing on September 22, 1976, the Director of the National Insti-
tute of Health, the Assistant Administrator for Research and Development of the Environ-
mental Protection Agency, a nanel of eminent scientists, and the President of the Phar-
maceutical Manufacturers Association, provided thoughtful testimonv concerning the
status of recombinant DNA research and the guidelines recently promulgated by the
National Institute of Health for the conduct of such research. As expressed by the
Director of NIH, the object of the guidelines is to minimize the associated risks while
permitting appropriate tynes of this research to continue with its great potential bene-
fit to mankind.

The NIH guidelines are now being adopted by all federal agencies conducting or
supporting such research. Mr. Joseph Stctler, the President of the Pharmaceutical
Manufacturers Association stated at the subcommittee hearing that pharmaceutical com-
panies intended to conform with the NIH guidelines and that the PMA would continue to
work closely with NIH to work out minor problems so that compliance could be achieved.

It was the consensus of the witnesses before the subcommittee that the NIH
guidelines should be extended to all sectors of the research community conducting recom-
binant DNA research, including the private sector and the international community. The
subcommittee shares this view.

We wrote to President Ford on July 19, 1976, oointing out the necessity for
an extension and urging exploration of the means of implementation, including suggest
legislation if necessary. President Ford's reply of September 22, 1976, indicated the
the Interagency Committee on Recombinant DNA Research would be formed to review the
activities of all government agencies performing or supoorting such research and to
coordinate activities with non-federal institutions. The first meeting of the Inter-
agency Committee was held on November 4, 1976 and there have been several subsequent
meetings. The Committee has discussed, among other things, the need to establish a
central registry of all recombinant DNA research and existing legislative authority
regulation of such research.

[229]

-2-

In anticipation of the possible need for additional legislation to implement
such registration and regulation, 1 would appreciate it if you would furnish the
following information by March 15, 1977.

1. Is your company or institution engaged, or has it previously been engaged,
in the conduct or support of recombinant DMA research in the United States or elsewhere?
If so, please provide information concerning the nature and location of such research and
identity of the company or institution conducting such research. Also please furnish the
same information about any contemplated research of this kind.

2. If your company or institution has not engaged in recombinant DKA research,
is such research being contemplated? If so, please provide the nature and location of
such research and the identity of the company or institution which will conduct the
research.

3. If recombinant DNA research is being conducted or contemplated, is your
company or institution willing to register such research and comply with the Mill guide-
lines?

4. If your company or institution can not comply with the Kill guidelines, what
changes in the guidelines would you suggest to make compliance possible?

5. has your company or institution obtained any patents for recombinant DNA?

If so, please furnish information concerning the nature of the patents and the dates they
were issued.

Your cooperation in this important matter will be very much appreciated.

[230]

American

Heart

Association

National Center Telephone

ille Avenue 214 750-5448

Dallas. Texas 75231

March 30, 1977

Donald S. Fredrickson, M.D.

Di rector

I National Institutes of Health
f Building 1 , Room 124
Bethesda, MD 20014

Dear Don,

I am writing in behalf of the American Heart Association Research
Committee concerning actions it took at its recent meeting relating
to human experimentation and recombinant DNA research.

The Committee voted that in future the AHA Research Committee and
all Research Study Conmittees will require applicants to affirm,
where pertinent, that their research will conform to the National
Institutes of Health Guidelines for Recombinant DNA Research and to
those for Protection of Human Subjects.

Another matter discussed and still unresolved is the inability of the
NIH to provide any supplementation to AHA Established Investigators
working in one of your Institutes. If you recall, you and I discussed
very briefly at the AHA Annual Meeting last fall, problems relating to
administration of potential El awards.

Since 1973 the AHA has followed the practice of negotiating Established
Investigator stipends with the sponsor institution so that the Associa-
tion pays 75% and the El's institution pays 25% of the total annual
salary according to the awardee's rank in relationship to his or her
peers. The Association guarantees a minimum first-year salary of $15,000
with annual increments of $1,000 and its maximum contribution to a nego-
tiated (75%-25%) stipend is $26,000 for any of the five award years. The
maximum allowable salary for a first year Ei is $37,000 and no more than
two times the Association's maximum contribution ($26,000) for any sub-
sequent year of the award.

Virtually all of our Established Investigators receive institutional
supplementation and it would seem timely that the National Institutes
of Health explore the possibility of obtaining funds or a discretionary
fund that would allow for some supplementation (however minor) to insure

Chairman ot the Board

President Elact

[231]

Vice Presidents

T reasurer

Richard Don,

Harriet P Dustan. M D

Philip P Arden,
Owen Beard M D

Ira L Lavm
John G Martin

John S Andrews

Ptrndmt

Immachata Past President

John J DeFeo. Ph D

Edward Mailman. M D

Secretary

John T Shepherd M D

Eftot Rapaport M D

Immadiata Pan
Chairman o < lha Board
Rom Raid

Mrs Frank A Dresslar Jr
Ham Jackson. M D
Kenneth W Kihle M D

Nanette K WengeT M D
Stanford Wessler M D
James G White. M D

Mrs M Jeanne Ponoous, R N

Executive Vice President
William W Moore

Dr. Donald S. Fredrickson
March 30, 1977
Page Two

continued favorable consideration of El applicants for work at NIH.

There were two approved applications for work at NIH this year; one
candidate declined because of administrative and fiscal restri ctions ;
the other is accepting the award, at a considerable reduction in annual
salary, with only our $15,000 per year guaranteed minimum stipend.

I would be happy to hear your thoughts on this dilemma since if it remains
a stalemate I sadly fear that in future candidates for awards at NIH will
be in jeopardy for serious consideration if, indeed, we would be able to
even accept such applications for review.

Kind regards.

Yours sincerely.

Howard Weisberg
Di rector

Division of Research

HW:mn

cc: Dr. Mary J. Osborn

[232]

FEDERAL INTERAGENCY COMMITTEE

Inquiry Into Research

Programs of Government Agencies and Industry
""Involving Recomoinan'PDNA

Page

Summary Minutes of Interagency

Committee, 11/23/76 234

Minutes. 11/23/76 240

[233]

Interagency Committee on Recombinant DNA Research

Summary Minutes of Meeting
November 2 3, 1976
National Institutes of Health
Bethesda, Maryland

The second meeting of the Interagency Committee on Recombinant DNA
Research was convened at the National Institutes of Health on
November 23. The meeting, chaired by Dr. Donald S. Fredrickson,

Director of the NIH, was held from 9:00 a.m. to 12:30 p.m. and was
conducted in three sections — reports given by the performer agencies,
reports rendered by the regulatory agencies, and other business.

Research departments and agencies that reported included Agriculture,

Defense, Energy Research and Development Administration, National
Aeronautics and Space Administration, and the National Science Foundation.

The Department of Agriculture reported that an ad hoc committee has been
established to review the NIH guidelines and to determine what permanent
mechanisms need to be established to ensure implementation of the guidelines.
Review of the guidelines will be completed shortly and it is expected that
the Department of Agriculture will endorse the guidelines. Upon initial
review Agriculture has determined that there are four research, proj ects
being supported by the Department involving recombinant DNA research.

The Department of Defense reported no currently active or planned
recombinant DNA research activity. The Department reaffirmed a previous
commitment to comply voluntarily with the guidelines if such research were
to be conducted in the future. Defense suggested that as a means for
uniformly interpreting and enforcing the NIH standards, there may be need

[234]

for a standing committee, perhaps at the level of the Scientific Advisor
to the President.

The Energy Research and Development Administration (ERDA) reported that
instructions had been sent to all associated laboratories that the NIH
guidelines are to govern recombinant DNA research. Because most research
supported by ERDA is done in facilities run by ERDA, strict surveillance
is possible. ERDA suggested, for purposes of management, that research
proposals perhaps could be forwarded to an NIH study secrion for a
scientific and biohazard review. ERDA, however, would retain the right
of final approval or disapproval after that review. At present, there
is currently no recombinant DNA research in progress or being planned
but there are a number of scientists working in related areas.

The National Aeronautics and Space Administration (NASA) reported that
there is no current or planned recombinant DNA research activity.

The National Science Foundation (NSF) has accepted the NIH guidelines
and is currently reviewing mechanisms for implementation. For example,
NSF is considering the creation of its own appellate mechanism concerning
questions over standards, practices, and procedures, as outlined in the
guidelines. NSF currently has awarded 52 research projects that involve
at least in part recombinant DNA research. Twenty more projects are
pending. Of those awarded, 6 require physical containment at the
third level (moderate potential risk). The total amount for the 52
awarded projects is $3.3 million, but as noted, recombinant DNA research
activities comprised an undetermined fraction of this total.

(235)

The second half of the program of the committee meeting was devoted to

reports of the regulatory departments and agencies. Those reporting Included

the Animal and Plant Health Inspection Service of the Department of

Ag: •iculture, the Center for Disease Control, the Food and Drug Administration

of the Department of Health, Education, and Welfare, the Occupational Safety

and Health Administration of the Department of Labor, the Department of

Transportation, the Environmental Protection Agency, and the Civil
Aeronautics Board.

The Department of Agriculture reviewed its authority to control the
Interstate movement of organisms hazardous to plants and animals. Thus,
the interstate shipment of materials relevant to recombinant DNA research
may be possibly governed by this authority if such materials are hazardous
to plants or animals.

The Center for Disease Control summarized legislative authorities, including
Section 361 of the Public Health Service Act. Section 361 permits regulation
of the interstate shipment of etiological agents. The committee has under
review a petition to the Secretary of HEW from the Environmental Defense
Fund to issue regulations for recombinant DNA research on the basis of
Section 361 of the PHS Act.

The National Institute for Occupational Safety and Health (NIOSH)
of the Center for Disease Control provides standards for the Occupational
Safety and Health Administration (OSHA) to enforce. This model was
suggested as one relevant to the implementation of the NIH guidelines.

A number of suggestions were made to ensure appropriate

[236]

employee health and safety in laboratories where recombinant DNA
research is being conducted. Among measures recommended included a
central registry of laboratories, workers, and research projects
with long-term follow-up studies. Further, medical examinations for
workers before and during research activity was recommended.

The Food and Drug Administration (FDA), in its review of legislative
authority, reported that FDA regulations would come, into play when
recombinant DNA research results in commercial application for drugs,
chemicals, or the like.

The Occupational Safety and Health Administration of the Department of
Labor is responsible for the protection of the employee in the work place.
Relevant statutory and regulation may be applicable to govern the conduct
of recombinant DNA research for purposes of employee safety. However,
there is a statutory gap in the coverage provided by OSHA:

There are 26 states without state plans; and in those states, local
governments are exempt from OSHA, including state universities.

The Department of Transportation has legislative authority to issue
regulations concerning transportation of substances which create an
unreasonable risk to health, safety, or property. These regulations
are currently being revised and will become available to the committee
for review.

The Civil Aeronautics Board has legislative authority to regulate the
amount of hazardous substance that an airline company may carry.

(237]

On a passenger flight, the limit is 50 ml and on a cargo flight the limit
is 4 liters.

The Environmental Protection Agency has a number of legislative authorities
such as the Clean Air Act and the Water Pollution Control Act that allow
EPA to set emission and effluent standards. However, the more relevant
legislative authority is the Toxic Substances Control Act recently passed
by Congress. In an analysis of that Act, it was suggested that EPA may have
regulatory authority to govern recombinant DNA research. However, there
are certain exemptions concerning laboratory research in the Act. Further
review of the authority and implementation will be done.

In the concluding portion of the program, the representative from the
Commerce Department reported on a meeting with private industry on the
subject of extending the NIH guidelines to govern research in the private
sector. As a result of the meeting, a number of suggestions were offered
by the industrial representatives. These include that there might
perhaps need to be mandatory registration for all recombinant DNA research
done nationally but that there should be, if possible, voluntary compliance
with the guidelines. An advisory committee or industrial forum was
recommended that would relate to the government and serve as a means of
communication between industry as a whole and the government. This
advisory committee could continually review the standards and suggest
modifications where appropriate. Certain modifications need to be
done in the present NIH guidelines in order that intellectual property
rights and patenting of new inventions not be compromised.

[238]

At the conclusion of the meeting, Dr. Fredrickson, with the approval of

the committee, created a subcommittee that would review the analyses
presented and report to the full committee possible recommendations on
the basis of that review. Representatives from the following departments
will serve on the subcommittee: Agriculture, Commerce, Justice, OSHA,

CDC, EPA, NIH, and the White House Office of Science and Technology Policy.

Respectfully submitted

, J.D.

Associate Director for
Program Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

December 3, 1976

[239]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Minutes of Meeting
November 23, 1976
National Institutes of Health
Bethesda, Maryland

I. Reports of Performer Agencies

The second meeting of the Interagency Committee on Recombinant DNA
Research was convened at the National Institutes of Health on
November 23. The meeting, chaired by Dr. Donald S. Fredrickson,

Director of the NIH, was held from 9:00 a.m. to 12:30 p.m. and was
conducted in three sections — reports given by the performer agencies,
reports rendered by the regulatory agencies, and other business.

Dr. Charles Lewis, representing the Department of Agriculture, was the
first to outline his agency's plans to fulfill the functions involved
in conducting recombinant DNA research in accordance with the NIH
guidelines. Dr. Lewis reported that an ad hoc committee had been
formed to determine what permanent bodies need to be established to
take care of implementing the guidelines. A draft letter from this
committee has recently been sent to the administrators of the four
agencies of USDA stating that the Department will comply with the guide-
lines as written. Responses to this letter have not yet been received.

It was further reported that the Forest Service is currently conducting
two projects in which recombinant DNA research is involved, the
Agricultural Research Service is conducting another, and a fourth is
being supported at the University of California at Davis. The Coopera-
tive State Research Service inventory of projects was not received

[240]

-2-

prlor to this meeting and It was not established whether the extra-
mural project was supported by means of a grant or a contract.

In summary, the USDA has committed Itself to adopting the NIH guidelines
and to setting up the machinery necessary to Implement these guidelines.

Drs. Samuel Koslov and William Belsel reported on the results of their
Informal contacts within the Department of Defense and reaffirmed the
previous DOD commitment to voluntarily comply with the guidelines. Even
though there Is currently no active or planned recombinant DNA activity,
the DOD has the capability for such and plans to make any future request
for funding contingent upon a project evaluation similar to that con-
ducted at the NIH. Since extramural projects are rarely funded by the
grant mechanism, tight control can be exercised over any future contract
awards.

DOD Indicated its willingness to participate In the registration of
recombinant DNA activities and the Implementation of the NIH guidelines,
with the contingency that such compliance might be altered In the event
of a foreign threat to the national defense. Problems which might be
encountered in this Implementation Include securing additional staff,
Interpreting the guidelines, and enforcing the guidelines. The use of
the NIH study sections and personnel was mentioned as a possible solu-
tion to the former problem, with DOD retaining final authority
regarding the disposition of a proposal. The creation of a governmental
body, composed of representatives from all concerned sectors of the

[241]

-3-

population, at the level of the scientific advisor to the President,
was suggested as a means of uniformly interpreting and enforcing the
guidelines and resolving any interagency conflicts that might arise.

Dr. Charles Carter, representing the Energy Research and Development
Administration, reported that there is currently no recombinant DNA
research in progress or being planned but that there are many investigators
working on the rim of this area (i.e., enzyme preparation). ERDA has
sent instructions to all its laboratories that the NIH guidelines are
to be adhered to. These instructions have the force of regulations
within the agency and a unit exists to insure compliance. Since most
research, both extramural and intramural, is conducted within ERDA-owned
facilities, stringent surveillance is possible. There is some research
activity, however, in independent and university laboratories which
cannot be monitored as closely. In addition, the biological divisions
throughout the agency have formed recombinant DNA research committees
to evaluate any future activities, facilities, and practices.

Dr. Carter then suggested that a proposal, after receiving a scientific
review by ERDA staff, be forwarded to an NIH study section for both a
scientific and a biohazards review, with ERDA retaining the right of
final approval or disapproval. This is viewed as useful from a manage-
ment standpoint because it will facilitate the creation of a registry,
eliminate duplication, provide a uniform basis for selecting projects,
and will provide national oversight of local training procedures and
biohazards committees.

[242]

-4-

The National Aeronautics and Space Administration representative,

Dr. Young, reported that there is no current or planned recombinant
DNA research activity but that NASA is supporting (mostly through the
grant mechanism) related work such as nuclear transplantation and poly-
peptide synthesis. NASA conducts its own peer review but suggested
need for a centralized review for the evaluation of biohazards, but not
of scientific merit, to insure uniform and high quality implementation
of the NIH guidelines.

The National Science Foundation, represented by Dr. Herman Lewis, accepts
the NIH guidelines in toto except for the role of the NIH study sections.
Two documents have been formulated, but not yet approved, to facilitate
the implementation of the guidelines. The first of these is a letter to
universities outlining the guidelines, the responsibilities of all
Involved in recombinant DNA research, and a format to be followed in
future proposals. The second document, addressed to NSF program personnel,
recommends the appropriate containment levels for various types of projects
and also establishes a coding system for computerization of activities.

In addition, an Office of Recombinant DNA Research has been formed to
maintain a detailed registry of relevant activities.

While recognizing the NIH as the lead agency, the NSF stated that it
wants to establish its own appellate system. No such mechanism has yet
been decided upon, but there is support for the establishment of a
committee of consultants. Channels of communication have been opened

[243]

-5-

with the NIH Biohazards Safety Officer and the NSF would want to
continue using his expertise on an informal basis.

Dr. Herman then supplied the following figures describing the magnitude
of the recombinant DNA effort currently being supported by NSF: of the

113 proposals submitted, 52 have been awarded and 20 more are pending;
of the 52 awarded, 46 require PI or P2 levels of containment and 6 require
P3; of the 52 awarded, 25 are using phage and bacteria DNA while the
others are using plant, amphibian, and insect sources. The total amount
of the 52 awarded projects is $3.3 million, but recombinant DNA
activities may comprise only a portion of each project. The actual
expenditures on recombinant DNA activity, therefore, is thought to
consume only a fraction of this total.

II. Reports from Regulatory Departments and Agencies
Environmental Protection Agency (EPA)

Pope Lawrence spoke first for EPA, noting that EPA had received
comments concerning the potential hazards of recombinant DNA.

He stated that the opinions given by him and Mr. McGarity were
for the edification of the Committee and were not necessarily
final EPA policy.

Thomas McGarity of EPA's Office of General Counsel reviewed
EPA authorities which might have an impact upon recombinant DNA.

The Clean Air Act and the Water Pollution Control Act, he explained,
authorize EPA to set emissions and effluents standards. He believed
that these Acts were not aimed at the small amounts of emissions
or effluents involved in research work. (The Guidelines address
the issue of physical containment.)

[244]

-6-

The Toxic Substances Control Act was cited by Mr. McGarity as
EPA's broadest authority in terms of the possible regulation of
recombinant DNA. Section 6 of the Act contains the authorities
which may apply to recombinant DNA. In sum, section 6, according
to Mr. McGarity might authorize EPA to regulate or prohibit "uses"
of recombinant DNA. Regulation could include registration, moni-
toring, inspection, etc. Section 5 of the Act contains authorities
which focus upon the manufacture or processing of hazardous
substances. Subsection 5(h) provides an exemption from most of
the requirement of the Act for scientific research. Some
discussion occurred concerning whether or not the exemption
was an exemption from the requirements of section 5 or of the
entire Act. Mr. McGarity was asked to review section 5 with
Dr. Schweitzer of EPA for clarification, and to inform the
Committee of the results of that review.

Department of Agriculture (USDA)

Dr. Charles Lewis introduced Dr. Schlief who summarized the
authorities of the Department of Agriculture which might impact
upon recombinant DNA. He said that the Department's authorities
include control of the interstate movement of organisms hazardous
to plants or animals. He Indicated that recombinant DNA could
be regulated only if it fell under this definition. In the
event of an emergency, he said, the Department would not be
limited by the interstate requirement. The Office of General
Counsel in Agriculture will provide a memorandum summarizing the
relevant authorities for the Committee.

[245]

-7-

Department of Health, Education, and Welfare (DHEW)

1. Center for Disease Control (CDC)

Dr. John Richardson, Director of CDC's Office of Biosafety,
said that section 361 of the Public Health Service Act
offered some potential for regulating recombinant DNA. CDC
regulations, he said, applied to etiological agents. Some
recombinant DNA might not have any relation to etiological
agents and thus might not be subject to CDC authorities.

2. National Institute of Occupational Safety and Health (NIOSH)

Dr. John Finklea, Director of NIOSH, said that his organization
recommended "standards" for OSHA to enforce. The NIH Guide-
lines could be the basis for a "standard", he said. He
focused most of his comments on the hazards to the persons
working with recombinant DNA. He suggested that there be:

a. a central registry of laboratories, workers, and research
projects connected with recombinant DNA and that these
records be kept for 30 years so that follow-up studies
could be conducted;

b. medical examinations for workers before and during
recombinant DNA projects;

c. informed consent by workers;

d. DNA markers in order to ease the difficulties of bio-
monitoring; and

e. special health insurance since workmen's compensation
might be inadequate in this situation.

[246]

-8-

3. Food and Drug Administration (FDA)

Carolyn Poplin of FDA's Office of General Counsel said that
current FDA authorities were geared for regulation of
commercial use of drugs, chemicals, etc. Therefore, FDA
would not be involved in the regulation of recombinant DNA
research at this stage of basic research.

Department of Labor (DoL)

Occupational Safety and Health Administration (OSHA)

Byung Kwon of OSHA indicated that his organization's authorities
were broad enough to regulate recombinant DNA in the work place .
The main gap was in the 26 States without a State OSHA Plan.

In those States, State and local governments are exempt from OSHA.
Thus, State universities would be exempt. He noted that it was a
long and difficult process to promulgate a "standard." Such a
promulgation is necessary before OSHA can use its enforcement
powers. Once an appropriate "standard" (the NIH Guidelines,
for example) was promulgated, he said, trained inspectors would
be needed. OSHA has no such person now and it would take time,
money, and personnel to establish such an inspection system.

Department of Transportation (DoT)

Mr. Grella of DoT's Office of General Counsel said that the
Transportation Safety Act of 1974 gave DoT authority to issue
regulations concerning the transportation of substances which
create an unreasonable risk to health, safety, or property.

The regulations, he said, were framed in terms of etiological
agents. He added that DoT is currently revising its regulations
and would provide the Committee with an advance copy.

[247]

-9-

Civil Aeronautics Board (CAB)

Dr. Limmer of CAB said that his agency regulates the amount of
hazardous substances which an airline company may carry. On a
passenger flight, the limit is 50 milliliters. On a cargo flight,
the limit is 4 liters. Amounts over 4 liters are completely
prohibited.

III. Other Business

Dr. Hartwell, substituting for Dr. Ancker -Johnson of Commerce
Department, reported the results of an informal conference held on
November 19th with representatives from the industrial sector. These
spokesmen endorsed the concept of compulsory registration of recombinant
DNA research projects but recommended that compliance be voluntary.
Concerns were expressed for the protection of proprietary information.

The representatives added that the desire of industry to protect its
facilities and public reputation would cause industrial plants, in many
cases, to institute controls even tighter than those mandated in the
NIH guidelines. Dr. Hartwell emphasized that the Commerce Department
has no regulatory authority to compel industrial compliance.

Following this presentation, Dr. Fredrickson recommended that
representatives be appointed to serve on a subcommittee that would
review all reports presented by Departments and Agencies and set the
future committee agenda. The following Departments and Agencies will
be represented on the Subcommittee: USDA, OSHA, EPA, CDC, Justice,

Commerce, OSTP, and NIH. The Committee gave its approval to this action.

[248]

-10-

Dr. Fredrickson also made a motion that the press be supplied with
copies of the summary minutes of the Committee meetings. After some
discussion. Dr. Fredrickson stated that the Executive Summary of the
Minutes would be cleared by telephone with the relevant Departments
and Agencies prior to release.

Materials from the following agencies will be forwarded to all
representatives as they become available:

(1) EPA - a clarification of the regulatory authority granted

by the Toxic Substances Control Act as decided upon by the Office
of the General Counsel in collaboration with the Toxic Substances
Control Office.

(2) USDA - a General Counsel review of the authority of the
Animal and Plant Health Inspection Service.

(3) DOT - advance notice of proposed changes in the current
regulatory authority.

The agency representatives will be notified of the date and agenda of
the next meeting. Any suggested agenda items should be forwarded to
Dr. Fredrickson. The meeting was adjourned.

Respectfully submitted

Joseph G. Perpich, M.D. , J.D.
Associate Director for
Program Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

December 3, 1976

[249]

FEDERAL INTERAGENCY COMMITTEE

Legislative Events Related to
Recombinant DNA

Page

Summary Minutes of Interagency

Committee, 2/25/77 251

Minutes, 2/25/77 253

Summary Minutes, 3/10 & 3/14/77 262

Minutes, 3/10 & 3/14/77 266

Press Release on Interim Report 276

Interim Report of the Interagency

Committee 279

[250]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Summary Minutes of Meeting
February 25, 1977
National Institutes of Health
Bethesda, Maryland

The third meeting of the full Interagency Committee took place on
February 25th at the National Institutes of Health from 1:30 to 4:45 p.m.
The meeting was chaired by Dr. Donald Fredrickson, Director of the NIH.

The purpose of this meeting was to review the work of the subcommittee to
the Interagency Committee and to develop recommendations for the implemen-
tation of a common set of standards applicable to recombinant DNA research

Review of Federal and State/Local Activities

Public hearings have been held in California and New York, and local
advisory groups have been formed in Cambridge, Princeton, and other
municipalities. In New York, the hearings have resulted in the State
Attorney General's Environmental Health Bureau proposing legislation
calling for adherence to safety standards with state certification of
researchers and monitoring of facilities. The Cambridge City Council has
also adopted a resolution with similar provisions.

Members of the Committee have received the provisions of a bill (S.621)
introduced by Senator Bumpers (with the companion bill being introduced
into the House by Representative Ottinger). Congressional hearings on the
regulation of recombinant DNA research are tentatively scheduled for early
April.

Review of Existing Regulatory Authorities

The Committee agreed that Federal regulation of recombinant DNA research
was desirable and each member received the document "Regulation of Recombinant
DNA Research in Laboratories" analyzing the adequacy of existing authorities
for such regulation. It was the final conclusion of a group of lawyers
representing the various regulatory agencies that no single authority exists
which would adequately regulate such research. The Committee agreed with
this conclusion.

Contacts with Various Sectors

Various member agencies of the Committee have been in contact with sectors
with whom they frequently deal. The Department of Agriculture is in the
process of developing a report stating the position of their non-biomedical
scientists, and minutes will soon be available of a recent meeting of the

(251]

EPA with environmentalists. OSHA will soon be meeting with health officials
of the AFL-CIO and will have a report for the Committee, while the results
of a November 19th meeting between the Commerce Department and industrial
representatives were reported in the minutes of the November 23rd meeting
of the Committee. At a February 19th meeting at the NIH of approximately
thirty biomedical scientists, the imminence of some form of regulation
seemed to be recognized and, it was generally agreed, Federal regulation
is preferred to insure uniform standards.

Elements in Possible Legislation

Committee members reviewed the following elements for the regulation of
recombinant DNA research:

(1) General Requirements

(2) Licensure and Registration

(3) State Pre-Emption

(4) Inspection and Enforcement

(5) Patents

The Committee members agreed to review these and other possible elements
for inclusion in proposed legislation. It was agreed that another meeting
would be scheduled to develop specific recommendations on this matter.

Respectfully submitted,

^Joseph G.^Perpich, M.D. , J.D.
Associate Director for
Program Planning and Evaluation

[252]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Minutes of Meeting
February 25, 1977
National Institutes of Health
Bethesda, Maryland

The third meeting of the full Interagency Committee took place on
February 25th at the National Institutes of Health from 1:30 to 4:45 p.m.

The meeting was chaired by Dr. Donald Fredrickson, Director of the NIH.

Dr. Fredrickson stated that the purpose of this meeting was to review the
work of the subcommittee to the Interagency Committee and to develop
recommendations for the implementation of a common set of standards
applicable to recombinant DNA research.

Review of State/Local Activities

In California, two legislative committees have held hearings and legislation
may be proposed to regulate all recombinant DNA research conducted in
California. In New York, the State Attorney General's Environmental Health
Bureau has held Hearings and has proposed a bill providing for: adherence

to safety standards regardless of the source of funding of the prolect;

certification of researchers by state health officials; inspection of
facilities by state health officials; creation of institutional biohazards
committees; submission of periodic reports to state health officials; and,
medical surveillance of laboratory personnel.

In addition, Cambridge, Princeton, and other municipalities have formed
advisory groups.

[253]

The Advisory Committee to the Cambridge City Council made the following
recommendations: adherence to the NIH Guidelines; establishment of

institutional biohazards committees broadly based with community representa-
tion; preparation of a manual for safety and training by each institution;
establishment of a city-wide biohazards committee to oversee all recombinant
DNA research conducted in Cambridge; and issuance of uniform guidelines
through Federal legislation. This latter resolution was adopted by the
Cambridge City Council.

Review of Congressional Activities

Members of the Committee have received the provisions of a bill (S.621)
introduced by Senator Bumpers. Representative Ottinger has introduced a
companion bill in the House. Legislative hearings on the regulation of
recombinant research are tentatively scheduled for early April by the
Senate Health Subcommittee.

Review of International Activities

In Canada, draft guidelines have been issued which are comparable to those
of the United Kingdom and the NIH guidelines with certain modifications on
levels of containment and scope of research activity. In Europe , "Genetics
Manipulation Advisory Groups (GMAGs)"are being formed on the basis of the
model developed in the United Kingdom. There is strong international
eff°rt to achieve broad exchange of information and cooperation.

Agreement to Regulation of Recombinant DNA Research

Dr. Fredrickson asked if any committee representatives believed federal
regulation of recombinant DNA research was unnecessary. There were none

[254]

who believed so. The following comments were offered:

• regulation will be an expensive proposition for a hazard
which may ultimately prove to be non-existent

• other forms of potentially harmful research are conducted
without regulation

• other harmful materials used in research are regulated (eg. radioactive
substances)

• regulations may prove to be more flexible than legislation

• recombination as a result of plant and animal breeding is not
now (and should not be) Included in the guidelines.

Review of Existing Laws

Each representative has received a thirteen page document "Regulation of
Recombinant DNA Research in Laboratories" analyzing the adequacy of
existing authorities for the regulation of recombinant DNA research.

The final conclusion — no single authority currently exists which would
adequately regulate such research.

The EPA representative suggested that the Toxic Substances Control Act
(TOSCA) could be amended to meet the regulatory requirements for recombinant
DNA research. The CEO representative commented that TOSCA was already very
broad and that extension into this field was unwise for EPA t

It was the consensus of the Committee to agree with the conclusion expressed
In this document.

[255]

Reports of Contacts with Various Sectors

Non-Biomedical Scientists: The policy-making body of the fifty-nine

agricultural experiment stations is developing a report stating its
position on recombinant DNA research. Also, a workshop is planned for
April to discuss the relationship of agricultural research to the NIH
guidelines .

Environmentalists: The EPA met on February 15th with environmentalists.

The minutes of this meeting will be available for the next meeting of the
Committee.

Labor: OSHA has a meeting scheduled with health officials of the AFL/CIO

on March 4th. Informal contacts have identified the following as concerns
of Labor: training of laboratory personnel, medical surveillance of laboratory

personnel, and the availability of medical records for inspection.

Industry: Commerce Department officials met with representatives from

industry on November 19th, at which time concern was voiced over the
protection of proprietary information and it was suggested that a special
advisory committee be formed to represent the industrial sector. Also,
the concept of compulsory registration was endorsed but it was urged
that compliance be voluntary.

In addition, the Industrial Research Institute and the Pharmaceutical
Manufacturers Association are in the process of surveying their members to
determine the scope of the research effort in the private sector.

[256]

Biomedical Scientists: At a February 19th meeting of approximately

thirty prominent scientists at the NIH, the imminence of some form of
regulation seemed to be recognized and, it was generally agreed, Federal
regulation is preferred to ensure uniform standards. Issues discussed
by the participants included: the scope of any legislation, with concern

expressed that it not broadly encompass all laboratory research and that

%

consideration be given to having the bill deal with use and production of
recombinant DNA molecules rather than solely with such research; the costs
to be incurred by institutions in implementing the regulations; and, the
availability and cost of insurance for protection from civil liability,
with the opinion expressed that a strict liability provision in legislation
would effectively stop all such research.

Bill of Particulars

Each representative was given a copy of the provisions of S.621 and a draft
Bill of Particulars for discussion purposes.

The following elements were discussed by the Committee:

General Requirements

Three alternatives were presented. It was the consensus of the Committee
that the language "production or use of recombinant DNA molecules" is
preferable to "recombinant DNA research." Dr. Koslow, DOD, suggested that
Congress may not approve the absence of "research" and Dr. Fredrickson
replied that "research" is included in "production or use." Mr. Swanberg
of the NRC suggested that the term include "possession" as well as "use
and production of," recombinant DMA molecules.

[257]

The representatives from the DOD (Drs. Beisel and Koslow) voiced concern
over Dr. Fredrickson's conclusion that all authority and responsibility
be focused in one agency. They made the point that a national emergency
might require the ability to act quickly. Dr. Kwon, Labor Department,
stated that the OSHAAct provides for exemption after public hearings.

Dr. Koslow promised to provide the committee with a memorandum on the
position of the Defense Department on the matter. The State Department
representative raised the question of the handling of Federally-supported
projects in foreign countries. Dr. Fredrickson agreed that this problem
is a difficult one that the NIH is currently attempting to address.

Licensure and Registration

Licensure implies approval while registration implies notification.

Dr. Fredrickson stated that most scientists were concerned that

licensure not extend to individuals or the research Droiect itself* but
rather extend to institutions.

Jt was agreed that requiring licensure of projects before research
could commence could result in delays; further, the "imminent hazards"
clause affords protection if the occasion were called for. It was the
consensus of the Committee that institutions should be licensed and
individual projects registered.

Pre-Emption

Mr. Kwon and Drs. Elder (FDA) and Ancker- Johnson (Commerce) agreed that
manufacturers must have one set of national standards.

[258]

Inspection and Enforcement

Drs. Kennedy (OSTP) and Elder raised the question of whether this provision
should be more specific and leave less to the discretion of the Secretary.

Mr. Riseberg, NIH legal advisor, stated that this language is patterned
after the CDC Clincial Laboratory Improvement Act and that the details are
later to be specified by the regulatory agency. Dr. Elder promised to
provide further language for the committee to consider.

Patents

Dr. Ancker-Johnson explained the nature and purpose of the accelerated
handling order issued on January 13th and emphasized that this order could
serve an important function as an interim measure to obtain adherence to
the NIH guidelines. Each representative received a copy of the order and
Dr. Fredrickson asked that each review the order for further discussion at
the next committee meeting.

Discussion then turned to the protection of trade secrets. Dr. Ancker-Johnson
offered the opinion that neither Section 4 of the FOI Act nor the Disclosure
of Information section of the Bill of Particulars affords adequate protection.

Mr. Riseberg explained that the purpose of this section in the Bill of
Particulars is to provide an appeal mechanism for the submitter and that
it is similar to the language used in TOSCA. Mr. McGarity, EPA, stated
that this language has worked well for his agency.

[259]

Dr. Muir suggested the following as alternatives to specific exemptions
for proprietary information:

• allow a patent only if the applicant agrees to
adhere to the act

• supply statutory guidance as to what constitutes
a "trade secret."

Dr. Ancker-Johnson stated that the former suggestion is not possible because
it would require changes in international patent conventions, and that the
latter would be extremely difficult because we don't know what will be
discovered in the future. Each representative has been given relevant
materials addressing the patent issue.

In addition to the provisions contained in the Bill of Particulars, it was
suggested that provisions be included addressing:

• conflict of interest

• protection of an employee from employer harassment
after registering a complaint (such as section 14(b)
of S. 621)

• exemption of a project from certain provisions of this
legislation

• authorization for appropriations for implementing the act.

Next Meeting of the Interagency Committee

All agency representatives are urgently requested to attend the March 10th
meeting of the Interagency Committee from 9:30 a.m. to 12:30 p.m. in
Building lr conference room 114,

[260]

At this meeting it is hoped that elements for legislation can be agreed
upon. Each representative will be sent elements based on the committee's
discussions.

Respectfully submitted,

Joseph G. Perpich, M.D., J.D.
Associate Director for
Program Planning and Evaluation

C pr-fixzi

[261]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Summary Minutes of Meeting
March 10 & 14, 1977
National Institutes of Health
Bethesda, Maryland

The fourth and fifth meetings of the Interagency Committee took place
on JIarch 10 and 14 at the National Institutes of Health. Dr. Donald S.
Fredrickson, Director of the NIH, chaired both meetings.

In opening the meeting on March 10, Dr. Fredrickson noted that five
bills had been introduced into the Congress since the last meeting and
that the House Public Health Subcommittee would be holding hearings on
recombinant DNA research on March 15-17. Also, changes to the minutes
of the February 25 meeting of the Committee were accepted.

The main agenda item for both meetings was to prepare an Interim Report
for transmittal to HEW Secretary Califano on suggested elements for
legislation. The Committee reviewed at length a number of issues for
inclusion in the report and they are described below.

The Locus of Regulation

The Committee agreed unanimously that the regulatory authority for
recombinant DNA research should reside in DHEW. The Center for Disease
Control is one agency that might assume this regulatory function in the
Department in light of its responsibility for regulating clinical laboratories,
but it was noted that the FDA should have responsibilities when the use

[262]

2

of recombinant DNA molecules enters into a production phase.

Dr. Fredrickson explained that the suggested legislation would grant
the Secretary the discretion to determine when the regulatory function
should pass from one agency to another. The Committee agreed that the
Secretary should consult with appropriate regulatory bodies when making
such a determination.

Def lnit ions

The Committee agreed that the definition of recombinant DNA molecules
for the purposes of legislation should be that found in the NIH Guidelines,
subject to change by the Recombinant DNA Molecule Program Advisory
Committee, after public and scientific review and with the approval of
the Secretary. Dr. Fredrickson also explained that the phrase "health
and environment" Includes plant and animal life.

Licensure

Dr. Fredrickson explained that it is not the intent of the licensure

provision to be used as a means of controlling agency obligations or
of making judgments regarding the merit of a proposal. In case of a
dispute over the determination of the containment level, as defined in
the NIH Guidelines, the regulatory agency would make a determination
subject to an appeals process which should be developed as the details
of regulation are set forth.

Registration

There was general agreement by the Committee that registration of projects
and other activities involving the use or production of recombinant DNA

[263]

3

molecules was an important element of regulation and that registration
should occur prior to the initiation of the project.

The representatives of the Department of Defense noted their concern
about the handling of material classified on national security grounds.

It was decided that the mandate of the Committee does not extend to
considerations of national security, and that this matter might be
addressed by the National Security Council.

Disclosure of Information

Debate on this element of the suggested legislation began in the first
meeting and was concluded at the meeting on March 14. Dr. Ancker- Johnson,
Commerce Department, proposed a suggested element for legislation as did
representatives from DoD and the Office of the Assistant Secretary for
Health (OASH/DHEW) . It was the position of the former two representatives
that the submitter of a proposal would best be encouraged to fully disclose
relevant information if he was given strong assurance that such information
would be protected from public disclosure. The suggested element of the
latter would give the Secretary of HEW greater discretion in determining
what information would be protected from disclosure and was the language
selected by the Committee to appear in the Interim Report.

Commerce Department Order for Accelerated Processing of Patents
Dr. Ancker-Johnson requested the Committee's views on the recently
published Commerce Department Order concerning accelerated processing
of patent applications for recombinant DNA inventions. This Order was
partially withdrawn pending review by the Interagency Committee. However,
because most of the meeting on March 14 had been devoted to the Interim

[264]

4

Report, it was the consensus of the Committee to meet again to discuss
matters concerning patents. Dr. Fredrickson announced that another
meeting of the Committee would be scheduled in two weeks to review the
Commerce Department Order in great detail.

The Committee formally adopted the Interim Report, with no objections
and two abstentions, and reconmended that it be forwarded to the
Secretary of HEW.

Respectfully submitted

Ooseph G. Perpich, M.D., J.D.
Associate Director for
Program Planning and Evaluation

March 25, 1977

[265]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Minutes of Meeting
March 10 & 14, 1977
National Institutes of Health
Bethesda, Maryland

The fourth and fifth meetings of the Interagency Committee took place on
March 10, from 8:45 a.m. to 12:30 p.m., and March 14, during the same hours,
at the National Institutes of Health. Dr. Donald Fredrickson, Director of
the NIH, chaired both meetings.

In opening the meeting on March 10, Dr. Fredrickson noted that five bills
had been introduced into the Congress since the last meeting and that the
House Public Health Subcommittee, chaired by Representative Rogers, would
be holding hearings on recombinant DNA research on March 15-17. Changes
to pages 7,8, and 16 of the minutes of the February 25 meeting of the
Committee were accepted. New drafts of these pages were distributed to
all members of the Committee.

The main agenda item for both meetings was to prepare an Interim Report
for transmittal to HEW Secretary Califano on suggested elements for
legislation. The Committee reviewed at length a number of issues for
inclusion in the interim report to the Secretary and they are described
below.

The Committee formally adopted the interim report by unanimous consent,
save for abstentions by the representatives from the Council on Environmental
Quality and the Department of Justice.

[266]

2

The Locus of Regulation

The Committee agreed unanimously that the regulatory authority for
recombinant DNA research should reside in DHEW. Dr. Richardson, Center
for Disease Control, informed the Committee that the Center would consider
assuming this regulatory function in the Department in light of its respon-
sibility for regulating clinical laboratories. Dr. Koslov, Department of
Defense, noted that the FDA will have responsibilities when the use of
recombinant DNA molecules enters into a production process for new drugs,
for example. Dr. Fredrickson explained that the suggested legislation would
grant the Secretary the discretion to determine when the regulatory function
should pass from one agency to another so that a duplicative regulatory
process will not be created in the original regulatory agency as the activity
passed through the stages of research, pilot production, and manufacture.

The Committee agreed that the Secretary must have the authority for regulation
of research, pilot production and manufacture but that he should consult with
appropriate regulatory bodies and should defer to a regulatory body he deter-
mines is better empowered and equipped to deal with it.

Definitions

The Committee agreed that the definition of recombinant DNA molecules for
purposes of legislation be that found in the NIH Guidelines. Dr. Fredrickson
noted that this definition may be changed by the Recombinant DNA Molecule
Program Advisory Committee, after public and scientific review and with
the approval of the Secretary.

Dr. Lewis, USDA, then requested clarification of whether the language
"health and environment" in the suggested legislation includes plant and
animal life. Dr. Fredrickson assured him that it does.

[267]

3

Licensure

Dr. Lewis, USDA, wanted to be certain that the licensure provision of
this suggested legislation would not be used as a means of controlling
agency obligations or of making judgments regarding the merit of a proposal.
Dr. Fredrickson assured him that this was not the intent.

Dr. Lewis then asked for clarification of who shall determine the containment
level at which a laboratory is licensed. Dr. Fredrickson explained that
such a determination would be made by the funding agency, using the Guidelines
as its standard, and that, in the case of a dispute, the regulatory agency
would make the determination subject to an appeals process which should be
developed as the details of regulation are set forth.

Dr. Finklea, NIOSH, then offered as a motion that serious and willful
violations of safety standards be punishable by loss of licensure. Ensuing
discussion brought to light the possibility that all of the recombinant DNA
activities being conducted within a licensed facility would have to be
halted in the event of such a violation by a single individual. Rather
than recommending this measure as part of the suggested elements for legis-
lation, the Committee agreed that this matter be included in the section of
the report devoted to Committee views.

Registration

There was general agreement by the Committee that registration of projects
and other activities involving the use or production of recombinant DNA
molecules was an important element of regulation. It was the consensus
of the Committee that registration should occur prior to the initiation
of the project, but that prior approval to commence the project should not
be required.

[268]

4

The representatives of the Department of Defense called to the attention
of the Committee their concerns about how classified material on possible
national security grounds might be handled. It was noted that the mandate
of the Committee does not extend to considerations of national security,
and it was agreed that this matter is one of importance for the National
Security Council to address.

Disclosure of Information

Debate on this element of the suggested legislation began in the first
meeting and was concluded at the meeting on March 14. Dr. Ancker-Johnson,
Commerce Department, proposed a suggested element for legislation concerning
disclosure of Information that is included in Appendix I. Other proposals
on the issue by Defense and the Office of the The Assistant Secretary for
Health (OASH/DHEW) are also Included in Appendix I. Dr. Ancker-Johnson
explained that her proposal was designed to encourage the investment of
private risk capital in the commercial development of benefits to be gained
through recombinant DMA research. In response. Dr. Elder, Food and Drug
Administration, stated that the emphasis would shift from consideration
of public health and safety to one of protecting proprietary information.

It was agreed that the language submitted by Commerce and DOD would achieve
essentially the same results, but that the former was more specific than
the latter. Dr. Ancker-Johnson offered the following arguments in support
of the language submitted by either Dr. Koslov or herself:

1. the submitter of the proposal is in the best position to

make the determination of what information is of a proprietary
nature;

[269]

2.

5

the best way to insure that the appropriate governmental
review body(ies) receive all the information is to guarantee
to the submitter protection from public disclosure;

3. the appropriate review body referred to above can have
representatives from any and all sectors of the population;

4. section 5 contains a mechanism by which the interests of
the public and the proprietary rights of the submitter are
balanced; and

5. the language submitted by OASH/DHEW would not offer enough
protection to draw out the private risk capital required to
bring research advances to practical application in the
marketplace.

Dr. Koslov agreed that strong protection from disclosure would encourage
the submitter not to withhold relevant information from government review.

The following comments were made expressing concern over elements in
the language submitted for the protection of proprietary information:

1. the submitter may have more knowledge of the facts of his
proposal than anyone else, but this does not necessarily
put him in the best position to determine what information
should be publicly disclosed;

2. the language in the suggested elements for legislation is
designed to set forth the sense of the Committee on the
various issues and not to suggest the specific language
to be included in a draft bill;

[270]

6

3. the Secretary of HEW should receive a more general mandate
in dealing with this issue;

4. public interest groups might consider this to be a secret
process between government and industry in which others
are denied access; and,

5. this language might preclude laboratory workers from
having knowledge of the materials with which they are
dealing.

By a vote of sixteen to two, the Committee decided to include the
language offered by OASH/DHEW, as the suggested elements for legislation
on disclosure of information.

Commerce Department Order for Accelerated Processing of Patents
Dr. Ancker-Johnson requested the Committee's views on the Commerce
Department ^rder published in the Federal Register on Thursday, January 13,
1977 concerning accelerated processing of patent applications for recombinant
DNA inventions. In response to expressions of concern by members of
Congress about the ^rder. Secretary of HEW Joseph Callfano requested
Secretary of Commerce Juanita Kreps to withdraw the Order pending review
by the Interagency Committee. Dr. Ancker-Johnson urged that the Committee
act as expeditiously as possible on this matter.

However, because the Committee had devoted most of the meeting on March 14
to the interim committee report, it was the consensus of the Committee to
meet again shortly to discuss thoroughly matters concerning patents.

Dt. Fredrickson announced that another meeting of the Committee would be

[271]

7

scheduled within two weeks to consider this matter. It was agreed the
Committee would review the Commerce Department Order and the document
prepared by the Commerce Department explaining in great detail the
policies underlying that Order.

Respectfully submitted,

{''Joseph G. Perpich, M.D. , J.D.
Associate Director for
Program Planning and Evaluation

Attachment
March 25, 1977

[272]

APPENDIX I

SUGGESTED ELEMENT ON DISCLOSURE OF INFORMATION FOR LEGISLATION
I. The following is the language proposed by the Commerce Department to appear
in the section of the suggested elements headed "Disclosure of Information."

Proprietary information submitted to or otherwise obtained by
the Secretary or his representatives under this legislation
should be exempt from disclosure under Title 5, U.S. Code.

Proprietary information may be disclosed to any officer or
employee of, or consultant to, the United States for use in
connection with his official duties under this legislation
or any other Federal law for the protection of health or the
environment or other pertinent governmental purposes.

The question of what is or is not "proprietary" must ultimately
be determined by a court. The following procedures are recom-
mended :

(1) Upon receipt of an appropriate request for Information
which may be proprietary, the Secretary shall immediately
Inform the presumed owner of such requested information.

(2) The presumed owner shall have 30 days within which to
Inform the Secretary of those portions of the requested
information, if any, which he regards as proprietary.

(3) The Secretary shall have 15 days thereafter within
which he must either agree or disagree with the owner's
claim to proprietary information.

(4) If the Secretary agrees with the owner, all information
labeled as not proprietary may be released, and all
Information labeled as proprietary shall be defended
from disclosure by the Secretary in such litigation as
shall ensue.

(5) If the Secretary disagrees with any part of the owner's
claim to proprietary Information, the owner shall have
the right to substitute himself as defendant in such
litigation as shall ensue. If the owner is successful
in defending from release any Information which the
Secretary would have disclosed, the cost of the owner's
defense shall be reimbursed to him by the Government.

[273]

2

(6) At any point during the actual litigation, the
defendant (whether the Secretary or the owner)
shall have the right to tender full disclosure
to the requester under an appropriate judicial
decree of non-use and confidentiality. If, having
accepted this tender, the requester chooses to con-
tinue the litigation and loses, he shall be obliged
to reimburse the defendant for all the costs asso-
ciated with the successful defense.

Any officer, employee or consultant who knowingly and willfully
discloses proprietary information other than as provided by law
should be deemed guilty of a felony.

The legislation should clearly indicate that information listed
in 18 U.S.C. 1905, as well as information concerning research
protocols, hypotheses and designs, constitutes proprietary subject
matter to the extent it is not otherwise available.

II. The following is the language proposed by the Department of Defense to
appear in the section of the suggested elements headed "Disclosure of
Information. "

The legislation should provide that proprietary data submitted
to or otherwise obtained by the Secretary or his representatives
in compliance with provisions requiring the data, such as sub-
mission in compliance with standards, licensure requirements,
registration, etc., shall be kept in confidence by the Secretary.
No information concerning such submitted data shall be released
to the public without authority of the submitter, unless necessary
to carry out the provisions of any Act of Congress or in such
special circumstances as may be determined by the Secretary.
Special circumstances may include review restricted to other
Government agencies for purposes of public health, safety, and
other pertinent Governmental purposes.

This protection is necessary to assure that valuable intellectual
property rights are not lost by submitters of required data. A
balance of full disclosure to the regulatory body of all relevant
safety and scientific information, and the commercial value of
legally protectible intellectual property rights may thus be
achieved .

[274]

3

With regard to data which may be released to non-Government
entities, legislation should require that the submitter identify
any legally protectible intellectual property rights which is con-
tained in the submitted data that is to be released by the Secretary,
before such release is made. This provision should provide that
notice be given to the submitter before release and that a hearing
be allowed to the submitter if disagreement arises concerning such
release.

In addition, the exemptions of the Freedom of Information Act may
be available to protect such data from improper release.

III. The following is the language proposed by the Office of the Assistant

Secretary for Health, DREW, to appear in the section of the suggested

elements headed "Disclosure of Information."

The legislation should provide that all information submitted to
or otherwise obtained by the Secretary or his representatives
under the legislation shall be available to the public upon
request, except (1) information now exempt from disclosure under
the Freedom of Information Act, and (2) other information the
disclosure of which would cause the loss of proprietary rights.

At the time of submission, persons submitting information should
be able to identify those portions which they believe to be exempt.
The Secretary should not release such Information unless: (1) he
has found the information so identified not to be exempt after
having given the submitter advance notice of this finding and an
opportunity to rebut it, or (2) the public need to know so outweighs
the interest of the submitter as to require its release. Where
the Secretary releases information because of the public need to
know, he shall notify the submitter setting forth the urgent
health or environmental needs which serve as the basis for his
action.

[275]

FOR RELEASE AT 1:00 P.M. EST National Institutes of Health

Wednesday, March 16, 1977 Storm Whaley (301) 496-4461

New legislation is necessary to regulate the use and production of
recombinant DNA molecules, according to a report transmitted today to
the Secretary of Health, Education, and Welfare.

In accepting the report from the Federal Interagency Committee on
Recombinant DNA Research, Secretary Joseph A. Calif ano, Jr., said that
the Department will immediately begin drafting legislation in the light
of the recommendations made by the Committee.

Califano noted that he had been closely monitoring the recombinant
DNA issue since his confirmation and that he had been in continuous
communication with Dr, Donald S. Fredrickson, M.D., Director, National
Institutes of Health and Chairman of the Interagency Committee.

"I recognize that legislation in this area would represent an unusual
regulation of activities affecting basic science but the potential hazards
posed by recombinant DNA techniques warrant such a step at this time,"
Califano stated.

"But I believe that such a measure is necessary not just to safeguard
the public but also to assure the continuation of basic research in this
vital scientific area.

(more)

[276]

- 2 -

"We are noc saying Chat research should be halted. We are urging
that it should proceed under careful safeguards unless and until ve have
a better understanding of the risks and benefits posed by use of recombinant
DNA techniques without government regulation," Calif ano said.

While agreeing with what he called the prudent recommendations of
the Interagency Committee in this limited and most exceptional area,

Califano reaffirmed his commitment to the principle of unfettered inauiry
that applies in scientific research.

The Interagency Committee is composed of representatives of Federal
departments and agencies that support and conduct recombinant DNA research
or that have present or potential regulatory authority in this area.

The Interagency Committee recommended that any legislation should,
among other things:

* place primary responsibility for the administration of the act
on the Secretary of HEW;

• require any person engaging in such research, production, or
use of DNA recombinant molecules to do so only at a facility
licensed by the Secretary;

require any person engaging in 9uch activity to do so only after
the project has been registered with the Secretary; and
the Secretary should have authority to Inspect facilities, make
environmental measurements, and take other steps to ensure safety.

The Committee pointed out that this legislation would establish
uniform standards for such activities throughout the Nation.

(more)

[277]

- 3 -

In addition, the Committee recommended that the NIH Guidelines for
Research Involving Recombinant DNA Molecules become the national standard,
with such modifications as the Secretary may consider necessary.

Califano stated that he asked HEW's General Counsel-Designate to
work with Dr. Fredrickson, and the technical experts on the Interagency
Committee, and to consult closely with the relevant Congressional committees
in drafting legislation for clearance with the Office of Management and
Budget and eventual submission to Congress, that would follow the Interagency
Committee's recommendations.

# # # //

[278]

INTERIM REPORT OF THE

FEDERAL INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH
SUGGESTED ELEMENTS FOR LEGISLATION

Submitted to the

Secretary of Health, Education, and Welfare

March 15, 1977

[279]

CONTENTS

CHAPTER PAGE

I. Introduction 1

II. Development of the NIH Guidelines on Recombinant

DNA Research 2

III. Federal Interagency Committee on Recombinant DNA

Research 3

IV. Subcommittee Review of Existing Legislation 6

V. Suggested Elements for Legislation 10

VI. Suggested Elements for Legislation: Committee Analysis 15

VII. Future Agenda 20

APPENDICES

I. Interagency Committee on Recombinant DNA Research . . 22

II. Subcommittee of the Interagency Committee on Recombinant

DNA Research 25

III. Regulation of Recombinant DNA Research in Laboratories 27

IV. Petition: Environmental Defense Fund and Natural

Resources Defense Council 40

[280]

INTERIM REPORT OF THE

FEDERAL INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH:

SUGGESTED ELEMENTS FOR LEGISLATION
March 15, 1977

I . Introduction

Recent scientific developments in genetics, particularly in the last
four years, have culminated in the ability to join together genetic
material from different sources in cell-free systems to form recombinant
deoxyribonucleic acid (DNA) molecules. DNA is the material that determines
hereditary characteristics of all known cells. Recombinant DNA research
offers great promise for better understanding and improved treatment of
human diseases. Medical advances through use of this technology include
the opportunity to explore complicated diseases and the functioning of
cells, to better understand a variety of hereditary defects, and possibly
in the future, to create microorganisms useful in producing medically
important compounds for the treatment and control of disease. Aside from
the potential medical benefits, a variety of other applications in science
and technology are envisioned. An example is the large-scale production
of enzymes for industrial use. Potential benefits in agriculture include
the enhancement of nitrogen fixation in certain plants and the biological
control of pests, permitting increased food production.

There are risks in this new research area as well as anticipated
benefits. A potential hazard, for example, is that the foreign DNA in
a microorganism may alter it in unpredictable and undesirable ways. Should
the altered microorganism escape from containment, it might infect human
beings, animals, or plants, causing disease or modifying the environment.

(281)

Z

Or the altered bacteria might have a competitive advantage, enhancing
their survival in some niche within the ecosystem.

Until the potential risks are better delineated and evaluated in
light of developing scientific knowledge, the public should expect
such research to be conducted under strict conditions ensuring safety.

This was the fundamental principle that guided the Federal Interagency
Committee on Recombinant DNA Research in its deliberations — that is, the
desire to allow this significant research to continue while simultaneously
protecting, as much as humanly possible, man and the environment from
effects of potential hazards whose nature is as yet unknown.

The Committee formally adopted this interim report by unanimous con-
sent, save for abstentions by the representatives from the Council on
Environmental Quality and the Department of Justice.

II . Development of the NIH Guidelines on Recombinant DNA Research

Approximately three years ago, because of the perceived potential
hazards, scientists engaged in this research voluntarily called for a
moratorium on certain experiments pending an assessment of risk and the
development of appropriate guidelines. These scientists called upon the
National Institutes of Health (NIH), of the Department of Health,
Education, and Welfare, to create an advisory committee to develop such
guidelines. After what NIH considered to be extensive scientific and
public review, it released guidelines on June 23, 1976, which established
strict conditions for the conduct of NIH-supported research in this
area. The NIH Guidelines prohibit certain types of experiments and
require special safety conditions for other types. The provision0

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3

•re designed to afford protection with a vide margin of safety to workers
and the environment. The NIH Guidelines were published in the Federal
Re£ ister on July 7, 1976, for public comment.

The NIH also prepared and filed in the Federal Register on
September 9, 1976, a Draft Environmental Impact Statement on the Guidelines
for public comment. The final NIH Environmental Impact Statement will be
published shortly. In August 1976 the NIH published a volume containing
the transcript of a public hearing held on the Guidelines as well as the
correspondence received by the NIH Director on this matter prior to the
release of the Guidelines in June.

Ill . Federal Interagency Committee on Recombinant DNA Research

The Interagency Committee on Recombinant DNA Research was created to
address extension of the NIH Guidelines beyond the NIH to the public
and private sectors. The Committee was convened by the Secretary of Health
Education, and Welfare with the approval of the President. Dr. Donald S.
Fredrickson, Director of NIH, serves as chairman at the Secretary's request
The Interagency Committee is composed of representatives of Federal
Departments and agencies that support or conduct recombinant DNA research,
or that may do so in the future, and representatives of Federal Departments
and agencies that have present or potential regulatory authority in this
area. (The membership of the Committee is included in Appendix I.) The
mandate of the Committee is to

(1) review the nature and scope of Federal- and private-sector
activities relating to recombinant DNA research;

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(2)

determine the extent to which the NIH Guidelines may
currently be applied to research in the public and
private sectors;

(3) recommend, if appropriate, legislative or executive actions
necessary to ensure compliance with the standards set for this
research; and

(4) provide for the full communication and necessary exchange of
information on recombinant-DNA-research programs and activities
throughout' the Federal sector.

Two meetings of the Committee were held in November 1976. The first
of these, on November 4, was devoted to a review of the development of
the NIH Guidelines for Research Involving Recombinant DNA Molecules. The
Committee also reviewed activities in other countries on the development
of guidelines for this research. Recombinant DNA research is being conducted
in a number of countries, including Canada, the United Kingdom, most of
Western Europe, the Scandinavian countries. Eastern Europe, the Soviet
Union, and Japan.

In many countries appropriate governmental or scientific bodies have
reviewed the research and have agreed that it should proceed. Several
of the countries have acted to establish guidelines to govern the conduct
of this research, including the United Kingdom and Canada. In the
United Kingdom a parliamentary committee addressed the issue and indicated
that work in this area should continue under appropriate safety conditions.
Scientific advisory committees of international organizations, such as
the World Health Organization, the International Councils of Scientific

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5

Unions, and the European Molecular Biology Organization, have made similar
recommendations .

The European Science Foundation, representing member nations from
Western Europe and Scandinavia, has recommended to its members that they
follow the guidelines of the United Kingdom. These guidelines are, in intent
and substance, very similar to those of the National Institutes of Health.

The NIH is currently working closely with the United Kingdom and the European
Science Foundation to ensure a commonality of standards in the conduct of this
research. Thus far, there has been very close cooperation and coordination
among the various international and national scientific bodies, with a view
to reaching a consensus on safety practices, programs, and procedures.

At the meeting of the Committee held on November 23, the Federal research
agencies discussed their activities and possible roles in the implementation
of the NIH Guidelines. All Federal research agencies endorsed the Guidelines
to govern recombinant DNA research. At present, the NIH, the National
Science Foundation, the Veterans Administration, and the U.S. Department
of Ag riculture are supporting or conducting such research. The NIH has
123 grants in which recombinant DNA research is involved. The National
Science Foundation has 32 grants supporting such research in whole or
in part. The Veterans Administration has eight projects. The Department
of Agriculture and Agricultural Experiment Stations will soon have an
estimate of the number of projects in their area. The Department of Defense,
the National Aeronautics and Space Administration, and the Energy Research
and Development Administration do not at present conduct such research,
but all have endorsed the NIH Guidelines to govern future research should
it be undertaken.

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6

IV . Subcommittee Review of Existing Legislation

At the November 23 meeting of the Interagency Committee, the Federal
regulatory agencies also reported on their regulatory functions. Following
that review, a special Subcommittee was formed to analyze the relevant
statutory authorities for the possible regulation of recombinant DNA research.
All regulatory agencies were represented on the Subcommittee, assisted
by attorneys from their offices of general counsel. (See Appendix II for
the membership of the Subcommittee.) The Subcommittee held meetings on
December 13, 1976, and on January 11 and February 8, 1977.

The Subcommittee was charged to determine whether existing legislative
authority would permit the regulation of all recombinant DNA research in the
United States (whether or not Federally funded) and would include at least the
following regulatory requirements:

(1) review of such research by an institutional biohazards committee
before it is undertaken,

(2) compliance with physical and biological containment standards
and prohibitions in the NIH Guidelines,

(3) registration of such research with a national registry at the
time the research is undertaken (subject to appropriate
safeguards to protect proprietary interests), and

(4) enforcement of the above requirements through monitoring,
inspection, and sanctions.

It was the conclusion of the Subcommittee that present law could
permit imposition of some of the above requirements on much recombinant DNA
laboratory research, but that no single legal authority or combination of

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authorities currently exists that would clearly reach all research
and other uses of recombinant DNA techniques and meet all the requirements.
The complete Subcommittee analysis is included in Appendix III. The
Subcommittee, in reaching this conclusion, reviewed the following laws
that were deemed most deserving of detailed consideration:

(1) the Occupational Safety and Health Act of 1970 (Public Law
91-596),

(2) the Toxic Substances Control Act (Public Law 94-469),

(3) the Hazardous Materials Transportation Act (Public Law 93-633),

(4) Section 361 of the Public Health Service Act (42 U.S.C. Sec. 264).

The Occupational Safety and Health Act gives the Occupational Safety

and Health Administration (OSHA) broad powers to require employers to
provide a safe workplace for their employees. The term "employer" in the
Act, however, is defined in such a way as to exclude States and their
political subdivisions unless the OSHA standards are voluntarily adopted.
Twenty-four States have adopted the standards, but twenty-six states are not
subject to them. Further, the OSHA standards do not cover self-employed
persons. For these reasons it was determined that OSHA at present could
not regulate all recombinant DNA research.

The Environmental Protection Agency, under the Toxic Substances
Control Act, is directed to control chemicals that may present an
"unreasonable risk of injury to the health or the environment." The Sub-
committee determined that the materials used in recombinant DNA research

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8

would appear to be covered in most cases by the Act's definition of
"chemical substance." Section 5 of the Act, however, explicitly exempts
registration of chemical substances used in small quantities for the
purposes of scientific experimentation or analysis. This represents
a most serious deficiency, as the registration of activities was thought
to be an essential element of any regulatory effort. Also, in order
to meet the specifications of the Act, recombinant DNA research would
have to be found to present "an unreasonable risk of injury to health
or the environment."

The Hazardous Materials Transportation Act (HMTA) and Section 361
of the Public Health Service (PHS) Act give the Department of Transporta-
tion (DOT) and the Center for Disease Control (CDC), respectively,
authority to regulate the shipment of hazardous materials in interstate
commerce. Both the DOT and the CDC, in implementing these acts with
respect to biological products, have essentially aimed at imposing
labeling, packaging, and shipping requirements, and were found to
be wanting for regulation of all recombinant DNA research.

The Environmental Defense Fund, in November 1976, petitioned the
DHEW to regulate recombinant DNA research under Section 361 of the PHS Act.
(The petition is included in Appendix IV.) The Subcommittee carefully
reviewed this section, which is directed to organisms that are communicable
and cause human disease. Thus, under this section, there would have to
be a reasonable basis for concluding that the products of all recombinant
DNA research may cause human disease and are communicable. Further, Section

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9

361 does not apply Co plants, animals, or Che general environment. It was
Che conclusion of Che SubcommiCCee Chat Section 361 lacked Che requisite
authority to meet all of the requirements set for the regulation of this
research .

The Subcommittee also considered the authority of the CDC to license
and control the operation of clinical laboratories under Section 333 of
the PHS Act, but this provision was not considered to be applicable to
research laboratories.

Other authorities of EPA under the Clean Air Act, the Federal Water
Pollution Control Act, and the Resource Conservation and Recovery Act
of 1976 were considered briefly and thought only to apply, if at all, to
isolated aspects of recombinant DNA research. The authorities of the Food
and Drug Administration (FDA) were also reviewed, but it was concluded that
recombinant DNA research has not yet reached the stage of commercial appli-
cation that comes under the FDA's jurisdiction. The regulatory powers
of the U.S. Department of Agriculture (USDA) were also reviewed and found
applicable solely to nonhuman animals and plants.

In summary, the group concluded that no single legal authority, or
combination of authorities, currently exists which would clearly reach
all recombinant DNA research in a manner deemed necessary by the Committee.
Although there is existing authority that might be broadly interpreted to
cover most of the research at issue, it was generally agreed that
regulatory actions taken on the basis of any such interpretation would
probably be subject to legal challenge.

After completing an analysis of existing legislation, the Sub-
committee on February 8, 1977, considered elements which might be

[289]

10

included in legislation to regulate recombinant DNA research. The Sub-
committee referred the analysis of existing legislation and elements
for new legislation to the full Committee at a meeting held on February 25,
1977. The full Committee adopted the report of the Subcommittee on existing
legislation and agreed that new legislation was required.

V. Suggested Elements for Legislation

In considering the elements for legislation, the Committee reviewed
Federal, State, and local activities bearing on the regulation of recombinant
DNA research. Among congressional proposals reviewed were Senate Bill 621,
"The DNA Research Act of 1977," introduced by Senator Dale Bumpers, and the
companion measure introduced by Representative Richard L. Ottinger in the
House (H.R. 3591). The Committee also noted the resolution (H. Res. 131)
introduced by Representative Ottinger on January 19, 1977, requesting DHEW
to regulate recombinant DNA research under Section 361 of the PHS Act.

Hearings held by State and local governments, including State legis-
latures, were among State and local activities reviewed. Recommendations
for State regulation by the New York State Attorney General's Environmental
Health Bureau, and for city regulation by the Cambridge (Massachusetts) City
Council, were also considered.

Several committee representatives also reported on meetings with
other interested parties whose views had been solicited on legislation
to regulate recombinant DNA research. Those who were contacted include
agricultural scientists, biomedical scientists, environmentalists, labor

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11

unions, and private industry. At the request of the Chairman of the
Committee, the Industrial Research Institute and the Pharmaceutical
Manufacturers Association are surveying their member firms to determine
the scope of the research efforts in the private sector. The Pharma-
ceutical Manufacturers Association has adopted the NIH Guidelines
for safe conduct of this research.

In light of this review, the full Committee recommends that the
following elements should be included in proposed legislation for the
regulation of recombinant DNA research:

( 1) Definitions :

"Recombinant DNA molecules" should be defined in a manner consistent
with the NIH Guidelines.

Through an appropriate definition of the term "person," the legisla-
tion should cover any individual, corporation, association, Federal,

State, or local institution or agency, or other legal entity.

"Secretary" should mean the Secretary of Health, Education, and Welfare.

(2) General requirements :

The legislation should bar any person from engaging in the production
or use of recombinant DNA molecules in a State of the United States, in
the District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands, American Samoa, Guam, the Trust Territory of the Pacific Islands,
Wake Island, Outer Continental Shelf Lands as defined in the Outer Continen-
tal Shelf Lands Act, Johnston Island, or the Canal Zone, unless (a) such
production or use is permissible under standards promulgated by the
Secretary, (b) such production or use is in compliance with any such

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12

standards, (c) the licensing requirements prescribed in the legislation
have been satisfied, and (d) the registration requirements prescribed
in the legislation have been satisfied.

The legislation should permit the Secretary to exempt activities
from these requirements (a) where the activity is for specific commercial
purposes found by the Secretary, after consultation with the regulating
agency, to be regulated under other Federal law, or (b) where the Secretary
determines that the activity poses no unreasonable risk to health or the
environment .

(3) Standards :

The Secretary should be directed, as soon as practicable after passage
of the legislation, to promulgate the NIH Guidelines for Research Involving
Recombinant DNA Molecules as initial standards, with such clarifications
and modifications as the Secretary determines to be necessary. Standards
should assure, on the basis of the best currently available evidence,
that no employee will suffer material impairment of health or functional
capacity even if such employee engages in the production or use of recombinant
DNA molecules for an entire working lifetime.

The legislation should authorize the Secretary to modify and revoke
any of these initial standards and to promulgate new standards.

The legislation should include an appropriate provision for judicial
review.

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13

(4) Licensure of laboratories :

The legislation should bar any person from engaging in the production
or use of recombinant DNA molecules except at a facility licensed by the
Secretary. A license should not be issued unless the Secretary determines
that the facility will be operated in accordance with standards promulgated
under the legislation and such other conditions as the Secretary deems
appropriate .

The Secretary should have authority to exempt from the licensure
requirement categories of activity which he determines pose no unreasonable
risk to health or the environment. He should also, at his discretion,
be able to utilize qualified accreditation or licensing bodies to assist
him in carrying out this licensing function.

The legislation should have appropriate provisions for revocation,
suspension, and limitation of licenses and for judicial review.

(3) Registration :

The legislation should bar any person from engaging in the production
or use of recombinant DNA molecules unless the activity has been registered
with the Secretary, provided that the Secretary should be able to exempt from
the provisions of this section categories of production or use which he
determines pose no unreasonable risk to health or the environment.

(6) Imminent hazards :

The Secretary should have authority to sue to enjoin the production
or use of recombinant DNA molecules where he believes the activity would
constitute an imminent hazard to health or the environment.

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14

(7) Inspections , subpoenas , record-keeping , and reports ;

The Secretary, in carrying out the legislation, should have authority
to inspect facilities, make environmental measurements, conduct medical
investigations, inspect medical records, issue subpoenas and citations,
and require record-keeping and reports.

(8) Disclosure of information:

The legislation should provide that all records submitted to, or
otherwise obtained by, the Secretary or his representatives under the
legislation shall be available to the public upon request, except
(a) information now exempt from disclosure under the Freedom of Informa-
tion Act, and (b) other information the disclosure of which would cause
the loss of proprietary rights.

At the time of request, persons who have submitted records should
be given an opportunity to identify those portions which they believe
to be excepted from disclosure under the preceding paragraph. The Secretary
should not release such portions unless (a) he has found the portions
so identified not to be excepted and has given the submitter advance
notice of this finding and an opportunity to rebut it, or (b) the public
need to know so outweighs the interest of the submitter as to require
release. Where the Secretary releases records or portions thereof because
of the public need to know, he should notify the submitter, setting
forth the urgent health or environmental needs which serve as the basis
for his action.

(9) Coordination:

The legislation should provide specifically for interagency coordination
in setting standards and avoiding duplicative requirements.

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15

(10) Preemption :

The legislation should specifically preempt all State and local
laws regulating the production or use of recombinant DNA molecules;
except that where a State passes a law imposing requirements identical
to those contained in the Federal legislation, the Secretary should
have discretion to enter into an agreement with the State to carry out
the Secretary's responsibilities under the legislation.

(11) Enforcement :

The legislation should contain provisions for enforcement and sanctions.

(12) Employee rights :

The legislation should contain protections for employees who cooperate
in the enforcement of these provisions.

(13) Sunset :

The legislation should remain in effect for a period of five years
from the date of enactment, unless further action is taken by Congress.

VI . Suggested Elements for Legislation: Committee Analysis

In considering these elements for proposed legislation, a number of
issues were raised and discussed by the Committee. The issues that the
Committee considered of importance are described below.

( 1 ) Definition of the Term "Secretary" :

The Committee considered the appropriate locus in the Government for
the regulation of the use and production of recombinant DNA molecules.

It determined that the Department of Health, Education, and Welfare

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16

is the appropriate locus in light of

(a) NIH's role as a lead agency in setting the standards,

(b) the petition by the Environmental Defense Fund to DHEW
to issue regulations in this area,

(c) the congressional proposals that placed regulatory responsibility
in DHEW, and

(d) the experiences of DHEW's Center for Disease Control in regulating
infectious agents, and of its Bureau of Biologies (FDA) in licensing
the production of biological products, in close cooperation

with other Federal Departments and agencies.

This recommendation was formally approved by all members of the Committee.

The Committee also urges close cooperation and coordination in DHEW between
the NIH and regulatory agencies to ensure effective implementation of the
standards set for this research.

(2) The Scope of Regulation:

The Committee reviewed at great length the nature and scope of
regulation. Consideration was given to regulation of all laboratory
research where hazardous or potentially hazardous substances were employed.
Dr. Fredrickson reviewed the activities of committees at the NIH other
than the Recombinant DNA Molecule Program Advisory Committee which have
been created to study and recommend, if necessary, safety standards
for other research involving actual or potential biohazards.

There was general Committee agreement that, for the present, legislation
should be restricted to recombinant DNA techniques, allowing for sound
administrative and scientific expertise in developing safety standards

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17

and regulation in other areas. The Committee considered whether, in
the proposed legislation, the regulations should be limited to research.

As noted above in the analysis of existing legislation, no current single,
legal authority reaches all research under requirements set for regulation
by the Committee. However, the Occupational Safety and Health Administration
and the Environmental Protection Agency do have authority for regulation
of commercial applications of recombinant DNA molecules.

Regulation of research alone presents a problem because of the
difficulty in determining the border between research and pilot production.
Therefore, the Committee recommends that regulation cover the production
or use of recombinant DNA molecules. Such language would include research
activity, and makes immaterial any consideration of whether a given
activity constitutes research, pilot production, or manufacture. The
Committee recommends that the Secretary, in consultation with appropriate
regulatory agencies, be allowed to determine the nature of the activity
and should defer to a regulatory body he determines is better empowered
and equipped to deal with it.

The Committee also recommends as a suggested element for legislation a
"sunset provision" for the regulatory authority. This provision is intended
to mandate a review of regulation in light of accumulated scientific and
safety information. This provision, the Committee wishes to emphasize,
does not refer to records and other data relevant, for example, to medical,
occupational, or environmental surveillance.

(3) Registration:

There was general agreement by the Committee that registration of
projects and other activities involving the use or production of recombinant

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18

DNA molecules was an important element of regulation. It was the consensus
of the Committee that registration should occur prior to the initiation
of the project, but that approval before commencing the project should
not be required. Further, the Committee recommends that the Secretary
have the authority to exempt certain classes of projects from this
requirement .

(4) Licensure of Facilities :

It was the consensus of the Committee that the licensure provision
should apply only to facilities, and that the facility would, under the
terms of its license, accept responsibility for the particular activities
and individuals at the facility. The Committee concluded that licensure
of the facility and registration of projects would meet the needs for
safety monitoring without extension of licensure to the projects themselves.
The Committee discussed the possibility of revoking a license for serious
and willful violations of the regulations. There was concern expressed that
revocation was a very punitive measure, but it was agreed that the Secretary
may wish to consider it for serious violations of the standards.

(5) Disclosure of Information:

It was the scientific community that brought to public attention
potential hazards of recombinant DNA research, and the NIH Guidelines, in
that spirit, promote disclosure and dissemination of scientific and safety
information. The Committee urges full disclosure to the appropriate
regulatory body of all relevant safety and scientific information on the
use or production of recombinant DNA molecules. However, the Committee

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19

recognizes the important world-wide commercial potential of recombinant
DNA molecules in medicine, agriculture, and other areas of science and
technology. It believes that the potential commercial uses of recombinant
DNA techniques require that information of a proprietary nature and
patent rights be given appropriate protection from disclosure by the
regulatory agency receiving such information. Some Committee members
expressed concern that universities and inventors with limited resources
may be unable to adequately protect data of a proprietary nature if
the regulatory agency acts to disclose such information. The regulatory
agency should consider the burden of its action on these inventors.

(6) Preemption of State/Local Laws:

The potential hazards posed by the use of recombinant DNA techniques
extend beyond the local to the national and international levels. There-
fore, the Committee recommends that a single set of national standards
must govern and that, accordingly, local law should be preempted to
ensure national standards and regulations. The Committee, however, took
into account the activities at the State and local levels on regulation
of recombinant DNA research. It was agreed that if a State passes a
law imposing requirements identical to those contained in the Federal
legislation, then the Secretary may enter into an agreement with the
State to utilize its resources to assist the Secretary in carrying out
his duties.

(7) Inspection and Enforcement :

The Committee proposes that there be inspection and enforcement
requirements to ensure that standards are being met. In order to protect

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20

the public health from an imminent potential hazard, the Committee also
recommends that the Secretary have authority to enjoin the use or production
of recombinant DNA molecules when he deems it necessary.

The Committee also reviewed the question of civil liability in
the event of injury to humans or the environment. It believes that actions
for damages should be left to State and local law. It is concerned that
the inclusion of standards for strict liability as proposed in S. 621
could place a severe constraint on the ability of an institution to obtain
liability insurance. It was predicted that, without insurance, institutions
might have to terminate their research efforts unless national legislation
were passed to indemnify them against adverse judgments.

(8) Interagency Cooperation:

Because of the wide potential use and production of recombinant
DNA molecules and the need for uniform development and implementation
of standards, the Committee recommends that mechanisms be established
by the Secretary to ensure cooperation and coordination among appropriate
Federal Departments and agencies. The National Institutes of Health is
developing appropriate liaison between its Recombinant DNA Molecule Program
Advisory Committee and relevant Federal research agencies, such as the
Department of Agriculture, the National Science Foundation, and the Energy
Research and Development Administration.

VII. Future Agenda

Pending action on possible legislation, the Committee stands ready to
assist DHEW or whatever agency is made responsible for regulation of
activities involving the use or production of recombinant DNA molecules.

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21

For example, research agencies on the Committee are working in coordination
with the National Institutes of Health and its Recombinant DNA Molecule
Program Advisory Committee on setting standards and certifying new host-vector
systems. The research agencies have also been developing a registry of
projects supported by Federal funds. The survey being taken in the private
sector by the Pharmaceutical Manufacturers Association and the Industrial
Research Institute will provide data on the industry, in anticipation of
registration under a new law.

The Committee will consider suggestions by the representatives from
the State Department concerning further means to ensure international
control in the use and production of recombinant DNA molecules. At
present, there is voluntary coordination and cooperation among national
scientific bodies. The Biological Weapons Convention is considered by
the State Department to prohibit development, production, or stockpiling
of recombinant DNA molecules for purposes of biological warfare. The
Committee will review whether other measures need to be considered for
international control.

The Committee will also be reviewing current Federal policies on
the matter of patenting recombinant DNA inventions and other matters of
concern that may need to be addressed before the Committee concludes its
business and files a final report.

[301]

Appendix I

January 14, 1977

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

DEPARTMENT OF AGRICULTURE

Charles F. Lewis, Ph.D.

Staff Scientist

Plant and Entomological Sciences
National Program Staff, ARS, USDA
BARC-West

Beltsville, Maryland 20705

DEPARTMENT OF COMMERCE

Betsy Ancker- Johnson, Ph.D.
Assistant Secretary of Commerce
for Science and Technology
Department of Commerce
Washington, D. C. 20230

Mr. David H. Wallace (Alt.)
Associate Administrator for
Marine Resources
NOAA, Department of Commerce
6010 Executive Boulevard
Rockville, Maryland 20852

DEPARTMENT OF DEFENSE

Dr. Samuel Koslov

Special Assistant for Science

Office of the Assistant Secretary

of the Navy (Research and Development)
Room 4E741, Pentagon
Washington, D. C. 20350

William R. Beisel, M.D.

Scientific Adviser

U.S. Army Medical Research Institute
of Infectious Diseases
Ft. Detrick

Fredrick, Maryland 21701

DEPARTMENT OF HEALTH, EDUCATION,
AND WELFARE

Ms. Marian Mlay
Director

Office of Policy Development
and Planning , H
Parklawn Building, Room 17A-07
Rockville, Maryland 20852

CENTER FOR DISEASE CONTROL

John H. Richardson, D.V.M.
Director

Office of Biosafety
Center for Disease Control
Atlanta, Georeia 30333

John F. Finklea, M.D.

Director

National Institute for Occupational
Safety and Health
Parklawn Building, Room 3-30
Rockville, Maryland 20852

FOOD AND DRUG ADMINISTRATION

Robert L. Elder, Sc.D.

Deputy Associate Commissioner
for Science

Food and Drug Administration
Parklawn Building, Room 14-57
Rockville, Maryland 20852

Rosa M. Gryder, Ph.D. (Alt.)
Staff Science Advisor
Office of Science
Food and Drug Administration
Parklawn Building, Room 7-83
Rockville, Maryland 20852

22

[302]

FOOD AND DRUG ADMINISTRATION (Cont'd)

John C. Petricciani, M.D.

Deputy Director
Division of Pathology
Bureau of Biologies, FDA
NIH Building 29, Room 514
Bethesda, Maryland 20014

DEPARTMENT OF INTERIOR

Mariano Pimentel, M.D.

Medical Director

Department of Interior

18th and C Streets, N.W. Room 7045

Washington, D. C. 20240

DEPARTMENT OF JUSTICE

Mr. Anthony Llotta
Deputy Assistant Attorney General
Land and Natural Resources Division
Department of Justice
Washington, D. C. 20530

DEPARTMENT OF LABOR

Morton Corn, Ph.D.

Assistant Secretary for

Occupational Safety and Health
Department of Labor
Washington, D. C. 20210

Mr. Byung Kwon (Alt.)

Occupational Safety and
Health Administration
Department of Labor
Washinatnn, D. C. 20210

DEPARTMENT OF Sf ATE

Oswald H. Ganley, Ph.D.

Deputy Assistant Secretary for
Advanced and Applied Technology
Department of State
2201 C Street, N.W., Room 4327
Washington, D. C. 20520

DEPARTMENT OF STATE (Cont'd)

Mr. William J. Walsh, III

Science Officer

OES/APT/BMP

Department of State

2201 C Street, N.W. , Room 4333

Washington, D. C. 20520

DEPARTMENT OF TRANSPORTATION

Mr. William D. Owens

Deputy Assistant Secretary for

Systems Development and Technology
(TST-2)

Department of Transportation
400 7th Street, S.W.

Washington, D. C. 20590

ENERGY RESEARCH AND DEVELOPMENT
ADMINISTRATION

James L. Liverman, Ph.D.

Assistant Administrator for
Environment and Safety
Energy Research and Development
Administration
Washington, D. C. 20545

Charles E. Carter, M.D. (Alt.)
Manager, Biomedical Programs
Division of Biomedical and
Environmental Research
Energy Research and Development
Administration
Washington, D. C. 20545

Walter H. Weyzen, M.D. (Alt.)
Manager, Human Health Studies Prograi
Division of Biomedical and
Environmental Research
Energy Research and Development
Administration
Washington, D. C. 20545

23

[303]

ENVIRONMENTAL PROTECTION AGENCY

NATIONAL SCIENCE FOUNDATION

Delbert S. Barth, Ph.D.

Deputy Assistant Administrator for
Health and Ecological Effects
Environmental Protection Agency
401 M Street, S.W.

Washington, D.C. 20460

Herman W. Lewis, Ph.D.

Section Head of Cellular Biology
Division of Physiology, Cellular, and
Molecular Biology
National Science Foundation
Washington, D. C. 20550

Lawrence A. Plumlee, M.D. (Alt.)

Medical Adviser

Office of Principal Science Adviser, ORD
Environmental Protection Agency
Washington, D. C. 20460

EXECUTIVE OFFICE OF THE PRESIDENT

The Honorable H. Guyford Stever
Director

Office of Science and Technology Policy
Executive Office of the President
Washington, D. C. 20500

Laurence Berlowitz, Ph.D.

Special Assistant to the

Assistant Director for Biological,
Behavioral, and Social Sciences
National Science Foundation
Washington, D. C. 20550

NUCLEAR REGULATORY COMMISSION

Mr. Frank Swanberg, Jr.

Chief, Health and Environmental
Research Branch
Nuclear Regulatory Commission
Washington, D. C. 20555

Warren R. Muir, Ph.D.

Senior Staff Member for
Environmental Health
Council on Environmental Quality
722 Jackson Place, N.W.
Washington, D. C. 20006

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

David L. Winter, M.D.

Director for Life Sciences
National Aeronautics and Space
Administration
Washington, D. C. 20546

CHAIRMAN OF THE COMMITTEE

Donald S. Fredrickson, M.D.
Director

National Institutes of Health
Bethesda, Maryland 20014

U.S. ARMS CONTROL AND DISARMAMENT
AGENCY

Robert Mikulak, Ph.D.

Physical Science Officer
Nonproliferation and Advanced
Technology Bureau, WTD
U.S. Arms Control and
Disarmament Agency
Washington, D. C. 20451

VETERANS ADMINISTRATION

Jane S. Schultz, Ph.D.

Research Service

Veterans Administration Central Office
810 Vermont Avenue, N.W.

Washington, D.C. 20420

EXECUTIVE SECRETARY OF THE COMMITTEE

Joseph G. Perpich, M.D., J.D.

Associate Director for
Program Planning and Evaluation
National Institutes of Health
Bethesda, Maryland 20014

24

Appendix II

January 11, 1977

SUBCOMMITTEE OF THE

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Representatives

DEPARTMENT OF AGRICULTURE

General Counsels

Charles F. Lewis, Ph.D.

Staff Scientist

Plant and Entomological Sciences
National Program Staff, ARS , USDA
BARC-West

Beltsville, Maryland

Mr. Alexander W. Samofal
USDA Office of General Counsel
Room 2422, South Building
Washington, D.C. 20250

20705

DEPARTMENT OF COMMERCE

Dr. Vern Hartwell
Department of Commerce
Washington, D.C. 20230

PHEW, CENTER FOR
John H. Richardson, D.V.M.

Director

Office of Biosafety
Center for Disease Control
Atlanta, Georgia 30333

DISEASE CONTROL

Mr. Charles Gozonsky
Center for Disease Control
Building 1, Room B-43
Atlanta, Georgia 30333

John F. Finklca, M.D.

Director

National Institute for Occupational
Safety and Health
Parklavn Building, Room 3-30
Rockville, Maryland 20852

FOOD AND

Robert L. Elder, Sc.D.

Deputy Associate Commissioner
for Science

Food and Drug Administration
Parklawn Building, Room 14-57
Rockville, Maryland 20852

DEPARTMENT OF

Mr. Anthony Liotta
Deputy Assistant Attorney General
Land and Natural Resources Division
Department of Justice
Washington, D.C. 20530

ADMINISTRATION

Ms. Caroline Poplin
Food and Drug Administration
GCF - 1 - Parklawn Euilding
5600 Fishers Lane
Rockville, Maryland 20852

JUSTICE

Mr. Martin Green
Department of Justice
Poora 2609

9th St. and Penn. Ave.
Washington, D.C. 20530

DEPARTMENT OF LABOR

Mr . Byung Kwon
Occupational Safety and
Health Administration
Department of Labor
Washington, D.C. 20210

Ms. Joan Hollenbach
Department of Labor
Office of Solicitor
Room 4414

200 Constitution Avenue, N.W.
Washington, D.C. 20210

25

[305]

Representatives

General Counsels

DEPARTMENT OF TRANSPORTATION

Mr. William D. Owens
Deputy Assistant Secretary for

Systems Development and Technology
(TST-2)

Department of Transportation
400 7th Street, S.W.

Washington, D.C. 20590

Dr. Bohdan Giel
United States Coast Guard
400 7th Street, S.W.

Washington, D.C. 20590

ENVIRONMENTAL PROTECTION AGENCY

Mr. Douglas A. Crockett
Department of Transportation
Trans Point, Room 6222
2100 Second Street, S.W.
Washington, D.C. 20590

Delbert S. Barth, Ph.D.

Deputy Assistant Administrator for
Health and Ecological Effects
Environmental Protection Agency
401 M Street, S.W.

Washington, D.C. 20460

Lawrence A. Plumlee, M.D.

Medical Adviser
Office of Principal Science Adviser, ORD
Environmental Protection Agency
Washington, D.C. 20460

EXECUTIVE OFFICE OF THE PRESIDENT

Mr. Thomas 0. McGarity
Environmental Protection Agency
401 M Street, S.W.

Washington, D.C. 20460

The Honorable H. Guy ford Stever
Director

Office of Science and Technology
Executive Office of the President
Washington, D.C. 20500

CHAIRMAN OF THE SUBCOMMITTEE

Donald S. Fredrickson, M.D.
Director

National Insitutes of Health
Bethesda, Maryland 20014

EXECUTIVE SECRETARY OF SUBCOMMITTEE

Joseph G. Perpich, M.D., J.D.
Associate Director for
Program Planning and Evaluation
National Institutes of Health
Bethesda, Maryland 20014

26

[306]

Appendix III

REGULATION OF RECOMBINANT DNA
RESEARCH IN LABORATORIES

BACKGROUND

On December 20, 1976 a meeting was held at NIH of attorneys 1/
from the Departments of Justice, Agriculture, HEW, Labor, and Trans-
portation and the Environmental Protection Agency, for the purpose
of assessing whether legislative authority currently exists for
imposing at least the following regulatory requirements on all
recombinant DNA laboratory research in the United States (whether or
not Federally funded):

1. Review and approval of such research before it is undertaken
by a local biohazards committee.

2. Compliance with the physical and biological containment
standards and prohibitions In the NIH Guidelines.

3. Registration of such research with a nat ional registry at the
time the research Is undertaken (subject to appropriate safeguards to
protect proprietary Interests).

4. Enforcement of the above requirements through monitoring,
inspection, and sanctions.

It was generally conceded for purposes of the discussion that
these requirements could be imposed by funding agencies on Federally
conducted or supported research, and primary attention was therefore
directed to whether authority now exists to mandate these requirements

1/ A list of attendees is attached.

27

[307]

for all recombinant DNA laboratory research without regard to the
source of funding.

SUMMARY CONCLUSION

In summary, the group concluded that, while present law would
permit imposition of some of the above requirements on much recom-
binant DNA laboratory research, no single legal authority or combina-
tion of authorities currently exists which would clearly reach all
such research and all requirements. Although there is existing
authority which could be interpreted to cover most of the research
at issue, it was generally agreed that regulatory actions taken on
the basis of any such interpretation would probably be subject to
legal challenge.

LAWS CONSIDERED

In reaching this concensus, discussion centered on the following

laws:

1. The Occupational Safety and Health Act of 1970 (Public
Law 91-596).

2. The Toxic Substances Control Act (Public Law 94-469).

3. The Hazardous Materials Transportation Act (Public Law
93-633).

4. Section 361 of the Public Health Service Act (42 U.S.C.
§264).

28

[308]

Authorities of EPA under the Clean Air Act, the Federal Water
Pollution Control Act, and the new Resource Conservation and Recovery
Act of 1976, were mentioned in passing, but it was felt they would
apply, if at all, only to isolated aspects of recombinant DNA research
carried out in the laboratory. The FDA was also discussed briefly.
However, Inasmuch as recombinant DNA research has not yet reached the
stage where it has practical applications in fields regulated by FDA,
it was agreed that FDA probably does not have authority to impose
requirements on such research. The Department of Agriculture's
regulatory powers were also touched upon, but not considered in depth
because they relate solely to certain forms of non-human animal life
and plants.

DEPARTMENT OF LABOR

Of the four statutes on which discussion centered, primary
attention was directed to the Occupational Safety and Health Act
and the Toxic Substances Control Act, because each on its face would
give broad powers to the administering agencies.

The Occupational Safety and Health Act, administered by the
Occupational Safety and Health Administration (OSHA) in the Department
of Labor, requires every employer to: (1) furnish to each of its

employees ". . .employment and a place of employment which are free
from recognized hazards that are causing or are likely to cause death

29

[309]'

or serious physical harm. . ."to the employees, and (2) ". . .comply
with occupational safety and health standards promulgated under this
Act." The aforesaid Act gives OSHA broad power to enforce compliance
with the Act, including a right of entry, authority to require record-
keeping and reports, and sanctions. In addition, the Act specifically
directs that trade secret information shall be treated by OSHA as
confidential.

The term "employer" is defined in such a way, however, as to
exclude States and their political subdivisions, as well as the United
States. The Act contains a separate provision requiring Federal agencies
to follow OSHA standards, but States and their subdivisions are subject
to OSHA requirements only by voluntary agreement on the part of each
State. Only 24 States have so agreed and there is no immediate expec-
tation that this number will increase. Hence, such organizations as
State universities in 26 States are not subject to OSHA requirements.

In addition, OSHA has authority only in cases where an employment
relationship exists. Hence, it could not prevent a self-employed
person from conducting recombinant DNA research as long as no employees
would thereby be affected.

Turning to the requirements themselves, since recombinant DNA
research does not necessarily present a "recognized hazard" with
respect to all areas of that research, and because of possible liti-
gation problems in proving a recognized hazard, the imposition of
all NIH Guidelines on employers can best be achieved by adopting them

30

. [310]

as standards, in accordance with detailed rulemaking procedures spelled
out in the Act. Among the policy questions which would have to be
resolved in contemplating this step are: (1) whether OSHA would agree

to an outright ban of some activities since it has never in the past
actually prohibited a total activity, and (2) whether OSHA should give
priority to establishment of these standards over others that have been
awaiting promulgation, taking into account the statutory test of " . . .
urgency of the need for mandatory safety and health standards for
particular Industries, trades, crafts, occupations, businesses, workplaces
or work environments."

ENVIRONMENTAL PROTECTION AGENCY

The Toxic Substances Control Act (TSCA) , primarily administered by

EPA, was enacted in October 11, 1976, effective January 1, 1977. Section 6

of the TSCA states in part that:

"If the Administrator [of EPA] finds that there is
a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use, or disposal
of a chemical substance or mixture, or that any com-
bination of such activities, presents or will present
an unreasonable risk of injury to health or the
environment, the Administrator shall by rule apply one
or more of the following requirements to such substance
or mixture to the extent necessary to protect adequately
against such risk using the least burdensome requirements:

(1) A requirement (A) prohibiting the manufacturing,
processing, or distribution in commerce of such substance
or mixture, or (B) limiting the amount of such substance
or mixture which may be manufactured, processed, or
distributed in commerce.

31

[311]

(2) A requirement —

(A) prohibiting the manufacture, processing,
or distribution in commerce of such substance or
mixture for (i) a particular use or (ii) a
particular use in a concentration in excess of

a level specified by the Administrator in the
rule imposing the requirement, or

(B) limiting the amount of such substance
or mixture which may be manufactured, processed,
or distributed in commerce for (i) a particular
use or (ii) a particular use in a concentration
in excess of a level specified by the Adminis-
trator in the rule imposing the requirement."

The TSCA contains inspection and penalty provisions, and a section
limiting disclosure of data.

NIH scientists agree that materials used in recombinant DNA research
in the laboratory, and the immediate products of such research, would
appear to be covered in most cases by the definition of "chemical
substance" in the TSCA. The term "manufacture" is defined as meaning
. .to import. . .produce, or manufacture." The term "manufacture"
does not normally connote scientific experimentation in the laboratory.
Thus, some question could be raised as to whether section 6 has any
applicability to such research. However, another section of the TSCA
(section 5), which requires manufacturers to give EPA advance notice
of plans to manufacture a new chemical substance, contains an exemption
from the notice requirement for ". . .manufacturing or processing of
any chemical substance. . .only in small quantities. . .solely for
purposes of. . .scientific experimentation or analysis. ..." The
wording of this provision would seem to indicate that scientific

32

[312]

experimentation constitutes manufacturing under the TSCA, 2 / and also
the absence of a similar provision in section 6 creates a negative
implication that section 6 applies to such experimentation. Nevertheless
this is an area of some controversy that could well lead to future
litigation in the event EPA attempts to regulate laboratory research.

In the event EPA can regulate recombinant DNA laboratory research
under the TSCA, it can do so only if it finds such research presents an
"unreasonable risk of injury to health or the environment." This
offers another area of potential controversy should EPA attempt to
regulate all such research through this mechanism, j)/

The most serious deficiency in the TSCA, as a vehicle for regulation
of recombinant DNA laboratory research, is presented by section 5,
noted above, which requires manufacturers to notify EPA when they intend
to manufacture a new chemical substance. As has already been indicated,
scientific experimentation is specifically exempted from this requirement
Since section 5 deals directly with notice, and in effect registration.

2 / A point supported by the fact that section 5 has a separate

definition of "manufacture" solely for purposes of that section,
which is limited to manufacture "for commercial purposes." The
quoted phrase does not appear in the more general definition
applicable to section 6.

_3/ On the other hand, the TSCA authorizes any person to commence a
civil action to compel EPA to perform any act or duty under the
TSCA which is not discretionary. In some cases, this could lead
to litigation regardless of what course of action EPA adopts.

33

[313]

and provides an exemption for such experimentation, it is doubtful
that section 6 could be utilized to require registration. Otherwise,
the intent of Congress in enacting the exemption would be undermined.

DEPARTMENT OF TRANSPORATION
AND

CENTER FOR DISEASE CONTROL, HEW

The Hazardous Materials Transportation Act (HMTA) and section 361
of the PHS Act give the Department of Transportation and the Center for
Disease Control, HEW, respectively, authority to regulate shipment of
hazardous materials in interstate commerce. 4/ The HMTA authorizes the
Secretary of Transportation to issue and enforce regulations governing
any safety aspect of the transportation of hazardous materials, including
but not limited to packing, repacking, handling, labeling, mailing,
placarding, and routing, and the manufacture, fabrication, marking,
maintenance, reconditioning, repair, or testing of packages or containers
represented, marked, certified, or sold by certain persons for use in
the transportation of certain hazardous materials. 5/

Section 361 authorizes the Secretary of HEW to ", . .make and

4/ Including intrastate commerce that affects interstate commerce.

5 j In the Federal Register for November 26, 1976, at page 52086, the

Department of Transportation has asked for public comment as to
whether it should expand the definition of "etiologic agents" in
DOT regulations". . .to include biological materials (such as
recombinant DNA) used in or derived from genetic studies."

34

[314]

enforce. . .such regulations as in his [the Secretary's] Judgment are
necessary to prevent the introduction, transmission, or spread of
communicable diseases. . .from one State. . .into any other State. . . ."

Both DOT and CDC, in implementing the HMTA and section 361 with
respect to biological products, have essentially aimed just at imposing
labeling, packaging, and shipping requirements. This approach is in
line with the statutory language which emphasizes movement. Section 361
could perhaps be interpreted more broadly to serve as legal support for
more comprehensive regulation. However, in order to do so there would
presumably have to be a reasonable basis for concluding that the products
of all recombinant DNA research cause or may cause human disease. Such
a conclusion would undoubtedly be tenuous at best, and it is unlikely
that resulting requirements could be effectively Imposed and enforced.

Under section 353 of the PHS Act, however, CDC does have general
authority to license and control the operation of clinical laboratories.
Vhile this authority would not in general have applicability to research
laboratories, CDC's experience in Implementing this legislation, which
imposes comprehensive requirements on clinical laboratories, could be
of value in the implementation of any new legislation needed to regulate
laboratories conducting recombinant DNA research.

OTHER ISSUES CONSIDERED

1. In the event new legislation is sought, a model for the

35

[315]

registration requirement may be found in the Federal Insecticide,
Fungicide, and Rodenticide Act (Public Law 92-516), which sets forth
a detailed procedure for registration of pesticides.

2. On the issue of protection of proprietary information submitted
to the Government as part of the registration process, while the Freedom
of Information Act (FOIA) provides in general that records in the
possession of Government agencies are available to the public upon
request, the FOIA does not apply to, among other things, " . . .trade
secrets and commercial or financial information obtained from a person
and privileged or confidential. . ." (exemption 4). Moreover, 18 U.S.C.
§1905, part of the Federal criminal code, makes it illegal for a
Government employee to disclose " . . .to any extent not authorized
by law any information coming to him in the course of his employment. . .
which information concerns or relates to the trade secrets, processes,
operations, style of work, or apparatus. . .of any person, firm,
partnership, corporation, or association. ..." In Charles River Park
"A," Inc., et al, v. The Department of Housing and Urban Development,
et al., a 1975 decision, the United States Court of Appeals for the
District of Columbia held that, where an agency record is exempt from
FOIA disclosure by virtue of exemption 4 and the record contains infor-
mation covered by section 1905, the record would be subject to the
prohibition against disclosure in section 1905.

36

[316]

In Washington Research Project, Inc., v. Department of Health,

Education, and Welfare, et al., the same court had ruled in 1974 that
research designs submitted in certain NIMH grant applications are not
"trade secrets" within the meaning of exemption 4. However, in that case
the court noted". . .the burden of showing the trade or commercial char-
acter of the research design information was on the agency, and. . .it
did not introduce a single fact relating to the commercial character of
any specific research project. . . ." Thus, Washington Research Project
would not appear to govern situations in which the agency could show
that patentable information or similar proprietary matter was involved.

3. While it would be desirable from a scientific standpoint to
retain the flexibility to modify at least some parts of the Guidelines
without the delays attendant to the rulemaking process, most regulatory
legislation must be Implemented by regulations promulgated in accordance
with the Administrative Procedures Act (APA) or similar rulemaking
procedures. One approach which might overcome this problem would be
to publish regulations which set forth general standards but rely on
cross references to the Guidelines with respect to specific details.
However, this could present enforcement problems because any enforcement
action based on a cross reference could be challenged for noncompliance
with the APA. For this reason, a regulatory agency would probably insist
upon specificity in its regulations.

37

[317]

4. It was the general concensus of all attorneys present that,
to the extent no statutory basis existed for regulating non-Federally
funded recombinant DNA laboratory research, this could not be achieved
by Executive Order of the President. 6 j

5. There was a brief discussion of whether, if agency X could
regulate one type of recombinant DNA research and agency Y could regulate
another type, agency Y could delegate its authority to agency X so

that there could be comprehensive regulation by one agency. No conclusion
was reached as to whether such an arrangement was legally barred. However,
the only instance of this which any attorney could recall took place in
the context of a specific statutory provision allowing the agency (the
Customs Service) to do so.

i j Particularly insofar as the entity conducting the research received

no Federal funds for other recombinant DNA research.

38

[318]

Mr. Anthony C. Llotta
Mr. Martin Green
Department of Justice

Mr. Alexander W. Samofal
Office of the General Counsel
Department of Agriculture

Mr. Charles I. Hadden
Ms. Joan Hollenbach
Office of the Solicitor
Department of Labor

Mr. Thomas 0. McGarity
Office of the General Counsel
Environmental Protection Agency

Mr. Douglas A. Crockett
Office of the General Counsel
Department of Transportation

Mr. Richard J. Riseberg

Ms. Caroline Poplin

Office of the General Counsel

Department of Health, Education, and Welfare

Resource Personnel:

Dr. Joseph G. Perpich

Dr. William J. Gartland

Dr. Bernard Talbot

Mr. Joseph Hernandez

National Institutes of Health

Department of Health, Education, and Welfare

Dr. Harvey L. Arnold

Animal and Plant Health Inspection Service
Department of Agriculture

39

[319]

Appendix IV

1525 18th Street, NW, Washington, D.C. 20036 • 202/833-1484
November 11, 1976

The Honorable David Mathews
Secretary

Department of Health, Education & Welfare
South Portal Building, Room 615 F
200 Independence Avenue, S. W.

Washington, D. C. 20201

Dear Dr. Mathews:

The Environmental Defense Fund and the Natural Resources
Defense Council hereby submit to you a petition concerning
the regulation of recombinant DNA research and technology.

We would very much appreciate your giving this matter prompt
attention.

Enclosed also are copies of letters from Dr. Robert L.
Sinsheimer of the California Institute of Technology and
Mr. Alan McGowan, President, Scientists' Institute for Public
Information.

Sincerely yours

1 SB. .

Staff Scientist
Environmental Defense Fund

OFFICES IN: EAST 3CTAUKET. NY (MAIN

OFFICE): NEW YORK CITY (PROGRAM SUPPORT OFFICE): WASHINGTON. DC: BERKELEY. CALIFORNIA; DENVER. COLORADO

Frlnttd on 100 % Rocycttd Pipor

40

[320]

CALIFORNIA INSTITUTE OF

TECHNOLOGY

PAIAOCNA. CALIFORNIA OlltS

OlV1»iON O* aiOLOOV

October 28, 1976

Dr. A. Karin Ahned

Natural Resources Defense Council, Inc.

15 West Mth Street
Nev York, New York 10036

Dear Dr. Ahned:

I an pleased to support the petition of the Er.vironnental Defense Fund
and the National Resources Defense Council to the Secretary of Health,
Education and Welfare concerning reconbinant DITA activities. This petition
has two components: the first requests the Secretary to promulgate interim

regulations to sake the present NIH Guidelines concerning recombinant DNA
research binding on all parties engaged in recombinant DNA research in the
United States. The second requests the Secretary to conduct a "legislative-
type" hearing to obtain very broadly based testimony vhich might guide a
reformulation of the present recombinant DNA Guidelines, taking into
consideration issues not addressed and points of viev not presented during
their development.

The Guidelines have been developed out of the concept that there is a
potential hazard to public health in certain forms of recombinant DNA
research. It is evident that this hazard is not restricted to recombinant
DBA research conducted with the aid of NIH (or other Federal) funds.

1 therefore support their extension to cover all research activity in this
field, however supported and wherever performed. This research does not
require elaborate facilities and large capital investment. There is,
therefore, no reason to believe that it will be limited to large institutions
or industrial concerns with proven records of responsibility. Further, the
virtual certainty of the development of new techniques and of the extension
of these techniques to additional organisms and higher life forms will require
a free flow of information, a continuing updating of guidelines, and the
continuing scrutiny of this field of research by a body which will endeavor
to reflect the public interest.

The need to consider the reformulation of the Guidelines derives from the
perception that they were developed from too narrow a perspective. In my
opinion the Guidelines were developed to address solely the immediate medical

41

[321]

Dr. A. Karim Ahmed

October 28, 1976
Page 2

hazards that might arise in the conduct of such research. The Guidelines
do not address vhat I perceive as the larger, potential ecological and
evolutionary hazards implicit in this research. ■ Nor do the Guidelines
address the potential significance of the availability of this new technology
developed by scientists to solve their ovn scientific problems - to other
diverse sectors of our society, which may wish to use it for their ovn ends.

I believe the Guidelines do not provide sufficient recognition of the fact
that we are here creating novel living organisms - unprecedented in the
evolutionary order. As living organisms they are self-perpetuating and
destined to their own individual evolution. I do not believe we can predict
the properties of these organisms - created by the fusion of genes from
disparate species - or their subsequent evolution, or their impact, present
and future, on the existent biosphere. We do not know that there is a
hazard here but neither do we know there is not. If such hazard exists or
develops it will be in this instance uniquely irreversible. I believe a
thoughtful .reformulation of the Guidelines to take these circumstances into
account would be most appropriate.

Sincerely yours.

Robert L. Sinsheimer
Chairman

42

[322]

SCIENTISTS' INSTITUTE FOR PUBLIC INFORMATION

49 Cost 53 Struct. Nw York. NY 1002V 21 2/G-‘J8 4050

EXECUTIVE COMMITTEE

President
Alan MeGov/an

Past President:

Margaret Mead. Ph D

Chair rr.ari:

Barry Commoner. PhD

Vice Chairman:

Peter J Caws. Ph 0

Vice Chapman
Dona d Oanlsten. PhD

Vice Chairman •

Allen C. Nadler. M 0

Secretary:

Glenn Paulson. Ph 0

Treasurer:

Martin Sononberg.

M D . Ph D

BOARO OF DIRECTORS
George Berg. Ph 0
Louise Beaman
John Fowler. Pn D
David L.. Frank. Ph 0
Arthur W Galston Ph 0
Richaid Garcia. Ph 0
H. Jack Ge gcr. M.O
Clarer.ce C Gordon. Ph 0
Dan VV Lufkin
An than, Maazocchi
Michael McGmtock. Ph D
Bernard Raooport
Abbv Rockefeller
David W Swetland

Cllicoi Publication
Environment
Julian McCauil.

Publisher

November 5, 1976

Dr. Burke Zimmerman
Staff Scientist
Environmental Defense Fund
1525 18th Street N.W.

Washington, D. C. 20036

Dear Dr. Zimmerman:

The controversy over recombinant DNA research
has brought one of the most important facets of bio-
medical research out into the open. Although there
are substantial benefits that may accrue from the
research, there is also the possibility of enormous
costs, both short and long term.

The public is being asked to support this research,
both with its tax dollars* and by being in the physical
vicinity of the recombinant DNA research laboratories.
Fortunately, some public inquiry has begun in the form
of open hearings on the subject. These public hearings
have been held in Cambridge, New York City and San
Diego, and have expressed deep concern over how and
whether this research should be continued.

The public at large, however, is still in the
dark concerning the relevant issues in the debate. The
scientific jargon that accompanies the discussion with-
in the scientific community is, at best, confusing to
non-scientists. There is an overwhelming need for
accurate, up-to-date information, with the issues clearly
presented in terms understandable to all of us. The
public, government officials, and members of the Legis-
lature are in need of this information. Only with sub-
stantantive understanding of all the issues will effective
programs and regulations be promulgated.

43

[323]

November 5, 1976

Public hearings are absolutely essential in
this process of discussion and debate. The Scientists'
Institute for Public Information wholeheartedly support
the petition of the Environmental Defense Fund and
the Natural Resources Defense Council for the conduct
of public hearings on recombinant DNA research.

AM:m

cc: Dr. Karim Ahmed

Natural Resources Defense Council

1,5 W. 44th St.

liew York, New York 10036

Alan McGowan
President

44

[324]

UNITED STATES OF AMERICA

BEFORE THE

DEPARTMENT OF HEALTH, EDUCATION AND WELFARE

PETITION OF ENVIRONMENTAL DEFENSE FUND, INC.

AND NATURAL RESOURCES DEFENSE COUNCIL, INC.

TO THE SECRETARY OF HEALTH, EDUCATION AND WELFARE
TO HOLD HEARINGS AND PROMULGATE REGULATIONS UNDER
THE PUBLIC HEALTH SERVICE ACT GOVERNING RECOMBINANT
DNA ACTIVITIES

The Environmental Defense Fund (EDF) and the Natural
Resources Defense Council (NRDC) hereby petition the Secretary
of Health, Education and Welfare (hereafter "the Secretary")
under the authority granted him by 5361 of the Public Health
Services Act (42 U.S.C. 5264) to hold public hearings and

y

promulgate regulations governing recombinant DNA research
and technology in which fragments of DNA from different
organisms, cells or viruses are combined in novel ways and
introduced into a living host organism or cell.

1/ DNA - deoxyribonucleic acid, the chemical substance which
contains all genetic information.

45

(325)

Recombinant DNA technology permits the creation of organisms
or viruses with an unprecedented genetic make-up which may have
the potential of causing grave and irreversible harm to humans
and the environment. The extent of our current knowledge does
not allow us to predict all of the possible results of experi-
ments involving the manipulation of genes. Because most of
the present and proposed recombinant DNA research and technology
involves the genetic modification of bacteria or viruses, there
exists the potential danger of creating a highly deleterious
communicable infectious agent that could be introduced into
and spread among laboratory workers and/or the general popula-
tion (see infra, pp. 9 - 12) .

Recognizing the potential hazards inherent in recombinant

DNA research7 the National Institutes of Health (hereinafter

1/

"NIH") on 23 June, 1976 promulgated guidelines which
prohibit certain experiments where the potential risks to
human health are deemed to be particularly high, and require
a graded set of safety procedures for all other experiments
(see 41 red; Reg. No. 131, part II, pp. 27902-27943, July 7,

1976) . NIH also filed a draft environmental impact statement
(hereinafter the "impact statement") on 1 September, 1976,
which sets forth some of the possible dangers of recombinant
DNA research and technology (see 41 Fed. Reg. No. 176,
pp. 38425-44, Sept. 9, 1976). NIH indicated that the guide-
lines are not a final statement of public policy on

A/The petitioners take no position at this time concerning
the adequacy of the safety standards set forth in these
guidelines.

[326]

recombinant DNA research and technology but rather the beginning
of full public consideration of all relevant issues.

The guidelines apply only to recombinant DNA research
supported by the NIH. While Dr. Donald Fredrickson, the
director of NIH, has called on all government agencies and
"all who support or conduct such research throughout the
United States" (41 Fed. Reg. No. 131, p. 27906, July 7, 1976)
to voluntarily adopt the NIH guidelines, only the National
Science Foundation, Department of Defense, and the Energy Research
and Development Administration have formally done so.* Therefore,
a significant portion of recombinant DNA research and technology
is not covered by any mandatory set of safety procedures, leaving
the public unprotected from its potential hazards. Furthermore,
it is the position of the petitioners that the public did not
have an adequate opportunity to participate in the basic policy
decisions underlying the NIH Guidelines.

For these reasons, EDF and NRDC request that:

(1) a public hearing of broader scope than those held this
year at NIH be held on the questions of to what extent and
under what conditions recombinant DNA research and technology
should be allowed to proceed; (2) final regulations be
promulgated based on the record of that hearing which would
apply to all recombinant DNA research and technology in the

* Dr. Joe Perpich, National Institutes of Health, personal
communication .

47

[327]

United States; and (3) the present NIH guidelines be promulgated
immediately as interim relief ’regulations governing all parties
conducting or supporting such research.

This document includes:

I. A description of the scope of this petition (p. 4) ;

II. A description of the petitioners (p. 6) ;

III. A discussion of the need to control recombinant DNA
research and technology in the interest of public health
(p. 7) ;

IV. A discussion of the legal basis for the regulation of
recombinant DNA research and technology by the Secretary of
HEW (p. 13); and

V. A description of proposed relief (p. 15) .

I. Scope of the Petition

By this petition EDF and NRDC seek interim and
final regulations which will protect the public from the
potential Hazards of uncontrolled recombinant DNA research
and technology.

In this petition the term "recombinant DNA research
and technology" means all procedures in which DNA fragments
from two or more different organisms or viruses which do not norma
recombine in nature are recombined in the laboratory and inserted
into a living host cell or organism in such a way as to alter its
genetic make-up. This includes, but is not limited to, any experi
ments involving transportation of or commercial use of recombinan

48

[328]

DNA molecules or the products derived therefrom. NRDC and EDF
seek regulations governing all recombinant DNA research and
technology including, but not limited to:

(a) All experiments discussed in the "Guidelines
for Research Involving Recombinant DNA Molecules"
issued by the National Institutes of Health on
June 23, 1976 and published in the Federal Register
Part II on July 7, 1976;

(b) All experiments in which chemically or
enzymatically synthesized DNA is inserted into
a living host, plasmid or virus; and

(c) All other procedures in which DNA from
any two sources which do not normally exchange
genetic information may function within the
same cell.

NRDC and EDF seek regulations whicn would cover all persons and
organizations conducting or supporting recombinant DNA research
including, but not limited to:

1. Recipients of Research grants awarded by
any agency within the Department of Health,

Education and Welfare;

2. Private corporations;

3. Private and public universities; and

4. Other departments and agencies of the
Federal Government.

49

[329]

II. Petitioners

Petitioner Environmental Defense Fund, Inc., is a
not-for-profit public-benefit membership corporation organized
and existing under the laws of the State of New York. Its
principal office and place of business is located at 162 Old
Town Road, East Setauket, New York. It also maintains offices
in Washington, D.C.; New York, New York; Denver, Colorado;
and Berkeley, California. EDF has a nationwide membership of
over 40,000 persons, composed of scientists, educators, lawyers,
and other citizens dedicated to the protection of the environ-
ment and the wise use of natural resources. Many of these
persons and their children will be subjected to the increased
risk of adverse health effects discussed in at pp. 9-12, infra,
if the Secretary does not adopt effective regulations controlling
the relevant procedures. By its activities, EDF seeks the
preservation and restoration of environmental quality and the
protection of the country's natural resources on behalf of
the. general ’public. Its objectives include combining "the best
scientific findings with the most appropriate social action
discovered by the social sciences and legal theory in order
that practical decisions shall be made which shall best promote
a quality environment." (EDF By-laws, Art. 1:2 (d) ) .

Petitioner Natural Resources Defense Council, Inc. , is a
not-for-profit, tax-exempt corporation organized under the laws
of the State of New York, with offices at 15 West 44th Street,

New York, New York; 917 15th Street, N.W. , Washington, D.C.;
and 2345 Yale Street, Palo Alto, California. NRDC is a national

organization dedicated to environmental protection, including

50

[330]

protection of the human environment. NRDC has 24,000 members and
contributors in the United States. Many of these persons and
their children will be subjected to the increased risk of adverse
health effects discussed in pp. 9 - 12, infra, if the Secretary does
not adopt effective regulations controlling the relevant proce-
dures. Among the methods NRDC uses to achieve its objectives
are: (1) improving federal agency decision-making which affects

the environment by commenting, furnishing information, partici-
pating in administrative proceedings, and bringing lawsuits
where legal duties are not being fulfilled; and (2) improving
federal agency decision-making which affects the environment
by encouraging agencies to solicit and utilize the views,
knowledge, and expertise of members of the general public.

Ill . The Need to Control Recombinant DMA Pesearch

and Technology in the Interest of Public Health

The techniques defined above enable scientists to
recombine the DNA from two unrelated species and, thus, construct
organisms which may express genes from biologically unrelated
sources. Because the properties of such deliberately or
accidentally constructed organisms are unknown and may represent
hitherto nonexistent hazards both to human health and the
ecology, members of the scientific community have raised the
questions of whether or not proceeding with this type of
research at this time is prudent, and, if so, whether or not
the public and the environment can be adequately protected

51

[331]

from potentially hazardous novel organisms which might arise from
such research.

Addressing these questions, NIH formed a committee (the
Recombinant DNA Molecule Program Advisory Committee) composed of
scientists, many of whom were directly involved in recombinant
DNA research, to draft guidelines governing the conduct of
recombinant DNA research and establish safeguards to protect
the public and the environment from potential hazards. The
guidelines, applying only to NIH supported research, were made
public June 23, 1976. Recognizing the far-reaching environmental
consequences which could result if infectious or otherwise
dangerous organisms able to compete successfully with existing
organisms were to be produced by recombinant DNA research, and
in response to requests from the public, NIH prepared a Draft
Environmental Impact Statement which was released September 1,

1976.

The Impact Statement, in discussing the alternative of "no
action," unambiguously concludes that regulation of recombinant DNA
research and technology is essential for the protection of the public

"the 'no action' alternative would greatly
increase the probability that possible hazardous
organisms would be released into the environment.

... It is concluded that the 'no action' al-
ternative would not afford adequate protection
of laboratory workers, the general public, and
the environment from the possible hazards des-
cribed in section IV-C-1." (at p. 48).

Some of the possible hazards which could arise either

directly or as an inadvertent result of recombinant DNA research

are discussed in Section IV-C of the Impact Statement. One may

52

[332]

expand this list to include additional untoward health effects.

The following are examples of potential threats to human health

which could result from recombinant DNA research and technology:

1. Most of the proposed and ongoing recombinant DNA

research involves strains of the bacterium Escherichia

coli (E. Coli ) as a host for plasmids containing DNA

from other sources. E. coli is a common resident of

the human colon, is responsible for nearly 100% of

1/

human upper urinary tract infections^and for approxi-
mately 30-40% of the cases of sepsis (infection of
the human bloodstream) , which is often fatal. While
the strains of E. coli used in recombinant DNA research
(variants of strain K-12) do not normally colonize the
human golon, they can under unusual conditions, parti-
cularly in patients weakened by another disease state.

Perhaps more serious, however, is the capacity of K-12

strains of E. coli to exchanqe DNA with other similar
~ 1/

or related organisms. Genetic exchange between E. coli

*/ ~

and strains of Salmone 11a , a human pathogen, is well
documented. Since the genetic de terminants in infec-
tivity and virulence of bacteria are not understood,
one must consider the possibility that even a seemingly
trivial modification of the E. coli genome might greatly
alter its capacity for infection and propagation within
humans .

1/ B. IT Davis , et al., Microbiology 768 (2nd ed. 1973).

2/ Dr. Halstod Holman - Oral testimony before a hearing of the Sub-
committee on Health of the Senate Committee on Labor and Public
Welfare, Sept. 22, 1976

3/ Davis, et al. , supra at 182-200
4/ Id. at 194.

53

[333]

In view of the ubiquitous nature of E. coli , the fact
that all strains including K-12 already have the capacity
for human infection, and E. coli 1 s ability to exchange
genetic material with other bacteria, the deliberate
genetic modification of even "weakened" strains of E. coli
poses a potentially serious threat to human health.

2. DNA can be taken from organisms that produce toxins
(e.g. botulnum) creating the possibility that the host
organism, which occupies a different ological niche,
will acquire the ability to produce the toxin.

This would be particularly serious if such genes were
expressed in strains of E. coli capable of colonizing
the human colon.

3. Genes which code for resistance to antibiotics are
transferred by some recombinant DNA experiments to
strains of bacteria that were not previously resistant.

4. The animal virus on which the most genetic information
is available is simian virus 40 (SV-40) , which produces
tumors in some animals and infects humans, although apparently
with no pathological symptoms. However, the genetic

basis for- the virus causing tumors in monkeys but not
humans is not understood. Therefore, the possibility
exists that even an apparently innocuous modification
of SV-40 DNA could render the virus tumorigenic or
otherwise .pathogenic to humans, thus creating a serious
hazard to human health. Yet it is sy-40, and polyoma

54

[334]

virus, which also produces tutors in animals, which are the
primary objects of recombinant DNA research in animal
viruses.

5. The virulence of influenza virus, and the sponta-
neous occurrence in nature at certain times of devastating
flu epidemics (such as the one of 1918) is apparently
controlled by the reassortment in nature of the 12 sub-
units of the viral RNA-^ Yet the genetic basis and the
mechanism by which these viruses are rendered highly
virulent is not understood. Again, therefore, any
recombinant DNA procedure involving any animal virus

or cells containing such a virus must be considered
to pose the risk of creating highly virulent or
infectious strains.

6. The expression of any foreign gene, however seemingly
innocuous it may be in the cells of a human or other
mammal, whether inserted by viral infection or some
other mechanism, poses the risk that a protein will

be produced in the infected cells which has never been
seen by the host's immune system. Thus the possibility
of an auto immune disease exists (as in rheumatic fever
or degenerative kidney disease) in which the body produces
antibodies against proteins within or produced by its
own cells, ultimately destroying the cells themselves.

The NIH guidelines discuss "harmful" genes in the sense

of DNA specifying antibiotic resistance factors or protein toxins.

1/ Davis, et al., supra at 1318. RNA = ribonucleic acid. Some
viruses contain RNA rather than DNA.

55

[335]

In the context of auto- immune disease, however, the gene speci-
fying any foreign protein must be considered potentially harmful.
7. The expression of even a "normal" metabolic enzyme
in human, animal or plant cells which was not under the control
of the cell's normal complex regulatory mechanism, could lead
to severe metabolic disruptions and an ensuing disease
state, similar to existing cases of metabolic disease
where the defect is in a regulatory gene, rather than
once coding for a specific enzyme.

Both the NIH guidelines and the Impact Statement recognize
that humans harboring or infected by bacteria or viruses con-
taining recombinant DNA may, under certain conditions, suffer
a variety of serious adverse health effects. If such modified
bacterial or viral agents can survive and propagate outside the
laboratory and thus produce new identical organisms capable of
producing infection and/or toxic effects on human beings, there
exists the potential for a "communicable disease" within the
meaning of Section 361 of the Public Health Service Act (42
U.S.C. §264) (see Section II above). Because some of the
organisms created by recombinant DNA research have never existed
before, the health and environmental effects of such novel
microorganisms are inherently unpredictable. Nevertheless, the
danger of the creation of a potentially serious communicable
disease organism makes it incumbent upon the Department of
Health, Education and Welfare to exercise its statutory authority
and take whatever regulatory measures are necessary to protect
the public health.

56

[336]

While EDF and NRDC commend the monumental effort made by NIH
to regulate this potentially hazardous branch of research within
its own jurisdiction, we are disturbed by the fact that the
guidelines cover only NIH supported research, leaving large
segments of the scientific and industrial communities subject
to no required safety procedures. Recombinant DNA research and
technology is now being pursued and supported by private corpora-
tions, agencies of the Federal government, as well as scientists
at universities and private institutions.

General Electric is trying to develop a bacteria which can
degrade petroleum and could be used to consume oil spills.

Imperial Chemical Industries Ltd. (ICI) of Britain is trying
to develop a virus which produces insulin. (Janice Crossland,

"Hands on the Code", Environment 18:6, September 1976). The
drug industry in the United States has also expressed interest
in the commercial use of recombinant DNA techniques. Federal
agencies such as the Department of Defense may contemplate
conducting experiments. Scientists at universities whether
they receive government grants or not are conducting recombinant
DNA research. Therefore, we consider a uniform set of regu-
lations covering all parties engaging in recombinant DNA research

to be absolutely necessary.

IV. The Secretary of HEW Has the Authority

To Regulate All Recombinant DNA Activities

Section 361 of the Public Health Services Act (42 U.S.C. §264)

gives the Secretary of Health, Education and Welfare the authority

to regulate all recombinant DNA research and technology. The

Section empowers the Secretary to:

"... make and enforce such regulations as in
his judgement are necessary to prevent the intro-
duction, transmission, or spread of communicafc-le

57

[337]

diseases from foreign countries into the States
or possessions, or from one State or possession
into any other State or- possession . .

It further provides that:

for purposes of carrying out and enforcing such
regulations, the [Secretary] may provide for such
inspection, . . . disinfection . . . and other

measures, as in his judgment may be necessary.

Recombinant DNA research and technology could create novel
infectious agents or increase the virulence and range of existing
infectious agents. The Draft Environmental Impact Statement recog-
nizes that recombinant DNA activities could produce microorganisms
that cause disease in laboratory workers and the general public.

In describing the Guidelines the Draft EIS states:

"The emphasis on protection of laboratory workers from •
infection reflects the fact that laboratory workers are
the persons at the greatest risk of infection and that
the ntbst likely route of escape of possibly hazardous
agents from the laboratory is the laboratory worker.”

(41 Fed. Reg. 38432)

In describing the highest level of physical containment required

by the Guidelines to the Draft EIS states that such facilities are:

"designed to contain microorganisms that are extremely
hazardous to man or may cause serious epidemic disease."

The kinds of disease which may be caused by recombinant DNA

activities are described in Section III of this petition (infra

at pp. 9 - 12) .

The Secretary has defined "communicable disease" in regulations

promulgated under Section 361 to govern the importation of animals

and establish drinking water standards. For the purposes of both

these sets of regulations a communicable disease is "An illness due

to an infectious agent or its toxic product ..." transmitted by

persons, animals, plants or the inanimate environment. (42 C.F.R.

§§71. 1(b) , 72.1(b)). These regulatory definitions of communicable

58

[338]

disease illustrate that the Secretary has the authority under §361
to regulate infectious agents from any source/ transmitted by any
means

Because microorganisms produced by recombinant DNA activities

may spread disease among humans, it has already been recognized

that regulations promulgated pursuant to authority under §361

control transportation of DNA materials. Section II-C of the NIH

Guidelines (41 Fed. Reg. 27914) states that the shipment of

recombinant DNA materials is governed by 42 C.F.R. §72.25 which

specifies safety requirements for the transportation of etiologic

1/

agents. An "etiologic agent" is defined as " . . .a viable micro--
organism or its toxin which causes, or may cause, human disease."

(42 C.F.R. 572.25(a)(1)) Recombinant research and the commercial
use of recombinant technology pose an even greater risk that the
public will be exposed to infectious agents than does transporta-
tion. The same risk of communicable disease which gives the
Secretary the authority to regulate the transpor tation of recombinant
materials under §361 gives him the authority to regulate all re-
combinant. DNA activities.

V. Re lief

By this petition EDF and NRDC seek the following relief:

1. A legislative-type hearing to develop a policy on
recombinant DNA research and technology.

2. Regulations binding on all parties conducting recombinant
DNA research or otherwise engaged in recomb inant DNA technology.

17 §72.25 applies to microorganisms listed in subsection (C) which

includes most microorganisms used in recombinant DNA research such
as E. coli, Simian Viruses, Salmonella.

59

[339]

3. As interim relief, regulations which make the NIH guide-
lines binding on all parties engaged in recombinant DNA research
and technology.

This relief is necessary to insure that the public has an
adequate opportunity to participate in the decision of whether
and under what conditions recombinant DNA research and technology
should be permitted and to insure that the protection provided
the public by the NIH guidelines is immediately extended through
the application of the NIH guidelines to all recombinant DNA
research and technology.

'A. The Need for a Legislative-Type Hearing

The NIH guidelines, which at present are the only statement

of government policy on recombinant DNA research and technology,

are the product of the deliberations of scientists who are now

conducting, recombinant DNA research. The NIH guidelines had

their origin in the Asilomar Conference held in Pacific Grove,

California in February 1975. Many of the participants at that

conference were the foremost molecular biologists from all over

the .world. • The NIH Recombinant DNA Molecule Program Advisory

Committee translated the recommendations of that conference into

concrete proposals which became the NIH guidelines. The first

opportunity the public had to participate in the regulation of

recombinant research was in February of 1976 when the draft

guidelines were released for public comment, and the Advisory

1/

Committee to the Director of NIH held an open meeting.

.1/This committee should not be confused with the NIH Recombinant
DNA Molecule Program Advisory Committee, which drafted the guide-
lines, but is one assembled early in 1976 from representatives of
science, law, teaching, public interest groups, students, etc. to
advise the director of NIH on the correctness or shortcomings of
its efforts to regulate recombinant DNA research.

60

[340]

Although this meeting '.as .not well publicized, many

scientists, public interest groups and laymen, were invited to

2/

attend and to comment on the guidelines. Additional input was
sought from these same individuals during the two-month period
following this meeting. A considerable body of material was
received by commentators by the office of the Director of NIH,
and is summarized, in part, in the Decision of the Director,

NIH, to Release Guidelines for Research on Recombinant DNA
Molecules (see 41 Fed. Reg. No. 131, pp. 27902-27911, July 7,

1976} .

Little discussion was devoted to whether or not these experi-
ments ought to be performed at all, even though the question w as
raised both by concerned laymen and by prominent scientists.

That there is an intrinsic and even necessary good in recombinant
DNA research has been a tacit assumption on the part of the NIH
advisory committee which drafted the guidelines from the onset
of its deliberations. We believe that this is, at least in part,
a reflection of the fact that many of the committee members are
now doing recombinant DNA research and have a vested interest in
its future. In the public meeting held on February 9-10, 1976,
the request was made that such potentially hazardous research
should at least await the development of a strain of bacteria
which is not a ubiquitous inhabitant of the human colon. E. coli
is the current organism of choice simply because a large body of
genetic information exists concerning this bacterium. This

2/ A copy of the comments submitted by EDF at that time are
attached as Appendix 1.

[341]

request was denied in an administrative decision by the director
of NIH and not even submitted to the advisory committee for
further debate in its April 1-2, 1976 meeting in which final
revisions of the guidelines were made. At this meeting, all of
the outside comments had been distilled down to ten typewritten
pages of questions for the consideration of. the recombinant DNA
advisory committee, the same committee which had drafted the
working version prepared early in 1976. Except for relatively
minor changes in wording, the committee dealt summarily with
the questions from the public, and the final version of the
guidelines did not differ significantly from the version pre-
pared prior to public input.

The legislative-type hearing should consider the following
issues which were not adequately considered in the NIH pro-
ceedings which led to the promulgation of the guidelines:

(a) Whether or not recombinant DNA research on any
level should be permitted at this time in view
of our present state of knowledge.

(b) If some areas are to be permitted, what are they
and what precautions are necessary to adequately
protect the public and the environment? For
example, what degree of physical containment
should be considered adequate in light of
human fallibility?

62

[342]

(c) Whether or not a strain of bacteria should be
sought and studied to replace E. coli as the
subject of most recombinant DNA experiments
before this work be allowed to proceed.

(d) Whether or not an "ordinary” or normal, non-
hazardous gene from one organism might become
dangerous if expressed in the wrong place and
wrong time in the wrong organism (this important
question was virtually ignored by the advisory
committee) .

A legislative-type hearing conducted by HEW is the best
forum for full consideration of the issues raised by recombi-
nant DMA research and technology. In effect, such a hearing
would amount to a broad-based public review of the existing NIH
guidelines and would permit open debate on 'issues given little
or no attention by the NIH Drafting Committee or the office of
the director. Whether the activity is transportation of
recomb inant DNA materials, research, commercial production or
use in the environment, HEW has the authority to regulate
corporations and scientists whether oi not they receive federal
research support. Therefore, it is highly appropriate for HEW
to hold such a hearing.

B. Final Regulations Governing All Parties Engaged

Promulgation of the NIH guidelines reflects a consensus
that recombinant DNA research and technology pose a sufficient
hazard to the public health and the environment to require the
prohibition of some experiments and the imposition of safety

63

[343]

procedures for others. The hazards of recombinant DNA research
and technology are no different if the research is being con-
ducted by scientists employed by private corporations . rather
than the NIH. The risk that necessitated regulation of
NIH grantees necessxates regulation of other research and
technology. The need for regulation of all parties conducting
recombinant DNA research is particularly great because even
one release of a hazardous genetically altered bacterium,
virus or plasmid could cause widespread illness or disruption
of the environment.

C. Interim Relief

During the period before the hearing is held and final
regulations are promulgated the public will be exposed to the
potential hazards of recombinant DNA research and technology
not now subject to NIH guidelines. Individuals who do not
receive NIH grants or work for NIH are not effectively
restrained from conducting any of the experiments which NIH
deemed so dangerous that they should not be conducted at all.
Nor are scientists not now covered by the guidelines required
to practice physical and biological containment of organisms
with recombinant DNA molecules. To protect the public until
final regulations are promulgated, EDF and NRDC request that
the Secretary immediately promulgate regulations which make
the NIH guidelines binding on all parties engaged in recom-
binant DNA research and technology.

64

[344]

Respectfully submitted

Burke K . Z^jmrne rman , Ph . D .
Staff Scientist-
Environmental Defense Fund

Joseph H. Highland,* Ph . D .
Chairman

Toxic Chemicals Program
Environmental Defense Fund

A. Karim Ahmed, Ph.D.

Staff Scientist

Natural Resources Defense Council

-UC, X (^JcjS-vT^/Li-v

Marcia Cleveland
Staff Attorney

Natural Resources Defense Council

Philip /.Meuse V

Staff Attorney
Environmental Defense Fund

November 11, 1976

65

[345]

FEDERAL INTERAGENCY COMMITTEE

Inquiry Into Federal Patent Policies as
Related to Recombinant DNA ResearcF

Page

Summary Minutes of Interagency

Committee, 3/29/77 347

Minutes, 3/29/77 352

[346]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Summary Minutes of Meeting
March 29, 1977

National Institutes of Health
Bethesda, Maryland

The sixth meeting of the Interagency Committee took place on March 29
at the National Institutes of Health. The meeting was chaired by
Dr. Donald S. Fredrickson, Director of the NIH. The two agenda items
considered were: (a) the Commerce Department Order providing for the
accelerated processing of patent applications for inventions related
to recombinant DNA activities and (b) Committee review of the draft
legislation prepared by the Office of the General Counsel, DHEW .

REVIEW OF COMMERCE DEPARTMENT ORDER ON
ACCELERATED PROCESSING OF PATENT APPLICATIONS

The Department of Commerce Order providing for accelerated processing of

patent applications for recombinant DNA inventions was suspended on March 9

(except for applications relating to safety of research in this field) so

that the Interagency Committee could consider recommendations concerning

research in this field by the private sector. The Committee review of the
Order and the explanatory documents prepared by the Commerce Department
centered on the following issues:

1 . The Accelerated Processing of Patent Applications
Dr. Betsy Ancker-Johnson , the Commerce Department representative, explained
that the acceleration of the patent process will result in earlier dis-
closure of the information included in the patent application. She
emphasized that the manner in which the review of the application would be

[347]

-2-

conducted is not affected, but that this review would commence
approximately six months sooner than the average review. She noted that
precedents for such an acceleration exist for inventions in the fields of
energy and environmental protection and that the Order requires research
inventions receiving accelerated processing to adhere to the standards
established by the NIH Guidelines.

Committee reactions to the Order were solicited and it was noted, for
example, that environmental groups would prefer that the technology
transfer from research to commercial application not proceed as quickly
as in other areas because of the potential risks posed to public health
and the environment. Dr. Ancker-Johnson replied that the Order requires
research inventions receiving accelerated processing to adhere to the
safety assessments and standards required by the NIH Guidelines.

2 . Adherence to the NIH Guidelines

Dr. Ancker-Johnson explained that the Order requires foreign inventors
to adhere either to the Guidelines or to standards which are equivalent
to the Guidelines. It was noted that this might provoke protests from
these inventors and that most western European countries were following
the United Kingdom Guidelines, which are comparable, but not identical,
to the NIH Guidelines. Dr. Ancker-Johnson responded that foreign inventors
could still file patent applications through the normal process if they
could not or would not abide by the NIH Guidelines or their equivalent.

Dr. Ancker-Johnson further explained that the implementation of the
provisions of the Order regarding the Guidelines are self-executing; that
is, the accuracy of statements by the inventor will be relied on by the
Commerce Department, but misrepresentations may imperil patent rights if

[348]

-3-

challenged by another party, and misrepresentations are also subject to
criminal penalties under United States law.

3 . Exemptions from Adherence to the NIH Guidelines for Proprietary
Information on Patent Rights

Dr. Ancker-Johnson stated that the inventor defines that which is pro-
prietary or patentable, but the Patent Office would review such statements
in light of the NIH standards. The initial determination for exemption
would, however, lie with the inventor. Dr. Fredrickson expressed concern
that, in light of NIH standards and procedures promoting maximum disclosure,
these exemptions may significantly limit the applicability of the NIH
Guidelines .

Committee Advice

In stating their views on the Order, Committee members agreed that their
views relate only to the health and safety aspects of the Order.

The majority of Committee members were favorably disposed to the reinstate-
ment of the Commerce Department Order because: (1) accelerated processing
involves no change in patent procedures that appears to be inimical to the
public good; (2) it motivates compliance with the safety standards of the
NIH Guidelines by non-governmentally funded domestic investigators during
the period while national legislation is being considered; and (3) it
encourages compliance with a set of recognized safety standards by foreign
investigators who may not yet be subject to comparable standards in their
own countries. Representatives from the following agencies so recommended:
VA, NRC, NSF, NASA, ERDA, FDA, CDC, DOD, Commerce, and USDA.

[349]

-4-

Subsequent to the meeting, representatives from the Departments of State
and Transportation asked to be recorded in favor of this recommendation.

As NIH representative. Dr. Fredrickson also concurred on the basis that
the NIH standards might be extended to the private sector, pending legis-
lation, and suggested that the Commerce Department, if it were to reinstate
the Order, should publish it for public comment rather than as a final rule.

Representatives of the EPA and OSTP recommended that the Order not be
reinstated. Both believed that the advantages to be derived through
earlier disclosure of information were more than outweighed by the
public perception of this Order as being a means to rush recombinant DNA
activities through to the stage of commercial development. In addition,
the EPA representative noted that the Order might require the filing of
an environmental impact statement. Dr. Ancker Johnson stated the
Commerce Department view that this Order is merely the speeding-up of an
administrative procedure and therefore does not constitute a major Federal
action as defined in the National Environmental Policy Act.

Representatives from the following Departments abstained: Labor and

Justice. The following agency representatives were absent during the
discussion of the Patent Order at the meeting: Office of the Assistant

Secretary for Health (DIIEW) , Department of Interior, Council on Environ-
mental Quality of the Executive Office of the President, and U.S. Arms
Control and Disarmament Agency.

Dr. Fredrickson noted that the Committee review and comments would be
forwarded to the Secretary of HEW for his review.

[350]

-5-

REVIEW OF DRAFT LEGISLATION

Each of the Committee members had previously received for review a copy
of draft legislation dated March 21. Several recommendations of a tech-
nical nature were made which Dr. Fredrickson promised to forward promptly
to OMB. He also suggested that the agenda for the next meeting of the
Committee include discussion of the following: (1) international activities
and (2) institutional patent agreements.

Respectfully submitted,

Joseph G. Perpich, M.D., J.D.
Associate Director for
Program Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

April 15, 1977

[351]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Minutes of Meeting
March 29, 1977

National Institutes of Health
Bethesda, Maryland

The sixth meeting of the Interagency Committee took place on March 29
from 2:00 to 5:00 p.m. , at the National Institutes of Health. The
meeting was chaired by Dr. Donald Fredrickson, Director of the NIH.

The two agenda items considered were: (a) the Commerce Department Order
providing for the accelerated processing of patent applications for
inventions related to recombinant DNA activities and (b) Committee review
of the draft legislation prepared by the Office of the General Counsel,
DHEW.

REVIEW OF COMMERCE DEPARTMENT ORDER ON
ACCELERATED PROCESSING OF PATENT APPLICATIONS

The Department of Commerce published in the Federal Register on January 13,

1977, an Order concerning accelerated processing of patent applications

for recombinant DNA inventions.

In response to expressions of concern by members of the Congress about the
Order, Secretary of Health, Education, and Welfare Joseph A. Califano, Jr.,
requested Secretary of Commerce Juanita Kreps to withdraw the Order pending
review by the Interagency Committee.. In a notice filed in the Federal
Register on March 9, 1977, the Commerce Department announced suspension
of the Order (except for applications relating to safety of research in
this field, which would continue to receive expedited processing). The
suspension was ordered so that the Interagency Committee could consider
recommendations concerning research in this field by the private sector.

[352]

-2-

Dr. Betsy Ancker-Johnson, the Commerce Department representative on
the Interagency Committee, urged the Committee to advise on this matter
as expeditiously as possible. The Committee reviewed the Order and the
documents prepared by the Commerce Department explaining in detail the
underlying policies. The discussion at the March 29 meeting centered
on a number of issues contained in the Order, which follow below:

1 . The Accelerated Processing of Patent Applications

In reviewing the actions of the Commerce Department in this area,

Dr. Ancker-Johnson explained that the acceleration of the patent process
will result in earlier disclosure of the information included in the
patent application. She emphasized that the manner in which the review
of the application is conducted is not affected, but that this review
will commence approximately six months sooner than the average review.

She noted that precedents for such an acceleration exist for inventions
in the fields of energy and environmental protection.

Coranittee reactions to the Order were solicited and it was noted, for
example, that environmental groups would prefer that the technology
transfer from research to commercial application not proceed as quickly
as in other areas because of the potential risks posed to public health
and the environment. Dr. Ancker-Johnson replied that the Order requires
research inventions receiving accelerated processing to adhere to the
safety assessments and standards required by the NIH Guidelines.

2 . Adherence to the NIH Guidelines

Dr. Fredrickson raised the question of how the Order would affect foreign
inventors who might be working under standards other than the NIH Guidelines.

[353]

-3-

Dr. Ancker-Johnson explained that the Order requires the foreign inventor
to adhere to either the Guidelines or to standards which are equivalent to
the Guidelines. The State Department representative noted that this
might provoke protests from these inventors, and Dr. Fredrickson pointed
out that most western European countries are following the United Kingdom
Guidelines. These Guidelines are comparable, but not identical, to the
NIH Guidelines. Dr. Ancker-Johnson responded that foreign inventors could
still file patent applications through the normal process if they could
or would not abide by the NIH Guidelines or their equivalent.

The NIH Guidelines establish a number of procedural mechanisms for safety
review, and Dr. Fredrickson asked how the Commerce Department intended to
implement these requirements. Dr. Ancker-Johnson stated that provisions
of the Order on this matter are self-executing; namely, the accuracy of
statements by the inventor will be relied on by the Commerce Department,
but misrepresentations may imperil patent rights if challenged by another
party, and misrepresentations are also subject to criminal penalties under
United States law.

3. Exemptions from Adherence to the NIH Guidelines for Proprietary
Information on Patent Rights

Dr. Fredrickson questioned the effect of exemptions for patent rights and
proprietary information on compliance with the NIH Guidelines. Dr. Ancker-
Johnson stated that the inventor defines that which is proprietary or
patentable, but the Patent Office would review such statements in light
of the NIH standards. The initial determination for exemption would,
however, lie with the inventor. Dr. Fredrickson expressed concern that

[354]

-4-

in light of NIH standards and procedures promoting maximum disclosure,
these exemptions may significantly limit the applicability of the NIH
Guidelines .

Committee Advice

Dr. Fredrickson, at the suggestion of Dr. Ancker-Johnson, asked all
representatives to state their views on the Commerce Department Order.
Committee members agreed that their views relate only to the health and
safety aspects of the Order.

The majority of Committee members were favorably disposed to the reinstate-
ment of the Commerce Department Order because: (1) accelerated processing

Involves no change in patent procedures that appears to be inimical to the
public good; (2) it motivates compliance with the safety standards of the

%

NIH Guidelines by non-governmental ly funded domestic investigators during
the period while national legislation is being considered; and (3) it
encourages compliance with a set of recognized safety standards by foreign
investigators who may not yet be subject to comparable standards in their
own countries. Representatives from the following agencies so recommended:
Veterans Administration, Nuclear Regulatory Commission, National Science
Foundation, National Aeronautics and Space Administration, Energy Research
and Development Administration, Food and Drug Administration, Center for
Disease Control, Department of Defense, Department of Commerce, and
Department of Agriculture.

Subsequent to the meeting, representatives from the Departments of State
and Transportation asked to be recorded in favor of this recommendation.

[355]

-5-

As NIH representative, Dr. Fredrickson also concurred on the basis that the
NIH standards might be extended to the private sector, pending legislation,
and suggested that the Commerce Department, if it were to reinstate the
Order, should publish it for public comment rather than as a final rule.

Representatives of the Environmental Protection Agency and the Office of
Science and Technology Policy recommended that the Order not be reinstated.

Both believed that the advantages to be derived through earlier disclosure of
information contained in the patent application were more than outweighed by the
public perception of this Order being a means to rush recombinant DNA activities
through to the stage of commercial development. In addition, the EPA representa-
tive noted that the Order might require the filing of an environmental impact
statement. Dr. Ancker-Johnson stated the Commerce Department view that this
Order is merely the speeding-up of an administrative procedure and therefore
does not constitute a major Federal action as defined in the National Environ-
mental Policy Act.

Representatives from the following Departments abstained: Labor and Justice.

The following agency representatives were absent during the discussion of the
Patent Order at the meeting: Office of the Assistant Secretary for Health

(DHEW) , Department of Interior, Council on Environmental Quality of the Execu-
tive Office of the President, and U.S. Arms Control and Disarmament Agency.

Dr. Fredrickson noted that the Committee review and comments would be forwarded
to Secretary Califano for his review.

[356]

-6-

REVIEW OF DRAFT LEGISLATION

Each of the Committee members was asked to comment upon the draft legislation
dated March 21 which had been previously distributed. Mr. Kwon, the Labor
Department representative, identified the following items which the
Cormnittee approved but which were not included in the draft: (1) provisions

for a worker to file a complaint and to have it investigated while
simultaneously protecting the worker from any harassment due to the
filing of the complaint; (2) provision for medical examinations of workers;
and (3) provision for the Inspection of the medical records of workers
upon request by the Secretary. He also noted that the Occupational Safety
and Health Administration should have the authority to enforce the
Guidelines (excluding the licensure and registration provisions) in
commercial facilities in which OSHA currently has jurisdiction.

Mr. Llotta explained that the comments of the Justice Department have
already been forwarded to OMB and that the following points were Included:

(1) that Federal agencies should not be Included In the definition of
"persons" but should be handled In a separate section providing for
executive action to deal with these agencies; (2) that Section 2 (Findings)
should show more directly the kinds of impacts on interstate cotanerce
that are of concern; (3) that Section 6 (Judicial Review Concerning
Standards and Licensing) be extensively rewritten so that specific
actions will take place in specific courts; (A) that Section 15 (Enforce-
ment) should be amended to provide a full scheme of administrative enforce-
ment and assessment of civil penalties; and (5) that Section 17 may raise
constitutional problems.

[357]

-7-

Mr. Walsh stated that the State Department had also submitted its comments
to OMB and these included: (1) the addition to Section 3(c) (General
Requirements) of a statement pertaining to national security and foreign
policy; (2) that Section 11(a) (Disclosure of Information) also include
the other sections of 5 U.S.C. 552; and (3) that the need for reference
to Section 102(2) (c) of The National Environmental Policy Act (NEPA)
and to 5 U.S.C. 553 in Section 4 (Standards) of the draft is questionable.

Dr. Lewis explained that the executive council of the NSF was in the
process of formulating comments for transmittal to OMB, but, in the
process of discussing the draft with various staff members, the sections
providing for criminal provisions and for the destruction of materials
seemed to be particularly troublesome.

The Defense Department has forwarded its comments to OMB, and Dr. Koslov
explained that these included: (1) that the addition to Section 3 as
offered by the State Department be accepted; (2) that the language of
Section 11 needs to be more specific; and (3) that Section 8 (Inspections)
be amended so that the investigator retains ownership of samples taken
during inspections.

Dr. Elder, FDA, pointed out the lack of an appropriations section in the
draft, and the representatives from the Transportation Department and the
Veterans Administration explained the position of their agencies that (1)
State involvement in the regulation of recombinant DNA activities is vague
and may conflict with the Hazardous Materials Transportation Act and (2)
the Secretary is given too much discretionary authority, respectively.

[358]

-8-

Mr. McGarity explained that comments of the EPA, transmitted to OMB by
phone, noted two instances in which language recommended by the Committee
had been omitted from the draft: (1) Section 3(c) does not include that

the Secretary "defer" to the appropriate agency after consultation and
(2) Section 12 (Preemption of State and Local Law) does not permit the
drafting of standards which are identical to those instituted by the
Federal government. In addition, Mr. McGarity cited the lack of
provision for public participation and suggested that the exemption from
the provisions of NEPA be deleted from Section 4.

Dr. Lewis explained that the Agriculture Department has not yet formulated
an official position. However, a committee representing the four agencies
of USDA has drafted a letter to the Secretary of Agriculture stating
that: (1) there is an apparent contradiction in the language of Section

16 and Section 17; (2) the USDA needs some relief from Section 3(a)(4)
of the guidelines which prohibits the deliberate release of recombinant
DNA molecules from the laboratory; and (3) the USDA has problems with
the amount of discretionary authority residing with the Secretary of HEW.

Dr. Fredrickson explained that any substantive consnents he receives will
be promptly forwarded to OMB and that the agenda for the next meeting of
the Conmittee would include discussion of the following: (1) international

activities and (2) institutional patent agreements. In regard to the
former issue. Dr. Fredrickson asked all of the representatives to be
prepared to describe the nature of their formal and informal contacts
with research and regulatory bodies in other nations which might be
relevant to the extension of policy concerning recombinant DNA activities.

[359]

-9-

With regard to
to describe to

the latter, he asked that each representative be prepared
the Committee the policy of his agency.

Respectfully submitted,

^Joseph G. Perpich, M.D., J.D.
Associate Director for
Program Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

April 15, 1977

[360]

FEDERAL INTERAGENCY COMMITTEE

Inquiry Into International Activities Regarding
"Recombinant DNA Research

Page

Summary Minutes of Interagency

Committee, 5/6/77 362

Minutes, 5/6/77 366

Summary Minutes, 11/3/77 371

Minutes, 11/3/77 375

Report of the Federal Interagency
Committee on Recombinant DNA

Research: International Activities 381

[361]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Summary Minutes of Meeting
May 6, 1977

National Institutes of Health
Bethesda, Maryland

The seventh meeting of the Interagency Committee took place on May 6
at the National Institutes of Health. The meeting was chaired by

Dr. Donald Fredrickson, Director of the NIH, whose staff briefly reviewed
the current state of Federal legislative proposals concerning recombinant
DNA activities. Senator Kennedy and Representative Rogers have intro-
duced the Administration bill into their respective committees, and it
is expected that both committees will report one bill by the end of. May.

Institutional Patent Agreements

An analysis of the NIH Institutional Patent Agreement (IPA), which had
previously been distributed, was then discussed and each representative
was asked to describe his agency's patent arrangements.

It was learned that NSF has an IPA system similar to that of NIH,
while the DoD negotiates patent agreements on a grant-by-grant basis.

The VA has no extramural research so there is no relevant patent policy.
USDA, ERDA, NSF, and DoD will be forwarding the comments of their
patent experts to Dr. Fredrickson.

Dr. Fredrickson also reported that he sent a memorandum on April 19, 1977,
to HEW Secretary Califano describing the Interagency Committee discussions
concerning the Commerce Department order on the accelerated processing
of patent applications.

[362]

2

International Activities

Dr. Fredrickson opened this discussion by noting that the NIH,

Canada, and the United Kingdom have all published guidelines setting
forth standards for the conduct of recombinant DNA research. The
European Science Foundation (ESF) has urged its member nations to
adopt the U.K. model and several of these nations have done so. In
addition, the European Medical Research Council has voted to accept
the recommendation of the ESF. Holland, however, is relying on the
NIH Guidelines, while the Soviet Union has created its own DNA
Recombinant Guidelines Committee.

There are several initiatives underway to achieve a commonality of
standards. A workshop was held in London in March under the sponsorship
of the NIH and the European Molecular Biology Organization (DfBO) at
which the technical aspects of primary and secondary physical containment
were discussed. The physical containment measures of all three sets of
guidelines were found to be within an appropriate range, but adjustments
need to be made to achieve uniformity. Also in March there was a meeting in
France of representatives of the ESF that convened for the purpose of con-
sidering the harmonization of guidelines throughout Europe.

In addition, the Committee on Genetic Experimentation (COGENE) of the
International Council of Scientific Unions (ICSU), and the World
Health Organization (WHO) are taking an active part in fostering the
discussion of Issues associated with this research.

(363)

3

Dr. Fredrickson then queried the Committee members as to the nature
of their overseas contacts. The USDA and Interior reported that they
maintain formal cooperative programs with the U.S.S.R. while the
international contacts of CDC, NSF, FDA, Commerce, and DoT are not
directly with other governments but either through the State Department
or international organizations such as the WHO.

Mr. William Walsh, the State Department representative, suggested that
the current state of affairs has not yet reached a stage to warrant an
international convention. State would, however, like to develop a
formal statement for recombinant DNA research outlining the procedures
to which foreign submitters of grant and contract proposals must
adhere. It was noted that foreign scientists supported by NIH at
present must adhere to the NIH Guidelines.

To address international recombinant DNA research issues. Dr. Fredrickson
asked the Committee whether it would be appropriate to form a subcommittee
for the purpose of preparing an analysis of international activities to
date with recommendations to the full Committee on appropriate steps for
achieving common safety standards wherever the use of recombinant DNA
techniques take place. There were no objections to the formation of such
a subcommittee, and the following agencies were appointed to serve on it:
NIH, State, ACDA, USDA, DoD, OSTP, CDC, Commerce, and Justice.

[364]

u

In closing the meeting, Dr. Fredrickson stated if there were no other
issues the Committee representatives wished to consider, a report on
international activities may conclude the Committee's business.

Respectfully submitted,

C/. Joseph G. Perpich, M.D., J.D.
Associate Director for
Program Planning and Evaluation

[365]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Minutes of Meeting
May 6, 1977

National Institutes of Health
Bethesda, Maryland

The seventh meeting of the Interagency Committee took place on May 6,
from 9:00 to noon, at the National Institutes of Health. The meeting
was chaired by Dr. Donald Fredrickson, Director of the NIH.

Dr. Fredrickson's staff briefly reviewed the current state of Federal
legislative proposals concerning recombinant DNA activities. Senator
Kennedy introduced the Administration bill on April 1 and subsequent
revisions were dated April 13, 23, and 27. Representative Rogers,
Chairman of Health and the Environment Subcommittee, has introduced the
Administration bill into the House. It is expected both Committees
will report one bill by the end of May.

Institutional Patent Agreements

Also at this meeting. Dr. Fredrickson asked each of the representatives
to brief the Committee regarding the nature of the patent agreements
entered into by the member agencies. An analysis of the NIH Institu-
tional Patent Agreement (IPA) had previously been distributed.

The National Science Foundation representative explained that his agency
currently has about 50 IPA's in force, and there are no plans to treat
recombinant DNA-related inventions differently than others.

[366]

2

The Veterans Administration representative stated that all the research
supported by that agency is intramural; therefore, no patent agreements
have been established.

The Defense Department representative reported that Defense negotiates patent
agreements with each grantee/contractor on a case-by-case basis.

USDA, ERDA, NSF, and DoD have forwarded the NIH analysis to their respec-
tive patent experts for review and will send the comments to Dr. Fredrickson.

Dr. Fredrickson reported that he sent a memorandum on April 1* to
HEW Secretary Callfano describing the Interagency Committee discussions
concerning the Commerce Department order on the accelerated processing of
patent applications.

International Activities

The Committee in its interim report to the Secretary on proposed legislation
noted that its future agenda Included a review of international activities.

Dr. Fredrickson opened the discussion with an NIH update of international
activities. The NIH, Canada, and the United Kingdom have all published
guidelines setting forth standards for the conduct of recombinant DNA research.
The UK has also established a Genetic Manipulation Advisory Group (GMAG) to
Implement the guidelines, and the Health and Safety Commission (comparable
to OSHA in the U.S.) has assumed the enforcement responsibilities. The
European Science Foundation (ESF) representing 45 national research councils
from 18 western European countries has urged its member nations to adopt
this model, and GMAG's have been established in several of these nations. In
addition, the European Medical Research Council has voted to accept the

(367]

3

recommendation of the ESF. Holland, however, is relying on the NIH
Guidelines ; while the Soviet Union has created its own DNA Recombinant
Guidelines Committee.

There are several initiatives underway to achieve a commonality of
standards. Dr. Emmett Barkley, Director of the National Cancer Institute's
Office of Research Safety, described a March workshop held in London
under the sponsorship of the NIH and the European Molecular Biology
Organization (EMBO) . The technical aspects of primary and secondary
physical containment were discussed and agreement was reached on the
appropriate range in which physical containment levels should fall.

All three sets of guidelines are within this range, but adjustments
need to be made to achieve uniformity.

Dr. William Gartland, Director of the NIH Office of Recombinant DNA
Research, described the mandate of the Committee on Genetic Experimenta-
tion (COGENE) of the International Council of Scientific Unions (ICSU) ,
and also the many activities being sponsored by the World Health Organiza-
tion (WHO) to foster the discussion of issues associated with this research.
He also reported on a March meeting in France of representatives of the
various GMAG's convened for the purpose of considering the harmonization
of guidelines throughout Europe. The problem of loss of patent rights
due to disclosure of information to review bodies was also discussed, and
an investigation into this legal problem is in progress.

Dr. Fredrickson then queried the Committee members as to the nature of

their overseas contacts and received the following replies:

(1) NSF - has no formal foreign contacts but interacts informally,
usually through the Agency for International Development (AID) ;

[368]

4

(2) NASA - maintains no formal or informal relationships involving
this research;

(3) DoD - has hospitals and laboratories throughout the world but
has not had significant involvement in this research area
internationally;

(4) CDC - surveys the status of diseases throughout the world but
does so through the WHO;

(5) FDA - has its most formal relationships with Canada and Britain
and then relies mainly on the WHO;

(6) Commerce - works mostly through the State Department except for
matters related to patents;

(7) DoT - works mostly through international organizations rather
than directly with nations;

(8) USDA - has several relationships including the support of research
with U.S. -owned foreign currency, a U.S.-U.S.S.R. group to foster
cooperation in agricultural research, and the review of segments
of the United Nations Environmental Program; and

(9) Interior - has an arrangement with the U.S.S.R. to exchange
scientists and also exchanges scientific information through
the AID.

Dr. Belsel, DoD, described an informal interagency group (State, DoD, and
others) which meets to consider the problem of epidemics throughout the
world.

Mr. William Walsh, the State Department representative, reviewed a letter
sent to Dr. Fredrickson from the State Department on January 2, requesting
Committee review of international activities. Mr. Walsh suggested that
the current state of affairs has not reached a stage to warrant an
international convention. State would like to develop a formal statement
for recombinant DNA research outlining the procedures to which foreign
submitters of grant and contract proposals must adhere. Dr. Gartland
noted that foreign scientists supported by NIH at present must adhere to
the NIH Guidelines.

[369]

5

To address international recombinant DNA research issues, Dr. Fredrickson
asked the Committee whether it would be appropriate to form a subcommittee
for the purpose of preparing an analysis of international activities to
date with recommendations to the full Committee on appropriate steps for
achieving common safety standards wherever the use of recombinant DNA
techniques take place. There were no objections to the formation of such
a subcommittee, and the following agencies were appointed to serve on it:
NIH, State, ACDA, USDA, DoD, OSTP, CDC, Commerce, and Justice.

In closing the meeting. Dr. Fredrickson stated if there were no other
issues the Committee representatives wished to consider, a report on
international activities may conclude the Committee's business.

Respectfully submitted.

Joseph G. Perpich, M.D., J.D.
Associate Director for Program
Planning and Evaluation

[370]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Summary Minutes of Meeting
November 3, 1977
National Institutes of Health
Bethesda, Maryland

This eighth meeting of the Committee was convened at the National
Institutes of Health (NIH) under the chairmanship of Dr. Donald S.
Fredrickson, Director, NIH.

Review of Congressional Activities

In a brief review of Congressional activities since the Committee
meeting of May 6, Dr. Fredrickson noted that a Senate bill was reported
to the Floor, and a House bill was reported to the Interstate and
Foreign Commerce Committee. Although the two bills contain many elements
of the original Administration bill, one difference of special concern to the
Administration is that the Senate bill gives reponsibility for regulation
and the enforcement of standards to an autonomous regulatory commission.

Concerns expressed by the scientific community about these Congressional
bills center on provisions for penalties and Federal preemption of State/
local regulations.

It now appears that no legislation will be passed in this session of
Congress. In the House, a report and bill from the Subcommittee on
Health and the Environment has yet to receive full Committee approval.

And Senator Kennedy has announced that he is now considering a simple
bill that would extend the NIH Guidelines for a year while a special
commission studies and reports to Congress possible legislative
recommendations .

[371]

2

Review of Scientific Activities

Dr. Fredrickson reviewed three events which have served to change the
opinion of many scientists concerning the potential hazards associated
with the use of recombinant DNA technology:

• several scientists have demonstrated that biological containment
measures would prevent bacteria from surviving in a natural
environment if they were to escape from the laboratory;

• evidence presented at the Falmouth Conference indicates

that insertion of recombinant DNA into E. coli K-12 could not
transform the bacteria into a dangerous agent; and

• additional evidence suggests that the recombinations of DNA
produced in the laboratory may be very similar to those that
occur in nature.

The Committee Report on International Activities

After discussion and minor revision, the Committee voted unanimously
to submit the amended report to Secretary for his review and approval.

Proposed Revisions to the 1976 NIH Guidelines for Recombinant DNA Research
Dr. Fredrickson announced that the final Environmental Impact Statement
(EIS) concerning the Guidelines has recently been approved by the
Secretary of HEW, and that a set of proposed revisions to the Guidelines
was published in the Federal Register on September 27 . Comments are

[372]

3

now being received on these revisions, and public hearings are
scheduled for December 15-16. Witnesses will be invited to give oral
presentations, while others will also be heard as time permits. Those
not able to testify may submit written comnents for inclusion in the
record .

Members of the Interagency Committee will be invited to attend the
public hearing, and all relevant briefing documents for the hearing
will be provided to the Committee members.

A copy of the revisions has been sent to all industrial representatives
on record as attending the February 1976 public hearings. The rationale
for the revisions, as developed by the Recombinant Advisory Committee (RAC),
will be widely distributed and available upon request.

Following the analysis of all comments and the transcript of the
hearings. Dr. Fredrickson will consult with the RAC and others prior
to reaching any decisions. The final revisions will be published in
the spring of 1978 along with an EIS if an impact assessment indicates
that such a statement is needed.

OSTP Survey

Dr. Omenn, OSTP, led a discussion of the recent OSTP survey concerning
the perceived need by Federal agencies for legislation to regulate
recombinant DNA activities. Of particular interest to the Committee

[373]

4

was the question of whether the NIH Guidelines could be extended by
the Commerce Department to non-f ederally supported activities.

Dr. Galler, Commerce, replied that a voluntary surveillance program could
be initiated, and he has informally contacted industrial representatives
to explore their concept of what would constitute a satisfactory system.

He added that such a program would be a very complicated one to implement.

Dr. Barth, EPA, stated that compliance on a voluntary basis is laudable
but too often a difficult goal to achieve even with legal enforcement
powers. Mrs. Bastian, CEQ, reinforced this position and stated that, once
safeguards are deemed necessary, voluntary compliance is no longer
adequate. Dr. Galler stated that he was sensitive to Dr. Barth's
position but noted that abuses will exist even with a regulatory
process. Furthermore, many people in the private sector would welcome
legislation to avoid a patchwork of inconsistent State/local statutes.

Future of the Committee

In the absence of legislation, Secretary Califano has asked the Committee
to continue to serve as a forum for the discussion of recombinant DNA
issues .

Respectfully submitted.

■Associate Director for Program
Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

November 10, 1977

[374]

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

Minutes of Meeting
November 3, 1977
National Institutes of Health
Bethesda, Maryland

This eighth meeting of the Committee was convened at the National
Institutes of Health (NIH) under the chairmanship of Dr. Donald S.
Fredrickson, Director, NIH.

Review of Congressional Activities

In a brief review of Congressional activities since the Committee
meeting of May 6, Dr. Fredrickson noted that the Administration bill
was considered in Congressional hearings, and other bills on the
subject were introduced in the Congress. After several redrafts by
the relevant Subcommittees, a Senate bill was reported to the Floor,
and a House bill was reported to the full Committee.

Although the two bills reported out contain many elements of the
original Administration bill, a number of differences concerned the
Administration. For example, the Senate bill would give responsibility
for regulation and the enforcement of standards to an autonomous
regulatory commission. The House provisions placed many of these
responsibilities in HEW but also established an advisory committee
with operating functions. These approaches, especially the Senate
bill, would necessarily involve a greater administrative burden
and further delays and duplication in handling the highly technical
matters involved in standard-setting and monitoring.

(375)

2

Further concerns expressed by the scientific community about this
legislation center on provisions for civil and criminal penalties
and on standards for Federal preemption to ensure uniform standards
and regulations.

It now appears that no legislation will be passed in this session of
Congress. In the House, the Subcommittee report and bill has yet to
receive full Committee approval. In the Senate, Senator Kennedy has
announced that he is considering a simple bill that would merely
extend the NIH Guidelines nationally while a commission would study
the whole matter for a year and report to Congress with legislative
recommendat ions .

The Subcommittee on Science, Technology, and Space (Senate Committee on
Commerce, Science, and Transportation), chaired by Senator Stevenson,
scheduled recombinant DNA Oversight hearings for November 2, 8, and 10;
and Mr. Thornton, chairman of the Subcommittee on Science, Research,
and Technology (House Committee on Science and Technology), has expressed
an interest in holding hearings.

Review of Scientific Activities

Dr. Fredrickson reviewed three events which have served to change the
opinion of many scientists concerning the potential hazards associated
with the use of recombinant DNA technology:

Dr. Roy Curtiss III, Professor of Microbiology at the University
of Alabama School of Medicine in Birmingham, and others have demon-
strated that biological containment measures — methods developed to
weaken bacteria used in the experiments — would prevent these bacteria
from surviving in a natural environment if they were to escape from
the laboratory.

[376]

3

At a scientific conference held this past spring in Falmouth,
Massachusetts, further evidence was given that the insertion of
recombinant DNA into E. coli K-12 (the principal organism used in
these experiments) could not transform the bacteria into a dangerous agent
Dr. Sherwood Gorbach, chairman of the conference, reported there
was substantial scientific consensus on this matter, not only among
the molecular biologists in attendance but also among microbiologists
who work with disease-producing bacteria.

Additional evidence suggests that the recombinations of DNA
produced in the laboratory may be very similar to those that occur
in nature. If further work confirms and extends the evidence presented
by Dr. Stanley N. Cohen, a distinguished molecular biologist at Stanford
University, then the alarm about creating new forms of life may be
put into a new perspective.

The Report of the Committee on International Activities
All members previously received the international activities report
for review. After discussion and minor revision, the Committee voted
unanimously to submit the amended document to Secretary Califano for
his review and approval.

Proposed Revisions to the 1976 NIH Guidelines for Recombinant DNA Research
Dr. Fredrickson announced that the final Environmental Impact Statement
(EIS) concerning the Guidelines has recently been approved by the
Secretary of HEW. He also outlined the following administrative
mechanism that has been established to deal with matters of interpretation
of the Guidelines:

[377]

4

• all such questions are referred initially to the Office of Recombinant
DNA Activities (ORDA) , NIH, under the directorship of Dr. William
Gartland;

• questions that cannot be resolved by ORDA are referred to the
Recombinant DNA Executive Committee under the chairmanship of
Dr. DeWitt Stetten, Deputy Director for Science, NIH;

• questions that cannot be resolved at this level are referred to the
full Recombinant Advisory Committee (RAC), also chaired by Dr.

Stetten; and

• any issues decided by either the Executive Committee or the RAC are
submitted to the Director, NIH, for review and approval.

The RAC also certifies host-vector systems and proposes revisions to the
Guidelines, with the approval of the Director, NIH.

A set of proposed revisions to the Guidelines was published in the
Federal Register on September 27. Comments are now being received, and
public hearings on these revisions are scheduled for December 15-16.
Witnesses will be invited to give oral presentations, while others will
also be heard as time permits. Those not able to testify may submit
written comments for inclusion in the record.

Members of the Interagency Committee will be invited to attend the
public hearing and all relevant briefing documents for the hearing
will be provided to the committee members.

[378]

5

Dr. Caller, Commerce, asked if industry had been informed of the
proposed revisions. Dr. Fredrickson explained that all industrial
representatives on record as attending the February 1976 public
hearings have been sent a copy of the revisions.

Dr. Barth, EPA, and Mrs. Bastian, CEQ, asked whether the rationale
for the revisions, as developed by the RAC at a meeting on October 31,
would be published in the Federal Register. Dr. Fredrickson explained
that such a document will be widely distributed and available upon
request. There are currently no plans, however, to have it published
in the Federal Register .

Following the analysis of all comments and the transcript of the
hearings, Dr. Fredrickson will consult with the RAC and others prior
to reaching any decisions. The final revisions will be published in
the spring of 1978 along with an EIS if an impact assessment Indicates
that such a statement is needed.

OSTP Survey

Dr. Omenn, OSTP, led a discussion of the recent OSTP survey concerning
the perceived need by Federal agencies for legislation to regulate
recombinant DNA activities. Of particular interest to the Committee
was the question of whether the NIH Guidelines could be extended by
the Commerce Department to non-federally supported activities.

Dr. Caller replied that a voluntary surveillance program could be
initiated, and he has informally contacted Industrial representatives
to explore their concept of what would constitute a satisfactory system.

He added that such a program would be a very complicated one to implement.

[379]

6

Dr. Barth stated that compliance on a voluntary basis is laudable
but too often a difficult goal to achieve even with legal enforcement
powers. Mrs. Bastian reinforced this position and stated that, once
safeguards are deemed necessary, voluntary compliance is no longer
adequate. Dr. Galler stated that he was sensitive to Dr. Barth's
position but noted that abuses will exist even with a regulatory
process. Dr. Galler further stated that many people in the private
sector would welcome legislation to avoid a patchwork of inconsistent
State/local statutes.

Future of the Committee

It was originally thought that the submission of the International
activities report would conclude the business of the Committee. In
the absence of legislation, however, Secretary Calif ano has asked
the Committee to continue to serve as a forum for the discussion of
recombinant DNA issues.

Respectfully submitted

Joseph G. Perpicn, M.D., J.D.
'Associate Director for
Program Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

November 10, 1977

[380]

A

REPORT OF THE

FEDERAL INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH
INTERNATIONAL ACTIVITIES

Submitted to the

Secretary of Health, Education, and Welfare

November 1977

(381 ]

REPORT OF THE

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH:
INTERNATIONAL ACTIVITIES
November 1977

Contents

SUMMARY iii

PART A — Committee Analysis and Recommendations 1

I. Introduction 1

II. Subcommittee Review of International Recombinant DNA Activities . 2

III. International Scientific Activities: An Analysis 3

IV. International Health and Safety Activities: An Analysis 7

V. Ethical Implications of Genetic Research 11

VI. Committee Recommendations 13

PART B — Survey of International Activities 16

I. Foreword 16

II. International Activities 16

III. International Organizations 34

IV. International European Organizations: Membership 47

GLOSSARY OF ABBREVIATIONS 49

APPENDICES 50

[382]

Summary

On May 6, 1977, the Federal Interagency Committee on Recombinant
DNA Research met to consider possible means for fostering international
control of the use and production of recombinant DNA molecules. A
Subcommittee on International Issues was created. It met in June and
July 1977 to review international activities in this field with a view
to making recommendations on means for achieving common safety standards.
By way of assistance, NIH staff surveyed all recombinant DNA activities
occurring internationally, and the State Department had the survey
reviewed by U.S. science attaches abroad.

The Subcommittee's analysis is presented. It reveals that scien-
tists throughout the world have played a leading role in bringing the
potential hazards of recombinant DNA research to the attention of
scientists, governments, and international organizations. As a result,
efforts have been made to adopt safety procedures for the conduct of the
research in many countries. The NIH and U.K. guidelines, imposing
similar safeguards, are being used as important models. The United
States has about 300 active projects involving the new technique, and
about half that number are under way in Europe. All are being done under
some form of safety standards.

National and international safety organizations in many countries
have studied the recombinant DNA issue, usually recommending some form
of control. The European Molecular Biology Organization, the Interna-
tional Council of Scientific Unions, and the World Health Organization

iii

[383]

endorse both the NIH and U.K. Guidelines, and the European Science
Foundation endorses the latter. The activities of these and other
organizations are described.

International organizations are also examining the ethical
implications of biological research generally and genetic research
particularly. UNESCO held meetings to this end in 1975 and October
1977, and WHO and the Nobel Foundation will sponsor conferences
in 1978 to examine ethical, social, and legal questions. In the
United States, activities have been undertaken to address similar
ethical concerns. Appropriate government agencies are expected
to study these important issues.

The Federal Interagency Committee recommends that U.S. Government
agencies continue to work closely with national, international, and
regional organizations to promote safeguards and disseminate relevant
information. In the Committee's view, no formal governmental action is
necessary at present to produce international control by means of a
treaty or convention. The Committee emphasizes that the Biological
Weapons Convention prohibits the use of recombinant DNA for biological
warfare .

Results of the survey are presented alphabetically by country.

The nations comprising international organizations are listed. Nine
appendices contain key documents, including the U.K. Guidelines.

iv

[384]

PART A— COMMITTEE ANALYSIS AND RECOMMENDATIONS

I . Introduct ion

In September 1976 a Federal Interagency Committee on Recombinant DNA
Research was created to consider an extension of the "NIH Guidelines for
Research Involving Recombinant DNA Molecules" beyond the NIH to the public
and private sectors. The Committee was convened by the Secretary of
Health, Education, and Welfare (HEW) with the approval of the President.

Dr. Donald S. Fredrickson, Director of the National Institutes of Health
(NIH), serves as chairman at the Secretary's request. (See Appendix I for
Committee membership.)

The Committee met eight times from November 1976 to March 1977.

Details of these meetings, and the recommendations of the Committee for
legislation to govern the conduct of recombinant DNA activities nationally,
are contained in the Committee's Interim Report, released by the Secretary
of HEW on March 16.*

f

After making its recommendations for legislation, the Committee met,
at the request of representatives from the State Department, to consider
possible means for fostering international control of the use and pro-
duction of recombinant DNA molecules. Dr. Fredrickson reported on the
voluntary coordination and cooperation that exist among national and
international scientific bodies to promote uniform safety practices and

♦Copies of the Interim Report may be obtained from the Office of the
Associate DirecLor for Program Planning and Evaluation, National Insti-
tutes of Health, Bethesda, Maryland 20014. (301) 496-3132.

1

[385]

procedures. Further, the representative from the U.S. Arms Control and
Disarmament Agency reported that the State Department considers the Bio-
logical Weapons Convention as prohibiting development, production, or
stockpiling of recombinant DNA molecules for purposes of biological war-
fare. It was agreed, however, that the Committee, prior to concluding its
business, should inquire into the activities in other countries relative to
the use of recombinant DNA techniques and should make recommendations to
the Secretary of HEW regarding Federal measures to promote international
control. Recombinant DNA research has aroused widespread international
debate, and the actions in other countries deserve careful attention when
U.S. policy is being developed for legislation and regulation. (See
Appendix III.)

Accordingly, a Subcommittee on International Issues of the Inter-
agency Committee on Recombinant DNA Research was created for the purpose
of preparing an analysis of international activities to date and recom-
mending means for achieving common safety standards wherever the use of
recombinant DNA techniques takes place. The work of the Subcommittee
and its recommendations are the basis for this Committee report. (See
Appendix II for membership of the Subcommittee.)

II . Subcommittee Review of International Recombinant DNA Activities

Two meetings of the Subcommittee on International Issues were held to
review recombinant DNA research activities outside the United States. To
assist in this review, NIH staff prepared a survey of all recombinant DNA
activities occurring internationally. The State Department subsequently

2

[386]

attaches abroad, and it was revised in

sent the survey to U.S. science
response to comments received. The survey appears as Part B of this

report .

The Subcommittee also received reports from a number of persons who
serve in or work with various international organizations involved in
recombinant DNA research activities. On the basis of an analysis of this
information, the Subcommittee developed several recommendations that were
transmitted to the full Committee for consideration. The analysis and
recommendations follow.

HI. International Scientific Activities: An Analysis
Scientists in the United States and abroad have played a leading role
in bringing the potential hazards of recombinant DNA research to the atten-
tion of scientists, governments, and international organizations. As a
result, safety procedures for the conduct of this research are being
adopted in many countries. Although nations differ in their percep-
tions of the need to adopt safety measures, and of the nature of these
measures, the NIH and U.K. Guidelines are being used as important models.
(See Appendix IV for the "Williams Report," also known as the "U.K. Guide-
lines.") As of the summer of 1977, there were an estimated 150 recombinant
DNA projects under way in Europe, 300 in the United States, and perhaps
20-25 altogether in Canada, Australia, Japan, and the Soviet Union. All
are being conducted under some form of safety practices and procedures.

Details concerning the activities of individual scientific organiza-
tions are given in Part B.

3

[387]

A. National Scientific Organizations

The issue of recombinant DNA research has been studied by national and
international bodies in countries throughout the world. In many cases
some form of control has been recommended, but in no case has a total ban
on the research been advocated. The United Kingdom and Canada have issued
guidelines that differ in detail but are similar conceptually to the NIH
Guidelines.* Other countries are generally following the NIH or U.K.
Guidelines, including Denmark, the Netherlands, the Germany Federal
Republic, Israel, Sweden, and Switzerland. Endorsement of the U.K.

Guidelines has been given by the European Science Foundation (ESF). The
European Molecular Biology Organization (EMBO) endorsed the use of either
the U.K. or NIH Guidelines. The International Council of Scientific
Unions (ICSU) and the World Health Organization (WHO) have urged nations
to adopt the principles embodied in these two sets of guidelines.

As detailed in the international survey, scientific and governmental
activities comparable to those in the United States have been under
way in the United Kingdom since July 1974. A working party established
at that time recommended that recombinant DNA research in the United
Kingdom be permitted to continue under appropriate controls. A followup
working group chaired by Sir Robert Williams issued a report in August
1976 that established guidelines for the conduct of recombinant DNA
research within the United Kingdom.

In Canada, in March 1976, a special committee of the Canadian Medical

*Copies of the Canadian guidelines may be obtained from the Director, Special
Program, Medical Research Council, Ottawa, Canada K1A 0W9 .

4

[388]

Research Council recommended guidelines to govern the handling of recombin-
ant DNA molecules in Council-supported research. The Council adopted these
guidelines in February 1977. Many other nations have also reviewed
recombinant DNA activities to determine the measures necessary for safety.
With the urging of regional and international bodies, however, most have
adopted the NIH or U.K. Guidelines as a basic framework for safety
practices and procedures.

B . Regional Scientific Organizations

The European Molecular Biology Organization, the European Science
Foundation, and the European Medical Research Councils ( EMRC) have been
instrumental in closely coordinating recombinant DNA research activities
in western Europe. All three have worked closely to promote a commonality
of safety practices and procedures to govern recombinant DNA research
activities. With the support of these organizations, scientific technical
committees have been created in the western European countries to serve
as a focus for coordinating and monitoring all recombinant DNA activities
within each country. Many of these bodies function in the manner of
the United Kingdom’s Genetic Manipulation Advisory Group, which is respon-
sible for reviewing all recombinant DNA research to ensure that the
projects conform to appropriate safety standards and practices.

Research is also being conducted in the eastern European countries and
the Soviet Union. They are considering the adoption of safety practices
comparable to those specified in the U.K. or NIH Guidelines. The U.K.
or NIH standards serve as a model to govern recombinant DNA research under

5

[389]

way in Japan and Australia. Other than in Japan, there is little known
activity in Asian, African, or Latin American countries.

C . International Scientific Organizations

International scientific organizations involved in recombinant DNA
activities include ICSU and WHO. The activities of WHO are described under
health and safety efforts (section IV). A description of the activities
of ICSU and its Committee on Genetic Experimentation (COGENE) was presented
to the Interagency Subcommittee by Dr. William J. Whelan, Chairman of COGENE
and Professor and Chairman of Biochemistry at the University of Miami School
of Medicine. (Additional information about COGENE is given in Appendix V.)
COGENE was established in October 1976 and has created three task forces to
study and analyze various aspects of recombinant DNA research. These groups
and their current tasks are as follows:

• A Working Group on Recombinant DNA Guidelines, chaired by Dr . S.

Cohen of the United States, is reviewing extant guidelines to deter-
mine important similarities and differences.

• A Working Group on Training and Education, chaired by Professor K.
Murray of the United Kingdom, is seeking in its efforts the assis-
tance of the United Nations Environmental Program (UNEP) and the
United Nations Educational, Scientific, and Cultural Organization
(UNESCO) .

• A Working Groups on Risk Assessment, chaired by Dr. A. Skalka of the
United States, is drafting a questionnaire surveying all relevant
activities internationally.

6

[390]

COGENE also plans to sponsor, if support is available, an inter-
national conference for industrial representatives to discuss recombinant
DNA activities in the private sector throughout the world.

COGENE has liaison representatives from the major European science
organizations and relevant U.N. organizations, including UNEP, Food
and Agriculture Organization (FAO), UNESCO, and WHO.

IV . International Health and Safety Activities: An Analysis
A . National

A number of nations have initiated activities to foster governmental
monitoring of recombinant DNA research for purposes of safety and
health. In the United States the recommendations for legislation
by the Interagency Committee were designed to allow this significant
research to continue under uniform national safety standards that would
assure the best possible protection for man and the environment from the
effects of potential hazards, the nature of which are as yet unknown.

In the United Kingdom the government's Health and Safety Executive
(HSE) will have the responsibility after October 1978 of ensuring that the
standards of the U.K. Genetic Manipulation Advisory Group (GMAG) are
followed. HSE has authority under the Health and Safety at Work Act to
monitor the workplaces of all facilities. It maintains a force of inspec-
tors for this purpose who have the authority to investigate industrial,
governmental, and university laboratories. Advisory Groups similar to the
U.K. GMAG have also been established in other European countries, and

7

[391]

efforts are under way to identify appropriate governmental bodies to ensure
compliance with safety standards for this research.

B . Regional

The European Medical Research Councils, the European Molecular Biology
Organization, and the European Science Foundation strive to ensure consist-
ency in safety standards to govern this research throughout western Europe.
All have varying degrees of contact with government organizations to enlist
their assistance and to coordinate activities. Under the sponsorship of NIH
and EMBO, a workshop was convened in London in March 1977 to discuss param-
eters of physical containment.* The technical aspects of primary and
secondary physical containment were discussed, and agreement was reached
on the appropriate range in which physical containment provisions should
fall. The report of this meeting indicates that, while adjustments are
still required if these guidelines are to offer uniform physical contain-
ment standards, all three sets are comparable. This effort complements
the work of WHO as described below (section IV-C) .

The European Economic Community (EEC), as discussed in the survey, has
legal authority under certain circumstances to enact policy decisions bind-
ing on its member nations. In this context, EEC has begun to examine scien-
tific activities of member states to ensure that safety measures they
have adopted are uniform and that private industry adheres to the same
standards as the public sector. Meetings have been held, and a directive

*The "Report of the NIH/EMBO Workshop (Parameters of Physical Containment)"
may be obtained from the Office of Research Safety, National Cancer Insti-
tute, Room 2E47, Building 13, National Institutes of Health, 9000 Rockville
Pike, Bethesda, Maryland 20014.

8

[392]

19 currently under consideration which would require each member state
to establish its own administrative mechanism to ensure that all recom-
binant DNA research is subject to national guidelines.

The application of safety standards to the private sector raises policy
questions concerning the international protection of proprietary informa-
tion and patent rights. At a meeting convened in Strasbourg in March
1977 under the auspices of ESF, the problem of disclosure of information
was reviewed as it relates to the operations of the various national com-
mittees of the member countries. The discussion centered on balancing
the need for disclosure of information in research protocols among nations
(in order to implement uniform safety practices) with the need to protect
proprietary information and patent rights. A9 a result, a meeting of
European patent experts was convened in June for the purpose of studying
the complex issues of proprietary rights and patent laws.

Another organization, the World Intellectual Property Organization
(WIPO), has drafted a treaty and regulations pertaining to the interna-
tional recognition of the deposit of microorganisms for purposes of patent
procedures. (See summary of the treaty, Appendix IX.) WIPO is an inde-
pendent organization, funded through grants and contracts from a number
of private and public entities, which has members of various scientific
societies on its board of directors. A final treaty is under negotiation
and would presumably speak to 9ome of the needs that have arisen in
the context of recombinant DNA inventions.

As previously mentioned, COGENE (of the International Council of
Scientific Unions) is seeking financial support to convene a meeting of

9

[393]

international representatives from the private sector to consider the
questions of patents and the commercial use of this technology.

C . International

The World Health Organization has initiated a number of activities to
promote safety practices in recombinant DNA research. In June 1975 the
Advisory Committee on Medical Research (ACMR) of WHO issued a report con-
cluding that recombinant DNA research should continue under appropriate
safeguards. In September 1976, in Geneva, NIH and WHO jointly organized
a conference on the subject of safety practices for the international
transfer of research materials, especially in respect to infectious sub-
stances. As a result of that conference, it was recommended that WHO
establish an Advisory Group for Safety Measures in Microbiology and that
four international working groups be created to initiate and monitor
activities in the following areas: safe transfer of infectious materials,
laboratory safety elements, maximum containment laboratories, and develop-
ment of emergency services.

ACMR accepted these recommendations in June 1977. Dr. K. Bogel cur-
rently heads the Special Programme on Safety Measures in Microbiology;
the four working groups have been created; and NIH is considering support
for this program to develop international biological safety standards.

(See Appendix VI.)

At a meeting in June 1977, a subcommittee of ACMR recommended that WHO
have a role in disseminating information and assisting other scientific
organizations in performing risk-assessment studies relating to recombinant

10

[394]

DNA research. It was further recommended, however, that the technical
analysis of guidelines, the performance of risk-assessment studies, and
other technical activities be left to organizations such as ICSU. These
recommendations were made in light of the close cooperation and coordina-
tion among international scientific, health, and safety organizations.

For March 1978 WHO has also scheduled a symposium entitled "Practical
Applications of Genetic Engineering." This will provide a forum for dis-
cussion of the potential application of benefits from this research,
especially with regard to the lesser-developed countries.

V . Ethical Implications of Genetic Research
In light of the international interests in recombinant DNA research,
international organizations have sponsored a number of conferences to
examine the ethical implications of biological research generally and
genetic research particularly. These include the following:

• UNESCO sponsored a meeting in Bulgaria, in June 1975, to examine
the ethical, legal, and social implications of research advances
in biology, including advances in genetic research;

• UNESCO sponsored a meeting in Madrid, Spain, in October 1977, to
examine the ethical implications of genetic research, including
recombinant DNA;

• WHO will sponsor a meeting in Milan, Italy, in March 1978, to examine
the implications of genetic research for "genetic engineering"; and

• the Nobel Foundation will sponsor a meeting in Stockholm, Sweden, in
August 1978 to examine ethical questions in key science policy areas.

11

[395]

In the United States, activities have been undertaken to address
similar ethical concerns. In both House and Senate hearings on recombinant
DNA research legislation, questions have been raised by Committee members
regarding the long-range ethical implications of this research. Indeed,
in both House and Senate bills, there are provisions calling for studies
concerning the broad social, legal, and ethical aspects of this research.
Further study of these aspects will undoubtedly be initiated by appropriate
government agencies.

Still other questions have been raised concerning the possible use of
this research for biological warfare. With regard to this question, the
use of recombinant DNA for such purposes is prohibited by the Biological
Weapons Convention. In a statement to the conference of the Committee of
Disarmament on August 17, 1976, Ambassador Joseph Martin, Jr., confirmed
the U.S. interpretation of the convention to prohibit this research for
purposes of biological warfare. (See Appendix VII for Ambassador Martin's
discussion. )

It is noteworthy that prior to this statement, Dr. David Baltimore
had requested an opinion from James L. Malone, General Counsel of the U.S.
Arms Control and Disarmament Agency, on whether the Biological Weapons
Convention prohibits production of recombinant DNA molecules for purposes
of constructing biological weapons. On July 3, 1975, Mr. Malone replied:
"In our opinion the answer is in the affirmative. The use of recombinant
DNA molecules for such purposes clearly falls within the scope of the
convention's provisions."

12

[396]

VI. Committee Recommendations

In developing the following recommendations, the Interagency Committee
on Recombinant DNA Research considered the activities to date of national,
regional, and international scientific organizations and governmental health
and safety organizations. Also, a concerted effort was made to obtain the
most comprehensive possible survey of international activities related to
recombinant DNA research. The survey of activities, prepared by NIH staff,
was circulated by the State Department to all U.S. science attaches abroad,
with a request to update the report and to supply any information available
on governmental actions taken to legislate or regulate recombinant DNA
activities. The survey, which appears as Part B, includes all relevant
information received by the State Department.

Professor William J. Whelan, Chairman of the Committee on Genetic
Experimentation of the International Council of Scientific Unions, attended
both meetings of the Subcommittee and briefed it on the actions of his
Committee and of other international scientific organizations. Further, a
number of NIH officials reported on extensive NIH activities of interrelat-
ing U.S. efforts with those of WHO and European organizations such as the
European Molecular Biology Organization, the European Science Foundation,
and the European Medical Research Councils. After review and discussion
of all the information obtained, the following recommendations are made:

• In light of the activities of national, regional, and international
organizations, the Committee recommends that cognizant Federal
agencies continue to work in close cooperation with such organiza-
tions as ESF, EMBO, EMRC, WHO, and ICSU. The Committee takes special

13

[397]

note of the activities of ICSU and recommends that Federal agencies
work with ICSU and support its working groups on recombinant DNA
guidelines, training/education, and risk-assessment.

• The Committee recognizes the special need to ensure wide dissemina-
tion of information on all international recombinant DNA activities.
Hence, the Committee recommends that relevant Federal agencies, such
as NIH, the Department of Agriculture, and the National Science
Foundation, conduct or support information programs to ensure that
international developments in recombinant DNA activities are periodi-
cally and widely reported. It was noted that NIH's Recombinant DNA
Technical Bulletin ( formerly Nucleic Acid Recombinant Scientific
Memoranda) is designed to serve as a useful vehicle in this regard.

• The Committee strongly endorses WHO efforts to achieve uniformity in
safety practices in biological research. Therefore, it recommends
that relevant Federal agencies provide support to WHO and other
international organizations with the capability to develop inter-
national biological safety codes of practice.

• The Committee recognizes the importance of private-sector research
activities and the problems presented in the protection of propri-
etary information and patent rights. The Committee, therefore, urges
relevant Federal agencies, such as the Department of Commerce, to
assist international efforts in seeking a resolution of these issues.
The Committee further believes that the conference proposed by COGENE
for private industry is of key importance and that support for the

14

[398]

conference should be considered by relevant industries within the
United States as well as by companies abroad.

• The Committee notes that a number of international organizations have
held or are planning meetings to examine the social, ethical, and
legal implications of biological research. The Committee urges that
relevant Federal agencies closely monitor international activities
addressing the ethical implications of genetic research (including
techniques employing recombinant DNA) in relation to the broad sub-
ject of "genetic engineering."

• In noting the extensive international cooperation among scientific,
environmental, health, and safety organizations, it is the
Committee's view that no formal governmental action is necessary

at present to produce international control by means of a treaty
or convention. Such activities, in this Committee's view, would
be premature. More international collaboration, especially among
national health and safety organizations, is necessary to determine
whether formal control at the international level is warranted
and feasible. Finally, the Committee emphasizes that use of
recombinant DNA for purposes of biological warfare is prohibited
by the Biological Weapons Convention.

15

[399]

PART B— SURVEY OF INTERNATIONAL ACTIVITIES
Prepared by the National Institutes of Health

I . Foreword

The following document summarizes the relevant worldwide activities
relating to recombinant DNA research. Sources of information included
meetings and conferences at which National Institutes of Health (NIH)
personnel were in attendance, journal articles, personal correspondence
and discussion between NIH staff and their colleagues overseas, documents
published by a number of governmental and scientific organizations, and
information received through the State Department from science attaches
assigned to various United States embassies around the world.

II . International Activities

ARGENTINA

Little, if any, recombinant DNA research appears to be in progress,
in Argentina. The Argentine Biochemical Society has formed a committee
to study the need for guidelines, but there has been no report of
the development of guidelines by either this Society or the government.

Note : The NIH Guidelines for Research Involving Recombinant DNA Molecules
and the Report of the Working Party on the Practice of Genetic Manipulation
(the Williams Report) are referred to throughout Part B as the "U.S.
Guidelines" and the "U.K. Guidelines," respectively. For an explanation
of "physical" and "biological containment" as used in the U.S. Guidelines,
see Appendix VIII.

16

[400]

AUSTRALIA

The Australian Academy of Science, an independent body that receives
government support but neither controls research activities nor disburses
research funds, has formed a committee of which half the members are sci-
entists. This committee, chaired by Dr. Gordon Ada, developed an abbre-
viated set of guidelines in 1976 which are based on the U.S. and U.K.
Guidelines. However, adherence to committee recommendations regarding
appropriate safety procedures is voluntary. The committee has reviewed
approximately 20 recombinant DNA research proposals, all of a low-risk
nature, and negotiations are in progress for the creation of at least
one facility appropriate for the conduct of moderate-risk experiments.

AUSTRIA

The Austrian Research Council has created a working group to advise
it on matters pertaining to recombinant DNA research. The group is
expected to recommend (1) that guidelines be promulgated which are
similar to those of the NIH but with additional emphasis on training,

(2) that responsibility for safety measures rest primarily upon the
investigator and the institution, and (3) that a Standing Committee on
Recombinant DNA Research be established in the Council to register
laboratories, maintain records, advise investigators, and recommend
revisions to the guidelines.

No legislation is envisaged at this time. No recombinant DNA
activities are currently in progress, although two or three projects
are in the planning stages.

17

[401]

BELGIUM

The Belgian Committee on Medical Ethics has a Subcommittee for
Recombinant DNA Research, chaired by Walter Fiers, that is currently con-
sidering the definition of recombinant DNA research and the establishment
of a voluntary register of all laboratories conducting recombinant DNA
experiments in Belgium. The Subcommittee was scheduled to meet again in
September 1977.

BRAZIL

Professor A. Miranda, of the Biophysics Institute of the University
of Rio de Janeiro, reports that a group of Brazilian scientists is study-
ing the preparation of guidelines based upon developments in both the
United States and Europe. Guidelines are to be issued from a committee
of the National Council for Research. Recombinant DNA research is
currently in progress in Professor Miranda's laboratory, and pharmaceuti-
cal companies may soon be initiating activities.

CANADA

After the Asilomar Conference, the Canadian Medical Research Council
(MRC) created an ad hoc committee for the purpose of making recommenda-
tions regarding the safety aspects of recombinant DNA research. The com-
mittee issued a draft report in March 1976, and in February 1977 the
Council published a report entitled Guidelines for the Handling of
Recombinant DNA Molecules and Animal Viruses and Cells that applies to all
research supported by the Council. In addition, the following agencies
have agreed to apply these guidelines to their intramural and extramural

18

[402]

research progtams: Health and Welfare of Canada, the National Research
Council of Canada, the National Cancer Institute of Canada, and the Coun-
cil on Research and Health of Quebec. Means are now being sought for ex-
tending the Guidelines to other sectors.

Although the recombinant DNA sections of the Canadian Guidelines dif
fer in detail from those of the United States and the United Kingdom, the
three documents ate broadly similar. For example, whereas the U.S. Guide
lines describe four levels of physical containment (as do the U.K.) and
three of biological containment, the Canadian Guidelines provide for six
and three levels, respectively. (See Appendix VIII.)

The Canadian Guidelines specifically discuss three levels of respon-
sibility for ensuring the implementation of the safety procedures
involved. The major responsibility is seen as resting on the principal
investigator. Although the duties of this individual are not identified
in detail, it is stated that his responsibility for ensuring the safety
of the laboratory extends beyond mere compliance with the Guidelines.

Responsibility for monitoring both the facilities and the procedures
on a continuous basis is assigned to the research institution. Each
institution is advised to establish a biohazards committee to ensure
that (1) the staff is knowledgeable of the Guidelines and properly
trained so as to be able to adhere to them, (2) the physical facilities
and laboratory procedures comply with the assigned safety precautions,
and (3) up-to-date information concerning the nature of the biohazards
is available.

The third level of responsibility rests with the MRC. The Guide-

19

[403]

lines recommend that this body determine the containment level required
for the research being performed, assist the biohazards committees to
function as effectively as possible, monitor the Guidelines in terms of
making revisions, monitor the biohazards committees, certify host-vector
systems, and review all reports of ill health that might possibly be due
to this work.

To perform these duties, a Biohazards Committee of the Council has
been formed, consisting of a lay chairperson, four additional lay per-
sons, and four scientists. This Committee set as its first priority the
modification of the Guidelines through the elimination of inconsistencies
and the provision of additional information where needed. Several such
modifications were accepted by the MRC in September 1977.

In addition, the Committee has created a Subcommittee on Performance
Standards for the purpose of establishing design criteria for equipment
and laboratories involved in research presenting a potential biological
hazard .

The Council holds itself responsible for providing equipment needed
to comply with the Guidelines and, to this end, has recently been ac-
cepting applications for such funding.

Legislation to govern recombinant DNA activities is being consid-
ered by an interdepartmental committee led by the Ministry of State for
Science and Technology, and a document will soon be submitted to the
Cabinet recommending mechanisms expected to parallel those in place in
the United Kingdom.

20

[404]

DENMARK

Two committees are actively involved in dealing with the issues
raised by recombinant DNA technology in Denmark:

• The Advisory Board for Recombinant DNA Research. Headed by
Kjeld Marcker and composed solely of experts in the field, the
Board has been established by the country's research council for
the purpose of examining the work being done and deciding if a
special research program should be instituted.

• An ad hoc committee for registration of research in genetic infor-
mation. Chaired by Dr. Bent Harvald, this Committee was estab-
lished at the end of 1976 for the purpose of examining the safety
aspects of recombinant DNA research and devising rules for its
conduct in Denmark. It is composed of representatives from re-
search councils and industry and would oversee the implementation
of any Danish regulations or directives from the European Economic
Community .

There are currently four statutes in force which may possibly be
applicable to the registration and supervision of this research. These
are in the areas of the environment, epidemics, radioactive materials,
and infectious materials.

As of October 1977, work with plasmids was being done, but recombinant
DNA techniques had not yet been used.

FRANCE

The Delegation Gene'rale a la Recherche Scientifique et Technique,

21

[405]

which is responsible for coordinating the activities of the French
Research Councils, created two national groups in June 1975 to study
recombinant DNA issues:

• The Ethical Review Group. This is chaired by Professor Jean
Bernard and has been given the responsibility of investigating
the philosophical, legal, moral, and ethical issues involved in
this research.

• The Control Commission. This is chaired by Professor J.F. Miguel
and is composed of experts in the field, a medical epidemiologist,
and trade union representatives. It has been meeting monthly for
the purpose of reviewing recombinant DNA research proposals and
recommending appropriate safety procedures. Approximately 50
proposals have been reviewed, with fewer than 10 requiring phys-
ical containment above a low level.

The Commission has also assumed the duties of a central administra-
tive agency concerned with safety aspects of recombinant DNA technology.
First, it has drafted a declaration of agreement under which governmental,
academic, military, and industrial laboratories would submit recombinant
DNA projects to the Commission for review while still in the planning
stages. All of the research funding organizations of the French Govern-
ment have agreed to adhere to this procedure, and the pharmaceutical in-
dustry has agreed to cooperate voluntarily with the Commission. Indus-
trial projects will be reviewed by one or two members of the Commission
who will report orally to the full Commission.

22

[406]

Second, the Commission is establishing a national registry based
upon a questionnaire that has been distributed. Both the pharmaceutical
industry and the military have agreed to join the registry when recombi-
nant DNA activities are planned.

Finally, the Commission issued a draft document, French Guidelines
on Recombinant DNA Exper iment s , dated June 1977 . After first using
the Asilomar recommendations and then the U.S. Guidelines, the French
have now adopted their own guidelines, which draw upon those of the
United Kingdom and the United States.

GERMAN FEDERAL REPUBLIC

Following the Asilomar Conference, the Deutsche For schungsgemein-
schaft established a Senate Commission for Safety Questions Posed by New
Gene Combinations for the purpose of establishing guidelines, advising on
the construction of containment laboratories, and advising on possible
legal actions and international cooperation. This Commission comprises
biologists and representatives of several ministries, is chaired by Pro-
fessor H. Brewer, and works in close cooperation with German industry
and the government.

The Ministry of Research and Technology has recently issued draft
guidelines written with "due regard" to the U.S. and U.K. Guidelines.

The draft is designed to serve as an initial discussion paper for the
preparation of recombinant DNA guidelines. In the meantime, any institu-
tion receiving funds for this research is required to adhere to the
provisions of the U.S. Guidelines.

23

[407]

There are approximately 16 recombinant DNA laboratories in Germany,
none known to be in the industrial sector. The first maximum-containment
laboratory is being constructed in Heidelberg under the auspices of
the European Molecular Biology Organization (EMBO).

INDIA

Some microbiological work involving recombinant DNA techniques is
in progress in at least two universities (Bangalore and Madura), and pro-
jects are in the discussion stage at the All-India Medical Institute in
New Delhi. No national committee has yet been established.

IRAN

Recombinant DNA research is currently in progress at the Inter-
national Institute of Biophysics and Biochemistry of Tehran University
under the guidance of Dr. Chamsodin Mofidi. Information concerning the
nature of these activities and the safety standards employed is not
yet available.

IRELAND

A Committee on Recombinant DNA Research, chaired by L. K. Dunican,
has been created by the Medical Research Council to consider the issues
raised by recombinant DNA technology.

ISRAEL

A Committee of the Academy of Science and Humanities, chaired by
Professor Leo Sachs and composed of representatives from the government,
universities, research centers, and the National Council for Research and

24

[408]

Development, has recommended the creation of a national safety committee
for recombinant DNA research and of special committees at universities
and research centers. These special committees would recommend safety
precautions for each research proposal, but the national safety committee
would have the final decision. The intention is to follow the U.S.
Guidelines in general and also to take into account other recommenda-
tions, especially those of EMBO.

Some experimentation is currently in progress, but none requires
facilities for containment above a low level. A moderate-level contain-
ment facility is expected to be completed this autumn in Rehovoth, but no
maximum-containment laboratories are planned. Any experiments requiring
this highest degree of physical containment are expected to be carried
out in the European Molecular Biology Laboratory in Heidelberg.

ITALY

A committee of the Italian Society of Molecular Biology, chaired by
Professor E. Calef, was created in 1976 with the charge of preparing a
report for submission to the Italian government. At a meeting of the
Society in April 1977, motions were drafted requesting the Minister of
Health to establish a committee to register and manage the safety aspects
of recombinant DNA experiments. A national committee has recently been
established and is expected to meet in the near future.

At a recent public seminar, it was the consensus of the Society
that recombinant DNA research should be encouraged with appropriate
safeguards, including the training of personnel.

25

[409]

The Italian National Institute of Health has prepared a draft docu-
ment detailing the functions of such a committee, but it has not yet been
approved, in part as a result of uncertainty whether the Minister of
Health or the Minister of Scientific Research should have the responsi-
bility for such an initiative.

Meanwhile, no experimentation is being conducted that would require
containment measures beyond the minimum level, and for the present, the
rules of safety generally applied in Italy under standard laboratory
regulations are considered to be applicable.

JAPAN

In 1975 the Committee on Plasmid Research, chaired by Dr. Y. Tajima
and composed entirely of biological scientists, was created in the Science
Council of Japan under the jurisdiction of the National Committee of
Biological Sciences. The Committee formed a Working Group on the Problems
of Recombinant DNA, chaired by Dr. T. lino, which submitted in January
1977 an interim report entitled General Principles for Recombinant
DNA Research in Japan . The report, which was approved by the Committee
and forwarded to the Council, recommends that:

• a set of proposed safety standards (which consists of items from
the U.S. and U.K. Guidelines) be adopted;

• a Steering Committee for Gene Manipulation, composed of research-
ers in the field, be created under supervision of the Council for
the purpose of collecting information, revising the guidelines,
and providing advice concerning their application;

26

[410]

• all recombinant DNA activities be registered with the Steering
Committee while in the planning stages so that the safety aspects
of the activity can be evaluated before its inititiation;

• no government agency or foundation support a recombinant DNA
activity until the Steering Committee has ruled on the safety of
the proposal;

• the government subsidize laboratory safety equipment;

• the government establish an educational system, including overseas
training in the safety techniques of genetic experimentation;

• the government construct a national laboratory to conduct experi-
ments at moderate and maximum physical containment levels (no
such facility currently exists in Japan); and

• a specific council, composed of experts in the field and nonexpert
intellectuals, be created in the Science Council for the purpose
of advising the Steering Committee.

The Science Council has acted upon at least one of the Subcommit-
tee's recommendations and has created a Special Committee on Science
and Society to study the impact of research activities on man and
society from a broad point of view. The first meeting, convened
on June 10, focused on genetic engineering. It was decided to appoint
an interdisciplinary subcommittee to study all the problems involved
in recombinant DNA research.

In addition, an interagency study group composed of representatives
from eight government ministries has been established. The group will

27

[All]

focus initially on the state of recombinant DNA activities in Japan and
then review these activities internationally. The ultimate objective
is to prepare legally binding guidelines on recombinant DNA research
and development. Since research at academic institutions will be
controlled by the guidelines formulated by the Science Council, the
activities of this interagency group will be devoted to extension of
the guidelines to the industrial sector.

No experiments taking place in Japan require more than a low level
of containment. The most advanced work is being conducted by Dr. Matsu-
bara at the Osaka University Medical School . One pharmaceutical firm
(the Kyohako Company) has also been identified as conducting very
preliminary recombinant DNA studies.

MEXICO

Preliminary reports suggest that modest recombinant DNA research
programs are being developed in several medical institutions. The
Mexican Society of Biochemistry has formed a Commmittee on the Study
of Recombinant Molecules to ensure that activities proceed under
appropriate conditions of physical and biological containment. No
government policy has been established, but it is expected that Mexican
scientists, many of whom have been trained in the United States, will
rely upon the U.S. Guidelines.

NETHERLANDS

In January 1976 the Royal Netherlands Academy of Arts and Sciences
created a committee, under the chairmanship of Dr. D. Bottsma, for the

28

[412]

purpose of surveying all recombinant DNA research being conducted in
Holland, advising laboratories on safety procedures, and advising the
government on appropriate control measures to be implemented. The Report
of the Committee in Charge of the Control on Genet ics , dated March 1977,
recommends that:

• the ESF recommendation for the use of the U.K. Guidelines be
adopted, but that certain elements of the U.S. Guidelines be
included as well;

• another committee be appointed to consider the ethical and social
issues involved and to determine the necessity for developing
legislation to control other forms of biological research;

• at least one laboratory be constructed that meets the specifica-
tions for moderate containment (level III) of the U.K. Guidelines;

• any experiments requiring maximum-level containment be conducted
outside the country in an intra-European laboratory; and

• a Supervisory Commission composed of scientists, government
officials, and representatives of society be created for the
purpose of registering all recombinant DNA experiments, issuing
certificates stating the conditions under which the activity may
proceed, monitoring compliance with these conditions, and imposing
sanctions against violators.

The survey indicated that, in the universities, one recombinant DNA
project was in progress and eight others were in the planning stages as
of December 31, 1976. In industry, one project was expected to begin in

29

[413]

1977. No project requires other than a low physical-containment level.
NEW ZEALAND

A National committee to consider the issues raised by recombinant
DNA research has been established.

NORWAY

A committee of the Norwegian Research Council for Science and the
Humanities has met twice to examine the legal aspects of control over
recombinant DNA research. A questionnaire has revealed that six insti-
tutions hope to start experiments in the next two years. As of this
date, however, the government has received no requests for the support
of such projects.

PORTUGAL

The establishment of a national committee under the chairmanship
of Dr. L.P. Archer is planned for 1978. No research is in progress.

SWEDEN

An ad hoc committee of the Royal Swedish Academy of Sciences was
replaced in the winter of 1976 by an eleven-member Committee Concerning
Research with Recombinant DNA. This Committee was established for the
purpose of assisting granting agencies in determining appropriate safety
conditions for funded research and for advising researchers regarding
safety. It includes representatives from the lay public, research
councils, Ministry of Health, industry, and the scientific community.
Professor Peter Reichard is chairman.

30

[414]

The Committee plans to use the U.K. Guidelines in determining safety
procedures. It has recommended that local safety committees be respon-
sible for supervising safety procedures and that all recombinant DNA
experiments be reported to the Committee and the Swedish central public
health authority. The Department of Education is considering whether
existing statutes would suffice to ensure compliance with these
recommendations .

As of March 1977 one group was actively involved in recombinant DNA
work and six others were planning projects, pending laboratory modifica-
tion to come up to the necessary physical containment levels.

SWITZERLAND

In the summer of 1975 the Swiss Academy of Medical Sciences created
a standing Commission on Experimental Genetics for the purpose of
studying the safety of recombinant DNA work, recommending guidelines,
establishing channels of communication, and monitoring developments both
nationally and internationally. This Commission, chaired by Professor
Werner Arber, is composed entirely of experts from government, industry,
and academia.

The Commission has recommended that Swiss researchers follow the
U.S. Guidelines, that registration be voluntary, and that disputes con-
cerning the classification of a project be submitted to the Standing
Advisory Committee on Recombinant DNA of the European Molecular Biology
Organization. It is the Commission's position that the primary responsi-
bility for safety rests with the individual researcher. Although industry

31

[415]

is reportedly not yet involved, recombinant DNA research is being con-
ducted in Switzerland. Forms to register such research have been
distributed, and Professor Arber has reported that this voluntary system
is working well .

UNITED KINGDOM

In January 1975 a working party, established by the Advisory Board
of the Research Councils and chaired by Lord Ashby, then Master of Clare
College, Cambridge, released a report recommending that recombinant DNA
research in the United Kingdom be permitted to continue under appropriate
controls. A followup working group under Sir Robert Williams was then
appointed to consider the implementation of the recommendations of the
Ashby Committee and the practical aspects of this research, including
the drafting of a code of practice establishing a central advisory
service for recombinant DNA laboratories, providing training facilities,
and establishing controls.

The Report of the Working Party on the Practice of Genetic Manipula-
tion, also known as the Williams Report or the U.K. Guidelines, was
released in August 1976 (Appendix IV). It divides experiments into
four categories according to the potential hazard represented. Each
category contains a list of safety procedures designed to provide
physical containment. In addition, the report calls for the establish-
ment of a U.K. Genetic Manipulation Advisory Group (U.K. GMAG) for
the purpose of advising and training researchers, and the appointment
of biological safety officers in all laboratories.

32

[416]

The U.K. Guidelines require that researchers submit the details of
their experiments to the U.K. GMAG for the assignment of a containment
level. The GMAG, chaired by Sir Gordon Wolstenholme , is supported
by the U.K. Medical Research Council and is responsible to the Secretary
of State for Education and Science. It includes 19 representatives
from industry, labor, the informed public, and the scientific community,
and meets monthly to review proposals.

Details of experiments must also be submitted to the Health and
Safety Executive (HSE), for which the GMAG is the source of technical
advice. HSE has authority under the Health and Safety at Work Act to
monitor the workplace of all facilities. It maintains a force of inspec-
tors with the authority to investigate industrial, governmental, and
university laboratories.

In August 1976 HSE circulated a draft consultative document contain-
ing regulations directed specifically to the control of experiments
involving genetic manipulation. The document includes a provision that
would require prior approval of the GMAG and mandatory compliance with
the physical-containment level recommended by the GMAG. This responsi-
bility of the HSE will be activated in October 1978.

As of September 1977, the U.K. GMAG had reviewed more than 100
applications. None in progress has yet required maximum containment.

UNION OF SOVIET SOCIALIST REPUBLICS

Little information is available, but a Committee on Recombinant DNA
Molecules, chaired by Professor Bayev, has drafted a set of guidelines.

33

[417]

The U.K. and U.S. Guidelines have been taken into account.

YUGOSLAVIA

In November 1976 a group of scientists in Yugoslavia formed a
private group for the discussion of recombinant DNA research in that
country. Since then a national committee has also been established.

Three of the six republics of Yugoslavia have facilities for recombinant
DNA research, and work is expected to begin soon. (Each republic has a
science council, in addition to a national council.) A register of these
activities will be maintained, and the health and safety-at-work stat-
utes are expected to provide the basis for any regulations and safety
guidance .

FINLAND, GREECE, NIGERIA, AND SPAIN

As of this time, no recombinant DNA research is being conducted,
none is being planned, and no scientific or national commissions have
been established to investigate the new technology in these countries.

Ill . International Organizations

EUROPEAN ECONOMIC COMMUNITY (EEC)

EEC was established in May 1955 by the Treaty of Rome for the
purpose of reducing barriers to commerce and improving scientific
cooperation and political integration among the member nations. The

34

[418]

European Commission of EEC initiates and implements EEC legislation
and has the following legal instruments available for the enactment
of policy decisions:

• regulations — are binding on all the member states and have the
same strength as national laws;

• directives — are binding on all the member states but allow them
to choose the means of execution;

• decisions — are only binding upon the parties named (may be
addressed to individuals, organizations, or governments); and

• recommendations and opinions — are not binding.

The Commission has stated that it does not intend to duplicate the
activities of other international organizations in this area, but
emphasizes that it has the responsibility of ensuring (1) that the
safety measures adopted by member states are harmonized and (2) that
private industry adheres to the same standards as the public sector.

The Commission is being assisted by the Advisory Committee for Medical
Research .

To these ends, the Commission convened a meeting of national GMAG
representatives in Brussels, in January 1977, for informal discussions
on recombinant DNA research. A subgroup of the Commission met in Febru-
ary and again in June. An EEC directive is under consideration which
would require that genetic manipulation activities be registered with
and approved by the appropriate national commission. (The precise
definition of "genetic manipulation" is under consideration.)

35

[419 ]

EUROPEAN MEDICAL RESEARCH COUNCILS ( EMRC)

EMRC is an association of representatives of national medical
research councils (or their equivalent) that was created in May 1971 for
the purpose of fostering collaboration in medical research among member
organizations. Important functions of EMRC include exchanging informa-
tion, providing advice, and stimulating cooperative research projects.

At a meeting convened in March 1977 in Berne, EMRC concluded that:

• uniformity of safety standards and monitoring of recombinant
DNA activities was desirable among member countries;

• EMRC should be involved in assisting harmonization of standards
and procedures;

• steps should be taken to register all recombinant DNA activities
in Europe, but with flexibility to permit adaptation to the
rapidly changing developments in this field; and

• given the range of activities being undertaken by other inter-
national organizations, EMRC will limit its role to suggesting
changes in the proposals of the European Science Foundation

( ESF ) .

To carry out this role, the following were appointed to represent
EMRC in the deliberations of the European Liaison Committee for Recombin-
ant DNA Research of ESF: Dr. S. Owen of the United Kingdom, Professor B.
Gustafsson of Sweden, and Professor E. Weibel of Switzerland.

In addition, progress reports were received from national represent-
atives at the September 1977 meeting in Copenhagen, and an overall

36

[420]

review of the topic is scheduled for the September 1978 meeting to
be held in London.

EUROPEAN MOLECULAR BIOLOGY ORGANIZATION (EMBO)

EMBO is a private organization of more than 300 molecular biologists
founded in 1964 for the purpose of (1) promoting collaboration in the
field of molecular biology, (2) creating a molecular biology laboratory
to be shared by its members, and (3) establishing fellowships to support
training and research. Professor Michael Sela is the chairman, and
headquarters are maintained in Heidelberg. Funds for the support of EMBO
were provided by the Volkswagen Foundation until 1970, when the European
Molecular Biology Conference was created. This is an intergovernmental
organization comprising 17 member nations which meets annually and
provides funding for EMBO.

EMBO was one of the first international European organizations to
become involved in the issues surrounding recombinant DNA research. In
January 1976 an ad hoc Advisory Committee on Recombinant DNA became a
Standing Advisory Committee under the chairmanship of Charles Weissman.
This Standing Committee is composed entirely of experts in the field and
is designed to (1) advise (on request) governments, research councils,
national committees, institutes, and individual scientists on scientific
and technical matters concerning recombinant DNA research; (2) explore
the possibility of instituting training programs; and (3) maintain close
liaison with ESF and other governmental and nongovernmental organiza-
tions concerned with recombinant DNA activities. It has no regulatory

37

[421]

or legislative functions and is concerned only with questions of science
and technology.

At a meeting in London in September 1976, the Committee issued the
following recommendations:

• that national advisory groups be established to specify contain-
ment measures for all experiments;

• that experiments forbidden under the U.S. Guidelines not be
conducted; and

• that either the U.S. or U.K. Guidelines be consulted for standards
to govern the conduct of the research.

In London, in March 1977, representatives from seven nations partic-
ipated in a workshop cosponsored by NIH and EMBO entitled "Parameters of
Physical Containment," the purpose of which was to define the elements
of physical containment for the safe handling of potentially hazardous
biological materials.* Attention was focused upon the technical aspects
of primary and secondary physical containment, and agreement was reached
on the appropriate range in which physical-containment levels should
fall. Further meetings are planned for work on standardization of
physical-containment procedures for all guidelines.

EMBO has also sponsored 3-week courses to train European researchers
in recombinant DNA methods. These were conducted in Basel (1976) and
Paris (1977), and a third is scheduled for the summer of 1978 in Basel.

A laboratory for recombinant DNA research, which will satisfy the

*See footnote, page 8.

38

[422]

most stringent physical-containment requirements of both the U.K. and
U.S. Guidelines, is being constructed at the European Molecular Biology
Laboratory (EMBL) in Heidelberg. EMBL, created in 1974, is under the
direction of Sir John Kendrew and is supported by nine western European
nations and Israel. The additional facility is scheduled for completion
by the end of 1977.

EUROPEAN SCIENCE FOUNDATION (ESF)

ESF is a nongovernmental organization founded in November 1974 for
the purpose of facilitating cooperation in basic research, assisting the
free flow of information and ideas, promoting the harmonization of
research efforts, facilitating cooperation in the use of existing facili-
ties, providing specialized services, and assessing and conducting
research projects of major importance. It includes 45 national research
councils from 16 European nations and maintains its headquarters in
Strasbourg. Sir Brian Flowers serves as president and Dr. Friedreich
Schneider as secretary general of the governing board. ESF maintains
extensive international contacts and is an important vehicle for facil-
itating cooperation among the European community of science.

In April 1975 ESF established an ad hoc Working Group on Genetic
Manipulation composed of biologists, physicists, and lawyers. Its
purpose was to (1) survey recombinant DNA literature and initiatives in
Europe, (2) study the scientific, social, legal, and philosophical
implications of this research, and (3) recommend action to be taken at
the European level concerning the responsibilities of scientists and the

39

[423]

regulations needed to minimize risks. The final report of the Working
Group was submitted to the Executive Council of ESF in October 1976 and
contained the following proposals:

• that the U.K. Guidelines be adopted as the guiding principles for
recombinant DNA research because of the greater degree of physical
containment and flexibility offered;

• that adherence to the Guidelines be voluntary and supervision a
national responsibility; and

• that a standing committee be established for the continued delib-
eration of recombinant DNA issues.

In response to the latter recommendation, the European Liaison Com-
mittee for Recombinant DNA Research was created under the chairmanship of
Professor Povl Riis. The objective of this Committee is to meet the
needs of governments and the law on the one hand and of the scientific
community on the other concerning the matter of safety procedures. The
problem of disclosure of information was reviewed at a meeting in
Strasbourg in March 1977, with representatives of EEC, EMBO , and NIH in
attendance. Discussion centered on how to balance the need for disclo-
sure of information in research protocols among nations (in order to
implement uniform safety practices) with the need to protect proprietary
and patent rights.

In an effort to obtain more expert advice on this complex issue, the
newly created Working Group on Legislation and Recombinant DNA Research
met in London on June 22 under the chairmanship of Professor H. Hart.

The Group concluded that it should be possible to devise a system in
which the potential risk of an experiment could be determined without
requiring an amount of information that would prejudice either the
patentability of a project or the academic advantage of the researcher
should the details be disclosed. Thus the information disclosure
requirements should be restricted to those aspects of the research
strictly necessary for the required safety evaluation. Furthermore,
basic safety information could also be submitted to an international
body such as the Liaison Committee.

The Working Group also discussed a number of possible elements of
legislation for the hypothetical case of a country that wanted to con-
sider introducing legislation. These elements included registration,
licensure, inspection, and record-keeping. The minutes of the delibera-
tions of the Working Group and the Liaison Committee will be reported
to the Executive Council.

INTERNATIONAL COUNCIL OF SCIENTIFIC UNIONS ( ICSU)

ICSU was created in 1931 as the successor to the International
Research Council, with the principal objective of encouraging interna-
tional scientific activity by initiating, designing, and coordinating
international research projects. Sir John Kendrew is the current Secre-
tary General. The Council acts as a focus for the exchange of ideas and
information and the development of standards in methodology, nomencla-
ture, etc. It has a role of potentially great importance as a vehicle
for involving east European and Third World nations, as well as the

41

[425]

Union of Soviet Socialist Republics, in discussions concerning recombin-
ant DNA research.

ICSU is a nongovernmental scientific organization composed of 18
international scientific unions (each representing individual scientific
disciplines) and more then 60 national research councils, academies of
science, or similar national scientific institutions. This dual member-
ship, unique to ICSU, is organized into the following structure:

• the General Assembly — consists of representatives of both the
national bodies and the scientific unions, meets biannually,
and is the policy-making arm of the Council;

• the General Committee — includes representatives of both of
the membership components, meets annually to review scientific
activities and to set priorities on science affairs;

• the Executive Board — consists of 10 persons, including the
officers of ICSU, and directs affairs between Council sessions;

• the Secretariat — located in Paris, assists in the administration
of ICSU; and

• committees and commissions — created to coordinate activities
in a research area that does not fall completely under the
aegis of a single scientific union.

Funding is received from dues paid by the unions, national members,
cooperating organizations (such as UNESCO), and from intergovernmental
organizations supporting targeted projects.

In response to a recommendation of an ad hoc committee, ICSU created

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[426]

the Committee on Genetic Experimentation (COGENE) in October 1976 under
the chairmanship of Professor William J. Whelan. COGENE is an interna-
tional, nongovernmental scientific committee with the following
objectives :

• advising governmental and nongovernmental bodies;

• assembling, reviewing, and making available information on safe-
guards, containment facilities, and other technical matters;

• fostering opportunities for the training and international
exchange of workers in the field;

• serving as a medium through which the many regional, national, and
international bodies with interests in recombinant DNA research
may communicate; and

• promoting the harmonization of guidelines throughout the world.

Some of the potential activities of COGENE include (1) the con-
ducting of risk-assessment experiments, (2) the examination of the large-
scale use of this technology by industry, (3) the supporting of lectures
and training courses on safety techniques, and (4) the investigation of
the possibility of providing ICSU support for a facility to construct
and maintain large cultures of cloned DNA fragments.

COGENE comprises 14 members representing 8 nations, including the
United States, United Kingdom, Union of Soviet Socialist Republics,
France, Japan, India, Switzerland, and the German Federal Republic. In
addition, four intergovernmental organizations have appointed observers —
WHO, UNESCO, UNEP, and FAO .

43

[427]

The first meeting of COGENE was held in Paris in May 1977. It was
decided that recombinant DNA would be the issue receiving first priority
Accordingly, working groups on recombinant DNA guidelines (S. Cohen,
Chairman), risk-assessment (A. Skalka, Chairwoman), and training and
education (K. Murray, Chairman) were established to study, analyze,
and report on their respective topics. Questionnaires distributed
by Dr. Cohen's group indicate that 16 nations* have so far developed
guidelines. In addition, Dr. Skalka is awaiting the return of question-
naires designed to determine the level of effort aimed at assessing
the risks of recombinant DNA activities.

UNITED NATIONS ORGANIZATIONS

Two organizational entities within the U.N. have shown an interest
in the issues associated with recombinant DNA technology.

UNEP has been concerned primarily with the possibilities of nitro-
gen fixation through the use of these techniques and with the problems
surrounding the potential release of recombinant DNA molecules into the
environment .

UNESCO has centered its attention on the ethical aspects of this
research. A conference entitled "Science in the Contemporary World: The
Human Implications of Scientific Advances" was held in Bulgaria in 1975,
and a symposium "Genetics and Ethics" was held in October 1977 in Madrid
Topics discussed at the latter included the benefits of genetic studies,

*Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Israel,
Italy, Japan, Norway, Sweden, Switzerland, the Netherlands, the United
Kingdom, and the United States.

44

[428]

the physical unity of physiology and genetics, and the ethics of research
in genetics. In addition, UNESCO renders financial support for training
courses in cell biology.

WORLD HEALTH ORGANIZATION (WHO)

In June 1975 the Advisory Committee on Medical Research (ACMR)
issued a report concluding that recombinant DNA research should continue.
In June 1977 a subcommittee to ACMR recommended that WHO should have a
role in disseminating information and assisting other science organiza-
tions in performing risk-assessment studies relating to recombinant DNA
research. It was specifically recommended, however, that the formulation
of guidelines and the performance of risk-assessment studies be conducted
by the scientific organizations.

The ACMR endorsed the broad outlines of these statements and, in a
report to the Director-General, (1) reaffirmed the WHO global responsi-
bility for safety measures in microbiology (of which recombinant DNA re-
search is a part) and (2) stated that the public health aspects of
recombinant DNA research, rather than technical guidelines, should be
WHO's chief concern.

In Geneva, in September 1976, NIH and WHO jointly organized a con-
ference entitled "Facilitation and Safety in the International Transfer
of Research Materials." In addition to defining the responsibilities of
the sender, carrier, and receiver of infectious substances, the partici-
pants turned their attention to discussions on the safety of micro-
biological practices.

45

[429]

It was recommended that WHO initiate discussions with other inter-
national organizations concerning the scientific, ethical, and political
aspects of genetic engineering and that technical cooperation in this
field also be developed. It was further recommended that WHO establish
an Advisory Group for Safety Measures in Microbiology and that four
international working groups be created to initiate and monitor activi-
ties in the following areas: safe transfer of infectious material,
laboratory safety elements, maximum-containment laboratories, and
development of emergency services. In June 1977 the WHO Advisory Board
on Medical Research accepted these recommendations. Dr. K. Bogel cur-
rently heads the Special Programme on Safety Measures in Microbiology.

WHO is also initiating ethical studies by sponsoring, in Milan in
March 1978, an international symposium entitled "Genetic Engineering:
Scientific Developments and Practical Applications." Topics of dis-
cussion will include: (1) developments and trends in genetic engineering;
(2) basic technological issues, such as the modification and improvement
of microorganisms, the preparation of suitable vectors and hosts, and
modern approaches to gene control; (3) practical applications of re-
search, especially as related to immunology, pharmacology, agriculture,
industry, and developing countries; and (4) international cooperation,
including the diffusion of information, a code of safety practice,
and training.

WORLD INTELLECTUAL PROPERTY ORGANIZATION (WIPO)

WIPO is an independent organization whose board of directors

46

[430]

comprises members of various scientific societies. It is funded through
grants and contracts (including those from NIH) . A meeting was convened
in Budapest in April 1977 for the purpose of negotiating a treaty and
regulations pertaining to the international recognition of the deposit
of microorganisms for purposes of patent procedure. (See summary of the
treaty, Appendix IX.)

IV . International European Organizations: Membership

European Molecular Biology Organization

Austria

Belgium

Denmark

Finland

France

German Federal Republic

Greece

Iceland

Ireland

Israel

Italy

Netherlands

Norway

Spain

Sweden

Switzerland

United Kingdom

European Medical Research Councils

Austria

Belgium

Denmark

Finland

France

German Federal Republic
Ireland

European Sc ience Foundation

Austria

Belgium

Denmark

France

German Federal Republic

Greece

Ireland

Italy

Italy

Netherlands
Norway
Sweden
Switzerland
United Kingdom

Netherlands

Norway

Portugal

Spain

Sweden

Switzerland

United Kingdom

Yugoslavia

47

[431]

European Economic Community

Belgium

Denmark

France

German Federal Republic
Ireland

48

Italy

Luxembourg
Netherlands
United Kingdom

[432]

GLOSSARY OF ABBREVIATIONS

ACMR . .

. . Advisory Committee on Medical Research of the
World Health Organization

COGENE .

. . Committee on Genetic Experimentation of the
International Council of Scientific Unions

DNA . .

. . deoxyribonucleic acid

EEC . .

. . European Economic Community

EMBL . .

. . European Molecular Biology Laboratory

EMBO . .

. . European Molecular Biology Organization

EMRC . .

. . European Medical Research Councils

ESF . .

. . European Science Foundation

GMAG . .

. . genetic manipulation advisory group

FAO . .

. . Food and Agriculture Organization of the United Nations

HSC . .

. . Health and Safety Commission, United Kingdom

ICSU . .

. . International Council of Scientific Unions

NIH . .

. . National Institutes of Health

U.K . . .

. . United Kingdom

U.N. . .

. . United Nations

UNEP . .

. . United Nations Environmental Programme

UNESCO .

. . United Nations Educational, Scientific, and
Cultural Organization

U.S. . .

. . United States

U.S.S.R .

. . Union of Soviet Socialist Republics

WHO . .

. . World Health Organization

WIPO . .

. . World Intellectual Property Organization

49

[433]

APPENDICES

I. Interagency Committee on Recombinant DNA Research (membership)

II. Subcommittee of the Interagency Committee (membership)

III. International Interest in Genetic Research, Hon. Olin E. Teague
(in Congressional Record , July 11, 1977)

IV. Report of the Working Party on the Practice of Genetic Manipulation
(U.K. Guidelines)

V. The International Council of Scientific Unions (report by COGENE)

VI. A. Facilitation and Safety in the International Transfer of Research
Materials (report by ACMR, WHO)

B. Excerpt from Report to the Director-General on the Nineteenth
Session of ACMR, WHO

VII. Statement by Ambassador Joseph Martin, Jr., before the Conference
of the Committee on Disarmament, August 17, 1976

VIII. Explanation of terms "physical containment" and "biological
containment"

IX. Summary and Main Advantages of the Budapest Treaty (memorandum
from WIPO)

50

[434]

Appendix I

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH
October 1977

DEPARTMENT OT AGRICULTURE

Dr. James Nielson

Deputy Assistant Secretary for

Conservation, Research, and Education
U.S. Department of Agriculture
Washington, D.C. 20250

Charles F. Levis, Ph.D. tAlt.)

Staff Scientist

Plant and Entomological Sciences
National Program Staff, ARS , USDA
BARC-Wesl

Bellsville, Maryland 20705

Dr. Clarence 0. Grogan (Alt.)

Principal Agronomist

Conservation, Research, and Education
U.S. Department of Agriculture
Washington, D.C. 20250

DEPARTMENT Of COMMERCE

Jordan J. Baruch, Sc.D.

Assistant Secretory of Commerce
for Science anu Technology
U.S. Department of Commerce
Washington, D.C. 20230

DEPARTMENT OF DEFENSE

Dr. Samuel Koalov
Special Assistant for Science
Office of the Assistant Secretary
of Navy (Research and Development)
Room 4E741, Pentagon
Washington, D.C. 20350

William R. Beisel, M.D.

Scientific Adviser

U.S. Army Medical Research Institute
of Infectious Diseases
Ft. Detrick

Frederick, Maryland 217C1

DEPARTMENT OF HEALTH, EDUCATION,
AND WELFARE

Ms. Marian Mlay
Office of Assistant Secretary
for Health

DHF.W South Portal Bldg., Rm. 703
Washington, D.C. 202C1

CENTER FOR DISEASE CONTROL

John H. Richardson, D.V.M.
Director

Office of Biosafety
Center for Disease Control
Atlanta, Georgia 30333

John F. Finklea, M.D.

Director

National Institute for Occupa-
tional Safely and Health
Parklavn Building, Room 8-05
Rockville, Maryland 20C52

FOOD AND DRUG ADMINISTRATION

Robert L. Elder, Sc.D.

Deputy Associate Co-mi ssioner
for Science

Food and Drug Adr.inistrat ion
Parklavn Building, Room 14-57
Rockville, Maryland 20852

Rosa M. Gryder, Ph.D. (Alt.)
Staff Science Advisor
Office of Science
Food and Drug Administration
Parklavn Building, Room 7-83
Rockville, Maryland 20352

John C. Petricciani, M.D.
Deputy Director
Division of Pathology
Bureau of Biologies, FDA
NIH Building 29, Room 514
3elhesda, Maryland 20014

1-1

fAtsl

DEPARTMENT OF INTERIOR

Mariano Pimentel, M.D.

Medical Director

Department of Interior

18th and C Streets, N.W., Room 7045

Washington, D.C. 20240

DEPARTMENT OF JUSTICE

!

Mr. Anthony Liotta
Deputy Assistant Attorney General
Land and Natural Resources Division
Department of Justice
Washington, D.C. 20530

DEPARTMENT OF LABOR

Eula Bingham, Ph.D.

Assistant Secretary for

Occupational Safety and Health
Department of Labor
Washington, D.C. 20210

DEPARTMENT OF STATE

Oswald H. Ganley, Ph.D.

Dep. Asst. Secretary for Advanced
and Applied Technology Affairs
Department of State
2201 C Street, N.W., Room 4327
Washington, D.C. 20520

Mr. William J. Walsh III

Science Officer

OES/APT/BMP

Department of State

2201 C Street, N.W., Room 4333

Washington, D.C. 20520

DEPARTMENT OF TRANSPORTATION

Mr. Douglas A. Crockett
Department of Transportation
Trans Point Building, Room 6222
2100 Second Street, S.W.
Washington, D.C. 20590

ENERGY RESEARCH AND DEVELOPMENT
ADMINISTRATION

James L. Liverman, Ph.D.

Assistant Administrator for
Environment and Safety
Energy Research and Development.

Administration
Washington, D.C. 20545

Charles E. Carter, M.D. (All.)
Manager, Biomedical Programs
Division of Biomedical and
Environmental Research
Energy Research and Development
Administrat ion
Washington, D.C. 20545

Walter H. Weyzen, M.D. (Alt.)
Manager, Human Health Studies Program
Division of Biomedical and
Environmental Research
Energy Research and Development
Administration
Washington, D.C., 20545

ENVIRONMENTAL PROTECTION AGENCY

Delbert S. Barth, Ph.D.

Deputy Assistant Administrator for
Health and Ecological Effects
Environmental Protection Agency
401 M Street, S.W.

Washington, D.C. 20460

Lawrence A. Plumlee, M.D.

Medical Adviser

Off. of Principal Sci. Adviser, ORD
Environmental Protection Agency
Washington, D.C. 20460

EXECUTIVE OFFICE OF THE PRESIDENT

Gilbert S. Omenn, M.D., Ph.D.

Assistant Director for Human Resources
Office of Science and Technology Policy
Old Executive Office Building, Room 360
Washington, D.C. 20500

1-2

[436]

EXECUTIVE OFFICE OF THE PRESIDENT
(CpnL 1 d )

Mrs. Carroll L. Raslian
Senior Staff Member for
Environmental Health and
Toxic Substances

Council on Environmental Qjality
722 Jackson Place, N.W.
Washington, D.C. 20006

NATIONAL AERONAUTICS AND SPACE
ADMINISTRATION

David L. Winter, M.D.

Director for Life Sciences
National Aeronautics and Space
Adroini slrat ion
Washington, D.C. 20546

NATIONAL SCIENCE FOUNDATION

Herman W. Lewis, Ph.D.

Section Head of Cellular Biology
Division of Physiology, Cellular,
and Molecular Biology
National Science Foundation
Washington, D.C. 20550

Philip D. Harriman, Ph.D.

Program Director of Genetic Biology
National Science Foundation
Washington, D.C. 20550

NUCLEAR REGULATORY COMMISSION

Mr. Frank Swanberg, Jr.

Chief, Health and Environmental
Research Branch
Nuclear Regulatory Commission
Washington, D.C. 20555

U.S. ARMS CONTROL AND DISARMAMENT
AGENCY

Robert Mi kulak, Ph.D.

Physical Science Officer
Nonproliferation and Advanced
Technology Bureau, WTD
U.S. Arms Control and
Disarmament Agency
Washington, D.C. 20451

VETERANS ADMINISTRATION

Jane S. Schultz, Ph.D.

Research Service

Veterans Administration Central Office
810 Vermont Avenue, N.W.

Washington, D.C. 20420

CHAIRMAN OF THE COMMITTEE

Donald S. Fredrickson, M.D.
Director

National Institutes of Health
Bethesda, Maryland 20014

EXECUTIVE SECRETARY OF THE COMMITTEE

Joseph G. Perpich, M.D., J.D.
Associate Director for Program
Planning 3nd Evaluation
National Institutes of Health
Bethesda, Maryland 20014

1-3

[437]

Appendix II

SUBCOMMITTEE ON INTERNATIONAL ISSUES
of the

INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

June 1977

DEPARTMENT OF AGRICULTURE

I'r. James Nielson

Deputy Assistant Secretary for

Conservation, Research, and Education
U.S. Department of Agriculture
Washington, D.C. 20250

Charles F. Lewis, Ph.D. (Alt.)

Staff Scientist

Plant and Entomological Sciences
National Program Staff, ARS , USDA
BARC-West

Beltsville, Maryland 20705

Dr. Clarence 0. Grogan (Alt.)
Principal Agronomist

Conservation, Research, and Education
U;S. Department of Agriculture
Washington, D.C. 20250

DEPARTMENT OF COMMERCE

Jordan J. Baruch, Sc.D.

Assistant Secretary of Commerce
for Science and Technology
U.S. Department of Commerce
Washington, D.C. 20230

DEPARTMENT OF DEFENSE

Dr. Samuel Koslov
Special Assistant for Science
Office of the Assistant Secretary
of Navy (Research and Development)
Room 4E741, Pentagon
Washington, D.C. 20350

DEPARTMENT OF DEFENSE (Cont.d)

William R. Beisel, M.D.

Scientific Adviser

U.S. Army Medical Research Institute
of Infectious Diseases
Ft. Detrick

Frederick, Maryland 21701

DEPARTMENT OF HEALTH, EDUCATION,

AND WELFARE

CENTER FOR DISEASE CONTROL

John H. Richardson, D.V.M.

Director

Office of Biosafety
Center for Diseases Control
Atlanta, Georgia 30333

DEPARTMENT OF JUSTICE

Mr. Anthony Liotta
Deputy Assistant Attorney General
Land and Natural Resources Division
Department of Justice
Washington, D.C. 20530

DEPARTMENT OF STATE

Oswald H. Ganley, Ph.D.

Deputy Assistant Secretary for

Advanced and Applied Technology Affairs
Department of S'.ate.

2201 C Street, N.W., Room 4327
Washington, D.C. 20520

Mr. William J. Welsh III

Science Officer

OES/APT/BMP

Department of State

2201 C Street, N.W., Room 4333

Washington, D.C. 20520

II-l

[438]

Appendix III

CONGRESSIONAL RECORD, pages E4331-2
July 11, 1977

INTERNATIONAL INTEREST IN
GENETIC RESEARCH

HON. OLIN E. TEAGUE

OF TEXAS

IN THE HOUSE OF REPRESENTATIVES
Monday. July 11. 1977

Mr TEAOUE. Mr. Speaker, it may
soon be necessary for the Members ot
this body to consider the need for en-
actment of legislation on an issue which
has aroused an unusual degree of con-
troversy in both scientific and public dis-
cussions. The new ability to manipulate
experimentally the basic genetic mate-
rial of a cell — known as deoxyribonucleic
acid or DNA — has produced a science
and public policy issue of considerable
Importance. DNA recombinant molecule
research, which is what one of these new
techniques of genetic manipulation is
called, has been under examination as a
potential public policy issue for several
years and Is finally being addressed m
proposed Federal legislation. It is clear
that the policy Implications are not go-
ing to be resolved easily.

DNA recombinant molecule research
is being encouraged by proponents for
the potential benefits it appears to offer,
such as the biological production of a
pure form of insulin and other drug
products, for its potential contribution to
basic biological knowledge, and for other
practical applications in agriculture and
Industry. At the same time, a potential
risk to the public health and the envi-
ronment. as well as philosophical prob-
lems dealing with the social aspects of
the technique, are being cited by oppo-
nents of the research.

The fact that there are so many un-
known factors which must be estimated
means that society, and the Congress,
must exert a considerable effort to main-
tain a high level of awareness about the
DNA recombinant molecule issue and to
be prepared to take the best actions
determined to be necessary. My state-
ment today is in part a request that the
Members become familiar with this issue
before it reaches the House for con-
sideration in the form of legislation.

Few developments in biological re-
search have aroused such widespread and
truly international debate as the DNA
recombinant molecule research issue. I
noted this fact during a recent official
visit to France when the topic became a
part of our policy discussion. I believe
that the Members of the House should
be aware that mast of the nations In
Western Europe are engaged in the same
task with which we are struggling in the

United States; namely: How are we to
permit the continuation of biological re-
search using DNA recombinant tech-
niques which scientists tell us offers
such great potential benefits to society
and at the same time Insure that applica-
tions of this new knowledge do not place
our citizens or the environment in some
unexpected Jeopardy? Should Federal
regulation preempt local regulation?
How should responsibilities be assigned?
What form should the regulating body
assume? How much regulation is re-
quired? What authorities need to be as-
signed by legislation?

There are now at least five major or-
ganizations trying to coordinate this
international debate. These include the
World Health Organization — WHO; the
International Council of Scientific
Unions — IC6U: the European Molecular
Biology Organization — EMBO: the Eu-
ropean Science Foundation — ESF; and
the European Commission of the Eu-
ropean Economic Communities.

Some sort of advisory or voluntary or-
ganizational structure for review of DNA
research now exists in most Western Eu-
ropean countries, and Canada. Australia,
and Japan are involved in these debates.
Some of these countries, as in the United
Kingdom, have established formal or-
ganizations such as their Oenetlc Manip-
ulation Advisory Group — GMAO — and
these groups review the proposed re-
search protocols and determine whether
the rucombinant research should pro-
ceed Research guidelines very similar to
the guidelines developed by our National
Institutes of Health are utilized to pro-
vide direction. As in the United St.-ies.
except for Government-funded research,
participation by submittal of projects for
review and acceptance of the guidelines
is mostly voluntary. The Netherlands and
Sweden are considering the need for spe-
cial legislation Just as we may be required
to decide here In the House in the near
future. The United Kingdom Is taking ac-
tion to secure legal compliance with reg-
ulations established by its Health and
Safety Commission. In all of these ac-
tions, the Western European nations are
watching our proposed legislative activity
with great Interest.

It is Important that we all realize that
the DNA recombinant research Issue can-
not be dealt with in isolation from the
rest of the world. Just as it is necessary
for the Congress to evaluate the relative
merit* of permitting potentially different
seta of State and local regulations to
emerge as contrasted with Federal pre-
emption of State and local option, the

III-l

[439]

Western European nations are beginning
to see the international implications of
different national rules and guidelines.

Scientific research capabilities are no
longer confined within national barriers.
The, international diversification of our
large commercial firms, particularly the
drag firms, has eliminated such limita-
tions if indeed they ever existed. We need
to evaluate the information being made
available from the debates in this coun-
try and abroad and determine the full
implications of any of our decisions be-
fore we enact legislation in this area.
Fortunately, these debates on genetic
manipulation are occurring in the form-
ative stages of public policy. We have a
unique opportunity to make sound deci-
sions if we can muster the attention to
detail required to sort out the facts from
the conjecture. The House Science and
Technology Committee, Subcommittee
on Science, Research, and Technology
has already devoted a series of hearings
to the science policy implications of this
issue, and the record of these hearings
will soon be available for your study.

I believe that the DNA recombinant
molecule research issue has many impli-
cations for science policy which extend
beyond the immediate task of regulating
a specific type of genetic manipulation.
I urge the Members to became familiar
with this issue before we make a
decision on any legislation which may
come before us. The House Science and
Technology Committee has had prepared
an informative background report for the
Members which can be obtained by con-
tacting the committee for copies — Ge-
netic Engineering, Human Genetics, and
Cell Biology. Evolution of Technological
Issues. DNA Recombinant Molecule Re-
search [Supplemental Report HI De-
cember 1976. The Congressional Re-
search Service has prepared an Issue
brief which is available on this topic and
which they can provide on request. Their
.issue brief provides current information
on the status of legislative actions being
considered in the Congress and cites
other sources of information. I offer the
services of my office to any Member who
desires additional information and I as-
sure you that this issue will have my own
continuing attention. This is an issue of
worldwide interest in which once again
the actions of tlie United States are the
center of attention and will have a far-
reaching impact on world decisions.

III-2

[440]

Appendix IV

REPORT OF THE WORKING PARTY
ON THE PRACTICE OF
GENETIC MANIPULATION

Presented to Parliament

by the Secretary of State for Education and Science
by Command of Her Majesty
August 1976

LONDON

HER MAJESTYS STATIONERY OFFICE
50p net

Cmnd. 6600

IV-1

[441]

The Right Hon. Frederick W. Mulley, MP

Dear Secretary of State,

I have pleasure in submitting the report of the Working Party that you
appointed in August 1975 to follow up the recommendations of the Ashby
Report on the Experimental Manipulation of the Genetic Composition of
Micro-Organisms and, in particular, to draft a code of practice and to make
recommendations on the establishment of a central advisory service.

We have consulted many of the individuals and organisations likely to be
concerned with the techniques of genetic manipulation and we believe that
there is a pressing need for the implementation of a system of advice and control
for experiments in this field, in order that valuable work may proceed both
rapidly and safely. We trust therefore that you will agree to publish this
report and that you will give consideration to our recommendation that the
central advisory service that we propose should be set up as quickly as possible.

Yours sincerely,

Professor Sir Robert Williams

June 1976.

IV- 2

[442]

REPORT OF THE WORKING PARTY ON THE PRACTICE OF

GENETIC MANIPULATION

CONTENTS

Membership of the Working Party

1. Introduction

2. Categorisation of Experiments

3. Code of Practice

4. Training

5. Central Advice and Control

6. Recommendations

7. Conclusion

Appendices [omitted]:

I. List of organisations and individuals consulted.
II. Code of practice.

Page

5

7

12

14

15

19

20

IV-3

[443]

MEMBERSHIP OF THE WORKING PARTY

Professor Sir Robert Williams MD,
FRCP, FRCPath, FFCM
( Chairman)

S. Brenner, Esq., MB, DPhil, FRS

J. B. Brooksby, Esq., CBE, DSc, PhD,
MRCVS, FRSE

Professor J. P. Duguid, MD, BSc,
FRCPath

R. J. C. Harris, Esq., PhD, FRIC,
FIBiol, FRCPath

Professor D. A. Hopwood, DSc, MA,
PhD, FIBiol

W. House, Esq., MIBiol

Director, Public Health Laboratory
Service, London

MRC Laboratory of Molecular
Biology, Cambridge

Director, Animal Virus Research
Institute, Pirbright, Surrey

Department of Bacteriology,
Ninewells Hospital, Dundee

Director, Microbiological Research
Establishment, Porton Down,
Salisbury

Department of Genetics, John Innes
Institute, Norwich

Manager of Laboratories, Imperial
Cancer Research Fund Laboratories,
London

R. Owen, Esq., MB, ChB, DIH, DMJ, Deputy Director of Medical Services,
LRIC Health and Safety Executive

D. A. J. Tyrrell, Esq., MD, FRCP, MRC Clinical Research Centre,

. FRCPath, FRS Harrow

Professor P. M. B. Walker, CBE, BA, Director, MRC Mammalian Genome
PhD, FRSE Unit, Department of Zoology,

University of Edinburgh

Assessors:

Dr. H. M. Archibald

Dr. M. Ashley-Miller

Mr. D. Evan Morgan
Dr. C. Wray

Department of Health and Social
Security

Scottish Home and Health
Department

Department of Education and Science

Ministry of Agriculture Fisheries and
Food

Secretaries:

Dr. E. J. Herbert Department of Education and Science

Dr. G. N. J. Port

Department of Education and Science

IV-4

[444]

1. INTRODUCTION*

1.1 Following the report of Lord Ashby's Working Party,* which assessed
the benefits and hazards of techniques of genetic manipulation, we were
appointed by the Secretary of State for Education and Science, in consultation
with his colleagues, with the following terms of reference:

"In the light of the reports of the Advisory Board for the Research Councils'
Working Party on the potential benefits and potential hazards associated
with the genetic manipulation of micro-organisms* and of the Working
Party on the Laboratory Use of Dangerous Pathogens-!- —

(a) to draft a central code of practice and to make recommendations for
the establishment of a central advisory service for laboratories using the
techniques available for such genetic manipulation, and for the
provision of necessary training facilities:

(b) to consider the practical aspects of applying in appropriate cases the
controls advocated by the Working Party on the Laboratory Use of
Dangerous Pathogens."

We have met nine times and have received evidence from the bodies and
individuals listed in Appendix I. of whom some met the Working Party and
some submitted written evidence. We are grateful to our witnesses for the
trouble they took to let us have their views, which have helped us in our
considerations.

1.2 We record our warm appreciation of the work of our two secretaries
Dr. E. J. Herbert and Dr G. N. J Port, whose assistance and skill have con-
tributed substantially to our considerations, and of the nelp we have had from
the presence at our meetings of Mr. K. N. Burns (Agricultural Research
Council), Dr. D O. Haines (Health and Safety Executive) and Dr T. Vickers
(Medical Research Council). W'e also thank Miss Lynda Ison of the Depart-
ment of Education and Science who typed most of our working papers and the
several drafts of our report.

1.3 We have concentrated our attention on work involving the creation of
new genetic elements by methods such as those described in the Ashby Report
whereby restriction enzymes or comparable biochemical methods are used to
prepare fragments of nucleic acid and to link them into the genomes of viable
heterologous organisms in which they are capable of continued propagation X
This excludes genetic manipulations carried out by previously established
methods that in principle simply add special selective methods to ger.etic
changes that must occur in nature W’e briefly considered the implications
of the probable eventual use of genetic manipulation techniques in large-scale
manufacturing processes and concluded that this use is so remote that the
increase in knowledge preceding such development will greatly contribute to
their safety. The Government may need at a later stage to reconsider our
proposed control measures in the light of such developments but we have
concentrated in the present report on the types of laboratory experiment that
we can foresee being undertaken in the next few years. W'e agree with the

• Report of the Working Parly on the E*perimental Manipulation of the Genetic
Composition of Micro-Organisms (Cmnd 5880. HMSO. January 1975).

T Report of the Working Party on the Laboratory Use of Dangerous Pathogens (Cmnd
<054. HMSO. May 1975).

! References in this report to "genetic manipulation" are to be read in this limned sense.

IV-5

[445]

conclusion of the Ashby Working Party that genetic manipulation using
restriction enzymes offers opportunities of great potential value and we are
anxious to provide guidance on the appropriate conditions for such work as
quickly as possible. It should be recognised moreover that the techniques we
have been asked to consider are not the only ones that may have associated
hazards. However, a variety of other genetic techniques leading to the intro-
duction of new characteristics into cells have been employed for many years
and such epidemiological surveys as have been conducted show no evidence
of hazard.

1.4 The underlying reason for the present review, and of course for the
establishment of the Ashby Working Party, was the concern of the scientific
community that some experiments involv ing the techniques of genetic manipula-
tion might lead, perhaps inadvertently or in an unpredictable manner, to the
release of harmful products into man, animals or plants. It should be stressed
at the outset that most of the hazards that may be involved are conjectural.
At present there is no experimental evidence that some of the most serious
hazards that can be envisaged — for example those due to the incorporation of
deoxyribonucleic acid (DNA) from oncogenic viruses, or from bacteria carrying
mammalian DNA, into the human body — are real; but equally there is no
proof that they are not. It is clear however that the introduction of drug
resistance into a drug-susceptible pathogenic bacterium could have serious
consequences if the organism should escape. Until further knowledge is
gained of the use of the novel genetic techniques under discussion, it seems to
us essential that rigorous precautions, based on the best estimate of possible
hazard, should be observed by all laboratory workers using these techniques.
We therefore consider that work in this field should be done only under appro-
priate containment conditions and to this end we have devised a set of guide-
lines for categorising experiments (Section 2 below) that take account both of
the conjectured hazards and of methods available for biological containment;
and w? have drawn up a code of practice (Section 3 below and Appendix II)
for the operating procedures and physical containment levels appropriate to
each category of experiment.

1.5 In the present state of knowledge of the field, containment measures
should allow a suitable margin of safety until any areas of doubt can be clarified
by further experimental evidence. We see a need for a flexible approach and
consider this will be better met by requiring those who plan to work in the field
of genetic manipulation to submit their experimental protocols to a central
advisory group — referred to below as the Genetic Manipulation Advisory
Group (GMAG) — for advice on the appropriate safety precautions, rather
than by imposing rigid guidelines. We define certain cases in which work
should not proceed until the GMAG has given approval and we can envisage
circumstances in which the group could advise against the conduct of a particular
experiment because of the possible hazard, or could propose modifications of
the experimental procedures or safety precautions. As work proceeds, the
experience gained should quite quickly build up into a body of “‘case law” on
which future experimental protocols could draw, and the GMAG should gain
valuable expertise not only in the design of safe experiments but also in related
matters such as training, health monitoring and epidemiological studies and
the role of safety committees and safety officers.

1.6 Conscious of the restraint already shown by the scientific community, and
of the importance of work in this field, we consider that certain types of
experiment (ie those falling into categories I and II defined below), which would

IV- 6

[446]

not in our view carry a serious hazard, should proceed subject to the precautions
recommended below and subject to the tiling of an experimental protocol with
the GMAG. Work in other categories for which adequate higher degrees of
containment are available should, subject to the advice of the GMAG. be
encouraged, both for us intrinsic importance and to increase understanding of
the techniques and of any associated hazards. We recommend that further
work should be done on the development and characterisation of disabled
organisms which will oiler an important safeguard against hazard and that any
such organisms that arc developed should be made freely available to all
workers in the held.

1.7 We define in the remainder of our report and in the code of practice
measures that we consider necessary to ensure that work proceeds as safely as
possible. These include the provision of training, the involvement of local
safety committees and biological safety officers, the establishment and operation
of the GMAG and the application of a central code of practice, and could be
put into early operation on a basis of voluntary co-operation by laboratories.
W’e believe that these measures will provide a system to safeguard the public:
the working of the system in practice will also enable the Government to con-
sider the desirability of introducing statutory powers additional to existing
powers, such as those in the Health and Safety at W'ork Act.

1.8 We have of course been aware of consideration of this subject similar to
our own in other countries, particularly at the National Institutes of Health in
the United States of America, and within various international scientific
organisations. We believe that our own proposals for categorisation of
experiments are generally in line with those developing in the United States
although we envisage that the central advisory body — the GMAG — in the
United Kingdom should advise on all experiments in genetic manipulation
wherever these are carried out. We support the view expressed in various
places that there should be some international action to ensure widespread
consultation and even co-ordination of principles on a world-wide basis,
perhaps through the W'orld Health Organisation, which we understand has
begun to consider the question. This course would be for the Government to
pursue, but in the meantime we recommend that there should be no delay in
implementing the system of advice and control which we believe to be necessary
in the United Kingdom.

2. CATEGORISATION OF EXPERIMENTS

2.1 It isacentral feature of our recommendations that all experiments involving
genetic manipulation should be considered by the Genetic Manipulation
Advisory Group (GMAG). which will assess the hazards* and will categorise
experiments according to the appropriate level of physical containment and
other safety precautions. The basis for categorisation described below is one
that leans on the side of caution and should reduce to manageable proportions
the task of assigning suitable protective measures to particular experiments.
We intend it as a guide to assist the initial deliberations of the GMAG and
envisage that, with experience and as the field develops, the GMAG will be
able to build up a body of "case law" against which to judge individual
experiments.

• We refer simply to "hazards” throughout the remainder of the report without repealing
the point in paragraph 14.

IV- 7

[447]

2.2 The techniques oogenetic manipulation with which we have been con-
cerned usually involve the use of a restriction enzyme to cut a fragment of
nucleic acid from an organism in such a way that the fragment can be recombined
with a similarly cut fragment of nucleic acid (the "vector", often a plasmid or
bacteriophage) in a different organism. The multiplication of the nucleic acid
fragment in the vector occurs by its growth in a host cell, often a bacterium.

The hazards involved depend on the following factors:

i. the source of the nucleic acid from which the fragment to be linked
is derived;

ii. the degree of specification, that is the purity, of the nucleic acid
sequence;

iii. the vector/host system to be involved in the recombination and in
which the sequence is to be multiplied: and

iv. the manipulative procedures proposed.

2.3 In the following paragraphs we refer in general terms to the weight which
should be given to the four factors referred to in paragraph 2.2. It will be
important for the GM AG to obtain quantitative assessments of hazard wherever
possible but in our opinion this cannot be done with anv precision at this stage
and we have not therefore attempted to give figures either for the purity of the
nucleic acid sequence needed to meet the criterion of sub-paragraph 2.5.i below
or for the degree of biological containment required in sub-paragraph 2.6.i.
In paragraphs 2.4 - 2.7 we lav most emphasis on the risk to man. since laboratory
workers will be involved in all experiments: but in particular circumstances the
hazard of the nucleic acid for animals or plants may be equally important.

2.4 Source of the nucleic acid

Sources of the nucleic acid are of three main types:

i. nucleic acid from bacteria, fungi or protozoa should be categorised
according to the known ability of the source microbe to infect or
cause disease in man, animals or plants;

ii. nucleic acid from viruses should be categorised according to the
“hazard classification” of their host or for viruses with a range of
hosts, of the highest class of host indicated in paragraph iii;

iii. nucleic acid from higher organisms is generally considered to offer a
hazard related to the closeness of the evolutionary relationship
between the organism constituting the source of the nucleic acid and
the organism at risk. On this basis we should regard nucleic acid
from plants and invertebrates as carrying a low hazard to man (except
perhaps for invertebrates that may harbour microbes pathogenic for
man); nucleic acid from amphibia, reptiles and birds would be assigned
an intermediate hazard classification, and nucleic acid from mammals,
including man, would be the most hazardous.

2.5 Specification of the nucleic acid sequence

i. The safest nucleic acid fragments are well-characterised sequences
that do not specify a known hazard. One way of initially purifying
such sequences would be by selection and growth in a vector/host
system under rigorous containment conditions;

IV-8

[448]

ii. the use of random nucleic acid fractions that nay include any com-
ponent of the genome introduces greater possible hazards;

iii. nucleic acid sequences selected on the basis of their intrinsic patho-
genicity, or of the known toxicity of their products, are still more
likely to be dangerous.

2.4 The sector host system

Vettors for the recombinant nucleic acid include free DNA. plasmids, bacterio-
phages and viruses, and the viable hosts into which the nucleic acid is linked
maybe prokaryotic (bacterial or eukaryotic (eg animal and plant cells). The
first two of the systems listed below employ the principle known as biological
containment:

i the safest system is considered to be a combination of a host bacterium
that is "disabled" and has been shown by in nr o experiments to have
a very small chance of survival in. or of transferring information to,
man or animals (or plants as appropriate), with a vector that is specific
and confined to that host. A less well-attested system, which might
be as safe, is one differing from the above only in that the "disable-
ment” of the bacteria has been demonstrated by in vitro rather than
in tivo experiments;

ii. phage or plasmid vectors used in conjunction with, and able to grow
only in. attenuated laboratory strains of bacteria also provide a
degree of biological containment

iii. those systems in which the vectors are capable of infecting the cells
of higher eukaryotes are considered the most potentially hazardous.

2.7 Manipulative procedures

Simple experimental procedures ifor example, the inoculation of culture plates
with bacterial colonies) involving small volumes of material offer the smallest
hazard. Special methods of manipulating hosts and their vectors with rigorous
containment may be developed which could further reduce any hazard. Use
of an increased volume of material or the introduction of operations such as
centrifugation, fraction collection or sonic disintegration, with the risk of
aerosol production, clearly increases the hazard.

2.8 Containment measures

The hazards have their origin in the nucleic acid but these may be reduced,
depending on the vector host system into which it is to be introduced. When
this system is such that the nucieic acid can survive and replicate only in highly
artificial conditions, any hazardous element that might escape could not
survive. This is the principle of biological containment. Physical containment
measures, on the other hand, arc designed to ensure that any hazardous elements
that are created do not escape from the laboratory. We have defined four
levels of physical containment and associated safety measures in the code of
practice referred to in Section 3 below and set out in full in Appendix II and
we propose that an experiment should be assigned to one of these levels on the
basis of the factors in paragraph 2.2 above Even though genetic material
thought to be completely harmless is being used in an experiment it is con-
ceivable that a hazardous product might result because of an unexpected
interaction and for this reason we recommend that no genetic manipulation
experiment should be undertaken in containment conditions less stringent than

IV-9

[449]

those used for work with common pathogens* corresponding to the conditions
of our level I. The four levels are described in detail in the code of practice
(Appendix II) but may be briefly summarised as follows:

I. conditions conforming to the standard necessary for the maintenance
of good microbiological practice, as required for work with common
pathogens m a medical microbiology laboratory;

II. conditions as at I above in a laboratory which is additionally sited
away from areas used by the general public and has controlled air
flow and an exhaust-protective cabinet for aerosol-producing
operations;

III. conditions as at II above but with access to the laboratory only
through an airlock containing washing facilities and with an autoclave
and provision for decontamination of all effluent from the laboratory;

IV. conditions provided by a laboratory equivalent to the category A
toxic laboratory referred to in Appendix III to the Report of the
Working Party on the Laboratory Use of Dangerous Pathogens, ie
those at III above with, additionally, provision for a full change of
clothing and showering on leaving the laboratory and a double-ended
autoclave.

2.9 Categorisation

There is a continuous spectrum of hazard but any categorisation must be done
in steps. We assume that there are conditions of biological containment and
nucleic acid purity that will allow an experiment to be moved from one category
to another but these cannot be absolutely defined without reference to the
individual experiment. We therefore give some examples to illustrate the
principles we have adopted in the following table. It will be seen that, experi-
ments involving recombination between the nucleic acids of non-pathogenic
bacteria are considered to require only category I containment. Depending
on the degree of biological containment achieved, and on the nature of the
nucleic acid sequence inserted, certain other classes of experiment can be
acceptably undertaken with Category I or II containment and some examples
of such experiments are given in the following table. We stress that the table
gives illustrative examples of some typical experiments and is intended to serve
only as a guide and not as a definition of the whole area of possible work in
each category. It will of course be for the GMAG to advise on specific cases
and to establish a more complete categorisation as part of the “case law” as
the work proceeds.

• For example, streptococci, staphylococci, salmonellae and other pathogens commonly
present in the community and not especially liable to cause laboratory-acquired infection.

IV-10

[450]

Suggested categorisations for some txpical experiments in Categories I, II, III

& IV

(These examples all assume standard biochemical manipulations)

Source of nucleic acid

Specification
of nucleic
acid sequence

Vector/ Host System

Category

Mammals

Random

Phage or plasmid bacteria,
not disabled

IV

Random

Phage or plasmid bacteria,
disabled

III

Purified*

Phage or plasmid bacteria,
not disabled

III

Purified*

Phage or plasmid bacteria,
disabled

II

Amphibians and reptiles

Random

Phage or plasmid bacteria,
not disabled

III

Random

Phage or plasmid bacteria,
disabled

II

Purified*

Phage or plasmid bacteria,
not disabled

II

Purified*

Phage or plasmid; bacteria,
disabled

I

Plants and invertebrates
and lower eukaryotes

Random

Phage or plasmio/bacteria,
not disabled

II

Random

Phage or plasmid'bactena,
disabled

I

Purified*

Phage or plasmid bacteria,
not disabled

I

Mammals

Amphibians and reptiles
Birds

Random

Virus capable of infecting
man or growing in tissue
culture cells

IV

Purified*

Virus capable of infecting
man or growing in tissue
culture cells

III

Viruses pathogenic to
vertebrates

Random

Phage or plasmid bacteria,
disabled

IV

Purified*

Phage or plasmid, 'bacteria,
disabled

III

Animal viruses, non-
pathogenic to man

Random

Phage or plasmid/bacteria,
disabled

II

• The term “purified” means fractions with little chance of including any unrecognised
extraneous sequences (see paragraph 2 6 it. It is of course possible to have sequences selected
because of their pathogenicity and these would raise the level of containment required.

IV-11

[451]

Source of nucleic acid

Specification Vector/ Host System

of nucleic
acid sequence

Category

Bacteria specifying
toxins virulent to man

Random Phage or plasmid/bacteria,
disabled

IV

Plant pathogenic
bacteria

Random Phage or plasmid/bacteria,
not disabled

II

Plant viruses

Random Phage or plasmid/bacteria,
not disabled

II

Bacteria or fungi
non-pathogenic to man.
animals or plants

Random Phage or plasmid/bacteria,
not disabled

I

3. CODE OF PRACTICE

3.1 We were asked to draft a central code of practice for laboratories under-
taking experiments involving the techniques of genetic manipulation. We
have done this on the basis of the four levels of physical containment (I- IV)
summarised in paragraph 2.8 above: the code of practice is set out in full in
Appendix II, together with a table illustrating the major differences between
the four containment levels. The following headings are used in the code, as
far as these are applicable to the particular level of containment being described:

Laboratory (premises and facilities)

Biological Safety Officer

Staff — selection
training
supervision
protective clothing
health
discipline

Packaging and transport of samples
Security

Special requirements of experiments involving laboratory animals or plants.

3.2 In drawing up the code of practice, we have taken account of the
code set out in the Report of the Working Party on the Laboratory Use of
Dangerous Pathoeens and in view of the similar requirements of our category
IV containment level and the category A level for dangerous pathogens, we
have tried as far as possible to follow the provisions and wording of that
Working Party’s code of practice. We also noted that a code of practice
covering three containment levels is being prepared by Sir James Howie's
Working Party on the Prevention of Infection in Clinical Laboratories.

3.3 As indicated in the introduction to the code of practice, we have not
attempted to deal with all the technical queries that may arise on various aspects
of the recommended containment levels: we have sought rather to provide
guidelines for the GMAG to build on in drawing up the detailed specifications
that may be necessary for assessment of individual laboratories.

IV- 12

[452]

3.4 We recommend that every laboratory conducting genetic manipulation
experiments must have both a properly constituted and representative local
safety committee and a Biological Safety Officer answerable to the adminis-
trative head of the establishment or department, who must ensure that the
Biological Safety Officer, on whose role we place particular emphasis, has the
necessary training, experience and authority to enable him to carry out his
duties. As we explain in Section 5 below, these are factors that we telieve
should be taken into account by the CMAG when it advises on whether or
not a particular experiment should be conducted at a particular laboratory.
We discuss training further in Section 4.

Experimental Animals

3.5 From time to time there will be a need to introduce live bacteria, viruses
or phages bearing introduced genetic material into laboratory animals, initially
to study whether genetic information is indeed transferred to animals in
particular circumstances and to study the distribution, survival and replication
of the vector in the animal. If this is done, the animals used must be kept in
appropriate isolation facilities offering at least the level of containment appro-
priate to the experiment in question and desirably a higher level in view of the
increased risk of dissemination when animals are involved.

3.6 Once the results of such experiments are available it may be possible to
reduce the strictness of isolation for further experiments of the same type, if
for example it has been shown that genetic information is unlikely to be trans-
ferred from the vectors. But it will reed to be remembered that host-parasite
relationships are rather specific and although there may be no undesirable
sequels when a vector is put into one species, the outcome may be different
if a different vector of species of animal is used, or if germ-free animals are used
instead of conventional animals.

Plants

3.7 When suitable vectors become available, there will undoubtedly be
proposals to introduce foreign nucleic acid into whole plants, especially if some
of the exciting possibilities for genetic manipulation referred to in the Ashby
Report (paragraph 3.4) are to be explored. Suitable measures of containment
for the plants will be needed and we include some comments in Section 34
of Appendix II. These will vary with the nature of the vector and of the foreign
nucleic acid etc, as in paragraphs 2. 4-2.7 above.

3.8 In view of the availability of experience and expertise in plant pathology
in the Agriculture Departments, and of the rather general nature of the measures
required under the present licensing system for known plant pathogens, as
summarised in Section 34 of the code of practice, which in any case apply only
to imported organisms, we feel it would be illogical to attempt to make detailed
recommendations for the containment of plants inoculated with vectors of
recombinant nucleic acid that might involve a hazard to plant populations.
We therefore recommend that, for the present, all experiments involving the
introduction of recombinant nucleic acid into plants should require the prior
approval of the GMAG and that the GMAG should, at an early stage, agree
with the Agriculture Departments a procedure for specifying suitable con-
tainment measures for such experiments proposed to it. However, it should
be borne in mind that by no means all such experiments will necessarily require
measures as strict as those needed for the pathogens at present covered by
licences and it may be possible to reduce the strictness of isolation procedures
as more knowledge of the properties of the new genetic entities becomes
available.

IV- 13

[453]

4. TRAINING

4.1 The Ashby Report (paragraph 7.3) recommended that all those who work
with these techniques should ha\e training in the handling of pathogens. We
were asked to make recommendations for the provision of necessary training
facilities.

4.2 The first generation of workers in genetic manipulation will be largely
self-taught, but we consider that appropriate training should be made available
to all research workers, technicians and Biological Safety Officers intending to
work in the field and that the head of each establishment or department, advised
by the Biological Safety Officer, should ensure that anyone selected for the
work has satisfactorily completed an appropriate course of training.

4.3 Biological Safety Officers will need:

i. to understand both the nature and implications of the genetic experi-
ments being undertaken, and also the methods advised for physical
containment;

ii. to judge the training requirements of the research workers and
technicians and, as necessary, to recommend appropriate courses, or
arrange to supplement a new entrant's experience with in-house
training;

iii. to be familar with health monitoring procedures and to be able to
collaborate with the supervisory medical officer in organising them;

and

iv. to understand the legal and medical provisions relating to work in
laboratories (for example, the Health and Safety at Work Act, relevant
codes of practice and the organisation of local health services) and
the procedures for consulting the Genetic Manipulation Advisory
Group (GMAG).

Training for Biological Safety Officers will best be provided by special courses,
preferably at. or in association wfith. a laboratory that has the necessary con-
tainment facilities and experience of containment techniques.

4.4 For research workers and technicians, we see a need for three types of
training:

i. general education in the science of genetic manipulation, in the nature
of the potential hazards and of the special precautions required to
counter them. This should be required for all research workers
without relevant experience and would include molecular biology and
genetics, microbiology, epidemiology and relevant aspects of other
disciplines. Such training might be provided at a university summer
school;

ii. as a minimum, practical training in the procedures and manipulations
appropriate to work in a genetic manipulation laboratory at the
physical containment level of categories I and II above. This might
be provided by industrial employers or at special university, poly-
technic or other suitable courses; and

iii. special training for anyone intending to work in a genetic manipulation
laboratory at the physical containment level of categories III or IV
above. Such training should include practice in the use of such
facilities and there is therefore a need for specimen physical contain-
ment laboratories which can be made available for training as well as
for research.

IV- 14

[454]

4.5 The demand for training is difficult to judge and flexible arrangements will
be needed Training facilities will necessarily be found mostly in uni\ersities
and polytechnics although industrial employers and appropriate Go\ernment
laboratories will also have a part to play. Universities and polytechnics are
already providing some related courses and. suitably modified, these should be
appropriate. The GMAG will need to be aware of the general nature of the
training being provided since this will be relevant in the consideration of advice
on individual experiments. They should also maintain a register of training
courses and facilities and be prepared to provide information and advice
about training.

5. CENTRAL ADVICE AND CONTROL

5.1 The Ashby Report (paragraph 6.5(d)) suggested that "as an initial step a
widely publicised advisory service, perhaps otfered by public health laboratories,
would help to safeguard the interests of the public and of those engaged in the
experiments". The Government has already accepted that it has a responsi-
bility to ensure that authoritative advice and guidance are available to labora-
tories using the techniques available for genetic manipulation and we were
asked to make recommendations for the establishment of a central advisory
service

5.2 We were also asked to consider the practical aspects of applying in appro-
priate cases the controls advocated by the Working Party on the Laboratory
Use of Dangerous Pathogens, which recommended that initially control should
be on the basis of voluntary acceptance by laboratories of the advice of a
centrally appointed Dangerous Pathogens Advisory Group (DPAG). but that
various existing legal powers which could be invoked to give statutory force to
such advice should "be consolidated so that the Departments of Health and
Agriculture can act with full authority, without delay and with uniform
principles.”*

A voluntary system of advice and control

5.3 W'e recommend the establishment of a Genetic Manipulation Advisory
Group (GMAG). Since a central advisory service will need to command the
respect of the public as well as of the scientific community, including scientists
in industry, the membership of the GMAG should include not only scientists
with knowledge both of the techniques in question and of relevant safety
precautions and containment measures but also individuals able to take account
of the interests of employees and the general public. We hope that the Govern-
ment will agree to the establishment of the GMAG on this basis at an early
date so that work which is scientifically desirable may proceed quickly and
safely.

5.4 The main functions of the GMAG should be to advise on the category
into which a particular experiment would fall, taking into account the factors
discussed in Section 2 above and on the application to particular cases of the
code of practice recommended in Section 3 above. To do this the GMAG will
need to maintain records of the facilities available in different laboratories and
the qualifications of Biological Safety Officers: in time n should in effect estab-
lish a register of approved laboratories. It should also review experimental
protocols regularly as part of a continuing assessment of precautions which

• Report of the Working Party on the Laboratory Use of Dangerous Pathogens,
paragraph 61.

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[455]

may need to be changed as the subject develops. In particular, the GMAG
should assess any new methods of physical or biological containment that may
be developed by laboratories and consider whether they would justify major
modifications of practice. Such assessment would need to be on the basis not
only of submitted documents but also of independent technical evaluation and
validation and all interested laboratories should be kept informed of such
developments. A procedure for the acceptance by the GMAG of new methods
of containment and of disabled strains might be introduced. The GMAG
should publish an annual report and be ready to advise on general matters
connected with the safety of genetic manipulation, including health monitoring,
for which it should be able to call upon the experience of epidemiologists, and
the training of staff.

5.5 At first sight, there would seem to be a case for assigning to the existing
DPAG the functions which we envisage for the GMAG. But those functions
go considerably beyond the current activities of DPAG and the factors to be
considered in assessing genetic manipulation experiments are different from
those where dangerous pathogens are involved. The control of dangerous
pathogens involves the application of well-known precautions against a small
number of easily identifiable and well characterised agents. With genetic
manipulation on the other hand the hazards and the precautions to be taken
will depend on the detail of the experiment being undertaken. It will therefore
be necessary for the GMAG to scrutinise indi\idual scientific proposals in
detail and perhaps to establish a dialogue with the scientists concerned about,
for example, particular details of the conditions in the laboratory concerned.
It seems to us that the roles and methods of working of the proposed GMAG
and of the existing DPAG will be so different that the combination of the two
roles as the responsibility of a single group would reduce the efficiency with
which both tasks were carried out. We therefore recommend that the GMAG
should be separate from the DPAG but that, because comparable laboratory
containment measures are key safety features in both fields, there should be
liaison between the two groups: in particular, if a proposed genetic manipula-
tion experiment involved the use of a dangerous pathogen in the DPAG’s
Category A, then DPAG procedures for control would apply, although the
GMAG would clearly need to be involved as well.

5.6 We envisage the following stages in the consideration of a proposal for
an experiment involving genetic manipulation:

i. discussions within the laboratory both of scientific merits and of
potential hazards. The laboratory's Biological Safety Officer and a
properly constituted and representative safety committee should have
key roles to play and the discussions should lead to provisional
conclusions about the desirability of conducting the experiment and
about the containment category into which the experiment should
fall;

ii. if as a result of these discussions there is no doubt that the proposed
experiment belongs to Category I or II the GMAG should be notified
immediately, but work could proceed under the appropriate conditions
as specified in the code of practice;

iii. if the discussions suggest that the proposed experiment falls into
category III or IV, reference must be made to the GMAG for advice
before a final decision to undertake the experiment is taken;

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[456]

iv. a proposal referred to the GMAG will be examined for the detail of
the proposed experimental protocol and of the physical facilities and
safety measures at the laboratory concerned. After such considera-
tion the GMAG would either:

(a) advise that there would be no objection to the work proceeding
as proposed ; or

(b) advise that there would be no objection if specified precautions
were adopted; or

(e) advise that the experiment could not be undertaken safely.

5.7 It will be important for rapid assessments to be made of category I and II
protocols which are reported to the GMAG so that any inconsistencies in a
local decision can be quickly corrected The GMAG will therefore need a
scientific secretariat able to react quickly to protocols (consulting a member
of the GMAG as necessary) and to deai directly with a laboratory if it seems
necessary to question a local decision and to ask for delay pending consideration
by the GMAG. Such cases may be rare but the possibility emphasises the
need for speed and flexibility in the procedures for transmitting ads ice to
laboratories.

5.8 The protocols of experiments likely to fall into category III or IV will
need more thorough consideration by the GMAG. possibly at a regular meeting
of the whole group, taking into account:

i. the nature of the experiment, with special reference to the biological
factors referred to in Section 2;

ii. the facilities at the laboratory concerned. An inspection may be
necessary for this purpose in the early stages until a register of
approved laboratories (paragraph 5.4 above) is established;

iii. the experience, ability and training of the research workers and
technicians and of the Biological Safety Officer; and

iv. the arrangements for monitoring the health of staff.

5.9 Formulation of advice on protocols for experiments in category III or IV
may take some time and could in general proceed in parallel with a laboratory's
preparations and planning But if a voluntary system is to maintain the
conifidence and co-operation of the scientists concerned, it is important that the
time taken should be kept to a minimum and should only rarely exceed three
months.

5.10 The efficacy of the advisory machinery recommended above will depend
on the willingness of laboratories to accept and act on central advice. Our
consultations with both academic and industrial scientists convince us that
scientists will in fact welcome and be ready to comply with authoritative
guidance from the centre.

Statutory control

5.11 On the basis in paragraph 5.10 above, the advisory system we describe
would in practice amount to a system of control broadly comparable to that
now operating through the DPAG for laboratories working with dangerous
pathogens. Some of our witnesses urged that there was a need for specific
statutory powers similar to those advocated by the Working Party on the
Laboratory Use of Dangerous Pathogens (paragraph 5.2 above). We carefully
considered these views and set out our conclusions below.

IV-17

[457]

5.12 Wc noted that the Health and Safety at Work Act lays a clear duty on
the employer to protect his employees and also to avoid hazard to the public.
We were advised that in the event of legal action a court, in considering whether
an employer had taken all reasonably practical steps, would be likely td give
great weight to whether he had sought or taken advice from the Genetic
Manipulation Advisory Group once it was set up. The Health and Safety
Executive also has powers of inspection to ensure compliance with requirements
for the safety of workers and the public. These existing powers and duties
arising from the Health and Safety at Work Act already provide a safeguard to
the public. We were advised that as an additional measure, regulations could
be made under the Act to require laboratories to submit experimental protocols
and appropriate supporting information to the GMAG and we recommend
that this should be done. Given such a requirement, it seems very unlikely
that the advice of the GMAG would be disregarded.

5.13 The Health and Safety at Work Act does not however cover hazards to
the plant and animal populations and it seems unlikely that existing powers
available to the Agriculture Departments could be invoked to provide any
necessary statutory controls in this field. In any case, if statutory control is
to be envisaged it may be desirable, on the analogy of the recommendations of
the Working Party on the Laboratory Lse of Dangerous Pathogens referred to
in paragraph 5.2 above, to envisage some consolidating legislation. Such
specific legislation might be directed simply towards compulsory consultation
with the GMAG or perhaps extend to a system of licensing for laboratories.
A practical difficulty is that a definition of the work to be controlled (for
example, on the lines in paragraph 1.3 above) would almost inevitably become
outdated as the science developed and as new techniques emerged. Such a
difficulty could be met by a provision that the work suoject to control should
be specified in regulations which could be amended as necessary more readily
than major legislation.

5.14 We recommend that the system of voluntary control we have described
should be established as quickly as possible since we believe this could provide
immediate and effective control of the hazards while permitting valuable work
to proceed safely. The operation of this system will enable the Government
to consider the desirability and practicability of introducing specific consolidating
legislation at a later date.

Procedure

5.15 We have considered whether the GMAG should tender its advice direct
to laboratories or to a Government department. We understand that it is
intended that laboratories wishing to work with dangerous pathogens will
submit their applications to the appropriate Health or Agriculture Department
and that the Department concerned will reply after consulting the DPAG
and other interested departments: but in our view this analogy should not be
pressed too far for the reasons we have discussed in paragraph 5.5 above. The
role we see for the GMAG will be a scientific advisory one requiring it to
maintain close and continuing contact with the laboratories where the work is
being done. The GMAG will need to be aware of new developments in the
science of genetic manipulation and in health monitoring, training and other
safety related matters and it will need to be able to respond quickly to request
from laboratories for advice on these topics. This is rather different from the
role of the existing DPAG, which is essentially running a licensing system for
laboratories working with dangerous pathogens. Because of possible doubts

IV-18

[453]

about what should W within the remit of the GMAG and of the need for speed
and flexibility in dealing with a succession of protocols, each of w hich will need
to be reviewed bv scientific experts, we consider that it would be best if the
GMAG is an independent advisory body dealing directly with the laboratories
concerned. It would certainly be appropriate for the GMAG to come under
the aegis of a Government department which could for example provide a
secretariat and supporting services, and it would be necessary tor the GMAG
to keep appropriate Government departments informed of the advice given
to laboratories.

5.16 We would in any case expect Government departments. Research
Councils and other grant-giving bodies to make it a condition of granting funds
for genetic manipulation research that institutions and individual investigators
should follow the advice of the GMAG and conduct their experiments in
accordance with the procedures recommended. We would also hope that all
scientific papers in this field would include a statement of both the physical
and biological containment measures involved in the experiments.

6. RECOMMENDATIONS
We recommend that:

i. experiments in genetic manipulation, conducted in appropriate
conditions of physical and biological containment, should be
encouraged (1.3):

ii. further work should be done on the development and characterisation
of disabled organisms and that any which are developed should be
made freely available to all workers in the held (1.6);

iii. no genetic manipulation experiment should be undertaken in con-
tainment conditions less stringent than those used for work with
common pathogens (2.8):

iv. the code of practice in Appendix II should be adopted as a basis for
the conduct of these experiments (3.1);

v. every laboratory conducting these experiments should have a safety
committee and a Biological Safety Officer (3.4);

vi. appropriate training should be made available and be required for
all research workers, technicians and biological safety officers in
genetic manipulation laboratories (4.2);

vii. a Genetic Manipulation Advisory Group (GMAG) should be estab-
lished to advise on appropriate precautions for the conduct of these
experiments (5.3);

viii. the GMAG should be separate from the Dangerous Pathogens
Advisory Group (DPAG) although there should be liaison between
the two groups (5.5);

ix. a system of voluntary control should be established as quickly as
possible (5.14);

x. regulations should be made under the Health and Safety at Work
Act to require laboratories to submit experimental protocols to the
GMAG (5.12);

(Numbers in brackets refer to paragraphs in the report)

IV-19

[459]

7. CONCLUSION

We see the system of advice and control we have proposed as providing a
framework within which progress can be made in an exciting and important
new field of science that offers great potential benefit. Provided that the
system operates flexibly so that advice to laboratories can be made available
quickly and so that there can be a rapid response to new developments (with
a view for example to modification of precautions if necessary), we believe that
scientists will welcome and act on authoritative guidance from the centre. We
think that it may be necessary for the Government to consider the introduction
of specific statutory powers to control genetic manipulation but that a decision
on this should be deferred until there is experience of the operation on a
voluntary basis of the system which we recommend.

IV- 20

[460]

Appendix V

T h‘ e Committee on Genetic Expo rime n tot . > n

' A SCIENTIFIC COMMITTEE OF THE INTERNATIONAL COUNCIL OF SCIENTIFIC UNIONS

FROM THE CHAIRMAN 0- W J Whelan Biochemistry-UMED PO Box 520875 Miami. Florida 33152 USA
Phone 305-547-6265 Cable BiOQuimica Miami Tele* 519308

THE INTERNATIONAL COUNCIL OF SCIENTIFIC UNIONS
History

The International Council of Scientific Unions (ICSU) is the successor to the
first truly global association of scientists, the International Research Council, a body
formed under the auspices of the Allied Powers in 1919 and with membership originally
restricted to the Allied Powers, certainneutral countries and international Scientific
Unions.

The unions themselves represent individual scientific disciplines - chemistry,
astronomy, geography, pharmacology , etc. Their infrastructure is via the scientists of
the nations in which that science is in a developed state. Adherence to the union is
usually via the national academy, as in the U.S., sometimes via the national society for
that discipline.

The International Research Council was dissolved in 1931, to be replaced by
ICSU, an organization now open to scientists from throughout the world. The structure
of ICSU, with its dual membership of national academies (or research councils) and
international scientific unions is unique, and provides an effective mechanism for en-
suring international cooperation in science.

Composition and Government

The ICSU of 1977 is an international non-governmental scientific organization
composed of 18 autonomous international Scientific Unions and more than 60 National
Members, i.e., academies of science, research councils or similar scientific institutions.

The General Assemhl y , the highest authority of ICSU, is composed of representa-
tives of the Scientific Unions, the National Members and the Scientific and National
Associates. At its biennial meetings, the General Assembly elects officers, ratifies
the nominations of the Scientific Unions to the General Committee, elects the representa-
tives of the National Members, approves the creation or dissolution of Committees and
Commissions, and determines the general policy of the Council.

The ICSU General Committee meets annually to review the international scientific
scene, .0 study scientific problems, to encourage and coordinate cooperative activities
between the Unions and other parts of the Council, and to determine priorities among the
scientific activities of the Council. The General Committee consists of the Officers, a
single representative from each of the Member Unions (currently 18) and representatives
(currently 11) of the National Members. P

- ihe Executive Board, consisting of the President, the Vice-President, the Secretary-

eneral, the Treasurer, the Past President, and four ordinary members, directs the affairs
of the Council between sessions of the General Assembly.

The Council has a Secretariat located in Paris which assists the Secretary-
General, and the other Officers as necessary, in the administration of the Council.

(A flowsheet showing the structure of ICSU and its associated bodies is
omitted here.]

V-l

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Aims and Objectives

The main purpose of ICSU is "encourage international scientific activity for
the benefit of mankind" (Statute 3a). The primary means by which ICSU fulfills this
objective is to initiate, design and coordinate international scientific research pro-
grams, as, for example, the International Geophysical Year (IGY) and the International
Biological Program (IBP). In addition, ICSU acts as a focus for the exchange of ideas,
the communication of scientific information, and the development of standards in method-
ology, nomenclature and units. The various members of the ICSU family organize inter-
national conferences, congresses, symposia, summer schools, and meetings of experts in
many parts of the world, as well as general assemblies and other meetings to decide
policies and programs.

Committees and Commissions of ICSU are created to facilitate and coordinate
collaborative research programs in interdisciplinary areas which are not completely
under the aegis of one of the Scientific Unions, such as Antarctic, Oceanic, Space and
Water Research, Problems of the Environment, etc.. Activities in areas common to all the
Unions, such as teaching of science, numerical data, science and technology in develop-
ing countries, etc., are also coordinated by committees.

The ICSU family issues a wide range of publications including newsletters,
handbooks, proceedings of meetings, congresses and symposia, professional scientific
journals, data compilations and standard references.

Finances

ICSU itself operates on a current budget of about $650,000, Its member
unions and commissions have an income of about $4 M,

The income to ICSU comes from its unions, who pay 2-5% of their own dues,
from the national members and from cooperating organizations such as UNESCO, which
makes an annual subvention, 55% of which is made over to the member unions, the re-
mainder to ICSU's committees and commissions. It is becoming increasingly common for
the intergovernmental organizations to finance targeted objectives, while the level of
the general subvention decreases.

Relations with Other International Organizations

ICSU has cooperated with UNESCO since the latter's inception in 1946. UNESCO
influence and the intellectual resources of the Unions have assured success in studies
of numerous problems of mutual interest, such as the International Indian Ocean Expedi-
tion, Hydrological Decade, UN 1ST ST , Geological Correlation, etc.

Cooperation also occurs with EC0S0C, WMO, FAO, WHO, IAEA and ITU, as noted in
the flowsheet.

Examples of Programs and Services

Inter-union activities of a major and long-term nature are under the control
of Scientific Committees. These are formed whenever:

1. The work of the Scientific Committee is of major interest to not less than
three Scientific Unions.

2. The task of the Scientific Committee requires the formation of a strong Com-

v-2

[462]

mittee to carry out the said task.

3. The programme of the said task is of a long-term nature.

Examples of current Scientific Committees are those on :

Antartic Research (SCAR), founded by ICSU in 1958 to take advantage of the
excellent international scientific cooperation that had developed during the Inter-
national Geophysical Year. SCAR is in a unique position to assess the status of
scientific knowledge related to practical problems referred to SCAR by the consultative
meetings of the Antarctic Treaty. Matters upon which SCAR advice is sought, and for
which some 20 years' accumulation of knowledge has proved invaluable, cover such problems
as the disposal of nuclear waste in the ice-sheet, biological resources of the southern
oceans and the likely impact on the environment of exploration of exploitation of minerals.

Space Research (COSPAR). Founded in 1958, COSPAR's membership includes 12
ICSU unions and 34 national scientific institutions.

COSPAR contributes to the development of several space-based observational
systems. In particular, those in the field of meteorology and pollution monitoring have
special practical benefits. Through the dissemination of information on the use of earth
survey data from spacecraft, COSPAR participates in the transfer of knowledge on how these
data can be used for the purpose of national development. Although it is impossible to
evaluate the effects of COSPAR's activity in pecuniary terms, it is evident that coordinated
actions in specific areas of research permit important savings in time and money for the
scientific community. The universality of COSPAR activities contributes to the promotion
of peaceful international and interdisciplinary cooperation.

v-3

[463]

THE COMMITTEE ON GENETIC EXPERIMENTATION

ICSU appointed an ad hoc group in 1975 to advise whether recombinant DNA
research was an area in which ICSU should become involved. W.J. Whelan was the
chairman and his committee's report is appended as Annex 1. There was a unanimous
recommendation that ICSU establish a Scientific Committee with the objectives of
serving as a source of advice to governments and non-governmental bodies alike, to
review safeguards and other technical matters, to foster training and scientific exchange
to be a medium through which national, regional and other international bodies might
communicate and to be vigilant regarding the possibilities of deliberate and inadvertent
dispersal of agents constructed by recombinant DNA techniques.

The General Assembly of ICSU, meeting at the U.S. National Academy in
October 1976, unanimously accepted this recommendation and widened the scope of the
committee to include genetic experimentation in general.

The membership of COGENE has now been assembled and is as follows:

Eight members of COGENE have been appointed by seven ICSU unions and six
members by the ICSU Executive Board. Four inter-governmental organizations have
appointed observers.

A. A. Bayev (USSR)

IUB

P. Berg (USA)

IUPAC

G. Bernardi (France)

ICSU

S.N. Cohen (USA)

ICSU

S. Glover (UK)

IUBS

H.N. Munro (USA)

IUNS

K. Murray (UK)

IUPAB

N. Notani (India)

ICSU

R. Riley (UK)

IUBS

A.M. Skalka (USA)

IUPHAR

C. Steinberg (Switzerland)

IUIS

J. Tooze (BDR)

ICSU-Secretary

I. Watanabe (Japan)

ICSU

W.J. Whelan (USA)

ICSU-Chai rman

fers are: .

A. Bozzini

FAO

A. A. Buzzati-Traverso

UNEP

S. Passman

UNESCO

K. Bogel

WHO

V. Sgaramella

WHO

The draft terms of reference of COGENE are appended as Annex 2. These are
the terms recommended by COGENE for adoption by the General Committee at its next meeting

COGENE held its first meeting in Paris on 20-21 May 1977. It was decided that
there are three areas of recombinant DNA activities in which COGENE might immediately
play a useful role. Working groups were appointed to study and advize on these topics.
Their reports will form the basis of actions to be taken at the next meeting of COGENE.

V-4

[464]

The working groups and their convenors arc:

Recombinant DNA Guidelines S.N. Cohen

Risk Assessment A.M. Skalka

Training and Education K. Murray

The question of appointing national members of COGENE will be considered at
the next meeting. As an interim measure, both to provide a means of communication with
the National Members of ICSU and to enable the working groups to gather information on
recombinant DNA activities, interested National Members have been invited to name a
correspondent knowledgeable in such activities.

V-5

[4651

ANNEX 2

TERMS OF REFERENCE OF

THE COMMITTEE ON GENETIC EXPERIMENTATION (COGENE)

This is the draft constitution of COGENE, as recommended by COGENE to the
General Committee of ICSU for approval at its meeting in Budapest on 8-9 September
1977.

I. PURPOSES AND OBJECTIVES

COGENE is a Scientific Committee of ICSU, established to serve as a non-
governmental, interdisciplinary and international council of scientists and as a source
of advice for the benefit of governments, inter-governmental agencies, scientific
groups, and individuals, concerning recombinant DNA activities.

Among its purposes shall be:

a) to review, evaluate and make available information on the practical and
scientific benefits, safeguards, containment facilities and other technical matters,

b) to consider environmental, health-related and other consequences of
any disposal of biological agents constructed by recombinant DNA techniques,

c) to foster opportunities for training and international exchange, and

d) to provide a forum through which interested national, regional and
other international bodies may communicate.

COGENE shall also consider, if necessary, other related activities which may give
rise to public concern.

II. MEMBERSHIP

The composition of COGENE shall be as follows:

a) representatives designated by each international union federated in
ICSU which desires to participate in the work of the Committee, and

b) members appointed by the General Assembly to achieve appropriate
geographical representation and liaison with other bodies active in the field.

CCGENE may appoint subordinate bodies to assist in discharging its tasks.

III. FUNCTIONS

To accomplish its stated purposes and objectives, the Committee shall direct its
attention especially to the following tasks:

1. POLICY CONSIDERATIONS

a) To take note of official actions in relation to recombinant DNA.

V-6

[466]

b) To provide expert advice on policy matters, including the establishment
and harmonization of national guidelines, in order to facilitate international
cooperation in research in this field and to ensure appropriate safety measures.

c) To cooperate closely with other international organizations in order to
reach all scientific disciplines concerned.

d) To foster the development of an informed public opinion in relation to
research on recombinant DNA.

2. INFORMATIONAL AND TECHNICAL SERVICES

A) i he Committee shall, insofar as is practicable and useful, collect and
make available information about recombinant DNA activities, for example:
beneficial applications; evaluation of hazards; ethical and legal issues; physical,
chemical and biological containment for safe conduct of experiments; sources of
technical advice, equipment and materials; identification of laboratories engaged in
research on recombinant DNA; national and international repositories of host and
vector systems.

b) The Committee should encourage the universal availability of suitable
host and vector systems for use in recombinant DNA experiments.

3. TRAINING AND EDUCATION

The Committee shall promote training in the techniques of recombinant
DNA research and in the appropriate safety procedures, since those engaged in
recombinant DNA activities should be conversant with the practical application of
safety guidelines and advanced experimental techniques. These opportunities should
be created in the first instance for those who do not, at the national or regional level,
have access to training programmes. These programmes might include: (0 practical
courses, (ii) fellowships, (iii) workshops, and (iv) lecture tours.

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[467]

Appendix VI. A

WORLD HEALTH ORGANIZATION
ORGANISATION MONDIALE DE LA SANTfi

FACILITATION AND SAFETY IN THE
INTERNATIONAL TRANSFER OF RESEARCH MATERIALS

Report of WHO/NIH (USA) Consultations, Geneva, 14 - 17 September 1976

CONTENTS Page

List of participants 2

Introduction ................. 3

PART I. Facilitation and safety in the international transfer

of research materials [omitted . . • • • • • • • . 3 & 8]

PART II. Safety measures in microbiological practice ....... 8

Summary of Recommendations (for PART I and PART II) 10

References XI

Fig. 1. - Proposed label for infectious substances consignments .... 12

Annex 1 - Class 4 Pathogens: Classification by Center for Disease Control, USA 13

Annex 2 - Category A Pathogens: Report of British Working Party .... 14

Annex 3 - List A: Notifiable diseases of the International Office of Epizootics 15

Annex 4 - Proposed objectives for Working Groups of the WHO Special Programme

on Safety Measures in Microbiology ......... 16

The issue of this document does not constitute
formal publication. It should not be reviewed,
abstracted or quoted without the agreement of
the World Health Organization. Authors alone
are responsible for views expressed in signed
articles.

Ce document ne constitue pas une publication.
II ne doit faire I'objet d’aucun compte rendu ou
rdsumd ni d'aucune citation sans I’autorisation de
I’Organisation Mondiale de la Sante. Les opinions
exprimdes dans les articles signds n’engagent
que leurs auteurs.

VI-1

[468]

LIST OF PARTICIPANTS

Dr W. Arber, Abteiling Mikrobiologie , Biozentrum, K1 \ngel bergs t rasse 70, 4056 Basel, Switzerland

Dr G. Berencsi, Institute of Microbiology, Sommelweis Medical University, 1092 Budapest, Hungary

Mr W. Bruce, Disease Security Officer, Animal Virus Research Institute, Pirbright , Woking,

Surrey GU24 ONF, United Kingdom

Mr C.H. Collins, Public Health Laboratory, Dulwich Hospital, London SE22 8QF, United Kingdom

Dr R. Fontanges, Division de Microbiologie , Centre de Recherches du Service de Sante des
Armees, 108 Boulevard Pinel, 69272 Lyon Cedex 1, France

Dr W.J. Gartland, Office of Recombinant DNA Activities, National Institute of General Medical
Sciences, National Institutes of Health, Bethesda , Maryland 20014, United States of America

Dr R.J. Harris, Microbiological Research Establishment, Porton Down, Salisbury,

Wiltshire SP4 0JC, United Kingdom (CHAIRMAN)

Dr W. Heine, Central Institute for Laboratory Animals, Lettow-Vorbeck-Al lee 57, Postfach 910345,
3000 Hannove r 91, Federal Republic of Germany

Dr T. Holme, Head, Department of Bacteriology, Karolinska Institute, S-10 501 Stockholm 60,
Sweden (RAPPORTEUR)

Dr K.M. Johnson, Special Pathogens Branch, Center for Disease Control, Atlanta, Georgia 30333,
United States of America (RAPPORTEUR)

Dr M.A. Koch, Robert Koch Institute, Bundesgesundhe i tsamt , Postfach, 1000 Berlin

Dr 1. N'asz, Professor of Microbiology, Semmelweis Medical University, 1092 Budapest, Hungary
Om E -CHAIRMAN)

Dr A. Oya, Director, Department of Virology 4 Rickettsiology , National Institute of Health,
2-10-35 Kamiosaki, Shinagawa-ku, Tokyo 141, Japan

Dr J.H. Richardson, Director, Office of Biosafety, Center for Disease Control, Atlanta,

Ceorgia 30333, United States of America

Dr W. Schumacher, Ministry for Youth, Family and Health, Deutschherrenstrasse 87, 53 Bonn-
Bad Godesberg, Federal Republic of Germany

Dr V. Sgaramella, Lab. Gen. Bioch. Evoluz., C. N. R., 27100 Pavia, Italy

Dr M. Valle, Department for Viral Vaccines, Central Public Health Laboratory,

Mannerhe imint ie 166, SF-00280 Helsinki 28, Finland

Dr F. Waldvogel, Hopital Cantonal, 1211 Geneva 4 , Switzerland

Dr R.G. Wanner, Associate Director for Environmental Health and Safety, Division of Research
Services, National Institutes of Health, Bethesda , Maryland 20014, United States of America

Representatives from other Organizations

Food and Agriculture Organization of the United Nations, Animal Production and Health Division,
Rome , Italy (Dr H. Konigshofer)

International Air Transport Association, P.0. Box 160, 1216 Cointrin, Geneva, Switzerland
(Mr H. Kerkhoven, Mr P.A. Lecomte)

European Molecular Biology Organization, Postfach 1022.40, 6900 Heidelberg 1, Federal Republic
of Germany (Dr J. Tooze)

United Nations Office at Geneva, Division of Human Rights, 1211 Geneva 10 (Mr Boiarshinov)

Secretariat

Dr P.N. Acha, Chief, Division of Disease Control, WHO/PAHO, Washington
Dr K. Bogel, Veterinary Public Health, WHO, Geneva (JOINT SECRETARY)

Dr P. Bres, Chief, Virus Diseases, WHO, Ceneva

Dr H.C. Goodman, Director, Office of Research Promotion and Development, WHO, Geneva
Mr M. Keiser, Supply Services/Shipping, WHO, Geneva

Mr V.R. Oviatt, Chief, Environmental Safety Branch, Division of Research Services, National
Institutes of Health, Bethesda, Maryland 20014, USA (JOINT SECRETARY)

Dr F.T. Perkins, Chief, Biologicals, WHO, Geneva

Vl-2

[469]

INTRODUCTION

Safety measures in the international transfer of biological research materials and
microbiological practice were discussed in Geneva from 14 - 17 September 1976 at consultations
jointly organized by the World Health Organization and the National Institutes of Health,
Bethesda, USA.

Dr Goodman, Director, WHO Office of Research Promotion and Development, and Mr Oviatt,
Chief, Environmental Safety Branch of NIH, welcomed the participants on behalf of the Director
General of WHO and the Director of the National Institutes of Health. They stressed the
necessity to improve the international transfer of infectious substances in view of recent
developments in microbiology and genetics. Since safety in the transfer of infectious
substances depends on the experience, equipment and reliability of the sender as well as of the
carrier and receiver, shipment conditions must be considered within the wider context of safety
measures in microbiology and genetics. This report proposes, therefore, in Part I, require-
ments and procedures for the international transfer of infectious or presumably infectious
substances for research or diagnostic purposes whereas, with Part II, the group recommends to
WHO specific activities on safety measures in microbiological practice.

In line with the recommendations of the Advisory Committee on Medical Research (1975 and
1976) the group stresses the major global responsibility of WHO to keep health ministries and
other appropriate authorities fully informed of developments with regard to safety, benefits
and hazards, both real and conjectural, with respect to pathogens, microorganisms and work on
DNA recombinant research. Because of the rapid developments in the field under review, the
consultants welcomed the initiative taken by WHO and expressed their hope that the actions
proposed in this report as an essential minimum will be implemented in due course through
international technical cooperation.

PART II. SAFETY MEASURES IN MICROBIOLOGICAL PRACTICE

In this second part of the report the group presents the main conclusions of discussions
on safety of microbiological practices. In particular, the group recommends that WHO initiate
discussions with other international organizations, associations and institutions on the wide
scope of problems of genetic engineering. Besides such discussions on scientific, ethical and
political aspects the group recommends to initiate without delay technical cooperation on
clearly defined programme areas. Permanent international working groups of experts and public
health officers should be established in order to address the most urgent problems of safety
measures and emergency services. These groups should consider, in particular, the needs of
developing countries and ensure harmonization of safeguards at a worldwide level.

The practice of microbiology involves a number of risks associated not only with the
handling of microorganisms but also with apparatus and chemicals. The specific concern of
this group has been the evaluation of measures for the safe handling of potentially dangerous
microorganisms, including organisms carrying new genetic combinations where the danger is
unknown .

VI-3 thru -8

[470]

The following copies were considered to be of special relevance:

1. In the United States and the United Kingdom lists of agents infective for man and animals

are in existence (3,4). The agents are grouped with reference to their danger. The group

believed that plant pathogens and agents infective for cells in tissue culture should be added
and chat each country should prepare such a list so Chat their groupings reflect specific
safety situations, e.g. yellow fever virus will only be a Class 4/Category A pathogen wherever
the insect vector is to be found.

2. A parallel list of microbial toxins should also be prepared, since the treatment of those
exposed requires the expertise of medical microbiologists. The handling of other biological
toxins such as snake venoms also requires attention but the group found that recommendations
for including such substances in this list should be left to national expertise.

3. A number of codes of practice for the safe handling of dangerous organisms, including
organisms containing new genetic combinations, have been formulated (8, 9). The group agreed
that these should be compared and presented as a framework to help che Member States of WHO to
elaborate national guidelines for safety measures in microbiology. These national guidelines
should specify the minimum requirements for the safe handling of infective microorganisms,
including those containing new genetic combinations.

4. The group believed that it should be possible for the Member States of WHO to coordinate
their codes of basic practice in the following areas:

a) Each laboratory, or group of laboratories, handling dangerous microorganisms should
have both a safety conmittee and a designated biological safety officer.

b) The biological safety officer should have experience in handling microbes or have
been specifically trained. All laboratory staff should receive instruction in safety
practice. Formal courses should be organized and meetings arranged for the presentation
and discussion of safety measures. Some countries have already arranged such meetings.*

c) The medical surveillance of staff should be mandatory. All laboratory accidents
involving the release of potentially dangerous organisms must be reported to the health
authorities. Where Class 4/Category A pathogens are being handled, the family of staff
members should be included in the medical surveillance.

d) The existing codes of practice (3, 4, 8, 9) relate the degree of physical containment
required for the laboratory to the danger from the organism. Thus work with Marburg
disease agent necessitates a maximum security laboratory whereas agents of no hazard may
be handled in a microbiological laboratory without special apparatus or equipment.

Similar codes have been applied to potentially dangerous experiments with organisms
containing new genetic combinations.

5. The group believed that it would be desirable for countries to designate reference centres
for the establishment of laboratory safety measures, the provision of advisory services, the
collection and transmission of data and the general monitoring of laboratories.

6. Paragraphs 4 (a) to 4 (d) apply equally to research involving organisms produced by
techniques of new genetic recombination, but the group wished to add the following:

a) No outright restriction on such experiments should be applied although meticulous
technique and requirements for containment must be observed.

* Information on relevant training programmes in the USA can be obtained from the Center for
Disease Control (Dr Richardson) and National Institutes of Health (Dr Gartland).

VI-9

[471]

b) The suggestion of incorporating selective genetic markers in hosts was, in general,
supported except that the markers should not involve increased infectivity, pathogenicity
or resistance to antibiotics and other drugs in clinical use.

c) Where disabled organisms and vectors can be used the degree of phycical containment
may be relaxed. The development of alternative or disabled hosts and vectors should be
given priority within the natural development of the whole field.

d) Special housing and maintenance will be required for testing the infectivity of
organisms in man, animals or plants. National centres might be provided for the testing
of organisms containing new genetic combinations, whether this was considered to be
important by the research group itself or by the laboratory safety committee.

e) Both the national and international transfer of materials of new genetic combinations
should be in the form of nucleic acid molecules without live vector or host organisms
wherever this is possible.

f) Since this is a rapidly expanding field of research the group believed that a
continuing review of safety measures was of great importance.

RECOMMENDATIONS

I. For Part I

1. WHO should submit rules for safe handling to the United Nations Committee of Experts
on the Transport of Dangerous Goods, Ninth Session, and to the Universal Postal
Union.

2. WHO should provide Member States with illustrated detailed directions for packaging.

3. WHO should propose to the United Nations and to the Universal Postal Union the adoption
of a standard label of diamond shape, size 10 cm x 10 cm, with black printing on a white
background. The upper half shows the approved Infectious Material symbol; the lower
half contains the following wording: "INFECTIOUS SUBSTANCE. In case of damage or leakage
immediately notify public health authority". This text can be translated into the
appropriate language.

4. WHO should convene further meetings as needed to keep these recommendations updated and
effective .

II . For Part II

The group was aware that there was currently great public alarm about the possibility of
epidemics (or even pandemics) arising from either the mishandling of known pathogens or the
ill-considered use of DNA recombinant techniques. Codes of practice to regulate these now
exist for the United States and the United Kingdom but the public tend to regard these merely
as an attempt at self-regulation by medical scientists.

1. The group proposes that WHO should initiate the establishment of an Advisory Group for
Safety Measures in Microbiology. It is hoped that this Group will ensure, in an
appropriate form, the participation of other organizations and institutes such as the
United Nations Division of Human Rights, the International Labour Organization, the
United Nations Environment Programme, industrial organizations, together with research
organizations, the International Council of Scientific Unions, the International
Committee for Laboratory Animals and universities. Following also the recommendation
of the Advisory Committee on Medical Research (1976), full support should be given to a
new, comprehensive assessment of the potential benefits and the conjectural risks of
recombinant nucleic acid research.

Vi-10

[472]

2. The group also proposes the establishment of four small working groups to be responsible
for the continuation and development of activities in the following areas of the present
discussion:

a) Safe transfer of infectious materials

b) Laboratory safety elements

c) Maximum containment laboratories

d) Development of emergency services

The terms of reference for each group are given in Annex 4.

REFERENCES

1. 1ATA Restricted Articles Regulations, 19th edition. International Air Transport Association,

Ceneva, September 1976.

2. Heine, W., Cnotob iotechnik , Verlag M. & Schaper, H., Hannover, 1968.

3. Classification of Etiological Agents on the Basis of Hazard, 4th edition. Center for

Disease Control, Atlanta, USA, 1974.

4. Report of the Working Party on the Laboratory Use of Dangerous Pathogens, Cmnd. 6054,

Her Majesty's Stationery Office, London, May 1975.

5. International Office of Epizootics, Annual Report of the Ceneral Director, Paris, 1976.

6. Report of the Working Party on the Experimental Manipulation of the Genetic Composition

of Micro-Organisms, Cmnd. 5880, Her Majesty's Stationery Office, London, January 1975.

7. Report of the ad hoc Committee on Recombinant DNA Molecules, International Council of

Scientific Unions, Heidelberg, 1-2 July 1976.

8. Guidelines for Research Involving Recombinant DNA Molecules, National Institutes of

Health (USA), Bethesda, June 1976.

9. Report of the Working Party on the Practice of Genetic Manipulation. Cmnd. 6600, Her

Majesty's Stationery Office, London, August 1976.

VI-11

[473]

FIGURE 1. PROPOSED LABEL FOR INFECTIOUS SUBSTANCES CONSIGNMENTS

The Cext of this label can be translated into the appropriate
language.

This label has been accepted by the United Nations Committee of
Experts on the Transport of Dangerous Goods at their Ninth meeting in
December 1976 and referred by them for publication to the United Nations
Economic and Social Council at its first meeting in 1977.

VI-12

[474]

ANNEX 1

CLASS 4 PATHOGENS

*

according to US Public Health Service classification scheme

Alastrim, Smallpox, Monkey pox, and Whitepox, when used for transmission
or animal inoculation experiments

Hemorrhagic fever agents, including Crimean hemorrhagic fever (Congo),
Junin, and Machupo viruses, and others as yet undefined

Herpesvirus simiae (Monkey B virus)

Lassa virus

Marburg virus

Tick-borne encephalitis virus complex, including Russian spring-sunraer
encephalitis, Kyasanur forest disease, Omsk hemorrhagic fever, and
Central European encephalitis viruses

Venezuelan equine encephalitis virus, epidemic strains, when used for
transmission or animal inoculation experiments

Yellow fever virus - wild, when used for transmission or animal
inoculation experiments

*

Classification of Etiological Agents on the Basis of Hazard, 4th
edition. Center for Disease Control, Atlanta, USA, 1974.

VI-13

[475]

ANNEX 2

CATEGORY A PATHOGENS

•k

according to Report of the British Working Party

CATEGORY A PATHOGENS

Organisms so dangerous as to present great risks to the health either of laboratory
workers or of the human or animal communities such that material containing live
organisms should not be accepted knowingly or held at all in this country without
authorisation.

(i) Pathogens presenting hazards primarily or significantly to the human community.

Viruses Herpes B virus of monkeys

Lassa Fever virus
Marburg virus
Rabies virus
Smallpox virus

(ii) Pathogens presenting hazards primarily to animals.

Viruses African Horsesickness virus

African Swine Fever virus
Bluetongue virus

Equine Encephalomyelites group of viruses

Foot and Mouth Disease virus

Fowl Plague viruses

Infectious Pancreatic Necrosis virus

Infectious Haematopoietic Necrosis virus

Japanese B virus

Lumpyskin Disease virus

Newcastle Disease virus

Rift Valley Fever virus

Rinderpest virus

Saint Louis virus

Sheep Pox virus

Spring Viraemia virus

Swine Fever virus

Swine Vesicular Disease virus

Teschen Disease virus

Vesicular Exanthema virus

Vesicular Stomatitis virus

Viral Haemorrhagic Septicaemia virus

Wesselsbron virus

Bacteria Aeromonas salmonicida (Furunculosis)

Flexibacler columnaris ( Chondrococcus columnaris )
Francisella tularensis

Fungus Ffistoplasma farciminosum

Protozoa Myxosoma ( Leniospura ) cerebratis (Whirling disease)

Piroplasma Theilcria, all species

Flagellates Trypanosoma cruzi (Chagas’ disease)

Trypanosoma equiperdum
Trypanosoma vivax

Not Yet Classified Agent of Ulcerative Dermal Necrosis
Agent of Erythrodermatitis

*

Report of the Working
Pathogens, Cmnd. 6054,
May 1975.

Party on the Laboratory Use of Dangerous
Her Majesty's Stationery Office, London,

VI-14

[476]

ANNEX 3

OIE LIST A

Compulsory notifiable disease as defined by the International
Office of Epizootics *

Foot-and-Mouth Disease
Rinde rpest

Contagious Bovine Pleuropneumonia

Lumpy skin disease
Anthrax

Sheep pox
Bluetongue

African Horse Sickness

Glanders

Dourine

Classical Swine Fever
African Swine Fever
Teschen Disease
Swine Vesicular Disease

Fowl Plague
Newcastle Disease

Fievre Aphtheuse
Peste Bovine

P£ripneumonie contagieuse des
bovid£s

Dermatose nodulaire contagieuse
Fifcvre charbonneuse

Clavelle

Fidvre catarrhale du mouton

Peste equine

Morve

Dourine

Peste porcine classique
Peste porcine africaine
Enc£phalomy£lite enzootique porcine
Maladie Vlsiculeuse du Pore

Pest aviaire vraie
Maladie de Newcastle

Rabies Rage

*

International Office of Epizootics: Annual Report of the General

Director, Paris, 1976.

VI-15

[477]

ANNEX 4
page 1

PROPOSED OBJECTIVES FOR WORKING GROUPS OF
THE WHO SPECIAL PROGRAMME ON SAFETY MEASURES IN MICROBIOLOGY

I. SAFE TRANSFER OF INFECTIOUS SUBSTANCES

1. The recommendations of the consultative meeting to WHO on the transport of
infectious materials should be brought to the attention of the United Nations
Committee of Experts on the Transport of Dangerous Goods for their inclusion into
Class 6.2 of the United Nations recommendations on the transport of dangerous goods.
This Committee will meet for its Ninth Session in November 1976.

2. The group will revise and update the recommendations submitted by the WHO/NIH
Consultations on Facilitation and Safety in the International Transfer of Research
Materials in the light of future developments.

3. The group will develop detailed directives for packing, shipment and reception
of infectious substances.

4. The group will solicit, both formally and informally, incidents of refusals by
carriers to transport an infectious substance which is properly packed, labelled and
documented.

5. The group will keep in contact by letter and will meet if this proves necessary.

II. LABORATORY SAFETY ELEMENTS

1. The five broad categories of concern to this working group are hazard (risk)
assessment, facility and equipment design (less than "MCL") , laboratory practice,
training and education, and employee health.

2. The immediate objectives of this group are to:

a) Establish a list of experts to serve as technical advice resources.

b) Develop methodology for risk and hazard assessment.

c) Collect available data and documents regarding the five basic concerns
listed in paragraph 1.

d) Promote establishment of a central library of training material references.

e) Collect lists of "unanswered" questions relative to laboratory-associated
infections and hazards.

3. The long-range objectives of the group include:

a) Development of an international code (standard) of practice.

b) Conduction of morbidity and mortality studies of laboratory workers by
profession and of laboratory-associated infections.

c) Determination of the need for international training programmes and development
of the same if indicated.

d) Establishment in the WHO Library of a film (video) reference and loan collection
of available materials on laboratory safety.

e) Working through WHO programmes to introduce safety practice into university
curricula by their introduction into normal class work.

VI-16

[478]

ANNEX 4
page 2

III. MAXIMUM CONTAINMENT LABORATORIES

1. The term "Maximum Containment Laboratory" (MCL) should be used to describe
the physical facilities for work with highly hazardous microorganisms.

2. The responsibilities of the working group should include:

a) A listing of agents to be contained: - natural pathogens

- novel genetic combinations

b) A summary of critical physical requirements

c) An inventory of existing "MCL" laboratories and those under construction,
providing the following information:

- physical description and age

- staffing

- kind of activity

- potential availability to others

- user evaluation of present facility

d) An inventory of existing operational procedures and safety programmes

e) To plan and conduct a workshop to review and disseminate the collected
data .

IV. DEVELOPMENT OF EMERGENCY SERVICES

1. The working group should develop and provide emergency guidelines for the
isolation and treatment of people accidentally contaminated with infectious
agents or genetic recombinants. They should also be concerned with newly-
recognized pathogens. The emergency guidelines should provide for both
transport- and laboratory-associated accidents and emergencies. These guidelines
would be available to national health authorities for adoption or development of
their own emergency procedures.

2. The guidelines should enable health authorities to:

a) Recognize whether an accidental exposure has really occurred.

b) Define the nature of the infective agent.

c) Find out whether contamination of people and animals has occurred and
provide for their complete isolation.

d) Raise additional questions in cases of exposure to recombinants,

i.e. is the agent one with an easily recognizable biological projection?
Should contaminated animals be destroyed? Should people be considered
as contagious and be isolated? etc.

e) Set up the necessary measures of decontamination.

f) Make available on an emergency basis diagnostic reagents, vaccines and
inraune sera.

3. Members of the working group will provide on request information in response
to the emergency situations outlined in this paper until such time as the
emergency guidelines are completed and published.

* * *

VI-17

[479]

Appendix VI. B

V WORLD HEALTH ORGANIZATION

ORGANISA MON MONDIALK DE LA SAN 1 £

EXCERPT

ADVISORY COMMITTEE ON MEDICAL RESEARCH

REPORT TO THE DIRECTOR-GENERAL

on its nineteenth session
held at WHO headquarters, Geneva,
13-17 June 1977

Dates for the Twentieth session: 19-23 June 1978

The i68uc of this document does not constitute
formal publication It should not be reviewed,
abstracted or quoted without the agreement of
the World Health Organization Authors alono
are responsible for views expressed in signed
articles

Ce document ne con6titue pas une publication
II ne doit faire l objet d’aucun compte rendu ou
r6sum6 ni d'aucune Citation sans I'autonsation de
('Organisation Mondiale de la Sant£ Les upmions
exprim6es dans Ie6 articles sign^s n engagent
que leurs auteurs

VI-18

[480]

Agenda item 6.6: Developments relating to the problem of safety in the handling of

microorganisms and cells employed in research and in public health practice

The ACMR received the report of a pre-ACMR meeting^ on the above subject, and endorsed
the broad outlines of the report. The ACMR reaffirmed that WHO has a global responsibility
for safety measures in microbiology, and that the issue of recombinant DNA research is only a
part of a much larger problem area. One useful outcome of the recombinant DNA controversy
was that it had focused attention on the field of laboratory safety as a whole.

The participants were:
ACMR Members

Professor 0. G. Andjaparidze, Member of the Academy of Medical Sciences of the USSR and
Director, Moscow Institute for Research on Virus Preparations, Moscow, USSR

Professor S. Bergstrom, Professor of Biochemistry, Karolinska Institute, Stockholm, Sweden

Professeur R. M. Fauve, D6partement de Biologie mollculaire, Institut Pasteur, Paris, France

Sir Gustav Nossal, Director, The Walter and Eliza Hall Institute of Medical Research,
Melbourne, Victoria, Australia (Chairman)

Temporary Advisers

Dr M. M. Kaplan, Director-General, Pugwash Conferences on Science and World Affairs, Geneva,
Switzerland

Dr V. Sgaramella, Laboratorio di Genetica, Blochimica ed Evo luzionist ica del Consiglio
Nazionale delle Ricerche, Pavia, and Professor of Molecular Biology, University of Milan,

Italy

Dr J. E. M. Whitehead, Deputy Director, Public Health Laboratory Service, Colindale Hospital,
London, United Kingdom

Representatives from other Organizations

Dr Z. Bankowski, Executive Secretary, Council for International Organizations of Medical
Sciences, Geneva, Switzerland

Dr W. Emmett Barkley, Director, Office of Research Safety, National Cancer Institute, National
Institutes of Health, Bethesda, MD, USA

Miss S. Coates, Coomittee on Recombinant DNA Molecules, European Science Foundation,
Strasbourg, France

Dr J. Tooze, Secretary, Committee on Genetic Experimentation, International Council of
Scientific Unions and Executive Secretary, European Molecular Biology Organization,

Heidelberg, Federal Republic of Germany

WHO Secretariat

Dr K. BOgel; Dr H. C. Goodman

VI-19

[481]

In commending a continued strong involvement of the secretariat in this field, the ACMR
made the following points:

1. Public health aspects, rather than detailed technical guidelines for specific research
projects, should be WHO's chief concern.

2. The need for adequate training of laboratory personnel in safe handling of microbio logica
materials was stressed.

3. Monitoring of the health of laboratory workers is an issue in which WHO may become
involved, and the secretariat should closely follow national initiatives in this regard.
Research on the monitoring technology itself will be important.

4. The strong action for improvement in the safety of shipment of infectious agents was
warmly endorsed.

5. WHO documents in the general area of genetic research should avoid the word "engineering"
which has emotional overtones, and should stress the great contributions which genetics has
already made and continues to make to human knowledge and medical science.

6. The collaboration with other organizations interested in the recombinant DNA field was a
most valuable aspect of the pre-ACMR meeting. Specifically, it may open possibilities of
strenthening the WHO Secretariat with a full-time staff member seconded from a Member State.

7. Early publication and wide distribution of the proposed brochure on genetic research was
recommended .

8. Special attention should be given to international cooperation in contingency planning
for emergency situations arising out of laboratory or transport-associated accidents.

The following recommendations, including a plan of work for 1977/78, arising from the
pre-ACMR meeting, were endorsed:

Specific recommendations for a WHO policy on genetic research

1.1 Research activity in the field of genetics should be encouraged, on account of its
potential benefits to many areas of medical and agricultural science. However, genetic and
microbiological research should be carried out with stringent and effective safeguards.

1.2 Member countries should be fully informed of the wide-ranging potentialities of genetic
research, particularly with respect to health and nutrition problems of the developing
countries.

1.3 Because of the conjectural risks associated with recombinant DNA research, authorities
should ensure that all appropriate steps are being taken for the protection of research
workers and the public.

1.4 National expert committees should be created under the aegis of the appropriate
authorities. The committees should include geneticists, microbiologists, molecular
biologists, epidemiologists, ecologists, lawyers and representatives of those responsible for
research funding and for industrial application.

1.5 The immediate task of the national committees should be the establishment of registers
of all research and production activities in genetic modification.

VI-20

[482]

1.6 The national committees, when appropriate, should elaborate guidelines for those
activities. In particular:

(a) projects involving organisms or cells derived by genetic modification technologies
should be submitted to the consnittee. Where appropriate, licensing of institutions
should be considered

(b) its examination procedures should give consideration to the importance of
confidentiality;

(c) the committee should make sure that both laboratory personnel and facilities are
adequate for the safe performance of the proposed work;

(d) local biological safety officers should be nominated and trained to assist local
safety committees so that compliance with the regulations by all workers involved is
ensured;

(e) responsibility for damage to people and property should be clearly attributable.

( f) plans should be developed to cope with laboratory-associated accidents;

(g) proper consideration should be given to relevant safety regulations in handling
and shipment of Infective substances;

(h) ethical considerations should be kept in mind, and appropriate liaison with
ethical committees established.

1.7 The national committees should also give prompt and thorough attention to the assessment
of the risks and to their minimization, for example, through the characterization, development
and use of biologically harmless or disabled host-vector systems that are made freely

aval lable.

1.8 Equal attention should be given to the exploitation of the potential benefits, with
particular emphasis on the biomedical and agricultural needs of developing countries.

1.9 The safety problems, like the potential benefits, are of international concern.
Representatives of national committees and other Interested bodies should be convened
periodically under the aegis of WHO to compare their problems and share their experience.

Among the results of these meetings could be an international forum for discussing national
guidelines and regulations, and the organization of training courses.

Reconmendatlons concerning public health aspects of microbiological safety

2.1 The draft brochure for public health services on the implications of work involving
new genetic combinations should be modified as proposed and should be printed during 1977.

2.2 Position documents should be prepared for the ACMR 1978 on the attempts to assess the
risks, now still conjectural, of recombinant DNA research and on the measures taken by
Member States to license or register laboratories or research projects not only involving
genetic engineering but highly pathogenic organisms in general.

2.3 The proposed Lorenzinl Foundation/WHO Symposium on Practical Application of Genetic
Engineering should be organized in such a way that a continuing cooperation of industries
towards a common code of practice could be expected as a major result.

VI-21

[483]

2.4 WHO should keep Member States informed of the progress made by the ICSU Committee on
Genetic Experimentation (COGENE) in the areas of risk assessment, comparison of national
guidelines for safe experimentation, and training of research workers and safety officers.

2.5 The Committee stressed the need for more adequate laboratory safety elements (staff,
facilities and equipment) in microbiological practice since the professional disciplines
working with pathogenic organisms are increasing, often without proper training in safety
measures and supervision. WHO's role, particularly with respect to the promotion of
research in developing countries, is evident. The international working group for laboratory
safety elements should further aim, therefore, to promote the implementation of codes of
practice and technical cooperation in the organization of laboratory safety services and in
the training of safety officers and research workers at the national level.

2.6 The secretariat should also place further emphasis on technical cooperation for
emergency plans and services in case of laboratory- and transport-associated accidents. The
international working group established within the Special Programme for the development of
emergency services should receive full support and prepare draft guidelines and its detailed
plan of work for a three-year period in collaboration with the working group for laboratory
safety elements.

2.7 The Committee endorsed the proposal of the secretariat to review the Special Programme
at consultations in 1978. For this purpose, a Board for the programme should comprise two
ex-o f f i c io ACMR members, the presently acting Chairman, and the four heads of the international
working groups. This Board could in future replace the ACMR Sub-Committee which finds it
almost impossible to give appropriate guidance for a Special Programme of the magnitude now
attained in the short time available. The Board would have the functions of "advisory
committee" and "steering group" recommended in previous reports and should ensure the
cooperation of all interested governmental and non-governmental international organizations.

2.8 In the area ot recombinant DNA research, various national and international institutions
have now become active. Their activities concern research coordination, application of the
new technology, comparison and harmonization of safety guidelines, assessment of risks,
ethical problems, etc. Important conclusions can be expected during the next two years.

WHO should begin to explore, therefore, the possibility of a comprehensive symposium with all
organizations involved in these subjects (e.g. FAO, ILO, UNEP, UNESCO, the International
Council of Scientific Unions (ICSU), the European Molecular Biology Organization (EMBO), the
European Science Foundation (ESF) and leading national committees) in order to assess the
potential benefits and the conjectural risks of recombinant DNA research.

2.9 The Committee noted with appreciation that NIH (USA) has developed a mechanism for the
international exchange of memoranda between experts involved in recombinant DNA research.

WHO should investigate the possibility of cooperating with such services and resources
available at the national level in order to establish an exchange of safety information
concerning the whole field of microbiology for research workers and public health services.

2.10 All the aforementioned activities are essentially part of technical cooperation with
developing countries to advance their microbiological research and practice. It would be
advisable, therefore, if very close ties could be established between the Special Programmes
for Research and Training in Tropical Diseases and for Safety Measures in Microbiology.

2.11 The Special Programme on Safety Measures in Microbiology has rapidly reached a
magnitude which calls for increased secretariat support particularly because of its importance
for developing as well as industrialized countries. It is the conviction of the ACMR that
the rapid progress made is due not only to the competent coordination through its secretary,
but also to the apparent need of this Special Programme to meet the most urgent needs of
Member States in an area which, as historically seen, has been unchecked for many decades and
now has become a prominent problem.

VI-22

[484 J

The ACMR concluded that it is impossible for WHO to discharge its heavy responsibilities
in this area with the limited staff and funds so far allocated. The Committee recommends
to the Director-General that consideration should be given to the obvious need of the Special
Programme for a full-time staff member or for a full-time epidemiologist/microbiologist
seconded for a period of at least one year by a country closely participating in this Special
Programme. Furthermore, WHO should explore the possibility of contractual technical
agreements in order to carry out various components of the programme.

VI-23

1485]

Appendix VII

United States Arms Control and Disarmament Agency

WASHINGTON. D.C. 20451

December 10, 1976

Dr. Joseph G. Perpich

Associate Director for Program Planning
and Evaluation

National Institutes of Health
Bethesda, Maryland 20014

Dear Dr. Perpich:

At the first meeting of the Interagency Committee
on Recombinant DNA Research, a statement was requested
from ACDA concerning the Biological Weapons Convention.

We believe that a recent speech by the United States
representative to the Geneva-based Conference of the
Committee on Disarmament, Ambassador Joseph Martin, Jr.,
provides the information. (A copy is enclosed. The
relevant portion is found on pages 5-7.)

Briefly stated, the use of recombinant DNA molecules
for weapons purposes is prohibited by the Biological Weapons
Convention. However, the Convention does not restrict re-
combinant DNA activities that are justified for peaceful
purposes .

Sincerely,

Robert Mikulak
ACDA Representative
Interagency Committee on
Recombinant DNA Research

Enclosure :

As stated.

Vll-1

[486]

THE UNITED STATES DELEGATION
TO THE

CONFERENCE OF THE COMMITTEE ON DISARMAMENT

CAUTION: CHECK

AGAINST DELIVERY

STATEMENT TO BE MADE BY AMBASSADOR JOSEPH MARTIN, JR.
AT THE 721ST PLENARY MEETING ON
TULSuAY, AUGUST 17, 1976

tlr. Chairman:

Last week the United States participated In active and
Interesting Informal meetings with experts on the question of the
prohibition of the development and production of new types of
weapons of mass destruction.

The proposal by the Soviet Union, involving a comprehensive
ban, is embodied in a draft agreement set out in Document
Number CCD/511. It is elaborated to some extent, particularly
as to definitions, in Document Number CCD/51^.

The Soviet proposal raises many complex and difficult
questions. In light of the uncertainties remaining to be
resolved or clarified further, many of the views expressed by
the U.S. expert in the informal meetings were of a preliminary
character .

It is the long-standing practice of the United States to
contribute in a constructive manner to technical examination of

Vll-2

[487]

a wide range of arms control and disarmament Issues in this
Committee. Entry into such examinations has not necessarily
implied endorsement of any particular proposal. This applies
to the proposal of the Soviet Union.

The Government of the United States has not come to a
policy decision regarding possible treaty prohibitions on new
types of weapons of mass destruction.

We entered into these informal discussions for the specific
purpose of seeking clarification of the issues involved in order
to move toward an informed opinion on the Soviet proposal. The
four days of discussion were instructive to the United States
delegation. We noted a considerable range of topics to be taken
into account in further studies before we formulate our views.

The United States reorgnizes the dangers posed by weapons
of mass destruction — new or existing -- and is prepared to
consider any practical steps toward overcoming such dangers.
However, experience suggests that examination of diverse new
types of weapons of mass destruction would require substantially
different approaches to questions of definition, scope, and
verification on a case-by-case basis. We will continue to take
this experience into account in the process of judging the
feasibility and desirability of a comprehensive agreement on
new types of weapons of marc destruction.

VII-3

[488]

Representatives of the Soviet Union, ana others, have
recommended considering the question of definition of the tern
'new t^.es cf weapons of mass destruction.1’ This, of course, is
an impcrtant aspect of the subject at hand, and we would be
prepared to consider suggestions for defining the term. We
recognise, however, that legitimate questions can be raised
about the feasibility of developing a rigorous definition that
could SM've as a sound basis for formal international restraints.
There would be a significant risk that any formal definition
either would be too general or ambiguous to be applied
effectively to individual cases or would be so specific or rigid
that unforeseen scientific developments deserving to be covered
would be unintentionally excluded. We believe these consider-
ations should be kept in nind as we proceed on the question of
defining weapons of mass destruction.

The term 'weapons of mass destruction1 has been in general
international usage for about 30 years. It seems clear to me
that this general usage places nuclear, chemical and biological
weapons in the category of weapons of mass destruction." There
is, of course, the potentiality, in principle, of creating new
types of weapons with characteristics comparable to these
generally recognized types.

We should take careful note of the fact T;b\t important
■ crr'tional agreements have already been brought into force
4 'Vr - - llmitatl.crr on ’■'••.clear weapons, chemical weapons --d

VII-4

f 489 J

biological weapons. Furthermore, the process of searching for
further limitations continues, including serious current efforts
in the CCD.

The United States attaches great importance to the existing
agreements and negotiations applicable to nuclear, chemical and
biological weapons. We are strongly of the view that discussions
of the very broad proposal of the Soviet Union should not in any
way, directly or indirectly, suggest dilution of the integrity
or scope of application of existing treaties or negotiations
concerned with specific kinds of weapons of mass destruction.

Any international agreement on arms limitation or
disarmament should be subject to appropriate modernization in
light of new scientific findings and other new facts. However,
my Government would find it difficult to accept statements
that appear to call into question the scope of already existing
agreements. These statements could be very harmful to the
general cause of arms control and disarmament, by casting
unwarranted doubt on the effectiveness of such agreements.

As to current negotiations, I point to intensive efforts
in the CCD at this time on a prospective convention concerning
environmental modification.

VII-5

[490]

We can also take note of continuing and active discussions
of limitations on chemical warfare.

.o agreements already in existence, a particularly
important example is the Biological Weapons Convention.

In this connection, I would like to draw the attention of
v,.ie Committee to some statements made in December 197^, during
the ratification process of the BW Convention in my country.

The Foreign Relations Committee of the D.S. Senate inquired
whether the Biological Weapons Convention would prohibit future
types of biological warfare which might employ techniques beyond
the current "state of the art". The Executive Branch responded
that :

"The Biological Weapons Convention would prohibit any
future type of warfare which employed biological agents
or toxins, regardless of when the agent was first
developed or discovered. This also applies to weapons,
equipment and means of delivery. In other words, the
Convention prohibits not only existing means of biologi-
cal and toxin warfare but also any that might come into
existence in the future."

VII-6

[491]

Permit me to recall that on August 5, 1970, the
distinguished biologist. Dr. Joshua Lederberg, pointed out to
the CCD the advances being made in molecular biology and
expressed his concern that newly developed techniques in this
field might eventually be used to create infective agents against
which no credible defense is possible. The most widely-
discussed techniques are often referred to as "genetic
engineering" but technically are properly known as
"recombinant DNA techniques''. These are techniques for joining
two different p' •'s of DNA in the laboratory to produce new
DNA sequences, known as recombinant DNA molecules. In
principle, such techniques could be used to design radically
new viruses for biological warfare purposes.

When advances in science and technology are made, it is
natural to ask about their possible use for hostile purposes
and whether or not such uses are prohibited or restricted by
existing international agreements. In the case of potential
use of recombinant DNA molecules for weapons purposes it is
our view that such use clearly falls within the scope of the
Convention's prohibition. This interpretation is based upon
the negotiating history as well as the explicit language of
the Convention, and we believe that it is shared by the other
signatories .

VI i- 7

[492]

I do not believe it is possible to read the Biological
Weapons Convention and come to any other conclusion. The
Preamble states that the States Parties are ’’determined , for
the sake of all mankind, to exclude completely the possibility
of bacteriological (biological) agents and toxins being used as
v/eapons.' The intent of Article I which begins, 'Each State
Party tc this Convention undertakes never in any circumstances
. . .''is equally forceful and clear. To take a more restricted
view of the Convention's scope would rob the Convention of much
of its value and could even lead States to call into question
the continued viability of the Biological Weapons Convention.

These were the views of the United States when the
Convention was negotiated and ratified. They are still its
views today. This is a natter of great importance to my Govern-
ment and one on which doubt cannot be permitted to exist.

Mr. Chairman, the United States took note of many
signifies .v points raised by various delegations in the
informal meetings. We will give all of them careful study.

In conclusion, Mr. Chairman, I must repeat that the
proposal of the USSR presents us with a very complex subject.

The subject is no*- only complex. It also remains conceptually
elusive because it not yet been placed on a stable
'ourdation of clear *-.u t°nerallv accepted understandings.

VI 1-3

[493]

Any efforts toward further development must strive to
establish such a foundation and, at the sane time, assure a
harmonious relationship with existing agreements and negotiations.
Within the confines of these complementary requirements, the
United States will continue to view the proposal of the Soviet
Union as an initiative to be given careful and constructively
critical attention.

VII-9

[494]

Appendix VIII

i:\cerpted from The Recombinant-DNA Debate by Dr. Clifford Grobstein.
Copyright ®19y7 by Scientific American, Inc. All rights reserved.

BKXOGtCAL CONTAINMENT (FOR E COU MOST SYSTEMS ONLY)

e*t

E*2

EX 3

DNA kom nonpadiogonc proAaryotaa rtm
nokjrwt, tit»«ng» ganaa «• E CO t

P-asnaa o t Mcmcpi^o. Dna kom neat
cat rial nae^aPy aacnanpa oanat amr
f cot it ptotmo or tacmct/w
3#nor-a :ow*ni ’■*■■*> arm o> t
DNA mqihw « xr 9$ n»c*m
»/« and cnaracten.iad Npfiar a. an at
CQntamman/ era raqunafl |

ONA fcoffl oNr cotd-Qioodad mniM end

DNA kom noomtfyont ooto-tsoodad

ONA from modarata-naa ptncgtrac

nanmd n na laoorMory tor Im>
n to grarMorai

yt E cot

DNA kom plants laacapt ptants contanrg
tixat' paVtogana v proOLrcmg tnom

xrxamgax proaaryotaa rial

ONA from ttsa na* paPioqaisc proaaryotaa

rat oatatai aicnanga ganaa MX £ oof

Qraanata Dna kom nonpmaia
auaarvotaa *Fpr or qaraaa Bna nai a
aaa nan W pa»cant pixa Ngnat a»as ot

DNA kom
do not tat/d|
E cot

ONA from plant nrusas
OaantM Dna ton prmatas I For
jroanaN N> i w N" W

p/t lya> am o< corumrt
ara 'aqua ad i

Waantd or oacKnoonaoa ONA kpm neat
cat rat do not latxiN t^anat
arnaa a*f cot i» »a>t imN

- ncratw ptregtsty

or OCOOOKO potano# pt np»i tagrjr
avaN of comanmant art 'aounad )

DNA trow nonpafioganc proaaryotaa
•at do not Mud) aataga ganaa

aa> E cot

QNA kgm pant rn^aa

Ptasnaa or oacarppnaoa ONA kom non
<*» —» y* 7* *^trot Ural

■*1 to* 1* *«t« a j nia rat

■a nc.ntt Mraotntty or

ONA kom amdryonc pnmaa IIH.1 or

DNA kom norartr«nc pnmaa I

tgg!« ? Nona am
<* cpntannant at 'aNrrad I

ONA kom oaar mammakan caaa
ONA kom badi

ONA kom amOryorac nonanOryonc or
•• 0* ’

"I

ONA kpm anmai rruaaa |t oorad ONA

garaaT

ONA kom noflaka naa patiogarac
pronaryotat rat do not naaxaay aicnanga
ganaa •» E cot

ONA kom aramat nrutas i« gonad DNA
doaa not conar Harmful aanaa.

ONA kom nonamoryorac pnmaaa kaaua
’DNA kpm anmai .ruaaa < ctpnad DNA

SHOTGUN EXPERIMENTS USING E COU X-12 OR ITS DERfV
ATIVES AS THE MOST CELL ANO PLASMlOS BAC1
OR other viruses as the Cloning vectors

Mi H EXPERIMENTS IN WHICH PURE CHARACTERIZED FOREIGN

ATIVES AS THE HOST CELL ANO PLASMOS BACTERIOPHAGES GENES CaRRiE 0 By PlaSM'OS SACTERiOPhaGES OR'^ThER

VIRUSES ARE Cloned IN £ CPU < '? OR ITS DERIVATIVES

I Hr Hi PJ, n a mi At tmayoat rapar-

ItlMI IXAMflXJ at ik« pkyatcal a ad H.lagtraf caatataaaat ra-
i aal fartk tm Ms MH pMfci fa raarrk a.at->ta« ra-
l ON A aataaata. I aaad la laaa. 1*7*. at pira a tfca ta-
aMidaa. afcak rrpMcad tk«

at tka yarattal rkto

ONA ny «a nk C:
•attia. A

DNA

a. kaawa a rickaagr ( .. a wtek F. call la l
at.faada at |aad lat.ralary prartH. ipty
nitHkaaMatka itaatirt C-1J ktiniiry aaaa at £. rati Ikta-
m«irai raatataaaat Hr it mu Bataaaa Na. mrtaa Na MH
fntrUan praarrNa MPtpMi nattaiia at la rraaaa phyak
.1 .ad tuilipral raataaaaat fa tacnaatag Ira at aadmatat rlak.
»• »*• i- ItcTMMi frwi l«#V !• b«« rtekt.)

k» H £12 rWart U tW m W ‘ertf
ihMi |n«(k ItfMli iMlfd to

- a 1 . A 1.1 II ■ at a Ha

■ ■•WlWtJ ■MIIM;

ad fa aa UUnd kaat-rarta iyv

t addklaaal MM

Na .ary kaMad a. II > Mary at A* fardMa aad
kaak.acaa qdia kaa yat kaaa rarttMd ky Na NTH a atkdytag

Na U) crunk Na racn I DNA iiparf iak aaa la praf

raa la Na t'A aaa E. eati Ha lyataa ara aN a fra asrafidaaa

leatady aaty Na patyaaa aad IVad kail)
ra^atra Mtkar Na H m Na N led at pkyatcal cMklaaaM. Es-
yanant «ak plaal ika kaal tyalaaa ka». apatial pAydral na

Na fl

VIII-1

[495]

Appendix IX

WIPO

BP/ PCD /2 • Rev.
ORIGINAL : English

DATE: June 15, 1977

WORLD INTELLECTUAL PROPERTY ORGANIZATION

GENEVA

BUDAPEST TREATY

ON THE INTERNATIONAL RECOGNITION OF
THE DEPOSIT OF MICROORGANISMS FOR THE PURPOSES OF PATENT PROCEDURE

Documents Issued after the Diplomatic Conference
held in Budapest from April 14 to 28, 1977

SUMMARY AND MAIN ADVANTAGES
OF THE BUDAPEST TREATY

Memorandum prepared by the International Bureau

Background

1. Disclosure of the invention is a generally recognized requirement for the
grant of patents. Normally, an invention is disclosed by means of a written
description. Where an invention involves a microorganism, or the use of a
microorganism, which is not available to the public, such a description is
not sufficient for disclosure. That is why in the patent procedure of an
increasing number of countries it is necessary not only to file a written
description but also to deposit, with a specialized institution, a sample of the
microorganism. Patent offices are not equipped to handle microorganisms,
whose preservation requires special expertise and equipment to keep tnem viable,
to protect them from contamination and to protect health or the environment
from contamination. Such preservation is costly. The furnishing of samples
also requires specialized expertise and equipment.

IX-1

[496]

2 When protection is sought in several countries for an invention involving a
microorganism or the use of a microorganism, the complex and costly procedures of
the deposit of the microorganism might have to be repeated in each of those
countries. It was in order to eliminate or reduce such multiplication of deposits
that the United Kingdom proposed, in 1973, that the World Intellectual Property
Organization (WIPO) should study the possibilities of one deposit serving the
purposes of all the deposits which would otherwise be needed. The proposal was
adopted by the Executive Committee of the Paris Union for the Protection of
Industrial Property (Paris Union) at its 1973 session. Thereafter, the Director
General of WIPO convened a Committee of Experts, which held three sessions, in
1974, 1975 and 1976. In the first session of the Committee of Experts, the matter
was thoroughly discussed and the general outlines of a solution emerged; moreover,
the Committee of Experts found that the solution required the conclusion of a
treaty. In its second session, the Committee of Experts examined the first draft,
prepared by the International Bureau of WIPO. of a Treaty on the International
Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure,
and of Regulations thereunder. In its third session, the Committee of n^Perts
examined a second draft of the said Treaty and Regulations, also prepared by the
International Bureau of WIPO.

3. The third draft of the sAld Treaty and Regulations was prepared by the
International Bureau on the basis of the conclusions reached by the Committee
of Experts at its third session. It was published on October 14, 1976, and
served as a basis for the deliberations of the Diplomatic Conference which,
under the title of the ‘Budapest Diplomatic Conference for the conlusion of

a Treaty on the International Recognition of the Deposit of Microorganisms
for the Purposes of Patent Procedure," was convened by the Director General
of WIPO, organized by him in cooperation with the Government of Hungary, and
held in Budapest from April 14 to 28, 1977.

4. All States members of the Paris Union were invited to the Budapest Diplomatic

Conference with the right to vote; the following 29 were represented: Australia,

Austria, Bulgaria, Czechoslovakia, Denmark, Egypt, Finland, France, German
Democratic Republic, Germany (Federal Republic of), Hungary, Indonesia, Italy,
Japan, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Senegal
Soviet Union, Spain, Sweden, Switzerland, United Kingdom, United States of America,
Yugoslavia. Several States not members of the Paris Union, which showed an inter-
est in the preparatory work, were invited to be represented by observers; two of
them — the Democratic People's Republic of Korea and Pakistan — were so represented.
The Interim Committee of the European Patent Organisation (EPO) was represented by
an observer.

5. Several non-governmental organizations interested in the subject matter of
the Budapest Diplomatic Conference were Invited as observers and the following
eleven were represented: Committee of National Institutes of Patent Agents (CNIPA)

European Federation of Agents of Industry in Industrial Property (FEMIPI) , Council
of European Industrial Federations (CEIF) , International Association for the Protec
tion of Industrial Property (AIPPI) , International Chamber of Commerce (ICC) , Inter
national Federation of Patent Agents (FICPI) , International Federation of Pharma-
ceutical Manufacturers Associations ( IFPMA) , Pacific Industrial Property Associa-
tion (PIPA) , Union of European Patent Attorneys and Other Representatives Before
the European Patent Office (UNEPA) , Union of Industries of the European Community
(UNICE) , World Federation for Culture Collections (WFCC) .

6. The Budapest Diplomatic Conference adopted a treaty consisting of 20 Articles
under the title of the "Budapest Treaty on the International Recognition of the
Deposit of Microorganisms for the Purposes of Patent Procedure" (hereinafter

IX- 2

[497]

referred to as "the Treaty") on April 27, 1977. It bears the date of April 28, 1977,
the day on which it was opened for signature. The said Conference also adopted
Regulations consisting of 15 Rules under the title of "Regulations under the Budapest
Treaty on the International Recognition of the Deposit of Microorganisms for the
Purposes of Patent Procedure" (hereinafter referred to as "the Regulations"). Thev
are annexed to the Treaty.

Summary of the Treaty and the Regulations

7. Substantive Provisions. The main feature of the Treaty is that a Contracting
State which allows or requires the deposit of microorganisms for the purposes of
patent* procedure must recognize, for such purposes, the deposit of a microorganism
with any "international depositary authority" (see Article 3 (1) (a) ) , irrespective
of whether such authority is on or outside the territory of the said State. In
other words, one deposit, with one international depositary authority, will suffice
for the purposes of patent procedure before the national patent offices (called
"industrial property offices" in the Treaty) of all of the Contracting States and
before any regional patent office (e.g. , the future European Patent Office) if such
a regional office declares that it recognizes the effects of the Treaty (see
Article 9(1)).

8. What the Treaty calls an "international depositary authority" is a scientific
institution — typically a "culture collection" — which is capable of storing micro-
organisms. Such an institution acquires the status of "international depositary
authority" through the furnishing by one of the Contracting States of assurances
to the Director General of WIPO to the effect that the said institution complies
and will continue to comply with certain requirements (see Article 6(1)), including,
in particular, the fact that it will be available, for the purposes of the deposit
of microorganisms, to any "depositor" (person, firm, etc.), that it will accept
and store the deposited microorganisms and that it will furnish samples thereof
to anyone entitled to such samples but to no one else. The said assurances may
be furnished also by certain intergovernmental industrial property organizations
(see Article 9 (1) (a) ) ; the future European Patent Organisation could qualify as
such an organization.

9. The Regulations contain detailed provisions (see Rule 11) on who is entitled —
and when — to receive samples of the deposited microorganism. The depositor him-
self has a right to a sample at any time (see Rule 11.2 (i) ) . He may authorize any
third party (authority, natural person, legal entity) to ask for a sample and such
a third party will receive a sample upon producing such an authorization (see
Rule 11.2(ii)). Any "interested" industrial property office to which the Treaty
applies may ask for a sample and will receive one; an industrial property office
will mainly be regarded as "interested" where the microorganism is needed for the
purposes of patent procedure before the said office (see Rule 11.1). Any other
party may obtain a sample if, roughly stated, an industrial property office to
which the Treaty applies certifies that, under the applicable law, such a party
has the right to a sample of the given microorganism; the elements of the certi-
fication are provided for in detail to ensure that the maximum extent of caution
will be exercised by the industrial property office before it issues a certifica-
tion (see Rule 11.3(a)). An alternative to this certification procedure consists

* All references in this paper to patents are to be understood as references
also to inventors' certificates.

IX- 3

[498]

in the industrial property office communicating, from time to time, to the inter-
national depositary authorities lists of the accession numbers of those micro-
organisms which are referred to in patents granted by them, the effect of such
communication being that the said authorities may furnish samples of such micro-
organisms to anyone; it is to be noted that it follows from the above that this
alternative is not available before the grant and publication of the patent (see
Rule 11.3(b)).

10. The Treaty and the Regulations also contain provisions allowing for what is
called a "new* deposit where no samples of the originally deposited microorganisms
can be furnished (see Article 4) ; permitting the termination or limitation of the
status of international depositary authority at the will of the Contracting States
where the said authority does not, or does not fully, comply with its assumed
duties (see Article 8) ; requiring that all microorganisms deposited with an inter-
national depositary authority be transferred to another such authority if the
former is about to cease functioning as such (see Rule 5.1); regulating the content
of the receipt that each International depositary authority is required to give to
the depositor for the deposited microorganism (see Rule 7) ; providing for the
testing of the viability of the deposited microorganisms and the issuance of
viability statements (see Rule 10); allowing the international depositary author-
ity to charge a fee for each deposit, the fee covering the minimum 30 years during
which the deposited microorganism must be stored (see Rules 9 and 12) ; providing
for a special status and a special role for certain intergovernmental organizations
(see Article 9) .

11. Administrative Provisions. The States party to the Treaty constitute a Union
(see Article 1) ("the Budapest Union”). Only States members of the Paris Union may
become members of the Budapest Union (■•• Article 15(1)). The Budapest Union has
an Assembly consisting of the States members of the said Union, the main tasks of
the Assembly being to deal with all matters concerning the maintenance and develop-
ment of the Union and the implementation of the Treaty (see Article 10(2)), including
the power to amend certain provisions of the Treaty (sec Article 14) , to amend the
Regulations (see Article 12(3)) and to take away or limit the status of any given
international depositary authority (see Article 8(1)). Certain administrative tasks
are entrusted to the International Bureau of WIPO (see Article 11) . The possibility
of amending the Treaty in revision conferences is also provided for (see Article 13) .

12. It is to be noted that the Treaty contains no financial provisions. No State
can be asked to pay contributions to the International Bureau of WIPO, or for any
other purpose, on account of its membership in the Budapest Union. (The very small
costs of the International Bureau connected with the Budapest Union are part of the
budget of the Paris Union.)

final Provisions. As already stated, only States members of the Paris Union
may become members of the Budapest Union (see Article 15(1)). To become a member
of the latter, any State which has signed the Treaty must deposit an instrument
of ratification*; those which have not signed must deposit an instrument "of
accession"; such instruments must be deposited with the Director General of WIPO
(see Article 15) . Entry into force of the Treaty requires the deposit of five
Instruments of ratification or accession (see Article 16). The Treaty contains
the usual provisions on denunciation (see Article 17) and notifications (see
Article 20) .

IX-4

[499]

Main Advantages of the Treaty

14. The Treaty is primarily advantageous to the depositor who is an applicant
for patents in several countries; the deposit of a microorganism under the pro-
cedures provided for in the Treaty will save him money and strengthen his security.
It will save him money because, instead of depositing the microorganism in each
and every country in which he files a patent application referring to that micro-
organism, he will have to deposit it only once, with one depositary, with the
consequence that in all but one of the countries in which he seeks protection he
will save the fees and costs that deposits would otherwise entail. In most cases,
there will be at least one international depositary authority in the country of
the depositor, which means that he will deal with an authority which is close to
him, with which he can deal in his own language, to which he can pay the fees in
his own currency and which he may even know from personal experience; in other
words, he will be able to avoid dealing with distant authorities, in foreign
currencies and in foreign languages. He will probably have a natural trust in
that the authority will carefully preserve the viability of the deposited micro-
organism and that it will furnish samples only to those to whom it is supposed
to fqrnish them.

15. The security of the depositor is increased by the fact that, for an institu-
tion to become an international depositary authority, solemn assurances as to
the seriousness and continued existence of that institution must be given; ' such
assurances must be given by a State or by an intergovernmental organization and
they are addressed to all the member States of the Budapest Union. Consequently,
it may be expected that the assurances will be strictly respected, all the more
so since, if they are not so respected, the member States may take away from the
defaulting institution the status of international depositary authority.

16. Finally, it is to be noted, as indicated in paragraph 12, above, that adherence
to the Treaty entails no financial burden or obligations for any Government. In
some countries, this may mean that ratification of the Treaty does not require a
decision by the legislative authority but that a decision by the Government (the
executive authority) suffices.

[End of document]

IX-5

[500]

REVIEW OF FEDERAL LEGISLATION
ADDRESSED TO RECOMBINANT DNA ACTIVITIES

Page

Summary of Federal Recombinant DNA
Legislation, 95th Congress, First

Session (1977) 502

Bills and Resolutions 509

Statements by NIH Director 812

[501]

SUMMARY OF FEDERAL RECOMBINANT DNA LEGISLATION
95TH CONGRESS --FIRST SESSION

The 95th Congress, first session, which began January 4 and ended
December 22, 1977, saw the introduction of 16 bills on the topic of
recombinant DNA. In addition, there were numerous proposed bills
that were debated and discarded without ever being formally introduced.
Four different committees held a total of 25 hearings or markup
sessions, listening to nearly 100 witnesses. Because of the intense
interest and widely differing viewpoints, no consensus was achieved
and the discussions will continue in 1978.

A few of the key figures in the legislation area are Senators Edward
Kennedy, Gaylord Nelson, Adlai Stevenson, Jacob Javits, and Harrison
Schmitt, and Representatives Harley Staggers, Paul Rogers, Ray
Thornton, Andrew Maguire, Tim Lee Carter and Olin Teague. Senator
Kennedy chairs the Subcommittee on Health and Scientific Research,
and Senator Stevenson chairs the Subcommittee on Science, Technology,
and Space. Representative Staggers chairs the Interstate and Foreign
Commerce Committee, which includes the Subcommittee on Health and
the Environment, chaired by Representative Rogers. Representative
Teague chairs the Committee on Science and Technology, which includes
the Subcommittee on Science, Research, and Technology, chaired by
Representative Thornton.

Thus far, the Kennedy and Rogers subcommittees have exercised
sole jurisdiction over legislation involving recombinant DNA issues in
their respective bodies. However, the Stevenson and Thornton sub-
committees have held a number of oversight hearings concerning
the science policy issues involved in recombinant DNA activities and
have demonstrated a strong interest in this issue. They may receive
sequential referral of any bills reported out of other committees.

A substantially amended version of S. 1217, backed by Senator
Kennedy, was reported out of the Committee on Human Resources on
July 22, 1977. In the House, H. R. 7897, sponsored by Representative
Rogers, was reported out by the Subcommittee on Health and the
Environment. Action was not completed on either bill in the First
Session of the 95th Congress.

[502]

FEDERAL DNA LEGISLATION - 95th CONGRESS, FIRST SESSION

H. Res. 131:
S. 621:

H.R. 4232:

S. 945:

H.R. 4759:

H.R. 6158:

Summary of Bills and Resolutions

This resolution proposes that the Secretary of HEW
regulate recombinant DNA activities through use of section
361 of the PHS Act. Section 361 pertains to the prevention
of the spread of communicable disease.

This bill would require the Secretary of HEW to regulate
recombinant DNA research. A license for each project,
issued by the Secretary, would be mandatory. The penalty
for a willful violation would be a fine of up to $10,000,
imprisonment for up to one year, or both. Liability for
harm would be imposed without regard to fault. No patents
would be allowed unless the NIH Guidelines had been strict-
ly adhered to and full disclosure of the process made.

This bill would establish a temporary, one-year study
commission to make a report on recombinant DNA issues.

This bill would require the Secretary of HEW to regulate
recombinant DNA research. The NIH Guidelines would serve
as the scientific standards. The penalty for a violation
would be a fine of up to $10,000, imprisonment for up to
one year, or both. The penalty for a willful violation
would be a fine of not less than $10,000, Imprisonment for
not less than one year, or both. The bill would also
establish a temporary, 27-month study commission to make
a report on recombinant DNA issues.

This bill would require the Secretary of HEW to regulate
recombinant DNA research. The NIH Guidelines would serve
as the scientific standards. A license for each facility,
issued by the Secretary, would be mandatory. The penalty
for a violation would be a fine of up to $1,000. There
would be a limit of ten P-4 centers. State/local govern-
ments would be able to impose their own requirements if
they were at least as strict as the comparable Federal
standards .

This is the Administration bill and was introduced in the
Senate as S. 1217: The bill would require the Secretary

of HEW to regulate recombinant DNA activities. The NIH
Guidelines would serve as the scientific standards. A
license for each facility, issued by the Secretary, would
be mandatory. The penalty for a violation would be a fine

[503]

of up to $5,000. The penalty for a willful violation
would be a fine of up to $5,000, imprisonment for up to
one year, or both. State/local governments would be able
to impose their own requirements if they were at least as
strict as the comparable Federal standards.

H.R. 7418:

This bill would require the Secretary of HEW to regulate
recombinant DNA activities. The NIH Guidelines would serve
as interim standards. A license for each facility, issued
by the Secretary, would be mandatory. Local Biohazards
Committees would be established to review each project and
all license applications. A national advisory committee,
with several operational mandates, would also be established.
The penalty for a violation would be a fine of up to $50,000.
The penalty for a willful violation would be a fine of up to
$50,000, or imprisonment for not more than one year, or both.
State/ local governments would be able to impose their own
requirements if the requirement is necessary to protect
health or the environment and is required by compelling
local condition.

H.R. 7897:

(As reported by the Subcommittee on Health and the Environ-
ment) . This bill would require the Secretary of HEW to
regulate recombinant DNA activities. The NIH Guidelines
would serve as the interim standards. A license for each
facility, issued by the Secretary, would be mandatory.

Local Biohazards Committees would be established to review
each project and all license applications. The penalty
for a violation would be a fine of up to $5,000. The
penalty for a willful violation would be a fine of up to
$50,000, imprisonment for not more than one year, or both.

A national advisory committee, with some operational func-
tions, would be established. State/local governments would
be able to impose their own requirements if the require-
ments were necessary to protect the local health or the
environment. A temporary, 2-year study commission would
be established to make a report on recombinant DNA issues.

S. 1217:

(As reported by the Committee on Human Resources) . This
bill would establish an 11-member, free-standing commission
to regulate recombinant DNA activities. A license for each
facility, issued by the Commission, would be mandatory.
Institutional Biohazards Committees would be established
to approve each project at a licensed facility. The penalty
for a violation would be a fine of up to $10,000. State/
local governments would be able to impose their own require-
ments if the requirements were stricter than the comparable
Federal standards and were "material and relevant" to
local health and environmental concerns. The Commission
would, within two years, study and report on recombinant
DNA issues.

[504]

S. 1217:

(Amendment #754: an amendment in the nature of a

substitute for S. 1217). This bill would require the
Secretary of HEW to regulate recombinant DNA activities.
The NIH Guidelines would serve as the interim standards.

A license for each facility, issued by the Secretary,
would be mandatory. Local Biohazards Committees would
be established to review each project and all license
applications. The penalty for a willful violation would
be a fine of up to $2,000. A national advisory committee
would be established. Other Federal agencies would need
the permission of the Secretary before promulgating any
regulation in this area. State/local governments would
be able to impose their own requirements only if the
Secretary granted such permission and if the requirement
were stricter than the comparable Federal standard, were
necessary to protect health or the environment, and were
required by compelling local conditions.

[505]

FEDERAL DNA LEGISLATION-95TH CONGRESS, FIRST SESSION

BILLS AND RESOLUTIONS

House

Bill

Chief Sponsor

Date

H. Res. 131

Richard Ottinger (D-N.Y.)

1/19/77

H.R.

3191

(Identical

to

S. 621)

ft It II

2/7/77

H.R.

3591

( "

It

" )

It II II

2/16/77

H.R.

3592

( "

ft

" )

II II II

2/16/77

H.R.

4232

Stephen Solarz (D-N.Y.)

3/1/77

H.R.

4759

Paul Rogers (D-Fla.)

3/9/77

H.R.

4849

(Identical

to

H.R. 4759)

II 11 It

3/10/77

H.R.

5020

(Identical

to

S. 621)

Ottinger

3/14/77

H.R.

6158

(Administration bill)

Rogers

4/6/77

H.R.

7418

II

5/24/77

H.R.

7897

II

6/20/77

Senate

S. 621

Dale Bumpers (D-Ark.)

2/4/77

S. 945

Howard Metzenbaum (D-Ohio)

3/8/77

S. 1217

(Administration bill)

Edward Kennedy (D-Mass.)

4/1/77

S. 1217

(As reported: accompanied
by Report 95-359)

II II 11

7/22/77

S. 1217

(Amendment 754 in the
nature of a substitute)

Gaylord Nelson (D-Wisc.)

8/2/77

[506]

FEDERAL DNA LEGISLA.TION-95TH CONGRESS, FIRST SESSION

HEARINCS ANT) MARK UPS

House

Subcommittee

II

on

•i

Hcalt

II

• 1

••

II

II

ii

• •

•1

ii

• 1

It

•i

• 1

II

•i

II

and the Environment*

M •• »l

M •• ft

•« II II

II II II

•• II

•I II II

3/17/77

3/18/77

3/19/77

5/3/77

6/7/77

6/8/77

6/10/77

Subcommittee on Science,

II II II

•I II II

•I II II

II II II

•I II II

II II II

II II II

•I II II

II II II

II II II

II II II

Research, and TecJjnology^

•I tl II

•I II II

II II II

•I II II

II II II

II II II

II I* II

II II II

II II II

II II II

I'M]

3/31/77

4/27/77

4/28/77

5/3/77

5/4/77

5/5/77

5/25/77

5/26/77

9/7/77

9/3/77

Committee on

II II

Interstate and Foreign Commerce*

10/12/77

10/18/77

Senate

1

Subcommittee on Health and Scientific Research-^
Committee on Human Resources1 2 3

Subcommittee on Science, Technology, and Space4

II •• a II II II II

II II II II II II

4/6/77

6/16/77

11/2/77

11/3/77

11/10/77

1) Chaired by Representative Paul Rogers (D"Fla.)» this Subcommittee is
part of the Interstate and Foreign Commerce Committee which is chaired
bv Representative Harley Staggers (D-W. Va.).

2) Chaired by Representative Ray Thornton (D-Ark.)» this Subcommittee is
part of the Committee on Science end Technology which is chaired by
Representative Clin Teague (D-Te::as) .

3) Chaired by Senator Edward Kennedy, this Subcommittee is part of the
Committee on Human Resources which is chaired by Senator Harrison
Williams (D-N.J.).

4) Chaired by Senator Adlai Stevenson (D-Ill.), this Subcommittee is
part of the Committee on Commerce, Science, and Transportation which is
chaired by Senator Warren Magnuson (D-Wash.)»

[507]

FEDERAL DNA LEGISLATION-95TH CONGRESS, FIRST SESSION

STATEMENTS BY NIH DIRECTOR

House Date

Subcommittee on Health and the Environment of the House

Committee on Interstate and Foreign Commerce 3/17/77

Subcommittee on Science, Research, and Technology of the

House Committee on Science and Technology 3/31/77

Senate

Subcommittee on Health, Senate Committee on Labor and

Public Welfare 9/22/76

Subcommittee on Health and Scientific Research of the

Senate Committee on Human Resources 4/6/77

Subcommittee on Science, Technology, and Space; Committee

on Commerce, Science, and Transportation 11/8/77

[508]

95th CONGRESS
1st Session*

H. RES. 131

IX THE HOUSE OF REPRESENTATIVES

January 19, 1977

Mr. Ottincer submitted the following resolution; which was referred to the
Committee on Interstate and Foreign Commerce

RESOLUTION

Whereas unregulated research involving recombinant DXA is
potentially devastating to the health and safety of the
American people,

Whereas the guidelines issued by the Xational Institutes of Health
governing research involving recombinant DXA apply only
to research supported by the Xational Institutes of Health,
and

Whereas the Secretary of Health, Education, and Welfare has
the authority under the Public Health Service Act to make
and enforce regulations to prevent the introduction, trans-
mission, or spread of communicable diseases: Xow, there-
fore, be it

1 Resolved, That it is the sense of the House of Rep-

2 resentatives that the Secretary of Health, Education, and

3 Welfare, pursuant to the authority of the Secretary of Health,

V

[509]

1 Education, and Welfare under section 361 of the Public

2 Health Service Act (42 U.S.C. 264), should, 'by April 30,

3 1977, cause to be published in the Eederal Register pro-

4 posed regulations governing all research involving recom-

5 binant DNA.

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[510]

Dot u COXGRKSS
1st Session

S. 621

IN TIIE SENATE OF THE UNITED STATES

February 4 ( legislative day, February 1), 1977

Mr. Bumpers introduced the following bill; which was read twice and referred
to the Committee on Labor and Public Welfare

A BILL

To provide for guidelines and strict liability in the development
of research related to recombinant DNA.

1 Be it enacted by the Senate and House of Representa-

2 fives of the United States of America in Conyress assembled,

3 That this Act may be cited as the “DNA Research Act of

4 1977”.

5 FINDINGS

6 Sec. 2. The Congress finds that —

7 (1) research related to recombinant DNA is of

8 exceptional importance, with many potential benefits,

9 but also with major uncertainties regarding its possible
10 effects on human beings and other organisms ;

n

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(2) research involving recombinant DXA may
involve a high risk not only to those pursuing such
research but to the population in general ;

(3) it is essential in the public interest that the
health and welfare of the Xation be protected by requir-
ing that all research conducted with regard to recom-
binant DXA comply with strict standards of performance
and safety ; and

(4) all research with regard to recombinant DXA
is either in interstate connnerce or substantially affects
such commerce and regulations by the Secretary of
Health, Education, and Welfare as contemplated by this
Act are necessary and proper to prevent and eliminate
burdens on interstate commerce, to regulate such com-
merce effectively, and to protect the health and welfare
of the Xation.

DEFINITION'S

Sec. 3. As used in this Act the term —

( 1 ) “recombinant DXA” means molecules that con-
sist of different segments of deoxyribonucleic acid which
have been joined together in cell-free systems to infect
and replicate in some host cell, either autonomously or on
an integrated part of the host’s genome ;

(2) “Secretary” means the Secretary of Health,
Education, and Welfare ;

(3) “commerce” means —

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(A) any activity which affects commerce be-
tween any State or territory and any place outside
thereof, and

(B) commerce within the District of Columbia
or within any territory.

ESTABLISHMENT OF GUIDELINES
Sec. 4. The Secretary shall promulgate guidelines for
research involving recombinant DNA within ninety days
after the date of euactment of this Act.

APPLICATION OF GUIDELINES
Sec. 5. The guidelines promulgated under section 4
shall apply to all research involving recombinant DNA that
is in or affects commerce, or that is carried on in any area
subject to the jurisdiction of the United States.

PATENT RESTRICTIONS

Sec. 6. Notwithstanding any other law, no patent shall
be granted on any procedure or organism which results from
research on recombinant DNA unless all applicable guide-
lines have been strictly adhered to, and full and complete
disclosure has been made with regard to such process or
organism.

CIVIL LIABILITY'

Sec. 7. Persons carrying out research involving recom-
binant DNA shall be strictly liable, without regard to fault,
for all injury to persons or property caused by such research.

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PROHIBITED ACTS

Sec. 8. Xo person shall solicit or accept, directly or
indirectly, any specimen for research which shall involve
recombinant DXA or conduct such research unless there
is in effect a license for such research issued by the Secretary.

LICENSES

Sec. 9. (a) The Secretary is authorized to Issue licenses
for research involving recombinant DXA.

(b) A license issued by the Secretary under this section
shall be valid for a period of one year, or such shorter period
as the Secretary may establish for any research project and
may be renewed in such manner as the Secretary may
prescribe.

(c) The Secretary may require payment of reasonable
fees for the issuance and renewal of licenses but the amount
of such fee shall not exceed an amount necessary to defray
the reasonable costs of reviewing and passing upon applica-
tions for licenses, and of enforcing guidelines.

(d) Licenses may contain such terms and conditions as
the Secretary finds are necessary and appropriate to carry
out the purposes of this Act.

APPLICATION REQUIREMENT

Sec. 10. A license shall not be issued by the Secretary
unless —

(1) the application therefor contains or is accom-

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panied by such information as the Secretary finds neces-
sary; and

(2) the Secretary determines that such facility will
be operated in accordance with the guidelines promul-
gated under section 4.

REVOCATION, SUSPENSION, OK LIMITATION
Sec. 11. A license issued by the Secretary may be re-
voked, suspended, or limited if the Secretary finds, after
reasonable notice and opportunity for a hearing to the li-
censee, that such licensee —

( 1 ) has been guilty of misrepresentation in obtain-
ing a license;

(2) has engaged or attempted to engage or rep-
resented himself as entitled to perform any research
or procedure or category of procedures not authorized
by the license;

(3) has failed to comply with guidelines with re-
spect to research facilities or personnel prescribed bv
the Secretary pursuant to this Act;

(4) has failed to comply with reasonable requests
of the Secretary for any information or materials the
Secretary deems necessary to determine continued eli-
gibility for its license or continued compliance with the
Secretary’s guidelines;

(5) has refused a request from the Secretary" or any

S. 621 2

[515]

G

1 Federal officer or employee designated by the Secretary

2 for permission to inspect the research facility and its

3 operations and pertinent records at any reasonable time ;

4 or

5 (6) has violated or aided and abetted any violation

6 of any provision of this section or of any guideline pro-

7 mulgated hereunder.

8 UNSEASONABLE HAZARDS TO TUBLIC HEALTH

& Sec. 12. Whenever the Secretary has reason to believe

10 that a continuation of any activity by a research facility fi-
ll censed under this section would constitute a significant hazard

12 to the public health, the Attorney General may, at the Sec-

13 retary’s request, bring suit in the name of the United States
H in the district court for the district in which such facility is

15 situated to enjoin continuation of such activity and upon a

16 proper showing, a temporary injunction or restraining order
I" against continuation of such activity pending issuance of a
1® final order may be granted without bond.

19 INSPECTION AUTHORITY

20 Sec. 13. (a) In order to enforce this Act, officers, em-

21 ployees, or agents designated by the Secretary, upon present-

22 ing appropriate credentials to the owner, operator, or agent

20 in charge of a facility engaged in research involving re-

21 combinant UNA, are authorized —

[516]

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( 1 ) to enter, at reasonable times, any such research
facility ; and

(2) to in>]>ect, at reasonable times and in a reason^
able manner, such research facility and all equipment,
materials, containers, records, files, papers, processes,
controls, facilities, and other things therein, in order to
determine whether such research facility is being oper-
ated in compliance with this Act, the guidelines issued
hereunder, and the terms of any license that may have
been issued with respect to such research facility.

(b) T’pon completion of any such inspection and prior
to leaving the premises, the officer, employee, or agent
making the inspection shall give to the owner, operator, or
agent in charge a report summarizing any conditions or
practices observed by him by which, in his judgment, indi-
cate a violation of this Act or any guideline or license issued
hereunder. Fie shall also prepare a written report of his
findings and send it to such owner, operator, or agent within
a reasonable time.

VIOLATIONS AND PENALTIES
Sec. 14. (a) Any person who willfully violates any
provision of this Act or any guideline promulgated hereunder
shall be guilty of a misdemeanor and shall, upon conviction
therefor, be subject to imprisonment for not more than one

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year, or a fine of not more than $10,000, or both. For pur-
poses of computing such fine, each day .of a continuing
violation shall be deemed a separate violation. In addition,
the court may order that the person or entity convicted be
ineligible for F ederal funds, in whole or in part, for a period of
up to five years.

(b) No research facility employer shall discharge any
employee or otherwise discriminate against any employee
with respect to his compensation, terms, conditions, or priv-
ileges of employment because the employee has —

(A) commenced, caused to be commenced, or is
about to commence or cause to be commenced a pro-
ceeding under this Act;

(B) testified or is about to testify in any such pro-
ceeding ; or

(C) assisted or participated in or is about to assist
or participate in such a proceeding or in any other action
to carry out the purposes of this Act.

[513]

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[51Q]

95th COXGEESS * V A <r\r\

^ H. R. 4232

IN THE HOUSE OF REPRESENTATIVES

March 1, 1977

Mr. Solarz introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce

A BILL

To establish a commission to study and evaluate the scope and
consequences of genetic research and engineering'.

1 Be it enacted by the Senate and House of Representa-

2 fives of the United States of America in Congress assembled,

3 SHOET TITLE

4 Section 1. This Act may he cited as the “Commission

5 on Genetic Research and Engineering Act of 1977”.

6 APPOINTMENT OF COMMISSION

7 Sec. 3. (a) There is established a Commission on Ge-

8 netic Research and Engineering (hereinafter in this Act

9 referred to as the “Commission”) which shall be composed

10 of seventeen members appointed in accordance with this

11 section.

I

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(b) (1) The President shall appoint as members of the
Commission two individuals who are officials of the executive
hraneh of the Federal Government.

(2) The majority leadt-r of the Senate, after consulta-
tion with the minority leader of the Senate, shall appoint
two Senators as members of the Commission. Xo more than
one of the two Senators shall be affiliated with the same
political party.

(3) The Speaker of the House of Representatives, after
consultation with the minority leader of the House of Repre-
sentatives, shall appoint two Representatives as members of
the Commission. Xo more than one of the two Representa-
tives shall he affiliated with the same political party.

(c) ( 1 ) The President, upon the recommendation of
the majority leader of the Senate and the Speaker of the
House of Representatives and after consultation with the
appropriate health agencies of the Federal Government and
independent, nongovernmental organizations, shall appoint
as members of the Commission eleven individuals who are
not officials or employees of the Federal Government, who,
because of their knowledge, expertise, diversity of experi-
ence, and distinguished service to their professions, are
particularly qualified for service on the (Commission, and

[521]

3

1 who include representation of the following interested

2 parties :

3 (A) State and local governments ;

4 (B) members of the academic community con-

5 cerned with genetic research and engineering; and

6 (C) citizen groups and associations concerned with

7 consumer protection.

8 (2) Appointments made under this subsection shall be

9 made without regard to political affiliation.

10 (d) Members of the Commission —

U (1) shall be appointed not later than ninety daj^s

12 after the date of enactment of this Act, and

13 (2) shall he appointed for the life of the Com-

14 mission.

15 (e) One of the members of the Commission shall be

16 designated by the President as Chairperson of the Com-

17 mission. Such individual shall serve as Chairperson for the

18 life of the Commission.

19 (f) A vacancy on the Commission shall be filled in the

20 manner in which the original appointment was made.

21 (g) Xine members of the Commission shall constitute

22 a quorum, but a lesser number may hold hearings.

23 (h) The Commission shall meet at the call of the Chah>

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person or whenever nine members present a petition to the
Chairperson asking for a meeting of the Commission.

POWERS OF THE COMMISSION
Sec. 3. (a) Subject to such rules and regulations as
may be adopted by the Commission, the Chairperson of the
Commission may procure, in accordance with section 3109
of title 5, United States Code, the temporary and intermittent
services of experts or consultants. Persons so employed >liall
receive compensation at a rate to be fixed by the Commis-
sion, but not exceeding for any day (including traveltime)
the daily equivalent of the effective rate for grade GS-18
of the General Schedule.

(b) The Commission may enter into contracts with
organizations, institutions, and individuals to cam* out such
studies, surveys, or research and to prepare such reports
as the Commission determines are necessary to earn out its
duties.

(c) The Commission may use the United States mails
in the same manner and upon the same conditions as any
other Federal agency.

DUTIES OF THE COMMISSION
Sec. 4. (a) The Commission shall study and evaluate
present laws and regulations concerning genetic research
and engineering, particularly with respect to —

(1) their effect on scientific inquiry;

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(2) tlie risks of and benefits from such research
and engineering; and

(3) the promotion of 'the increased use of those
genetic research and engineering methods that mini-
mize the risks involved in such research and engineering.

(b) The Commission shall —

(1) advise, consult with, and make recommenda-
tions to, Federal agencies concerning the support and
application of genetic research and engineering;

(2) review and make recommendations with re-
spect to policies, regulations, and other requirements
of Federal agencies governing the support and applica-
tion of genetic research and engineering; and

(3) review and make recommendations with re-
spect to changes in the scope, purpose, and type of
genetic research and engineering being conducted and
methods of genetic engineering being developed by or
with support of a Federal agency.

(c) (1) The Commission shall publish an annual report
summarizing the activities and studies conducted by the Com-
mission during the preceding year and such other reports at
such other times as it deems appropriate. The Commission
shall promptly transmit a copy of any report it has published
to the appropriate committees of each House of Congress.

(2) The Commission may disseminate to the public

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such information, recommendations, and other matters re-
lating to its functions and studies as it deems appropriate.

COOPERATION OF OTHER FEDERAL AGENCIES
Sec. 5. (a) Each department, agency, and instru-
mentality of the Federal Government shall furnish to the
Commission, upon request made by the Chairperson, and to
the extent permitted by law, such data, reports, and other
information as the Commission deems necessary to carry out
its functions under this Act. All such requests shall be made
by the Chairperson of the Commission.

(b) The head of each department or agency of the
Federal Government is authorized to provide to the Commis-
sion such services as the Commission requests on such basis,
reimbursable and otherwise, as may be agreed upon by
such head and the Chairperson of the Commission.

(e) The Administrator of General Services shall pro-
vide to the Commission on a reimbursable basis such ad-
ministrative support services as the Commission may
request.

PAY AND TRAVEL EXPENSES
Sec. 6. (a) Except as provided in subsection (b),
members of the Commission shall serve without pay.

(b) While away from their homes or regular places of
business in the performance of services for the Commission,
members of the Commission shall be allowed travel expenses,

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including per diem in lieu of subsistence, in the same man-
ner as persons employed intermittently in the Government
service are allowed expenses under section 5703 (b) of title
5, United States Code.

FINAL EEPOET AND TEBMINATION

Sec. 7. (a) The Commission shall transmit to the Presi-
dent and the Congress, not later than one year after the
first day on which all members of the Commission have
been appointed, a final report containing a detailed state-
ment of the findings, recommendations, and conclusions of
the Commission, together with such recommendations as
it deems advisable (including recommendations for legis-
lation) .

(b) At the end of the ninety-day period beginning on
the day after the date the Commission submits its final
report to the President under subsection (a) , the Com-
mission shall cease to exist.

DEFINITIONS

Sec. 8. For the purposes of this Act :

(1) The term “Federal agency” means a department,
agency, or instrumentality of the Federal Government.

(2) The term “genetic research” means research into
the methods of changing or creating genetic material in
plants, animals, and human beings.

[526]

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1 (3) The term “genetic engineering” means the ap-

2 plication of methods of changing or creating genetic mate-

3 rial in plants, animals, and human beings.

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[527]

Ojtti congress

1st Sessiox

S. 945

IX THE SEXATE OF THE EXITED STATES

March S (legislative day. February 21), 1977

Mr. Metzexbattm introduced the following bill : which was read twice and
referred to the Committee on Human Resources

A BILL

To regulate the conduct and development of research related to
recombinant DXA, to establish a national commission to
studv recombinant DXA research and technology, and to
provide citizens and governmental remedies.

1 Be it enacted by the Senate and House of Bepresenta-

2 fives of the United States of America in Congress assembled,

3 That this Act may he cited as the “Recombinant DXA

4 Standards Act of 1977”.

II

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TITLE I— REGULATIONS GOVERNING TIIE CON-
DUCT AND DEVELOPMENT OF RECOMBINANT
DNA RESEARCH

PURPOSE

Set. 2. Tlu* recent acceleration of research involving
recombinant DNA has provided far-rencliing scientific ad-
vancements. While these scientific advancements promise
many far-reaching benefits, they also raise serious questions
regarding hazards to human lyings and other organisms. It
is the interest of Congress to protect the health and welfare
of the Nation by regulating the conduct and development of
recombinant DNA research.

FINDINGS

Sec?. 3. The Congress finds that:

(1) Research related to recombinant DNA raises seri-
ous questions regarding potential benefits and hazards to
human Wings and other organisms.

(2) Research involving recombinant DNA may in-
volve a high risk not only to those pursuing such research
hut to the population in general.

(3) It is essential in the public interest that the health
and welfare of the Nation be protected h\* requiring that
the conduct and development of all research involving
recombinant DNA comply with minimum Federal stand-
ards of safety and performance.

(4) It is essential in the public interest that moral,

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environmental and scientific issues involved in recombinant
DNA research be thoroughly studied and that findings and
recommendations be made to the Congress and the President.

(5) It is premature to establish a finalized policy with
respect to the advantages of continued recombinant DNA
research. Therefore, it is necessary to give the minimum
safety procedures established by the National Institutes of
Health the force of law over ail recombinant DNA research.

DEFINITIONS

Sec. 4. As used in this Act the term —

(a) “recombinant DNA” means molecules that
consist of different segments of deoxyribonucleic acid
which have been joined together in cell-free systems to
infect and replicate in some host cell, either autono-
mously or as an integrated part of the host’s genome ;

(b) “Secretary” means the Secretary of Health,
Education, and Welfare ;

(c) “person” means any individual, corporation,
governmental entity or group of individuals with similar
interests.

PROMULGATION OF STANDARDS FOR RESEARCH RELATING
TO RECOMBINANT DNA

Sec. 5. The Secretary shall, within ninety days after the
date of enactment of this Act, promulgate regulations ap-
plicable to research relating to recombinant DNA which are

[530]

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1 at least equivalent to those standards promulgated in regula-

2 tions of the Secretary on July 7, li)7G (41 Fed. Reg. 131 ) .

3 APPLICATION OF REGULATIONS

4 Sec. G. The regulations promulgated under section .">

5 shall apply to all research involving recombinant DNA that

6 is in or affects commerce, or that is carried on in any area

7 subject to the jurisdiction of the Fnited States.

8 INSPECTION AUTHORITY

9 Sec. 7. (a) In order to enforce this Act. officers, cm-

10 ployecs, or agents designated by the Secretary, upon prc-

11 senting appropriate credentials to the owner, operator, or

12 agent in charge of a facility engaged in research involving

13 recombinant DNA are authorized —

14 (1) to enter, at reasonable times, any such research

15 facility; and

1G (2) to inspect, at reasonable times and in a reason-

17 able manner, such research facility and all equipment,

18 materials, containers, records, files, papers, processes,

19 controls, facilities, and other things therein, in order to

20 determine whether such research facility is being op-

21 crated in compliance with this Act, the regulations issued

22 hereunder.

23 (b) Upon completion of any such inspection, the officer,

24 employee, or agent making the inspection shall deliver or

25 mail to the owner, operator, or agent in charge a written

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report summarizing any conditions or practices observed by
him or her which, in his or her judgment, indicate a violation
of this Act or of any regulation.

INJUNCTIVE AUTHORITY

Sec. 8. (a) Whenever the Secretary has reason to
believe that a continuation of any activity by a facility con-
ducting research involving recombinant DXA would con-
stitute a significant hazard to the public health, the Attorney
General shall, at the Secretary’s request, bring suit in the
name of the United States in the district court for the district
in which such facility or person is situated or in any district
in which such person is doing business, to enjoin contin-
uation of such activity and upon a proper showing, a
temporary injunction or restraining order against continua-
tion of such activity pending issuance of a final order may
be granted without bond.

(b) Whenever any person has reason to believe that a
continuation of any activity by a facility conducting research
involving recombinant DXA constitutes a significant hazard
to the public health, that person may bring suit in the United
States district court in which such facility is situated to enjoin
continuation of such activity and upon a proper showing,
a temporary injunction or restraining order against con-
tinuation of such activity pending issuance of a final order
may be granted without bond.

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attorneys’ fees; fees and costs of experts;

LITIGATION EXPENSES

Sec. 10. (a) For the purpo>e of this section, the term
“person” means any person defined by seetiou 4 (e) of this
title and includes a class of individuals and any individual
member of such class.

(b) Notwithstanding any other provision of law, any
party or party intervenor in a civil action shall be entitled to
recover reasonable attorneys’ fees, fees and costs of experts,
and other reasonable costs of litigation, including taxable
costs, from the defendant if —

( 1 ) the court afTords such person the relief sought

in substantial measure; or

(2) the court determines that such action served

an important public purpose.

(c) Reasonable attorneys’ fees, fees and costs of experts,
and other costs of litigation awarded under this section shall
be based upon prevailing market rates for the kind and qual-
ity of the services furnished.

VIOLATIONS AND PENALTIES

Sec. 11. (a) Any person who violates any provision of
this Act or any regulation promulgated hereunder shall be
guilty of a misdemeanor and shall, upon conviction therefor,
be subject to imprisonment for not more than one year, or a
fine of not more than $10,000, or both.

(b) Any person who willfully violates any provision of
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this Act or any regulation promulgated hereunder shall be
guilty of a felony and shall, upon conviction therefor, he sub-
ject to imprisonment for not less than one year, or a fine of
not less than $10,000, or both.

(e) No research facility employer shall discharge any
employee or otherwise discriminate against any employee
with respect to his or her compensation, terms, conditions, or
privileges of employment because the employee has —

(1) conmienced, caused to be commenced, or is
about to commence or cause to be commenced, a pro-
ceeding under this Act ;

(2) testified or is about to testify in any such pro-
ceeding ; or

(3) assisted or participated in or is about to assist
or participate in such a proceeding or in any other action
to carry out the purposes of this Act.

TITLE II— STUDY OE RECOMBINANT DNA
RESEARCH AND TECHNOLOGY
Paet A— National Commission foe the Study of
Recombinant DNA Research and Technology

ESTABLISHMENT OF COMMISSION

Sec. 201. (a) There is established a Commission to be
known as the National Commission for the Study of Recom-
binant DNA Research and Technology (hereinafter in this
title referred to as the “Commission”) .

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1 (b) (1) The Commission shall be composed of thirteen

2 members appointed by the Secretary of Health, Education,

3 and Welfare. The Secretary shall select members of the

4 Commission from individuals distinguished in the fields of

5 medicine, law, ethics, theology, the biological, physical, and
G environmental sciences, philosophy, humanities, health ad-

7 ministration, government, and public alTairs; but six (and

8 not more than six) of the members of the Commission shall

9 be individuals who arc or who have been engaged in rceom-

10 binant DNA research and shall reflect diverse opinion on

11 safety and appropriateness. In appointing members of the

12 Commission, the Secretary shall give consideration t<> recom-

13 mendations from the National Academy of Sciences and

14 other appropriate entities. Members of the Commission shall

15 be appointed for the life of the Commission. The Secretary
lb shall appoint the members of the Commission within sixty

17 days of the date of the enactment of this Act.

18 (2) (A) Except as provided in subparagraph (15),

19 members of the Commission shall each be entitled’ to receive

20 the daily equivalent of the annual rate of the basic pay in

21 effect for grade CS-18 of the General Schedule for each day

22 (including traveltime) during which they are engaged in

23 the actual performance of the duties of the Commission.

24 (B) Members of the Commission who are full-time offi-

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cers or employees of the United States shall receive no addi-
tional pa}' on account of their service on the Commission.

(C) While away from their homes or regular places of
business in the performance of duties of the Commission,
members of the Commission shall be allowed travel expenses,
including per diem in lieu of subsistence, in the same manner
as persons employed intermittently in the Government serv-
ice are allowed expenses under section 5703 (b) of title 5 of
the United States Code.

(c) The Chairman of the Commission shall be selected
by the members of the Commission from among their number.

(d) (1) The Commission may appoint and fix the pay
of such staff personnel as it deems desirable. Such personnel
shall be appointed subject to the provisions of title 5, United
States Code, governing appointments in the competitive
service, and shall be paid in accordance with the provisions
of chapter 51 of subchapter III of chapter 53 of such title
relating to classification and General Schedule pay rates.

(2) The Commission may procure temporary and inter-
mittent services to the same extent as is authorized by section
3109 (b) of title 5 of the United States Code, but at rates for
individuals not to exceed the daily equivalent of the annual
rate of basic pay in effect for grade GS-18 of the General
Schedule.

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COM M ISSION DUTIES

Sec. 202. (a) The Commission shall carry out the
following:

(1) (A) The Commission shall (i) conduct a study
as to the appropriateness of continuing recombinant
PNA research; (ii) conduct a comprehensive investiga-
tion and study to identify the basic ethical and scientific
principles which should underlie the conduct of DNA
research; (iii) develop guidelines which should he fol-
lowed in such research to assure that it is conducted in
accordance with such principles; and (iv) make rec-
ommendations to the Secretary (I) for such administra-
tive action as may he appropriate to apply such guide-
lines to recombinant DNA research conducted or sup-
ported under programs administered by the Secretary,
and (II) concerning any other matter pertaining to
recombinant DNA research and technology.

(13) In carrying out subparagraph (A), the Com-
mission shall consider at least the following:

(i) The protection of researchers and the gen-
eral public from the dangers of recombinant DNA
research.

(ii) The role of assessment of risk-benefit
criteria in the determination of the appropriateness
of research involving recombinant DNA.

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(iii) Appropriate guidelines for the conduct
of recombinant DNA research.

(iv) Mechanisms for evaluating and monitor-
ing the performance of review mechanisms estab-
lished by the National Institutes of Health and
National Cancer Institute and appropriate enforce-
ment mechanisms for carrying out their decisions.

(v) Determine the status and extent of recom-
binant DNA research conducted in foreign countries
and consult with such individuals as they deem
appropriate.

SPECIAL STUDY

Sec. 203. The Commission shall undertake a compre-
hensive study of the ethical, social, and legal implications of
advances in recombinant DNA research and technology.
Such study shall include —

(1) an analysis and evaluation of scientific and
technological advances in past, present, and projected
recombinant DNA research and sendees ;

(2) an analysis and evaluation of the implications
of such advances, both for individuals and for society;

(3) an analysis and evaluation of laws and moral
and ethical principles governing the use of technology
in the medical practice and other fields ;

(4) an analysis and evaluation of public under-

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landing of and attitudes toward such implications and
laws and principles; and

(5) an analysis and evaluation of implications for
public policy of such findings as arc made bv the Com-
mission with respect to advances in recombinant DXA
research and technology and public attitudes toward such
advances.

ADMINISTRATIVE PROVISIONS

Sec. 204. (a) The Commission may for the purpose of
carrying out its duties under sections 202 and 203 hold such
hearings, sit and act at such times and places, take such testi-
mony, and receive such evidence as the Commission deems
advisable.

(b) The Commission may secure directly from any
department or agency of the Tinted States information nec-
essary to enable it to carry out its duties. Tpon the request of
the Chairman of the Commission, the head of such depart-
ment or agency shall furnish such information to the Com-
mission.

(c) The Commission shall not disclose any information
reported to or otherwise obtained by it in earning out its
duties which contains or relates to a trade secret or other
matter referred to in section 1905 of title 18 of the United
vStates Code.

(d) Except as provided in subsection (b) of section

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202, the Commission shall complete its duties under sections

202 and 203 not later than the expiration of the twenty-four-
month period beginning on the first day of the first month
that follows the date on which all the members of the Com-
mission have taken office. The Commission shall make
periodic reports to the President, the Congress, and the
Secretary respecting its activities under sections 202 and

203 and shall, not later than ninety days after the expiration
of such twenty-four-month period, make a final report to the
President, the Congress, and the Secretary respecting such
activities and including its recommendations for administra-
tive action and legislation.

(e) The Commission shall cease to exist thirty days
following the submission of its final report pursuant to
subsection (d).

DUTIES OF THE SECKETAEY

Sec. 205. Within sixty days of the receipt of any recom-
mendation made by the Commission under section 202, the
Secretary shall publish it in the Federal Register and provide
opportunity for interested persons to submit written data,
views, and arguments with respect to such recommendation.
The Secretary shall consider the Commission’s recommenda-
tion and relevant matter submitted with respect to it and,
within one hundred and eighty days of the date of its publica-
tion in the Federal Register, the Secretary shall ( 1 ) deter-

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mine whether the administrative action proposed by such
recommendation is appropriate to assure the safety and ap-
propriateness of recombinant DNA research conducted or
supported under programs administered by him, and (2) if
he determines that such action is not so appropriate, publish
in the Federal Register such determination together with an
adequate statement of the reasons for his determination. If
the Secretary determines that administrative action recom-
mended by the Commission should be undertaken by him. he
shall undertake such action as expeditiously as is feasible.

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[542]

93th CONGRESS « W M pmm mm*

"Sm“m H. R. 4759

IN THE HOUSE OF REPRESENTATIVES

March 9, 1977

Mr. Rogers (for himself. Mr. Mag lire, Mr. Preyer, Mr. Sciiecer, Mr. Wax-
max, Mr. Florio, Mr. Market, Mr. Waujren, Mr. Carter, and Mr.
Madigax) introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce

A BILL

To amend the Public Health Service Act to regulate research
projects involving recombinant DNA.

1 Be it enacted by the Senate and House of Jtepresenta-

2 tives of the United States of America in Congress assembled,

3 SHORT TITLE

4 Section 1. This Act may be cited as the “Recombinant

5 DNA Research Act of 1977”.

6 FINDINGS

7 Sec. 2. The Congress finds that —

8 (1) research related to recombinant DNA is of ex-

9 ceptional importance, with many potential benefits, but
I

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also with major uncertainties regarding its possible effects
on human beings and other organisms ;

(2) research involving recombinant DA A may in-
volve a high risk not only to those pursuing such re-
search but to the population in general;

(3) it is essential in the public interest that the
health and welfare of the Xation be protected by requir-
ing that all research conducted with regard to recom-
binant DA A comply with strict standards of perform-
ance and safety ; and

(4) all research with regard to recombinant DHA
is either in interstate commerce or substantially affects
such commerce and regulations by the Secretary of
Health, Education, and Welfare as contemplated by fhe
amendments made by this Act are necessary and proper
to effectively regulate such commerce.

REGULATION OF RECOMBINANT DNA RESEARCH

Sec. 3. Title IV of the Public Health Service Act is
amended (1) by redesignating part I as part J, (2) by re-
designating sections 471 through 476 (and all references to
such sections) as sections 481 through 486, respectively,
and (3) by inserting after part H the following new part:

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“Part I — Regulation of Recombinant DNA
Research

“licensing requirements
“Sec. 471. (a) Within one hundred and eight}' days of
the date of enactment of this part, the Secretary shall pro-
mulgate regulations to implement the license requirements
prescribed by this part. Such regulations shall —

“ ( 1 ) prescribe physical and biological containment
requirements for recombinant DNA research projects
which during the one hundred and eighty-day period
beginning on the date of the promulgation of regulations
under this section shall be no less stringent than the
physical and biological containment requirements pre-
scribed by the recombinant DNA research guidelines
published in part II of the Federal Register for July 7,
1976;

“(2) prescribe requirements respecting laboratory
safety techniques to be followed by personnel involved
in recombinant DNA research projects;

“(3) prescribe requirements respecting the estab-
lishment and operation of institutional review commit-
tees for recombinant DNA research projects;

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“(4) prescribe requirements respecting reports to
be made by persons engaged in recombinant DNA projT
ects ; and

“ (5) include such other provisions as the Secretary
determines to be necessary for the effective administra-
tion of the requirements of this part.

“(b) The Secretary shall periodically review regula-
tions promulgated under subsection (a) and promulgate such
amendments to such regulations as the Secretary determines
to be necessary.

“(c) For purposes of this part, the term ‘recombinant
DNA’ means molecules that consist of different segments
of deoxyribonucleic acid which have been joined together
in cell-free systems to infect and replicate in some host cell,
either autonomously or on an integrated part of the host’s
genome.

“licenses

“Sec. 472. (a) Effective one hundred and eighty days
after the date of the enactment of this part, no person may
engage in a recombinant DNA research project unless such
person holds a license issued under this part authorizing such
person to engage in such research project or is under the
direct supervision of a person holding such a license.

“(b) (1) A license to authorize a person to engage in

[546]

5

1 a recombinant DNA research project shall be issued only

2 upon an application made by such person in such form and

3 maimer as may be prescribed by the Secretary. An appli-

4 cation for such a license shall include —

5 “(A) a detailed description of the research project

6 to be authorized by the license, the identity, and

7 qualifications of the personnel to be engaged in such

8 project, and the facilities and materials to be used in

9 such project ;

10 “(B) assurances satisfactory to the Secretary that

11 the research project will meet all applicable require-

12 raents prescribed by paragraph (3) and the regulations

13 under section 471; and

“ (C) such additional information as the Secretary
l'* may prescribe.

“ (2) A license issued under this section shall be valid
for such period (but not in excess of twenty-four months)
as the Secretary may prescribe and may be renewed in such
10 manner as the Secretary may prescribe. Such a license shall
-0 contain such terms and conditions as the Secretary finds are
-I necessary and appropriate to cany out the purposes of this
22 part and shall identify the research project which may be
conducted under the license. No license may be issued or
24 renewed under this section unless the Secretary has provided

[547]

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1 the advisory committee established under section 479 with a

2 reasonable opportunity to provide him its recommendations

3 on the issuance or renewal of such license.

4 “ (3) In the case of a research project involving recom-

5 binant DNA which under the guidelines referred to in section

6 471 (a) (1) requires physical containment at the P-4 level

7 prescribed by such guidelines, a license may not be issued

8 under this section, during the six-month period beginning

9 on the date of the promulgation of initial regulations under

10 section 471, for the conduct of such project unless it is to be

11 conducted at a center designated under section 473. After

12 the expiration of such six-month period no license may be

13 issued under this section for the conduct of a research project

24 involving recombinant DNA which under the regulations

25 promulgated under section 471(a) requires physical con-
tainment equivalent to such P-4 level unless the project is to

27 be conducted in such a center. The Secretary may require as

28 a condition to the approval of a license for a project involv-
-jy ing recombinant DA A which under such regulations requires
20 physical containment at a level equivalent to the P-3 level
22 prescribed by such guidelines that the project be conducted

22 in such a center.

23 “(c)(1) Upon the issuance or renewal of a license under

24 this section, the Secretary shall, except as provided in para-

25 graph (2), publish in the Federal Eegister a detailed de-

[548]

7

] scrip tion of the research project for which the license was

2 issued or renewed, including a description of the sources

3 of the biological materials to be used in such project, the

4 physical and biological containment requirements applicable

5 to such project, and the objectives of such project.

6 '(-) I*1 making the publication required bv para-

7 graph (1), the Secretary shall not publish any information

8 which is exempt from disclosure pursuant to subsection (a)
0 of section 552 of title 5, Tinted States Code, by reason of

10 subsection (b) (4) of such section.

11 “designation* of centers

1- “Sec. 473. (a) The Secretary shall designate not more
than ten centers for the conduct of research projects in-

14 voicing recombinant DX A molecules which under regula-

15 tions prescribed under section 471(a) (1) require physical

16 containment at the F-4 level prescribed by the guidelines

17 referred to in such section or physical containment at an

18 equivalent level. Any facility of the Federal Government
If) may be designated n> a center under this section.

20 “(b) A center may be designated under this section

21 only upon application made in such form and manner as

22 may he prescribed by the Secretary. Such an application

23 shall include —

24 “(1) assurances satisfactory to the Secretary* that
the applicant has facilities capable of providing the

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1 physical containment described in subsection (a) for

2 recombinant DXA research projects; and

3 “(2) such additional information as the Secretary

4 may prescribe respecting the facilities and personnel of

5 the applicant and such other matters as the Secretary

6 may prescribe.

7 Designation of a center under this section shall be made for

8 a period of five years and may be renewed.

9 “ (c) (1) The Secretaiy may make grants, imder such

10 terms and conditions as the Secretary may prescribe, to non-

11 profit private centers designated under this section for the

12 purpose of enabling such centers to meet the costs of com-

13 plying with the requirements for designation under this

14 section (including costs of construction, acquisition of equip-

15 ment, and operation) .

16 (2) Dor the purpose of making grants imder para-

17 graPh (1), there are authorized to be appropriated

18 821,500,000 for the fiscal year ending September 30, 1978,

19 827,500,000 for the fiscal year ending September 30, 1979,

20 and $12,500,000 for the fiscal year ending September 30,

21 1980.

22 “inspections

23 Sec. 4 i 4. (a) For purposes of enforcement of the

24 licensing requirements of this part, officers, employees, or

25 agents designated by the Secretary, upon presenting appro-

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priate credentials and a written notice to the owner, opera-
tor, or agent in charge and after clearly informing him of
their authority, are authorized to enter and insepct any
laboratory in a State in which a recombinant DNA research
project is being conducted. A separate notice shall be given
for each such inspection, but a separate notice shall not be
required for each entry made during the period covered by
the inspection. Such an inspection ( 1 ) shall be made during
the normal business hours of the laboratory being inspected
and in a reasonable manner, and (2) may extend only to
relevant equipment, materials, containers, records, files,
papers, processes, controls, facilities, and all other things in
the laboratory bearing on whether the recombinant DNA
research project is being conducted in accordance with the
licensing requirements of this part.

“(b) Upon completion of any such inspection and prior
to leaving the premises, the officer, employee, or agent mak-
ing the inspection shall give to the owner, operator, or agent
in charge a preliminary report which summarizes any condi-
tions or practices observed by him which, in his judgment,
indicate a violation of the licensing requirements of this part.
He shall also prepare a written final report of his findings
and send it to such owner, operator, or agent within thirty
days of the completion of the inspection.

“(c) Xo officer, employee, or agent designated by the

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Secretary to enter a laboratory and conduct an inspection
pursuant to this section shall be required to obtain a search
warrant from any judicial officer prior to entering any lab-
oratory and conducting any inspection which is authorized
by this section.

‘‘license revocation

“Sec. 475. (a) If the Secretary finds, after reasonable
notice and opportunity for a hearing to a person licensed
under this part to conduct a recombinant DXA research
project, that such person —

“ ( 1 ) has been guilty of misrepresentation in ob-
taining such license,

“(2) has engaged or attempted to engage in any
recombinant DXA research project not authorized by
such license,

“ (3) has failed to comply with the terms and con-
ditions upon which such license was issued or renewed,
or

“(4) has failed or refused to permit an inspection
authorized by section 474,

the Secretary may revoke the license of such person for
the remainder of its term or may make such person ineligible
to apply for a license under this part for such period as the
Secretary may prescribe, or may take both such actions.

[552]

11

1 “penalties

2 "Sec. 476. (a) Any person who violates section 472

3 (a) shall be liable to the United States for a civil penalty

4 in an amount not to exceed $1,000 for each such violation.

5 Each day such a violation continues shall, for purposes of

6 this subsection, constitute a separate violation of section

7 472(a).

8 “(b) A civil penalty for a violation of section 472(a)

9 shall be assessed by the Secretary by an order made on the

10 record after opportunity (provided in accordance with this

11 subsection) for a hearing in accordance with section 554

12 of title 5. United States Code. Before issuing such an order,

13 the Secretary shall give written notice to the person to be
assessed a civil penalty under such order of the Secretary's

15 proposal to issue such order and provide such person an
I** opportunity to request, within fifteen days of the date the
1 * notice is received by such person, such a hearing on the
1® order.

19 “ (c) Any person who requested in accordance with sub-

2ft section (b) a hearing respecting the assessment of a civil

21 penalty and who is aggrieved by an order assessing a civil

22 penalty may file a petition for judicial review of such order

23 with the United States Court of Appeals for the District of

24 Columbia Circuit or for any other circuit in which such

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person resides or transacts business. Such a petition may
only be filed within the thirty-day period beginning on the
date the order making such assessment was issued.

“(d) If any person fails to pay an assessment of a civil
penalty —

“ ( 1 ) after the order making the assessment has
become a final order and if such person does not file a
petition for judicial review of the order in accordance
with subsection (c) , or

“ (2 ) after a court in an action brought under sub-
section (c) has entered a final judgment in favor of the
Administrator.

the Attorney General shall recover the amount assessed
(plus interest at currently prevailing rates from the date of
the expiration of the thirty-day period referred to in subsec-
tion (c) or the date of such final judgment, as the case may
be) in an action brought in any appropriate district court of
the United States. In such an action, the validity,, amount,
and appropriateness of such penalty shall not be subject to
review.

‘‘INJUNCTION AUTHORITY

“Sec. 477. The district courts of the United States shall
have jurisdiction over civil actions to restrain anv violation
of section 472 (a ) . Such a civil action may be brought in the
United States district court for the judicial district wherein

[554]

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1 any act, omission, or transaction constituting a violation of

2 section 472(a) occurred or wherein the defendant is found

3 or transacts business. In any such civil action process may

4 be served on a defendant in any judicial district in which a

5 defendant resides or may be found. Subpenas requiring at-

6 tendance of witnesses in any such action may be served in

7 any judicial district.

8 “effect on state and local requirements

9 “Sec. 478. (a) Exoept as provided in subsection (b),

10 no State or political subdivision of a State may establish

11 or continue in effect w’ith respect to recombinant DNA re-

12 search projects any requirement which is different from, or

13 in addition to, any requirement applicable under this part
to such projects.

15 “(b) Upon application of a State or political subdivi-

1® sion of a State, the Secretary shall, by regulations promul-
1? gated after notice and opportunity for an oral hearing,

18 exempt from subsection (a), under such conditions as may

19 be prescribed in such regulation, a requirement of such State

20 or political subdivision applicable to recombinant DNA re-

21 search projects if the requirement is the same as, or more

22 stringent than, a requirement under this part which would

23 be applicable to such projects if an exemption were not in

24 effect under this subsection.

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“advisory committee

“Sec. 479. (a) There is established the Eecombinant
DNA Research Advisory Committee (hereinafter in this
section referred to as the ‘advisory committee’) to make rec-
ommendations to the Secretary with respect to the approval
of applications for the issuance or renewal of licenses under
this part, the issuance or renewal of designations of centers
under this part, and other matters related to the effective
administration of this part. The advisory committee shall
consist of fifteen members appointed by the Secretary from
individuals who by virtue of their training or experience are
qualified to participate in the functions of the advisory com-
mittee. Of the individuals appointed as members of the advi-
sory committee, at least two shall have backgrounds in the
ethical concerns involved in biomedical research, at least
three shall represent the interests of the general public, and
at least eight shall be individuals who are not engaged in
or have a financial interest in recombinant DNA research
projects. The term of office of a member of the advisory com-
mittee shall be three years, except that of the members first
appointed to the advisory committee, five shall be appointed
for a term of one year and five shall be appointed for a term

[556]

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1 of two years, as designated by the Secretary at the time of

2 appointment. Section 14 of the Federal Advisory Commit-

3 tee Act shall not apply with respect to the duration of the

4 advisory committee.”.

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[558]

9.3th CONGRESS
1st Session

H. R. 6158

IX TIIE HOUSE OF REPRESENTATIVES

April 6, 1977

Mr. Rogers introduced the following bill; which was referred to the Com-
mittee on Interstate ami Foreign Commerce

A BILL

To regulate activities involving recombinant deoxyribonucleic

acid.

1 Be it enacted by the Senate and House of Bepresenta-

2 tives of the United States of America in Congress assembled,

3 That this Act may be cited as the “Recombinant DNA

4 Regulation Act”.

5 FINDINGS

6 Sec. 2. The Congress finds that —

7 (1) work with recombinant DNA will improve the

8 understanding of basic biological processes and offers

9 many potential benefits,

10 (2) there exists, however, a possible risk that

I

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microorganisms containing recombinant DNA may cause
disease or alter the environment,

(3) microorganisms containing recombinant DNA
could spread throughout the United States and to other
countries, adversely affecting human health, the en-
vironment, industry, and agriculture,

(4) the only effective way to minimize the risk
to health, the environment, industry, and agriculture
is by regulating activities involving recombinant DNA,
whether or not those activities are in interstate com-
merce, and therefore,

(5) all activities involving recombinant UNA.
either affect or are in interstate commerce.

GENERAL REQUIREMENTS

Sec. 3. (a) Except as provided in subsection (b), no
person may possess or engage in the production of recom-
binant DKA unless —

( 1 ) the production or possession complies with the
standards promulgated under section 4,

( 2 ) the production or possession occurs in a facility
licensed under section 5, or the possession occurs while
transporting recombinant DNA from one such facility
to another, and

(3) the production or possession occurs as part of
a project that has been registered under section 6.

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(b) The Secretary may exempt from some or all of the
requirements of subsection (a) any category of activities he
finds poses no significant risk to health or the environment

(1) because of the nature of those activities, or (2) because
the category is adequately regulated under other Federal
law.

STANDARDS

Sec. 4. (a) For purposes of protecting the health and
safety of individuals who work with recombinant DNA, the
health and safety of the public at large, and the integrity of
the environment, the Secretary —

(1) shall, no later than ninety days after the en-
actment of this Act, promulgate (without regard to
section 102(2) (C) of the National Environmental
Policy Act of 1969 or 5 U.S.C. 553) as interim stand-
ards applying to the production or possession of recom-
binant DNA the Recombinant DNA Research Guide-
lines (41 Fed. Reg. 27901 (1976) ), with such modi-
fications as he finds are needed,

(2) shall, no later than one hundred and eighty days
after the promulgation of interim standards under clause
( 1 ) , initiate procedures to promulgate final standards
applying to the production or possession of recombinant
DNA,

(3) shall, no later than one year after the promulga-

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tion of interim standards under clause ( 1 ) , promulgate
final standards applying to the production or possession
of recombinant DNA, and

(4) may, from time to time, promulgate (A) new
standards applying to the production or possession of
recombinant DNA, and (B) amendments to standards
promulgated under this section.

(b) (1) Any person adversely affected by an action of
the Secretary under this section may obtain review of the
action in the United States Court of Appeals for the District
of Columbia. The petition for review must be filed within
sixty days of the action. Review shall conform to chapter 7
of title 5 of the United States Code.

( 2 ) An action with respect to which review could have
been obtained under paragraph (1) shall not be subject
to judicial review in any other proceeding.

licensing of facilities

Sec. 5. (a) The Secretary may issue or renew a license
for a facility to permit the production or possession (or cer-
tain categories of production or possession) of recombinant
DNA at that facility only if (1) the facility submits an
application therefor containing or accompanied by such
information concerning recombinant DNA activities at that
facility as the Secretary may prescribe, (2) the facility
agrees and the Secretary determines that such production

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or possession (including the transportation of recombinant
DNA to or from that facility) will comply with the stand-
ards promulgated under section 4 and such ancillary condi-
tions as he may prescribe, and (3) the facility agrees atid
the Secretary determines that such production or possession
will occur only as part of a project registered under section 6.

(b) The Secretary’ may require payment of a fee from
a facility for the issuance or renewal of a license under this
section to cover all or part of the costs of administering
this Act in respect to that facility.

(c) A license issued or renewed by the Secretary’ under
this section is valid for the period prescribed by the Secre-
tary, not to exceed three years.

(d) The Secretary may pertnit an appropriate State or
local agency or a licensing or accrediting body to issue and
renew licenses for facilities to permit the production or
possession (or certain categories of production or possession)
of recombinant DNA at those facilities if and for so long as
the Secretary determines that the agency or body —

( 1 ) requires a facility to comply with the standards
promulgated under section 4 and such ancillary condi-
tions as the Secretary may prescribe,

(2) requires a facility to permit the production or
possession of recombinant DNA only ns part of a project
registered under section 6, and

[563]

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1 (3) has the capacity to and does make provision

2 for assuring that the requirements of clauses (1) and

3 (2) continue to be met.

4 (e) The Secretary may revoke, suspend, or limit a

5 license issued under this section if he finds, after notice and

6 opportunity for a hearing to the facility, that the facility —

7 (1) has misrepresented any material fact in obtain-

8 ing the license,

9 (2) has engaged or attempted to engage or repre-

10 sented itself as entitled to perform any activities involv-

11 ing recombinant DNA not authorized by its license,

12 (3) has failed to comply with any of the terms or

13 conditions of the license,

14 (4) has failed to comply with a request of the Sec-

15 retary for any information or materials the Secretary

16 finds necessary to determine the facility’s continued

17 eligibility for its license or to evaluate the possible effects

18 on health or the environment of activities involving

19 recombinant DNA,

20 (5) has failed to comply with a request of the Sec-

21 retary to inspect any portion of the facility, its opera-

22 tions, or its records, which are related to activities in-

23 volving recombinant DNA, or

24 (6) has violated or aided and abetted in the viola-

25 tion of any requirement established under this Act.

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REGISTRATION

Sec. 6. The Secretary shall register any project involving
recombinant DNA if the request for registration is accom-
panied by such information as the Secretary may prescribe
concerning recombinant DNA activities which are part of
that project.

INSPECTIONS

Sec. 7. An individual designated as an inspector by the
Secretary, upon presenting appropriate credentials to the
owner, operator, or agent (if any of these be present) in
charge of a facility at which the inspector has reasonable
grounds to believe that recombinant DNA is present or is
being produced may enter that facility at reasonable times,
and inspect, at reasonable times and in a reasonable manner,
the facility and all things at (or being transported to or from)
that facility which he has reasonable grounds to believe are
involved with recombinant DNA and obtain appropriate sam-
ples of such things. When an inspector has completed such
an inspection he shall, before he leaves the facility, inform
the owner, operator, or agent in charge of the facility of any
conditions or practices which in the inspector’s judgment
constitute a violation of any of the requirements of this Act.
The inspector shall also prepare a written report of his find-
ings and send it to the owmer, operator, or agent in charge
of the facility within a reasonable time.

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RECORDS AXD SAMPLES

Sec. 8. Each facility at which recombinant DXA is
produced or located shall keep and make available to the
Secretary such records (including medical records of per-
sonnel) and samples involving recombinant DXA at (or
being transported to or from) that facility as the Secretary
may prescribe.

REPORTS

Sec. 9. Each facility at which recombinant DXA is
produced or located shall submit to the Secretary such re-
ports concerning recombinant DXA at (or being trans-
ported to or from) that facility as the Secretary may
prescribe.

EFFECT ox STATE AXD LOCAL EEQCTRE3IEXTS

Sec. 10. (a) Except as provided in subsection (b),
no State or political subdivision of a State may establish or
continue in effect with respect to recombinant DXA activi-
ties any requirement which is different from, or in addition
to. any requirement applicable under this Act to such
activities.

(b) Upon application of a State or political subdivision
of a State, the Secretary shall exempt from subsection (a)
a requirement of that State or political subdivision applicable
to recombinant DXA activities if he determines that the
requirement is, and will be administered so as to be, as

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stringent as, or more stringent than, a requirement under
this Act. The Secretary may not withdraw any such exemp-
tion for so long as he finds that such requirement remains
unchanged and continues to be so administered.

EMPLOYEE PROTECTION

Sec. 11. (a) Xo employer may discharge any em-
ployee or otherwise discriminate against any employee with
respect to the employee’s compensation, terms, conditions,
or privileges of employment because the employee (or any
person acting pursuant to a request of the employee) has —

(1) commenced, caused to be commenced, or is
about to commence or cause to be commenced a pro-
ceeding under this Act,

(2) testified or is about to testify in any such pro-
ceeding, or

(3) assisted or participated or is about to assist
or participate in any manner in such a proceeding or
in any other action to cam’ out the purposes of this Act.
(b) (1) Any employee who believes that the employee

has been discharged or otherwise discriminated against by
any person in violation of subsection (a) of this section may,
within thirty days after such alleged violation occurs, file
(or have any person file on the employee’s behalf) a com-
plaint with the Secretary of Labor (hereinafter in this sec-
tion referred to as the “Secretary”) alleging such discharge
H.R. 6158 2

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or discrimination. Upon receipt of such a complaint, the Sec-
retary shall notify the person named in the complaint of the
filing of the complaint.

(2) (A) Upon receipt of a complaint filed under para-
graph (1). the Secretary shall conduct an investigation of
the violation alleged in the complaint. Within thirty days
of the receipt of such complaint, the Secretary shall complete
such investigation and shall notify in writing the complainant
(and any person acting on behalf of the complainant) and
the person alleged to have committed such violation of the
results of the investigation conducted pursuant to this para-
graph. Wiihin ninety days of the receipt of such complaint
the Secretary shall, unless the proceeding on the complaint
is terminated by the Secretary on the basis of a settlement
entered into by the Secretary and the person alleged to have
committed such violation, issue an order eirher providing
the relief prescribed by subparagraph (B) or denying the
complaint. An order of the Secretary shall be made on the
record after notice and opportunity for agency hearing. The
Secretary may not enter into a settlement terminating a pro-
ceeding on a complaint without the participation and consent
of the complainant.

(B ) If in response to a complaint filed under paragraph
( 1 ) the Secretary determines that a violation of subsection
(a) of this section has occurred, the Secretary shall order

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(i) the person who committed such violation to take affirma-
tive action to abate the violation, (ii) such person to re-
instate the complainant to the complainant’s former position
together with the compensation (including back pay) , terms,
conditions, and privileges of the complainant’s employment,
(iii) compensatory damages, and (ir) where appropriate,
exemplary damages. If such an order is issued, the Secretary,
at the request of the complainant, shall assess against the
person against whom the order is issued a sum equal to the
aggregate amount of all costs and expenses (including at-
torney’s fees) reasonably incurred, as determined by the
Secretary, by the complainant for. or in connection with, the
bringing of the complaint upon which the order was issued.

(c) ( 1 ) Any employee or employer adversely affected
or aggrieved by an order issued under subsection (b) may
obtain review of the ordei in the United State» court of
appeals for the circuit in which the violation, with respect
to which the order was issued, allegedly occurred. The pe-
tition for review must be filed within sixty days from the
issuance of the Secretary’s order Review shall conform to
chapter 7 of title 5 of the United States Code.

(2) An order of the Secretary, with respect to whi*J>
review could have been obtained under paragnqdi ( 1 )
shall not be subject to judicial review in any criminal or
other civil proceeding.

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(d) Whenever a person has failed to comply with an
order issued under subsection (b) (2), the Secretary shall
file a civil action in the United States district court for the
district in which the violation was found to occur to enforce
such order. In actions brought under this subsection, the
district courts shall have jurisdiction to grant all appro-
priate relief, including injunctive relief and compensatory
and exemplary damages. Civil actions brought under this
subsection shall be heard and decided expeditiously.

(e) Subsection (a) of this section shall not apply with
respect to any employee who, acting without direction from
the employee’s employer (or any agent of the employer) ,
deliberately causes a violation of any requirement of this
Act.

CONSULTATION

Sec. 12. In administering this Act, the Secretary shall
consult with the Secretaries of Agriculture, Commerce, De-
fense, Labor, and Transportation, the Administrators of
Energy Eesearch and Development, the Environmental
Protection Agency, and Veterans’ Affairs, the Director of
the National Science Eoundation, other appropriate officials,
and such interagency committees and other advisory bodies
as the Secretary may establish, concerning the promulga-
tion of standards and of amendments to standards, the

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avoidance of duplicative requirements, and such other
matters which may be of mutual interest.

ENFORCEMENT

Sec. 13. (a) Upon petition by the Secretary, the dis-
trict courts of the United States may restrain violations of
this Act.

(b) (1) Any person who violates a provision of this
Act (other than in section 11) may be assessed a civil
penalty by the Secretary of not more than $5,000 for each
violation.

(2) No civil penalty shall be assessed unless the perso:
charged shall have been given notice and opportunity for a
hearing on such charge. In dcitermining the amount of the
penalty the Secretary shall consider the appropriateness of
such penalty to the gravity of the violation.

(3) In case of inability to collect such civil penalty
or failure of any person to pay all, or such portion of such
civil penalty as the Secretary may determine, the Secretary
shall refer the matter to the Attorney General, who shall
recover such amount by action in the district court of the
United States for the district in which that person resides
or has his principal place of business.

(c) Any person who knowingly or willfully violates any
provision of this Act (other than in seotion 11) shall be

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subject, upon conviction, to a fine of not more than $5,000,
or to imprisonment for not more than one year (and not more
than ten years for a related series of violations) , or both.

(d) Each day a violation of this Act continues shall
constitute a separate violation for purposes of this section.
EMERGENCY PROCEDURE FOR HAZARDOUS RECOMBINANT

DNA

Sec. 14. The Secretary may commence a civil action,
by process of libel or otherwise, in an appropriate district
court of the United States for the seizure or destruction of
hazardous recombinant DNA or for other appropriate relief
to prevent its production, movement, or spread.

ADMINISTRATIVE RESTRAINT OR SEIZURE
Sec. 15. If during an inspection under section 7 an in-
spector finds material he has reaonable grounds to believe is
hazardous recombinant DNA, he may order the material not
to be moved or may seize the material. Within twenty days
after such action by an inspector the Secretary must com-
mence a civil action under section 14 with respect to the in-
spector’s action, unless the owner of the material has agreed
otherwise.

TRAINING

Sec. 16. The Secretary may conduct and support train-
ing in the safe handling of recombinant DNA.

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REPRESEN T ATION BY ATTORNEY GENERAL

Sec. 17. The Attorney General shall appear and repre-
sent the Secretary or the Secretary of Labor at any civil or
criminal action initiated under this Act.

DEFINITIONS

Sec. 18. For purposes of this Act —

(1) “Secretary” (except as used in section 11)
means the Secretary of Health, Education, and Welfare,

(2) “DNA” means deoxyribonucleic acid,

(3) “recombinant DNA” means DNA that consists
of different segments of DNA which have been joined
together in a cell-free system and that has the capacity
to infect and replicate in some host cell either autono-
mously or as an integrated part of the host’s genome,

(4) “hazardous recombinant DNA” means recom-
binant DNA which either —

(A) poses a significant risk to health or the
environment, or

(B) (i) (I) is neither located at a facility
licensed under section 5 nor being transported from
one such facility to another, or

(II) is likely to be moved or to spread from
such a facility or transportation to a location not at
such a facility or part of such transportation, and

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(ii) is not known not to pose a significant risk
to health or the environment,

(5) “person” means any individual, partnership,
corporation, association, or any Federal, State, or local
governmental entity,

(6) “district court of the United States” includes
the District Court of Guam, the District Court of the
Virgin Islands, tile highest court of American Samoa,
and a similar or equivalent court in any other United
States territory or possession or in the Trust Territory
of the Pacific Islands, and

(7 ) in relation to transportation to or from a facility,
a suitable facility in a foreign country shall be treated
as a facility licensed under section 5.

GEOGRAPHIC APPLICABILITY OF ACT

Sec. 19. This Act applies to the United States, its ter-
ritories and possessions, and the Trust Territory of the
Pacific Islands.

RELATIONSHIP TO OTHER FEDERAL LAWS
Sec. 20. (a) This Act shall not affect the authority
of any Federal agency to regulate under any other Act
activities involving recombinant DVA.

(b) In exercising any authority under this Act, the
Secretary, or any person acting on his behalf or pursuant
to the provisions of this Act, shall not, for purposes of sec-

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tion 4(b) (1) of the Occupational Safety and Health Act
of 1970, be deemed to be exercising statutory authority to
prescribe or enforce standards or regulations affecting oc-
cupational safety and health.

(c) (1) Upon request by the Secretary, each Federal
agency is authorized —

(A) to make its services, personnel, and facilities
available (with or without reimbursement) to the Sec-
retary to assist the Secretary in the administration of
this Act, and

(B) to furnish to the Secretary such information,
data, estimates, and statistics, and to allow the Secretary
access to all information in its possession, as the Sec-
retary may reasonably determine to be necessary for
the administration of this Act.

(2) Upon request by any Federal agency, the Sec-
retary is authorized —

(A) to make the services, personnel, and facilities
of the Department of Health, Education, and Welfare
available (with or without reimbursement) to that
agency in the administration of any Act with respect to
activities involving recombinant DNA, and

(B) to furnish to that agency such information, data,
estimates, and statistics, and to allow that agency access
to all information in the Secretary’s possession, as the

[575]

18.

1 agency may reasonably determine to be necessary for the

2 administration of any Act with respect to activities in-

3 volving recombinant UNA..

4 SEPARABILITY

5 Sec. 21. If any provision of this Act is held invalid by

6 reason of being inconsistent with the Constitution, all provi-

7 sions of this Act which are separable from that invalid pro-

8 vision shall remain in effect.

9 EFFECTIVE DATE AND EXPIRATION DATE OF ACT

10 Sec. 22. (a) (1) This Act is effective upon enactment,

11 except that sections 3(a), 10(a), and 18(4) (B) are ef-

12 fective one hundred and eighty days after enactment.

13 (2) Upon promulgation of standards under section 4, no

14 person may possess or engage in the production of reconci-
le binant UNA unless the production or possession complies
1® with those standards.

1^ (b) This Act shall expire five years after its enactment

1® except with respect to records made within that period.

[576]

[577]

95tk CONGRESS T? f?
1st Session »

iA iAQ

IN TEE HOUSE OE REPRESENTATIVES

May 24. 1977

Mr. Rogees introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce

IF I

Ai

To amend the Public Health Service Act to regulate activities
involving recombinant ENA and for other purposes.

1 Be it enacted by the Senate and House of Beyresenta-

2 lives of the United States of America in Congress assembled,

3 SHORT TITLE

4 Section 1. This Act may be cited as the “Recombinant

5 DNA Act’’.

6 FINDINGS

7 Sec. 2. The Congress finds that —

8 { 1 ) research and other activities involving recom-

9 binant DNA will improve the understanding of funda-

10 mental biological processes ;

11 (2) the knowledge gained from such research and

I

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other activities may be of great benefit to medicine and
agriculture and may provide many other benefits to
society ;

(3) there exist, however, uncertainties regarding
the extent to which recombinant DXA or organisms or
viruses containing recombinant DXA and activities in-
volving recombinant DXA may present « risk of injury
to human health or the environment, and there is a risk
that such organisms and viruses may spread quickly and
without warning to persons, agricultural plants and
products, and other items in or affecting commerce;

(4) the public interest requires that the health and
welfare of the population of the United States be pro-
tected from such risk, and commerce in the United States
is dependent upon such protection being provided; and

(5) to effectively accomplish such protection and
consequently to effectively regulate commerce requires
that the possession of recombinant DXA and any
activity engaged in for its production (whether a re-
search or commercial activity) be subject to control.

AMENDMENT TO TIIE TUBLIC HEALTH SERVICE ACT

Sec. 3. Title IV of the Public Health Service Act is
amended (1) by redesignating part I as part J, (2) by re-
designating sections 471 through 47G (and all references to

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such sections’) as sections 486 throng'll 491. respectively, and
(3) by inserting after part II the following new part:
“Part I— Recombinant DAA
“definitions

“Sec. 471. For purposes of this part:

“ (1) The term ‘DAA’ means deoxyribonucleic acid.
“(2) (A) Except as provided in subparagraph
(B), the term ‘recombinant DAA’ means DA A mole-
cules that (i) consist of DAA segments which have
been joined together in a cell-free system and (ii) have
the capacity to enter in any cell and to replicate in any
cell either autonomously or after they ha^e become an
integrated part of a host cell’s genome.

“(B) The term ‘recombinant DA A’ does not include
DAA molecules which —

“ (i) consist entirely of prokaryotic DAA seg-
ments which have been joined together in a cell-free
system and which are derived from —

“ (I) the same species or organism as, or
a species or organism related to, the species
or organism from which each prokaryotic cell
which such molecules have the capacity to
enter and replicate in is derived,

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“ (II) a plasmid or natural parasite of any
such cell, or

“(III) such species or organism and
plasmid or natural parasite; and
“ (ii) can only enter and replicate in a prokary-
otic cell by a process which the Secretary deter-
minco is known to occur naturally.

“(3) The term ‘local biohazards committee’ means
a local biohazards committee established in accordance
with section 476.

“(4) The possession in a State of recombinant
DNA by any individual or public or private entity and
any activity (including research and transportation)
undertaken in a State by any individual or public or
private entity for the production of recombinant DNA
are collectively referred to as ‘recombinant DNA
activities’.

“interim control

“Sec. 472. (a) (1) During the period beginning on the
tenth day after the date of the enactment of this part and
ending —

“(A) eighteen months after such date, or
“(B) on the date the regulations required by sec-
tion 475 take effect,

whichever occurs first, all recombinant DNA activities shall

[581]

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1 be earned out in accordance with the physical and biological

2 containment requirements described in paragraph (2) .

3 “(2) The physical and biological containment require-

4 ments referred to in paragraph (1) are the physical and

5 biological containment requirements —

6 “(A) as contained in the recombinant DMA re-

7 search guidelines of the Department of Health, Educa-

8 tion, and Welfare published in part II of the Federal

9 Register for July 7, 1976,

10 “(B) if revised between July 7, 1976, and the

11 date of the enactment of this part, as so revised, or

12 “ (C) if revised under subsection (c) , as so revised.

13 “(3) Before the expiration of ihe ten-day period be-
ll ginning on the date of the enactment of this part, the Sec-

15 retary shall take such action as may be necessary to publicize

16 and make available the requirements described in paragraph

17 (2), including the publication of such requirements in the

18 Federal Register.

19 “(b) From the date of the enactment of this part until

20 the expiration of the period described in subsection (a) ,

21 all the requirements of the recombinant DMA research guide-

22 lines of the Department of Health, Education, and Welfare —

23 “ ( A) as published in part II of the Federal Register

24 for July 7, 1976.

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“(B) if revised between July 7, 1976, and the date
of the enactment of this part, ns so revised, or

“(C) if icvised under subsection (c) , as so revised,
shall continue to apply as specified in such guidelines.

“ (c) The physical and biological containment require-
ments of the guidelines described in subsection (a) which are
in effect on the date of the enactment of this part may be
revised only by regulations promulgated by the Secretary in
accordance with section 553 of title 5, United States Code,
but without regard to section 102(2) (C) of the National
Environmental Policy Act of 1969.

“(d) (1) Each individual or entity which, on the dote
of the enactment of this part, is responsible for the conduct of
any recombinant DXA activity shall, in accordance with
regulations promulgated under paragraph (3) and before
the expiration of ninety days from the date of the enactment
of this part, report in writing to the Secretary —

“ (A) such individual's or entity’s name, and
“(B) a description of such activity and an identifi-
cation of the place or places in which it is being con-
ducted.

“(2) Each individual or entity which is to be respon-
sible for a recombinant DXA activity to be commenced dur-
ing the period described in subsection (a) shall upon the
commencement of such actiwty report in writing to the

[583]

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1 Secretary such individual's or entity’s name, a description of

2 such activity, and an identification of the place or places in

3 which such activity is to be conducted.

4 “(3) Before the expiration of the forty-five-day period

5 beginning on the date of the enactment of this part, the

6 Secretary shall, without regard to subsections (c) and (d)

7 of section 553 of title 5, United States Code, promulgate

8 such regulations as may be necessary for the administration

9 of the requirements of this subsection.

10 “general requirements

11 “Sec. 473. (a) Except as provided under subsection

12 (b) , the following requirements apply under this part with

13 respect to recombinant DNA activities:

14 “(1) Each facility in which a recombinant DNA

15 activity is to be conducted shall be licensed in accordance

16 with section 475.

17 “(2) The transportation of recombinant DNA and

18 any other recombinant DNA activity which is not con-

19 ducted in a facility licensed under section 475 shall be

20 earned out in accordance with regulations promulgated

21 by the Secretary under section 474.

22 “(b) The Secretary may by regulation exempt from the

23 requirements of this part any recombinant DNA activity

24 which the Secretary finds does not present a significant risk

25 to the public health and safety or the environment.

[584]

8

1 “control of non-facility recombinant dna

2 ACTIVITIES

3 “Sec. 474. (a) The Secretary shall promulgate r^gula-

4 dons to control the conduct of recombinant DNA activities

5 described in section 473(a) (2). Such regulations shall —

6 “ (1) prescribe physical and biological containment

7 requirements for the conduct of such activities;

8 “(2) apply as appropriate, to the conduct of such

9 activities, the personnel safety requirements prescribed

10 under section 475;

11 “(3) include such special requirements as the

12 Secretary determines necessary for the conduct of recom-

13 binant DNA activities involving more than ten liters

14 of recombinant DNA and for the conduct of any com-

15 mercial recombinant DNA activity which the Secretary

16 determines may present a significant risk to the public

17 health and safety or the environment; and

18 “(*) include such other provisions as the Score-

19 tary determines to be necessary for the protection of the

20 public health and safety and the environment.

21 “(b) The regulations required by subsection (a) may

22 not be initially promulgated unless the Secretary has pro-

23 vided the advisory committee established under section 481

24 with a reasonable opportunity to provide him its recom-

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raenda lions on sinir regulation?, -and such regulations may
not be amended to revise the requirements described in sub-
section (a) (1) unless the Secretary has provided the ad-
visory committee with a reasonable opportunity to provide
him its recommendations on such revision.

“ (c) The regulations required by subsection (a) shall
be initially promulgated within one year of the date of the
enactment of this part and shall take effect upon the expira-
tion of one hundred and eighty days from the date of their
promulgation.

“ (d) The Secretary shall provide for an annual review
of the regulations required by subsection (a) to determine if
their requirements continue to protect the public health and
safety and the environment.

“(e) If the Secretary receives a petition for the pro-
mulgation of a regulation to prescribe an additional require-
ment under subsection (a) or to revise or repeal a require-
ment contained in a regulation promulgated under that
subsection, the Secretary shall either approve or deny the
petition within one hundred and twenty days after the date
the petition is received by the Secretary. If the Secretary
approves such a petition, the Secretary shall, as soon as prac-
ticable after the date the petition is approved, commence a
proceeding as requested by the petition. If the Secretary
II.R. 7418 2

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denies such a petition, lie shall notify the petitioner of the
denial and the reasons therefor and shall publish such reasons
in the Federal Register.

“licenses

“Sec. 475. (a) (1) Licenses for facilities in which re-
combinant DXA activities are to be conducted shall be issued,
amended, and renewed in accordance with this section.

“(2) A license under this section is the authority for
the conduct of recombinant DXA activities in the facility
or facilities for which the license is issued. The Secretary
shall prescribe guidelines respecting —

“ (A) the types imd number of facilities that may be
covered by a single license, and

“ (B) the types of recombinant DXA activities that
may be authorized by a single license.

“(3) (A) The Secretary shall promulgate regulations
to implement the administration of this section. Such regu-
lations shall—

“(i) prescribe physical and biological containment
requirements for recombinant DXA activities author-
ized to be conducted under licenses issued under this
section;

“ (ii) prescribe requirements for —

“(I) laboratory safety training to be given

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to, and safety techniques to be followed by, per-
sonnel to be involved in such activities,

“(II) monitoring systems to protect against
accidental exposure and other hazards to the health
of such personnel while engaged in such activities,
“ (III) the type and form of information to be
given such personnel concerning the nature of the
health risks presented by such activities and the
frequency and manner of giving them such informa-
tion, and

“(IV) the type and frequency of medical
examinations to be given such personnel while en-
gaged in such activities ;

“ (iii) prescribe requirements respecting reports to
be made and records to be maintained by the holders
of licenses issued under this section ;

“(iv) include such special requirements as the
Secretaiy determines necessary for the conduct of recom-
binant DNA activities involving more than ten liters
of cell cultures containing recombinant DNA and for the
conduct of any commercial recombinant DNA activity
which the Secretary determines may present a signifi-
cant risk to the public health and safety or the environ-
ment; and

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“ (v) include such other provisions as the Secre-
tary determines necessary for the effective administration
of the requirements of this section.

“(B) Regulations required by subparagraph (A) shall
be initially promulgated within one year of the date of the
enactment of this part and shall take effect upon the expira-
tion of one hundred and eighty days from the date of their
promulgation.

“(C) The regulations required by subparagraph (A)
may not be initially promulgated unless the Secretary has
provided the advisory committee established under section
481 with a reasonable opportunity to provide him its recom-
mendations on such regulations, and such regulations may not
be amended to revise the requirements described in sub-
paragraph (A) (i) unless the Secretary has provided the
advisory committee with a reasonable opportunity to provide
him its recommendations on such revision.

“(D) The Secretary shall provide for an annual review

9

of the regulations required by subparagraph (A) to deter-
mine if their requirements continue to protect the public
health and safety and the environment.

“(E) If the Secretary receives a petition for the promul-
gation of a regulation to prescribe an additional requirement
under subparagraph (B) or to revise or repeal a requirement
contained in a regulation promulgated under that subpara-
graph, the Secretary shall either approve or deny the petition

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within one hundred and twenty days after the datp the peti-
tion is received by the Secretary. If the Secretary approves
such a petition, the Secretary shall, as soon as practicable
after the date the petition is approved, commence a proceed-
ing as requested by the petition. If the Secretary denies such
a petition, he shall notify the petitioner of the denial and the
reasons therefor and shall publish such reasons in tire Fed-
eral Register.

“ (4) (A) A license to authorize the conduct in a facility
of any recombinant DXA activity which under the applicable
physical containment requirements promulgated under para-
graph (3) (A) (i) requires physical containment at the
equivalent of the P-4 level prescribed by the guidelines
referred to in section 472(a) (2), may only be issued,
amended, or renewed by the Secretary, and the Secretary
may issue, amend, or renew such a license only upon the
recommendarion of the local biohazards committee with
jurisdiction over such facility.

“(B) a license to authorize the conduct in a facility
of any recombinant DXA activity which under the applicable
physical containment requirements promulgated under para-
graph (3) (A) (i) requires physical containment at the
equivalent of the P-3 level prescribed by the guidelines
referred to in section 472 (a) , may be issued, amended, and
renewed by a local biohazards committee if, within the thirty-

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1 day period beginning on the date such committee submits to

2 the Secretary —

3 “ ( 1 ) the application for such action together with

4 any materials submitted to the committee respecting the

5 application, and

6 “ (2) a statement of any conditions imposed by the

7 committee on the approval of the application,

8 the Secretary does not deny the application.

9 “(C) A license to authorize the conduct in a facility

10 of any recombinant DXA activity not described in sub-

11 paragraph (A) or (B) may be issued, amended, and

12 renewed by a local biohazards committee. Upon the issu-

13 ance, amendment, or renewal of a license by a local bio-

14 hazards committee, such committee shall submit to the

15 Secretary (i) the application for such action together with

16 any materials submitted to the committee respecting the

17 application, and (ii) a statement of any conditions imposed

18 by the committee on tho approval of the application.

19 “(D) If the Secretory determines that the issuance,

20 amendment, or renewal of a license by a local biohazards

21 committee under subparagraph (B) or (C) was not in

22 accordance with the requirements vi this section, the Secre-

23 tauy’ may take such action with respect to the license as he

24 determines is necessary, including revoking, suspending, or

25 limiting the license*

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“(E) The issuance, amendment, and renewal of a single
license to authorize the conduct of any combination of re-
combinant DN A activities described in subparagraphs (A) ,
(B) , and (0) shall be carried out jointly7" by the Secretary
and the local biohazards committee involved in accordance
with guidelines prescribed by the Secretary.

“(b) Any individual or public or private entity may
apply for the issuance of a license under this section. An
application for the issuance of a license shall be made in such
form and manner as the Secretary shall prescribe and shall
contain —

“(i) a detailed description of each recombinant
DNA activity to be conducted under the license applied
for (including applicable research protocols, designs, and
hypotheses) , identification of the professional personnel
to be engaged in each such activity and their qualifica-
tions, and a description of the facilities and materials to
be used in each such activity;

“(2) assurances satisfactory to the issuer of the
license applied for that each recombinant DNA activity
to be conducted under the authority of the license will
be conducted in accordance with applicable physical and
biological containment requirements prescribed under
subsection (a) (3) (A) (i) ;

“(3) assurances satisfactory to the issuer of the

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license that in that conuucf nf each such activity there
will be compliance with applicable personnel safety
requirements prescribed under subsection (a) (3) (A)

(ii) ;

“(4) assurances satisfactory to the issuer of the
license that the holder of the license applied for shall
make such reports, and shall maintain such records,
respecting each such activity (including reports and
records of any illness, injury, or death of any personnel
engaged in such activity and of the health care provided
such personnel while engaged in such activity) as arc
required under subsection (a) (3) (A) (iii) ; and

“(5) such additional information as the Secretary
may prescribe.

Applications for the renewal of a license or for the amend-
ment of a license to cover changes in facilities or recombin-
ant DXA activities shall be made in such form and manner
ns the Secretary shall prescribe.

“(c) (1) A license issued under this section shall be
valid for such period (but not in excess of thirty-six months)
as the Secretary may prescribe. Such a licence shall contain
such terms and conditions as the Secretary finds arc neces-
sary and appropriate to carry out the requirements of this
section and shall identify each recombinant DXA activity
which may be conducted under the license.

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“ (2) In the case of a license to authorize the conduct of
a recombinant DXA activity described in subparagraph (A)
of subsection (a) (4) , such a license may not be issued,
amended, or renewed under this section unless the Secretary
has provided the advisory committee established under sec-
tion 481 with a reasonable opportunity to provide him its
recommendations on the issuance, amendment, or renewal of
such license. To the extent practicable, the Secretary shall
consult with such advisory committee respecting applications
for the issuance, amendment, or renewal of a license to au-
thorize the conduct of a recombinant DXA activity described
in subparagraph (B) of subsection (a)(4).

“(d) The Secretary may revoke, suspend, or limit, a
license issued under this section for a facility if he finds, after
reasonable notice and opportunity for a hearing to the holder
of the license, that the holder of the license, any employee
or agent of the holder, or any person engaged in a recombi-
nant DNA activity in such facility —

“ ( 1 ) misrepresented any material fact in obtaining
the license,

“ (2) has engaged in or attempted to engage in, or
represented itself as entitled to perform, any recombinant
DNA activity not authorized by its license,

“ (3) has failed to comply with any of the terms or
conditions of the license,

H.R. 7418 3

[594]

18

1 “ (4) has failed to comply with a request of the

2 Secretary for any information or materials the Secre-

3 tary finds necessary to determine the continued eligi-

4 bility for its license or to evaluate the possible effects

5 on health or the environment of the recombinant DNA

6 activities conducted in the facility,

. 7 “(5) has failed to comply with a request of die

8 Secretary to inspect any portion of the facility, its op-

9 erations, or its records, which are related to reconnunant

10 DNA activities, or

11 “ (6) has violated or aided and abetted in the viola:

12 tion of any requirement established under this part.

13 “ (e) The Secretary’ shall, within one year after die

14 regulations initially promulgated under subsection (a) (3)

15 take effect, compile a list of the recombinant DNA activities

16 authorized to be conducted under licenses issued under this
IT section and shall, subject to section 480, make such list avail-

18 able for inspection by the public at reasonable times and

19 places. Such list shall be kept current by the Secretary.

20 “local biohazards committees

21 “Sec. 476. (a) No facility may be licensed under sec-

22 tion 475 unless a local biohazards committee has been estab-

23 lished in accordance with this section with jurisdiction over

24 such facility. The Secretary shall prescribe the number and

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type of facilities which may be within the jurisdiction of a
single local biohazards committee.

“(b) Each local biohazards committee (hereinafter in
this section referred to as a 'committee’) shall be established
and operate in the manner prescribed by this section and
regulations of the Secretary under this section. Such regula-
tions shall be initially promulgated within one hundred and
eighty days of the date of the enactment of this part.

“(c) (1) Each committee shall have the authority
prescribed by section 475 with respect to the issuance,
amendment, and renewal of licenses under that section. A
committee shall receive and consider license applications in
accordance with such procedures as che Secretary shall pre-
scribe. A committee may not approve an application for the
issuance, amendment, or renewal of a license unless at least
three-fourths of the members of the committee vote to ap-
prove the application. Upon the written request of any
member of a committee for review by the Secretary of
any decision of the committee to issue, amend, or renew
a license, the Secretary shall conduct such review and report
the results of his review to the committee. Such a request
shall contain a detailed statement of the reasons for requesting
review by the Secretary.

“(2) A committee shall, with respect to a facility

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licensed under section 175, carry out sucli inspections (in
accordance with section 4T7) and monitoring activities as
the Secretary may require to assure that the recombinant
DNA activities conducted in such facility are conducted in
accordance wi*h the requirements of this part and of the
license of the facility.

“ (d) Each committee shall have not less than seven or
more than fifteen members. The members of a committee
shp'l be individuals who by virtue of their training or expe-
rience are qualified to participate in the functions of the
committee. There shall be a correlation between the expertise
of the members of a committee and the recombinant DXA
activities under the jurisdiction of the committee. At least
one-third of the members of any committee shall be indi-
viduals who are not employees of, or who do not have a
financial interest in, any applicant for a license under sec-
tion 475.

“inspections

“Sec. 477. (a) (1) For purposes of enforcement of the
licensing requirements of this part, individuals (including
employees or agents of local biohazards committees) desig-
nated as inspectors by the Secretary, upon presenting appro-
priate credentials and a written notice to the owner, operator,
or agent in charge and after clearly informing him of their
authority, are authorized to enter and inspect any facility

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in a Smte in which a recombinant DXA activity is being
conducted or in the case of individuals conducting an inspec-
tion for a local biohazards committee, anj7 facility under the
jurisdiction of such committee in which a recombinant DXA
activity is being conducted. A separate notice shall be given
for each such inspection, but a separate notice shall not be
required for each entry made during the period covered by
the inspection. Such an inspection (A) shall be made during
the normal business hours of the facility being inspected and
in a reasonable manner, and (B) may extend to relevant
equipment, materials, containers, records, files, papers, proc-
esses, controls, facilities, and all other things in the facility
bearing on whether the recombinant DXA. activity’ is being
conducted in accordance with the licensing requirements of
this part.

“(2) Upon completion of any inspection of a facility
authorized by paragraph (1) and prior to leaving the fa-
cility, the individual making the inspection shall give to* the
owner, operator, or agent in charge a preliminary report
which summarizes any condition or practice observed by him
which, in his judgment, indicates a violation of the licensing
requirements of this part. He shall also prepare a written
final report of his findings and send it to such owner, opera-
tor, or agent within thirty days of the completion of the
inspection.

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“(b) For purposes of enforcement of the requirements
prescribed by or under sections 472 and 474, an individual
designated as an inspector by the Secretary, upon presenting
appropriate credentials to the owner, operator, or agent (if
any of these be present) in charge of —

“ ( 1 ) a vehicle or other facility which may be used
in the transportation of recombinant DNA and in which
the inspector has reasonable grounds to believe that
recombinant DNA is present, or

“(2) any real property which is not subject to
inspection under subsection (a) and in w’hich the inspec-
tor has reasonable grounds to believe recombinant DNA
is present,

may enter such facility or real property at reasonable times,
and inspect, at reasonable times and in a reasonable manner,
such facility or real property and all things at that facility or
real property which he has reasonable grounds to believe are
involved with recombinant DNA. When an inspector has
completed such an inspection he shall, before he leaves the
facility or real property, inform the owmer, operator, or agent
in charge of the facility or real property of any conditions or
practices w'hich in the inspector’s judgment constitute a viola-
tion of any of the requirements prescribed by or under sec-
tion 472 or 474. The inspector shall also prepare a written
report of his findings and send it to the owner, operator,

[599]

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2 or agent in charge of the facility or real property within a

2 reasonable time.

3 (c) At the request of an inspector conducting an

4 inspection under subsection (a) or (b) of a facility or real
- property, the person in charge of such facility or property
g shall provide such samples of recombinant DNA or of
rj materials used in or produced by any recombinant DNA
3 activity conducted in such facility or on such property as
9 the inspector may require to determine if the applicable

20 requirements of sections 472, 474, and 475 are being com-
22 plied with.

22 “ (d) If during an inspection of a facility or real property

23 conducted under subsection (a)- or (b), recombinant DNA

24 or any material used in or produced by a recombinant DNA

25 activity which the inspector making the inspection has

26 reason to believe presents a significant risk to health or

27 the environment is found in such facility or property, such

28 inspector may order the recombinant DNA or material

29 detained (in accordance with regulations promulgated by
2o the Secretary) for a reasonable period which may not exceed
22 twenty days unless the Secretary determines that a period of

22 detention greater than twenty days is required to institute an

23 action under section 479(b), in which case the Secretary

24 may authorize a detention period of not to exceed thirty

25 days. Any recombinant DNA or material subject to a deten-

[600]

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tion order issued under this subsection shall not be moved
by any person from the place at which it is ordered detained
until —

“ ( 1 ) released by the Secretary, or
“ (2) the expiration ol the detention period applica-
ble to such order,
whichever occurs first.

“ (e) Xo individual designated by the Secretary to
conduct an inspection under subsection (a) or (b) shall
be required to obtain a search warrant from any judicial
officer before entering any facility or real property to con-
duct such inspection.

“prohibited acts and penalties
“Sec. 478. (a) Xo person may —

“(1) conduct any recombinant DXA activity in
violation of any applicable requirement of section 472
or any regulation under section 474;

“(2) conduct any recombinant DXA activity in a
facility for which a license is required by section 475
unless —

"(A) a license is in effect for such facility un-
der such section, and

“(B) the activity is conducted in accordance
with the requirements of such license; or
“ (3) fail or refuse to —

[601]

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25

“ (A) establish or maintain records,

2 “(B) make reports or provide information, or

3 “ (C) permit entry or inspection,

4 as required by this part or any regulation promulgated

5 under this part.

6 “ (b) (1) Any person who violates subsection (a) shall

7 be liable to the United States for a civil penalty in an amount

8 not to exceed $50,000 for each such violation. Each day such

9 a violation continues shall, for purposes of this paragraph,

10 constitute a separate violation of subsection (a) .

11 “(2) A civil penalty for a violation of subsection (a)

12 shall be assessed by the Secretary by an order made on the

13 record after opportunity (provided in accordance with this

14 subsection) for a hearing in accordance with section 554

15 of title 5, United States Code. Before issuing such an order,

16 the Secretary shall give written notice to the person to be

17 assessed a civil penalty under such order of the Secretary’s

18 proposal to issue such order and provide such person an

19 opportunity to request, within fifteen days of the date the

20 notice is received by such . person, such a hearing on the

21 order.

22 “ (3) Any person who requested in accordance with para-

23 graph (2) a hearing respecting the assessment of a civil

24 penalty and who is aggrieved by an order assessing a civil

25 penalty may file a petition for judicial review of such order

[602]

26

1 with the United States Court of Appeals for the District of

2 Columbia Circuit or for any other circuit in which such

3 person resides or transacts business. Such a petition may

4 only be filed within the thirty-day period beginning on the

5 date the order making such assessment was issued.

6 “ (4) If any person fails to pay an assessment of a civil

7 penalty —

8 “(A.) after the order making the assessment has

9 become a final order and it such person does not file

10 a petition for judicial review of the order in accord-

11 ance with paragraph (3) , or

12 “ (B) after a court in an action brought under para-

13 graph (3) has entered a final judgment in favor of the

14 Secretary,

13 the Attorney General shall recover the amount assessed

16 (plus interest at currently prevailing rates from the date of

17 the expiration of the thirty-day period referred to in para-

18 graph (3) or the date of such final judgment, as the case

19 may be) in an action brought in any appropriate district

20 court of the United States. In such an action, the validity,

21 amount, and appropriateness of such penalty shall not be

22 subject to review.

23 “ (c) Any person who knowingly or willfully violates

24 subsection (a) shall be subject, upon conviction, to a fine

25 of not more than $50,000, to imprisonment for not more

[603]

27

1 than one year (and not more than ten yearn for a related

2 series of violations) , or to both. Each day a violation of

3 subsection (a) continues shall constitute a separate viola-

4 tion for purposes of this subsection.

5 “ (d) No grant, contract, or other form of financial

6 assistance for any purpose related to recombinant DXA may

7 be provided under this Act to any person who is liable

8 for a civil penalty under subsection (b) or who has been

9 convicted under subsection (c) of a violation of subsection

10 (a).

11 “injunction authority; emergency procedure

12 “Sec. 479. (a) The district courts of the United States

13 shall have jurisdiction over civil actions to restrain any vio-

14 lation of section 478 (a) . Such a civil action may be brought

15 in the United States district court for the judicial district

16 wherein any act, omission, or transaction constituting a

17 violation of section 478 (a) occurred or wherein the defend-

18 ant is found or transacts business. In any such civil action,

19 process may be served on a defendant in any judicial district

20 in which a defendant resides or may be found. Subpenas

21 requiring attendance of witnesses in any such action may

22 be served in any judicial district.

23 “ (b) The district courts of the United States shall have

24 jurisdiction over any civil action brought for the seizure or

25 destruction of any recombinant DhTA, or an}' material used

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in or produced by a recombinant DNA activity, which
recombinant DNA or material presents or may present a
significant risk to health or the environment or for other
appropriate relief io prevent its production or movement.
“disclosure of data

“Skc. 480. (a) Any information reported to, or other-
wise obtained by, the Secretary (or any representative of
the Secretary) or any local biohazards committee under this
part, which is exempt from disclosure pursuant to subsection
(a) o.' section 552 of title 5, United States Code, by reason
of subsection (b) (4) of such section, shall, notwithstanding
the provisions of any other section of this Act, not be dis-
closed by the Secretary, by any officer or employee of the
United States, or by any such committee, except that such
information —

“ ( 1 ) shall be disclosed to any officer or employee
of the United States —

“(A) in connection with the official duties of
such officer or employee under any law for the pro-
tection of health or the environment, or

“(B) for specific law enforcement purposes;
“(2) shall be disclosed if the Secretary determines
it necessary to protect health or the environment against
an unreasonable risk of injury ; or

“(3) may be disclosed when relevant in any pro-

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ceedirg under this part, except that disclosure in such
a proceeding shall he made in such mauner as to pre-
serve confidentiality to the extent practicable without
impairing the proceeding.

In any proceeding under section 552 (a) of title 5, United
States Code, to obtain information the disclosure of which
has been denied because of the provisions of this subsection,
the Secretary or committee may not rely on section 552 (b)
(3) of such Litle to sustain the Secretary’s or committee’s
action.

“(b) (1) In submitting data under this part, the indi-
vidual or entity submitting the data may (A) designate the
data which such individual or entity believes is entitled to
confidential treatment under subsection (a), and (B) sub-
mit such designated data separately from other data sub-
mitted under this part. A designation under this paragraph
shall be made in writing and in such manner as the Sec-
retary may prescribe.

“(2) (A) Except as provided in subparagraph (B) ,
if the Secretary or a local biohazards committee pro-
poses to release for inspection data which has been desig-
nated under paragraph (1) (A) , the Secretary or committee
shall notify, in wilting and by certified mail, the individual
or entity which submitted such data of the intent to release
such data. If the release of such data is to be made pursu-

[606]

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30

ant to a request made under section 552 (a) of title 5,

2 United States Code, such notice shall be given immediately

3 upon approval of such request by the Secretary or oominit-

4 tee. The Secretary or committee may not release such data

5 until die expiration of thirty days after the individual or

6 entity submitting such data has received the notice required

7 by this subparagraph.

8 “(B) Subparagraph (A) shall not apply to the release

9 of information under paragraph (1), (2), or (3) of subsec-

10 tion (a) except that the Secretary or committee may not

11 release data under paragraph (2) of subsection (a) unless

12 the Secretary or committee has notified each individual or

13 entity who submitted such data of such release. Such notice

14 shall be made in writing by certified mail at least fifteen days

15 before the release of such data, except that if the Secretary

16 or committee determines that the release of such data is nec-

17 essary to protect against an imminent, unreasonable risk of

18 injury to health or the environment, such notice may be made

19 by such means as the Secretary or committee determines will

20 provide notice at least 24 hours before such release is made.

21 “ (c) Any officer or employee of the United States or

22 member or employee of a local biohazards committee or for-

23 mer officer or employee of the United States or former mem-

24 ber or employee of such a committee, who by virtue of such

25 employment or official position has obtained possession of, or

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has access to, material the disclosure of which is prohibited
by subsection (a) , and who knowing that disclosure of such
material is prohibited by such subsection, willfully discloses
the material in anjr manner to any person not entitled to
receive it, shall be guilty of a misdemeanor and fined not
more than $5,000 or imprisoned for not more than one year,
or both. Section 1905 of title 18, United States Code, does
not apply with respect to the publishing, divulging, disclos-
ing, or making known of, or making available, information
reported or otherwise obtained under this part.

“(d) Notwithstanding any limitation contained in this
section or any other provision of law, all information reported
to or otherwise obtained by the Secretary (or any represent-
ative of the Secretary’) or by any local biohazards committee
under this part shall be made available, upon written request
of an}’ duly authorized committee of the Congress, to such
committee.

“(e) Each local biohazajds committee shall be consid-
ered an agency subject to the requirements of section 552 of
title 5, United States Code.

“advisory committee

“Sec. 481. (a) There is established the Recombinant
DNA Advisory Committee (hereinafter in this section re-
ferred to as the ‘advisory committee’) which will carry out
the functions prescribed for it under sections 474 and 475

[608]

32

1 and which will make recommer.dafiun* to tbc Secretary for

2 the effective admini-trntion of thi* part.

3 “ (b) The advisory committee sh*U consist of fifteen

4 members appointed by the Secretary from individuals who

5 by virtue of their training or experience are nualified to par-

6 ticipate in the functions of the advisory committee. The mem-

7 bership of the advisory committee shall include indi viJuals who

8 are representative of the various scientific and medical dis-

9 ciplires concerned with recombinant DXA activities and tlie

10 potential risks to health aud the environment presented by

11 such activities. Of the individual* appointed as members of

12 the advisor}' committee, at least two shell have backgrounds

13 in the ethical oouccras involved in biomedical research, at

14 least three shall represent the interests of the general public,

15 and at least eight shall be individuals who are net engaged

16 in any recombinant DXA activity and do not have a financial

17 interest in any person engaged in such an activity. The term

18 of office of a member of the advisory committee shall be three

19 years, except that of the member? first appointed to the ad-

20 visor}' committee, five shall be appointed for a term of one

21 year and fi\c shall be appointed for a term of two years, as

22 designated by the Secretary at the time of appointment. Sec-

23 tion 14 of the Federal Vdvi«ory Committee Act shall not

24 apply with respect to the duration or die advisory committee.

25 “(c) Members of the advisory committee (other than

[609]

33

1 officers or employees of the United Stal es) , while attending

2 meetings or conferences of the advisory committee or other-

3 wise engaged in its business, shall be entitled to receive

4 compensation at rates to be fixed by the Secretary, but not

5 at rates exceeding the daily equivalent of the rate in effect

6 for grade GS-18 uf the General Schedule, for each day so

7 engaged, including traveltime; and while so serving away

8 from their homes or regular places of business each member

9 may be allowed travel expenses (including per diem in lieu

10 of subsistence) as authorized by section 5703 (b) of title 5,

11 United States Code, for persons in the Government service

12 employed intermittently.

13 “employee protection

14 “Sec. 482. (a) Xo employer may discharge any em-

15 ployee or otherwise discriminate against any employee with

16 respect to the employee’s compensation, terms, conditions,

17 or privileges of employment because the employee (or any

18 person acting pursuant to a request of the employee) has —

19 “(1) commenced, caused to be commerced, or is

20 about to commence or cause to be commenced a pro-

21 ceeding under this part,

22 “(2) testified or is about to testify in any such

23 proceeding, or

24 “(3) assisted or participated or is about to assist

25 or participate in any maimer in such a proceeding or

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in any other action to enforce any requirement of this

part,

“(h) (1) Any employee who believes that he has
been discharged or otherwise discriminated against by
any person in violation of subsection (a) of this section may,
within thirty days after such alleged violation occurs, file
(or have any person file on the employee’s behalf) a com-
plain., with the Secretary of Labor (hereinafter in this sec-
tion referred to as the 4Secr:tary’) alleging such discharge
or discrimination. Upon receipt of such a complaint, the Sec-
re taiy shall notify the person named in the complaint of the
filing of the complaint.

“ (2) (A) Upon receipt of a complaint filed under para-
graph ( 1 ) , the Secretary shall conduct an investigation of
the violation alleged in the complaint. Within thirty days
of the receipt of such complaint, the Secretary shall complete
such investigation and shall notify in writing the complainant
(and any person acting on behalf of the complainant) and
the person alleged to have committed such violation of the
results of the investigation conducted pursuant to this subpar-
agraph. Within ninety days of the receipt of such complaint
the Secretary shall, unless the proceeding on the complaint
is terminated by the Secretary on the basis of a settlement
entered into by the Secretary and the person alleged to have
committed such violation, issue an order cither providing

[611]

35

1 the relief prescribed by subparagraph (B) or denying the

2 complaint. An order of die Secretary shall be made on the

3 record after notice and opportunity for agency hearing. The

4 Secretary may not enter into a settlement terminating a pro-

5 ceeding on a complaint without the participation and consent

6 of the complainant

7 “(B) If in response to a complaint filed under paragraph

8 (1) the Secretary determines that a violation of subsection

9 (a) of this section has occurred, the Secretary shall order

10 (i) the person who committed such violation to take affirma-

11 tive action to abate the violation, (ii) such person to re-

12 instate the complainant to the complainant’s former position

13 together with the compensation (including back pay) , terms,

14 conditions, and privileges of the complainant’s employment,

15 (iii) compensatory damages, and (iv) where appropriate,

16 exemplary damages. If such an order is issued, the Secretary,

17 at the request of the complainant, shall assess against the

18 person against whom the order is issued a sum equal to the

19 aggregate amount of all costs and expenses (including at-

20 torney’s fees) reasonably incurred, as determined by the

21 Secretary, by the complainant for, or in connection with, the

22 bringing of the complaint upon which the order was issued.

23 “ (c) (1) Any employee or employer adversely affected

24 or aggrieved by an order issued under subsection (b) may

25 obtain review of the order in the United States court of

[612]

36

1 appeals for the circuit in which the violation, with respect

2 to which the order was issued, allegedly occurred. The peti-

3 tion for review must he filed within sixty days from the

4 issuance of the Secretary’s order. Review shall conform to

5 chapter 7 of title 5 of the United States Code

6 “(2) An order of the Secretary, with respect to which

7 review could have been obtained uuder paragraph ( 1 ) ,

8 shall not he subject to judicial review in any criminal or

9 other civil proceeding.

10 “(d) Whenever a person has failed to comply with an

11 order issued under subsection (b) (2), the Secretary shall

12 file a civil action in the United Stales district court for the

13 district in which the violation was found to occur to enforce

14 such order. In actions brought under this subsection, the

15 district courts shall have jurisdiction to grant all appropriate
10 relief, including injunctive relief and compensatory and

17 exemplar}* damages. Civil actions brought under this sub-

18 section shall be heard and decided expeditiously.

19 “(e) Subsection (a) of this section shall not apply with

20 respect to any employee who, acting without direction from

21 the employee’s employer (or any agent of the employer),

22 deliberately causes a violation of any requirement of this

23 part.

24 “relationship to other federal laws

25 “Sec. 483. (a) This pail shall not affect the authority

26 of any Executive agency (as that term is defined in section

[613]

37

1 105 of title 5, United States Code) to regulate under any

2 other Act recombinant DHA activities.

3 “ (b) In exercising any authority under this part, the

4 Secretary, or any person acting on his behalf or pursuant

5 to this part, shall not, for purposes of section 4(b) (1) of

6 the Occupational Safety and Health Act of 1970- be deemed

7 to be exercising statutory authority to prescribe or enforce

8 standards or regulations affecting occupational safety and

9 health.

10 “(c) (1) Upon request by the Secretary7, each Execu-

11 rive agency is authorized —

12 “ (A) to make its services, personnel, and facilities

13 available (with or without reimbursement) to the Sec-

14 retary to assist the Secretary in the administration of

15 ' this part, and

16 “(B) to furnish to the Secretary such information,

17 data, estimates, and statistics, and to allow the Secretary

18 access to all information in its possession, as the Sec-

19 retary may reasonably determine to be necessary for

20 the administration of this part.

21 “(2) Upon request by any Executive agency, the Sec-

22 retary is authorized —

23 “ (A) to make the services, personnel, and facilities

24 of the Department of Health, Education, and Welfare

25 available (with or without reimbursement) tc that

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agency in the administration of a^y Act with respect to
recombinant DXA activities, and

“(B) to famish to that agency such information,
data, estimates, and statistics, and to allow that agency
access to all information in the Secretary's possession, as
the agency may reasonably determine to be necessary
for the administration of auv Act with respect to
recombinant DXA activities.

“EFFECT ON STATE AND LOCAL BEQUIBEMENTS
“Sec. 484. (a) Except as provided in subsection (b),
no State or political subdivision of a State may establish
or continae in effect with respect to recombinant DXA
activities any requirement which is different from, or in
addition to, any requirement applicable under this part to
such activities.

“(b) Upon application of a State or political subdivi-
sion of a State, the Secretary shall, by order promulgated
after providing (in accordance with this subsection) no tic*
and opportunity for an oral hearing on such application,
exempt from subsection (a), under suA conditions as may
be prescribed in such order, a requirement of such StaD*
or political subdivision applicable to recombinant DX •'
activities if —

“ ( 1 ) the requirement is the same as, or more
stringent than, a requirement under this part which

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world be applicable to such activities if an exemption
were not in effect under this subsection; and

“ (2) the requirement is necessary to protect health
or the environment and is required by compelling local
conditions.

A State or political subdivision which submits an application
under this subsection shall be given an opportunity for an
oral hearing on such application to be commenced not later
than sixty days from the date the application is submitted.
The presiding officer at such a hearing shall upon conclusion
of the hearing make a written recommendation to the Secre-
tary respecting approval of the application upon which the
hearing was iield.

“ (c) Within-

“ ( 1 ) sixty days of the conclusion of a hearing held
on an application submitted under subsection (b) , or
“ (2) one hundred and twenty days of the date the
application was submitted.

whichever occurs later, the Secretary shall either approve
or disapprove such application. The decision of the Secretary
shall be in writing, shall, if a hearing was held on the appli-
cation, contain the recommendation made by the presiding
officer at such hearing, and shall include a complete state-
ment of the reasons for the decision of the Secretary.

[616]

40

1 “training and studies

2 “Sec. 485. (a) The Secretary may conduct and support

3 training in the safe handling of recombinant PNA.

4 “(b) The Secretary shall conduct or support on a con-

5 tinning basis studies designed to assess the risks to health

6 and the environment which may be presented by recom-

7 binant PNA activities.”.

?

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a. 2.

[617]

95tii CONGRESS
1st Session

IN THE HOUSE OF REPRESENTATIVES

June 20,1977

Mr. Rogers (for himself, Mr. Preyer, Mr. Sciieuer, Mr. Waxman, Mr. Florio,
Mr. Maguire, Mr. Markey, Mr. Ottinger, Mr. Walg.ien, Mr. Carter,
Mr. Madigan, and Mr. Skubitz) introduced the follow'd g bill ; which was
referred to the Committee on Interstate and Foreign Commerce

To amend the Public Health Service Act to regulate activities
involving recombinant I)NA, and for other purposes.

1 Be it enacted by the Senate and House of Iiepresenta-

2 tives of the United States of America in Congress assembled ,

3 SHORT TITLE

4 Section 1. This Act may be cited as the “Recombinant
5.v DNA Act”.

6 TITLE I— REGULATION OE RECOMBINANT DNA

7 ACTIVITIES

8 FINDINGS

9 Sec. 101. The Congress finds that —

10 (1) research and oilier activities involving rccom-

I

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binnnt DXA will improve the understanding of funda-
mental biological processes;

(2) the knowledge gained from such research and
other activities may he Qf great benefit to medicine and
agriculture and may provide many other benefits to
society;

(3) there exist, however, uncertainties regarding
the extent to which recombinant DXA or organisms or
viruses containing recombinant DXA and activities in-
volving recombinant DXA may present a ri>k of injur}'
to health or the environment, and there is a risk that
such organisms and viruses may spread quickly and
without warning to persons, agricultural plants and prod-
ucts, and other items in or affecting commerce;

(4) the public interest require? that the health and
welfare of the population of the United States be pro-
tected from such risk, and commerce n the United States
is dependent upon such protection being provided; and

(5) to effectively accomplish such protection and
consequently to effectively regulate commerce requires
that the possession of recombinant DXA and any activity
engaged in for its production (whether a research or
commercial activity) be subject to control.

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AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT
Sec. 102. Title IV of the Public Health Service Act is
amended (1) by redesignating part I as part J, (2) by re-
designating sections 471 through 476 (and all references to
such sections) as sections 486 through 491, respectively, and
(3) by inserting after part H the following new part:
“Part I — Recombinant DNA
“definitions

“Sec. 471. Por purposes of this part:

“ (1) The term ‘DNA’ means deoxyribonucleic acid.
“(2) (A) Except as provided in subparagraph
(B), the term ‘recombinant DNA’ means DNA mole-
cules that (i) consist of DNA segments which have
been joined together in a cell-free system and (ii) have
the capacity to enter in a cell and to replicate in such
cell either autonomously or after they have become an
integrated part of such cell’s genome.

“(B) The term ‘recombinant DNA’ does not include
DNA molecules —

“ (i) which consist entirely of —

“(i) DNA segments which are derived
from the chromosomal DNA of prokaiyotic
cells,

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“(II) I)NA segments which are derived
from plasmids of prokaryotic cells,

“(III) DNA segments which are derived
from the DNA of viruses which can only infect
prokaryotic cells, or

“ (IV) any combi’ nation of such DNA seg-
ments,

and which DNA molecules can only enter and
replicate in cells in which each DNA segment from
which such DNA molecules were formed can also
enter and replicate hy a process which the Secretary
determines is known to occur naturally; or

“ (ii) which consist entirely of DNA segments
from a single nonchromosomal DNA source.

“(3) The term ‘local biohazards committee’ means
a local biohazards committee established in accordance
with section 476, and the term ‘Advisory Committee’
means the Recombinant DNA Advisory Committee
established under section 481.

“ (4) The possession in a State of recombinant
DNA by any individual or public or private entity and
any activity (including research and transportation)
undertaken in a State by any individual or public or
private entity for the production of recombinant DNA
are collectively referred to as ‘recombinant DNA a. iiv-

[621]

5

1 ities’. The term ‘public entity’ includes any Federal,

2 State, or local governmental entity.

3 “interim control

4 “Sec. 472. (a) (1) During the period beginning on the

5 tenth day after the date of the enactment of this part and

6 ending —

7 “ (A) eighteen months after such date, or

8 “(B) on the date the regulations required by sec-

9 tion 475 take effect,

10 whichever occurs first, all recombinant DNA activities shall

11 be carried out in accordance with the physical and biological

12 containment requirements described in paragraph (2).

13 “(2) The physical and biological containment require-

14 ments referred to in paragraph (1) are the physical and

15 biological containment requirements —

16 “(A) as contained in the recombinant DNA re-

17 search guidelines of the Department of Health, Educa-

18 Register for July 7, 1976,

19 tion, and Welfare published in part II of the Federal

20 “(B) if revised between July 7, 1976, and the

21 tenth day after the date of the enactment of this part,

22 as so revised, or

23 “(C) if revised under subsection (c) , as so revised.

24 “(3) Before the expiration of the ten-day period be-

25 ginning on the date of the enactment of this part, the Sec-

1622]

6

1 retary shall take such action as may he necessary to publicize

2 and make available the requirements described in paragraph

3 (2), including the publication of such requirements in the

4 Federal Register.

5 '‘(b) From the date of the enactment of this part until

6 the expiration of the period described in subsection (a),

7 all the requirements of the recombinant DNA research guide-

8 lines of the Department of Health, Education, and Welfare —

9 “ ( 1 ) as published in part II of the Federal Register

10 for July 7, 1976,

11 “(2) if revised between July 7, 1976, and the

12 tenth day after the date of the enactment of this part,

13 as so revised, or

14 “ (3) if revised under subsection (c) , as so revised,

15 shall continue to apply as specified in such guidelines.

16 “(c) The physical and biological containment requirc-

17 ments of the guidelines described in subsection (a) which are

18 in effect on the tenth day after the date of the enactment

19 of this part may be revised only by regulations promulgated

20 by the Secretary in accordance with section 553 of title 5,

21 United States Code.

22 “(d) (1) Each individual or entity which, on the date
-23 cf the enactment of this part, is responsible for the conduct of
24 any recombinant DNA activity shall, in accordance with

[623]

7

1 regulations promulgated under subsection (e) and before

2 the expiration of ninety days from the date of the enactment

3 of this part, report in writing to the Secretary' —

4 “(A) such individual’s or entity’s name, and

5 “ (B) a description of such activity and an identifi-

6 cation of the place or places in which it is being con-

7 ducted.

8 “(2) Each individual or entity which is to be respon-

9 sible for a recombinant DNA activity to be commenced dur-

10 ing the period described in subsection (a) shall upon the

11 commencement of such activity report in writing to the

12 Secretary such individual’s or entity’s name, a description of

13 such activity, and an identification of the place or places in

14 which such activity is to be conducted.

15 “(e) (1) Before the expiration of the forty-five-day pe-
10 riod beginning on the date of the enactment of this part, the

17 Secretary shall, without regard to subsections (c) and (d)

18 of section 553 of title 5, United States Code, promulgate

19 such regulations as may be necessary for the administration

20 of the requirements of this section.

21 “ (2) The regulations described in subsection (c) and

22 paragraph ( 1 ) of this subsection may be promulgated witli-

23 out regard to section 102(2) (C) of the National Environ-

24 mental Policy Act of 1969.

[624]

8

1 “GENERAL EEQUIlIgMENTS

2 “Sec. 473. (a) Except as provided under subsection

3 (b), the following requirements apply under this part with

4 respect to recombinant ENA activities :

5 “(1) Each facility in which a recombinant EE A

6 activity is to be conducted shall be licensed in accordance

7 with section 475.

8 “(2) The transportation of recombinant ENA and

9 any other recombinant ENA activity (including an

10 agricultural activity) which is not conducted in a facility

11 shall be carried out in accordance with regulations

12 promulgated by the Secretary under section 474.

13 “(b) The Secretary may, with the concurrence of the

14 Advisory Committee and by regulation, exempt from the

15 reouirements of this part any recombinant ENA activity

16 which the Secretary finds does not present a significant risk

17 to health or the environment.

18 “CONTROL OF NON-FACIL’TY RECOMBINANT DNA

19 ACTIVITIES

20 “Sec. 474. (a) The Secretary shall promulgate regula-

21 tions to control the conduct of recombinant ENA activities

22 described in section 473 (a) (2). Such regulations shall —

23 “ (1) prescribe physical and biological containment

24 requirements for the conduct of such activities;

[625]

9

1 “(2) apply as appropriate, to the conduct of such

2 activities, the personnel safety requirements prescribed

3 under section 475 ;

4 “ (3) include such special requirements as the
'5 Secretary determines necessary for the conduct of recom-

6 binant I>NA activities involving more than ten liters

7 of cell cultures containing recombinant DNA and for the

8 conduct' of any commercial recombinant DNA activity

9 which the Secretary determines may present a sig-

10 nificant risk to health or the environment; and

11 “(4) include such other provisions as the Secre-

12 tary determines to be necessary for the protection of

13 health or the environment.

14 “(b) The Secretary shall consult with the Advisory

15 Committee respecting the promulgation of the regulations

16 required by subsection (a) (including the promulgation of

17 amendments to such regulations other than amendments to

18 make clerical or technical changes ) , and any notice of pro-

19 posed rulemaking issued by the Secretary respecting such

20 regulations shall contain any comments submitted to the

21 Secretary by the Advisory Committee respecting such

22 regulations.

23 “(c) The regulations required by subsection (a) shall

24 be initially promulgated within one year of the date of the

11.11. 7897 2

[626]

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enactment of this part and shall take eJTect upon the expira-
tion of one hundred and eighty days from the date of their
promulgation.

“(d) The Secretary shall provide for an annual review
of the regulations required by subsection (a) to determine, if
their requirements continue to protect health and the
environment.

“(e) If the Secretary receives a petition for the pro-
mulgation of a regulation to prescribe an additional require-
ment under subsection (a) or to revise or repeal a require-
ment contained in a regulation promulgated under that
subsection, the Secretary shall, after consultation with the
Advisory Committee, either approve or deny the petition
within one hundred and twenty days after the date the
petition is received by the Secretary. If the Secretary
approves such a petition, the Secretary shall, as soon as prac-
ticable after the date the petition is approved, commence a
proceeding as requested by the petition. If the Secretary
denies such a petition, he shall notify the petitioner of the
denial and the reasons therefor and shall publish such reasons
in the Federal Register.

“licenses

“Sec. 475. (a) (1) Licenses for facilities in which re-
combinant LUST A activities are to be conducted shall be issued,
amended, and renewed in accordance with this section.

[627]

11

1 “(2) A license under this section is the authority for

2 the conduct of recombinant DXA activities in the facility

3 or facilities for which the license is issued. The Secretary

4 shall prescribe guidelines respecting —

5 “ (A) the types and number of facilities that may

%

6 be covered by a single license, and

7 “ (B) the types of recombinant DXA activities that

8 may be authorized by a single license.

9 “(3) (A) The Secretary shall promulgate regulations
10 to implement the administration of this section. Such regu-
ll lations shall —

12 “ (i) prescribe physical and biological containment

13 requirements for recombinant DXA activities authorized

14 to be. conducted under licenses issued under this section ;

15 “ (ii) prescribe requirements for —

16 “ (I) laboratory safety training to be given

IT to, and safety techniques to be followed by, per-

18 sonnel to be involved in such activities,

19 “ (II) monitoring systems to protect against

20 accidental exposure and other hazards to the health

21 of such personnel while engaged in such activities,

22 “ (III) the type and form of information to be

23 given such personnel concerning the nature of the

24 health risks presented by such activities and the

[628]

12

X frequency and manner of giving tliern such informa-

2 tion, and

3 “ (IV) the type and frequency of medical

4 examinations to he given such personnel while en-

5 gaged in such activities;

6 “ (iii) prescribe requirements respecting reports to

7 be made and records to be maintained by the holders

8 of .licenses issued under this section;

9 “ (iv) include such special requirements as the

10 Secretary determines necessary tor the conduct of recom-

11 binant DU A activities involving more than ten liters

12 of cell cultures containing recombinant DNA and for

13 the conduct of any commercial recombinant DNA ae-

14 tivity which the Secretary deiermines may present a

15 significant risk to health or the environment; and

10 “ (v) include such other provisions as the Secre-

17 tary determines necessary for the effective administration

18 of the requirements of this section.

19 “(D) Regulations required by subparagraph (A) shall

20 be initially promulgated within one year of the date of the

21 enactment of this part and shall take effect upon the expira-

22 tion of one hundred and eighty days from the date of their

23 promulgation.

24 “(C) The Secretary shall consult with the Advisory

25 Committee respecting the promulgation of the regulations

[629]

12

] frequency' and manner of giving them such informa-

2 tion, and

3 “ (IV) the type and frequency of medical

4 examinations to be given such personnel while en-

5 gaged in such activities;

6 “ (iii) prescribe requirements respecting reports to

7 be made and records to be maintained by the holders

8 of licenses issued under this section;

9 “ (iv) include such special requirements as the

10 Secretary determines necessary for the conduct of recom-

11 binant DXA activities involving more than ten liters

12 of cell cultures containing recombinant DNA and for

13 the conduct of any commercial recombinant DNA ac-

14 tivity which the Secretary determines may present a

15 significant risk to health or the environment ; and

16 “ (v) include such other provisions as the Secre-

17 1ar}T determines necessary for the effective administration

18 of the requirements of this section.

19 “(B) Regulations required by subparagraph (A) shall

20 be initially promulgated within one year of the date of the

21 enactment of this part and shall take effect upon the expira-

22 tion of one hundred and eight}*- days from the date of their

23 promulgation.

24 “(C) The Secretary shall consult with the Advisory

25 Committee respecting the promulgation of the regulations

[630]

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required by subparagraph (A) {including the promulgation
of amendments to such regulations other than amendments
to make clerical or technical changes) , and any notice of
proposed rulemaking issued by the Secretary respecting such
regulations shall contain any comments submitted to the
Secretary by the Advisory Committee respecting such
regulations.

“ (D) The Secretary shall provide for an annual review
of the regulations required by subparagraph (A) to deter-
mine if their requirements continue to protect the public
health and safety and the environment.

“(E) If the Secretary receives a petition for the promul-
gation of a regulation to prescribe an additional requirement
under subparagraph (A) or to revise or repeal a requirement
contained in a regulation promulgated under that subpara-
graph, the Secretary shall, after consultation with the Advi-
sory Committee, either approve or deny the petition within
one hundred and twenty days after the date the petition is
received by the Secretary. If the Secretary approves such a
petition, ihe Secretaiy shall, as soon as practicable after the
date the petition is approved, commence a proceeding as
requested by the petition. If the Secretary denies such a peti-
tion, he shall notify the petitioner of the denial and the rea-
sons therefor and. shall publish such reasons in the Federal
Register.

[631]

14

1 “ (4) (A) A license to authorize the conduct in a facility

2 of any recombinant DXA activity which under the applicable

3 physical containment requirements promulgated under para-

4 graph (3) (A) (i) requires physical containment at the

5 equivalent of the P-4 level prescribed by the guidelines

6 referred to in section 472(a) (2), may only he issued,

7 amended, or renewed by the Secretary, and the Secretary

8 may issue, amend, or renew such a license only if the Advi-

9 sory Committee and the local biohazards committee with

10 jurisdiction over such facility recommend that such license be

11 issued, amended, or renewed.

12 “(B) A license to authorize the conduct in a facility of

13 any recombinant DXA activity which under the applicable

14 physical containment requirements promulgated under para-

15 graph (3) (A) (i) requires physical containment at the

16 equivalent of the P-3 level prescribed by the guidelines

17 referred to in section 472 (a) (2), may be issued, amended,
IS and renewed by a local biohazards committee in accordance

19 with this subparagraph. If the committee proposes to approve

20 cm application for the issuance, amendment, or renewal of

21 such a license, such committee shall submit to the Secretary —

22 “ ( 1 ) the application for such action together with

23 any materials submitted to the committee respecting the

24 application, and

25 “ (2) a statement of any conditions proposed to be

[632]

15

1 imposed by the committee on the approval of the

2 application to assure that requirements under this part

3 applicable to recombinant DNA activities which would

4 be conducted under the license are complied with,

5 and, within thirty days of the submittal of such application
g and statement, the Secretary shall, in consultation with the

7 Advisory Committee, review the application to determine if

8 its approval would be in accordance with the requirements of

9 this part. The Secretary, upon request of the Advisory Com-

10 mittee, shall extend such thirty-day review period for an ad-

11 ditional period of not to exceed sixty da}^s. The local bio-

12 hazards committee may approve the application unless within

13 the applicable review period the Secretary determines that

14 it may not be approved. The Secretary shall, subject to sec-

15 tion 480, publish in the Federal Register the results of any
lg application review conducted under this subparagraph, the

17 comments of the Advisory Committee on such application,

18 and if the Secretary did not disapprove an application which

19 the Advisory Committee recommended be disapproved, the
2Q reasons for not disapproving the application.

21 “(C) A license to authorize the conduct in a facility

22 of any recombinant DNA activity not described in sub-

23 paragraph (A) or (B) may be issued, amended, and re-

24 newed by a local biohazards committee. Upon the issuance,

25 amendment, or renewal of a license by a local biohazards

[633]

16

1 committee, such committee shall submit to the Secretary (i)

2 the application for such action together with any materials

3 submitted to the committee respecting the application, and

4 (ii) a statement of any conditions imposed by the cominit-

5 tee on the approval of the application to assure compliance

6 with requirements under this part applicable to recombinant

7 DiN"A activities which are to be conducted under the license.

8 “(D) If the holder of a license under this section

9 pn-poses —

10 “ (i) to conduct a recombinant DXA activity which

11 is not authorized by such license, such activity may not

12 be conducted under such license before it is amended to

13 authorize such activity ; or

14 “ (ii) to alter or expand a facility licensed by such

15 license, no recombinant Di\ A activity may be conducted

16 in such facility before the license is amended to cover
II such facility as so altered or expanded.

18 The Secretary shall prescribe procedures, as appropriate,

19 for the expeditious handling of applications for amendments

20 of licenses.

21 “(E) If the Secretary determines that the issuance-

22 amendment, or renewal of a license by a local biohazards

23 committee under subparagraph (B) or (C) was not hi
21 accordance with the requirements of this section, the Sccre-

[634]

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tary may take such action with respect to the license as he
determines is necessary, including revoking, suspending, or
limiting the license.

“(F) The issuance, amendment, and renewal of a single
license to authorize the conduct of any combination of re-
combinant BN A activities described in subparagraphs (A) ,
(B) , and (C) shall be carried out jointly by the Secretary
and the local biohazards committee involved in accordance
with guidelines prescribed by the Secretary.

“ (b) Any individual or public or private entity may
apply for the issuance of a license under this section, and the
holder of a license may apply for its amendment or renewal.
An application for the issuance or renewal or a license shall
be made in such form and manner as the Secretary shall pre-
scribe and shall contain —

“ ( i ) a thorough description of each recombinant
DNA activity to be conducted under the license (includ-
ing applicable research hypotheses designs, and proto-
cols) , identification of the professional personnel to be
engaged in each such activity and their qualifications,
and a description of the facilities and materials to be used
in each such activity ;

“(2) assurances satisfactory to the issuer of the
license that each recombinant PiNA activity to be con-
H.E.7897 3

[635]

18

1 ducted under the license will be conducted in accordance

2 with applicable physical and biological containment re-

3 quirements prescribed under subsection (a) (3) (A) (i) ;

4 “(3) assurances satisfactory to the issuer of the

5 license that in that conduct of each such activity there

6 will be compliance with applicable personnel safety

7 requirements prescribed under subsection (a) (3) (A)

8 (ii) ;

9 “ (4) assurances satisfactory to the issuer of the

10 license that the holder of the license shall make such re-

11 ports, and shall maintain such records, respecting each

12 such activity (including reports and records of any sig-

13 nificant or recurring illness, serious injury, or death of

14 any personnel engaged in such activity and of the

15 health care provided such personnel while engaged in

16 such activity) as are required under subsection (a) (3)

17 (A) (iii) ;

18 “(5) a comprehensive statement of the results of

19 any evaluation made by or known to the applicant of

20 the risks to health or the environment which may be

21 presented by any recombinant DNA activity to be

22 conducted under the license; and

23 “(6) such additional information as the Secretary

24 may prescribe.

25 Applications for the amendment of a license shall contain

[636]

19

1 such of the information required by the preceding sentence

2 as the Secretary determines is necessary.

3 “(c) A license issued under this section shall be

4 valid for such period (but not in excess of thirty-six months)

5 as the Secretary may prescribe. Such a license shall contain

6 such terms and conditions as the Secretary finds are ncces-

7 sary and appropriate to carry out the reqi irements of this

8 section and shall identify each recombinant DNA activity

9 which may be conducted under the license and the facility

10 in which it is to be conducted.

11 “(d) The Secretary may revoke, suspend, or limit a

12 license issued under this section for a facility if he finds, after

13 reasonable notice and opportunity for a hearing to the holder

14 of the license, that the holder of the license, any employee

15 or agent of the holder, or any person engaged in a recombi-

16 nant DNA activity in such facility7 —

17 “ (1 ) misrepresented any material fact in obtaining

18 the license,

19 “ (2) has engaged in or attempted to engage in, or

20 represented himself as entitled to perform, any recombi-

21 nant I)NA activity not authorized by the license,

22 “(3) has failed to comply with any of the terms

23 or conditions of the license,

24 “(4) has failed to comply with, a request of the

25 Secretary for any information or materials the Secre-

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taiy finds necessary to determine tlic continued eligi-
bility for the license or to evaluate the possible efTects
on health or the environment of the recombinant DXA
activities conducted m the facihty,

“(5) has failed to comply with a request of the
Secretary to inspect any portion of the facility, its op-
erations, or its records, which are related to recombinaqt
DA A activities, or

“ (6) has violated or aided and abetted in the viola-
tion of any requirement established under this part.
“(e) The Secretary shall, within one year after the
regulations initially1' promulgated under subsection (a) (3)
take effect, prepare a summary of the recombinant DA A
activities authorized to be conducted under licenses issued
under this section and shall, subject to section 480, make such
summary available for inspection by the public at reasonable
times and places. Such summary shall be kept current by the
Secretary.

“local biohazards committees
“Sec. 476. (a) Xo facility may be licensed under sec-
tion 475 unless a local biohazards committee has been estab-
lished in accordance with this section with jurisdiction over
such facility. The Secretary shall prescribe the number and
type of facilities which may be within the jurisdiction of a
single local biohazards committee.

[638]

21

1 “(b) Each local biohazards committee (hereinafter in

2 this section referred to as a ‘committee’) shall he established

3 and operate in the manner prescribed by this section and

4 regulations of the Secretary under this section. Such regula-

5 tions shall be initially promulgated within one hundred and

6 eighty7 days of the date of the enactment of this part, and

7 shall provide that a committee ma}r not exercise the func-

8 tions prescribed by subsection (c) unless the Secretary has

9 authorized its establishment for purposes of this part.

10 “(c)(1) Each committee shall have 'he authority

11 prescribed by section 475 with respect to the issuance,

12 amendment, and renewal of licenses under that section. A

13 committee shall receive and consider license applications in

14 accordance with such procedures as the Secretary shall pre-

15 scribe. A committee may not approve an application for the
Id issuance, amendment, or renewal of a license unless at least

17 three-fourths of the members of the committee vote to

18 approve the application. Upon the written request of any

19 member of a committee for review by the Secretary of

20 any decision of the committee respecting the issuance,

21 amendment, or renewal of a license, the Secretary shall, in

22 consultation with the Advisory7 Committee, conduct such re-

23 view and report the results of his review to the committee.

24 Such a request shall contain a detailed statement of the

25 reasons for remresting review by the Secretary.

[639]

22

4 '‘(2) A committee shall, with respect to a facility

2 licensed under section 475, he responsible for such inspec-

3 tions (in accordance with section 477) and monitoring

4 activities as the Secretary may require to assure that the

5 recombinant DNA activities conducted in such facility are

6 conducted in accordance with the requirements of this part

7 and of the license of the facility. No person who is a mem-

8 ber of a committee and who is engaged in or has a financial

9 interest in any recombinant BNA activity may participate

10 in any function of the committee with respect to such

11 activity.

12 “ (d)(1) Each committee shall have not less than seven

13 or more than thirteen voting members. The members of a

14 committee shall be individuals who by virtue of their train-

15 ing or experience are qualified to participate in the functions

16 of the committee. At least one member of a committee shall

17 represent the interests of nonprofessionals engaged in recom-

18 binant DNA activities and one shall represent a local public

19 health authority within the jurisdiction of the committee; and

20 there shall be two nonvoting members, one of whom shall

21 represent a local government within such jurisdiction, and

22 one shall be representative of the interests of a community

23 within such jurisdiction. At least one-third of the voting

24 members of any committee shall be individuals who are not

[640]

28

1 employees of, and who do not have a financial interest in,

2 any applicant for a license under section 475.

3 “(2) The Secretary, in consultation with the Advisory

4 Committee, may require a committee to use a biological

5 safety officer to cany out the monitoring and inspection func-

6 tions of the committee with respect to recombinant DNA

7 activities described in subparagraphs (A) and (B) of sec-

8 tion 475(a) (4). Such an officer shall have such public

9 health, microbiological, and other appropriate training as the

10 Secretary shad prescribe.

11 “inspections

12 “Sec. 477. (a) (1) Tor purposes of enforcement of the

13 licensing requirements of this part and the requirements of

14 section 472 applicable to facilities, individuals (including

15 employees and agents of local biohazards committees) desig-

16 nated as inspectors by the Secretary, upon presenting appro-

17 priatc credentials and a written notice to the owner, operator,

18 or agent in charge and after clearly informing him of their

19 authority, are authorized to enter and inspect any facility
20' in a State in which a recombinant DNA activity is being

21 conducted or in the case of individuals conducting an inspec-

22 tion for a local biohazards committee, any facility under the

23 jurisdiction of such committee in which a recombinant DNA

24 activity is being conducted. A separate notice shall he given

[641]

24

1 for each such inspection, hut a separate notice shall not he

2 required for each entry made during the period covered by

3 the inspection. Such an inspection (A) shall be made during

4 the normal business hours of the facility being inspected and

5 in a reasonable manner, and (B) may extend to relevant
G equipment, materials, containers, records, files, papers, proc-

7 esses, controls, facilities, and all other things in the facility

8 hearing on whether the recombinant DNA activity is being

9 conducted in accordance with the licensing requirements of
40 this part or the applicable requirements of section 472.

11 “(2) Upon completion of any inspection of a facility

12 authorized by paragraph (1) and prior to leaving the fa-

13 cility, the individual making the inspection shall give to the

14 owner, operator, or agent in charge a preliminary report
1^ which summarizes any condition or practice observed by such
1® individual which, in his judgment, indicates a violation of the
1^ licensing requirements of this part. He shall also prepare a
1^ written final report of his findings and send it to such owner,
19 operator, or agent within thirty days of the completion ol
2° the inspection.

21 "(b)(1) For purposes of enforcement of the require-

22 ments prescribed by or under sections 472 and 474, individ-

23 uals (including employees and agents of local biohazards

21 committees) designated as inspectors by the Secretary, upon

[642]

25

1 presenting appropriate credentials to the owner, operator, or

2 agent (if any of these be present) in charge of—

3 “(A) a vehicle or other conveyance which may be

4 used in tne transportation of recombinant DNA and in

5 which the inspector has reasonable grounds to believe

6 that recombinant DA A is present, or

7 “(E) an}’ real property which is not subject to

8 inspection under subsection (a) and in which the inspec-

9 tor has reasonable grounds to believe recombinant DNA

10 is present,

11 and after clearly informing him of their authority under this

12 paragraph, may enter such conveyance or real property at

13 reasonable times, and inspect, at reasonable times and in a

14 reasonable manner, such conveyance or real property and
1^ all things in that conveyance or real property which he
1® has reasonable grounds to believe bear on whether a re-

17 combinant DNA activity is being conducted in accordance

18 with the applicable requirements of section 472 or 474. .

19 ■ “(2) Upon completion of any inspection of a convey-

20 ance or real property authorized by paragraph (1) and

21 prior to leaving it, the individual making the inspection shall

22 give to the owner, operator, or agent in charge a preliminary

23 report which summarizes any condition or practice observed

24 by such individual which, in his judgment, indicates a viola-

H.lh 7897 4'

[643]

26

1 lion of the requirements of section 472 or 474. lie shall also

2 prepare a written final report of his findings and send it

3 to such owner, operator, or agent within thirty days of the

4 -completion of the inspection.

5 ’■“(c) At the request of an inspector conducting an

6 inspection under subsection (a) or -(b) * of a facility, con-
% veyance, or' real property, the' person in charge of such

8 -facility, conveyance, or property shall provide such samples

9 ■' of — *

10 “ ( 1 ) recombinant DNA in such facility, convey-

11 ancc, or property, or ' 1

12- “' (>2) materials used in or produced by any re-

13 -combinant PjSFA^ -activity ^conducted in such facility or

14 :v ‘ 'propertyV

15 ks the inspector may require I'o determine if the applicable

16 requirements of sections 472, 474; and-475 -are* being com-
17- ■ plied with."

18 - * (d) If during an Inspection of a facility, conveyance,

19. ’ dr real property, conducted -under subsection (a) or (b) ,
2j0 : ;.recombihaiitPNA or aiiy material used in or produced by

21 a fecombinaiit DN A activity which the inspector making the

22 inspection has- reason to believe' presents a significant risk
23' 7 to health or the environment is fotuid in such facility, con-

24 veyance, or property'*, such inspector may order the recom-

25 binant DXA or material detained (in -accordance with regu-

[644]

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1 lations promulgated by the Secretary) for a reasonable

2 period which may not exceed twenty days unless the Sed-

3 rotary determines that a period of detention greater than

4 twenty days is required to institute an action under section

5 479 (b) , in which case the Secretary may authorize a de^

6 tention period of not to exceed thirty days. Any recoiri-

7 binant DNA or material subject to a detention order issued

8 under this subsection shall not be moved by any person from

9 the place at which it is ordered detained until —

10 “ (l) released by the Secretary, or

11 “ (2) the expiration of the detention period applica-

12 ble to such order,

13 whichever occurs first. -

14 “ (e) 'No individual designated by the Secretary to'

15 conduct an inspection under subsection (a) or (b) shall

16 be required to obtain a search or inspection warrant from

17 any judicial officer before entering any facility, conveyance,

18 or real property to conduct such inspection.

19 “ (f) No individual who is engaged in or has a direct

20 financial interest in any recombinant DNA activity may be

21 designated by the Secretaiy to conduct an inspection under

22 subsection (a) of the facility in which such activity is being

23 conducted, and no individual who is engaged in or has a

24 direct financial interest in any recombinant PXA activity

25 subject to regulation under section 472 or 474 may be desig-

[645]

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1 nated b}T the Secretary to conduct an inspection under sub-

2 section (b) with respect to the activity in which he is

3 engaged,

4 “PROHIBITED^ ACTS AND PENALITIES

5 “Sec. 478. (a) Xo person may—

6 “(1) conduct any recombinant DXA activity in

7 violation of any applicable requirement of section 472

8 or any regulation under section 474 ;

9 “(2) conduct any recombinant DXA activity in a

10 facility unless —

11 “(A) a license is in effect for such facility

12 under section 475, and

13 “ (B) the activity is conducted in accordance

14 with the requirements of such license ; or

15 “ (3) fail or refuse to —

16 “ (A) establish or maintain records,

17 “ (B) make reports or provide information, or

18 “(C) permit entry or inspection,

19 as required by this part or any regulation promulgated

20 under this part.

21 “(b)(1) Any person who violates subsection (a) shall

22 be liable to the United States for a civil penalty in an amount

23 not to exceed $5,000 for each such violation. Each day such

24 a violation continues shall, for puiposes of this paragraph,

25 constitute a separate violation of subsection (a) .

[646]

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1 “(2) A civil penalty for a violation of subsection (a)

2 shall be assessed by the Secretary by an order made on the

3 record after opportunity (provided in accordance with this

4 subsection) for a healing in accordance with section 554

5 of title 5, United States Code. Before issuing such an order,

6 the Secretary shall give written notice to the person to be

7 assessed a civil penalty under such order of the Secretary’s

8 proposal to issue such order and provide such person an

9 opportunity to request, within fifteen days of the date the

10 notice is received by such person, such a hearing on the

11 order.

12 “ (3) Any person who requested in accordance with

13 paragraph (2) a hearing respecting the assessment of a civil

14 penalty and who is aggrieved by an order assessing a civil
lb penalty may file a petition for judicial review of such order
lb with the United States Court of Appeals for the District of
11 Columbia Circuit or for any other circuit in which such

18 person resides or transacts business. Such a petition may

19 only be filed within the thirty-day period beginning on the

20 date the order making such assessment was issued.

21 . “ (4) If any person fails to pay an asessment of a civil

22 penalty —

23 “(A) after the order making the assessment has

24 become a final order and if such person does not file

[647]

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1 a petition for judicial review of the order in accord-

2 ance with paragraph (3) , or

3 “(B) after a court in an action brought under para-

4 graph (3) has entered a final judgment in favor of the

5 Secretary,

6 the Attorney General shall recover the amount assessed

7 (plus interest at currently prevailing rates from the date of

8 the expiration of the thirty-day period referred to in para-

9 graph (3) or the date of such final judgment, as the case

10 may he) in an action brought in any appropriate district

11 court of the -United States. In such an action, the validity,

12 amount, and appropriateness of such penalty shall not he

13 subject to review.

14 “ (c) Any person who knowingly or willfully^ violates

15 subsection (a) shall he subject, upon conviction, to a fine

16 of not more than $50,000, to imprisonment for not more
II than one year (and not more than ten years for a related

18 series of violations) , or to both. Each day a violation of

19 subsection (a) continues shall constitute a separate viola-

20 tion for purposes of this subsection.

21 “(d) No grant, contract, or other form of financial

22 assistance for any purpose related to recombinant UNA may

23 be provided under this Act to any person against whom an

24 order assessing a civil penalt}*- under subsection (b) has

[648]

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4 become final or who has been convicted, under subsection

2 (c) of a violation of subsection (a) .

3 “injunction authority; emergency procedure

4 “Sec. 479. (a) The district courts of the United States

5 shall have jurisdiction over civil actions to restrain any vio-
g lation of section 478 (a) . Such a civil action may be brought
7 in the United States district court for the judicial district
g wherein any act, omission, or transaction constituting a
9 violation of section 478 (a) occurred or wherein the defend-

40 ant is found or transacts business. In any such civil action,
44 process may be served on a defendant in any judicial district

42 in winch the defendant resides or may be found. Subpenas

43 requiring attendance of witnesses in any such action may

14 be served in any judicial district.

15 “ (b) The district courts of the United States shall have

16 jurisdiction over any civil action brought ( 1 ) for the seizure

17 or destruction of any recombinant PXA, or any material used

18 in or produced by a recombinant DNA activity, which

19 recombinant DNA or material presents or may present a

20 significant risk to health or the environment or (2) for other

21 appropriate relief to prevent its production or movement.

22 Such civil action shall be brought in the district court of the

23 United States within the jurisdiction in which such recom-

24 binant I)NA or material is found,

[649]

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1 “DISCLOSURE OF DATA

2 “Sec. 480. (a) (1) Any information reported to. or

3 otlicnvise obtained by, the Secretary (or any representative

4 of the Secretary) or any local bioliazaids committee under

5 this part, which is exempt from disclosure pursuant to sub-

6 section (a) of section 552 of title 5, United States Code, by

7 reason of subsection (b) (4) of such section, shall not be

8 disclosed, except that such information —

9 “(A) shall be disclosed by the Secretary to any

10 officer or employee of the United States —

11 “(i) in connection with the official duties of

12 such officer or employee under any law for the pro-

13 tection of health or the environment, or

14 “ (ii) for specific law enforcement purposes;

15 “ (B) shall be disclosed by the Secretary if the Sec-

16 retary determines it necessary to protect health or the

17 environment against an unreasonable risk of injury; or

18 “ (C) may be disclosed by the Secretary when role-

19 vant in any proceeding under this part, except that dis-

20 closure in- such a proceeding shall be made in such

21 manner as to preserve confidentiality to the extent

22 practicable without impairing the proceeding.

23 A research hypothesis, design, or protocol shall, for purposes

24 of this paragraph, be considered to be information which is

25 exempt from disclosure pursuant to subsection (a) of section

[650]

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1 552 of title 5, United States Code, by reason of subsection

2 (b) (4) of such section.

3 “ (2) In any proceeding under subsection (a) of section

4 552 of title 5, United States Code, to obtain information the

5 disclosure of which has been denied because of the provisions

6 of paragraph ( 1 ) of this subsection, the Secretary or a local

7 •biohazards committee may not rely on subsection (b) (3) of

8 such section 552 to sustain the Secretary’s or committee’s

9 action.

10 “(b) Subsection (a) (1) does not prohibit the disclosure

11 of any statement of an evaluation of risks submitted under

12 section 475 (b) (5) .

13 “(c) (1) In submitting data under this part, the indi-

14 vidua] or entity submitting the data may (A) designate the

15 data which such individual or entity believes is entitled to

16 confidential treatment under subsection (a) (1), and (B)

17 submit each designated data separately from other data sub-

18 mitted under this part. A designation under this paragraph

19 shall be made in writing and in such manner as the Secretary

20 may prescribe.

21 "(2) (A) Except as provided in subparagraph (B), if

22 the Secretary or a local biohazards committee proposes

23 to release for inspection data which has been designated

24 under paragraph (1) (A), the Secretary or committee shall

25 notify, in writing and by certified mail, the individual or

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entity which submitted such data of the intent to release
such data. If the release of such data is to be made pursu-
ant to a request made under section 552 (a) of title 5,
United States Code, such notice shall he given immediately
upon approval of such request by the Secretary or commit-
tee. The Secretary or committee may not release such data
until ;hc expiration of thirty days after the individual or
entity submitting such data has received the notice required
by this subparagraph.

“(B) Subparagraph (A) shall not apply to the release
of information under subparagraph (A), (B), or (C) of
paragiaph (1) of subsection (a), except that the Secretary
may not release data under subparagraph (B) of such
paragraph (1) unless the Secretaiy has notified each in-
dividual or entity who submitted such data of such release.
Such notice shall be made in writing by certified mail at least
fifteen days before the release of such data, except that if
the Secretary determines that the release of such data is nec-
essary to protect against an imminent, unreasonable risk of
injury to health or the environment, such notice may be made
by such means as the Secretary determines will provide
notice at least twenty-four hours before such release is made.

“ (d) Any officer or employee of the United States (in-
cluding any member or employee of the Advisory Commit-

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1 tec) or member or employee of a local biohazards committee

2 or former officer or employee of the United States or former

3 member or emplo}ree of such a committee, who by virtue of

4 such employment or official position has obtained possession

5 of, or has access to, material the disclosure of which is prohib-

6 ited by subsection (a), and who knowing that disclosure of

7 such material is prohibited by such subsection, willfully dis-

8 closes the material in any manner to any person not entitled

9 to receive it, shall be guilty of a misdemeanor and fined not

10 more than $5,000 or imprisoned for not mo -e than one year,

11 or both. Section 1905 of title 18, United States Code, does

12 not apply with respect to publishing, divulging, disclosing,

13 making known, or making available information reported or

14 othenvise obtained under this part.

15 “(e) Notwithstanding any limitation contained in this

16 section or air^ other provision of law, all ir formation reported

17 to or otherwise obtained by the Secretary (or any represent-

18 ative of the Secretary) or by any local biohazards committee

19 under this part shall be made available, upon written request

20 of any duly authorized committee of the Congress, to such

21 committee.

22 “(f) Each local biohazards committee shall be consid-

23 ered an agency for purposes of section 552 of title 5, United

24 States Code.

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“advisoey committee

“Sec. 481. (a) There is established the Recombinant
DXA Advisory Committee which shall carry out the func-
tions prescribed for it under this part and which shall make
recommendations to the Secretary for the effective adminis-
tration of this part.

“(b) The Advisory Committee shall consist of seven-
teen members appointed by the Secretary from individuals
who by virtue of their training or experience are qualified to
participate in the functions of the 'Advisory Committee. Of
the individuals appointed as members of the Advisory Com-
mittee (1) one shall be representative of the interests of
nonprofessional personnel engaged in recombinant DXA
activities; (2) one shall be representative of the interests of
entities engaged in such activities for commercial purposes;
and (3) and at least nine shall be individuals who are not
engaged in any recombinant DXA activity and do not have
a direct financial interest in such an activity. Of those
nine individuals, four shall be scientists who are knowledge-
able in the various scientific and medical disciplines neces-
sary for an evaluation of the potential risks to health and the
environment presented by recombinant DXA activities, one
shall be a specialist in public health, one shall have back-
ground in the ethical concerns involved in biomedical re-
search, and three shall represent (he interests of (he general

[654]

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j public. The term of oflice of a member of the Advisory Com-

2 inittee shall be three years, except that of the members first

3 appointed to the Advisory Committee, six shall be appointed

4 for a term of one year and six shall be appointed for a term
i 5 of two years, as designated by the Secretary at the time of
„ 6 appointment. Section 14 of the Federal Advisory Committee

7 Act shall not apply with respect to the duration of the

8 Advisoiy Committee.

9 “(c) Members of the Advisory Committee (other than

10 officers or employees of the United States), while attending

11 meetings or conferences of the Advisory Committee or other-

12 wise engaged in its business, shall be entitled to receive

13 compensation at rates to be fixed by the Secretary, but not

14 at rates exceeding the daily equivalent of the rate in effect

15 for grade GS-18 of the General Schedule, for each day so

16 engaged, including traveltime; and while so serving away
I 17 from their homes or regular places of business each member

18 may be allowed travel expenses (including per diem in lieu

19 of subsistence) as authorized by section 5703 of title 5,

20 United Stales Code, for persons in the Government service

21 employed intermittently.

22 ‘'employee protection

23 “Sec. 482. (a) No employer may discharge any em-

24 ployee or otherwise discriminate against any employee with

25 respect to the employee’s compensation, terms, conditions.

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or privileges of employment because the employee (or any
person acting pursuant to a request, of tlm employee) has —

“ID commenced, caused to be commenced, or is
about to commence or cause to he commenced a pro-
ceeding under this part,

“(2) testified or is about to testify in any such
proceeding, or

“(3) assisted or participated or is about to assist
or participate in any manner in such a proceeding or
in any other action to enforce any requirement of this
part.

“(b) (1) Any employee -who believes that he has
been discharged or otherwise discriminated against by any
person in violation of subsection (a) of this section may,
within thirty days after such alleged violation occurs, file
(or have any person file on the employee’s behalf) a com-
plaint with the Secretary of Labor (hereinafter in this sec-
tion referred to as the ‘Secretary’) alleging such discharge
or discrimination. Upon receipt of such a complaint, the Sec-
retary shall notify the person named in the complaint of the
filing of the complaint.

“ (2) (A) Upon receipt of a complaint filed under para-
graph (1), the Secretaiy shall conduct an investigation of
the violation alleged in the complaint. Wiihin thirty days
of the receipt of such complaint, the Secretary shall complete

[656]

89

1 such investigation and shall notify in writing the complainant

2 (and any person acting on. behalf of the complainant) and

3 the person alleged to have committed such violation of the

4 results of this, investigation conducted pursuant to this subpar-

5 agraph. Within ninety days of the receipt of such complaint

6 the Secretary shall, unless the proceeding on the complaint

7 is terminated by the Secretary on the basis of a settlement

8 entered into by the Secretary and the person alleged to have

9 committed such violation, issue an order either providing

10 the relief prescribed by subparagraph (B) or denying the

11 complaint. An order of the Secretary shall be made on the

12 record after notice and opportunity for agency hearing. The

13 Secretary may not enter into a settlement terminating a pro-

14 ceeding on a complaint without the participation and consent

15 of the complainant.

16 “(B) If in response to a complaint filed under para-

17 graph (I) the Secretary determines that a violation of sub-

18 section (a) of this section has occurred, the Secretary shall

19 order (i) the person who committed such violation to take

20 affirmative action to abate the violation, and (ii) such per-

21 son to reinstate the complainant to the complainant’s former

22 position together with the compensation (including back

23 pay) , terms, conditions, and privileges of the complainant’s

24 employment. If such an order is issued, the Secretary, at the

25 request of tin' complainant, shall assess against the person

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against whom the order is issued a sum equal to the aggre-
gate amount of all costs and expenses (including attorney's
fees) reasonably incurred, as determined by the Secretary,
by the complainant for, or in connection with, the bringing of
the complaint upon which the order was issued.

“(c) (1) Any employee or employer adversely affected
or aggrieved by an order issued under subsection (b) may
obtain review of the order in the United States court of
appeals for the circuit in which the violation, with respect
to which the order was issued, allegedly occurred. The peti-
tion for review must be filed within sixty days from the
issuance of the Secretary’s order. Review shall conform to
chapter 7 of title 5 of the United States Code.

“(2) An order of the Secretary, with respect to which
review could have been obtained under paragraph (1),
shall not be subject to judicial review in any criminal or
other civil proceeding.

“ (d) Whenever a person has failed to comply with an
order issued under subsection (b) (2), the -Secretary shall
file a civil action in the United States district court for the
district in which the violation was found to occur to enforce
such order. In actions brought under this subsection, the
district courts shall have jurisdiction to grant all appropriate
relief, including injunctive relief. Civil actions brought under
this subsection shall be heard and decided expeditiously.

[658]

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1 “(e) Subjection (a) of this section shall not apply with

2 respect to aiy employee who, acting without direction from

3 the employee’s employer (or any agent of the employer),

4 deliberately causes a violation of any requirement of this

5 part.

q “relationship to other federal laws

7 “Sec. 483. (a) This part shall not affect the authority

8 of any Executive agency (as that term is defined in section

9 105 of title 5, United States Code) to regidate under any

10 other Act recombinant DXA activities.

11 “ (b) In exercising any authority under this part, the

12 Secretary, or any person acting on his behalf or pursuant

13 to this part, shall not, for purposes of section 4(b) (1) of

34 the Occupational Safety and Health Act of 1970, be deemed

35 to be exercising statutory authority to prescribe or enforce
10 standards or regulations affecting occupational safety and
37 health.

18 “(c) (1) Upon request by the Secretary, each Execu-

19 tive agency is authorized —

20 “ (A) to make its services, personnel, and facilities

21 available (with or without reimbursement) to the Sec-

22 retary to assist the Secretary in the administration of

23 this part, and

24 “ (B) to furnish to the Secretary such information,

25 data, estimates, and statistics, and to allow the Secretary

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access to all -information in its possession, as the Sec-
retan may reasonably determine to be necessary for
the administration of this part.

“(2) Upon request by any Executive agency, the Sec-
retary is authorized —

“ (A) to make the services, personnel, and facilities
of the Department of Health, Education, and Welfare
available (with or without reimbursement) to that
agency in the administration of any Act with respect to
recombinant DXA activities, and

“(B) to furnish to that agency such information,
data, estimates, and statistics, and to allow that agency
access to all information in the Secretary’s possession, as
the agency may reasonably determine to be necessary for
the administration of any Act with respect to recombi-
nant DHA activities.

“effect ox state axd local kequibements
“Sec. 484. (a) Except as provided in subsection (b),
no State or political subdivision of a State may establish or
continue in effect any requirement for the regulation of re-
combinant DXA activities which requirement is different
from, or in addition to, any requirement applicable under
' this part to such activities.

“ (b) Upon application of a State or political subdivision
of a State, the Secretary sh.ill, Ire order promulgated after

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providing (in accordance with this subsection) notice and
opportunity for an oral hearing on such application and after
considering local conditions, exempt from subsection (a),
under such conditions as may be prescribed in such order, a
requirement of such State or political subdivision applicable
to recombinant DXA activities if —

"(1) the requirement is the same as, or more
stringent than, a requirement under this part which
would be applicable to such activities if an exemption
were not in effect under this subsection; and

“ (2) the requirement is necessary to protect health
or the environment.

A State or political subdivision which submits an application
under this subsection shall be given an opportunity for an
oral hearing on such application to be commenced not later
than sixty days from the date the application is submitted.
The presiding officer at such a hearing shall upon conclusion
of the hearing make a written recommendation to the Sec-
retary respecting approval of the application upon which
the hearing was held.

“(c) Within—

“ (1) sixty days of the conclusion of a hearing held
on an application submitted under subsection (b) , or
“ (2) one hundred and twenty days of the date the
application was submitted,

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whichever occurs later, the Secretary shall either approve
or disapprove such application. The decision of the Secretary
shall be in writing, shall, if a hearing was held on the appli-
cation, contain the recommendation made by the presiding
officer at such hearing, and shall include a complete state-
ment of the reasons for the decision of the Secretary.
“training and studies

“Sec. 485. (a) The Secretary may conduct and support
training in the safe handling of recombinant DNA.

“(b) The Secretary shall conduct or support on a con-
tinuing basis studies designed to assess the risks to health
and the environment which may be presented by recom-
binant DNA activities.”.

TITLE II— COMMISSION FOE THE STUDY OE
RECOMBINANT DNA ACTIVITIES
Sec. 201. (a) There is established a Commission for
the Study of Recombinant DNA Activities (hereinafter in
this title referred to as the “Commission”).

(b) (1) The Commission shall be composed of thirteen
members appointed by the Secretary of Health, Education,
and Welfare. The Secretary shall select members of the
Commission from individuals distinguished in the fields of
medicine, law, ethics, theology, the biological, physical, and
environmental sciences, philosophy, humanities, health ad-
ministration, government, and public affairs. Six of the mem-

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bers of the Commission shall be individuals who are or who
have been engaged in recombinant DNA activities and who
reflect, diverse opinion on the safety and appropriateness of
recombinant I) A A activities. In appointing members of the
Commission, the Secretary shall give consideration to recom-
mendations from the National Academy of Sciences, the
National Science Foundation, the Environmental Protection
Agency, the National Institute for Occupational Safety and
Health, and other appropriate entities. Members of the Com-
mission shall be appointed for the life of the Commission.
The Secretary shall appoint the members of the Commission
within sixty days of the date of the enactment of this Act.

(2) (A) Except as provided in subparagraph (13) ,
members of the Commission shall each be entitled to receive
the daily equivalent of the annual rate of the basic pay in
effect for grade GS-18 of the General Schedule for each day
(including traveltime) during which they are engaged in
the actual performance of the duties of the Commission.

(B) Members of the Commission who are full-time offi-
cers or employees of the United States shall receive no addi-
tional pay on account of their service on the Commission.

(C) While away from their homes or regular places of
business in the performance of duties of the Commission,
members of the Commission shall be allowed travel expenses,
including per diem in lieu of subsidence, in the same manner

[663]

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1 as persons employed intermittently in the Government serv-

2 ice are allowed expenses under section 5703 of title 5

3 of the United States Code.

4 (c) The Chairman of the Commission shall be selected

5 by the members of the Commission from among their

6 number.

7 (d) (1) The Commission may appoint and fix the pay

8 of such staff personnel as it deems desirable. Such personnel

9 shall be appointed subject to the provisions of title 5, United

10 States Code, governing appointments in the competitive

11 service, and shall be paid in accordance with the provisions of

12 chapter 51 and subchapter III of chapter 53 of such title

13 relating to classification and General Schedule pay rates.

14 (2) The Commission may procure temporary and inter-

15 mittent services to the same extent as is authorized by sec-

16 tion 3109 (b) of title 5 of the United States Code, but at

17 rates for individuals not to exceed the daily equivalent of the

18 annual rate of basic pay in effect for grade GS-18 of the

19 General Schedule.

20 Sec. 202. (a) The Commission shall —

21 (1) conduct a study as to the appropriateness of

22 continuing recombinant DXA activities;

23 (2) conduct a comprehensive investigation and

24 study to identify the basic ethical and scientific princi-

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pies which should underlie the conduct, applications, and
use of recombinant DXA activities;

(3) conduct a comprehensive review and critique of
. the regulations promulgated under part I of title IV of

the Public Ilealth Service Act; and

(4) on the basis of the activities conducted under
paragraphs (1), (2), and (3) make recommendations
to the Congress and Secretary of Health, Education, and
"Welfare (A) regarding the best approaches for assuring
the safest and most appropriate applications and uses of
recombinant DXA, if any ; and (B) for any modifica-
tion or expansion of such part I which tne Commission
determines is necessary.

(b) In carrying out subsection (a), die Commission
shall consider at least the following:

(1) The protection of personnel engaged in recom-
binant DXA activities and die general public from the
dangers of recombinant DXA activities.

(2) The role of assessment of risk-benefit criteria
in the determination of the appropriateness of activities
involving recombinant DXA.

(3) Appropriate guidelines for the conduct of re-
combinant DXA activities.

(4) Mechanisms for evaluating and monitoring

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the performance of the local biohazards committees estab-
lished under section 476 of the Public, Health Service
Act and appropriate enforcement mechanisms for carry-
ing out their decisions.

(5) The status and extent of recombinant I)XA
activities conducted in foreign countries.

(c) Within sixty days of the receipt of any recommenda-
tion made by the Commission under subsection (a) (4) , the
Secretary shall publish it in the Federal Register and pro-
vide opportunity for interested persons to submit written
data, views, and arguments with respect to such recommen-
dation. The Secretary shall consider the Commission’s rec-
ommendation and relevant matter submitted with respect to
it, and, within one hundred and eighty days of the date of its
publication in the Federal 1’egister, the Secretary shall (1)
determine whether the administrative action proposed by
such recommendation is appropriate to assure the safety and
appropriateness of recombinant DXA activities conducted or
supported under programs administered by him, and (2) if
he determines that such action is not so appropriate, pub-
lish in the Federal Register such determination together with
an adequate statement of the reasons for his determination. If
the Secretary determines that administrative action recom-
mended by the Commission should be undertaken by him,
he shall undertake. Mich action expeditiously as is feasible.

[666]

49

1 Sec. 203. The Commission shall undertake a compre-

2 hensivc study of the ethical, social, and legal implications of

3 advances in recombinant DMA activities. Such study shall

4 include —

5. (1) an analysis and evaluation of scientific and

6 technological advances in past, present, and projected

7 recombinant DMA activities;

8 (2) an analysis and evaluation of the implications

9 of such advances, both for individuals and for society;

10 (3 ) an analysis and evaluation of the laws and

11 moral and ethical principles governing the use of rccom-

12 binant DMA technology in medical practice and other

13 fields ;

14 (4) an analysis and evaluation of public under-

15 standing and attitudes toward such implications and laws

16 and principles ;

17 (5 ) an analysis and evaluation of the implications

18 for public policy of such findings as are made by the

19 Commission with respect to advances in recombinant

20 DMA research and technology and the public attitude

21 toward such advances; and

22 (G) an analysis and evaluation of the implications

23 of recombinant DMA activities within the field of

24 genetic engineering.

25 Sec. 2 O-l. (a) The Commbsma diail in carrying out

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Sec. 203. The Commission shall undertake a compre-
hensive study of the ethical, social, and legal implications of
advances in recombinant DXA activities. Such stud}7 shall
include —

(1) an analysis and evaluation of scientific and
technological advances in past, present, and projected
recombinant DXA activities;

(2-) an analysis and evaluation of the implications
of such advances, both for individuals and for society;

(3) an analysis and evaluation of the laws and
moral and ethical principles governing the use of recom-
binant DXA technology in medical practice and other
fields ;

(4) an analysis and evaluation of public under-
standing and attitudes toward such implications and laws
and principles ;

(5) an analysis and evaluation of the implications
for public policy of such findings as are made by the
Commission with respect to advances in recombinant
DXA research and technology and the public attitude
toward such advances; and

(6) an analysis and evaluation of the implications
of recombinant DXA activities within the field of
genetic engineering.

8lX'. 2o4. (a)- The ( 'i>iiimi.->ion shall in carrying out

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its duties under sections 202 and 203 hold public hearings as
appropriate.

(b) The Commission may secure directly from any
department or agency of the United States information nec-
essary to enable it to carry out its duties. Upon the request
of the Chairman of the Commission, the head of such depart-
ment or agency shall furnish such information to the Com-
mission.

(c) With respect to the disclosure of any information re-
ported to or otherwise obtained by the Commission in carry-
ing out hs duties the Commission shall be subject to section
480 of the Public Health Service Act.

Sec. 205. (a) Within two years of the date of the enact-
ment of this Act, the Commission shall (1) complete the
duties prescribed by section 202 (a), and (2) complete the
study prescribed by section 203 and report the results of such
study to the Congress and the Secretary of Health, Educa-
tion, and Welfare.

(b) The Commission shall terminate within sixty days
of the date upon which it has carried cut subsection (a) .

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[670]

95th CONGRESS
1st Session

Calendar No. 334

S. 1217

[Report No. 95-359]

IN THE SENATE OF THE UNITED STATES

April 1 (legislative day, February 21), 1977

Mr. Kennedy introduced the following bill ; which was read twice and referred
to the Committee on Human Resources

July 22 (legislative day, July 19), 1977
Reported by Mr. Kennedy, with an amendment

October 26, 1977

Ordered to lie on the table until the last day of the first session of the

95th Congress

December 15, 1977

Ordered returned to the calendar pursuant to the order of October 26, 1977

[Strike out all after the enacting clause and Insert the part printed In Italic]

A BILL

To regulate activities involving recombinant deoxyribonucleie

acid.

1 Be it enacted by the Senate and House of Representa-

2 fives of the United States of America in Congress assembled ,

3 That this Aot may bo oitod as the “Reoombinant DNA Bogu

4 lation Act”.

5 FINDINGS

6 Sec. 9. The Oongrcoo finda that —

7 (1) work with recombinant DNA will improve -fee

II— O

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understanding of basic biologioal prooooooo and offera
many- potential benefits,

(2) ' there exists, -however, a possiblo risk that micro-
organisms containing recombinant DNA may eauae
disease or alter the environment,

(3) micro -organisma containing recombinant DNA
oould oproad throughout tbo United States and to othor
countrios, adversely affecting human hoalth, tho onviron
ment, industry, and agriculture,

(4) tho only effective way to minimize tho risk to
hoalth, tho environment, industry, and agriculture is
by rogulating activities involving reoombinant DNA,
whether or not those activities aro in interstate com
moroo, and thoroforo

(5-)- alb-activities involving-r-eoombinant DNA cither
affect- or are in interstate commerce-.

GENERAL BEQUIBEMEN'TS

Seo. 3?- (a) Except -as- provided in subsection (b), no
p croon may possess or engage in tho production of rooom
binant DNA unless —

( 1-) tho production or possession complioo with tho
standards promulgatod under acctionHL,

(2)- the produotion or possession ooouro in a facility
lioonsod under section 5, or the possession oocurs white
transporting recombinant DNA from one such facility
to another, and

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(3) 4ho production or possession ooours as part of
a projoot that has beon registered undor section 6.

(b) Tho Soorotary may oxompt from somo or all of
tho requirements of subsection (a) any category of activities
he finds poses no significant risk to health or tho onvironmcnt
(1) bcoauso of tho nature of those activities, or (2) because
tho catogory is adoquatoly^-rogulatod undor other Federal

gKPA^DABDS

Seo. 4. (a) For purposes of pro-teeting-tko health and
safety of individuals who work with recombinant BN A, tho
health and safoty of tho-publio at largo, end ■ tho integrity
of the environment, tho Soorotar}* —

(-4}- shall, no later -than ninoty days -af tor tho -enact-
ment-of this Aot, promulgate (without regard- -to section
102-(2) (C) -ef tho National Environmental Policy Act
of 1-969 or 5 U.S.C, 553) as interim standards -applying
to the production or possession of rooombinant DNA-thc
Reeombinant DNA Bo soar oh Guidolinos — (41- Fodoral
Register 27901 (1976) ) , with ouoh modifications as ho
finds are neodod,

(2) shall, no later than one hundred and eighty
days aftor tho promulgation of interim standards undor
elause ( 1 ) , initiate procedures to promulgate final stand
ards applying to tho production or possession ofrecom-
binant DNA>

[673]

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(3) shall, no lator than ono year after the promulga-

-fmal- standards- applying to the production or possession
-of -recombinant DNA, and

(4) may, -from time-to-feifflej-pfomulgate (A) now
■standards applying to the -production or -possession of
recombinant DNA, and (E) amendments to standards
promulgated under this section-.

(b) (1) — Any- person adversely affected by an aotion-
of the Secretary under this section may obtain review of the »
notion in tho United States Court of Appeals for the District
of Columbia--The petition for review must be-filed within
sixty days of the action. Beyiew shall conform to chapter 7-
of title 5 of the United States Code.

-(2 ) An action with respect to which review-could have-
bcon obtained under paragraph- -{4-)- shall not be subject to-
judicial-reviowin-any -otherproceedingr

LICENSING OF FACILITIES

-Seg. 5. (a) The Secretary may issue-or renew a license-
for a faoility to permit the production -or- possession (or cer-
-4ain categories of production or possession) of recombinant-
DNA at that facility only if (1). the facility submits an
application-therefor containing -or accompanied by such in-
-jormation concerning recombinant DNA -activities at thot-
faoility as the- Secretary may prescribe, — (2-) — thelacihty
-agrees

1674]

5

1 -possession—- (including — fee — transportation of rocombinanfe

2 ~B?f Ar-to or from that facility) will comply with the standards

3 -promulgated under section 4 and such ancillary conditions

4 - as he may prescribe?- and---(-3-)- the facility agrees- and the-

5 — Secretary determines that such production or possession will

6 -occur only-as part of a project registered under section 6.

9 -seetion-to cover all or part of the costs of administering this
10 Act in respect to thatdacility.

11 -OH L license issued or renewed by the Secretary under

12 thi3 section is valid for the period prescribed by the Score -

13 ~tary, not to exceed three years.

14 (d) The Secretary- may permit an appropriate State or

15 -local agency or a licensing or accrediting body to issue and

16 renew licenses for -facilities to permit the production or pos-
17. -session (or certain categories of production-or possession)

18 of recombinant -DNA at those facilities if and for so long as

19 the Secretary determines- that the agency or body —

20 -fl) requires a facility to comply with the standards

21 promulgated under section 4 and such ancillary condi-

22 -taon3 as the Secretary may preserihe,-

23 -(2) requires a facility to permit the production or

24 possession of recombinant DNA only as part of a project

25 -registered under section 6, -and

[675]

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-f&) -has the capacity to and docs make-provision for
•aesuring that tbe ^oqtHfemeftte^-elQuscs (1)- and (2-)--
continue to be met:

-ftr) — The Secretary may -revoke, —suspend, or limit a
Ikense dssued-under -tbis section if be -finds, after notice and

opportunity for a bearing to the facility, that the- -facility

-( 1 ) has misrepresented any- material fact in obtain-
-4ng4be lieensey-

) hag -engaged or Attempted to engage or repre-
sented itself as entitled to perform any activities- involv-
ing- recombinant DXA not authorized by its license,
-■(-3-)- -has failed to comply-vvitb-any of tire terms or
-conditions of the license,

-fb) — has tailodr-4o-- comply- with a request of the
Secretary for any information or materials tho Secretary

-eligibility- -for its license ■ or to evaluate the possible-
effects on - health - -or - tbe - environment of activities in-

— has failed to comply with -a-requost of the
-Secretary- to inspect any portion of tho facility , its oper-
-aliens, -or its records, which arc related to activities
-involving recombinant DX A, or

-{£) has violated or aided and abetted in the vio-
lation of an}r requirement established under this Act.

[676]

7

1 REGISTRATION

2 Sec. 6. The So^retaiy- shftll rogistor any project involv

3 ing recombinant DNA if the request for registration- ■ is

4 'accompanied l>y such information as tho Secretary may pro-

5 scribe oonoer-ning ■ recombinant DNA activities which aye

6 part of that project-.

7 INSPECTIONS

8 SeC:-7. An- individual designated as an inspector by tho

9 Secretary) upon presenting appropriate credentials to the

10 owner, operator; -or agent (if any of these -be prosont)-4a

11 charge of a facility at which the inspector has reasonable

12 grounds4o believe that recombinant DN A is prosont or -is

13 boing produced may enter that facility at reasonable timers,

14 and- inspect^ at roasonable times and -in -a reasonable manneT,

15 tho faoility and ail things at (or being transpor-tod-te or

16 from) that facility which he has reasonable grounds to-believe

17 are involvod with recombinant -DNA and obtain appropriate

18 samples of such- -things. When an inspector has complotod

19 suoh- an -inspection he shall) before he loavos tho faeility>

20 inform tho owner) operator) or -agent in ehargeof tho facility

21 of any eenditions or practices which- in tho inspootor’s judg

22 mont constitute a violation of any of- the requirements of

23 this Aot. The mspootor shall -also- proparo a writton roport

24 of -Ms findings and send it to the owner, operator) or -agent

25 in-ehargo of the facility within a roasonable timo.

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RECORDS AND SAMPLES

■Sec. 8. Each facility at- which- recombinant DNA ia
produced or located shall keep and make available) to tho
Secretary such records — (including medical records of per
sonnel) and samples involving recombinant DNA at — (or-
being transported to or from) that facility as the Secretary
may prescribe.

REPORTS

Sec. 9. Each facility at which recombinant DNA is
produced or located shall submit to the -Secretary- such reports
concerning recombinant DNA at- -(or being transported to
or from) that facility as the Secretary may-prescribe.

■EFFECT --Oy STATE A2sD LOCAL REQUIREMENTS-
Sec. 10. (a) Except as provided in subsection -(-h)-, no
State -or-political subdivision of a State may establish or con-
■tinue ■ in. effect- with respect to -recombinant DNA activities
any requirement whieh-is- different from, or in addition to>
any requirement applicable under this Act to such activities*
(b) Upon application of a State or political subdivision
of a State, the Secretary shall exempt from subsection- (a) a
■requirement' of' that State or political subdivision applicable
to recombinant 13 X A activities' if-fae determines thatr-the
requirment is, and will be administered so as to be> as-
stringent as, or more stringent than,- a requirement under

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j this Act. The Secretary -may not withdraw any such exemp-

2 tion for -so long as he finds- that such requirement remains

3 unchanged and continues to be so administered.

4 EMPLOYEE PROTECTION-

5 -Seo. 11. (a) No employer may discharge any employee

6 or otherwise discriminate---against any employee with respect

7 -to the- employee’s compensation, termsy- conditions-, ■ or- pri-v-

8 fleges-ef employment because the employee- (or any person

9 -acting -pursuant to a request of the employee) has —

10 4±f- oommenced> caused to bo commenced, or is

11 about to - commence or cause to be commenced a pro-

12 ceeding undor this Act,

13 -43)- testified -or— is about to testify in -any such

14

15 43)- assisted or participated or is about to assist

16 or- participate- in any manner in such- ar-precoeding -or-in

17 any- other action to- carry out the purposes of this Act.

18 (b) (1) Any employee who believes that the employee

19 -has been discharged or otherwise discriminated against by

20 any person in-violation of subsection (a) of- this section may,

21 within thirty days after such alleged violation occurs, file (or

22 harve any person file on the employee’s behalf) a complaint

23 with the Secretary of Labor — (hereinafter in this section

24 roforred to as the “Secretary”) alleging such discharge or

S. 1217—0- — 2

[679]

10

1 -discrimination. Upon receipt-ef such a complaint, the Secro-

2 tary shall notify the person-mamed in tho complaint-of -the

3 filing of tho complaint.

4 (2) (A) U-pon receipt of a -complaint filed under para-

5 graph (1), the Secretary shall conduct an investigation of
g tho violation alleged in tho -complaint-:- Within thirty days of
ij the r-eceipt- of- such eemplaint, tho Secretary shall complete
g snch-in-vcstigation and shall -notify in writing -the complainant
9 (and- any person acting on bohalf of the complainant) and

10 the person allogod to have committed such violation of the

11 respite- of the investigation conducted pursuant to thin para-

12 graph. Within ninety days of tho receipt of euoli complaint

13 the Secretary shall, -unless- the proceeding on the complaint

14 is -terminated by the Secretary -on-the basis- -of a- settlement

15 entered into by the -Seorotary-and -the person allogod to have

16 committed such violation, issne an order either providin'

17 relief prescribed-hy subparagraph (B) or denying then

18 plaint. An- order of the Secretary shall he made on -the- roe

19 -after- motice- and opportunity for agency hearing. Tho Sccre-

20 tary may not enter into a settlement terminating a proceeding

21 on a complaint without the participation and consent of tho-

22 complainant.

23 (B) If in response tea complaint-filed under paragraph

24 ( 1 ) the SeOreiary--detefmines- that a-violation of subseetion

25 (a) of this section faas-ocenrred, the Secretary shall-er-dep

[680]

11

2 -(i) the person who committed such violation to take affirma-

2 -tive action to abate the violation, (ii) such person to-gein-

3 state the complainant to -the complainant’s former position

4 together with the compensation (including back pay) , terms,

5 conditions, and privileges of the complainant’s-employment,

6 (iii) compensatory damages-, - and- -(A ) whero appropriate,

7 exemplary damagest If such an-order is issued, the Secretary,

8 at the request of the- complainant, -shall assess against tho

9 person against whom the order is issued -a sum equal to the

10 aggregate' amount ol all costs and expenses (including at-

11 -tomey’s fees) — reasonably incurred, as determined by the

12 SecretaryT-by the complainaat-forf -or in connection with, the

13 bringing ef-the complaint upon which tho ordor was issued.

24 (e) fl) Any employee or employer adversely affected

25 or aggrieved- by an order issued under subsection (b) may

26 obtain -review of the -ordor in- the -United States Court of

27 Appeals for- the circuit 4n -which the violation- with respect

28 -to- which the order was issued, allegedly ooourrod. Tho poti

29 -tion for review must4>e -filed within sixty days from the
20 -issuance) of tho Secretary’s-order. Review shall oonform--to
22 chapter 7 of title 5 of the United States Code.

22 (£■) An order of the Secretary, with- respect to- which

23 review could have been obtained- -under paragraph — (-l-)-,

24 shall not bo subject to judicial rev4ew in any oriminal or

25 othor civil procooding.

[681]

12

1 (d) Whenever a person has failed -to comply with an

2 order issued under subsection — (b) (2), the --Secretary shall

3 file a civil action in the United Statue district court for the

4 district in which the violation wag found to occur to enforce

5 such order. In actions brought uiidor this subsection, tlio die-

6 trict -coufte -&balb- jttiigdiGt-ioD ■ to grant all appropriate

7 -relief, including injanctive relief and- compensatory and ex-

8 -emplary damages. -Civil actions brought under -this -subsection

9 shall be beard and decided expeditiously.

10 -(e) Subsection (a) of this section shall not apply with

11 respect to any employee who, acting without direction from

12 -the employee’s employer (or any agent of the employer-),

13 deliberately causes a violation of any requirement of this Act.

14 — CONSULTATION

15 Sec. 12. In administering this Act. the Secretary ■shall

16 consult- with the Secretaries of Agriculture, Commerce, Do-

17 fense, Labor, and Transportation, the Administrators of the

18 Environmental Protection Agency and Yeterans-’-Affairs, the

19 Director of the National Science Foundation -other appro-

20 priate officials, and such interagency committees and other-

21 advisory bodies as the Secretary may establish, concerning

22 the promulgation of standards and of amendments to stand-

23 -ards, the avoidance of duplicative requirements, and- such

24 other -matters which may be of mutual interest

[682]

13

1 ENFORCEMENT

2 Sec. 13-.- (a)-Upon potition by the- Secretary-,- 4ho district

3 courts of tho United-States may restrain violations of this-A-et.

4 (b) (1) Any person who violates- a provision of this

5 Act (othor than in section 11) may be assessed a -civil -pen-
5 alty by- the Secretary of not mor-e than $5,000--for - eaeh
7 violation.

g (2) No -civil penalty shall be assessed- unless the person

9 charged shall -have been given notice --and opportunity for a

40 hearing on such charge; -In -determining the amount of the

41 penalty the Secretary shall -consider the appropriateness of
12 such penalty to the gravity- -el -the -v-ielatien-.

43 -(3}-In- case of inability to collect such civil- -penalty or

14 failure of any person to -pay all, or such portion of such

15 civil penalty as the Secretary- may determine, the Secretary

16 shall refer the matter to the Attorney- General,- - who shall

17 recover such amount by action in the district court -of --the

18 United States for the district in which that person resides or

19 has his principal place of business.-

20 (c) Any- person who knowingly or willfully violates any

21 provision of -this Act (other than in section 11) shall be

22 subjoot, upon conviction, to a fino-ef-not more than-$5,000,

23 or to imprisonment for not moro than one year (and not

[683]

14

1 more than ten years for a related series of violations) , or

2 both.

3 (d) Eachr day a- violation of this Act-continues shall

4 constitute a ■ separate -violation for purposes of this. -section,

5 EMERGENCY - BBQGEDIJRE FOB HAZARDOUS RECOMBINANT

6 BN A-

7 Sec. 14. The Sooretary may commence- a oi-vil action,

8 by process- of litvel or otherwise^ in an appropriate district

9 -court-of- the United States for the seizure or destruction of-

10 hazardous-recombinant' DNA or for other appropriate relief

11 to prevent its production, movement,' or spread.

12 ADMINISTRATIVE RESTRAINT OB SEIZURE

13 SeCi 15. If during- -an -inspection under section -7 an

14 inspector finds material he has reasonable grounds to- believe-

15 is hazardous recombinant DNA, he may order the material

16 not to be moved or may seize the material. Within -twenty -

17 days after-such action by an inspector- the- -Secretary must

18 -eommonco a oivil -aetion undor sooti-on- 14 with rospoct to

19 tho inspector’s aotion, unloss tho ownor of the material has

20 agreed otherwise:

21 TRAINING

22 Sec. 16. Tho Sooretary -may conduct and support train-

23 hag in the safo handling of recombinant 4)N A.

[684]

15

1 REPRESENTATION BY -ATTORNEY GENEK-A-L

2 Sec. 17, The Attornoy Gonoml shall appear and rcpre-

3 sent the Secretary or -fee Secretary of Labor at any -civil

4 or criminal action initiated undor this Act.

5 DEFINITIONS

6 Sec. 18. For purposes of this Act —

7 -fb) — “Secretary” — (except as used in -section 11)

8 means feo- Socrotary of -H-eak-h-Edaeation, and Welfare,

9 (2)-“DNA” means -dooxy-ribon-uoleie-Tund-,

10 -fk) — “recombinant- D-NA” means DNA -feat con-

11 slats of different segments of - DXA whioh bavo boon

12 joined together in a cell-free system and that has the

13 capacity -to infect and replicate in some host coll oithor

14 autonomously or - as an integrated part of ■ feo host’s

15 -genome,

16 (4) “hazardous recombinant DNA” means recom-

17 binant DNA which oithor —

18 (A) poses a significant risk to-bealfe-or ■ fee

19 environment, or

20 (B) (i) (I) 4s- -neither located at a facility

21 -licensed under section 5 nor boing transported from

22 -one such facility- to another, or

23 is likoly to be moved or to spread from

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such a facility of transportation to a location not at
suoh a facility of part of such transportation,- and-
(ii) is not known not to pose a significant-risk
to health- or the environmentr

-fo) — “person” means- any individual, partnership-,
corporation, association, or any Federal, State, or local-
government entity,

(6) - --^district court of the United States” ineludes
the District Court of Guam, the District Court of the
Virgin Islands, the highest court of American Samoa,
and a similar- -or equivalent court in any other United
States territory or possession or-in tho Trust Territory
-of -the Pacific Islands, and

( 7 ) in relation to transportation to or from a facility,
a suitable facility in' a foreign eountry shall bo treated as
q facility licensed under -section 5.

GEOGRAPHIC APPLICABILITY OF ACT
-Sec. 19. This Act applies to the United -States, its terri-
tories and possessions, and the Trust Territory of the Pacific
Islands.

RELATIONSHIP TO OTHER FEDERAL LAWS-

Sec. 20. (a) This Act shah- not affectthe authority-of
any- Federal agency to regulate under any other Act activities
involving recombinant DNA.

(b) In exercising any authority under this Act, the Soo

[686]

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2 retary, or my person acting on bis behalf- or pursuant to the

2 provisions of this Act, shall not, for purposes-of section 4-(-b)

3 (1) of the Occupational Safety and Health-Act of 1970, be

4 deemed to be exercising statutory authority to preserve- or

5 enforce standards- or -regulations affecting occupational safety

7 (e)-(l) -Upon, request by the Secretary, each Federal

8 -agency is authorized —

9 (A|- -to make its--servicesr personnel, and facilitios

10 available -(with-ar without reimbursement) to the Score-

11 tary to assist die Secretary in the administration of -this

12 Aot, and

13 -(B)- te furnish to the Secretary such information,

14 -data, estimates, and statistics, and to allow the Secretary

15 access to all information in its possession, as the Secre-

16 tary may reasonably determine to be necessary -for the

17 administration of tb.is Act.

18 (2) Upon request by any Federal agency, the Secretary

19 is authorized —

20 (A) to make the services, personnel, and- facilities-

21 -of - the Department— of— Health, Education, and-W-d-

22 fare available (with or without reimbursement) to that

23 agency to assist the agency in the administration of

24 any Aot with respect to activities involving recombinant

25 DNA, and

S. 1217—0 3

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-(B) to furnish to that agcnoy such information,
-data, estimates, and statistics,- and to allow that agency
access to all information- in the Secretary’s possession,
as the agency -may reasonably determine to bo necessary
-for- the administration of any Act with respect to activi-
ties mv<dvmg-reoond»iaftBtr-I)yA-.

SEPARABILITY

Sec. 21. If any provision of this Act is held invalid by
reason of being inconsistent with the Constitution, all provi-
sions of this- Aetwhieh are separable -from that invalid provi-
sion shall remain in effect.

EFFECTIVE DATE AXD EXPIRATION DATE OF ACT

Sec. 22. (a) (4-) -Tins Act is offoctivo upon enactment,
except -that sections 3(a)-) 10(a), and l-8-(4) (B) — are-
effective one hundred and eighty days after -enactment.-

(2) Upon promulgation of standards undor section 4,
no person may possess or engage in the production of recom-
binant DXA unless -the production or possession complios
with those standards.

(b) This Act shall expire five years after its onaotmont
except with respect to -records made within that period.

8HORT TITLE

Section 1. This Act may he cited as the “Recom-
binant DNA Safety Regulation Act”.

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FINDINGS

Sec. 2. The Congress finds that —

(1) work with recombinant DNA will improve the
understanding of basic biological processes;

(2) recombinant DNA activities offer many poten-
tial benefits, but also raise serious questions regarding
potential hazards;

(3) microorganisms containing recombinant DNA
could spread throughout the United States and to other
countries, adversely affecting human health, the environ-
ment, industry, and agriculture;

(4) it is essential in the public interest that the health
and welfare of the Nation be protected by requiring
that all recombinant DNA activities comply with stand-
ards of safety and performance and that there be a uni-
form Federal policy regarding such standards; and
therefore

(5) it is necessary to establish a Commission to be
known as the National Recombinant DNA Safety Reg-
ulation Commission to assure that recombinant DNA
activities be conducted in a manner to protect the public
health and welfare of the American people.

(6) all recombinant DNA activities are either in
interstate commerce or substantially affect such com-

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1 merce and regulations and licensure by the National

2 Recombinant DNA Safety Regulation Commission are

3 necessary and proper to effectively regulate such

4 activities.

5 Sec. 3. The Public Health Service Act is amended by

6 adding after title XVII the following new title:

7 “TITLE XVIII— NATIONAL RECOMBINANT DNA

8 SAFETY REGULATION COMMISSION

9 “establishment of commission

10 “Sec. 1801. (a)(1) There is established within the

11 Department of Health, Education, and Welfare a commis-

12 sion to be known as the National Recombinant DNA Safety

13 Regulation Commission (hereinafter in this title referred to

14 as the ‘Commission’ ) .

15 “(b) The Commission shall be composed of eleven mem-

16 bers. The President shall, within sixty days from the date

17 of enactment of this title, appoint —

18 “( 1) Six members of the Commission from individ-

19 uals —

20 “(A) who are not and have never been pro-

21 fessionally engaged in biological research,

22 “(B) who are qualified to serve on the Com-

23 mission as members of the general public including

24 persons who by virtue of their training, experience,

25 or background in the fields of medicine, law, ethics,

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education, physical, behavioral, and social sciences,
philosophy, humanities, health administration, gov-
ernment, or public affairs, and

“(C) who have no financial interest in recombi-
nant DNA activities.

“(2) Five members of the Commission from
individuals —

“(A) who are or have been professionally
engaged in biological research,

“(B) who are qualified to serve on the Com-
mission by virtue of their training, experience,
or background, and

“(C) who have no financial interest in recom-
binant DNA activities.

“(c) Except as provided in subsection (e)(4), no
individual who is a full-time employee of the United States
may be eligible to be appointed as a member of the Com-
mission.

“(d) The term of office of each member of the Com-
mission shall be four years; except that —

“( 1) the terms of office of members first taking
office shall begin on the date of appointment and shall
expire, as designated by the President at the time of
their appointment, four at the end of two years, four at

[691]

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1 the end of three years, and three at the end of four

2 years;

3 “ (2) any member appointed to fill a vacancy oc-

4 curving prior to the expiration of the term for which his

5 predecessor was appointed shall be appointed for the

6 remainder of such term; and

7 “(3) a member whose term has expired may serve

8 until his successor has been appointed.

9 “(e)(1) The Chairman of the Commission (hereinafter

10 in this part referred to as the ‘Chairman1 ) shall be appointed

11 by the President, by and with the advice and consent of the

12 Senate, and the Chairman shall be selected from among those

13 individuals appointed under subsection (b)(1).

14 “(2) The Chairman shall serve as a full-time employee

15 of the Commission and shall administer the daily activities

16 -of the Commission.

17 “(3) The Secretary of Health, Education, and W el-

18 fare (hereinafter in this title, except section 1815, referred
10 to as the ‘Secretary1 ) shall compensate the Chairman at a

20 rate not to exceed the annual rate of basic pay in effect for

21 grade GS-18 of the General Schedule, without regard to

22 the provisions of title 5, United States Code, governing

23 appointments in the competitive service, and the provisions

24 of chapter 51 and subchapter 111 of chapter 53 of such title,

25 relating to classification and General Schedule pay rates.

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“(4) Subsection (c) shall not apply in the case where a
chairman is reappointed as a member of the commission .

“(f)(1) The members of the Commission shall elect a
Vice Chairman and such other officers as deemed necessary
from among themselves.

“(2) Seven members of the Commission shall con-
stitute a quorum as long as of the members present four
are members who were appointed under paragraph (1)
of subsection (b) and three are members who were ap-
pointed under paragraph (2) of such subsection, but a
lesser number may conduct hearings.

“(3) The Commission shall meet at the call of the Chair-
man or at the caU of a majority of its members.

“(4) No individual may be appointed to serve as a
member of the Commission, if such individual has served for
two terms of four years each.

“(5) A vacancy on the Commission shall not afreet the
authority or activities of the Commission.

“(g) Members of the Commission shall receive compensa-
tion at a rate to be fixed by the Secretary, but not exceeding
for any day (including traveltime) the daily equivalent of the
effective rate for GS-18 of the General Schedule while en-
gaged in the actual performance of the duties vested in the
Commission, and shall be reimbursed for travel, subsistence,

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and other necessary expenses incurred in the performance of
such duties.

“duties and functions of the commission
“Sec. 1802. (a) (1) (A) The Commission is au-
thorized—

“(1) to direct and supervise all personnel of the
Commission;

“(2) to promulgate such rules and regulations as
may be necessary or appropriate to carry out the duties
and functions vested in it hy this title;

“(3) to carry out the provisions of this title;

“(4) except as provided in section 1816(f), to
utilize, with their consent, the services, personnel, and
facilities of other Federal agencies and of state and
private agencies and instrumentalities with or without
reimbursement therefor ;

“(5) except as provided in section 1816(f), to
enter into and perform such contracts, leases, cooperative
agreements, or other transactions as may be necessary
or appropriate in the conduct of the work of the Com-
mission and on such terms as the Commission may deem
appropriate, with any agency or instrumentality of the
United States, or with any state, territory or possession,
or any political subdivision thereof, or with any public

[694]

25

or private person , firm, association, corporation , inde-
pendent testing laboratory, or institution;

“(6) to monitor compliance by the owners or opera-
tors of a licensed facility and persons authorized by a
license to engage in recombinant DNA activities in con-
nection with a licensed facility with the requirements of
this title ; and

“(7) to undertake such other activities as are inci-
dental to enforcement of the provisions of this title.
“(b) The Commission shall encourage, through con-

11 tracts, the development of effective epidemiological methods

12 and safety monitoring technologies to identify and follow the

13 production and dissemination of recombinant DNA and the

14 biological or chemical products thereof.

15 “(c) The Commission shall encourage on a continuing

16 basis studies designed to assess the risks to human health

17 and the environment which may be presented by recombinant

18 DNA activities. The Commission shall insure that the find-

19 ings of such studies shall be maintained and readily accessible

20 to all interested persons.

21 “general requirements

22 “Sec. 1803. (a) Effective two hundred and sixty-five

23 days after the date of the enactment of this title, no person

24 may engage in recombinant DNA activities in the States or in

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any area subject to the jurisdiction of the United States
unless such activities are conducted in a facility which is
licensed under this part authorizing such activities to be
conducted in such facility.

“(b)(1) A license to authorize recombinant DNA ac-
tivities to be conducted in a facility shall be issued only upon
an application made by persons who own or operate a
facility in such form and manner as may be prescribed
by the Commission. An application for such a license shall
include —

“(A) the names of persons who own or operate the
facility to be licensed and the location of such facility;

“(B) the names, addresses and qualifications of
persons to be authorized by the license to engage in
recombinant DNA activities in connection with such
facility;

“(C) a description of the proposed recombinant
DNA projects to be conducted in such facility;

“(D) a description of such facility and materials
to be used in connection with recombinant DNA activi-
ties at such facility;

“(E) certification to the Commission that such
facility and such activities will meet all applicable re-
quirements prescribed by regulations under section 1804,
and appropriate State and local governmental require-

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merits if such requirements have been exempted by the
C ommission under subsection (b) of section 1813 ;

“(F) certification to the Commission that all person-
nel who will work in such facility will receive adequate
training related to the safety of recombinant DNA
activities;

“(G) certification to the Commission that persons
who own or operate such facility and persons who are
authorized by the license to engage in recombinant DNA
activities in connection with such facility agree to —

“(1) permit inspections of such facility in ac-
cordance with the provisions of section 1806; and
“(2) accept a duty to promptly report to the
Commission any material changes regarding any
information submitted under this title and to prompt-
ly report such changes; and

“(H) such additional information and certification
related to the safety of recombinant DNA activities as
the Commission may prescribe.

“(2) (A) A license issued under this section shall be valid
for such period (but not in excess of twenty-four months)
and may be renewed in such manner as the Commission may
prescribe. Such a license shall contain such terms and con-
ditions as the Commission finds are necessary and appropriate
to carry out the purposes of this title and shall specify —

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“(i) the names and addresses of persons to he au-
thorized by the license to engage in recombinant DNA
activities in connection with the licensed facility ;

“(ii) a description of the recombinant DNA ac-
tivities authorized to be conducted in such facility; and
“( Hi) such additional information related to the
safety of recombinant DNA activities as the Commis-
sion may prescribe.

“(B) A license issued under this section shall be posted
in a place in the facility which is readily accessible to all em-
ployees of such facility. Such license shall remain so posted
as long as such license is valid.

“ (c) Upon receipt of an application for the issuance or
renewal of a license under this section, the Commission shall
publish in the Federal Register a detailed description of the
1 activities to be conducted, including a descripton of the sources
of the biological materials to be used in such activities, the
physical and biological containment requirements applicable
to such activities, the objectives of such activities, the names
of persons who own or operate the facility to be licensed, and
the location of such facility.

“(d) ( 1) Any owner or operator of a facility may include
in a single submission for application for a license under
this section all of its facilities which it desires to be licensed
on the condition that such single submission contain all

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required information and certifications for each such facility
to be licensed, and all such facilities are within the same
geographic locality J

“(2) The Commission shall develop a procedure to
permit the modification of material information previously
submitted under subsection (b) (1) ,

“(e) The Commission shall not issue an initial license
unless it has determined that, prior to engaging in recom-
binant DNA activities at the facility —

“ (1) all the requirements of this 'title will be met ;

and

“(2) the' recombinant DNA activities to he conducted
in the facility to be licensed will be conducted in q man-
ner as to protect die health of the persons exposed to
recombinant DNA, protect the environment, and protect
the health of the population r of the surrounding com-
munity,

“(f) The Commission shall not issue a renewal of a

“(if all the requirements of , (his litlefiave been met;

and

“(2) the recombinant DNA. activities which have
been conducted in the facility , which was previously
licensed under this title, were conducted in a manner as
to protect the health of the persons exposed to recombinant

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DNA, protect the environment , and protect the health of
the population of the surrounding community.

“(g) Effective one hundred and fifty days after the
date of enactment of this title, no person may engage in
recombinant DNA activities in the States, or in any area
subject to the jurisdiction of the United States unless such
activities comply with the regulations promulgated under sec-
tion 1804(a)(1) or until licensed under section 1803.

“ LICENSING REQUIREMENTS
“Sec. 1804. (a) For purposes of protecting the health
and safety of individuals who work with recombinant DNA,
the health and safety of the public at large, and the integrity
of the environment, the Commission shall —

“(1) no later than one hundred and twenty days
after the date of enactment of this title, promulgate, as
final, regulations which prescribe physical and biological
containment requirements for recombinant DNA activi-
ties which during the one hundred and eighty day period
beginning on the date of the promulgation of regulations
under this paragraph shall be no less stringent than the
physical and biological containment requirements pre-
scribed by the recombinant DNA Research Guidelines
of the National Institutes of Health which are in effect
on the date of enactment of this title ;

“(2) no later than ninety days after the date of

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promulgation of final regulations under paragraph (1),
promulgate regulations to implement the license and
other requirements prescribed by this title. Including
the requirements promulgated under paragraph ( 1 ) of
this subsection, amended, if necessary, the regulations
shall —

“(A) prescribe requirements respecting labora-
tory safety techniques and monitoring to be followed
by persons authorized by a license to engage in re-
combinant DNA activities in connection with the
licensed facility, including —

“(i) the laboratory safety training to be
given to, and the safety techniques to be followed
by, personnel involved in such activities,

“(ii) the monitoring systems which may in-
clude periodic health screening to protect against
accidental exposure or accidental exposure and
other hazards to the health of all personnel who
may he affected in such activities and,

“(in) the type and form of information to
be given to such personnel concerning the nature
of the health risks involved in such activities;
“(B) prescribe requirements respecting —
“(i) the maintenance of a register at a
licensed facility which shall include the names,

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addresses and health records of person s exposed
to recombinant DNA in connection with the li-
censed facility ; and

“ ( ii) the monitoring by the person who
owns or operates the facility of the health of
each such person;

“(C) prescribe requirements respecting the
establishment , functions , and operations of Institu-
tional Biohazard Review Committees affiliated with
each facility licensed pursuant to section 1803. Such
regulations shall contain requirements —

“( i) prescribing that the composition of
the members on such committees be as
follows —

“ (I ) at least one-third of the total mem-
bers be individuals —

“(a) who are not and have never
been professionally engaged in biologi-
cal research;

“(b) who are qualified to serve as
members of the general public including
persons who by virtue of their training,
experience or background in the fields of
medicine, law, ethics, education, physi-
cal, behavioral and social sciences,

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8. 1217-G-

philosophy, humanities, health adminis-
tration, government, or public affairs;

“(c) who have no financial inter-
est in recombinant DNA activities and
who are not employees of the owners or
operators of such facility or of persons
who have a financial interest; and

“(d) who are residents of a local
community which is proximate to the
facility; and

“(TI) at least, another one-third of the
total members be individuals —

“(a) who are employees of the
owners or operators of the facility ; and
“(b) who are qualified through
their expertise and training to provide
a diversity of viewpoints relevant to
recombinant DNA activities and tech-
nology, biological safety and engineer-
ing, and biohazard monitoring.

“(ii) providing for the review and ap-
proval by such committees of all recombinant
DNA projects to be undertaken by a facility
licensed under section 1803. Such review and
approval shall include the adequacy of the con-
-5

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tainment level and the safety of the procedures
contemplated to assure compliance with the re-
quirements of this title.

“( Hi) providing for public notice to the
local communities by such committees of each
recombinant DNA project approved by such
committees.

“(D) prescribe requirements respecting the pos-
session and handling of recombinant DNA and the
biological or chemical products of recombinant DNA
activities outside of a licensed facility or in commerce;

“(E) prescribe requirements respecting records
and reports, related to the safety of recombinant
DNA activities, to be maintained and submitted by —
“(i) persons who own or operate the facility
licensed under section 1803; and

“(ii) persons who are authorized by a
license to engage in recombinant DNA activi-
ties in connection with the licensed facility;
“(F) prescribe requirements respecting the
responsibilities of owners or operators of a facility
licensed under section 1803 to monitor compliance
of the facility and persons authorized by the license
to engage in recombinant DNA activities in connec-

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tion with the licensed facility with the requirements
of this title; and

“(G) include such other provisions related to
the safety of recombinant DNA activities as the
Commission determines to be necessary for carrying
out the provisions of this title.

“(b)(1) The Commission shall periodically review
regulations promulgated under subsection (a) and promul-
gate such amendments to such regulations as it determines
to be necessary.

“(2) (A) Upon promulgation of a proposed regulation
which would be more stringent than an existing final regu-
lation promulgated under subsection (a), the Commission
shall provide notice , in accordance with subparagraph (C),
to each state and political subdivision which has been granted
an exempt requirement.

“(B) During the review and comment period for such
proposed regulation, the Commission shall make a deter-
mination as to the effect of such regulation, when final, on
each exempt requirement. If the Commission determines
that such regulation would, when final, supersede any
exempt requirement, the Commission shall provide notice, in
accordance with subparagraph (C), to each State and
political subdivision which has an exempt requirement.

[705]

36

1 “(C) The Commission shall provide notice, as required

2 under subparagraphs (A) and (B) by sending, in writing

3 and through certified mail —

4 “(i) a copy of the proposed or final regulation;

5 “(ii) a statement that such proposed or final regu-

6 lation may supercede the exempt requirement of the

7 state or political subdivision;

8 “(Hi) a letter, signed by the Chairman of the

9 Commission, informing the state or political subdivision

10 that the Commission has made the determination,

11 required by subparagraph (B), and the effect of such

12 determination on the exempt requirement of such state

13 or political subdivision;

14 “(iv) a time schedule of when the proposed or final

15 regulation would become effective.

16 “(D) For purposes of this paragraph, ‘ exempt require-

17 ment’ means a requirement of a state or political subdivision

18 which has been exempt under subsection (b) of section 1813.

19 “( c) Within two years from the enactment of the Recom-

20 binant DNA Safety Regulation Act, and updated on an

21 annual basis thereafter, the Commission, in coordination and

22 consultation with and after review by the National Com-

23 mission for the Protection of Human Subjects of Biomedical

24 and Behavioral Research, shall prepare and transmit to the

25 Congress a comprehensive study that identifies the basic ethical

[706]

37

1 and scientific 'principles which should underlie the conduct,

2 applications, and use of recombinant DNA activities which

3 shall include:

4 “(. 1) an analysis and evaluation of scientific and

5 technological advances in past, present, and projected

6 recombinant DNA activities in the United States and

7 other countries;

8 “(. 2) an analysis and evaluation of the implication

9 of the application of such advances, both for individuals

10 and for society;

11 “(3) an analysis and evaluation of the laws and

12 ethical principles governing the use and potential appli-

13 cation of recombinant DNA technology;

14 u(4) an analysis of the exemptions given State and

15 political subdivisions of States from Federal preemption,

16 including an analysis of the reasons therefor;

17 “(5) an analysis and evaluation of the implications

18 of recombinant DNA activities within the field of genetic

19 engineering;

20 u(6) an analysis of the advantages and disadvan-

21 tages of approaches for assuring the safest and most

22 appropriate applications and uses of recombinant DNA

23 with regard to the protection of researchers, workers, the

24 general public, and the environment;

25 “(7) any proposals for changes in the definition of

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recombinant DNA, as defined in section 1821(a)(2),
which would lead to greater 'protection of researchers,
the public, and the environment or would further the
purposes of the Recombinant DNA Safety Regulation
Act, and its recommendations with regard thereto;

“(8) appropriate additional recommendations for
the conduct of recombinant DNA activities particularly
with respect to the best approaches for assuring the safest
and most appropriate applications and uses of recom-
binant DNA and the appropriate role of assessment of
risk-benefit criteria in these determinations;

“( 9) a determination of the status and extent of
recombinant DNA activities conducted in exempted
areas in the United States and in areas outside the
United States, and an analysis of the nature of regula-
tion in other countries;

“(10) a summary of the Commission's decisioris
with respect to the facilities which have been licensed and
the terms and conditions attached thereto; and

“(11) a summary of actions taken to accomplish the
purposes of the Recombinant DNA Safety Regulation
Act, the nature of the difficulties encountered in enforce-
ment, the number and nature of penalties imposed during
the preceding year and an evaluation of their adequacy
as deterrants to future violations, areas of recombinant

[708]

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1 DNA activity outside this title which might pose a

2 danger to researchers, the public or the environment, and

3 any other enforcement, administrative, or jurisdictional

4 problems or questions encountered by the Commission in

5 carrying out its duties under this title and a recommen-

6 dation for administrative or legislative actions which

7 would correct such problems.

8 “license revocation, suspension, or limitation

9 “Sec. 1805. (a) If the Commission finds, after reason-

10 able notice and opportunity for a hearing to a person who

11 owns or operates a facility licensed under this title, that such

12 person or a person authorized to engage in recombinant DNA

13 activities in connection with such facility —

14 “(1) has knowingly, wilfully, or negligently main-

15 tained or submitted any required records, reports, or data

16 which contain any false or misleading information or

17 which omit any material information,

18 “(2) has knowingly, wilfully, or negligently engaged

19 or attempted to engage or represented himself as entitled

20 to perform any recombinant DNA activities in a manner

21 not authorized by the license,

22 “(3) has knowingly, wilfully, or negligently failed

23 to register a recombinant DNA project, prior to the com-

24 mencement of such project in accordance with section

25 1818 ,

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“(4) has knowingly, wilfully, or negligently failed
to comply with a request of the Commission for any in-
formation or materials the Commission believes necessary
to determine the facility s continued eligibility for its
license or to evaluate the possible effects on health or the
environment of recombinant DNA activities, or

“(5) has knowingly, wilfully, or negligently failed
to comply uhth a request of the Commission, an inspector,
or any other duly authorized agent of the Commission,
to inspect any portion of the facility, its operations, or
its records, which are related to recombinant DNA
activities,

the Commission shall revoke the license of such facility for
the remainder of its term and may make any facility owned
or operated by such person ineligible for a license under this
title for such period of time as the Commission may determine.

“(b) If the Commission finds, after reasonable notice
and opportunity for a hearing before the Commission to a
person who owns or operates a facility licensed under this
title, that such person or a person authorized to engage in
recombinant DNA activities in connection with such facility —
“(1) has knowingly, willfully, or negligently failed
to comply with any of the terms or conditions of the
license, or

“(2) has knowingly, willfully, or negligently vio-

[710]

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1 lated or aided and abetted in the violation of any require -

2 ment established under this title,

3 The Commission may revoke, suspend, or limit the license of

4 such facility for up to the remainder of its term and may make

5 any facility owned or operated by such person ineligible for

6 a license under this title or limited under whatever terms and

7 conditions it finds appropriate.

8 “INSPECTIONS

9 “Sec. 1806. (a) For purposes of carrying out the pro-
IQ visions of this title, an inspector, upon presenting appro-

11 priate credentials to the owner, operator, or agent in charge

12 of a facility at which the inspector has reasonable grounds to

13 believe that recombinant DNA activities are being conducted

14 or the biological or chemical products Of such activities are

15 present, are being produced, or in which records pertaining

16 to such activities Or products are kept is authorized to enter

17 that facility at reasonable times, and inspect, at reasonable

18 times and, in a reasonable manner, the facility and all things

19 at '(or being transported to oi from) that facility which he

20 has reasonable grounds to believd are involved with recom-

21 binant DNA activities or the bwlbgicttl or chemical products

22 of Such activities and obtain appropriate samples of such

23 things. Such an inspection may extend to relevant equipment,

24 materials, contmners, records, files, papers , processes, con-

25 irols, facilities, and all other things in the * facility bearing Ok

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whether the recombinant DNA activities are being conducted
or the biological or chemical products of such activities are
being used or possessed in accordance with the requirements
of this title.

“(b)(1) When an inspector has completed an inspec-
tion under this section, he shall, before he leaves the facility,
inform the owner, operator, or agent in charge of the facility
of any conditions or practices which in the inspector s judg-
ment constitute a violation of any of the requirements of this
part and the inspector shall post a written notice of such viola-
tion in a place in the facility which is readily accessible to
all the employees of such facility. Any information provided
to the owner, operator, or agent in charge of the facility by an
inspector or posted prior to the written final report, described
in paragraph (2) shall not be legally binding on the inspector
or the Commission and shall not be a limitation on the in-
spector or the Commission.

“(2) The inspector shall prepare a written final report
of his findings and send it to such owner, operator, or agent
within thirty days of the completion of the inspection. Upon
receipt of such report, the owner, operator, or agent shall post
a copy of such report in the same place as the written notice
was placed, under paragraph (1).

“(c) No inspector authorized pursuant to this section
shall be required to obtain a search warrant or a warrant

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for seizure from any judicial officer prior to entering any
facility and conducting any inspection or seizure of recom-
binant DNA or the biological or chemical products thereof.

11 (d) Whenever an inspector obtains a sample, under
the authority of this title, such inspector shall comply with
the requirements of section 1 804 (a) (2) (D) .

“(e)(1) Except as provided in paragraph (2), the
Commission shall conduct initial and annual inspections
authorized by this title in the following order:

“(A) First, all those facilities, which are required
to meet the highest physical containment requirements,
established under section 1804(a) (1);

“(B) Then, all those facilities which are required
to meet the next highest physical containment require-
ments established under section 1804(a)(1); and

“(C) Then, if the Commission determines that it is
necessary, facilities which are otherwise required to
meet physical containment requirements established
under section 1804 (a)(1).

“(2) Whenever a bona fide request for an inspection is
made by any person who has reasonable grounds to believe
that there is a hazardous product of recombinant DNA
activities present, an inspection shall immediately be con-
ducted.

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“records, reports, and samples
“Sec. 1807. Each person who owns or operates a facil-
ity required to he licensed pursuant to section 1803 shall
maintain and submit to the Commission such records, reports,
and samples related to the safety of recombinant DNA ac-
tivities as the Commission may require.

“ PROHIBITED acts

“SEc. 1808. The following acts and the causing thereof
are hereby prohibited:

“(a) The failure to comply with section 1803 or section
1804 or the regulations promulgated thereunder.

“(b) The refusal to permit access to or copying of any
record required by this title; or the failure to establish or
maintain any record or sample, or make any report, re-
quired under this title ; or the maintenance or submission of
any required records, reports, samples, or data which con-
tain any false or misleading information or that omit material
information; or the refusal to permit access to or verification
or copying of any such required record, report, or data.

“(c) The refusal to permit entry or inspection as author-
ized by section 1806.

“(d) The failure to comply with any conditions or lim-
itations placed on a license granted under this title.

“(e) The failure to register a recombinant DNA project,

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prior to the commencement of such project in accordance with
section 1818.

“ CIVIL PENALTIES

“Sec. 1809. (a) Any person who knowingly, willfully,
or negligently violates a provision of section 1803 or sec-
tion 1808 shall be liable to the United States for a civil
penalty in any amount not to exceed $ 10,000 for each such
violation. Each day such a violation continues shall, for pur-
poses of this section, constitute a separate violation of section
1803 or section 1808.

“(b) A civil penalty for a violation of section 1803
or section 1808 shall be assessed by the Commission by an
order made on the record after opportunity (provided in
accordance with this subsection) for a hearing in accordance
with section 554 of title 5, United States Code. Before
issuing such an order, the Commission shall give written
notice to the person to be assessed a civil penalty under such
order of the Commission's or its delegates' proposal to issue
such order and provide such person an opportunity to request,
within fifteen days of the date the notice is received by such
person, such a hearing on the order.

“(c) Any person who requested in accordance with sub-
section (b) a hearing respecting the assessment of a civil
penalty and who is aggrieved by an order assessing a civil

[715]

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1 penalty may file a petition for judicial review of such order

2 with the United States Court of Appeals for the District of

3 Columbia Circuit or for any other circuit in which such per-

4 son resides or transacts business. Such a petition may only be

5 filed within the thirty-day period beginning on the date the

6 order making such assessment was received by such person.

7 “( d) If any person fails to pay an assessment of a civil

8 penalty —

9 “(1) after the order making the assessment has fee-

10 come a final order and if such person does not file a peti-

11 tion for judicial review of the order in accordance with

12 subsection (c), or

13 “(2) after a court in an action brought under sub-

14 section (c) has entered a final judgment in favor of the

15 Commission,

16 the Attorney General shall recover the amount assessed

17 ( plus interest at currently prevailing rates from the date of

18 the expiration of the thirty-day period referred to in sub-

19 section (c) or the date of such final judgment, as the case may

20 be) in an action brought in any appropriate district court of

21 the United States. In such an action, the validity, amount,

22 and appropriateness of such penalty shall not be subject to

23 review.

24 “administrative restraint, seizure, or destruction

25 “Sec. 1810. If during an inspection pursuant to section

26 1806 an inspector finds material he has reasonable cause to

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believe is a hazardous product of recombinant DNA activi-
ties, he may order the material not to be moved, may seize the
material, or may destroy the material in accordance with
procedures adopted by the Commission, which procedures
shall provide for the prior approval of the seizure or destruc-
tion of material by the Chairman or the Acting Chairman.
Within seven days after such action by an inspector , the
Corrtmission must commence a civil action under section 1811
with respect to the inspector s action, unless the owner of the
material has agreed otherwise.

“procedure for hazardous products of

RECOMBINANT DNA ACTIVITIES
“Sec. 1811. The Commission may commence a civil
action, by process of libel or otherwise, in an appropriate
district court of the United States for the seizure or destruc-
tion of hazardous products of recombinant DNA activities
or for other appropriate relief to prevent its production,
movement, or spread.

“ INJUNCTION AUTHORITY

“Sec. 1812. The distriot courts of the United States
shall have jurisdiction over civil actions to restrain any viola-
tion of section 1803, 1804 or 1808. Such a civil action may
be brought in the United States district court for the judicial
district wherein any act, omission, or transaction constituting
a violation of any such section occurred or wherein the
defendant is found or transacts business. In any such

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civil action process may be served on a defendant in any
judicial district in which a defendant resides or may be
found. Subpenas requiring attendances of witnesses in any
such action may be served in any judicial district.

“ EFFECT ON STATE AND LOCAL REQUIREMENTS
“Sec. 1813. (a) It is declared to be the express intent
of Congress to supersede any and all laws of the states and
of the political subdivisions thereof insofar as they may
establish or continue in effect with respect to recombinant
DNA activities any requirement which is different from, or
in addition to, any requirement applicable under this title,
except as provided in subsection (b).

“(b) Upon receipt of an application by a state or by
a political subdivision of a state and after notice and oppor-
tunity for a hearing on the record, the Commission shall, no
later than three months from the date the application was
received and in accordance with the provisions of paragraphs
(1) and (2) of this subsection, exempt any existing or pro-
posed requirement from subsection (a) of this section.

“( 1) The Commission shall grant an exemption under
this subsection only if it finds —

“(A) that the requirement of a state or political
subdivision of a state applicable to recombinant DNA
activities is, and will be administered so as to be, more
stringent than a requirement under this title;

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“(B) the reason for the requirement is relevant and
material to the health and environmental concerns or
comparable compelling local conditions of such state or
political subdivision; and

“(C) compliance with the requirement will not cause
such activities to be in violation of any applicable require-
ment under this title.

The Commission may not withdraw any such exemption for
so long as it finds that such requirement remains more
stringent than a requirement under this title and continues
to be so administered.

“(2) The Commission shall not grant an exemption under
this subsection if the Commission finds that such requirement
is arbitrary and capricious.

“(c) An application for such an exemption may be
accompanied by any materials gathered by the applicant
in its legislative or administrative consideration of the exist-
ing or proposed requirement. Upon receipt of such an ap-
plication and such materials, if submitted, the Commission
shall publish such application in the Federal Register as a
proposal, accompanied by a description of any supporting
materials submitted therewith.

“(d) It is not the intention of the Congress that enact-
ment of the Recombinant DNA Safety Regulation Act,
promulgation of regulations thereunder, or compliance there-

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with should be considered in any way to reduce or affect the
common law or statutory rights or remedies of any person
regarding recombinant DNA activities.

“judicial review of licensing
“Sec. 1814. (a) Any person adversely affected by an
action of the Commission under section 1803 or 1805 con-
cerning the issuance, revocation, suspension, or limitation
of a license, may obtain review of the action in the United
States court of appeals for the circuit in which that person
resides or has his principal place of business. The petition
for review must be filed within sixty days of the date no-
tice of such action is received by such person. Review shall
conform to chapter 7 of title 5 of the United States Code.

“(b) An action with respect to which review could have
been obtained under subsection (a) shall not be subject to
judicial review in any other proceeding.

“ EMPLOYEE PROTECTION

“Sec. 1815. (a) No employer may discharge any em-
ployee or otherwise discriminate against any employee with
respect to the employee's compensation, terms, conditions, or
privileges of employment because the employee (or any per-
son acting pursuant to a request of the employee) has —

“(1) commenced, caused to be commenced, or is
about to commence or cause to be commenced a proceed-
ing under this Act,

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“(2) testified or is about to testify in any such
proceeding, or

“(3) assisted or participated or is about to assist
or participate in any manner in such a proceeding or
in any other action to carry out the purposes of this Act.
“(b)(1) Any employee who believes that he has been
discharged or otherwise discriminated against by any per-
son in violation of subsection (a) of this section may, within
sixty days after such alleged violation occurs, file (or have
any person file on the employee’s behalf) a complaint with
the Secretary of Labor (hereinafter in this section referred
to as the ‘Secretary ) alleging such discharge or discrimina-
tion. Such sixty-day period shall be tolled during the pendancy
of any grievance procedures or other efforts at conference,
conciliation, or mediation. Upon receipt of such a complaint,
the Secretary shall notify the person named in the com-
plaint of the filing of the complaint.

“(A)(i) Upon receipt of a complaint filed under
paragraph (1), the Secretary shall conduct an in-
vestigation of the violation alleged in the complaint.
Within thirty days of the receipt of such complaint, the
Secretary shall complete such investigation and shall
notify in writing the complainant (and any person act-
ing with the authority of the complainant) and the per-
son alleged to have committed such violation of the re-

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suits of the investigation conducted pursuant to this
paragraph. Within ninety days of the receipt of such
complaint the Secretary shall, unless the proceeding on
the complaint is terminated by the Secretary on the
basis of a settlement entered into by the Secretary and
the person alleged to have committed such violation ,
issue an order either providing the relief prescribed by
subparagraph (B) or denying the complaint. An order
of the Secretary shall be made on the record after notice
and opportunity for agency hearing. The Solicitor of
Labor shall, with the consent of the complainant, repre-
sent such complainant at any such hearing. The Secre-
tary may not enter into a settlement terminating a
proceeding on a complaint without the participation
and consent of the complainant.

“(ii) If in response to a complaint filed under para-
graph (1) the Secretary determines that a violation of
subsection (a) of this section has occurred, the Secretary
shall order (i) the person who committed such violation
to take affirmative action to abate the violation, (ii)
such person to reinstate the complainant to the com-
plainant’s former position together with the compensa-
tion (including back pay), terms, conditions, and privi-
leges of the complainant's employment, (Hi) compensa-
tory damages , arid (iv) where appropriate exemplary

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damages. If such an order is issued , the Secretary , at
the request of the complainant , shall assess against the
person against whom the order is issued a sum equal
to the aggregate amount of all costs and expenses ( in-
cluding attorney's fees) reasonably incurred , as deter-
mined by the Secretary, by the complainant for, or in
connection with, the bringing of the complaint upon
which the order was issued.

“(Hi) Any person adversely affected or aggrieved
by an order issued under subparagraph (i) may obtain
review of the order. The petition for review must be
filed within sixty days from the date of issuance of the
Secretary's order. Review shall conform to chapter 7 of
title 5 of the United States Code.

“(iv) An order of the Secretary, with respect to
which review could have been obtained under subpara-
graph (Hi), shall not be subject to judicial review in any
criminal or other civil proceeding.

“(B) Whenever a person has failed to comply with
an order issued under subparagraph (i), the Secretary
shall file a civil action in the United States district court
for the district in which the violation was found to
have occurred to enforce such order. In actions brought
under this paragraph, the district courts shall have ju-
risdiction to grant all appropriate relief, including iri-

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junctive relief and compensatory and exemplary dam-
ages. Civil actions brought under this paragraph shall
be heard and decided expeditiously.

“(C) Subsection (a) of this section shall not apply
with respect to any employee who, acting without direc-
tion from the employee's employer (or any agent of the
employer) , deliberately causes a violation of any require-
ment of this Act.

“administrative provisions
“Sec. 1816. (a) The Commission may for the purpose
of carrying out its duties hold such public hearings, sit and
act at such times and places, take such testimony, and receive
such evidence as the Commission deems advisable.

“(b)(1) The Commission may appoint and fix the
compensation of such employees as it deems advisable, how-
ever, in no event may the Commission appoint more than
fifty employees.

“(2) (A) The Commission may procure, in accordance
with the provisions of section 3109 of title 5, United States
Code, the temporary or intermittent services of experts or
consultants. Persons so employed shall receive compensation
at a rate to be fixed by the Commission, but not exceeding for
any day (including traveltime) the daily equivalent of the
effective rate for Grade GS-18 of the General Schedule.
“(B) While away from his home or regular place of

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business in the performance of services for the Commission,
any such person may be allowed travel expenses, including
per diem in lieu of subsistence, as authorized by section 5703
(b) of title 5, United States Code, for persons in the Govern-
ment service employed intermittently.

“(3) To appoint technical committees composed of such
private citizens and officials of the Federal, State, and local
governments as it deems desirable to advise it with respect to
its functions under the law subject to its jurisdiction, and to
pay such members (other than those regularly employed by
the Federal Government) while attending meetings of such
committees, or otherwise serving at the request of the Commis-
sion, compensation and travel expenses at the rate provided
for in paragraph (2) of this subsection with respect to ex-
perts and consultants.

“(c) The Commission may publish and disseminate to
the public such reports, information, recommendations, and
other material relating to its functions, activities, and studies
as it deems appropriate.

“(d) The Commission may enter into contracts for the
purpose of carrying out the provisions of this title.

“(e) The Commission may conduct and support train-
ing of personnel of the Commission for purposes of carry-
ing out the provisions of this title.

“(f) The Commission shall not delegate any of the

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duties and functions vested in it under this part, including
the functions and duties respecting licensing and inspection,
of facilities to any individual who is not an employee of the
Commission, or to any partnership, corporation, association,
or to any Federal, State, or local government entity.

“(g) The Commission shall require such periods of time
for the retention and maintenance of records required under
this title as the Commission determines are necessary and
appropriate.

“ DISCLOSURE OF DATA

“Sec. 1817. (a) General. — Except as provided by
subsection (b), any information reported to, or otherwise
obtained by, the Commission or any representative of the
Commission, under this title, which is exempt from disclosure
pursuant to subsection (a) of section 552 of title 5, United
States Code, by reason of subsection (b)(4) of such section,
shall, notwithstanding the provisions of any other section of
this title, not be disclosed by the Commission or by any
officer or employee of the United States, except that such
information —

“(1) shall be disclosed to any officer or employee of
the United States —

“(A) in connection with the official duties of
such officer or employee under any law for the pro-
tection of health or the environment, or

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“(B) for specific law enforcement purposes;
“(2) shall he disclosed to contractors with the Com-
mission and employees of such contractors if in the opin-
ion of the Commission such disclosure is necessary for
the satisfactory performance of the work of such con-
tractor in connection with this title and under such con-
ditions as the Commission may specify;

“(■ 3 ) shall be disclosed if it is necessary to protect
health or the environment against an unreasonable risk
of injury to health or the environment; or

u( 4) may be disclosed when relevant in any pro-
ceeding under this title, except that disclosure in such
proceeding shall be made in such manner as to preserve
confidentiality to the extent practicable without impairing
the proceeding.

In any proceeding under section 552(a) of title 5, United
States Code, to obtain information the disclosure of which
has been denied because of the provisions of this subsection,
the Commission may not rely on section 552(b) (3) of such
title to sustain the Commission’s action.

“ (b)(1) In submitting data under this title, a person
may (A) designate the data which such person believes is
entitled to confidential treatment under subsection (a), and
(B) submit such designated data simultaneously but sepa-
rately from other data submitted under this title. A designa-

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tion under this paragraph shall be made in writing and in
such manner as the Commission may prescribe.

“(2) (A) Except as provided by subparagraph ( B ), if
the Commission proposes to release for inspection data which
has been designated under paragraph (1)(A) or any other
information which is exempt from disclosure pursuant to
subsection (a) of section 552 of title 5, United States Code,
by reason of subsection (b)(4) of such section, the Commis-
sion shall notify, in writing and by certified mail, the person
who submitted such data of the intent to release such data.
If the release of such data is to be made pursuant to a request
made under section 552(a) of title 5, United States Code,
such notice shall be given immediately upon approval of
such request by the Commission. The Commission may not
release such data until the expiration of thirty days after
the person icho submitted such data has received the notice
required by this subparagraph.

“(B) Subparagraph (A) shall not apply to the release
of information under paragraph (1), (2), (3), or (4) of
subsection (a), except that the Commission may not release
data under paragraph (3) of subsection (a) unless the Com~
mission has notified each person who submitted such data of
such release. Such notice shall be made in writing by certi-
fied mail at least fifteen days before the release of such data,
except that if the Commission determines that the release of

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such data is necessary to protect against an unreasonable
risk of injury to health or the environment, such notice may
be made by such means as the Commission determines will
provide notice at least twenty-four hours before such release
is made.

“(c) Any officer or employee of the United States or
former officer or employee of the United States, who by vir-
tue of such employment or official position has obtained pos-
session of, or has access to material the disclosure of which
is prohibited by subsection (a) or (e) and who knowing
that disclosure of such material is prohibited by such sub-
section, willfully discloses the material in any manner to
any person not entitled to receive it, shall be guilty of a mis-
demeanor and fined not more than $ 10,000 or imprisoned
for not more than one year, or both. Section 1905 of title 18,
United States Code, does not apply with respect to the pub-
lishing, divulging, disclosure, or making known of, or making
available, information reported or otherwise obtained under
this title.

“(d) For purposes of this section, the term ‘ officer or
employee of the United States’ includes —

“(1) any contractor with the United Stales who is
furnished information as authorized by this section and
any employee of any such contractor, and

“(2) any member of an institutional biohazard

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review committee, established pursuant to this part as
long as information submitted to or otherwise obtained
by such member is information related to a facility
affiliated with such committee.

“ (e)(1) Any person who maintains a health record
which contains individually identifiable personal data (here-
inafter in this subsection referred to as 1 personal data’ ) and
which receives a request from any governmental authority
for such record for purposes of this part shall not disclose or
transfer any such data to a governmental authority unless
the individual whose personal data is to be so disclosed or
transferred gives an informed consent for such disclosure or
transfer and such consent is evidenced by a document con-
taining the signature of such individual and the signature
of the person who explained the provisions of paragraph ( 4) .

“(2) Notwithstanding any provision of law, personal
data received or maintained by a governmental authority for
purposes of this title, may not be disclosed or made available
by a governmental authority to any person other than the
individual who is the subject of such data. Such personal
data may not be required to be disclosed by any Federal,
State, or local civil, criminal, administrative, legislative, or
other proceeding.

te( 3) For purposes of this subsection, the term ‘govern-

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mental authority means any Federal agency, including the
Commission, any State or local governmental authority, its
employees, contractors, grantees, or agents.

“(4) For purposes of this subsection, ‘ informed consent ’
includes a complete explanation of risks and benefits to the
individual whose personal data is to be disclosed or transferred
of such disclosure or transfer, including —

“(A) a statement informing such individual of \
whether he is legally required, or may refuse, to consent
to such disclosure or transfer, and informing him of any
specific consequences of consenting or not consenting to
such disclosure or transfer;

“(B) a statement informing such individual that he
may review the data and any other information which is
proposed to be disclosed or transferred, prior to such
consent ;

“(C) a statement informing such individual of the
use to be made of such data and other information and of
the identity of persons and governmental authorities which
will use the data and other information and their rela-
tionship to the recombinant DNA activities.
“KEGISTRATION OF RECOMBINANT DNA PROJECTS
“Sec. 1818. (a) The owner or operator of a facility
licensed under section 1803 shall, after appropriate review

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and approval, file with the Commission a Project Registra-
tion Statement for each recombinant DNA project conducted
in such facility.

“(b) A Project Registration Statement shall be filed, in
such form and manner as the Commission may require by
rule, prior to the commencement of the project or, in the case
of projects in progress on the date of enactment of this part,
as part of the initial licensing application. The statement shall
contain all information regarding the project that the Com-
mission, by rule, has determined is necessary for an informed
assessment of the precautions to be taken for assuring its
safety and compliance with the requirements of this title.

“ CONSTRUCTION OF FACILITIES

“Sec. 1819. (a) Notwithstanding any other provision
of law, no Federal funds shall be expended for more than
50 per centum of the actual cost, as determined by the Com-
mission, of construction of a facility for the purpose of
meeting the highest physical containment requirements, estab-
lished under section 1804.

“ RELATIONSHIP TO OTHER FEDERAL LAWS

“Sec. 1820. (a) Notwithstanding any other provision
of law, no Federal agency may, except as provided in sub-
sections (b) and (c) of this section, impose or continue in
effect any safety or health requirement applicable to activities
involving recombinant DNA activities which is different

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from, or in addition to, any requirement prescribed pursuant
to this title.

“(b)(1) Upon application by a Federal agency and
after consultation with such agency, the Commission may,
pursuant to this subsection, exempt any existing or proposed
requirement from subsection (a) of this section.

“(2) An application for such an exemption may be
accompanied by any materials gathered by the applicant in
its consideration of the existing or proposed requirement.
Upon receipt of such application and such supporting mate-
rial the Commission shall publish such application in the
F ederal Register as a proposal, accompanied by a description
of the supporting material submitted therewith.

“(3) A proposed exemption shall not be granted by the
Commission unless it finds that the requirement is more
stringent than a requirement under this title and that it is
consistent with the policies of the Commission.

“(4) The Commission shall make a determination with
respect to an application under this subsection unthin three
months from the date the application was received by the
Commission.

“( c) This title shall not affect the authority of the Secre-
tary or the Secretary of Labor to excercise their respective
authority pursuant to the Occupational Safety and Health
Act of 1970 . And provided further, that in exercising author-

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ity under this title, the Secretary, the Commission, or any per-
son acting on behalf of the Secretary or Commission or pur-
suant to the provisions of this title, shall not, for the purposes
of section 4(b)(1) of the Occupational Safety and Health Act
of 1970, be deemed to be exercising statutory authority to
prescribe or enforce standards or regulations affecting occu-
pational safety and health." .

“ DEFINITIONS

“Sec. 1821. ( a) For purposes of this part:

“(1) ‘DNA’ means deoxyribonucleic acid.

“(2) (A) 'Recombinant DNA’ means DNA molecules
that consist of different segments of DNA which have been
joined together outside any cell, and have the potential
for entering and propagating in a particular host cell, either
autonomously or as an integrated part of the host celVs
genome.

“(B) Except as provided in subparagraph (C), the
Commission shall, upon its finding and after final publica-
tion of such finding in the Federal Register, exempt from
the definition in subparagraph (A) DNA molecules com-
posed only of DNA segments from the following sources: the
host species, a related species which is known to exchange
genetic information in nature with the host cell, and/or a
natural parasite or plasmid of the host cell; such composite

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DNA molecules must propagate within the host cell by proc-
esses which are known to occur naturally there.

“(C) The Commission shall not exempt DNA molecules
under subparagraph (B) from the definition in subpara-
graph (A) unless the Commission determines that such mole-
cules do not present an unreasonable risk to the health of the
persons exposed to such molecules, to the environment, or
to the health of the public.

“(3) ‘ Recombinant DNA activities' means any research,
study, investigation, experiment, or activity in connection
with recombinant DNA.

“(4) ‘ Hazardous product of recombinant DNA activi-
ties' means a biological or chemical product of recombinant
DNA activities which is handled, treated, or contained in
such a manner as to pose a significant risk to health or to the
environment, as determined by the Commission.

“(5) ‘ Commerce ' means any activity which affects (1)
commerce between any State or territory and any place out-
side thereof, and (2) commerce within the District of Co-
lumbia or within any other territory not organized with a
legislative body,

“(6) ‘ Commission ' means the National Recombinant
DNA Regulation Commission, established under section
1801,

“(7) ‘ Construction of a facility ' means a facility which

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is not owned or operated by the United States and includes
the construction, leasing, acquisition, or maintenance of new
buildings, including equipment, laboratory installations,
instrumentation, acquisition of land or offsite improvements,
and architects’ fees; and the alteration, improvement, leasing,
acquisition, maintenance, expansion, major repair, remodel-
ing, replacement, and renovation of existing buildings, in-
cluding equipment, laboratory installations, instrumentation,
acquisition of land or offsite improvements, and architects’
fees.

“( 8) For purposes of section 1801(b) (2) (C), ‘finan-
cial interest in recombinant DNA activities’ does not include
wages or salary earned by an employee of a nonprofit educa-
tional or research corporation.

“(9) ‘State’ means any State or territory of the United
States, including the District of Columbia, the Common-
wealth of Puerto Rico, Guam, the Northern Mariana Islands,
American Samoa, and the Virgin Islands.

“(10) ‘ District court of the United States’ includes a
similar or equivalent court in any State.

“(11) ‘ Person includes any individual, partnership,
corporation, association, or any Federal, State, or local gov-
ernment entity.

“(12) ‘Inspector’ means any qualified officer, employee,

[736]

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1 or agent authorized hy the Commission to carry out the ap-

2 propriate provisions of this title.

3 “(13) ‘ Name' shall include in the case of a partnership

4 the name of each partner, and in the case of a corporation the

5 name appearing on the corporation's charter or certificate of
g incorporation and the name of each principal corporate
7 officer and director and the State of incorporation.

g “( 14) ‘ Owns or operates ’ means any person who owns,

9 operates, leases, charters, or controls any facility used in re-

10 comhinant DNA activities.

11 “(15) (A) ‘ Facility ’ means a single building, including

12 the laboratories, premises, records, reports, data, research

13 materials, equipment, instrumentation, products of recombi-

14 nant DNA activities, and everything contained in such build-

15 ing or adjacent thereto.

16 “(B) For purposes of inspections authorized under this

17 title, the term ‘ facility includes in addition to subparagraph

18 (A), any other premises or building which contains records

19 or reports related to recombinant DNA activities.

20 “(16) *. Persons authorized by the license to engage in

21 recombinant DNA activities in connection with a licensed

22 facility ’ means the principal scientist and all other scientists

23 who have responsibility for directing a recombinant DNA

24 project carried out in a facility licensed under this title.

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“(17) * Recombinant DNA project ’ and ‘ project ’ means
any research, study , investigation, experiment, act or closely
related set of acts that have a common research objective and
utilize the same or similar host /vector systems, and are car-
ried out in a facility.

“(18) ‘ Federal agency ’ means each authority of the
Government of the United States, whether or not it is within
or subject to review by another agency, but does not include —
“(A) the Congress; and
“(B) the courts of the United States.

“(19) ‘ Persons exposed to recombinant DNA ’ means
those persons authorized by the license to engage in recom-
binant DNA activities in connection with a licensed facility
and all other persons who are exposed to recombinant DNA
or the biological or chemical products thereof in connection
with a licensed facility.

“(20) For purposes of section 1803(b)(1)(B), ‘quali-
fications’ means experience and training solely related to
assuring compliance with the physical and biological safety
requirements applicable to recombinant DNA activities.

“(21) ‘ Political subdivision ’ and ‘local government'
means a unit of general local government as defined in sec-
tion 601 (1) (10) of Public Law 93-203.

“(22) For purposes of subsection (a) of section 1818,
‘appropriate review and approval ’ means the review and

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approval by the Institutional Biohazard Review Committee
which is affiliated with a licensed facility as required by sec-
tion 1804(a) (2) (C).

“ AUTHORIZATIONS

“Sec. 1822. For the purpose of carrying out the pro-
visions of this title, there are authorized to be appropriated
such sums as may be necessary for fiscal years 1978, 1979,
1980, 1981, and 1982 F .

SEPARABILITY CLAUSE

Sec. 4. If any provision of this title is declared uncon-
stitutional or the applicability thereof to any person or cir-
cumstance is held invalid, the constitutionality of the re-
mainder of the title of the applicability thereof to other persons
and circumstances shall not be affected thereby.

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[740]

Calendar No. 334

95th Congress )

SENATE

j Report

1st Session f

{ No. 95-359

RECOMBINANT DNA SAFETY REGULATION ACT

July 22 (legislative day, July 19) , 1977. — Ordered to be printed

Mr. Kennedy, from the Committee on Human Resources,
submitted the following

REPORT

together with

SUPPLEMENTAL VIEWS

[To accompany S. 1217]

The Committee on Human Resources, to which was referred the
bill (S. 1217) to regulate activities involving recombinant deoxy-
ribonucleic acid, having considered the same, reports favorably there-
on with an amendment and recommends that the bill as amended do
pass.

CONTENTS

I. Summary of legislation

II. Background and definition of the issue

III. Hearings

IV. Committee views

V. Votes in committee

VI. Congressional Budget Office — Cost estimate

VII. Regulatory impact statement

VIII. Section-by-section analysis

IX. Changes in existing laws

X. Supplemental views of Senators Eagleton and Chafee.
XT. Supplemental views of Senator Nelson

I. Summary of Legislation

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As approved by the Committee, S. 1217 would —

( 1 ] Establish within the Department of Health, Education, and
Welfare a National Recombinant DNA Safety Regulation Com-
mission composed of elevent members appointed by the President :

(1)

S. Rep. 369-77 1

[741]

2

(2) Require that all recombinant DNA activities must be con-
ducted in facilities licensed by the Commission according to regu-
lations promulgated by the Commission ;

(3) Authorize the Commission to promulgate safety regulations
with respect to recombinant DNA activities, to prescribe the re-
quirements for licensure of facilities that are used for the conduct
of recombinant DNA activities, and to prescribe requirements for
the establishment and functions of Institutional Biohazards Re-
view Committees ;

(4) Authorize the Commission to prepare and transmit to the
Congress a comprehensive study that identifies the basic ethical
and scientific principles which should underlie the conduct, ap-
plications and use of recombinant DNA activities;

(5) Prescribe the conditions for which the Commission may
revoke, suspend or limit the license of a facility ;

(6) Authorize the Commission to conduct initial and annual
inspections of facilities where recombinant DNA activities are
being conducted, and prescribes on order and conditions for such
inspections ;

(7) Provide for administrative restraint, seizure or destruction
of hazardous products of recombinant DNA activities;

(8) Supersede any and all laws of state and their political sub-
divisions that establish or continue in effect any requirement with
respect to recombinant DNA activities; but authorizes the Com-
mission to provide for exemptions, to federal preemption if the
application from state and local political divisions meet the neces-
sary conditions ;

(10) Prescribe the procedures for the protection and disclosure
of data ;

(11) Require that a recombinant DNA project be approved by
the local Institutional Biohazards Committee ;

(12) Direct that no Federal funds be expended for more than
50 percent of the actual cost of construction of a facility'' for the
purpose of meeting the highest level of physical containment
requirements; and

(13) Authorize that such sums as necessary be appropriated
for fiscal 3'ears 1978, 1979, 1980, 1981, and 1982.

II. Background and Definition of the Issue

Recombinant DNA research enables scientists to isolate bits of
genetic material from an organism and recombine them with similar
material from related or unrelated plants or animal species. The
acronym DNA comes from the chemical name deoxyribonucleic acid,
the material that makes up all genes.

Research involving recombinant DNA has been a controversial issue
within the scientific community for some time. As people outside of
research circles have become more and more aware of the work, the
public has become involved. In a number of local communities around
the country, public actions have been taken. These actions have served
to highlight the controversy over genetic recombination and have also
provided a unique example of citizen participation in decison making
with regard to the conditions under which DNA activities should
be carried out.

[742]

3

The recombinant DNA research issue raises short-range and long-
range problems. The short-range problems concern protection of pub-
lic health and the environment from potentially hazardous organisms
produced in the course of DNA research. The long-range problems
concern the ethical implications of the man-made genetic recombina-
tions which such research may make possible.

In 1973, during the Gordon Conference on Nucleic Acids in New
England, a group of scientists indicated their concern about the po-
tential public health hazard posed by certain kinds of genetic research
involving recombinant DNA. This concern stemmed from the scien-
tists' realization that this new “biochemical tool'5 might accidentally
produce a recombinant molecule with hazardous characteristics. For
example, the scientists hjrpothesized that an accidental modification of
a molecule of an otherwise harmless organism might produce in that
organism the ability to cause cancer or some highly infectious
disease which might be highly dangerous if inadvertently released into
the environment. There were also questions raised about the ethical
and moral implications of genetic interventions in humans using tech-
niques derived from DNA methodologies.

As a result of these and other concerns, and as recommended in a
later letter to the National Academy of Sciences, an international
group of eminent scientists met to discuss the problem at Asilomar,
California, in 1975. From this meeting, the so-called “Asilomar Guide-
lines” for the safe conduct of recombinant DNA research emerged,
together with recommended restrictions on the conduct of certain more
hazardous types of this research. These restrictions on certain experi-
ments were reportedly voluntarily observed by scientists throughout
the country and in many parts of the world.

The original Asilomar guidelines were subsequently reviewed bv
the Special DNA Recombinant Molecule Advisory Committee of the
National Institutes of Health (NIH). The NIH guidelines covered
recombinant DNA research funded by the 17. S. Department of Health,
Education, and Welfare (DHEWi. After several months’ considera-
tion, the Advisory Committee further modified, and in some instances
strengthened, the original Asilomar guidelines. These new NIH guide-
lines were published in Part II of the Federal Register for July 7,
1976, to apply to all HEW-funded recombinant DNA research proj-
ects. Subsequently, a special interagency advisory group was estab-
lished. Its purpose was to coordinate all federally funded research with
recombinant DNA. Participating Federal agencies agreed to utilize
the guidelines established by NIH in order to have a uniform Federal
policy.

This Committee has been concerned for some time about the implica-
tions of recombinant DNA research activities and has conducted sepa-
rate hearings to examine various aspects of the issue since 1975. The
first Avas held in April 1975, very soon after the Asilomar Conference.
During that hearing, witnesses explained the state-of-the-art of recom-
binant DNA research at that time, highlighted some of the possible
risks associated with the research, and generally raised the issue of the
effect of public involvement in decisions relating to the conduct of sci-
entific research. The second hearing, held in September 1976, was an
oversight hearing on the implemenation of the NIH Recombinant
DNA Guidelines. The third hearing, in April 1977, addressed specific

[743]

4

legislative proposals involving recombinant DNA activities. The legis-
lative proposals before the subcommittee were bills S. 621 (introduced
by Senator Bumpers), S. 945 (introduced by Senator Metzenbaum),
and S. 1217 (introduced by Senator Kennedy) .

III. Hearings

The Committee has conducted public hearings on the issues sur-
rounding the recombinant DNA controversy on three different occa-
sions since 1975 :

1975

Witnesses were Stanley N. Cohen, M.D., of the Stanford University
Departemnt of Medicine ; Donald Brown, Ph. D., of the Department of
Embryology, Carnegie Institute of Washington, Baltimore, Md. ;
Willard Gaylin, M.D., President of the Hastings Institute of Society,
Ethics and the Life Sciences, Hastings-on- Hudson, N. Y. ; and Halsted
Holman, M.D. of the Stanford University School of Medicine.

Dr. Cohen, a physician and microbiologist who was involved in the
early development of the recombinant DNA research technology, pre-
sented an overview of state-of-the-art of that technology, including
potential benefits and risks. He summarized the history of the Asilomar
Conference. He described potential benefits that might result from
recombinant DNA research. He expressed concern that the research not
be impeded by the development of unnecessary and burdensome
requirements.

Dr. Halsted Holman, Chief of Immunology at Stanford School of
Medicine, applauded the scientists’ initiative in convening the Asilo-
mar Conference. He viewed that as the beginning of what he hoped
would be an expanded dialogue between the scientific community and
the public. He raised concerns about potential risks involved with
conducting research in an area with no previous experience and with
so many unknown factors.

Dr. Donald Brown, a researcher in embryology at the Carnegie In-
stitute of Washington, testified that scientists have the responsibility
to publicly explain their actions. He differed with Dr. Holman on the
degree to which the public should become a part of a formal decision-
making process. He expressed the view that the complexities of scien-
tific research necessitated scientific responsibility for research pro-
grams.

Dr. Willard Gaylin, a psychiatrist and the president of the Hastings
Institute of Society, Ethics and the Life Sciences, raised three main
issues concerning public participation in decision making relating to
scientific research. These questions were: Does the public have the
right to regulate scientific pursuit ? Can the public intelligently regu-
late science, that is, does it have the knowledge, the ability, and the
expertise? Should the public regulate science, and if so, what are the
appropriate methods of control ? He argued for a meaningful role for
the public in the decision-making process.

September 22, 1976

Witnesses included Dr. Donald S. Fredrickson, Director of the Na-
tional Institutes of Health ; Dr. Wilson K. Talley, Assistant Admin-
istrator for Research and Development of the Environmental Pro-

[744]

5

tection Agency; a panel made up of David Baltimore, Ph. D., of the
Massachusetts Institute of Technology; Halsted Holman, M.D., of the
Stanford University Medical School ; Norton D. Zinder, Ph. D., of the
Rockefeller University ; and Robert Sinsheimer of the California In-
stitute of Technology; another panel made up of C. Joseph Stetler,
President of the Pharmaceutical Manufacturers Association (PMA) ;
John G. Adams, Ph. D., Vice President for Scientific and Professional
Relations, PMA : and Sidney Udenfriend, Ph. D., Vice President and
Director of the Roche Institute of Molecular Biology; and Burke K.
Zimmerman, Ph. D., of the Environmental Defense Fund, Washing-
ton, D.C.

Dr. Fredrickson, Director of the NIH, described the potential risks
and benefits associated with recombinant DNA research, and noted
that the object of the NIH guidelines is to minimize potential risks. He
discussed the way the guidelines were developed and explained their
intent. Dr. Fredrickson indicated that :

. . . recombinant DNA research has strong potential in
medicine as well as in science and technology generally. In
medicine it is capable of providing hitherto unobtainable
knowledge of the organization and expression of genes in
health and disease. It possibly may also permit economical
production of important meclicinals. Potential benefits in ag-
riculture and industry include more abundant crops and syn-
thesis of industrially important biochemical agents such as
enzymes. There are risks, however, as well as potential bene-
fits in this new research. For example, bacteria with trans-
it] anted genes may prove hazardous to man or other forms
of life. Like many of the potential benefits, these risks remain
speculative, for there is still scanty evidence that genes from
one form of life can be expressed in any other form. We must
assume, however, that they may be. Thus, our present state
of knowledge dictates strict controls on this form of experi-
mentation. The NIH guidelines prohibit certain types of ex-
periments— those, for instance, that might produce disease
germs with increased resistance to antibiotics. Other experi-
ments will go forward under special safety conditions. The
guidelines have a definitive administrative framework for as-
suring that safety is an essential and integrated component
of research involving recombinant DNA molecules.

Dr. Talley, representing EPA, commented on the potential environ-
mental impact of the research :

Although the risks of recombinant DNA research appear
to be low, the consequences of an untoward event could be cat-
astrophic. Prudence dictates that we proceed with extreme
caution in this area of research.

The first panel consisted of Drs. Baltimore, Zinder, Sinsheimer and
Holman. They discussed the adequacy of the guidelines. The panel
focused on the appropriate role for the participation of representatives
of the public in recombinant DNA decision-making processes. The
panel discussed the idea of expanding the authority of the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research in this area. Dr. Burke Zimmerman, with the

[745]

6

Environmental Defense Fund, stressed his concern that the NIII
guidelines were limited solely to HEW-funded research. He also noted
the lack of enforcement provisions in the guidelines. Dr. Zimmerman
indicated :

... I think we have to consider the failings of human
nature, the fact that no matter how strict a set of safety pro-
cedures appears on paper, that people will always make mis-
takes. Somehow there has to be some sort of system of checks
and balances whereby laboratories are inspected periodically,
and the contents examined periodically. And as long as it is
agreed there is sufficient potential hazard, such as we must if
the NIH issues an unprecedented environmental impact state-
ment, then we must assume that wTe must never relax our
guard. I really feel that without strict regulation and strict
enforcement of those regulations, and especially if recombi-
nant DNA research proliferates, then we may well find a lot
of incidents such as those that I described with radioactive
materials taking place.

A panel of pharmaceutical industry representatives — Mr. Stetler,
Mr. Adams and Dr. Udenfriend — testified that their industry would
work with NIH to comply with the spirit of the NIH guidelines.
Mr. Stetler indicated :

For PMA’s part, we will exert every effort to keep apprised
of our member firms’ involvement in such research, and will
encourage cooperation with the scientific community and other
peer groups, including Government agencies, in adopting nec-
essary controls. It is too early to know the ultimate outcome of
much of this research, which has and will be undertaken. We
might predict, however, that recombination of DNA in a host
bacterial cell could produce quantities of medically needed
natural products such as hormones and other important drugs
by fermentation processes rather than by extraction of such
raw materials as pancreas or other tissues of animals and
plants . . . The application of this technology to basic re-
search of the disease process — more specifically to genetically
induced or associated disease — offers great promise . . . The
potential risks of recombinant DNA research and its commer-
cial application are well recognized ... It is important, we
believe, to emphasize that the present state-of-the-art and the
provisions of the NIH guidelines militate against research
and development that would pose such a threat to society.

April 6 , 1977

Hearings on recombinant DNA legislation were also held on April 6,
1977, and the witnesses were : (1) Dale Bumpers, U.S. Senator, Arkan-
sas; (2) Howard Metzenbaum, U.S. Senator, Ohio; (3) Michael Du-
Kakis. Governor, Massachusetts; (4) Brendan T. Byrne, Governor,
New Jersey; (5) Joseph A. Califano, Jr., Secretary, Department of
Health, Education, and Welfare; (6) Halsted R. Holman, professor
of medicine, Stanford Medical Center; (7) Norton Zinder, professor,
Rockefeller University; (8) Alexander Rich, professor of biophysics,
Massachusetts Institute of Technology; (9) Harlyn Halvorson, presi-

[7461

7

dent, American Society for Microbiology; (10) Daniel Hayes, former
mayor, Cambridge, Mass., and Chairperson, Cambridge Experimen-
tal Review Board; (11) David Clem, Member, Cambridge City Coun-
cil, Massachusetts; (12) Joseph Stetler, president, Pharmaceutical
Manufacturers Association; (13) Jacqueline Warren, Environmental
Defense Fund, Washington, D.C. ; (14) Pamela Lippie, Friends of the
Earth, Washington, D.C. ; (15) Jeremy Rif kin, Peoples Business Com-
mission, Washington, D.C.

The witnesses addressed the following proposals as outlined by the
Subcommittee Chairman :

(1) A national commission, with a majority of nonscientists,
might be the best vehicle to regulate recombinant DNA activities ;

(2) All recombinant DNA activities in this country should be
subject to the same regulations ;

(3) The regulatory process ought to be flexible and reflect new
knowledge or risks and benefits as it becomes available ;

(4) The ethical, legal and moral implications of this work
should be given careful scrutiny ; and

(5) Local communities should retain the right to be stricter
than the Federal regulations — including the right to prohibit re-
combinant DNA research in their own communities.

There was uniform agreement that recombinant DNA activities
have the potential to create novel forms of life and that the implica-
tions of these activities could have a profound impact upon the future
of mankind.

Some witnesses expressed the view that recombinant DNA research
should be banned. Others maintained that scientists should be free to
continue this research in an unrestricted manner. Proposals monitoring
the safety and application of recombinant guidelines would assure the
safety of the research. Others favored strict licensing procedures and
safety monitoring. Several witnesses felt that dissemination of infor-
mation would be necessary in order to keep the public informed and
allow them the opportunity to participate effectively in the decision-
making process.

The implications of various applications of recombinant DNA ac-
tivities were also debated. There were proponents of the idea that ge-
netic recombination could produce immeasurable benefits for mankind
including cures for disease; methods for producing needed drugs and
medications which are now expensive and time-consuming to make ;
manipulation of agricultural crops to allow them to fix nitrogen di-
rectly from the atmosphere instead of using expensive, energy-con-
suming methods for producing nitrogen-rich fertilizers ; and most im-
portantly to some, a significant advancement in man’s knowledge of
basic biological processes. Other witnesses raised serious questions
about potential risks associated with these activities and pointed that
benefits remain purely speculative at this time. One witness construct-
ed a doomsday scenario of what could happen if this work produced
new and dangerous organisms capable of damaging worldwide vege-
tation or microorganisms which could cause widespread epidemics be-
cause of the absence of host resistance. Some witnesses raised grave
concern about the possible unethical use of the recombinant technique
toward the end of human genetic engineering.

[747]

b

Tie Secretary of Health. Education, and Welfare. Joseph A.
Califano. Jr., stated that until additional necessary information on the
nature of the risks posed by recombinant DXA research becomes
available, the best course is to allow recombinant DXA research to go
forward, but only under strict conditions to assure safety. Most of
:he witnesses shared Secretary Califano's view of the need for safety
precautions. The Secretary also testified the challenge would be to
maximize potential benefits while minimizing potential risks. He also
supported the concept that states and local communities be allowed
to impose more stringent safety standards than those required by the
Federal Government.

Other witnesses, disagreeing with the Secretary, thotight a more
cautions approach, one which involved a more complete assessment
of risks prior to continuing the research, would be appropriate. Repre-
sentatives of the Peoples Business Commission and the Friends of the
Earth both stated that an immediate moratorium on all recombinant
DXA research should i - imposed until the public had an opportunity
to study and assess the situation.

Hr. Halsted R. Holman of the Stanford Medical School expressed
the view that less hazardous alternative techniques exist to accom-
plish the same o: jectives in many instances. He suggested these be
explored.

Dr. Xorton D. Zinder of Rockefeller Tniversity stressed the need
for flexible regulation in order to adjust the guidelines to the ever-
hanging scientific data base. He stated his belief that current XIH
guidelines would be acceptable to the majority of the nation's
seientists.

All witnesses agreed on the desirability of some public partici-
pation in decisionmaking on recombinant DXA activities. The degree
of appropriate public involvement was an area of disagreement. Basic
doubts were expressed concerning the capability of citizens to make
decisions based upon potential risks and benefits associated with such
advanced research. Governor Byrne of Xew Jersey advocated that
the Federal Government have the authority to permit state and local
communities to impose stricter regulations than the Federal regula-
tions under certain circumstances. In statins: his views. Governor
DvKakis of Massachusetts summed np his feelings by saying that it
would bo unwise for the Federai Government to say. ”We will pro-
tect you this far. You may not protect yourself further." Daniel
Hayes. Jr.. Chairman of the Cambridge Experimentation Review
Board, recommended that no P-4 level of research, as defined by the
XIH guidelines ( be allowed in a locality without the approval of the
local governing body.

Witnesses representing industry and academic research scientists
stated that a uniform national set of regulations would be important in
order to protect scientific research from arbitrary and capricious ruling
of local communities. Dr. Xorton Zinder stated that multiple laws
at state, city and neighborhood levels would only lead to confusion
and. ultimatelv. to inadvertent violations along with the unnecessary
obstruction of the ongoing process of basic research.

[748]

9

IV. Committee Views

I. Findings

The Committee believes that recombinant DXA techniques hold
great promise for biologic research. The products of this research may
have significant benefits for the health of the American people — by
helping scientists better understand the nature of specific diseases and
by facilitating the development of effective, inexpensive therapies
for those diseases. In addition, the Committee believes that recom-
binant DXA activities hold great promise in other areas, such as agri-
culture and industrial production. The Committee notes the important
implications for the development of nitrogen fixation.

The Committee is impressed with the process by which the national
debate over recombinant DXA research has been conducted. The
process has involved the continuing dialogue between members of
the general public and the scientists conducting the research. These
discussions have ben carried out in many communities throughout
the nation. They have served to bring scientists and members of the
public together. They have shown that citizens who take an active
interest in recombinant DXA policy can become informed and make
responsible judgments.

II. National Commission

The Committee believes that an expanded role for members of the
general public in the establishment, development and evaluation of
recombinant DXA policy is important. In order to build on what
has already been achieved in many communities throughout the na-
tion, the Committee believes that the regulation of the safety of recom-
binant DXA activities should be conducted by a national commission
which would bring members of the general public and scientists,
including those competent in recombinant DXA research, together
in a regulatory body. Such a vehicle assures that the process of regu-
lation will not be solely in the hands of those doing the research. The
committee believes that the X.I.H., with its mission of promoting the
development of research, is not the appropriate agency to regulate it.
Thus, the commission will consist of eleven members, six of whom are
not engaged in and have never been engaged in biological research and
who are members of the general public, including those who are quali-
fied by virtue of their training, experience or background in the fields
of medicine, law, ethics, education, physical, behavioral and social
sciences, philosophy, humanities, health administration, government
or public affairs. Five members of the commission will be individuals
who have been or are engaged in biologic research. Because of the
significance of this new approach of bringing members of the public
and members of the scientific community together in a joint effort
to regulate a potentially hazardous area of research so as to ensure
its safe conduct, the Committee believes that the commission members
should be appointed by the President and that the chairman should
be subject. to the advice and consent of the Senate.

The Committee believes that the talents of university researchers
must be tapped for service on this commission. Thus, it is not the intent
of the Committee to equate the receipt of scientific research grants with
a “financial interest” in recombinant DXA activities.”

[749]

10

The full responsibility for the promulgation of the rules and regula-
tions necessary to carry out all the sections of this act are the responsi-
bility of the national Commission.

The Committee believes that adequate monitoring is an important
component of this regulatory process and believes that to be effective
it must be carried out as a Federal responsibility.

It is tba Committee's intention that within 150 days of enactment
of this lvw. the existing XIH guidelines, for recombinant DXA activi-
ties must be followed, as a minimum, by all researchers in the country,
whether they be working for private or public institutions. Because
it will take a longer period to set up and implement the licensing proce-
dures. research may continue without a license until 265 days after the
enactment of this law. After that point, no recombinant DXA activities
may be conducted except in a licensed facility.

The Committee believes the 265-day period permitted for DXA ac-
tivities to continue without a license is sufficient time for the Commis-
sion to review and act upon applications for licenses for existing
activities. The Committee believes that the Commission should develop
practices and procedures to enable it to review new applications
promptly and fairly in the order they are received so that no unneces-
sary delay will be imposed in the licensing of DXA activities.

The Committee believes that the recombinant DXA research guide-
lines of XIH. as of the date of enactment of this law. are a fine begin-
ning point for the Xational Commission in its attempt to study and
develop physical and biological containment requirements for recom-
binant DXA activities. Thus, the first set of regulations to be promul-
gated by the Xational Commission may be no less stringent than the
requirements.

III. Institutional Bio-Hazai'd Review Committees

It is the Committee's intent that no licenses be issued to any recom-
binant DXA research facility unless there is an Institutional Bio-
Hazards Review Committee affiliated with the facility. This Institu-
tional Bio-Hazards Review Committee represents another point where
representatives of the general public can play an important role. It
is the Committee's intent, through the mandated requirements for
public participation on the Bio-Hazards Review Committees, to foster
continuing discussion between scientists and representatives of the
general public. Thus, the Committee believes that at least one-third of
the total members of each Institutional Bio-Hazards Review Commit-
tee must be individuals who are not and have never been professionally
engaged in biologic research. The Committee believes at least another
of the members should be employees of the owners and operators of
the facility who are qualified to provide a diversity of viewpoints
relevant to recombinant DXA activities and technology, biolosic safety
and engineering, and bio-hazard monitoring. It is not intended to ex-
clude anv category of employees from participation on Bio-Hazards
Review Committees or in any way to limit participation to those en-
gaged in recombinant DXA activities. The Committee leaves it to the
local institution to determine the composition of the rest of the mem-
ber? of the Bio-Hazards Review Committee.

The Committee wishes to point out that several facilities may be
served by the Bio-Hazards Review Committee if the facilities are part
of a single institution.

[750]

11

The Committee believes that the functions of the Bio-Hazards Re-
view Committee are essential if the public health and safety is to be
adequately protected. The Committee requires that these institutional
review committees review and grant prior approval to all recombinant
DNA projects to be undertaken by the licensed facility. In order to
be sure that there is continued maximum opportunity for exchange
between members of the scientific community, it is required that pub-
lic notice be provided to all communities in which research is going
on about each specific recombinant DNA project approved by the
Institutional Bio-Hazards Review Committee.

IV. Updating of regulations

In the Committee’s view, research with recombinant DNA may not
require the same degree of safety regulation in the future as it does
at the present. Certain regulatory provisions may need to be tightened,
certain may need to be loosened. As more becomes known about the
potential hazards of recombinant DNA research, changes in the safety
regulation of the activities may need to be made. It is certainly possible
that as more is known there will be less concern about hazards and
the need for any special safety regulation may disappear. On the other
hand, it is also conceivable that the need for more stringent safety
regulation will become evident. Thus, the Committee believes that
among the most significant aspect of this legislation is the require-
ment that the National Commission periodically review the regulations
governing recombinant DNA activity in order to adjust them to the
new information that becomes available. It is not the intention of the
Committee to perpetuate a regulatory apparatus which is not justi-
fied. The Committee intends to carefully carry out its oversight re-
sponsibilities to be sure that the continued safety regulation of recom-
binant DNA activities is necessary to protect the public health and
environment.

V. General licensing requirements

It is the Committee’s intent to require each separate facility to be
individually licensed. Single institutions which have multiple facilities
may submit their application on one application form to cover all fa-
cilities within the institution. The Committee has provided that the
license application contain a listing of the names, addresses and quali-
fications of persons authorized to engage in recombinant DNA activi-
ties, a detailed desci’iption of the proposed recombinant DNA projects
to be conducted in the facility, a description of the facility and ma-
terials to be used in connection with recombinant DNA activities, the
names of persons who own or operate the facility to be licensed, and
the location of each facility. This information is necessary for the
licensing and monitoring responsibilities of the National Commission
to be carried out.

Because of the uncertainty with regard to the potential hazards of
this research, the Committee is particularly concerned with the health
and safety of personnel working in the research facilities. Thus, it is
reouired that each person receive adequate training related to the
safety of recombinant DNA activities.

The Committee notes that many persons who may be involved in
recombinant DNA activities may not be experienced in microbiological
containment techniques and may not be accustomed to working with

[751]

12

potentially hazardous or infectious organisms. The Committee is con-
cerned that brief or inadequate training in such techniques may in-
crease the potential hazards posed by recombinant DXA activities
and therefore places strong emphasis on the responsibility of licenses
to ensure proper training of all personnel who will be working in the
facility.

TY. Additional Commission responsibilities
The Committee believes that in order to properly do its job, the
National Commission must be aware of the implications of the appli-
cation of advances resulting from recombinant DXA research for
individuals and for society; the laws and ethical principles govern-
ing the use and potential applications of recombinant DXA technol-
ogy ; the reasons why exemptions from F ederal preemption have been
applied for and granted to states and political subdivisions; the im-
plications of recombinant DXA activity within the field of genetic
engineering; alternative approaches for assuring the safest and most
appropriate applications and uses of recombinant DXA with regard
to the protection of researchers and workers, the general public, and
the environment ; possible alternatives to the definition in the law of
recombinant DXA: and the status and extent of recombinant DXA
activities conducted in exempted areas in the United States and in
areas outside the United States. Thus, the Committee has required,
within two years from the date of enactment, a comprehensive study
be conducted to provide this information. Becaiise a significant com-
ponent of the stud}’ focuses on the ethical and scientific principles
which should underlie the conduct, applications, and uses of re-
combinant DXA activity, the Committee believes that there is an
important role to be played by the National Commission for the Pro-
tection of Human Subjects of Biomedical and Behavioral Research.
The Human Subjects Commission should have the opportunity to
review and comment on the study proposal and the final report before
it is issued by the recombinant DXA safety regulation commission.

U II. License revocation, suspension or limitation
It is. however, unavoidable in those cases where a license is revoked
that all researchers, whether or not they are involved in the violation,
are penalized. The Committee sees no alternative to this because of the
inadvisability of individual licensing. However, license revocation is
restricted to cases of willful, knowing or negligent violations of the
most serious nature. For lesser violations, the Committee has provided
for suspension or limitation of licensure. The Committee has also
provided due process protection so as to assure that none of these ac-
tions are arbitrarily applied.

U II. Inspection , administrative restraint , seizure or destruction

Only in extreme cases is seizure or destruction of material justified.
In those instances and in order to fully safeguard the rights of the
users of the material and to be sure that no adverse public health
consequences result from the process of destruction of potentially
hazardous material, the Commission is required to establish proce-
dures which must include specific approval of any seizure or destruc-
tion of material by the Chairman of the Committee or his designee.

[752]

13

IX. Effect on State and local requirements

The Committee believes that there are certain circumstances under
which states and local political subdivisions should have the right to
petition the National Commission for exemption from Federal pre-
emption. The Committee is mindful of the difficult positions that
research institutions are in if they are not given a clear and consistent
set of procedures to follow, and is wary of the concerns expressed in
the hearings about multiple laws and standards to be met. Thus, state
and local preemption is viewed as a necessary exception and not the
rule. States and local communities are encouraged, however, to study
their own situations, to involve their communities in public dialogues,
and to see if an application for an exemption from preemption is
necessary.

The Committee has thus devised a procedure whereby exemptions
may be granted under certain circumstances. Under these procedures,
an exemption may be granted only if the Commission finds that all
the following conditions are met : the requirement of the state or po-
litical subdivision of the state applicable to recombinant DNA activi-
ties is more stringent than the national requirements and that it can
be administered so as to be more stringent than the national require-
ments ; the reason for the more stringent requirement must be relevant
and material to the health and environmental concerns of that state
or local community or to comparable compelling local conditions which
are neither health nor environmental concerns. In addition, the exemp-
tion cannot be granted unless the Commission find that compliance with
the exemption would not cause the activities to be in violation of any
other section of this act, or if the Commission finds that the local re-
quirement is arbitrary and capricious. The Committee believes that this
approach protects both the right of the states and local political sub-
divisions to become fully involved in the safety regulation of recom-
binant DNA activities in their own communities, and at the same time
protects researchers from unnecessary and harassing intrusions into
their research activities.

X. Registration of recombinant DNA projects

The Committee believes that full knowledge of projects being car-
ried out is necessary if regulation to ensure the safe conduct of recom-
binant DNA activities is to be effective. Therefore, it is required that
each Institutional Bio-Hazards Committee approve each recombinant
DNA project and each project be registered with the National Com-
mission. Only in this manner, the Committee believes, can the extent
and nature of recombinant DNA activities in the United States be
known.

XI. Relationship to other Federal laws

The Committee is concerned that conflicts and confusion may arise
between the Commission’s requirements and those of other Federal
agencies. These conflicts may cause a hardship on institutions conduct-
ing recombinant DNA activities because these institutions may not
know which requirements are to be complied with. Therefore, the
Committee designed this provision to overcome this potential prob-
lem and to eliminate duplication and inconsistencies. It is the Com-
mittee’s intent that the National Commission should be the lead agency

[753]

14

within the Federal Government with respect to health and safety re-
quirements for recombinant DXA activities. The Committee notes that
other Federal agencies have authority to establish general health
and safety requirements. However, in order to prevent a Federal maze
of overlapping and inconsistent requirements, the provision provides
for a procedure by which an orderly resolution of conflicts and dupli-
cation of requirements can be worked out. Generally, the health and
safety requirements of other Federal agencies will be preempted by the
requirements of the Commission when these requirements are incon-
sistent with or differ from those promulgated by the Commission. If
the Commission has not established a requirement, the requirement
instituted by another Federal agency should remain in force and no
application for an exemption from the Commission is necessary. For
example, a Federal agency may have a requirement pertaining to a
certain system for the health monitoring of all workers in all research
it supports, including recombinant DXA work. The Commission may
require a different system of health monitoring. In this case, the Com-
mission's requirements would prevail unless the other Federal agency
applies to the Commission and is granted an exemption.

The exception to this is OSHA. where the language continues to
follow the Administration's recommendation so that this agency will
continue to set standards to protect the health and safety of employees
who are within their jurisdiction now. The Commission will still be
able to take action with respect to unique protections for the health
and safety of employees affected by DXA research. The Committee
believes that the two agencies, the Xational Commission and OSHA,
should consult with each other to assure that there are no duplicative
or inconsistent requirements.

XII. Definitions

There was much discussion in the Committee about the definition
of recombinant DXA. In general, the Committee's definition treats any
novel occurrence resulting from use of the recombinant technique,
i.e.. an occurrence which cannot happen naturally, as recombinant
DXA. In addition, the definition includes DXA techniques which
present an unreasonable risk to the public health and environment,
whether or not that risk may also result from natural processes. Thus,
the Committee believes that the definition encompasses both novel
organisms and those presenting an unreasonable risk whether or not
the latter group is novel.

The burden of proof as to whether something should be exempted
from the definition of recombinant DXA for the purposes of this act
rests with the petitioner. The Commission then must make a deter-
mination that a given class or part of a class of experiments does not
present an unreasonable risk to the health of the persons exposed to
such molecules, to the environment, or to the health of the public. The
Committee believed that the benefit of the doubt ought to be given to
the public and that more activities rather than less should be covered
initially with the Commission making a class-by-class determination
of which activities are safe enough to be removed from the definition.
The Committee wishes to point out that this has nothing to do with
whether or not activities can be conducted: it simply relates to the
safety regulations which would apply to the activities.

[754]

15

DISCLOSURE OF DATA

The Committee takes note of the importance of appraising the pub-
lic of the current status of recombinant DNA activities. In addition,
the Committee recognizes the importance of protecting both the pro-
prietary interests of commercial institutions in the data submitted as
well as the intellectual and proprietary interests of researchers and
noncommercial research and educational institutions.

Because the Committee realizes that a delicate weighing of public
and private interests is involved here, the Committee has provided
due process protections.

When an extreme situation arises which would require the public
disclosure of this information in order to protect the health or environ-
ment against an unreasonable risk, the Commission may follow an
expedited due process procedure. The Committee believes that this
expedited procedure should only be used in situations which warrant
this exceptional action.

V. Votes in- Committee

Pursuant to section 133(b) of the Legislative Reorganization Act
of 1949, as amended, the following is a tabulation of votes in com-
mittee :

Motion by Senator Javits to establish the criteria by which the Com-
mission would grant exemptions to State or political subdivisions for
requirements with respect to recombinant DNA activities which are
different from or in addition to requirements applicable under the bill
carried by unanimous voice vote.

Motion by Senator Kennedy to order the bill favorably reported to
the Senate, as amended, carried as follows :

Yeas
Williams
Randolph
Pell

Kennedy
Eagleton
Cranston
Hathaway
Riegle
Javits
Schweiker
Stafford
Chafee
Hayakawa

VI. Congressional Budget Office — Cost Estimate

1. Bill number : S. 1217.

2. Bill title : Recombinant DNA Safety Regulation Act.

3. Purpose of bill : S. 1217 provides for the addition of Title XVIII
to the Public Health Service Act for the purposes of establishing
within the Department of Health, Education and Welfare a mecha-

Nays Not voting

Nelson Hatch

[755]

16

nism for regulating research activities involving recombinant deoxy-
ribonucleic acid. Among the provisions included in the bill are.:

A. Establishment of an 11 member National Recombinant DNA
Safety Regulation Commission to oversee research activities,
publish appropriate information, and to enter into contracts,
leases and cooperative agreements with appropriate agencies, pri-
vate persons, firms, etc.

B. Hiring of up to 50 inspector's to visit licensed facilities in or-
der to monitor compliance with safety regulations.

C. Appointment of technical advisory committees composed of
private citizens and Federal, state and local officials who will be
compensated for meeting time and travel expenses.

D. Enforcement of civil penalties for violations of rules re-
garding safety regulations in an amount not to exceed $10,000 for
each violation.

E. Protection of research facility employees from discrimina-
tion on the basis of their reporting safety violations to the Com-
mission or inspector.

F. Establishment of Institutional Biohazard Review Commit-
tees affiliated with each licensed facility engaged in DNA research.

4. Cost estimate :

Projected costs

Fiscal year :

1978

1979

1980

1981

19S2

Millions

_ $3. 6S
_ 3. 63
_ 3. SO
_ 3.99
4. 16

5. Basis for estimate :

Safety regulation commission costs

Fiscal year :

1978

1979

1980

1981

19S2

Millions
SO. 92
.99
_ 1. 05
_ 1. 11
L 17

S. 1217 cites that the 11 members of the Safety Regulation Commis-
sion be compensated at the annual rate of pay for grade GS-18 of the
Federal Employee General Schedule. The total estimate for salaries
was $552,000 per 11 members for FY 1978. In addition, 10 percent has
been added to this figure to cover employee benefits. Administrative
expenses (including clerical help, equipment, travel, etc.) have been
computed, based upon information from G.S.A., to be 60 percent of
the total salaries. The CBO Federal pay deflator was applied to deter-
mine outyear costs.

Costs of 50 inspectors

Fiscal year :

197S

1979

1980

1981

1982

Millions
_ $1. 76
_ 1.89
_ 2.00
. 2. 12
2. 24

The estimate for salaries and administrative expenses is based on the
assumption that 50 inspectors will travel t<y approximately 85 institu-

[756]

17

tions located throughout the United States. S. 1217 cites that the 50
inspectors be compensated at the annual rate of pay for GS-11 of the
Federal Employee General Schedule or approximately $20,000 for
fiscal year 1978. An additional 10 percent has been added to this figure
to cover employee benefits. Administrative expenses were also com-
puted to be 60 percent of the total salaries. The CBO Federal pay de-
flator was applied to determine outyear costs.

Part time ( fee for service) contract , individual consultant and technical
advisory committee' 8 costs

Fiscal year : Millions

1978 $1. 0

1979 — . 75

1980 . 75

1981 . 75

1982 . 75

The magnitude of individual consultant hours, contractual agree-
ments and technical advisory committees’ time and services is not in-
dicated in S. 1217. Thus, projected costs were based upon the experience
of the National Commission for the Protection of Human Subjects
in Clinical Research which is similar in composition and function.
After the first year, in which guidelines are set and personnel are
trained, continued periodic consultation services will be needed ; thus
it is estimated that although outlays in the first year will be greater,
there will be costs associated with the technical advisory committees
in subsequent years.

Penalties. — It is estimated that during fiscal year 1978 few or no
penalties will be incurred. However, after more laboratories are opened
and monitoring begins, violations with civil penalties may occur, but
it is impossible to determine the magnitude of this at present.

Employee protection. — The Occupational Safety and Health
Agency of the Department of Labor estimates that while investigatory
costs must be assumed by the National Recombinant DNA Safety
Regulatory Commission in the course of an employee-complaintant’s
action, these costs would be, nominal.

6. Estimate prepared by : Martha Jane Coury.

7. Estimate approved by :

C. G. Ntjckols
(For James L. Blum,
Assistant Director for Budget Analysis.)

VII. Regulatory Impact Statement

The Committee is aware of its responsibility to make a determina-
tion pursuant to Section 602 of Senate Resolution 4 of the regulatory
impact of legislation. Though the actual number of facilities, labora-
tories. and individuals involved with recombinant DNA activities is
unavailable, the Committee estimates that approximately 340 labora-
tories, in 85 facilities involving 1,700 scientists and technicians, would
be affected by the regulations to be promulgated pursuant to this bill.
With particular regard to Section 1817 of this bill which addresses
‘"disclosure of data,” the Committee determines that the regulations
to be promulgated pursuant to this bill would not have an undue effect
on personal privacy. While the regulations to be promulgated pursuant

S. Rep. 359—77 3

[757]

18

to this bill will have an impact on the amount of additional paper-
work the additional burden cannot be estimated.

VIII. Section-by- Section” Analysis — S. 1217

Section 1. Short title, names the act (S. 1217) the “Recombinant
DXA Safety Regulation Act.”

Section 2, Findings, provides that the Congress finds that —

(1) work with recombinant DXA. will improve the understand-
ing of basic biological processes ;

(2) recombinant DXA activities not only offer many potential
benefits, but also raise serious questions regarding potential
hazards :

(3) microorganisms containing recombinant DXA could spread
throughout the United States and to other countries, adversely
affecting human health, the environment, industry, and agricul-
ture;

(4) that the public health must be protected by requiring that
all recombinant DXA activities comply with standards of safety
and performance and that there must be a uniform Federal policy
regarding such standards ; and therefore

(5) it is necessary to establish a Commission, known as the
Xational Recombinant DXA Safety Regulation Commission, to
assure that recombinant DXA activities be conducted in a manner
to protect the public health and welfare of the American people ;
and

(6) all recombinant DXA activities are either in interstate
commerce or substantially affect such commerce so that regula-
tions and licensure by the Xational Recombinant DNA Safety
Commission are necessary to effectively regulate such commerce.

Section 3 amends the Public Health Service Act by adding after
title XVII the following new title :

Title XVIII — Xational Recombinant DXA Safety Regulation

Commission

ESTABLISHMENT OF COMMISSION

Section 1801 establishes within the Department of Health, Educa-
tion, and Welfare the Xational Recombinant DXA Safety Regulation
Commission. The Commission shall be composed of 11 members ap-
pointed by the President within 60 days from the date of enactment
of the Act. The President shall appoint six members of the Commis-
sion from individuals — (a) who are not and have never been profes-
sionally engaged in biological research, (b) who are members of the
general public including persons who are trained or have experience
in the fields of medicine, law, ethics, education, physical, behavioral,
and social sciences, philosophy, humanities, health administration,
government, or public affairs, and (c) who have no financial interest
in recombinant DXA activities. The President shall appoint five mem-
bers of the Commission from individuals who are or have been pro-
fessionally engaged in biological research, (b) who are qualified to
serve on the Commission by virtue of their training, experience or
background, and (c) who have no financial interest in recombinant

[758]

19

DNA activities. Full-time employees of the United States are not eligi-
ble to be appointed as a member of the Commission except in the case
where a chairman is reappointed as a member of the Commission. The
term of office of each member of the Commission is set at 4 years. How-
ever, the terms of office of members first taking office shall begin on
the date of appointment and shall expire as designated by the Presi-
dent at the time of their appointment : four at the end of 2 years, four
at the end of 3 years, and three at the end of 4 years. Any member
appointed to fill a vacancy occurring prior to the expiration of the
term for which his predecessor was appointed shall be appointed for
the remainder of that term. A member whose term has expired may
serve until his successor has been appointed. The Chairman of the
Commission will be appointed by the President by and with the ad-
vice and consent of the Senate, and the Chairman will be selected
from among the individuals appointed to the Commission.

The Secretary of HEW shall compensate the Chairman at a rate
not to exceed the annual rate of basic pay in effect for grade GS-18
of the General Schedule. Other Commission members will receive com-
pensation in an amount not to exceed the daily equivalent of a GS-18
pay schedule rate as well as reimbursement for travel and expenses.
The members of the Commission shall elect a Vice Chairman and
other such officers as deemed necessary from among themselves. The
Commission shall meet at the call of the Chairman or at the call of
the majority of its members. Consequently, seven members of the Com-
mission shall constitute a quorum as long as of the members present
four are members who are appointed as not having been professionally
engaged in biological research and three are members who are ap-
pointed as having been professionally engaged in biological research.
However, a lesser number may conduct hearings. No individual may be
appointed to serve as a member of the Commission if such individual
has served for two terms of 4 years each and vacancies on the Com-
mission shall not affect the authority and activities of the Commission.

DUTIES AND FUNCTIONS OF THE COMMISSION

Section 1802 of bill S. 1217 outlines the duties of the Commission as
follows :

(1) to direct and supervise all personnel of the Commission;

(2) to promulgate such rules and regulations as may be neces-
sary or appropriate to carry out the duties and functions invested
in the Commission ;

(3) to utilize with their consent with or without reimbursement
the services, personnel, and facilities of other Federal agencies
and of State and private agencies ;

(4) to enter into and perform such contracts, leases, cooperative
agreements or other transactions as may be necessary or appro-
priate in the conduct of the work of the Commission and on such
terms as the Commission may deem appropriate with any agency
or instrumentality of the United States or with any State, Terri-
tory or possession or any political subdivision thereof, or with
any public or private person, firm, association, corporation, in-
dependent testing laboratory, or institution ;

[759]

20

(5) to monitor compliance by the owners or operators ‘of a
licensed facility and persons authorized by license to engage in
recombinant DNA activities, in connection with a licensed fa-
cility ; and

(6) to undertake any other such activities that are incidental
to enforcement of provisions of this bill. The Commission shall
encourage through contracts the development of effective epide-
miological methods and technologies to monitor the production
and dissemination of recombinant DNA and the biological or
chemical products of recombinant DNA activities.

GENERAL REQUIREMENTS

Section 1803 of the bill S. 1217 states that effective 265 days after
the enactment of the bill no person may engage in recombinant DNA
activities in the States or in any area subject to the jurisdiction of the
United States unless such activities are conducted in a licensed fa-
cility. A license to authorize recombinant DNA activities to be con-
ducted in a facility shall be issued only upon an application made by
the persons who own or operate the facility in such a form and manner
as will be described by the Commission. The application for a license
shall include the following :

(A) The names of persons who own or operate the facility to
be licensed and the location of such facility ;

(B) The names, addresses and qualifications of persons to be
authorized by the license to engage in recombinant DNA activities
in connection with such facility ;

(C) A detailed description of the proposed recombinant DNA
projects to be conducted in the facility ;

(D) A detailed description of the facility and the materials to
be used in connection with recombinant DNA activities at the
facility ;

(E) Certification to the Commission that the facility and
recombinant DNA activities will meet all applicable requirements
prescribed by regulations under this bill and appropriate State
requirements if such requirements have been exempted by the
Commission.

(F) Certification to the Commission that all personnel who
will work in the facility will receive adequate training related
to the safety of recombinant DNA activities ;

(Gr) Certification to the Commission that persons who own or
operate such facility and the persons who are authorized by the
license to engage in recombinant DNA activities in connection' with
the facility agree to permit inspections of the facility and accept a
;duty to promptly report to the Commission any material changes
regarding any information submitted to the Commission under
this bill, and to promptly report such changes ; and

(H) Any additional information and assurances related to the
safety of recombinant DNA activities as the Commission- may
prescribe.

A license issued under this Section shall be valid for such period
(but not in excess' of 24 months) as the Commission may prescribe
and may be renewed in such manner as the Commission may prescribe.
Such a license shall contain such terms and conditions as the Com-

[760]

21

mission finds are necessary and appropriate to carry out the purposes
of the hill. The license shall specify the following :

( i ) The names and addresses of persons to be authorized by the
license to engage in recombinant DNA activities in connection
with a licensed facility ;

(ii) A description of the recombinant DNA activities author-
ized to be conducted in the facility ;

(Hi) Such additional information related to the safety of recom-
binant DNA activities as the Commission may prescribe.

A -license issued under this section shall be posted in a place in the'
facility which is readily accessible to the employees of the facility. The
license shall remain posted as long as the license is valid.

Upon application for the issuance or renewal of a license under this
-section, the Commission shall accept for information which is exempt
from disclosure, publish in the Federal Register a description of the
activities to be conducted, including a description of the sources' of the
biological materials to be used in the recombinant DNA activities, the
-physical and biological cotnainment requirements applicable to such
•activities, the objectives of such activities, the names of persons who
own or operate the facility to be licensed, and the location of the
facility.

An owner or operator of a facility may include in a single submission
for application for a license all of its facilities which it desires to be
licensed on the condition that such single submission contain all re-
quired information and certifications for each such facility to be
licensed, and all such facilities are within the same geographic locality.

The Commission shall develop a procedure to permit the modi-
fication of material information previously submitted in the initial
application for a license.

The Commission shall not issue an initial license unless it has
determined that prior to engaging in recombinant DNA activities
at the facility all of the requirements of this part will be met and'
the recombinant DNA activities to be conducted in the facility to be
licensed will be conducted in a manner as to protect the health of
the persons exposed to recombinant DNA, protect the environment,
and protect the health of the population of the surrounding com-
munity.

The Commission shall not issue a renewal of a license unless it is
determined that all of the requirements of this part have been met
and the recombinant DNA activities which have been conducted
in the facility which was previously licensed were conducted in a
manner as . to protect the health of the persons exposed to recombi-
nant DNA, protect the environment, and the population of the sur-
rounding community.

Effective 150 days after the date of enactment of this part, no person
may engage in recombinant DNA activities in the States or in any
area subiect to the jurisdiction of the United States unless the recom-
binant DNA activities comply with the regulations promulgated
under section 1804 or until a license under this section, 1803, has
been issued.

LICENSING REQUIREMENTS

Section 1804 of bill S. 1217 directs the Commission to promulgate
final regulations with respect to recombinant DNA activities, within

[761]

22

120 days of enactment of this act. During the 180-day period begin-
ning on the date of enactment, the regulations shall not be less
stringent than the recombinant DNA guidelines published in part
II of the Federal Register for July 7, 1976. The Commission must
promulgate regulations to implement the license requirements of this
section within 90 days after the date of the promulgation of final
regulations. These regulations shall —

(A) prescribe requirements for laboratory safety techniques
and requirements for monitoring to be followed by workers
engaged in recombinant DNA activities at licensed facilities ;

(B) prescribe the requirements for the maintenance of a
register at a licensed facility which will include the names,
addresses, and health records of all persons exposed to recom-
binant DNA in connection with the facility and the require-
ments for the monitoring by the owner or operator of the facility
of the health of each such person ;

(C) will provide requirements for the establishment, func-
tions and operations of Institutional Biohazards Review Com-
mittees affiliated with each facility. The composition of the
members on the committees will be as follows :

(1) at least one- third of the total members be individuals —

( a) who are not and have never been professionally en-
gaged in biological research ;

(b) who are qualified to serve as members of the gen-
eral public including persons who by virtue of their
t raining, experience or background in the fields of medi-
cine, law, ethics, education, physical, behavioral and so-
cial sciences, philosophy, humanities, health administra-
tion, government, or public affairs ;

(c) who have no financial interest in recombinant DNA
activities and who are not employees of the owners or
operators of such facility or of persons who have a finan-
cial interest; and

(d) who are residents of a local community which is
proximate to the facility ; and

(2) at least another one-third of the total members be
individuals — •

(a) who are employees of the owners or operators of
the facility ; and

(b) who are qualified through their expertise and train-
ing to provide a diversity of viewpoints relevant to re-
combinant DNA activities and technology, biological
safety and engineering, and biohazard monitoring.

All recombinant DNA projects to be undertaken by a facility must
be reviewed and approved by the Institutional Biohazards Review
Committees in order to assure the adequacy of the containment levels
(both biological and physical) and the safety of the procedures con-
templated. The committees must provide public notice to local com-
munities of all recombinant DNA projects that have been approved.
The regulations shall include requirements with respect to the re-
sponsibilities of the owners or operators of the facility to monitor
compliance of the facility and persons authorized by the license to
engage in recombinant DNA activities at the facility.

[762]

23

The Commission shall periodically review the regulations and pro-
mulgate such amendments as it determines necessary. Upon the pro-
mulgation of a proposed regulation, that would be more stringent than
an existing final regulation, the Commission must provide notice to
each State and political subdivision which has been granted an exempt
requirement. During the review and comment period for a proposed
regulation, the Commission will determine the effect of the regulation
on each exempt requirement. If the Commission finds that such regu-
lation, when final, would supersede any exempt requirement, the
Commission will provide notice to each State and political subdivision
which has an exempt requirement.

The Commission shall provide notice by sending, in writing and
through certified mail —

(i) a copy of the proposed or final regulation ;

(ii) a statement that such proposed or final regulations may
supersede the exempt requirement of the State or political
subdivision ;

(iii) a letter, signed by the Chairman of the Commission, in-
forming the state or political subdivision that the Commission has
made the determination, required by subparagraph (B), and the
effect of such determination on the exempt requirement of such
State or political subdivision;

(iv) a time schedule of when the proposed or final regulation
would become effective.

Within two years from the enactment of the Recombinant DNA
Safety Regulation Act, and updated on an annual basis thereafter, the
Commission, in coordination and consultation with and after review
by the National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research, shall prepare and transmit to
the Congress a comprehensive study that identifies the basic ethical
and scientific principles which should underlie the conduct, applica-
tions, and use of recombinant DNA activities which shall include :

(1) an analysis and evaluation of scientific and technological
advances in past, present, and projected recombinant DNA activi-
ties in the United States and other countries ;

(2) an analysis and evaluation of the implication of the appli-
cation of such advances, both for individuals and for society ;

(3) an analysis and evaluation of the laws and ethical prin-
ciples governing the use and potential application of recombinant
DNA technology ;

(4) an analysis of the exemptions given State and political sub-
divisions of States from Federal preemption, including an analy-
sis of the reasons therefor ;

(5) an analysis and evaluation of the implications of recombi-
nant DNA activities within the field of genetic engineering;

(6) an analysis of the advantages and disadvantages of ap-
proaches for assuring the safe and most appropriate applica-
tions and uses of recombinant DNA with regard to the protection
of researchers, workers, the general public, and the environment ;

(7) any proposals for changes in the definition of recombi-
nant DNA, as defined in section 1821(a) (2), which would lead to
greater protection of researchers, the public, and the environment
or would further the purposes of the Recombinant DNA Safety
Regulation Act, and its recommendations with regard thereto ;

[763]

24

(8) appropriate additional recommendations for the conduct
of recombinant DXA acivities particularly with respect to the
best approaches for assuring the safest and most appropriate
applications and uses of recombinant DXA and the appropriate
role of assessment of risk-benefit criteria in these determinations;

(fi) a determination of the status and extent of recombinant
DXA activities conducted in exempted areas in the United States
and in areas outside the United States, and an analysis of the
nature of regulation in other countries :

(10) a summary of the Commission's decisions with respect to
the facilities which have been licensed and the terms and condi-
tions attached thereto ; and

(11) a summary of actions taken to accomplish the purposes of
the Recombinant DXA Safety Regulation Act. the nature of the
difficulties encountered in enforcement, the number and nature of
penalties imposed during the preceding year and an evaluation
of their adequacy as deterrants to future violations, areas of re-
combinant DXA activity outside this part which might pose a
danger to researchers, the public or the environment, and any other
enforcement, administrative, or jurisdictional problems or ques-
tions encountered by the Commission in carrying out its duties
under this part and a recommendation for administrative or legis-
lative actions which would correct such problems.

LICENSE REVOCATION’. SUSPENSION OR LIMITATION

Section 1505 of bill S. 1217 outlines the conditions for license revoca-
tion. suspension or limitation. If at a facility the Commission finds that
a person authorized to engage in Recombinant DXA activities lias
knowingly, wifiingfully. or negligently —

1. maintained or submitted any required records, or data which
contain any false or misleading information,

2. engaged or attempted to engage or represent himself as en-
titled to perform any Recombinant DXA activities in a manner
not authorized by the license.

3. failed to register a Recombinant DXA project, prior to the
commencement of the project in accordance with section ISIS.

4. failed to comply with a request of the Conunission for any
information or materials the Commission finds necessary to deter-
mine the facility’s continued eligibility for a license or to evaluate
the possible health or environmental etf'ects of Recombinant DXA
activities, or

5. failed to comply with the request of the Commission or in-
spector. or other authorized agent of the Conunission to carry out
an inspection of the facility or its operations.

The Commission shall revoke the license of the facility for the re-
mainder of its term and may make the facility ineligible for a license
as a period of time as the Commission may determine.

If the Commission finds that a person authorized to engage in
Recombinant DXA activities in connection with a faeilitv has know-
ingly. willingfully or negligently —

1. failed to comply with any of the terms or conditions of the
license, or

[764]

25

2. has violated or aided or abetted in the violation of any re-
quirement established in this part,
the Commission may revoke, suspend or limit the license of the facility
for up to the remainder of its term and may make the facility ineligible
for a license or limited under whatever terms and conditions the
Commission finds appropriate.

INSPECTIONS

Section 1806 of bill S. 1217 outlines the procedures for inspections.
An inspector upon presenting appropriate credentials to the owner,
operator, or agent in charge of a facility at which the inspector has
reasonable grounds to believe that recombinant DNA activities are
being conducted or products of such activities are present or being
produced or in which records' pertaining to such activities or prod-
ucts are kept is authorized to enter that facility at reasonable times
and inspect at reasonable times and in a reasonable manner the facility
and all things at (or being transported to or from) that facility which
he has reasonable grounds to believe are involved with recombinant
DNA activities or the biological or chemical products of such activi-
ties and obtain appropriate samples of such things. The inspection
may extend to relevant equipment, materials, containers, records,
files, papers, processes, controls, facilities and all other things in the
facility bearing on whether the recombinant DNA activities are being
conducted or the biological or chemical products of such activities
are being used or possessed. Upon completion of an inspection an in-
spector shall before he leaves the facility inform the owner, operator,
or agent in charge of the facility of any conditions or practices which
in the inspector’s judgment constitute a violation of any of the require-
ments of this bill and the inspector shall post a written notice of such
violations in a place in the facility which is readily accessible to the
employees of the facility. Any information provided to the owner,
operator, or agent in charge of the facility by the inspector or posted
prior to the written final report shall not be legally binding on the
inspector or the Commission and shall not be a limitation on the
inspector or the Commission. The inspector shall prepare a written
final report of his findings and send it to the owner, operator, or agent
in charge of the facility within thirty days of the completion of the
inspection.

Upon receipt of the report the owner, operator, or agent in charge
of the facility shall post a copy of the report in the same place as the
initial written notice is placed. No inspector authorized under this
Section shall be required to obtain a search warrant or a warrant for
seizure from 'any judicial official prior to entering any facility and
conducting any inspection or seizure of recombinant DNA or the
biological or chemical products of recombinant DNA activities.

The Commission shall conduct initial and annual inspections in the
following order :

(A) first, all those facilities which are required to meet the
highest physical contaiment requirements established under
section 1804

(B) then, all those facilities which are required to meet the next
highest physical containment required under section 1804, and

[765]

26

(C ) then, if the Commission determines mat it is necessary those
facilities which are otherwise required to meet physical contain-
ment requirements under section 1804.

However, whenever a bonafide request for an inspection is made by
any person who has reasonable grounds to believe that is hazardous
product of recombinant DNA activities, an inspection shall be immedi-
ately conducted.

RECORDS, REPORTS, AND SAMPLES

Section 1807 of bill S. 1217 requires the person who owns or oper-
ates a licensed, facility to maintain and submit to the Commission such
records, reports and samples related to the safety of recombinant DNA
activities as the Commission may require.

PROHIBITED ACTS

Section 1808 of bill S. 1217 outlines the acts that are prohibited. The
following acts and their causation are prohibited :

(a) The failure to comply with section 1803 or the regulations
as promulgated thereunder.

(b) The refusal to permit access to or copying of any record
required by this part; or the failure to establish or maintain any
record or sample, or make any report, required under this part;
or the maintenance or submission of any required records, reports,
samples, or data which contain any false or misleading informa-
tion or that omit material information; or the refusal to permit
access to or verification or copying of any such required record.

(c) The refusal to permit entry or inspection as authorized by
section 1806.

(d) The failure to comply with any conditions or limitations
placed on a license granted under this part.

(e) The failure to register a recombinant DNA project, prior
to the commencement of such project in accordance with section
1818.

CIVIL PENALTIES

Section 1809 of bill S. 1217 outlines the provisions for the assess-
ment of Civil Penalties. Any person who knowingly, willfully, or
negligently violates the general requirements of the bill (section 1803)
or commits a prohibited act as outlined in section 1808 shall be liable
to the United States for a civil penalty in any amount not to exceed
$10,000 for each violation. Each day a violation continues shall con-
stitute a separate violation of section 1803 or a provision of section
1808.

(b) A civil penalty for a violation of section 1803 or a provision
of section 1808 shall be assessed by the Commission by an order made
on the record after opportunity (provided in accordance with this
subsection) for a hearing in accordance with section 554 of title 5,
United States Code. Before issuing such an order, the Commission
shall give written notice to the person to be assessed a civil penalty
and provide such person an opportunity to request, within 15 days of
the date the notice is received by such person, such a hearing on the
order.

[766]

27

Any person who requested a hearing respecting the assessment of a
civil penalty and who is aggrieved by an order assessing a civil penalty
and may file a petition within the 30-day period beginning on the date
the order was received for judicial review of such order with the
United States Court of Appeals for the District of Columbia Circuit
or for any other circuit in which such person resides or transacts
business.

Failure by any person to pay an assessment of a civil penalty will
result in the Attorney General recovering the amount assessed (plus
interest at currently prevailing rates) in an action brought in any
appropriate district court of the United States. The validity, amount
and appropriateness of the penalty shall not be subject to review.

ADMINISTRATIVE RESTRAINT, SEIZURE, OR DESTRUCTION

Section 1810 of bill S. 1217 outlines the procedure for the restraint,
seizure, or destruction of hazardous products of recombinant DNA
activities. If during an inspection under section 1806 an inspector finds
material he has reasonable cause to believe is a hazardous product of
recombinant DNA activities, he may order the material not to be
moved, may seize the material, or may destroy the material in accord-
ance with procedures adopted by the Commission. The inspector
must have prior approval of the seizure or destruction of material by
the Chairman or acting Chairman of the Commission. Unless the
owner of the material has agreed otherwise, within 7 days or such
action by an inspector, the Commission must begin civil action under
section 1811 with respect to the inspector’s action.

PROCEDURES FOR HAZARDOUS PRODUCTS OF RECOMBINANT DNA ACTIVITIES

Section 1811 of bill S. 1217 permits the Commission to commence
a civil action by process of libel or otherwise, in an appropriate dis-
trict court of the United States for the seizure or destruction of haz-
ardous products of recombinant DNA activities or for other appro-
priate relief to prevent its production, movement, or spread.

INJUNCTION AUTHORITY

Section 1812 of bill S. 1217 authorizes the district courts of the
United States to have jurisdiction over civil actions to restrain any
violations of sections 1803 and 1801 or provisions of section 1808. The
civil action may be brought in the U.S. district court for the judicial
district where the violation of sections 1803, 1804, or 1808 occurred or
the defendant is found or transacts business. In any civil action, proc-
ess may be served on a defendant in any judicial district in which the
defendant resides or is found. Furthermore, subpenas requiring at-
tendances of witnesses in any such action may be served in any judi-
cial district.

EFFECT ON STATE AND LOCAL REQUIREMENTS

Section 1813(a) declares that it is the express intent of the Congress
to supersede any and all laws of the States and political subdivisions
of States that established or continue in effect any requirement with

[767]

28

respect to recombinant DNA activities that is different from or any
addition to, any requirement applicable under this part except as pro-
vided in subsection (b). Subsection (b) states that upon receipt of an
application by a State or by a political subdivision of a State and after
notice and opportunity for a hearing on the record, the Commission
within 3 months from the date of the application, shall grant on exemp-
tion under this subsection only if it finds :

(A) that the requirement of a State or political subdivision of
a State applicable to recombinant DNA activities is, and will be
administered so as to be, more stringent than a requirement under
this bill ;

(B) the reason for the requirement is relevant and material to
the health and environmental concerns or comparable compelling
local conditions of such State or political subdivision ; and

(C) compliance with the requirement will not cause such activ-
ities to be in violation of any applicable requirement under this
title.

The Commission may not withdraw any such exemption for so long
as it finds that such requirement remains more stringent than a re-
quirement under this bill and continues to be so administered. The
Commission shall not grant an exemption under this subsection if the
Commission finds that such a requirement is arbitrary and capricious.

Subsection (c) provides that an application for an exemption may
be accompanied by any materials gathered by the applicant in its
legislative or administrative consideration of the existing or proposed
requirement. Furthermore, upon receipt of an application, the Com-
mission shall publish the application as a proposal in the Federal
Register, accompanied by a description of any support materials.

Subsection (d) states that it is not the intent of the Congress that
enactment of this will, promulgation of regulations under this bill
or compliance with this bill should be considered to in any reduce or
affect the common law or statutary rights or remedies of any person
regarding DXA activities.

JUDICIAL REVIEW OF LICENSING

Section 1814 of bill S. 1217 provides for judicial review of licensing.
Any person adversely affected by an action of the Commission under
section 1803 or 1805 concerning the issuance, revocation, suspension,
or limitation of a license, may obtain review of the action in the U.S.
court of appeals for the circuit in which that person resides or has
his principal place of business. The petition for review must be filed
within 60 days of the date notice of such action is received by the
person. Review shall conform to chapter 7 of title 5 of the United
States Code.

An action with respect to which review could have been obtained
under this section shall not be subject to judicial review in any other
proceeding.

EMPLOYEE PROTECTION

Section 1815 of bill S. 1217 prohibits an employee from discharging
any employee or otherwise discriminating against any employee with
respect to the employee^ compensation, terms, conditions or privileges
of employment because the employee has —

[768]

29

1. commenced, caused to be commenced or is about to commence
or cause to be commenced a proceeding under the act,

2. testified or is about to testify in any proceeding, or

3. assisted or participated or is about to participate or assist
in any manner in a proceeding or other action to carry out the
purpose of the act.

Any employee who believes that he has been discharged or other-
wise discriminated against by an employer in violation of this section
may file a complaint with the Secretary of Labor within 60 days after
the alleged violation occurs. Upon receipt of the complaint, the Secre-
tary (i.e. the Secretary of Labor) must notify the person named in
the complaint of the filing of the complaint; and, the Secretary must
conduct and complete within 30 days, an investigation of the violation
alleged in the complaint. Upon completion of the investigation, the
Secretary must notify in writing the complainant and the person
alleged to have committed the violation. Unless the proceeding on the
complaint is terminated by the Secretary on the basis of a settlement
entered into by the Secretary and the person alleged to have committed
the violation, the Secretary shall issue an order either providing the
prescribed relief or denying the complaint. An order of the Secretary
will be made on the record after notice and oppoidunity for agency
hearing. With the consent of the complainant, the Solicitor of Labor
will represent the complainant at the hearing. The Secretary may
not enter into a settlement terminating a proceeding on a complaint
without the participation and consent of the complainant.

If in response to a complaint, the Secretary determines that a vio-
lation has occurred, the Secretary shall order the person who commit-
ted the violation to take affirmative action to abate the violation and
reinstate the complainant to the complainant’s former position to-
gether with compensation (including back pay ) , terms, conditions and
privileges of the complainant’s employment. In addition, the Secre-
tary shall order compensatory damages and where appropriate exem-
plory damages. Moreover, the Secretary, at the request of the
complainant, shall assess against the person whom the order is issued
all costs and expenses including attorney’s fees incurred in bl’inging
the complaint.

Any person adversely affected or aggrieved by an order issued under
this section may obtain a review, conforming to chapter 7 of title 5
of the United States Code, of the order.

Whenever a person has failed to comply with an order, subsection
B of this section directs the Secretary to file a civil action in the U.S.
district court for the district where the violation occurred to enforce
the order. This section will not apply to any employee who, acting
without direction from the employee's employer, deliberately causes
a violation of this act.

ADMINISTRATIVE PROVISIONS

Section 1816 of bill S. 1217 authorizes the Commission for the pur-
pose of carrying out its duties to hold such public hearings, sit and act
at such times and places, take such testimony, and receive such evi-
dence as the Commission deems advisable.

The Commission may appoint and fix the compensation of such
employees as it deems advisable, however, in no event may the Com-
mission acooint more than 50 employees.

[769]

30

The Commission may procure, in accordance with the provisions of
section 3109 of title 5, United States Code, the temporary or inter-
mittent sendees of experts or consultants. Persons so employed shall
receive compensation at a rate to be fixed by the Commission, but not
exceeding for any day (including traveltime) the daily equivalent of
the effective rate for grade GS-18 of the General Schedule.

"While away from his home or regular place of business in the per-
formance of services for the Commission, any such person may be
allowed travel expenses, including per diem in lieu of subsistence, as
authorized by section 5703 (b) of title 5, United States Code, for per-
sons in the Government service employed intermittently.

The Commission may appoint technical committees composed of
Such private citizens and officials of the Federal, State, and local gov-
ernments as it deems desirable to advise it with respect to its functions
under the law subject to its jurisdiction, and to pay such members
(other than those regularly employed by the Federal Government)
while attending meetings of such committees, or otherwise serving
at the request of the Commission, Compensation, and travel expenses
-at the rate provided by section 5703(b) of title 5, United States Code
\vith respect to experts and consultants.

The Commission may publish and disseminate to the public such
reports, information, recommendations, and other material relating
to its functions, activities, and studies as it deems appropriate.

The Commission may enter into contracts for the purpose of carry-
ing out the provisions of this part.

The Commission may conduct and support training of personnel
of the Commission for purposes of carrying out the provisions of this
part.

The Commission shall not delegate any of the duties and functions
vested in it under this part, including the functions and duties re-
specting licensing and inspection, of facilities to any individual who
is not an employee of the Commission, or to any partnership, corpora-
tion, association, or to any Federal, State, or local government entity.

The Commission shall require such periods of time for the retention
and maintenance of records required under this part as the Commis-
sion determines are necessary and appropriate.

DISCLOSURE OF DATA

Section 1817 of bill S. 1217 declares that except as provided in sub-
section (b). any information obtained by the Commission or any
representative of the Commission which is exempt from disclosure
pursuant to subsection (a) of section 552, title 5 of the United States
Code, by reason of subsection (b) (4) of such section, shall not be dis-
closed bv the Commission or any officer or employee of the United
States. However such information —

(1) shall be disclosed to any officer or employee of the United
States —

(a) in connection with the Official duties of such officer or
employee under any law for the protection of health or the
environment, or

(b) for specific law enforcement purposes :

(2) shall be disclosed to contractors with the Commission and
employees of such contractors if in the opinion of the Commission

[770]

31

such disclosure is necessary for the satisfactory performance of the
work of such contractor and under such conditions as the Com-
mission may specify ;

(3) shall be disclosed if it is necessary to protect health or the
environment against an unreasonable risk of injury to health or
the environment ; or

(4) may be disclosed when relevant in any proceeding under
this part, except that disclosure in such proceeding shall be made
in such manner as to preserve confidentiality to the extent prac-
ticable without impairing the proceeding.

In submitting data under this part, a person may (a) designate the
data which such person believes is entitled to confidential treatment
under subsection (a), and (b) submit such designated data simul-
taneously but separately from other data submitted under this part.
A designation under this paragraph shall be made in writing and in
such manner as the Commission may prescribe. Except in the release
of information under paragraph (1), (2), (3), or (4) of subsection
(a), if the Commission proposes to release for inspection data which
has been designated under paragraph (1) (a) of any other informa-
tion which is exempt from disclosure pursuant to subsection (a) of
section 552 of title 5, United States Code by reason of subsection (b)
(4) of such section the Commission shall notify in writing and by
certified mail the person who submitted such data of the intent to
release such data. If the release of such data is to be made pursuant to
a request made under section 552(a) of title 5, United States Code,
such notice shall be given immediately upon appi’oval of such request
by the Commission. The Commission may not release such data until
the expiration of 30 days after the person who submitted such data has
received the notice required by this subparagraph.

The Commission may not release data under paragraph (3) of
subsection (a) unless the Commission has notified each person who
submitted such data of such release. Such notice shall be made in
writing, by certified mail at least 15 days before the release of such
data, except that if the Commission determines that the release of
such data is necessary to protect against unreasonable risk of injury to
health or the environment, such notice may be made by such means as
the Commission determines will provide notice at least 24 hours before
such release is made.

Any office or employee of the United States who by virtue of his
employment obtains information or has access to information the
disclosure of which is prohibited and who knows that the disclosure
of the material is prohibited willfully discloses the material in any
manner to any person not entitled to receive it, shall be guilty of a
misdemeanor and fined not more than $10,000 or imprisoned for one
year or both. Section 1905 of title 18 of the United States Code does not
apply to the publishing, disclosure, or making known of, or making
available information reported or otherwise obtained under this part.

REGISTRATION OF RECOMBINANT DNA PROJECTS

Section 1818 of bill S. 1217 directs the owner or operator of a licensed
facility to file with the Commission a Project Registration Statement
for each recombinant DNA project conducted in the facility.

[771]

32

The Project Registration Statement shall be filed in such form and
manner as the Commission may require prior to the commencement
of the project or. in the case of projects in progress on the date of
enactment, as part of the initial licensing application. The statement
shall contain all information regarding the project that the Commis-
sion. by rule, has determined is necessary for an informal assessment
of the precautions to be taken for assuring its safety and compliance
with the requirements.

CONSTRUCTION OF FACILTITES

Section 1819 of bill S. 1217 directs that no Federal funds shall be
expended for more than 50 percent of the actual cost (as determ’ ned
by the Commission) of construction of a facility for the pur ose of
meeting the highest physical containment requirements, established
under section 1804.

RELATIONSHIP TO OTHER FEDERAL LAWS

Section 1820 of this bill declares that notwithstanding any other
provision of law. no Federal agency may except as provided in sub-
section (b) and (c) of this section, impose or continue in effect any
safety or health requirement applicable to recombinant DXA activities
which is different from or in addition to. any requirement prescribed
pursuant to this bill.

Subsection (b) outlines the procedure that the Commission may
utilize in exempting existing or proposed requirements of a Federal
agency from this section. The Federal agency must apply to the Com-
mission for an exemption. The application and its supporting mate-
rials shall not be granted unless the Commission finds that the require-
ment is more stringent than a requirement under this bill and that it
is consistent with the policies of the Commission. The Commission
must make a determination with respect to an application within three
months of receiving the application. Subsection (c) declares that this
part shall not affect the authority of the Secretary of Health. Educa-
tion. and Welfare or the Secretary of Labor to exercise their respective
authority pursuant to the Occupational Health and Safety Act of
1970. Moreover, in exercising authority under this part, the Secretary
of Health. Education, and Welfare, the Commission or any persons
acting on their behalf shall not (for the purpose of section 4(b) (1) of
the Occupational Health and Safety Act of 1970) lie deemed exercising
statutory authority to enforce standards or regulations affecting occu-
pational health and safety.

DEFINITIONS

Section 1821 establishes for the purpose of this bill the following
definitions :

( 1 ) "DX A” means deoxyribonucleic acid.

(2) (A) "Recombinant DXA” means DXA molecules that consist of
different segments of DXA which have been joined together outside
any cell, and have the potential for entering and propagating in a
particular host cell, either autonomously or as an integrated part of
the cell's genome.

[772]

33

(B) Except as provided in subparagraph (C), the Commission-
shall, upon its finding and after final publication of such finding in the
Federal Register, exempt from the definition of subparagraph (A)
DNA molecules composed only of DNA segments from the following
sources : the host species, a related species which is known to exchange
genetic information in nature with the host cell, and/or a natural
parasite or plasmid of the host cell ; such composite DNA molecules
must propagate within the host cell by processes which are known to
occur naturally there.

(C) The Commission shall not exempt DNA molecules under sub-
paragraph (B) from the definition in subparagraph (A) unless the
Commission determines that such molecules do not present an unrea-
sonable risk to the health of the persons exposed to such molecules,
to the environment, or to the health of the public.

(3) “Recombinant DNA activities” means any research, study, in-
vestigation, experiment, or activity in connection with recombinant
DNA.

(4) “Hazardous product of recombinant DNA activities’* means a
biological or chemical product of recombinant DNA activities which
is handled, treated, or contained in such a manner as to pose a sig-
nificant risk to health or to the environment, as determined by the
Commission.

(5) “Commerce” means any activity which affects (1) commerce
between any State or territory and any place outside thereof, and
(2) commerce within the District of Columbia or within any other
territory not organized with a legislative body,

(6) “Commission” means the National Recombinant DNA Regu-
lation Commission, established under section 1801.

(7) “Construction of a facility” means a facility which is not owned
or operated by the United States and includes the construction, leas-
ing, acquisition, or maintenance of new buildings, including equip-
ment. laboratory installations, instrumentation, acquisition of land or
offsite improvements, and architects’ fees ; and the alteration, improve-
ment. leasing, acquisition, maintenance, expansion, major repair, re-
modeling, replacement, and renovation of existing buildings, includ-
ing equipment, laboratory installations, instrumentation, acquisition
of land or offsite improvements, and architects’ fees.

(8) For purposes of section 1801(b) (2) (C), “financial interest in
recombinant DNA activities” does not include wages or salary earned
by an employee of a nonprofit educational or research corporation.

(9) “State” means anv State or territory of the United States, in-
cluding the District of Columbia, the Commonwealth of Puerto Rico,
Guam, the Northern Mariana Islands, American Samoa, and the Vir-
gin Islands.

(lOj “District court of the United States” includes a similar or
equivalent court in any State.

(11) “Person” includes any individual, partnership, corporation,
association, or any Federal. State, or local government entity.

(12) “Inspector” means any qualified officer, employee, or agent
authorized by the Commission to carry out the appropriate provisions
of this part.

(13) “Name” shall include in the case of a partnership the name of
each partner, and in the case of a corporation the name appearing on

S. Rep. 359—77 4

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34

the corporation’s charter or certificate of incorporation and the name
of each principal corporated officer and director and the State of
incorporation.

(14) “Owns or operates” means any person who owns, operates,
leases, charters, or controls any facility used in recombinant DNA
activities.

(15) (A) “Facility” means a single building, including the labora-
tories, premises, records, reports, data, research materials, equipment,
instrumentation, products of recombinant DNA activities, and every-
thing contained in such building or adjacent thereto.

(B) For purposes of inspections authorized under this part, the
term “facility” includes in addition to subparagraph (A), any other
premises or building which contains records or reports related to
recombinant DNA activities.

(16) “Persons authorized by the license to engage in recombinant
DNA activities in connection with a licensed facility” means the prin-
cipal scientist and all other scientists who have responsibility for
directing a recombinant DNA project carried out in a facility licensed
under this part.

(17) “Recombinant DNA project” and “project” means any re-
search, study, investigation, experiment, act or closely related set of
acts that have a common research objective and utilize the same or
similar host/vector systems, and are carried out in a facility.

(18) “Federal agency” means each authority of the Government of
the United States, whether or not it is within or subject to review by
another agency, but does not include —

(A) the Congress; and

(B) the courts of the United States.

(19) “Persons exposed to recombinant DNA” means those persons
authorized by the license to engage in recombinant DNA activities in
connection with a licensed facility and all other persons who are ex-
posed to recombinant DNA or the biological or chemical products
thereof in connection with a licensed facility.

(20) For purposes of section 1803(b) (1) (B), “qualifications” means
experience and training solely related to assuring compliance with the
physical and biological safety requirements applicable to recombinant
DNA activities.

(21) “Political subdivision” and “local government” means a unit of
general local government as defined in section 601(1) (10) of Public
Law 93-203.

(22) For purposes of subsection (a) of section 1818, “appropriate
review and approval” means the review and approval by the Institu-
tional Biohazard Review Committee which is affiliated with a licensed
facility as required by section 1804(a) (2) (C) .

AUTHORIZATIONS

Section 1822 authorizes that such sums as necessary be appropriated
for fiscal years 1978, 1979. 1980. 1981, and 1982 for the purpose of carry-
ing out the provisions of the bill.

SEPARABILITY CLAUSE

Section 4 states that if any provision of this part is declared uncon-
stitutional or its applicability to any person or circumstance is held

[774]

35

invalid, the constitutionality of the remainder of the part of its ap-
plicability to other persons or circumstances shall not be affected.

IX. Changes in Existing Law

In compliance with subsection (4), of rule XXIX of the Standing
Rules of the Senate, changes in existing law made by the bill, as re-
ported, are shown as follows (existing law proposed to be omitted is
enclosed in black brackets ; new matter is shown in italic) :

Public Health Service Act, As Amended

****«••

“ TITLE XVIII— NATIONAL RECOMBINANT DNA SAFETY
REGULATION COMMISSION

“establishment of commission

“Sec. 1801. ( a ) ( 1 ) There is established within the Department of
Health , Education , and Welfare a commission to be known as the
National Recombinant DNA Safety Regulation Commission ( herein-
after in this title referred to as the 4 Commission ’) .

“(b) The Commission shall be composed of eleven members. The
President shall , within sixty days from the date of enactment of this
title, appoint —

“(1) Six members of the Commission from individuals —

“(A) who are not and have never been professionally en-
gaged in biological research ,

“(B) who are qualified to serve on the Commission as mem-
bers of the general public including persons who by virtue of
their training, experience, or background in the fields of
medicine , law, ethics, education , physical , behavioral, arid
social sciences, philosophy, humanities, health administra-
tion, government , or public affairs , and
“(C) who have no financial interest in recombinant DNA
activities.

“ (2) Five members of the Commission from individuals —
“(A) who are or have been professionally engaged in bio-
logical research ,

“(B) who are qualified to serve on the Commission by
virtue of their training, experience , or background , and
“(C) who have no firumcial interest in recombinant DNA
activities.

“(c) Except as provided in subsection (e) (If) , no individual who is
a full-time employee of the United States may be eligible to be ap-
pointed as a member of the Commission.

“(d) The term of office of each member of the Commission shall be
four years; except that — -

“ (1 ) the terms of office of members first taking office shall begin
on the date of appointment and shall expire, as designated by the
President at the time of their appointment, four at the end of two
years, four at the end of three years, and three at the end of four
years;

[775]

36

“ (2) any member appointed to fill a vacancy occurring prior to
the expiration of the term for which his predecessor was appointed
shall he appointed for the remainder of such term; and

“( 3 ) a member whose term has expired may serve until his suc-
essor has been appointed.

“(e) ( 1 ) The Chairman of the Commission (hereinafter in this port
referred to as the ‘Chairman*) shall be appointed by the President, by
and with the advice and consent of the Senate, and the Chairman shall
be selected from among those individuals appointed under subsec-
tion (b) ( 1 ) .

“ (2) The Chairman shall serve as a full-time employee of the Com-
mission and shall administer the dolly activities of the Commission.

"{3) The Secretary of Health . Ed ucation . and TF elf are ( hereinafter
in this title , except section 1815, referred to as the ‘ Secretary ’) shall
compensate the Chairman at a rate not to exceed the annual rate of
basic pay in effect for grade GS-18 of the General Schedule , without
regard to the provisions of title 5, United States Code , governing ap-
pointments in the competitive service, and the provisions of chapter 51
and subchapter III of chapter 53 of such title , relating to classification
arud General Schedule pay rates.

“(f) Subsection (c) shall not apply in the case where a chairman is
reappointed as a member of the commission.

“(f) ( 1 ) The members of the Commission shall elect a Vice Chair-
mam and such other officers as deemed necessary from among
themselves.

“(2) Seven members of the Commission shall constitute a quorum
as long as of the members present four are members who were ap-
pointed under paragraph (1) of subsection (b) and three are members
who were appointed under paragraph (2) of such subsection, but a
lesser number may conduct hearings.

“( 3 ) The Commission shall meet at the call of the Chairman or at
the call of o. majority of its members.

“ (I) No individual may be appointed to serve as a member of the
Commission, if such individual has served for two terms of four years
each.

“(•5) A vacancy on the Commission shall not affect the authority or
activities of the Commission.

“(g) Members of the Commission shall receive compensation at a
rate to be fixed by the Secretary , but not exceeding far any day ( includ-
ing traveltime ) the dally equivalent of the effective rate for GS-18 of
the General Schedule while engorged in the actual performance of the
duties vested in the Commission, and shall be reimbursed for trowel,
subsistence, o;rd other necessary expenses incurred in the performance
of such duties.

“duties and functions of the commission

“Sec. 1802. (a) (1) (A) The Commission is authorized —

“( 1 ) to direct and supervise oil personnel of the Commission;

“ (2) to 'promulgate such rules and regulations as may be neces-
sary ar appropriate to carry out the duties and functions vested '
in it by this title;

“(3) to camp out the provisions of this title;

[776]

37

“ (h) except as provided in section 1816 (/) , to utilize, with their
■consent, the services, personnel, and facilities of other Federal
agencies and of state and private agencies and instrumentalities
with or without reimbursement therefor;

“(5) except as provided in section 1816(f) , to enter into and
'perform such contracts, leases, cooperative agreements, or other
transactions as may be necessary or appropriate in the conduct
of the work of the Commission and on such terms as the Commis-
sion may deem appropriate, with any agency or instrumentality
of the United States, or with any state, territory or possession, or
■any political subdivision thereof , or with any public or private
person, firm, association, corporation , independent testing labora-
tory. or institution ;

“(<?) to monitor compliance by the owners or operators of a
licensed facility and persons authorized by a license to engage in
recombinant DNA activities in connection with a licensed facility
with the requirements of this title ; and

“(7) to undertake such other activities as are incidental to en-
forcement of the provisions of this title.
u(b) The Commission shall encourage through contracts, the de-
velopment of effective epidemiological methods and safety monitoring
technologies to identify and follow the production and dissemination
of recombinant DNA and the biological or chemical products thereof.

u(c) The Commission shall encourage on a continuing basis studies
designed to assess the risks to human health and the environment
which may be presented by recombinant DNA activities. The Com-
mission shall insure that the findings of such studies shall be main-
tained and readily accessible to all interested persons.

'‘'‘GENERAL REQUIREMENTS

uSec. 1803. (a) Effective two hundred and sixty-five days after the
date of the enactment of this title, no person may engage in recorri-
binant DNA activities in the States or in any area sub feet to the
jurisdiction of the United, States unless such activities are conducted
in a facility which is licensed under this part authorizing such activi-
ties to be conducted in such facility.

li (b)(1) A license to authorize recombinant DNA activities to be
conducted in a f acility shall be issued only upon an application made
by persons who own or operate a facility in such form and manner
as may be prescribed by the Commission. An application for such a
license shall include —

“(J.) the names of persons who own or operate the facility
to be licensed and the location of such facility ;

“ (B ) the names, addresses and qualifications of persons to be
authorized by the license to engage in recombinant DNA activities
in connection with such facility ;

“ (C) a description of the proposed recombinant DNA projects
to be conducted in such facility;

“ (D) a description of such facility and materials to be used
in connection with recombinant DNA activities at such facility y

“ (E) certification to the Commission that such facility and such
activities will meet all applicable requirements prescribed by reg-

[777]

38

motions under section 1804, and appropriate State and local gov-
ernmental requirements if such requirements have been exempted
by the Commission under subsection (b) of section 1813 ;

li (F) certification to the Commission that all personnel who
will work in such facility will receive adequate training related
to the safety of recombinant DNA activities;

“(G) certification of the Commission that persons who own or
operate such facility and persons who are authorized by the
license to engage in recombinant DNA activities in connection
with such facility agree to —

“ ( 1 ) permit inspections of such facility in accordance with
the provisions of section 1806 ; and
“ (2) accept a duty to promptly report to the Commission
any material changes regarding any information submitted
under this title and to promptly report such changes : and
“ (II) such additional information and certification related to
the safety of recombinant DNA activities as the Commission may
prescribe .

“ (2) (A) A license issued under this section shall be valid for such
period ( but not in excess of twenty-four months ) and may be renewed
in such manner as the Commission may prescribe. Such a license shall
contain such terms and, conditions as the Commission finds are neces-
sary and appropriate to carry out the purposes of this title and shall
specify —

“( i ) The names and addresses of persons to be authorized by
the license to engage in recombinant DNA activities in connection
with the licensed facility;

“(ii) a description of the recombinant DNA activities author-
ized to be conducted in such facility ; and

11 (Hi) such additional information related to the safety of re-
combinant DNA activities as the Commission may prescribe.

11 (B) A license issued under this section shall be posted in a place
in the facility which is readily accessible to all employees of such fa-
cility. Such licernse shall remain so posted as long as such license is
valid.

“(c) Upon receipt of an application for the issuance or renewal of
a license under this section, the Commission shall publish in the Fed-
eral Register a detailed description of the activities to be conducted,
including a description of the sources of the biological materials to be
used in such activities , the physical and biological containment re-
quirements applicable to such activities , the objectives of such activi-
ties, the names of persons who own or operate the facility to be licensed ,
and the location of such facility.

“(d)(1) Any owner or operator of a facility may include in a,
single submission for application for a license under this section all
of its facilities which it desires to be licensed on the condition that
such single submission contain all required information and certifica-
tions for each such facility to be licensed and all such facilities are
within the same geographic locality.

“(2) The C ommission shall develop a procedure to permit the mod-
ification of material information previously submitted under subsec-
tion(b)(1).

[7781

39

“(e) The Commission snail not issue an initial license unless it Tias
determined that , 'prior to engaging in recombinant DNA activities
at the facility —

“(i) all the requirements of this title will be met; and

“(2) the recombinant DNA activities to be conducted in the
facility to be licensed will be conducted in a manner as to pro-
tect the health of the persons exposed to recombinant DNA , pro-
tect the environment , and protect the health of the population
of the surrov/nding community.

“ (/) The Commission shall not issue a renewal of a license unless
it has determined that —

“(1) all the requirements of this title have been met ; and

“(2) the recombinant DNA activities which have been con-
ducted in the facility , which teas previously licensed under this
title , were conducted in a manner as to protect the health of
the persons exposed to recombinant DNA , protect the environ-
ment, and protect the health of the population of the surround-
ing community.

“ (g) Effective one hundred and fifty days after the date of enact-
ment of this title , no person may engage in recombinant DNA activi-
ties in the States , or in any area subject to the jurisdiction of the
United States unless such activities comply with the regulations
promulgated under section 1801(a) (1) or until licensed under section
1803.

“ LICENSING REQUIREMENTS

“Sec. 180 Jj. (a) For purposes of protecting the health and safety of
individuals who work with recombinant DNA , the health and safety
of the public at large , and the integrity of the environment , the Com-
mission shall —

“(1) no later than one hundred and twenty days after the date
of enactment of this title , promulgate , as final , regulations which
prescribe physical and biological containment requirements for
recombinant DNA activities which during the, one hundred and
eighty day period beginning on the date of the promulgation of
regulations u/nder this paragraph shall be no less stringent than
the physical and biological containment requirements prescribed
by the recombinant DNA Research Guidelines of the National In-
stitutes of Health which are in effect on the date of enactment of
this title;

“(2) no later than ninety days after the date of promulgation
of final regulations under paragraph (1) , promulgate regulations
to implement the license and other requirements prescribed by this
title. Including the requirements promulgated under paragraph
(1) of this subsection , amended , if necessary , the regulations
shall —

“(A) prescribe requirements respecting laboratory safety
techniques and monitoring to be followed by persons author-
ized by a license to engage in recombinant DNA activities in
connection with the licensed facility , including —

“ (i) the laboratory safety training to be given to , and
the safety techniques to be followed by , personnel in-
volved in such activities ,

[779]

40

“(ii) the monitoring systems which may include
periodic health screening to protect against accidental
exposure or accidental exposure and other hazards to the
health of all personnel who may he affected in such ac-
tivities. and

“(mj the type and form, of information to he given to
such personnel concerning the nature of the health risks
involved in such activities;

“(B) prescribe requirements respecting —

“(i) the maintenance of a register at a licensed facility
which shall include the names, addresses and health rec-
ords of persons exposed to recombinant DXA in connec-
tion with the licensed facility: and
“(ii) the monitoring hy the person who owns or op-
erates the facility of the health of each such person;
“(C) prescribe requirements respecting the establishment ,
functions, arid operations of Institutional Biohazard Review
Committees affiliated with each facility licensed pursuant to
section 1803. Such regulations shall contain requirements —
“(i) prescribing that the composition of the members
on such committees be as follows —

“(I) at least one-third of the total members be
individuals —

“(a) who are not and have never been pro-
fessionally engaged in biological research ;

“(b) who are qualified to serve as members
of the general public including persons who by
virtue of their training, experience or back-
ground in the fields of medicine, law. ethics, ed-
ucation... physical, behavioral and social sciences ,
philosophy, humanities, health administration ,
government, or public affairs:

“(c) who have no financial interest in recom-
binant DXA activities and who are not employ-
ees of the owners or operators of such facility or
of persons who hare a financial interest ; and
“ ( d) who are residents of a local community
which is proximate to the facility: and
“(II) uf. least another one-third of the total members
be individuals —

“(o) who are employees of the owners or opera-
tors of the facility; and

“(b) who axe qualified through their expertise and
training to provide a diversity of viewpoints rele-
vant to rer-ombinant DXA activities and technology .
bioloaicol safety and engineering, and biohazard
monitoring.

“(ii) providing for the review and approval by such com-
mittees of all recombinant DXA projects to be undertaken by
a facility licensed under section 1803. Such review and ap-
proval shall include the adequacy of the containment level
and the safety of the procedures contemplated to assure com-
pliance with the requirements of this title.

[780]

41

“(Hi) providing for public notice to the local communities
by such committee of each recombinant DNA project ap-
proved by such committees.

“(D) prescribe requirements respecting the possession and han-
dling of recombinant DN A and the biological or chemical products
of recombinant DN A activities outside of a. licensed facility or
in commerce ;

“ (E) prescribe requirements respecting records and reports,
related to the safety of recombinant DN A activities , to be main-
tained and submitted by —

“ (i) persons who own or operate the facility licensed under
section 1803; and

u(ii) persons who are authorized by' a license to engage in
recombinant DNA activities in connection with the licensed
facility ;

“(F) prescribe requirements respecting the responsibilities of
owners or operators of a facility licensed under section 1803 to
•monitor compliance of the facility and, persons authorized by the
license to engage in recombinant DNA activities in connection
with the licensed facility with the requirements of this title; and

“(G) include such other provisions related to the safety of re-
combinant-DN A activities as the Commission determines to be
necessary for carrying out the provisions of this title.

“(b)(1) The Commission shall periodically review regulations
promulgated under subsection (a) and promulgate' such amendments
to such regulations as it determines to be necessary.

“ (2) (A ) Upon promulgation of a proposed regulation which would
be more stringent than an existing f had regulation promulgated under
Subsection (a), the Commission shall provide notice, in accordance
with subparagraph (C) . to each state and political subdivision which
has been granted an exempt requirement.

“(B) During the review and comment period for such proposed
regulation, the Commission shall make a . determination as to the effect
of such regulation , when final, on each exempt requirement. If the
Commission determines that such regulation would , when final, super-
cede any exempt requirement, the Commission shall provide notice , in
accordance with subparagraph (C), to each state and political sub-
division which has an exempt requirement.

“(C) The Commission shall provide notice, as required under sub-
paragraphs (A) and (B) by sending, in writing and through certi-
fied maid —

“ (i) a copy of the proposed or final regulation;

“(ii) a statement that such proposed or final regulation may
supersede the exempt requirement of the state or political
subdivision;

“ (Hi) a letter, signed by the Chairman of the Commission, in-
forming the state or political subdivision that the Com/mission
has made the determination, required by subparagraph (B), and
the effect of such determination on the exempt requirem.ent of such
State or political subdivision;

“(iv) a time schedule of when the proposed or final regulation
would become effective.

[781]

42

U(D) For purposes of this paragraph , ‘ exempt requirement ’ means
a requirement of a state or political subdivision which has been exempt
under subsection (5) of section 1813.

“(<?) Within two years from the enactment of the Recombinant
BN A Safety Regulation Act , and updated on an annual basis there -
after , the Commission , in coordination and consultation with and after
review by the National Commission for the Protection of Human Sub -
jects'of Biornedical and Behavioral Research, shall prepare and trans-
mit to the Congress a comprehensive study that identifies the basic
ethical and scientific principles which should underlie the conduct ,
applications , and use of recombinant BN A activities which shall
include :

“ (1) an analysis and evaluation of scientific and technological
advances in past, present, and projected recombinant BN A ac-
tivities in the United States and other countries ;

“ (2) an analysis and evaluation of the implication of the appli-
cation of such advances , both for individuals and for society;

“ (3) an analysis and evaluation of the laws and ethical prin-
ciples governing the use and potential application of recombinant
BN A technology ;

“ (If) an analysis of the exemptions given State and political
subdivisions of States from Federal preemption , including an
analysis of the reasons therefor;

“ (5) an analysis and evaluation of the implications of recom-
binant BN A activities within the field of genetic engineering ;

u(6) an analysis of the advantages and disadvantages of ap-
proaches for assuring the safest and most appropriate applica-
tions and uses of recombinant BN A with regard to the protection
of researchers , workers, the general public, and the environment;

“ (7) any proposals for changes in the definition of recombinant
BN A, as defined in section 1821 (a) {2), which would lead to
greater protection of researchers, the public , and the environment
or would further the purposes of the Recombinant BN A Safety
Regulation Act, and its recommendations with regard thereto ;

“(8) appropriate additional recommendations for the conduct
of recombinant BN A activities particularly with respect to the
best approaches for assuring the safest and most appropriate ap-
plications and uses of recombinant BN A and the appropriate role
of assessment of risk-benefit criteria in these determinations;

“( 9 ) a determination of the status and extent of recombinant
BN A activities conducted in exempted areas in the United States
and in areas outside the United States, and cm analysis of the
nature of regulation in other countries ;

“ (10) a summary of the Commission's decisions with respect to
the facilities which have been licensed and the terms and condi-
tions attached thereto; and

11 (11) a summary of actions taken to accomplish the purposes
of the Recombinant BN A Safety Regulation Act, the nature of
the difficulties encountered in enforcement , the number and nature
of penalties imposed during the preceding year and cm evaluation
of their adequacy as deterrents to future violations, areas of re-
combinant BN A activity outside this title which might pose a
danger to researchers, the public or the environment, and any other

[782]

43

enforcement , administrative , or jurisdictional 'problems or ques-
tions encountered by the Commission in carrying out its duties
under this title and a recommendation for administrative or legis-
lative actions which would correct such problems.

“LICENSE REVOCATION, SUSPENSION , OR LIMITATION

“Sec. ±805. (a) If the Commission finds, after reasonable notice and
opportunity for a hearing to a person who owns or operates a f acidity
licensed under this title, that such person or a person authorized to
engage in recombinant DNA activities in connection with such
faculty —

“(1) has knowingly i willfully, or negligently maintained or
submitted any required records, reports, or data which contai/n
any false or misleading information or which omit any material
information,

“(2) has knowingly , willfully, or negligently engaged or at-
tempted to engage or represented himself as entitled to perform
any recombinant DNA activities in a manner not authorized by
the license,

“ (3) has knowingly, willfully, or negligently failed to register
a recombinant DNA project, prior to the commencement of such
project in accordance with section 1818,

“ (If) has knowingly , willfully , or negligently failed to comply
with a request of the Commission for any information or mate-
rials the Commission believes necessary to determine the facility"1 s
continued eligibility for its license or to evaluate the possible
effects on health or the environment of recombinant DNA activi-
ties, or

“(5) has knowingly, willfully, or negligently failed to comply
with a request of the Commission, an inspector, or any other duly
authorized agent of the Commission, to inspect any portion of the
facility, its operations, or its records, which are related to re-
combinant DNA activities.

the Commission shall revoke the license of such facility for the re-
mainder of its term and may make any facility owned or operated by
such person ineligible for a license under this title for such period of
time as the Commission may determine.

“(b) If the Commission finds, after reasonable notice and oppor-
tunity for a hearing before the Commission to a person who owns or
operates a facility licensed under this title , that such person or a person
authorized to engage in recombinant DNA activities in connection
with such facility —

"(1) has knowingly, willfully, or negligently failed to comply
with any of the terms or conditions of the license, or

“(2) has knowingly, willfully, or negligently violated or aided
and abetted in the violation of any requirement established u/nder
this part,

The Commission may revoke, suspend, or limit the license of such
facility for up to the remainder of its term and may make any facility
owner or operated by such person ineligible for a license under this
title or limited under whatever terms and conditions it finds
appropriate.

[783]

44

“INSPECTION'S

“Sec. 1806. (a) For purposes of carrying out the provisions of this
title , an inspector, upon- presenting appropriate credentials to the
owner, operator, or agent in charge of a facility at which the inspec-
tor has reasonable grounds to believe that recombinant DNA activi-
ties are being conducted or the biological or chemical products of such
activities are present. are being produced, or in which records pertain-
ing to such activities or products are kept is authorized to enter that
facility at reasonable times, and inspect, at reasonable times and in a
reasonable manner . the facility oral all things at {or being traris-
ported to err from) that facility which he has reasonable grounds to
believe are involved with recombinant DXA activities or the biologi-
cal or chemical products of such activities and obtain appropriate sam-
ples of such things. Such an inspection may extend to relevant equip-
ment. materials, containers, records, files, papers , processes, controls,
facilities, and all other things in the facility bearing/ on whether the
recombinant DXA activities are being conducted or the biological orr
chemical products of such activities are being used, or possessed in
accordance with the requirements of this title.

"(b)(1) When an inspector has completed an inspection under tils
section, he shall. beDsre he leaves the facility, inform the owner, oper-
ator. or agent in charge of the facility of any conditions err practices
which in the inspector's judgment constitute a. 'violation of any of the
requirements of this part and the inspector shall post a, written notice
of such violation in a place in the facility ichirh is readily accessible
to all the employees of such facility. Any information provided to
the owner, operator , err agent in charge of the facility by an inspector
or posted prierr to the written final report, described in paragraph (2)
shall nsA be legally binding era the inspector or the Commission and
shall not be a limitation on the inspector err the C om,mlssion.

"(2) The inspector shall prepare a written final report of his find-
ings oral send it to such owner , operator, err agent within thirty days
of the completion of the inspection. TJpern receipt of mch reprrrt. the
owner, operator, or argent shall, post a copy of such reperrt in the some
place ejs the written notice was placed, under paragraph (1).

"(c) Xo inspect err authorized pursuant to this section shall be
required to obtain a search warrant or a, warrant fern seizure from any
judicial officer prior to entering any facility and conducting any inspec-
tion or seizure of recombinant DXA err the biological or chemical
products thereof.

“(d) Whenever an inspector obtains a, sample, under the authority
of this title, such inspector shad comply with the requirements of sec-
tion 1804(a) (2) (D).

“ (e)(1) Except ns provided, in paragraph (2) , the Commission shall
conduct initial a/nd annual inspections authorized by this title in the
following orrdcr:

" (A ) First, all those f aridities, which a/re required to meet the
highest physical containment requirements, established, under sec-
tion 180Jj(al) (1):

‘‘(B) Then, all those facilities which are required, to meet the
next highest physical containment requirements established under
section 180 If (a) (1) ; a,nd

[784]

45

“ (£7) Then , if the Commission determines that it is necessary,
facilities which are otherwise required to meet physical contain-
ment requirements established under section 180 1+ (a) ( 1 ).

“(2) Whenever a bona fide request for an inspection is made by any
person who has reasonable grounds to believe that there is a hazardous
product of recombinant DNA activities present , an inspection shall
immediately be conducted.

“ RECORDS , REPORTS , AND SAMPLES

“/Sec. 1807. Each person wlw owns or operates a facility required
to be licensed pursuant to section 1803 shall maintain and submit to
the Commission such records, reports, and samples related to the safety
of recombinant DN A activities as the Commission may require.

"prohibited acts

“/Sec. 1808. The following acts and the causing thereof are hereby
prohibited :

“(a) The failure to comply with section 1803 or section 1804- or the
regulations promulgated thereunder.

“(b) The refusal to permit access to or copying of any record re-
quired by this title; or the failure to establish or maintain any record
or sample, or make any report , required under this title; or the main-
tenance or submission of any required records, reports , samples, or
data which contain any false or misleading information or that omit
material information ; or the refusal to permit access to or verification
or copying of any such required record, report , or data.

“(c) The refusal to permit entry or inspection as authorized by
section 1806.

“ (d) The failure to comply with any conditions or limitations placed
on a license granted under this title.

“(e) The failure to register a recombinant DNA project, prior to
the commencement of such project in accordance with section 1818.

“civil penalties

“Sec. 1809. (a) Any person who knowingly, willfully, or negligently
violates a provision of section 1803 or section 1808 shall be liable to
the United States for a civil penalty in any amount not to exceed
$10,000 for each such violation. Ea.ch day such a violation continues
shall, for purposes of this section, constitute a separate violation of
section 1803 or section 1808.

“(b) A civil penalty for a violation of section 1803 or section 1808
shall be assessed by the Commission by an order made on the record
after opportunity (provided in accordance with this subsection) for
a hearing in accordance with section 554 of title 5, United States Code.
Before issuing such an order , the Commission shall give written notice
to the person to be assessed a civil penalty under such order of the
Commission's or its delegates ’ proposal to issue such order and provide
such person an opportunity to request, within fifteen days of the date
the notice is received by such person, such a hearing on the order.

“(c) Any person who requested in accordance with subsection (b)
a hearing respecting the assessment of a civil penalty and who is

[785]

46

aggrieved by an order assessing a civil penalty may file a petition for
judicial review of such order with the United States Court of Appeals
for the District of Columbia Circuit or for any other circuit in which
such person resides or transacts business. Such a petition may only be
filed within the thirty-day period beginning on the date the order
making such assessment was received by such person.

“(d) If any person fails to pay an assessment of a civil penalty —
“ (1 ) after the order making the assessment has become a final
order and if such person does not file a petition for judicial review
of the order in accordance with subsection (c),or
“ (2) after a court in an action brought under subsection ( c )
has entered a final judgment in favor of the Commission,
the Attoimey General shall recover the amount assessed (plus interest
at currently prevailing rates from the date of the expiration of the
thirty -day period referred to in subsection (c) or the date of such final
judgment , as the case may be) in an action brought in any appropriate
distinct court of the United States. In such an action , the validity ,
amount , and appropriateness of such penalty shall not be subject to
review.

“ ADMINISTRATIVE RESTRAINT , SEIZURE , OR DESTRUCTION

11 Sec. 1810. If during an inspection pursuant to section 1806 an
inspector finds material he has reasonable cause to believe is a haz-
ardous product of recombinant DNA activities , he may order the ma-
terial not to be moved , may seize the material, or may destroy the
material in accordance with procedures adopted by the Commission ,
which procedures shall provide for the prior approval of the seizure or
destruction of material by the Chairman or the Acting Chairman.
Within seven days after such action by an inspector, the Commission
must commence a civil action under section 1811 with respect to the
inspector's action, unless the owner of the material has agreed other-
wise.

“ PROCEDURE FOR HAZARDOUS PRODUCTS OF RECOMBINANT DNA

ACTIVITIES

“Sec. 1811. The Commission may commence a civil action , by process
of libel or otherwise, in an appropriate district court of the United
States for the seizure or destruction of hazardous products of recomr
binant DNA activities or for other appropriate relief to prevent its
production, movement, or spread.

“ INJUNCTION AUTHORITY

“Sec. 1812. The district courts of the United States shall have juris-
diction over civil actions to restrain any violation of section 1803,
180 j or 1808. Such a civil action may be brought in the United States
district court for the judicial district wherein any act, omission , or
transaction constituting a violation of any such section occurred or
wherein the defendant is found or transacts business. In any such
civil action process may be served on a defendant in any judicial dis-
trict in which a defendant resides or may be found. Subpenas requir-
ing attendances of witnesses in any such action may be served in any
judicial district.

[786]

47

“ EFFECT ON STATE AND LOCAL REQUIREMENTS

“Sec. 1813. (a) It is declared to be the express intent of Congress
to supersede any and all laws of the states and of the political subdi-
visions thereof insofar as they may establish or continue in effect with
respect to recombinant DNA activities any requirement which is dif-
ferent from , or in addition to, any requirement applicable under this
title, except as provided in subsection (b) .

“(b) Upon receipt of an application by a state or by a political sub-
division of a state and after notice and opportunity for a hearing on
the record , the Commission shall, no later than three months from the
date the application was received and in accordance with the provi-
sions of paragraphs (1) and (2) of this subsection, exempt any exist-
ing or proposed requirement from subsection (a) of this section.

“(1) The Commission shall grant an exemption under this subsec-
tion only if it finds — •

“(J.) that the requirement of a state or political subdivision
of a state applicable to recombinant DNA activities is, and will
be administered so as to be, more stringent than a requirement un-
der this title;

“(B) the reason for the requirement is relevant and material
to the health and environmental concerns or comparable compel-
ling load conditions of such state or political subdivision; and

“(C) compliance with the requirement will not cause such ac-
tivities to be in violation of any applicable requirement under this
title.

The Commission may not withdraw any such exemption for so long
as it finds that such requirement remains more stringent than a re-
quirement under this title and continues to be so administered.

“(2) The Commission shall not grant an exemption under this sub-
section if the Commission finds that such requirement is arbitrary and
capricious.

“ (c) An application for such an exemption may be accompanied by
any materials gathered by the applicant in its legislative or adminis-
trative consideration of the existing or proposed requirement. Upon
receipt of such an application and such materials, if submitted, the
Commission shall publish such application in the Federal Register as
a proposal, accompanied by a description of any supporting materials
submitted therewith.

“(d) It is not the intention of the Congress that enactment of the
Recombinant DNA Safety Regulation Act, promulgation of regula-
tions thereunder, or compliance therewith should be considered in any
way to reduce or affect the common law or statutory rights or remedies
of any person regarding recombinant DNA activities.

“judicial review of licensing

“Sec. 181 4- (a) Any person adversely affected by an action of the
Commission under section 1803 or 1805 concerning the issuance, revoca-
tion, suspension, or limitation of a license, may obtain review of the
action in the United States court of appeals for the circuit in which
that person resides or has his principal place of business. The petition
for review must be filed within sixty days of the date notice of such

[787]

48

action is received by such person. Review shall conform to chapter 7
of title 5 of the United States Code.

“(b) *4/). action icith respect to which review could have been ob-
tained under subsection (a) shall not be subject to judicial review in
any other proceeding.

“ EMPLOYEE PROTECTION

‘‘‘‘Sec. 1815. (a) Xo employer may discharge any employee or other-
wise discriminate against any employee with respect to the employee's
compensation, terms, conditions, or privileges of employment because
the employee ( or any person acting pursuant to a reguest of the em-
ployee) has- —

"{1) commenced, caused to be commenced , or is about to com-
mence or cause to be commenced a proceeding under this Act ,

" (2) testified or is about to testify in any such proceeding , or
li(3) assisted or participated or is about to assist or participate
in an y man tier in such a proceeding or in any other action to carry
out the purposes of this Act.

li(b) (1) Any employee who believes that he has been discharged or
otherwise discriminated against by any person in violation of subsec-
tion (a) of this section may. within sixty days after such alleged vio-
lation occurs, file (or have any person file on the employee's behalf) a
complaint with the Secretary of Labor (hereinafter in this section
referred to as the ‘‘Secretary') alleging such discharge or discrimina-
tion. Such sixty-day period shall be tolled during the pendancy of any
grievance procedures or other efforts at conference , conciliation , or
mediation. Upon receipt of such a complaint, the Secretary shall notify
the person named in the complaint, of the filing of the complaint.

“(J.) ( i ) Upon receipt of a complaint filed under paragraph
(1). the Secretary shall conduct an investigation of the violation
alleged in the complaint. Within thirty days of the receipt of
such complaint, the Secretary shall complete such investigation
and shall notify the complainant ( and any person acting with
the authority of the complainant) and the person alleged to have
committed such violation of the results of the investigation con-
ducted pursuant to this paragraph. Within ninety dags of the
receipt of such complaint the Secretary shall, unless the proceed-
ing on the complaint is terminated by the Secretary on the basis
of a settlement entered into by the Secretary and the person al-
leged to have committed such violation, issue an order either pro-
viding the relief prescribed by subparagraph (B) or denying the
complaint. An order of the Secretary shall be made on the. record
after notice and opportunity for agency hearing. The Solicitor
of Labor shall, with the consent of the complainant, represent
such complainant at any such hearing. The Secretary may not
enter into a settlement terminating a proceed in a on a complain
without the participation and consent of the complainant.

“ (ii) If in response to a complaint fled under paragraph ( 1 )
the Secretary determines that a violation of subsection (a) of
this section has occurred, the Secretary shall order (i) the per-
son. who committed such violation to take affirmative action to
abate the violation, (ii) such person to reinstate the complainant

[788]

49

to the complainant’’ s former position together with the compensa-
tion ( including back pay ), terms , conditions , and privileges of
the complainant’s employment, ( Hi ) compensatory damages , and
(iv) where appropriate exemplary damages. If such an order is
issued , the Secretary , at the request of the complainant , shall
assess against the person against whom the order is issued a sum
equal to the aggregate amount of all costs and expenses (including
attorney’s fees) reasonably incurred, as determined by the Secre-
tary, by the complainant for, or in connection with, the bringing
of the complaint upon which the order was issued.

“(Hi) Any person adversely affected or aggrieved by an order
issued under subparagraph (i) may obtain review of the order.
The petition for review must be filed within sixty days from the
date of issuance of the Secretary’s order. Review shall conform
to chapter 7 of title 5 of the United States Code.

11 (iv) An order of the Secretary, with respect to which review
could have been obtained under subparagraph (Hi), shall not
be subject to judicial review in any criminal or other civil pro-
ceeding.

“(B) Whenever a person has failed to comply with an order
issued wider subparagraph (i), the Secretary shall file a civil
action in the United States district court for the district in which
the violation was found to have occurred to enforce such order.
In actions brought wider this paragraph, the district courts shall
have jurisdiction to grant all appropriate relief, including in-
junctive relief and compensatory and exemplary damages. Civil
actions brought under this paragraph shall be heard and decided
expeditiously.

“(C) Subsection (a) of this section shall not apply with respect
to any employee who, acting without direction from the em-
ployee’s employer (or any agent of the employer ), deliberately
causes a violation of any requirement of this Act.

“ ADMINISTRATIVE PROVISIONS

“Sec. 1816. (a) The Commission may for the purpose of carrying
ou.t its duties hold such public hearings, sit and act at such times and
places, take such testimony, and receive such evidence as the Commis-
sion deems advisable.

“(b)(1) The Commission may appoint and fix the compensation of
such employees as it deems advisable, however , in no event may the
Commission appoint more than fifty employees.

“ (£) (A) The Commission may procure, in accordance with the pro-
visions of section 3109 of title 5, United States Code , the temporary or
intermittent services of experts or consultants. Persons so employed,
shall receive compensation at a rate to be fixed by the Commission , but
not exceeding for any day (including traveltime) the daily equivalent
of the effective rate for Grade GS-18 of the General Schedule.

“(B) While away from his home or regular place of business in the
performance of services for the Commission, any such person may be
allowed travel expenses, including per diem in lieu of subsistence, as
authorized by section 5703(b) of title 5, United States Code, for per-
sons in the Government service employed intermittently.

S. Bep; 359-77 2

[789]

50

" (J) To appoint technical committees composed of such private
citizens and omcials of the Federal , State , and local governments as it
deems desirable to advise it with respect to its f unctions under the law
subject to its jurisdiction, and to pay such members ( other them those
regularly employed by the Federal Government ) while attending
meetings of such committees, or otherwise serving at the request of the
Commission, compensation and travel expenses at the rate provided
for in paragraph (2) of this subsection with respect to experts and
consultants.

"(c) The Commission may publish and disseminate to the public
such reports, information, recommendations, and other material re-
lating to its functions , activities, and studies as it deems appropriate.

"(d) The Commission may enter into contracts for the purpose of
carrying out the provisions of this title.

"(e) The Commission may conduct and support training of person-
nel of the Commission for purposes of carrying out the provisions of
this title.

"(f) The Commission shall not delegate any of the duties and func-
tions vested in it under this part, including the functions and duties
respecting licensing and inspection, of facilities to any indivdual who
is not an employee of the Commission, or to any partnership, corpora-
tion. association, or to any Federal, State, or local government entity.

"(g) The Commission shall require such periods of time for the
retention and maintenance of records required under this title as
the Commission determines are necessary and appropriate.

l' DISCLOSURE OF DATA

"Sec. 1817. (a) General. — Except as provided by subsection (b),
any information reported to, or otherwise obtained by, the Commission
or any representative of the Commission, under this title , which is
exempt from disclosure pursuant to subsection (a) of section 552 of
title 5. United States Code, by reason of subsection (b)(4) of such
section, shall, notwithstanding the provisions of any other section of
this title, not be disclosed by the Commission or by any officer or em-
ployee of the United States, except that such information —

"(1) shall be disclosed to any officer or employee of the United
States —

“(J.) in connection with the official duties of such oncer
or employee under any law for the protection of health or
the environment, or

"(B) for specific law enforcement purposes;

" (2) shall be disclosed to contractors with the Commission and
employees of such contractors if in the opinion of the Commission
such disclosure is necessary for the satisfactory performance of
the work of such contractor in connection with this title and under
such conditions as the Commission may specify:

u(3) shall be disclosed if it is necessary to protect health or
the environment against an unreasonable risk of injury to health
or the environment; or

"(4) may be disclosed when relevant in any proceeding under
this title, except that discolsure in such proceeding shall be made
in such manner as to preserve confiderdiality to the extent practic-
able without impairing the proceeding.

[790]

51

In any proceeding under section 552(a) of title 5, United States Code ,
to obtain information the disclosure of which has been denied because
of the provisions of this subsection , the Commission may not rely on
section 552(b) (3) of such title to sustain the Commission's action.

“(b)(1) In submitting data under this title , a person may (A)
designate the data which such person believes is entitled to confi-
dential treatment under subsection ( a ), and (B) submit such desig-
nated data simultaneously but separately from other data submitted
under this title. A designation under this paragraph shall be made
in writing and in such manner as the Commission may prescribe.

“(2) (A) Except as provided by subparagraph (B), if the Com-
mission proposes to release for inspection data which has been desig-
nated under paragraph (1) (A) or any other information which is
exempt from disclosure pursuant to subsection (a) of section 552 of
title 5, United States Code , by reason of subsection (b) (I) of such
section , the Commission shall notify , in writing and by certified mail ,
the person who submitted such data of the intent to release such data.
If the release of such data is to be made pursuant to a request made
under section 552(a) of title 5, United States Code , such notice shall
be given immediately upon approval of such request by the Com-
mission. The Commission may not release such data u/ntil the expira-
tion of thirty days after the person who submitted such data has re-
ceived the notice required by this subparagraph.

“(B) Subparagraph (A) shall not apply to the release of informa-
tion under paragraph (1), (2), (3), or (i) of subsection (a), except
that the Commission may not release data under paragraph (3) of
subsection (a) unless the Commission has notified each person who
submitted such data of such release. Such notice shall be made in writ-
ing by certified mail at least fifteen days before the release of such
data , except that if the Commission determines that the release of such
data is necessary to protect against an unreasonable risk of injury to
health or the environment , such notice may be made by such means
as the Commission determines will provide notice at least twenty-four
hours before such release is made.

“(c)- Any officer or employee of the United States or former officer
or employee of the United States , who by virtue of such employment
or official position has obtained possession of, or has access to material
the disclosure of which is prohibited by subsection (a) or (e) and who
knowing that disclosure of such material is prohibited by such sub-
section, willfully discloses the material in any manner to any person
not entitled^ to receive it, shall be guilty of a misdemeanor and fined
not more than $10,000 or imprisoned* for not more than one year, or
both. Section 1905 of title 18, United States Code, does not apply roith
respect to the publishing , divulging , disclosure , or making known of,
or making available, information reported or otherwise obtained under
this title.

“(d) F or purposes of this section, the term 1 officer or employee of
the United States' includes —

“(1) any contractor with the United, States who is furnished
information as authorized by this section and any employee of any
such contractor , and

“(2) any member of an institutional biohazard review commit-
tee, established pursuant to this part as long as information sub-

1791]

52

mitted to or otherwise obtained by such member is information re-
lated to a facility affiliated with such committee.

“(e) ( 1 ) Any person who maintain s a health record which contains
individually identifiable personal data (hereinafter in this subection
referred to as 'personal doled) and which receives a request from any
governmental authority for such record for purposes of this part shall
not disclose or transfer any such data to a governmental, authority un-
less the individual whose personal data is to be so disclosed or trans-
ferred gives an informed consent for such discloure or tranfer and
such consent is evidenced by a document containing the signature of
such individual and the signature of the person who explained the
provisions of paragraph (if).

“ (2) Notwithstanding any provision of law , personal data received
or maintained by a governmental authority fen n purposes of this title ,
may not be disclosed or made available by a governmental authority
to any person other than the individual who is the subject of such
data. Such personal, data may not be required to be disclosed by any
Federal , State , or local civil , criminal , administrative , legislative , or
ocher proceeding .

“( 3 ) For ^purposes of this subsection, the terrm '■governmental au-
thority' means any Federal agency , including the Commission , any
Stole or local gove'mmental authority , its employees , contractors ,
grantees , or agents.

“(i) For purposes of this subsection. Informed consent ’ includes a
complete explanation of risks and benefits to the individual whose
personal data is to be disclosed or transferred of such disclosure or
transfer , mcl/uding —

U(A) a statement informing such individual of whether he is
legally required, or may refuse, to consent to such disclosure or
transfer , and informing him of any specific consequences of con-
senting or not consenting to such disclosure or transfer;

U(B) a statement informing such individual that he may review
the dala arnd any other information which is proposed to be dis-
closed or transferred, prior to such consent;

“ ( C) a statement informing such individual of the use to be
made of such data and other information and of the identity of
persons and governmental autho'rilies which will use the dala and
other information and their relationship to the recombinant DNA
activities.

“registration or recombinant dna projects

“Sec. 1818. (a) The owner or operator of a facility licensed under
section 1803 shall, after appropriale review and approval, file with
the Com/mission a Project Registration. Statement for each recombinant
DNA p'roject conducted in such facility.

“(b) A Project Registration Statement shall be fled, in such form
and manner as the Commission may require by rule, prior to the com-
mencement of the project or, in the cose of projects in progress on the
date of enactment of this part, as part of the initial licensing appli-
cation.. The statement shall contain all information regarding the
p'roject thal the Commission, by rule, has determined is necessarry fo'r
an informed assessment of the precautions to be taken for assuring its
safety and, complwnce with the requirements of this title.

[792]

53

“construction of facilities

“/Sec. 1819. (a) Notwithstanding any other 'provision of laic , no
Federal funds sliall he expended for more than 50 per centum of the
actual cost , as determined- by the Commission , of construction of a
facility for the puiqpose of meeting the highest physical containment
requirements, established under section 180 If.

“RELATIONSHIP TO OTHER FEDERAL i-iTTS

“Sec. 1820. (a) Notwithstanding any other provision of law, no
Federal agency may, except as provided in subsections (b) and (c)
of this section, impose or continue in effect any safety or health re-
quirement applicable to activities involving recombinant DN A activi-
ties which is different from, or in addition to, any requirement pre-
scribed pursuant to this title.

"(b) (1) Upon application by a Federal agency and after consulta-
tion with such agency , the Commission may, pursuant to this subsec-
tion, exempt any existing or proposed requirement from subsection
(a) of this section.

"(2) An application for such an exemption may be accompanied by
any materials gathered by the applicant in its consideration of the
existing or proposed requirement. Upon receipt of such application and
such supporting material the Commission shall publish such applica-
tion in the Federal Register as a proposal, accompanied by a descrip-
tion of the supporting material submitted therewith.

" {3) A proposed exemption shall not be granted by the Commission
unless it finds that the requirement is more stringent than a- require-
ment under this title and that it is consistent with the policies of the
Commission.

" (4) The Commission shall make a determination with respect to an
application under this subsection within thi'ee months from the date
the application was received by the Commission.

“(c) This title shall not affect the authority of the Secretary or the
Secretary of Labor to exercise their respective authority pursuant to
the Occupational Safety and Health Act of 1970. And provided fur-
ther, that in exercising authority under this title, the Secretary, the
Commission, or any person acting on behalf of the Secretary or Com-
mission or pursuant to the provisions of this title, shall not . for the
purposes of section 4(b)(1) of the Occupational Safety and Health
Act of 1970. be deemed to be exercising statutory authority to pre-
scribe or enforce standards or regulations affecting occupational safety
and healths.

“ DEFINITIONS

“Sec. 1821. (a) For the purposes of th is part :

“(1) iDNA’> means deoxyribonucleic acid.

“ (2) (A ) ‘ Recombinant DNA' means DNA molecules that consist of
different segments of DNA which have been joined together outside
any cell, and have the potential for entering and propagating in. a par-
ticular host cell, either autonomously or as an integrated part of the
host cell's genome.

“(B) Except as provided in sub paragraph (C), the Commission
shall, upon its finding and after filial publication of such finding in the

[793]

54

Federal Register , exempt from the definition in subparagraph (A)
DNA molecules composed only of DNA segments from the following
sources: the host species , a related species which is known to exchange
genetic information in nature with the host cell , and/ or a natural para-
site or plasmid of the host cell; such composite DNA molecules must
propagate within the host cell by processes which are krwwn to occur
naturally there.

“(6') The Commission shall not exempt DNA molecules under
subparagraph ( B ) from the definition in subparagraph (A) unless
the Commission determines that such molecules do not present an
unreasonable risk to the health of the persons exposed to such mole-
cules, to the environment , or to the health of the public.

“ (3) Recombinant DNA activities ’ means any research , study , in-
vestigation, experiment , or activity in connection with recombinant
DNA.

“ (1) ‘ Hazardous product of recombinant DNA activities'1 means a
biological or chemical product of recombinant DNA activities which
is handled , treated , or contained in such a manner as to pose a sig-
nificant risk to health or to the environment , as determined by the
C ommission.

“(o) ‘ Commerce ’ means any activity ichich affects ( 1 ) commerce be-
tween aivy State or territory and any place outside thereof , and (2)
commerce within the District of Columbia or within amy other terri-
tory not organized with a legislative body ,

“(6) ‘‘Commission'1 means the National Recombinant DNA Regula-
tion Commission , established under section 1801,

“(7) ‘‘Construction of a facility' means a facility which is not owned
or operated by the United States and includes the construction , leas-
ing. acquisition, or maintenance of new buildings , including equip-
ment, laboratory installations , instrumentation, acquisition of land or
offsite improvements , and architects’’ fees; and the alteration , improve-
ment. leasing, acquisition, maintenance, expansion , major repair, re-
modeling, replacement, and renovation of existing buildings, including
equipment, laboratory installations , instrumentation, acquisition of
land or offsite improvements , and architects' fees.

“(8) For purposes of section 1801(b) (2) (C), “ financial interest in
recombinant DNA activities’ does not include wages or salary earned
by an employee of a nonprofit educational or research corporation.

“(9) ‘‘/State’ means any State or territory of the United States, in-
cluding the District of Columbia, the C ommomcealth of Puerto Rico,
Guam , the Northern Mariana Islands. American Samoa, and the
Virgin Islands.

“(10) ‘ District court of the United States’ includes a similar or
equivalent court in any State.

“(11) ‘ Person ’ includes any individual, partnership, corporation ,
association, or any Federal, State, or local government entity.

“(12) 'Inspector’ means any qualified officer , employee, or agent
authorized by the C ommission to carry out the appropriole provisions
of this title.

“(13) ‘ Name ’ shall include in the case of a partnership the name of
each partner, and in the case of a corporation the name appearing on
the corporation’s charter or certificate of incorporation and the name
of each principal corporate officer and director and the State of in-
corporation.

[794]

55

“ (14) ‘■Owns or operates ’ means any person who owns , operates ,
leases , charters , or controls any facility used in recombinant DNA
activities.

“(15) (A) ‘ Facility ’ means a single building , including the labora-
tories, premises , records , reports , research materials , equipment ,

instrumentation , products of recombinant DNA activities , every-
thing contained in such building or adjacent thereto.

“(B) For purposes of inspections authorized under this title the
term ‘ facility'’ includes in adition to subparagraph (A), any other
premises or building which contains records or reports related to re-
combinant DNA activities.

“(16) ‘ Persons authorized by the license to engage in recombinant
DNA activities in connection with a licensed facility ’ means the prin-
cipal scientist and all other scientists who have responsibility for di-
recting a recombinant DNA project carried out in a facility licensed
under this title.

“(17) ‘ Recombinant DNA project’’ and ‘ project ’ means any research ,
study , investigation , experiment , avt or closely related set of acts that
have a common research objective and utilize the same or similar host /
# vector systems , awe? are carried out in a facility.

“ (./#) ‘ Federal agency’’ means each authority of the Government of
the United States , whether or not it is within or subject to review by
another agency , but does not include —

“(il) Z/te Congress; and
“ (Z?) the courts of the United States.

“(19) ‘ Persons exposed to recombinant DNA ’ means those persons
authorized by the license to engage in recombinant DNA activities in
• connection with a licensed facility and all other persons who are ex-
posed to recombinant DNA or the biological or chemical products
thereof in connection with a licensed facility.

“(20) F or purposes of section 1803 (b) (1) (B) ,l qualifications'* means
expedience and training solely related to assuring compliance with
the physical and biological safety requirements applicable to recom-
binant DNA activities.

“(21) ‘ Political subdivision 5 and ‘ local government’’ means a unit
of qeneral local government as defined in section 601 (1) (10) of Pub-
lic Law 93-203.

“(22) For purposes of subsection (a) of section 1818, ‘appropriate
review and approval ’ means the review and approval by the Institu-
tional Biohazard Review Committee which is affiliated with a licensed
facility as required by section 180 Jj (a) (2) (C) .

“a uthoriza tions

“Sec. 1822. For the purpose of carrying out the provisions of this
title, there are authorized to be appropriated such sums as may be nec-
essary for fiscal years 1978 , 1979, 1980, 1981, and 1982 P.

SEPARABILITY CLAUSE

Sec. Jj. If any provision of this title is declared unconstitutional or
the applicability thereof to any person or circumstance is held invalid,
the constitutionality of the remainder of the title of the applicability
thereof to other persons and circumstances shall not be affected thereby.

[795]

X. SUPPLEMENTAL VIEWS OF SENATOR E AGLETON AND
SENATOR CHAFEE ON RECOMBINANT DNA

While we agree that the potential risks, as well as the potential
benefits, of recombinant DNA research dictate some form of Federal
regulation, we have reservations about the independent Commission
established in this bill to license, regulate and make policy decisions
regarding recombinant DNA activities.

As constituted in S. 1217, the Commission would be composed of
11 members, appointed by the President, 6 of whom would be non-
scientists, and 5 of whom are or were engaged in recombinant DNA
research. Although the members would not be full-time employees of
the Federal Government, they would be charged with the responsi-
bility of directing all of the staff personnel of the Commission, pro-
mulgating rules and regulations to implement the act, reviewing
license applications, issuing licenses, monitoring compliance by li-
censees, determining biological species which exchange chromosomal
DNA by cellular recombinational processes, and contracting for the
development of effective epidemiological methods. In our view, this
wide range of responsibilities, and the technical nature of these re-
sponsibilities, make such a Commission structure unworkable. In
practice, most decisions would be made at the Commission staff level,
and we question whether or not the Commission members would even
be able to carefully review these staff decisions.

An even broader concern goes to the establishment of independent,
policy making bodies such as this proposed Commission. Although
it can be argued that the regulatory range of recombinant DNA re-
search is broader than the Department of Health, Education, and
Welfare, we believe that the preponderance of such activity will fall
within the traditional framework of the National Institutes of Health.
Given HEW’s regulatory action in this area at the present time, it
appears to me that it would be far better to vest the authority for
recombinant DNA safety regulation in the Secretary of HEW, and
to require that he establish an advisory committee. An advisory com-
mittee, with a structure similar to that of the Commission in the
committee bill, would assure adequate public and outside scientific
input on all matters relating to recombinant DNA research.

As presently drafted S. 1217 simply produces an added layer of
bureaucracy, which, in our judgment, will not regulate the safety
of DNA research as effectively as the Department,

(56)

[796]

XI. SUPPLEMENTAL VIEWS OF SENATOR NELSON

S. 1217, a bill to regulate deoxyribonucleic acid (DNA) activities lias
a laudable goal: the protection of public health and safety by re-
quiring that uniform national guidelines be met by scientists conduct-
ing recombinant DNA research, both in publicly supported and pri-
vate industry research laboratories.

However, I am concerned that S. 1217 is unnecessarily burden-
some and detrimental to the future of this important biomedical
research.

Scientists all agree that the joining together of different segments
of deoxyribonucleic acid (DNA) is a potent tool for the conquest of
disease and other beneficial scientific advances. The recently announced
discovery that recombined genes facilitate the production of insulin
by bacteria is an example of such an important breakthrough. Re-
combining fragments of DNA occurs continually in nature. Four
years ago, however, at a 1973 Gordon Conference on Nucleic Acids,
scientists involved in developing recombinant DNA research drew
attention to the possible hazards of manmade recombinants.

Because scientists and laboratory technicians are at greatest risk
of direct contact with the organisms involved, they have been most
concerned with clearly defining the hazards. To date, despite many
thousands of recombinant DNA experiments, no known hazards have
occurred.

Nevertheless, as a result of concerns expressed in the 1973 Gordon
Conference, and a 1975 Asilomar Conference, guidelines were promul-
gated by the National Institutes of Health (NIH) in 1976, which
are required to be met by any reserchers having Federal financial
support. The guidelines, however, cannot be enforced in the private
sector without enabling legislation.

Therefore, legislation to simply extend the NIH Guidelines to all
sectors engaged in recombinant DNA activities seems appropriate.

NIH guidelines

The NIH guidelines prohibit certain kinds of recombinant DNA
experiments and the release of recombinant molecules into the en-
vironment. Permissible experiments are outlined and are assigned both
a physical and biological containment level, depending on assess-
ment of potential biohazards.

Physical containment refers to methods used to prevent release of
organisms containing recombinant DNA molecules from the lab.
Relying on proven methods that have been developed for handling
known pathogenic organisms in clinical and research laboratories,
physical containment is approached in two wavs: (1) standard micro-
biological practices and training are prescribed by the guidelines;
(2) special kinds of equipment and facilities are used. Four levels
of physical containment are described, progressing from least to most
strict ; P-1, P-2, P-3, P-4.

(57)

[797]

58

Biological containment refers to methods whereby organisms are
weakened, so that, in the event of their escape from the laboratory,
their survival is extremely improbable. The guidelines characterize
three levels of impairment of a weakened laboratory strain known as
E-coli K-12.

The guidelines also provide an administrative framework for their
implementation and a compendium of safety information.

The guidelines require establishment of institutional bio-hazard
committees for local review of recombinant DXA activities.

A Recombinant DXA Advisory Committee, under the auspices of
the National Institutes of Health, meets regularly to review and
update the guidelines. At their May 15, 1977, meeting, the Advisory
Committee issued the following statement :

During this period the committee has become better in-
formed about the general ecology and epidemiology of in-
fectious microorganisms. Experiments have been reported
showing that the incorporation of foreign DXA does not
increase but rather tends to decrease the growth rate of micro-
organisms, and this further contributes to the unlikelihood
that cells earning recombinant DXA will survive in nature
and produce harmful effects. Indeed, everything that we have
learned has tended to diminish our estimate of risk. Neverthe-
less. the revised guidelines continue to represent a deliberately
conservative approach, with the intent of erring on the side
of caution.

Uniform guidelines

The Federal Inter-Agency Committee on Recombinant DXA Re-
search in 1976 proposed that a single set of national standards be
applied to all recombinant DXA activities.

HEW and representatives of private industry testified before the
Health .Subcommittee that all laboratories receiving Federal grants
now comply with the XTIT guidelines, and private laboratories volun-
tarily impose the same guidelines on themselves. However, the extent
to which the guidelines are enforced in the pri vate sector, cannot be
determined without Federal law.

Therefore, the administration proposed a bill, largely based on the
committee’s recommendations, which provided IIEW with the re-
sponsibility for regulation and specified that the XIH guidelines be
promulgated as initial standards. The scope of the regulation was
directed to the use and production of recombinant DXA molecules.
The Department was to exercise its regulator}" authority in close con-
sultation with other appropriate agencies.

Scientists' concerns

A 1977 Gordon Research Conference on Nucleic Acids expressed
serious reservations about pending legislation. An open letter to Con-
gress. June 18, 1977, signed by 137 members of the conference states:

We are concerned that the benefits of recombinant DXA
research will be denied to society by unnecessarily restric-
tive legislation.

Four years ago, the members of the 1973 Gordon Confer-
ence on Nucleic Acids were the first to draw public attention

[798]

59

to possible hazards of recombinant DNA research. The dis-
cussions which started at that meeting resulted in the issuance
in 1976 of the NIH guidelines for the conduct of this research.

We, members of the 1977 Gordon Research Conference on
Nucleic Acids, are now concerned that legislative measures
now under consideration by congressional, State and local
authorities will set up additional regulatory machinery so
unwieldy and unpredictable as to inhibit severely the further
development of this field of research. We feel that much of
the stimulus for this legislative activity derives from exag-
gerations of the hypothetical hazards of recombinant DNA
research that go far beyond any reasoned assessment.

This meeting made apparent the dramatic emergence of new
fundamental knowledge as a result of application of recom-
binant DNA methods. On the other hand, the experience of
the last 4 years has not given any indication of actual hazard.
Under these circumstances, an unprecedented introduction of
prior restraints on scientific inquiry seems unwarranted.

We urge that Congress consider these views. Should legis-
lation nevertheless be deemed necessary, it ought to prescribe
uniform standards throughout the country and be carefully
framed so as not to impede scientific progress.

The 137 undersigned are members of the 1977 Nucleic Acids
Gordon Conference.

In addition, a number of other scientists and scientific organiza-
tions have expressed similar concerns, including the Inter-Society
Council for Biology and Medicine, comprising officers of seven pro-
fessional organizations: the American Institute of Biological Scien-
ces, the American Society for Medical Technology, the American
Society for Microbiology, the American Society of Allied Health
Professions, the Association of American Medical Colleges, the Fed-
eration of American Societies for Experimental Biology, and the Na-
tional Society for Medical Research.

Thirteen members of the National Academy of Sciences signed a
resolution as follows :

Resolution of the National Academy of Sciences
April 26, 1977

Three years ago the National Academv of Sciences played
an important role in initiating responsible and informed dis-
cussion on the need for controls on recombinant DNA re-
search. The subsequent debate, both inside and outside the
scientific community, resulted in a set of guidelines for-
mulated under the sponsorship of the National Institutes
of Health. Now the Congress is considering several drafts of
detailed and far reaching legislation dealing with the regul-
ation of recombinant DNA research.

The NIH guidelines are the result of careful deliberation
and we favor their simple conversion into a uniform national
set of regulations. However, much of the proposed legisla-
tion now before Congress would allow local communities

[7991

60

or states to set their own stricter regulations, including even
a complete ban on this type of research. It is reasonable for
the local community to participate in supervising adherence
to regulations. But the question concerns speculative rather
than known dangers and these would not vary from one
locality to another.

The research institutions of the country constitute an im-
portant national resource, and differing local options could
subject that resource to arbitrary regulations. Overly re-
stricting this type of research would severely degrade the
capability of biomedical research and limit its contribution
to the public welfare. In essence, it would allow a local com-
munity to affect a critical component of national policjn
Above all, local option would set a dangerous pattern for
the regulation of basic research in a manner that might de-
prive society of substantial future benefits.

Some of the legislation proposes to establish a national
regulatory commission expressly to govern recombinant DNA
research. Its broad powers for controlling basic research
represent a wholly new and unfortunate departure. We are
also concerned that it would set a precedent for the regula-
tion of other areas of science. A much simpler and more
flexible mechanism allowing for public participation could
carry out those functions that may be needed.

Therefore, be it resolved that we voice concern about legis-
lative developments in this area and ask the president of
the National Academy of Sciences to relay these concerns
to appropriate officials in the government.

D. Baltimore, B. D. Davis, H. Eagle, J. T. Ed-
sall, C. Grobstein, D. M. Horstmann, R.
Hotchkiss, R. J. Huebner, A. Rich, W. A.
Rosenblith, F. N. Ruddle, R. L. Sinsheimer.

E. L. Smith.

Thus, while I agree with the intent of S. 1217, I have serious res-
ervations about its approach, based on scientists' concerns that it will
impose unnecessarily burdensome controls on scientific research. My
concerns are as follows :

(1) Commissi ov. — The bill will create a new and expensive bureauc-
racy that is unwarranted.

Section 1801 of S. 1217 establishes an independent Commission to
license, regulate and make policy decisions regarding recombinant
DNA activities. Members would be appointed by the President, with
Senate approval for the Commission Chairman. A majority of the
members would be public, nonscientists. Section 1801(b) prohibits a
majority of members on the Commission who are or have been engaged
in recombinant DNA research. This would severely limit the expertise
of a Commission whose major purpose is to protect health and safety
from untoward effects of such research.

Furthermore, all members would have other primary responsibilities
besides their Commission activities. Given the number and the highly
technical nature of the assigned tasks, such a part-time Commission
would be unworkable, in mv view. Section 181fi(e) permits the Com-
mission to delegate technical matters to its staff or to ad hoc working

[800]

61

groups ; however, I do not believe it is our intent to delegate these im-
portant duties to staff. An important question also arises as to who
actually would be accountable for the regulatory activities of such a
free-standing Commission.

Section 361 of the Public Health Service Act already provides HE W
with the following broad authority to regulate laboratory work with
disease-producing microorganisms :

The Surgeon General with the approval of the Secretary is
authorized to make and enforce such regulations as in his
judgment are necessary to prevent the introduction, trans-
mission or spread of communicable diseases from foreign
countries into the states or possessions or from one state or
possession into any other state or possession.

Under this statute, the Center for Disease Control has established
regulations for containment and requirements for working with differ-
ent classes of organisms, including total prohibition on work with a
few lethal microorganisms. As a result, there have been very few cases
of laboratory-associated infection in the history of the United States
and none that have spread to the community.

Existing law also provides HEW with authority to regulate private
and public interstate clinical laboratories (Clinical Laboratories Im-
provement Act of 1967, Public Law 90-174) and legislation is being
considered to broaden HEW’s regulatory authority to intrastate clin-
ical laboratories. This authority will not cover biomedical reseach nor
is it my intent that it should, but as with the above-mentioned authority
to regulate laboratory work with disease-producing organisms, it can
provide an alternative mechanism in place for monitoring compliance
with the guidelines for recombinant DNA activities.

Finally, the NIH has an administrative mechanism in place to im-
plement its guidelines on recombinant DNA activities.

Therefore, a simple extension of HEW’s authority to allow for en-
forcement of DNA guidelines in the private sector would accomplish
the objective of establishing uniform national guidelines for recom-
binant DNA activities.

(2) Penalties. — Section 1809 establishes penalties for noncompli-
ance, for “any person who knowingly, willfully or negligently” vio-
lates a provision of section 1803, general requirements and section 1808,
prohibited acts. It authorizes a penalty of $10,000 for each violation
with each day constituting a separate violation.

The term “negligence” is not clearly defined. Such a penalty also
appears to be excessive and disproportionate. License revocation in
itself is an effective penalty. Furthermore a dollar penalty would not
deter those who wish to willfully disregard regulations. In short, we
run the risk of enacting legislation which will obstruct the law-abiding
while not effectively deterring the law-breaker.

(3) Seizure and destruction of research material. — Section 1810
gives inspectors authority to seize and destroy “a hazardous product
of recombinant DNA activities” with the approval of the Commission
Chairman or his designee. A better procedure would be to seize and
hold material pending a judicial hearing.

(4) Preemption.— On the whole, I support Section 1813, which ex-
presses Congressional intent that Federal Guidelines supersede any
and all laws regarding recombinant DNA activities of States, and of

[801]

02

political subdivisions. I believe, however, that the granting of exemp-
tions should take into account the national interest. The purpose of
legislation should be to establish uniform national standards to regu-
late recombinant DMA activities; otherwise, legislation is not neces-
sary. Since microbes do not respect Federal, State, or community
boundaries, the most effective standards will be those adopted inter-
nationally. If we are to negotiate for international standards, we must
have good uniform national standards, not a potpourri of domestic
standards.

Citizens should have input into decisions regarding protection of
the health and environment of their local communities. However, the
authority to grant exemptions should be at the Secretary’s discretion,
based on clear demonstration that the public health and environment
is endangered. If a locality proposes more stringent requirements for
DXA research as necessary to protect health and environment, it is
likely that other communities would require it; thus, the Secretary
should evaluate the need for inclusion of more stringent requirements
in the general Federal guidelines, rather than grant individual exemp-
tions from them.

(5) Disclosure of research details. — Detailed descriptions of recom-
binant DXA projects are required to be reported at three places in the
bill: General requirements and licensure (secs. 1803(b)(1)(C) and
1803(b) (2) (A) (ii) ) : and registration of DXA projects (sec. 1818
(a)). Such detailed descriptions of research protocols would thus lie
given to local biohazard committees; to the Commission for licensure;
and to the Commission for purposes of registering each research
project. Section 1803(c) requires the Commission to publish such in-
formation in the Federal Register with each license application.

The requirements impose enormous paperwork burdens on research-
ers. In addition, although Section 1817 contains certain exemptions
from disclosure, it is not clear that it will protect the research proto-
cols. designs, and hypotheses of academic and industry researchers. In
a recent court ruling relating to subsection (a) of section 552 of title 5,
United States Code (b)(1) (Freedom of Information Act). HEW
was ordered to release research protocols on grounds they were not
trade secrets (Washington Desearch Project. Inc. v. DREW) . A stat-
ute affording positive protection, therefore, for intellectual property
rights associated with recombinant DXA activities should be devel-
oped in accordance with subsection (b)(3) of the Freedom of Infor-
mation Act (FOIA) .

(6) u Sunset'' provision. — There should be a “sunset” provision that
requires review of the need for the legislation after a reasonable time
period.

(7) Impact on small business. — The paperwork and compliance
requirements of the legislation will be particularly difficult for small
companies to meet, putting them at competitive disadvantages with
large industries. Compliance with the XTH Guidelines already has
imposed administrative burdens on small laboratories, although they
are able to meet the requirements.

In summary, I must dissent from the decision of the Committee to
recommend passage of S. 1217 as reported. Appropriate legislation to
allow the application of uniform Guidelines by HEW to all sectors
will enable the United States to negotiate for international guidelines
for recombinant DXA activities.

[302]

63

S. 1217, however, sets a bad precedent for future restrictive regu-
lation of biomedical research in general. The compliance provisions
and paperwork are excessive, possibly unworkable, and particularly
burdensome for small businesses. The potential for obstructing re-
search and impeding progress in conquering diseases appears to be
much greater than the benefits accruing to the public through the
provisions of this legislation.

[803]

S 13312

CONGRESSIONAL RECORD — SENATE August 2, 1977

SPECIAL
INTEREST . ITEM

RECOMBINANT DNA ACT— S. 1217

AMENDMENT NO. 7 54

(Ordered to be printed arid to lie on
the table.)

Mr. NELSON. Mr. President. I am to-
day introducing an amendment in the
nature of a substitute t6 S. 1217, a bill to
regulate activities involving recombinant
deoxyribonucleic acid (DNA) research.

S. 1217 has generated much new in-
formation and commentary since its in-
troduction April 1, 1277.

The substitute proposal reflects new
information and views, and differs from
both the Senate bill (S. 1217) and from
H.R. 7897, a bill penaing before the
House Interstate and Foreign Commerce
Committee, with respect to a number of
major issues: the nature and the extent
of regulation necessary to combat poten-
tial risks from DNA research activities;
the definition of recombinant DNA ac-
tivities to be regulated; penalties for
compliance; the authority of the Fed-
eral Government to preempt State and
local regulations. The proposal reflects
concerns expressed in supplemental
views filed with the report (No. 95-359)
of the Human Resources Committee on
S. 1217.

We are interested in the views of all
interested parties on this important leg-
islation.

I ask unanimous consent that the
amendment be printed in the Record
following these remarks, along with sup-
plemental views on S. 1217, and an ar-
ticle in the New York Times, July 31,
1977, by Walter Sullivan, science editor.

There being no objection, the mate-
rial was ordered to be printed in the
Record, as follows:

Amendment No. 754

Strike out all after the enacting clause
and substitute the following :
short imr

Section 1. This Act may be cited as the
"Recombinant DNA Act".

FINDINGS

Sec. 2. The Congress finds that —

(1) research and other activities Involv-
ing recombinant DNA will Improve tie
understanding of fundamental biological
esses:

(2) the knowledge gained from such re-
search and other activities may be of great
benefit to medicine and agriculture end may
provide many other benefits to society;

(3) there exist, however, uncertainties
regarding the extent to which recombinant
DNA or organisms or viruses containing re-
combinant DNA end activities Involving
recombinant DNA may present a tire of
Injury to health or the environment, end
there Is a risk that such organisms and
viruses may spread quickly and without
warning to persons, agricultural plants and
products, and other items In or affecting
commerce;

(4) the public interest requires that the
health and welfare of the population of the
United States be protec red from such risk,
and commerce In the United States 1« de-
pendent upon such protection being pro-
vided; and

(5) to effectively accomplish such protec-
tion and consequently to effectively regulate
commerce requires that the possession cf
recombinant DNA and any activity engaged
In for Its production (whether a research or
commercial activity) be subject to control.

AMENDMENT TO THE PUBLIC HEALTH SERVICE
ACT

Sec. S. Title IV cf the Public Health Serv-
ice Act is amended (1) by redesigantlug;
part I as part J. (2) by redesignating sec-
tions 471 through 476 (and all references to
such sections) as section 486 through 431,
respectively, and (3) by inserting afier part
H the following new part :

"Part I — Recombinant DNA

* ‘DEFINITION S

“Sec. 471. For purposes of this part:

“(1) The term ’DNA’ means deoxyribonu-
cleic acid.

“(2) The term ‘recombinant DNA’ means
DNA molecules consisting of segments of
DNA from different genomes which have been
Joined together outside of living cells and
which have the capacity to Infect seme host
cell and be maintained therein and which
are novel. Novel' means, molecules that con-
sist of segments of any DNA from different
species that are not known to exchange
chromosomal DNA by natural physiological
processes. The Secretary shall prepare a list
of DNA combinations (viral, extrachromo-
somal. or chromosomal) which are not novel.
Recombinant DNA molecules formed from
any combination of DNA's will not be con-
sidered novel when all of the components
are derived from genomes known to replicate
naturally within the organism used to pro-
pagate the recombinant DNA.

"(3) The term ‘local biohazards commit-
tee' means a local biohazards committee es-
tablished in accordance with section 475, and
the term 'Advisory Committee" means the
Recombinant DNA Advisory Committee es-
tablished under section 481.

“(4) The possession In a State cf recom-
binant DNA by any individual or public or
private entity and any activity (including
research and transportation) undertaken In
a State by any individual or public or pri-
vate entity for the production of recom-
binant DNA are collectively referred to as

[804]

August 2, 1977 CONGRESSIONAL RECORD — SENATE

S 13313

‘recombinant DNA activities’. The term ’pub-
lic entity’ Includes any Federal, State, oV
local governmental entity.

•’(5) Tire term ’Secretary’ means the Secre-
tary ot Health, Education and Welfare.

"INTERIM CONTROL

’’Sec. 472. (a)(1) During the period be-
ginning on the tenth day after the date of
the enactment of this part and ending
■'(A) eighteen months after such date, or
“(B) on the date the regulations required
by section 475 take effect,

whichever occurs first, all recombinant DNA
activities shall be carried out In accordance
wtth the physical and biological containment
requirements described In paragraph (2) .

"(2) The physical and biological contain-
ment requirements referred to In paragraph
(1) are the physical and biological contain-
ment requirements —

“(A) as contained In the recombinant
DNA research guidelines of the Department
of Health. Education and Welfare published
in part XI of the Federal Register for July 7,
1970.

“(B) If revised between July 7. 1976, and
the tenth day after the date of the enact-
ment of this part, as so revised, or

“(C) If revised under subsection (c), as so
revised.

"(3) Before the expiration of the ten-day
period beginning on the date of the enact-
ment of this part, the Secretary shall take
such action as niAy be necessary to publicize
»Dd make available the requirements de-
scribed In paragraph (2), Including the pub-
lication of such requirements in the Federal
Register.

“(b) From the date of the enactment of
this part until the expiration of the period
described In subsection (a), all the require-
ments of the recombinant DNA research
guidelines of the Department of 'Health, Edu-
cation, and Welfare — •

“(1) as published In part II of the Federal
Register for July 7. 1976,

“(2) If revised between July 7, 1976. and
the tenth day after the date of the enact-
ment of this part, as so revised, or

“(3) If revised under subsection (c). as so
revised, shall continue to apply as specified
In such guidelines.

“(c) The phj-slcal and biological contain-
ment requirements of the guidelines de-
scribed In subsection (a) which are In effect
on the tenth day after the date of the en-
actment- of this part may be revised only by
regulations promulgated by the Secretary In
accordance with section 553 of title 5. United
States Code.

“(d)(1) Each Individual or entity which,
on the date of the enactment of this part. Is
responsible for the conduct of any recombi-
nant DNA activity shall. In accordance with
regulations promulgated under subsection
(e) and before the expiration of ninety days
from the date of the enactment of this part,
report In writing to the Secretary —

“(A) such Individual's or entity's name,
and

“(B) a description of such activity and an
identification of the place or places In which
It Is being conducted

“(2) Each Individual or entity which Is to
be responsible for a recombinant DNA ac-
tivity to be commenced during the period
described In subsection (a) shall upon the
commencement of such activity report in
writing to the Secretary such individual’s or
entity's name, a description of such activity,
and an identification of the place or places
In Which such activity Is to he conducted.

“(e) Before the expiration of the forty-five
day period beginning on the date of the
enactment of this part, the Secretary shall,
without regard to subsections (c) and (d)
of section 553 of ttlle 5. United States Code,
promulgate such regulations as may be nec-
essary for the administration of the require-
ments of this section.

“(f) The regulations described in this sec-
tion and In section 476 may be promulgated
without regard to section 102(2) (C) of the
National Environmental Policy Act of 1969.

“GENERAL REQUIREMENTS

“Sec. 473. (a) Except as provided under
subsection (b), the following requirements
apply under this part with respect to recom-
binant DNA activities:

“(1) Each facility In which a recombinant
DNA activity Is to be conducted shall be
licensed In accordance with section 475.

“(2) The transportation of recombinant
DNA and any other recombinant DNA ac-
tivity (Including an agricultural activity)
which Is not conducted in a facility shall be
carried out in accordance with regulations
promulgated by the Secretary under section
474.

“(b) The Secretary may, by regulation,
exempt from the requirements of this part
any recombinant DNA activity which the
Secretary finds does not present a significant
risk to health or the environment.

“CONTROL OF NONFACILITY RECOMBINANT
DNA ACTIVITIES

“Sec. 474. (a) The Secretary shall promul-
gate regulations to control the conduct of
recombinant DNA activities described In sec-
tion 473(a)(2). Such regulations shall —

“(1) prescribe physical and biological con-
tainment requirements for the conduct of
such activities:

“(2) apply as appropriate, to the conduct
of such activities, the personnel safety re-
quirements prescribed under section 475;

“(3) Include such special requirements as
the Secretary determines necessary for the
conduct of recombinant DNA activities In-
volving more than ten liters of cell cultures
containing recombinant DNA and for the
conduct of any fommercial recombinant
DNA activity which the Secretary deter-
mines may present a significant risk to
health or the environment; and

“(4) Include such other provisions as the
Secretary determines to be necessary for the
protection of health or the environment.

“(b) The Secretary shall consult with the
Advisory Committee respecting the promul-
gation of the regulations required by subsec-
tion (a) (including the promulgation of
amendments to such regulations other than
amendments to make clerical or technical
changes) , and any notice of proposed rule-
making issued by the Secretary respecting
such regulations shall contain any com-
ments submitted respecting such regulations.

“(c) The regulations required by subsec-
tion (a) shall be initially promulgated-wlth-
ln one year of the date of the enactment of
this part and shall take effect upon the ex-
piration of one hundred and eighty-days from
the date of their promulgation.

“(d) The Secretary shall provide for an
annual review of the regulations required by
subsection (a) to determine If their require-
ments continue to protect health and the
environment.

“(e) If the Secretary receives a petition
for the promulgation of a regulation to pre-
scribe an additional requirement under sub-
section (a) or to revise or repeal a require-
ment contained in a regulation promulgated
under that subsection, the Secretary shall
either approve or deny the petition within
one hundred and twenty days after the date
the petition Is received by the Secretary. If
the Secretary approves such a petition, the
Secretary shall, as soon as practicable after
the date the petition Is atjproved. commence
a proceeding as requested by the petition. If
the Secretary denies such a petition, he shall
notify the petitioner of the denial and the
reasons therefor ar.d shall publish such rea-
sons In the Federal Register.

“LICENSES

“Sec. 475. (a)(1) Licenses for facilities
in which recombinant DNA activities are to

be conducted shall be Issued, amended, and
renewed in accordance with this section.

“(2) A license under this section Is the
authority for the conduct of recombinant
DNA activities in the facility or facilities for
which the license Is Issued. The Secretary
shall prescribe guidelines respecting —

“(A) the types and number of facilities
that may be covered by a single license, and

“(B) the types of recombinant DNA activi-
ties that may be authorized by a single
license.

"(3) (A) The Secretary shall promulgate
regulations to Implement the administration
of this section. Such regulations shall —

“(1) prescribe physical and biological con-
tainment for recombinant DNA activities au-
thorized to be conducted under licensee Is-
sued under this section;

“(11) prescribe requirements for —

“(I) laboratory safety training to be given
to, and safety techniques to be followed by,
personnel to be Involved In such activities.

“ (II) monitoring sys terns to protect against
accidental exposure and other hazards to the
health of such personnel while engaged In
such activities,

“(III) the type and form of Information
to tb given sucK personnel concerning the
nature of the health risks presented b7 such
activities and the frequency and manner of
giving them such Information, and

"(IV) the type and frequency of medical
examinations to be given such personnel
wrhlle engaged In such activities;

“(111) prescribe requirements respecting re-
ports to be made and records to be main-
tained by the holders of licenses Issued under
this section;

"(iv) Include such special requirements as
the Secretary determines necessary for the
conduct of recombinant DNA activities In-
volving more than ten liters of cell cultures
containing recombinant DNA and for the
conduct of any commercial recombinant DNA
activity which the Secretary determines may
present a significant risk to health or the
environment; and

“(v) Include such other provisions as the
Secretary determines necessary for the ef-
fective administration of the requirements
of this section.

“(B) Regulations required . by subpara-
graph (A) shall be Initially promulgated
within one year of the date of the enactment
of this part and shall take effect upon the
expiration of one hundred and eighty days
from the date of their promulgation.

“(C) The Secretary shall consult with the
Advisory Committee respecting the promul-
gation of the regulations required by sub-
paragraph (A) (including the promulgation
of amendments to such regulations other
than amendments to make clerical or techni-
cal changes), and any notice of proposed
rulemaking Issued by the Secretary respect-
ing such regulations shall contain any com-
ments submitted to the Secretary by the Ad-
visory Committee respecting such regula-
tions.

"(D) The Secretary shall provide for an
annual review of the regulations required by
subparagraph (A) to determine if their re-
quirements continue to protect the public
health and safety and the environment.

“(E) If the Secretary receives a petition
for the promulgation of a regulation to pre-
scribe an additional requirement under sub-
paragraph (A) or to revise or repeal a re-
quirement contained in a regulation promul-
gated under that subparagraph, the Secre-
tary shall either approve or deny the petition
within one hundred and twenty days after
the date the petition Is received by the Secre-
tary. If the Secreta'ry approves such a peti-
tion. the Secretary shall, as soon as practica-
ble after the date the petition is approved,
commence a proceeding as requested by the
petition. If the Secretary denies such a peti-
tion, he shall notify the petitioner of the

[805]

CONGRESSIONAL RECORD — SENATE August 2y 1977

S 13314

denial and the reasons therefor and shall
publish such reasons In the Federal Register.

“(4) (A) A license to authorize the con-
duct In a facility of any recombinant DNA
activity which under the applicable physical
containment requirements promulgated un-
der paragraph (3) (A)(1) requires physical
containment at the equivalent of the P-4
level prescribed by the guidelines referred
to In section 472 (a) (2), may only be Issued,
amended, or renewed by the Secretary. Any
comments of the Advisory Committee and
the local biohazards committee with Jurls-
dlctlon over such facility chall be published
In the Federal Register.

"(B) A license to authorize the conduct
In a facility of any recombinant DNA activity
which under the applicable physical contain-
ment requirements promulgated under para-
graph (3) (A)(1) requires physical contain-
ment at the equivalent of the P-3 level pre-
scribed by the guidelines referred to In sec-
tion 472 (a) (2), may be Issued, amended, and
renewed by a local biohazards committee in
acoordance with this subparagraph. If the
committee proposes to approve an applica-
tion for the Issuance, amendment, or re-
newal of such a license, such committee 6hall
submit to the Secretary —

"(1) the application for such action to-
gether with any materials submitted to the
committee respecting the application, and

"(11) a statement of any conditions pro-
posed to be Imposed by the committee on the
approval of the application to assure that re-
quirements under this part applicable to re-
combinant DNA activities which would be
conducted under the license are complied
with,

and, within thirty days of the submittal of
such application and statement, the Secre-
tary shall review the application to deter-
mine If its approval would be In accordance
with the requirements of this part. The local
biohazards committee may approve the ap-
plication unless within the applicable review
period the Secretary determines that It may
not be approved. The Secretary shall, subject
to section 480, publish In the Federal Register
the results of any application review con-
ducted under this subparagraph, and the
comments of the Advisory Committee on such
application.

“(C) A license to authorize the conduct In
a facility of any recombinant DNA activity
not described In subparagraph (A) or (B)
may be Issued, amended, and renewed by a
local biohazards committee. Upon the issu-
ance, amendment, or renewal of a license by
a local biohazards committee, such commit-
tee shall submit to the Secretary (1) the ap-
plication for such action together with any
materials submitted to the committee re-
specting the application, and (11) a state-
ment of any conditions Imposed by the com-
mittee on the approval of the application to
assure compliance with requirements under
this part applicable to recombinant DNA ac-
tivities which are to be conducted under the
license.

"(D) If the holder of a license under this
section proposes —

"(1) to conduct a recombinant DNA ac-
tivity which is not authorized by such li-
cense. such activity may not be conducted
under such license before It Is amended to
authorize such activity; or

“(11) to alter or expand a facility licensed
by such license, no recombinant DNA ac-
tivity may be conducted In such facility be-
fore the license Is amended to cover such
facility as so altered or expanded.

The Secretary shall prescribe procedures, as
appropriate, for the expeditious handling of
applications for amendments of licenses.

•■'(E) If the Secretary determines that the
Issuance, amendment, or renewal of a license
by a local biohazards committee under sub-
paragraph (B) or (C) was not in accordance
with the requirements of this part, or was

not In the best interests of the public, the
Secretary may take such action with respect
to the license as he determines is necessary.
Including revoking, suspending, or limiting
the license.

••(F) The Issuance, amendment, and re-
newal of a single license to authorize the
conduct of any combination of recombinant
DNA activities described in subparagraphs
(A). (B) , and (C) shall be carried out Jointly
by the Secretary and the local biohazards
committee involved In accordance with
guidelines prescribed by the Secretary.

“(b) Any Individual or public or private
entity may apply for the issuance of a license
under this section, and the holder of a license
may apply for Its amendment or renewal.

An application for the Issuance or renewal
or a license shall be made In such form and
manner as the Secretary shall prescribe and
shall contain —

"(1) a description of each recombinant
DNA activity to be conducted under the li-
cense (Including applicable research hypo-
theses, designs, and protocols). Identification
of the primary professional personnel to be
engaged In each such activity and their qual-
ifications, and a description of the faculties
and materials to be used in each such
activity;

“(2) assurances satisfactory to the Issuer
of the license that each recombinant DNA
activity to be conducted under the license
will be conducted in accordance with appli-
cable physical and biological containment re-
quirements prescribed under subsection
(a) (3) (A) (1);

“(3) assurances satisfactory to the Issuer
of the license that In that conduct of each
such activity there will be compliance with
applicable personnel safety requirements
prescribed under subsection (a) (3 (A) (11) ;

"(4) asssurances satisfactory to the Issuer
of the license that the holder of the license
shall make such reports, and shall maintain
such records, respecting each such activity
(Including reports, and records of any sig-
nificant or recurring Illness, serious Injury,
or death of any personnel engaged In such
activity and of the health care provided such
personnel while engaged In such activity) as
are required under subsection (a)(3)(A)
(HI):

“(5) a statement of the results of any
evaluation made by or known to the appli-
cant of the risks to health or the environ-
ment which may be presented by any recom-
binant DNA activity to be conducted under
the license; and

"(6) such additional information as the
Secretary may prescribe.

Applications for the amendment of a license
shall contain the Information required by the
preceding sentence as the Secretary deter-
mines Is necessary.

“(c) A license Issued under this section
shall be valid for such period (but not In
excess of thirty-six months) as the Secretary
may prescribe. Such a license shall contain
such terms and conditions as the Secretary
finds are necessary and appropriate to carry
out the requirements of this section and shall
Identify each recombinant DNA activity
which may be conducted under the license
and the facility In which it Is to be con-
ducted.

"(d) The Secretary may revoke, suspend,
or limit a license If he finds, after reason-
able notice and opportunity for a hearing to
the holder of the license, that the holder
of tha license, any employee or agent of the
holder, or any person engaged In a recom-
binant DNA activity In such facility—

“(1) misrepresented any material fact In
obtaining the license,

“(2) has engaged In or attempted to en-
gage-in, or represented himself as entitled to
perform, any recombinant DNA activity not
authorized by the license.

“(3) has failed to comply with any of the
terms or conditions of the license.

“(4) has failed to comply with a request
of the Secretary for any Information or ma-
terials the Secretary finds necessary to de-
termine the continued eligibility for the
license or to evaluate the possible effects on
health or the environment of the recom-
binant DNA activities conducted in the
facility.

“(5) has failed to comply with a request of
the Secretary to Inspect any portion of the
facility. Its operations, or Its records, which
are related to recombinant DNA activities,
or

"(6) has violated or aided and abetted In
the violation of any requirement established
under this part.

“(e) The Secretary ehall, within one year
after the regulations Initially promulgated
under subsection (a) (3) take effect, prepare
a summary of the recombinant DNA activ-
ities authorized to be conducted under li-
censes Issued under this section and shall,
subject to section 480, make such summary
available for Inspection by the public at rea-
sonable times and places. Such summary
shall be kept current by the Secretary.

“LOCAL BIOHAZARDS COMMITTEES

“Sec. 476. (a) No facility may be licensed
under section 475 unless a local biohazards
committee has been established in accord-
ance with this section with Jurisdiction over
such facility. The Secretary shall prescribe
the number and type of facilities which may
be within the Jurisdiction of a single local
biohazards committee.

"(b) Each local biohazards committee
(hereinafter In this section referred to as
a ‘committee’) shall be established and op-
erate In the manner prescribed by this sec-
tion and regulations of the Secretary under
this section. 8uch regulations shall be Ini-
tially promulgated within one hundred and
eighty days of the date of the enactment
of this part, and shall provide that a com-
mittee may not exercise the functions pre-
scribed by subsection (c) unless the Secre-
tary has authorized its establishment for
purposes of this part.

“(c)(1) Each committee shall have the
authority prescribed by section 475 with re-
spect to the Issuance, amendment, and re-
newal of licenses under that section. A com-
mittee shall receive and consider license ap-
plications in accordance with such proce-
dures as the Secretary shall prescribe. A com-
mittee may not 'approve an application for
the Issuance, amendment, or renewal of a li-
cense unless at least three-fourths of the
members of the committee vote to approve
the application. Upon the WTltten request of
any member of a committee for review by
the Secretary of any decision of the commit-
tee respecting the Issuance, amendment, or
renewal of a license, the Secretary shall con-
duct such review and report the results of
this review to the committee. Such a de-
tailed statement of the reasons for request-
ing review by the Secretary.

"(2) A committee shall, with respect to a
facility licensed under section 475, be re-
sponsible for such Inspections (In accord-
ance with section 477) and monitoring ac-
tivities as the Secretary may require to as-
sure that the recombinant DNA activities
conducted In such facility are conducted In
accordance with the requirements of this
part and of the license of the facility. No
person who is a member of a committee and
who is engaged In or has a financial interest
In any recombinant DNA activity, may par-
ticipate in any function of the committee
with respect to such activity.

"(d)(1) Each committee shall have hot
less than seven or more than thirteen voting
members. The members of a committee shall
be Individuals who by virtue of their train-
ing or experience are qualified to participate

[806]

CONGRESSIONAL RECORD — SENATE

S 13315

j August 2, 1977

In the functions of the committee. At least
one member of a committee shall represent
the Interests of ronprofessionals engaged In
recombinant DNA activities and one shall
represent a local public health authority
within the jurisdiction of the committee;
ar.d there shall be two nonvoting members,
one of whom shall represent a local govern-
ment within such Jurisdiction, and one shall
be representative of the interests of a com-
munity within such Jurisdiction At least
one-lhlrd of the voting members of any
committee shall be Individuals who are not
employees of. and who do not have a finan-
cial interest In, any applicant for a license
under section 475.

! •'(2) The Secretary may require a com-

mittee to use a biological safety officer to
carry out the monitoring and Inspection
functions of the committee with respect to
recombinant DNA activities described in .sub-
paragraphs (A) and (B) of section 475(a)
(4). Such an officer shall have such public
health, microbiological, and other apropri-
ate training as the Secretary shall prescribe.

"INSPECTIONS

"Sec. 477. (a)(1) For purposes of enforce-
ment of the licensing requirements of this
part and the requirements of section 472 ap-
plicable to facilities. Individuals (Including
employees and agents of local biohazards
committees) designated as inspectors by the
Secretary, upon presenting appropriate cre-
dentials and a written notice to the owner,
operator, or agent In charge and after clearly
Informing him of thetr authority, are au-
thorized to enter and Inspect any facility in
a State In which a recombinant DNA activity
Is being conducted or In the case of Individu-
als conducting an Inspection for a local bio-
hazards committee, any facility under the
Jurisdiction of such committee In which a
recombinant DNA activity is being con-
ducted. A separate notice shall be given for
each such Inspection, but a separate notice
shall not be required for each entry made
during the period covered by the Inspection.
Such an Inspection (A) shall be made during
the normal business hours of the facility be-
ing Inspected and In a reasonable manner,
and (B) rnay extend to relevant equipment,
materials, containers, records, flies, papers,
processes, controls, facilities, and all other
things in the facility bearing on whether the
recombinant DNA activity Is being conducted
In accordance with the licensing require-
ments of this part or the applicable requlre-
I ments of section 472.

“(2) Upon completion of any Inspection of
a facility authorized by paragraph (l) and
prior to leaving the facility, the Individual
making the Inspection shall give to the
owner, operator, or agent in charge a pre-
liminary report which summarizes any con-
dition or practice observed by such indl-.
vldual which. In hts Judgment. Indicates a
violation of the licensing requirements of
this part. He shall also prepare a written
i final report of h!s findings and send It to
such owner, operator, or agent within thirty
days of the completion of the Inspection.

"(b)(1) For purposes of enforcement of
the requirements prescribed by or under
sections 472 and 474. Individuals (Including
employees and agents of local btohazards
committees) designated as inspectors by the
Secretary, upon presenting appropriate cre-
dentials to the owner, operator, or agent (If
any of these be present) In charge of —

“(A) a vehicle or other conveyance which
may be used In the transportation of recom-
binant DNA and In which the Inspector has
reasonable grounds to believe that recom-
binant DNA ts present, or

"(B) any real property which Is not sub-
ject to Inspection under subsection (a) and
tn which the Inspector has reasonable
grounds to believe recombinant DNA Is
present.

and after clearly informing him of their
authority under this paragraph, may enter
such conveyance or real property at reason-
able times, and Inspect, at reasonable times
and in a reasonable manner, such convey-
ance or real property and all things in that
conveyance or real property which he has
reasonable grounds to believe bear on
whether a recombinant DNA activity Is being
conducted In accordance with the applicable
requirements of section 472 or 474.

“(2) Upon completion of any inspection
of a conveyance or real property authorized
by paragraph (1) and prior to leaving It, the
Individual making the inspection shall give
to the owner, operator, or agent In charge
a preliminary report which summarizes an^
condition or practice observed by such In-
dividual which, in his Judgment, Indicates a
violation of the requirements of section 472
or '474. He shall also prepare a written final
report of hLs findings and send it to such,
owner, operator, or agent within tlilrty days
of the completion of the Inspection.

"(c) At the request of an Inspector con-
ducting an inspection under subsection (a)
or (b) of a facility, conveyance, or real prop-
erty, the person In charge of such facility,
conveyance, or property shall provide such
samples of —

"(1) recombinant DNA In such facility,
conveyance, or property, or

"(2) materials used In or produced by any
recombinant DNA activity conducted In
such facility or property, as the Inspector
may require to determine If the applicable
requirements of sections 472, 474, and 475
are being complied with.

"(d) If during an Inspection of a facility,
conveyance, or real property conducted un-
der subsection (a) or (b), recombinant DNA
or any material used In or produced by a
recombinant DNA activity which the Inspec-
tor making the Inspection has reason to
believe presents a significant risk to health
or the environment is found in such facility,
conveyance, or property, such Inspector may
order the recombinant DNA or material de-
tained (In accordance with regulations pro-
mulgated by the Secretary) for a reasonable
period which may not exceed twenty days
unless the Secretary determines that a pe-
riod of detention greater than twenty days
Is required to Institute an action under sec-
tion 479(b), In which case the Secretary may
authorize a detention period of not to ex-
ceed an additional thirty days. Any recom-
binant DNA or material subject to a deten-
tion order issued under this subsection shall
not be moved by any person from the place
at which It Is ordered detained until —

“(1) released by the Secretary, or

"(2) the expiration of the detention pe-
riod applicable to such order,
whichever occurs first.

"(e) No Individual deslgnatd by the Sec-
retary to conduct an Inspection under sub-
section (a) or (b) shall be required to ob-
tain a search or Inspection warrant from
any Judical officer before entering any fa-
cility, conveyance, or real property to con-
duct such Inspection.

“(f) No Individual who Is engaged In or
has a direct financial Interest In any recom-
binant DNA activity may be designated by
the Secretary to conduct an Inspection un-
der subsection (a) of the facility In which
such activity Is being conducted, and no
Individual who Is engaged In or has a di-
rect financial Interest In any recombinant
DNA activity subject to regulation under
section 472 or 474 may be designated by the
Secretary to conduct an inspection under
subsection (b) with respec^ to the activity
In which he Is engaged.

"PROHIBITED ACTS AND PENALTIES

"Sec. 478. (a) No person tnay violate the
provisions of this part or any\ regulation pro-
mulgated under this part.

“(b)(1) Any person who violates subsec-
tion (a) may have their license revoked, sus-
pended, or limited by the Secretary In ac-
cordance with section 475(d).

"(c) Any person who knowingly or will-
fully violates subsection (a) shall be sub-
ject, upon conviction, to a fine of not more
than £2.000. Each day a violation of subsec-
tion (a) continues shall constitute a sepa-
rate violation for purposes of this subsec-
tion.

"(d) For a period of time to be deter-
mined by the court, no grant, contract,
or other form of financial assistance for
any purpose related to recombinant DNA
may be provided under this Act to any per-
son convicted under subsection (c) of a
violation of subsection (a).

“injunction authority; emergency
procedure

“Sec. 479. (a) The district courts of the
United States shall have Jurisdiction over
civil actions to restrain any violation of
section 478 (a). Such a civil action may be
brought In the United States district court
for the Judicial district wherein any act.
omission, or transaction constituting a vio-
lation of section 478 (a) occurred or wherein
the defendant Is found or transacts business.
In any such civil action, process may be
served on a defendant In any Judicial district
in which the defendant resides or may be
found. Subpenas requiring attendance of
witnesses In any such action may be served
In any Judicial district.

“(b) The district courts of the United
States shall have Jurisdiction over any civil
action brought (1) for the seizure or de-
struction of any recombinant DNA, or any
material used In or produced by a recombi-
nant DNA activity, which recombinant DNA
or material presents or may present a sig-
nificant risk of health or the environment
or (2) for other appropriate relief to prevent
its production or movement. Such civil ac-
tion shall be brought In the district court
of the United States within the Jurisdiction
In which such recombinant DNA or material
Is found.

“disclosure of data

"Sec. 480. (a) (1) Any Information report-
ed to. or otherwise obtained by, the Secre-
tary (or any representative of the Secretary)
or any local biohazards committee under
this part, which Is exempt from disclosure
pursuant to subsection (a) of section 552
of title 5. United States Code, by reason of
subsection (b) (4) of such section, shall not
be disclosed, except that such Information —

"(A) shall be disclosed by the Secretary
to any officer or employee of the United
States —

"(1) In connection with the official duties
of such officer or employee under any law for
the protection of health or the environment,
or

"(11) for specific law enforcement pur-
poses;

"(B) shall be disclosed by the Secretary If
the Secretary determines it necessary to pro-
tect health or the environment against an
unreasonable risk of Injury: or

"(C) may be disclosed by the Secretary
• when relevant In any proceeding under this
part, except that disclosure In such a pro-
ceeding shall be made In such manner as to
preserve confidentiality to the extent prac-
ticable without Impairing the proceeding.

A research hypothesis, design, or protocol
shall, for purposes of this paragraph, be con-
sidered to be Information which Is exempt
from disclosure pursuant to subsection (a)
of setclon 552 of title 5, United States Code,
by reason of subsection (b) (4) of such sec-
tion.

“(2) In any proceeding under subsection
(a) of section 552 of title 5, United States
Code, to obtain Information the disclosure
of which has been denied because of the pro-

[807]

CONGRESSIONAL RECORD — SENATE

S 13316

visions of paragraph (1) of this subsection,
the Secretary or a local biohazards commit-
tee may not rely on subsection (b) (3) of such
section 552 to sustain the Secretary's or
committee's action.

"(b) Subsection (a)(1) does not prohibit
the disclosure of any statement of an evalua-
tion of risks submitted under section 473
0>)(5).

"(c)(1) In submitting data under this part,
the Individual or entity submitting the data
may (A) designate the data which such in-
dividual or entity believes is entitled to con-
fidential treatment under subsection (a) (1),
and (B) submit each designated data sep-
arately from other data submitted under
this part. A designation under this para-
graph shall be made in writing and in such
manner as the Secretary may prescribe.

"(2) (A) Except as provided in subpara-
graph (B), if the Secretary or a local bio-
hazards committee proposes to release for
inspection data which has been designated
under paragraph 1 1 > ( A ) . the Secretary cr
committee shall notify, in writing and by
certified mail, the individual or entity which
submitted such data of the intent to release
such data. If the release of such data is to be
made pursuant to a request made under sec-
tion 552(a) of title 5. United States Code,
such notice shall be given immediately upon
approval of such request by the Secretary or
committee. The Secretary or committee may
not release such data until the expiration of
thirty days after the Individual or entity
submitting such data has received the notice
required by this subparagraph.

(B) Subparagraph (A)'shall not apply to
the release of Information under subpara-
graph (A), (B), or (C) of paragraph (1) of
subsection (a), except that the Secretary
may not release data under subparagraph
(B) of such paragraph (1) unless the Sec-
retary has notified each individual or entity
who submitted such data of such release.
Such notice shall be made In writing by
certified mail at least fifteen days before
the release of such data, except that if the
Secretary determines that the release of such
data . Is necessary to protect against an
Imminent, unreasonable risk of injury to
health or the environment, such notice may
be made by such means as the Secretary
determines will provide notice at least
twenty-four hours before such release Is
made.

(d) Any officer or employee of the United
States (Including any member or employee
of the Advisory Committee) or member or
employee of a local biohazards committee or
former officer or employee of the United
States or former member or employee of such
a committee, who by virtue of such employ-
ment or official position has obtained posses-
sion of, or has access to, material the dis-
closure of which Is prohibited by subsection
(a) . and who knowing that disclosure of such
material Is prohibited by such subsection,
willfully discloses the material tn any man-
ner to any person not entitled to receive It,
shall be guilty of a misdemeanor and fined
not more than $5,000 or imprisoned for not
more than one year, or both. Section 1905
of title 18, United States Code, does not ap-
ply with respect to publishing, divulging,
disclosing, making known, or making avail-
able information reported or otherwise ob-
tained under this part.

(e) Notwithstanding any limitation con-
tained in this section or any other provision
of law, all information reported to or other-
wise obtained by the Secretary (or any rep-
resentative of the Secretary) or by any local
biohazards committee, under this part shall
be made available, upon written request of
any duly authorized committee of the Con-
gress, to such committee.

“(f) Each local biohazards committee shall
be considered an agency for purposes of sec-
tion 552 of title 5. United States Code.

“ADVISORY COMMITTEE

“Sec. 481. (a) There Is established the
Recombinant UNA Advisory Committee
which shall 3dvise the Secretary and make
recommendations to the Secretary for the
eflective administration of this part.

"(b) The Advisory Committee shall con-
sist of seventeen members appointed by the
Secretary from Individuals who by virtue of
their training or experience are qualified to
participate in the functions of the Advisory
Committee. Of the individuals appointed as
members of the Advisory Committee (1) one
shall be representative of the Interests of
nouprofessional personnel engaged In recom-
binant DNA activities; (2) one shall be rep-
resentative of the interests of entities en-
gaged In such activities for commercial pur-
poses; and (3) at least nine shall be Indi-
viduals who are not actively engaged in any
recombinant DNA activity and do not have
a direct financial Interest in such an activity.
Of those nine Individuals, at least four shall
be scientists who are knowledgeable in the
various scientific and medical disciplines
necessary for an evaluation of the potential
risks to health and the environment pre-
sented by recombinant DNA activities.

Receipt of a salary1 from an Institution
that sponsors recombinant DNA activity
shall not qualify as a direct financial inter-
est. One member of the Advisory Committee
shall be a specialist in public health, one
shall have background In the ethical con-
cerns Involved in biomedical research, and
three shall represent the Interests of the gen-
eral public. The term of office of a member
of the Advisory Committee shall he three
years, except that of the members first ap-
pointed to the Advisory Committee, six shall
be appointed for a term of one year and six
shall be appointed for a term of two years,
as designated by the Secretary at the time of
appointment. Section 14 of the Federal Ad-
visory Committee Act shall not apply with
respect to the duration of the Advisory Com-
mittee.

"(c) Members of the Advisory Committee
(other than officers or employees of the
United States), while attending meetings or
conferences of the Advisory Committee or
otherwise engaged Ln Its business, shall be
entitled to receive compensation at rates to
be fixed by the Secretary, but not at rates
exceeding the daily equivalent of the rate
In effect for grade GS-18 of the General
Schedule, for each day so engaged, including
traveltime; and while so serving away from
their homes or regular places of business
each member may be allowed travel expenses
(Including per diem in lieu of subsistence)
as authorized by section 5703 of title 5. United
States Code, for persons ln the Government
service employed Intermittently.

"EMPLOYEE PROTECTION

"Sec. 482. (a) No employer may discharge
any employee or otherwise discriminate
against any employee with respect to the
employee's compensation, terms, conditions,
or privileges of employment because the em-
ployee (or any person acting pursuant to a
request of the employee) has—

"(1) commenced, caused to be commenced,
or is about to commence or cause to be com-
menced a proceeding under this part,

"(2) testified or is about to testify ln any
such proceeding, or

"(3) assisted or participated or is about to
assist or participate in any manner ln such
a proceeding or In any other action to en-
force any requirement of *his part.

"(b) (1) Any employee who believes that
he has been discharged or otherwise discrimi-
nated against by any person in violation of
subsection (a) of this section may, within
thirty days after such alleged violation oc-
curs, file (or have any person file on the em-
ployee’s behalf) a complaint with the Secre-
tary of Labor (hereinafter ln this section re-
ferred to as the 'Secretary') alleging such

August 2, 1977

discharge or discrimination. Upon receipt of
such a complaint, the Secretary shall notify
the person named ln the complaint of the
filing of the complaint.

"(2) (A) Upon receipt of a complaint filed
under paragraph (1), tho Secretary shall
conduct an Investigation of the violation al-
ledgc-d in the complaint. Within thirty days
of the receipt of such complaint, the Secre-
tary shall complete such Investigation and
shall notify ln writing the complainant (and
any person acting on behalf of the complain-
ant) and the person alleged to have comit-
ted such violation of the results of this in-
vestigation conducted pursuant to this sub-
paragraph. Within ninety days of the re-
ceipt of such complaint the Secretary shall,
unless the proceeding on the complaint is
terminated by the Secretary on the basis of
a settlement entered Into by the Secretary
and the person alleged to have committed
such violation, issue an order either provid-
ing the relief prescribed by subparagraph (B)
or denying the complaint. An order of the
Secretary shall be made on the record after
notice and opportunity for agency hearing.
The Secretary may not enter into a settle-
ment terminating a proceeding on a com-
plaint without the participation and consent
of the complainant.

"(B) If in response to a complaint filed
under paragraph ( 1 ) the Secretary deter-
mines that a violation of subsection (a) of
this section has ocerured. the Secretary shall
order (1) the person who committed such
violation to take affirmative action to abate
the violation, and (li) such person to rein-
state the complainant to the complainant's
former position together with the compen-
sation (including back pay), terms, condi-
tions, and privileges of the complainant's
employment. If such an order Is Issued, the
Secretary, at the request of the complainant,
shall assess against the person against whom
the order is issued a sum equal to the ag-
gregate amount of all costs and expenses (in-
cluding attorney's fees) reasonably incured,
as determined by the Secretary, by .the com-
plainant for, or in connection with, the
bringing of the complaint upon which the
order was issued.

“(c)(1) Any employee or employer ad-
versely affected or aggrieved by an order Is-
sued under subsection (b) may obtain review
of the order ln the United States court of
appeals for the circuit ln which the viola-
tion, with respect to which the order was
Issued, allegedly occurred. The petition for
review must be filed within sixty days from
the Issuance of the Secretary's order. Review
shall conform to chapter 7 of title 5 of the
United States Code.

“(2) An order of the Secretary, with re-
spect to which review could have been ob-
tained under paragraph (1), shall not be
subject to Judicial review ln any criminal
or other civil proceeding.

“(d) Whenever a person has failed to
comply with an order Issued under subsec-
tion (b)(2), the Secretary shall file a civil
action ln the United States district court for
the district ln which the violation was found
to occur to enforce such order. In actions
brought under this subsection, the district
courts shall have Jurisdiction to grant all
appropriate relief, including Injunctive re-
lief. Civil actions brought under this subsec-
tion shall be heard and decided expedi-
tiously.

"(e) Subsection (a) of this section shall
not apply with respect to any employee who,
acting without direction from the employee’s
employer (or any agent of the employer),
deliberately causes a violation of any re-
quirement of this part.

“RELATIONSHIP TO OTHER FEDERAL LAWS

"Sec. 483. (a) Except as provided ln sub-
section (b), notwithstanding any other pro-
vision of law. this section shall limit the
authority of any Federal agency to regulate

[80S]

August 2, 1977 CONGRESSIONAL RECORD — SENATE S 13317

or to make any requirements applicable to
recombinant DNA activities.

■‘(b)(1) Upon application by a Federal
agency, and after consultation with euch
agency, the Secretary may exempt euch
agency from subsection (a) .

"(2) An application for an exemption shall
be accompanied by the proposed require-
ment and the reasons therefor.

“(3) If the Secretary grants an exemption,
the proposed requirement shall be promul-
gated in accordance with section 553 of title
5 of the United States Code.

"(4) The Secretary may limit, alter, or
withdraw such exemption.

“EFFECT OH STATE AND LOCAL. REQUIREMENTS

“Sec. 484. (a) Except as provided in sub-
section (b), no State or political subdivision
of a State may establish or continue in ef-
fect any requirement for the regulation of
recombinant DNA activities.

“(b) Upon application of a State or po-
litical subdivision o* a State, the Secretary
may allow, by order promulgated after pro-
viding (in accordance with this subsection)
notice and opportunity for an oral hear-
ing on such application and after consider-
ing local conditions, exempt from subsec-
tion (a), under such conditions as may be
prescribed In such order, a requirement of
such State or political subdivision applica-
ble to recombinant DNA activities if —

"(1) the requirement is more stringent
than a requirement under this part which
would be applicable to such activities if an
exemption were not In effect under this sub-
section; and

“(2) the requirement is necessary to pro-
tect health or the environment and Is re-
quired by compelling local conditions.

A State or political subdivision which sub-
mits an application under this subsection
6hall be given an opportunity for an oral
hearing on such application to be commenced
not later than sixty days from the date the
application is submitted. The presiding offi-
cer at such a hearing shall upon conclusion
of the hearing make a written recommenda-
tion to the Secretary respecting approval of
the application upon which the hearing was
held.

“(c) Within—

“(1) sixty days of the conclusion of a hear-
ing held on an application submitted under
subsection (b) , or

"(2) one hundred and twenty days of the
date the application was submitted,
whichever occurs later, the Secretary shall
either approve or disapprove such applica-
tion. The decision of the Secretary shall be
In writing, shall, if a hearing was held on
the application, contain the recommendation
made by the presiding officer at such hearing,
and shall Include a statement of the reasons
for the decision of the Secretary.

“training and studies

“Sec. 485. (a) The Secretary may conduct
and support training in the safe handling of
recombinant DNA.

“(b) The Secretary shall conduct or sup-
port on a continuing basis studies designed
to assess the risks to health and the envi-
ronment which may be presented by recom-
binant DNA activities.”.

expiration of act

Sec. 4. This Act expires five years after Its
enactment.

XT Supplemental Views or
Senator Nelson

S. 1217, a bill to regulate deoxyribonucleic
acid (DNA) activities has a laudable goal:
the protection of public health and safety
by requiring that uniform national guide-
lines be met by scientists conducting recom-
binant DNA research, both in publicly sup-
ported and private Industry research labora-
tories.

However, I am concerned that 8. 1217 Is
unnecessarily burdensome and detrimental
to the future of this Important biomedical
research.

Scientists all agree that the Joining to-
gether of different segments of deoxyribo-
nucleic acid (DNA) is a potent tool for the
conquest of disease and other beneficial
scientific advances. The recently announced
discovery that recombined genes facilitate
the production of insulin by bacteria is an
example of such an important breakthrough.
Recombining fragments of DNA occurs con-
tinually in nature. Four years ago, however,
at a 1973 Gordon Conference on Nucleic
Acids, scientists involved in developing re-
combinant DNA research drew attention to
the possible hazards of manmade recom-
binants.

Because scientists and laboratory techni-
cians are at greatest risk of direct contact
with the organisms involved, they have been
most concerned with clearly defining the haz-
ards. To date, despite many thousands of
recombinant DNA experiments, no known
hazards have occurred.

Nevertheless, as a result of concerns ex-
pressed in the 1973 Gordon Conference, and
a 1975 Asilomar Conference, guidelines were
promulgated by the National Institutes of
Health (NIH) in 1976, which are required to
be met by any researchers having Federal fi-
nancial support. The guidelines, however,
cannot be enforced In the private sector
without enabling legislation.

Therefore, legislation to simply extend the
NIH Guidelines to all sectors engaged in re-
combinant DNA activities seems appropriate. '
NIH guidelines

The NIH guidelines prohibit certain kinds
of recombinant DNA experiments and the
release of recombinant molecules into the en-
vironment. Permissible experiments are out-
lined and are assigned both a physical and
biological containment level, depending on
assessment of potential blohazards.-

iPhyslcal containment refers to methods
used to prevent release of organisms con-
taining recombinant DNA molecules from
the lab. Relying on proven methods that
have been developed for handling known
pathogenic organisms in clinical and research
laboratories, physical containment Is ap-
proached in two ways: (1) standard micro-
biological practices and training are pre-
scribed by the guidelines; (2) special kinds
of equipment and facilities are used. Four
levels of physical containment are described,
progressing from least to most strict; P-1,
P-2, P-3, P-4.

Biological containment refers to methods
whereby organisms are weakened, so that, in
the event of their escape from the laboratory,
their survival is extremely improbable. The
guidelines characterize three levels of im-
pairment of a weakened laboratory strain
known as E-coll K-12.

The guidelines also provide an administra-
tive framework for their implementation and
a compendium of safety information.

The guidelines require establishment of
Institutional bio-hazard committees for local
review of recombinant DNA activities.

A Recombinant DNA Advisory Committee,
under the auspices of the' National Institutes
of Health, meets regularly to review and up-
date the guidelines. At their May 15, 1977,
meeting, the Advisory Committee issued the
following statement:

During this period the committee has be-
come better Informed abou/t the general ecol-
ogy and epidemiology of infectious micro-
organisms. Experiments have been reported
showing that the incqrporation of foreign
DNA does not Increase but rather tends to
decrease the growth rate of microorganisms,
and this further contributes to the unlikeli-
hood that cells carrying recombinant DNA
will survive in nature and produce harmful
effects. Indeed, everything that we have

[809]

learned has tended to diminish our estimate
of risk. Nevertheless, the revised guidelines
continue to represent a deliberately conserva-
tive approach, with the intent of erring on
the side of caution.

Uniform guidelines

The Federal Inter-Agency Committee Re-
combinant DNA Research in 1976 proposed
that a single set of national standards be
applied to all recombinant DNA activities.

HEW and representatives of private indus-
try testified before the Health Subcommittee
that all laboratories receiving Federal grants
now comply with the NIH guidelines, and
private laboratories voluntarily impose the
same guidelines on themselves. However, the
extent to which the guidelines are enforced
in the private sector, cannot be determined
without Federal law.

Therefore, the administration proposed a
bill, largely based on the committee's recom-
mendations, which provided HEW with the
responsibility for regulation and specified
that the NIH guidelines be promulgated as
Initial standards. The scope of the regulation
was directed to the use and production of
recombinant DNA molecules. The Depart-
ment was to exercise its regulatory authority
In close consultation with other appropriate
agencies.

Scientists’ concerns -

A 1977 Gordon Research Conference on
Nucleic Acids expressed serious reservations
about pending legislation. An open letter to
Congress, June 18, 1977, signed by 137 mem-
bers of the conference states:

We are concerned that the benefits of re-
combinant DNA research will be denied to
society by unnecessarily restrictive legisla-
tion.

Four years ago, the members of the 1973
Gordon Conference on Nucleic Acids were
the first to draw public attention to possible
hazards of recombinant DNA research. The
discussions which'started at that meeting re-
sulted in the Issuance in 1976 of the NIH
guidelines for the conduct of this research.

We, members of the 1977 Gordon Research
Conference on Nucleic Acids, are now con-
cerned that legislative measures now under
consideration by congressional, State and
local authorities will set up additional reg-
ulatory machinery so unwieldy and unpre-
dictable as to inhibit severely the further
development of this field of research. We feel
that much of the stimulus for this legisla-
tive activity derives from exaggerations of
the hypothetical hazards of recombinant
DNA research that go far beyond any rea-
soned assessment.

This meeting made apparent the dramatic
emergence of new fundamental knowledge
as a result of application of recombinant
DNA methods. On the other hand, the ex-
perience of the last 4 years has not given any
Indication of actual hazard. Under these cir-
cumstances, an unprecedented Introduction
of prior restraints on scientific inquiry seema
unwarranted.

We urge that Congress consider these views.
Should legislation nevertheless be deemed
necessary, it ought to prescribe uniform
standards throuhgout the country .and be
carefully framed so as not to impede scien-
tific progress.

The 137 undersigned are members of the
1977 Nucleic Acids Gordon Conference. _

In addition, a number of other scientists
and scientific organizations have expressed
similar concerns, Including the Inter-Society
Council for Biology and Medicine, compris-
ing officers of seven professional organiza-
tions; the American Institute of Biological
Sciences, the American Society for Medical
Technology, the American Society for Micro-
biology. the American Society of Allied
Health Professions, the Association of Amer-
ican Medical Colleges, the Federation of
American Societies for Experimental Biology

s 13318 CONGRESSIONAL RECORD — SENATE August 2, 197?

and the National Society for Medical Re-
search.

Thirteen members of the National Acad-
emy of Sciences signed a resolution as fol-
lows:

Resolution or the National Academy or
Sciences, Ateil 26, 1927
Three years ago the National Academy of
Sciences played an Important role In Initiat-
ing responsible and Informed discussion on
the need for controls and recombinant DNA
research. The subsequent debate, both In-
side and outside the scientific community,
resulted In a set of guidelines formulated
under the sponsorship of the National In-
stitutes of Health. Now the Congress Is con-
sidering several drafts of detailed and far
reaching legislation dealing with the regul-
ation of recombinant DNA research.

The NTH guidelines are the result of care-
ful deliberation and we favor their simple
conversion Into a uniform national set of
regulations. However, much of the proposed
legislation now before Congress would allow
local communities or states to set their own
stricter regulations. Including even a com-
plete ban on this type of research. It Is rea-
sonable for the local community to partici-
pate In supervising adherence to regulations.
But the question concerns speculative rather
than known dangers and these would not
vary from one locality to another.

The research Institutions of the country
constitute an Important national resource,
and differing local options could subject that
resource to arbitrary regulations. Overly re-
stricting this type of research would severely
degrade the capability of biomedical research
and limit Its contribution to the public wel-
fare. In essence, It would allow a local com-
munity to affect a critical component of na-
tional policy. Above all, local option would
set a dangerous pattern for the regulation of
basic research In a manner that might de-
prive society of substantial future benefits.

Some of the legislation proposes to estab-
lish a national regulatory commission ex-
pressly to govern recombinant DNA research.
Its broad powers for controlling basic re-
search represent a wholly new and unfortu-
nate departure. We are also concerned that
it would set a precedent for the regulation
of other areas of science. A much simpler and
more flexible mechanism allowing for public
participation could carry out those functions
that may be needed.

Therefore, be It resolved that we voice
concern about legislative developments In
this area and ask the president of the Na-
tional Academy of Sciences to relay these
concerns to appropriate officials In the gov-
ernment.

D. Baltimore. B. D. Davis, H. Eagle. J. T.
Edsall, C. Grobsteln, D. M. Horstmann, R.
Hotchkiss, R. J. Huebner, A. Rich, W. A.
Rosenbllth, P. N. Ruddle, B. L. Slnshelmer.
E. L. Smith.

Thus, while I agree with the Intent of
8. 1217, I have serious reservations about Its
approach, based on scientists' concerns that
It will Impose unnecessarily burdensome con-
trols on scientific research. My concerns are
as follows:

(1) Commission.— The bill will create a
new and expensive bureaucracy that Is un-
warranted.

Section 1801 of 8. 1217 establishes an In-
dependent Commission to license, regulate
and make policy decisions regarding recom-
binant DNA activities. Members would be
appointed by the President, with Senate ap-
proval for the Commission Chairman. A
majority of the members would be public,
nonscientists. Section 1801(b) prohibits a
majority of members on the Commission
who are or have been engaged In recombinant
DNA research. This would severely limit the
expertise of a Commission whose major pur-

pose Is to protect health and safety from
untoward effects of such research.

Furthermore, all members would have
other primary responsibilities besides their
Commission activities. Given the number
and the highly technical nature of the as-
signed tasks, such a part-time Commission
would be unworkable, in my view. Section
1816(e) permits the Commission to delegate
technical matters to Its staff or to ad hoc
working groups; however. I do not believe
It Is our Intent to delegate these Important
duties to staff. An Important question also
arises as to who actually would be account-
able for the regulatory activities of such a
free-standing Commission.

Section 361 of the Public Health Service
Act already provides HEW with the following
broad authority to regulate laboratory work
with disease-producing microorganisms:

"The Surgeon General with the approval
of the Secretary Is authorized to make and
enforce such regulations as In hts Judgment
are necessary to prevent the introduction,
transmission or spread of communicable dis-
eases from foreign countries Into the states or
possessions or from one state or possession
Into any other state or possession.”

Under thl3 statute, the Center for Disease
Control has established regulations for con-
tainment and requirements for. working with
different classes of organisms, Including total
prohibition on work with a few lethal micro-
organisms. As a result, there have been very
few cases of laboratory-associated Infection
In the history of the United States and none
that have spread to the community.

Existing law also provides HEW with au-
thority to regulate private and public Inter-
state clinical laboratories (Clinical Labora-
tories Improvement Act of 1967, Public Law
90-174) and legislation is being considered
to broaden HEW's regulatory authority to
Intrastate clinical laboratories. This author-
ity will not cover biomedical research nor
Is It my Intent that It should, but as with
the above-mentioned authority to regulate
laboratory work with disease-producing or-
ganisms, It can provide an alternative mech-
anism In place for monitoring compliance
with the guidelines for recombinant DNA
activities.

Finally, the NIH has an administrative
mechanism In place to Implement Its guide-
lines on recombinant DNA activities.

Therefore, a simple extension of HEW’s
authority to allow for enforcement of DNA
guidelines In the private sector would ac-
complish the objective of establishing uni-
form national guidelines for recombinant
DNA activities.

(2) Penalties. — Section 1809 establishes
penalties for noncompliance, for "any per-
son who knowingly, willfully or negligently”
violates a provision of section 1803, general
requirements and section 1808, prohibited
acts. It authorizes a penalty of 810,000 for
each violation with each day constituting
a separate violation.

The term "negligence” Is not clearly de-
fined. Such a penalty also appears to be
excessive and disproportionate. License revo-
cation In Itself Is an effective penalty. Fur-
thermore a dollar penalty would not deter
those who wish to willfully disregard regu-
lations. In short, we run the risk of enacting
legislation which will obstruct the law-abid-
ing while not effectively deterring the law-
breaker.

(3) Seizure and destruction of research
material. — Section 1810 gives Inspectors au-
thority to seize and destroy "a hazardous
product of recombinant DNA activities” with
the approval of the Commission Chairman
or his designee. A better procedure would
be to seize and hold material pending a Ju-
dicial hearing.

(4) Preemption. — On the whole. I support
Section 1813, which expresses Congressional
Intent that Federal Guidelines supersede any

and all laws regarding recombinant DNA ac-
tivities of States and of political subdivisions.
I believe, however, that the granting of ex-
emptions should take Into account the na-
tional Interest. The purpose of legislation
should be to establish uniform national
standards to regulate recombinant DNA ac-
tivities; otherwise, legislation is not neces-
sary. Since microbes do not respect Federal,
State, or community boundaries, the most
effective standards will be those adopted
Internationally. If we are to negotiate for
International standards, we must have good
uniform national standards, not a potpourri
of domestic standards.

Citizens should have Input Into decisions
regarding protection of the health and en-
vironment of their local communities. How-
ever, the authority to grant exemptions
should be at the Secretary's discretion, based
on clear demonstration that the public
health and environment Is endangered. If a
locality proposes more stringent require-
ments for DNA research as necessary to pro-
tect health and environment. It Is likely that
other communities would require It; thus,
the Secretary should evaluate the need for
Inclusion of more stringent requirements la
the general Federal guidelines, rather than
grant Individual exemptions from them.

(5) Disclosure of research details. — De-
tailed descriptions of recombinant DNA pro-
jects are required to be reported at three
places In the bill : General requirements and
licensure (secs. 1803(b)(1)(C) and 1803(b)
(2) (A) (11)), and registration of DNA proj-
ects (sec. 1818(a)). Such detailed descrip-
tions of research protocols would thus be
given to local biohazard committees: to the
Commission for licensure; and to the Com-
mission for purposes of registering each re-
search project. Section 1803(c) requires the
Commission to publish such Information In
the Federal Register with each license ap-
plication.

The requirements Impose enormous paper-
work burdens on researchers. In addition,
although Section 1817 contains certain ex-
emptions from disclosure. It Is not clear
that It will protect the research protocols,
designs, and hypotheses of academic and In-
dustry researchers. In a recent court ruling
relating to subsection (a) of section 552 o 1
title 5, United States Code (b) (4) (Free-
dom of Information Act). HEW was ordered
to release research protocols on grounds they
were not trade secrets (Washington Re-
search Project, Inc. v. DHEW) . A statute
affording positive protection, therefore, for
Intellectual property rights associated with
recombinant DNA activities should be devel-
oped In accordance with subsection (b) (3)
of the Freedom of Information Act (FOIA).

(6) " Sunset ” provision. — There should be
a "sunset" provision that requires review of
the need for the legislation after a reason-
able time period.

(7) Impact oh small business. — The paper-
work and compliance requirements of the
legislation will be particularly difficult for
small companies to meet, putting them at
competitive disadvantages with large In-
dustries. Compliance with the NIH Guide-
lines already has Imposed administrative
burdens on small laboratories, although they
are able to meet the requirements.

In summary. I must dissent from the deci-
sion of the Committee to recommend pas-
sage of 8. 1217 as reported. Appropriate leg-
islation to allow the application of uniform
Guidelines bv HEW to all sectors will en-
able the United States to negotiate for In-
ternational guidelines for recombinant DNA
activities.

S. 1217, however, sets a bad precedent for
future restrictive regulation of biomedical
research in general. The compliance pro-
visions and paperwork are excessive, possi-
bly unworkable, and particularly burden-
some for small businesses. The potential for^

[810]

CONGRESSIONAL RECORD — SENATE

S 13319

August 2, 1977

obstructing research and Impeding progress
In conquering diseases appears to be much
greater than the benefits accruing to the
public through the provisions of this legis-
lation.

[From the New York Times, July 31, 1977]
Lecisi-ating the Laboratories
(By Walter Sullivan)

One of the tragedies of modern science
was the destruction of Soviet genetics dur-
ing the 1930’s and 1940's, In effect by govern-
ment decree. It was decided by the leaders
of the Communist Party that Trofim D.
Lysenko was right and that classical Rus-
sian geneticists were reactionary and dis-
loyal. Nikolai I. Vavilov, widely recognized
as one of the world's leading plant genetic-
ists, and many others were exiled. Vavilov
apparently died In the labor camp at Maga-
dan on the Sea of Oknotsh. Lysenko's Ideas
were applied to agriculture, resulting In near
disaster.

Now It Is being argued that In the United
States 6teps are about to be taken toward
similar suppression of genetic research,
though the motives differ. The concern Is
for legislation pending both In Albany and
Washington that would establish elaborate —
some researchers say stifling — controls over
research Involving manipulation of the key
molecules In genetics: those of DNA (de-
oxyribonucleic acid). 6uch altered mole-
cules are known as recombinant DNA.

Ironically the legislation Is moving toward
enactment at a time when a number of those
who first sounded the alarm on such re-
search have become convinced by new find-
ings that it can be done In absolute safety.
The result Is an Intensive effort by such sci-
entists to head off the most stringent provi-
sions, particularly those In a Senate bill In-
troduced by Senator Edw'ard Kennedy.

There Is also deep concern that Federal
legislation will allow local and state govern-
ments to Impose even more severe limits, or
ban such research entirely.

Recombinant DNA molecules, as defined
In the Senate bill, "consist of different seg-
ments of DNA which have been Joined to-
gether In a cell-free system, and have the
potential for entering and propagating In a
particular host cell, either autonomously or
as an Integral part of that cell’s genome."
The genome Is the cell’s storehouse of In-
formation, coded Into DNA, that controls Its
development, function and reproduction.

Among the goals of producing such mole-
cules Is the Introduction of new capabilities
Into organisms, such as food crops, or the
alteration of viruses and bacteria In the war
against disease. Both the House and Senate
bills. In their preambles, recognize these
potential benefits, as well as certain health
and environmental hazards.

The favorite tool for genetic research Is a
group of Intestinal bacteria known as Esch-
erichia coll. They occur In thousands of vari-
eties. Meet are harmless, even beneficial, in-
habitants of the Intestinal tracts of human
beings and other warm-blooded animals.
Some cause diarrhea, notably among tourists
exposed to unfamiliar strains.

When recombinant DNA Is allowed to enter
a culture of such bacteria (known for short
as E. coll) It proliferates there, making the
bacteria an Ideal "nursery." The fear has
been that a bacterial culture with an "un-
natural” load of genetic material might es-
cape the laboratory and create an epidemic
•gainst which there was little or no resist-
ance.

When biologists from many parts of the
world: met in Asllomar, Calif., in 1975 to
consider a voluntary moratorium on some
aspects of DNA research, pending assessment
of possible hazards. Dr. Roy Curtiss 3d of
the University of Alabama proposed that the
K12 strain of E. coll could be made so help-
less than It could multiply only under special

laboratory conditions. There would then be
no danger of Its spreading.

Now, In a detailed report to Dr. Donald
Frederlckson, director of the National In-
stitutes of Health, he has. In effect, reported
’success In this effort.

In recent weeks 277 participants In two of
the Gordon Research Conferences In New
Hampshire have signed protests against the
proposed legislation. The conferences, each
summer, bring together top-ranking re-
searchers In a variety of fields.

One document was signed by 137 special-
ists In research on nucleic acids Including
DNA. The second was signed by 140 of 164
biologists at a five-day meeting on biologi-
cal regulatory mechanism. It said "no In-
dication of actual danger has been uncov-
ered,” and termed the proposed regulations
unprecedented “prior restraint” that could
"deprive society of needed improvements In
public health, agriculture. Industry and en-
vlronmntal protection.” Lest the foundation
supporting the conferences lose its tax-ex-
empt status It was emphasized that the or-
ganization was In ho way associated with
the appeals.

Then, on July 14, Dr. Sherwood L. Gor-
bach of Tufts University Medical School re-
ported to Dr. Frederlckson on a workshop
held at Falmouth, Mass., under sponsorship
of two units of Dr. Frederlckson’s National
Institutes of Health. The participants, some
50 In number, he said, "arrived at unanimous
agreement that E. coll K12 cannot be con-
verted Into an epidemic pathogen by lab-
oratory manipulations with DNA Inserts.”

During the workshop, researchers from
American laboratories and the Public Health
Laboratory Service In London told of tests
with human volunteers supporting the belief
that such bacteria cannot colonize outside
the laboratory.

While the proposed supervision. Inspection
and accounting are not a complete novelty —
they have features In common, for example,
with those applied to private nuclear power
plants — they have evoked vehement respon-
ses. Americans for Democratic Action, a lib-
eral offshoot of the Democratic Party, stated
In part: “It should be remembered that
strict societal control of the activities of
scientists has been a step in the establish-
ment of totalitarian states." This, It added,
led to "Inhuman" experiments In Nazi Ger-
many and to Lysenkolsm In Russia.

The parallel with Lysenkolsm, however,
6eems questionable. The purpose here Is not
to decree what Is true but what Is safe. The
concern of those who first sounded the
alarm — end now almost wish they had not —
Is that control over research will come Into
the hands of political appointees Incapable
even of understanding the Issues.

The Senate bill provides for an 11-member
National Recombinant DNA Regulation Com-
mission to be appointed by the President.
It specifies that six members be chosen “who
are not and have never been professionally
engaged In biological research." The other
five would be specialists In such research
but with no financial Interest In recombi-
nant DNA activities. The commission would
be empowered to regulate and license the
research and send Inspectors to Insure com-
pliance.

The House bill Is lower key. The Secretary
of Health, Education and Welfare would pro-
mulgate the regulations, subject to “recom-
mendations” by a Recombinant DNA Advi-
sory Committee. Of the 17 members of that
committee a majority would not be engaged
In DNA research, but some. In that majority
could be biologists. Details of licensing pro-
cedures are left to the government. Local
biohazards committees could do the Inspec-
tions under government auspices. In cases
of violation one bill provides for fines up
to *10,000 per day. The other allows fines
as large as *50,000.

The prospect of Ill-Informed regulation by

local governments seems to have convinced
many DNA researchers that the best they
can hope for Is a bill like that before the
House, which leaves regulation In the hands
of government. Guidelines for DNA research
have already been set forth by the National
Institutes of Health providing, In the most
extreme cases, for safety measures as strin-
gent as those used when biological warfare
agents were being developed. These guide-
lines are widely accepted by the researchers
as reasonable and prudent. They would pre-
sumably form the basis for more formal reg-
ulations.

Among those who signed the original 1974
appeal for a temporary moratorium was Dr.
James D. Watson who shared a Nobel Prize
for his work on the structure of DNA. Now
he feels the call for caution has almost re-
sulted in panic.

"The vision of the hysterics has so peopled
biological laboratories with monsters and
super bugs,” he wrote recently, "that I often
feel the discussion has descended to the
realm of a surrealistic nightmare."

[811]

FOR RELEASE UPON DELIVERY

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
BETHESDA. MARYLAND 20014

STATEMENT BY

DR. DONALD S. FREDRICKSON, DIRECTOR
NATIONAL INSTITUTES OF HEALTH

ON RECOMBINANT DNA RESEARCH

BEFORE THE

SUBCOMMITTEE ON HEALTH

SENATE COMMITTEE ON LABOR AND PUBLIC WELFARE
SEPTEMBER 22, 1976

[812]

Mr. Chairman and Members of the Subcommittee:

It is a pleasure to appear before you today to discuss the NIH
guidelines on recombinant DNA research.

In June, the National Institutes of Health, with the approval of
the Secretary of HEW and the Assistant Secretary for Health, issued
guidelines to govern NIH-supported research on recombinant DNA molecules.
Accompanying the guidelines was a document describing in detail the
issues which the Director of NIH considered in reaching the decision to
release the guidelines. These guidelines, governing research conducted
at the laboratories of NIH as well as projects supported by grants and
contracts, delineate stringent safeguards for the conduct of experiments
involving the production of recombinant DNA molecules and their insertion
into organisms such as bacteria. The object of the guidelines is to
minimize the risks associated with recombinant DNA research — primarily
through a series- of procedures aimed at physical and biological contain-
ment of possibly dangerous organisms — while permitting research of great
potential benefit to mankind. The NIH guidelines replaced the recom-
mendations from the 1975 Asilomar Conference on Recombinant DNA Molecules,
which permitted research under less strict conditions.

Recombinant DNA molecules are formed in the laboratory from recom-
bination of segments of deoxyribonucleic acid, the material that determines
the hereditary characteristics of all living cells. These techniques,
permitting genetic information from quite different organisms to be
combined, have a remarkable potential for furthering the understanding
of fundamental biochemical processes of both lower and higher organisms.

[813]

2

Recombinant DNA research has strong potential in medicine as well
as in science and technology generally. In medicine it is capable of
providing hitherto unobtainable knowledge of the organization and
expression of genes in health and disease. It possibly may also permit
economical production of important medicinals. Potential benefits in
agriculture and industry include more abundant crops and synthesis of
industrially important biochemical agents such as enzymes.

There are risks, however, as well as potential benefits in the new
research. For example, bacteria with transplanted genes may prove
hazardous to man or other forms of life. Like many of the potential
benefits, these risks remain speculative, for there is still scanty
evidence that genes from one form of life can be expressed in any other
form. We must assume, however, that they may be. Thus our present
state of knowledge dictates strict controls on this form of experimentation.

The NIH guidelines prohibit certain types of experiments — those,
for instance, that might produce disease germs with increased resistance
to antibiotics. Other experiments will go forward under special safety
conditions. The guidelines have a definitive administrative framework
for assuring that safety is an essential and integrated component of
research involving recombinant DNA molecules. The section dealing with
roles and responsibilities sets forth a developed review structure
involving the principal investigator, local biohazards committees, and
the NIH Advisory Committee, as well as peer review committees. The
guidelines now provide extensive opportunity for advice, from the local
to the national level. Several levels of review and scrutiny are

[814]

provided, ensuring the highest standards for scientific merit and
conditions for safety. We believe these provisions will afford protec
tion, and with a wide margin of safety, to workers and the environment
while permitting this type of research to proceed. And the NIH is
sponsoring additional experimental work to determine possible hazards
and new safety practices and procedures.

Development of the Guidelines

Recombinant DNA research brings to the fore certain problems in
assessing the potential impact of basic science on society as a whole,
including the manner of providing public participation in those assess
ments. The field of research involved is at the leading edge of bio-
logical science. New information is accruing rapidly and requires
continuing evaluation and re-synthesis. The experiments involved are
extremely technical and complex. Molecular biologists active in this
research require diligence to keep abreast of the newest developments.
It is not surprising that scientists in other fields and the general
public have difficulty in understanding advances in recombinant DNA
research. Yet public awareness and understanding of this line of
investigation is vital.

It was the scientists engaged in recombinant DNA research who
called for a moratorium on certain kinds of experiments in order to
assess the risks and devise appropriate guidelines. At their behest,
the National Academy of Sciences created a committee that organized an
international conference at Asilomar Conference Center in California,
held February 1975. The committee also called on the NIH to establish

[815]

4

an advisory committee to draft guidelines for the conduct of this
research. At Asilomar, temporary guidelines were issued pending
issuance of NIH guidelines.

In response, the NIH Recombinant Advisory Committee (formally "NIH
Recombinant DNA Molecule Program Advisory Committee") was established in
October 1974 to advise the Secretary of HEW, the Assistant Secretary for
Health, and the Director of NIH to accomplish these tasks. The several
meetings at which the Recombinant Advisory Committee developed its
proposed guidelines in 1975 were announced in the Federal Register and
were open to the public. The committee, after working several draft
versions, reached agreement on a recommended revised version of proposed
guidelines that were referred to the NIH Director for review in January
1976.

A special meeting of the Advisory Committee to the Director, NIH,
was convened in February of this year to review these proposed guidelines.
In addition to current members of the committee, a number of former
committee members as well as other scientific and public representatives
were invited to participate in the special February session. There was
ample opportunity for comment and an airing of the issues, not only by
the committee members but by public witnesses as well. All major points
of view were broadly represented.

The proposed guidelines were reviewed in the light of the comments
and suggestions made by the participants at the public hearing as well
as extensive written correspondence received after the meeting. The
NIH has published a volume containing the transcript of the public
hearing of the Director's Advisory Committee, all correspondence directed

[816]

5

to the NIH on this matter, and summaries of meetings with representatives
from Government, Departments, and Agencies, Congressional staff, and
industry. The Decision of the Director, NIH, that accompanied the
release of the guidelines in June is based on that record.

Steps are underway for further opportunity for debate, scrutiny,
and subsequent decisions relevant to the guidelines. The guidelines
were published in the Federal Register on July 7, and a 120 days' period
was allowed for comment. Further, in response to the recommendations of
public commentators, the NIH undertook an environmental impact assessment
in accordance with the National Environmental Policy Act of 1969. A
draft environmental impact statement was published in the Federal Register
on Thursday, September 9, 1976, for public comment. The statement was
given widespread distribution to interested environmental Federal,

State, and local groups for comment. In this way, yet another review
will be provided from the perspective of the environmental impact of
this research.

Application to Public and Private Sector

The Department and NIH have given high priority to the implementation
of the NIH guidelines and their application beyond the NIH. A meeting
was held with representatives of relevant HEW agencies and other depart-
ments of the Federal Government on April 8. The purpose was to exchange
information on recombinant DNA research and to discuss the applicability
of NIH guidelines to research or regulatory activities of other depart-
ments and agencies.

[817]

6

A meeting was also held on June 2 with representatives of private
industry to provide them with full information about the guidelines and
to help determine the present and future interest of industrial labora-
tories in this type of research. The meeting afforded one of the first
opportunities for industry representatives to convene for discussion of
this research.

The expressed concern for the extension of these guidelines to
other Federal agencies and the private sector is shared by the NIH and
the Department of Health, Education, and Welfare. The letter from you,

Mr. Chairman, and Senator Javits to the President expressed well these
timely concerns. Following the NIH initiatives, the Department has been
reviewing an appropriate mechanism to allow for a policy review of
Government activities in this research area, including relevant activi-
ties in the private sector. The Department has proposed to the President
that an interagency committee be created to review the activities of all
Government agencies conducting or supporting recombinant DNA research or
having regulatory authority relevant to this scientific field. This
committee could also coordinate activities with the private sector. The
President has written to relevant Department Secretaries and Agency
Heads urging their cooperation and participation in naming representatives
to serve on this committee.

The interagency committee will assist in facilitating compliance
with a uniform set of guidelines for the public and private sectors and
provide coordination among the several Government agencies that support
or conduct this research. It is mandated to suggest appropriate adminis-
trative or legislative proposals deemed appropriate for national

[818]

7

implementation. For this purpose a review of authorities — the Public
Health Service Act, the Occupational Safety and Health Act, the National
Environmental Policy Act, and other relevant statutes — will be carried
out.

It should be noted that the National Science Board has adopted by
resolution the NIH guidelines for all such research supported by the
National Science Foundation. We anticipate similar letters of endorse-
ment from all of the Federal agencies that are now conducting or supporting
such research, or consider that they may do so in the near future.

Since the NIH meeting with private industry in June and following
publication of the NIH guidelines in the Federal Register, the Pharma-
ceutical Manufacturers Association has been reviewing the applicability
of the guidelines to industry research activities. The PMA has expressed
general support for the guidelines with relatively minor revisions
considered necessary to meet the needs of industry.

In order to ensure that implementation of the guidelines within the
NIH be achieved without delay, an NIH Office of Recombinant DNA Activi-
ties was created in June to administer and coordinate activities. This
office will serve as liaison to the institutional biohazard committees
for administration of the guidelines. There will be special emphasis on
activities pertaining to the operation and implementation of containment
and safety practices and procedures. The NIH office will also closely
monitor reports and information concerning accidents, containment, and
safety research innovation.

[819]

8

To ensure that those who conduct recombinant DNA research will
have notice and adhere to the guidelines, the NIH distributed the
guidelines to approximately 25,000 grantees and contractors. The
investigators and institutions supported by the NIH have a special
responsibility for maintaining the safety practices outlined in the
guidelines, and the NIH will work closely with them to fulfill that
objective.

In response to public concern that broad support for the guidelines
be solicited, the NIH undertook to distribute them through a number of
channels. Letters were sent to professional organizations soliciting
support for the guidelines among their member scientists and to editors
of journals requesting editorial endorsement. The guidelines were also
sent to all science attaches of foreign embassies located in Washington
and to U.S. science attaches in our embassies in foreign countries.

Various international health and scientific organizations have also
been briefed on the guidelines.

The NIH recognizes its responsibility to continuing discussions on
the international level to ensure that there be as uniform a standard of
guidelines as possible to govern the conduct of this research in all
nations. As an example of international cooperation, the European
Molecular Biology Organization recently announced plans for a voluntary
registry of recombinant DNA research in Europe. Following this EMBO
initiative, NIH shall similarly maintain a voluntary registry of investi-
gators and institutions engaged in such research in the United States.

Plans for establishing this registry are under way, and the new interagency
committee will be asked to address the scope of the registry as one
of its earliest tasks. Great Britain has endorsed continuation of

[8201

9

recombinant DNA research, and a Government report has just been issued
containing guidelines that technically are similar to the NIH guidelines.

Patent Policy Review

Currently there is also a review underway of the Department patent
policies as they relate to discoveries in recombinant DNA research. A
number of universities where such research is being conducted are
reviewing possible patent applications for these discoveries. Stanford
University and the University of California have filed patent claims in
this research area and have solicited the views of the Department and
the NIH. These patent activities, the certitude that other important
inventions in this field are forthcoming, and the public's apprehension
over control of recombinant DNA research compel inquiry into whether the
Department's policies for allocating invention rights are consonant with
the concerns about this research.

Invention rights are normally allocated in either of two ways under
current Department patent regulations:

The Department has institutional patent agreements with 65 universi-
ties having identified technology transfer capabilities. Such an
agreement provides the institution the first option to ownership in all
inventions made in performance of Department research, subject to a
number of conditions deemed necessary to protect the public interest.
Stanford and the University of California are among the institutions
that hold such agreements with the Department.

[821]

10

Second, for those institutions who do not have an institutional
patent agreement, the Department defers determination of ownership until
an invention has been made. Under the deferred determination policy, an
innovating institution may petition the Department for ownership of an
invention after it is identified. In the past, approximately 90 percent
of all such petitions have been granted.

The Department's policy of allocating invention rights is designed
to facilitate the transfer of technology from the bench to the market-
place by inducing industrial investment and continued development of
inventions generated with Department support. The incentives provided
by Department patent policy have encouraged the development of new
technology in general and afforded patent protection for some inventions
to the economic benefit of the United States. The control of DNA
research envisioned by the guidelines, however, requires a delicate
balance between need for rapid exchange of information and a potential
means for achieving greater uniformity in safety practices by setting
conditions for safety in licenses under patent agreements.

Stanford and the University of California have indicated a willingness
to consider modification of their patent agreement with the Department
as it relates to such research. A number of possible policies, short of
the present allocation of rights under the agreement, are currently
being considered by the NIH as possible alternatives to the present
allocation of rights made under all such agreements. As part of that
review, the NIH has solicited the views not only of members of the NIH

[822]

11

community but or the public as well, including all those who participated
in the public hearing on the guidelines.

The prudence and caution inherent in the guidelines must also be
reflected in patent policies underlying administration of recombinant
DNA research inventions.

Conclusion

In summary, the potential benefits and risks of recombinant DNA
research have posed a singular challenge. The prospects of harnessing
these techniques to the benefit of man are indeed great. From what we
know today, we must assume that if these promises are to be realized,
our efforts must be marked by extraordinary diligence to avoid harm.

This combination of benefits and risks provides not only opportunity but
obligation for the scientific community and the public to proceed
together in assessment of risks and benefits and to agree upon procedures
that will allow the continuation of these investigations under conditions
of minimal risk.

Our immediate task is threefold: First, to maintain a satisfactory

process for updating and revising the guidelines in the light of both
public scrutiny and new research developments. Secondly, to pursue
steps to ensure that all sectors of the scientific enterprise in this
country concur and adopt these or comparable guidelines, and to use all
influence available to us to encourage a consistent policy throughout
the world. Thirdly, we must now, in concert with all interested parties,
consider whether additional measures to assure a common approach to
problems here are advisable. Let me assure the Committee that the

[823]

12

Department will make every effort to accomplish these tasks.

Thank you for the opportunity to discuss these issues before the
Committee. My colleagues and I would be happy to try to answer questions
you or other members may have.

[824]

FOR RELEASE UPON DELIVERY

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
BETHESDA, MARYLAND 20014

STATEMENT BY

DR. DONALD S. FREDRICKSON
DIRECTOR, NATIONAL INSTITUTES OF HEALTH

ON RECOMBINANT DNA RESEARCH

BEFORE THE

SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT
OF THE

HOUSE COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE
MARCH 17, 1977

[825]

I. Introduction

I am pleased to appear before you today to discuss Federal policies
concerning Recombinant DNA Research. Specifically, I want to tell you
about the activities of two organizations — those of the National
Institutes of Health and of a recently formed Federal Interagency
Committee — that are relevant to such policy development.

Recent scientific developments in genetics, particularly in the
last four years, have culminated in the ability to join together genetic
materials from different sources in cell-free systems to form recombinant
DNA molecules. "DNA" — which is the shorthand way of saying "Deoxyribonucleic
Acid" — is the material that determines hereditary characteristics of all
known cells. Thus new forms of living material are created with the
ability to replicate themselves. From testimony already received, you
will be aware that this new and powerful tool of science has generated
great hope and excitement, and, concommitantly, many expressions of concern.

Recombinant DNA research offers great promise for better understanding
and improved treatment of human diseases. Medical advances through use of
this technology include the opportunity to explore complicated diseases
and the functioning of cells, to better understand a variety of hereditary
defects, and possibly (in the future) to create microorganisms useful in
producing medically important compounds for the treatment and control of
disease. Aside from the potential medical benefits, a variety of other
applications in science and technology are envisioned. An example is the

[826]

2

large-scale production of enzymes for industrial use; and potential beneiits
in agriculture include the enhancement of nitrogen fixation in certain
plants and the biological control of pests, permitting increased food
production.

There are risks in this new research area as well as anticipated
benefits. A potential hazard, for example, is that the foreign DNA micro-
organism may alter the host in unpredictable and undesirable ways. Should
the altered microorganism escape from containment, it might infect human
beings, animals, or plants, causing disease or modifying the environment.

Or the altered bacteria might have a competitive advantage, enhancing their
survival in some niche within the ecosystem.

Until the potential risks are better delineated and evaluated in light
of developing scientific knowledge, the public should expect such research
to be conducted under strict conditions ensuring safety. This was the
fundamental principle that guided the National Institutes of Health and
the Federal Interagency Committee in their deliberations on Recombinant DNA
Research — that is, the desire to allow this significant research to
continue while protecting man and his environment, to the extent humanly
possible, from the effects of potential hazards whose nature is as yet
unknown. I would like to review with the Committee the activities of
the NIH in developing guidelines to govern this research, and then devote
the rest of my testimony to the work of the Interagency Committee.

[827]

3

II. Development of the NIH Guidelines

Scientists engaged in recombinant DNA research first expressed concern
about the potential biohazards at the Gordon Research Conference on Nucleic
Acids in July 1973. At their request, the National Academy of Sciences
created a committee that outlined restrictions for these types of experi-
ments and organized an international conference to consider this problem
further. The committee also called on the NIH to establish an advisory
committee to study containment procedures and draft guidelines for the
conduct of this research. At the International Conference on Recombinant
DNA Molecules held at Asilomar, California, in February 1975, temporary
guidelines were issued calling for a moratorium on some experiments but
allowing others to proceed with appropriate biological and physical safe-
guards, pending issuance of NIH guidelines.

In response to the National Academy of Sciences, the NIH Recombinant
DNA Molecule Program Advisory Committee (hereafter, the NIH Recombinant
Advisory Committee) was established in October 1974 to advise the Secretary
of HEW, the Assistant Secretary of Health, and the Director of NIH in
accomplishing their tasks. In December 1975, the Committee, after several
open meetings and half a dozen working drafts, recommended proposed guide-
lines to the NIH Director for his review and decision.

To assist the Director in his review of the proposed guidelines, a
special meeting of the Advisory Committee to the Director, NIH, was
convened in February 1976. Members of the Committee represented not
only science but such other disciplines as law, ethics, and consumer

[828]

4

affairs. Comments received from committee members and a number of public
witnesses represented a wide range of views. Follow-up written comments
were also solicited. In April, the NIH Recombinant Advisory Committee
considered these comments from the February meeting, and a number of
changes to the guidelines were made. Concurrently, meetings for information
exchange were held with representatives from other Federal agencies and
private industry as well as with Congressional staffs. Finally, on
June 23, 1976, with the approval of the Secretary of HEW and the Assistant
Secretary of Health, the NIH issued guidelines to govern the research it
supports on recombinant DNA molecules. The NIH Guidelines established
strict conditions for the conduct of this research, prohibiting certain
types of experiments and requiring special safety conditions for other
types. The provisions were designed to afford protection — with a wide
margin of safety — to workers and the environment. Two weeks later, on
July 7, 1976, the NIH Guidelines — together with a document indicating the
basis of decisions by the Director, NIH, on principal issues — were
published in the Federal Register for public comment.

Copies of the Guidelines were widely distributed to foreign embassies,
medical and scientific journals, NIH grantees and contractors, and major
professional research societies.

[829]

5

III. NIH Activities Following Release of the Guidelines

These include:

(1) Office of Recombinant DNA Activities

To facilitate implementation of the Guidelines, the NIH, in June,
established the Office of Recombinant DNA Activities: to administer and

coordinate intramural and extramural activities at the NIH; to review the
institutional biohazards committees and certification statements; and to
monitor reports and information concerning accidents, containment, and
safety research innovation. This office is also responsible for establish'
ing a national registry of recombinant DNA research which will include the
coding of projects from other agencies.

(2) Published Proceedings

In August, the NIH published a volume containing the transcript of
the February NIH public hearing on the proposed guidelines, as well as
related correspondence received by the Director, NIH, and the results of
relevant meetings held prior to the release of the guidelines in June.

A second volume is planned for publication in late Spring documenting the
correspondence that the NIH received on the guidelines, the Environmental
Impact Statement, and the Departmental patent policy.

[830]

5A

(3) Environmental Impact Statement

The NIH, in accordance with the National Environmental Policy Act of
1969, undertook an environmental impact assessment to review environmental
effects, if any, of research that may be conducted under the guidelines.

The NIH Guidelines were released prior to the completion of the assessment
because they provide greater protection for the public and the environment
than the Asilomar Guidelines which they replaced. For example, in a
number of instances the NIH Guidelines require more stringent safety and
containment measures, extension of the list of prohibited experiments, and
a specific ban on the release of recombinant molecules into the environment*
A Draft Environmental Impact Statement was filed and published in
the Federal Register on September 9, 1976, to afford additional public
review and comment. The draft statement is currently being analyzed and
comments received will be responded to in the final Environmental Impact
Statement to be published in late March.

[831]

6

(A) Department Patent Policy

In June, shortly before the release of the Guidelines, Stanford
University and the University of California asked NIH to review DHEW
policies relating to the patenting of recombinant DNA research inventions
developed under NIH grants or contracts. Under current DHEW patent
regulations, invention rights to discoveries developed under the Depart-
ment's research support are normally allocated in either of two ways:

• The Department may enter into an Institutional Patent Agreement
(IPA) with a university or other nonprofit institution that has
adequate mechanisms for administering patents on inventions.

The IPA provides the institution the first option to own all
inventions made in performance of Department grants or contracts,
subject to a number of conditions deemed necessary to protect the
public interest.

• For those institutions that have not entered into a patent agreement
with the Department, determination of ownership is deferred until

an invention has been made, at which time an institution may petition
the Department for ownership of the invention.

The NIH solicited opinions from a number of different groups in the
scientific community and the public and private sectors concerning those
departmental patent policies, with respect to recombinant DNA research
inventions. An analysis of the issues raised by the commentators is
under review by the Federal Interagency Committee.

[832]

7

IV. The Interagency Committee on Recombinant DNA Research

I would now like to devote the remainder of my testimony to the
activities of the Interagency Committee on Recombinant DNA Research.

This Committee was created, with the approval of the President, to address
extension of the NIH Guidelines beyond the NIH, to the public and private
sectors .

The specific mandate of the Interagency Committee is as follows:
to review the nature and scope of all recombinant DNA research conducted
in the United States, to determine the applicability of NIH standards
to the government of this research nationally, and to recommend mechanisms
to ensure that the standards are being complied with. The Committee is
advisory to the Secretary of Health, Education, and Welfare. It includes
representatives of Federal Departments and Agencies that support and
conduct recombinant DNA research (or may do so in the future), and repre-
sentatives of Federal Departments and Agencies that have present or
potential regulatory authority in this area. At the Secretary’s request,

I serve as Chairman of the Committee.

Two meetings of the Committee were held in November 1976. The first
of these, on November 4, was devoted to a review of the development of
the NIH Guidelines. The Committee also reviewed activities in other
countries on the development of guidelines for this research. Recombinant
DNA research is being conducted in a number of countries, including Canada,
the United Kingdom, the Scandinavian countries, most other parts of western
Europe, eastern Europe, the Soviet Union, and Japan.

[833]

8

In many countries, appropriate governmental or scientific bodies have
reviewed the research and have agreed that it should proceed . Several of
the countries have acted to establish guidelines to govern the conduct of
this research, including the United Kingdom and Canada. In the United
Kingdom, a parliamentary committee addressed the issue and indicated that
work in this area should continue under appropriate safety conditions.
Scientific advisory committees of international organizations, such as
the World Health Organization, the International Councils of Scientific
Unions, and the European Molecular Biology Organization, have made similar
recommendations .

The European Science Foundation, representing member nations from
Western Europe and Scandinavia, has recommended to its members that they
follow the guidelines of the United Kingdom. These guidelines are, in
intent and substance, very similar to those of the National Institutes
of Health. The NIH is currently working very closely with the United
Kingdom and the European Science Foundation to ensure a commonality of
standards in carrying out this research. Thus far, there has been very
close cooperation and coordination among the various international and
national scientific bodies, with a view to reaching a consensus on safety
practices, programs, and procedures.

At the meeting of the Committee held on November 23, the Federal
research agencies discussed their activities and possible roles in the
implementation of the NIH Guidelines. All research agencies endorsed the
Guidelines to govern recombinant DNA research. At present, the NIH, the

[834]

9

National Science Foundation, the Veterans Administration, and the U.S.
Department of Agriculture are supporting or conducting such research.

The Department of Defense, National Aeronautics and Space Administration,
and the Energy Research and Development Administration do not at present
conduct such research, but all have endorsed the NIH Guidelines to govern
future research should it be undertaken.

Subcommittee Review of Existing Legislation

At the November 23 meeting, the Federal regulatory agencies reported
on their regulatory functions. Following that review, a special Subcom-
mittee was formed to analyze the relevant statutory authorities for the
possible regulation of recombinant DNA research. All regulatory agencies
were represented on the Subcommittee, assisted by attorneys from their
offices of general counsel.

The Subcommittee was charged to determine whether existing legislative
authority would permit the regulation of all recombinant DNA research in
the United States (whether or not federally funded) and would include at
least the following regulatory requirements:

(1) Review of such research before it is undertaken by an institutional
biohazards committee.

(2) Compliance with physical and biological containment standards
and prohibitions in the NIH Guidelines.

(3) Registration of such research with a national registry at the
time this research is undertaken (subject to appropriate
safeguards to protect proprietary interests) .

[835]

10

(4) Enforcement of the above requirements through monitoring,
inspection, and sanctions.

It was the conclusion of the Subcommittee that present law could
permit imposition of some of the above requirements on much recombinant
DNA laboratory research, but that no single legal authority or combination
of authorities currently existed that would clearly reach all research
and other uses of recombinant DNA techniques and meet all stated require-
ments. Although there is existing authority that might be interpreted
broadly to cover most of the research at issue, it was generally agreed
that regulatory actions taken on the basis of any such interpretation
would probably be subject to legal challenge. The Subcommittee, in
reaching this conclusion, reviewed the following laws that were deemed
to warrant detailed consideration:

(a) The Occupational Safety and Health Act of 1970 (Public Law 91-596)

(b) The Toxic Substances Control Act (Public Law 94-469)

(c) The Hazardous Materials Transportation Act (Public Law 93-633)

(d) Section 361 of the Public Health Service Act (42 U.S.C. 264).

The full Committee adopted the report of its Subcommittee and agreed
that new legislation was required.

Interagency Committee Analysis of Elements for Legislation:

In considering the elements for legislation, the Committee reviewed

[836]

11

Federal, State, and local activities bearing on the regulation of
recombinant DNA research. Among Congressional proposals reviewed were
Senate Bill 621, "The DNA Research Act of 1977," introduced by Senator
Dale Bumpers, and the companion measure introduced by Representative
Richard L. Ottinger in the House (H.R. 3591). The Committee also noted
the resolution introduced by Representative Ottinger on January 19, 1977
(H. Res. 131), requesting DHEW to regulate recombinant DNA research under
Section 361 of the PHS Act.

Hearings held by State and local governments, including State legis-
latures, were among State and local activities reviewed. Recommendations
by the New York State Attorney General's Environmental Health Bureau for
State regulation, and by the Cambridge (Massachusetts) City Council for
city regulation, were also considered.

Several committee representatives also reported on meetings with
other interested parties whose views had been solicited on legislation
to regulate recombinant DNA research. Those who were contacted include
agricultural scientists, biomedical scientists, environmentalists, labor
unions, and private industry. At my request, the Industrial Research
Institute and the Pharmaceutical Manufacturers Association are surveying
their member firms to determine the scope of the research efforts in the
private sector. The Pharmaceutical Manufacturers Association has adopted
the NIH Guidelines as standards for conduct of this research.

[837]

12

In considering elements of proposed legislation, a number of issues
were raised and discussed fully by the Committee. After detailed delib-
erations at meetings on March 10 and 14, 1977, the Committee agreed on a
set of elements for proposed legislation. The elements agreed upon and
the various alternatives reviewed by the Committee were presented in an
Interim Report transmitted to HEW Secretary Califano on March 15, 1977.
Secretary Califano, in releasing the report on March 16, stated that
"legislation in this area would represent an unusual regulation of
activities affecting basic science but the potential hazards posed by
recombinant DNA techniques warrant such a step at this time." The
Secretary added that the Department will begin immediately to draft
legislation in the light of the recommendations made by the Committee.

Mr. Chairman, I would like to submit for the record this "Interim
Report of the Federal Interagency Committee on Recombinant DNA Research
on Suggested Elements for Legislation."

[838]

13

IV. Conclusion

This much is clear: the international scientific community is

in substantial agreement that, until the potential hazards of recombi-
nant DNA techniques are better understood, a common set of standards
must everywhere exist for the use of those techniques. The question
being debated now is how this is to be accomplished.

In attempting to settle a question such as this, it is natural
for society to look first along lines of maximum common boundaries of
governance or law. For recombinant work, these have so far been
national boundaries. The United States and the United Kingdom were
first to develop guidelines; Western Europe, acting initially as
individual nations, is beginning to organize a common process; and
now Canada has issued a set of guidelines. The substance of all
guidelines is sufficiently similar; how to apply them locally and
nationally remains the issue.

In the United States, this question has attracted far more public
attention than in other countries. A number of local jurisdictions or
states are engaged in action or debate. Federal action would assure
commonality, if commonality is desirable.

A final point to bear in mind is that changes in DNA — the nucleic
acid that is present in all living organisms and determines their
inherited characteristics — also occur spontaneously in nature: they

have made possible the never-ending process of evolution. We are as
we are as the result of a long series of changes in the DNA of our

[839]

14

biological ancestry — and aberrations or faults in DNA are undoubtedly
responsible for inherited disabilities and predispositions to disease.
Under proper safeguards, much good can flow from this latest develop-
ment in the steady process of science. Research on recombinant DNA
holds the promise of becoming a powerful tool in the conquest of
disease and, ultimately, in the prevention or correction of inherited
malfunctions and disabilities.

In conclusion, I want to note that biomedical research is entering a
new era in its relationship to society. It is passing from an extended
period of relative privacy and autonomy to an engagement with new ethical,
legal, and social imperatives under concerned public scrutiny. NIH has
responded to this concern by requiring the formation of review boards to
oversee human experimentation, animal care, and now genetic recombination
experiments. Similar bodies may soon have to oversee other hazardous
laboratory work. These responsibilities are inescapable adjustments to
the rising demand for public governance of science, though this need not —
and, indeed, should not — go beyond what is clearly required for public
safety lest we inadvertently Impede successful research and hamper
creativity. The progress of science will continue to depend on the
initiative and insights — call it inspiration, if you like — of individual
scientists.

[840]

FOR RELEASE UPON DELIVERY

DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
BETHESDA. MARYLAND 20014

STATEMENT BY

DONALD S. FREDRICKSON, M.D .

DIRECTOR, NATIONAL INSTITUTES OF HEALTH
ON RECOMBINANT DNA RESEARCH
BEFORE THE

SUBCOMMITTEE ON SCIENCE, RESEARCH, AND TECHNOLOGY

OF THE

HOUSE COMMITTEE ON SCIENCE AND TECHNOLOGY
MARCH 31, 1977

[841]

I.

INTRODUCTION

Good day, Mr. Chairman and other Committee members. I am pleased
to appear before you today to discuss Federal policies concerning
recombinant DNA techniques. Specifically, I want to tell you about
the activities of two organizations — the National Institutes of Health
and the Federal Interagency Committee on Recombinant DNA Research.

Recent scientific developments in genetics, particularly in the
last four years, have culminated in the development of a powerful new
tool for research — the ability to join together genetic materials from
different sources in cell-free systems to form recombinant DNA molecules.
I would like to emphasize the point that recombinant DNA is a tool for
accomplishing the types of research that scientists have been pursuing
for decades. "DNA" — which is the shorthand way of saying "deoxyribo-
nucleic acid" — is the material that determines hereditary characteristics
of all known cells. Thus altered cells are created with the ability to
replicate themselves. From testimony already received, you are aware
that this new and powerful tool of science has generated great hope
and excitement and, concomitantly, many expressions of concern.

Research using recombinant DNA techniques offers great promise for
better understanding and improved treatment of human diseases. Medical
advances through use of this technology include the opportunity to
explore complicated diseases and the functioning of cells, to better
understand a variety of hereditary defects, and possibly (in the future)
to create microorganisms useful in producing medically important
substances for the treatment and control of disease. Aside from

[842]

2

potential medical benefits, a variety of other applications in science
and technology are envisioned. An example is the large-scale production
of enzymes for industrial use; and potential benefits in agriculture
include the enhancement of nitrogen fixation in certain plants and the
biological control of pests, permitting increased food production.

There may be risks in this new research area as well as anticipated
benefits. A potential hazard, for example, is that the foreign DNA
microorganism may alter the host in unpredictable ways. Should the
altered microorganism escape from containment, it might infect human
beings, animals, or plants, causing disease or modifying the environment.

Until the potential risks are better delineated and evaluated in light
of developing scientific knowledge, the public should expect such research
to be conducted under strict conditions ensuring safety. This was the
fundamental principle that guided the National Institutes of Health and
the Federal Interagency Committee in their deliberations. That is, the
desire to allow this significant research to continue while protecting
humans and the environment from the effects of potential hazards whose
nature and the occurrence of which is as yet uncertain. I would like
to review with the Committee the activities of the NIH in developing
guidelines to govern this research, and then devote the rest of my
testimony to the work of the Interagency Committee.

[843]

3

II. DEVELOPMENT OF THE NIH GUIDELINES

The first step in the development of the Guidelines was taken by
the scientific community. Scientists engaged in research using recombinant
DNA technology first expressed concern about the potential biohazards at
the Gordon Research Conference on Nucleic Acids in July 1973. At their
request, the National Academy of Sciences created a committee that called
for a moratorium on certain types of experiments and for an international
conference to consider this problem further. The committee also called on
the NIH to establish an advisory committee to study containment procedures
and draft guidelines for the conduct of this research. At the International
Conference on Recombinant DNA Molecules held at Asilomar, California, in
February 1975, temporary guidelines were issued, including a continued
moratorium on some experiments but allowing others to proceed with appropriate
biological and physical safeguards, pending issuance of NIH guidelines.

The NIH Recombinant DNA Molecule Program Advisory Committee was
established in October 1974 to advise the Director of NIH. In December
1975, the Committee, after several open meetings, recommended proposed
guidelines for my review and decision.

To assist me in the review of the proposed guidelines, a special
meeting of the NIH Advisory Committee was convened in February 1976.

Members of the Committee represented not only science but such other
disciplines as law, ethics, and consumer affairs. Comments received
from committee members and a number of public witnesses represented a

[844]

4

wide range of views. Follow-up written comments were also solicited.

In April, the NIH Recombinant Advisory Committee considered these
comments from the February meeting, and a number of changes to the
guidelines were made. Concurrently, meetings for information exchange
were held with representatives from other Federal agencies and private
industry as well as with Congressional staffs. Finally, on June 23, 1976,
with the approval of the Secretary of HEW and the Assistant Secretary of
Health, the NIH issued guidelines to govern the research it supports involving
recombinant DNA molecules. The NIH Guidelines established strict
conditions for the conduct of this research, prohibiting certain types
of experiments and requiring special safety conditions for other types.

The provisions were designed to afford protection — with a wide margin
of safety — to workers and the environment. Two weeks later, on July 7,

1976, the NIH Guidelines — together with a document indicating the basis
of my decisions on principal issues — were published in the Federal Register
for public comment.

Over 40,000 copies of the Guidelines have been widely distributed to
foreign embassies, medical and scientific journals, NIH grantees and
contractors, and major professional research societies.

[845]

5

III. NIH ACTIVITIES FOLLOWING RELEASE OF THE GUIDELINES

Subsequent to the release of the Guidelines, NIH Initiated several
actions.

A. Office of Recombinant DNA Activities

To facilitate implementation of the Guidelines, the NIH, in June 1976,
established the Office of Recombinant DNA Activities: to administer

and coordinate intramural and extramural activities at the NIH; to
review the institutional biohazards committees; and to monitor reports
and information concerning accidents, containment, and safety research
innovation.

B. Published Proceedings

In August 1976, the NIH published a volume containing the transcript
of the February NIH public hearing on the proposed guidelines, voluminous
related correspondence, and the results of relevant meetings held prior
to the release of the Guidelines in June. A second volume is planned
for publication in late Spring documenting the correspondence that the
NIH received on the Guidelines, the Environmental Impact Statement, and
the Departmental patent policy.

C. Environmental Impact Statement

The NIH, in accordance with the National Environmental Policy Act
of 1969, undertook an environmental impact assessment to review
environmental effects, if any, of research that may be conducted under
the Guidelines. The NIH Guidelines were released prior to the completion

[846]

6

of the assessment because they provide greater protection for the
public and the environment than the Asilomar Guidelines or no guidelines.

A Draft Environmental Impact Statement was filed and published in
the Federal Register on September 9, 1976, to afford additional public
review and comment. The draft statement has been analyzed
and comments received are addressed in the- final Environmental
Impact Statement to be published soon.

D. Department Patent Policy

In June, shortly before the release of the Guidelines, Stanford
University and the University of California asked NIH to review DHEW
policies relating to the patenting of inventions perfected through the
use of recombinant DNA techniques and financed by NIH. Under current
DHEW patent regulations, invention rights to discoveries developed under
the Department’s research support are normally allocated in either of
two ways:

e The Department may enter into an Institutional Patent Agreement
(IPA) with a university or other nonprofit institution that has
adequate mechanisms for administering patents on inventions.

The IPA provides the institution the first option to own all
inventions made in performance of Department grants or contracts,
subject to a number of conditions deemed necessary to protect the
public interest.

• For those institutions that have not entered into a patent agreement
with the Department, determination of ownership is deferred until
an invention has been made, at which time an institution may petition
the Department for ownership of the invention.

[847]

7

The NIH solicited opinions from a number of different groups in
the scientific community and the public and private sectors concerning
departmental patent policies, with respect to recombinant DNA research
inventions. An analysis of the issues raised by the commentators is
currently under review.

IV. THE INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

I would now like to devote the remainder of my testimony to the
activities of the Interagency Committee on Recombinant DNA Research.

This Committee was created, with the approval of President Ford, to address
extension of the NIH Guidelines beyond the NIH, to the public and private
sectors .

The specific mandate of the Interagency Committee is as follows:
to review the nature and scope of all recombinant DNA research conducted
in the United States, to determine the applicability of NIH standards
to regulate this research nationally, to recommend mechanisms to ensure
that the standards are being complied with, and to facilitate exchange
of information throughout the Federal sector. The Committee is advisory
to the Secretary of Health, Education, and Welfare. It includes
representatives of Federal Departments and Agencies that support and
conduct recombinant DNA research (or may do so in the future) , and
representatives of Federal Departments and Agencies that have present
or potential regulatory authority in this area. At the Secretary's
request, I serve as Chairman of the Committee.

[848]

8

Two meetings of the Committee were held in November 1976. The first
of these, on November 4, was devoted to a review of the development of
the NIH Guidelines. The Committee also reviewed activities in other
countries on the development of guidelines for this research. Recombinant
DNA research is being conducted in a number of countries, including Canada,
the United Kingdom, the Scandinavian countries, most other parts of western
Europe, eastern Europe, the Soviet Union, and Japan.

In many countries, appropriate governmental or scientific bodies have
reviewed the research and have agreed that it should proceed. Several of
the countries have acted to establish guidelines to govern the conduct of
this research, including the United Kingdom and Canada. In the United
Kingdom, a parliamentary committee addressed the issue and indicated that
work in this area should continue under appropriate safety conditions.
Scientific advisory committees of international organizations, such as
the World Health Organization, the International Council of Scientific
Unions, and the European Molecular Biology Organization, have made similar
recommendations .

The European Science Foundation, representing member nations from
Western Europe and Scandinavia, has recommended to its members that they
follow the guidelines of the United Kingdom. These guidelines are, in
intent and substance, very similar to those of the National Institutes
of Health. The NIH is currently working very closely with the United
Kingdom and the European Science Foundation to ensure a commonality of

[849]

9

standards in carrying out this research. Thus far, there has been very
close cooperation and coordination among the various international and
national scientific bodies, with a view to reaching a consensus on safety
practices, programs, and procedures.

At the meeting of the Committee held on November 23, 1976, the Federal
research agencies discussed their activities and possible roles in the
implementation of the NIH Guidelines. All research agencies endorsed the
Guidelines to govern recombinant DNA research. At present, the NIH, the
National Science Foundation, the Veterans Administration, and the U.S.
Department of Agriculture are supporting or conducting such research.

The Department of Defense, National Aeronautics and Space Administration,
and the Energy Research and Development Administration do not at present
conduct such research, but all have endorsed the NIH Guidelines to govern
future research should it be undertaken.

A. Subcommittee Review of Existing Legislation

Also at the November 23 meeting, the Federal regulatory agencies
reported on their regulatory functions. Following that review, a special
Subcommittee was formed to analyze the relevant statutory authorities for
the possible regulation of research involving recombinant DNA technology.
All regulatory agencies were represented on the Subcommittee, assisted by
attorneys from their offices of general counsel.

The Subcommittee was charged to determine whether existing legislative
authority would permit the regulation of all recombinant DNA research in

[850]

10

the United States (whether or not federally funded) and would include at
least the following regulatory requirements:

(1) Review of such research by an institutional biohazards committee
before it is undertaken.

(2) Compliance with physical and biological containment standards
and prohibitions in the NIH Guidelines.

(3) Registration of such research with a national registry at the
time this research is undertaken (subject to appropriate
safeguards to protect proprietary interests) .

(4) Enforcement of the above requirements through monitoring,
inspection, and sanctions.

It was the conclusion of the Subcommittee that present law could
permit imposition of some of the above requirements on much laboratory
research involving recombinant DNA techniques, but that no single legal
authority or combination of authorities currently existed that would
clearly reach all research and other uses of recombinant DNA techniques
and meet all stated requirements. Although there is existing authority
that might be interpreted broadly to cover most of the research at issue,
it was generally agreed that regulatory actions taken on the basis of any
such interpretation would probably be subject to legal challenge. The
Subcommittee, in reaching this conclusion, reviewed the following laws
that were deemed to warrant detailed consideration:

[851]

11

(a) The Occupational Safety and Health Act of 1970 (Public Law 91-596)

(b) The Toxic Substances Control Act (Public Law 94-469)

(c) The Hazardous Materials Transportation Act (Public Law 93-633)

(d) Section 361 of the Public Health Service Act (42 U.S.C. 264).

In addition, several other laws were examined. The Clean Air Act,
the Federal Water Pollution Control Act, the Resources Conservation
and Recovery Act, and the authorities of the FDA and the Department of
Agriculture.

The full Committee adopted the report of its Subcommittee and
agreed that new legislation was required.

B. Interagency Committee Analysis of Elements for Legislation
In considering the elements for legislation, the Committee reviewed
Federal, State, and local activities bearing on the regulation of
recombinant DNA research.

Among Congressional proposal reviewed were S. 621, "The DNA Research
Act of 1977," introduced by Senator Dale Bumpers, and the companion
measure introduced by Representative Richard L. Ottinger in the House
(H.R. 3591). The Committee also noted the resolution introduced by
Representative Ottinger on January 19, 1977 (H. Res. 131), requesting
DHEW to regulate recombinant DNA research under Section 361 of the PHS Act.

Among State and local activities reviewed were recommendations by the
New York State Attorney General's Environmental Health Bureau for State
regulation, and the Cambridge (Massachusetts) City Council's resolution
on recombinant DNA research.

[852]

12

Several committee representatives also reported on meetings with
other interested parties whose views had been solicited on legislation
to regulate recombinant DNA research. Those who were contacted include
agricultural scientists, biomedical scientists, environmentalists, labor
unions, and private industry. At my request, the Industrial Research
Institute and the Pharmaceutical Manufacturers Association are surveying
their member firms to determine the scope of the research efforts in the
private sector. The Pharmaceutical Manufacturers Association has .endorsed
the NIH Guidelines as standards for conduct of this research.

In considering elements of proposed legislation, a number of issues
were raised and discussed fully by the Committee. After detailed delib-
erations at meetings on March 10 and 14, 1977, the Committee agreed on a
set of elements for proposed legislation. The elements agreed upon and
the various alternatives reviewed by the Committee were presented in an
Interim Report transmitted to HEW Secretary Calif ano on March 15, 1977.
Secretary Calif ano, in releasing the report on March 16, stated that
"legislation in this area would represent an unusual regulation of
activities affecting basic science but the potential hazards posed by
recombinant DNA techniques warrant such a step at this time." He
went on to say, "...I believe such a measure is necessary not just
to safeguard the public but also to assure the continuation of basic
research in this vital scientific area. We are not saying that research
should be halted. We are urging that it should proceed under careful
safeguards unless and until we have a better understanding of the

[853]

13

risks and benefits posed by use of recombinant DNA techniques without
Government regulation."

The Department is now drafting legislation in the light of the
recommendations made by the Committee. This legislation should be
ready soon.

Mr. Chairman, I would like to submit for the record the Federal
Interagency Committee’s "Interim Report on Suggested Elements for
Legislation," along with a copy of the Secretary’s press release.

With your permission, I would like to review briefly some of the
major elements addressed by the Committee. The Committee determined that
the Department of Health, Education, and Welfare is the appropriate locus
in the Government for the regulation of the use and production of
recombinant DNA molecules. In reaching this determination, the Committee
took into account existing roles of certain agencies within DHEW — for
example, that of the NIH in developing the Guidelines, and of the Center
for Disease Control and Bureau of Biologies (FDA) in regulating infectious
agents and biological products. The Committee also had before it the
petition by the Environmental Defense Fund, requesting DHEW to issue
regulations for recombinant DNA research.

The Committee reviewed at great length the nature and scope of
regulation. Consideration was given to regulation of all laboratory
research where hazardous or potentially hazardous substances were
employed. There was general Committee agreement that present legisla-
tion should be restricted to recombinant DNA techniques.

[854]

14

However, I have established a committee at the NIH, chaired by
Dr. Richard Krause, Director, NIAID, to study and recommend, if
necessary, safety standards for other NIH-supported research involving
actual or potential biohazards. The preliminary report is expected
shortly, and I will keep the Committee informed of the progress on
this NIH review.

Regulation of just the research aspects of recombinant DNA
techniques presents a problem because of the difficulty in determining
the border between research and pilot production. Therefore, the
Committee recommends that regulation cover the production or use of
recombinant DNA molecules. Such language would include research
activity, and makes immaterial possible concerns whether a given
activity constitutes research, pilot production, or manufacture.

The Committee recommends that the Secretary, in specific instances, in
consultation with appropriate regulatory agencies, be allowed to determine
the nature of the activity and should defer to a regulatory body that the
Secretary determines is better empowered and equipped to deal with it.

There was general agreement by the Committee that registration of
projects involving the use or production of recombinant DNA molecules
was necessary. The Committee also recommends that facilities be licensed
and that the terms of the license include acceptance of responsibility
for the particular activities and individuals at the facility. The
Committee concluded that licensure of the facility and registration of
projects would be more feasible and would more adequately meet the needs

[855]

15

for safety monitoring rather than licensure or' registration of
individuals engaged in research.

The Committee urges full disclosure to the appropriate regulatory
body of all relevant safety and scientific information pertaining to the
use or production of recombinant DNA molecules. However, the Committee
recognizes the important world-wide commercial potential of recombinant
DNA. molecules in medicine, agriculture, and other areas of science and
technology. It believes that the potential commercial uses of recom-
binant DNA techniques require that information of a proprietary nature
and patent rights be given appropriate protection from disclosure by
the regulatory agency receiving such information. However, the Secretary
may immediately release information if public safety requires it.

Because the potential hazards posed by the use of recombinant DNA
techniques extend beyond the local to the national and international
levels, the Committee recommends that a single set of national standards
must govern and that, accordingly, local law should be preempted to
ensure national standards and regulations. The Committee, however,
took into account the activities at the State and local levels on
regulation of recombinant DNA research. It was agreed that, if a State
passes a law imposing requirements identical to those contained in the
Federal legislation, then the Secretary may enter into an agreement
with the State to utilize its resources to assist the Secretary in
carrying out his duties .

[856]

16

Protection of workers was also considered by the Committee.

Training of workers in proper laboratory techniques and long-term medical
monitoring are important aspects of worker safety and were endorsed by
the group.

A number of other recommendations are made, and I can discuss them
further if you have questions. I would like to emphasize that the work
of the Interagency Committee has been done in a most cooperative and
helpful way.

DHEW will continue to cooperate and coordinate with relevant
Federal Departments and Agencies in this important matter.

IV. CONCLUSION

In conclusion, this much is clear: the international and national

scientific community is in substantial agreement that, until the potential
hazards of recombinant DNA techniques are better understood, a common set
of standards must everywhere exist for the use of those techniques. The
question being debated now is how this is to be accomplished. The
substance of all guidelines is sufficiently similar; how to apply them
locally and nationally remains the issue.

In the United States, this question has attracted far more public
attention than in other countries. A number of local jurisdictions or
states are engaged in action or debate.

[857]

17

Finally, I want to note that biomedical research is entering a
new era in its relationship to society. It is passing from an extended
period of relative privacy and autonomy to an engagement with new ethical
legal, and social imperatives under concerned public scrutiny. NIH has
responded to these concerns by requiring the formation of review boards
to oversee human experimentation, animal care, and now DNA recombinant
experiments. Similar bodies may soon have to oversee other hazardous
laboratory work. These responsibilities are inescapable adjustments to
the rising demand for public governance of science, though this need not-
and, indeed, should not — go beyond what is clearly required for public
safety lest we inadvertently impede successful research and hamper
creativity. The progress of science will continue to depend on the
initiative and insights — call it inspiration, if you like — of individual
scientists .

[853]

FOR RELEASE UPON DELIVERY

DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE

PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
BETHESDA. MARYLAND 20014

STATEMENT BY

DONALD S. FREDRICKSON, M.D .
DIRECTOR, NATIONAL INSTITUTES OF HEALTH
ON RECOMBINANT DNA TECHNOLOGY
BEFORE THE

SUBCOMMITTEE ON HEALTH AND SCIENTIFIC RESEARCH

OF THE

SENATE COMMITTEE ON HUMAN RESOURCES
APRIL 6, 1977

[859]

I. INTRODUCTION

Good day, Mr. Chairman and other Committee members. It is a pleasure
to have the opportunity to discuss with you Federal policies concerning
recombinant DNA techniques. The focus of my remarks will be the
activities of two organizations — the National Institutes of Health and
the Federal Interagency Committee on Recombinant DNA Research.

As you know, recent scientific developments in genetics, particu-
larly in the last four years, have culminated in the development of a
powerful new tool for research — the ability to join together genetic
materials in cell-free systems to form recombinant DNA molecules. I
would like to emphasize the point that recombinant DNA is a tool for
accomplishing the types of research that scientists have been pursuing
for decades .

"DNA" — which is the shorthand way of saying "deoxryibonucleic acid" —
is the material that determines hereditary characteristics of all known
cells. These new techniques allow us to join together DNA segments from
different sources or to rejoin the DNA from one source in a different
order. This new and powerful tool of science has generated great hope
and excitement and, concomitantly, many expressions of concern.

Research using recombinant DNA techniques offers great promise for
better understanding and Improved treatment of human diseases. Medical
advances through use of this technology include the opportunity to
explore complicated diseases and the functioning of cells, to better
understand a variety of hereditary defects, and possibly (in the future)

[860]

2

to create microorganisms useful in producing medically important
substances for the treatment and control of disease. Aside from
potential medical benefits, a variety of other applications in science
and technology are envisioned. An example is the large-scale production
of enzymes for industrial use; and potential benefits in agriculture
include the enhancement of nitrogen fixation in certain plants and the
biological control of pests, permitting increased food production.

There may be risks in this new research area as well as anticipated
benefits. A potential hazard, for example, is that the foreign BNA
microorganism may alter the host in unpredictable ways. Should the
altered microorganism escape from containment, it might infect human
beings, animals, or plants, causing disease or modifying the environment.

Until the potential risks are better delineated and evaluated in light
of developing scientific knowledge, the public should expect such research
to be conducted under strict conditions ensuring safety. This was the
fundamental principle that guided the National Institutes of Health and
the Federal Interagency Committee in their deliberations. That is, the
desire to allow this significant research to continue while protecting
humans and the environment from the effects of potential hazards whose
nature and occurrence is as yet uncertain. I would like
to review with the Committee the activities of the NIH in developing
guidelines to govern this research, and then devote the rest of my
testimony to the work of the Interagency Committee.

[861]

3

II. DEVELOPMENT OF THE NIH GUIDELINES

The first step in the development of the Guidelines was taken by
the scientific community. Scientists engaged in research using recombinant
DNA technology first expressed concern about the potential biohazards at
the Gordon Research Conference on Nucleic Acids in July 1973. At their
request, the National Academy of Sciences created a committee that called
for a moratorium on certain types of experiments and for an international
conference to consider this problem further. The committee also called on
the NIH to establish an advisory committee to study containment procedures
and draft guidelines for the conduct of this research. At the International
Conference on Recombinant DNA Molecules held at Asilomar, California, in
February 1975, temporary guidelines were issued, including a continued
moratorium on some experiments but allowing others to proceed with appropriate
biological and physical safeguards, pending issuance of NIH guidelines.

The NIH Recombinant DNA Molecule Program Advisory Committee was
established in October 1974 to advise the Director of NIH. In December
1975, the Committee, after several open meetings, recommended proposed
guidelines for my review and decision.

To assist me in the review of the proposed guidelines, a special
meeting of the NIH Advisory Committee was convened in February 1976.

Members of the Committee represented not only science but such other
disciplines as law, ethics, and consumer affairs. Comments received
from committee members and a number of public witnesses represented a

[862]

4

wide range of views. Follow-up written comments were also solicited.

In April, the NIH Recombinant Advisory Committee considered these
comments from the February meeting, and a number of changes to the
guidelines were made. Concurrently, meetings for information exchange
were held with representatives from other Federal agencies and private
industry as well as with Congressional staffs. Finally, on June 23, 1976,
with the approval of the Secretary of HEW and the Assistant Secretary of
Health, the NIH issued guidelines to govern the research it supports involving
recombinant DNA molecules. The NIH Guidelines established strict
conditions for the conduct of this research, prohibiting certain types
of experiments and requiring special safety conditions for other types.

The provisions were designed to afford protection — with a wide margin
of safety — to workers and the environment. Two weeks later, on July 7,

1976, the NIH Guidelines — together with a document indicating the basis
of my decisions on principal issues — were published in the Federal Register
for public comment.

Over 40,000 copies of the Guidelines have been widely distributed to
foreign embassies, medical and scientific journals, NIH grantees and
contractors, and major professional research societies.

[863]

5

III. NIH ACTIVITIES FOLLOWING RELEASE OF THE GUIDELINES

Subsequent to the release of the Guidelines, NIH initiated several
actions.

A. Office of Recombinant DNA Activities

To facilitate implementation of the Guidelines, the NIH, in June 1976,
established the Office of Recombinant DNA Activities: tr administer

and coordinate intramural and extramural activities at the NIH; to
review the institutional biohazards committees; and to monitor reports
and information concerning accidents, containment, and safety research
innovation.

B. Published Proceedings

In August 1976, the NIH published a volume containing the transcript
of the February NIH public hearing on the proposed guidelines, voluminous
related correspondence, and the results of relevant meetings held prior
to the release of the Guidelines in June. A second volume is planned
for publication in late Spring documenting the correspondence that the
NIH received on the Guidelines, the Environmental Impact Statement, and
the Departmental patent policy.

C . Environmental Impact Statement

The NIH, in accordance with the National Environmental Policy Act
of 1969, undertook an environmental impact assessment to review
environmental effects, if any, of research that may be conducted under
the Guidelines. The NIH Guidelines were released prior to the completion

[864]

6

of the assessment because they provide greater protection for the
public and the environment than the Asilomar Guidelines or no guidelines.

A Draft Environmental Impact Statement was filed and published in
the Federal Register on September 9, 1976, to afford additional public
review and comment. The draft statement has been analyzed
and comments received are addressed in the- final Environmental
Impact Statement to be published soon.

D . Department Patent Policy

In June, shortly before the release of the Guidelines, Stanford
University and the University of California asked NIH to review DHEW
policies relating to the patenting of inventions perfected through the
use of recombinant DNA techniques and financed by NIH. Under current
DHEW patent regulations, invention rights to discoveries developed under
the Department's research support are normally allocated in either of
two ways:

• The Department may enter into an Institutional Patent Agreement
(IPA) with a university or other nonprofit institution that has
adequate mechanisms for administering patents on inventions.

The IPA provides the institution the first option to own all
inventions made in performance of Department grants or contracts,
subject to a number of conditions deemed necessary to protect the
public interest.

• For those institutions that have not entered into a patent agreement
with the Department, determination of ownership is deferred until

an invention has been made, at which time an institution may petition
the Department for ownership of the invention.

[865]

7

The NIH solicited opinions from a number of different groups in
the scientific community and the public and private sectors concerning
departmental patent policies, with respect to recombinant DNA research
inventions. An analysis of the issues raised by the commentators is
currently under review.

IV. THE INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

I would now like to devote the remainder of my testimony to the
activities of the Interagency Committee on Recombinant DNA Research.

This Committee was created, with the approval of President Ford, to address
extension of the NIH Guidelines beyond the NIH, to the public and private
sectors .

The specific mandate of the Interagency Committee is as follows:
to review the nature and scope of all recombinant DNA research conducted
in the United States, to determine the applicability of NIH standards
to regulate this research nationally, to recommend mechanisms to ensure
that the standards are being complied with, and to facilitate exchange
of information throughout the Federal sector. The Committee is advisory
to the Secretary of Health, Education, and Welfare. It includes
representatives of Federal Departments and Agencies that support and
conduct recombinant DNA research (or may do so in the future) , and
representatives of Federal Departments and Agencies that have present
or potential regulatory authority in this area. At the Secretary’s
request, I serve as Chairman of the Committee.

[366]

8

Two meetings of the Committee were held in November 1976. The first
of these, on November 4, was devoted to a review of the development of
the NIH Guidelines. The Committee also reviewed activities in other
countries on the development of guidelines for this research. Recombinant
DNA research is being conducted in a number of countries, including Canada,
the United Kingdom, the Scandinavian countries, most other parts of western
Europe, eastern Europe, the Soviet Union, and Japan.

In many countries, appropriate governmental or scientific bodies have
reviewed the research and have agreed that it should proceed. Several of
the countries have acted to establish guidelines to govern the conduct of
this research, including the United Kingdom and Canada. In the United
Kingdom, a parliamentary committee addressed the issue and indicated that
work in this area should continue under appropriate safety conditions.
Scientific advisory committees of international organizations, such as
the World Health Organization, the International Council of Scientific
Unions, and the European Molecular Biology Organization, have made similar
recommendations .

The European Science Foundation, representing member nations from
Western Europe and Scandinavia, has recommended to its members that they
follow the guidelines of the United Kingdom. These guidelines are, in
intent and substance, very similar to those of the National Institutes
of Health. The NIH is currently working very closely with the United
Kingdom and the European Science Foundation to ensure a commonality of

[867]

9

standards in carrying out this research. Thus far, there has been very
close cooperation and coordination among the various international and
national scientific bodies , with a view to reaching a consensus on safety
practices, programs, and procedures.

At the meeting of the Committee held on November 23, 1976, the Federal
research agencies discussed their activities and possible roles in the
implementation of the NIH Guidelines. All research agencies endorsed the
Guidelines to govern recombinant DNA research. At present, the NIH, the
National Science Foundation, the Veterans Administration, and the U.S.
Department of Agriculture are supporting or conducting such research.

The Department of Defense, National Aeronautics and Space Administration,
and the Energy Research and Development Administration do not at present
conduct such research, but all have endorsed the NIH Guidelines to govern
future research should it be undertaken.

A. Subcommittee Review of Existing Legislation

Also at the November 23 meeting, the Federal regulatory agencies
reported on their regulatory functions. Following that review, a special
Subcommittee was formed to analyze the relevant statutory authorities for
the possible regulation of research involving recombinant DNA technology.
All regulatory agencies were represented on the Subcommittee, assisted by
attorneys from their offices of general counsel.

The Subcommittee was charged to determine whether existing legislative
authority would permit the regulation of all recombinant DNA research in

[863]

10

the United States (whether or not federally funded) and would include at
least the following regulatory requirements:

(1) Review of such research by an institutional biohazards committee
before it is undertaken.

(2) Compliance with physical and biological containment standards
and prohibitions in the NIH Guidelines.

(3) Registration of such research with a national registry at the
time this research is undertaken (subject to appropriate
safeguards to protect proprietary interests) .

(4) Enforcement of the above requirements through monitoring,
inspection, and sanctions .

It was the conclusion of the Subcommittee that present law could
permit imposition of some of the above requirements on much laboratory
research involving recombinant DNA techniques, but that no single legal
authority or combination of authorities currently existed that would
clearly reach all research and other uses of recombinant DNA techniques
and meet all stated requirements. Although there is existing authority
that might be interpreted broadly to cover most of the research at issue,
it was generally agreed that regulatory actions taken on the basis of any
such interpretation would probably be subject to legal challenge. The
Subcommittee, in reaching this conclusion, reviewed the following laws
that were deemed to warrant detailed consideration:

[869]

11

(a) The Occupational Safety and Health Act of 1970 (Public Law 91-596)

(b) The Toxic Substances Control Act (Public Law 94-469)

(c) The Hazarduus Materials Transportation Act (Public Law 93-633)

(d) Section 361 of the Public Health Service Act (42 U.S.C. 264).

In addition, several other laws were examined. The Clean Air Act,
the Federal Water Pollution Control Act, the Resources Conservation
and Recovery Act, and the authorities of the FDA and t'.e Department of
Agriculture.

The full Committee adopted the report of its Subcommittee and
agreed that new legislation was required.

B. Interagency Committee Analysis of Elements for Legislation
In considering the elements for legislation, the Committee reviewed
Federal, State, and local activities bearing on the regulation of
recombinant DNA research.

Among Congressional proposal reviewed were S. 621, "The DNA Research
Act of 1977," introduced by Senator Dale Bumpers, and the companion
measure introduced by Representative Richard L. Ottinger in the House
(H.R. 3591) . The Committee also noted the resolution introduced by
Representative Ottinger on January 19, 1977 (H. Res. 131), requesting
DHEW to regulate recombinant DNA research under Section 361 of the PHS Act.

Among State and local activities reviewed were recommendations by the
New York State Attorney General's Environmental Health Bureau for State
regulation, and the Cambridge (Massachusetts) City Council's resolution
on recombinant DNA research.

[870]

12

Several committee representatives also reported on meetings with
other interested parties whose views had been solicited on legislation
to regulate recombinant DNA research. Those who were contacted include
agricultural scientists, biomedical scientists, environmentalists, labor
unions, and private industry. At my request, the Industrial Research
Institute and the Pharmaceutical Manufacturers Association are surveying
their member firms to determine the scope of the research efforts in the
private sector. The Pharmaceutical Manufacturers Association has .endorsed
the NIH Guidelines as standards for conduct of this research.

In considering elements of proposed legislation, a number of issues
were raised and discussed fully by the Committee. After detailed delib-
erations at meetings on March 10 and 14, 1977, the Committee agreed on a
set of elements for proposed legislation. The elements agreed upon and
the various alternatives reviewed by the Committee were presented in an
Interim Report transmitted to HEW Secretary Califano on March 15, 1977.
Secretary Califano, in releasing the report on March 16, stated that
"legislation in this area would represent an unusual regulation of
activities affecting basic science but the potential hazards posed by
recombinant DNA techniques warrant such a step at this time." He
went on to say, "...I believe such a measure is necessary not just
to safeguard the public but also to assure the continuation of basic
research in this vital scientific area. We are not saying that research
should be halted. We are urging that it should proceed under careful
safeguards unless and until we have a better understanding of the

[871]

13

risks and benefits posed by use of recombinant DNA techniques without
Government regulation."

Mr. Chairman, I would like to submit for the record the Federal
Interagency Committee's "Interim Report on Suggested Elements for
Legislation," along with a copy of the Secretary's press release.

With your permission, I would like to review briefly pome of the
major elements addressed by the Committee. The Committee determined that
the Department of Health, Education, and Welfare is the appropriate locus
in the Government for the regulation of the use and production of
recombinant DNA. molecules. In reaching this determination, the Committee
took into account existing roles of certain agencies within DHEW — for
example, that of the NIH in developing the Guidelines, and of the Center
for Disease Control and Bureau of Biologies (FDA) in regulating infectious
agents and biological products. The Committee also had before it the
petition by the Environmental Defense Fund, requesting DHEW to issue
regulations for recombinant DNA research.

The Committee reviewed at great length the nature and scope of
regulation. Consideration was given to regulation of all laboratory
research where hazardous or potentially hazardous substances were
employed. There was general Committee agreement that present legisla-
tion should be restricted to recombinant DNA techniques.

[872]

14

However, I have established a committee at the NIH, chaired by
Dr. Richard Krause, Director, NIAID, to study and recommend, if
necessary, safety standards for other NIH-supported research involving
actual or potential biohazards. The preliminary report is expected
shortly, and I will keep the Committee informed of the progress on
this NIH review.

Regulation of just the research aspects of recombinant DNA
techniques presents a problem because of the difficulty in determining
the border between research and pilot production. Therefore, the
Committee recommends that regulation cover the production or use of
recombinant DNA molecules. Such language would include research
activity, and makes immaterial possible concerns whether a given
activity constitutes research, pilot production, or manufacture.

The Committee recommends that the Secretary, in specific instances, in
consultation with appropriate regulatory agencies, be allowed to determine
the nature of the activity and should defer to a regulatory body that the
Secretary determines is better empowered and equipped to deal with it.

There was general agreement by the Committee that registration of
projects involving the use or production of recombinant DNA molecules
was necessary. The Committee also recommends that facilities be licensed
and that the terms of the license include acceptance of responsibility
for the particular activities and individuals at the facility. The
Committee concluded that licensure of the facility and registration of
projects would be more feasible and would more adequately meet the needs

[373]

15

for safety monitoring rather than licensure or registration of
individuals engaged in research.

The Committee urges full disclosure to the appropriate regulatory
body of all relevant safety and scientific information pertaining to the
use or production of recombinant DNA molecules. However, the Committee
recognizes the important world-wide commercial potential of recombinant
DNA molecules in medicine, agriculture, and other areas of science and
technology. It believes that the potential commercial uses of recom-
binant DNA techniques require that information of a proprietary nature
and patent rights be given the appropriate protection from disclosure by
the regulatory agency receiving such information as is currently provided
by existing law. However, the Secretary may immediately release information
if public safety requires it.

Because the potential hazards posed by the use of recombinant DNA
techniques extend beyond the local to the national and international
levels, the Committee recommends that a single set of national standards
must govern and that, accordingly, local law should be preempted to
ensure national standards and regulations. The Committee, however,
took into account the activities at the State and local levels on
regulation of recombinant DNA research. It was agreed that, if a State
passes a law imposing requirements identical to those contained in the
Federal legislation, then the Secretary may enter into an agreement
with the State to utilize its resources to assist the Secretary in
carrying out his duties.

[874]

16

Protection of workers was also considered by the Committee.

Training of workers in proper laboratory techniques and long-term medical
monitoring are important aspects of worker safety and were endorsed by
the group.

A number of other recommendations are made, and I can discuss them
further if you have questions. I would like to emphasize that the work
of the Interagency Committee has been done in a most cooperative and
helpful way.

DHEW will continue to cooperate and coordinate with relevant
Federal Departments and Agencies in this important matter.

IV. CONCLUSION

In conclusion, this much is clear: the international and national

scientific community is in substantial agreement that, until the potential
hazards of recombinant DNA techniques are better understood, a common set
of standards must everywhere exist for the use of those techniques. The
question being debated now is how this is to be accomplished. The
substance of all guidelines is sufficiently similar; how to apply them
locally and nationally remains the issue.

In the United States, this question has attracted far more public
attention than in other countries. Indeed, a number of local jurisdictions
or States are engaged in action or debate.

[875]

17

Finally, I want to note that biomedical research is entering a
new era in its relationship to society. It is passing from an extended
period of relative privacy and autonomy to an engagement with new ethical
legal, and social imperatives under concerned public scrutiny. NIH has
responded to these concerns by requiring the formation of review boards
to oversee human experimentation, animal care, and now D?3A recombinant
experiments. Similar bodies may soon have to oversee r .her hazardous
laboratory work. These responsibilities are inescapable adjustments to
the rising demand for public governance of science, though this need not-
and, indeed, should not — go beyond what is clearly required for public
safety lest we inadvertently impede successful research and hamper
creativity. The progress of science will continue to depend on the
initiative and insights — call it inspiration, if you like — of individual
scientists .

[876]

FOR RELEASE UPON DELIVERY

DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE

PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
BETHESDA. MARYLAND 20014

STATEMENT BY

DONALD S. FREDRICKSON, M.D.

DIRECTOR, NATIONAL INSTITUTES OF HEALTH

ON

RECOMBINANT DNA
BEFORE THE

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE
COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
NOVEMBER 8, 1977

[877]

Mr. Chairman and Members of the Committee:

In June 1976 the National Institutes of Health, with the concurrence

i

of the Secretary of Health, Education, and Welfare and the Assistant
Secretary for Health, issued Guidelines to govern the conduct of NIH-
supported research involving recombinant DNA molecules. A number of
scientific, administrative, and legislative events have occurred since
that time which I would like to summarize for the Committee. Then
perhaps a quick look at issues in evolving Federal policies for
recombinant DNA research would be in order.

The new recombinant DNA technique has resulted in a profound and
qualitative change in the field of genetics. Developments in genetic
research, particularly in the last four years, open avenues to science
that were previously inaccessible. Hypotheses and ideas that were not
confirmed can now be rigorously tested. The understanding of basic
biological phenomena has already been enhanced, and the promise of
recombinant DNA research for better understanding and improved treatment
of human disease is great. Further experimental data will be required
to delimit the benefits that may be derived through this technique.

Some of the same scientists who foresaw the widening of the
horizons of biology through these means were the first to express concern
that they might be hazardous as well. The worst scenarios imagined
microorganisms with foreign genes that could cause disease or adversely
affect the environment if they should escape from the laboratory and
infect human beings, animals, or plants. The Guidelines that resulted

[878]

2

were conservative, prohibiting all experiments with known risks.

Where risks were unknown but potentially significant, appropriate
standards were set to minimize those risks. Many recombinant DM
experiments have been conducted throughout the world during the past
five years and are continuing. To date, no known hazardous organism
has been produced in this work, and the risk of converting harmless
organisms to harmful ones by recombinant DM experiments remains
speculative. Further work will eventually determine the limits of
these speculative risks.

Scientific Developments

There is new scientific information developed over the past year
that lessens concern over the possible environmental hazard from the
research conducted under the NIH Guidelines. Dr. Roy Curtiss III,
Professor of Microbiology at the University of Alabama School of
Medicine in Birmingham, and others have demonstrated that biological
containment measures — methods developed to weaken bacteria used in
the experiments — would prevent these bacteria from surviving in a
natural environment if they were t<? escape from the laboratory.

At a scientific conference held this past spring in Falmouth,
Massachusetts, further evidence was given that the insertion of
recombinant DNA into E. coli K-12 (the principal organism used in these
experiments) could not transform it into a dangerous agent. Thus, risks
from this cause appear minimal, either for laboratory personnel or the
public at large. Dr. Sherwood Gorbach, chairman of the conference,

[879]

3

reported to me that there was substantial scientific consensus on this
matter, not only among the molecular biologists in attendance but also
among microbiologists who work with disease-producing bacteria. Proposed
experiments involving insertion of recombinant DNA into organisms other
than E. coli K-12 will also receive careful scrutiny before they are
approved by NIH.

Much of the concern expressed about recombinant DNA experiments
relates to the creation of novel organisms in the laboratory. However,
additional evidence to be published this month suggests that the
recombinations of DNA produced in the laboratory may be very similar
to those that occur in nature. If further work confirms and extends
the evidence presented by Dr. Standley N. Cohen, a leading molecular
biologist at Stanford University, then the concern about creating new
forms of life will be put into a new perspective.

Mr. Chairman, I would like to submit for the record some documents
describing in greater detail the scientific matters I have reviewed today.

Administrative Developments

The NIH Guidelines provide not only explicit instructions about
permissible experiments, but also an administrative framework for
their implementation. They set out the respective responsibilities
of the principal investigator, the institution where the work is
conducted (including the institutional biohazards committee) , and
the NIH initial review group (study section) which judges the
scientific worthiness of. the proposal. They also detail the responsi-
bilities of the NIH Recombinant DNA Molecule Program Advisory Committee
(or simply "Recombinant Advisory Committee," the technical body
responsible for proposing the Guidelines), and the NIH staff.

[880]

4

The Office of Recombinant DNA Activities (ORDA), in the National
Institute of General Medical Sciences, was established to coordinate
the administration of NIH policies and procedures for safe utilization
of recombinant DNA technology in research. Dr. William Gartland is
Director of ORDA. Over the past year and a half, the implementation
of the Guidelines by participants in this research has proceeded well.
Approximately 110 institutions where NIH-supported research is taking
place have established institutional biohazards committees, and
approximately 228 projects are involved.

Over the past year and a half, administrative practices have
evolved to deal with requirements of the Guidelines. One of the
requirements is a means for interpretation. The standards in the
Guidelines are very explicit about the conduct of permissible experi-
ments. Still, questions of interpretation continue to arise and must
be dealt with. Our determination to assure that the experiments comport
with the standards of the Guidelines has necessitated a number of
administrative delays in acting on research protocols. Where
interpretation of the Guidelines requires exercise of discretion,
an Executive Committee at NIH will review pertinent requests and
advise appropriate officials and committees in order to expedite the
administrative review of experiments.

Another area of difficult administration has been certification
of new host-vector systems. These systems represent microorganisms
weakened by various methods to prevent their survival were they to

[081]

5

escape from their specially contained environment in the laboratory.
Presently, the Recombinant Advisory Committee must review all

$

applications for new host-vector systems and recommend for certification
those that meet the relevant criteria.

Because of the technical complexity of these certification
decisions, the Recombinant Advisory Committee must frequently defer
its recommendations for certification for several meetings in order
to evaluate further scientific evidence. It was this latter circumstance
that posed difficulties for the researchers at the University of
California in San Francisco, who cloned genes in a host-vector system
not approved at that time and therefore had to destroy their work
and begin again once approval was granted. We have devised
better lines of communication to ensure that investigators and
institutions are kept fully aware of the status of their requests
for certification.

There is no question but that experiments have been postponed
and some scientific work delayed by the presence of the Guidelines and
their implementation. At the same time, having embarked upon this
course of self-restriction, NIH believes it must guarantee the
integrity of the administrative safeguards and assure that due
process is observed in implementation and revision of the Guidelines.

Mr. Chairman, I would like to insert for the record relevant
documents on the implementation of the NIH Guidelines.

[382]

6

Legislative Developments

As you know, a Federal Interagency Committee on Recombinant DNA
Research recommended in March 1977 that legislation be passed to
extend the standards of the NIH Guidelines to all recombinant DNA
activities in the public and private sectors. With your permission,

I would like to submit a copy of that report for the record. On the
basis of the recommendations, legislation was developed under Health,
Education, and Welfare Secretary Joseph A. Califano, Jr., and an
Administration bill was introduced in the Congress. The bill was
considered in Congressional hearings, and other bills on the subject
were introduced in the Congress. After several redrafts by the
relevant Subcommittees, a Senate bill was reported to the Floor and
a House bill was reported to the full Committee.

Although the two bills reported out contain many elements of the
original Administration bill, a number of differences concern the
Administration. For example, the Senate bill would give responsibility
for regulation and the enforcement of standards to an autonomous
regulatory commission. The House provisions are preferable because
they appropriately place many of these responsibilities in HEW.

However, the House version does establish an advisory committee that
would have operating functions. These approaches, especially the
Senate bill, would necessarily involve a greater administrative burden
and some further delays and duplication in handling the highly technical
matters involved in standard-setting and monitoring.

[883]

7

Mr. Chairman, certain of the principles embodied in the original
Administration bill continue to serve as a model for simple legislation.
At the same time, whatever legislation is enacted should avoid detailed
listing of responsibilities that limit needed discretionary powers of
relevant Federal officials and bodies. For example, subject to Congres-
sional oversight, the Secretary of HEW, in developing and implementing
regulations for recombinant DNA activities, should have flexibility
to accommodate rapidly growing knowledge in the subject area.

Also desirable would be appropriate means to remove such regulation
if demonstrated to be unnecessary. Legislation should facilitate
maximum governance at the level of the institution where the research
takes place, including responsibility for overseeing the conduct of
these activities. Whatever the nature of the regulation, there must
be careful regard for due process, full disclosure of information to
the public, and a safeguard of its Interests.

In the absence of legislation, recombinant DNA research in the
private sector which is federally funded will continue to comply with
the NIH standards as currently agreed upon by agencies involved.
Elsewhere in the private sector, the pharmaceutical manufacturers

[884]

8

have publicly given their assurance of voluntary compliance. No evidence
has been offered that any research in this country is being done outside
the standards of the NIH Guidelines. The Federal Interagency Committee
on Recombinant DNA Research will continue to serve as a forum for
coordination and cooperation for recombinant DNA activities in the
relevant Federal research and regulatory programs. The members of
the Interagency Committee will continue to maintain close liaison
with their respective communities, including agricultural scientists,
biomedical scientists, environmentalists, labor unions, and private
industry. For example, the Commerce Department is exploring means to
ensure appropriate coordination of efforts in broader reaches of the
private sector along lines developed in the past with the Pharmaceutical
Manufacturers Association and the Industrial Research Institute.

International Activities

The Federal Interagency Committee will soon issue a report to
HEW Secretary Calif ano on recombinant DNA activities in other countries,
with recommendations for fostering common safety standards. I will
provide copies to the Committee when that report is issued. Let me say
that scientists abroad, as in the United States, have played a leading
role in bringing potential hazards of recombinant DNA research to
the attention of scientists, governments, and international
organizations .

The issue of recombinant DNA research has been studied by
national and international bodies throughout the world. In many

[885]

9

cases some form of control has been adopted, but nowhere has the
research been totally banned. The United Kingdom and Canada have
issued guidelines that differ in detail but are similar conceptually
to the NIH Guidelines. Other countries are generally following the
NIH or U.K. Guidelines, including Denmark, the Netherlands, France,
the German Federal Republic, Israel, Sweden, and Switzerland. The
European Science Foundation (ESF) has endorsed the U.K. Guidelines;
the European Molecular Biology Organization (EMBO) has endorsed use
of either the U.K. or the NIH Guidelines; and the International
Council of Scientific Unions (ICSU) and the World Health Organization
(WHO) have urged nations to adopt the principles that these two sets
of guidelines embody.

As of the summer of 1977, there were an estimated 150 research
projects using recombinant DNA techniques under way in Europe, 300 in
the United States, and perhaps 20-25 altogether in Australia, Japan,
and the Soviet Union. All appear to be conducted under some form
of safety practices and procedures.

A number of national and international activities foster the
monitoring of recombinant DNA research for purposes of safety and
health. In the United Kingdom, the government's Health and Safety
Executive will be responsible after October 1978 for ensuring that
the standards of the U.K. Genetic Manipulation Advisory Group (GMAG)
are followed in matters relating to safety of employees and the
general public. The GMXG, consisting of representatives from the

[886]

10

scientific, public, and private sectors, reviews all recombinant DNA
research projects for conformance to appropriate safety standards
and practices. Similar advisory groups have also been established
in other European countries, and efforts are under way to identify
appropriate governmental bodies to ensure compliance with GMAG
standards.

The European Economic Community (EEC) has legal authority under
certain circumstances to enact policy decisions binding on its member
nations. In this context, EEC has begun to examine scientific
activities of member states to verify that the scientific and safety
measures adopted are consistent and that private industry adheres to
the same standards as the public sector. An EEC directive is
currently under consideration which would require each member
state to establish its own administrative mechanism to ensure that
all recombinant DNA research is subject to national guidelines.

Proposed Revised Guidelines

In 1977 the Recombinant Advisory Committee, in accordance with
its mandate in the original Guidelines, began the process of proposing
revisions to them. Revisions were proposed, based on accumulated
information on the effectiveness of physical and biological containment
and on the biology of the hosts and vectors utilized in recombinant
DNA research, by a subcommittee of the RAC which held open meetings in
March and April. Following this, the proposed revisions were considered

[887]

11

and revised by the full Committee at public meetings in May and June.

On September 1, 1977, revised Guidelines were referred to me for consider-
ation and decision.

These proposed Guidelines were published in September for
comment in the NIH Recombinant DNA Technical Bulletin. The Bulletin
is a new NIH publication that will attempt to link investigators
involved in recombinant DNA research both in the United States and
abroad with the advisory groups and organizations active in this
subject area. To provide further opportunity for public comment,
the proposed revised Guidelines were published in the Federal Register
on September 27.

Over the past two years, NIH has developed a roster of those in
the public and private sectors who have followed and shared in the
developing of NIH recombinant DNA policies. They have received
copies of the publication in the Federal Register to ensure proper
notice and opportunity to comment. All comment received from the
public and the scientific community, including the private sector,
will be considered by a public body, tne Advisory Committee to the
Director, NIH, at its December meeting. On the basis of the comments
received and the reviews by the Director's Advisory Committee and the
Interagency Committee, I will decide on the proposed revisions to the
Guidelines and will issue a decision document explaining any modifications.

[888]

12

Mr. Chairman, MIH Is preparing a description of the
the proposed revisions to the current Guidelines which I
to submit for the record as soon as It Is completed.

That concludes my statement^ I would be pleased to
questions .

nature of
would like

answer

[889]

BIBLIOGRAPHY OF
NONTECHNICAL ARTICLES,
APPEARING IN 1976 AND 1977,
CONCERNING RECOMBINANT DNA

[890]

BIBLIOGRAPHY

Abelson, J. (1977). Recombinant DNA: Examples of Present-day Research.
Science 1 96:1 59-60.

Bennett, W. and Gunn, J. (1977). Science that Frightens Scientists.
Atlantic, Feb. 1977:43-62.

Berg, P. and Singer, M. (1976). Seeking wisdom in recombinant DNA
research. Federation Proceedings 35(14):2542 -3.

Cavalieri, L. (1976). New strains of life — or death. The New York Times
Magazine, Aug. 22, 1976.

Chargaff, E. (1976). On the Dangers of Genetic Meddling. Science 192:938.

Cobb, J. (1976). Public Involvement in Scientific Decision Making.

Science 1 94:674.

Cohen, C. (1977). When May Research be Stopped? New England Journal
of Medicine 2 96:1203-10.

Cohen, S. (1977). Recombinant DNA — Fact or Fiction? Science 195:654-7.

Creating New Forms of Life — Blessing or Curse ? U. S. News and World
Report, Apr. 11, 1977.

Crossland, J. (1976). Hands On the Code. Environment 18(7);6-1 6.

Culliton, B. (1976). Recombinant DNA: Cambridge City Council Votes
Moratorium. Science 153:300-1.

Culliton, B. (1978). Recombinant DNA Bills Derailed: Congress Still
Trying to Pass a Lawl Science 199:274-277.

Davis, B. (1976). Evolution, Epidemiology, and Recombinant DNA.

Science 193:442. “ “

Davis, B., Chargaff, E. and Krimsky, S. (1977). Recombinant DNA
Research: A forum on the benefits and risks. Chemical and Engineering
News, May "TO, 1977 .

Dyson, F. (1976). Costs and Benefits of Recombinant DNA Research.
Science 1 93:6. ”™

Fields, C. (1977). Debate over Genetic Research Spreads Across the
Country. The Chronicle of Higher Education, Jan. 31, 19777

[391]

2

Fields, C. (1977). Who Shall Control Recombinant DNA ? The Chronicle
of Higher Education, Mar. 21, 1977.

Fields, C. (1977). Federal Control of Gene Research. The Chronicle
of Higher Education, Apr. ll, 1977.

Frederickson, D. (1976). Recombinant DNA Guidelines; Environmental
Impact Statement. Science 153:1192-4.

Fruits of Gene -juggling: Blessing or Curse? Medical World News,

—

Genesis of a Gene. National Science Foundation, MOSAIC, May /June 1977.

Goldstein, R. (1977). Public Health Policy and Recombinant DNA. New
England Journal of Medicine 296:122 6-6.

Grobstein, C. (1977). Recombinant DNA Research: Beyond the NIH
Guidelines. Science 194:1133-5.

Grobstein, C. (1977). The Recombinant DNA Debate. Sci. Amer. 2 37:
22-33.

Gwynne, P. (1977). Caution: Gene Transplants. Newsweek, Mar. 21,
1977.

Holliday, R. (1977). Should Genetic Engineers be Contained? New
Scientist, Feb. 17, 1977.

Hopson, J. (1977). Recombinant lab for DNA and my 95 days in it.
Smithsonian, June 1 977.

Hubbard, R. (1976). Recombinant DNA: Unknown Risks. Science 193:
834-5.

ICSU: Guidelines on DNA and Freedom. Science News 110:259.

Insulin Gene Transferred to Bacterium. Chemical and Engineering
News, ffiyWT&777

Lambert, P. (1976). Manipulations gen£tiques du laboratoire a la cite.
Le Recherche 7_(71):887:

Leeper, E. (1977). NEPA and Basic Research: DNA Debate Prompts
Review of Environmental impacts. BioScience 27(8):5l5-7.

Lewin, R. (1977). U S changes tack on genetic engineering. New
Scientist, Oct. 6, 1TF7T.

Lubow, A. (1977). Playing God with DNA. New Times, Jan. 7, 1977.

N

[392]

3

McCaull, J. (1977). Research in a Box. Environment 19(3):317.

Norman, C. (1976). Laying the Guidelines Bare. Nature 263:89.

Norman, C. (1976). Now New York Steps In. Nature 263:718-9.

Norman, C. (1977). Judgment of the People. Nature 265:98-9.

Norman, C. (1977). After the Carrot, the Stick. Nature 266; 292-3.

Randal, J. (1977). Life from the Labs: Who Will Control the New
Technology ? Current, May/ June 1 977.

Randal, J. (1977). If the Gene Splicers Win Their Battle, Will They
Lose the War? Change, Oct. 1977:48-9.

Recombinant DNA; local or federal regulation? (1977). Nature 267:475.

Recombinant DNA: Clashing Views Aired. Science News, Mar. 19,

T5TT

Research with Recombinant DNA. (1977). National Academy of Science,
an Academic Forum, 1977. (Anthology).

Rifkin, J. (1977). One Small Step Beyond Mankind. The Progressive,

Mar. 1977.

Rifkin, J. (1977). DNA: Have the corporations already grabbed control
of new life forms ? Mother Jones Magazine, Feb/Mar 1977.

Siekevitz, P. (1976). Recombinant DNA Research: A Faustian Bargain?
Science 194:256-7. " ~

Simring, F. (1976). On the Dangers of Genetic Meddling. Science 1 92:940.

Simring, F. (1977). The Double Helix of Self-interest. The Sciences, May/
June 1977. “ “ ~ '

Shuuring, C. (1977). Dutch go ahead on DNA. Nature 266:671.

Singer, M. and Berg, P, (1976). Recombinant DNA: NIH Guidelines.
Science 193:186-8. "

Singer, M. (1977). The Recombinant DNA Debate. Science 196:127.

Splicing Genes (1977). The Hastings Center Report, Apr. 1977.

Stettin, DeW. (1977). A parable on recombination. Nature 266:488.

Szekely, M. (1977). Sequencing DNA. Nature 267:104.

[893]

Szymborski, K. (1977). Genetic Hitchhikers. Poland, Illustrated
Magazine, Jan. 1977.

Tinkering with Life. Time Magazine, April 18, 1977.

4

Wade, N. (1976). Recombinant DNA: Chimeras Set Free Under Guard.
Science 193:215-7.

Wade, N. (1976). Recombinant DNA: A Critic Questions the Right to Free
Inquiry. Science 194: 303-6.

Wade, N. (1976). New York State Ponders Action to Control Research.
Science 1 94:705-6.

Wade, N. (1977). Gene -splicing; Cambridge Citizens OK Research but
Want More Safety. Science 195:268-9.

Wade, N. (1977). Gene-splitting: Congress Starts Framing Law for
Research. Science 196:39-40.

Wald, G. (1976). The Case Against Genetic Engineering. The Sciences,
Sep/Oct 1977. ~ ~

Wright, S. (1977). Recombinant DNA Research. Science 195:131 -2.

Young, P. (1977). Democracy vs. DNA — Tinkering With Genes: Extreme
Hopes, Fears. National Observer, Mar. 19, 1977.

[894]

SELECTED NEWSPAPER CLIPPLINGS
CONCERNING
RECOMBINANT DNA

[895]

Lock the labs in Cambridge?

Wash. Star Like ships passing unseen in the night, two of The Star's

7 / 12/76 editorial writers commented independently on the same topic,

and sailed tq a differing wind.

MAYBE

There is a thoroughly modem collision occur-
ring in the hamlet of Cambridge in Massa-
chusetts. It is one of those disagreements in
which either side can be viewed with bemuse-
ment or contempt or, more sensibly, sympathy.

The modernity in the case of Cambridge City
Council vs. Deoxyribonucleic Acid Recombinant
lies in the ambivalence with which many per-
sons regard the exuberance of scientific
achievement.

Science, of course, in a sophisticated defini-
tion, is largely a child of the 19th and 20th cen-
turies. and skepticism has been its sibling. The
more we learn — or think we learn — about our-
selves and the cogs and rotors of the universe,
the more straitened becomes the tension be-
tween .that accrual of knowledge and the
manner of its application. Which at least in part
is at issue in Cambridge. The city council the
other day. voted 5-3 to institute a three-month
moratorium on plans for advanced genetic re- '
search at Harvard and the Massachusetts Insti-
tute of Technology, both of which do business '
within the municipality of Cambridge. '

The experiments involve combining deoxyri-
bonucleic acid — .DNA, which can be viewed as
an organism's genetic Western Union — with
two types of organisms, usually a warm-blood-
ed animal and a special bacterial strain. From
this recombinant process can come a new
organism: The possibility exists that the new-
comer may be 'utterly unknown and its proper-
ties could be unpredictable.

Opponents of .the experiments fear that the
wiggy fellows in the labs may create nasty exi-

NO

Mayor Alfred E. Vellucci of Cambridge,
Mass., has a problem. He seems to think that he
is running an inquisition rather than a city
council. At least, the city council of that city,
over which he presides, has assumed in-
quisitorial powers over the scientific labs of
Cambridge.

They did so, it seems, because Harvard
University is preparing to conduct so-called
"recombinant" experimentation with the basic
genetic material deoxyribonucleic acid, or
DNA, the messenger of heredity.

It is proposed, as we understand it, to take
apart the DNA of different organisms and
“recombine" it, creating a new organic strain.
Where this experimentation might lead
essentially unknowable — as is often the case
with basic research. Maybe somewhere inter-
esting. Maybe nowhere at all.

The prospect of this genetic engineering in
Cambridge has aroused opposition, even among
scientists. This is nothing new, of course. When
Louis Pasteur first undertook to develop rabies
inoculation, the paradox of it all spread terror
not only in the populace but among some con-
ventional medical practitioners 'who had mas-
tered the "knowledge”of the time.

We profess no foresight in the matter. But it
would seem that too many copies of Michael
Crichton’s fantasy novel. The Andromeda
Strain, have circulated in Cambridge, Mass.

Reprinted by

gencies with their scientific tinkering, from
.which new diseases could bloom for which we
have no antidotes. Proponents argue that the
experiments may provide basic scientific
understanding of cell reproduction that could,
among other things, aid in the search for cancer
cures. There is no unanimity among the aca-
demic community in favor of the research —
supporting the city council, for example, is
Nobel laureate George Wald.

There is a further element: The action by the
Cambridge officialdom is worrying the scientif-
ic brotherhood — that it may set a precedent of
community control over such specialized re-
search. Ticklish issue there. What it may mean
is that scientists are going to have to learn to
talk to the rest of us.

We said this was a thoroughly modem head-
butting, but the antecedents of ambivalence are
inherent in the very bones of science. Two gen-
tlemen from the 19th Century were eloquent
from different, if not necessarily opposing, per-
spectives. Charles Lamb, in a letter to a friend,
wrote: "Can we unlearn the arts that pretend to
civilize, and then bum the world? There is a
march of science; but who shall beat the drums
of its retreat?" Thomas Huxley in mid-century
expressed the sense of inevitability of man’s
curiosity: "The generalizations of science sweep
on in ever-widening circles, and more aspiring
flights, through a limitless creation.”

The Cambridge affair is, in this fundamental
sense, intractable: But terms must be found by
which to address it. It can be argued that the
debate is already decades late.

There are visions of some devastating new
organism escaping from the recombinant test
tubes and assailing the good people of the city.
And who, after all, is to say the possibility nay?

No one is ever sure where basic experimenta-
tion in any field will lead. But Cambridge has
made an impermissible response; it has voted
to set up a system of political control. "Cam-
bridge has six square miles, and we're boss
here," commented Mayor Vellucci.

This is obscurantism in the pure state,
whatever form it takes; and in Cambridge it
has taken the form of a "moratorium" ordi-
nance suspending all recombinant DNA re-
search while a committee writes a “city policy"
for future control of the experimentation.

Much has been said and written, in recent
years, about the ethical responsibiity of re-
search scientists, especially those who labor at
the frontiers of nuclear physics and genetics.

There is, indeed, an ethical responsibility to
see that the applications and uses of scientific
discovery are benign. But political control of the
Cambridge variety is not the answer. If there
are to be ethical norms for research, those who
do the research are themselves best qualified to
set them. Mayor Vellucci and his councilmen
should confine themselves to holding the dog-
catcher to his duties and leave the science labs
alone.

permission of The Washington Star.

[896]

On Letting the Gene Out of the Bottle 3*™s

MORATORIUM ON RESEARCH
IN GENETICS IS EXTENDED

NYTimes 9-30-76

CAMBKluot, Mass., sept. 29 (AP ) —

The city’s moratorium on genetic re-
search at Harvard University and the
Massachusetts Institute of Technology
has been extended another three months.

City officials have argued that experi-
ments in genetic engineering could pro-
duce a serious danger to public health
and cause a major biological disaster.

In July, at the urging of Mayor Alfred
Vellucci, the City Conned adopted a reso-
lution putting a three-month moratorium
on all research that combines DNA genet-
ic material from different organisms to
create new life forms. The council ap-
proved the additional delay at a meeting
this week.

The resolutions were aimed directly at
delaying Harvard's plans to build a maxi-
mum-security laboratory in the city.

Daniel J. Hayes Jr., chairman of the
Citizen's Committee, an eight-member
board appointed to study the affect of
genetic research on Cambridge, said yes-
terday that the three-month extension
was needed because results of an environ-
mental impact study by the Federal Gov-
ernment were not available.

Copyright © 1976/77
by The New York Times
Company. Reprinted
by permission.

Copyright © by The
Washington Post.

Panel to Review

Genetic Research

A national commission with a ma
joritv ot nonscientists should be
named to make regular reviews of the
federal guidelines that govern poten-
tially dangerous genetic research.
Sen. Edward M. Kennedy (D-llass.)
said yesterday.

"What 1 am describing is a continu-
ing version of the citizens' council in
Cambridge. Mass.." said Kennedy—
chairman of the Senate Health Sub-
committee now reviewing those guide-
lines— to scientists at the Hoffman-La
Roche Laboratories in Nutlet .

On advice of its citizens’ council,
the Cambridge City Council voted ro-
sirirlions on genetic studies that go
well beyond federal guidelines.

Local communities should retain
the right "to add requirements they
think essential to protect their own
communities." Kennedy said.

He thus disagreed sharply with the
recommends ions of a federal inters
genev committee, and the vir vs ol
most scientists, who think that genet ir
research and the growth of universt
lies will suffer if there is a patchwork
of local regulation instead of national
standards.

Kennedy argued that citizens must
help make social decisions about sci-
ence in genetics and other fields. On
saccharin — subject to an imminent
federal ban as a possible cause of can-
cer— he said. “Perhaps some foods
should follow the tobacco precedcni
and be left to each of us to decide
Whether to buy it or pass it by."

“We wanna make sure nothing comes crawling out
of that lab,” said the Mayor of Cambridge, when Harvard
proposed to study genetic modification. As it happened,
tire Cambridge City Council recently voted to let Har-
vard proceed, but the concerns about genetic engineering
and "Frankenstein genes” have become international.

Within the scientific community, genetic engineering
has produced the widest philosophical debate since the
splitting of the atom. Is it a promising research tool?
Is it an unacceptably dangerous intrusion into the genetic
heritage of life? Until recently, the debate was left to
the scientists. Now the Legislatures of California and
New York are considering bills to control the research,
as are several members of Congress. On a scientific Issue
with such enormous implications, who should decide?

Gene-splicing has become the fastest-growing field
in biology. The research involves separating and recom-
bining DNA, deoxyribonucleic acid, the active substance
in the genes of all living things. DNA governs the
heredity of life. Characteristics of an organism can be
altered by splicing in DNA pieces from another organ-
ism: genetic transplants can be done between cells as
diverse as mammal and plant. A bright high school
biology student can do it.

Eighty-six universities in the United States are, doing
DNA research; so are at least nine private companies.
The pure researchers are trying to leant how DNA gives
organisms their hereditary traits, while pragmatic biolo-
gists are pursuing practical applications for drugs and
vaccines. Synthetic insulin and a vaccine for swine and
cattle diseases are two immediate possibilities. Yet more
dazzling results are imaginable. Recombinant DNA tech-
nology could lead to an increase in the world’s food
supply by enabling plant genes to manufacture their
own nitrogen fertilizer from the air. "Gene therapy"
in human beings may be only five to fen years away;
genetic engineering might wipe out diseases such as
sickle cell anemia.

The potential for harm, however, is also immense.
Seme distinguished scientists, including Nobel Prize-
winner George Wald, have called for a moratorium on
gene-splicing experiments. The recombinant DNA’s can
reproduce themselves in their host cells. Once released
into the world, they might be impossible to control.
Science fiction possibilities abound. Bacteria bred to eat

Progress or Peril?

Gene Transplants Stir
Communities’ Fears;
Scientists Are Split

Some See Important Benefits
While Others See Danger

Of Unheard-of Diseases
WSt Jml 9/28/76

oil spills could go on an indiscriminate rampage through
useful oil in automobiles and aircraft. A new strain of
bacteria dumped accidentally into a sink could make
its way from ocean to fish and back to human intestines.
"Knowing human frailty," said Cal Tech’s Robert Sins-
heimer, "these structures will escape, and there is no
way to recapture them.”

The opponents of recombinant DNA research do ignore
the success of science in handling agents as hazardous
as rabies, plague and typhus in secure laboratories. And
indeed, most of the research follows the careful guide-
lines of the National Institutes of Health.

More important than these arguments and counter-
arguments, however; more important than whether such
research should or should not be controlled, is the ques-
tion of who should make that decision.

The DNA issue should not be left to the scientific
community alone. Neither can it be left to well-inten-
tioned city and state legislators. For one thing, the broad
appeal of the research means only that a tough law
in one place will send researchers to another. More
important, on issues of such immense consequence for
good or ill, the public must participate in the decision.

Scientists may feel that any legislative restrictions
would interfere with their treasured freedom of inquiry.
But the public is already part of the process; the research
grants to study recombinant DNA come from the national
Government. The scientists have here an opportunity,
indeed a duty, to educate the public and its elected
representatives — devising, for example, a national frame-
work for biological research and a possible commission
similar to the Atomic Energy Commission. Congress
goals and purposes of the research. A well-thought-out
goals and purposes of the research. A well-thought-of
legal framework for such research could do more than
provide the foundation for rational decisions and proper
safeguards. An American law could provide world leader-
ship as well. Gene-splicing is going on everywhere, and
its products are going to be no respecters of national
borders.

Biological and biochemical research have come upon
exciting times, much as physics did 50 years ago. If
the history of science is any guide, sooner or later, the
research will be carried to its ultimate conclusion. We
had better first be clear on the means and the goals.

NYTimes 3-29-77

Federal Scientists Plan to Determin •
Potential Hazard of Gene Splicing
in Safeguarded Laboratories

By HAROLD M. SCHMECK Jr.

Special lo The New York Time*

Confrontation at Cambridge

By Daviii Gi mpekt

StuIJ Rr/jorti r «>/ THE Wall STREET JOURNAL

Federal Control Urged
Over All Laboratories

# WASHINGTON POST/3-15

Doing DNA Research

Street Journal © 1977
Dow Jones & Company,
Inc. All Rights
Reserved.

By Victor Cohn

Test-tube ‘re-evolution’: Can Congress cope?

12-17-76

B> Itohrrt < . < owrn
Staff comvspondont of
The Christian Si n-nee Monitor

Washington

As the new Congress considers the thou-
md> i>f bills and problems to come before it
ext year, it will have to give a little attention
• what Prof l.it-bc Cavalicri calls the ‘Tc-cvo-
i'ion of life on our planet ”

The Cornell University biochemist sees this
is the ultimate thrust of the budding tech-
lnlngy of genetic manipulation - a technology
that has lh<- potential to reshuffle the genetic
inheritance of earthly life

In the opinion of hiolngi-.ls, it also has an un-
known |nilential to create life forms never be-
fore known on this planet. - microbes that
might lx- dangerous to earth’s plants and anim-
als After a self-imposed moratorium to work
out h.lMiratory safeguards to prevent escape of
ncti iniemtu-s. mail) research groups now are
n - nn:ng their uoil. But many experts do not
n.r ;il- r emslii.S ,n the United States ade-

’. i:ng this. Rep i.illx-rt riude (R) of Mary-
•: r 1 i vs hills to r. gulatc this pew line of re-
. i. . will e-roe up in l*«th Houses of Con
• . r-e\» \e.ir To prepare lawmakers to deal

it *t tins rmvrl I- i Hie congressional Knvi-
r u.mi-iil.il Slu»l> ( i nfcieiicc, of which Mr
is i m- inu'T joiiieii forces with the Sci-
•■n* * s institute for 1‘iihhe Information this
we: k to give legislative aides a crash course in
••■si :-il>e genetic nianipu'ation
Only grantees restricted
Right now. regulation that docs exist stems
from :• vrn*s of guidelines worked out by the
y .'o.inl Institutes of Health (Nil!) and im-
• i! on all research i s who work with NIII
money

'inese guidelines specify increasingly strict
dan:! -ids of physical containment, depending
•■n IV assumed ri*k m an experiment They
f-div • from normal laboratory precautions to
the la-rnietically se ded cnn-litions once used
for ha logic al wa»f.in* laboratories
hi addition. c-\|k ri merits considered rela-
tively dangerous have to he carried out with a
cc » 1 strain of bacteria believed unlikely to
sm -. w if it did cseaj-c- The guidelines also

prohibit expe-nments that might enhance the
ability of microbes to produce poisons or In-
crease the hazard from microbes judged dan-
gerous to health

While experts' continue to debate whether or
not the guidelines are adequate, their real
drawback - as Maxine Singer of NIII, one of
their authors, explained - is that they have
limitr-d authority NIII can enforce them only
on its grantees

Dr Singer said that the Department of De-
fense. Energy Research and Development Ad-
ministration. and National Science Foundation
have also adopted the guidelines - and the De-
partment of Agriculture may soon do so too
That leaves a vast unregulated area, not only
for academic researchers with other sources
of funds but in industry, where many ex-
periments are being made.

Differences disclosed

The other members of the briefing panel -
Rolx-rt Pollack of New York State University.
Robert Sinshcimer of the California Institute of
Technology, and I)r. Cavalicri - agreed that
wider regulation is needed. But Drs. Sinshei-
mer and Cavalicri emphasized that they repre-
sent a more conservative view than many of
the: colleagues would support

For example. Dr. Singer said she thinks rele-
vant agencies, such as the Center for Disease
Control, already have enough authority to im-
pose the needed regulation, if they will exert
themselves. While favoring creation of a na-
tional commission to examine the issue, she
urged exploring what can be done under
present law. before Congress enacts special
control legislation. The other panel members
disagreed, saying they couldn't see existing
agencies doing an adequate job.

Dr. Sinshcimer went further. He would sub-
stantially tighten the NIII guidelines to limit all
experiments with unknown gene recombina-
tions to the most stringent physical contain-
ment. license ownership, and use of the special
chemical reagent needed for this work. He also
urged that researchers be encouraged to con-
centrate on evaluating potential dangers,
rather than rushing ahead to see what new
cimhinations of genes they can construct.

Dr. Cavalicri would go even farther, requir-

ing inspection of the laboratories and li-g.dlv
limiting experiments to merely evaluate1!: the
hazards

Dr Pollack objected that such a severe limi
tation on research and restriction to a few- >•:
per-isolatcd facilities would virtually exclude
young scientists from this research field,
which promises to be one of the main avenues
for understanding genetic s for many y« rs to
come

All the panelists pointed ou! that many bi-do
i-i is twlieve the present saferpiatcU and
gm- d ri-'-d.ition to l»o more than ubpiite
H*ev i-o -lr n- intcrfereni - \dh the-*- 'nr
r *f — »•; I fre» -»m of r ■• earth - a wpm-: ?

• p: • n!« d on the panel C’\< :h»; ■v»c

-|-c ••! aMi’nde. I' -t tube j»ree <b ;ff?!?”» no.v.i
ir ?-r way in mjny laboratories Dr sjpvhe.
mcr pci|»M;:l - d the number 1o V *'» or If) fron
his own direct knnv.lodeo. rg.idi'v agro--
with ?tr Singer that this c- 'imn'o f’vght •
h- far too low

KEEPING WATCH ON DEOXYRIBONUCLEIC ACID/NYTimes / 2- 20- 7 7

By Harold m. schmeck Jr.

WASHINGTON — "Recombinant DNA research” is
a subject so abstruse that until recent years, it was
seldom mentioned beyond the biologist’s laboratory.

But now there have been public hearings in Cam-
bridge. Mass., Ann Arbor* Mich, and other cities.
There is legislation before the state of California
and the United States Congress and the prospect
of hearings here soon in the Senate. This uncommon
subject for public debate and legislation is the chemi-
cal called deoxyribonucleic acid — better known as
DNA. It is the master chemical of heredity. It dictates
what every living cell can make, do and become
because DNA is the message-bearing substance of
the genes and chromosomes in all living things.

The current debate is over the question of restrict-
ing experiments in DNA research and even prohibit-
ing some experiments altogether. The scientists
themselves called for a moratorium on auch work
in 1974 while they considered the balance of risks
and benefits and tried to define safety guidelines.

The discussion has arisen because scientist* have
now devised ways of altering the genetics of -living
things in ways that may possibly go far beyond
what nature has contrived. They are learning how
to splice into the native DNA of a living cell i
segment of foreign DNA which might give Uiat cell
traits and capabilities it never had in nature. Genes
of man or animal could be spliced into the genetic
apparatus of plants or bacteria or vice versa. As

a tool for studying life, gene splicing seems to have
immense promise even though it is not clear that
the transplanted genes would always function the
way they did in their original home.

Bacteria Made to Order

On the ^racucal side the potentialities of recombi-
nant DNA work seem revolutionary. One' might, for
example, design bacteria that would gobble up pe-
troleum from oil spills. Other microbes might be
turned into living factories for producing vitally
needed substances such as insulin or human growth

Copyright © 1976/77 by The
New York Times Company.
Reprinted by permission.

agent has been created by recombinant DNA tech-
nology "

No practical T efit has yet been realized either,
but enough exp. " ments have been done with bac-
teria to show thui this is a technique of real power.
Transfer of genes from one bacteria! species to an-
other has been accomplished, although this is not
surprising considering that bacteria can do it them-
selves without human guidance. In some of the lab-
oratory experiments, however, much larger jumps
across species lines have been achieved deliberately
— transplants of genes from fruit flies, toads and
even rabbits into bacteria.

In other genetic manipulations, cells of tobacco
plants have been fused with human cancer cells to
form hybrids containing some genes of each. Such
studies have been useful primarily in studying the
action and control of genes. No science fiction
progeny have emerged from the test tubes. Clearly,
however, there is a need for safety rules and a need
for everyone involved in the research to obey them.

Last year, after much study and the airing of con-
flicting views, the National Institutes of Health pub-
lished strict guidelines to govern recombinant DNA
experiments in all research the institutes helped sup-
port. By now the guidelines have been adopted, or
are about to be, by every Federal department believed
to have any direct interest in recombinant DNA Re-
search.

Senator Dale Bumpers. Democrat of Arkansas, has
introduced a bill requiring licensing of institution*
doing recombinant DNA research and giving the De-
partment of Health, Education and Welfare national
regulatory powers over the field. Senator Edward
M. Kennedy. Democrat of Massachusetts, who had
been a congressional leader in concern over recombi-
nant DNA studies is planning hearings this spring.
And the state of California is considering a bill that

hormone. The genetics of plants nught be engineered ^ ^

to make some important food crops fix their own

nitrogen for fertilizer.

Any of these accomplishments, if achieved, could
confer profound benefits on mankind. But each such
potential boon is matched by a comparable theoreti-
cal catastrophe.

What if the postulated oil-gobbling bacteria got
loose and became a contagious disease of automo-
biles. aircraft and all other machinery lubricated by
oil? What if the insulin-producing bacteria learned
to thrive inside humans and. somehow, sent every
infected person into insulin shock? What if sciential*
inadvertently produced a super germ or a super weed

recombinant DNA research within its borders.

In Cambridge, the city council, which has heard
a long and sometimes acrimonious debate over DNA
research during the last several months, finally voted
against banning such studies at Harvard University
and Massachusetts Institute of Technology. The
council adopted an ordinance setting up strict guide-
lines for construction of a laboratory at Harvard
for the research.

Inevitably some scientists think public concern
over recombinant DNA research has been blown out
of proportion by the science-fiction aura that seems
to color it. But one thing seems clear: If other areas

capable of upsetting the entire balance of life on of biological research are also potentially hazardous.
eaJ^9 they have not struck the public as subject for regula-

To date all of the harmful possibilities remain li°n and restriction,
entirely potential and theoretical. "It should be em- —

phasized," said a recent Government report, "that Harold M. Schmeck Jr. reports on science for The
there is no known instance ra which a hazardous New York Times.

Reprinted by permission from The Christian Science Monitor . Copyright ©
1976 by The Christian Science Publishing Society. All Rights Reserved.

[893]

NATIONAL OBSERVER
3-19-77

Democracy vs. DNA

Tinkering With Genes: Extreme Hopes.

By Patrick Young
From Washington, DC.

SOME of the nation’s leading sci-
entists came face to face with the
hurly-burly of democracy here
last week. They didn’t much like It.

Scientists generally are not used to
defending their research on moral,
ethical, and social grounds, nor having
their work and their motives questioned
in debate with laymen. So last week’s
often-heated 2'/2-day public discussion
at the august National Academy of
Sciences provided some scientists
with a taste of what they may face In
the future The sessions Included ac-
cusations. Insults, and even a feeble
protest demonstration.

The issue: The risks and benefits
of a relatively new scientific technique
called recombinant DNA, In which a
bit of genetic material from one living
thing Is placed In another living thing
to create new forms of life.

Laboratory Safeguards
DNA recombination appears quite
common in nature, particularly among
bacteria, and may account for the In-
creasing resistance of various germs to
antibiotics. But man’s ability to tinker
thus with genes Is barely four years
old.

Yet such work Is booming— with
funds from the National Institutes of
Health (NIH), the National Science
Foundation, and the Department of Ag-
riculture—and so Is the controversy
surrounding It. A Washington Post sur-
vey finds recomblnant-DNA research In
the United States "13 moving ahead at
86 universities and research centers
and at least nine private companies.”
Control of these efforts may become
the biggest and most controversial
science-policy Issue since the debate
over atmospheric testing of nuclear
weapons in the 1950s. Both the Federal
Government and several local govern-
ments are establishing laboratory safe-
guards. while some scientists are call-
ing for uniform standards. And there
are demands for greater regulation If
not an outright ban on research.

Visionary proponents of recombl-
nant-DNA research have predicted
marvelous advances— from the cure for
cancer and the prevention of severe ge-
netic diseases to a solution to the
world's food problems. Fevered oppo-
nents have raised the specter of some
"Andrdmeda Slrain” loosed to spread
devastating illness world wide and of
the cloning of humans, the reproduc-
tion of genetically identical individuals.

Such hopes and fears both appear
extreme Yet the issues raised by re-
combinant DNA have badly— though
not evenly- split scientists, even pitting
Nobel laureate against Nobel laureate.
Scientists tegard emotionalism ns

unscientific, but as one chemist
said: “The opposition Is necessarily
emotional. We're operating from a gut
feeling that is very real, and to Ignore
that gut feeling. I think, is being un-
scientific.”

The Bigger Questl on

Although the conference focus was
the relative benefits versus the risks of
recombinant DNA, a few participants
tried repeatedly to raise another issue.
"The very much bigger question is not
how to ■ do this research safely, but
wnether to do it at all," said George
Wald, professor of biology at Harvard
University. But the leaders of science.
In and out of Government, here and In
Western Europe, have already agreed
that the research shall continue, albeit
with some restrictions. And stopping
work In the United States probably
stop It everywhere.

As debate continued, It became clear
that neither the risks nor the benefits of
recombinant DNA can be foreseen with
any certainty. The technique could pro-
vide great Insights Into the basic nature
and functioning of the genes that con-
trol humans, animals, and plants. How
cells determine whether they are liver,
bone, or blood cells, for example, or
why cells turn cancerous. But there
was disagreement whether other meth-
ods might not supply the same informa-
tion more safely. If more slowly.

‘Not the Only Animal1

The potential benefits of recombi-
nant DNA Include a better understand-
ing and treatment of some diseases;
new means of producing Insulin for dia-
betics, Interferon— the body's natural
antiviral agent— clotting chemicals for
hemophiliacs, enzymes, and antibiot-
ics; the creation of plants that take the
nitrogen they need directly from the
air. The envisioned risks Involve crea-
tion of new life forms that adversely af-
fect the animal and plant life of earth,
or spread Illness and death.

“We are not the only animal on this
planet," said Ruth Hubbard, professor
of biology at Harvard University. "We
can louse up our environment as well
as our health.”

It is a lack of certainty about the
benefits and risks and the potentially
Immense stakes that are making re-
combinant DNA a national Issue. Last
summer NIH Issued safety guidelines.
These now apply to all Federally fi-
nanced recomblnant-DNA research, but

not to private work, such as that of
drug companies. The guidelines require
that recombination be done within a va-
riety of physical and biological "con-
tainments.”

They also ban certain experiments:
The use of organisms that cause major
diseases In humans and animals; the
use of potent toxins, such as those that
cause botulism and diphtheria, and the
venoms ot snakes and insects; and the
transfer of drug resistance to organ-
isms that are not known to acquire It
n: illy.

Fears

Strict Enough?

For the work that Is allowed, the
greater the suspected potential hazard,
the more containment required. There
are four classes of physical contain-
ment, ranging from P-1— precautions
routinely used In bacteriology laborato-
ries—to P-4, the most stringent. This
requires an airtight lab, entry by air
lock, special clothing for workers, and
decontamination of everything leaving
the building— people, air, clothing, and
wastes.

Questions have been raised, how-
ever. whether these rules are strict
enough and whether Federal regula-
tions should be Imposed on industry.
The city council of Cambridge, Mass.,
home of Harvard University and the
Massachusetts Institute of Technology,
has written Its own rules, slightly
tougher than the NIH guidelines, for re-
comblnant-DNA work within Its Juris-
diction. Several other cities have done
likewise or are considering action.

Federal legislation has been Intro-
duced In the House and Senate. A com-
mittee representing two dozen Federal
agencies has concluded that no single
agency has the authority to regulate all
recomblnant-DNA work, nor are exist-
ing Federal regulations sufficient to
cover all aspects of the problem. Com-
mittee members expect to recommend
that the Carter Administration propose
new Federal legislation.

Such legal and political activity
frightens many scientists, who see It as
anti-intellectual, an unwarranted Intru-
sion on their freedom of Inquiry, and an
attempt to stifle research philosophi-
cally unpalatable to some pressure
groups.

Other Nations’ Standards

In 1974, when a committee of the Na-
tional Academy of Sciences requested a
temporary halt to some forms of re-
comblnant-DNA work, many scientists
assumed that a set of voluntary guide-
lines would sufficiently reassure the
public. Last year the NIH rules were
grudgingly accepted by many scien-
tists. But now many researchers are
pleading for uniform Federal standards
that pre-empt the powers of local au-
thorities to regulate the research.

England and Canada have set na-
tional standards, and many European
countries have adopted the English reg-
ulations. But all regulations and safety
precautions might yet be too little. For
as recomblnant-DNA work progresses.
It will become easier to wield the tech-
nique. And eventually someone, some-
where—perhaps a brilliant hlgh-school
student In Garden City, Kan. — will
create a new life form, without regard
to any precautions, Just to prove he or
she can do It. And no one knows how
safe that new life will prove to be.

Reprinted with permission of The National Observer © 1977 Dow
Jones & Company, Inc. All Rights Reserved.

[899]

Washington Post 4-12-77

How To Regulate Basic Research

THE FEDERAL government is in the process o.

writing legislation to control research on DNA
molecules— the material that determines the heredi-
tary characteristics of all known cells. This is a par-
ticularly delicate undertaking, because Congress has
no experience with regulating basic, scientific re-
search and because the kind of research under scru-
tiny has the potential not only of bringing great good
to mankind but also of threatening it with untold
harm. So we would like to underline the plea of Dr.
Norton Zinder of Rockefeller University to the Sen-
ate Health Subcommittee last week that “this be done
with extreme care and without haste."

With that in mind, it seems to us that the licensing
proposal presented by Secretary of Health. Education
and Welfare Califano is a useful starting point. Mr.
Califano has followed the general outline proposed
by an inter-agency committee which urged that fed-
eral safety standards be set for the laboratories in
which this research is conducted. But he rejected the
committee's key recommendation that the federal
standards override state and local safety legis-
lation In this field. This, it seems to u* is a serious
mistake.

It is not good enough for the federal government to
say, as Mr. Califano recommends, that it is setting
minimum standards and letting states and local gov-
ernments set higher ones, if they want to. The federal
standards must be sufficiently high to provide ade-
quate safety for all the country if anything should go
wrong in the experimental process; the potential for
harm is that great. But if federal standards are that

high, there Is no sound reason for local governments
to drive them higher. When the federal government
talks about minimum standards, it almost invites ad-
ditional regulation by local governments.

There are, as we see it, seveial dangers in such an
invitation. One is that some local governments would
create unrealistic standards; the expertise available
to the federal government in drafting regulations of
this kind is not so readily available to state and local
governments. Another is that local governments
might erect standards so stringent that scientists
could not meet them. Either possibility would drive
this kind of research out of institutions located in cer-
tain communities and cause a reshuffling of scien-
tists between institutions as they sought more con-
genial regulations. Indeed, it is conceivable that fear
of DNA research could produce a series of local regu-
lations that would drive this research out of the in-
stitutions best equipped to conduct it and force this
work into less qualified institutions or, in the worst
possible case, underground.

It seems quite remarkable that the federal govern-
ment would consider giving local governments so
much leeway in handling so delicate a subject when
it has denied local option in such matters as regulat-
ing the amount of meat in a package of bacon. This is
one area where Congress must exercise that "ex-
treme care” of which Dr. Zinder spoke— extreme
care that citizens not only are protected against the
harm that DNA research might do but are also as-
sured that this research ran mntinue under the best
possible conditions.

Washington Post/4-26

‘Minimum Standards’ for DNA Research

Your editorial “How to Regulate
Basic Research” raises the valid issue of
“minimum" federal standards for DNA
(deoxyribonucleic acid) research. ' At
the same time, however, it erroneously
c. includes that communities should not
have the opUon of setting higher stan-
dards for genetic research. Such ac-
. ions would ostensibly lead to unrealis-
tically high standards or force
researchers to seek a more conducive
(i.e., less regulated) climate for study.

Much the same controversy surroun-
ded passage of the Clean Air Act when
Congress called for nationwide air
quality standards but permitted states
to set higher standards. California sub-
sequently developed auto emission st-
andards that reflected the state's belief
that federal “minimum" standards
would not adequately meet local and
statewide environmental and public
health goals.

If the elected officials in a commu-
nity believe that a federal standard—
be it for occupational safety, nuclear
power, clean air or genetic research-
does not adequately protect the health
and welfare of its citizens, it should bo
the right and, indeed, the duty of those
officials to act to ensure such protec-
tion. While local standard-setting will
obviously be a delicate and highly tech-
nical endeavor, its sheer complexity
should not be the justification for pro
hibiting active local involvement. Fur
thermore, it is improbable that com-
munities with sophisticated research
institutions in their midst will pass laws
that drive those institutions away. And,
finally, the spectre of forcing DNA re-
search underground will remain even
if the federal government is the sole
standard-setter.

The debate over stringent local stan-

lifano Urges Strict Safeguards

Control Research on DNA?

W. Star, 3/18/77

Sought

jlslative controls
on the search tor new life forms through genetic
research, HEW Secretary Joseph Califano said
yesterday.

"I recognize that legislation in this area would
represent an unusual regulation of activities af-
fecting basic science," Califano said, “but the
potential hazards posed by recombinant DNA tech-
niques warrant such a step at this time."

Copyright

Post.

© by The Washington

Reprinted by permission of The
Washington Star.

.ards for genetic research will be mini-
mized if federal standards are suffi-
ciently rigorous and encompassing. Un-
fortunately, the word “minimum" con-
notes a lack of stringency, but for the
federal government to set “maximum"
standards will clearly undercut the
right of a community to decide what is
needed to protect the health and safety
of its citizens.

DIANA H. WAHL

Washington

Wcisii S pm, 4-7-77

The Carter administration has
asked Congress to impose unprece-
dented federal controls on research
into the manipulation of genes to
create new forms of life.

The legislation, proposed yester-
day, would allow the controversial
recombinant DNA research to con-
tinue but only under federally ap-
proved standards and safeguards.

Joseph A. Califano Jr., secretary
of health, education and welfare, told
a Senate health subcommittee that
the potential but still unidentified
hazards posed by such research lead
to the conclusion that "there is no
reasonable alternative to regulation
under law."

"Only continued research, pro-
ceeding under strict safeguards, will
tell us whether these restrictions
must continue in force or whether
they can be relaxed at some time in
the future," Califano said.

"I understand that legislation in
this area constitutes unusual govern-
ment involvement in the workings of
basic science," Califano said. "But
the potential risks inherent in present
recombinant DNA techniques justify
such a measure at this time. "

Califano called recombinant DNA
"a scientific tool of enormous poten-
tial.” reciting the possibilities that
the technique it represents could be
of significant help in the fields of
medicine, agriculture and industry
as well as providing the means of
gaining a far greater insight into
basic biological processes than ever
befer-

[900]

1

®j>e tUasliington |Jost

THURSDAY. MARCH 2 4, 1977

Controlling Genetic Research

THERE ARE FEW areu of Kientific research
that hold as much hope, and danger, as genetic
experimentation. In the future may lie such develop-
ments as the creation of oil-eating bacterid’ that
would eliminate much of the damage caused by oil
spills, and such spectacular developments as break-
throughs in the cure and prevention of many dis-
eases and human disabilities. But also in the future
may lie the possibility that organisms may be created
which man cannot control. It is even conceivable that
some scientists might choose to tinker malevolently
with the genetic makeup of human beings.

These various possibilities led many prominent sci-
entists in 1974 to call for a moratorium on such re-
search. They also led to the guidelines issued last
summer by the National Institutes of Health on how
federally-funded projects in this field must conduct
their work. Now. a high-level government committee
has recommended that those guidelines, with some
modification, form the base of a new federal law,
which would control tightly the production and use
of the molecules that are the focus and product of ge-
netic research.

The committee, on which all federal agencies con-
cerned with this research were represented, has
taken the right approach. It believes that research
Into genetic materials must be allowed to go on: the
potential benefits to mankind are so great that it
would be foolish to deny ourselves their discovery,
and the research Is so challenging that some scien-
tists would continue with it illegally even if it were
barred by law. But the committee also believes that
the dangers are too great to permit the research to
proceed unregulated and that the federal govern-

ment is the proper source of that regulation.

Drafting of the legislation has begun at the Depart-
ment of Health, Education and Welfare, and will no
doubt be difficult We have bad precious little experi-
ence in limiting what research scientists can and can-
not do. And we have not had much more experience
in requiring Industrial scientists to keep the govern-
ment Informed of the kind of products they are at-
tempting to develop for their employers. But the
need is clear for requiring that the federal govern-
ment be told what kind of genetic research is under
way and that it have the power to ensure that the re-
search is conducted in facilities that meet safety
standards sufficiently high to minimize the possibil-
ity of, say, loosing new creatures in the world. Devel-
oping rules that accomplish those ends without sti-
fling scientific inquiry may be difficult, particularly
for a department noted for its ability to complicate
enormously the administration of even simple pro-
grams, but it must be done, and done quickly.

Genetic research Is more than an American prob-
lem, and concerns about its promise and its dangers
are widely shared. Substantial work is under way, on
both the research itself and the ways In which it
should be regulated, in other countries: these include
the United Kingdom and most of Western Europe
and Canada Once Congress determines how research
is to proceed in this country, the groundwork for an
international agreement will have been laid. The
need for such an agreement is as clear as the need for
domestic regulation. A tragic mistake in this kind of
research anywhere in the world could endanger all
of us, just as a brilliant discovery in any country
could benefit all mankind.

Copyright © 1977
by The Washington
Post.

Reprinted with
permission of
The Wall Street
Journal © 1977
Dow Jones & Co . ,
Inc. All Rights
Reserved.

Copyright ©
1976/77 by The
New York Times
Company. Re-
printed by
permission.

HEW to Propose
Laws to Regulate
Genetic Research

WStJrnl 3-17-77

By a Wall Stmut Journal Staff Reporter

WASHINGTON - The Department of
Health. Education and Welfare said It plans
to propose legislation to regulate laboratory
experimentation with new life forms.

The government controls would be de-
signed to permit necesaary scientific re-
search but to protect the public against dan-
ge sms experiments and the fabrication of
disease-causing organisms.

"We aren't saying that research should
be halted." explained HEW Secretary Jo-
seph Calftano. "We are urging that It should
proceed under careful safeguards unless and
until we have a better understanding of the
risks and benefits posed by use of recombl-
nant DNA techniques (genetic engineering)
without government regulation."

The new legislation would be based on
recommendations by a federal Interagency
committee that, reported yesterday to Mr.
Callfano. The committee called for a law re-
quiring any person engaged In genetic-engi-
neering research to register with the HEW
Secretary and to work only In facilities li-
censed by the Secretary. The HEW Secre-
tary would have authority to Inspect the fa-
cilities and to take other steps to protect the
public.

Agencies Ask Law to Curb
Research on Gene-Splicing

NYTIMES 3-17-77

WASHINGTON, March 16— Legislation
that would closely regulate a controver-
sial area of genetics experimentation was
proposed today by a high-level committee
representing all Federal agencies con-
cerned with the research.

The Department of Health, Education
and Welfare, which would be the main
regulating agency in the proposal, an-
nounced today that efforts to draft legis-
lation would begin immediately. Congress
already has before it several bills to regu-
late the experiments, which are generally
known as recombinant DNA research.

The experiments, often described as
gene-splicing, involve newly developed
techniques that give scientists the ability
to take genetic material from one organ-
ism and incorporate it into living cells
representing an entirely different form
of life — for example, animal genes into
bacteria.

The research is believed to hold great
promise but also to involve potentially
great hazards through the production of
novel forms of life. DNA, the short name
for deoxyribonucleic acid, is the funda-
mental genetic material in all living
things. It is the key material of the genes
and chromosomes.

Joseph A. Califano Jr.. Secretary of
Health, Education and Welfare, accepted
the interagency report today and an-
nounced that his department would begin
drafting legislation at once.

By HAROLD M. SCHMECK Jr.

Sptdal lo The New York Times

Potential Hazards Cited

“I recognize that legislation in this area
.would represent an unusual regulation of
(activities affecting basic science,” he said
I in the announcement, "but the potential
|hczards posed by recombinant DNA tech-
niques warrant such a step. ’

He described legislation as necessary
to afeguard the public while assuring
that basic research would continue in
"this vital scientific area." r

The interagency report recommended
that all facilities engaged in recombinant
DNA research be licensed, and that all
research projects in this field be regis-
tered before the work began.

The report said that the primary re-
sponsibility for regulating the research
should rest with the Department of
Health, Education and Welfare, and that
the Secretary should have authority to
inspect facilities where the research was
being done.

Guidelines for conduct of the research
have been developed by the National In-
stitute of Health, an agency of H.E.W.
All other Government agencies concerned
with this type of research have adopted
the guidelines, but they arc not at present
binding on industry. A major reason for
the widespread interest in Federal legisla-
tion is the desire to bring industry’s re-
search efforts in this field under regula-
tion.

The Federal interagency committee
recommended that the Secretary of
H.E.W. be authorized to set standards
for the research and to sue to halt
production or use of recombinant DNA
materials if they appeared to constitute
a hazard to health or environment.

‘Sunset’ Provision Urged

The committee proposed that the
Federal legislation be drafted to pre-empt
state and local laws on the same subject
and that the Federal law have a iife of
only five years. This so-cal!e-! "sunset”
provision was recommended on the
ground that recombinant DNA research
was advancing so fast that major revi-
sions in regulation cf the field were likely
to be needed within five years.

Hearings on recombinant DNA research
are in progress before the Health and
Environmental Subcommittee of the
House Commerce Committee. In opening
the hearings yesterday. Representative
Paul G. Rogers, Democrat of Florida, the
subcommittee chairman, said that the re-
search held great promise but that the
threat of its potential hazards required
a uniform set of safety procedures.

The Federal interagency committee is
made up of representatives of the Depart-
ments of Agriculture. Commerce. De-
fense, Interior, Justice. Labor. State,
Transportation and of Health. Education
and Welfare.

Also, the Center for Disease Control,
the Food and Drug Administration, the
Energy Research and Development Ad-
ministration, the Er.’. iror.mcntal Protec-
tion Agency, the Exccuv.ve Off-cc of the
President, the Nation?: Aeronautics and
Space Administration, the National
Science Foundation, the Nuclear Regula-
tory Commission, the Arms Control and
Disarmament Agency and the Veterans
Administration.

[901]

Controlling Gene Transplants

VSWrnl ;-li-T7

By Ga£l 3s vs. k

Abec a year up; -< Kubaskl IssS-
ur.es af Health esuxfef aaiety gtabe-
-33 fcr frferaly pot tra.-agt.iJ3:

remarcfc.

Four lewd* * of pby*cu: tonianaea: a t
ruurcl arpaaxrj were set from Pi
ncrma lai pncaam a Pi nfitfei
sealed -xri d:*Jble deer* uni pmec0*e
ciaChe* Also bast feKtarta * wtorr taper-
-rcera are perixtocd tna* be botof>
ciZj *eemre TTaJ a they sua ax be
uie c *crr; ^ :f Cay caoe a aac*. w.tfc

Tv piliBwi were drr eloped Is deal
w-.to toe vr'rrlu. hazards a rejatbraat
DSA ff rarifc or toe shitty to
rer.a fr:n tre orrun.nr; le ly^it DKA-
3- iecsyr3tcr^cl« add. ndeatfi carry
toe genes wfcdci are toe ItRtftoy Chirac -
'.era Otc Btangcs of il Irap ijp !be
Ascot e-y to a: DKA ■*«*■ 3- be sp..:
aper ant rejaned arcAdtfy new esa-
taut tow rata wrto the apL.:tng of toe
atax r. topertaas? -'. opens a ban: of ex-
c-t-rg pout P_ tea lor earcfcag tr.rr.ur _le
aril i3> earircssaem. GUrtBtoij. si auc
r»jtj toe specter X creamg & Frarxcn-
ster msotier X & rev urgunusm toil co_ld
wreak nparaB t»*-i bars ac toe hur-.a-
raoe.

A tl rrber af hTa to Cangreaa .ncrjtdLng
ere backed by ire Carter ui-iruKruix
ci*_ Irr lb* 5TH r-obr’.nea is !xr toe
found si: iso of & rations- _aw refti.ub.rTf re-
aac.b. T.u.n: re»e:arcr_ li was noperi toa!
sort a -w would ddu £e conrroveryy
over reeabasai reseum irk aLow tad
wot Is p forward.

Bat Curgrec? It Ktrr -arn tie soar-
uge X -U federal coe'VjcPrca. A E.gnJ’-.rar:
roe drool appears tlrntm uertato to be ul-
toched to whatever ad mutj
err eyes L.bcal urtbanDes wonid be em-
powered I: tighter. bat not tuse nanoca.
reftf.u crs ir taey icc« S-eaisa
-ary X vuc. backed re ties X federa.
pnit-x.e5 would find toemaecvea B_b>tX
to reftjuuat or rwr tereia

Loral Option*

Seaxatx Etoard K Kennedy X Kas«-
inrsf.2 u & heading proposal X socr &
iocuri ccbor. Federc. VegXj&st rrust en-
-xrif* nor*: ioct- purihc Lrsceer--tmj be
•ays Tbey riara icnxi ae tbue to
rr.aase 201.1 .real rerirebeti. ar 1 crepi
fadcnl EL;rilirla.

!- " t Raise u srr'jcr. nee c*.-*rre-i
-7 Rep Pi— C. P-'fsn X Fbrtda j re-
-■ Tin? lie a;rr-sruix ad to prcnvie
jt /aiik xm lea to eatobtrr figifter
•jmforii far rei-anbrart researdL A
ito-*T atrabt? says tb* cassmOees
b-idy bKlaie Lswye's rrr repnrsErUr-
:re* . rd eaperto -rii brr^.xurl spetoa.-
— s to r.2 i - ft b-grt* X experdse
Jrs: irbere Lbe iaca cap— flea sre
nrppasek to Crrf sudh epeu fact oear
aw ., er. I wraijS nsa iag^cu: to uart
=5 *>• S&ArraS fjium r .■■ at. writ to

. I _t|«ris jzx± rcaaia-raa.

'•.. l -e - -4 bettes- ygXre to tssrcs toe
i— - -i X ur^A r • -an* lbs ' IktI

— -jr Jto. a€ --,.^4 inrrz JJtX _s n -*-ft ■»■

- 'I.- a. 1^' c.csraaaj5y 'f ' * -

•je-A v If Hat 1 & iurfw tncn *n£ re-
wrtb ti tteff to be a :n>aa. aX yot
a oca-, bn uri

7b* laoc litobf we «ntat r a cnxj-yt-:
X oca. kaws s&ys Tartar D ZLnbe- a
r»a.er_ir pe-bebns: al Prckdeto er D«m-
sty 'Wei bare wet states uad ±7 gate*
tsa&oasl lav cau>i rsesa toe oas X per-
Ktbe. a: ccrta.r. ntT'erari-a &r*mr.s to
wo-id =*are to perbtps toe p-uaea wb*re
f arV-br* aren't pod bx there * *ta re-
sci ibao ae research

If sifbi.ebt oca! bi.-n.-f x pur-bf
iawr X work xrn reaeartoen nay be

If sufficient local ban-
rung or paring dcam of re-
combinant DSA work oc-
curs, researchers may be
driven underground like
the bootleggers of the Pro-
hibition era.

Grn ec urtrrgruaad lie toe be obegeen X
toe Prub-b.bar era. 'Peopie rd obey toe
law ccly J they .'et. .: 1 nvfVnma I. Dr ZLb-
aer sijx Kutat Sure: a boeberus at
toe ^ateal Ctbcer Lasru te. aids TSe
iiea X local a.toa r.7 tosat faster
tocrpbEaoe wito toe faar. IT* a iaoy

*4ea“

BeenUuf DXA rescerefa to a toe
escbryacic sdpt pur irizr.y x toe ut>
Xiai area dx. iiTered by Mffi godtiBa
Day uXC a i;cti aaxpatoto rawe ei-'d
toey ftBTe ax interest x. a- bar* beg_r toe
earbe*: r—p-u X pre-rerieb' x remnbt-
-iito‘. d?fA research. These brras iacbjde
221 LMy A Co . AbX-C. LAboratartea CPC
.7.-, --r ’ inc. G D StEri* fc Co and
riXdxtrr-L— P.acbe Inc.

Sac-toKLi* Carp. *x erurple. ropei to
totretae toe pn»±>cax yislid X ur Etodr-s.
feed ad£9ve nrw oc toe oariKl aas pr>
ijee a race x* api^s: rwxe dysexery
_a;tog recaibniTT DXA tectcbqpes- Geo-
e-i_ SLectr.c to curitflf laborutory cx-
per_to£=its to*: cacid n-iej iead to
r«rw way* X ue-antor j? oC spCis cr be-
▼e-Vcptog rsd^ablt Xiem— ds oX X waste
cedhdbst ratoer tozr. frxc cosdy pe-to>
jsx Db Pont sees recitobtoart p-ic"sses
as ptffis-b. y >ȣag te plants tosi caa r .ure
efSciesiCy pbX-'jsyr'- >esxe s-rdigX. into m>-
trtota

Bat Fd iK gjrrrised If ary X ton
car";? *!>:•_■: t-Xnre tr>* Tw-cyd'drc. Cea-
tury Dr Ptolpt w F Hardy a* Di Pd.
says Other cose parses agree that resalto
are a long way 3d

Tie r-or. £*r*d=g pXesXSX for rer.c-
btoan: L>'A wort _,es to toe crisAcai Old-

The recc rcttorarl JitoS may vd? Elidy

ksedkary dtoarim x arx'rK geaebc
ceC rnwtos Oai :cad to carr Ttoar 3- -
r-*ei vto,". ca^se 1 toiler exad atoc be ex-
plored lianr^Jb fcr.; 13*j? PrwJoeSSto a X
tber^pe-br pr-.trss tor didbetos and btoa-
ypbdla a CwetinEy pcssible.

X c- .- a toe r.X -jr£-d to - to-
_m.wts toe q — -t to poasd oat toe t w

....

A 0*9* deadly bacteria W!to no knTcrn
ar.iiote wdd be istoodjoed Jala so Ody.
making 1: di££x*b to bait

For toal r' woc toe >TH f nrV nr* te-
edade a bar oc potenbaTy dtofrrvji ex-
perttoenis Itomixiag drag resstoace ib bac-
te-to and of mol burtr *arj»e».

But acdj Dr Dam there a setnetotog
j-rabanai ato_: people bcrr.arrtong risk-
free recoab ran: DKA reaearefc wtxfle they
take lor granted toil tores— gatori w...
take on highly risky researsfc to find toe
cause X Le-g.cnsA.rt s disease And bac-
teria X ad ktods are cu!L~r uteri 2 besputai
aioru x-a da£y.

It was at toe behest X toe scientists
toem.welwes that JOB begar. ts deE.g» X
safety gtodeLnes and hazard* assesEment
pmgrarc for recidb.nan: DKA pro>ects
Tb*e KIH CMnihltlee ladled tor a year and a
h£— 1 before agreetog ob toe riii-: :« is-
sueri last Jane
No -Bimre E»-ents'

Widiars J Gardl&ad. —rector X toe
DKA act: Tiber* Xtce a: MK says We
feel cjrpxtoehcal hazarls are man-ge-abj?
with biaiog,csJ and pbyscal caxuuranent
He say* tout orcr toe pax toree or lour
years ta erfclcb spec-d research bacteria
nave been constructed far scjc± wore toere
fartal bees ary "btrarre erenti and
aren't likely to be to toe futore.

Ir Gartiand aids tost loctl comraxtty
ewctot toees appu-toed to oversee stieuBfk
research have toe pakrital to be rather
d-srrpcrre because they area t as weC
ve^ed to toe £*id u people (taeeby at-
woiiTeri- He po-na out toa: under toe KTH
gtodel-nes the SI tesCtatioBS w htefc house
rscombtoiatil DKA projects under tederai
grant have their own bofazzrd coccsstt-
tees already

These com suttees are reo-cred by KTH
to rer^ew federal grant reqjXi and retie
- »w-?. progreES reports x toe work to toe
go» emment. D* CarLand say* tost KIH
has recontrr ended that these group? opes
her meetings to toe public »i people caa
better understand DKA research

Various bd? now -under congreasicrto.:
cortoideratioa cal for toe Departmeat X
Hes-'to Ed-jeatoce and Wtfae to license
research facilities and regXer prejecto
Proruaons are made fo- rpdatng federal
r-tdtltne? for keeping medico! records or.
persccnel and tospeettog lacL:Pes a* HE"*
jeers necessary. Sen KeTnedyi b£D also
specrf.caHy call? fcr toe HEW Secretory to
consult w.to otoer agraoe* or establish
coscmixtee* as he sees fit to help develop
nabora. stand-ardis Chat avoid "(digpfcaBrr
nytaats amcog federal agmpes

Bat t! dcplicaCve recrure-nents are uo-
deatianle aanog federal agencies a?
*ure-j they are wry are they any mere de-
xrafcfe among federa state and local
bodies X fcrtrcned' In toe mind* X
many en.-r.eni sc-ent-Sto and observers a
federal clause mand-tr^ local rerr.ew
would hare toe effect X unnertessarljy de-
dartog open season vpoa recombinant re-
sear'S Preferably. O' •egress wrj] rpe^-f-
ca9f quash touit possT-. - ty to the legtoU-
tdCBL

Vs Br ^m&jm.. 0 wakr X tAr /MWrf*»

.Vor y /'*- * - .» '* -• i*r «l

Reprinted with permission of The Wall Street
Journal © 1977 Dow Jones & Company, Inc.

All Rights Reserved.

- L\ S. QGrveKSMEST PRSmNG O-HCI IK- If- s*‘ «'St

[902]

.

DHEW Publication No. (NIH) 78- 1 139