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Full text of "Improved Standards for Laboratory Animals Act; and enforcement of the Animal Welfare Act by the Animal and Plant Health Inspection Service : hearing before the Subcommittee on Department Operations, Research, and Foreign Agriculture of the Committee on Agriculture, House of Representatives, Ninety-eighth Congress, second session, on H.R. 5725, September 19, 1984"

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IMPROVED STANDARDS FOR LABORATORY ANI- 
MALS kCl; AND ENFORCEMENT OF THE ANIMAL 
WELFARE kCl BY THE AMMAL AND PLANT 
HEALTH INSPECTION SERVICE 



HEARING 

BEFORE THE 

SUBCOMMITTEE ON DEPAKTMENT OPERATIONS, 
BESEAKCH, AND FOREIGN AGRICULTURE 

OF THE 

COMMITTEE ON AGRICULTUKE 
HOUSE OF REPRESENTATIVES 

NINETY-EIGHTH CX)NGRESS 

SECOND SESSION 

ON 

H.R. 5725 



SEPTEMBER 19, 1984 

ris RtCOBD ONW! 
Serial No. 98-86 ^ ^^^ 




Printed for the use of the Committee on Agriculture 



U.8. OOVERNBCENT PRINTING OFFICE 
41-970 O WASHINOTON '. 1985 



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COMMITTEE ON AGRICULTURE 



E (KIKA) DE LA GARZA, Texas, Chairman 



THOMAS S. FOLEY, Washington, 

Vice Chairman 
WALTER B. JONES, North Carolina 
ED JONES, Tennessee 
GEORGE E. BROWN, Jr., California 
CHARLES ROSE, North Carolina 
JIM WEAVER, Oregon 
TOM HARKIN, Iowa 
BERKLEY BEDELL, Iowa 
GLENN ENGLISH, Oklahoma 
LEON E. PANETTA, California 
JERRY HUCKABY, Louisiana 
DAN GLICKMAN, Kansas 
CHARLES WHITLEY, North Carolina 
TONY COELHO, California 
TOM DASCHLE, South Dakota 
CHARLES W. STENHOLM, Texas 
HAROLD L. VOLKMER, Missouri 
CHARLES HATCHER, Georgia 
ROBIN TALLON, South Carolina 
HARLEY O STAGGERS, Jr., West Virginia 
RICHARD J. DURBIN, Illinois 
LANE EVANS, Illinois 
ROBERT LINDSAY THOMAS, Georgia 
JAMES R. OLIN, Virginia 
TIMOTHY J. PENNY, Minnesota 



EDWARD R. MADIGAN, Illinois, 

Ranking Minority Member 
JAMES M. JEFFORDS, Vermont 
E. THOMAS COLEMAN, Missouri 
RON MARLENEE, Montana 
LARRY J. HOPKINS, Kentucky 
GEORGE HANSEN, Idaho 
ARLAN STANGELAND, Minnesota 
PAT ROBERTS, Kansas 
BILL EMERSON, Missouri 
JOE SKEEN, New Mexico 
SID MORRISON, Washington 
STEVE GUNDERSON, Wisconsin 
COOPER EVANS, Iowa 
GENE CHAPPIE, California 
WEBB FRANKLIN, Mississippi 



Professional Staff 

A. Mario Castillo, Staff Director 

Robert M. Bor, Chief Counsel 
John E. Hogan, Minority Counsel 
Bernard Brenner, Press Secretary 



.Subcommittee on Department Operations, Research, and Foreign 

Agriculture 



GEORGE E. BROWN, Jr., California, Chairman 
HARLEY O STAGGERS, Jr., West Virginia PAT ROBERTS, Kansas 
TIMOTHY J. PENNY, Minnesota 
LEON E. PANETTA, California 
THOMAS S. FOLEY, Washington 
TONY COELHO, California 
HAROLD L. VOLKMER, Missouri 
JAMES R. OLIN, Virginia 



STEVE GUNDERSON, Wisconsin 
COOPER EVANS, Iowa 
WEBB FRANKLIN, Mississippi 



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CONTENTS 

Page 

H.R. 5725, a bill to amend the Animal Welfare Act to ensure the proper 

treatment of laboratory animals 4 

Report from U.S. Department of Agriculture 16 

Brown, Hon. George E., Jr., a Representative in Congress from the State of 
California, opening statement 1 

Roberts, Hon. Pat, a Representative in Congress from the State of Kansas, 
opening statement 19 

Witnesses 

Brown, Howard C, Jr., vice president, scientific affairs. National Association 

of Life Sciences Industries, Inc 67 

Prepared statement 177 

Geelhoed, Glenn, director, surgical research laboratories and transplantation 
division, George Washington University, on behalf of the Association of 

American Medical Colleges 46 

Prepared statement 149 

Hawkins. Bert W., Administrator, Animal and Plant Health Inspection Serv- 
ice, U.S. Department of Agriculture 23 

Prepared statement 110 

Kopperud, Steven L., legislative director, American Feed Manufacturers Asso- 
ciation 100 

Prepared statement 202 

Loew, Franklin M., dean. School of Veterinary Medicine, Tufts University 37 

McArdle, John, director, laboratory animal welfare, the Humane Society of 

the United States 43 

Prepared statement 130 

McCaig, Donald, Yucatec Farm, Williamsville, VA 103 

Melby, Edward C, Jr., dean, Cornell Veterinarian College, and president. 

Association for Biomedical Research 60 

Orlans, F. Barbara, executive director. Scientists Center for Animal Welfare ... 63 

Prepared statement 158 

Proctor, Stuart E., Jr., assistant director, national affairs division, American 

Farm Bureau Federation 97 

Prepared statement 191 

Rackow, Herbert, M.D., diplomate, American Board of Anesthesiology; profes- 
sor emeritus. College of Physicians and Surgeons, Columbia University; 

representing Scientists Group for Reform of Animal Experimentation 98 

Prepared statement 193 

Randall, Walter C, professor of physiology, Stritch School of Medicine, Loyola 

University of Chicago, on behalf of the American Physiological Society 48 

Rose, Hon. Charles, a Representative in Congress from the State of North 

Carolina 22 

Rosenberg, Marc H., executive director. National Coalition for Science and 

Technology 69 

Prepared statement 186 

Seamer, John H., member, British Veterinary Association, representing 

Humane Information Services of the United States 71 

Steinberg, Marshall, secretary. Society for Toxicology 65 

Prepared statement 172 

Stevens, Christine, secretary. Society for Animal Protective Legislation 104 

Prepared statement 210 

(III) 



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IV 

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Van Hoosier, Gerald, Jr., professor, director, and attending veterinarian. 
Division of Animal Medicine, School of Medicine, University of Washington, 
on behalf of the National Association of State Universities and Land-Grant 
Ck)lleges, American Council on Education, and Association of American 

Universities 40 

Prepared statement 124 

Wyler, Gretchen, vice chairman. The Fund for Animals, Inc 99 

Prepared statement 199 

Wyngaarden, James B., Director, National Institutes of Health 28 

Prepared statement 115 

SuBMriTED Material 

American Heart Association, statement 252 

American Institute of Biological Sciences, statement 259 

Congressional Research Service, Library of Congress, Henry Cohen, Legisla- 
tive Attorney, American Law Division, Authority of the Department of 
Agriculture to implement provisions of H.R. 5725, 98th Congress, concern- 
ing treatment of laboratory animals plus addendum, report 267 

Dole, Hon. Robert, a U.S. Senator in Congress from the State of Kansas, 

statement 272 

Genoways, Hugh H., president, American Society of Mammalogists, letter of 

September 24, 1984 275 

Hirsch, Leon C, president, United States Surgical Corp., statement 279 

Homing, Marjorie G., president, American Society for Pharmacology and 

Experimental Therapeutics, letter of September 18, 1984 287 

Huber, Linda H., member, Californians for Responsible Research, statement ... 288 
Hurst, J. Willis, M.D., president. Department of Medicine, Emory University 
School of Medicine, on behalf of the Association of Professors of Medicine, 

letter of September 25, 1984 291 

Jacobs, Leon, scientific consultant. National Society for Medical Research, 

letter of September 11, 1984 297 

Johnson, Jennifer, chairman of the legislative committee. Progressive Animal 

Welfare Society, letter of September 19, 1984 298 

Mayer, Jean, president, Tufts University, letter of September 12, 1984 299 

Mondy, William L., president. Replenishment of Endangered Species Conser- 
vation Union, letter 300 

Our Animal WARDS, statement 302 

Pallak, Michael S., executive officer, American Psychological Association, 

statement 306 

Smith, Cathy, creative services director. Animal Protection Institute of Amer- 
ica, statement 317 

Squire, Ann, director, research and education, scientific adviser, the Ameri- 

C€ui Society for the Prevention of Cruelty to Animals, statement 319 

Wood, Peter D., professor of research medicine, Stanford University Medical 
School; associate director, Stanford Center for Research in Disease Preven- 
tion, letter of September 15, 1984 322 



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IMPROVED STANDARDS FOR LABORATORY ANI- 
MALS ACT; AND ENFORCEMENT OF THE 
ANIMAL WELFARE ACT BY THE ANIMAL AND 
PLANT HEALTH INSPECTION SERVICE 



WEDNESDAY, SEPTEMBER 19, 1984 

House op Representatives, 
Subcommittee on Department Operations, 

Research, and Foreign Agriculture, 

cjommittee on agriculture, 

Washington, DC. 
The subcommittee met, pursuant to notice, at 10 a.m., in room 
1302, Longworth House Office Building, Hon. George E. Brown, Jr. 
(chairman of the subcommittee) presiding. 

Present: Representatives Staggers, Penny, Foley, Volkmer, Rob- 
erts, Gunderson, Evans of Iowa, and Franklin. 

Also present: Representative Rose, a member of the full commit- 
tee. 

Staff present: Cristobal P. Aldrete, special counsel; Glenda L. 
Temple and Peggy L. Pecore, clerks; William A. Stiles, Jr., Jim 
Davis, and Gerald R. Jorgensen. 

OPENING STATEMENT OF HON. GEORGE E. BROWN, JR., A REPRE- 
SENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. Brown. The subcommittee will come to order. 

I would like to thank all of those who have come today to discuss 
the enforcement of the Animal Welfare Act in regard to laboratory 
animals and the legislation which we have introduced, H.R. 5725, 
the Improved Standards for Laboratory Animals Act of 1984. 

This bill would amend the Animal Welfare Act to help ensure a 
more humane and uniform approach to the treatment of laboratory 
animals. It is a revised version of S. 657, introduced by our distin- 
guished colleague in the Senate, Senator Dole. 

The use of live animals in research is not a new issue for me nor 
for the Congress. Both those concerned with animal care and those 
involved in the science community have come a long way in their 
perspective on this issue. While several legislative remedies have 
been introduced, I feel that H.R. 5725, which has over 50 cospon- 
sors, offers a reasonable and effective approach to the problem. 

Today we will receive testimony from the Animal and Plant 
Health Inspection Service and from the National Institutes of 
Health, as well as from a cross-section of science, agriculture, and 

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animal care organizations. I have already received several carefully 
thought-out suggestions regarding H.R. 5725. 

It is my hope that today we will continue our education about 
the issues at hand and enter into constructive discussion on meth- 
ods to better ensure the humane treatment of laboratory animals. 
We will explore the question of whether animals are receiving ade- 
quate care in existing facilities. 

During recent years, there has been an increasing concern 
among the public that some laboratories are below currently set 
standards. H.R. 5725 would address this problem by initiating a 
form of self-regulation by each facility using live animals by means 
of animal research committees. 

Also in question today is whether current law adequately ad- 
dresses the humane care of laboratory animals. At present, there is 
no law which requires researchers to use painkillers during an ex- 
periment causing pain to animals. My legislation would require 
this as well as other strengthening measures, unless they would 
specifically interfere with the research protocol. 

Because more than one Federal agency undertakes research 
using live animals, and several independent facilities use animals, 
there is concern that there is unnecessary duplication of experi- 
ments. The legislation before us would provide for a voluntary na- 
tional data base which would help reduce unintended duplication 
and ensure that researchers are aware of their alternatives. 

I have received numerous comments regarding H.R. 5725 since 
its introduction in May 1984, including hundreds of supportive let- 
ters and signed petitions, some signed by doctors, nurses, and other 
professionals in the medical field. However, it is clear that there is 
real concern that legislation could lead to an interference with sci- 
entific freedom, or create a large regulatory or financial burden on 
their facilities. 

H.R. 5725 would not interfere with the freedom of the decision of 
a scientist to conduct an experiment but instead takes precautions 
to ensure that humane handling of the animals occurs whenever 
possible. 

I have often been asked why I made the decision to introduce 
this legislation. I have been one of the more active advocates and 
supporters of science in this House. However, I feel that we cannot 
allow any field, whether it be defense, science, or any others, to be 
free from scrutiny or improvement. I feel strongly that while medi- 
cal research is vital to the health of our society, we must accept 
the responsibility which comes with using live animals. We should 
ensure that needless suffering is eliminated. 

As all of you are aware, we have a long day ahead of us. Because 
of the strong interest in this hearing, I felt that we should allow as 
many people as possible to comment on the topics at hand. We 
have put spokesmen with differing viewpoints on the same panel. I 
hope that this will encourage constructive discussion. 

However, this will require that we exercise certein discipline 
with regard to the use of time, and I am going to ask the witnesses 
to hold their testimony down to 5 minutes, with, of course, the op- 
portunity to include any additional material that they wish in the 
record, and it will be made a part of the record. 



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I would also like to ask that all the witnesses confine themselves 
as much as possible to the topic of this hearing, as time is at a pre- 
mium. I am looking forward to all of your comments. 

[H.R. 5725 and the report from U.S. Department of Agriculture 
follow:] 



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98th congress 
2d Session 



H.R.5725 



To amend the Animal Welfare Act to ensure the proper treatment of laboratory 

animals. 



IN THE HOUSE OF REPRESENTATIVES 

May 24, 1984 

Mr. Bbown of California (for himself and Mr. Foley) introduced the following 

bill; which was referred to the Committee on Agriculture 



A BILL 

To amend the AnimaJ Welfare Act to ensure the proper 
treatment of laboratory animals. 

1 Be it enacted by the Senate and House of Representa- 

2 tives of the United States of America in Congress assembled^ 

3 SHOBT TITLE 

4 Section 1. This Act may be cited as the "Improved 

5 Standards for Laboratory Animals Act". 

6 FINDINGS 

7 Sec. 2. The Congress finds that — 

8 (1) methods of testing that do not use animals 

9 have been developed which show promise of being 

10 faster, less expensive, and more accurate than tradi- 

11 tional animal experiments for some purposes and fur- 



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2 

1 ther opportunities exist for the development of these 

2 methods of testing; 

3 (2) measures which eliminate or minimize the un- 

4 necessary duplication of experiments on animals can 

5 result in more productive use of Federal funds; and 

6 (3) measures which help meet the public cpncem 

7 for laboratory animal care and treatment are important 

8 in assuring that research will continue to progress. 

9 DEFINITIONS 

10 Sec. 3. (a) Section 2(e) of the Animal Welfare Act (7 

11 U.S.C. 2132(e)) is amended by adding after "The term 're- 

12 search facility' means" the following: "each department, 

13 agency, or instrumentality of the United States which uses 

14 animals for research or experimentation,". 

15 (b)(1) Subsections (f), (g), (h), (i), and (j) of section 2 of 

16 such Act are redesignated as subsections (i), (j), (k), 0)> and 

17 (m), respectively. 

18 (2) Such section is amended by inserting after subsection 

19 (e) the following subsections: 

20 "(f) The term 'Federal agency' means an executive 

21 agency as such term is defined in section 105 of title 5, 

22 United States Code, and with respect to any research facility 

23 means the agency from which the research facility has re- 

24 ceived or may receive a Federal award for the conduct of 

25 research, experimentation, or testing, involving the use of 

26 animals; 

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1 "(g) The term 'Federal award for the conduct of re- 

2 search, experimentation, or testing, involving the use of ani- 

3 mals' means any mechanism (grant, award, loan, contract, or 

4 cooperative agreement) under which Federal funds are pro- 

5 vided to support the conduct of such research; 

6 "(h) The term 'quorum' means a majority of the com- 

7 mittee members;". 

8 (c) For purposes of this Act, the term "animal" shall 

9 have the same meaning as defined in section 2(]) of the 

10 Animal Welfare Act (7 U.S.C. 2132(j)), as redesignated by 

11 subsection (b)(1). 

12 STANDABD8 AND CERTIFICATION PBOCESS 

13 Sec. 4. (a) Subsection (a) of section 13 of the Animal 

14 Welfare Act (7 U.S.C. 2143(a)) is amended by inserting 

15 "(1)" after "(a)". 

16 (b) The second sentence of such subsection is amended 

17 to read as follows: "Such standards shall include — 

18 "(A) requirements with respect to handling, hous- 

19 ing, feeding, watering, sanitation, ventilation, shelter 

20 from extremes of weather and temperatures, and ade- 

21 quate veterinary care, including the appropriate use of 

22 anesthetic, analgesic, or tranquilizing drugs, ^hen such 

23 use would be proper in the opinion of the attending 

24 veterinarian of such research facilities; 



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1 "(B) provisions for separation by species where 

2 the Secretary finds that such separation is necessary 

3 for humane handling; 

4 "(C) exercise for dogs, and 

5 exceptions to such standards may be made only when speci- 

6 fied by research protocol". 

7 (c) The last sentence of such subsection is amended to 

8 read as follows: "Nothing in this Act shall be construed as 

9 authorizing the Secretary to promulgate rules, regulations, or 

10 orders with regard to design, outlines, or guidelines of actual 

11 research or experimentation by a research facility. The Sec- 

12 retary shall promulgate standards for research facilities, in- 

13 eluding requirements for animal care, treatment, and prac- 

14 tices in experimental procedures to ensure that animal pain 

15 and distress are minimized. The Secretary shall require every 

16 research facility to be able to show that the professionally 

17 acceptable standards governing the care, treatment, and 

18 practices on animals, including appropriate use of anesthetic, 

19 analgesic, and tranquilizing drugs during experimentation, 

20 are being followed by the research facility during research 

21 and experimentation. The Secretary shall require, at least 

22 annually, every research facility to report that the standards 

23 governing the care, treatment, and practices on animals are 

24 being followed. In* its statement of compliance, the research 



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1 facility shall provide assurances satisfactory to the 

2 Secretary — 

3 "(A) demonstrating that the principal investigator 

4 has considered alternatives to any procedure likely to 

5 produce pain to or distress in an experimental animal 

6 and shall provide details of any procedure likely to 

7 produce pain or distress in any experimental animal; 

8 and 

9 "(B) in any practice involving pain to unanesthe- 

10 tized animals — 

11 "(i) that a doctor of veterinary medicine has 

12 been consulted in the planning of such procedures; 

13 ''(ii) for the use of tranquilizers, analgesics, 

14 and anesthetics; 

15 "(iii) for pre- and post-surgical care by labo- 

16 ratory workers in accordance with established 

17 medical and nursing procedures; 

18 "(iv) against the use of paralytics without 

19 anesthesia; and 

20 "(v) that the withholding of tranquilizers, an- 

21 esthesia, analgesia, or euthanasia when scientifi- 

22 cally necessary shall continue for only the neces- 

23 sary period of time; and 

24 "(C) except in cases of scientific necessity or 

25 other special circumstances as determined by the 

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1 aniinal research committee, assurances that no animal 

2 may be used in more than one major operative proce- 

3 dure from which it is allowed to recover. 

4 "(2) Paragraph (1) shall not prohibit any State (or a 

5 poUtical subdivision of such State) from promulgating stand- 

6 ards in addition to those standards promulgated by the Secre- 

7 tary under paragraph (1)/'. 

8 (d) Subsection (a) of such section is amended by adding 

9 at the end thereof the following: 

10 **iS)(A) The Secretary shall require that each research 

11 facility establish an animal research committee (hereinafter in 

12 this subsection referred to as the 'committee'). Each animal 

13 research committee shall be appointed by the chief executive 

14 officer of such research facility and shall be composed of not 

15 fewer than three members. Such members shall possess suffi- 

16 cient ability to assess animal care, treatment, and practices in 

17 experimental research as determined by the needs of the re- 

18 search facility. Of the members of the committee — 

19 "(i) at least one member shall be a doctor of vet- 

20 erinary medicine; 

21 ''(ii) at least one member shall have no association 

22 with such facility and shall be responsible for repre- 

23 senting community concerns regarding the welfare of 

24 animal subjects; and 



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1 ''(iii) in those cases where the committee consists 

2 of more than three members, not more than three 

3 members shall be from the same administrative unit of 

4 such facility. 

5 . /'(B) A quorum shall be required for all formal actions of 

6 the committee, including — 

7 ''(i) inspecting at least semiannually all animal 

8 study areas and facilities of such research facility; 

9 ''(ii) reviewing as part of the inspection of such 

10 research facility practices involving pam to unanesthe- 

11 tized animals and the condition of research animals to 

12 ensure compliance with the standards of animal care, 

13 treatment, and practices and that pain and distress to 

14 such animals is minimized. 

15 "(C)(i) The committee shall file each inspection certifica- 

16 tion report at the research facility. Such report shall — 

17 ''(I) be signed by a majority of the committee 

18 members involved in the inspection; 

19 "(H) include reports of any violation of the stand- 

20 ards promulgated by the Secretary, including any defi- 

21 cient conditions of animal care or treatment and any 

22 deviations of research practices from originally ap- 

23 proved proposals that adversely affect animal welfare; 

24 "(m) include any minority views of the commit- 

25 tee; and 

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1 "(IV) include any other information pertinent to 

2 the activities of the committee. 

3 ''(ii) Such report shall be maintained for at least three 

4 years by the research facility and shall be available for in- 

5 spection by the Secretary or the funding Federal agency. 

6 "(iii) In order to give the research facility an opportuni- 

7 ty to correct any deficiencies or deviations discovered by 

8 reason of subparagraph (B), such committee shall notify the 

9 administrative representative of the research facility of any 

10 unacceptable conditions. If, after notification and an opportu- 

11 nity to make corrections, such conditions remain unaccept- 

12 able, the committee shall notify the Animal and Plant Health 

13 Inspection Service of the Department of Agriculture and the 

14 funding Federal agency, in writing, of such conditions. 

15 ''(D) The inspection results shall be available to Depart- 

16 ment of Agriculture inspectors for review during inspections. 

17 Department of Agriculture inspectors shall forward any com- 

18 mittee inspection records which include reports of deficiencies 

19 or deviations to the Animal and Plant Health Inspection 

20 Service of the Department of Agriculture and any funding 

21 Federal agency. 

22 ''(4) The research facility shall provide for annual ses- 

23 sions for scientists, animal technicians, and other personnel 

24 involved with animal care and treatment in such facility. 

25 Such sessions shall provide instruction or training in — 

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1 "(A) the humane practice of animal maintenance 

2 and experimentation; 

3 ''(B) research or testing methods that minimize or 

4 eliminate the use of animals or limit animal pain or dis- 

5 tress; and 

6 "(C) utilization of the information service at the 

7 National Agricultural Library, established under sub- 

8 section (e), to prevent unintended or unnecessary dupli- 

9 cation of animal experimentation as determined by the 

10 needs of the research facility. 

11 ''(5) Research facilities shall inform their employees of 

12 the provisions of this section and shall inform such employees 

13 to report to the committee any violations of such provisions. 

14 Employees of such facilities may not be discriminated against 

15 on grounds that such employees reported any violation of 

16 such provisions.". 

17 (e) Section 13 of the Animal Welfare Act (7 U.S.C. 

18 2143) is amended by adding at the end thereof the following: 

19 ''(e) The Secretary shall establish an information service 

20 at the National Agricultural Library. Such service shall, in 

21 cooperation with the National Library of Medicine, provide 

22 information on improved methods of animal experimentation 

23 including methods which could — 

24 "(1) reduce or replace animal use; 



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1 "(2) minimize pain and distress to animals, such 

2 as anesthetic and analgesic procedures; and 

3 **(3) prevent unintended duplication between re- 

4 search facilities of animal experimentation as deter- 

5 mined by the needs of the research facility. 

6 "(f) In any case in which the funding Federal agency 

7 determines that conditions of animal care, treatment, or prac- 

8 tice in a particular project have not been in compliance with 

9 applicable standards, despite notification to the research facil- 

10 ity, that agency shall suspend or revoke Federal support for 

11 the project. Any research facility losing Federal support as a 
12. result of actions taken under the preceding sentence shall 

13 have the right of appeal as provided in sections 701 through 

14 706 of title 5, United States Code.". 

15 Sec. 5. Section 21 of the Animal Welfare Act (7 U.S.C. 

16 2151) is amended by inserting before the period ", except 

17 that no rule, regulation, or order may require a research fa- 

18 cility to disclose trade secrets or commercial or financial in- 

19 formation which is privileged or confidential''. 

20 Sec. 6. The Animal Welfare Act (7 U.S.C. 2131-2156) 

21 is amended by adding at the end thereof the following 

22 section: 

23 "Sec. 27. (a) It shall be unlawful for any member of the 

24 animal research committee to release any confidential infor- 

25 mation of the research facility, including any information that 

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1 concerns or relates to the trade secrets, processes, oper- 

2 ations, style or work, or apparatus, or to the identity, confi- 

3 dential statistical data, amount or source of any income, prof- 

4 its, losses, or expenditures of the research facility. 

5 ''(b) It shall be unlawful for any member of such com- 

6 mittee to use or attempt to use to his advantage, or reveal to 

7 any other person, any information which is entitled to protec- 

8 tion as confidential information under subsection (a). 

9 "(c) A violation of subsection (a) or (b) is punishable 

10 by— 

11 ''(1) removal from such committee, and 

12 "(2)(A) a fine of not more than $1,(X)0 and im- 

13 prisonment of not more than 1 year, or 

14 "(B) if such violation is willful, a fine of not more 

15 than $10,(X)0 and imprisonment of not more than 3 

16 years. 

17 "(d) Any person, including any research facility, injured 

18 in its business or property by reason of a violation of this 

19 section may recover all actual and consequential damages 

20 sustained by such person and the cost of the suit including 

21 reasonable attorney's fees. Nothing in this section shall be 

22 construed to affect any other rights that any such person may 

23 have, nor shall this paragraph be construed to limit the exer- 

24 cise of any such rights arising out of or relating to a violation 

25 of subsections (a) and (b).". 

HR5726 IH 



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12 

1 EFFECTIVE DATE 

2 Sec. 7. This Act shall take effect beginning one year 

3 after the date of enactment of this Act. 

O 



HR 5725 IH 



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• rr^X' AA5-" NC'CN. 0. C 20250 



October 3 1989 

Honorable E (Kika) de la Garza 
Chairman, Committee on Agriculture 
House of Representatives 
Washington, DC .20515 

Dear Mr. Chairman: 

This Is In response to your request for the Department of Agriculture's 
recommendations on H.R. 5725, a bill "To amend the Animal Welfare Act to ensure 
the proper treatment of laboratory animals." 

The bin, H.R. 5725, Is similar to and has the same purpose as S. 657, I.e., to 
ensure the proper treatment of laboratory animals. On October 12, 1983, this 
Department submitted a report on S. 657 to the Senate Committee on Agriculture, 
Nutrition, and Forestry. While H.R. 5725 addresses some of our objections to 
S. 657, we continue to believe that our common goals of ensuring proper car* 
and treatment and appropriate use of laboratory animals can be achieved under 
current authorities. Therefore, we do not recommend enactment of H.R. 5725. 
However, we wish to be on record as strongly supporting humane care and 
treatment of animals used for purposes of biomedical research. 

Our comments on the bill, H.R. 5725, are enclosed. 

The Office of Management and Budget advises that there is no objection to the 
presentation of^ this report from the standpoint of the Administration's 
program. 

Sincerely, 



SyLdiB&u. 



^\jjhx\ R Bloolc 
3»or«tary 



Enclosure 



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Comnents of the 

Department of Agriculture 

on H.R. 5725 

The bill amends the Animal Welfare Act as follows: 

1. Expands the definition of the term "research facility" to Include each 
department, agency or Instrumental ity of the United States which uses animals 
fbr research or Mperlnentatloft; defln#s the term ^Federal agency" to mean any 
Executive agency from which a research facility has received or may receive 
Federal Ajnds to support the conduct of research ^ experimentation or testing 
involving the use of animals; and* make* it clear that the definition of 
"animal" is the same as that provided under the current Act. 

2. Deletes the language stating that minimum requirements be applied to 
the standards promulgated by the Secretary of Agriculture to govern the humane 
^an{J^ ng, care, reatment, and transportation of animals by dealers, research 
fad Ufes and wtrfbitors^ adds txerc se for dogs as a standard; and, allows 
the Secretary to make ejcceptlons to the standards, but only when such 
exceptions are ^ecffied by the research protocol. 

3. R«qtilr«!s the Secretary to promulgate standards for research 
facilities, including requirements for animal care, treatment, and practices in 
experimental procedures, to ensure that animal pain and distress are 
minimized. Requires each research ficlllty. In Its annual statentent of 
compliance, to provide the Secretary of Agriculture with assurances that such 
standards are being followed. Also requires the research facility to provide 
annual training sessions fbr personnel involved with animal care and 
treatment . 

4.. Provides that any State (or political subdivision of that State) mqy 
promulgate standards In addftion to those prtrntul gated by the Secretary. 

5. Mandates the establishment and makeup of an animal researcii Coimitttee 
of three or more meters wittiin each research facility- Makes It unlawful tbr., 
any ncmber of the connilttee to release trade secrets or confidential 
Information. The comlttee must make inspections at least semiannually of all 
animal study areas of the research faculty af>d file an i'^spectton report 
which must remain on file at the research facility fbr three years. The 
coflvnlttee must notify. In wrftfrrg* t^e Anfmal and Plarrt Health Inspection 
Service {APHIS of the Department of Agriculture and the funding Federal agency 
Of any unacceptable conditions that are not corrected despite notification. 
Federal support for a particular project can be suspended or revoked for 
continued failure by a research facility to comply with the standards of aniwal 
care, treatment or practices such suspension or revocation may be appeal ed» 

6. The inspection results of the animal research comnlttee mu^ be 
available to the Department of Agriculture's inspectors for review during 
Inspection. These inspectors must forward to APHIS and thi? funding Federal 
agency any Inspection records of the committee which Include reports of any 
deficient conditions of animal care or treatment and any deviations of research 
practices from the originally approved proposal that adversely affect animal 
welfare. 



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7. Prohibits the Secretary from promulgating rules, regulations, or 
orders that may require a research facility to disclose trade secrets or 
commercial or financial Information which Is privileged or confidential. 

8. Mandates the establ shment of an Information service on Improved 
methods of animal experimentation at the National Agrict^ftural Library. 

The Department of Agriculture » through APHIS, adnlnlstprs th& Animal Welfare 
Act* APMIS ts required to register State-owned dnd privately-owned research 
facilities and inspect their research sites to ensure compliance with the 
Department of Agriculture' s stafidards of animal cart and treatment Currently, 
there are 1,166 registered facilities with approximately 3,300 research sites. 
Federal agencies are not required to regUter wfth APHtS^ and thei 
laboratories are flot Inspected by APHTS, Federal agencies are responsible for 
ensuring that their aboratories comply with the Department of Agriculture 
standards. However both APHIS registered research faci ities and Federal 
laboratories must submit an annual conrpT ance report to APHIS stating whether 
any regu ated animals were used for research, testing, teaching, or 
experimentation any procedures nvolved were painful and^ when pain- 

relieving drugs were omitted during any painful procedures. Therefore, we 
question the i^eed to expand the definition of "research facility" to Include 
Federal laboratories, making these laboratories subject to APHIS registration 
and Inspection. 

Deletion of the term "minimum" as the lower limit f9r standards of animal care 
and treatment would require the development of new regulations. Such an 
approach would make it very difficult to reach an agreement on a final set of 
standards* 

We do not favor adding "exercise for dogs" as a required standard. Our 
regulations require that the primary enclosure fbr each animal including 
dogs, be constructed and maintained to allow the animal adequate space for 
freedom of movement In all directions. Our inspectors pay special attention to 
animals kept in small enclosures to ensure that the space provided meets our 
requirements, unless restricted space Is specified by the research protocol. 

Under our current registration procedures each research facility and the 
responMble attending veterinarian must agree to a program of adequate 
veterinary care* A copy of the agreement is retailed by the participants. 
Including the Department of Agriculture inspector, and a copy Is sent to the 
Area Veterinarian in Charge (AVIC) of the State where the facility Is located. 

When compliance Inspections are conducted, our Inspectors must document any 
deficient conditions of animal care and treatment and together with the 
attending veterinarian review the research protocols for afl> deviations from 
the established veterinary care program. The funding Federal agency is 
notified of any major deficient conditions, as well as the sche^JuTe for 
compliance. Thus, the directives in the bill concerning the <f1 semination of 
Information on deficient conditions and deviations from the protocol that would 
adversely affect animal welfare are being Implemented administratively. 

Currently, research facilities are required to keep records on the purchase, 
sale, transportation. Identification and previous ownership of live dogs or 



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cats. They are also required to file reports regarding animal research, 
especially with respect to the use of pain-relieving drugs. The bill's 
prohibition against regulatory action that would require disclosure by a 
research facility of trade secrets or commercial or financial Information which 
Is privileged or confidential would make It difficult. If not Impossible, to 
administer the recordkeeping provisions of the act. These provisions were 
enacted to assure humane treatment during research and to prevent the purchase, 
sale and use of stolen animals. 

The establishment of an Information systein on Improved methods of animal 
experimentation at the National Agricultural Library (NAL) can be achieved 
under current authorities. Presently, the NAL provides basic level services in 
support of programs within the Department, These services Include collecting 
and Indexing the leading publications in a particular field, document delivery* 
general reference, current awareness, and computerized bibliographies. Thus, 
with relatively little additional effort, NAL could expand these services to 
Include animal experimentation. 

Mr. Brown. I now recognize Mr. Roberts, the ranking minority 
member, for any statement he may wish to make. 

OPENING STATEMENT OF HON. PAT ROBERTS, A 
REPRESENTATIVE IN CONGRESS FROM THE STATE OF KANSAS 

Mr. Roberts. Thank you, Mr. Chairman. 

You have already indicated your long-time interest in scientific 
research and that you recognize the value of animal experimenta- 
tion in furthering that research. 

I would like to go a step further and thank you for your leader- 
ship in this whole area, and I look forward to working with you as 
well as my senior Senator from Kansas, Senator Bob Dole. 

I think the fact is that we are holding a hearing that will demon- 
strate to all concerned that humane animal care is of concern, and 
that we cannot tolerate any substandard lab facilities or any inhu- 
mane animal treatment; that all who are engaged in animal re- 
search need to double their efforts to provide improved facilities 
and treatment. 

We have many fine witnesses. It is their testimony that we have 
come to hear. With that, Mr. Chairman, I would simply ask that 
my full statement may be part of the record at this particular 
point. 

Mr. Brown. Without objection; it is so ordered. 

[The prepared statement of Mr. Roberts follows:] 



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STATEMENT OF THE HONORABLE PAT ROBERTS 
September 19, 1984 

Mr. Chairman, I know of your long-time interest in scientific 
research and that you recognize the value of animal experimen- 
tation in furthering that research. You have indicated your 
belief that the legislation we have under consideration will not 
interfere with experiment procedures or results. However, I have 
several concerns. 

The first deals with whether this legislation is absolutely 
necessary. It would appear to me that if laboratory standards 
are not being maintained then we should look to the United States 
Department of Agriculture for additional enforcement of the 
present Animal Welfare Act rather than giving additional legisla- 
tive authority. I worry that the approach of H.R. 5725 is just 
added government regulation which will cost additional money, 
reduce the already limited funds for research, and in the long 
run will not contribute much to humane animal care. Does the 
Animal and Plant Health Inspection Service have the wherewithal 
to conduct the necessary surveillance or should additional funds 
and manpower be made available to them? I think we should explore 
all avenues to this problem before we pass added legislation 
which may or may not contribute to better animal care. The fact 
we are holding a hearing demonstrates to all involved that humane 
animal care is of concern and that we cannot tolerate substandard 
laboratory facilities or inhumane animal treatment and that all 
who are engaged in animal research need to double their efforts 
to provide improved facilities and treatment. 



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Mr. Chairman, I represent a district in Western Kansas that 
is heavily dependent upon animal agriculture. There is 
widespread concern over whether the proponents of this type of 
legislation wish to eliminate the use of animals in research and 
ultimately eliminate animal agriculture. 

I would only say that millions of children through out the 
world are immunized against polio, diphtheria, mumps, measles, 
hepatitis and other diseases because of research done on animals. 
Every person who receives antibiotics or insulin for diabetes can 
thank animal experimentation. In short, Mr. Chairman we should 
never lose sight of the benefits that have come from animal 
research efforts. 

And finally, in much of the mail my office has received on 
this legislation, the writer often alludes to the fact that many 
unnecessary tests are performed on animals and that these tests 
should be eliminated. However, Mr. Chairman, from the experience 
this subcommittee has had in dealing with FIFRA there seems to be 
another school of thought that we need more testing of chemicals 
and pesticides before registering them for use. There are those, 
within the animal welfare movement that say that substitute tests 
have been developed and these tests should be used instead of 
live animals. However, in testing for carcinogens there are no 
totally adequate substitutes for animal feeding studies. How we 
reconcile these differences is a task that will not be easy. 

Having said this I want to assure you that with an open mind 
I look forward to assessing what the witnesses today have to say 
about this legislation. Thank you, Mr. Chairman. 



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Mr. Brown. Does any other member care to comment at this 
point? 

As is customary, we will first recognize Members of the Congress 
who have asked to testify. Senator Dole had asked to testify and 
expected to be here, and he may be here, but if he is not, we will 
insert his statement in the record. If he comes in later, we will, of 
course, recognize him to make that statement in person. 

[The prepared statement of Senator Dole appears at the conclu- 
sion of the hearing.] 

Mr. Brown. The next Member of Congress is Hon. Charles Rose, 
a Member of Congress from North Carolina and a distinguished 
colleague on the Agriculture Committee. 

Mr. Rose. 

STATEMENT OF HON. CHARLES ROSE, A REPRESENTATIVE IN 
CONGRESS FROM THE STATE OF NORTH CAROLINA 

Mr. Rose. Thank you, Mr. Chairman. 

Mr. Chairman and members of the subcommittee, I would like to 
thank you for the opportunity to testify before you today on H.R. 
5725, a bill that amends the Animal Welfare Act to ensure the 
proper treatment of laboratory animals and which was introduced 
by you, Mr. Chairman, my colleague, and 49 of our colleagues in 
the Congress. 

I feel that this is an extremely fair and realistic bill. This legisla- 
tion establishes better requirements for the care and treatment of 
laboratory animals. It would assure that there are better standards 
for animal care and treatment. 

Currently, the U.S. Department of Agriculture sends veterinar- 
ians to inspect these facilities. Although I believe that most of 
these laboratories are honest and professional in their care of these 
animals, I have seen, myself, Mr. Chairman, that there has been 
abuse. Either USDA inspectors are not thoroughly inspecting these 
facilities or there is not enough emphasis on the humane treat- 
ment of the animals involved. 

This bill also authorizes that an animal welfare committee be es- 
tablished and that they meet twice annually to review the care of 
laboratory animals. This is important because, for the first time, 
the public and the people concerned with the treatment and well- 
being of animals will have input. 

This legislation also establishes for the first time a data base 
that contains information on all of the completed animal research, 
something that, hopefully, would lead to an end to the much waste- 
ful duplication that occurs in animal research. In addition, this 
data base will provide information on improved methods for mini- 
mizing pain and alternatives to using animals for research. 

Mr. Chairman, I want to compliment you, as chairman of this 
subcommittee, for bringing this necessary and, unfortunately, con- 
troversial legislation to the attention of the committee. I am very 
distressed to learn that there are farm groups that are opposed to 
this legislation. Personally, I would hope that they could see that 
laboratory animals are not farm animals, and that because of the 
kinds of experiments that they undergo and the pain that they 
suffer, they deserve special attention. 



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In your statement, Mr. Chairman, you said that no frontier of 
science or of life in this country should be free from scrutiny and 
improvement. Scrutiny and improvement are exactly what I think 
is needed in this area. I am distressed that a great many of my 
friends in the agricultural sector do not believe that this is an im- 
portant problem. They think that this can be laughed away or 
minimized. 

I can assure them, as I am sure Senator Dole is aware and I am 
sure you are aware, Mr. Chairman, the American public is holding 
us to a higher standard of care in this area than has existed in the 
past. 

I hope that my colleagues are not pressured into not stud3ring 
this bill closely and giving it serious attention. The chairman has 
done a remarkable job, and he is giving all sides equal attention. I 
certainly hope that the little animals that do not have votes or 
voices will not be neglected, and I think this legislation moves to 
see that that does not take place. 

Thank you, Mr. Chairmsui. 

Mr. Brown. Thank you very much, Mr. Rose. 

I would now like to call on Mr. Bert Hawkins, the Administrator 
for the Animal and Plant Health Inspection Service, U.S. Depart- 
ment of Agriculture. 

He will be accompanied by Mr. Richard Rissler, doctor of veteri- 
nary medicine, who is Assistant Director of the program and of the 
Inspection Service. 

I might point out that APHIS and the Department of Agricul- 
ture have had the responsibility for the humane treatment of ani- 
mals for a generation, and during that period of time we have 
sought to make continued improvement in standards; we will con- 
tinue to seek that. Mr. Hawkins is the official responsible for carry- 
ing out these duties within the Department. 

Mr. Hawkins. 

STATEMENT OF BERT W. HAWKINS, ADMINISTRATOR, ANIMAL 
AND PLANT HEALTH INSPECTION SERVICE, U.S. DEPARTMENT 
OF AGRICULTURE, ACCOMPANIED BY RICHARD L. RISSLER, AS- 
SISTANT DIRECTOR, ANIMAL HEALTH PROGRAMS, ANIMAL 
AND PLANT HEALTH INSPECTION SERVICE 

Mr. Hawkins. Thank you very much, Mr. Chairman and mem- 
bers of the subcommittee. 

As indicated, I am the Administrator of the Animal and Plant 
Health Inspection Service, and I have with me Dr. Richard Rissler, 
who is my key staff person in charge of the Animal Care Program. 

I will apologize once for my voice. I will try to do the best that I 
can, but I am having a little trouble. 

With your concurrence, we will submit the total context of our 
remarks for the record. 

Mr. Brown. Without objection, it will be made a part of the 
record, Mr. Hawkins. 

Mr. Hawkins. Thank you, sir. 

Since the passage of the Animal Welfare Act in 1966, we have 
had the responsibility for it, for the administration of it, and I 
would have to say at the outset that it is one of the more difficult 



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acts given to us by Congress to administer. The reason for this 
being that many of the factors that it takes to administer the act 
are judgment factors, and no two of us can use judgment in exactly 
the same manner. 

Just as one brief example, if one of you gentlemen had a saddle 
horse and I had one, and you kept yours in a padded stall £uid I 
gave mine freedom to roam; I might think that yours was being 
confined under conditions that were less than humane, and con- 
trary, you might think that the free-roaming aspects of mine al- 
lowed him to come into contact with elements that would be very 
detrimental to him. 

I just mention that as one of the reasons why we feel that this 
act is one of the more difficult. Under current authorities, we in- 
spect nearly all State-owned and privately owned research facili- 
ties. These are registered facilities, and they must also submit 
suinual reports to us that have to do with their care and treatment 
of animals. Each registered facility must report on the conditions 
and the treatment of their lab animals and any painful research 
that they are involved in with these particular £uiimals. 

As you gentlemen also, I am sure, are aware. Federal facilities 
are not required to be inspected by us, but we do monitor them and 
ifeceive annual reports from them as to their care and treatment of 
animals they are using in their research. One reason for this being 
that they have their own internal monitoring systems; they have 
their own veterinarifiuis and have established, in concert with us, 
the standards necessary to humanely handle animals and keep 
them as free of pain as possible. 

We do try, on an average, to visit each one of these registered 
facilities at least twice annually. This is not alwajrs possible. It is 
not alwajrs really necessary. Again, it is a judgment call with some 
of our inspectors. If we have a facility that has a long history of 
being up front, treating their animals very humanely, and submit- 
ting good reports, we might only visit it one time in 1 year. 

So some people do take us to task and say that we should be vis- 
iting them more, but again, this is one of the judgment calls that 
we do make. 

Mr. Chairman, the Department's commitment to accomplish the 
goals of the Animal Welfare Act have never been greater. In the 
past 2 years, we have initiated several new initiatives to improve 
our administration of the act. We have created our own internsd 
system for reviewing what we did in the past and how the program 
is being handled currently, and on top of that, we are takmg a 
hard look at our program to decide what improvements need to be 
made. 

We have made organizational changes that make us more re- 
sponsive to not only the public complaints and comments but also 
to deal more effectively with the weak spots that our internsd 
review indicates. We have established training courses for all of 
our people that have to work with the Animal Welfare Program. 

On May 15-18 of this last year, we had a training course for the 
animal care specialists, our regional compliance officers, and €dl 
animal care coordinators. A total of 42 persons attended that 3-day 
meeting. 



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In September we initiated another training session for the veteri- 
narians who actually do the inspection of research facilities. We 
had a total of 14 at this training course. 

We have undergoing at the present time, September 18-21, a 
training course for the animal care coordinators in the northern 
region. We have 21 people attending that training course. 

Also, in December of this year, we will have a second training 
course for veterinarians who inspect research facilities. I mention 
that in passing to show our great concern for tr3ring to do a better 
job with the authority and responsibility given to us by Congress. 

I would also like to mention that since I have been administrator 
of APHIS, I have placed a great amount of emphasis on the compli- 
ance with the law and regulations. We can pass laws and we can 
administer and promulgate regulations, but without strong compli- 
ance, they are a needless waste of activity. We put a lot of empha- 
sis on this. We are reviewing our Compliance Program and have 
already made very substantive changes in it. 

In addition to the internal initiatives that I spoke of, we have in- 
creased our cooperation with other Federal agencies as well. We 
have recently become a member of an Interagency Research 
Animal Care Committee made up of several of these agencies, two 
of them being the National Institutes of Health and the Food and 
Drug Administration. 

We think this is important. Since they have the authority to take 
care of their own animal health care needs and report to us, we 
can get a dialog going between us and bring all of our animal care 
activities up to the same level and thereby, we feel, do a much 
better job of coordination. 

Mr. Chairman, the efforts of the Federal conmiunity to see that 
animals used in research receive proper care suggest that these 
agencies should be able to continue to monitor compliance of their 
own laboratories. Therefore, we do not see the need to expand on 
the definition of research facility to include Federal laboratories, in 
order to make them subject to APHIS registration and inspection. 

We feel strongly that it would be a duplication of effort. They 
have already established their animal care committees and are al- 
ready meeting with us in concert to try to establish uniform inspec- 
tions. 

We also believe that the bill will increase the enforcement prob- 
lems. For example, the term "minimum" is not included in the bill 
as the lower limit for standards of care, and this would require new 
regulations. The word "minimum" is accepted and more easily de- 
fined in a court of law than the suggested change in this bill. It is 
easier for us to establish minimum levels. We would like to recom- 
mend that the term be retained. Similarly, the added requirement 
of exercise for dogs could cause difficulty in establishment of an en- 
forceable standard. Again, we have (Ufferent types of dogs — big 
ones, little ones. What is good for one is not necesarily good for the 
other. One is a house dog; one is an outside dog. This makes it very 
difficult to make a judgment that would be enforceable. 

Mr. Chairman, my remarks have been short, as you indicated, 
for time. We would be pleased to answer any questions that you or 
the subcommittee may have. 



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[The prepared statement of Mr. Hawkins appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Thank you very much, Mr. Hawkins. 

Dr. Rissler, did you have any comments you wished to add? 

Mr. Rissler. No, sir; I have no additional comments. 

Mr. Brown. Mr. Hawkins, just a couple of quick questions. 

You have some problems with certain aspects of the bill. You did 
not mention the requirement for the animal care committees in 
the research laboratories, which is already the practice in the Fed- 
eral laboratories; nor the data bank for voluntary collection of in- 
formation on experiments so as to avoid duplicative experiments. 

May I take it that you find no strong objections to those provi- 
sions of the bill? 

Mr. Hawkins. Yes, sir. 

Mr. Brown. Mr. Roberts, do you have any questions? 

Mr. Roberts. Yes, Mr. Chairman. 

I think the basic concern I have is this: Does the Animal and 
Plant Health Inspection Service have the wherewithal to actually 
conduct the necessary surveillance, or should we be in the business 
of providing some additional funds? What is your budget for the 
implementation of the Animal Welfare Act? 

Mr. Hawkins. Our budget is $3.6 million in the upcoming 1985 
animal welfare program. 

Mr. Roberts. In your opinion, Bert, is that adequate to do the 
job? 

Mr. Hawkins. I am sorry. I was under the impression that you 
meant what we asked for in the fiscal year 1985 budget. It is cur- 
rently $4,865,000. 

Mr. Roberts. I am sorry, I am confused on that. What were the 
figures again? 

Mr. Hawkins. The current 1984 budget is $4,865,000. 

Mr. Roberts. So it is not $3.6 million but $4.8 million? 

Mr. Hawkins. That is right. 

Mr. Roberts. We increased that, as I recall. 

Mr. Hawkins. Yes, sir; I was speaking of the 1985 budget re- 
quest. 

Mr. Roberts. Is this budget adequate, in your view, to do the job? 
We will hear panelists later, obviously, who think that we do not 
have adequate funds, and some of the adjectives and adverbs I 
won't get into at this particular time. But is this funding adequate? 

Mr. Hawkins. Yes, sir; we feel it is adequate, and the reason 
being that Rome wasn't built in a day, and all people's ideas of 
care of animals won't be changed in a day. We could put an army 
of people out there with an abundance of funds to support them, 
and we would still have infractions of the act. 

I think it is an educational process that we must go through, and 
with the changes that we are implementing, I feel, Mr. Roberts, 
that we do have sufficient funds and personnel. 

Mr. Roberts. That wks my next question. How many personnel 
are involved? 

Mr. Hawkins. I am going to ask Dr. Rissler to answer that. I 
know of some figures, but since he is here, I would rather he 
answer. 



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Mr. RissLER. Of our veterinary medical officers field force, ap- 
proximately 300 of them are involved in animal welfare activities. 
In addition, we have approximately 200 that we call animal health 
technicians. This also includes our compliance officers. 

So in round figures, about 500 of our field force spend a percent- 
age of their time on the cmimal welfare program. This means they 
do not spend full time on the program. They also do other things. 

Mr. Roberts. Pardon me for interrupting, but in terms of this 
number, how many are veterinarians? 

Mr. RissLER. Approximately 300 of these people are veterinary 
medical officers. The remaining 200 are animal health technicians 
who are lajrmen. 

Mr. Roberts. We have a quorum call, Mr. Chairman. I have no 
further questions. 

Mr. Brown. Mr. Staggers, do you have any questions? 

Mr. Staggers. Yes; Mr. Chairman, I will take as short a time as 
I can. 

I understand that there is a GAO study under way right now and 
that the preliminary reports would indicate that there is very little 
enforcement of the Animal Welfare Act to date. 

I hear you respond to Mr. Roberts that in fact you do have ade- 
quate funding. I guess the issue then is, can we enforce the act, or 
can we enforce the amendments? It would appear there is an en- 
forcement problem here. How do we respond to that? 

Mr. Hawkins. Your point is well taken. It is an enforcement 
problem, and as I indicated in my remarks, we have made a sub- 
stantial inroad in the area of compliance. 

I have taken a strong stand on this. Again, some people are not 
too aware that we are following up on the compliance issue. We 
have recently been involved in many violation cases for which you 
gave us the authority to impose civil penalties. We are citing 
people very regularly. We are publicizing these facts, and we are 
going to have compliance not only in animal welfare but in the 
other programs that Congress gives us authority and responsibility 
for. 

Mr. Staggers. So your point would be that we don't need to 
amend this; we don't need more funding; we don't need more per- 
sonnel; just give you more time and you will be able to do the job? 
Is that your bottom line? 

Mr. Hawkins. That is correct, sir; because, as I mentioned earli- 
er the training that we are presently involved in, the establish- 
ment of a full-time coordinator, and a coordinator in each State re- 
sponsible to the AVIC of that State, are making substantial inroads 
in compliance with the regulations. 

Mr. Staggers. I guess your point would be that the GAO study 
should be ignored for at least how long? How long can we expect 
your internal 

Mr. Hawkins. We will never have 100 percent compliance, sir. 
There will always be some violators that will have to be identified 
by those who care. We cannot police the total United States all the 
time. 

I feel definitely that given another year, with the action that we 
have taken, you will see substantive changes in our responsibility 
for carrying out the authority that you have given us. 



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28 

Mr. Staggers. So if we come back next year and it has not hap- 
pened, then you will be right behind us saying that you need more 
money, more funding, more personnel, amendments to change the 
law, and so forth? 

Mr. Hawkins. If it is identified that that is the problem, yes, sir; 
we would. There may be other things that would make them more 
important at that time, but yes, I would have to agree to that state- 
ment. 

Mr. Staggers. Thank you. 

Thank you, Mr. Chairman. 

Mr. Brown. Mr. Hawkins, if I may just emphasize something 
you have said here, I think what you are sajdng is that this is not a 
system which will ever be perfect, and it will continue to require 
input from the public and input from voluntary organizations such 
as animal care committees in the laboratories. 

Mr. Hawkins. Yes, sir; we are very appreciative of their identify- 
ing problems, because they are broadly scattered across this 
Nation. They are a big help to us in our enforcement activities. 

Mr. Brown. Thank you. We appreciate that. 

Mr. Hawkins, I am qoing to excuse you at this time. We have a 
quorum call on, and as soon as we return from answerinq the 
quorum call, I will call Dr. Wyngaarden from the National Insti- 
tutes of Health. 

Mr. Hawkins. Thank you, sir. 

Mr. Brown. The subcommittee will be in recess for about 10 
minutes. 

[Recess taken.] 

Mr. Brown. The subcommittee will come to order. 

We will next hear from Dr. James B. Wyngaarden, Director of 
the National Institutes of Health, who is accompanied by Dr. Wil- 
liam E. Raub, Deputy Director for Extramural Research and Train- 
ing. 

We very much appreciate your being here, and you may proceed 
with your testimony. Dr. Wyngaarden. 

STATEMENT OF JAMES B. WYNGAARDEN, DIRECTOR, NATIONAL 
INSTITUTES OF HEALTH, ACCOMPANIED BY WILLIAM E. RAUB, 
DEPUTY DIRECTOR FOR EXTRAMURAL RESEARCH AND TRAIN- 
ING 

Mr. Wyngaarden. Thank you, Mr. Chairman and members of 
the subcommittee. 

I am pleased to present to you this morning the views of the Na- 
tional Institutes of Health on legislation concerning the care and 
treatment and use of research animals, and to describe to you some 
of the activities we have undertaken to address this issue. 

Let me begin by stating our general views on H.R. 5725. We 
think the bill reflects a good understanding of some of the funda- 
mental concerns and needs of the biomedical research community. 
We agree with its goal; namely, a system that provides for effective 
oversight of the use of animals in research; close involvement of in- 
stitutional committees with the animal care and use programs of 
those institutions; training of administrators, scientists, and techni- 
cians in humane animal care; availability of information about po- 



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29 

tentially useful methods and models which might reduce the 
number of animals needed for research; and adequate and effective 
communication with the public about the use of animals in re- 
search. 

We do not agree, however, with the premise that new legislation 
is needed to achieve that end. We are convinced that under exist- 
ing law and administrative authority, we are working effectively in 
pursuit of goals I know we share with you, others in the Congress, 
and the public. 

The Animal Welfare Act administered by the Department of Ag- 
riculture applies to research institutions. We believe that its cur- 
rent authority is satisfactory and allows the USDA to change pro- 
cedures and standards as necessary. 

In addition, the Public Health Service has used its authority to 
promulgate policies and guidelines relative to animal welfare for 
its own awardees. There is sufficient flexibility under that author- 
ity to modify this policy as needed. 

I would like to describe briefly our current policies and proce- 
dures relative to awarding institutions where animals are used in 
research. Under current PHS policy, as a condition of a PHS award 
for research in which vertebrate animals are used, the awarding 
institution must provide written assurance that it has established 
an animal care committee to oversee care and welfare of animals 
used in research. 

Every institution for which we provide funds for vertebrate 
animal research in fact has such a committee, composed of a mini- 
mimi of five members, at least one of whom is a veterinaricm. 
Every institution using vertebrate animals in research must in- 
clude in its written assurance, which is kept on file with the NIH 
Office for Protection from Research Risks, a statement that the in- 
stitution is committed to following the principles and guidelines of 
the NIH Guide for the Care and Use of Laboratory Animals. 

About one-third of these institutions have accreditation from the 
American Association for Accreditation of Laboratory Animal 
Care — the best evidence, we believe, of full compliance with our 
guide. The remaining institutions are either in full compliance 
with the guide, as determined by their animal care committees, or 
are working toward full compliance. 

In terms of compliance with our PHS animal welfare policy and 
with our guide, NIH relies on a system of written institutional as- 
surances. We have not felt the need to establish a system of rou- 
tine inspections, a costly system which would needlessly duplicate 
activities of other agencies. 

Because of our awareness of congressional and public concern, 
we have initiated a number of activities designed to evaluate our 
assurance system, tighten our animal welfare policy, and enhance 
our communications. I would like to describe some of these. 

In the spring of 1983, we participated with the Food and Drug 
Administration and the USDA in the development of a memoran- 
dum of understanding designed to increase interagency communi- 
cations with respect to deficiencies related to animal care and 
treatment. We expect that communication will continue to improve 
because we, the FDA, and the USDA have a commitment to im- 
prove it. 



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30 

For more than a year, we have shared information among these 
agencies. This has improved compliance while reducing the cost of 
inspections. 

Over the summer of 1983, NIH site visited 10 randomly selected 
awardee institutions. The purpose of these visits was to discuss the 
viability of our own assurance statement system. The visits were 
organized by the NIH Office of Extramural Research and Training 
and included members of intramural and extramural staffs and 
outside consultants, including veterinarians. 

There were two significant findings of the site visits: no abuses of 
animals were found, and our assurance statement system and our 
animal welfare policy were determined to be effective, although not 
perfect. 

Incidentally, Mr. Chairman, the findings from this series of site 
visits are summarized by Ann Landers in the Washington Post this 
morning, and with your permission, I would like to insert this into 
the record. 

Mr. Brown. Without objection, it will be made a part of the 
record. 

[The material follows:] 



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32 

Mr. Wyngaarden. As a result of our site visits, we made several 
decisions. First, we decided to continue a small program of random 
site visits. Indeed, another series of five was completed about 3 
weeks ago. Again, these visits were not to duplicate or replace the 
unannounced inspections of the USDA Animal and Plant Health 
Inspection Service. They followed a carefully designed protocol to 
evaluate the effectiveness of our assurance system. They also em- 
phasize to awardee institutions that their assurance statements are 
living documents and must accurately reflect the status of the in- 
stitution's animal care and use programs. 

Second, we proposed a revision of the PHS policy on animal wel- 
fare, strengthening the policy in accordance with suggestions by 
site team visit teams and suggestions made to us through various 
means by the Congress and the concerned public. 

We published the proposed revision in a special edition of the 
NIH Guide for Grants and Contracts in April 1984 and solicited 
public comment. We have received a great deal of comment, and 
we are currently analyzing those replies. 

Let me highlight a few aspects of the proposed revision that 
relate particularly to H.R. 5725. Our proposal would require that 
institutional animal research committees include a member not af- 
filiated with the institution and also a nonscientist and that the 
committees be involved in the review of each proposed research 
protocol. One objective of this review would be to determine that 
the care and use of the animals is in compliance with the guide 
and other applicable laws and regulations. 

The proposed revision would also require a more frequent updat- 
ing of institutional assurance statements and a specific timeframe 
for complying with the NIH guide for those institutions that are 
not already in compliance. 

Next, we initiated an educational campaign which includes a 2- 
day national symposium, already held, and a series of regionsd 
workshops dealing with PHS animal welfare policy, directed pri- 
marily to institutional animal research committees and research 
administrators. 

Concern about animal welfare frequently leads to discussion of 
the extent to which the use of animals can be reduced. The NIH 
Division of Research Resources has funded a series of workshops, 
sponsored by the National Academy of Sciences, on the subject of 
what are sometimes termed "alternative" or "adjunct'' methods of 
research. 

The workshops, which were completed in late summer, brought 
together scientists from many disciplines to discuss such topics as 
cell culture methods, mathematical and computer modeling, and 
the use of lower organisms in research. These workshops served to 
make many more scientists aware of various research methods and 
models that might now or in the future be available for particular 
kinds of research activities. 

It is expected that the forthcoming report of the National Acade- 
my of Sciences will include recommendations regarding the fund- 
ing of research and the development of promising models and 
methods. NIH is funding such research already and is ready to 
expand its efforts into promising new areas. 



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33 

In closing, Mr. Chairman, I want to say that we are convinced 
that researchers, with rare exceptions, respect animals as unique 
and valuable resources, use them prudently, and do not abuse 
them. 

Further, we at NIH are committed to the humane care and treat- 
ment of research animals and to their appropriate, thoughtful, and 
careful use. The same commitment is expected of our awardee in- 
stitutions. 

Thank you, Mr. Chairman. I will be pleased to answer any ques- 
tions you may have. 

[The prepared statement of Mr. Wyngaarden appears at the con- 
clusion of the hearing.] 

Mr. Brown. Thank you very much. Dr. Wyngaarden. 

Did you have an3rthmg additionally. Dr. Raub? 

Mr. Raub. No, sir, I don't. 

Mr. Brown. Mr. Staggers. 

Mr. Staggers. Thank you, Mr. Chairman. 

In your statement, you mentioned that you do not agree with the 
premise that new legislation is needed to achieve the goals that we 
all are pursuing, that you are convinced that under existing law 
and the administrative authority you can in fact achieve effectively 
the goals that we all are pursuing. 

I would bring your attention to the GAO study I mentioned earli- 
er with the witness that preceded you, that the preliminary reports 
indicate that there is very little enforcement of the Animal Wel- 
fare Act, and that there may be some abuses, and ask for your 
comments. 

Mr. Wyngaarden. I think, with respect to the use of animals in 
research, that the compliance with the guidelines is general 
throughout the research community and that the periodic revisiogi 
of these guidelines as problems are identified does serve to improve 
the care of animals. 

There is no difference of opinion whatever concerning objectives. 
We think that the periodic site visits that have been conducted re- 
cently will tune up the sjrstem; they will convey a message to the 
awardee institutions that we take seriously the compliance, as they 
do, but that we also will, from time to time, check on our interpre- 
tation of compliance and stimulate their improvement where there 
may be deficiencies. 

We also think that the revision of the guidelines incorporates 
many of the proposals that are in this bill, the ones that we feel 
particularly valuable. I could cite those specific features if you 
would like where the proposed guidelines are in consonance with 
this proposal. 

Mr. Staggers. Let me ask you, with some of the perceived 
abuses, when can we start to expect — as you say, under existing 
law and administrative authority — that we will see the results/ 
Are we seeing them now? Is that your perception? 

Mr. Wyngaarden. I think we are seeing them now. It is ongoing. 
Where there are deficiencies or specific allegations of abuse, we 
have a system and a procedure for dealing with these complaints, 
which includes working with the institutions to identify the validi- 
ty of complaints and, if there is some v.alidity, moving to the next 
level of investigation, which may include site visits, if that is indi- 



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34 

cated, to the institution. If, indeed, there is a serious degree of non- 
compliance, we have certain remedies available to us in suspending 
the award, terminating the award, or even withdrawing the assur- 
ance from the institution. That last has never been necessary. 

Mr. Staggers. At what point, in terms of time, do we reach 
where we do need to change the legislation, if in fact we don't per- 
ceive the results coming forth? I mean, next year, if in fact we 
have people testifying that there are the abuses, that we should 
start looking at it next year or 2 years from now or what? 

Mr. Wyngaarden. I don't really find it possible to put a time- 
frame on that probably because I don't really agree with the impli- 
cation that there is widespread abuse of the use of animals in re- 
search that would require such legislation. 

Mr. Staggers. Let me switch tracks. What type of justification 
does a scientist need to make in proposing an experiment when he 
is going to use animals now? 

Mr. Wyngaarden. The first line of approval involves the animal 
care committee at the institution, and if that approval is forthcom- 
ing, the application comes to the National Institutes of Health, 
where it is reviewed by a study section for scientific merit and 
technical feasibility, and if animals are proposed for use, the report 
of that committee in either approving or disapproving the proposal 
must include a statement about the use of animals. 

We find that that is a powerful assurance that the guidelines of 
the Public Health Service are indeed being met. 

Mr. Staggers. For a layman, what does that mean? I mean, 
what can I look at, what justifications? I understand the procedure 
that you go through, but what are the justifications? 

Mr. Wyngaarden. The justification has to do with the review at 
the local level for the appropriate care and use of those animals, 
and at the level of the scientific review at the NIH, for the need for 
use of animals in this particular research proposal. 

Mr. Staggers. So there is no overall review; it is totally at the 
discretion of the local level whether in fact 

Mr. Wyngaarden. No; at the level of the National Institutes of 
Health, there is the review of the research proposal to see that the 
use of animals is appropriate, that the species are appropriate, the 
numbers are appropriate, and that, indeed, there is not a better 
way to do the research. 

There must be an extensive justification in the proposal for this 
work related to other work which has been done, which then ap- 
proaches directly the subject of unnecessary duplication. If, in the 
view of the scientists reviewing this proposal, this is strictly dupli- 
cative work, it would not be funded. 

Mr. Staggers. Thank you, Mr. Chairman. 

Mr. Brown. Dr. Wyngaarden, generally speaking, your state- 
ment presents an encouraging analysis of the situation with regard 
to research using live animals; yet we still find examples, and they 
are in very prestigious institutions, where there seems to be some 
lack of adequate standards for the use of laboratory animals. 

We have had well publicized incidents in my own State at the 
University of California and Stanford and other places. It may well 
be that there is no strictly institutional way in which you can 
achieve perfection or perhaps even reasonably satisfactory stand- 



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35 

ards. For example, assume that APHIS makes their annual two 
visits per year but the inspector is a little careless and does not 
visit all the facilities; the local animal care committee does not 
meet very often and does not get around to seeing some of these 
things. You can have, then, situations in which the standards were 
not being met, and, obviously, this is what happened in a number 
of cases. 

What recourse do we have when there is some failure in this in- 
stitutional or bureaucratic system to maintain the kinds of stand- 
ards which you and I and other reasonable people would like to see 
maintained? 

Mr. Wyngaarden. Yes, Mr. Chairman. Let me point out that we 
fund about 17,000 investigator-initiated awards, and about 40 or 45 
percent of those involve animals. 

Yet, since September 1981, 3 years now, the NIH Office for Pro- 
tection from Research Risks has conducted 11 investigations of alle- 
gations of noncompliance with the guidelines or potential abuse of 
use of animals. In nine of those investigations, the allegations 
reached us by individuals who were not directly concerned with the 
research. In three instances, onsite visits were conducted. Five in- 
vestigations yielded no evidence of noncompliance. In three, some 
deficiencies were found and corrective measures taken. In one, evi- 
dence led to the conclusion that there was material failure to 
comply with the policy and the grant was terminated. 

I submit that those are minuscule figures compared with the 
total universe of research that we support. We do have the reme- 
dies in the case of noncompliance that I have mentioned. We can 
suspend an award until the institution or laboratory is in compli- 
ance. We can terminate the award if necessary. We could, indeed, 
withdraw the assurance of the entire institution, but that has 
never been necessary. 

Mr. Brown. I have looked at this Ann Landers column that you 
referred to; I have it in front of me, as a matter of fact. I am told 
that some of the institutions on this list which you found adequate 
to excellent, that USDA inspectors found major deficiencies in 
them. 

Do you feel that there is any possibility that that could be the 
case? 

Mr. W\NGAARDEN. Let me ask Dr. Raub, whose office conducted 
these site visits, to speak to that if he would. 

Mr. Brown. While you are at it, were these announced or unan- 
nounced site visits? 

Mr. Raub. These were announced site visits, sir. 

Part of the preparation for the visits was the examination of 
USDA reports on those institutions, so we had some cues as to 
where there might be particular problems. 

Our primary thrust was to examine the total management 
system and the facilities within those institutions, looking for the 
kinds of systemic strengths or weaknesses that would serve, in the 
first case, our purposes over the long term, or for which some spe- 
cific remedies would be needed. 

In our judgment, all of the institutions involved were in compli- 
ance with their statement of assurance to us. In a few instances, 
we were able to identify areas where improvements were possible. 



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36 

and we shared those observations with the institutions and will be 
working with them to ensure that there is foUowthrough. 

Mr. Brown. Well, I am not obsessed with the idea that we are 
going to achieve perfection here. I am just concerned that we 
achieve the highest standards that are reasonable under the cir- 
cumstances. 

Without objection, I will be allowed to continue for an additional 
couple of minutes, even though the red light is on. 

It came to my attention that we had a situation at the Universi- 
ty of California at Berkeley where the psychology department was 
conducting some live animal experiments, and the supervising vet- 
erinarian at the university was so dissatisfied with the situation 
that he refused to sign the appropriate reports. Yet the deficiencies 
continued, anyway. 

Now, I am not prepared to feel that the psychology department 
is composed of evil, lawbreaking men, but there is something 
wrong with the system there. It could be lack of funds to accom- 
plish what is needed to be done or lack of motivation; I don't know. 
But how do you analyze a situation like that, Mr. Wyngaarden? 

Mr. Wyngaarden. We stay in very close contact with that par- 
ticular situation that you mentioned. Dr. McCarthy's office, the 
Office for Protection From Research Risks, has tracked it, £is has 
Dr. Raub. We have just this week discussed the matter. I under- 
stand there have been substantial improvements at the University 
of California in Berkeley, that they are now in compliance, and 
that the veterinarian who had earlier reservations has signed the 
statements of compliance. 

Mr. Brown. Did you use some persuasion, threat of withholding 
grants, or something like that? 

Mr. Wyngaarden. I would have to ask Dr. Raub whether it 
reached that level. 

Mr. Raub. It did not reach that explicit stage, sir, but we con- 
ducted, as I recall, two separate site visits, the second one in con- 
junction with a representative from the USDA. We were focusing, 
specifically, on the findings of the USDA, the concerns of the local 
veterinarian, and concerns and allegations that had been expressed 
by citizen groups in the area. We came away satisfied from the 
second visit that the institution was clearly on the track and com- 
mitted to remedying the kinds of structural and communications 
deficiencies that had existed before. 

We have a negotiated assurance with the institution that we 
intend to follow closely, and we are confident that the institution 
will reciprocate. 

Mr. Brown. I have no theory of an evil conspiracy at the Univer- 
sity of California. I like the University of California. I am an alum- 
nus of it, myself, and I think it is a great institution. But it may be 
that they have a situation somewhat like we have here in Congress 
with our Ethics Committee. We don't always diligently pursue 
some of the allegations that we might, just because we are all part 
of the same club, you know, institutional framework. 

It is that kind of problem that I think we need to be concerned 
about, and where your reassurances don't always satisfy me that 
we have achieved the kinds of results that we ought to achieve. 

Are you concerned about that, Dr. Wyngaarden? 



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37 

Mr. Wyngaarden. I think it is a very valid point, and it is a 
matter of concern, but I do think that the performance record of 
the NIH in this respect indicates that we can be firm and forceful 
when the situation requires it, even to the point of terminating 
support when necessary. 

Mr. Brown. Generally speaking, though, the situation only re- 
quires that when there is a loud public hue and cry. Isn't that the 
case? 

Mr. Wyngaarden. No; I would certainly agree that our concern 
is intensified when the public is greatly concerned. But we have 
also investigated many complaints that have not had much news- 
paper coverage. 

Mr. Brown. That is reassuring, and again, I propound this line 
of questioning not because of any conspiracy theory but because I 
am quite familiar with human nature and how it works, and I am 
concerned that we do everything we can to create systems which 
will help to overcome that as much as possible. 

Thank you very much for your testimony. If you would care to 
submit any additional material after you have reviewed the record, 
we would be pleased to have that. 

Mr. Wyngaarden. Thank you very much, Mr. Chairman and Mr. 
Staggers. 

Mr. Brown. We are now ready to call our first panel of wit- 
nesses, which will include Dr. Van Hoosier, Dr. McArdle, Dr. Geel- 
hoed, and Dr. Randall. In addition, I have asked Dr. Frank Loew to 
appear on this panel as a substitute for Dr. Jean Mayer, president 
of Tufts University, who was unable to come but asked Dr. Loew to 
appear in his behalf. Dr. Loew is dean of the College of Veterinary 
Medicine at Tufts University. 

STATEMENT OF FRANKLIN M. LOEW, DEAN, SCHOOL OF 
VETERINARY MEDICINE, TUFTS UNIVERSITY 

Mr. Loew. Mr. Chairman and subcommittee members, thank you 
for the opportunity of appearing before you. 

As the chairman noted. I am dean of the School of Veterinary 
Medicine at Tufts University in Boston, and I am here to speak in 
support of this proposed legislation and to give you my assessment 
of the effectiveness and enforcement of the current Animal Wel- 
fare Act and its regulations. 

I also bring you the greetings of the president of Tufts Universi- 
ty, Jean Mayer. 

I am a member of many national scientific organizations such £is 
the Commission of Life Sciences of the National Research Council, 
National Academy of Sciences. As well, I recently completed a 3- 
year term as chairman of the Institute of Laboratory Animal Re- 
sources of the National Research Council, National Academy of 
Sciences. 

I am chairman of the Board of Trustees of the Boston Zoological 
Society and president-elect of the Association of American Veteri- 
nary Medical Colleges. 

In every way, issues affecting animals and their care constitute 
my total occupation. But I also hold a Ph.D. degree in addition to 



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38 

my veterinary degree, and I have carried out research in which 
animals were studied. 

As a scientist, therefore, I am a member of several scientific soci- 
eties such as the Society of Toxicology and the American Institute 
of Nutrition, a constituent society of FASEB, the Federation of 
American Societies for Experimental Biology. 

But I do not speak to you today representing the official views of 
any of these organizations and societies. I wish to give you my own 
personal, professional, and scientific opinion. This opinion is based 
on 20 years in this field, most of it since the passage of the original 
Laboratory Animal Welfare Act in 1966. 

Concern, Mr. Chairman, about animals of all kinds has never 
been higher in this country. But as usual, in controversy, where 
you stand depends on where you sit. That is why I have chosen to 
represent only my own views today. 

H.R. 5725 deserves acceptance if not support by all scientists who 
occasionally or frequently must study animals in the course of 
their important work on behalf of human or animal health. First, 
what will the proposals not do? The proposed amendments will not 
measurably affect the ability of scientists to carry out well planned 
animal studies, in my opinion. Indeed, these proposals would not 
restrict even painful research providing that appropriate review 
and accountability at the local institutional level takes place — 
review which this bill directs to take place at the local institutional 
level by local people, not by Washington-based inspectors. 

Thus, those who come today to talk about total antivivisection or, 
on the other hand, about bureaucratic big brother watching us, will 
have to look elsewhere, not here. Such extreme and unacceptable 
approaches should never, I hope, be considered as acceptable by the 
Congress. 

But H.R. 5725 is far from extreme. Its passage would result in 
little that is different from currently proposed changes in the U.S. 
Public Health Service, NIH, requirements of its grantees using ani- 
mals. More about that in a moment. 

Science, throughout history, has always been a product of the 
culture and society which support the scientific enterprise. Ameri- 
can culture and society in these last 20 years of the 20th century 
clearly have expressed a desire for greater accountability from all 
scientists, including those who use human subjects or recombinant 
DNA or vertebrate, nonhuman animals. 

I find it neither surprising nor upsetting that this is happening. 
It was predictable. It was inevitable, and in my view it is decent 
and proper. 

You will hear today from some critics that these proposed 
amendments are too weak and mealy-mouthed, and you will hear 
from others that they will be costly to implement, or too bureau- 
cratic, or invasive of the principle of free scientific inquiry. 

I disagree with these criticisms. The tenor of H.R. 5725 is just 
about right in reflecting informed public criticism as well as the 
conclusion of many enlightened scientists, in my opinion. Criti- 
cisms of these proposals on the basis of cost are particularly weak, 
I think, in view of other research grant-borne costs such as word 
processors, travel to meetings, technical and professional salaries, 
or even the cost of the animals themselves. 



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39 

The chairman and subcommittee members will know that the 
National Institutes of Health is currently proposing changes in its 
grantee requirements for annimal care and use. I support those 
proposed changes, also. The needs of human medical, veterinary 
medical, biological and agricultural research are simply too great 
to risk a loss of public faith, congressional faith, in the research en- 
terprise. 

I hope that appropriate consultation between the Public Health' 
Service and the USDA's Animal and Plant Health Inspection Serv- 
ice will take place to ensure consistency or complementarity in the 
eventual regulations, guidelines, assurances, and procedures. 

In my opinion, the study of human and animal subjects contin- 
ues to be a crucial component of life science research and teaching 
throughout the world. Careful periodic revision of NIH require- 
ments and USDA regulations will, I think, go far in preserving the 
freedom to use these approaches when appropriate. But such revi- 
sions must be well thought out, as these are, and not so frequent as 
to make compliance or planning for compliance futile for our uni- 
versities, industrial laboratories, or research institutions. 

I would like now to briefly assess the current APHIS enforce- 
ment of the Animal Welfare Act. In a word, it has been uneven. 
The program suffers, in my opinion, from a lack of adequate funds, 
a tocHsmall professional and technical staff which ranges in compe- 
tence and interest in this act's requirements from excellent to mar- 
ginal, and from internal legal support which is stretched too thinly. 

I understand that the GAO will be or has reported to you on this 
program. The U.S. Department of Agriculture is among the most 
distinguished of American Federal Departments, from the days of 
the old Bureau of Animal Industry to today's superb and well-run 
laboratories, to the vital financial support provided to our experi- 
ment stations and land-grant universities. It is a part of all of our 
lives. 

But it is not always perfect and, as such, is often a scapegoat for 
all sorts of real or imagined problems. The Animal Welfare Act is, 
by and large, a good act, and its regulations are, by and large, good 
regulations. Your proposed changes will make it even better, in my 
view. 

But it will not succeed without a commitment at the highest 
level, without adequate funding, without enough properly and reg- 
ularly trained veterinary medical and compliance officers. After 
all, there are over 1,100 registered research facilities in this coun- 
try. I urge you to assess the situation, with the help of the GAO, 
and act if you agree. 

As requested, I have refrained from discussing many other as- 
pects of animal experimentation, but these have been considered in 
hearings held in 1981 by Mr. Walgren and in 1982 by Mr. Waxman. 
There is a good and complete record. 

In conclusion, Mr. Chairman, many of my fellow scientists, physi- 
cians, dentists, and veterinarians across the country believe that a 
sound, properly enforced law protects not only the animals but also 
scientists and the public interest in good science. 

Strangely, it is difficult for many of us to say this publicly, for 
there can be an orthodoxy in science just as in antiscience. Where 
you stand really does depend on where you sit. I sit here speaking 



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for myself and what I believe to be necessary for the maintenance 
of continued public confidence in and support of the American sci- 
entific enterprise. 

Thank you, Mr. Chairman. 

Mr. Brown. Thank you very much, Dr. Loew. I appreciate your 
statement and your willingness to substitute at the last minute for 
Dr. Mayer. 

I should reiterate what I said at the beginning, that members of 
the panel will hold a variety of different views on this subject, and 
this has been deliberate in order that we could, hopefully, create a 
dialog here. We hope that everyone will seek to broaden his out- 
look on this subject during the course of the hearing. 

Dr. Van Hoosier, we would appreciate your testimony now. Dr. 
Van Hoosier is from the Division of Animal Medicine, School of 
Medicine, University of Washington, and he represents the Nation- 
al Association of State Universities and Land-Grant Colleges, the 
American Council on Education, and the Association of American 
Universities. That is a pretty heavy load. Dr. Van Hoosier. 

STATEMENT OF GERALD VAN HOOSIER, JR., PROFESSOR, DIREC- 
TOR, AND ATTENDING VETERINARIAN, DIVISION OF ANIMAL 
MEDICINE, SCHOOL OF MEDICINE, UNIVERSITY OF WASHING- 
TON, ON BEHALF OF THE NATIONAL ASSOCIATION OF STATE 
UNIVERSITIES AND LAND-GRANT COLLEGES, AMERICAN COUN- 
CIL ON EDUCATION, AND ASSOCIATION OF AMERICAN UNIVER- 
SITIES 

Mr. Van Hoosier. Thank you, Mr. Chairman. It is not nearly as 
heavy as what your load here is. 

Mr. Chairman and members of the subcommittee, my name is 
Gerald Van Hoosier. I am the attending veterinarian and professor 
of animal medicine at the University of Washington. Among my 
professional activities is included a tenure as chairman of the 
American Association of Laboratory Animal Care, the independent 
accrediting body for this Nation. 

Thank you on behalf of the Joint Committee on Health Policy of 
the Association of American Universities, the American Council on 
Education, and the National Association of State Universities and 
Land-Grant Colleges for the opportunity of appearing before your 
subcommittee this morning to discuss an issue of major concern, 
the use of animals in research. 

I would be remiss, Mr. Chairman, if I did not take a few mo- 
ments of my allotted time to note some reluctance on the part of 
our universities to raise questions about this legislation, given your 
extraordinary record in Congress these past few years in behalf of 
scientific research. 

We see this bill as a thoughtful attempt to address important 
issues about the care and treatment of animals in research. That 
objective is laudable, and we are prepared to try to assist in 
making it succeed. We take this opportunity, however, to state 
some basic principles. 

First, Mr. Chairman, we believe, as you do, that wise legislation 
should be based on as much information as may be gathered on the 
subject in question. During almost this entire Congress, both the 



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House and Senate committees responsible for biomedical research 
have had pending a proposal for an 18-month study, conducted by 
an organization like the National Academy of Sciences, to look into 
all aspects of the use of animals in research and to make recom- 
mendations for such legislation as may be needed. 

Some of our colleagues in the animal welfare community have 
said that studies are a stall. Had we full support from all sides of 
this issue on that study, it could have been completed by this time. 

We maintain that absent such a study, any proposed legislation 
is subject to responding to mistaken perceptions that could require 
legislative amendments after avoidable problems have been gener- 
ated. 

Second, the National Institutes of Health is engaged in the con- 
sideration of a revised set of guidelines governing the use of ani- 
mals in research. All interested parties were invited to comment 
on these proposed guidelines at three public hearings this past 
year. The final product will represent a balanced approach to this 
complex issue. We question whether legislation at this time, until 
those new guidelines are finalized and tested in the field, is pru- 
dent. 

Differences between these guidelines and the legislation, however 
unintentional they may be, could cause confusion and delay reach- 
ing precisely the objective called for by the animal welfare commu- 
nities. 

As a consultant to this committee for revision of the guide, I can 
personally assure you that the current draft does have some signifi- 
cant inconsistencies with this proposed law. 

Third, we believe that it has been generally understood by the 
Congress and the general public that animals are used in research 
because it is necessary in order to improve the health of humans 
and animals. While many of these are familiar to you, I call to 
your attention a presentation prepared by the California Biomedi- 
cal Research Association citing the role of animals in important 
medical progress such as acquired immunodeficient disease, diabe- 
tes, hypertension, and several others. Copies of this will be made 
available to your committee. 

While adjunct methods have been developed in recent years and 
the numbers of animals used in research decreased, fundamental 
elements of biomedical research will always require the use of ani- 
mals. We do not believe the word "alternative is reasonable. It is 
not fair nor accurate to hold out the promise that there are or will 
be research substitutes for animals, other than human beings. 

In addition, it is important to note that such adjunct methods 
typically are developed through the conduct of research, not 
through research on methods of research. Congress, representing 
the citizens, wants better forms of heart surgery, wants new dis- 
ease-preventing vaccines, wants new cures for old diseases. 

It would seem appropriate when there are all sorts of attacks on 
the use of animals in research that the Congress, on behalf of the 
Nation, state as a matter of public policy the reality that if we are 
to make continuing progress in the Nation's health, the use of ani- 
mals is imperative. It would help, too, to have the Congress de- 
nounce recent behavior, sometimes criminal in nature, to disrupt 
centers of science research because animals are being used. 



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Mr. Chairman, I am a veterinarian and a scientist, and like my 
colleagues in this profession, I have dedicated myself for the past 
27 years to the care and treatment of animals. I would not be asso- 
ciated with any enterprise in which animals were treated careless- 
ly or indifferently, where pain was not prevented wherever possible 
or not treated if possible. 

It should be understood that animals used in research must be 
healthy and cared for if the research conducted is to be reliable 
and useful. Allegations of general or broad spread mistreatment of 
animals in research are devoid of factual basis. 

While we operate in restricted circumstances, with restricted 
funds, improvements cannot only be made but are being made reg- 
ularly at academic health centers where research is conducted 
using animals. Such improvements in facilities are necessary to the 
science and for the humane and proper care of animal subjects. 

Nevertheless, these improvements require resources that are not 
always available. The committee is aware of the limits of such re- 
sources and the legitimate claim of many to them. A mandate to 
provide state-of-the-art facilities for research animals without funds 
to accomplish this would require a shifting of resources from other, 
perhaps equally essential, functions. 

We all know that bricks and mortar do not an institution make. 
In addition to funds for facilities, there are real needs for funds for 
training. There are just not adequate people trained in the field of 
laboratory animal medicine to staff adequately all the institutions 
in the United States. We need additional facilities for the diagnosis 
of laboratory animal diseases. We also need more research on those 
diseases we do not yet understand and know how to prevent in lab- 
oratory animals. 

It is not difficult to find ways to significantly improve the appli- 
cation of current standards. As you know, APHIS is mandated to 
conduct inspections of facilities using animal research. Little else 
would be needed to achieve this congressional goal of better over- 
sight than to provide APHIS with adequate funding annually. 

There are too few inspectors, and too few of them able to devote 
themselves to this area of animal welfare. Frequently, it is a very 
minor part of their overall activities. 

It may be well to add that we do not need more legislation, just 
more support for inspection and training. I would add here that the 
accreditation mechanism in effect, which this bill does not men- 
tion, has had a tremendous impact for good on animal care pro- 
grams. 

We believe that the current Animal Welfare Act, along with 
NIH standards, is adequate to meet reasonable standards of care 
for animals in research. New legislation may not be necessary. In 
addition, there is no reason to believe that the new legislation 
would be enforced any better than present law, absent adequate 
support for APHIS. 

We will not undertake, in this testimony, to offer a detailed anal- 
ysis of various points in the proposed legislation that we would like 
to have clarified and modified. If it would prove helpful, we will 
submit such an analysis for the record. 

There are, however, a few issues that are of particular concern. 
Given the red light, I will submit the text of this for the committee 



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but would particularly emphasize that section 4(c) would certainly 
reduce current prohibitions on interference in the actual research 
and conduct of experiments. This, we feel, is a matter of special 
concern. 

Thank you, Mr. Chairman. I will be glad to answer any questions 
you may have. 

[The prepared statement of Mr. Van Hoosier appears at the con- 
clusion of the hearing.] 

Mr. Brown. Thank you. Dr. Van Hoosier. 

We will ask you to make the analysis that you suggested. There 
will be no big hurry about it, but we do invite you to consider that 
and to submit it to the subcommittee at a convenient time for you. 

Next, Dr. John McArdle, who is director of laboratory animal 
welfare for the Humane Society of the United States. 

STATEMENT OF JOHN McARDLE, DIRECTOR, LABORATORY 
ANIMAL WELFARE, THE HUMANE SOCIETY OF THE UNITED 
STATES 

Mr. McArdle. Mr. Chairman, I am Dr. John McArdle, director of 
laboratory animal welfare for the Humane Society of the United 
States. I am here today to represent our 300,000 constituents. 

As to my personal background, I have a doctorate in anatomical 
sciences from the University of Chicago and approximately 10 
years of experience working with laboratory animals, including ex- 
perimental surgery. 

My detailed testimony has been submitted for the committee, in- 
cluding an appendix itemizing the situation at the University of 
California at Berkeley. What I would like to do this morning is to 
highlight specific areas of concern, initially talking about the en- 
forcement program with APHIS and then talking about ways I be- 
lieve that this legislation will help clear up those problems. 

Mr. Brown. Dr. McArdle, we will include the full text of your 
prepared statement in the record. 

Mr. McArdle. Right. I just simply have notes here. I am not 
going to read my testimony. 

Mr. Brown. We would appreciate it if you would be as restrained 
as the two previous witnesses. 

Mr. McArdle. I intend to be. 

Particularly with APHIS, we think the problems have to do with 
the inspectors, that there is a need for a consistent interpretation 
of inspection and enforcement requirements in the field, and that 
they, in fact, are inadequately trained. 

Dr. Robert Crawford, at the USDA, recently noted that we have 
inspectors who have no interest in inspecting; we have some who 
have no training or have inadequate training. I believe there is a 
problem with funding, as has been mentioned. 

Areas within the United States, such as California, often receive 
less than one inspection per year. We understand that some insti- 
tutions in fact have not been inspected in several years. 

We are particularly concerned about the issue of funding. At a 
time when they claim that there is not enough money to hire ade- 
quate numbers of inspectors to do adequate inspections, the GAO 
study found that last year they still managed to produce a surplus 



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of $700,000, which was spent on a fleet of new cars for their inspec- 
tors. 

We are particularly concerned because we received word this 
year, due to a reallocating of Animal Welfare Act inspectors for 
the State of Pennsylvania, that funds are piling up due to a lack of 
Animal Welfare Act inspections, and they are producing another 
surplus this year somewhere in the vicinity of $200,000 to $300,000. 
We are wondering exactly whether or not that is going to mean an- 
other fleet of cars. We also wonder how seriously they take this 
issue, since they are in fact having surplus money this year. 

With regard to enforcement, there is evidence that contested vio- 
lations against dealers have remained pending in the Office of Gten- 
eral Counsel for periods of 2 or more years. We are concerned 
about that. 

As you mentioned, there is a situation at Stanford University. 
The Peninsula Humane Society in Palo Alto is presently in court 
seeking judicial review of the failure of the Palo Alto Veterans' Ad- 
ministration Hospital and Stanford University to comply with pro- 
visions of the Animal Welfare Act and for APHIS to fail to enforce 
them. 

I would like to just itemize, I think, the situation at Berkeley be- 
cause it is indicative, I think, of the problem. Substantial and ille- 
gal conditions have existed at that university since at least 1974 
when they were first documented. As was mentioned, the campus 
veterinarian refused to sign the compliance forms for the years 
1980 and 1983. 

Last winter, several thousand animals died at that facility due to 
repeated malfunctions of the heating system. This was a problem 
that had been known to exist for some time. Such losses would not 
have necessarily been reported to the APHIS inspectors. 

Despite repeated violations of the Animal Welfare Act and fail- 
ure to pass APHIS inspections, APHIS still took no action against 
the university for several years. A citizens' group, Californians for 
Responsible Research, finally brought suit against APHIS to force 
action. Shortly thereafter, APHIS filed a count with 42 violations 
of the Animal Welfare Act against Berkeley. This has led to a 
$12,000 fine of which they will actually only pay $2,000. 

I think there are two very specific ways in which the present leg- 
islation can help improve the situation on APHIS inspections. The 
first of these is that I believe it will be difficult to hide a lack of 
inspections or to hide serious violations of the Animal Welfare Act 
when a responsible member of the local humane community is on 
the animal care committee. We think that is a critical provision, 
and it has been included with NIH's revision. That needs to be an 
outside person. 

We are also concerned that the composition of that committee be 
done on a percentage basis rather than an individual basis, so that 
the one outside person will not be swamped by large committees. 

We would also recommend an additional category. We believe 
that the animal care technicians who are responsible on a daily 
basis and are the only ones with daily contact with these animals 
should be included in that committee. 

We have another specific thing that we would like to request be 
added to the act, a section titled **Civil Enforcement Suits.'' We 



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would like to provide that any person may commence a civil suit 
on his own behalf or on behalf of any animal protected by this 
chapter to compel the Secretary to apply and enforce the provi- 
sions of this chapter; that the district courts shall have jurisdiction, 
without regard to the amount in controversy or the citizenship of 
the parties, to order the Secretary to take any action necessary to 
apply and enforce the provisions of the chapter; that the court may 
in fact give reimbursement to the parties involved; and that the 
relief provided by the section shall not restrict any right to other 
or additional relief which any person may have under any statute 
or common law. 

I think, as has been shown by the case in Berkeley, that there is 
some issue of whether citizens have standing in this case. We think 
this specific addition to the bill will provide that standing and an 
incentive for APHIS to do its job. 

Some basic general comments on points within H.R. 5725 that we 
think are important: We think that it would be important to man- 
date that the animals be kept under species-specific behavior and 
physical requirements rather than just sort of general. The best 
way to deal with things such as exercise, we think, is to allow the 
animals to simply engage in their natural behavioral repertoires. 
Exercise should not be limited to dogs but should be available to all 
species that require it. 

Proper pre- and post-operative care, we believe, is important, but 
we need some clear-cut objective scales — even invasiveness, if you 
will — rather than subjective indications of whether or not the 
animal might be in pain. 

When I was in training and doing research at the University of 
Chicago, I was told by my superiors not to worry about post-opera- 
tive pain relief because it was a waste of money and the animals 
really didn't feel pain, anyhow, and these were surgery cases I was 
involved in. 

We think there is a very serious problem in combining the use of 
paral3^ics with anesthetics. The concern we have here is that afi 
animal may come out of the anesthetic while it is still paralyzed. 

We would like an addition specifying that the animal's central 
nervous system must be monitored while it is in such a situation. 

We believe that the individuals on the committee must inspect 
all facilities at a university and not just the animal holding facili- 
ty. To give you a very specific example of a problem here, at the 
University of Cincinnati they had two individuals, one of whom 
was raising cats in his basement for use in his own research pro- 
gram. This would not have been known. Another individual was 
keeping rats in a closet in his laboratory in order to avoid paying 
per diem charges to the central animal facility. 

I want to stress the importance of the alternative information 
center at the National Agricultural Library. I believe it is very im- 
portant that this information be readily available. 

I am a member of the panel for the OTA study on alternatives. 
We met yesterday, and the panel is meeting today. One of the com- 
ments that has come up is that many people in the research com- 
munity are not aware of the extent to which alternatives are avail- 
able or the ones that are in development. So I want to emphasize 
the importance of this section. 



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My final comment is we notice one major deficiency will still 
exist with the passage of this legislation, and that is that at the 
present time, 85 percent of the animals used in research are ex- 
cluded from the Animal Welfare Act. With all the good provisions 
in this bill, it will accomplish little if those animals are still ex- 
cluded. 

Thank you. 

[The prepared statement of Mr. McArdle appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Thank you very much. Dr. McArdle. 

Next is Dr. Glenn Geelhoed, director of the Surgical Research 
Laboratory and Transplantation Division, George Washington Uni- 
versity. He will represent the Association of American Medical Col- 
leges. 

STATEMENT OF GLENN GEELHOED, DIRECTOR, SURGICAL RE- 
SEARCH LABORATORIES AND TRANSPLANTATION DIVISION, 
GEORGE WASHINGTON UNIVERSITY, ON BEHALF OF THE ASSO- 
CIATION OF AMERICAN MEDICAL COLLEGES 

Mr. Geelhoed. Thank you, Mr. Chairman and other members of 
the subcommittee. 

My name is Glenn Geelhoed, and I am professor of surgery at 
George Washington University and have been for some time the di- 
rector of Surgical Research Laboratories there and, in addition, 
carry on an active research program and membership on a number 
of the organizations also represented on this panel. 

I am pleased today, however, to be able to represent the Associa- 
tion of American Medical Colleges and the National Society for 
Medical Research. This is the national voice for 127 of the Nation's 
medical schools and 400 of their teaching hospitals and over 70 of 
their professional and academic societies that are engaged in this 
biomedical research effort. 

Because of that broad constituency in the organizations that 
comprise the largest of the biomedical research interests in the 
United States, we have considerable interest in H.R. 5725. 

In the interest of time, Mr. Chairman, if I might be allowed to do 
so, I will summarize the statement and respectfully request that I 
submit it to you for the entirety in the hearing record. 

Mr. Brown. Without objection, the full statement will appear in 
the record, and we would appreciate your summarizing it. 

Mr. Geelhoed. At the outset, Mr. Chairman, this group of orga- 
nizations would like to recognize the enormous and vast contribu- 
tions that you have made to the scientific effort during your tenure 
in Congress. While we realize that you and your staff have made 
considerable headway in improving the language of the Dole bill, 
we regret that we cannot offer our full support for H.R. 5725 at 
this time. 

As has been recognized generally by each of the panelists, labora- 
tory animals provide a very critical role in biomedical and behav- 
ioral research, and I would think scientists especially are deeply 
committed to the humane care and use of these animals. 

I, myself, serve on several committees in both human research 
and animal care, and I would like to say that I do not carry out a 



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species chauvinism but try to use the same ethical standards in the 
care of each. 

Scientists, too, have that vital stake in the animal care and their 
humane welfare, because only healthy, well fed, and well cared for 
animals yield valid scientific data. However, by citing very infre- 
quent and rather severe, extreme cases, several organizations have 
painted a rather unfair and unrepresentative, distorted picture of 
what occurs in our research institutions. 

Though we are especially — not equally disturbed, but especially 
disturbed — that there have been a few isolated instances in which 
there are violations of these standards and noncompliance with 
these existing animal care guidelines, we caution that these have 
been the exception and not the rule in hundreds upon hundreds of 
research institutions across the Nation. 

As a participant in the National Institutes of Health as well, I 
point out in terms of Dr. Wyngaarden's examples this morning 
that they are very, very rare. 

There are three very compelling reasons why the enactment of 
H.R. 5725 would be premature at this time. First, because we are 
not aware of any grave systematic deficiencies that exist within 
our laboratories regarding the treatment of animals, we feel that a 
comprehensive study should be conducted before enacting any re- 
strictive animal legislation. Such a study would identify what prob- 
lems, if any, exist and determine the need for and content of future 
legislation in this complex area. 

Second, we question the wisdom of enacting H.R. 5725 until the 
existing regulations under APHIS are better enforced. APHIS, the 
Government agency charged with the enforcement of these acts, 
has rarely, if ever, been provided with sufficient resources to 
ensure full compliance with the law. 

Even though Congress has endorsed our Nation's biomedical re- 
search enterprise for over four decades, generously increasing these 
appropriations, the animal welfare unit of APHIS, with the major 
responsibility of ensuring that these laboratory animals are treated 
humanely, ironically has remained overburdened, underfunded, 
and understaffed. 

With only 6 of the 485 inspectors working full time in animal in- 
spection, and the remaining inspectors devoting only 6 percent of 
their time to that inspection, of over 3,000 U.S. research facilities, 
it is clear to us that before new legislation increasing the responsi- 
bility of APHIS is enacted, that agency should be significantly 
strengthened with increased appropriations and direction. 

Third, we believe that Congress should postpone the enactment 
of any animal welfare legislation until all efforts within other gov- 
ernmental agencies to develop and revise existing guidelines for 
animal care are completed. Currently, no less than three agencies 
are in the process of revising existing guidelines and principles in 
their area of authority and responsibility. We feel that it would be 
prudent to postpone any legislative activity in this area until all 
these avenues in the regulatory arena have been completed. 

While we feel our arguments for not enacting H.R. 5725 at this 
time are sound, we have pointed out in our full statement the con- 
cerns with some of the specific provisions of H.R. 5725. To briefly 
summarize our major concerns, we do not support the expansion of 



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the roles of the Secretary and the animal committees in the con- 
duct of research. 

Some of the proposed requirements, such as the semiannual in- 
spection of all animal research facilities and reports thereon, will 
be costly and extremely burdensome. The language in general 
seems to denigrate the time-honored and proven peer review proc- 
ess already in place in many institutions, and there is no language 
authorizing the Federal prosecution of anyone involved in laborato- 
ry breakins and destruction and theft of laboratory animals and 
equipment, at least as injurious to the welfare of the animals as 
are some of the proposed less frequent abuses. 

In conclusion, the AAMC and the NSMR sincerely believe that 
the enactment of H.R. 5725 would be premature, unwise, and un- 
necessary until, first, Congress mandates a comprehensive study of 
the entire research animal issue; second. Congress strengthens 
APHIS through increased appropriations; and, third, that the 
animal care guidelines under revision at at least three governmen- 
tal agencies are implemented and their effectiveness analyzed. 

If these recommendations are fulfilled and the subcommittee still 
feels the need to enact further animal legislation, the AAMC and 
NSMR would be happy to assist you in the development of appro- 
priate, effective language. 

I appreciate the opportunity to come before you and appreciate 
the Chair's concerns. 

At this point, I would be very happy to answer any questions 
should you have some. 

Thank you. 

[The prepared statement of Mr. Geelhoed appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Thank you very much, doctor. That is a very good 
statement. 

We will have questions as soon as Dr. Randall completes his tes- 
timony. 

Dr. Randall is professor of physiology, Stritch School of Medicine 
at Loyola University of Chicago, and is speaking on behalf of the 
American Physiological Society. 

Dr. Randall. 

STATEMENT OF WALTER C. RANDALL, PROFESSOR OF PHYSIOL- 
OGY, STRITCH SCHOOL OF MEDICINE, LOYOLA UNIVERSITY OF 
CHICAGO, ON BEHALF OF THE AMERICAN PHYSIOLOGICAL SO- 
CIETY 

Mr. Randall. Mr. Chairman and member of the subcommittee, 
my name is Walter Randall and I am here to represent the Ameri- 
can Physiological Society's views concerning H.R. 5725, the Im- 
proved Standards for Laboratory Animals Act. 

Fourteen months ago, I presented the views of the society at the 
Senate hearing on S. 657, which is the companion bill to H.R. 5725. 
I am pleased to report that most of the recommendations and 
many of the concerns of the society expressed at that time have 
been incorporated now as changes in the House version of this con- 
gressional proposal to amend the laboratory animal sections of the 
Animal Welfare Act. 



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The society applauds Mr. George Brown, sponsor of H.R. 5725, 
for his inclusion of our recommendations and for his sensitive un- 
derstanding of our concerns. 

The American Physiological Society, which I recently served as 
national president, represents more than 6,200 physiologists who 
use laboratory animals in their work as researchers and teachers. 
Because physiology is the study of how living beings function, it is 
understandable that physiologists are the largest users of live 
animal models for research, with more than half of the total 
number of animals required being used in areas of cardiovascular, 
neurophysiological, endocrinological, and respiratory research. 

The need for laboratory animals in research is crucial and will 
continue, inasmuch as there are no nonanimal adjunct methods 
available that can replace them. May I reemphasize that the spec- 
tacular advances in medicine during the last 20 years have been 
vitally dependent upon animal models, and this dependency will 
continue for the foreseeable future. 

On the other hand, the subcommittee should know that there is 
a decline in the number of dogs, cats, and frogs used by physiolo- 
gists for educational purposes. According to a society survey, only 
66 percent of the departments of physiology in the Nation's col- 
leges and universities are using those animals now for teaching, 
compared with 90 percent in 1979. 

There is an obvious and growing use of computer and cell culture 
models as supplements to animal experiments in teaching. Howev- 
er, what must be understood is that such computer models cannot 
be used for much basic live animal research, and the validity of the 
computer models used in teaching depends entirely upon the re- 
search measurements gained from live animal experiments. 

I cite this difference in the use of animals in research with the 
use of animals in education because it is evidence that when 
proven and reliable nonanimal adjunct methods are available, they 
are used voluntarily by responsible physiologists as a means to con- 
serve a vital resource. 

There also is conclusive evidence from Federal records that in 
other areas of research and teaching, the use of live animal models 
decreases whenever reliable adjunct methods become available. 

Because of the evidence showing both a definitive trend of de- 
crease in number of laboratory animals being used and the growing 
use of reliable and proven adjunct methods, the American Physio- 
logical Society questions seriously whether laboratory animals 
standards as provided by the Animal Welfare Act is a legislative 
issue or a regulatory issue. 

It is the opinion of the Society that it is a regulatory issue and 
that the provisions for change in the act are to be initiated by the 
Secretary of Agriculture. 

Many of the amendments proposed in H.R. 5725 already are 
being addressed by the regulatory bodies within the National Insti- 
tutes of Health, the Public Health Service, the Office of Technology 
Assessment, and by the Interagency Research Animal Committee. 
The actions proposed by these groups very well could and should 
accomplish most of what is now being proposed in H.R. 5725. 

What the society believes to be a primary need at this time to 
assure compliance with standards set for laboratory animals is for 



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Congress to strengthen the role and authorities of the Animal and 
Plant Health Inspection Service — that is, APHIS — the agency 
within the U.S. Department of Agriculture responsible for enforce- 
ment of the Animal Welfare Act. 

For the Congress to add additional areas of responsibility for 
APHIS without advancing its authorities and resources, surely will 
lead to greater frustrations for everyone concerned with the wel- 
fare of laboratory animals. Such an action certainly will not satisfy 
the intent of the Congress, nor will it serve the best interests of the 
public, science, and animal welfare. 

The judgment of the society is that the logical approach to ensur- 
ing proper care and treatment of laboratory animals lies within the 
regulatory framework of the Animal Welfare Act, currently the 
only Federal legislative authority governing the use of animals. 

For this reason alone, the society has opposed other proposals 
that would place similar legislative authorities in other depart- 
ments of the Federal Government, because such actions would lead 
to a divergence of Federal standards and regulations, thus creating 
confusion to the researchers and increasing both the institutional 
and Federal costs in monitoring the Nation's Biomedical Research 
Program. 

If the Congress has conclusive evidence that the standards for 
laboratory animals require additional legislative restrictions, the 
society then would support the concept of amending the Animal 
Welfare Act. 

The society would like to offer to the subcommittee an amend- 
ment to the Animal Welfare Act, which was proposed at the 
annual meeting of the membership last month and has been unani- 
mously endorsed by the society's governing board. 

The basis for this proposed amendment is the recent criminal 
events at more than a dozen federally supported research institu- 
tions where laboratories were trashed, equipment vandalized, re- 
search data destroyed, animals stolen. Such actions have caused 
the loss of untold millions of Federal dollars and a waste of incal- 
culable numbers of scientific manhours of work. 

Each of the projects which was interrupted by such actions will 
have to be restarted with the expense being borne by the Federal 
Government. It is especially ironic that these actions also double 
the animal usage for this research. 

The society urges the Congress to add provisions to the Animal 
Welfare Act authorizing Federal prosecution of those persons in- 
volved either directly or indirectly in the interference with federal- 
ly funded research by the destruction and/or theft of equipment, 
animals, or data materials, as well as the prosecution of those per- 
sons who obtain such stolen equipment, animals, or data material. 

Those who are convicted of such offenses should be held liable 
for both punitive damages and the cost of replacing materials, 
data, equipment, animals, or records which may have been dam- 
aged or cannot be returned, as well as the cost for repeating the 
experiments that have been interrupted and invalidated. 

Most federally supported research institutions are looking to 
Congress to provide the support needed to halt the increasing 
number of incidents of attack that go beyond limits of civil demon- 
strations. The scientific community will work closely with the Con- 



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gress to develop adequate provisions that would stem this unneces- 
sary burden for the researcher and this inexcusable waste of 
monies the Congress appropriates for biomedical research and the 
loss of animal lives. 

The American Physiological Society appreciates this opportunity 
to express its views on H.R. 5725 and the opportunity to submit to 
the subcommittee its recommended amendment to the Animal Wel- 
fare Act. In addition to this statement, the society also has submit- 
ted some proposed language changes for H.R. 5725. 

It would be my pleasure to respond to the members of the sub- 
committee who may have questions. 

Thank you very much. 

[The attachment follows:] 



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The American Physiological Society 

9650 ROCKVILLE PIKE • BETHESDA. MARYLAND 20814 
exeCUTIve office XlSaO- 7164 • business office X1 S30- 7160 

September 19, 1984 



Subcommittee on Department Operations, 

Research, and Foreign Agriculture 
Representative George E. Brown, Chairman 
U.S. House of Representatives 
Washington, DC 20515 

Re: HR. 5725, The "Improved Standards for Laboratory Animals Act." 

The following recommendations are supplement to the American 
Physiological Society testimony on HR. 5725. 

(1.) Exercise for dogs (Page 4, line 4) 

Recommendation : Delete the sentence "(C) excerise for 
dogs" and add the word "exercise" in the preceding paragraph (lines 
1-3) so it would read: "(B) provisions for exercise , separation by 
species , or other special provisions where the Secretary finds that 
such separati©n-is provisions are necessary for humane handling of 
species ;" 

Rationale : Exercise should not be limited to dogs. 

( 2 . ) Prohibition on Interference with Protocols (Page 4, 
lines 8-15T r^ 

The Animal Welfare Act now states that "Nothing in this 
Act shall be construed as authorizing the Secretary to promulgate 
rules, regulatins, or orders with regard to design, outlines, guide- 
lines or performance of actual research or experimentation by a 
research facility as determined by such research facility;...." 
Added to this statement (lines 11-15) is the sentence that: "The 
Secretary shall promulgate standards for research facilities, in- 
cluding requirements for animal care, treatment, and practices in 
experimental procedures to ensure that animal pain and distress are 
minimized." 

Recommendation : The current language in this section of 
the Animal Welfare Act be left unchanged and sentence in lines 11-15 
should be deleted. 



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Subcommittee on Department Operations 

Research, and Foreign Agriculture 
September 19, 1984 
Page Two 



Rationale : The prohibition of interference by the Secre- 
tary or any other governmental department regarding the design, 
outlines, guidelines, or experimentation by a research facility is 
of paramount importance to continued good research. For any govern- 
mental agency to determine research methodologies, experimental 
design or standards for research facilities would destroy the peer 
review system which has proven to be the most effective tool to 
validate proposed research and to weed out frivolous research pro- 
posals. 

This prohibition against governmental interferences with 
research is weakened by adding to this section a charge to the 
Secretary to promulgate standards for research facilities. Standards 
for animal care and treatment are provided for in the previous sec- 
tion of the Animal Welfare Act along with the authority for the 
Secretary to promulgate such standards. To again give the authority 
to the Secretary in this section of the bill is both repetitious and 
unnecessary and is a serious concern to the scientific community. 

(3.) Animal Research Committee (Pages 6-10) . 

The Society has six recommendations for change in this 
section. They are: 

Recommendation I : The committee's name (page 6, line 11) 
should be "Institutional Animal Care Committee." 

Rationale : This committee is not charged with animal 
research, but rather it is a committee charged with assuring pro- 
per care and treatment of research animals. 

Recommendation II : All members of the committee should 
be charged with being responsible for the "welfare of the animal 
subjects" and a sentence should be inserted (page 6, line 11) saying: 
"research facility. All members of the committee shall be respon- 
sible for the welfare of the animal subjects. Of the members of 
the committee--". 

The definition of the non- affiliated member of the commit- 
tee (Page 6, lines 21-24) should be broadened to read: "(ii) at 
least one member shall have no association with such facility and 
shall be responsible for the public's interest; representing-com- 
munity-eeneerns -regarding -the- welfare- of -animal- sub jeetst and". 



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Subconmittee on Department of Operations 

Research, and Foreign Agriculture 
September 19, 1984 
Page Three 



Rationale : All members of the committee should be charged 
with having concern for the welfare of the animal subjects, not just 
the non-affiliated members. Furthermore, the non-affiliated members 
should represent all of the public's interests which in some cases 
would include more than the animals, such as the environment, toxic 
waste, etc. 

Recommendation III : The inspection of research facilities 
(Page 7, line 7) should be "at least annually" rather than "semi- 
annually." 

Rationale : At large universities and major research 
facilities, semiannual inspection requirements very well could 
amount to engaging a full-time committee working year around in- 
specting the various animal sites at the principal locations as 
well as the satellite facilities. 

Recommendation IV : The reports citing violations of 
standards (Page 7, lines 22-23) should be changed to read: "devi- 
ations of research practices from those practices originally ap- 
proved proposals that would adversely affect animal welfare;". 

Rationale : Reports of violation of standards should be 
based on approved practices rather than proposals. 

Recommendation V : The inspection results (Page 8, lines 
15-16) should be a required review for Department of Agriculture 
inspectors. Suggested language: "(D) The inspection results shall be 
required by available- te Department of Agriculture inspectors fer 
review during inspections." 

Rationale: The Society has found that some Department of 
Agriculture inspectors do not always review committee inspection 
reports. 

Recommendation VI : The provision for suspension or revo- 
cation of Federal support (Page 10, lines 9-10) should be changed 
to read: "applicable standards, and the opportunity to make the 
necessary corrections, that agency shall suspend or revoke Federal 
support for. . .". 



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Subcommittee on Department Operations 

Research, and Foreign Agriculture 
September 19, 1984 
Page Four 



Rationale : Before any suspension or revocation of 
Federal support, the research facility should be given due noti- 
fication and a reasonable time to correct the deficiencies. 
Unfortunately, this has not always been the case in some previous 
instances of suspension or revocation of such support. 

(4.) Proposed Amendment to the Animal Welfare Act . 

Recommendation : Adding to the Section entitled "Findings" 
and preceding the section entitled "Effective Date", the following 
amendments are offered: 

^^^^ Findings (Page 2) . 

The Congress further finds that the welfare or animals 
as well as productive use of Federal research funds require regu- 
lation to prevent unauthorized possession, alteration, destruction 
or transporting of research records, test data, research materials, 
equipment and/or research animals. 

Amendment (Page 12) . 

SEC. 28(a) It shall be unlawful for any person- - 

(1.) to break and enter into any Federally 
supported research facility with intent t^ destroy, alter, duplicate 
or obtain unauthorized possession of records, data, materials, 
equipment or animals. 

(2.) by theft or deception knowingly to obtain 
control which is unauthorized or to exert control which is unauthor- 
ized over records, data, materia], equipment or animals of any research 
facility for the purpose of depriving the rightful owner or research 
facility of the records, material, data, equipment or animals or 
for the purpose of using, concealing, abandoning or destroying such 
records, material, data, equipment or animals. 

(3.) to possess or use records, material, data, 
equipment or animals or in any way to copy or reproduce records or 
data of a research facility knowing or reasonably believing such 
records, materials, data, equipment or animals to have been obtained 
by theft or deception or without authorization of the research 
facility. 



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Subconunittee on Department Operations 

Research, and Foreign Agriculture 
September 19, 1984 
Page Five 



(b) Any person who violates any provision of 
this section shall be fined not more than $5,000 or imprisoned for 
not more than one year, or both, for each such violation, and the 
United States District Court or the United States Magistrate, as 
the case may be, shall determine the reasonable cost of replacing 
materials, data, equipment or animals, and records which may have 
been damaged or cannot be returned and the reasonable cost of re- 
peating any experimentation which may have been interrupted or 
invalidated in consequence of a violation of this section; and any 
persons convicted of such violation shall be ordered jointly and 
severally to make restitution to the research facility in the full 
amount of the reasonable cost so determined. 

The American Physiological Society appreciates the opportunity 
to provide these supplemental recommendations for change in the 
language of HR. 5725. 



William M. Samuels, CAE 
American Physiological Society 
Bethesda, Maryland 20814 

(301) 530-7164 

Mr. Brown. Thank you very much, Dr. Randall. 

I just want to express my own appreciation for the excellent 
analysis that you and the society have made of this legislation and 
your recommendations for changes and amendments. You can be 
sure that we will give very careful attention to those and will try 
to include those recommendations wherever possible. 

I would like to say to all of the panelists that your testimony has 
been excellent. It has been directly to the point; it has been re- 
strained; and we appreciate the contribution it makes. 

In view of the fact that several of you have said such complimen- 
tary things about me, I have difficulty in finding any criticism of 
your statements. 

Before I turn to Mr. Volkmer for questions, I want to place into 
the record some statements that the subcommittee has received 
from Our Animal WARDS of Washington, DC; Ms. Linda Huber of 
Piedmont, CA; and Leon C. Hirsch, president of United States Sur- 
gical Steel Corp., concerning this proposed legislation. 

[The prepared statements of Our Animal WARDS, Ms. Huber, 
and Mr. Hirsch appear at the conclusion of the hearing.] 

Mr. Brown. Mr. Volkmer, do you have any questions that you 
would like to propound? 

Mr. Volkmer. I would just like to ask Dr. McArdle if he has a 
number that he can give us, say, within the past year of research 
institutions, whether federally or privately funded or what, which 
have caused unnecessary pain to animals or abused animals or not 
treated them properly. 



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Mr. McArdle. To give you a specific number as to how many of 
them exist where they have had problems? 

Mr. VoLKMER. As 1 understand it, we have approximately 3,000 
institutions that are conducting the research, and I am just won- 
dering, how many institutions are we talking about that are abus- 
ing the animals and are maltreating them or causing them unnec- 
essary pain? 

Mr. McArdle. Under the present system, that question cannot 
be answered because the system is closed. 

Mr. VoLKMER. Well, then are we going on the assumption that 
the research institutions are doing this and, therefore, we have to 
make a correction? 

Mr. McArdle. There have been specific instances, but I cannot 
give you the complete number because thie complete number is an 
unknown figure. The fact that any exist at all, particularly ones 
such as the University of California at Berkeley, where the entire 
campus was in violation, I think that is the critical point to be 
made. If something that large can exist for that long a period of 
time, there is no way to know how many smaller ones. This is spe- 
cifically the reason we want an outside person on the animal care 
committee, so we can find out whether or not the institutions are 
in fact causing problems with animals. 

If they are not, there should be no problem. If they are, we will 
finally find out. 

Mr. VoLKMER. Is it possible that a study could be made, at least 
in the Federal funding area, by authority to the agencies directly 
involved in the funding; or to give APHIS the authority or funds to 
investigate and find out how widespread this is? 

Mr. McArdle. Certainly, APHIS should have more funds. I think 
everyone here would agree with that. 

Mr. VoLKMER. I am one of those who has always gone on the 
adage that if it isn't broken, don't fix it. I am not quite convinced 
yet that we need to impose restrictions unless something is really 
necessary. I hate to see biomedical and other types of research im- 
peded in any way. 

Mr. McArdle. I would ask you to read the report I submitted as 
an appendix to my testimony. 

Mr. VoLKMER. I will read it. I haven't had time yes, but I will 
read it. 

I have no further questions, Mr. Chairman. 

Mr. Brown. Thank you, Mr. Volkmer. 

Let me explore one area here. Several of you have indicated — Dr. 
Van Hoosier particularly and Dr. Geelhoed — that we have several 
ongoing efforts to improve the operation of the present system, and 
it is a little premature to make changes without the benefit of 
knowing how these present efforts are going. 

I think that is a valid point, but I would raise this question with 
you. We do have some studies already in existence — the General 
Accounting Office report — and we have a rather extensive study 
that you referred to, Dr. McArdle, that the OTA is carrying on. It 
will not be ready for probably a few months yet, but it may be 
ready in a reasonably short period of time. 

Would it be your opinion. Dr. Van Hoosier and Dr. Geelhoed, 
that if we could get a sufficient number of authoritative and reli- 



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able studies that indicate that corrections or modifications of the 
present law are necessary, that you would be supportive of making 
any changes that would be recommended by them? 

In other words, you are not just dragging your feet here. You 
would be prepared to move at some point if it appeared that there 
was an appropriate basis on which to do something? 

Mr. Van Hoosier. Well, certainly I have no insight to the GAO 
report to which you refer, Mr. Chairman. 

I would point out what might be an appropriate analogy with the 
human subjects experience, where there was conflicting oversight 
by both the FDA as well as NIH. This really does create a lot of 
confusion in the ranks in the field, and I would certainly hope we 
would learn from that lesson and not make the same mistake as 
we proceed on the protection of animal research subjects. 

Certainly there are inconsistencies, although we recognize that 
the law supersedes policies and guidelines. For example, in the cur- 
rent Animal Welfare Act, there are differences in terms of cage 
sizes for rabbits with the NIH guide, and people will think they are 
in compliance with the NIH policy and yet have a citation by a 
USDA inspector because of inadequate cage size. The differences 
are a matter of a few inches rather than anything of any substan- 
tial nature, more of a technical nature. 

I know of one institution which really had to expend tens of 
thousands of dollars for this technical aspect^ust an illustration 
of how discrepancies can generate a lot of expenditure of funds 
that may not be the best use and really help the animal on the 
bottom line, which is really what we want to do. 

Mr. Brown. Dr. Geelhoed. 

Mr. Geelhoed. I would add that the scientific community is used 
to waiting for judgments until a good deal of evidence is in and 
avoids generalization from anecdotal evidence. 

From the studies that are now under way— OTA's particularly — 
we are awaiting that evidence in some series. On the basis of those 
incidental reports that are usually quite well publicized by virtue 
of their very existence, pointing out that they are violations of the 
regulations, we are underwhelmed with a number of those, and 
looking at those as statements that should be generalized, I would 
say at the present time, I have listened carefully to such series as 
have been looked over by the oversights from NIH and have found 
those to be such vanishingly rare examples as to prove the rule 
rather than to point out the need for a further investigative body. 

Mr. Brown. You did use the term ^'underwhelmed'' there, didn't 
you? 

Mr. Geelhoed. That is correct. 

Mr. Brown. I wanted to be sure I understood that. 

I would like to take this occasion to acknowledge the value of 
several of the suggestions that both of you made. Dr. Geelhoed and 
Dr. Van Hoosier. I think that it would be appropriate for this legis- 
lation to include a statement with regard to the importance of 
animal research, and I think both of you indicated that. 

As long as we continue to experiment on human beings, I think 
it is appropriate we should indicate the need to continue animal re- 
search, and I think it is appropriate that we should also condemn 
violations of the law with regard to maintaining adequate ssdTe- 



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guards against the sort of thing represented by the trashing of the 
laboratories. I don't think that the Congress would want to con- 
done that in any way, shape, or form. 

I would further state that I think we would be in pretty good 
agreement that we have to continue to improve the enforcement of 
the present law and to provide the resources necessary to do that. 

So what I am trying to do here is to indicate the areas in which I 
think we are moving toward commonly agreed statements or goals 
in connection with this legislation. 

Gentlemen, I could prolong this at considerable length with some 
additional questions, but I am so pleased with the statements that 
you have made, which are excellent, that I think I will refrain 
from any additional questions in light of the fact that we have 
reached the hour of noon. 

Let me just say again that I very much appreciate the contribu- 
tions that you have made this morning. We will continue to keep 
in touch with you for your help on this matter. 

I will adjourn the subcommittee meeting at this time, to recon- 
vene at 2 o'clock for the next panel. 

[Whereupon, at 12:05 p.m., the subcommittee recessed, to recon- 
vene at 2 p.m., the same day.] 

AFTERNOON SESSION 

Mr. Brown. The subcommittee will come to order. 

We have a very distinguished list of witnesses for this afternoon, 
and we have divided them up into two panels, somewhat as we did 
this morning. We expect that if we can keep each panel to about 
an hour, we will be able to proceed in good order. 

Let me say again that all of the testimony so far — and I am sure 
that will be true this afternoon — has made a very good contribu- 
tion to a balanced evaluation of the legislation before us and to the 
general subject of animal welfare. What we are trying to achieve in 
this hearing is a course which is balanced and prudent and not one 
which is either precipitous or fails to face up to the reality of the 
problems that do exist. 

We also expect to have other members who will be here shortly. 
But in the interests of keeping us somewhere close to our schedule, 
I am going to proceed with the witnesses. Again, if you can keep 
your oral testimony somewhere close to 5 minutes, we will appreci- 
ate it. Of course, any material that you wish to submit for the 
record will be received. But in order to accommodate even a rea- 
sonable part of the witnesses that wanted to testify, we have to ex- 
ercise some discipline here. 

Our first panel is composed of Dr. Edward C. Melby, Jr., dean of 
the Cornell Veterinarian College, and president of the Association 
for Biomedical Research; Dr. F. Barbara Orlans, executive director 
of Scientists for Animal Welfare; Dr. Marshall Steinberg, secretary 
of the Society for Toxicology; Mr. Howard C. Brown, Jr., vice presi- 
dent of Scientific Affairs for the National Association of Life Sci- 
ences Industries; Mr. Marc Rosenberg, executive director of the Na- 
tional Coalition of Science and Technology; and Dr. John Seamer, 
member of the British Veterinary Association, representing 
Humane Information Services. 



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They indicate that all of you have a distinguished background in 
this field, and we are grateful for your appearance here. 
You may begin, Dr. Melby, if you will. 

STATEMENT OF EDWARD C. MELBY, JR., DEAN, CORNELL VETER- 
INARIAN COLLEGE, AND PRESIDENT, ASSOCIATION FOR BIO- 
MEDICAL RESEARCH 

Mr. Melby. Thank you, Mr. Chairman. 

I am Dr. Edward C. Melby, Jr. I am dean of the College of Vet- 
erinary Medicine at Cornell University, and currently the presi- 
dent of the Association for Biomedical Research. The association 
represents some 200 institutions and companies around the country 
who are dependent upon the use of animal models in biomedical 
research and testing. 

I want to thank you for allowing me the opportunity to appear 
before you today to discuss H.R. 5725, the Improved Standards for 
Laboratory Animals Act. 

The bill proposes to amend the Animal Welfare Act. Let me start 
by saying it is the opinion of many within the scientific community 
that if improvements are required regarding the care and treat- 
ment of laboratory animals, then amending the current Federal 
statutory authorities, the Animal Welfare Act which is responsible 
for inspection of research facilities, is the appropriate vehicle, 
rather than promulgating new regulations within another Federal 
agency. 

Thus, we agree completely with the general approach taken by 
the bill. 

Having said that, however, H.R. 5725 makes two major assump- 
tions by its very existence with which we must disagree. The first 
is that the overall care and treatment of laboratory animals in this 
country is inadequate and that the APHIS, Animal and Plant 
Health Inspection Service, within the USDA is equipped to imple- 
ment additional requirements as outlined in H.R. 5725. To say that 
all research facilities meet the highest standards and to say that 
all animals in research are treated humanely and only used when 
necessary would be to imply that this is a perfect system which, of 
course, it is not. 

On the other hand, the extent to which there are problems re- 
garding the use of animals in research is still unknown. We cannot 
overlook the fact that at the present time there are no current reli- 
able data regarding the use of animals in research. It is our hope 
that study legislation, which was authored by Mr. Madigan in the 
House and subsequently passed as part of the NIH reauthorization 
legislation, H.R. 2350, and introduced by Senators Hatch and Ken- 
nedy as an amendment to the Senate NIH reauthorization legisla- 
tion, S. 773, which is still pending, will be enacted into law. 

Within 18 months of that enactment, we would finally have accu- 
rate data regarding the care and use of laboratory animals in bio- 
medical research. Until that time, it truly is difficult to assess the 
current conditions surrounding the use of animals in research and 
thus be assured that legislation to be enacted would accurately ad- 
dress deficiencies so identified. 



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Let me stress that the research community is not opposed to, and 
indeed supports, inspection of its research facilities. Unfortunately, 
the current Federal authority does not have the financial resources 
which are really necessary to ensure a quality inspection program 
with all inspectors throughout the country well informed and well 
trained. As a result, the APHIS inspection program is often found 
to be inconsistent and lacking in uniformity. Yet, H.R. 5725 pro- 
poses to expand APHIS's responsibility even though there is no au- 
thorization for appropriations to allow that agency to do so. 

There are also several broad concerns with the legislation. They 
include the following: Because of the nonspecificity of some of the 
language in H.R. 5725, it is implied that the Secretary of Agricul- 
ture has the authority to interfere with the actual research per- 
formance, which goes beyond the purview of the current Animal 
Welfare Act. While we believe that APHIS responsibilities should 
include reviewing the care and treatment of laboratory animals, to 
allow the agency to get involved with research design seriously 
threatens the research community's ability to pursue scientific 
knowledge. By providing the Secretary of Agriculture with this au- 
thority, we are assuming that all USDA inspectors do possess a 
broad-based knowledge of the vast types of research being conduct- 
ed in this country and enough expertise to assess the quality or ne- 
cessity of this research. 

The pjotential pitfalls of this language are, in our opinion, obvi- 
ous. I will address this issue in greater detail in a moment. 

The Association for Biomedical Research supports wholehearted- 
ly an active animal research committee within each licensed re- 
search facility. Further, the association does not impose, and 
indeed supports, representation on that animal research committee 
of an outside member. 

However, we strongly oppose the definition of an outside member 
in H.R. 5725 as, "one who represents community concerns regard- 
ing the welfare of animal subjects.'* This definition assumes that 
no one else on the committee is concerned with animal welfare. 

Additionally, it would be impossible to determine the extent to 
which someone is aware of a specific community's concern regard- 
ing animal welfare. 

Perhaps more importantly, the outside member should have 
some understanding of the scientific process as well as some under- 
standing of the ethical considerations of using animals in research. 

The association supports the language in the Walgren amend- 
ment, also part of H.R. 2350, the NIH reauthorization legislation, 
which defines the outside member as having no affiliation with the 
research facility and who is appointed by the chief executive officer 
of that organization. 

I am submitting for the record, as an addendum, a more detailed 
discussion of the technical comments regarding the specifics of the 
language. However, I would like to take the remainder of my time 
to discuss some of our general concerns with H.R. 5725 and also to 
discuss these concerns within the larger context of the growing 
movement in this country which is, in our opinion, intent upon dis- 
continuing the use of animals in research. 

We recognize the tremendous pressure under which Congress has 
been placed regarding the use of animals in research. However, we 



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must not lose sight of the fact that virtually every major advance 
made in medicine during this century has been directly derived 
from animal research. Nowhere in H.R. 5725 is there mention of 
the importance of animal research in improving the quality of life 
of both humans and animals. There is no question that in certain 
toxicity testing and other research procedures, nonanimal method- 
ologies are scientifically sound, especially in prescreening tech- 
niques. Yet, as I am sure you are aware, ultimately, testing must 
take place in animals if we are to ensure consumer safety. The re- 
search community will continue as part of the scientific process to 
develop additional nonanimal or adjunct techniques. But to lead 
the public to believe that science is anywhere near replacing the 
whole animal in basic or biomedical research is to misinform the 
public. The outcome should seriously impede the progress of sci- 
ence. 

The Association for Biomedical Research supports not only 
humane and responsible use of animals in research and testing, 
and as such is willing and anxious to work with this committee and 
other Members of the Congress to achieve these goals. The major 
question which must be taken by this committee and other deci- 
sionmakers is whether there are problems with the current Animal 
Welfare Act or with the enforcement of this act. 

As I mentioned earlier, APHIS has been chronically underfund- 
ed. This association and other scientific groups testify before the 
House and Senate Agriculture Appropriations Committees each 
year to increase APHIS's budget to ensure a quality inspection pro- 
gram. Earlier today. Dr. McArdle testified today about this concern 
as well. 

Yet, additional appropriations have not been forthcoming. Recog- 
nizing fiscal realities in an effort to assist in the improvement of 
the inspection program, the Association for Biomedical Research 
would like to offer the following assistance to APHIS for this com- 
mittee's consideration. 

We will, in cooperation with ABR member institutions, provide a 
training program for all USDA/ APHIS inspectors. This training 
program will include a curriculum developed in cooperation with 
the American Association for Laboratory Animal Science to insure 
that all APHIS inspectors have the same training regarding 
animal welfare. The cost of this undertaking will be underwritten 
by institutions which have a commitment to quality laboratory 
animal programs and who believe inspectors should be up to date 
and well informed regarding the speciality area of laboratory 
animal research. 

We would like to suggest that we begin with a pilot program, 
training perhaps 50 inspectors initially and allowing APHIS the op- 
portunity to assess the effectiveness of such a program. If the train- 
ing program is considered effective and worthwhile, we will insti- 
tute it on a regional basis to make sure that all APHIS inspectors 
have the opportunity to receive the same training. In this manner 
perhaps we can improve the quality of inspection at no cost to the 
Federal Government. 

Second, we would like to request that this subcommittee and 
others within the Congress assist the scientific community and 
animal welfare groups in insuring that the APHIS budget is in- 



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63 

creased to a degree which will allow it to implement more effective 
enforcement. 

At this point, the question really remains, do we need additional 
legislation to amend the Animal Welfare Act or do we simply need 
to improve the enforcement program? New information, which 
should arise from the study authored by Representative Madigan, 
will assist in making this determination. 

We also encourage the committee to closely review the activities 
of the National Institutes of Health, which is reviving its Public 
Health Service policies on the use of animals in research to insure 
complementary rather than contradictory or duplicative require- 
ments. 

In conclusion, I would like to emphasize that this association and 
its constituents stand ready to assist this committee in any way 
possible to insure the highest quality care and treatment of labora- 
tory animals in the continuation of animal research to improve the 
health of this Nation. 

We wish to thank you, Mr. Chairman, for your continuing under- 
standing and interest and the leadership you have taken to resolve 
these very difficult issues. Thank you. 

Mr. Brown. Thank you very much. Dr. Melby. We particularly 
appreciate the offer that you have made to assist with the improve- 
ment of the training of the inspectors. I think that is an extremely 
constructive offer, and I hope we will be able to work out some- 
thing on that. 

Mr. Melby. Fine. 

Mr. Brown. Our next witness is Dr. Orlans, executive director of 
the Scientists for Animal Welfare. 

Dr. Orlans. 

STATEMENT OF F. BARBARA ORLANS, EXECUTIVE DIRECTOR, 
SCIENTISTS CENTER FOR ANIMAL WELFARE 

Ms. Orlans. Mr. Chairman, members of the subcommittee, I am 
Barbara Orlans, executive director of the Scientists Center for 
Animal Welfare. 

I speak on behalf of the organization's board of trustees in sup- 
port of H.R. 5725. The Scientists Center for Animal Welfare is an 
organization of scientists concerned about the humane treatment of 
animals used in experimentation. We recognize the importance of 
the use of animals in biomedical research, and we believe that this 
effort should be adequately supported by Congress. 

We were founded in 1979, and the center is an educational non- 
profit organization based in Washington, DC. We are currently con- 
ducting a series of regional workshops on how to run effective 
animal care and use committees, also known as animal research 
committees. The first of this series was held at Johns Hopkins Uni- 
versity last May, and other, similar workshops are being held later 
this year in conjunction with other leading universities. 

Over 2,000 copies of the Scientists Center's newsletter are distrib- 
uted each quarter to individual and institutional members and to 
libraries. 

There is an approximately equal representation of Ph.D.'s, 
D.V.M.'s, and M.D.'s on the nine-member board. Dr. Dodds, the 



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chief of hematology at New York State Department of Health in 
Albany, is currently the president. I am a Ph.D. physiologist, 
member of the American Society of Pharmacology and Experimen- 
tal Therapeutics, author of a book on animal care, and founding 
president of the Scientists Center for Animal Welfare. 

We believe that H.R. 5725 is a good bill. It represents a reasona- 
ble balance between the protection of animals and the needs of le- 
gitimate research. It will not impede responsible research, but it 
will strengthen the Animal Welfare Act in needed areas. 

In my testimony I am going to just give a very brief outline of a 
couple of points that we want to highlight and a more detailed tes- 
timony will be submitted with your concurrence for the record. 

I want to discuss two aspects, the animal research committees 
and the training of investigators, two provisions, important provi- 
sions, of the bill. 

Some institutions have established highly effective animal re- 
search committees, but many others have given only lipservice to 
Federal requirements on these matters. Unfortunately, a number 
of these committees function very poorly, are only paper commit- 
tees and exist in name alone. The recent NIH site visit study indi- 
cated the weaknesses of these committees in many cases. 

What is needed is a strong stimulus to improve the effectiveness 
of these committees. This bill would provide such a stimulus. Par- 
ticularly important are the review practices involving pain to un- 
anesthetized animals and the review to be conducted by these com- 
mittees of the condition of the animals. 

Animal welfare review performed by animal research commit- 
tees has a number of unique and invaluable features not found in 
any other levels of review. Unlike USDA inspectors or NIH review 
committees, these local committees are on the spot, they can take 
quick, immediate action and respond quickly to any known defi- 
ciencies. They know the people involved, and I think that very 
often, local peer pressure from an animal research committee is 
more effective than remote oversight. 

Experience of many research facilities has shown that these com- 
mittees can function effectively with minimum delay for the inves- 
tigator and do not constitute an administrative burden. Evidence of 
this was presented at the Scientists Center's May workshop, 1984. 
This was held at Johns Hopkins University as previously men- 
tioned. 

Regarding community members, already a number of institutions 
have appointed community representatives. These include the Uni- 
versity of California, San Francisco; the Massachusetts General 
Hospital; Tufts; the University of Southern California, among 
others. 

Such committees tend to be among the most successful of cur- 
rently operating committees. To our knowledge, a number of others 
are in the process of appointing outside community members. 

It is important that community members partake in the decision- 
making process of determining the standards of laboratory animal 
use. When Federal dollars are involved, then public accountability 
is a must. Not only the scientists themselves, but also the general 
public, must be assured that proper humane standards are main- 
tained. Having a community member broadens the committee's 



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representation, helps avoid conflict of interest, and also encourages 
dialog between the scientists and the public to understand each 
other's viewpoint. 

Regarding training, adequate training courses do not currently 
exist. Investigators are particularly poorly served in comparison 
with technicians. Many investigators are conducting highly inva- 
sive, pain-inflicting experiments on animals, with never having 
taken a course on humane techniques at any point in their educa- 
tion. Some investigators don't even know that the Animal Welfare 
Act exists or that NIH has established guidelines and policies. It is 
a situation that defies common sense. 

Two types of courses are needed: first, the practical nuts and 
bolts of humane techniques, and second, another covering philo- 
sophical and ethical aspects. According to a survey that the Scien- 
tists Center for Animal Welfare did recently, there are some 21 
U.S. colleges that offer courses on ethics and animals. Considering 
the fact that there are many hundreds of colleges in the United 
States that are training scientists, biomedical scientists, and only 
21 offer any instruction at all on humane attitudes, it can be seen 
that there is much room for improvement. 

In addition, there are almost no separate courses on humane 
techniques that are available for investigators. Some are available 
for technicians that are given very ably by the American Associa- 
tion for Laboratory Animal Science. 

Some Federal initiative, backed up by Federal dollars, needs to 
be given in this important area of investigator and other personnel 
training. H.R. 5725 provides a needed start in this important 
matter. We do think that annual training sessions may be too fre- 
quent at this stage and that this provision may be premature, be- 
cause there is such a lack of courses available. 

In summary, the board of trustees of the Scientists Center for 
Animal Welfare believes that this bill is a necessary piece of legis- 
lation worthy of support. Its passage would provide the needed 
force to ensure that research institutions fulfill their responsibil- 
ities for animal welfare. It is of prime importance that federally 
funded animal experiments are conducted with utmost care and 
regard for the animals. Thank you. 

[The prepared statement of Ms. Orlans appears at the conclusion 
of the hearing.] 

Mr. Brown. Thank you very much. Dr. Orlans. 

Our next panelist is Dr. Marshall Steinberg, secretary of the So- 
ciety for Toxicology. 

STATEMENT OF MARSHALL STEINBERG, SECRETARY, SOCIETY 
FOR TOXICOLOGY 

Mr. Steinberg. Mr. Chairman, my name is Dr. Marshall Stein- 
berg. I am the secretary of the Society for Toxicology. Mr. Chair- 
man, in the interest of time I would like to summarize my state- 
ment, but I ask that it be included in the record in its entirety. 

Mr. Brown. The statement will be included in its entirety. 

Mr. Steinberg. The Society of Toxicology is a nonprofit scientific 
organization dedicated to the furtherance of the science of toxicol- 
ogy. We are not affiliated with any trade organization, and our 



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membership is drawn internationally from academia, government, 
and industry, with the largest single bloc of membership being 
from academia. 

The Society of Toxicology supports the principles of H.R. 5725 in 
ensuring the health and well-being of laboratory animals. We are 
pleased to note that H.R. 5725 is an amendment to the existing 
Animal Welfare Act rather than a new act. 

Annual training sessions for all personnel involved with animal 
care and use in the research facility are also supported. 

However, I would like to make a few points. In toxicology, scien- 
tific investigations range from the use of whole-animal models to in 
vitro subcellular techniques. The research conducted includes work 
done by educational institutions, the government, chemical and 
drug manufacturers, and contract laboratories. The gamut of toxi- 
cological research ranges from studies of basic mechanisms of 
action to testing to meet regulatory requirements. 

While in vitro techniques have proven to be invaluable tools in 
basic research, they have not been the replacement that people 
thought they would be for safety evaluation studies using whole 
animals. They have, however, proven to be an extremely valuable 
addition to the armamentarium of tests that are conducted for 
safety evaluation of agrichemicals or drugs. 

We believe that there is a need for clarity of definition with re- 
spect to distress in an experimental animal, as used in the pro- 
posed legislation. Safety studies are required by regulation to 
produce a toxic effect or a high dose. It is usually the improperly 
designed study where the high dose does not produce an effect. 
Technically, a well-designed study could be in conflict with the law 
and/or could require considerable documentation to accomplish 
that which is scientifically valid. 

It is suggested that, rather than the Secretary of Agriculture de- 
veloping standards, there be provision for guidelines and each facil- 
ity be required to develop standard operating procedures to ensure 
that animal pain and distress are minimized consistent with the 
relevant scientific needs of the experimental procedures. These 
SOP's would then be subject to good laboratory practices, where ap- 
plicable. 

It is felt that the amendment tends to make the animal research 
committee an extension of Government instead of an integral over- 
sight group of the institution, as in the case of the quality assur- 
ance unit. People providing input to the committee should see their 
role as one of bettering the handling and treatment of animals 
rather than reporting on the activities of the institution. 

We also believe that the requirement for separation of species 
needs a provision for exemption, and the requirement for exercise 
is an issue requiring the professional judgment of the attending 
veterinarian. Some research, such as inhalation studies, must by 
necessity have several species in separate cages but in the same 
chambers. A review of the literature would indicate that there is 
no difference in the physical parameters for a laboratory-bred dog 
that is penned under the provisions of the National Research Coun- 
cil guidelines and the same animal that is exercised according to a 
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As indicated in the amendment, the members of the committee 
are required to possess sufficient ability to assess the various as- 
pects of animal care. It is suggested that the committee possess suf- 
ficient ability for it to carry out its mandate. This would permit the 
assignment of various specialists to the committee and allow great- 
er flexibility, particularly with respect to the outside member. It is 
conceivable that the surrounding community may not be able to 
provide an individual with the knowledge in animal care, treat- 
ment, and practices in experimental research. 

There is no dichotomy between animal welfare and the develop- 
ment of the science of toxicology, and it is noted that H.R. 5725 
does recognize the need to conduct research and that the use of 
animals may be central to that research. The Society of Toxicology 
has animal welfare and legislative liaison and assistance commit- 
tees that would be pleased to work with the committee members 
and the staff in providing scientific input that may be indicated. 

Mr. Chairman, thank you for the opportunity to present these 
viewpoints, and I would be pleased to answer any questions. 

[The prepared statement of Mr. Steinberg appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Thank you very much. Dr. Steinberg. 

Our next panelist is Mr. Howard C. Brown, Jr., vice president of 
scientific affairs for the National Association of Life Sciences In- 
dustries. 

Mr. Brown. 

STATEMENT OF HOWARD C. BROWN, JR., VICE PRESIDENT, SCI- 
ENTIFIC AFFAIRS, NATIONAL ASSOCIATION OF LIFE SCIENCES 
INDUSTRIES, INC., ACCOMPANIED BY ANDREW S. TEGERIS, 
M.D., VICE PRESIDENT, SCIENTIFIC AFFAIRS, NATIONAL ASSO- 
CIATION OF LIFE SCIENCES INDUSTRIES, INC., PRESIDENT, 
PHARMACOPATHICS RESEARCH LABORATORIES 

Mr. Howard Brown. Thank you, Mr. Chairman. My name is 
Howard Brown. I am the vice president and executive director of 
the National Association of Life Sciences Industries, which we call 
NALSI, for short. NALSI is a nonprofit trade association comprised 
of independent toxicology testing laboratories, usually referred to 
as the "contract laboratories." 

Mr. Chairman, I am accompanied today by a distinguished physi- 
cian and scientist. Dr. Andrew Tegeris, at the end of the table, who 
is vice president of scientific affairs for NALSI, and who also is 
president of Pharmacopathics Research Laboratories of Laurel, 
MD. 

With your permission, Mr. Chairman, I would like to submit the 
full text of our statement for the record and summarize the salient 
points in the interest of time. 

Mr. Brown. Without objection, that will be the order. 

Mr. Howard Brown. A primary objective of H.R. 5725 is to mini- 
mize pain and distress in laboratory animals used in research and 
testing. The chairman may recall that NALSFs strict code of ethics 
which evolved as a result of the chairman's guidance requires that 
each of its members comply with all government regulations — 
State, Federal, and local — on laboratory animal care and use. A 



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mechanism that the bill would institute to achieve its objectives is 
the requirement that each facility establish an animal research 
committee; one member of that committee would have no associa- 
tion with the facility and would represent community concerns. 

NALSI believes that this mechanism involves risks to the private 
commercial laboratory and risks to the nonassociated community 
member as well. In a contract laboratory the proprietary data or 
trade secrets that may be involved in the product or device being 
tested may be the property of the product sponsor, the contract lab- 
oratory, or both. We assume that individuals serving on the com- 
mittee would offer high personal integrity and scientific compe- 
tence. The fact is, however, that the financial worth of the proprie- 
tary data involved in the studies will be substantially greater than 
the personal resources of most individuals. 

The sanctions which the bill provides against the unauthorized 
release or use of trade secrets — namely, fines and imprisonment 
and the recovery of actual and consequential damages — certainly 
represent powerful deterrents. Nevertheless the financial conse- 
quences to the owner of the product or device resulting from its 
compromise may dictate that the product not be tested under cir- 
cumstances in which a substantial proprietary investment is ex- 
posed to individuals who have no contractual responsibility for its 
protection. 

In brief, the sanctions provided in the bill are deterrents, but 
they cannot assure recovery of the loss of a substantial investment 
in a new health product. 

The nonassociated community member also is placed in an awk- 
ward position. The individual does not enjoy the rewards or bene- 
fits of employment, but would be exposed to the same risks that 
attend laboratory scientists and technicians. It is the very nature 
of toxicity testing that toxic or carcinogenic effects of products or 
devices be observed. Superimposed on these possible risks are the 
sanctions of fines and imprisonment for the release of confidential 
data. 

We are concerned that qualified candidates may not find service 
on this committee particularly attractive in view of these kinds of 
exposures. 

If the provision in the bill for a nonassociated community 
member of the animal research committee is to be retained, we rec- 
ommend further study of the anomalies we have briefly described. 
NALSI believes that such a provision is not necessary to the 
achievement of the bill's objectives. In addition to the Department 
of Agriculture inspectors, for whom we have great respect, there 
are four other Government entities which have statutory responsi- 
bilities for the proper care and use of laboratory animals. These en- 
tities are the National Institutes of Health, the Public Health Serv- 
ice, the Food and Drug Administration, and the Environmental 
Protection Agency. They, too, employ highly competent personnel. 

We believe that these resources are more than adequate to 
assure achievement of the bilFs objectives. 

Mr. Chairman, in the interest of the limitations of the commit- 
tee's time, we haye focused on one aspect of the bill that we consid- 
er potentially troublesome. Time permitting, we would have liked 



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to have underscored with approval other provisions of the bill 
which are in it. 

This completes our oral summary. Dr. Tegeris and I would be 
pleased to respond to questions from the committee or from our 
colleagues on the panel. Thank you. 

[The prepared statement of Mr. Brown appears at the conclusion 
of the hearing.] 

Mr. Brown. Thank you very much, Mr. Brown. You have raised 
an important question which, as you know, we have been con- 
cerned with, and we will continue to give that very careful study. 

The next panelist is Mr. Marc Rosenberg, executive director of 
the National Coalition of Science and Technology. 

STATEMENT OF MARC H. ROSENBERG, EXECUTIVE DIRECTOR, 
NATIONAL COALITION FOR SCIENCE AND TECHNOLOGY 

Mr. Rosenberg. Mr. Chairman, my name is Marc Rosenberg. I 
am the executive director of the National Coalition for Science and 
Technology. Our membership includes approximately 1,000 re- 
search scientists, educators, business people, and engineers. We 
also count a number of corporations and professional societies 
among our members. 

We would like to submit our prepared statement for the record 
and present a very brief summary of it this afternoon. 

Mr. Brown. Without objection, so ordered. 

Mr. Rosenberg. The subject of animal welfare is of keen interest 
to many of the individuals and organizations we represent. It is a 
controversial topic, as you are well aware, and we commend you 
for holding today's hearing. The National Coalition for Science and 
Technology believes it is useful to have a public forum for a con- 
tinuation of the dialog between those who do animal research and 
those who are involved in the animal welfare movement. 

For several reasons, however, the national coalition does not sup- 
port passage of H.R. 5725 or any other animal welfare legislation 
in these closing days of the 98th Congress. As you know, there is a 
comprehensive study presently being conducted by the Office of 
Technology Assessment, and they are expected to report their find- 
ings in 1985. The coalition believes the Congress should have the 
benefit of that detailed study before any new legislation is enacted. 

Moreover, this is a very difficult subject that will require a broad 
consensus, which may take longer than the few weeks remaining 
in Congress in order to be obtained. 

In fact, earlier this year the National Coalition for Science and 
Technology itself sponsored a national forum on the use of animals 
in research and testing. After a full day of presentations in work- 
shops, there emerged a consensus that more could be done to 
reduce the duplication of animal research, to reduce the number of 
animals used in certain testing, and to improve dissemination of in- 
formation about alternative methods of research and testing. The 
relative ease with which this consensus emerged leaves us optimis- 
tic about the outcome of a responsible and reasoned public dialog 
on this subject. 

We are aware that there are many people who question whether 
animals in laboratories are adequately protected by the current 



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law. In several areas of the country, including the chairman's 
home State of California, concern over the care of animals used in 
research has jeopardized public support for certain health-related 
research programs. 

With respect to the specifics of H.R. 5725, we would like to focus 
our comments on five particular provisions in the pending legisla- 
tion. First, the requirement that laboratories using animals estab- 
lish local review committees. We are worried that each local review 
committee would be left to establish its own standards and values 
concerning how animals should be treated. As a result, we could 
end up with a hodge-podge of inconsistent requirements, with a 
particular practice deemed acceptable at one institution and pro- 
hibited at another. 

As we are talking about federally funded research or Govern- 
ment-mandated testing, we feel that before these local review com- 
mittees are established, we should have some agreement as to what 
standards are to be applied. 

We also believe there should be a definite and swift appeals proc- 
ess that would provide researchers recourse in the event that a 
local panel strays from the national norms. 

Second, there is the provision that the members of a local review 
panel must agree to the protection of trade secrets and proprietary 
data. This provision is a marked improvement over other proposals 
we have seen, and we commend you for it. 

Third, there is the proposal to create a voluntary national clear- 
inghouse for information concerning animal research and alterna- 
tive methods of research and testing. Such a clearinghouse would 
be useful, and we support it in concept. 

Even if the clearinghouse is placed within the National Agricul- 
tural Library, as proposed in this legislation, it would either re- 
quire a separate line item in the budget or an explicit reprogram- 
ming of funds already available for other purposes. Perhaps H.R. 
5725 is not the appropriate vehicle for that sort of language, but we 
believe that it should be included in either authorizing or appropri- 
ating legislation. 

Additionally, we feel that stronger language is needed to assure 
full cooperation and interaction with the National Library of Medi- 
cine and the Department of Health and Human Services. 

Fourth, there is the requirement that institutions using animals 
for research and testing must annually provide their personnel 
with information and training relevant to the humane treatment 
of laboratory animals. As an alternative to this specific provision, 
we suggest accepting the inclusion of this information in continu- 
ing education or periodic recertification requirements of the princi- 
pal investigators or the professional staff of the facilities. 

Additionally, if such courses and training are required, then we 
should consider what assistance the Federal Government can pro- 
vide in meeting this new obligation. If I could stray from our text 
at this point, we would like to underscore our concern that the 
ability of these institutions to provide the necessary training pro- 
grams is our primary concern, and we think that some structure 
outside of the specific institution is probably going to be more effec- 
tive. 



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The fifth point is that there are some specific rules set forth for 
surgical procedures involving animals. NCST recommends that 
these be removed from the legislation. Rather than setting these 
rules of surgical procedure in the statute, we think it would be 
more appropriate and pragmatic to leave the setting of standards 
of care to the regulatory process. Again, we are concerned by the 
inconsistencies that could result from leaving this up to the local 
review panels to grant exceptions in the absence of guidelines. 

In summary, Mr. Chairman, I again stress that the National Coa- 
lition for Science and Technology applauds your efforts to promote 
rational dialog on this subject. We believe that today's hearing 
helps to pave the way for substantive legislation in this coming 
year, and we stand ready to help you develop legislation which 
would assure the public that laboratory animals are indeed being 
treated humanely while the Nation's researchers are permitted to 
make further progress in protecting and improving the health and 
well-being of our citizens. 

[The prepared statement of Mr. Rosenberg appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Thank you very much, Mr. Rosenberg. 

Our last panelist is Dr. John Seamer, who is a Member of the 
British Veterinary Association, representing the Humane Informa- 
tion Services. And I should comment that the British have had leg- 
islation in this area for over 100 years. Their experience should be 
very valuable to us. 

Dr. Seamer. 

STATEMENT OF JOHN H. SEAMER, MEMBER, BRITISH VETERI- 
NARY ASSOCIATION, REPRESENTING HUMANE INFORMATION 
SERVICES OF THE UNITED STATES 

Mr. Seamer. Thank you, Mr. Chairman. My name is John 
Seamer, and I am appearing on behalf of the Humane Information 
Services of the United States. But I am the honorary secretary of 
the British Veterinary Association. I would like to say what an 
honor it is to be invited to appear before you. 

You may wish first, of all, that I establish my credentials. I have 
spent many years in scientific research using both animals and 
tissue cultures. Latterly, I was responsible for the breeding and 
supply of animals for research and was also curator of an experi- 
mental animal house. I have written scientific papers and contribu- 
tions to scientific books, and I have edited a handbook called, 
''Safety in the Animal House." 

I am a member of the editorial board of the Journal of Laborato- 
ry Animals, and earlier I was president of both the Laboratory 
Animal Science Association and the British Laboratory Animal 
Veterinary Association. 

I have served on the council and committees of the British Vet- 
erinary Association for many years and was chairman of the 
Animal Welfare Committee before becoming the association's hon- 
orary secretary last year. 

As you say, Mr. Chairman, in Britain there has been a law con- 
trolling experiments on animals for more than 100 years. It is my 
opinion, and indeed I believe, that of the general opinion of British 



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scientists also, that this law has in no significant way restricted the 
advance of experimental science. 

I have read the provisions of the U.S. Animal Welfare Act, as 
amended, and also the bill H.R. 5725. The provisions of the present 
U.S. legislation on animal experiments and those in the new bill 
are very different in detail from the law in Britain. The British law 
is, however, more restrictive, for it applies to all vertebrates, 
whereas the U.S. law, as I understand it, applies only to warm- 
blooded animals. 

The principal welfare problem in animal experiments is animal 
suffering or pain. In this respect also, the protection of animals in 
the United States does not seem to extend as far as it does in Brit- 
ain. For more than 50 years, all British animal experiments have 
been subject to what is known as the pain condition. The most im- 
portant clause of the pain condition states: "If an animal at any 
time during any experiment is found to be suffering from severe 
pain which is likely to endure, such animal shall forthwith be pain- 
lessly killed." 

Thus, regardless of the nature or purpose of the experiment, and 
regardless of whether or not a result has been achieved, it is the 
rule that any animal suffering severe pain which is likely to 
endure shall be killed forthwith. 

I know of no great difficulties that British scientists have had 
with this particular condition. It is, of course, virtually impossible 
to define pain in such terms as "endure." Nevertheless, as I say, 
British biological scientists have worked with the pain clause for 
many years without detriment to their experiments and with bene- 
fit to the welfare of animals. 

Indeed, the pain clause is not now considered to be sufficiently 
restrictive. The British Veterinary Association, with the support of 
the Committee for the Reform of Animal Experimentation and the 
Fund for the Replacement of Animals in Medical Research — these 
are two worthy animal welfare organizations in my country — the 
British Veterinary Association is pressing the British Government 
for improvements in the law relating to experimental animals. I 
would wish, Mr. Chairman, to submit to you evidence which can be 
written in, if that is your wish. 

Mr. Brown. We would be pleased to have that, and it will be 
made a part of the record. Dr. Seamer. 

Mr. Seamer. Thank you, sir. 

With regard to pain, my association wishes that all animal ex- 
periments should be subject to the condition that any animal that 
is suffering severe pain or severe distress that cannot be alleviated 
should be killed, even if the object of the experiment has not been 
achieved. In this way, we propose to reduce still further the upper 
limit already existing on the amount of pain that animals under 
experiment may suffer. 

As an eminent British scientist. Sir Graham Wilson, said when 
appearing before a U.S. congressional committee considering 
animal experimentation in 1965, scientific workers believe that 
there is a degree of pain which no human being has the right to 
inflict on an animal no matter what increase in knowledge might 
be expected to result. 



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It is at this point that the claims of morality overstep those of 
scientific inquiry. Thank you, sir. 
[The attachments follow:] 



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Animal Experimentation 
in the United Kingdom 



PROPOSALS SUBMITTED TO THE HOME SECRETAR 

JOINTLY BY 

THE BRITISH VETERINARY ASSOCL\TION 

THE COMMITTEE FOR THE REFORM OF 

ANIMAL EXPERIMENTATION 

AND 

THE FUND FOR THE REPLACEMENT OF ANIMALS 

IN MEDICAL EXPERIMENTS 



MARCH 1983 



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The Britisb Veterinary Association (BVA), tiie Committee for tiie Reform of 
Animal Experimentation (CRAE) and tiie Fond for tlie Replacement of Animals 
in Medical Experiments (FRAME) having agreed on the measures which should 
be indoded in new legidation for the control of Animal Experimentation in the 
United Kingdom have the honour to submit these views for the consideration of 
the Secretary of State. 

We belieye that these proposals represent an effectiye compromise between the 
welfare needs of the animals, the legitimate demands of the public for accounta- 
bility and the equally legitimate requirements of medicine, science and commerce. 



BRITISH VETERINARY ASSOCIATION 

7 Mansfield Street. London. WIM OAT. 

COMMITTEE FOR THE REFORM OF ANIMAL EXPERIMENTATION 
10 Queensferry Street. Edinburgh. EH2 4PG. 

FUND FbR THE REPLACEMENT OF ANIMALS IN MEDICAL 
EXPERIMENTS 

5b The Poultry. Bank Place. Nottingham. NGl 2JR. 



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INTRODUCnON 

Experiments on animals to advance biological knowledge, to improve human 
and animal health and welfare and for essential safety- and potency tests havered, 
and continue to lead, to significant benefits for man and animals. Such experiments 
should continue provided Uiat the new legislation safeguards the welfare of animals 
used in experiments by incorporating the provisions detailed below. 



1. PROCEDURES AND ANIMALS 

A procedure, for the purposes of the legislation, should be Refined as any 
experimental or scientific act involving interference with or departure from the 
normal condition of well-being of an animal, which may cause pain, sudffering, 
distress or lasting harm. All procedures should come within the scope of tte 
legislation and it should be an offence to carry out a procedure without authority. 
There must be suitable exemption for the performance, of veterinary procedures 
carried out in accordance with the provisions of the Veterinary Surgeons' Act 
of 1966 and amendments. 

The legislation should apply to aU non-human animals in the sub-phylum 
Vertebrata including the foetuses of animals and the embryonic or larval forms 
of other classes that have attained a stage of development capable of discrete 
existence outside the egg or maternal tract 



2. ACCEPTABLE PURPOSES 

Procedures should be allowed only for one or more of the following 
purposes: — 

(a) The avoidance, prevention, diagnosis or treatment of disease, ill-health or 
other abnormality, or their effects in man, animal or plant This purpose 
includes the production and safety testing of medicinal products and oUier 
substances, the quality control of foods, and the development of surgical 
techniques. 

(b) The assessment or detection of physiological conditions, including the 
diagnosis of pregnancy. 

(c) The prolongation of life of man, animal or plant 

(d) The protection of the natural environment 

(e) The breeding of animals. 

(f) The advancement of biological knowledge. 

(g) Some educational and training purposes. The use of anaesthetised animals 
which are not allowed to recover consciousness for the acquisition of 
manual skill should be permissible under strictly controlled conditions. 
Survival surgery for the acquisition of manual skill should be permitted 
only in exceptional circumstances such as training in micro-surgery. The 
use of recorded material for demonstration in higher education should 
be extended. 



3. LICENSING OF PREMISES AND PLACES 

All procedures under the legislation must be carried out on premises or places 
licensed for the purpose. The licence for the premises or places should specify 
the types of procedures which may be carried out The licence should identify 
two or more people by name: — 

(a) The person or persons ultimately responsible for the care of the animals 
in the premises or places; and 

(b) the veterinary surgeon, either from the staff of the establishment or 
employed on a part-time basis, responsible for advice on animal health 
and welfare. 



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A legally enforceable Code of Practice should lay down required standards 
for premises, places and fac^ties availaUe for the care of the animals and for 
the carrying out of the licensed ^rocedures^ 

The Code should specify that a sufficient number of competent staff are 
available at all times to care for the animals, especially those that have undergone 
surgical interference. The Code should also specify that an animal used or 
intended for use in a procedure is provided witfi suitable and adequate accom- 
modation, an environment, sufficient freedom of movement, and food and water 
appropriate to its health and well-being. The environmental conditions should be 
checked at least daily and the state of health of all animals in licensed premises 
or places should be observed sufficiently frequently and in sufficient detail to ensure 
their well-being in the context of the procedure. The Code of Practice should 
specify conditions for the transfer of animals between licence holders, or between 
licensed establishments during the course of, or at the end of, a procedure. 

Legislation should permit the performance of procedures in open spaces and 
natural environments. 



4. UCENSING OF PERSONS AND PROCEDURES 

Licences for individuals to carry out procedures should be issued by the 
Secretary of State on application by the prospective licensee. The application 
should be counter-signed by two sponsors. The first sponsor should be tiw holder 
of a senior appointment in the biological sciences at the establishment of the 
applicant, who is familiar with the api^icant and the facilities available. He should 
certify that the applicant is a suitable person to hold a licence, and that* he. is 
competent in the handling of the animds to be used in the procedures specified 
in the application, and is competent to perform the specified procedure or 
procedures and any anaesthetic or analgesic techniques to be used. The first 
sponsor should also certify that the procedure or procedures conform to the 
provisions of the legislation, with particular reference to the acceptaUe purpose 
for which the procedures are to be performed. The applicant and first spoi^or 
may wish to consult with a non-statutory local ethical committee before forwarding 
the application to the second sponsor. 

The second sponsor should be an independent biological scientist from another 
establishment whose name is listed in a register of sponsors approved by the 
Secretary of State. The second sponsor should certify that, in his opinion, the 
procedure or procedures conform to the legislative provisions, and that they are 
justified in the circumstances, after having considered the possibility of using 
alternative techniques which do not involve the use of animals. In any application 
involving the use of primates, the second sponsor should certify additionally tiiat 
the use of primates is essential. 

Strict control should be exercised over the procedures and animal species 
permitted on licences. When procedures arc to be carried out on unanaesthetised 
animals, or on anaesthetised animals which are to be allowed to recover, the 
licence should specify such species as may be used and ^ould define the permitted 
procedures. 

The recipient of a first licence should be subject to the direction and super- 
vision of an experienced licensee, irrespective of the qualifications and training of 
the recipient This first licence should normally be valid for one year only, ami a 
report from the Supervisor to the local Inspector should be submitted and con- 
sidered before the licence is renewed without the supervision condition. There 
should be provision for the issue of licences wiUi longer-term supervision 
conditions, provided that there is always an assessment of competence after the 
expiry of the first year. 

Variations of any licence should be made either at the request of the holder, 
or of the Secretary of State. 

Licences should be available for inspection at all reasonable times by an 
Inspector. 



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An undergraduate or postgraduate student of any biological science should 
be permitted to carry out procedures on licensed premises without being the holder 
of a licence, provided that it is under the direct supervision of and in the presence 
of a licence holder, and that the animal is anaesthetised throughout the procedure 
and is humanely killed at the end of the procedure without regaining consciousness. 

5. CONDUCT OF PROCEDURES 

A procedure starts when an animal is first prepared for use in that procedure, 
and ends when no further observations are to be made for the purpose of the 
procedure. 

It is reasonable to allow the re-use of animals under certain conditions. It 
must be decided at the end of any procedure whether the animal shall be kept 
alive or humanely killed, provided that it shall not be kept alive if it is likely to 
remain in lasting pain or distress. At the end of a procedure animals whidi are 
to be kept alive must continue to be kept subject to the conditions of the procedure 
and must be placed under the supervision of the veterinary surgeon identified on 
the licence of the premises. An animal may be exempted from these conditions 
if, in the opinion of the veterinary surgeon, it would not suffer as a consequence 
of such exemption. It may be necessary for the purposes of the procedure to set 
non-domesticated animals free or return domesticated animals to their normal 
(i.e. non-experimental) environment This should be permitted by the licence 
provided that the Secretary of State is satisfied that Uie maximum practicable 
care has been taken to safeguard the animal's well-being. 

When an animal is not to be kept alive, it should be humanely killed without 
avoidable delay. 

6. PAIN, ANAESTHESIA AND ANALGESIA 

The problem of defining pain, suffering or distress has not been resolved 
satisfactomy. However, it is possible to recognise various states of discomfort, 
stress or pain, both in the intensity and the duration of the suffering. For example, 
a ver^ brief painful stimulus such as the insertion of a sharp needle through the' 
skin IS probably inconsequential; on the other hand, the stress imposed in the 
restraint and immobilisation of the animal prior to the insertion of the needle 
may be severe. Thus it is the recognition of the response of the animal to a 
stimulus that should be the criterion of suffering, rather than the nature of the 
stimulus itself. It is possible also to recognise differences in the origin of the 
suffering, whether it be from wilful neglect or incompetence, wheUier it be 
incidents to or unexpected within the procedure, or whether it be a necessary 
component of the procedure. 

The following provides a useful guide to the recognition of the various states 
of suffering, based on paragraph 181 of the Littlewood Report. Discomfort may 
be characterised by such negative signs as poor condition, torpor and diminished 
appetite or by positive signs such as avoidance. Stress is a condition of tension 
or anxiety which may be predicted or readily explained by environmental causes 
whether distinct from or including physical causes. Pain is recognisable, but not 
necessadly quantifiable, by positive signs such as struggling, screaming or 
squealing, convulsions and severe palpitations or by measurement of chemical, 
changes within the body. 

During any procedure, suitable anaesthesia, analgesia or other measures 
compatible witib the standards of contemporary veterinary practice, and designed 
to alleviate pain, suffering or distress of whatever origin occurring during the 
procedure, should be applied at any time, unless they are more distressing for the 
animal than tbe procedure itself or unless they wodd conflict with the purposes 
of the procedure. If a procedure is likely to cause pain, suffering or distress of 
more than momentary duration or triviad intensity, which cannot be alleviated, 
prior authorisation by the Secretary of State should be obtained. Such authorisa- 
tion should only be given when the procedure is judged to be of exceptional 
importance in meeting essential needs of man or animals. 



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All licences should contain provisions to ensure that any animal tiiat is 
su£fering severe pain or severe distress which cannot be alleviated should be killed 
even if the object of the procedure has not been achieved. 

The use of curariform drugs should be prohibited, except in conjunction with 
anaesthesia of sufficient depth to produce loss of consciousness. 



7. ACQUISITION OF ANIMALS 

Animals for use in experiments should be bred for the purpose, although 
exceptions should be permitted for scientific reasons and in the case of farm 
animals. The use for experimental purposes of cats or dogs taken from the streets 
should never be permitted. Exceptions to the purpose breeding rule for cats and 
dogs should be stringently controlled: financial grounds alone should not be a 
sufficient reason for an exception to be made. 

Animals of the species listed below which are intended for use in procedures 
should be obtained only from registered breeding establishments, except: — 

(a) That exemptions from this requirement may be given for specific reasons 
or procedures; and 

(b) that free-living varieties of the listed species may be used in a procedure 
where the main object of the procedure is the study of the free-living 
variety. 

Animals of species other than those listed below should be acquired 
from registered establishments wherever possible. In reaching a decision to use 
wild animals for experimental purposes Uie welfare of the animals, the survival 
of the species and the quality of the experimental material should be taken into 
account: financial grounds alone should not be a sufficient reason for an exception 
to be made. The general source of animals intended for use in procedures which 
will not be acquired from registered establishments should be stated when applica- 
tion is made for the licence to carry out the procedure. 

Listed Species 

Mouse Mus musculus 

Rat Rattus norvegicus 

Guinea Pig Cavia porcellus 

Rabbit Oryctolagus cuniculus 

Dog Canis familiaris 

Cat Felis catus 

Hamster Mesocricetus awratus and Cricetulus griseus 

Other species, and particularly primates, should be added to this list as 
soon as there is reasonable prospect of a sufficient supply of purpose-bred 
animals. 



8. REGISTRATION OF BREEDING AND SUPPLYING PREMISES 

Control of the breeding, keeping, supply and transport of animals intended 
for use in procedures is essential. Establishments which breed or supply animals 
should be registered by the Secretary of State, and a legally enforceable Code of 
Practice should lay down the required standards for premises breeding and 
supplying animals for experimental purposes. The Code should specify the 
standards of premises, and the facilities required before registration is granted. 
The numbers and competence of staff should be specified. The certificate of 
registration should identify the person or persons ultimately responsible for the 
care of the animals in the establishment and the veterinary surgeon responsible for 
advice on animal health and welfare in the establishment 



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9. RECORDS AND RECORDING 

In order to facOitate the keeping of records of animal movement and usage. 
canidae. felidae, ungulates and primates intended for use in procedures, should 
be individually identified at the earliest practicaUe time after birth or after being 
taken into a licensed or registered establishment The identification should be in 
the most permanent form available for the species and nature of the individual. 
Full records of the identity and origin of each member of the families listed above 
should be kept by all licensed or registered establishments. 

Records of the movement of other species should be recorded by total number 
only. 

The records should be in such a form as to show, as far as practicable, the 
origin, lifetime movement, usage in procedures and disposal of all animals, either 
by group or individually, as described above. 

All persons licensed to carry out procedures should keep records of move- 
ments of animals intended for use in their own procedures and of the usage of 
animals in the procedures. Records from all licensed or registered persons should 
be submitted annually to the Secretary of State. 



10. ANNUAL REPORT 

The Secretary of State should present to Parliament, annually, a report whidi 
should include at least: 

(a) The total number of procedures carridd out during the previous year. 

(b) The purposes for which the procedures were carried out. 

(c) The number and species of animals used. 

(d) The number of exemptions from the basic pain condition granted during 
the year. 

(e) A statement of any infringements of the legislation, and the consequences. 

(f) The subjects on which the Advisory Committee had advised duriiig the 
year. 



11. INSPECTORS 

Inspectors should continue to be recruited from mature persons holding 
registered medical or veterinary qualifications. 

Their statutory duties should include: 

(a) The scrutiny of applications for licences in regard to the nature and 
purpose of the procedures to be carried out, and the assessment of the 
suitability of the applicants to perforin such procedures. 

(b) The unannounced periodic inspection of licensed and registered establish- 
ments and the inspection of those for which application has been made. 
Refusal of entry to an authorised inspector at any reasonable time should 
be an offence. 

(c) To advising the Secretary of State as to the exercise of their duties. 

Inspectors should have absolute discretion to order the killing of any animals 
considered to be suffering unduly at a licensed or registered establishment 



U. ADVISORY COMMTTIEE 

An Advisory Committee should be estaUished and should consist of a 
Chairman and twelve members, all appointed by the Secretary of State in a 
personal and not in a representative capacity. 



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The Committee should: 

(a) Keep under continuous review (i) the extent to which animals are used 
in procedures which may cause pain, suffering or ill-health and (ii) other 
matters relating to the welfare of animals used or for use in procedures. 

(b) Provide the Secretary of State with such other relevant advice and guidance 
as they think he requires, particularly wiUi reference to the use of 
alternative techniques. 

(c) Consider particular procedures which come to their notice or are referred 
to them by the Secretary of State and advise whether or not, and subject 
to what conditions, such procedures are justified. 

(d) Advise the Secretary of State on any relevant matters which he may refer 
to the Conmnittee for their opinion. 

The Conunittee should be composed of persons qualified by their knowledge 
and experience to render competent advice to the Secretary of State on any or 3l 
aspects of the matters referred to in (a) to (d) above. The members should include 
veterinary surgeons, biological scientists, representatives of the medical profession 
and lay persons. 

13. APPEALS 

There should be an adequate statutory procedure for appeals against a 
decision made by the Secretary of State, concerning licences for procedures, 
licences for premises and places, or registrations for establishments. 

14. PUBUC EXHramoN 

Exhibition to the general public of visual recordings of procedures on living 
animals should be permitted where the recordings of procedures were originally 
made for an acceptable purpose as defined in Section 2. 

Exhibition to the general public of procedures, or recordings of procedures, 
on living animals made specifically for exhibition, should not be permitted except: 

(a) Where the prior approval of the Secretary of State has been obtained: or 

(b) where the audience consists entirely of students or workers in the 
biological sciences. 

15. RESTRICnON ON RIGHT TO PROSECUTION 

To protect licensees or holders of certificates of registration from malicious 
or vexatious prosecution, a prosecution against a person licensed or registered 
under the legislation for an offence under the legislation should not be begun 
except on the instructions or with the consent of the Director of Public 
Prosecutions. 

Proceedings should be commenced within two years of the commission of the 
offence or within six months of tibe discovery of the offence. 



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ILARNEWS 

INSTITUTE OF LABORATORY ANIMAL RESOURCES 



About the Author 

After a two-year term as 
Chairman of the Animal 
Welfare Committee of the 
British Veterinary Associa- 
tion, Dr. John Seamer is 
now the official nominee to 
become Honorary Secretary 
of the BVA in September 
1983. He has played a lead- 
ing role in laboratory ani- 
mal science in Britain and 
internationally. He has 
served as Council Member, 
Secretary, and President of 

the Laboratory Animal Science Association and of the 
British Laboratory Animate Veterinary Association and 
was also Scientific Member of the Governing Board of 
the International Council for Laboratory Animal 
Science. For several years he was responsible for the 
breeding, production, and care of experimental animals 
at Allington Farm, Chemical Defence EsUblishment, 
Porton, Salisbury, UK, and he has published many 
papers on laboratory animals and on microbiology. A 
member of the editorial board of Laboratory Animals, 
he has ako edited the handbook Se^fety in the Animal 
House. 




HISTORICAL BASIS OF BRITISH VETERINARY 
ASSOCIATION POLICY ON ANIMAL 
EXPERIMENTS 

John Seamer, British Veterinary Association. 
7 Mansfield Street. London W1M OAT 

INTRODUCTION 

I The British Veterinary Association (BVA) has a mem- 
I bership of some 7,000 graduate veterinarians. It is the 
professional association that represents the interests of 
all arms of the veterinary profession in Britain, whereas 
the legal control of the practice of veterinary medicine is 
vested in the Royal College of Veterinary Surgeons 
(RCVS). On becoming a member of the RCVS every vet- 
erinarian makes a solemn declaration and a promise that 
*TDv constant endeavour will be to ensure the welfare of 
animals committed to my care." All full members of the 
BVA are members of the RCVS. Thus, although many 
people and professions play a part in animal welfare in 
Britain, veterinarians have a particularly important role to 
play by virtue of their solemn promise. 

The interest of British veterinarians in animal experi- 
mentation goes back at least into the latter half of 
the nineteenth century when experiments on animals be- 
came a matter of public concern. Veterinarians were 
particularly disturbed that in France fully conscious 
animals were being used for physiological experiments 
and for surgical practice. This general concern led to the 
passage in 1876 of the Cruelty to Animals Act, which 
has dominated British thinking and practice for 100 
years despite the enormous advances that have been 



Volume XXVII, Number 1 , Fall 1983 



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made in science, and particularly in biology and anes- 
thesia, during that time. 

The Cruelty to Animals Aa was intended to permit 
experiments on vertebrate animals -that is to say, it 
permits the infliction of pain on animals for scientific 
purposes but with safeguards. The term experiment is 
not defined under the aa, but it has come to mean a 
procedure that is calculated to cause pain when carried 
out on a living vertebrate animal to test a hypothesis or 
to provide unknown information -in other words, to 
answer a scientific question. Demonstrations on live 
animals, mostly undertaken to instruct undergraduates 
in physiology, also are covered by the act. Experiments 
on animals are usually permitted only in universities, 
research institutes, and on the premises of commercial 
firms, although provisions exist for experiments to be 
conducted on farms or under natural conditions where 
necessary. About 600 places are registered for the con- 
duct of experiments. 

LICENSING PRCX:EDURES 

To carry out an animal experiment a scientist must have 
a license from the Home Office, which is the Depart- 
ment of State responsible for administering the act. 
Licenses are given only to scientists or senior technicians 
and are obtained by application to the Home Office. 
The application must be recommended by a professor of 
certain medical sciences and also by a president of one 
of several learned societies. The license permits only ex- 
periments that are carried out completely under anes- 
thesia, in which the animal is killed before it recovers 
consciousness. In some experiments an anesthetic is un- 
necessary or would conflict with the purpose of the ex- 
periment. An exemption from the use of anesthetics is 
granted in these cases by obtaining a Certificate A. 

There are occasions when it is necessary to anesthetize 
an animal and to allow it to recover. Exemption from 
the requirement to kill an animal before it regains con- 
sciousness is granted by obtaining a Certificate B. 
Authority to use animals for demonstrations is granted 
with a Certificate C. Cats, dogs, and Equidae have 
always had a special position, and experiments on these 
animals require separate permission, which also is 
granted by certificates. All of these certificates, which 
contain limitations on the procedures that may be done, 
are obtained by application to the Home Office in a sim- 
ilar way to the application for licenses. Holders of 
licenses and certificates are required to declare annually 
to the Home Office the number of experiments they 
have undertaken, and an analysis of these statistics is 
submitted to Parliament and published each year. 

The aa is administered by IS inspeaors who have 
medical or veterinary qualifications. Inspeaors inter- 
view existing and prospeaive license holders; discuss 
new procedures with them; and check premises, animal 



husbandry praaices, and the animals under experiment 
to ensure that the welfare of the animals is safeguarded 
and that legal provisions are met. Although the inspec- 
torate has legal powers, it is not a police force; inspec- 
tors are administrators and advisers to the Home Office 
and to the scientific community. The Home Secretary 
also receives advice from the Advisory Committee on 
Animal Experiments. This committee, which was re- 
formed in 1979, has, among others, two members with 
veterinary qualifications. 

Although there are about 20.000 persons licensed to 
perform animal experiments in Britain today, only 
about 12,000 are aaively engaged in this work. In 1981, 
the last year for which figures are available, there were 
4.344,843 animal experiments (Command 86S7, 1982). 
Most of these (80 percent) were carried out with rats and 
mice; 6.186 monkeys. 13.439 dogs. 8.016 cats, and 434 
equine animals also were used. Many animals are used 
in association with the pharmaceutical industry, and in 
1981 more than half the experiments reported were per- 
formed by one-fifth of the license holders, working for 
commercial concerns. 



HISTORICAL BASIS FOR BVA POLICY 

General Information 

A number of problems arise in applying the 1876 Cruelty 
to Animals Aa today. For example, the system of licens- 
ing, which worked well in a small scientific community 
where most of the members were known to each other, 
is no longer appropriate. The aa contains no definition 
or evaluation of pain— a problem referred to later in 
this paper. There is also no definition of what consti- 
tutes an experiment, and the definition that has evolved 
is not entirely satisfaaory. There are a number of scien- 
tific procedures that cause pain in animals, but since 
they do not ask a question they are not considered 
experiments under the act. An example of this is the use 
of animals for the passage of viruses and tumors. In 
1876 most animal experiments were a surgical or physio- 
logical nature. Animals were not used to test drugs and 
vaccines, and the LD50 test, which has recently caused 
so much concern, had not been devised. Thus, although 
it was contemplated at the time that most experiments 
would be done under anesthesia, the vast majority are 
now done without it. 

Control animals, which accompany the experimental 
animals throughout the procedure but which may them- 
selves receive no painful treatment whatsoever, are not 
included under the terms of the aa nor does the aa ap- 
ply to the breeding and supply of animals for experi- 
mental purposes. Proteaion of these animals is ac- 
corded under the Proteaion of Animals Aa of 1911, 
which excludes anything lawfully done under the Cruel- 
ty to Animals Aa. Lastly, in their concern to protea 



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animals from those who would want to practice surfery 
on them, the legislators of the nineteenth century specif- 
ically prohibited the use of animab for the acquisition 
of manual skill. Thus, the use of animals by surgeons to 
become proficient in such techniques as microsurgery, 
which will save human lives and restore bodily function, 
is prohibited. 

The number of animal experiments increased from 
about 480 in 1878 to 46,073 in 1906, and public concern 
grew. A Royal Commission on animal experimenu was 
set up in 1906 under the chairmanship of Sir John 
McFadyean, Principal of the Royal Veterinary College, 
London. The commission reported in 1912. Among its 
recommendations was the proposal that the Home 
Secretary should be advised by an advisory committee. 
The most important recommendation referred to pain, 
and as a result new wcurding was added to each Home 
Office license to the effect that if an animal on experi- 
ment is suffering severe pain that is "likely to endure" it 
shall be painlessly killed, even if the object of the experi- 
ment has not been attained. The wording likely to en- 
dure" is important. Three of the eight members of the 
commission had reservations; they thought that animals 
suffering severe pain should be killed at once (Hume, 
1947). 

In line with the expansion of science, the usage of 
animals steadily increased, and in 1943 the total number 
of animal experiments passed the 1,000.000 mark. At 
this time scientists recognized that the uniformity and 
quality of animals available for research was not satis- 
factory and a Conference on the Supply of Experimen- 
tal Animals was set up. The conference included repre- 
sentatives from several learned societies, including the 
Royal College of Veterinary Surgeons and the National 
Veterinary Medical Association, the forerunner of the 
BVA (Anonymous. 1947). The conference reported to 
the Agricultural Research Council and the Medical 
Research Council, and in 1947 the latter established the 
Laboratory Animals Bureau, later to become the Labo- 
ratory Animals Centre, with the general aim of improv- 
ing the quality of laboratory animals and advising and 
assisting commercial animal breeders. 

The rapid postwar increase in the use of animals for 
experiments led to greatly increased interest in their 
husbandry and welfare by scientists and others. A land- 
mark was the enunciation of the 3 R's by Russell and 
Burch (19S9): replacement of animals by nonsentient 
systems wherever possible, refinement of experimental 
procedures to obtain humanely the best possible results, 
and reduction of numbers of animals used to the very 
minimum that will serve a useful purpose. 

Littlewood Committee 

In the early 1960s public concern led the government to 
establish a departmental committee to consider animal 
experimentation. This, the Littlewood Committee, had 



a veterinarian as a member and received evidence from 
the BVA. The committee pondered the question of pain 
in animals and proposed that within the concept of pain 
three states of suffering should be recognized: 

1. Discomfort (as may be characterized by such nega- 
tive signs as poor condition, torpor, and diminished ap- 
peUte). 

2. Stress (i.e.. a condition of tension or anxiety pre- 
dicuble or readily explicable from environmental 
causes, whether distinct from or including physical 
causes). 

3. Pain (recognizable by more positive signs, such as 
struggling, screaming or squealing, convulsions, and 
severe palpitation). 

Although these points can be criticized, they have the 
considerable advantage of simplifying and clarifying 
what the legislation should be about. The use of a single 
word such as pain or suffering clearly defined in the law 
would greatly facilitate its interpretation and adminis- 
tration. Although the Littlewood Committee concluded 
in its report (Command 2641, 1963) that nothing was 
seriously amiss, it recommended improvements it 
wanted to achieve by new legislation. 

The law remained unchanged, but many of the Little- 
wood recommendations were effected administratively 
by the Home Office. This was possible because the 1S76 
Crudty to Animals Act is loosdy drawn, and so the 
Secretary of State for Home Affairs can exercise his dis- 
cretion by administrative means. This useful less<Mi 
should be remembered when new legislation on animal 
experimenution is drafted. The law should be suffi- 
ciently flexible to meet both present and future re- 
quirements, requirements that may change rapidly with 
scientific progress. 

LDso Test 

More recently there has been concern about the greatly 
increased numbers of animals used in potency, toxicity, 
and safety tests on drugs and other chemicals. In 1977 
the Home Secretary asked the advisory committee to 
look into the LD50 test. Carefully planned and properiy 
executed, this test can provide useful information in 
numerical form. Various national and international reg- 
ulatory bodies have, therefore, come to require an LDm 
test of substances before issuing licenses for their use. 
The authority of these bodies is such that their re- 
quiremenu. although not always legally mandatory, 
tend to be regarded as such. In fact a cynic has con- 
trasted the 3 R's of Russell and Burch with the 4 R*s of a 
regulatory authority, which recommends procedures, 
requests them, and then requires them; and, finally, if 
the requirements are not met, rejects the data sub- 
mitted. 



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The advinry c 



mkue fepoffted (Report, 1979) thtt 
LDm fern riwuM ooiKiiiue, bat it 



potency «0d nfety of drup «0d tke HomeOffwe lo 
that tke welf aie of a 
cratioiL In this tke c 
ewiier by the B V A uid the Labonoory Ananal Sdenoe 
Anodation (Seaaoer, 1977). The onmmitter idn leooaiH 
aModed that eaperknems on pranates be subject to the 
saoK safeguards as thoae for dogs, cats, and Eqiiidar. 
and, again, because of the fkxifaility of the 1876 act, the 
Home Office has effected this r 



Inafl Mstmesperarissionxsralioenseisii 
conduct animal experhnents. In soi 
puimcnt is defowd as may scientific or indu s tria l pro- 
oadore performed on a live animal, regardtem of 
whether pain, suffering, or other harm remits. In odier 
co u nuies only those procedures that cause iiain or suf- 
fering are considered experiments. In nine countries the 
legislation iqiipiies only to vertebrates, while in others aU 



PMJiamentary Activity 

During tbc taut 10-lS years there have been a ttOBoba of 
attnnpts, mostly by way of private m e mb ers* biUs in 
Parliament, to change the legal status of animal experi- 

. Mott of these biUs were very restrictive, if not 
>oiitiontst. and all fukd to reach the 

; book. The two most notable and most reoem 
were the Halsbury Bill introduced into the Lords and 
the Fry Bill introduced into the House of Conomons in 
1979. Although both bais fukd to pass, it is noteworthy 
that there was a shift from the extreme views oi aboli- 
tionists and experimemalists, so that a redrafted versitMi 
(rf die Halsbury Bill received siqiport from both gnnqx. 
Before the 1979 general election the three major poht- 
iari parties induded in their numifrstos proposal s to 
revise the taw on animal eaqxriments; these were idso a 
feature of the 1963 election numifrstos. After the 1979 
election tbc Conservative Govemmem repeatedly af- 
firmed its intention to introduce new legislation, and die 
Home Office adviswy oomn^tee made proposals for 
changes in the taw (Rqwrt, 1961). However, the govern- 
mem decided not to act until the Council of Europe 
Convention on the Protection of Anknals used for Ex- 
perimental and Industrial Purposes had been finalized. 

Western European Activity 

The legislation on animal e xp erimen ta tion m 21 West- 
em European countries (all men4>er states of the Coun- 
cil of Europe) has been summarized by Erichaen (1962). 
Lidnmstein does not permit animal experiments, while 
in six other men4>er states regulatory l^istation is mini- 
mal or nonexistent (Cyprus, Greece, Malta, Portugal, 
Spam, and Turkey). The remaining 14 states (Austria, 
Bdgiuni, Denmark, Federal RepuUic of Germany, 
France, Icdand, Irdand, Itdy, Luxembourg, The Neth- 
erlands. Norway. Sweden, Switzeriand, and the United 
Kmgdom) all have regulatory oomrcris. The taw in 
Irdand is essentially the same as that in Britain. Apart 
from the Italian taw, which dates from 1941 , the k^sta- 
tion onrem in die remaining 1 1 countries was enaaed 
or revised after 1960. 



In France, as in Britain and Iretand, a system of mdi- 
vidual Koensing for e xp er im en ts is in force. In Norway, 
Denmwk. The Nedierlands, and some odier co untri e s , 
licenses are granted to institutions. Institutional li c enses 
usually require the presence of a qiedaHy co mp e t e m 
person widun the organization who may ddegate 
authority to other persons to conduct ammal experi- 
mems under his supervision and guidance. A third type 
of lioense, the project fioense, is issued by authorities in 
the Federal Republic of Germany and Switzeriand for 
each experiment or series of experiments. In Austria and 
West Germany a system of authorization for certain 
types oi experiments is contained in die law itself, aiKl 
these can be conducted without further formality. In 
Sweden all animal eaqxriments are qipraised by ethics 
committees with sciemifk and tay members before they 
are sanctioned. Ah states that have a Ucensing system 
also operate some form of infection. 

Federation <rf Veterinarians of the European Economic 



The Federation of Veterinarians of Europe (EVE) of the 
European Economic Community rqxesents a wide 
range of professional interests of veterinarians at na- 
tional and European levds from those countries that 
form the Community (Bdghun. Denmark, Federal Re- 
public of Germany, France, Greece, Irdand, Itafy, 
Luxembourg, The Nethertands, and the United King- 
dom). Other Western European countries send ob- 
servers to FVE meetings. At its meeting in Rome in O;- 
tober 1962, the FVE accepted the principles set out in 
the BVA policy donimtnt on ammal experimentation. 
The FVE has had observer status at meedngs of the Ad 
Hoc Conunittee of Experts, which is drawing iq> a 
CouncS of Europe Conventicm on animal experiments. 

Council <rf Europe Convention 

The Council of Eurcqie rqjreients 21 Western European 
countries. It aims to safeguard the European heritage 
and improve economic and social progress. In 1971 its 
Omsultadve Assembly produced Recommendation 621 , 
whidi proposed the formation <rf an Ad Hoc Committee 
of Ejqierts "to study proUems arising out of the use of 
live animals for experimental or industrial purposes." 
The committee has worthed to produce a convention. 
Progress has been very slow, but it now (June 1963) ap- 



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pears to be almost ready for approval by the Council of 
Ministers. The BVA has provided evidence to the British 
national delegation to the Committee of Experts and 
was abo represented at a Public Parliamentary Hearing 
at Strasbourg in December 1982. When the convention 
is accepted by the Council of Europe each member 
country will be obliged to adopt legishuion that is no 
less stringent. 

BVA POLICY ON ANIMAL EXPERIMENTATION 

It is against the background outlined above that the 
BVA has in recent years given much thought to the 
problems arising from animal experiments and their 
control. Initially a brief policy statement was produced, 
but this was considerably expanded in 1980, and some 
further revisions have also been made. The full current 
policy, as approved in March 1983, is attached to this 
article as an appendix. 

Need for Animal Experiments 

The BVA recognizes the need for animal experiments to 
advance biological knowledge, to improve human and 
animal health, and for essential safety and potency 
tests. Neverthdess the BVA supports the principles of 
the 3 R's. reFine, reduce, and replace, and would 
welcome the replacement of animal experiments when- 
ever this can satisfactorily be done. In a departure from 
the present legal requirements the BVA would require 
all experimental or scientiHc procedures that are likely 
to cause pain to animals to be legally controlled, for ex- 
ample, the production of antisera. Qinical veterinary 
procedures would of course be excluded. The BVA has 
not expressed a view on control animals, but to this 
writer it would seem illogical if these animals, which are 
frequently in cages adjacent to those on experiment, 
were not protected by the same legislation that covers 
animals on experiment. The use of anesthetized ani- 
mals, which are not allowed to recover, for demonstra- 
tions in higher education should continue to be per- 
mitted but should be rigidly controlled and kept to a 
minimum. In a departure from current practice the 
BVA believes that in excerpr/onff/ circumstances it should 
be permissible to use animals for the acquisition of 
manual skill, as in the case of surgeons practicing micro- 
surgical techniques for use in man. This would mean 
that the animals would be anesthetized and allowed to 
recover. However, the BVA does not believe that nor- 
mal living animals should be used by veterinary students 
to acquire or practice surgical skills. Rather, these skills 
should continue to be acquired as at present by the use 
of cadavers and later by supervised instruction on sick 
or injured animals that require treatment. 

Apart from the foregoing the BVA has not expressed 
views about what sorts of experiments should be al- 
lowed. Proposals to conduct experiments should be ac- 

Volume XXVII. Number 1 , Fall 1983 



cepted or refused by the Home Office aided by advice 
from the advisory committee. This committee is re- 
garded as the keeper of the public conscience and should 
reflect what is or is not publicly desirable or acceptable 
at any given time, particularly in terms of new and unus- 
ual procedures and the numbers of animals used in tests. 

Experimental Animals 

Although not stated, the BVA believes in the equality of 
all animal species and would not, therefore, offer the 
current special treatment for cats, dogs, horses, and 
monkeys. Rather, it feels that all species should be 
treated according to their own particular physiological 
needs and that the conservation of wild species must be 
taken into account. Recognizing the concern frequently 
expressed in Britain that pet dogs and cats should not be 
stolen for use in research (even though this is believed to 
be a rare occurrence), the BVA would require that dogs 
and cats taken from the streets never be used for ex- 
periments. As a general principle h believes that animals 
to be used for research should be bred for that purpose. 
Exceptions to this general rule should be made in the 
case of farm animals and for scientific purposes, such as 
the study of disease in wild animals, but financial 
grounds alone should not be a sufficient reason for such 
an exception to be made. The BVA believes that a code 
of practice should be drawn up to maintain satisfactory 
standards for the husbandry and welfare of animals 
bred, supplied, transported, and used for experiments. 
Experimenters, animal technicians, and others should 
be legally obliged to meet the provisions of this code. 

Registration of Facilities 

Premises where animals are bred, kept for supply, or ex- 
perimented on should be registered. As a condition of 
registration it should be necessary to demonstrate that 
proper facilities, management, and trained staff are 
available as well as the services of a full- or part-time 
veterinary surgeon. The veterinarian's duty would be to 
ensure the proper care and welfare of the animals. He 
would thus act as the "animals' friend" and as such 
would be responsible to the senior manager of the labo- 
ratory, who in turn would be identified to the Home Of- 
fice as the person responsible for the conduct of the 
registered premises. The identification of an animals' 
friend could, if required, replace some or all of the func- 
tions of an ethics committee. 

The BVA believes that the law must safeguard the 
welfare of animals but that its provisions and adminis- 
tration must recognize the value of science and of the 
work that experimenters carry out. The experimenter 
must be accountable for his conduct, but he should not, 
as has recently and regrettably been the case, be sub- 
jected to harassment and molestation from extremist 
groups. 



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Pain 

In practical terms the problem is to evaluate, in the Uv- 
ing animal, pain and other unpleasant sensations, such 
as discomfort and distress, and to determine and regu- 
Ute what is acceptable. All animals, even the most sim- 
ple, are sensitive to some external stimuli. Progression 
up the evolutionary tree increases the range of stimuli to 
which animals arc sensitive, and in higher animals there 
b consciousness rather than mere sensitivity. In- 
telligence and memory, in addition to consciousness, ex- 
ist in the very highly developed species. Somewhere 
along this scale certain stimuli can be recognized, by the 
recipients at least, as painful. Humans recognize that 
some stimuli are more painful than others, and this 
almost certainly holds true for higher animals. Similar- 
ly, pain can be of long or short duration, and who is to 
say whether short but severe pain is worse than milder 
pain of longer standing? It is paradoxical that so little is 
known about the interpreution of pain and suffering in 
animals, although in a recent book Dawkins (1980) in- 
dicates areas in which scientific progress is being nwde. 
Perhaps our understanding of pain may increase sud- 
denly and rapidly, as it occasionally does in other areas 
of science. 

In these circumstances the BVA had adopted as a 
yardstick the Littlewood categories of discomfort, 
stress, and pain. The BVA believes that anesthesia, 
analgesia, or other measures designed to alleviate paiii. 
consistent with the standards of contemporary veteri- 
nary practice, should be applied in experimental pro- 
cedures unless they are more distressing than the pro- 
cedure itself or unless they would conflict with the 
purpose of the procedure. If a procedure is likely to 
cause pain, suffering, or distress of more than momeii- 
tary duration of trivial intensity, which cannot be allevi- 
ated, prior authorization from the Home Office should 
be required. Such authorization should be given only 
when the procedure is judged to be of exceptional im- 
portance in meeting essential needs of man or animals. 
All licenses should contain provisions to ensure that any 
animal that suffers severe pain or severe distress that 
cannot be alleviated should be killed painlessly, even if 
the object of the experiment has not been achieved. It 
should be recognized that the criteria proposed by the 
BVA are more restrictive than those currently in force 
and that certain experiments currently undertaken 
would no longer be permissible. 

AGREEMENT WITH OTHER ANIMAL WELFARE 
GROUPS 

As a result of public discussion on aninoal experimenta- 
tion, the BVA held consultations with other interested 
organizations, noUbly CRAE and FRAME. The prin- 
cipal aim of FRAME is suggested by iu name: the Fund 
for Replacement of Animals in Medical Experiments. 



CRAE -the Committee for the Reform of Animal Ex- 
perimenution-is a loosely knit group representing 
parliamentarians and science, medicine, and animal 
welfare societies. During the course of discussions it 
became apparent that the BVA's policies were substan- 
tially acceptable to CRAE and FRAME. (The policies 
contained in the appendix to this article, which were ac- 
cepted by the BVA Council in March 1983, have also 
been approved by CRAE and FRAME.) This is a sig- 
nificant advance because, for the first time, a large pro- 
portion of the British animal welfare community has 
adopted a common policy. A joint policy statement was 
sent to the Secretary of State of Home Affairs and to all 
members of Parliament, where it has been welcomed 
not only by the government but also by press, radio, and 
television commentators. 

WHITE PAPER ON ANIMAL EXPERIMENTATION 
Just before the June 1983 election the Conservative 
Government produced a white paper on animal experi- 
mentation (Command 8883, 1981). (A white paper is the 
recognized means by which the British Government an- 
nounces, for consultation, proposals for legislation on a 
given topic.) The government proposals include the 
establishment of a new animal procedures committee of 
12 members, two-thirds of whom would be drawn from 
medicine, veterinary science, and the other biological 
sciences. Thecommitteewould perform the general func- 
tions of the present advisory committee, considering 
matters referred to it by the Home Secretary, including 
questions of policy, practice, procedure, trends in ex- 
perimental and scientific work, the development of al- 
ternatives to animals in experiments, and proposals for 
revision in the law. It will also have an enhanced role in 
advising on the administration of the new controls. The 
Home Secreury will consult with the committee on the 
standard conditions to which all licenses will be subject 
and on specified areas of work, such as cosmetics, that 
the Secretary regards as giving rise to special concern. 

The proposals include the extension of controls to the 
breeding and supply of animals for experiment. The 
controls will extend to all living nonhuman vertebrates 
in accordance with the draft European Convention and 
will apply to any experimental or scientific procedure 
that may cause pain, suffering, distress, or lasting harm. 
The present British pain clause, prohibiting severe pain 
that is likely to endure, would be maintained. However, 
there is a categorical statement that no exceptions to this 
condition would be permitted, even though these arc 
provided for in the Council of Europe Convention. The 
prohibition on the use of animals for the acquisition of 
manual skill for microsurgery will be lifted. Work on 
primates, but no other species, would continue to re- 
quire special authorization. 
The controls would be administered and supervised 

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by a strengthened inspectorate with medical or veteri- 
nary qualifications. Individual scientists would continue 
to need a license to carry out experiments, and a system 
of project licenses would be introduced. Applications 
for a personal license would require sponsorship from a 
senior license holder with personal knowledge of the ap- 
plicant. A project license would require sponsorship 
from a professor in a relevant discipline, or some similar 
person, who would be asked to pass an opinion on the 
likelihood of success of the project; the possibility of 
success of an alternative, nonsentient method; the type 
of animals to be used; and the adequacy of the proposed 
use of anesthesia or analgesia. 

Establishments at which experimenu are to be per- 
formed would continue to require registration. The 
Home Secretary would be empowered to attach general 
or particular conditions to certiflcates of registration. 
Conditions would be attached to all certificates to en- 
sure that (I) a named person or persons would have day- 
to-day responsibility for seeing that the conditions of 
registration were being fulfilled; (2) a veterinary surgeon 
would be available and responsible for advice on animal 
health and welfare; (3) adequate staff would be avail- 
able for animal care; (4) care and accommodation 
would be appropriate for the animals; and (S) environ- 
mental conditions would be checked daily. Fees would 
be payable for licenses and registration. 

The government welcomed the joint submission from 
the BV A, CRAE. and FRAME and noted that there was 
a large measure of agreement between their joint pro- 
posals and those of the government itself. This is indeed 
so. Many of the BVA proposals have been met, al- 
though not necessarily in the way envisaged in the policy 
statement. However, on the all-important subject of 
pain the government's proposal to maintain the existing 
pain clause is not as restrictive as the BVA, CRAE, and 
FRAME would wish, and these organizations will 
doubtless continue to press for the achievement in full 
of their proposals in new l^slation that the newly 
returned Conservative Government is expected to in- 
troduce. 



REFERENCES 

Anonymous. 1947. The animal laboratory. P. 39 in A. N. Worden, 
ed. . The UFAW HandlMok on the Care and Manatement of Labo- 
ratory Animals. 1st ed., London: BaiUierc, Tindall and Cox. 

Command 2641. 1963. Report of the Departmental Committee on Ex- 
periments on Animals. London: Her Majesty's Stationery Office. 

Command K57. 1982. Statistics of Experiments on Uvtnt Animals. 
Great Britain 1961 . London: Her Majesty's Stationery Office. 

Command 8883. 1913. Sdentific Procedures on Livtnt Animals. Lon- 
don: Her M^iesty's Stationery Office. 

Dawkins. M. S. 1980. Animal Saffering. the Science of Animal Wel- 
fare. London and New York: Chapman and Hall. 

Erichsen. S. 1982. Present State of National Rules. Paper presented to 
Council of Europe 9th European Public Parliamentary Hearing on 
the Use of Live Animals for Experimental and Industrial Purposes. 
Strasbourg. December 1982. 

Hume. C. W. 1974. Law and praaice: The rights of laboratory 



ufaMh. Pp. 6-8 In A. N. Wordo^ ed., TlK UFAW HMdbook OS 
the Cart and MaaaiMMat of Labontory AiriMk, l« ed. LMrfoK 



I. lUport OB the LDm MM piCMMad to the Saenttry of 
Sum by Uk Advisory ComidiMe oa the Adtinlwraiiuii of the 
Cruelty to Aataiab Act. I8T6. Loodon: HoMOniee. 

lUport. 1911 . Advisory Comnittce on Adnil Expcrincaa Report 10 
Uk Secretwy of Sum oa the Pranework of LciWMioa to RaplMC 
the Cruelty to AiyiMb Act, 1876. Londoo: Ho«e Office. 

RiHsdl. W. M. S.. and R. L. Bmch. I9S9. TIk Prindplct of Hummm 
Experimental Technique. Loodon: Mcthuca. 

Scner. J. 1977. Pp. 87-90 to The Wetfaic of LahoiMory Aaliih. 
Legal, SdcMiflc and HuoMnc RequirMBcnts. Potten Bar: Utdvcr- 
sities Fedciation for Animal Welfare. 

APPENDIX 

•VA Policy on Animal Ex p er i men t ation 

INTRODUCTION 

Experimenu on animals to advance Mdofical knowledse. 
to improve human and animal hcahh and welfare and for 
essential safety and potency tesu have led. and continue to 
lead, to significant benefltt for man and animab. Such experi- 
ments should continue provided that the new legislation safe- 
guards the welfare of animals used in experimenu by incor- 
porating the provisions detailed below. 

1. PROCEDURES AND ANIMALS 

A procedure, for the purposes of the legislatioa. should be 
defined as any experimental or scientific act invohnng in- 
terference with or departure from the normal otmdition of 
wdl-beint of an animal, which may cause pain, suffering, 
distress or lasting harm. All procedures should come within 
the scope of the legislation and it should be an offence to 
carry out a procedure without authority. There must be suit- 
able exemption for the performance of veterinary procedures 
carried out in accordance whh the provisions of the Veteri- 
nary Surgeoiu* Act of 1966 and ameodmenu. 

The legislation should apply to all non-human animals in 
the sub-phylum Vertebrata including the foetuses of animals 
and the embryonic or larval forms of other classes that have 
attained a stage of development capable of discrete existence 
outside the egg or maternal tract. 

2. ACCEPTABLE PURPOSES 

Procedures should be allowed only for one or more of the 
following purposes: - 

(a) The avoidance, prevention, diagnosis or treatmem of 
disease, ill-health or other abnormality, or their effeco in 
man, animal or plant. This purpose includes the production 
and safety testing of medicinal producu and other substances, 
the quality control of foods, and the devdopmem of surgical 
techniques. 

(b) The assessment or detection of physiological otmdi- 
tions, including the diagnosis of pregnancy. 

(c) The prolongation of life of man. animal or plant. 

(d) The protection of the natural environment. 

(e) The breeding of aninuds. 

(0 The advancement of biological knowledge. 

(g) Some educational and training purposes. The use of 
aiuiesthetised animals which are not allowed to recover con- 
sciousness for the acquisition of manual skill should be per- 
missible under strictly controlled conditions. SurvivaLsurgery 
for the acquisition of manual skill should be permitted only in 
exceptional drctrnistaiKCs such as training in micro>surgery. 
The use of recorded material for demonstration in higher 
education should be extended. 



Volume XXVII, Number 1. Fall 1983 



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i. LICENSING OF PREMISES AND PLACES 

All procedufci imder the legislation mutt be cwried out oo 
premises or places licensed for the purpose. The licence for 
the premises or places should specify the types of procedures 
which may be carried out. The licence should identify two or 
more people by name: - 

(a) The person or persons ultimately responsible for the 
care of the animals in the premises or pbices; aW 

(b) the veterinary surgeon, either from the suff of the 
ettablishment or employed on a part-time basis, responsible 
for advice on animal health and welfare. 

A legidly enforceable Code of Practice should lay down re- 
quired ttandards for premises, pbKes and fadUties available 
for the care of the animals and for the carrying out of the 
licensed procedures. 

The Code should specify that a sufficient number of compe- 
tent staff are available at all times to care for the animals, 
especially those that have under^me surgical interference. 
The Code should also specify that an animal used or intended 
for use in a procedure is provided with suitable and adequate 
accommodation, an environment, sufflcieni freedom of 
movement, and food and water apprapriaic to itt hcahh and 
well-being. The environmental conditions should be checked 
ai least daily and the uate of health of all animals in licensed 
premises or pbKes should be observed suffkiemly frequently 
and in sufficiem detail to ensure their well-being in the context 
of the procedure. The Code of Practice should specify condi- 
tions for the transfer of animals between licence holders, or 
between hcensed esublishmenu during the course of, or at the 
end of, a procedure. 

Legislation should permit the performance of procedures in 
open spaces and natural environmentt. 



4. LICENSING OF PERSONS AND PROCEDURES 

Licences for individuals to carry out procedures should be 
issued by the Secretary of State on application by the prospec- 
tive licensee. The application should be counter-signed by two 
sponsors. The firtt sponsor should be the holder of a senior 
appointment in the biological sciences at the esuUishmeu of 
the api^cant, who is familiar with the applicam and the facil- 
ities available. He should certify that the applicant is a suit- 
able person to hold a licence, and that he is competent in the 
handling of the animals to be used in the procedures speciFied 
in the application, and is competent to perform the specified 
procedure or procedures and any anaetthetic or analgesic 
techniques to be used. The first sponsor should also certify 
that the procedure or procedures conform to the provisions of 
the legislation, with particular reference to the acceptable pur- 
pose for which the procedures are to be performed. The appli- 
catt and flrst sponsor may wish to consult with a non- 
statutory local ethical committee before forwarding the 
application to the second sponsor. 

The second sponsor should be an independem biolo^cal 
scientist from another ettablishment whose name is litted in a 
regitter of sponsors approved by the Secretary of State. The 
second sponsor should certify that, in his opinion, the pro- 
cedure or procedures conform to the legislative provisions, 
and that they are justified in the circumstances, after having 
considered the possibility of using alternative techniques 
which do not involve the use of animals. In any application in- 
volving the use of primates, the second sponsor should certify 
additionally that the use of primates is essential. 

Strict control should be exercised over the procedures and 
animal species permitted on licences. When procedures are to 
be carried out on unanaesthetised animals, or on anaesthe- 
tised animals which are to be allowed to recover, the licence 



should specify such species as may be used and should define 
the permitted procedures. 

The recipient of a firtt licence should be subject to the direc- 
tion and supervision of an experienced licensee, irrespective of 
the qualifications and training of the recipiem. This firtt 
licence should normally be valid for one year only, and a 
report from the Supervisor to the local Inspector should be 
submitted and considered before the licence is renewed with- 
out the supervision condition. There should be provision for 
the issue of licences with longer-term supervision conditions, 
provided that there is always an assessment of competence 
after the expiry of the firtt year. 

Variations of any licence should be made either at the re- 
quett of the holder, or of the Secretary of Sute. 

Licences should be available for inspeaion at all reasonable 
times by an Inspector. 

An undergraduate or postgraduate student of any biolog- 
ical science should be permitted to carry out procedures on 
licensed premises without being the holder of a licence, pro- 
vided that it is under the direct supervision of and in the 
presence of a licence holder, and that the animal is anaes- 
thetised throughout the procedure and is humanely killed at 
the end of the procedure without regaining consciousness. 

5. CONDUCT OF PROCEDURES 

A procedure staru when an animal is firtt prepared for use 
in thia procedure, and ends when no further observations are 
to be made for the purpose of the procedure. 

It is reasonable to allow the re-use of animals under ceruin 
conditions. It mutt be decided at the end of any procedure 
whether the animal shall be kept alive or humanely killed, 
provided that it shall not be kept alive if it is Ukdy to remain 
in latting pain or distress. At the end of a procedure aninuds 
which are to be kept alive mutt continue to be kept subject to 
the conditions of the procedure and mutt be placed under the 
supervision of the veterinary surgeon identified on the Ucence 
of the premises. An animal may be exempted from these con- 
ditions if, in the opinion of the veterinary surgeon, it would 
not suffer as a consequence of such exemption. It may be 
necessary for the purposes of the procedure to set non- 
doroetticated animals free or return domesticated animals to 
their normal (i.e. non-experimental) environment. This 
should be permitted by the licence provided that the Secretary 
of State is satisfied that the maximum practicable care has 
been taken to safeguard the animal's well-being. 

When an animal is not to be kept alive, it should be 
humanely kiHed without avoidable delay. 

6. PAIN, ANAESTHESIA AND ANALGESIA 

The problem of defining pain, suffering or dittress has not 
been resolved satisfactorily. However, it is possible to recog- 
nise various states of discomfort, ttress or pain, both in the in- 
tensity and the duration of the suffering. For example, a very 
brief painful ttimulus such as the insertion of a sharp needle 
through the skin is probably inconsequential; on the other 
hand, the stress imposed in the restraint and immobilisation 
of the animal prior to the insertion of the needle may be 
severe. Thus it is the recognition of the response of the animal 
to a ttimulus that should be the criterion of sufferhig, rather 
than the nature of the stimulus itself. It is possible also to 
recognise differences in the origin of the suffering, whether it 
be from wilful neglect or incompetence, whether it be inciden- 
tal to or unexpected within the procedure, or whether it be a 
necessary component of the procedure. 

The following provides a useful guide to the recognition of 
the various states of suffering, based on paragraph 181 of the 
Littlewood Report. Discomfort may be characterised by such 



18 



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negative signs as poor condition, torpor and diminished ap- 
petite or by positive signs such as avoidance. Stna is a condi- 
tion of tension or anxiety which may be predicted or readily 
explained by environmental causes whether distinct from or 
including physical causes. Ann is recognisable, but not neces- 
sarily quantiriable, by positive signs such as struggling, 
screaming or squealing, convulsions and severe palpiutions 
or by measurement of chemical changes within the body. 

During any procedure, suitable anaesthesia, analgesia or 
other measures compatible with the standards of contem- 
porary veterinary practice, and designed to alleviate pain, suf- 
fering or distress of whatever origin occurring during the pro- 
cedure, should be applied at any time, unless they are more 
distressing for the animal than the procedure itself or unless 
they would conflict with the purposes of the procedure. If a 
procedure is likely to cause pain, suffering or distreu of more 
than momentary duration or trivial intensity, which cannot be 
alleviated, prior authorisation by the Secretary of State 
should be obtained. Such authorisation should only be given 
when the procedure is judged to be of exceptional Importance 
in meeting essential needs of man or animals. 

All licences should contain provisions to ensure that any 
animal that is suffering severe pain or severe distress which 
cannot be alleviated should be killed even if the object of the 
procedure has not been achieved. 

The use of curariform drugs should be prohibited, except in 
conjunction with anaesthesia of sufficient depth to produce 
loss of consciousness. 

7. ACQUISITION OF ANIMALS 

Animals for use in experimenu should be bred for the pur- 
pose, although exceptions should be permitted for scientific 
reasons and in the case of farm animals. The use for experi- 
mental purposes of cats or dogs taken from the streets should 
never be permitted. Excepticms to the purpose breeding rule 
for cats and dogs should be stringently omtroUed: financial 
grounds alone should not be a sufficient reason for an excep- 
tion to be made. 

Animals of the species listed below which are intetided for 
use in procedures should be obtained only from registered 
breeding establishments, except: - 

(a) That exemptions from this requirement may be given 
for specific reasoiu or procedures; arul 

(b) that free-living varieties of the listed species nuiy be 
used in a procedure where the main object of the procedure is 
the study of the free-living variety. 

Animals of species other than those listed below should be 
acquired from registered establishments wherever possible. In 
reaching a decision to use wild animals for experimental pur- 
poses the welfare of the animals, the survival of the species 
and the quality of the experimental material should be taken 
into account: financial grounds alone should not be a suffi- 
cient reason for an exception to be made. The general source 
of animals intended for use in procedures which will not be 
acquired from registered establishments should be stated 
when application is made for the licence to carry out the pro- 
cedure. 



Species 




Mouse 


Musmuscuhis 


Rat 




Guinea Pig 




Rabbit 


Oryctolagus cunicutus 


Dog 


Canisfamiliaris 


Cat 


Felts cams 


Hamster 


Mesocrkxtus auratus and 




Cricetulus griseus 



Other spcdcs, and particularly primates, should be added 
to this list u soon as there is reasonable prospect of a suffi- 
cient supply of purpose-bred animals. 

8. REGISTRATION OF BREEDING AND SUPPLYING 
PREMISES 

Control of the breeding, keeping, supply and transport of 
animals intended for use in procedures is essential. Establish- 
ments which breed or supply animals should be registered by 
the Secretary of State, and a legally enforceable Code of Prac- 
tice should lay down the required standards for premises 
breeding and supplying animals for experimemal purposes. 
The Code should specify (he standards of premises, and the 
facilities required before registration is granted. The numbers 
and competence of suf f should be specified. The certificate of 
registration should identify the person or persons ultimately 
responsible for the care of (he animals in the establishment 
and the veterinary surgeon responsible for advice on ani(nal 
health and welfare in the establishment. 

9. RECORDS AND RECORDING 

In order to facilitate the keeping of records of animal move- 
ment and usage, canidae, felidae, ungulates and primates in- 
tended for use in procedures, should be individually identified 
at the eariiest practicable time after birth or afier being taken 
into a licensed or registered establishment. The identification 
should be in the most permanent form available for the spe- 
cies and nature of the individual. Full records of the identity 
and origin of each member of the families listed above should 
be kept by all licensed or registered establishments. 

Records of the movement of other species should be re- 
corded by total number only. 

The records should be in such a form as to show, as far as 
practicable, the origin, lifetime movement, usage in pro- 
cedures and disposal of all animals, either by group or indi- 
vidually, as described above. 

All persons licensed to carry out procedures should keep 
records of movements of animals intended for use in their 
own procedures and of the usage of animals in the proce- 
dures. Records from all licensed or registered persons should 
be submitted annually to the Secretary of State. 

10. ANNUAL REPORT 

The Secretary of State should present to Parliament, an- 
nually, a report which should include at least: 

(a) The total number of procedures carried out during the 
previous year. 

(b) The purposes for which the procedures were carried 
out. 

(c) The number and species of animals used. 

(d) The number of exemptions from the basic pain condi- 
tion granted during the year. 

(e) A statement of any infringements of the legislation, and 
the consequences. 

(0 The subjects on which the Advisory Conunittee had ad- 
vised during the year. 

11. INSPECTORS 

Inspectors should continue to be recruited from mature per- 
sons holding registered medical or veterinary qualifications. 

Their statutory duties should include: 

(a) The scrutiny of applications for licences in regard to the 
nature and purpose of the procedures to be carried out. and 
the assessment of the suitabiUty of the applicants to perform 
such procedures. 



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(b) The uMuuKNiaoed periodic inspection of ttocmed and 
lefittefed esttbiishmentt and tiw inspection of tinee for 
which application has been made. Refusal of entry to an 
authorised inspector at any reasonable tine should be an of- 
fence. 

(c) Advising the Secretary of State as to the exerdse of dMir 
duties. 

Inqwctors should have absohite discretion to order the kill- 
ing of any animals considered to be suffering unduly at a 
licensed or registered establishment. 

12. ADVISORY COMMITTEE 

An Advisory Committee should be established and should 
consist of a Chairman and twelve members, all appointed by 
the Secretary of State in a personal and not in a representative 
capacity. 

The Committee should: 

(a) Keep under continuous review (i) the extent to which 
animals are used in procedures which may cause pain, suffer- 
ing or ill-health and (it) other matters relating to the welfare of 
animals used or for use in procedures. 

(b) Provide the Secretary of State widi such other relevant 
advice and guidance as they think he requires, particulariy 
with reference to Uie use of ahemative tectaiques. 

(c) Consider particular procedures which come to their 
notice or are referred to tiiem by the Secretary of State and ad- 
vise whether or not. and subject to what conditions, such pro- 
oedures are justified. 

(d) Advise the Secretary of State on any rdevam matters 
which he may refer to the Committee for their opinion. 

The Committee should be composed of persons qualiried by 
their knowledge and experience to render competent advice to 
the Secretary of State on any or all aspecto of the matten 
referred to in (a) to (d) above. The members should include 
veterinary surgeons, biological scientists, representatives of 
the medical profession and lay persons. 

13. APPEALS 

There should be an adequate statutory procedure for ap- 
peals against a decision made by the Secretary of State, con- 
cerning licences for procedures, licences for premises and 
places, or registrations for esttblishmenu. 

14. PUBLIC EXHIBITION 

Exhibition to the general public of visual recordings of pro- 
cedures on living animals should be permitted where the 
recordings of procedures were originally made for an accept- 
able purpose as defined in Section 2. 

Exhibition to the general public of procedures, or record- 
ings of procedures, on living aimals made specifically for ex- 
hibition, should not be permitted except: 

(a) Where the prior ^>proval of the Secretary of State has 
been obtained; or 

(b) where the audience consistt entirely of studems or 
workers in the biological sciences. 

15. RESTRICTION ON RIGHT TO PROSECUTION 

To protect licensees or holders of certificates of registration 
from malicious or vexatious prosecution, a prosecution 
against a person licensed or registered under the le^slation for 
an offence under the legislation should not be begun except on 
the instructions or with the consent of the Director of Public 
Prosecutions. 

Proceedings should be commenced within two years of the 
commission of the offence or within six months of the discov- 
ery of the offence. 
MARCH 1983 



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Mr. Brown. Thank you very much, Dr. Seamer. That is extreme- 
ly helpful testimony. 

May I start with a question to you to follow up on your state- 
ment. I am not well informed about the operation of the British 
law. Can you tell me, in addition to what you have already men- 
tioned about its broader scope, what the mechanism for administra- 
tion of the law is, enforcement of the law? Does it provide for the 
kind of inspections of laboratories which we have in this country? 

Mr. Seamer. Yes, sir; there are similar inspections. They are con- 
ducted by medical or veterinary qualified inspectors who work to 
our home office, not to our Agricultural Department. They are 
made usually unannounced, and the inspector has the right at any 
time to order the killing of any animal which he considers is suffer- 
ing. 

Mr. Brown. Do you have the provisions for animal welfare com- 
mittees, by whatever name they may be called, within the laborato- 
ries? 

Mr. Seamer. No; there is no statutory provision for animal care 
committees. I understand that some laboratories have them. There 
is a move to introduce them. But there is no statutory responsibil- 
ity for them. 

Mr. Brown. Just through casual reading of the European press, I 
have noted that there seems to be a great deal more public concern 
in Europe and in England with regard to the welfare of animals 
than there is in this country. Could you clarify a little bit on that 
situation, what the impact of it is on scientific experimentation and 
so forth? 

Mr. Seamer. I think that there has been growing concern in Brit- 
ain and in Europe over the past 10 years, partly because of the de- 
liberations which have been taking place in the Council of Europe 
about introducing a convention for the welfare of animals on exper- 
iment. 

There has been agitation in Britain for a long time for reform of 
the law because it is so old and because in some respects it is out- 
dated. The Government has published a white paper, which is our 
way of stating the intention of the Government, and it is anticipat- 
ed that a new bill will be brought in in the lifetime of the present 
Parliament. 

Mr. Brown. Dr. Rosenberg, you made some reference to my 
home State of California and the problems we have out there. 
Would you like to elaborate a little bit on the possible adverse ef- 
fects on scientific research of the public alarm over the way in 
which some of the laboratories have been operated? 

Mr. Rosenberg. I hesitate to try to educate the chairman on the 
political situation in California. However, it is illustrative, particu- 
larly in the San Francisco Bay area, where one of the academic in- 
stitutions was seeking an appropriation from the State government 
to build a new animal research facility and that appropriation ran 
into considerable political difficulty because of past problems that 
institution had had with alleged abuses of animals that had been 
used in research there. 

The institution, I suppose, counterclaimed that the more modem 
facility would make it easier for them to provide proper care of the 
animals. 



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But the point that we wish to make is that a large body of sci- 
ence in the United States depends heavily upon support from the 
government, be it Federal, State, or in some instances, even local, 
and that the public has a right to demand that research which is 
funded or supported in any way by the government is conducted in 
a way that is in keeping with tne public s sensibilities. 

We feel that one of the purposes of animal welfare legislation, be 
it the Animal Welfare Act or any other, not only is to tend to the 
actual animals involved but also to provide the public at large with 
an assurance that its money is being put to proper use and not sup- 
porting activities which individuals within the public would object 
to. To the extent that there is any cloud over the research commu- 
nity, we encourage legislation which would dispel that cloud and 
leave the public with the necessary assurances that their concerns 
are being looked after. 

Mr. Brown. Well, the public in a democracy such as the United 
States has not only the right but the power to do all sorts of things, 
including sometimes some unreasonable things. It is the purpose of 
good legislation to try to avoid the unreasonable things and provide 
for the reasonable things that the public ought to be assured of. 

A couple of you in your testimony — and I have forgotten just 
which testified to which — made some reference to the desirability 
of maintaining a research data center on this area within the Li- 
brary of Medicine rather than within the National Agricultural Li- 
brary. There is no gain saying the importance of maintaining a 
close relationship between the Library of Medicine, which probably 
is more available to most researchers than in the Library of Agri- 
culture. 

Is this a problem which can be resolved in some reasonable way? 
Do any of you have comments here? I hear so much about the mir- 
acles of modern data bank networking that I can't believe this is 
an insuperable problem. 

Mr. Melby. Mr. Chairman, perhaps I can give or make an at- 
tempt at responding. Since I am dean of the College of Veterinary 
Medicine, one would think perhaps at first glance the Library of 
Agriculture would be the most viable suggestion. I admit in all 
candor I do not know the operations of either of the library sys- 
tems in personal detail. But I can tell you that the library in our 
college, which I believe is the largest of any college of veterinary 
medicine in the Nation, its interfaced through the various data 
linkages you have mentioned is primarily to that of the Library of 
Medicine. 

So I think your perception is quite valid that perhaps a lot of in- 
stitutions would be very comfortable with the Library of Medicine. 
But again I underscore I don't know the inner workings and nu- 
ances of the two. 

Mr. Brown. Any other comments? Dr. Steinberg? 

Mr. Steinberg. Mr. Chairman, I think that the basic information 
regarding biomedical testing flows through the National Library of 
Medicine. The well-being and proper care of the animals is funda- 
mental to that biomedical information, particularly for those stud- 
ies, of course, that involve animals, and that to separate the two 
would be separating two items that are interdependent upon one 
another and we probably might be better served if we would 



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expand some of the centers that already exist at NLM and then 
feed, possibly feed, the information to the Agricultural Library, if 
necessary. 

Mr. Brown. Well, I have had the opportunity to visit both facili- 
ties, and there is no question but what the Library of Medicine is 
more advanced and sophisticated from almost any standpoint. On 
the other hand, the National Agricultural Library is making rapid 
strides to improve the availability of its data. I see no reason why 
there couldn't be an arrangement worked out where both of the fa- 
cilities should have the data available and it could be readily acces- 
sible to all research institutions, which I think is the ultimate pur- 
pose of it. 

Mr. Rosenberg. Mr. Chairman, we had commented on that for 
two reasons. One is the fact that many researchers are hooked up 
to either one or the other of the library systems but not both, and a 
large number of animals that are used in research are used in the 
life science research rather than animal husbandry or whatever 
other areas. 

The other concern that we had was that, historically, the ex- 
change of information between the two libraries sometimes needs 
some facilitating from the Congress. Our recommendation in the 
testimony was that whatever legislation emerges, make it clear 
that the Congress does expect those two agencies to work together. 

Mr. Brown. Well, that is a dynamic situation. That is, there are 
changes taking place in both setting, and I think that some proper 
solution can be worked out. 

In case that multitude of bells confuses anyone, this is what we 
call, I think, a notice quorum call or else it's a quorum call with a 
vote following in 5 minutes after the quorum call. We will know 
shortly. 

Let me ask this. Each of you has heard the testimony of the 
others, all of which I have found to be very constructive, but do 
any of you have any comments that you would care to make that 
would be based upon statements that you have heard from the 
other panel members, anything that you, other than a policy point 
of view, that you would vitally disagree with or would feel should 
be amplified on or something of that sort? Dr. Orlans? 

Mr. Orlans. I would like to comment further, Mr. Chairman, 
about the reviewer protocol of the actual experiments in order to 
see whether the degree of pain that the animals are suffering is ap- 
propriate, in conformity with nationally accepted guidelines. 

Dr. Melby did use the word "interfere'' with respect to this type 
of review of the animal research committees. I would like to com- 
ment on that. I don't think that it's a matter of interference. I* 
think that it is a matter of prime responsibility that we do improve 
the review system for the total system of review of animal experi- 
ments, in order to see that questionable procedures, very painful 
procedures, are properly reviewed for humaneness and that the 
amount of pain is reduced in every possible way. A key way of 
doing this and one that is, I think, well accepted and is becoming 
more and more accepted by the biomedical community is that the 
animal research committees shall have this role. 

Of interest, I think, is a survey that was conducted by the Scien- 
tists Center for Animal Welfare at the workshop in May on how to 



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run an effective animal care and use committee. This was a very 
well attended, widely acclaimed workshop. Half of the people at- 
tending responded to a survey. That was a problem just because we 
didn't give the questionnaires out in enough time. 

But, of the 90 respondents, 85 said that they thought that it was, 
**Very important that there should be review of protocols by 
animal research committees.'* Three said that it was somewhat im- 
portant. None said that it was not important or that these commit- 
tees shouldn't do it. Two did not answer. 

So I think that although this is not a cross-section of the biomed- 
ical community, because these are people who are already keen on 
doing a good job with their committees, it nevertheless does indi- 
cate that there is very good support. 

Mr. Brown. I am sure the question of whether that is a true 
cross-section of the scientific community would arise. 

Dr. Melby. 

Mr. Melby. Mr. Chairman, just to clarify a point, I think as a 
matter of communication, in my testimony when I used the term 
"interfere," I was referring to the nonspecificity of some of the lan- 
guage in the present bill as it would relate to implying the Secre- 
tary of Agriculture might have powers beyond which you might 
have intended. 

I take no issue with Dr. Orlans. I agree completely, and I think 
our association does, about the internal responsibilities of the inter- 
nal review committee in reviewing such protocols and accept them. 
So I was not concerned at all about their interfering with research. 
Indeed, that's an ongoing activity. 

Mr. Brown. Well, I think, if I understand the situation correctly, 
that there is still a great deal of ambiguity in the definition and 
evaluation measurement of pain. As a matter of fact, the House of 
Representatives is right now debating the question of pain in 
human beings, and the steps that might be taken and the justifica- 
tion for using heroin to ameliorate that pain. 

I was very interested in Dr. Seamer's statement about the fact 
that the British have considered the pain factor for a number of 
years. Perhaps you can tell us if you have developed objective crite- 
ria by which you can determine the degree to which animals suffer 
pain. But I don't think it's really so important that we know pre- 
cisely as that we be concerned about it. 

Mr. Seamer. Yes; thank you, sir. No; unfortunately, we don't 
have a scale, of course, where we can measure pain. But we do 
from experience have knowledge of certain procedures which are 
more painful or likely to cause more distress than others. 

Following the discussion at the other end of the table, I can say 
that, for example, there are certain procedures which I think 
would not be permitted in Britain. I believe one is — I may get the 
name slightly wrong— I think it's called the Noble-CoUett drum, 
which is used for shocking rats by putting them in a centrifuge. I 
do not think that that would be allowed to be used in Britain today 
because we believe it is too cruel, really, to be permitted. 

Mr. Brown. But who makes that judgment. Dr. Seamer? 

Mr. Seamer. It's a complex situation. The person wishing to do 
the experiment would first of all make an application. This would 
go to the Home Office and would be considered by one of the in- 



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spectors. The inspector could then discuss it with the, I will call 
him, the licensee; that is, the would-be experimenter. If they can't 
reach agreement as to what is going to happen, then it would go to 
our advisory committee, which is a committee sitting, a nonexecu- 
tive committee which advises on these matters. 

But at the end of the day the decision rests with the Department 
of State, the Home Office, ultimately with the Home Secretary, 
who would make that ruling. 

Mr. Brown. Yes, Dr. Tegeris. 

Mr. Tegeris. Thank you, Mr. Chairman. I am Dr. Tegeris, here 
with Mr. Brown on behalf of the National Association of Life Sci- 
ence Industries. 

One of the earlier speakers made a statement to the effect that 
many scientists perform experiments which are very painful to ani- 
mals and that many scientists are not familiar with any humane 
treatment principles for animals. 

I don't know where these figures are coming from, but we take 
strong exception to that. Vl\ tell you why. It is a basic scientific 
principle that for the results of an experiment to be valid, all vari- 
ables must be very rigidly controlled. Any scientist who is worth 
the paper his diploma is written on knows that pain and stress se- 
verely compromise the results of an experiment. So it would be- 
hoove all of us, as indeed it does, to make sure that our animals 
are very properly cared for. 

As a matter of fact, in the contract toxicology industry, we con- 
sider our laboratories to be long-term pediatric hospitals. Now, 
there is another reason for which we are anxious to make sure that 
as many animals as possible survive on an experiment. Let us 
make the assumption that we put on test 480 animals. There are 
approximately 240 million human beings in this country. What 
that means is that every animal is a surrogate for 50,000 people. So 
that animal is very meaningful to us because the information that 
it carries, it will affect 50,000 people, and we must have as many 
animals as possible getting to the end of the experiment because 
we must have enough numbers to make valid statistical evalua- 
tions to allow us to draw the conclusions that we're after in order 
to ultimately guard and protect the safety and care of human 
beings as well as of the environment in the country. 

Thank you, Mr. Chairman. 

Mr. Brown. Thank you for that statement. Dr. Tegeris. 

I will have to recess the subcommittee briefly to respond to those 
bells. Because of time pressure, I am going to excuse the panel at 
this point and ask the next panel to come forward. 

Let me say again I think that your testimony has been outstand- 
ing this afternoon and an excellent contribution to our discussion. 

The subcommittee will be in recess for 10 minutes. 

[Recess taken.] 

Mr. Brown. We are informed we have a distinguished visitor, 
Mr. Michael Morrison, a House of Parliament Member in Great 
Britain. I would like for him to stand and be acknowledged. [Ap- 
plause.] 

We have been known to invite Members of Parliament to come 
up here and join us, Mr. Morrison. [Laughter.] 



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We have before us our last panel, and I apologize for the sched- 
ule delay due to the votes on the floor. We do appreciate the pa- 
tience of the various witnesses. I will call them in the order in 
which they are listed. 

First of all, let me say we have Mr. Stuart Proctor, Jr., who is 
assistant director of national affairs for the American Farm 
Bureau Federation; Ms. Gretchen Wyler, vice chairman. Fund for 
Animals; Mr. Steve Kopperud, legislative director of the American 
Feed Manufacturers Association; and Mrs. Christine Stevens, secre- 
tary of the Society for Animal Protective Legislation. 

I perceive that we have certain advisers along with some of the 
witnesses. We welcome you all here. 

Mr. Proctor. 

STATEMENT OF STUART E. PROCTOR, JR, ASSISTANT DIRECTOR, 
NATIONAL AFFAIRS DIVISION, AMERICAN FARM BUREAU FED- 
ERATION 

Mr. Proctor. Yes, Mr. Chairman. My name is Stuart Proctor. I 
am assistant director of national affairs for the American Farm 
Bureau Federation. I would like to submit a copy of my testimony 
for the record and summarize my statement. 

Mr. Brown. We will appreciate that, and the full text of your 
testimony will be made a part of the record. 

Mr. Proctor. Thank you. 

Farmers have the enviable reputation of being compassionate 
stewards of their livestock. But despite our documented concern for 
the treatment of animals, we are currently under attack from a 
number of associations and individuals who make inaccurate and 
misleading statements about the treatment of farm animals. We 
feel that the same emotional arguments and the same tactics that 
are being used against us in agriculture are also being used now to 
describe the treatment of laboratory animals. We question whether 
Congress has been presented with sufficient evidence to substanti- 
ate the need for corrective legislation. Without such evidence. Con- 
gress is being asked to overreact to an undocumented problem. 

To provide the data necessary to make legislative decisions con- 
cerning the regulation of laboratory animals, the Farm Bureau 
supports the 18-month study that has been referenced several 
times today, specifically the bill H.R. 2350. 

We feel that legislative action is premature without thoroughly 
assessing how animals are currently being used in research. In my 
statement I go on and list a number of questions and a number of 
issues that will be resolved by the study. But I think Congressman 
Volkmer hit the nail on the head this morning when he asked the 
question, **How do you quantify the number of violations and the 
abuses that are going on throughout the country today?'* There 
was no answer to that question. 

The Farm Bureau will not support H.R. 5725 or other legislation 
on this issue until these basic questions are addressed. Answers to 
these questions will help determine the need for a legislative solu- 
tion to this problem. 

We feel that if legislation is necessary, it should be specific, tar- 
geted at specific areas. We feel the problems associated with the 



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treatment of laboratory animals could be better handled with more 
diligent enforcement of current regulations. Current regulations 
should be properly implemented before additional legislation is 
passed. 

If current regulations are ineffectively administered, we question 
why additional legislation and additional regulation will be any 
more effectively carried out. 

Congress and this administration have given low priority to en- 
forcement of the Animal Welfare Act by steadily reducing APHIS's 
budget. It seems inconsistent for Congress now to say this is a high- 
priority issue which needs additional attention, legislation, and reg- 
ulation. 

If there is a problem, APHIS should be given enough funds to 
properly enforce the act. 

That completes the summary of my statement. 

[The prepared statement of Mr. Proctor appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Well, we thank you very much, Mr. Proctor, for that 
statement, and it contains a great deal that we can agree with, I 
am sure you know. 

Ms. Wyler. 

Ms. Wyler. Thank you. Congressman Brown. My name is 
Gretchen Wyler. I am vice chairman of the 250,000-member Fund 
for Animals and sharing my time today is Dr. Herbert Rackow. 

STATEMENT OF HERBERT RACKOW, M.D., DIPLOMATE, AMERI- 
CAN BOARD OF ANESTHESIOLOGY; PROFESSOR EMERITUS, 
COLLEGE OF PHYSICIANS AND SURGEONS, COLUMBIA UNIVER- 
SITY; REPRESENTING SCIENTISTS GROUP FOR REFORM OF 
ANIMAL EXPERIMENTATION 

Mr. Rackow. My name is Herbert Rackow. I am a retired physi- 
cian, diplomate of the American Board of Anesthesiology, and pro- 
fessor emeritus of the College of Physicians and Surgeons, Colum- 
bia University. 

My statement is on behalf of the Scientists Group for Reform of 
Animal Experimentation and is in favor of prompt enactment of 
H.R. 5725. 

All of the members of this group are either physicians, veterinar- 
ians, or research scientists. 

I would like to submit a more detailed statement for the record. 

Mr. Brown. Dr. Rackow, we welcome your more detailed state- 
ment, and it will be made a part of the record. 

Mr. Rackow. Thank you. I will discuss only the animal research 
committee as provided for in the bill. The need for an animal re- 
search committee is very well described in "Whistleblowing in Bio- 
medical Research, 1981.'' This study concerned human experimen- 
tal subjects. It was sponsored by three groups: The President's 
Commission for the Study of Ethical Problems in Medicine and Bio- 
logical Research, by the American Association for the Advance- 
ment of Science, and by Medicine in the Public Interest. 

It points out that scientists in a university setting are under 
pressure to produce results and justify more money for more re- 
search. Promotion, tenure, salary, laboratory space and help. 



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travel, and other professional requisites depend upon research pro- 
ductivity. There is a strong conflict of interest that may affect even 
the best of persons. The university system of governance grants 
almost complete autonomy to departments and individual scien- 
tists. This may result in inadequate protection for human research 
subjects. 

If these considerations concerning research on human subjects 
are valid, then the need for protection is even greater when the 
subjects are animals. 

The establishment of an effective animal research committee is a 
key provision of H.R. 5725. We know from past experience that 
NIH inspections and USDA inspections can be inadequate to 
ensure humane treatment of laboratory animals. In what way will 
the animal research committee inspections be different? H.R. 5725 
brings to the inspection committee an independent, unpaid member 
who is not affiliated with the research facility, has no conflict of 
interest, and whose primary responsibility is to the welfare of the 
animal subjects — not to NIH and not to the USDA. 

The effectiveness of H.R. 5725 in ensuring humane treatment of 
research animals will depend on the quality of this member of the 
animal research committee. I suggest that the qualifications of this 
person be expanded in report language to include that the person 
has demonstrated an active interest in animal welfare over a 
period of years and has no conflict of interest in representing com- 
munity concern for the welfare of laboratory animal subjects. 

I thank you for the opportunity to make this statement in sup- 
port of H.R. 5725. 

[The prepared statement of Mr. Rackow appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Thank you. Dr. Rackow. 

STATEMENT OF GRETCHEN WYLER, VICE CHAIRMAN, THE FUND 

FOR ANIMALS 

Ms. Wyler. Yes, Congressman Brown. The Fund for Animals 
supports the bill also. I am very proud to submit to you today, from 
your State of California, signed statements by physicians and veter- 
inarians supporting very strongly H.R. 5725 as a bill worthy of con- 
sideration. 

Mr. Brown. We will make that a part of the record. 

Ms. Wyler. Also, Congressman Brown, I have submitted docu- 
mentations which I would appreciate being put into the record. 

But today I have just seen a film, and, to put it very mildly, I am 
very stunned by the film I saw this morning. I would like to make 
some comments on that. Congressman Brown, because it totally, to- 
tally relates to your fine bill. 

The film will be shown all day until 5 p.m. at St. Mark's Episco- 
pal Church, which is Third Avenue and A, Southeast. But I would 
like to say. Congressman Brown, that if your bill were the law of 
the land, the film would not exist. It did not come from Russia. 
This film that I saw this morning came from the University of 
Pennsylvania. It was painful to watch, but certainly not as painful 
as the animal cast of characters had to go through. 



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I believe the film I saw is not becoming to a civilized nation. Was 
this unusual? Was this isolated? I think we no longer know. That's 
why we need the Brown bill. 

The Brown bill requires training sessions for scientists and tech- 
nicians in methods to limit animal pain and distress. If there were 
a Brown bill, this film would not exist, because there was no effort 
in this film to even limit distress. The pain seems, on the contrary, 
to provide entertainment and merriment to the researchers on this 
film. 

The Brown bill requires that pain-relieving drugs never be with- 
held longer than necessary. In the film I saw this morning, it was 
necessary to use pain-relieving drugs — and they were not used. 

The Brown bill requires the institutional committee to be noti- 
fied of any changes in practices adversely affecting the welfare of 
the animals. In the film I saw this morning, hammers and screw- 
drivers were unconscionably and incessantly used on the pri- 
mates — and this was not even in the grant request. If we had a 
Brown bill, that would not have happened. 

The Brown bill requires semiannual inspections by an animal re- 
search committee, including a veterinarian and an outside member 
responsible for representing community concerns for the welfare of 
animal subjects. 

No committee, I tell you, Mr. Brown — no committee — could have 
passed this. There was no concern for animal welfare. 

The Brown bill provides that a Federal agency suspend or revoke 
support for a project if animal care, treatment, or practices have 
not been in compliance with applicable standards. This was totally 
nonsterile, with cigarette ashes falling in wounds and instrumente 
falling on the floor. I do not believe a veterinarian could have ever 
authorized or directed this film. 

Your bill also permits personnel to report violations without dis- 
crimination. I would like to believe that some member of that re- 
search team would have reported that if we had a Brown bill. I 
would encourage this committee to consider passage of H.R. 5725. 
We have been given for much too long false reassurances of 
humane treatment historically given us by the users of animals. 
Your bill is not antiscience. I encourage its passage, as it would dis- 
tinguish us as a more civilized nation. 

Thank you. 

[The prepared statement of Ms. Wyler appears at the conclusion 
of the hearing.] 

Mr. Brown. Thank you very much, Ms. Wyler. 

Our next witness is Mr. Steve Kopperud, legislative director for 
the American Feed Manufacturers Association. 

STATEMENT OF STEVEN L. KOPPERUD, LEGISLATIVE DIRECTOR. 
AMERICAN FEED MANUFACTURERS ASSOCIATION 

Mr. Kopperud. Thank you very much. Chairman Brown. 

I, too, would like to briefly summarize my statement and ask 
that the full statement be placed in the record. 

Mr. Brown. Without objection, so ordered. 

Mr. Kopperud. As you said, I am Steve Kopperud, legislative di- 
rector for the American Feed Manufacturers Association. For over 



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75 years AFMA has been the national trade association represent- 
ing the Nation's animal feed manufacturers. Members of the asso- 
ciation produce more than 70 percent of the primary formula live- 
stock and poultry feed sold in the United States. 

In addition, some AFMA members raise large numbers of food- 
producing animals. 

AFMA is proud of its longstanding concern for the proper treat- 
ment of all animals. Our official policy simply states, "AFMA is 
committed to the humane and compassionate care of all animals." 
AFMA is vitally concerned that animals used in all research are 
treated in accordance with the highest professional standards. 

AFMA has vital interests in animal nutrition research, in many 
cases on a cooperative basis with both public and private facilities. 
But AFMA is also concerned that Congress not act in a manner 
which might ultimately and unintentionally place barriers in the 
path of biomedical research through increased bureaucracy or act 
precipitously or unnecessarily to correct wrongs which may not 
exist to the extent some may contend. 

Chairman Brown's public support for necessary animal research 
and his assurances that H.R. 5725 is in no way intended to halt the 
use of necessary research using animals which satisfies AFMA's 
concerns over the intent of this bill. 

However, AFMA must question the need for this legislation. As 
has been said today on several occasions, there is no verifiable 
record of the alleged widespread abuse of lab animals. AFMA has 
long supported legislation to investigate current lab animal care 
standards as a method of discovering any actual inhumane treat- 
ment, prior to taking congressional action. 

More important, however — and I stress that — if remedial action 
is necessary should such a study be undertaken, then it is logical 
that the time, the money, and the effort that is being expended on 
H.R. 5725 and similar legislation might be more productively fo- 
cused on raising the priority of the Animal Welfare Act both 
within Congress and the administration in its enforcement within 
FDA. 

AFMA undertook an independent review of the Animal Welfare 
Act and has concluded that the Secretary of Agriculture currently 
has sufficient legal authority to implement all but one of the statu- 
tory requirements on the use and treatment of lab animals, as pro- 
posed by H.R. 5725. 

In writing the Animal Welfare Act, it is clear that Congress in- 
tends the Secretary to have the broad authority necessary to carry 
out the purpose of the act; namely, "to ensure that animals intend- 
ed for use in research facilities are provided humane care and 
treatment.'' 

Let me briefly look at four of the major provisions of H.R. 5725 
and the status of those proposals under the current AWA. Annual 
compliance assurances by research facilities: H.R. 5725 would re- 
quire yearly assurances by the research facility that it is in compli- 
ance with humane standards of animal care, especially in any prac- 
tice involving the administration of pain to an unanesthesized 
animal. A proviso to section 13(a) of the Animal Welfare Act, 7 
U.S.C, subsection 2143(a) provides that authority now. 



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Animal research committee. Chairman Brown's bill would order 
the establishment of internal animal research committee by each 
research facility. Our review shows no difference between H.R. 
5725 and current authority. Indeed, current regulations allow for 
the Secretary of Agriculture to use animal research committees in 
lieu of or in addition to attending veterinarians. It is apparent the 
Secretary was given the implied or inherent authority to require 
such panels. 

While it must be recognized that many research facilities cur- 
rently have such committees voluntarily, the precedent has already 
been set by other agencies, including NIH and FDA. 

Inspection provisions. H.R. 5725 calls for the inspection results of 
the animal research committee to be made available for review by 
USDA inspectors. The Secretary has the authority to conduct in- 
spections to see if the facility has violated law, regulation, or stand- 
ard under section 16(a), 7 U.S.C., subsection 2146. No new authority 
would be needed. 

State or local standards. 5725 would not preempt the States 
rights to pass stricter regulations. The current AWA allows for 
State regulation. This section allows the Secretary to cooperate 
with the States in carrying out rules, regulations on animal wel- 
fare. 

It appears the only administrative change which cannot be made 
by the Secretary is to impose the criminal penalties for release of 
trade secrets by any member of the animal research committee. 
This would also apply to the criminal penalties for laboratory 
raids, et cetera, as have been suggested today. 

It is apparent then that the Secretary has the tools to do the job. 
The key then is priority, manpower, training, and money. There 
exists no legitimate reason for legislating another set of permis- 
sions to overlay this current authority. The need is not for further 
legislative authority but rather for congressional, administrative, 
and public support for more diligent enforcement of the act. 

I would ask the question that several other groups have asked 
today, *'Why should we expect a new law and a new set of regula- 
tions would be any better enforced than the current law?'' GAO 
has issued a report that is critical of APHIS enforcement. Senate 
Appropriations, in its consideration of USDA's fiscal 1985 budget, 
took note of the GAO study and has admonished APHIS on the 
overall priority given the enforcement of the AWA. 

The logical route then is to seek administrative changes in the 
current implementation of the AWA. The Association of Biomedi- 
cal Research this morning in offering to underwrite APHIS inspec- 
tor training is an example of this type of cooperation. Biomedical 
research interests, agriculture, and animal welfare interests, using 
the GAO report and other developments as guides, can cooperate 
with USDA to achieve reasonable, mutually acceptable goals. This 
is preferable to a legislative tug-of-war that may go on indefinitely 
and where the innocent victim may be necessary in vital biomedi- 
cal research. 

[The prepared statement of Mr. Kopperud appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Thank you very much, Mr. Kopperud. We appreci- 
ate your testimony and your reference to the Senate Appropria- 



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103 

tions Committee. We do intend to try and give additional weight to 
that recommendation ourselves and hope that it will result in some 
improvements. 

Now, Mrs. Stevens, before we take your testimony, I think we 
better go vote, and this will be the last vote of the evening, and I 
ask your indulgence, if we may. 

We will be in recess for a few moments. 

[Recess taken.] 

Mr. Brown. The subcommittee will be in order. 

Our last witness this afternoon is Mrs. Christine Stevens. We are 
very pleased to have Mrs. Stevens here. 

You may proceed with your testimony. 

Mrs. Stevens. Thank you, Mr. Chairman. I would like, if I may, 
to ask our farm adviser, Mr. Donald McCaig, to precede me on this 
panel, which includes farm interests. 

STATEMENT OF DONALD McCAIG, YUCATEC FARM, 
WILLIAMSVILLE, VA 

Mr. McCaig. I would like to thank the chairman and the sub- 
committee for allowing me to testify. My name is Donald McCaig. 
My home is in Highland County in Virginia's Sixth Congressional 
District. I am a sheep farmer and a writer. I belong to the Virginia 
Sheep Breeders Association, the Virginia Farm Bureau, and am 
president of the Virginia Border Collie Association. 

My wife, Anne, and I raise commercial and purebred sheep, and 
I write, often on rural matters. My latest book is "Nop's Trials." 

Livestock farming isn't the easiest way to make a living, and I 
don't know anyone who keeps stock who doesn't like and admire 
animals. It's a paradox. During lambing, we spend sleepless nights 
in the bitter cold, saving newborns who are destined for slaughter 
a few months later. We'll spend more than a ewe is worth doctor- 
ing her, but when she doesn't respond and is suffering, we're the 
ones who put her down. 

In the Book of Genesis, God gives man dominion over animals. 
We are the sovereign authority. We decide if and how they live, 
where and when they die. 

There may be a livestock farmer indifferent to animals in pain, 
but I have never met him. There may be livestock farmers who can 
look at these pictures of tormented laboratory animals and shrug. 
There may be such men. 

The essence of livestock farming is attentiveness and care. Ani- 
mals are valuable. You don't waste them. You don't terrify them. 
You don't cause them needless pain. If they are in pain, you deal 
with it now, not after an 18-month study period. 

H.R. 5725 is a good bill. It promotes the most basic sort of animal 
husbandry. It should save tax revenues, and will certainly reduce 
animal pain. Most livestock farmers who knew its provisions would 
support it wholeheartedly. 

Thank you. 

Mr. Brown. Thank you, Mr. McCaig. May I suggest you talk to 
your Congressman, also, and see if you can influence him a little? 

Mr. McCaig. Thank you, sir. 

Mr. Brown. He happens to be on the subcommittee. 



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STATEMENT OF CHRISTINE STEVENS, SECRETARY, SOCIETY FOR 
ANIMAL PROTECTIVE LEGISLATION 

Mrs. Stevens. Mr. Chairman, I would like to confine my re- 
marks, leaving my testimony in the record, to the problem that we 
have heard over and over again that people think there isn't any 
documentation to show widespread animal suffering in laborato- 
ries. Therefore, we have prepared charts, and this large one that 
you see on your left — I hope it will be visible to you — this is a 
study in which 186 institutions have been looked at under the Free- 
dom of Information Act. We have taken the USDA reports, both 
the annual reports and the repeated reports of the inspectors. 

Far from being a rarity, animal abuse is extremely common, as 
demonstrated in this survey. The data collected shows that major 
and repeated deficiencies or alleged violations of the minimum 
standards of the Animal Welfare Act by 23.7 percent of the sample 
of 186 institutions. Another 22 percent have less frequent major 
violations, 28.5 percent have only minor ones, and 1.6 percent are 
under investigation. 

Thus, even using the most optimistic assumptions, only 24.2 per- 
cent of registered research facilities are regularly meeting the ex- 
isting minimum standards of the Animal Welfare Act. 

You will note there, if you can read the columns, that many of 
the institutions that are — these are category 1; these are the ones 
with major repeated deficiencies — many are AAALAC-accredited 
facilities, thus clearly demonstrating that the National Institutes of 
Health position that accreditation guarantees good animal care 
and treatment is untenable. 

Further, 79 percent of the severely deficient institutions were re- 
warded by an increase in NIH funds in the second year noted. 
Twenty-five percent of the 44 used more animals and got more 
money from NIH, despite their bad record with USDA. 

It is not true to say that animals, animal use is just decreasing 
by nature. 

Further, the column on the far right gives the numbers of ani- 
mals used in painful research where no pain relief was offered 
them. This is a very iffy column. It has not been properly enforced. 
It is very unreliable. Nevertheless, it's good to look at it. The curi- 
ous fact — this is a curious fact, which is a measure of the urgent 
need for passage of H.R. 5725. Whether the person who fills out an 
institution's annual report is deliberately misstating the amount of 
unrelieved animal suffering or is simply blind to it matters little. 
The animals are needlessly suffering, and legislation is essential to 
prevent it. 

Such legislation has been widely adopted by countries where lab- 
oratory animals are used extensively, and the only two major ex- 
ceptions to this are Japan and the Soviet Union, where there is vir- 
tually no legislation to protect animals at all. 

Now, the reason that you're hearing so much about we don't 
really know if there is any animal suffering is that a great deal of 
that is coming from the Association for Biomedical Research. It is a 
trade organization founded by Charles River Breeding Laborato- 
ries, a multinational, multimillion-dollar business which recently 
became a part of Bausch & Lomb, the big optical company. To give 



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you an idea of the size of the funds involved, I would quote the 
Boston Globe: 

Charles River had about $45 million in sales during the last twelve months and 
earnings of $6.2 million. Bausch and Lomb, based in Rochester, New York, is nearly 
thirteen times the size of Charles River. Dr. Henry L. Foster, founder and president 
of Charles River, owns 29 percent of the company's stock, which would be worth 
about $37.8 million if the deal goes through. 

And it did. 

How are these huge profits made? The answer is simple: by skill- 
ful and unrelenting promotion of the sale of the maximum num- 
bers of animals to scientific institutions. Even animals as small and 
inexpensive as white mice can turn a fat profit if they are pro- 
duced by the tens of millions and marketed with full-page ads in 
every issue of the right journals. Monkeys, of course, bring far 
higher prices, and Charles River trumpets their ready availability 
in ads which, since Bausch & Lomb took the company over, are not 
only full-page but full-color, too. "Don't put your research on hold,'' 
their scientists are advised, *link up with our primate that means 
quality. Our cyno. And any of our other 10 commonly used spe- 
cies." 

Mr. Chairman, I see the red light is on, so I am going to cease. 

Mr. Brown. Mrs. Stevens, you may make a suitable conclusion. 
We're not being all that rigorous. So if you want to sort of summa- 
rize what your main points are, that will be fine. 

Mrs. Stevens. Fine, thank you. 

Well, I would like then to turn to the recommendations at the 
end. Also, I certainly would be glad to answer any questions about 
these charts, which I think is a very key and essential matter, be- 
cause the charts simply quantify what we already know from our 
own laboratory visits from many other sources, but the question 
has been so often raised that this is an unexplored area that we 
felt it was important to put it down in black and white. 

There is a second chart right behind that one, Mr. Chairman, if 
somebody would like to move it so you can see the next batch. 
Those are the 44 institutions of the 186 that have the major repeat- 
ed violations. 

Now I would like to turn to the recommendations that, one, that 
the subcommittee should ask for regular reports on the measures 
taken by Veterinary Services to make the Animal Welfare Act pro- 
gram effective. 

They should also have methods of rewarding good and discourag- 
ing poor enforcement by all personnel. That is essential. Prompt re- 
porting of deficiencies found in all federally funded institutions to 
the funding bodies. The memorandum of understanding is not 
working as well as it should. It's an excellent idea, but there needs 
to be oversight. 

The NIH peer review panels are unaware of the findings of the 
U.S. veterinary inspectors. They don't know about any of this infor- 
mation that is there on the charts, and certainly not about the spe- 
cific reports on the laboratories. 

The Office of General Counsel is not doing its job on the Animal 
Welfare Act. The inspectors are far, far superior to the Office of 
General Counsel, and they deserve a good deal of scrutiny. 



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106 

Further, the subcommittee should make clear to the Secretary of 
Agriculture that any shifting of funds away from the Animal Wel- 
fare Act will not be tolerated in the future. 

The number of animal care specialists should be at least doubled, 
because what happens — I would like to say that it's not quite as 
bad as it sounds about the fleets of cars — they took away the in- 
spectors when they had an avian flu epidemic, and there should be 
a solid body of inspectors who are always there so that if a disaster 
of that kind occurs and some of the inspectors are taken away from 
that work, there should be somebody there continuing to inspect 
the laboratories and other places. 

So, Mr. Chairman, that's the main body of what I would like to 
say. Thank you for the opportunity to do it. 

[The prepared statement of Mrs. Stevens appears at the conclu- 
sion of the hearing.] 

Mr. Brown. Thank you very much, Mrs. Stevens. 

Without objection, the full text of your statement will be in the 
record. 

Now I would like to have a little better understanding of how 
you obtained the data that's reflected in the charts. Is that based 
upon an analysis of the actual inspection records? 

Mrs. Stevens. That's correct. We write to USDA requesting, 
under the Freedom of Information Act, their reports on different 
institutions. And we have been doing this for, I guess, about 8 
months now, and we've gotten up to the total of 186. Obviously, we 
should continue to do this, but when I hear people saying, "Well, 
there's just a few around," we find that the majority, as I say, have 
deficiencies in different — that's why we made these different cate- 
gories. So that there was one gentleman that said there is 3,000 
laboratories and he's only heard of one or two, well, if you extrapo- 
late from 186, you get over 2,000 that have alleged violations and 
deficiencies under the Animal Welfare Act. 

Think how much more there would be if your bill, which is so 
much needed, were actually in effect. 

Mr. Brown. Mrs. Stevens, as you know, the problem before us is 
not to convince me that the bill is needed but to convince a number 
of other Congressmen to the same effect. [Laughter.] 

Even beyond the 50 who are cosponsoring it. 

I am going to ask if any member of the panel wishes to make a 
comment or to seek to clarify the testimony that they have heard. 
Now, we have made a sincere effort to keep the panels reasonably 
well balanced with regard to the different points of view here. We 
haven't been 100 percent successful, but that was our effort. I don't 
want to start any fights or anything, but I am interested in a fairly 
balanced record, and for that reason I am going to ask any of the 
panel members who wish to do so to add to their comments or to 
address a question based on the others. 

Mr. Proctor. 

Mr. Proctor. Mr. Chairman, I would like to make a comment. I 
think the statistics that Ms. Stevens has provided us with are ex- 
cellent, and that's just the kind of data that we need to properly 
analyze how animals are being treated, lab animals are being 
treated. 



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107 

To me, though, it seems hke if only 24.2 percent are regularly 
meeting standards of the Animal Welfare Act, that supports our 
position that the act is not being properly enforced and that it's a 
regulatory problem and one that does not need additional legisla- 
tion. That's the first point I would make. 

In relating to those numbers again, when youVe got 25 percent 
who aren't complying with current standards, what's going to 
happen when you impose new standards and new regulations with- 
out increasing the resources for enforcement? It only means that 
you're going to have a higher number of violations arid you're not 
doing anything to really solve the problem. 

We don't want to appear to be unsympathetic to the other par- 
ties concerned, but again we think it's a regulatory problem and 
not one that requires additional legislation. 

One other quick point. There is obviously a big difference of opin- 
ion here. Some people want to go the regulatory route, another 
group wants to go legislation. Another difference of opinion on the 
number of animals used in research. Dr. Randall this morning said 
the number is actually decreasing, Ms. Stevens says the number is 
increasing. Well, that's why we think the study is important, so 
that we can have somebody, an independent evaluation, by the Na- 
tional Academy of Science or some other reputable institution to 
tell us exactly where we are. 

Mr. Brown. Knowing what a reasonable woman Ms. Stevens is, I 
think she would agree with you that it would be desirable to im- 
prove the quality of the inspection that we have at the present 
time. 

Would you like to comment on that? 

Mrs. Stevens. I certainly would. We do want to improve the 
quality. I would like to say in answer to Mr. Proctor also, though, 
that it's not just a regulatory problem. These figures come from the 
regulations that exist. The reason, in my opinion, that USDA has 
to go back so often, why these repeated deficiencies occur, is that 
the laboratories have not really taken the USDA seriously. 

They try, the inspectors go, they have to go back. They are wast- 
ing Government funds having to go back in 24 hours or 30 days or 
whatever the thing happens to be. Still, they often have to actually 
say, "OK, we're going to write this up as a case." Then, usually, 
finally the laboratory pulls itself together and does something. 

We need to upgrade the whole perception of this piece of legisla- 
tion, which was passed, I may say, unanimously with tremendous 
public supports. The public expects that this is what is happening, 
but unfortunately the laboratories have been able to push USDA 
aside and have been using really very unfair methods, I may add, 
to do just that. 

I would like to comment, too, that NIH, on those site visits that 
Dr. Wyngaarden mentioned this morning, according to our statis- 
tics, three of them that he said had adequate to excellent animal 
care, are in category 1, major deficiencies and repeated major or 
minor ones. 

One of them, we can't even get the inspection report. That usual- 
ly means that there is a case and it's under investigation. 



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108 

So here are these wonderful — so-called wonderful, according to 
NIH— -which also believes as long as AAALAC says they have ac- 
creditation, that they're just fine. 

So those are representative reasons why we have to have your 
bill as well as solid support for USDA's inspection. 

Mr. Brown. Ms. Wyler, I can see you want to make a brief com- 
ment. [Laughter.] 

Ms. Wyler. Very brief. 

No; I just would like to go into the record and say that I com- 
mend Animal Welfare Institute for this chart and how shocking 
that our own Government hadn't put one together instead of you 
having to do it. 

I would also like to say that I have spoken to many exinspectors, 
and even some that are still there. They are intimidated by the sci- 
entific community, admittedly so. They are not properly trained to 
be investigators in the way of animal health and care. They are in- 
timidated, admittedly so. 

I also would like to bring to your attention something I got yes- 
terday. I think this is rather shocking. Under the law, the Animal 
Welfare Act, you must sign — the veterinarian who might not even 
see the actual experiment must just sign— just say, "Pain relievers 
were withheld because it would interfere." They don't even make — 
as you know, until your bill, they don't even have to say why. 

I have in front of me Syntex Research Corp. in California admit- 
ted in this category, Mr. Chairman, 260 dogs received pain without 
benefit of pain-relieving drugs and 150 primates. Strangely enough, 
in our Government survey of that same time period, under the 
State of California, it said, "Zero dogs and zero primates." 

So the recordkeeping here is not the least bit reflective, I would 
assume, from our own Government and that saddens me greatly. 
When in one institution in the State of California, Syntex has 150 
primates receiving real pain without benefit of pain-relieving 
drugs, they don't even show up on this form, the annual summary 
of the Government. 

Mr. Brown. Thank you for that comment. 

Do any of the other members of the panel wish to offer a com- 
ment at this time? 

[No response.] 

I might note that even Members of Congress are sometimes in- 
timidated by the scientific community, so it's not surprising that 
inspectors are sometimes intimidated. 

My perception is that the inspectors are going to receive more 
encouragement from the Congress not to be quite so intimidated 
and to do a more effective job. 

I am encouraged by the language of the Senate Appropriations 
Committee report in that regard. 

Ms. Wyler, this is a very brief comment. 

Ms. Wyler. This is the very last question. This is my first time 
testifying in Washington. May I just know, as a very proud Ameri- 
can, why you were the only one interested in your bill today? 
Might I just know that? Is it because they were scheduled to do a 
lot of other things? I am not criticizing; I am only curious. 

Mr. Brown. Well, your criticism or curiosity 

Ms. Wyler. Just curious. 



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109 

Mr. Brown [continuing]. Is quite justified. We have tried to hold 
this hearing while the House is in session considering a number of 
other bills. As the bells indicate, we are called over to vote again, 
and some Members get tired of this running back and forth all the 
time. 

We did have a full complement at the beginning, which is cus- 
tomary, and then they kind of fade away by the end of the day. 

However, I can assure you that each of the Members gets a full 
briefing from their staff on the results of the hearing and they con- 
sider it very carefully in their deliberations. 

Ms. Wyler. Thank you. 

Mr. Brown. At this point, we will make part of the record, state- 
ments submitted by a number of parties interested in this legisla- 
tion. 

I want to thank all of you very much. I really believe this has 
been a most constructive hearing and that we've compiled a good 
and effective record which will be of tremendous value to us. 

Since I am now called again to the floor, I am going to adjourn 
the hearing at this point. The subcommittee will be adjourned. 

[Whereupon, at 4:31 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 



41-970 0-85-8 

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UNITED STATES DEPARTMENT OF AGRICULTURE 

STATEMENT OF 

BERT W. HAWKINS, ADMINISTRATOR 

ANIMAL AND PLANT HEALTH INSPECTION SERVICE 

BEFORE THE 

SUBCOMMITTEE ON DEPARTMENT OPERATIONS, RESEARCH, AND FOREIGN AGRICULTURE 

OF THE 
HOUSE COMMITTEE ON AGRICULTURE 
SEPTEMBER 19, 1984 

Mr. Chairman, I am pleased to appear before you today to review the 
Department of Agriculture's (USDA) activities In regard to treatment of 
animals used In research and to present the USDA's views on H.R. 5725, a bill 
"To amend the Animal Welfare Act to ensure the proper treatment of laboratory 
animal s." 

Appearing with me Is Dr. Richard L. Rissler, Assistant Director of Animal 
Health Programs. Dr. Rissler has responsibility for directing enforcement of 
the Animal Welfare Act. 

Since passage of the Animal Welfare Act In 1966, USDA has been Involved In 
the enforcement of humane care and treatment for certain animals used In 
research. Under current authorities, almost all State-owned or privately- 
owned facilities that use animals for research must register with the USDA's 
Animal and Plant Health Inspection Service (APHIS). These registered 
facilities must also submit annual reports on the animals they use. The 
report must Indicate whether any painful experiments were conducted and 
whether pain-relieving drugs were used. 



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Registrants must meet our minimum standards of care In providing housing, 
handling, sanitation, food, water, transportation, and protection against 
extremes of weather and temperature. Also, each registered facility must 
establish a program of veterinary care which meets these standards, APHIS 
personnel perfbnn periodic, unannounced Inspections to see that the 
established program of adequate veterinary care Is being followed. 

Federal facilities are not required to register or be Inspected by APHIS 
personnel. However, like State-owned or privately-owned facilities, 
they are required to submit annual reports on animal use and abide by the 
same animal care and treatment standards. Federal agencies, through Internal 
systems, monitor compliance of their laboratories. 

Mr, Chairman, the Department's commitment to accomplishing the goals of the 
Animal Welfare Act has never been greater. In the past 2 years, we have 
taken several Initiatives to Improve our administration of the act. These 
Initiatives were fostered by our own Internal review processes; expressions 
of public concern, especially by humane groups; and Increased awareness by 
the research community. Including Federal agencies Involved In biomedical 
research, of the Importance of humane care and treatment of laboratory 
animals. 

During that time, we took a hard look at our animal welfare program and 
decided that improvements were needed. We made some organizational changes 
to make us more responsive to public complaints and deal more effectively 
with possible trouble spots. 



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A new position of Assistant Director of Anlnal Health programs was created to 
direct field enforceiient of the act» and anlnal care coordinators Mere 
assigned to each Area Veterinarian -In -Charge. These changes permit us 
to make better use of information furnished to us by concerned public groups 
and to use our own resources more effectively. Ue also recognized the need 
for better qualified inspectors and have placed increased emphasis on 
training Inspection personnel. 

In the past year, we conducted an In-depth review of our enforcement of 
the act as it relates specifically to research facilities. The review was 
directed toward determining whether our Inspections provided adequate 
assurance that laboratory animals are receiving appropriate care and 
treatment. As a result, we are revising a number of our Internal policy 
memoranda to provide more specific and unlfDrm Instructions for the people 
1*0 conduct the inspections. Me have just completed the first of several 
special training sessions for Veterinary Medical Officers who conduct 
inspections; these sessions are the first devoted entirely to procedures for 
ensuring compliance by research facilities. Also, we have established a 
special task force that recently traveled throughout our Northern Region to 
review facilities there. Over 50 percent of the registered facilities are 
located in this region. The findings of this task force, which covered 
facilities from Minnesota through New England, will be used to further 
Improve our Inspection procedures. 

In addition to our Internal Initiatives, we have Increased our cooperation 
with other Federal agencies Involved in research. For example, we have 



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Implemented a memorandum of understanding with the National Institutes of 
Health (NIH) and the Food and Drug Administration (FDA) to enhance our 
sharing of Infonnatlon, Including Information about deficient conditions 
Identified by their Inspections or ours. People from these agencies have 
also participated In training sessions with our people, and personnel from 
APHIS and NIH recently conducted a joint site visit at the University of 
California at Berkel^. 

Another positive step In ensuring humane care and treatment of animals 
used In Federal research has been the formation of an Interagency Research 
Animal Committee, composed of all Federal agencies known to use animals 1n 
biomedical research. This group, with our participation, has developed a set 
of principles that agencies will follow In the use of animals. In addition 
to the standards under the Animal Welfare Act, these principles address other 
areas of animal care and treatment. 

The full Impact of some of our Initiatives 1s just beginning to be felt, but 
a climate for progress in ensuring proper treatment of laboratory animals 
has been established. Clearly, H.R. 5725 addresses the need for the kinds of 
Improvements we have been Implementing. We believe that we are on the road 
to meeting most of the bill's objectives under our current authority. The 
Initiatives on uniform enforcement and information sharing are especially 
significant strides being made administratively. 

Mr. Chairman, efforts by the Federal cowmunlty to see that animals used in 
research receive proper care suggest that these agencies should be able to 



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continue to monitor compliance of their own laboratories. Therefore, we 
see no need to expand the definition of "research facility" to Include 
Federal laboratories, to make them subject to APHIS registration and 
Inspection. 

Also, we believe the bill will Increase enforcement problems. For, example, 
deletion of the term "minimum" as the lower limit for standards of care would 
require new regulations. The term "minimum" has an established meaning and 
has proved to be enforceable In a court of law. We recommend the term be 
retained. Similarly, the added requirement of exercise for dogs could cause 
difficulty In establishing an enforceable standard. 

Mr. Chairman that concludes my remarks. We will be happy to respond to any 
questions you and the Subconmlttee members wish to ask. 



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STATEMENT BY 

JAHES B. WYNGAARDEN. M.O. 
DIRECTOR, NATIONAL INSTITUTES OF HEALTH 

Mr. Chairman and members of the Subcommittee, I am pleased to present to you 
this morning the views of the National Institutes of Health (NIH) on 
legislation concerning the care, treatment, and use of research animals and to 
describe to you some of the activities we have undertaken to address this 
issue. I am accompanied by Or. William E. Raub, the NIH Deputy Director for 
Extramural Research and Training. 

Let me begin by stating our general views on H.R. bJZ!^. I think the bill 
reflects a good understanding of some of the fundamental concerns and needs of 
the biomedical research community. It seems to have been carefully crafted 
after a thorough review of the Issues. In particular, we agree with its goal: 
namely, a system that provides for effective oversight of the use of animals 
In research; close Involvement of institutional committees with the animal 
care and use programs of those Institutions; training of administrators, 
scientists, and technicians in humane animal care; availability of infonnation 
about potentially useful methods and models which might reduce the number of 
animals needed for research; and adequate and effective coninuni cation with the 
public about the use of animals In research. We do not agree, however, with 
the premise that new legislation is needed to achieve that end. I am 
convinced that under existing law and administrative authority we are working 
effectively In pursuit of goals I know we share with you, others in the 
Congress, and the public. 

I-^want to acknowledge your efforts, Mr. Chairman, and those of your staff, in 
recognizing and attempting to take Into consideration in drafting this bill 
some of the concerns of the Department of Health and Human Services (HHS), 



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NIH, and members of the research comnunlty. We believe that when animal 
welfare legislation reflects a clear understanding of the needs of research It 
is In everyone's best interests. We remain convinced that the physical and 
mental health and well-being of this Nation depend on biomedical research, and 
that the use of live animals In such research will continue to be 
imperative. We cannot foresee a time when this will not be the case. 

At the end of last year, HHS submitted coninents to the Senate Agriculture 
Committee expressing concern about Senate bill 657, which is similar in many 
respects to H.R. 5725. Two examples of differences between S. 657 and your 
bill reflect your understanding of those earlier HHS comments. One concern 
was the use of the term "methodology," a concept we believe is easily confused 
with the concept of protocol. Research protocols should be established and 
reviewed by scientists witn expertise in the particular area of research in 
question. Your bill takes account of this concern both by using the term 
"practices" and by clarifying, appropriately, that the promulgation of 
regulations regarding experimental design is not authorized. Another concern 
was the arooiguous requirement for "adequate exercise" for all research 
animals. This would have created a problem relative to the establishment and 
enforcement of standards, since exercise requirements differ among species and 
with environmental conditions. Your bill limits this problem by confining the 
exercise requirement to dogs. 



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Turning to connents of a nor« general nature, Mr. Cha1nnan» I would like to 
reiterate that there Is already sufficient legislative and administrative 
authority to assure humane care and treatment and appropriate use of research 
animals. There Is also sufficient authority for appropriate action when 
Federal awardees fall to observe laws, regulations, guidelines, principles, or 
policies. The Animal Welfare Act, administered by the Department of 
Agriculture (USDA), applies to research Institutions. We believe that Its 
current authority Is satisfactory and allows the USDA to change procedures and 
standards as necessary. In addition, the Public Health Service (PHS) has used 
Its authority to promulgate policies and guidelines relative to animal welfare 
for Its own awardees. There Is sufficient flexibility under that authority to 
modify this policy as needed. 

To clarify this point a bit, I would like to describe briefly our current 
policies and procedures relative to awardee Institutions where animals are 
used in research. Under current PHS policy, as a condition of a PHS award for 
research in which vertebrate animals are used, the awardee institution must 
provide written assurance that it has established an animal care committee to 
oversee care and welfare of animals used in research. Every institution for 
which we provide funds for vertebrate animal research in fact has such a 
committee, composed of a minimum of five members, at least one of whom is a 
veterinarian. Institutions provide us with the names and qualifications of 
ttre committee members, and are required to keep us informed when committee 
membership changes. Every institution using vertebrate animals in research 



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must include in its written assurance, which is kept on file with the NIH 
Office for Protection from Research Risks, a statement that the institution is 
committed to following the principles and guidelines of the NIH Guide for the 
Care and Use of Laboratory Animals (the Guide ). About one-third of these 
institutions have sought and received accreditation from the American 
Association for Accreditation of Laboratory Animal Care (AAALAC), the best 
evidence, we believe, of full compliance with our Guide. The remaining 
institutions are either in full compliance with the Guide as determined by 
their animal care committees or are working toward compliance. 

Let me Just mention that our Guide is generally acknowledged as being a 
standard of animal care and treatment. It is updated periodically to reflect 
the "state of the art" in animal care. In fact, the Guide is now being 
revised, under contract from NIH, by the National Academy of Sciences 
Institute for Laboratory Animal Resources. The revision will be published 
next year. 

In terms of compliance with our PHS animal welfare policy and with our Guide. 
as in other Matters, NIH has relied on an assurance system. We believe that 
the most effective way to ensure proper laboratory animal care is to place 
responsibility squarely on the shoulders of researchers and officials at 
institutions where animals are being used. This must be a full-time concern, 
and only those at the institutions are there full-time. We have not felt the 
need to establish a system of routine inspections— a system which would in 



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many wa^s duplicate activities of other agencies, including the USOA, and for 
which we do not have the necessary resources. We know that the Congress and 
the public have not always shared our confidence in the effectiveness of our 
system. We are also aware that even one report of a violation causes 
criticism to increase. Because of our awareness of your concern and that of 
the public, and because we believe the public trust Is important, we have 
Initiated and participated in a number of activities designed to evaluate our 
assurance system; tighten our animal welfare policy; and enhance our 
coninuni cations with the public, with our awardees, and with other government 
agencies having similar responsibilities for animal care and treatment. 

I would like to spend a few moments describing some of these activities, which 
I think Illustrate that we have adequate legislative authority and are willing 
to take positive action which can benefit the animal subjects of research 
while preserving the Integrity of the scientific process. 

In the NIH intramural program, we recently Issued a new ai recti ve on the care 
and use of laboratory animals. This document stipulates that each NIH 
Institute must have an animal research committee to advise the Institute's 
Scientific Director on the care and use of laboratory animals, review research 
proposals, and conduct animal care and handling training programs for 
Investigators and technicians. The committee is composed of five members, 
intluding a veterinarian who actually attends the animals in that Institute 
and a nonscientist from outside the Institute. 



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In the spring of 1983, we participated with the Food and Drug Administration 
(FDA) and the USDA in the development of a Hemoranduro of Understanding 
designed to Increase Interagency comnunl cations with respect to deficiencies 
related to animal care and treatment. We recognized that previous 
comnunl cations had been Inadequate, and that these agencies, with their 
inspection responsibilities, could be very helpful in calling attention to 
problems. We expect that comnuni cation will continue to improve because we, 
the FDA, and the USDA have a commitment to improve it. We know we must talk 
to each other and I assure you, Mr. Chainnan, that we will continue to do so. 

Over the summer of 1983, NIH site-visited a small sample of randomly selected 
awardee institutions. The purpose of these visits was not to evaluate tvtry 
institution's animal program comprehensively but to assess the viability of 
our own assurance statement system. The visits were organized by the NIH 
Office of Extramural Research and Training and Included members of intramural 
and extramural staffs and outside consultants, including veterinarians. There 
were two significant findings of the site visits: no abuses of animals were 
found, and our assurance statement system and our animal welfare policy were 
determined to be good but not perfect. As a result, we made several 
decisions. 

Flirst, we decided to continue a small program of random site visits. Indeed, 
another series of five was completed about three weeks ago. Again, these 



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visits are not to duplicate or replace the unannounced Inspections of the USOA 
Animal and Plant Health Inspection Service (APHIS). They are designed to 
continue to emphasize to our awardees that their assurance statements are 
essential and must accurately reflect the status of the institutions' animal 
care and treatment programs. Through such site visits we will continue to 
assess the effectiveness of our assurance system and identify any problems 
which roa^ develop with that system. 

Second, we have proposed a revision of the PHS policy on animal welfare, 
strengthening the policy in accordance with suggestions of site visit team 
members and suggestions made to us through various means by the Congress and 
the concerned public. We published the proposed revision in a special edition 
of the NIH Guide for Grants and Contracts in April 1984, and solicited public 
comment both in writing and at three public hearings in Kansas City, Boston, 
and Seattle, iite received over 300 comments from researchers, institutional 
officials, humane organizations, and individual citizens. We are currently 
analyzing those comments and will publish a final version of the revised 
policy after taking into account the views of all who commented. We expect 
this process- to be completed by early next^ar. 

Let me just highlight a few aspects of the proposed revision that relate 
particularly to H.R. 5726. Our proposal would require that institutional 
an4mal research committees (1) include a member not affiliated with the 
institution, and a nonscientist; and (2) be involved to some extent in the 



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review of proposed research protocols, with an objective being to determine 
that the care and use of the animals are In compliance with the Guide and 
other applicable regulations. I might mention, Hr. Chalnnan, that we have 
received a great deal of comment on this latter aspect of the proposed 
revision. As you might imagine, it was one of the more controversial 
aspects. The proposed revision would also require a more frequent updating of 
institutional assurance statements, and a specific timeframe for complying 
with the NIH Guide , for those institutions that do not have AAALAC 
accreditation. 

Next, we embarked on an education campaign which began with a two-day National 
Symposium in April of this year and will include a series of regional 
workshops dealing with the PHS animal welfare policy, directed primarily to 
institutional animal research committees and research administrators; 
development of a guidebook for animal research committees; archiving of 
available audiovisual material related to humane research procedures, animal 
care and handling, etc., and development of new ones; and preparation of 
printed materials to increase public understanding of animal use in 
research. 

Concern about animal welfare frequently leads to discussion of the extent to 
which the use of animals can be reduced. The NIH Division of Research 
RSources has funded a series of workshops, sponsored by the National Academy 
of Sciences, on the subject of what are sometimes termed "alternative" or 



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"adjunct" methods of research. The workshops, which were completed In late 
summer, brought together scientists from many disciplines, to discuss such 
topics as cell culture methods, mathematical/computer modeling, and the use of 
lower organisms In research. These workshops served to make many more 
scientists aware of various research methods and models that might now or In 
the future be available for particular kinds of research activities. It Is 
expected that the forthcoming report of the National Academy of Sciences will 
Include recommendations regarding the funding of research In the development 
of promising models and methods. NIH Is funding such research and Is ready to 
expand Its efforts Into promising new areas. 

In closing, Hr. Chairman, I want to say that we are convinced that 
researchers, with rare exception, respect animals as unique and valuable 
resources, use them prudently, and do not abuse them. Further, we at NIH are 
committed to the humane care and treatment of research animals and to their 
appropriate, thoughtful, and careful use. The same commitment Is expected 
from our awardee Institutions. 

Thank you. 

I would be pleased to answer any questions you ma^ have. 



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AAU 

N/ISULGC 

ACE 



TESTIMONY BEFORE THE SUBCOMMITTEE ON DEPARTMENT OPERATIONS, 

RESEARCH AND FOREIGN AGRICULTURE OP THE HOUSE 

AGRICULTURE COMMITTEE 

ON H.R. 5725, 

"IMPROVED STANDARDS FOR LABORATORY ANIMALS ACT" 



ON BEHALF OF 

ASSOCIATION OF AMERICAN UNIVERSITIES 

NATIONAL ASSOCIATION OF STATE UNIVERSITIES 

AND LAND-GRANT COLLEGES 

AMERICAN COUNCIL ON EDUCATION 



DELIVERED BY DR. GERALD VAN HOOSIER, JR. 

PROFESSOR AND DIRECTOR, AND ATTENDING VETERINARIAN 

DIVISION OF ANIMAL MEDICINE 

(PROFESSOR, DEPARTMENT OF PAHTOLOGY) SCHOOL OF MEDICINE 

UNIVERSITY OF WASHINGTON, SEATTLE, WASHINGTON 



SEPTEMBER 19, 1984 



Association of Amsrican Universitiss. One Dupont Circle. Washington, DC. 20036 (202) 466-5030 

National Association of State Universities & Und-Grant Colleges, One Dupont Circle. Washington, D.C. 20036 (202) 293-7120 



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Mr. Chairman and Members of the committee, my name is Gerald 
Van Hoosier. I am the attending veterinarian and Director and 
Professor of Animal Medicare at the University of Washington. 
Thank you on behalf of the Joint Committee on Health Policy of 
the Association of American universities, American Council on 
Education, and the National Association of State Universities and 
Land-Grant Colleges, for the opportunity of appearing before your 
subcommittee this morning to discuss an issue of major concern: 
the use of animals in research. I would be remiss, Mr. Chairman, 
if I did not take a few moments of my allotted time to note some 
reluctance on the part of our universities to raise questions 
about this legislation, given your extraordinary record in the 
Congress these past many years in behedf of science research and 
higher education generally. We see this bill as a thoughtful 
attempt to address important issues about the care and treatment 
of animals in research. That objective is laudable and we are 
prepared to try to assist in making it succeed. We take this 
opportunity, however, to state some basic principles. 

First, Mr. Chairman, we believe, as you do that wise 
legislation should be based on as much information as may be 
gathered on the subject in question. During almost this entire 
Congress, both the House and Senate committees responsible for 
biomedical research have had pending a proposal for an eighteen 
month study, conducted by an organization like the National 
Academy of Sciences, to look into all aspects of the uses of 
animals in research and to make recommendations for such 



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legislation as may be needed to assure that high standards are 
maintained. Some of our colleagues in the animal welfare 
community have said that studies are a stall. Had we full 
support from all sides of this issue on that study, it could have 
been completed by this time. We maintain that absent such a 
study, any proposed legislation is subject to responding to 
mistaken perceptions that could require legislative amendments 
after avoidable problems have been generated. 

Second, the National Institutes of Health is engaged in the 
consideration of a revised set of guidelines governing the use of 
animals in research. All interested parties were invited to 
comment on these proposed guidelines. The final product should 
represent a balanced approach to this complex issue. We question 
whether legislation at this time, until those new guidelines are 
finalized and tested in the field, is prudent. Differences 
between the guidelines and the legislation, however uninten- 
tional, could cause confusion and delay reaching precisely the 
objective called for by the animal welfare communities. 

Third, we believe that it has been generally understood by 
the Congress and the genered public that animals are used in 
research because it is necessary in order to improve the health 
of humans and animals. While adjunct methods have been developed 
in recent years and the numbers of animals used in research 
decreased* fundamental elements of biomedical research will 
always require the use of animals. We do not believe the word 
"alternatives" is reasonable. It is not fair nor accurate to 



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hold out the promise that there are*or will be^research substi- 
tutes for animals- other than other human beings. In addition, it 
is important to note that such adjunct methods typically are 
developed through the conduct of research, not through research 
on methods of research. Congress, representing the citisenry, 
wants better forms of heart surgery, wants new disease preventing 
vaccines, wants new cures for old diseases. It would seem 
appropriate when there are all sorts of attacks on the use of 
animals in research, that the Congress, on behalf of the Nation, 
state as a matter of public policy the reality that, if we are to 
make continuing progress in the Nation's health, the use of 
animals is imperative. It would help too, to have the Congress 
denounce recent behavior, sometimes criminal in nature, to 
disrupt centers of science research because animals are being 
used. 

Mr. Chairman, I am a veterinarian and a scientist, and like 
my colleagues in this profession, have dedicated myself to the 
care and treatment of animals. I would not be associated with 
any enterprise in which animals were treated carelessly or 
indifferently, where pain was not prevented wherever possible or 
not treated if possible. 

It should be understood that animals used in research must 
be healthy and cared for if the research conducted is to be 
reliable and useful. Allegations of general mistreatment of 
animals in research are devoid of factual basis. While we operate 
in restricted circumstances, with restricted funds, iiq>rovement8 
not only can be made, but are being made regularly at academic 



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health centers where research is conducted using animals. Such 
improvements in facilities are necessary to the science and for 
the humane and proper care of animal subjects. Neverthelessr 
these improvements require resources that are not always avail- 
able. The Committee is aware of the limits of such resources and 
the legitimate claim of many to them. A mandate to provide 
"state of the art" facilities for research animals, without funds 
to accomplish this, would require a shifting of resources from 
other-perhaps equally essential, functions. 

It IS not difficult to find ways to significantly improve 
the application of current standards. As you know, APHIS is 
mandated to conduct inspections of facilities using animal 
research. Little else would be needed to achieve the Congressio- 
nal goal of better over site than to provide APHIS with adequate 
funding annually. There are too few inspectors, and too few of 
them able to devote themselves to the area of animal welfare. It 
may well be that we do not need more legislation, just more 
support for inspection and training. 

We believe the current animal welfare act along with NIH 
standards is adequate to meet reasonable standards of care for 
animals in research. New legislation may not be necessary. In 
addition, there is no reason to believe that the new legislation 
would be enforced any better than present law, absent adequate 
support for APHIS. 

We will not undertake, in this testimony, to offer a 
detailed analysis of the various points in the proposed legisla- 
tion that we would like to have clarified and modified. If it 



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would prove helpfulr we will submit such an analysis for the 
record. There are however, a few issues that are of particular 
concern. First, the scientific community is zealous in protecting 
against federal officials intruding in the actual conduct and 
design of research proposals. We believe Section 4(c) of the 
bill would reduce current prohibitions on such interference. 

Further, in 4(c) (A), there is a requirement for research 
scholars to show that they have considered alternative to 
procedures that may cause distress to animals used in research. 
We doubt that there is any reasonable way in which investigators 
could demonstrate this without extraordinary consumption of time 
on their behalf: it is difficult to prove a negative. Also of 
concern is Section4(2) that, while written as a restriction on 
the federcd privilege of preemption, provides an invitation to 
states and local governments to introduce their own regulations 
governing animal care. Finally, while the presence of an outside 
member an the animal research committee is accepted by many of 
the members of the associations I speak for today, we believe the 
definitive requiring an outside member who is "responsible for 
representing the concerns of the community regarding the welfare 
of animal subjects", will cause unnecessary confrontation between 
the institutions and individuals and groups in the community. 
Mr. Chairman, we appreciate the opportunity of presenting our 
views regarding your bill. I would be pleased to respond to your 
questions and our associations welcome the opportunity to con- 
tinue further discussion on legislation in this area. 



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Statement of Dr. John McArdle 
Director, Laboratory Animal Welfare 
The Humane Society of the United States 

MR. CHAIRMAN AND MEMBERS OF THE COMMITTEE I am Dr . John 
McArdle, Director of Laboratory Animal Welfare for The Humane 
Society of the United States (HSUS) . In representing The HSUS, I 
also represent our constituency of 300,000. I was trained as a 
researcher and earned a Ph.D. in Anatomical Sciences at the 
University of Chicago. I have devoted ten years to the study of 
animals in research, from teaching biology and anatomy to 
university students, to my current position of advocate for 
laboratory animals. I am the author of two books and several 
scientific papers on primate functional anatomy. 

The reduction of pain and suffering endured by animals used 
in research in this country is a top priority for The HSUS, as is 
the promotion of research into the development of techniques that 
would ultimately eliminate the need for laboratory animals 
altogether. Thus, it is in the spirit of humane science that I 
offer my comments. 



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Dr. John McArdle 
September 19, 1984 
Page 1 



It is now well established that the physical and behavioral 
environment in which laboratory animals are bred, raised, 
transported and housed (before, during and a£ter any research, 
testing or educational procedures) has a direct, often major, 
influence on the physiology, biochemistry and behavior of those 
animals. Essentially everything the animals experience has a 
real or potential impact on the validity of results from each 
research project. Under the present system of laws, regulations 
and agency "guides,** researchers must assume that published data 
and grant proposals involve laboratory animals that received 
appropriate optimal care, and that the studies are not biased by 
poor experimental design, inadequate care and maintenance, abuse, 
neglect, pain or distress of the research animals. Furthermore, 
any attempt to compare experimental results between two or more 
institutions must assume equivalent, optimal care in each 
laboratory. The Humane Society of the United States (HSUS) 
believes the present system of regulations, inspections', 
assurances and peer review has failed in a significant number of 
cases to provide uniformly proper care of animals used in 
biomedical research (e.g. the cases of (1) Dr. Edward Taub and 
(2) the University of California-Berkeley). By allowing less 



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McArdle 
Page 2 



than optimal care of laboratory animals, the existing system has 
the potential to invalidate or limit the usefulness of taxpayer- 
funded biomedical research. The existing system may endanger the 
public health with faulty tests and experiments and present an 
unacceptable ethical cost, resulting from potential neglect or 
abuse of research animals. We believe H.R. 5725 will alleviate 
some of these concerns and encourage appropriate use of federal 
tax dollars supporting appropriate biomedical research. 

The existing Animal Welfare Act and National Institutes of 
Health (NIH) Guide both stress minimally acceptable standards of 
care and maintenance. This is not sufficient to establish and 
maintain normal physiological or behavioral parameters. We 
strongly request a change in emphasis from simply "requirements" 
to "proper" requirements. Furthermore, we vigorously urge that 
"proper" be interpreted to mean species-specific needs and that 
"behavioral needs" be added to the list of variables covered by 
the improved standards. There is no justification for the common 
practice of placing a heterogeneous population of animals species 
into a homogeneous laboratory environment. In their natural 
habitats, these animals have well-defined, species-specific 
characteristics. These are not lost when the species are 
domesticated or confined in research laboratories. Most 
institutions presumably already have the presently required 



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McArdle 
Page 3 



minimum standards. If they do not, then the research conducted 
in their laboratories has questionable validity. 

As is obvious from human clinical experience and modern 
veterinary practice, lack of exercise or activity produces a 
variety of physical and behavioral pathologies, and retards 
healing in response to accidentally or experimentally induced 
injuries. We strongly endorse the long-overdue recognition that 
research animals need physical exercise in order to maintain 
normal baseline physiology and behavior. This requirement should 
not be limited to dogs, but should apply to all species (as 
appropriate). One method to facilitate this new requirement is 
to allow research animals the opportunity to engage in their 
natural behavioral repertories. 

Although the value of proper post-surgical and nursing care 
is a basic tenet of modern veterinary practice, it is not 
univerally characteristic of biomedical research laboratories and 
is often absent in testing laboratories, whose goals usually are 
to allow the animals to die as a consequence of the testing 
protocols. As a graduate student in anatomical sciences, I was 
routinely told that post-operative nursing care and use of 
analgesics for my experimental animals (which were involved in 
surgical procedures) was not a serious concern. Revelation of 
the problems in the laboratories of the Unversity of California 



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McArdle 
Page 4 



in Berkeley (see Appendix) unequivocally established that the 
existing laws, regulations, inspections, NIH assurances and NIH 
peer review procedures are unable to identify or prevent the 
grossly inadequate conditions and lack of proper veterinary and 
nursing care at that institution. H.R. 5725 requires the formal 
recognition of these needs and provides the means to ensure their 
implementation. Since such procedures will improve both the 
quality and reliability of taxpayer-supported biomedical 
research, we do not understand any rationale for opposing their 
implementation. 

The HSUS continues to be amazed at the extent to which some 
representatives of the biomedical research and farming 
communities consistently misrepresent the content and intent of 
H.R. 5725. This legislation clearly differentiates between 
interference in the intellectual freedom of inquiry of the 
individual researchers (a theoretical function of the existing 
peer review system) , and oversight and review of the treatment 
and care of animals used in biomedical research. Few scientists 
have sufficient experience or knowledge in such areas as 
veterinary medicine, anesthesiology, and ethology to adequately 
provide for and monitor the care of their laboratory animals. 
This is a valid area of concern for the Secretary, APHIS, and the 
veterinarians employed to inspect for compliance with the proper 



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McArdle 
Page 5 



standards included in H.R. 5725. This proposed legislation 
specifically states: 

Nothing in this Act shall be construed as authorizing the 
Secretary to promulgate rules, regulations or orders with 
regard to design of research, outlines, or guidelines of 
actual experimentation by a research facility. 

Scientists are still free to propose any research protocol. H.R. 
5725 will only act to ensure that proper maintenance and care of 
laboratory animals are included. This is a prerequisite for any 
valid research project and should be supported by the scientific 
community. 

It is often stated that NIH suggestions in their "Guide for 
the Care and Use of Laboratory Animals," peer review, and annual 
reports of compliance by grantee institutions are sufficient to 
ensure proper care and treatment of laboratory animals. However, 
NIH only interacts with approximately half of the laboratories 
registered to perform animal experimentation. Obviously, the 
minimally acceptable standards of NIH are not universally applied 
in the United States research community. Further, a common 
complaint heard, even within the research community, is that NIH 
does not apply its own standards to its own labs. In addition. 



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McArdle 
Page 6 



those labs receiving funding froa NIH are not subject to routine 
inspections to verify their written assurances. As an initial 
attempt to reduce biasing factors in bioaedical research, %re 
strongly believe that the proper standards included in H.R. 5725 
need to be applied to all institutions and federal agencies using 
laboratory animals in basic research, product testing and 
education. 

The single, most significant portion of H.R. 5725, that 
which distinguishes it from the presently inadequate system and 
which assures compliance and uniformity of proper laboratory 
animal care, is the requirement for an Animal Studies Committee 
(ASC) and the structure of that committee. There are several key 
features of the proposed ASC which we very strongly endorse. 
These include: 

1. At least one member is not affiliated with and thus not 
biased or obligated to the research facility. The only possible 
mechanism to ensure compliance with the newly required proper 
standards of care, and that the public's legitimate concerns 
about laboratory animal welfare are considered, is to have such 
an individual, responsible for representing the local 
communities* interests. Since the public pays for this research 
and testing with its consumer and tax dollars, and supposedly 



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benefits from those uses of laboratory animals. The HSUS believes 
it is time to open the research establishments to the refreshing 
light of public accountability. We request, however, that the 
composition of the committee be determined by a percentage of 
each type of representative. Rather than at least 1 of 3 be 
unaffiliated, we prefer that 1/3 be so designated. This will 
avoid having the veterinarian and outside "conscience" 
representatives being overwhelmed by the larger committees (with 
memberships of 10 to 20 individuals). Further, membership on 
such committees should be opened to University students, as well 
as animal care technicians, who are the only individuals with 
detailed, daily knowledge of the animals housed in each facility. 

2. The committee should meet regularly and not on a schedule 
dictated by a single individual (i.e. the chairperson). If a 
serious problem arises any member of the committee should be able 
to schedule a meeting. 

3. At a minimum, the committee should inspect all areas of the 
institution involved in the use of laboratory animals semi- 
annually. These inspections must be unannounced and include the 
individual research laboratories. The former is necessary to 
avoid simple ritual visits of temporarily sanitized and 



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cosmetically acceptable facilities. The latter would prevent the 
practice of individual researchers secretly maintaining animals 
in their laboratories in order to avoid paying per diem charges 
to a central animal facility or raising animals in the basements 
of their homes. For example, both have occured at the University 
of Cincinnati. Unless identified, these animals have no 
protection under existing laws and regulations, regardless of the 
species involved. We would further urge that the Secretary 
authorize inspectors to examine individual research laboratories 
rather than myopically restricting their activities to central 
animal rooms and facilities. 

4. As now proposed by the NIH, the committee should review 
research methods, protocols and practices to ascertain if 
investigators are properly addressing such issues as humane care, 
behavioral needs, veterinary practices, anesthesia and 
analgesia. As clearly stated in H.R. 5725, this is not done to- 
intrude on the individual scientist's freedom of inquiry or 
scientific decisions, but to "ensure that animal pain and 
distress are minimized." 



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5. The provision to allow for filing of minority opinions is 
important and must be maintained. This is the only mechanism to 
ensure that serious violations will not be covered-up by a 
majority vote of the committee. Further, we strongly believe 
that the committee reports must be available for inspection by 
the public, to ensure compliance and that the outside member is 
actually reflecting the interests of the local community. 

The University of Southern California (USC) presently has a 
committee with a structure and role similar to that proposed in 
H.R. 5725 and the HIH. The existence of this committee has 
neither slowed nor impeded the biomedical research activities at 
USC, but has introduced the concept of ethical responsibilities 
to their biomedical research community. 

On August 3, 1983 Professor K.J. Obrink from the Uppsala 
Biomedical Center addressed the International Council for 
Laboratory Animal Science on the Swedish system for eoMpulsory 
ethical examination of animal experiments. His abstract notes 
thatt 

Since 1979 it is compulsory for Swedish scientists to 
let a local ethical committee examine animal research 
projects before they start. The initiative was taken by 
scientists in Uppsala, in 1976 with a pilot experiment that 



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included Uppsala University, the Swedish University of 
Agricultural Sciences, several state institutions and one 
pharmaceutical industry. 

The conunittee was and is composed of scientists, 
technicians and laymen. The idea was that the committee 
should advise the applicant and be his or her extended 
conscience. A project can be started after approval of a 
small group of three members of the committee. The committee 
itself is very large so that members should be available at 
all places where animal experiments are performed. It was 
hoped that bureaucracy in this way could be avoided. 

The experience as a whole is good. It has improved the 
communication between laboratory and society. The scientists 
express a positive attitude. 

We fail to understand why the United States biomedical 
research community so adamantly seeks to maintain the existing 
closed-door attitudes with regard to public knowledge and 
participation in local research activities. In addition, we 
believe the general public should have input through the vehicle 
of civil enforcement suits. We recommend the following additions 
to H.R. 5725: 



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Sec. -Civil Enforcement Suits 

(a) Any person may commerce a civil suit on his own behalf 
or on behalf of any animal protected by this chapter, to 
compel the secretary to apply and enforce the provisions of 
this chapter. 

(b) The district courts shall have jurisdiction, without 
regard to the amount in controversy or the citizenship of the 
parties, to order the Secretary to take any action necessary 
to apply and enforce the provisions of this chapter. 

(c) The Court, in issuing any final order in any suit 
brought pursuant to this section, may award costs of 
litigation (including reasonable attorneys fees and expenses, 
and expert witness fees and expenses) to any party, whenever 
the court determines such awards are appropriate. 

(d) The relief provided by this section shall not restrict 
any right to other or additional relief which any person may 
have under any statute or common law. 



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The requirement that the comnittee establish annual sessions 
for training in hunane methods of animal maintenance and 
experimentation, concepts of alternatives to traditional methods 
of research, and utilisation of the newly established information 
services at the National Agricultural Library is excellent and 
will counter the general level of ignorance on these subjects. 
We believe attendance at these sessions should be mandatory for 
all scientific staff and graduate students. Animal care 
technicians and other general staff should attend the sessions on 
humane care. Since jresearch faculty often automatically resort 
to the traditional animal model approach to answering biomedical 
questions, they need exposure to currently available alternative 
methodologies. Efforts to minimise the numbers of animals used, 
the degree of pain or suffering, and to seriously assess the 
available alternatives, should be part of all graduate student 
training and research faculty attitudes. A formal, mandatory 
series of courses could remedy tnis situation. Longevity of a 
researcher or a research program does not automatically correlate 
with substantial knowledge of the proper needs of the laboratory 
animals or to advances in relevant alternative techniques. 

There is no evidence that establishment of an ASC would 
entail significant new costs to research facilities or their host 
institotions. Ntabership on such A8Cs can be considered part of 



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a faculty member's normal committee responsibilities, which are 
generally done gratis. The requirement for a new series of 
courses could be included in the normal teaching load of the 
respective faculty members on the ASC. 

We strongly endores the provision protecting the employment 
of any individual who reports violations at their respective 
institutions. We routinely receive information on problems at 
individual research laboratories. Without exception, these 
individuals request anonymity because they fear losing their 
positions. '' 

The establishment of an information service at the National 
Agricultural Library should improve the quality and reliability 
of biomedical research in the United States by providing 
information on alternatives that reduce or replace animals 
traditionally utilized in research, refinement of existing 
techniques and procedures to minimize pain and suffering and 
focus on the increasingly serious problem of research funds and 
animals wasted in "unnecessary duplication of animal 
experimentation." Although replication is a fundamental 
principle of experimental science, interminable repetition and 
parametric tinkering are not. 



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We believe such a center would accomplish several positive 
goals, including: 

1. Conservation of research money by careful examination of the 
relevant issues in the planning of research proposals. By always 
attempting to utilize methods that minimize the numbers of 
animals required, the cost of individual projects could be 
reduced. 

2. Many of the presently available alternative techniques are 
more reliable and more time and cost effective than the 
traditional methods,. Animal tests for carcinogens can take three 
and a half years and half a million dollars to complete. Use of 
comprehensive non-animal alternatives would provide identical 
protection and take only three months at a cost of only 
$25,000. This is an example of the power of the alternative 
techniques. When properly developed and applied, such methods 
provide the needed information, while more efficiently utilizing 
the available research funds. 

3. Provide a mechanism to avoid funding unnecessary duplication 
of experiments, thus freeing money for valid, new studies that 
may provide new information, rather than encourage further 
insignificant parametric tinkering in fundamentally similar 
projects. 



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Although the biomedical research community claims that the 
existing peer review system addresses the issues raised in H.R. 
5725, there is well-documented evidence that this is not 
correct. We have compiled a comprehensive "Evaluation of Awarded 
Grant Applications Involving Animal Experimentation", which 
examined funded biomedical research projects to determine if 
scientists receiving federal funding for their research 
considered humane perspectives in their applications. Using the 
National Institute of Mental Health as an example, we found that 
only 62 percent of the grantees considered the appropriateness of 
the animal models selected for their projects, 41 percent 
discussed the applicability of alternatives to vivisection, 57 
percent considered the efficiency of animal use (i.e. selection 
of the appropriate species and methods to minimize numbers used), 
and less than 45 percent described the adequacy of their research 
facilities to maintain laboratory animals and to minimize the 
stress to which they were exposed. Even if grantees were honest 
and thorough, the information needed by the peer review panels 
was not generally present. 

There are five distinct points at which the peer review 
system could significantly affect the treatment and use of 
laboratory animals. The process of preparing, submitting and 
reviewing grant proposals is the most obvious point of 



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influence. Additional pressure could result from: (1) direct 
observations of laboratories and animal facilities by research 
colleagues; (2) the selection and discussion of papers presented 
at professional meetings; (3) evaluation of papers submitted for 
publication in scientific journals; and (4) consideration of 
promoting research faculty to tenured positions. 

Despite the many opportunities for the peer review system to 
address the concerns discussed in H.R. 5725, it is not being 
done. However, the peer review process will become more 
effective as a result of the certification required on page 1, 
section (c) that the appropriate aspects of individual 
experiments concerning care and treatment of animals must be 
addressed. In particular, we strongly support the requirement 
that every research proposal to a federal agency contain: 

1. detailed justification for "any procedure likely to produce 
pain or distress" and evidence that all possible alternatives to 
that procedure were considered. This should include a detailed 
explanation for the rejection of any of these alternatives. 
Although there may be technical disagreements on how to measure 
pain, its presence is easily recognized and can be scaled with 
respect to relative intensity. 



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2. evidence that a qualified veterinarian participated in the 
planning of the project. 

3. assurances that proper anesthetics, analgesics, 
tranquilizers, and post-operative medical and nursing care. 

4. assurances against unnecessary survival surgery. 

We strongly endorse the mandated use of analgesics and 
requirements for post-operative medical and nursing care. These 
aspects of proper laboratory animal care are routinely ignored in 
many research laboratories. However, we are concerned by section 
(D) , (iv) , page 5. We recommend it be reworded as follows: 
"(iii) against use of paralytics without surgical levels of 
anesthesia confirmed by central nervous system monitoring; and" 

The use of paralytics without full, surgical levels of 
anesthesia must be banned. Further, the Act should require that 
central nervous system activity be monitored throughout any 
procedure combining paralytics and anesthetics. This is the only 
acceptable method to avoid the situation where an animal regains 
consciousness, but is still paralyzed and thus experiencing 
intense pain from the surgical procedures. 

In its present form. The Humane Society of the United States 
supports H.R. 5725. We note only one major deficiency. As with 
the present Animal Welfare Act regulations, the provisions of 
H.R. 5725 would not apply and do not require the Secretary to 



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extend protection to all warm-blooded animals used in research. 
Currently, the Secretary chooses by regulation to specifically 
exclude rats, mice, and birds. At the present time 85 percent 
the 70 million laboratory animals killed annually in United 
States research and testing facilities are excluded from any 
legal protection. We will accomplish little if H.R. 5725 does 
not include these voiceless and unprotected animals within its 
provisions. 



(The appendix is held in the committee files.) 



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STATEMENT 



OF THE 



ASSOCIATION OF AMERICAN MEDICAL COLLEGES 

on H.R. 5725 
"Improved Standards for Laboratory Animals Act" 

Mr. Chairman and Members of the Subcommittee: 

I am Dr. Glenn Geelhoed, Associate Professor of Surgery and Director of 
the Suryical Research Laboratories and Transplantation Division of the George 
Washington University. I am pleased to be here today to speak on behalf of 
the Association of American Medical Colleges (AAMC) and the National Society 
for Medical Research (NSNR), and I am grateful to the Subcommittee for this 
opportunity. 

Serving as the national voice for the nation's 127 medical schools, over 
400 U.S. teaching hospitals, and over 70 academic and professional societies, 
the AAMC represents the largest single component of the nation's biomedical 
and behavioral research enterprise. Because the constituencies of both the 



Presented by Glenn u. Geelhoed, M.D., Associate Professor of Surgery and 
Director of the Surgical Research Laboratories and Transplantation Division of 
the George Washington University, before the Department Operations, Research, 
and Foreign Agriculture Subcommittee of the House Committee on Agriculture, 
September 19, 1984. 



Association of American Medical Colleges / One Dupont Circle, N.W. / Washington, D.C. 20036 / (202) 828-0525 



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AAMC and the NSMR are completely devoted to the humane care and use of labora- 
tory animals and to the conduct of research under optimum scientific and ethi- 
cal conditions, we have considerable interest in H.R. 5725, The Improved Stan- 
dards for Laboratory Animals Act. 

Mr. Chairman, at the outset we would like to acknowledge with apprecia- 
tion your significant contributions to science during your tenure in Congress. 
While we recognize the considerable effort of you and your staff in improving 
the language contained in s. 657, the companion Senate bill introduced by 
Senator Dole, we regret that we cannot offer our full support for H.R. 5725 at 
this time. 

Laboratory animals play a central and critical role in biomedical and 
behavioral research in that virtually no major advance in medical science 
could have been achieved without the basic knowledge gained through research 
Involving animals. However, over the past several years the research enter- 
prise in this nation, which has been spectacularly successful in determining 
the causes and cures of many fatal and debilitating diseases, has been under 
steady attack by many organizations. These groups, in their legitimate yet 
naive concern for the well-being of laboratory animals, have painted an ex- 
tremely unfair and distorted picture of what occurs in our nation's research 
institutions. By citing infrequent and extreme examples, they have created an 
unjust image of research laboratories as torture chambers where animals are 
mistreated and neglected. As a result, these organizations have been able to 
lend credibility to efforts encouraging the adoption of governmental policies 
that would seriously impede the progress of one of our nation's most treasured 
resources — its biomedical research enterprise. 



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It cannot be denied that there have been incidences In some research In- 
stitutions of non-compliance with existing animal care guidelines; but these 
have been Isolated and few and far between, while strict compliance has been 
the rule In a very large national research program involving hundreds upon 
hundreds of Institutions. The scientific community, as much as the animal 
rights organizations. Is disturbed over these instances and hopes that the 
problems will be eradicated through better enforcement of existing guidelines 
and through continued reliance on the competitive technical merit and program 
relevance peer review system of the NIH. Scientists, too, have a vital stake 
in the welfare of laboratory animals. To them, animals are a precious com- 
modity to be treated with respect and humaneness not only for ethical and 
moral reasons, but also for scientific and economic ones. Only healthy, well- 
cared for animals provide valid data; also, laboratory animals are increasing- 
ly expensive to obtain and maintain. Thus, the consequence of failure to 
treat animals with the utmost care is doubly expensive, invalid experimental 
data. 

There are three very compelling reasons why the enactment of H.R. 5725, 
or any other restrictive animal research legislation, would be premature at 
this time. These arguments require elaboration before we express specific 
concerns with some of the provisions of H.R. 5725. 

First, because we are not aware of any grave systematic deficiencies that 
exist within academic medical centers and research institutions in the care 
and treatment of lab animals, we feel that it is extremely unfair to enact 
legislation that will severely restrict the conduct of research Involving ani- 
mals. On numerous occasions, the research community has expressed support for 
a comprehensive study (as proposed in S. 964) to determine definitively what 
problems, if any, exist in this area. A detailed study, containing valid and 



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quantifiable data, would provide Congress with the necessary InforMtlon to 
determine the need and content of future legislative activities In this very 
complex area. Absent such data, we see no need to enact legislation which 
will substantially alter the conduct of research In our Institutions, 

Secondly, we question the wisdom of enacting H.R. 5725 until the current 
law governing animal welfare Is better enforced. The Animal and Plant Heath 
Inspection Service (APHIS), the government agency charged with enforcing the 
Animal Welfare Act, has rarely. If ever, been provided with sufficient resour- 
ces to ensure adequate compliance with the law. This Is a conclusion on which 
there is complete agreement between the animal welfare organizations and the 
research community. The inspection service of the animal welfare program 
within APHIS is critical to the enforcement of the Act and in ensuring that 
laboratory animals are treated humanely. 

Much higher appropriations are needed for APHIS to fulfill Its statutory 
inspection responsibilities. Currently, only 6 of the 485 animal Inspectors 
in APHIS are full-time, and the remaining 479 inspectors, because of limited 
resources, are only able to devote 6% of their time to the area of animal wel- 
fare. Considering that APHIS is responsible for over 3,000 research facili- 
ties in the United States, it is clear to us that its animal welfare program 
is severely overburdened, underfunded and understaffed. A strong national 
animal Inspection service, with a cadre of well-trained, well -coordinated pro- 
fessionals to reassure the public that animals are adequately protected. Is In 
the national Interest. We therefore strongly believe that before any new 
legislation Increasing the responsibilities of APHIS Is enacted, the agency 
should be significantly strengthened with more personnel and more funds. Only 
then can a valid determination be made as to the necessity for further 
restrictive animal legislation. 



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Thirdly, Me believe that Congress should postpone the enactment of any 
animal welfare legislation until all efforts within other governmental agen- 
cies to develop and revise existing guidelines and principles for animal care 
are completed. Currently, the Public Health Service, the Interagency Research 
Animal Committee, and the Institute of Laboratory Animal Resources of the Na- 
tional Academy of Sciences/National Research Council, are In the process of 
revising existing animal care guidelines and principles In their areas of au- 
thority or responsibility. Since some of those "guidelines" are being imple- 
mented as mandatory. It seems to us grossly premature to legislate further 
animal care restrictions until the effectiveness of these revised guidelines 
are determined. Moreover, the promulgation of these guidelines through the 
regulatory process should accomplish what H.R. 5725 proposes through the 
legislative process. 

While we hold to the foregoing general observations that caution against 
enacting animal welfare legislation at this time, we would like to point out 
our concerns with some of the specific provisions of H.R. 5725. 

The statement of congressional findings In Section 2 contains no 
acknowledgement of the vital Importance of animals to medical research. Given 
the fact that Congress has provided strong support for biomedical research for 
almost four decades, we believe that It Is Imperative that Section 2 contain 
some reference to the benefits of animal research to the promotion of health 
for both humans and animals. 

Section 2 further states that Congress finds that some alternative meth- 
ods are cheaper, faster and more accurate than animal models and will "result 
in more productive use of Federal funds." We are not aware of any data to 
confirm that alternative methods, generically, are cheaper and more accurate 



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than animal modtls and we do not support the Inclusion of such language. One 
can also rest assured that scientists, hard pressed for fumls and tine, readi- 
ly espouse valid alternatives to aniMi experlaents. 

The language In Section 4(c) substantially Modifies and expands the au- 
thority of the Secretary, deleting the current statutory prohibitions against 
the Secretary Interfering with research protocols. The legislative history of 
deleting this prohibition from Interference with the "perfonwnce" of actual 
research tacitly Implies that the Secretary would now possess such authority. 
We do not believe that it is proper for government officials to be in the 
business of monitoring or interfering with the conduct of animal research. 

Section 4(c) (A) further requires principal Investigators to demonstrate 
that they have considered "alternatives to any procedure likely to produce 
pein to or distress in an experimental animal and shall provide details of any 
procedure..." This requirement could prove to be prohibitively time-consuming 
and burdensome. It would be extremely difficult for Investigators to demon- 
strate that they have considered all alternative animal models for each 
procedure. 

Section 4(c)(6) requires that veterinarians be consulted in the planning 
of any procedures likely to produce pain or distress. Me question whether 
DVM's not trained in laboratory animal medicine are qualified to participate 
In such research planning processes. Moreover, we feer that this language may 
be particularly burdensome to small institutions, since there may not be an 
adequate nimiber of qualified D\M's to fulfill these requlrwents. 



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Section 4(2) adds a new provision to the law stating that H.R. 5725 
should not be construed as prohibiting states or other governmental subdivi- 
sions from promulgating their own animal care standards. Because of the re- 
cent flurry of activity at the state and local levels to enact restrictive 
animal legislation, we are concerned that this provision may only proliferate 
the myriad of restrictive animal laws, regulations and guidelines already on 
the books across the nation. 

Of particular concern to the research community Is the language in Sec- 
tion 4(3)(A) which requires the establishment of an "Animal Research Commit- 
tee" (ARC) and then sets forth the duties of that committee. First, the label 
"animal research committee" Implies that the committee will become involved in 
research. We would prefer to see usage of the term "animal care committee," 
which Implies that the committee will only be Involved, as it should be, in 
the care and treatment of laboratory animals. The requirement that "at least 
one member shall have no association with the facility and shall be respon- 
sible for representing community concerns regarding the welfare of animal sub- 
jects" gratuitously implies that the "outside member" on the ARC would be the 
only one concerned with animal welfare. Also, this language may cause en- 
forcement problems In that It may be difficult to define which "outsiders" 
represent the concerns of the community. 

The requirements in this section that the ARC make semi-annual Inspec- 
tions of all animal facilities and submit reports thereon would be unneces- 
sarily costly, burdensome and time-consuming. Many large Institutions have 
hundreds of animal rooms and facilities on several campuses that would be sub- 
ject to inspection. Moreover, the requirement that the ARC's review research 
facility practices involving pain to unanesthetized animals "to ensure com- 
pliance with standards of animal care, treatment and practices and that pain 



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and distress to animals is minimized," severely undermines the tine-honored 
and proven peer review process of the research institutions. The ARC in this 
provision is being assigned a responsibility that inherently belongs to, and 
can best be fulfilled by, expert scientists in a peer review context. 

Finally, Section 6 prohibits the release of confidential information and 
proscribes fines for such unlawful activity. This section should be expanded 
to authorize Federal prosecution of anyone involved in interrupting federally- 
funded research through breaking and entering laboratories and the destruction 
or theft of research data, animals or equipment. Given the increased frequen- 
cy of such unlawful break-ins, we believe that the law should be strengthened 
to prevent this violent waste of scarce federal resources. 

In conclusion, despite the few specific concerns expressed above, the 
AAMC and the NSMR sincerely believe that the enactment of any form of animal 
welfare legislation at this time is premature, unwise and unnecessary. Our 
recommendations to this Subcommittee are as follows: 

t Congress should mandate an in-depth study to determine the nature and 
scope of the problems, if any, and approach any animal welfare legis- 
lation with extreme caution until the impact on biomedical research 
has been carefully analyzed. 

e Congress should substantially increase appropriations for the animal 
welfare program of APHIS. 

t Congress should postpone consideration of any animal welfare legisla- 
tion until the animal care guidelines and principles currently under 
revision at three governmental agencies are implemented and their ef- 
fectiveness determined. 



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If these recommendations are fulfilled, and this Subcommittee then feels 
the need to enact further animal legislation, the AAMC and the NSMR would be 
happy to offer any assistance in the development of appropriate, effective 
language. However, at this time, we are unable to support any further action 
on H.R. 5725. 

I appreciate the opportunity to express the views of the AAMC and NSMR on 
this critical issue, and would be happy to answer any questions you might 
have. 



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SCIENTISTS CENTER FOR 
U ANIMAL WELFARE 



P.a BOX fSn. WASHINGTON, O.C 2MM 



SIAIBfKIT n 8UPP0IT OF l.&. 5725 

b€for« thm 

AOICOLIDKS CQMMZITSB, SUBCQMKITTBS OK DBPiJCZMBBT 

OPSRATIOn, BKSmBOT AID FOBZIOr AffiUCULTOlS 

U.S. HOUSE or KBPSSSSRAIZTSS 

8«ptCBber 19, 1984 

hf f • Barbara Orlana, Ph.D. 

BsaeatiT« Director 

Mr. CtaaixBan, aaabars of the flabcoBBittaa, I am Barbara Orlaaa, 
IzacatiTa Director of tha Sciantiats Cantar for AniiMl Valfara. I tpaak on 
bahalf of tha organisation's Board of Trustaas in support of H.R. 5725. 

Tha Scientists Canter for Aniaal Welfare is an organization of 
scientists concerned about aniaal welfare. It is non-profit and is based 
in Washington, D.C. The Center acts to foster hoawne stewardship of 
aniaal s by educating scientists and the public about aniaal welfare. The 
Center's programs have focussed particularly on the welfare of laboratory 
aniaals. Ve are currently conducting a series of regional workshops on how 
to run effective Aniaal Research Coonittees. The first of this series was 
held at Johns Hopkins University last Hay, was well attended and widely 
acclaiaad. We are organizing siailar workshops in 1984-84 in conjunction 
with other leading universities. 



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Th* C«atcr has published one book on hoaano anioal €zp«riaeiitatioii 
(1) and is enzrantlj praparing a aajor book on Aniaal Raseareh Conmittaas. 
Orar 2000 eopias of tha Scientists Cantar's Nevslattar ara distributed each 
quarter, to ■aabars, libraries, and others. 

in aetira Board of Trustees OTersees the Center's progrsas. It 
consists of nine scientists representing a broad field of disciplines. 
There is approziaataly equal representation of PhJ>s., O.V.Ms., and MJ>s. 
Dr. Jean Oodds, tha Chief of Haaatology at Nev York State Departaant of 
Health in Albany in tha current the president. 

I aa a 2hJ>, physiologist, resident in the U.S. for 30 years, an 
inrastigator vho has used aniaals in research, a member of tha Aaarican 
Society of Fbaraacology and Experiaental Therapeutics, author of a book on 
aniaal care, and founding president of the Scientists Center for Aniaal 
Welfare. I recently left ay position of Scientific Officer at the Kational 
Institutes of Health to assuaa the position of Szecutive Director of the 
Scientists Center. 

HE 5725 is a good bill. It is carefully vorded and represents a 
reasonable balance between the protection of aniaals and the needs of 
legitiaate research. It vill not iapade responsible research, but it vill 
strengthen the Aniaal Welfare Act in needed areas. This distinguished 



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Coiigr«««ion«l eoHBitt«« has an opportunity, with paaaaga of this lagiala- 
tion, to aaka significant iBproTaaanta in tha valfara of laboratory ani- 
aala. 

Tha aany proriaiona of tha bill ara sooad. Tha tactions daaling vith 
aliainatiag or raducing aniaal pain ara aspacially valcoaa. In ay tastiao- 
ny, I will concantrata on two provisions of tha bill about which tha 
Sciantists Cantar for Aniaal Valfara haa spacial knowladga; 1) thosa 
cowaring Aniaal Rasearch Coaaittaas and 2) thosa daaliag with training of 
inwastigators and tachnieiana on hoaana praetieas of aniaal axpariaanta- 
tion. 

1) ABiflAJL I^saareh ^^TMJti ^*** 

Tha Sciantists Cantar for Aniaal Valfara baliewas that affectiva 
Aniaal Rasaarch Coaaittaas ara assantial. Tha provisions of tha HR 572S 
would halp ansura that thaaa iaportant coaaittaas function wall. 



adainistrativa unit at aach fadarally licansad rasaarch facility 
aaat undartaka tha rasponsibility of anauring eoaplianea with tha Aniaal 
Valfara Act. Aniaal Raaaarch Coaaittaas (ARCa) ara an aecaptad and taatad 
aaahaaisa for discharg-ing thaaa obligationa. 8oaa inatitutiona hawa aatab* 
lishad highly affactiva ABCa, othara hawa only givan lip sarvica to fadaral 



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rt^ircBwnts on thttss oattttrt. Unfoxtuaatsly, a wmbmr of ARCs function 
poorly and soaa mem only papar eoaiittaaa azisting in naaa alona. Vhat i« 
naadad ia a ttrong stianlua to iaproYa tha aff activanaaa of thaaa iapottant 
eoHBittaaa. 

m 5725 proYidaa tueh a stiaalns. This proposad lafitlAtion vould 
■andata that AICa ondartaka tliaaa following dutiaa: 

o inapaet at laaat aani-anmial ly al 1 aniaal study araaa 
and faailitiaa 

o rariav practieas ittYolTing pain to ananas that isad 
aniaals and tha condition of raaaareh aniaals. 

It ia our strong conrietion that ASCa anat ba givan aandatad authori- 
ty. Tha prOYitiona of HR 5725 ara both sound and raasonabla. Raaaareh inatitutiona 
should haYa littla troubla in coaplying. 

Thaaa coonittaaa ara a kay link in tha raviev procaaa that sats tha 
atandard for hnaananaaa of sniaal axpariaants. An af f activa inatitutional 
eoHBittaa can profoundly inf luanca tha valfara of aniaala kapt for 
raaaareh. Cowrarsaly, an inaffaatiTa aosBittaa nay oaan poor eoopliaaca 
vith nationally aaeaptad faHHUia atandarda and lack of pnblia accounta- 
bility. 



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Zs ocd«r to cpprttciattt th* iaport«aett of AlC faaetions, it it 
iMCMSAry to oadorttaad tho plAco of IKU la tiM vtelo fri— orV. of r«Ti«v 
for aaiaAl volfAro eoncom* «ad alto look at tliair nai4«« foatucoa. for 
iaataaca, tbara is th* i&Toatigator's o«& iadlYidval eonaeionca, than tlMva 
la poor reriav la tha laboratosy hj th* inraaticator't ianadiata col- 
laagoaa, than foxaal inatitutional raviav by AICa, fandins acooey rariav, 
aditorial rariav prior to poblieation of tha raaalta, aad finally, pablia 
•erotiny aftar poblieatioa of tha rasults la tha sciaatific litaratara. 
Tha feiaatiata Caatar for iniaal Valfara baa addraaaad thaaa topiaa ia a 
raaaat hook (1). All thaaa liaka ia tha chaia of rariav aaad to ba ia 
plaaa aad aaad to vork affactivaly if high staadarda of aaiaal vtlfara ara 
to ba aaaurad. 

Aaiaal vtlfara rariav parfoxnad by ABCs baa a mnbar of aaiqaa aad 
iavaloabla faataraa not fouad ia othar larala of rariav. Ihilika ITSOA 
iaapactora aad HH rariav eoanittaat, ABCs ara oa tha spot locally. If 
action ia naadad to inprova tha valfara of cartaia lab aaiaalt, than local 
paar praaanra froa aa ABC ia oftaa aora af faetiTa thaa roaota ovaraight. 
Maabarf of AICa kaov tha local eoaditiona, aad tha ttraagtha aad vaakaaaaaa 
of cartaia aaiaal boaaiag facilitiaa aad laboratoriaa; thay kaov tha iavaa- 
tifatorc, tacfaaiciaaa, and cnpport ctaff , aad daralop a oaafnl hiatorical 
parapaativa that can prove Taloabla ia aaaaaaiag tha laval of naadad t«r- 
▼aillaaca of aay problaa araa. Alao» aa AtC eaa ^ickly raapoad to any 
daficianey ia aaiaal cara and taka iaaadiata rcaadial action. 



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8oa» fciaatitts el Aim that ABC tmwimw fuaetions are parforasd ade- 
qoatsly by USOA intp«ctions and funding acaacj rsviev eoHBitt«««. A £«d- 
srAl aandats for ARC* m in HE 5275 vottid, thej say, add an lumaeattary 
!•▼•! of buraancraey. 

On tba eontrasy, ARC fmetiona cannot ba adaqoataly aobsuaad by othar 
aaehaniaaa of raviav. U8SA inapactiona ara infraqoant and rasolntiona of 
daficianciaa can taka a. long tiaa. Also, tha raviav conduct ad by funding 
aganciaa auch aa tha National Inatitutaa of Baalth (HIE) or tha National 
Scianca foundation ia alow, typically taking 9 nontha to coBplata. It ia 
not gaarad for chocking an ianadiata problaa. bparianca of nany raaaarch 
faeilitiaa baa shovn that thaaa coBBittaaa can function aff actively vith 
ninimnm da lay for tha invaatigator and do not conatituta an adainistrativa 
burden. Svidanca of thia vaa presented at the Sclent iata Center's May 1984 
workshop, prarioualy aantionad. 

jfMlblCliVUL fl£. AfliMJL Raaarach ^fjt f * 



OL 5725 raquirea that ABC aaBbara be appointed by the chief ezeeutlTe 
officer of tha raaaarch facility and b* coapoaad of not fever than three 
■aBbars. Thaaa aaBbara auat be- able to aaaess aniaal care, treataant, and 
practicea in axperiaental reaaarch. At leaat one shall ba a ▼eterinarian, 
and one shall have no aaaociation vith tha facility. 



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Tlwt« «r« prudttiit ata<ar««. Xbm spttclAl «zp«rti«tt of ▼ttariaariaas 
rstsrding aniaAl hootinSf imtritioit, and otbar taasbandry iM«d«, and of 
aniaal antsthotlA, furgery, «ad pain r«ll«f , «r« «t««Bti«l arsat that aaat 
bo rapraaaatad. 

Aeeordins to HR 5725, aaothar AtC aaBbar would hava no aaaoeiatioa 
with tha faeilitj and would raprasant eoBHonity eoncaxna ragardins tha 
walfara of aniaal sob j acta. Va baliava soaa clarification of tha word 
"facility" ia naadad. It ia not claar whathar thia aaana juat aoaaona in a 
diffarant dapartaant (facility) but still ia in tha aaploy of tha inatitu-* 
tioB, or whathar it aaana that tha parson atist hava no conaactiona with tha 
rasaarch institution at all. Wa prafar tha lattar dafinition» Va, thara* 
fora, racoaoand that tha word "facility" ba changad to "inatitution". 

Alraady a mabar of institutions hava appointad cosHnnity rapra* 
santativas as waabars. Thasa includa tha nnivarsity of California, San 
Francisco, tha tfassacfausatts Ganaral Hospital, Boston, and tha Uniwaraity 
of Southam California, Los Angalas, saong othars. Such coaaittaas tand to 
ba aaong tha aost succassful of currently operating ARCa. To our 
ladga, a miabar of othars ara in tha process of appointing outside co 
nity 



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It Ic xaportant that cniwmity aaibArt partAkc in tiM dmciMiott^aMkiag 
procMt of d«t«ZBiai]ig th* sundards of laboratory aniaal usa. Whan fad- 
oral dollara ara lAvoIvad, than poblie aeeottatability lj a aaat. Sot only 
tha seiantiata th«uialYa«, but alto tha ganaral poblie mat ba aatorad that 
propar hoaana standards ara aaintainad. BaTiag a eoannnity nanbar on tha 
IRC broadans tha eoBBittaa*t raprasantation, halps a^roid conflict of 
intarast. Also, it sncooragas dialogoa batvaan sciantists and tha poblie 
to undarstand aach othar's viavpoints. Sciantists' reasons for and aathods 
of condocting rasaareh naad to ba oadarstood. 

Triininf i& Aauut ?gfqtUtff 



m 5725 raqoir aa that a rasaareh facility shall provida for inatroc- 
tion for thair personnel in tha hnaana practice of aninal experisMntation. 
Topics to be included in this training are oethods that miniaisa or eliai- 
nata tha use of anisMls, and aathods to liait aninal pain or distress. 
Annnal training sessions would be rehired for scientists, technicians, and 
other sniaal care staff. 

Tha Board of tha Scientists Center for Anioal Welfare strongly sup- 
ports these provisions. It stands to coaoon sense that investigators and 
others involved in aniaal experiaentation shoo Id knov how to condoct 



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mKfTimntB faHHUMly. It it not tooash for tlM invtstigatoM J««t to teov 
tiM seiaaes, tbmj atitt kaov hov to earo for aaiaalt properly, and hem to 
dotifft ud eoadvet an osporiBHit lumanmlj. Good attitvdot toward aaiaala 
aaad to ba daralopad. Xsraotlgatora tboald hava soaa aadarataadlac of 
^loaophioal «ad athieal eoaoidarationo. Xarattisatort tboald ba traiaad 
to earafallj quattion and juatify aaeb aad arary azpariaMit tbat iavalTaa 
pain or daatb to an aniaal for tba aaka of aadieal aeianca. 

Carrantly, adafuata traiaiac eoaraaa do aot asiat. ZaTaatigatora ara 
partiealarly poorly aarrad. Many invaatigatora ara eonduetiag highly 
ivraaiva, paia-inf lietiag aspariaanta oa aaiaala vith aavar haviag takaa a 
aoaraa oa baaona tachaiqaaa at any point in thair adaaatioa. Boat iavaati* 
gatora doa*t aran kaov that tha Aaiaal Valfara Aat asiata or that IH haa 
aatabliabad gaidaliaaa for boBaaa axpariantatioa. It ia a aitaatiaa Chat 
dafiaa roMMn MmoMm* 

Traiaiag for inraatigatora aboald aia to davalop aadarataadiag af tha 
▼alaa of aniaal lifa aad af aaaaitiva attitadaa to protact tha aalfara a£ 
laboratory aniaala. Topiaa eoald iaclada, aaoag othara, prariaioaa of tha 
Aaiaal Valfara lat; atata lava; aatioaal poliaiaa gararaiag tha aaa of 
aaiaala for aaiaatifie israatigatora; aaiaal haabaadry praatiaaa; gaacla 
haadliag of aaiaala; boa to aalaet an appropriata aodal (aoaatiaaa it aay 
ba battar if aniaala are aot tha taat objact at all • aoa-aaiaal aodala aay 



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be approprijittt); dssigs of experisantt vith th« least sthical cost; how to 
■iniaiio aaiaAl pain; ham to ottablish th« statistical Ij eorraet mnbor of 
anaaals to ba aaad; trainixig in sursieal taehniquas inelading adainistra- 
tion of aoalgaaiea and anasthaties aad proYision of post-sorgieal eara; 
salaction of tha aar liast possibla end-point for an experinant so as to 
avoid tarainal suffering (for instaaea to avoid tha painful taradnal stages 
of cancer); and aethods of killing an aniattl hnaanalj according to its 
spaciea » 

Two types of coursea are needed for investigators, practical courses 
vith tha nuts and bolts of hoaane techniques, and another type covering 
philosophical and ethical aapacts. In a very fev pioneering universities, 
soaa atteapt is aada to weave soae practical inforaation about aniaal 
experiaentatibn into general biology courses. Aaong these pioneers arc the 
Ihiiforaed Services University of tha Health Sciences and the Naval Research 
Institute, both in Bathesda, MD, and also the Ihiiversity of Wisconsin, 
Madison, WI. In hardly any inatances, however, do hnaana methods 
courses merit a separate identity. The Scientists Center for iniaal Wel- 
fare believes that huaana aethods coursea should ba required for all persons 
who intend to conduct ezpariaenta on aniaal s. 

Courses covering philosophical aspects of aniaal issues are aore preva- 
lent than practical aethods courses. According to recent estimates, soma 21 



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U.S. eoLLtgttt offttr tueh eoursst. Thm SdcatiJt* Ccatmr for Aniaftl Vtlfar* 
eoBpilcd A littiag of thoM itt 1983, C2)» Sot Tory aony biologj ttadoAtt 
attend rach elMtot, howoTor. Thoy aro naialj aTailablo for pbilotophy 
•todo&ts. Aeeording to tho feiontiftt Contor'f li«tixis» two biology 
dopartBoat offar tuch a eoisrta aa agaiaat 12 la philosophy dapartaanta. la 
additioa, thara ara 5 eoortaa ia vatariaary schoolf. aad oaa aaeh ia a 
psychology dapartaaat and a lav school. Whaa it is eoaaidarad that thara 
ara aaay fanadrads of eollegas ia tha U.S., and oaly 21 offar aay iastroe* 
tioa oa aaiaals aad athies, it eaa ba saaa thara is anch rooa for isprOYO* 

Sob* eoarsas for tachaieiaaa do alraady azist, ably rua by tha iaari-* 
eaa Associatioa Laboratory of Aaiaal Sciaaca. A 1978 listing <3) shova 
soaa 20 loeatioaa natioaally vhara thair eoorsas ara regularly givea. 
Although nora could be doaa ia this area, by far tha greatest need is for 
iavestigator traiaiag. 

We believe that strongs support can ba fouad vithia tha biomedical 
coonaity for traiaiag courses on hnauaa ezperineatatioa. Of iaterest ia a 
1984 survey conducted by the Scientists Center for AaisMl Welfare oa the 
respoasibilities of Aaiaal Research Coonittees to coaduct or advise persoa- 
nel oa these matters. Currently, very few A&Cs assume this responsibility 



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psrhapt bttc«at« so few sttitable eourfttt «re ayAllabl*. iajhov, of 90 
rtt«poiid«iit« in this maxrmj, 42 (47Z) faid that it vat vary iaportaat, aad 
37 (41Z) said that it vas soMwhat iapoctaat for ARCs to advisa parsoaaal 
oa training for aniaal valfare issuas (4). Oalj 6 (7Z) thought it vas not 
an important function of ABCs, and 2Z thought that ARCs should not assuM 
thasa tasks. Thraa parsons (3Z) did not ansvar. Raspondants vara oaialj 
▼atarinarians, PhJ). and MJ>. invastigators, soaa lab aniaal parsoaaal* and 
a fav othars. Thay vara participants at a May 1984 vorkshop organiaad by 
tha fciantists Cantar for iniaal Valfara on ARCs and ha Id at Johns Hopkins 
UniYarsity. 

Padaral Rasponsibilitr for TgiiaiRg 

▲. lagislativa aandata on aducation Ia hoaana tachniquas is tiaaly. and 
va balisYa vould ba vall accaptad by both scientists and tha public. It is 
of intarast that tha Housa and Sanata hava recently Totad favorably on 
legislation to make grants for schools of ▼aterinary nadicina for tha 
darelopaant of curricula and tha provision of training in the care of 
aniaals used in research and in tha davalopaent of alternatives to such 
use; (S. 2574). Additional legislation as proposed in HR 5725 vould mean 
that this type of education is available not only to veterinarians, but 
also to investigators and aniaal care personnel. 



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Sobs £«d«rAl initiAtlTtt, bmckmd up by ftdcral dollars, oaodo to b« 
givoa to h«Ip prorido eoortot for litTotticAtort «ad othftr laborAtory 
pttrsoimal on hmana aniaal todmiqiMt. 5725 prorido* a. nooded start itt 
this iaportsat aattar. 

Conclosion 

la nmmaxj, th« Bomrd of TxostMS of tbo Scioatists Csatar for ABiaal 
V^Ifsro bolisvos that HR 5725 is a naeassary piaea of lasislation, vorthy 
of support. Its passaga voald provida tha oaadad forea to okata^ that 
rasaareh Instittttions fulfill thair rasponsbilitias for sniaal valfara. It 
is of priaa iaportaaea that f adaral ly^fundad aaiaal axpariaants ara eondnetad 
with utBost eara and rafard for tha aniaals. 



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1) V. Jsan Doddt and f. Barbara Orlaaa, ads., Seiantific 
Parspactivat on Aniaal Valfara, Nev York: AeadaBie Praaa. 1982. 
ISBV 0-12-219140-0 

2) Collaga Couraaa on Kthiea and Anioala. Navalattar 5(2), May 
1983, pp» 3-6, SciantJLata Cantar for Aniaal Valfara, Vaahington, 
D.C. 

3) 6aid» for tha Cara and Uaa of Laboratory Aniaala, 1978, n.S. 
Dapt. of Baalth and Valfara, OHEV Publication No. (NIH) 78-23, 
pp. 63-65. 

4) Ihipobliabad data, Sciantiata Cantar for Aniaal Valfara, 
Vaahington, D.C. 



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^•oietg of ToMioologn 

475 Wolff UdgM Pvkway, Akron, Ohio 4431 1 216/782.2288 



OFFICE OF THE SECRETARY 

Marshall Stcinbarg 
Hazlaton Labor«ori«s Corporation 
9200 Laosburg Turnpika 
Vionna.VA 22180 USA 
(703) 893-5400 

OFFICERS 

Frodwick W. Oohma, Prowdont 
Emil A. Pfitzor, Vico-Prasidont 
John Doull. Vico-Presidom Etoct 
Richard S. Waritt, Traaaurar 
Qabriol L Plaa, Past Proaidont 



COUNCILORS 

Anna P. Autor (1 984-1 986) 
Mark Hit* (1983-1985) 
Jarry 8. Hook ( 1 983- 1 986) 
Barnard A. Schwou (1 984-1 986) 

EXECUTIVE SECRETARY 

Joaoph R. Wasdovich 
476 WoH LMlgoa Parkway 
Akron. OH 44311-1087 
(216)762-2289 



Prepared Statewent- on H.R. 5725 

Before the Subconilttee on Departnent of 

Operations, Research and Foreign Agriculture 

Coimlttee on Agrlcultuire 

House of Representatives 

September 19, 1984 



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Mr. Chalrnan: 

My name Is Dr. Marshall Steinberg* I an the secretary of the Society of 
Toxicology. 

The Society of Toxicology (SOT) Is a nonprofit scientific organization 
dedicated to the furtherance of the science of toxicology. Our nenbers 
are actively engaged In detennlnlng the conditions of ^afe use of 
chemicals In our environment. We are not affi Uted with any trade 
organization, and our membership is drawi Internationa 1y from academla, 
goverriiDent« and industry, with the largest single block of membership 
being from academia. 

Owing to the shortness of time, there was not the opportunity to 
circulate this statarent to the membership for approval. It, therefore, 
represents the op nions of officers of the Society. 

The Society of Toxicology supports t^e principles of H.R. 5725 In 
ensuring the he^klth and welT'belng of laboratory an'ftnals. We are pleased 
to note that HA, 572S is in anendnent to the ejiUtIng animal welfare act 
rather than a new act, Thi * reflection of the Misting act as a 
viable and important entity. But, to remain viable^ the act must be 
up9Taded to k^ep current with changes wUhin laboratory anlnal £t:1ence. 
Tt Is iflfrortant for changes to occur within current and established 
reguTations rather than to start over with a new act. 

By amending the anima welfare act, the Animal and Plant Health 
Inspection Service of the United States Department of Agriculture 
(APHIS-USDA) continues as the enforcement agency* Maintaining this 
progran with APHIS-USDA will ease implementation of improved Standards of 
animal care as APHIS-LJSDA potentially has the necessary experience and 
capabilities to oversee regulation changes. 

Annual training sessions for all personnel involved with animal care and 
use In a re$^arch faci fty are also supported. This Is an appropriate 
means to disseminate information and techniques to all Individuals as 
well as to sensitize them to anima welfare issues. A program of this 
nature could also function as an effective orientation for new 
employees. 

There are Issues that we would Invite your attention to and suggest 
modifications 

The wor d of toxicology Is complex and multlfaceted. The scientific 
investigators range from scientists using whole animal models to those 
using in vitro subcellular techniques. Most often. Investigators use a 
mixture of techniques depending upon the course of their research. 
Fundamentally, there are many different types of activities which conduct 



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bloniedlcal/toxicologlcal research. The research conducted Includes work 
done at educational 1 stitutlons under grant or contract, studies 
performed tither by or for the gov^rniuent the Mori, performed In 
conmerclal organ f zati on ^ !n support of t^e deve opment of new coawrclal 
compounds, and work performed by contract laboratories for either these 
comnercial organizations or governiMnt agencies 

The gamut of tox1co1og1c«1 research ranges frora studies of basic 
mechanisms of action to testing of confounds to meet regulatory 
requirements. While In vUro techniques have proven to b« invaluable 
tooU in basic researcii^ they have not been the repiacentent thht people 
thought they would be for safety evaluation studies k;s1ng whole animals. 
They have proven to be an extrenely valuable addf on to ttie 
armamentarium of tests that are conducted for safety eva nation of 
agrochemica or drugs. Therefore^ It s suggested that Section 2 be 
amended to show that these tests na^ show promise of being replacements 
for traditional animal experiments. 

There Is a need for clarity of definition with respect to distress in an 
experimental aninaTt as used i the proposed legislation. Safety Studies 
are designed to produce a toxic affect at a high dose. It Is only the 
in^aroperly designed study that does not produce an effect. Technically, 
a well'deslgned study would be in v olation of the law and/or wou d 
require extreme docutnentatfon to accomplish that which is scientifically 
valid. KigN'dose animals do not ordinarily experience pain but do 
experience extreme weight loss. Increased Incidence of tumors, effects on 
organ function, and sonieti;nes behavioral changes. 

There is soioe question regarding the establishment of a new Information 
service at the ^at1ona1 Agrlcultura L brary In cooperation with the 
Hationa Library of Medicine (HLM J, aiomedica Informat on flows through 
NLH^ and It may be a mistake to separate researc>i aninial care from the 
biomedica research It would be more expedient to expand Information 
centers already in existence at the National library of Hedldne. Tha 
facilities and expertise at NLM are aval able and should be utilized. 

The Implementation of the Good Laboratory Practices (GLPsl by a majority 
of the developed countries of the world has resulted n an upgrading of 
the practice of toxicology and the fic ities used to conduct research. 
Fundamental to the GLPs has been the development of star^dard operating 
procedures (SOPs) fo lowing guidelines provided by the various nation* 
agencies. These SOPs provide directions that are consistent with the 
experience, fad ties, cu tura pract ces, and capabilities found In 
each Institution Even within the United States, activities meeting Good 
Laboratory Practice standards vary in hew tficy implement these standards. 



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It Is suggested that rather than the Secretary developing standards, 
there be provision for guidelines and each faclHty be required to 
develop standard operating procedures to litp enent the guidelines. These 
standards shou d ensure that animal pain and distress are minimized 
consistent xnlth the relevant scientific needs of the experimental 
procedures. It is not reasonable to assume that the Department of 
Agriculture has the infonnatlon or the technica expertise to develop 
explicit standards for the operation of the myriad facilities In this 
country. 

Additionally, the quality assurance unit In each laboratory functions as 
an extension of the aboritory. The unit provides timeTy Information to 
the iwnagement of the laboratory regarding the qua My of the work being 
performed by the investigators. Prudence a well as connton sense have 
dictated that those in a position of responsibility pay heed to the 
findings of the unit and even capitalize on the ability of the quality 
assurance process to find deficiencies. This has resulted in a healthy 
aurrlage between science and Foanagenent that In turn has produced mare 
reliable, aud liable data. H.ft. 5725 n^ould benefit from tne saiw approach* 

The amendment details too many functions for the conmlttee and malces It, 
in effect, an extent on of government Instead of an Integra oversight 
group of the Inst tut Ion, The conmitteet as the quality assurance unit, 
should wqrV as part of a team to succeed in its mission. People 
providing Input to the committee should see their role as one of 
bettering the handling and treatment of animals rather than reporting on 
the activities of the Institution* We also have some concern about the 
connittee relating to comminity attitudes regarding animals rather than 
good veterinary practice standards, Comnunlty attitudes vary and nay be 
a function of the more strident voices rather than being based on 
knowledge. The regulation should not be an 1iif>ediment to cons1dered| 
caring research and should not detract front the prlcnary responsibilities 
of the facility veterinarian for cocipTiance with the an lira 1 welfare act. 

The requiretnent for separation of species needs a provision for exemption 
and the requirement for exercise Is an Issue requtr ng the professional 
Judgment of the attending veterinarian* The ?1ational Cancer Institute 
conducted numerous bioassays with rats and mice In the same room, with no 
demon str able ITl-effects owing to this practice. Some research, such as 
inhalation studies* must by necessity house several species In separate 
cages, but In the same chambers. 

The need to exercise dogs may be Incontrovertible on an emotional basis 
but a review of the literature would Indicate that there Is no difference 
In the physical parameters for a dog that Is penned under the provisions 



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Of the National Research Council guidelines and a dog that Is exercised 
according to a predetemlned schedule. Attachment A contains reprints 
froa the scientific literature supporting this statement. 

The decision to provide exercise should Involve professional judgaent. 
Captive primates and pound-source dogs, for exaq)le, may have more 
psychological needs for exercise than their laboratory- bred 
counterparts. It Is suggested that In the Interests of good science and 
better understanding of the needs of the animals, there be a distinction 
and that the appropriate agency Initiate activity to determine what 
differences may exist. 

As Indicated In the amendment, the members of the comlttee are required 
to possess sufficient ability to assess the various aspects of animal 
care. It Is suggested that the coilttee possess sufficient ability for 
It to carry out Its mandate ."This would permit the assignment of various 
specialists to the comlttee and allow greater flexibility, particularly 
with respect to the outside member. It Is conceivable that the 
surrounding coMunlty may not be able to provide an Individual with a 
knowledge of animal care, treatment, and practices In experimental 
research. 

Finally, while the citizenry rightfully desires that undue pain and 
distress to laboratory animals be avoided. It Is understood that the same 
citizens desire to be protected from the potentially noxious effects of 
chemicals used by our society. Tremendous strides have been made In 
recent years In understanding the mechanisms whereby environmental agents 
produce their toxicity. There Is no dichotomy between animal welfare and 
the development of the science of toxicology, and It Is noted that H.R. 
5725 does recognize the need to conduct research and that the use of 
animals may be central to that research. 

The Society of Toxicology has animal welfare and legislative liaison and 
assistance comlttees that would be pleased to work with the comlttee 
members and the staff In providing scientific Input and performing 
whatever research may be Indicated. 

Thank you for the opportunity to present these viewpoints. 



Marshall Steinberg, Ph.D., D.A.T.S. 
Secretary 



(The attachments are held In the conmlttee files.) 



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THE NATIONAL ASSOCIATION OF LIFE SCIENCE INDUSTRIES. Inc. 

11130 Rockvine Pike. Sixth Floor. 
Rockvllle. Maryland 20852 

ijgrepared Statement on H.R, 5725 

Before the Subcomlttee on Department Operations. Research and 
Foreign Agricu tiire* 
Committee on Agriculture. 
House of Representatives 

September 19. 1984 

Mr. Chairman: 

My name Is Howard C. Brown. Jr. I am the Vice-President. Executive 
Director of the National Association of Life Science Industries, Inc. 
(NALSI). 

I am privileged to be accompanied by Andrew S. Tegerls, M.D., F.A.C.P.. 
D.A.B.T. Dr. Tegerls Is the Vice-President of Scientific Affairs of 
NALSI. He also Is the President of Pharmacopathlcs Research 
Laboratories. Laurel. Maryland. 

NALSI Is a non-profit trade association comprised on Independent 
toxicology testing laboratories. 

We wery much appreciate this opportunity to present our comments on 
H.R. 5725. 

The policy of H.R. 5725 was succinctly stated by the distinguished 
Chairman of the Subcommittee before the House of Representatives on May 
24. 1984. Congressman Brown said. In part: "Poor animal care works 
contrary to the success of the research... Proper care of laboratory 
animals Increases research Integrity and accuracy, and thus benefits 
society." NALSI subscribes to that statement of policy. 

Indeed. In the strict Code of Ethics which NALSI created and adopted 
earlier In the year, each member laboratory shall "...In e^ery repect 
observe the Good Laboratory Practice Regulations and the established 
animal -care regulations of the federal, state and local governments." 

H.R. 5725 would supplement existing federal legislation and policy 
guidance In a unique way by authorizing the Secretary of the Department 
of Agriculture to promulgate professionally acceptable standards to 
ensure that animal pain and distress are minimized and It provides the 
Secretary with specific guidance. 

In our comments we should like to address what appear to us to be 
unnecessary redundancies In the government's regulatory and Inspection 



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programs and to explore with the subcommittee some of the practical 
problems that may plague the proposed Animal Research Committee. 

Existing Government Animal Care Monitoring Programs 

At the present time there are at least five Departments, agencies or 
entitles of the federal government which perform or have the authority 
to perform. Inspections of the care and treatment of laboratory animals 
1n both federal and private commercial laboratories. 

These entitles Include: 

The Department of Agriculture . Animal and Plant Health Inspection 
Service/ Veterinary Services; 

Department of Health and Human Services , National Institutes of 
Health; 

and the Public Health Service , and Centers for Disease Control, 
Center for Prevention Services, Division of Quarantine; 

The Food and Drug Administration ; 

The Environmental Protection Agency . 

In Attachment "A" hereto we summarize the responsibilities of each of 
the above entitles. 

The additional authority which H.R. 5725 would confer upon the 
Secretary of Agriculture makes It even more Important that overlapping 
authority and jurisdiction be sorted out, especially In the Inspection 
functions and reporting requirements. 

It should also be noted that the governmental regulations and 
Inspection functions are In addition to the private, professional 
monitoring activities to which private laboratories voluntarily submit 
and subscribe. 

The role of the American Association for Accreditation of Laboratory 
Animal Care (AAALAC) and the Toxicology Laboratory Accreditation Board 
(TLABS) also are delineated In Attachment "A". 



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Protection of Confidential Data » Effect of the Animal Research 
Committee 

We appreciate that the B111 endeavors to address the need to protect 
private comnterclal data but we believe that the protection afforded - 
mainly by sanctions - Is Inadequate. The reason for the Inadequacy may 
stem from a lack of understanding of the ownership, or admixture of 
ownership, or proprietary data In a contract testing laboratory. 

Although each NALSI laboratory contracts with the federal government 
from time to time for research or testing, the primary business for 
most NALSI laboratories consists of contracts with developers or 
manufacturers of products » such as, medical devises, prescription 
drugs, or chemicals used In pestl'Cldesor household products. These 
companies are referred to as the "product sponsors." 

Thus, the confidential data to be protected could be the property of 
the contract laboratory, the product sponsor or both. For purposes of 
our Illustration we assume that the confident al data Is the property 
of the product sponsor. The product could be wiywhere from a new 
chemotherapy drug to a new more efficient medical device. 

It Is possible, and In some cases, certain, that m Inspection of the 
use of laboratory animals In a particular research or testing procedure 
would reveal the nature of the device or compound being tested. If it 
1sn*t obvious to the eye, then the answers to the question, "Why this 
procedure?" would be revealing because the particular use of the wilmal 
would derive from the product being tested. 

The "Nqn-Asspclated" Coffiwlttee Hember . The Bill provides for the 
estabTishment on dn Animal Research Comnittee, one member of which 
wotjld b€ appointed fro« candidates outside the research facility. 
Specifically^ section (3)(A) woul<l provide that "...(1) at least one 
member shall have no association with such facility and shall be 
responsible for representing c o m m u nity concerns; ..." 

We do not Imply that the "community member" intentionally would publish 
the proprietary data observed during the course of m Inspection. But 
we do believe that observation is possible «id In some cases 
Inevitable. The problems are these: (1) what const tutes the 
proprietary Importance of a piece of Information may not be apparent to 
one not steeped In Its technical nuances nor fMlliar with the 
product's developmert or Its planned marketing in a highly competitive 
commercial environment; and, (2) the magnitude of research investment 
In the product or desvlce «id the dependency of recovery of investment 
on Its successful marketing mtiy represent • price tag not evident In 
the observance of the product or device. 



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The product sponsor may not feel justified In taking the risk of 
exposure to an Individual with no contractual responsibility for the 
protection of the confidential data. The contract laboratory, 
therefore, may be faced with the unhappy choice of foregoing the 
federal funding. If It exists, or foregoing the contract. 

We do not believe that It was Intended to create that kind of choice 
situation - one that could have a profound ffect of the economy of the 
contract testing Industry. 

The Anomolous Position of the Community Member 

Looking at the appointment from the committee member *s point of view, 
there are certain anomolles to contend with. 

We assume that, especially In the Washington area, a community member 
with the necessary credentials could be found. The Bill specifies that 
the members must have "...sufficient ability to assess animal care, 
treatment, and practices In experimental research as determined by the 
needs of the research facility. ..V 

The question Is whether an Individual offering those credentials would 
desire to serve on the Animal Research Committee. 

As a "non-assoclatee" member the Individual would probably enjoy the 
status of a visitor. 

In a contract of employment or consultation there are reciprocal rights 
and duties spelled out In the contract between the laboratory and the 
individual. Including, usually, the risk and liabilities Inherent In 
the nature of the laboratory's testing mission. It Isn't clear that 
the community member would enjoy this relationship. 

It Is the nature of toxicology testing that the toxic effects of 
chemicals or devices be observed. Itot Infrequently the effects observed 
are determined to be carcinogenic. Because of these risks of exposure, 
many laboratories may consider It appropriate to require that the 
non-employee execute written waivers of liability, holding the 
laboratory harmless. 

The laboratory management might also consider It fair to remind the 
member of the sanctions for compromise of confidential data - either 
willfully or ulnlntentlonally - consisting of fines or Imprisonment or 
both. 



y If a qualified Individual who would be wiling to serve could not be 
found, the remainder of the Bills' provisions for Inspection and 
reporting are placed In jeopardy. \to alternative Is provided. 



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In addition, the community member could be exposed to litigation for 
damages that might far exceed the member's personal resources. 

If, In the Committee's judgement. It Is necessary for the achievement 
of the Bill's objectives to mandate the appointment of a 
non-associated, community member. Me recommend that the anomolles 
discussed above be studied carefully. 

Be we do not believe that such an appointment Is essential to achieve 
the objectives of the Bill. 

The Inspectors of the Animal and Plant Health Inspection Service of the 
Department of Agriculture are eminently qualified to perform the 
required Inspections of the standards which the Bill would require the 
Secretary of Agriculture to promulgate. 

NALSI would be pleased to work with the committee members and Its staff 
In performing whatever additional research on the Bill may be Indicated 
or In modifying portions of the Bill as the committee deems 
appropriate. 

Thank you. 



Howard C. Brown, Jr., 
Vice-President, Executive Director 



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Attachment "A" 



Entities Presently Monitoring Research Animal Programs at Contract 
Testing Laboratories 



Government Monitoring 

t United States Department of Agriculture/Animal and Plant Health 
Inspection Service/Veterinary Services - USDA/APHIS/YS are 
responsible for enforcement of the Animal Welfare Act (P-L. 89-544) 
as amended 1970 (P.L. 91-579) and 1976 (P.L. 94-279). Areas of 
monitoring are transportation, purchase, sale, housing, care, 
handling and treatment of research animals. Monitoring accomplished 
by site inspections and by submission of various reports by the 
contract testing facility. 

• Department of Health and Human Services 

Each of the National Institutes of Health may monitor research aniMi 
care programs of recipient institutions by Miiy of site Inspection, 
protocol review or program review. These institutes laay further 



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control the res««rch animal care progran by specifying progran 
requirements In requests for proposals and/or the contract or award 
given. Additionally, Institutional animal care committees are required 
t^ NIH through the Public Health Service. This committee Is charged with 
protocol review and first hand monitoring of the Institution's animal 
care facilities and animal care program. 

In addition, the Public Health Service . Centers for Disease Control , 
Center for Prevention Services , Division of Quarantine monitors, through 
required quarterly or annual reports, those Institutions which Import 
non-human primates for research purposes. 

e Food and Drug A<li1n1 strati on (FDA) and Environmental Protection 
Agency (EPA) through site Inspections for compliance with their 
respective Good Laboratory Practice Regulation have the opportunity 
to monitor laboratory animal programs during such Inspections. These 
agencies may Invalidate studies submitted In support test agents if 
warranted by a poor program of laboratory animal care. 
Alternatively, through agreements between EPA, FDA and USDA, agency 
site Inspectors may report adverse findings which are not In 
compliance with Animal Welfare Regulations (10 CFR) to USDA for 
Investigation and action. 



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Voluntary External Monitoring 

The American Association for Accreditation of Laboratory Animal Care 
(AAALAC) is a long established not for profit entity established by a 
number of well recognized trade, academic and scientific associations. 
One of the major functions of AAALAC is the thorough review of laboratory 
animal care programs of those institutions who seek accreditation. 

Accreditation is based largely on the subject institutions compliance 
with the NIH Guide for Care and Use of Laboratory Animals, the Animal 
Welfare Act and other appropriate guidelines, regulations or laws. 
AAALAC inspections are conducted by AAALAC Council members and/or AAALAC 
consultants all of whom are qualified professionals in laboratory animal 
medicine. 



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Another Institution Mtilch conducts accrediting site Inspections Is the 
Toxicology Laboratory Accreditation Board (TLAB) which Inspects 
toxicology laboratories for their ability to adequately conduct various 
types of toxicologic testing. This Is not a GLP type Inspection, though 
this Is Included, but rather addresses the professional staff's 
capabilities and performance In Individual technical areas. Specific 
test procedures are reviewed and evaluated. Accreditation Is for 
specific procedures and not for the laboratories as a whole. One of the 
major areas of review Is the toxicology laboratory's animal care program 
which Is a critical element of safety testing. Each TLAB Inspection team 
has among Its members at least one professional qualified to determine 
the adequacy of the animal care program. 



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NATIONAL COALITION FOR SCIENCE AND TECHNOLOGY 

Suite 319. NEA BIdg. • 1201 16th Street. N.W. • Washington. DC 20036 • (202) 822-7312 



IXBCUTIVE COMMIT Til 
OomMaSliin 
n 

Taytor Testimony of 

Marc H. Rosenberg, Executive Director 



EXICUnVC ONKCTOfl 



National Coalition for Science and Technology 



BOARD OP AOVMOm 

nob«t C. Andmon 



swMMi z. Carton Concerning H.R. 5725 

Amendments to the Animal Welfare Act 



HuQh FudanbafQ 



CdMWd J. Konnondy 
Arthur KomtwfQ 



Can A. Modadd 

Hon. Cnartaa A. Moanar 



Hon. PaulTaongas 



Before the Subcommittee on Research, 

Committee on Agriculture, 

U.S. House of Representatives 



Washington, D.C. - September 19, 1984 



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Mr. Chalroan, my name Is Marc H. Rosenberg. I am 
the executive director of the National Coalition for Science 
and Technology. 

Our membership Includes approximately 1,000 research 
scientists, educators, business people and engineers. We 
also count a number of corporations and professional societies 
among our members. The subject of animal research Is of 
keen Interest to many of the people and organizations we 
represent . 

The use of animals In basic or applied research Is 
a controversial topic, as you are well aware, and we commend 
this panel for holding today's hearing. The National Coalition 
for Science and Technology believes It Is useful to have 
a public forum for a continuation of the dialogue between 
those who do animal research and those who are Involved 
In the animal welfare movement. There are, on each side 
of this Issue, people who take extreme positions, but there 
also are those who seek more reasoned alternatives to the 
existing laws and regulations. 

For several reasons, Mr. Chairman, NCST does not 
support passage of H.R. 5725 or any other "animal welfare" 
legislation In these closing days of the 98th Congress. 

As you know, there Is a comprehensive study presently 
being conducted by the Office of Technology Assessment. 
The OTA has formed a number of panels consisting of animal 
welfare advocates, research administrators, distinguished 
scientists and concerned citizens to examine a broad range 
of Issues pertinent to the use of animals In research. 
They are expected to report their findings In 1985. NCST 
believes the Congress should have the benefit of that detailed 
study before new legislation Is enacted. 

Moreover, there really Is not enough time left In 
this session of Congress to resolve the broad philosophical 
divisions which currently exist. That Is exactly why we 
feel today's discussion Is a helpful Interim step. 

In fact, earlier this year, NCST Itself sponsored 
a national forum on the use of animals In research and 
testing. We had participants from the academic and corporate 
research communities, animal welfare organizations, and 
several different governmental units. 



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Alter a fnll day of presentations and vor 
there nmr rggirt a consensus that aore could be dose to 
rednce dnplicatlon of aniaal research, to rednoe the 
nuaber of aniaals used in certain testing, and to iaprove 
disseaination of inforaation about altersatlve aethods 
of research and testinc- The relative ease with which 
this ccmsensns eaerged leaves us optiaistie about the 
outcoae of a respons ible and reasoned public dialocns 
on this subject. 

One of the issues to be addressed today is whether 
the ezistinc provisions of the Aniaal Velfare Act are 
adequate. The OTA r e p o rt should help answer this qaestioa. 

Begardless, we are aware that there are aany people 
in this country who question whether aniaals in lahoratorles 
are adequately protected by the law. In several areas 
of the country, including the chairaan's hoae state of 
California, concern ower the care of aniaals used in 
research has jeopardized public support for certain health- 
related research prograas. 

With respect to the specifics of H.E. 5725, the 
proposed aaendaents to the Aniaal Velfare Act include 
several constructive ideas, but there are soae features 
which need further work. MCST is prepared to cooperate 
with the chairaan and this coaaittee to help revise this 
legislation in anticipation of the activity that will 
occur after the OTA report is presented next year. 

Today, we will focus our coaaents on five specific 
provisions of the pending legislation. 

First, there is the requireaent that lahoratories 
using aniaals establish local review coaaittees which 
shall include veterinarians and persons froa outside 
the institutions. This roughly parallels proposals that 
have been aade for aonitoring aniaal research funded 
by the national Institutes of Health. While this proposal 
seeas reasonable, we do have several concerns we wish 
to express. 

In particular, we are worried that each local review 
coaaittee would be peraitted to establish its own standards 
and values concerning how aniaals should be treated. 
As a result, we could end up with a hodge podge of incon- 
sistent requireaents , with a particular practice being 
deeaed acceptable in one place and prohibited in another. 
As we are talking about federally funded research or 
govemaent-aandated testing, before these local review 
coaaittees are established, we should have soae agreeaent 
as to what standards are to be applied. 



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Similarly, ve question whether work on a federally 
sponsored, peer-revleved research project involving animals 
should be subject to yet another veto by a local review 
committee. At the very least, there should be a definite 
and swift appeals process that would provide the researchers 
recourse in the event of an over-zealous local panel 
which strays from the national norms. 

Second, there is the provision that members of 

a local review panel must agree to the protection of 

any trade secrets or proprietary data which might be 

revealed in the course of a review. This provision is 
a marked improvement over other proposals we have seen. 

Third, there is the proposal to create a voluntary 
national clearing house for information concerning animal 
research and alternative methods of research and testing. 
Such a clearing house would be useful, and we support 
it in concept. Again, though, we wish to express some 
reservations. 

Creation of the proposed information clearing house 
will require the expenditure of some money, either new 
or reprogrammed . Even if the clearing house is placed 
within the National Agricultural Library, it will either 
require a separate line item in the budget or an explicit 
reprogramoiing of funds already available for other purposes. 
Perhaps H.R. 5725 is not the appropriate vehicle » but 
such language is necessary in either authorizing or approp- 
riating legislation. 

Additionally, we suspect that stronger language 
would be necessary to assure full cooperation and inter- 
action with the National Library of Medicine. As so much 
animal research and testing is supported by the Department 
of Health and Human Services, that agency must be fully 
involved along with the Department of Agriculture in 
any data bank development. 

Fourth, there is the requirement that institutions 
using animals for research and testing must annually 
provide their personnel with information and training 
relevant to the humane treatment of laboratory animals, 
including a review of the national voluntary data base. 
The intention is laudable, but there are some problems 
here as well. 

In particular, NCST thinks that it is unrealistic 
to expect that smaller facilities could provide such 
training in any but the most cursory fashion. And for 
large facilities, it could create administrative and 
financial burdens. 



41-970 0-85-13 

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Therefore, we suggest considering accepting Inclusion 
of this information in continuing education or periodic 
recertificatlon requirements of the principal investigators 
or professional staff at the facilities. Additionally, 
if such courses and training are required, then we should 
consider what assistance the federal government can provide 
in meeting this new obligation. 

Fifth, there are some specific rules set forth 
for surgical procedures involving animals. At the risk 
of sounding as if we are contradicting our previous state- 
ment, NCST recoooMnds that these be removed from the 
bill. Instead of setting these rules of surgical procedure 
in the statute, we think it would be more appropriate 
and pragmatic to leave the setting of standards of care 
to the regulatory process, with ample opportunity for 
public comment. 

As an example of the kind of difficulty we seek 
to avoid, let me mention briefly the proposed ban on 
conducting more than one major operation on any one animal. 
While this may sound like a good idea on the face of 
it, the fact is that some medical research requires per- 
forming repeated surgery on the same subject. 

This is often the case, for example, in research 
on brain and spinal cord injuries, where additional surgical 
intervention and subsequent anatomical analysis is essential 
to evaluate the course of medical treatments which could 
promote nerve repair. Such research would be prohibited 
by the proposed amendments. 

Certainly, every reasonable effort should be made 
to assure that research animals are treated as carefully 
as possible, but flatly prohibiting specific procedures 
by law always runs the risk of casting the net too broadly. 

In summary, Mr. Chairman, I again stress that the 
National Coalition for Science and Technology applauds 
your efforts to promote rational dialogue on this subject. 
We believe that today's hearing helps to pave the way 
for substantive legislative progress next year, and we 
stand ready to help you develop legislation which would 
assure the public that laboratory animals are Indeed 
being treated humanely while this nation's researchers are 
permitted to make further progress in protecting and 
Improving the health and well being of our citizens. 



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STATEMENT OF THE AMERICAN FARM BUREAU FEDERATION 

BEFORE THE DEPARTMENT OPERATIONS, RESEARCH, AND 

FOREIGN AGRtCULTURE SUBCOMMITTEE OF THE 

HOUSE AGRICULTURE COMMITTEE 

REGARDING H.R. 5725, A BILL TO AMEND THE ANIMAL WELFARE ACT 

Presented by 

Stuart E. Proctor, Jr., Assistant Director 

National Affairs Division 

September 19, 1984 

The American Farm Bureau Federation is the nation's largest 
voluntary general farm organization with over 3.2 million member 
families in 48 states and Puerto Rico. We appreciate the opportunity 
to present our position on legislation affecting the treatment of 
laboratory animals. 

Our members are interested in the humane treatment of all animals 
because man is served by all animals. Farmers have the env able 
reputation of being corap^sGionate stewards of their 1 vestock But, 
despite our documented concern for the treatment of animals we are 
currently under attack from a number of associations and Indivlduale 
who make inaccurate and misleading statements about the treatment of 
farm animals Their Intent is to make major reforms n livestock 
production practices in this country using emotional arguments, 
examples and generalizations to fabricate a problem where one does not 
exist. 

We are concerned that some of these same tactics are being iised 
to describe the treatment of laboratory animals We question whether 
Congress has been presented with sufficient evidence to substantiate 
the need for corrective legislation. Congressional action to 
legislate and regulate in this ac^a is inappropriate unless evidence 
is presented which shows a problem Without such evidence Congress 
is being asked to overreact to an undocumented problem. We must 
remeraber that animal research is being conducted for the benefit of 
mankind. Unnecessary laws and regulations which could obstruct this 
research must be avoided. 

To provide the data neecessary to make legislative decisions 
concerning the regulation of laboratory animals, Farm Bureau supports 
the National Academy of Science study outlined in H.R. 2350 which 
passed the House- Legislative action is premature without thoroughly 
assessing how animals are currently being used in research. This 
study will provide an independent evaluation of this issue in a short 
period of tii&e. 

The study will help: 

~ Determine the type and number of animals used in such 
research; 



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- Review Federal and State laws and regulations 
governing the use of live animals in research. 
Evaluate the effectiveness of regulatory enforcement. 
Quantify enforcement problems by type and number; 

- Evaluate the extent to which accrediting laboratories 
and research facilities protect animals against 
inhumane treatment; 

- Analyze whether the use of animals is decreasing 
or increasing; 

- Evaluate the actions taken by the National Institutes 
of Health to improve oversight of the use of live 
animal research; 

- Assess the impact of establishing a requirement that 
research facilities be accredited; and 

- Estimate the cost of equipping and modernizing 
research facilities to meet accreditation standards. 

Farm Bureau will not support H.R. 5725 or other legislation on 
this Issue until these bas c questions are addressed. Answers to 
these questions will help determine the need for a legislative 
solution to the problem. If legislation is necessary, it should be 
targeted at specific problem areas and minimize any possible adverse 
affect on research being done for the benefit of mankind. 

We feel that problems associated with the treatment of laboratory 
animals coul<3 be better handled with more deligent enforcement of 
current regulations Last year the Committee on Appr opt iat ions asked 
for a GAO report on enforcement of the Animal KelEare Act This year 
the Senate Appropriations Committee reports that GAO is about to issue 
a report which is very critical of APHIS s enforcement of this Act. 
Current regulations should be properly Implemented before additional 
leg slat on is paa&ed If current regulations are ineftectively 
administered why will additional legislation and regulation be any 
more effectively carried out? 

Congress and the Administration have given low priority to 
enforcement of the Animal Welfare Act by steadily reducing APHIS'S 
budget. It seems inconsistent for Congress now to say this is a high 
priority issue which needs additional attention. If there is a 
problem, APHIS should be given enough funds to properly enforce the 
Act. 

In view of efforts by farm and laboratory animal welfare 
activists to seek legislation for emotional reasons, we are also 
concerned there will be future attempts to apply animal welfare 
regulations to agricultural research. Therefore, it is important that 
the problem be accurately documented before legislative action is 
taken. 



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SCIENTISTS GROUP FOR REFORM OF ANIMAL EXPERIMENTATION 

147-C1 THIRD AVENUE 
WHiTESTONE. NEW YORK 1 1 357 



12121767-8070 

Statement of Dr. Herbert Rackow 
On behalf of the Scientists Group for Reform of Animal Experimentation 

for the hearings of the 
Subcommittee on Department Operations, Research & Foreign Agriculture 
Agriculture Committee of the House of Representatives 
September 19, 1984 

>(y name is Herbert Rackow. I am a retired physiciar^ Diplomate 
of the American Doard of Anesthesiology, Professor Emeritus of the College 
of Physicians and Surgeons, Columbia University, and a Fellow of the 
American Academy of Pediatrics. My professional career was at the College 
of Physicians and Surgeons, Columbia University, and at the Babies Hospital 
of the Columbia Presbyterian Medical Center. I was full time and did 
both clinical practice and research. >Jy statement is on behalf of the 
Scientists Group for Reform of Animal Experimentation and is in favor 
of prompt enactment of H.R. 5725. 

Representatives of the scientific comnjunity and those who supply 
their experimental animals have always raised objections to any proposed 
regulatory changes designed to ensure more humane treatment of laboratory 
animals and the development of alternatives to animal use. These 
objections were on the grounds that any new regulatory changes would be 

1 ) extremely expensive 

2) would stop medical progress and biological research 

3) were unnecessary because laboratory animals are treated humanely. 

The expense can not be prohibitive. Many European countries, not 
nearly as well off as the United States, are able to provide for humane 
treatment of laboratory animals. Furthermore* their treatment of laboratory 
animals is far more humane than is ours in the' United States, and their 
humane regulations are more strictly enforced than are our own regulations. 

Humane treatment of laboratory animals would not stop medical 



DIRECTORS: Marjori* Anchel. Ph D . John McA/dle. Ph.D.. Herbert Rackow. M D.. Andrew Rowan. Ph D.. Oorge K. Rossefl. Ph.D.. Kenneth Shapiro. Ph D. 
ADVISOR ON LABORATORY ANIMAL CARE Geocge Bleibireu. D.V.M.^ Ph.D. 



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progress. The humane treatment of laboratory animals in these European 
democracies has not prevented their scientists from winning Nobel prizes. 
Some of our best young scientists go to their laboratories to complete 
their training. Many of our senior scientists go ^o these countries to 
spend their sabbatical years. The humane treatment of experimental 
animals has not brought their medical progress or biological research to 
a halt. 

The. proposed changes which H.R.5725 provides, are necessary. For 
example, there was strong evidence in the Taub case, of inhumane treatment 
of monkeys. The evidence resulted in a conviction in two courts in >laryland. 
The evidence wafi ton finned by the National Institutes of Health. The fact 
that the two courts were later found not to have jurisdiction, in no way 
changes the evidence of inhumane treatment. It just makes Taub not legally 
guilty. The evidence also demonstrates that in this instance, the National 
Institutes of Health and the United States Department of Agriculture were 
incapable .of monitoring and enforcing their own regulations for humane 
treatment of experimental animals. The changes as provided for in H.R. 5725 
are in fact necessary. 

Bill H.R. 5725 is designed to ensure humane treatment of laboratory 
animals, but its provisions are also valuable from a scientific standpoint. 
If experimental results in animals are to apply to man, it seems reasonable 
that conditions of ambulation, daily exercise, pre and post-surgical medical 
and nursing care similar to that provided for man, but appropriate for 
animals, be provided for the laboratory animal. The provisions of H.R. 5725 
for exercise ( page 4, line 4 ) and for pre and post-surgical medical and 
nursing care, would help ensure more humane treatment of caged and 
surgically treated animals. These provisions would also upgrade the . 
standards of scientific methodology. There* is recent evidence that exercise 
improves the quality of life and longevity in man. Exercise is even more 
important for the experimental dog who spends almost all of his restricted life 
in a laboratory cage that is just large enough 'for him to lie down in. 
No surgeon would treat a patient this way, by putting a healthy, vigorous 
person ( healthy except for the local pathology requiring surgery ) in bed 
for a few weeks before surgery and then after surgery, restricting the patient 
to bed rest for a few months. Because we know the value of early ambulation, 
even elderly patients are taken out of bed as soon as possible, often on 



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the first day post-op, if only to sit in a chair. Yet, expi rimental dogs 
are confined to cages for long periods of time* NIH Guidelines state that 
short terra confinement to cages is one to three months. The provision for 
exercise rai;;ht be expended in report language, to require daily exercise outside 
the cage, to provide for the physical and emDtian4l well being of the 
laboratory dog. Socialization with other suitable dogs should be a part of 
the exercise period outside the cage. The exceptions that are already 
provided for in the bill ( page 4, line 5 ) should be limited to the dog 
that is physically unable to exercise or because of scientific necessity 
as specified in the research protocol. 

To ensure that animal pain and distress are minimized, the bill 
provides that the Secretary promulgate standards ( page 4, line 12 ) for 
research facilities. The bill clearly states that the Secretfiry is not 
authorized to regulate the design of the actual -research ( page 4, line 8 ). 
Since the authority of the Secretary to promulgate standards is strictly 
limited, it- is hard to understand any objections to this provision. 
Progress in medicine and the biological sciences does not depend upon the 
Infliction of unneggssar^ pain and distress In experimental animals. This 
provision is important: it addresses a legitimate concern and has proper 
safeguards. It should be retained as written. 

In the same way, the Animal Research Committee ( page 6, line 11 ) 
is authorized to inspect the research facility ( page 7, lines 7-14 ) for 
standards of animal care and for the condition of the research animals. As 
in the case of the Secretary, this committee has no authority to evaluate 
scientific aspects of the research. The provision for a minority report 
( page 7, line 24 ) is necessary to ensure that all views of the committee 
are recorded. All these provisions should be retained as written. 

The need for an Animal Research Committee is very well described 
in Whistleblowing in Biomedical Research , 1981.* This study was sponsored 
by three groups: the Presidents Commission for the Study of Ethical 

• Superintendent of Documents, US Government Printing Office, Washington, DC 



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Probleav in Medicine and Biolo;sical Research, by the American Association 
for the Advanceaent of Science, and by 5tedicioc la the Public Interest. 
It points oat ( page 35 ) that scientists in a university setting are under 
pressure to produce results and justify aore Money -for sore research. 
ProBOtion, tenure, salary, laboratory space and help, travel and othsr 
professional requisites depend upon research prgductlvity,, There is a 
strong conflict of interest that nay affect tif*n tk* best of persons. Ths 
university system of governance grants alaost cooplete autonoay to departaents 
and individual scientists. This aay result in inadequate protection for 
hunan research subjects. If these considerations concerning research on 
huMui subjects, are valid, then the need for protection is even greater 
vhen the subjects are aniaals. 

A provision has been aade in the bill ( page 8, line. 9) that the 
CoMsittee report unacceptable conditions to the adainistrative representative 
of the research facility. This should be expanded in report language, 
that the -Director of Aniaal Care, in addition, be infonaed promptly of 
unacceptable conditiofis so that there is a aininua of delay in taking any 
needed action. 

Similarly , if an enployee reports a violation to the Aniaal 
Research Coonittee ( page 9, line 13 ) , the Director of Aniaal Care should 
be informed of the violation innediately. The Director of Animal Care is 
likely to oversee aniaal care on a daily basis, while the Aniaal Research 
Coaaittee is not. 

The provision for annual sessions for instruction ( page 8, line22 ) in: 

A) the hu3Huie practise of aniaal maintenance and experimentation 

B) research or testing aethods that minimize or eliminate the use of 
animals or limit pain or distress 

C) utilization of the information service at the National Agricultural 
Library, to prevent unintended or unnecessary duplication of animal 
experimentation 

should include manflatory attendance by the scientists or their representatives 
and by those involved in the actual care of the experimental animals. 



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This provision should not only reduce unnecessary animal suffering but 
also should reduce the financial cost of biomedical experimentation 
without interfering with the progress of science. Jt should be retained. 

The provision for the establishment of an information service at the 
National Agricultural Library, in cooperation with the National Library of 
.Medicine ( page 9, line 19 ) , to provide information on improved methods of 
animal experimentation, to reduce or replace animal use, minimise pain or 
distress, and prevent unintended duplication of animal experimentation, is 
excellent and should be enacted as written. 

The assurance of compliance provision ( page 4, lines 15-24; page 6, 
lines 1-3 ) and the provision for suspension or revoking of Federal support 
for non-compliance ( page 10, lines 6-11 ) are excellent and should be retained 
as written. 

The provision that any State or political subdivision of any State 
may promulgate standards ( page 6, line 4 ) is extremely important, I 
suggest that this be expanded in report language to ensure that each research 
facility with Federal funding must also be in compll^ncf with laws of its 
own State and all political subdivisions of that State, as well as with 
Federal Laws. This will permit each of the States to experiment with its 
own standards. Those experimental standards that turn out to be of value, 
may in time be adopted by the other States. 

The establishment of an effective Animal Research Committee is a key 
provision of H.R. 5729. We know from past experience that MH aitm 
inspections and USDA inspections can be inadequate to ensure humane treatment 
of laboratory animals. In what way will the Animal Research Conimittee 
inspections be different 7 The crucial difference is that for the first time, 
H.R. 5725 brings to the inspection committee ( page 6, line 21 ) , an 
independent, unpaid lay member, who is not affiliated with the research 
facility, has no conflict of interest, and whose primary responsibility is to 
the welfare of the animal subjects, not to NIH and not to the USDA. The 
effectiveness of M.R.5725 in ensuring humane treatment of research animals. 



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will stand or fall on the quality of this acmber of the Aniiaal Research 
Coininittee. I suggest that the qualifications of this person be listed 
in report language, to include that the person has demonstrated an active 
interest in animal welfare over a period of years , and has no conflict 
of interest in representing community concern for the welfare of 
animal subjects. 

Thank you for the oportunity to make this statement in support 
of H.R. 572i5. 



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S*7 



CALIFORNIA ADDRESS 12548 VENTURA BLVD.. STE 141 
STUDIO CITY. CA 91604 



Phone : 61 6-769- 1 1 90 Edward Walsh. Jr 

Lagai Countti 



TESTZMONY FBQM GRBTCHEN WYIER, VICX CHAIFMAN, THE FUND FOR ANINAI£ 

ON H.R. 5725 

19 SEPTQCER 1984 

BEFORE TOE 
SUBOGMCrriEE ON EXPARDCMT OPERATIONS, BESEARCH AND FOPEIGti ASRICUUIUFE 
U. S. HOUSE OF REPRBSENEKnVES 



m NAME IS GRETCHE14 Wyi£R AND I AM VICE CHAIBMAN OF TOE 250,000-MEIffiER HJND 
FOR miMKLS. OUR ORGWJIZATION SUPPORTS H.R. 5725. TOIS ACT ASKS FOR SO UTTIE - 
EXERCISE FOR DOGS, IN-HOUSE ANIMAL CAPE O0^MITIEES, RESTRICTIONS ON MUUTIPIZ SURVIVAL 
SURGERIES, MANDA3SD PPE- AND POST-OPERATIVE SURGICAL CAFE, AND MEANS TO FIND LIVE 
ANIMAL AKEEFNATIVES AND TO RQXXX DUPLICATION OF EXPERIMOnS. MANY PEOPIE WITO WHGM 
I'VE SPOKEN, INCUJDING OUR Otl MEMBERS AND FEOPIE FROM TOE MEDIA, ARE ASTOUNDED TOAT 
SUCH SIMPLE RBQUIIiDCnS ARE NOT ALPEADY TOE Uttf OF OUR Jjm>l 

DEFICIENCIES IN CURRE1<1T FEDERAL RBGUEATIONS ARE IN STARK CONTRAST WITO TOE 
FAI£E REASSURANCES HISTQRICAIliY HEARD FROM TOE RESEARCH OOMUNITY. BUT TODAY, EVEM 
THE MOST OGNSEFK^a<IVE ANIMAL RESEARCH LOBBY GROUPS ADMIT TOAT TOE CURRENT PNIMKL 
VEUARE ACT AND ITS ENFORCEMENT ARE GROSSLY DEFICIENr. FOR EXAMPIE, ON JWUARY 
31, 1984, IN AN ILLINOIS SPEECH TO TOE MEDICAL 0GM4LJNITY, MS. FRANKI TRULL, EXBCOTIVE 
DIRECTOR OF TOE FOUNDATION FOR BIOMEDICAL RESEARCH, SAID TOAT ONE REASON TOE MIMAL 
WEITARE ACT HASN'T WOFKED WELL IS BECAUSE THE APHIS INSPECTION PROGRAM RECEIVES ONLY 
4.8 MILLION A YEAR. TO QUOIE MS. TRULL: "lET'S FACE IT, TOAT'S AN ABSQLUIE DROP 
IN TOE BUCKET AND, OF COURSE, TOEY TOEREPORE HAVE INSPECTORS WHO ARE NOT TRAINED 
UNDER TOE SAME TRAINING PROGRAM, WHO ARE NOT NEQSSARILY QUALIFIED TO BE IN A RE- 
SEARCH INSTITUTION...! MEAN, WE'VE GOT A REAL PROBiai.- END OF QUOOE - FROM THE 
RESEARCH LCBBY. 

ONE AREA OP GBEAT OCNCEFN TO US IS PSYCHOiLOGICAL FESBAROi WITO ANINAI£. I AM 
SUBMITTING DOCUNENTATICN FROM mu MICHAEL GIANNELLI, A MEMBER OF TOE AMBRICMQ 
PSYCHOILOGICAL ASSOdATICN AND SCIENCE ADVISOR TO OUR ORGANIZATION. HIS OCMPREHENSIVE 
SURVEY OF 1984 ANIFAL RESEARCH PUBLISHED IN APA JOURNAIS RAISES REASONABLE QUESTIONS 
ABOOT THE NECESSITY OF MLCH PUBLISHED WOf«, PND PROVES ALL REASONABLE DOUBT TOAT 
ANIMAI£ ARE ROUTINELY MADE TO BEAR SUFFERING AND DESPAIR. 



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THE FUND FOR fNJMKB SUFFGRTS THIS BIU., NOT BECAUSE IT tdlL PRCVUE A KIRK1£ 
CURE FOR MI. THE RESEARCS INDUSUV'S II1£, BUT BECAUSE IT IS AN fCBWffeiE Bill, MID 
A STEP IN THE RIGHT DIFBCTICN. 

IN THAT SPIRIT, I AM PROUD TO SUBMIT A LIST (STIU, IN FORmTIGN) GF SIGNED 
SUPPORT STAlXMEUrS FROM 44 PHYSICIANS AND VKEERINARIM6 FROM THE AUIHQR'S SIKIE GF 
CAUPOBNIA. 

WITH OUR COUNTRY'S NEW FOCUS ON FAIBNESS, HONESTY AND ETHICS IN THE 
"MARKETPIAS:'', THERE IS GROMING PUBLIC MARQUESS CF TAX WASIE AND ANDAL ABUSE 
IN RESEARCH lABORATQRIES . SINCE MOST RESEARCH IS RIBLTCLY FTJNDED, I URQE THIS 
CCMOnXZ: to WCO^'B^ passage of H.R. 5725. IT IS AN OPPORTUNITY TO SHOW THE 
AMERIC3W PUBLIC THAT CONGRESS CAFES TO PRQMOOE AND lEGISIAIE HUMANE IEEAI£. 



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CALIFORNIA PHYSICIANS AND VETERINARIANS 
IN SUPPORT OF THE 
IMPROI/EP STANVARVS FOR LABORATORY ANIMALS ACT 
H.R. 5725 (Brown) and S. 657 (Dole) 



"As a jventer of the veterinazy>^nBdical profession, I am convinoed that the 
legitimate needs of science are both ocnpatible with and dependent upon the 
welfare of laboratory aninals. Poor care and treatment of laboratory animals 
can lead to innaocurate or unreliable research data as well as uinecessary 
suffering by the animsils themselves. 

Current federal Ism needs to be strengthened in this aiea if these scientdLfic 
and huiane goals are to be met. H.R. 5725 and S. 657 , the IMPROVED STAND?VPDS 
FOR lADORATORY PNJMM£ ACT, represent reasonable and moderate steps to in- 
crease cissuranoes that humane care and treatment of laboratory animals are 
provided without restricting scientific freedan. For this reason, I whole- 
heartedly s\:pport H.R. 5725 and S. 657". 

[List in fomatiGn and growing daily; current totals are: 
28 ra>s and 16 TMto] 



Gueri Axler, M.D. 
Jeanne Axler, M.D. 
Julia P. Badley, M.D. 
Patricia Badley, M.D. 
Richard P. Barrett, D.V.M. 
Robert W. Bell, M.D. 
Keith M. Berry, D.V.M. 
Stephen Reeve Blake, Jr. , D.V.M. 
Richard S. Blinstrub, M.D. 
Peter W. Bloch, D.V.M. 
Wayne M. Ocmeau, D.V.M. 
Gloria Dodd, D.V.M. 
Donald E. Doyle, M.D. 
Moneim A. Fadali, M.D. 
William L. Farber, D.V.M. 
Manuel A. Freitas, D.V.M. 
Lawrence J. Friedman, M.D. 
Jay N. Gordon, M.D. 
David Griffiths, D.V.M. 
Dennis R. Judserg, D.V.M. 
Barry B. Knaster, M.D. 
Martin P. Koke, M.D. 

(The attachments are held in 
the committee files.) 



Melvin M. Kbtkin, M.D. 
Terranoe MoGinnis, D.V.M. 
Franklin D. McMillan, D.V.M. 
Alan M. Mantell, M.D. 
Alfred D. Munson, M.D. 
Makram B. Masoud, D.V.M. 
Eugene Natale, M.D. 
John R. Oltinan, D.V.M. 
Chester Riillipson, M.D. 
Constance Pinkerman, M.D. 
Minton Ritter, M.D. 
Steven Sanders, D.V.M. 
Robert A. Shakman, M.D. 
Daniel Silver, M.D. 
James Stewart, M.D. 
Helen S. Swank, M.D. 
E. Douglas Tignor, D.V.M. 
J. Robert Tolle, M.D. 
Irma West, M.D. 
Jaoguelyn J. Wilson, M.D. 
Stephen Winters, M.D. 
James H. Yahr, M.D. , F.A.C.S. 

(List prepared 14 September 1984) 



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STATEMENT OF 

THE AMERICAN FEED MANOFACTORERS ASSOCIATION 

ON H.R. 5725 

"IMPROVED STANDARDS FOR LABORATORY ANIMALS ACT" 



SUBCOMMITTEE ON DEPARTMENT OPERATIONS, 
RESEARCH & FOREIGN AGRICULTURE 

HOUSE COMMITTEE ON AGRICULTURE 

SEPTEMBER 19, 1984 



Steven L. Kopperud 
ijegislative Director 



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Chairman Brown, members of the subcommittee r I am Steve Kop- 
perudr legislative director of the American Feed Manufacturers Associa- 
tion. On behalf ot AFMA, I wish to thank the subcommittee for giving 
us this opportunity to comment on the Chairman's bill, B.R. 5725, the 
"Improved Standards for Laboratory Animals Act." 

For over 75 years, AFMA has been the national trade associa- 
tion representing the nation's feed manufacturers. Members of the Asso- 
ciation produce more than 70% of the primary formula livestock and 
poultry feed sold annually in the U.S. In addition, some AFMA members 
raise large numbers of food producing animals. 

AFMA is proud of its long standing commitment to the proper 
treatment of all animals. In September, 1981, the Association's Board 
of Directors formalized that commitment in an official policy state- 
ment on the welfare of animals, the essence of which is that "AFMA is 
committed to the humane and compassionate care of all animals," A copy 
of that statement is attached to these comments. 

AFMA's role in the recent debate over the relative quality of 
laboratory animal care has been misinterpreted by some who support this 
legislation. AFMA is vitally concerned that animals used in biomedical 
and agricultural research be treated in accordance with the highest 
professional standards. Bowever, AFMA is also concerned that Congress 
not act in a manner which might ultimately — and unintentionally — place 



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barriers in the path of vital biomedical research, or act precipitously 
or unnecessarily to correct wrongs which aay not exist to the extent 
sone contend. 

Chairman Brown's public support for necessary animal research 
and his assurances that B.R. 5725 is in no way intended to halt the use 
of necessary research procedures using animals satisfies AFMA's concern 
over the intent of this bill. However, AFMA continues to be concerned 
with the need for this legislation, for two very basic reasons. 

First, the emotional "horror stories" which purport to show 
widespread disregard among biomedical research facilities using animals 
in experimental procedures have not been verified. Midnight raids on 
university research facilities to "liberate" such animals may make for 
good newspaper copy, but they do not constitute definable abuse and 
inhumane treatment. Legislation based on such an emotional response 
rather than the facts of the matter is undesireable. 

There needs to be a broad spectrum of issues independently 
examined before any legislative remedy is contemplated. The level of 
cooperation between OSDA and other federal agencies concerned with lab 
animal research, such as NIH, needs to be examined. Any administrative 
impediments to DSDA's ability to carry out the ANA must be identified 
and reasonable solutions found. The actual state of the art in alter- 
native research methods needs to be established, realistically ap- 
praised and implemented where practical. This type of scrutiny will 
permit any potential legislation to address specific problem areas with 
specific solutions while protecting necessary biomedical research 
procedures. 



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APNA supports House and Ssnate Isgislation to invsstigate 
current laboratory animal care standards as a aethod of discovering 
any actual inhumane treatment prior to taking congressional action to 
create a duplicative set of standards to be added to the current Animal 
Welfare Act. 

More importantly, however, if remedial action is necessary to 
ensure the high level of laboratory animal care, then it is logical 
that the time, money and energy being expended on H.R. 5725 and other 
similar legislation would be more productively focused on raising the 
priority of the Animal Welfare Act and its enforcement within the 
Administration and the Congress. The ANA has not enjoyed its highest 
priority in recent years, either in Congress, which has either seen fit 
to freeze or cut appropriations, or by the Administration which has not 
requested an increase for money or manpower. 

If the productive use of federal funds and meeting the 
public's concern for lab animal care are the goals of this bill, then 
vigorous pursuit of an adminstrative solution is the answer. 

Based upon a legal review of current law, AFMA concludes that 
the Secretary of Agriculture currently has sufficient legal authority 
to implement all but one of the statutory requirements on the use and 
treatment of laboratory animals proposed by H.R. 5725 

In writing the ANA, it is clear Congress intended the 
Secretary to have the broad authority necessary to carry out the 
purpose of the act, namely "to ensure that animals intended for use in 
research facilities.. .are provided humane care and treatment." 



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7 O.S.C. sections 2136, 2140 and 2143, give the Secretary the specific 
authority to prescribe rules and regulations for the registration of 
research facilities; establish recordkeeping and reporting 
requirements, and to promulgate humane standards for the use of 
laboratory animals. 

This standard-making authority is the most significant and 
the most specific within the AWA. It details the parameters of those 
standards and the required demonstration by the research facility that 
it is following professionally acceptable standards for laboratory 
animal care and treatment. It also orders the Secretary to consult and 
cooperate with other federal agencies in setting and carrying out the 
standards and purposes of the AWA. 

Let me discuss the major provisions of B.R. 5725 and the 
status of those proposals under the current AWAt 

1. Annual compliance assurances by research facilities: H,R. 
5725 would require yearly assurance by the research facility that it ic 
in compliance with humane standards of animal care, especially in any 
practice involving the administration of pain to an unanesthetized 
animal. A proviso to Section 13(a) ot the AWA, 7 O.S.C. ss: 2143(a) 
provides such authority: 



-The Secretary shall require, at least annually, every re- 
search facility to show that professionally acceptable stan- 
dards governing the care, treatment and use of animals, in- 
cluding the appropriate use of anesthetic, analgesic and 
tranquilizing drugs, during experimentation are being follow- 
ed by the research facility during actual research or experi- 
mentation." 



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2. Animal Research Connitteest Cftairman Brown's bill would 
order the establishment o£ internal animal research committees by each 
research facility. Our review shows no difference between H.R. 5725 
and current authority. Indeed, current regulations allow for the 
optional use of an animal research committee in lieu of or in addition 
to an attending veterinarian. It is apparent the Secretary was given 
the implied or inherent authority to require such panels. The 
precedent has been set by other agencies, i.e. FDA requires 
"institutional review boards" to be established by all entities seeking 
approval for new drugs and medical devices, a practice not expressly 
authorized under the Federal Food, Drug & Cosmetic Act. 

3. Inspection Provisions: H.R. 5725 calls for the inspection 
results of the Animal Research Committee to be made available for 
review by OSDA inspectors. Tne Secretary has the authority to conduct 
inspections to see if the facility has violated law, a regulation or 
standard under Sec. 16(a) 7 O.S.C. ss:2146(a). No new authority would 
be needed. 

4. State or Local Standards: H.R. 5725 would not preempt the 
states' right to pass stricter regulations. The current AWA allows for 
state regulation (Sec. 15 of the AWA 7 O.S.C. ss: 2145(b)). This 
section allows the Secretary to cooperate with the states in carrying 
on the same subject." 

xt appears the only administrative change which cannot be 
made by the Secretary is to impose criminal penalties for release of 
trade secrets, an area very important to public and private research 
facilities. Onder constitutional law, an administrative agency cannot 
impose a criminal penalty unless expressly authorized to do so by Con- 



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SOCIETY FOR ANIMAL PROTECTIVE LEGISLATION 

P.O. Box 3719 

Qeorgetown Station 

Washington. D.C. 20007 

(202) 337-2334 



STATEMENT IN SUPPORT OF H.R. 5725 

BEFORE THE SUBCOMMITTEE ON DEPARTMENT OPERATIONS, 

RESEARCH, AND FOREIGN MSRICDLTURE 

September 19, 1984 

by Christine Stevens, Secretary 

Mr. Chairman, on behalf of the Society for Animal Protective 
Legislation, I wish to commend the reasoned approach and the 
long-term interest you have demonstrated in seeking to limit 
the suffering of laboratory animals. As one of the best 
friends of science in the Congress, your efforts should be 
crowned with success. 

If H.R. 5725 is enacted into law, it will be helpful to 
research. The federal Aniin&l welfare Act, which it amends, 
now has the approval of th^ major biocQedical research 
organizations as detnonstrated by their endorsement of a two- 
thirds increase in appropriations to enforce the Act (1). 
Several of these organizations were at the forefront in 
fighting passage of the Act ia 1966 and its amenamenta in 
1970 and 76, but the fears they then expressed have proved to 
be groundless. The same will prove true with your bill. Hi. 
Chairman, if vested interests do not succeed in bIo<:king its 
passage. The interests I refer to are no^ scientific; they 
are commercial and they foster illusory fears and play on 
prejudice to gain their selfish ends -ends aa harmful to the 
scientific community as they are to the welfare of animals. 
Their rallying cry is: "Study I"; their aim: to delay, and, 
through delay, to defeat the urgently needed H.R. 5725. They 
portray needless animal suffering in laboratories as a rarity 
and want to pay the National Academy of Sciences to study the 
question at length. 

Far from being a rarity, the data collected by the Animal 
Welfare Institute on enforcement of the Animal Welfare Act * 
shows major and repeated "deficiencies" or "alleged 
violations" of the minimum standards of the Animal weifaie 
Act by 23.7% of the sample of 186 institutions whose 
inspection reports and emnual reports have so far been 
examined. Another 22% have less frequent major violations; 
28.5% have only minor ones; 1.6% are under inveatigationj and 
the rest, according to the USDA veterinary inspectors' 

*See Appendix A 

page 1 



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The conniittee also took exception to the DSDA's budgetary 
"assumption" that states, industry groups and others would take 
additional responsibility for enforcing the ANA, despite their lack of 
authority, and stressed that the Conmittee expects DSDA's fiscal 1986 
budget request will include sufficient funding to administer the ANA. 

The logical route then is to seek administrative changes in 
the current implementation of the ANA. Biomedical research interests, 
agriculture and animal welfare interests can cooperate as a unit to 
achieve reasonable, mutually acceptable goals. This is preferable to a 
legislative tug-of-war, where the innocent victim may be necessary, 
vital research successes. 

aFMA again thanks Chairman Brown and the subcommittee for 
this opportunity to comment on H.R. 5725. 



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SOCIETY FOR ANIMAL PROTECTIVE LEGISLATION 

P.O. Box 3719 

Georgetown Station 

Washington. D.C. 20007 

(202) 337-2334 



STATEMENT IN SUPPORT OF H.R. 5725 

BEFORE THE SUBCOMMITTEE ON DEPARTMENT OPERATIONS, 

RESEARCH, AND FOREIGN MSRICDLTURE 

September 19, 1984 

by Christine Stevens, Secretary 

Mr. Chairman, on behalf of the Society for Animal Protective 
Legislation, I wish to commend the reasoned approach and the 
long-term interest you have demonstrated in seeking to limit 
the suffering of laboratory animals. As one of the best 
friends of science in the Congress, your efforts should be 
crowned with success. 

If H.R. 5725 is enacted into law, it will be helpful to 
research. The federal Animal Welfare Act, which it amends, 
now has the approvtd of the major biomedical research 
organizations as demonstrated by their endorsement of a two- 
thirds increase in appropriations to enforce the Act (1) . 
Several of these organizations were at the forefront in 
fighting passage of the Act in 1966 and its amendnents in 
1970 and 76, but the fears they then expressed have proved to 
be groundless. The same will prove true with your bill, Mr. 
Chairman, if vested interests do not succeed in blocking its 
passage. The interests I refer to are jiot scientific; they 
are commercial, and they foster illusory fears and play on 
prejudice to gain their selfish ends — ends as harmful to the 
scientific communitiy as they are to the welfare of animals. 
Their rallying cry is: "Studyl"; their aim: to delay, and, 
through delay, to defeat the urgently needed H.R. 5725. They 
portray needless animal suffering in laboratories as a rari^ 
and want to pay the National Academy of Sciences to study the 
question at length. 

Far from being a rarity, the data collected by the Animal 
Welfare Institute on enforcement of the Animal Welfare Act * 
shows major and repeated "deficiencies" or "alleged 
violations" of the minimum standards of the Animal Welfare 
Act ksy 23.7% of the sample of 186 institutions whose 
inspection reports and annual reports have so far been 
exeimined. Another 22% have less frequent major violations; 
28.5% have only minor ones; 1.6% are under investigation; and 
the rest, according to the USDA veterinary inspectors' 

*See Appendix A 

page 1 



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records are abidinf by the, and I repeat r jBJlniflWQ standards. 
Even these cannot be assumed to be In regular oontpl lance with 
the law because some USDA inspectors have been found to have 
overlooked serious rLolations in the past. Indeed OSDA's 
Veterinary Services which administers the Act, tiae 
commendably Instituted a policy of double checking on 
Inspection repotta which show few if any obaervations in 
oi:der to ensure that compliance is as uniform as possible. 

Thus, even using the most optimistic assumptions , only 24.2% 
of registered reeearch facilities are regularly meeting the 
existing minimum standards of the Animal Welfare Actl 

Reading the veterinary Inspectors^ reports has been an 
astonishing experience for me, for though I have vial ted many 
laboratories and observed much needless purposeless 
suffering which is counterproductive to scientific aims, I 
would not have guessed that ^a many renowned institutions 
were .an oblivious to the duty {to which all give lip service) 
to treat laboratory animals decently^ that they allow gross 
mistreatment to continue unabated or if corrected under 
prodding by USDA inspectors, to recur. 

The attached listings specify the level of compliance of 186 
institutions. The chart prepared for the 44 in Category I 
indicates whether or not the institution is accredited by the 
American Association for the Accreditation of Laboratory 
Animal Care, and you will note that many AAALAC-accr edited 
facilities have major def iclenciesr clearly demonstrating the 
National institutes of Health, position that accreditation 
guarantees good animal care and treatmentr to be untenable 

The charts further indicate the level of NIH funding in two 
consecutive years, and the numbers of dogs cats, primates, 
rabbits, hamsters and guinea pigs used in those years. The 
number of animals used is higher in 40.9% of the 44 
institutions in the second year, demonstrating that the glib 
and often repeated statement that the use of animals is just 
naturally decreasing and there is no need of legislative 
encouragement in this area to be far from accurate. It is 
noteworthy, too, that 79% of these severely deficient 
institutions were rewarded by an Increase in NIH funds in the 
second year noted. Twenty-five percent of the 44 used more 
animals ^n^ got more money from NIH despite their bad record 
with OSDA. 

The chart's final column shows the numbers of emimals 
reported by the institutions to have suffered pain or 
distress unrelieved by emesthetic, analgesic, or 
tranquil izing drugs. These are decidedly the least reliable 
of the figures given since the majority of institutions 
decline to admit, in filling out their emnuad reports that 



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even one animal Bufferedl* This curious fact is a measure of 
the urgent need for enactment of H.R. 5725. Whether the 
person who fills out an institution's annual report is 
deliberately misBtating the amount of unrelieved animal 
suffering or 1b simply blind to it, matters little. The 
animals are needLeasly sufferingr and legislation is 
essential to prevent it. 

Such legislation has been widely adopted by countries where 
Isiboratory animals are used extensively. Indeed, the only 
major exceptions to this general rule are Russia and 
Japan, countries in which animal protective legislation of 
any kind Is almpot non-eiti stent. National pride alone should 
spur \iB to bring our standards up to those of th^ Western 
European democracies which have (and mainly have had for 20 
years or i&ote legislation aimed at pa in- reduction for 
laboratory animals Austria, Belgium, Denmark, Federal 
Republic of <3enDany, France, Iceland, Ireland, Italy, 
Luxembourgr The Netherlands, Norway, Sweden, Switzerland and 
the United Kingdom. 

Scientific endeavor experienced no setbacks as the result of 
these laws. Scientists have never sought their repeal. 

To illustrate the need for enactment of H.R. 5725 eight video 
sequences shot in six different institutions have been 
produced ksy the Society for Jlnimal Protective Legislation 
from footage taken ksy the Lifef orce Foundation. We will be 
happy to show this three-minute tape to Members, staff and 
others who wish to view them. I include herewith a brief 
description of each example and the relevemt provision of the 
bill. 

VIDEO SEQUENCES ILLUSTRATING NEED FOR 
SEVEN DIFFERENT PROVISIONS OF H.R. 5725 

All the laboratory animals in these sequences are alone and 
unattended. 

1. This pup may injure itself on the dangerous piece of 
loose metal projecting from the much gnawed whelping box, an 
exa^iple of negligence which the bill' a mAji dated ftn^**! 
Re^aarch Committer, including a £U£lLu: ttdttber tSi XAfiCAfifiHt 
commiini ty j^tiCgJlElJ £Q£ JJElfi welfare ^ ^h£ animal aUbjgCtfl, 
JCQlli^ correct In JJLfl g^mi-annual inept Ctignfl^ 

*For example, the USDA veterinarian inspecting Washington 
University in St. Louis wrote 4/22/82, "A sick kitten was 
observed which was not under the care of a veterinarian (a 
deficiency in itself] . Blood from rectimi and paresis of rear 
limb. No pain or distress report on file as prescribed by 
Section 2.28(4) of this regulation." 



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2. This dog, i^eed In a bone fracture experiment, has 
chewed through the bandage and bitten his own skin. Although 
observed by the Anim&l caretaker, no action to replace the 
dirty and half destroyed bandage has been taken. ThA bill 
Fg^uirfig poflt- operative s:a^£. in accordance with egtabliahed 
medical ii^ nurging procediirea. 

3. This dog is suffering unbearable pain and bleeding 
heavily following heart surgery- Clearly the necessary 
analgesics have not been administered. .Ili£ bill providgg 
J^h^ pain- relieving duifl^ ql euthanaala loay H^ bs. 
imneceg^arllv withheld tlSS^ fiiifferijig anifflalfi. 

4. After having their eyelids sewn shut, these cats are 
disoriented. They are hungry and thirsty because their food 
and water bowls were not attached andthus were easily 
spilled. The cats are In great distress^ Ihfi hill providgg 
tm l^QZ S^^ J^Y P ftrsonnel tQ impart viol at ions q^ J±£ 
a tandards tD. ih£, instil tut i anal eonunittee jind pgQtfiCtg thSM 
frojn dJEgfimination i££ finch I£IK3J^tilig* 

5. Honkeys in restraining chairs may be kept there for 
weeks or month a r though tethering devices which allow 
regulated adii]ini£trtttion of drugs can be substituted In many 
cases for inonkey chairs. An information Service ^ lb£ 
Mat-innal Agrlctiltimal Library In cooperation i^Lth ths. 
Mut-innal Library ^ Medicine 1^ provided in X^ hUX tSi SiSA 

information i^n improved a&^aOs ol fixpeciflientatioQ ntlilcti 
could replace, unneceasarily atressf ill piactiCfiB> 

6. Picking at hie wounds, with blood running down front 
the side of his head where the brain surgery and implanted 
electrodes leave his skull open, this monkey Is in danger of 
developing major and possibly lethal infection. Veterinary 
consultation. Afl i£ttJuiJ^&d b£ J±£ bill> agpeags ^ h^ flbaent* 

7. Primates are chained and a pole is used to force 
them into the restraint device. Fighting against his chain, 
this monkey may break his teeth. Th£ hill provides i^L 
inatr uction In JJElfi humang practice s£. dDimAl PalatgJiance^ 

8. In a convulsion caused by the experiinent but 
observed by no experitnenterF this primate suffers without 
relief. JJie bill reguirea iJiat in ^0^ practice involving 
pain ta unaneHthetiied animalSi ^ ijf^^i^^ st Vetfiiinary 
Medicine b$ consulted in th& pi anning . And thal^ withholding 
tranqulllzexa, aJl£^h£^X^j. analgesia, qi. eutibanasia when 
ggientif Ically necesaary shall continue n£l longer iban 
neceaaary. 

For anyone who 1) has a strong stomach and 2) is not 
convinced of the urgent need for enactment of H.R. 5725, I 
also recommend viewing videotapes taken by scientists of the 
University of Pennsylvania Head Injury Clinical Research 

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Center of themselves and their experimental subjects. 
Because the original tapes were stolen from the laboratory by 
a group called the Animal Liberation Front, copies are not 
being shown in the House of Representatives. People for the 
Ethical Treatment of Animals has a half-hour of excerpts from 
a copy of the 60-hour long tapes which can be viewed by all 
interested persons. 

In looking at this half-hour, I noted numerous graphic 
illustrations of needless suffering which could have been 
prevented by the legislation. Selecting seven sequences, I 
wrote corresponding citations of the bill's provisions, and 
this material follows. The relevance to the bill is given in 
all capitals, the experimenters' remarks in lower case. 

I should state that th« Society for Animal Protective 
Legislation apes not endorse the theft of the tapes. After 
consultation with coLuiBel, we find that It le not illegal to 
show and view these copies of the incriminating evidence. 
E)icerptB have already been widely vlewedon television. We 
believe an examination of them will be of value to the 
CongreEs in understanding why thet^e is such vehement and 
constantly Increasing di seat isf action with improper conduct 
of animal experimentation, as vividly documented in these 
tapes. And it Is especially relevant to Congress since it 
shows so clearly the waste of government money. 

Sequence 1 

THE HEAD INJURY CLINICAL RESEARCH CENTER OF THE UNIVERSITY 
OF PENNSYLVANIA RECEIVED NEARLY A MILLION DOLLARS FROM THE 
NATIONAL INSTITUTES OF HEALTH IN 1983. 

THE BRCWN BILL WOULD PREVENT DISCRIMINATION ASAINST 
PERSONNEL WHO REPORT fiNIWAL MISTREATMENT TO TOE 
INSTITDTIDN'S ANIMAL RESEARCH COMMITTEE SO TOAT 
CORRECTIONS CAN BE MADE WiTHOCfT PdNERSE PUBLICITY. 

TOIS BABOON IS UNDERGOING SURGERY WITHOUT ADEQUATE 
ANESTOESIA. NOTE THE ANIMAL RAISING HIS TAIL. TOIS IS 
CRUEL ON-TOE-JCB LEARNING. NOTE ONE EXPERIMENTER 
HOLDING DOWN TOE BABOON'S LEG. 

*(a) OhI He's lifting his headl 
Come on, baby I 

(b) I better get some nitrous, [nitrous oxide, an 
anesthetic agent] 

(a) StopI stop, for heaven's sake. He wants to get up. 
He says I've had it. It hurts him, for Christ's sake. 
All you got to do is make a little slit in the 
periosteum and and push it back. 

(b) Ya, but it bleeds. 

*Two experimenters talking are indicated by (a) and (b) 

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(a) You got to do something to control the bleeding. 
That's what the bovie is for.. .Not there, Therel 

THE BRCMN BILL REQUIRES TRAINING SESSIONS POR SCIENTISTS 
AND TECBHXCIAHS IN METHODS TO LiniT ANIMAL FAIN AND 
DISTRESS. IT R^UIRES TOE USE OP PAIN RELIEVING DRUGS TO 
MINIMIKE Snoa PArN it PROVIDES FOR AN INFORMATION 
SERVICE OM IMPRO/ED METHODS SUCH AS ANESTOETIC AND 
ANALGESIC PROCEDURES. 

TOE BROfN BILL REQUIRES TOAT PAIN RELIEVING DRUGS NEVER 
BE WITHHELD LCXiGER TOAN NECESSARY. 

Sequence II 

TOIS BABOON IS ABOUT TO BE SUBJECTED TO HIS SECOND INJURY 

(a) This is monkey B 9. The monkey now weighs 8.8 
kilos. The animal is down for a second latertd bang. 
That's him waving. As you can se& the monkey's awake, 
moving adl extremities Tbat s his trainei: who's taught 
him how to do those tricks. The animal is mounted in a 
helmet. He is monitored for ICP, EKG, EB6, blood 
pressure etcetera. The animal is to be thrust in the 
lateral position to become a chronic animal, uh, for 
long term studies^ 

(b) YOU might want to mention the monkey's already been 
banged once. 

(a) I said that, a second bang. 

(b) Did you say that? 

(a) This is his second bang. He was banged once at 
680 g force and quickly recovered. Cheer leading over 
in the corner. we have B 10. B 10 wishes his counterpart 
well. As you can see, B 10 is alive. B 10 is watching 
and hoping for a good result for future B 17 over here. 

fitfqnence TIT 

REMOVAL OF TOE HELMET APPEARS TO BE AN OCCASION FOR 
MERRIMENT 

(a) Change his name, and we' 11 call him "Slim." We 
could run a diet service, bring 'em in slam *em, 
put 'em to bed. (hammering and laughter} Thibault's 
weight reduction clinic. 

THE HELMET HBlCB IS CEMENTED TO TOE BABOON'S HEAD WITH 
DENTAL CEMENT IS BEING HAMMERED WITO A CARPENTER'S 
HAMMER AND SCREW DRIVER TO BREAK IT APART. 

(a) We don't know where to put *em. This guy's waking 
up. Conceivably we will come in and they'll be running 
around the lab. He's movingl He's moving I He has this 

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little string on his tail. We jnst poll, (aore 
haonner ing ) Pusfa ] 
Oohl It*s a boyl 

THIS OlDOe HBTBQD OF VBKCNTMG THE HEUBT GUIfiES 
UHQD3WT1FIED TRMJHA TO TEE EZFCRIISVTBL SCSJSCT. 

(a) We're tliinking of going on strike. Ihe contract 
says no more than three comatose boonies at any one 
time. That's in the contract, (more hammering) 

(a) Seems like I left a little ear behind. 

(b) Oooohayl 

THE BROWN BILL RBQUIRES TEE IRHTITUTlOilAL GOHHITTEE TO 
BE NOTIFIED OF ANT CHANGES IN PRACTICES AIXrERSELY 
AFFECTING TEE WELFARE OT THE ANIHALS. USE OF H AMffiR AND 
SOIEWIHIIVER WERE NOT MENTIONED IN TEE GRANT RJQUEST. 

Rwqn^nnafc TV 

RESEARCHERS r STANDING (JTER ANOTHER BABOGR ON TEE 
OPERATING TABLEr DISCD5S TEE LACK OF SANITATION 

(a) Wtay is it so dnsty doim here? Wfa^, because thcg^'re 
basically incompetent doim here. Well, I mean, jnst in 
general our prooedures caose dnst. 

They don't. • .They* re not regular in cleaning at all, and 
I've called them three times. When they do dam 
they're half-ass. 

Lately the ventilation system has been speiring out 
some sort of... dust. It's the type of tiling. ..Xa, I 
don't, yon know. I complain aix>nt it, but you kno«r.... 
When you come doim here it anells like urine. 

(b) We have three months of urine dovn in thm bottom of 
that thing. .. Urine asptayziati on. ..toxicity. 

(a) We had to get her out of tliat. She was just 
filling it up with buckets of urine. 

TEE BROWN BILL REQUIRES SSm-ANNUAL INSPBCTIOHS BY AN 
ANIHAL RESEARCZ GOHHITTEE INCLUDING A V ETORINA RIAN AND 
AN OUTSIDE ISnER RESPONSIBLE FOR REHtESENTING COHHUNITY 
CONCERNS FDR TEE WELFARE OF TEE ANmL SCSJSCTS. 
UNCORRECTED DEFICIENCIES HOST BE REPOTTED TO THE 
DCPARTIffiNT OF AGRICULTURE AND FUNDING AGENCIES. 



WHILE CONDUCTING A SURGICAL PROCEDURE ON ANOTHER 
BAB OON' S HEAD, TEE EXPERIHENTER, WHO WEAR S NO HASK, CAP 
OR STERILE CLOTHING, DROPS AN INSTKUHENT ON 1!H£ n<OGR, 
PICK S IT UP WITHOU T R EiK JVlH G H IS GLOMES AND WITHOUT 
STERILIZING IT, CONTINUES TEE OPERATION. 1!HE SURGEON IS 
SMOKING A PIPE. AN ASSISTANT IS SHOEING A CIGARETTE, AND 
A THIRD BOmS O^TER TEE UNDRAICD BABOON ON 1!HE OPERATING 



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TABLE, TOLDIHG A CIGARETTE WITH A LOHG ASH IN HIS MOOTH. 

(Bore BBoking) 

TBE B^ann BILL IROVIDBS THAT A FEDERAL ASEKC7 SUSPEND OR 
filVOlC£ SUPPORT FOR A IROJECT IF ANIMAL CARE, IREATHENT 
OR mACrlC£3 HAVE NOT BEEN IN COHFLIANCB WITH APILICABLE 
SI'hHEiARDS. THE NIH GUIDE WAS RBFEATESLT VIOLATED IN 
THIS NGNSTERILB SURGERY. 

gjiqiiAncg VI 

TSE BKOHK BILL REQUIRES IfiAT A VETERINARIAN BE CONSULTED 
IN THE RANK DIG OF ANT PROCEDURE INVOLVING PAIN TO 
OUEBMSETISED ANIMALS. NOTE THE BABOON PULLING AGAINST 
HI MVDE OH BIS LEGS AND SWITCHING HIS TAIL AS THE 
MACS INK ADRINISTERS THE POWERFUL FORCE. 

Saiatnss^ vtt 

(a Come on, aonkey, hang in there jost a little 
longet, bat^l 

A DYING BABOON IS ATTENDED ONLY BY A STUDENT WHO CURSES 
"THE PROBLEM" BUT CMJNOT DEAL WI^ IT. THE BROWN BILL 
REQUIRES FOST-SUHGICAL CAKE JH ACCORDANCE WITH ESTABLISHED 
MEDICAL AH& HURSl^ F&OCEIt]R£S. 

It Lb regrettable indeed that spokesmen for the Universi^ of 
Pennsylvania asserted poblidy (2) that the baboons were 
aneathetiied and felt no pain, Tftese Btatements show 
remarkably poor judgment inaa&uch as: 1> The videotape 
clearly ehcws a baboon undergoing head Eurgeiy with 
inadequate anesthesia (see above, 'It httrts bim for Christ's 
sake'); and 2) The NIB protocol i2) for the grant states 
that the general zmeathetic iB allowed to wear off for a full 
hour before the massive injury ie inflicted. Line 1, page 
193 of the grant appHcation reads 'Throo^ the endotracheal 
tube the animal spontaneously ventilates 70-80% nitrous oxide 
anesthesia ontil 1 hour before acceleration after which it 
breathes room air." 

To cap it all, the Universi^ of Pennsylvania claims in its 
annual report to the U. S. Department of Agriculture that it 
caused no unrelieved pain to animals 1 

As bad as the misrepresentation iSr even more serious is the 
fact that scientific results obtained with that kind of 
mistreatment of animals can t be depended upon because of the 
way the experiments are carried out. Following are the 
figures for the past four years of grants from the National 
Institutes of Health to the Bead Injury Clinical Researdi 
Center of the University of Pennsylvania: 1^80, 5 955,593; 
1981, $ 841,537; 1982, $ 886,334; 1983, $ 969,571. 

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Fine words can no longer convince the public that laboratory 
animals live pain-free lives. The scientific community would 
be wise to embrace the moderate bill, H.R. 5725, and 
encourage Its thorough enforcement to prevent the needless 
anlmed. pain and distress that dishonors otherwise reputable 
Institutions. 

Occasionally an opponent of the bill will attack the very 
concept of pain, alleging that It cannot be defined. A clear 
and useful definition made by Profeeaor Patrick t>» Wall 
states, "Pain In animals Is manifested by abnormal behavior 
which can be alleviated by analgesic procedures which relieve 
pain In humans The international journal Pain gives this 

definition of severe pain "Severe pain in animals Is pain 
produced by procedures to which normal humans would not 
voluntarily submit without appropriate analgesia or 
anesthesia." Dr. A. Lawrence Abel, former Vice President of 
the Royal College of Surgeons of England testifieij at 
Congressional hearings on laboratory cmlmal legislation In 
1965, "Fear Is the psychological equivalent of pain." Both 
must be avoided to the greatest possible extent, 
psychological distress being as serious as physical pain. 

I was Interested to learn that "learned helplessness" 
experiments a state of pathological inability to act as a 
result of Inescapable pain, have never been conducted in 
Britain, nor Is there ai^ Indication that they were ever 
proposed. A review of the literature In other countries 
describes dogs subjected to Intense Inescapable electrical 
shock (Including a series of 64 painful shocks in two hours 
while suspended in a harness] as follows: "They stopped 
running and sat or lay down quietly whining. * The paper 
concludes that "This relatively siDiple hypothesis has been 
supplanted by a more complicated f onnulation" and th^t 
"Investigators of human helplessness . . have become 

increasingly disenchanted with the adequacy o£ theoretical 
constructs originating in animal helplessness for 
understanding helplessness in humems." Nevertheless, we are 
told that "In the long run it is probably better to have 
compared and erred, than never to have compared at all." 
(From compariag Behavior; Studying Man fitut^iny Animals, 
edited by D. W. Rajecki (Lawrence Erlbaum Associates, 
Hillsdale, NJ, London, 1983) . 

The amount of pain and fear to which many dogs were subjected 
for the past 17 years only to find that investigators are 
"increasingly disenchanted* with the relevance of the results 
to humans, is not mentioned in the review of the subject. 

Whether or not more humane alternatives were considered by 
one or more of the investigators cited is not possible to 
say. But it is of fundamented. Importance that such 
consideration be given by principal investigators when they 

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are developing their Ideaq. The provision In H.R« 5725 Is 
mild. It simply requires that the principal Investigator 
consider eaternatlves to any procedure likely to produce pain 
or distress In an experimental animal. The Institution must 
provide an assurance demonstrating that he has done so. 

Completely non-authorltarlan, this provision vouldt bring to 
fertile scientific brains the concept of humane plemning of 
experiments. Asking a young experimental sLirgeon, who was 
showing me around a room containing horribly emaciated and 
cringing dogs, whether he tried to plcui experiments humanely, 
he responded with obvious surprise, "I never thought of 
that." 

If H.R. 5725 were law, the need to think before starting 
would be established. 

H.R. 5725 would not prevent all pain to animals. Rather it 
would prevent avoidable pain and pain that can be relieved by 
drugs and other methods The principal investigator would 
retain every privilege he now holds with respect to the 
design of his experiment. To comply with the law, he would 
consider alternativeE to any painful experiment* The 
Information Service at the National Agricultural Library in 
cooperation with the Rational Library of Medicine would 
provide him with updated information on substi bates for 
leUsoratory animals, ways of limiting their numbers to those 
strictly necessary, and the best ways of preventing pain and 
distress. He would report to the institution's Animal 
Research Committee any changes in his work vbich would 
adversely affect the welfare of the animals Be would 
consult with a veterinarian before performing an experiment 
which could cause pain in order to ascertain the best methods 
of avoiding it. The semi-annual inspections by the committee 
would assist the D, B^ Department of Agriculture in 
maintaining good standards,^ 

This bill is the product of years of work, consulting 
representatives of scientific and animal welfare 
organizations. The process began in 19S2 with a series of 
five four-hour long meetings including the American 
Physiological Society American Psychological Association, 
Association of American Medical Colleges, Rational Society 
for Kedical Jiesearch, Society for AnimeU. Protective 
Legislation, Bumane Society of the United states, American 
Humane Association and People for the Ethical Treatment of 
AnlmalSr among others* The process continued resulting in S. 
657 authored by Senator Robert Dole (R*KS and, after 
hearings July 20 r 19S3, additional work based on testimoi^ 
presented was undertaken. Many of the groups who asked for 
changes have e^pre^sed appreciation of new phraseology in 
B*H, 5725 yet still further suggestions continue to be made. 
I would like to take this opportunity to make two suggestions 
designed to increase scientific support for the bill. 

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Pagtt €, liM 18 add "and shall concarn thamsalvaa with tha 
walfara of tha animal subjacts." This would giva tha 
sclantiflc nambars a mandata on anlnal walfara Bupplamantlng 
tha vitally important diractiva to tha "outaida" mambar who 
"shall ba responsibla for repreaeritlng communis concarns 
regarding the welfare of animal eubjects." Thasa 13 words 
are central to the affactiveness of tha bill. 

The National Institutes of Health's proposed principles (4) 
include an outside member, but they lack these easantial 
words which are needetj by the laboratory animals and the 
scientific community alike. 

Until genuine efforts are made by all registered research 
facilities to put an and to the massive abuses and waste of 
funds in questionable research results obtained with 
naglectedr diseased, suffering or otherwlB« unsuitable animal 
subjects, more and more damaging disclosures will continue to 
be made concerning the needl«eB suffering of these animals. 
There is just one effective way to stop this rapidly growing 
trend: support H.R. 5725. Get it passed; and instruct all 
personnel to obey it, thus ensuring that laboratory animals 
are decently treated. Then the outside member charged with 
representing communis concerns for the welfare of the animal 
subjects will be able to state honestly that the concerns 
have been met. Tha hey 13 words, together with the pain 
preventing proviEione supply the means to accomplish tha goal 
which all concerned would like to seet an end to needless 
pain in animed. laboratories. 

The second suggestion is to move the sentence beginning "The 
Secretary" line 11, page 4 to follow line 4 on the same page. 
The purpose is to clarify the meaning. Further clarification 
could be achieved by re-ordering the words in the sentence 
(line 12) to read "promulgate research facility standards" 
rather than "standards for research facilities." 

The U.S. Department of Agriculture objected at hearings on 
S. 657 to use of the adjective "proper to modify the 
standards. In H.R.P 5725 no adjective is used, but I 
understand that USDA wemts to retain the word "minimum." 
This would be unwise because the word has been interpreted in 
a most deleterious way especially by dog deeders. To give an 
example, a deeper argued that because the standards are 
"minimum" it would be quite all right to use bits of old 
tires as watering vessels for the dogs. "Minimum" really 
means to everyone who wants to justify cutting corners that 
"anything goes." The word itself has contributed to the 
difficulty experienced in getting full enforoeinent of the 
Animal Welfare Act. We urge that it be dropped, as wisely 
done in H.R. 5725. 

USDA alBO asks for guidance on the addition to the standards 

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of exercise for laboratory dogs. The basic intent is that 
where dogs are caged, they be released at least daily from 
their cages. Some Institutions release them to an outside 
runway. Others sinply let them run around the room while the 
cages are being cleaned. In. some cases a hallway can be used 
as an exercise area or an inside pen can be used. If dogs 
are housed In p^tiB or kennel runways th«y do not need to be 
moved at all. The Subcommittee may wiah to include report 
language for the guidance of USDA in rule making on this 
matter. 

As recognized by a growing number of research facilities, 
dogs evolved ae pack animals running long distances to 
capture prey. A cage cannot even begin to meet this species' 
behavioral needs. The Animal Welfare Institute publishes a 
manual j^fanfort^ablg OuarHfefs tsiL. Labofatofy Animals which is 
made available free pn request to scientific institutions. 
It contains many different photographs of acceptable 
provision fof housing dogs and other laJt>oratory animals for 
the guidance of scientists and regulators alike. 

USDA also questions the requirement that its veterinary 
Inspectors visit the animal laboratories of other federal 
agencies to enforce the standards tfe believe this would 
have a highly beneficial result, because although the 
existing law requires all agencies to adhere to the standards 
established by the Secretary of Agriculture, there is no 
means of ensuring that this actually happens* This is the 
only part of the bill which would require any increased 
funding the cost of sending representatives of Veterinary 
Services to the different sites. In our opinion this would 
be well worth the expenditure, vie urge retention of the 
provision. 

OPPONENTS WITH A VESTED INTEREST 

The Association for Biomedical Research is a trade 
organization, founded by Charles River Breeding Laboratories, 
a multi-national, multi-million dollar business which 
recently become a part of Bausch 2uid Lonb, the big optical 
company . 

To give an idea of the size of the funds involved, I quote 
2hfi Boston Glflbe, November 24, 1983: "Charles River had 
about $45 million in sales during the last 12 months and 
earnings of $6.2 million.... Bausch & Lomb, based in 
Rochester, NY, is nearly 13 times the size of Charles 
River.... Dr. Henry L. Poster, the founder and president of 
Charles River, owns 29 percent of the company's stock which 
would be worth about $37.8 million if the deal goes through." 
It did. 

How were these huge profits made? The answer is simple; by 
skillful and unrelenting promotion of the sale of the maximum 

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numbers of anlnals to scientific institutions. Even animals 
as small and inexpensive as white mice can turn a fat profit 
if they are produced by the tens of millions and marketed 
with full page adB in every issue of the right journals. 
Monkeys, of course^ bring far higher priceB, and Charles 
River trumpets their ready availability in ade which since 
Bausch and Lonb took the compare over are nob only full page 
but full color, too. "Don't put your research on hold," 
scientists are advised "Link up with a primate that means 
quality. Our cyno. Or any of our other 10 commonly used 
species. " 

Readers would never guess that eQl primates are either on 
Appendix I or II of the Convention on International Trade on 
Endangered Species of Wild Fauna and Flora (endangered, or 
threatened with extinction) . Most are wild caught. 

Tbe more animals used, the larger the profits for Charles 
River/Bausch & Lomb. As founder of the biggest laboratory 
animal business in the world, Henry L. Foster was quoted in 
Ihfi Hall fitr^fil Xtanajiitipt/ 5/21/78, "...if you read the 
paper Sj everything seems to have carcinogenic effects. But 
that means more animal testing which nt^arts growth for Charles 
Siver Ju^t let me take a few more minuter to read you a 
list that rather excites us... .All these companies are 
building [testing facilities] . So you can see why we 
continue to be enthused and excited. " 

In the course of developing even more massive animal sales 
worldwide, Charles River boasts "a triumph for good breeding" 
of its animals, but when Th& lifitt York Tlmgg (5) reported that 
eUsout 1,000 experimenta had been thrown off when Charles 
River's BALB/c mice turned out to have been genetically 
contaminated the company barely turned a vhisker A lawsuit 
by cancer reseacher Brenda Kah^n, of the Universi^ of 
Wisconsin, charged that Charles River "deliberately did not 
notify its customers" or failed to perform the necessary 
tests was settled out of court, and the question asked by 
Alvin Warf el (6) "If they can't guarantee they're selling 
BALB/c mice when they say they are, why are they in 
business?" was never answered. 

The National Institutes of Health is a big and steady 
custoioer of Charles River. In 1983 alone NIH had eight 
contracts ^ith the compare for a total of $3,571,407 The 
ficience article, "Scientist Sues Over Genetically impure 
Nice, raised more questions than it answere^J about NIB a 
role. Certainly there were no eaarm signals sent out by NIH 
that were loud or clear enough to alert Dr Kahan that she 
had the wrong mice when she was conducting cancer research 
which depended on their genetic purity. Had there been, the 
wasted research, wasted government funds, and purposeless 
animed. usage would have been prevented. 



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Frank! e Trull, the Executive Director of the Foundation for 
Biomedical Research as well as the Association for Biomedical 
Research, works closely with NIB, organizing panels on which 
both the present and past directors of NIB appear, and, in 
turn, speaking on NIB panels. 

ABR and NIB have worked hard to convince the Congress that 
B.R. 5725 and S. €57 ftbould not be passed before an 18-month 
study is undertaken by the National Academy of Sciences and 
reported on - in other words until two more Congroeseg have 
run their course Thi^ time-honored way of killing mandatory 
legislation was acknowledged l^y^ Ms. Trull in a presentation 
January 31 1984 at the Health Sciences Center of the 
Univetalty of Illinois, open to all faculty r st^ff, and 
students where she noted, "Now we are criticized for being 
strong proponents of study legislation by animal welfare 
organizations who say this is a stalling tactic^ Well, I 
n«an, you know, none of us was born yesterday. The fact of 
the matter Is that, in some ways, it is a stalling tactic," 
a few minutes later she remarkedr "The party line is that 
most scientific associations oppose the Dole bill." (S. 657) 

It is understandable that a trade association, whose founding 
member depends for the continuation of its commercial 
expansion on the purchase of the largest possible numbers of 
laboratory animals, should fight legislation that calls upon 
investigators to consider alternatives which could reduce 
numbers of animals or replace them It is far less easy to 
understand why scientific organizations should follow ABft s 
■party line* It is not to thgjr best interest to do so 
They are not making money selling animals* On the contrary, 
scientists eh o old have an enlightened self-interest in using 
the smallest numbers of animals possible and treating them as 
humanely as possible. 

I personally regret the necessity to bring to public 
attention the massive neglect and mistreatnient of animals by 
research facilities in order to demonstrate the urgent need 
for enactment of B R> 5725. It would be far preferable for 
the scientific comBtunity as a whole to support B R. 5725. 
The longer scientists 2d.low lobbyists to fight this modest 
humane bill on theic behalf, the more widespread will public 
knowledge of leUsoratory animal suffering become. 

Some scientists may have been led to believe that NIB will 
take care of the problem. It is important that the Congress 
know that NIB alone is Incapable of dealing with it. ffhile 
we welcome any improvement In !4IE's Guidg qjx lh£ £ax£ AXXd Hafi 
q£ Animal fl ■ And in the principles recently put forth by NIB 
(we submitted testimony on both) , this activity not only 
lacks the necessary legal force but, laore seriously, lacks 
any practical means of enforcing the recommendations and 
principles* As NIB itself emphasizes, it does not want to be 
a policeman. That task has been properly assigned by the 

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224 

Congress to USDA regulatory veterinarians. 

FARM ANIMALS ARE EXEMPT 

As an amendnent to the Animal Welfare Act, H.R. 5725 is 
adnlnietered by the Secretary of Agriculture. Agricultural 
IntereaU should be especially pleased by this fact, and 
indeed the majority are. Regrettably, others, though totally 
exempt from the bill's requirements, nevertheless oppose its 
enactment. They do a distinct disservice to the farmers who 
are their constituency by opposing a much needed humane bill 
which farmers as individuals would take not interest in 
opposing. 

H.R. 5725, specifically exempts farm animals because it 
amends the Animal Welfare Act which excludes from the 
definition of the terro "aninwd" "horses not used for research 
purposes and other fa no animals, such as but not limited 
to, livestock or poultry used or intended for uee as food or 
fiber, or livestock or poultry used or intended for improving 
animal nutrition, breeding, management or production 
efficiency, or for improving the quality of food or fiber." 

This exemption has been in place for years and though this is 
the third time anendnents to the Act have been proposed 
(amenanents were passed in 197 and 1976) no change has ever 
been proposed to the exemption. The Act focuses on 
biomedical research and testing laboratories, their animal 
suppliers, and the transportation of these animals and other 
dogs, cats and wildlife exhibited in zoos and circuses. 

QfFORCEMENT OP THE ANIMAL WELFARE ACT 

As demonstrated in the findings from USDA inspection reports 
on the 186 institutions referred to earlier, a great deal of 
necessary work has been conducted by Veterinary Services in 
seeking correction of def icieitcies and alleged violations of 
the Animal Welfare Act. The difficulties experienced by 
inspectors in many instances in obtaining compliance are 
reflected in these reports. 

Large institutions receiving tens of millions of dollars each 
year from NIH often brush off the veterinary Inspectors' 
efforts to persuade them to correct abuses as required by the 
Animea Welfare Act. Persistent visits artd revisits, and the 
statement that a legal case will be filed if the institution 
continues its irresponsible course are frequently necessary. 

Basically, the problem stems from poor work by the Office of 
General Counsel where mai^ a case has waited for months or 
even years for action. Often the legal work, when finally 
accomplished, is inferior and fails in its purpose. 06C 
should provide the deterrent which would ease the inspectors' 
task throughout the country. We strongly recommend that this 

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dietingulehed subcommittee demand that 06C give the AnlAal 
HelfAie Act high priority and carry through effectively on 
cades. The current ftnd past failure to do bo results in 
needless vaste of govetnment funds when inspectors are forced 
to make repeated visits to obtain conpliance. In the 
meant Imer animals may suffer alcken, and die for lack of 
compliance with the minimum standards Veterinary Service's 
classification of both major and minor deficiencies is 
attached (Appendix A) > Note number 2 In the "aajor" 
classification: 'Enceeelve fecal buildup to the point where 
it appears that weeks or even months have transpired since 
the last cleaning." It is unpleasant to realize the 
University of Rochester fell Into that category i 7/20/82 
"Primates in Room B-7573B are being kept in cages which have 
not been sanitized for over six (€) weeks. (Since 6/1/82)". 

Further excerpts frott inspection reports are given in a 
sunaary which I would sufanit for the hearings record. 

Based on our observations of 08DA enforcement activi^ 
fron the time of the bill's passage in 1966 till today, the 
Socie^ for Animal Protective Legislation makes the following 

recommendations : 

1) Although inspection is better today than it has ever 
been, considerable improvement is still required to bring it 
up to uniformly high standards. 1*he Subcommittee should ask 
for regular reports on the nteaaures taken by Veterinary 
Services to make the program effective. 

At a minimum such a program should include a) training 
sessions, b) methods of rewarding good and discouraging poor 
enforcement by all personnel* c) prompt reporting of 
deficiencies found in all federally funded institutions to 
the funding body (The Memorandum of Qnder standing instituted 
for flow of Information among KIB, tJSDA and FDA seems to lack 
urgency in execution* Thus KIB peer review panels are 
generally unaware of the findings of the OSDA veterinary 
inspectors even when animal welfare standards are grossly 
neglected) * 

2) The Subcommittee should ask for a full report by the 
Office of General Counsel on its preparation and handling of 
cases under the Animal Welfare Actr and direct OGC to seek 
deterrent action so the law can no longer be disregarded with 
impunity as has often been the case during the past IS years. 

3) The Subcommittee should make clear to the Secretary of 
Agriculture that ai^ shifting of funds away form the Animal 
Welfare Act for other purposes will not be tolerated in the 
future. 

4) The Subcommittee should urge the Secretary to increase 
the number of Animal Care Specialists so that laboratory 

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inspections are not neglected when animal disease emergences 
take priority among the general inspectors. 



********************************* 



Referencea 

(1) American Association of Biological Sciences, testimony 
before the Subcommittee on Agricultural Appropriations, 
representing: American Society of Cell Biology, Association 
of American Medical Colleges, Federation of American 
Societies for Experimental Biology, National Foundation for 
Infectious Diseases, National Society for Medical Research, 
and the Public and Scientific Affairs Board of the American 
Society for Microbiology. 

(2) Bennett, Susan, and Price, Debbie M. , "Animal Rights 
Unit aaims Penn Raid," Philadelphia Daily ^fiu£. May 30, 
1984. 

(3) National Institutes of Health grant, "Head Injury 
Clinical Research Center," Number NS 08803-13. 

(4) " Proposed Public Health Service Policy on Humane Care 
and Use of Animals by Awardee Institutions. " 

(5) Boffey, Philip M. , "The House Mix-up", Ssa. York Times - 
July 27, 1982. 

(6) "Scientist Sues Over Genetically Impure Mice", by 
Jeffrey L. Fox, Science . (Vol. 221, August 21, 1983). 



(Attachments follow:) 



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APPENDIX A 

Through the Freedom of Information Act U.S. Department of 
Agriculture veterinary inspectors reports were requested for 
186 randomly selected research institutions. Those 186 
institutions are listed in Categories I, II, III, IV, or V 
according to the data found in the inspection reports. 

Category X consists of 44 institutions that had major and 
repeated major or minor deficiencies. 

Category u consists of 41 institutions with less numerous 
but still major and/or repeated major or minor deficiencies. 

Category III consists Of 3 institutions for which inspection 
reports were exempt from disclosure under 5 U.S. C. 552 
(b)(7)(a) which allows the Agency to withhold investigatory 
records compiled for law enforcement purposes if their 
disclosure could interfere with enforcement proceedings. 

Category j£ consists of 53 institutions with minor 
deficiencies. 

Category y consists of 45 institutions with no deficiencies 
reported. 



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U.S. DEPARTMENT OP ASRICDLTURE VETERIMART SERVICES NOTICE 

A. Minor Dftficlanciaa 

These are deficiencies of the standards or regulations which, 
due to their nature, would not pose a direct or iaimediate 
safety or health hazard to the animals involved. They also 
include those deficiencies which could potentially pose a 
safety or health hazard but, on the inspection date, are not 
observed in a severe or acute state. Examples includes 

1. Inadequate records or animal identification. 

2. Small clumps of weeds which border outdoor primary 
enclosure in which, however, no signs of pests are 
present. 

3. Fecal buildup of no more than 2 days' duration. 

4. Watering receptacles which appear not to have been 
cleaned and sanitized within the previous 2 weeks. 

5. Primary enclosures which contain a few loose wires. 

B. Major Dftf icianciaa 

These are deficiencies of the standard or regulations which, 
due to their nature, would usually constitute a health or 
safety hazard to the animals involved. They also include 
those deficiencies which, due to continuing neglect or 
advanced state of deterioration, constitute a safe^ or 
health hazard on the inspection date. Examples includes 

1. Animals in obvious need of veterinary care. 

2. Excesalve fecAl buildup to the point where it appears 
that weeks or even months have transpired since the 
last cleaning 

3. Primary enclosures and surrounding areas show evidence 
of dead rats, rat feces, rat holes, and other 
indications of major pest infestation. 

4. Primary enclosures in an advanced state of structural 
disrepair, even to the point that it is possible for 
the caged animeas to «Gcape or for outside animals or 
predators to enter, or where the caged animals can 
seriously injure themselves 

5. Indoor housing facilities with little or no 
ventilation, possibly to the point that the 
overpowering odors and ammonia scent are disagreeable 
to the inspector's well-being. 

6. Vermin infested feed. 

7. Lack of feed and water. 



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Google 



233 



Addendum tsi Category 1 

Many o£ the institutions in Category I received from NIH 
Research and Development Contracts in addition to the NIH 
research grants recorded in the chart. The following list 
shows the contract totals for each institution in 1983. 

1. Arizona State Univ. r $ 

2. University of Arizona, 1,577,794 

3. Syntex (USA) Inc., CA, 604,880 

4. Colorado State Univ. , 123,671 

5. Elars Bio Research Labs, CO, 

6. Univ. of Colorado, 244,628 

7. Yale University, CT, 1,826,492 

8. Howard Univ., D.C. , 715,515 

9. Univ. of Florida at Gainsville, 46,530 

10. Univ. of Miami, FL, 1,610,992 

11. Emory University, GA, 896,274 

12. University of Georgia, 340,355 

13. University of Hawaii, 679,258 

14. Hektoen Inst, for Ned. Res., IL, 

15. University of Chicago, IL, 5,514 

16. Purdue University, IN, 

17. Loui£iana State Univ., 275,742 

18. John Hopkins Univ., MD, 4,219,430 

19. University of Maryland, 4,841,934 

20. Beth Israel Hospital MA, 187,439 

21. Harvard University, HA, 2,017,034 

22. Tufts New England Med. Ctr. , MA, 411,246 

23. University of Mass. , at Worcester, 40,502 

24. Warner-Lambert/Park-Davis, MI, 1,009,430 

25. Univ. of Minnesota, 3,962,015 

26. Univ. of Mifisisfiippi, 94,887 

27. Washington University, MO, 1,189,360 

28. Rutgers, The State Univ., NJ, 

29. Cornell University at Ithaca, NY, 517,308 

30. New York University, NY, 391,758 
31a. State Univ. of NY at Downstate Med. Ctr., 217,146 
31b. State Univ. of NY at Stony Brook, 316,955 

32. Univ. of Rochester, NY, 1,151,807 

33. Duke University, NC, 1,279,019 

34. Univ. of NC at Chapel Hill, 7,002,462 

35. Case Western Reserve Univ., OH, 496,841 

36. Ohio State University, 564,557 

37. Oregon Regional Primate Center 

38. Univ. of Oregon Med. School, 45,639 

39. Univ. of Pittsburgh, PA, 3,730,401 

40. Univ. of Rhode Island 

41. Vanderbilt Univ., TN, 735,810 

42. Univ. of Virginia at Charlottesville, 375,708 

43. Med. Coll. of Wisconsin, 476,753 

44. Univ. of Washington 4,775,379 



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234 



Major and/or repeated major or minor deficiencies 

1. Jackson Laboratories, Inc., D.C. 

2. Qniversity of Alabjuaa, Birmingham, AL 

3. Standard Bremds, Inc., NY 

4. Dniversity of Utah, DT 

5. Dniverslty Health Center of Pittsburgh, PA 

6. University of Kentucky, KY 

7. Hayo Foundation, MN 

8. University of Missouri, NO 

9. University of Iowa, lA 

10. University of Wisconsin - Madison, Wl 

11. Columbia University, NY 

12. Stritch School of Medicine/ Loyola University IL 

13. Foundation for Behavioral Research, MI 

14. Hazelton Research Primates, VA 

15. Dartjnouth College, NH 

16. Phannacopathics Research, MD 

17. Abbott Labfi IL 

18. Otah State University, UT 

19. Kansas University Medical Center, KS 

20. Brigham Young University, UT 

21. ICI Americas Inc DC 

22. Norwich-Eaton Pharmaceuticals, NY 

23. Bristol Laboratories, NY 

24. Schering Corporation, NJ 

25. Flow Laboratories f VA 

26. Marquette University, WI 

27. Mount Sinai Hospital, WI 

28. Biomedical Research Labs, WA 

29. Hollister - Stier Labs, WA 

30. Creighton Univ. /School of Medicine, NE 

31. Princeton University, NJ 

32. University of Nevada, NV 

33. The Cleveland Clinic, OH 

34. Shriners Burns Institute, MA 

35. Bioassay Systems Co., MA 

36. Bates College, ME 

37. Michael Reese Hospital & Medical Center, IL 

38. Kansas State Qniversity, RS 

39. Yeshiva University, NY 

40. University of South Florida, FL 

41. Litton Bionetics, MD 



Page 7 



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235 



Category 1X1 



Exempt £rom disclosure. The Freedom of Information Act 

allows the agency to withhold investigatory records compiled 

for law enforcement purposes if their disclosure could 

interfere with enforcement proceedings. 



1. University of Conneticutf CT 

2. University of Texas, Austin TX 

3. Michigan State University, MI 



Page 8 



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2S6 

Category JDL 
Minor deficioncios 



1. American Rod Cross, ND 

2. Grady Investments, Inc., OH 

3. Unlveirsity of Illinois, IL 

4. K49&achusett Institute of Technology, MA 

5. tJniv«r£ity of Kansas, Lawrence, KS 

6. Indiana University, IN 

7. Brandeis University, MA 

8. Avon Products, Inc., NY — ^ 

9. Colgate University, NY 

10. Clrttichem, Inc., NY 

11. University of Nebraska, NE 

12. University of New Mexico, NM 

13. Children's Hospital of Pittsburgh, PA 

14. University of Pennsylvania, PA 

15. SI oan> Kettering Institute, NY 

16. Southwest Foundation for Research Education, TX 

17. Eli Lilly & Co., IN 

18. River Valley Farms, MN 

19. immune Hucleat Corp., MN 

20. Toit Monitor IL 

21. Medical College of Pennsylvania, PA 

22. Southwest Research Institute, TX 

23. Temple OnivoLSity, PA 

24. Hazel ton Labs Inc., VA 

25. Tufts University, MA 

26. Arthur D. Little, IL 

27. Toxicity Research Lab., MI 

28. Travenol Labs., IL 

29. University of Oregon, OR 

30. Quaker Oats Co., IL 

31. University of S. Alabama, AL 

32. Environmental Consultants, VA 

33. University of Tennessee, TN 

34. University of Texas, El Paso, TX 

35. St Louis University, MO 

36. Merrell Dow Pharmaceuticals, OH 

37. EG & G, MA 

38. University of Utah Research Institute, UT 

39. University of California, Santa Cruz, CA 

40. Qniversity of Texas, Dallas, TX 

41. Chicago Hedical School, IL 

42. Massachusetts General Hospital, MA 

43. Illinois Department of Mental Health, IL 

44. Ortho Research Institute, NJ 

45. American Cyemamid Co., NJ 

46. Allied Chemical Corp., NJ 

47. Father Fleuiagan's Boys Home, NE 

48. Merck & Co. Inc., NJ 

49. Tulauie University, LA 

50. University of Idaho, ID 

51. Meloy Labs, VA 

52. Childrens HospitzQ of DC, DC 

53. University of Michigan, MI 

Page 9 



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Google 



237 

Category X 
No deficiencies 



1. University of South Carolina, SC 

2. Schwartz College of Pharma<7, NY 

3. Northwestern University, IL 

4. Nt. Sinai Hospital School of Medicine, NY 

5. St. Vincent's Hospital, NY 

6. University of Cincinnati, OH 

7. Gillette Comp. Research Institute, MD 

8. Lovelace Foundation of Medicine, NM 

9. Eastern Kodak Co., NY 

10. Sotithern Illinois University, IL 

11. Thomas Jefferson University, IL 

12. ^iladelphia College of Osteopathic Medicine, PA 

13. Texas Hesearch Institate of Mental Science, TX 

14. University of Alabama, University, AL 

15. Cook County Graduate School of Medicine, IL 

16. University of Oklahoma, OS 

17. Latter Day Saints Hospital, UT 

18. Cornell University Ked. College, NY 

19. Culf South Research Institute, LA 

20. Ttie Jackson Laboratory ME 

21. Lahey Clinic Foundationr MA 

22. Rockefeller University, NY 

23. Childrens Hospital of ^iladelphia, PA 

24. Baylor University College of Medicine, TX 

25. Hazleton Hal tech Inc., WI 

26. Smith Kline Corp., PA 

27. Bristol Myers Phann, Research & Develop. Co., NJ 

28. Medtronic Inc., MN 

29. G.D. £earle & Co., IL 

30. Boehringer Ingelheim Ltd. , CT 

31. Dow Chemical Co., MI 

32. £> Tennessee State University, TN 

33. Shriners Hospital for Crippled Children, IL 

34. Monsanto Company, NO 

35. Halllnckrodt Chemical Works, NO 

36. Diamond Shacirock Corp., OH 

37. Ohio Valley Medical Center Inc., OH 

38. Bodil - Schmidt - Nielson, ME 

39. University of Texas, Tyler, TX 

40. University of Texas, Galveston, TX 

41. Riker Lab, MN 

42. Allergan Pharmaceutical, CA 

43. Arinoor Pharmaceutical, IL 

44. Brown Dnviversity, RI 

45. Hahnemann Medical College & Hospital, PA 



Page 10 



41-970 0-85-16 

Digitized by 



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238 




ANIMAL WELFARE INSTITUTE p.o b.x 365o w.d.in9.o«. d c. 20007 

A Suiranary of Deficiencies and Apparent Violations of the 

Federal Animal Welfare Act in Eleven AAALAC-accredited Institutions 

by Christine Stevens and Louise Wright 

Under the Freedom of Information Act, inspection reports 
made by veterinary inspectors of Veterinary Services, Animal 
and Plant Health Inspection Services, U.S. Department of 
Agriculture of a number of registered research facilities 
which have been accredited by the American Association for 
Accreditation of Laboratory Animal Care were examined. Ex- 
cerpts from the reports are given. 

The Johns Hopkins University School of Medicine including 
Baltimore City Hospital and Good Samaritan Hospital, and the 
School of Hygiene and Public Health have been AAALAC-accredited 
since 1979. The institution received $51,127,460 from NIH in 
1982. Following are a few examples from USDA veterinary inspectors' 
reports on different areas. 2/22/82 "Dogs and cats must be ID 
to records at all times by tag on collar or distinctive and legible 
tattoo marks... This should be corrected immediately." Nximerous 
sanitation deficiencies were also noted. 6/3/82 "Several outdated 
drugs stored in medicine cabinet ... rodent feces and roaches in a 
cabinet under the sink in the primate building. Also rodent feces 
were found in the feed room. . .peeling paint in primate cages... and 
kennels. . .all dogs not ID properly should be done immediately" 
(This seems to be a recurring problem) . 

10/4/83 "Rabbit rooms A-6 and A-5 have very poor air exchange — 
stinking with bad odors... In monkey room no. A-19 paint is chipping 
off at 4 different places in the wall contributing to inadequate 
sanitation." "In room No. 4-14213 and 4-142A where 3 and 4 monkeys 
are housed respectively, the primary enclosures were extremely 
dirty. The urine and feces receptacles were full of urine and 
excreta, and the monkeys were found wet and smeared with excreta." 
"In room No. 1357, Dogs N. 2193, 2236, 2243, 2237, 2195, 2194, 2184, 
2343 found housed in very small cages. . .several expired drugs in 
the medicine cabinet." 

3/12/84 "still found an extensive problem with peeling and 
chipping paint on walls in the dog kennels of the Dog Building and 
the kennels of the Primate House." 



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239 



Vanderbilt University in Nashville. Tennessee, has been 
AAALAC accredited since 1979, yet the October 27, 1981 report shows 
that priniates were held in improperly ventilated areas. The condi- 
tion continued according to the report 4/27/82. "Not enough air 
change in room 2147.*' On 5/20/82, "No water in bottle, leaked out 
. . . most all of feeders need cleaning." 1/27/84, "Cages neea 
cleaning more often for the squirrel monkeys . . . tree shrews 
replace cages or repaint. Rusty cages makes cleaning, sanitation, 
and housekeeping impossible." These tree shrews remained in the 
dirty, rusty cages for three years, as shown by the notation on the 
10/27/81 report, "Remove rust and fecal material from cages in tree 
shrew room." On that same inspection, it was noted that six research 
dogs were "not identified." NIH only requires an assurance that an 
institution is AAALAC accredited in order for it to approve the 
institution's animal care and welfare. In 1982 Vanderbilt University 
received $23,672,537 of taxpayers' money from the National Institutes 
of Health. 

The University of Utah received $17,360,175 in 1982 and, 
though AAALAC accredited, had numerous alleged violations under 
the federal Animal Welfare Act. For example, 6/30/81, "Primates 
have inadequate space . . . filters are pretty well plugged with 
hair . . . some of the cages are too small, large rabbits 9-11 lbs. 
have 432 square inches and they should have at least 540 square 
inches . . . some of the cages are not high enough that rabbits 
can stand up . . . feed in some feed containers are contaminated 
with urine from top cage." An inspection 4/6/82 notes, "Four 
rabbit cages with young litters. The litter pan takes most of the 
room, not allowing adequate space for the rabbit." 7/20/82, "Flush 
cages are marginal in sanitation. Urinary deposits on cages. Three 
or four heavy (10 lb.) pregnant rabbits too large for cage." 12/9/82, 
"Doors to outside pens 5, 6, 57, 59, and 60 have been clawed or 
chewed — holes in surface allow moisture into the wooden doors." 
The same problem had not been corrected by 3/3/84. 

The University of Rochester Schools of Medicine and Dentistry 
are AAALAC accredited, and the institution received $25,991,504 from 
NIH in 1982, yet USDA veterinary inspectors found 7/20/82, "Primates 
in room 6-7573B are being kept in cages which have not been sani- 
tized for over 6 weeks (since 6/1/82) . . . not being cleaned 
adequately to prevent contamination of the non-human primates 
contained therein." It is further noted that the room •*has organic 
matter smeared on walls, and floors are dirty." This violation of 
the standards is very properly marked as "major." The inspector 
returned 8/20/82 and found again that "primate cages are not being 
sanitized at least every two weeks as required . . . dates from 16 
racks were taken and of these 12 were overdue ... an effective 
program for the control of insects is not being maintained . . . 
room 6-7573B has organic matter smeared on walls. Floors are dirty. 
Repeat write-up from 7/20/82." 



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The University of Pittsburgh Medical School is AAAiAC accredited. 
The university received $17,552,164 from NIH in 1982. yet veterinary 
inspections by USDA show. 

7/25/83, "There were several holes in the wall of the cat room 
located at the first floor . . . the floor was dirty . . . cat 
room 575B used as a storage area, one of the feed bags found open 
and spilled on the floor. There was insufficient light and the 
room did not appear to have been cleaned for a long time. We 
recommend periodic cleaning. The light should be uniformly dif- 
fused throughout the animal room and supplies, boxes, and Fiberglas 
cages should not be stored in the animal room. " 

9/7/83, "The room did not appear to have been cleaned since 
the last inspection. The acid, detergents, cages and trash con- 
tainers must be removed from room 638A. 1 gave 24 hours for cor- 
rection. The facility will be inspected for compliance tomorrow, 
9/8/83." It was only after the USDA inspector insisted that the 
deficiency be corrected in 24 hours that ^his finally occurred. 

It is interesting to note that inspectors for AAALAC accredi- 
tation only return once every three to five years 1 It should not 
be necessary for USDA veterianry inspectors to return so frequently 
as noted in this case in order to obtain compliance with such 
obviously necessary standards, but it is equally clear that only 
such insistence by the government can achieve even minimum standards. 

Harvard University received $46,257,040 from NIH in 1982. 
Harvard Medical School is AAALAC accredited, yet USDA inspections 
since 1981 show multiple alleged violations of the Animal Welfare 
Act beginning 9/21/81, where the inspector urges that "chains with 
multiple hooks must be eliminated. Small chain and no hook at end 
allowed." The reference is to primates and squirrels. Too small 
rabbit cages are .also noted. 4/28/82, rabbit cages are still too 
small, as are those for a number of the primates. The report states, 
"Restraint chairs very dirty. Should be changed each time animals 
changed. Primary enclosures shall be sanitized often enough to 
prevent accumulation of debris and excreta." 

4/28/82, rabbit cages continue to be too small and self-feeders 
were not being cleaned out as needed "to prevent molding, deteriora- 
tion and caking of feert." Two dogs were confined to cages too small 
for them. 

11/17/82, rabbits continue to be confined to cages so cramped 
that they violate minimum standards. The quarantine room for 13 
squirrel monkeys "had inadequate ventilation and "fluctuations in 
temperature are too drastic. Thirty days to correct." In a list 
of old, rusty, difficult-to-clean cages, the following animals were 
housed: 



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3rd F;9ar 




Room 306A 


11 monkeys (Cebus) 


306B 


12 monkeys (Cebus) 


306C 


22 qerbils 


306G 


10 monkeys (Cebus) 


306H 


25 monkeys (Cebus) 


302 


8 monkeys (Cebus) 


333 


8 rhesus 


337 


20 squirrel monkeys 


345 


16 monkeys (Cebus) 


304 


3 squirrel monkeys 


4th FJopr 




Room A 


37 guinea pigs 




400 gerbils 


Basement 




Room B39 


6 rhesus 5 bal 


B35 


5 dogs 


B37 


5 dogs 


B31 


11 dogs 


B29 


10 dogs 


B33 


8 cats 




2 dogs 


B17 


87 guinea pigs 


B15 


103 guinea pigs 


B13 


22 rabbits 


Buildina 1. 


9th Floor 


Room 91 4 A 


19 cats 


914B 


22 cats 


914C 


14 cats 



3/15/83, "Two cages inspected with squirrel monkeys had loose, 
sharp wires on the caging where openings are located. Other parts 
of the cages were rusted and deteriorated ... It appears sanita- 
tion is nonexistent while animals are in isolation chambers. Areas 
around isolation chambers could be improved in housekeeping by 
sink, floors, etc." 

Yale University's School of Medicine was AAALAC-accredited 
in 1979. The accreditation has never been lifted, nor have any 
problems occurred with NIH, despite the fact that USDA inspections 
reveal such violations as (2-8-82) both dogs and cats were illegally 
purchased from Laka, Inc. of Canada. Further, four of the Medical 
School's sites were repeatedly found to have inadequate caging for 
both rabbits and primates. For example. Sterling Hall of Medicine 
was cited for inadequate primate cages (1-14-81, 5-23-82, and 
2-4-83) . USDA also noted lack of proper ventilation for cats and 
"excessive build-up of green material" in rabbit water bottles. 
Yale received $51,142,691 from NIH in 1982. 



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The University of Massachusetts Medical Center at Worcester 
was AAALAC-accredited 2-13-80 according to NIH Statements of 
Assurance submitted by Dr. William S. Webster, the Attending 
Veterinarian of the School of Medicine and a member of the AAALAC 
Council on Accreditation. AAALAC accreditation apparently continued 
even though Dr. Webster acknowledged multiple violations reported 
by USDA inspectors/ Including Inadequate , cages for primates and 
dogs in 1982 and for rabbits in 1981, '82' and '83. In 1981 
the USDA inspector noted build-up of feces and other waste In some 
of the institution's animal rooms, and In both 1981 and *82 
ventilation systems were not functioning properly. Heavy odors 
permeated areas where drains were clogged with feces. 

A more unusual violation is Dr. Webster's purchase of dogs 
from unlicensed sources, e.g. from one Ed Gauvln who provided 
greyhounds from Connecticut: "Dr. Webster Informed us this would 
cease as of today (6-11-81) .. .Any money exchanged after this date 
will result in an alleged violation being filed," according 
to the USDA report. Nevertheless, on 2-24-82, "A review of the 
records indicated U Mass did pay the Clinton dog officer money 
for transporting the dogs to U Mass as well as paying the to%m for 
the dogs...U Mass must cease paying transportation charges for 
dogs, cats or other animals unless they are licensed as dealers 
with USDA. " 

On 12-3-82 dogs were found overcrowded and in cages too small 
for them. The report also notes, "Where two greyhounds are housed 
together, they are both muzzled, making eating pellets difficult." 

On 2-9-83, "Ventilation - Dogs. Many ventilation filters are 
clogged with shavings, hair, dust." Also, "a number of water 
bottles have a green film coating the inside." 

These are just a few of the many deficiencies noted In the 
81-83 reports, including "bxilld up of rabbit feces on floors of 
cages," "odor of dog urine and feces strong," "large amount of 
fecal material and wet shavings In run. This i>en should be cleaned 
today." and "6 large rabbits weighing over 12 lbs. (we weighed 
two with Dr. Webster) Rabbits over 12 lbs. must be provided an 
area of 720 square Inches. Cages are 25" by 24" or 600 square 
Inches." The university received $6,556,969 from NIH In 1982. 

Two AAALAC-accredited institutions in the State University of 
New York system show abuses so serious and so often repeated that 
USDA inspectors recommended prosecution. Meantime, these Insti- 
tutions apparently remain in NIH's good graces based on their 
Statements of Assurance that they are AAALAC-accredited. For 
example, USDA reported August 19. 1982: "The dogs need rest boards 
in the runs to stay clear and away from dampness, urine and feces. 
The dogs were found to be sitting in urine and feces." Two months 
later the inspector reported: "On the previous Inspection dated 
8-19-82, it was pointed out that drainage of dog quarters is very 



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defective and accumulation of urine, feces, waste water and food 
in the area creates a potential health hazard for the animals. 
Nothing has been done so lar to rectify the deficiency. A case 
against the facility is recommended. ' The Stony Brook campus uses 
large numbers of dogs. The most recent figures available (10-1- 
82) show 328. 

In the case of Downstate Medical Center, the inspector com- 
plained 8-5-81: "There are four cats enclosed in one cage 26" 
X 32" making it very uncomfortable for them to turn about freely 
and to stay in their normal position. It is impossible for the 
group to sit and lie comfortably. This deficiency should imme- 
diately be rectified." He added that the cages "were found in 
very dirty condition." Despite warnings, rabbits were repeatedly 
found in cages too small for them. A case against the facility 
was recommended 5-27-80. SUNY at Stony Brook received $11,757,599 
and SUNY at Downstate received $6,014,228 from NIH in 1982. 



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ANIMAL WELFARE INSTITUTE po. box 365o w.d.m,«>.. d.c. 20007 



Examples of Registered Research 
Facilities Classed as Category I 

(major deficiencies and repeated major or minor deficiencies 
In minimum standards under the Animal Welfare Act) 

Inspection reports made by Onlted States Depaxrtment of 
AgrlcultucGr Animal and Plant Health Inspection Service 
Veterinary inep^ctora were requested under the Freedcno of 
Information Act for a random sample of 186 registered 
research itist. tutlons Of those 186 Institutions, 44 were 
found to have naJGr and repeated major or minor deficiencies 
constituting apparent violations of the Federal Animal 
Welfare Act. The following 10 summaries are based on 
excerpts from those Inspection reports. 

**************************** 

Since 1979 (if not before) Washington University in St. 
Louis has been admittedly out of compliance with Animal 
Welfare Act regulations, according to Statements of Assurance 
submitted to NIH, OPRR, and yet the amount of 91 ant money 
given to the University as a whole has increased by nearly a 
million dollars every year. In 1983 alone the TJniy^ersity 
received $42,895,879 from NIH. According to DJSniA required 
annual reports, 1,335 dogs, 581 cats, 1,560 guinea pigs, 739 
hamsters, 5,107 rabbits 39 primates were used In 1903, 
constituting an overall increase since 1982 in the number of 
animals covered by the Animal Welfare Act and used at the 
University. 

Some deficiencies noted by USDA inspectors during the last 
three years involve sanitation and cleanliness. Examples of 
these deficiencies include: 1/6/82 "excessive acciAoulatlon 
of excreta in litter boxes," 3/10/82, "Food receptacles 
in primate rooms were empty and dirty." Also on 3/10/82 It 
was noted that "several water receptacles in the cat colonies 
rooms were visibly dirty and felt slimy to the touch." 

On 4/22/82, "A sick kitten was observed which was not under 
the care of a veterinarian [a deficiency in itself]. Blood 
from rectum and paresis of rear limb. No pain or distress 
report on file as prescribed by Section 2.28(4) of this 
regulation. " 



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Beyond the deficiencies mentioned above, ones involving 
proper identification and record keeping were cited by OSDA 
inspector Arn^ldo Vaguerr DVM, on 4/22/82 and 9/27/83. 
*In one cat room Ui«y had 50% of cate without collar and/or 
ID tag. This deficiency vas noted before on Last inspection 
report of 3/16/82." And, *Dogs on hand were 47 at the 
facility and in the computer printout from OLAC they were 
supposed to have 134.* 

The University's Animal Care Committee has regularly made its 
own inspectiona of their faci ities made recommendations for 
impi overmen ts, and reported progress pad« each year, all 
reflected In the THIQ statemente Of Aflsurance t>eficiencle« 
noted ty the coniitiittee have been primarily with cage Biz^t 
however in late 983 and early 1984 the committee Inspected 
and noted that "unreported health problems were cited in 
three of the 21 facilities." 

************************************ 

The University of Georgia supports oar^ different sites 
including the Medical College of Georgia and as 4n 
organizational whole received 58,574,835 from ntb in 1983. 
The total number of covered animalB ufied by the University in 
1983 vas 1,438 dogs, 35S cats, 91 guinea pigs, 19,406 
hamsters, 4,6 55 rabbits and 24B ptlffatea, USDA inspections 
covering that year and two previous ones have revealed both 
major And repeated deficiences. 

On 6/30/83 it was discovered by a USDA inspector that the 
University had been buying dogs from an unlicensed dealer. 
*VS Form 18-6 attached for Llaird Kennel 1490 Whit Davis Road 
Athens, Georgia 30605 (404) 548-1988. With dates of : 



5-10-83 


4 dogs 


5-23-83 


4 dogs 


5-24-83 


3 dogs 


6-1-83 


2 dogs 


6-28-83 


1 dog 



I have no records that this kennel has a USDA dealer 
license. "In fact Llaird* s Kennel did not appear in USDA's 
published list of licensed dealers until 1984. 

The University ha£ also had repeated problems with proper 
identification of and recorda for doge. On 2/1/82 "Dogs in 
1106 D no ID. Ix?g in 192 bIao, Some raised dogs in outside 
runs n? ID ' and again at the siune inspection that dogs were 
purchased il egally, the USDA inspector reported "1 poodle 
does not have ID tags." 

Another deficiency observed by USDA inspectors was inadequate 
sanitaton that affected both primates, rabbits and guinea 
pigs. Regarding primates, on 4/29/81 "fecal material build- 
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up on floor" and on 2/1/82 it was reported that "owl monkeys 
cages need to be cleaned more often." Those sanitary 
deficiences affecting guinea pl^e and/oi rabbits were cited 
on 5/13/82, 7/21/82, B/i5/B3 and continued to be a problem 
even in 1984. On 8/25/S3 the specific problem was stated as 
follows: "floor of guinea pig cages are scheduled to be 
cleaned every Wednesday. Not cleaned this week." 

*************************** 

In 1983, the University of Mississippi received $4,259,155 
in grants from NIB, and according to their DSDA required 
annual reports, nBttd 50 dogs^ 17 fl cats, 358 guinea pigs, 
899 rabbits and 71 primates Inspect ons made by OSDA over 
the last three years have revealed nuiaerouE and repeated 
problems varying from inadequate veterinary care to 
inadequate cleaning practices. 

On 9/22/81 the USDA inspector reported "1 dog in (L007-3 
room) needs resuturing." Apparently the attending 
veterinarian had not been regularly checking on the animals. 

There was also a repeated problem with housekeeping. It was 
noted on 10/27/83 "Housekeeping needs to be improved to 
reduce the clutter/excess cages, equipment, used syringes & 
needles, etc." and again on 1/13/84 "used boxes - syringes - 
trash on floor in this room. " 

Deficiencies in cleaning were found on 2/12/81, 12/4/81 
7/15/82 and l2/2/fl2 ^nd a repeated problem with odor was 
also cited which involved ptimarily dogs but also some 
rabbits and nonkeye Thie deficiency in odor was, as the 
inspector noted an 2/2/82, "likely caused by improper 
cleaning or frequency t>t cleaning" or ^s noted on 7/8/83 by 
"overcrowding". It was at inspections made on 8/30/82, 
12/2/82, 10/27/83 and 1/13/84 that the problems with odor 
were noted. 

On 10/27/83 the University's metabolism cages for dogs were 
reported by a OSDA inspector, to be inadequate for use; 
however, on 1/13/84 the same OSDA inspector found "metabolic 
cages currently being used [which] cannot be cleaned & 
sanitized adequately i are unsatisfactory & cannot be used 
after March 11, 19B4." 

According ttj Statejaents of Assurance submitted to NIH, OFRR, 
the University s Animal Care Committee has been actively 
inspecting their facilities; however, the more serious 
probleias found by OSDA inspectors were not addressed. 

******************************* 

The University of Colorado was granted $24,288,934 by NIH in 
1983, a substantial increase over their 1982 grant of 

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$21,633,327. Likewise th^ number of animals used by the 
University in 1983 was larger than their 1982 total. 
According to their annual reports, 682 dogs, 177 cats, 442 
guinea pigs, 270 hamsters, 3,249 rabbits and 178 primates 
were used during FY 1983. 

On 10/7/81 fl USTJA Infipector of their facilities commented on 
the following ptoblem that affected the entire Bouider 
campus: " no single pecaon responsible ^difficult to find 
the animal B or even know It new speciefl have been added to 
some unspecified laboratory or newly procl aimed animal room". 
This pToblen va? readdres&ed on 2/10/82 when It was also 
mentioned that the Onlverslty did not have an Animal Care 
Committee. 

A deficiency directly associated with the animals housed was 
inadequate veterinary care. 6/24/fl2 "There are several doga 
with distemper These animals should be isolated t>i 
euthanized." Aa a jrefiult of this deficiency and another 
involving the records on those doga, the InBpector stated 
that "If the dog conditioning facility is not closed by Sept. 
1, 1982 the above deficiencies have to be coneldered ae a 
violation of the Act and a caae may b* filed. oeficlencieft 
in record keeping and proper identification were repeatedly 
noted (on 6/24/82 6/26/82 and 2/14/83) On 6/24/81, 
specifically it was found that "there is a great discrepancy 
between the number of dogs actually on hand and the number 
stated on the records." 

During the last 3 years OSDA inspectors have also found 
repeated problems with dog cages that did not meet even the 
minimum size requirentnt set try DSDA, On 6/28/82 "It appears 
that the teitiporary cages used to house the doga in the north 
wing are too snail for the animala housed in them" and on 
2/16/83 Several dags are being held in cages which might be 
adequate for one anlaal but two animals are held in these 
cages. " 

Also at the Onlverslty of Colorado, an extreme problem with 
odor and sanitation was cited for primatefl. On 6/28/32 the 
deficiency vae written up as followa 'The rooms u»ed to 
house the primate coloni«£ are not being cleaned often enough 
to prevent odors and manure from building up to unacceptable 
levels. There vas a lot of manure on the flooES and more 
than could be expected smeared on the vails and windtjws of 
the primate rooms some of the windows were smeared to the 
point it was dlCficult to see through them)." This 
deficiency was not resolved until after the follow-up 
inspection at which time it was recommended "that a case be 
filed as a violation of the Aniigal Helfare Act." 

****************************** 



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In 1983 Case Western Reserve University in Ohio received 
126,504,774 froei NIB and according to their annaal reports, 
used 892 dogs, 389 guinea pigs, 354 cats, 683 haaitters, 1,240 
rabbits, and 29 primates. 

ivo deficiencies found by OSDA inspectors reflected an 
immediate health hazard to the animals involved* On 1/14/83 t 
*Baby guinea pigs (newborn) are being kept on a cage floor of 
1/2" wire mesh. This mesh is toe large for baby guinea pigs 
and can result in broken llmbu"! end -iiabbit ^#2^ audi ovsky, 
NZK' in room EB12D has sore hocVa. A solid reetlng £urfaee 
should be provided for the floor of this rabbit's cage ft all 
rabbit cages." 

In 1982 and 1983 the University reported using 44 rabbits in 
painful expe imentB without the use of aneBbhe^i^j analgesic 
and tranquil lz«r£ Although an cxplAnation was given for 
those 4 4 cabbitE the UnivetBity failed to uention pain 
d«Bcrlbed on 7/39/83 by a tJSDA Inepecton •Some of Dr. 
Pomer^nz e guinea plg4 that have lepeAtedlv teen bled from 
the «ye havt ruptured glovefi or apparent k«ratitle aicca ft 
ulcerated corneas. These ar« pelnf li1 condltlonm and require 
veterinary care.* 

In addition to the above mentioned deficiencies and many 
other minor ones, on 7/14/83 the USDA inspector noted "There 
is an accumulation of organic material on the walls of the 
dogs cages, on ledges, and in corners that has apparently 
been present more than 2 weeks." 

**************************** 

Cornell University in Ithaca, New York received 110,882,713 
in grants from NIB in 1982| the same year that USDA 
inspectors found so niany and nAjor problems with their 
facilities. In 1982. Coi:nei:i reportedly used 1,624 dogs, 542 
cats, 272 guinea plgs^ 41 hamfiters, 810 rabbits and 11 
primates. One dsda inspector found that records were not 
being kept properly even while these l^rgv numbers of animals 
were being used: 3/17/82 "All records inuat include the name 
and address of seller or donor and the method of 
transportation. Several shipments 1 ieted do not have this 
information.* 

There have been an unwarranted repetition of deficiencies 
associated with the dogs housed at Cornell. According to 
DSi>A Inspection Reports, dogs were fi>nnd in cages to small 
for them. On 9/3/81, 10/16/Bl, 3/17/82, 4/5/82, and 5/8/84, 
and dog cages were cited as inadequately cleaned and 
sanitized on 1/25/80 and 7/23/81. One comment that reflect* 
the affect of such conditions on animals was made by the USDA 
inspector on 3/17/82: "Although dogs have been removed from 
the poorest caging, there are still dogs digging at the 
ceiling, making holes in the wall board." 

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Deficiencies involvir^g rabbits were no less major than those 
just mentioned: On 1/7/Bl and S/B/B4 rAbbitft were found in 
crowded in an&ll cageffj and On ll/2D/flO 1/16/82, 12/2/82 and 

n nay 19S4 at 3 different locations, cleaning ft sanitation 
of those cA^es wae inadequate. The pi obi era with cleaning ft 
sanitation was recorded on 12/2/al as follcva; "The^e Is no 
ev denoe that cages are being sanitized* Fans under rabbit 
f^iq&b have larger quantities of fecal matter in them and no 
evidence that they are being emptied once/week." 

On 1 /2D/B0 "The rabblta in all three rooms of this facility 
had either no vater or very small amounts of water (ie. less 
than apptoxlmately 1-2 teaspoons)." 

Cornell has also not been without deficlencleB in veterinary 
care: 7/23/ai "In the cat rooia, 1b the breeding colony an 
enaoiated cat with diatrhea, eye diechacge was observed. The 
caretakers did not knew If vet care had been provided and 
stated that he di<5 not think tha cat was being treatedr had 
been treated, or had been given an examination, The cat 
should be removed immediately , given veteririary care, and 
kept Isolated from cats of the breeding colony." 



In 1983 Purdue University in Indiana used 657 dogs, 18 cats, 
291 guinea pigs, M7 hansEterfi and 313 rabbite and was granted 

9«2B7raBl from NIF* Pain without the uB* Of anesthetic, 
analgesic of tranquil liei was reported In only 13 guinea 
pigs, inspections mad« In 1961 by n^HA Veterinarians 
revealed a Dnlverai ty-wlde problem with cleaning, &flnitatlon 
and odor; for hamstero, *Odor problem In this roojn^^. 
ventilation or air exchange eeemed to be a problem in B7'; 
for rabbi tSr "Urine buildup on cages - some cages becoming 
rusty... floors dirty, urine on floor ,* .ventilation ie. still 
poor"; and for dogs, "Accumulation of feces in dog pens - 
odor problem*. 

There ad so has been a continuing problem with ventilation and 
temperature control in the dog facilities of the School of 
Medicine as cited at inspections on 9/23/S2, 4/28/83 
5/31/83, 8/19/33 and 9/20/83. This deficiency continued to 
exist even after 6/8/63 when the Dean of Veterinary Medicine 
requested "ble share* of the Univerfiity's funds. One other 
deficiency that directly affected the doge was noted on 
9/23/82t "moldy feed in few feeders Rm S113 Lynn Hall." 

**************************** 

Tech America Research Center in Colorado previously known as 
Elars Bio Research Labs, Inc. used 570 dogs, 112 cats, 2,618 
guinea pigs, 18,636 hamsters and 1,269 rabbits in 1983 (the 
sane year that a OSDA inspector found records on the dogs 
to be incomplete and not up to stjandards) . At an inspection 

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Bade by OSDA on 6/8/83 nunerous and quite serious problesa 
were found in the facilitiee for dogai dog pens and luait 
were not sanitiied properly, "water pans were empty Water 
licks were Installed but not working*, and 2 dogs crowded in 
one cage. 'Cage measuEe 35* 35 ^ 1225 aq. in. Dog mcaGureB 
27" 27 + 6 * 33 1089 sg. In. Two doge would require 2173 
aq. inches. These cages will accommodate dogs measuring 29' 
+ 6" and cnly one per dage.' The def ctency in cage siie was 
a repeated appAreut violation since on 10/15/Al it was 
reported that "Dog cage meaEure 8.5 sq. ft... Space needed 15 
sq. feet, Approic. 6 dogs a^ip^ar to be too large for cages." 

**************************** 

Colorado State Oniverslty received a relatively snail amount 
of money from NIB in 1983 but still used 1732 dog£, 269 cats, 
659 guinea pigs, 20 hamster b and 389 rabbits. M though many 
deficiencies cited during the last 3 years by USCA inspectors 
were corrected before the follow-up inspections tbeie were 
many reoccurring problems, for instance^ rabbits and 
eonetimeB guinea pigs were found without water on 5/14/81* 
S/lO/Sl, 5/6/82, 3/22/84. 

On 9/10/81 rabbits had only "moldy feed" available. 

Rabbits were also found in cagee that were dirty and too 
small for them on 5/14/ai, 1/21/82, 5/6/82, 3/22/84 and 
5/14/81, 9/29/82, 3/22/34 respectively. On 5/14/Bl the 
deficiency in cleaning and satiitation was eported as 
follows; "Cage must be cleaned often enough to prevent litter 
buildup from trays above floor mesh". 

Also at Colorado State University there was a continuing 
problem with rodents near the dog facilities as noted on 
9/10/81 "Dogs. Evidence of Julce still preeent in service 
areas", and on 9/29/82 'Dead aouse and nouSft feces not 
removed from inside area between runs." 

************************* 

The University of Chicago used overall fewer animals in 1983 
than in 1982 however the number of dogs increased form 1,216 
to 1,304 and primates form 261 in 19B2 to 390 in 1583 NIH 
also increased their research grants from ¥31 399,139 in 1982 
to 136,816,448 in 1983 even while USDA veterinary inapectora 
were continually finding deficiencies in their animal care. 

On 12/12/83 the tJSEA veterinarian inspected a site that 
apparently had not been inspected before. In the reports he 
commented on the following not ancoftunon problem: 'Note; 
Many of thes^ sites were not known to Dr. Cera t nr £ept 
until recently vhen they requested all the Department heads 
to provide them a list. This is especially true for Dr. 
McCrea*s room J229. Having found him he is being brought 

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into conpliance with Oniversity requirements." The major 
deficiencies in room J229 were written up on 12/9/83 as 
follows: "Temporary holding rooms and surgery for squirrel 
monkeys 2 offices unmodified are being used. .. standard office 
with wood topped table - for surgery table. ...Room 229 is 
used as a surgical site for implantation of electrodes into 
subject animals [primates] brains. The animals are recovered 
and then utilized in computerized experiments. They are 
maintained for a long time post-operatively (Dr. McCrea is a 
Ph.D. researcher). Such surgery should be done in a sterile 
manner NOT in a regular office right off a busy hallway with 
only chemical sterilization of equipment." 

The Oniversity of Chicago also had a continuous problem with 
cleaning and sanitation. On 12/20/82 primate cages were 
found with a "heavy build up of feces and urine" and on 
12/7/83 the same problem was noted as cleaning and removal of 
fecal material needed more frequently. Even with good 
ventilation the odor was very strong." Rabbit enclosures 
were repeatedly found in that same condition (12/20/82 and 
8/9/83). 

On 12/20/82 and 8/9/83 respectively it was reported that 
"Primate feed being packed into trays by being walked on. 
Oliis allows contamination" and "Feed in Rm JS-60 is growing 
things - it's wet ft moldy". These deficiencies constitute a 
major health hazard to the animals involved. 

Also at the 12/20/82 USDA inspection it was found that "Dogs 
in cages during spraying ' Receiving backwash from spri^. 
Must be removed from cage and surrounding cages during 
spri^." 



(Additional material is held in the conmittee files.) 



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STATEMENT 
OF THE 
AMERICAN HEART ASSOCIATION 

The American Heart Association, on behalf of its 120,000 members and 
over two million volunteers nationwide, appreciates the opportunity to 
submit testimony to the Subcommittee and express its views on the use 
of animals in biomedical research and laboratory testing and In particu- 
lar on H.R. 5725, "Improved Standards for Laboratory Animals Act." 
Biomedical research is a key element in the overall mission of the Asso- 
ciation to "reduce premature death and disability due to cardiovascular 
disease." Since its establishment as a voluntary health organization in 
1948 a substantial portion of the dollars publicly contributed to support 
the Association have been invested in cardiovascular research. 

The establishment of the American Heart Association coincided with the 
establishment by Congress of the National Heart Institute, now the 
National Heart, Lung, and Blood Institute. During the ensuing 37 
years there has been close interaction between the Association and the 
Institute in a dedicated effort to direct funds into productive research 
which will diminish the extraordinary impact which cardiovascular dis- 
ease has had and continues to have on the health of our Nation. 

There can be no question that the result of this research has had a 
substantial impact on the reduction of cardiovascular disease in the 
United States. Although cardiovascular disease continues to be the 
nation's number one killer, the death rates due to cardiovascular dis- 
ease have decreased by an incredible 33 percent since 1968. The death 
rates from stroke have decreased by 46 percent over the same period. 



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These declines have been estimated to have resulted In the saving of 
and prolonging of the lives of over a million Americans. However, as 
noted above, the death and disability toll due to these diseases contin- 
ues to remain excessively high. 

Many of the discoveries and breakthroughs which converged to allow 
these dramatic declines in morbidity and mortality can be traced to the 
successful conduct of research involving studies with animals. One 
example, now well known by the public as a major lifesaving technique, 
is cardiopulmonary resuscitation (CPR). This technique could never 
have been successfully applied to humans had there not been an inter- 
val where the foundation of the technique was developed in experimental 
animals. Other techniques such as coronary by-pass, cardiac valve 
replacement, balloon angioplasty and many others are now being used to 
save victims of cardiovascular disease. None of these techniques and 
subsequent improvements to these techniques could ever have been 
developed without initial studies involving animals. 

During its entire history of support for biomedical research the Ameri- 
can Heart Association has subscribed to the highest standards of hu- 
mane treatment of animals. We have followed faithfully the evolution of 
standards prescribed for animal care by the Federal government and we 
have insisted continuously that these standards be a part of the 
research protocols supported by the Association. Our experience has 
been that in the medical centers where the scientists we support carry 

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out their work, these standards are locally monitored and faithfully 
followed and enforced. 

To the extent that these widely accepted principles are not adequately 
monitored and require further enforcement the American Heart Asso- 
ciation would be sympathetic to additional steps which might be needed 
to insure that laboratory animals receive humane and compassionate 
treatment. 

The multitude of issues surrounding the use of animals in research, 
many of which have reached a very high emotional level, are of great 
concern to the American Heart Association. Because of this, the Ameri- 
can Heart Association has established a "Task Force on Research Animal 
Use" in the hopes of analyzing the issue thoroughly and developing a 
national policy which is both rational and balanced and beneficial to all 
concerned. This Task Force, which is comprised of members from 
numerous disciplines including biomedical research, veterinary medicine, 
ethics, and the law, will be making its report and issuing its recommen- 
dations at the American Heart Association's Annual Meeting to be held 
this November in Miami, Florida. 

Because of the importance of this report and the impact that it will 
have on the directions and positions that the AHA will take in the 
coming months and years, we wish only at this time to make 



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preliminary comnMntt on H.R; 5725, the "Improved Standards for Labo- 
ratory Animals Act.** 

We commend the Chairman of the Subcommittee, Congressman Brown, for 
his efforts to introduce legislation which he feels represents a reason- 
able approach to what has become an emotional Issue. 

It is clear that the Congressman has given this Issue considerable 
thought. The basic premises and objectives of the legislation are 
sound. 

However, the American Heart Association believes that enactment of 
H.R. 5725 may not be necessary at this time or at least premature, 
since most of what the legislation seeks to accomplish can be carried 
out under existing laws and authorities, and/or is being assessed 
by on-going or proposed studies. Below are six such areas of activity 
which address some of the concerns raised by H.R. 5725 and which the 
American Heart Association supports: 

o We support the NIH*s decision to upgrade its guidelines for the 
use and care of animals in research. We testified eaHy this year 
in support of the proposed revisions to the guidelines, '*NIH Guide 
for the Care and Use of Laboratory Animals.*' We understand that 
these will be issued in final form next year. 



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o W« support th« formation of an Intaragancy Rataarch Animal 
Commlttaa to ba composad of Fadarai agancias who hava rasaarch 
programs involving animais. 

o Wa nota that tha Food and Drug Administration has just issued a 
raport by its Agancy Staaring Committaa on Animal Walfara issuas 
( Fadarai Ragistar . Vol. 49, No. 186 p. 37473). That Committaa 
was chargad with addrassing such issuas as: 



a) Ara FDA procaduras so ordarad as to obtain maximum 
amount of usafui scientific information whiia utilizing 
tha fawast numbar of animais? 

b) is FDA mai(ing maximum usa of and encouraging tha 

combined development of reliable m vitro alternatives to 
|n vivo methodologies? 

c) Are mechanisms in place to ensure continuing compliance 
with the Animal Welfare Act and with tha highest standards 
of animal care? 

d) Is the historical usefulness of animal testing in human 
health protection the primary mission of the FDA properly 
appreciated by our constituents? 



o We support provisions contained in House and Senate reauthorizing 
legislation for the National Institutes of Health which call for an 
eighteen -month study by the National Academy of Sciences to 
assess the current status of the use of live animals in biomedical 
and behavioral research. 

o We support the request made by Senator Orrin Hatch last year 

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that the Office of Technology Assessment (OTA) undertake a study 
which would make a scientific evaluation of alternative methods 
of animals in research, experimentation, and testing. This study 
we understand will be issued early next year. 

o We support increased funding for the NIH Division of Research 
Resources* Animal Resources Program which is responsible for 
supporting research projects that enable scientists to obtain and 
use animals effectively in health -related research. 

In view of these current activities being carried out by various Federal 
agencies, the American Heart Association believes that enactment of 
legislation, at this time, that contains further directives in the area 
of the use of animals in research may be premature and possibly a 
duplication of current effort. We would urge that Congress delay 
action on this issue until the results of current reviews and reports 
are available. 

Once the revisions to the NIH Guide for the Care and Use of Labora- 
tory Animals and the proposed National Academy of Sciences study 
are complete, all parties concerned with this issue will have a more 
complete base from which recommendations for action may be formulated. 
We would be happy to provide this Subcommittee with a copy of the 
American Heart Association's Task Force on Research Animal Use final 
report in November as well. 

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W« thank th« SubcommittM onc« again for this opportunity to commant 
and we loolc forward to worlcing with you on this issua in tha 99th 
Congress. 



Antonio M. Gotto, Jr., M.D., D. Phil. 
President 



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259 

Statement 

of the 

American Institute of Biological Sciences 

Presented to 

The Subcommittee on 

Department Operations, Research and Foreign Agriculture 

of the 

Committee on Agriculture 

of the 

U^. House of Representatives 



on 

KR. 3723 

"Improved Standards for Laboratory Animals Act*' 

September 19, 19S4 



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The American Institute of Bioiogicai Sciences (ABS) is a national confederation of 
over forty professional societies and research organizations in the iife sciences. Together 
our groups represent some 70,000 working biologists in the biological, agricultural, 
environmental and medical sciences. 

Biologists have watched with considerable interest the progress of proposed 
legislation aimed at protecting laboratory animals from misuse and poor care. The 
foundation of that interest is the belief in the absolute requirement that scientists deal 
with experimental and demonstration animals in a humane manner based upon sound 
ethics. The AIBS's major points of emphasis focus on ethics of handling research animals, 
quality of research data, and an overall respect for life. 

We are fearful that anti-science sentiments might prevail to the detriment of 
biological, medical, and veterinary research and training. We are concerned that some 
critics of live animal studies are unreallstically optimistic in their expectations 
concerning the usefulness of computer modeling, cell cultures, and other substitutes for 
iive animals. As scientists, we are disturbed by an attitude which would discourage 
"research duplication'* since repilcabiiity by other investigators is our only means of 
verification. 

As citizens and as individuals many biologists have been shocked and disappointed 
by the actions of a small minority of researchers who seem to lack compassion and 
respect for life. The well-publicized actions of these few and the resulting public 
reaction have had the positive effect of stimulating increased awareness of animal 
welfare issues among biologists, institutions, and funding agencies. 



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The ABS would encourage congressional initiatives to develop information 
concerning the extent of live animal procurement, handling, and use in the United States 
as well as funding support aimed at developing alternatives to the use of live animals. 
Despite the statement of congressional findings in Section 2 of the "Improved Standards 
for Laboratory Animals Act", much work must still be done to perfect alternative 
methods of research, and we would caution against excessive redirection of current 
research funding. Any such legislation should place the burden of responsibility with the 
institution and not on a new army of federal inspectors. We further recommend that the 
monitorship of such a program take into account the differences between legitimate 
research organizations and process- or production-oriented laboratories. 

Many laboratories that use live animals have long-established guidelines for animal 
care and many have established animal care committees. While some biologists oppose 
the inclusion of "public representatives" on animal care committees in the belief that this 
will only lead to confrontation and delay, others believe that generally this requirement 
will benefit researchers because it offers them an opportunity to communicate to the 
general public the benefits resulting from live animal research and the high quality of 
care by most laboratories. Of prime importance, however, is assuring that the outside 
member is a true representative of the public (the community) and not of one or another 
special interest group. 

At the Institute, we feel the essential features of any legislation must provkle for 
an opportunity for the general public to be informed regarding the extent to which our 
knowledge of all biology, including human biology, is dependent upon animal 



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experimentation. We also feel that the federal inspection should focus on the 
maintenance of quality records within Institutions. . .records ^at will demonstrate an 
effective animal care program with appropriate on-going supervision. ABS is continuing 
its efforts to encourage institutional commitment by research organizations to embrace 
both the philosophy and practice of proper animal care. 

Several years ago, AlBS adopted a statement regarding the use of animals in 
experimentation. For the record it is included here in its entirety. 

Live animals have long been an important tool in the conduct 
of scientific research and education. In biomedical, 
agricultural, toxlcological, behavioral, and other biological 
studies, intact animals perform a vital and irreplaceable 
function, often serving as models for man. No alternative 
procedures are known that permit the conduct of some 
critical kinds of research without live animals. The 
American Institute of Biological Sciences recognizes that live 
animals will continue to be an important research resource. 
The ABS also recognizes that live animals make a 
meaningful contribution to the educational process. Study of 
animals in the laboratory enhances student sensitivity to, and 
understanding of, all living creatures. 



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The use of animals mandates responsibility to provide quality 
care and humane treatment. The AIBS endorses the 
'Principles of Animal Use' promulgated by the National 
Institutes of Health and the National Association of Biology 
Teachers' 'Guidelines for the Use of Live Animals at the 
Pre-university Level.' Organisms of the lowest phylum 
consistent with the knowledge to be gained should be used in 
research and study. Intrusive studies should be discoufaged» 
especially below the intermediate college level. Educators 
should rely on demonstration and observation. Other 
procedures deemed necessary should be used under the direct 
supervision of a qualified instructor. In all circumstances, 
scientists and educators must fulfill their moral 
responsibilities to give proper care and human treatment to 
the animals they use." 

We do not feel that H.R. 3723, "Improved Standards for Laboratory Animals Act,'* 
would impose major hardships on most laboratories nor would it impede good research. It 
continues the logical approach of the Animal Welfare Act, which already has established 
standards, to ensuring good quality humane care and treatment of laboratory animals. If 
new legislation is considered necessary, we feel it is a much better vehicle for protecting 
animals and allowing good research than any other provisions under consideration. We 
suggest the following clarifications and adjustments to certain sections of the bill. 



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mji !m 



First, much biological research involves the observation of animals in their field 
habitats or other natural settings and analysis of their conduct, migration, etc., not only 
as indicators of inate species behavior and diversity, but also as measures of responses to 
environmental effects. Therefore, Section (f.(c) should include the following subsection: 
"(3) Paragraph (1) shall not prohibit the observation, identification, sampling, surveying, 
retention, or cataloging of animals in their natural habitats, at biological field stations or 
at zoological parks for purposes of conducting research on their inate biological behavior 
or their responses to prevailing environmental conditions." 

Next, Section (k(d) establishes the local oversight body as an animal research 
committee (emphasis added). The clear intent of the amendment is to restrict both the 
Committee and the Secretary to matters of animal care and not research. Thus, these 
bodies should be referred to as "animal care committees." 

Further, the same section requires that at least one member of the committee be a 
doctor of veterinary medicine. Given the diversity of research settings that occur 
throughout the postsecondary level, this is particularly difficult to either justify or nneet 
in every case. The member should "be a person appropriately qualified in the care and 
handling of animals used by the research facility." 

Finally, Section 4.(^ allows suspension or revocation of federal support after 
notification only. Elementary due process would suggest an opportunity for the research 
facility to respond to the determinations of noncompliance and take corrective action 
prior to being penalized. The additional amendment (f) should include the following 
statement: 



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"(f) In any case in which the funding Federal agency 
determines that conditions of animal care, treatment, or 
practice In a particular project have not been in compliance 
with applicable standards, despite notification to the 
research facility, and after it has had adequate opportunity 
to respond or take corrective measures, that agency shall..." 

Next, the inspection services provided by the Veterinary Service Division of 
USDA*s Animal and Plant Health Inspection Service (APHIS) are the proper vehicles for 
ensuring enforcement of the provisions of the Animal Welfare Act. The problem is that of 
the 483 animal inspectors in the field, only six are full-time. The remainder are able to 
devote only about six percent of their time to animal welfare concerns. To be effective, 
the animal welfare program must have a continuing level of stable appropriations. 
Adequate funding on a stable and continuing basis would permit APHIS to provide 
leadership through a professional, well-trained cadre of federal officials who could 
provide a uniform level of inspection, guidance and correction before regulatory action is 
required. APHIS could not only strengthen the training of its own staff and allocate more 
time, effort and personnel to a regular inspection cycle, it could provide services to 
research centers and local humane groups through such routes as workshops on research 
standards, federal regulation and modern animal care practices. Increased and im^oved 
funding patterns would also enable APHIS to collect and publish better data about the 
status of animal welfare in research and among licensed dealerships and would also permit 
better coordination between APHIS and accreditation groups, such as the American 
Association for the Accreditation of Laboratory Animal Care (AAALAC). 



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The Federal government supports about fifty-two percent of the biomedical 
research in this country, with more than a third coming through NIH alone. Thus, there is 
substantial federal concern that the research standards it establishes in the areas of 
animal care are met. In this regard, it would be prudent to wait until NIH and other 
federal entities which are currently revising animal welfare guidelines complete the 
process to determine the extent to which new legislation is needed and the extent to 
which it is compatible with new guidelines. 

In summary, the American Institute of Biological Sciences considers good care agid 
humane treatment of animals essential to good research, and good research is essential if 
we are to increase knowledge, conquer disease and illness, and provide plentiful, nutritious 
food supplies for the world. We feel that better enforcement of the current Animal 
Welfare Act is in the best interests of the Federal government, the biosdence research 
community and the humane societies, and that APHIS is the proper agency to administer 
this Act. If additional legislation is considered necessary, however, then we support the 
bill, H.R. 5723, with our recommended clarifications to properly protect the integrity of 
scientific research and its uses in protecting and maintaining human health and welfare. 



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Congressional Research Service 
The Library of Congress 



27o3 



""'"'^'^ t;»w iiccfm . ni: 



Washington. D.C. 20540 



AUTHORITY OF TFE DEPARTMENT OF AGRICULTURE TO IMPLEMENT PROVISIONS OF 
H.R. 5725, 98th CONGRESS, CONCERNING TREATMENT OF LABORATORY ANIMALS 






Henry Cohen 
Legislative Attorney 
American Lav Division 
October 24, 1984 



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AUTHORITY OF THE DEPARTMENT OF ACRICl»LTURE TO IMPLEMEKT PROVISIONS OF 
H.R. 3725, 98th CONGRESS, COKCERKING TREATMENT OF LABORATORY ANIMALS 

Thlf report considers whether the United States Department of Agriculture 
(U.S.D.A.) would have the authority, without additional legislation, to ioplc- 
oent the provisions of H.R. 5725, 98th Congress, even though that bill was not 
enacted by the 98th Congress. R.R. 3725, which was entitled the "Improved Stan- 
dards for Laboratory Animals Act," would have amended the Animal Welfare Act, 
7 J.S.C. §§2131-2156, which Is enforced by the Secretary of Agriculture. The 
major changes it would have made to the Act would have been toi 
(I^^include federal departments, agencies, and instrumentalities that use ani- 
mals for research or experimentation within the Act*s definition of "research 

1/ 
facility- (7 U.S.C. §2132(e)). 

(2) require the Secretary to promulgate standards requiring exercise for doge, 

(3) permit exceptions to the Secretary's standards (on any matter under the Act) 
to be made only when specified by research protocol, 

(4) require research facilities to provide details to the Secretary of any pro- 
cedure likely to produce pain or distress in an animal and to consider alterna- 
tives to any such procedure, 

(5) require research facilities, in any procedure Involving pain to unanesthe- 
tlzed animals, to consult a veterinarian In planning the procedure and to with- 
hold anaesthesia only for the necessary period of time, 



y Under 7 U.S.C. §2144, federal departments, agencies, and Instrumentali- 
ties must already comply with standards promulgated by the Secretary. Adding 
them to the definition of "research facility" apparently would make them subject 
to requirements of the Act apart from the Secretary's standards. 



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(6) except ai allowed by an animal reaearch comlttee (aee 8 and 9), prohibit 
the use of any anlnal In sore than one ma 'or operation from which It la allowed 
to recover, 

(7) allow atatea or their political subdlvlalona to promulgate atandarda In 
addition to thoae of the U.S.D.A. 

(8) require the Secretary to require each reaearch facility to eatabllah an ani- 
mal research conmlttee with at least three members at least one of which shall 
be a veterinarian and another a peraon having no association with the facility 
and representing the welfare of animals, 

(9; give animal reaearch committees various duties, including inspecting the 
research facllitlea and filing reports of violations of standards with the 
research facility, with such reports available to the Department of Agriculture, 

(10) require the Secretary to establish an information service at the National 
Agricultural Library^ which ahall, in cooperation with the Rational Library of 
Medicine, provide Information on improved methods of animal experimentation, 

(11) require federal agencies that fund animal experimentation to suspend or 
revoke federal support if it determines that a research facility has not com- 
plied with applicable standards, 

(12) prohibit the Secretary from requiring reaearch facilities to disclose trade 
secrets or commercial or financial information which is privileged or confiden- 
tial, 

(13) make it a crime for a member of an animal research committee to release any 
confidential information of the research facility, and 

(14) authorize civil suits to recover dmmagas sustained as a result of the 
release of confidential information of a reaearch facility. 



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Authority of U.S.P.A. 

Section 13(«) of the AnliMl Welfare Act, 7 U.S.C. $2U3(a), authorizes the 
Secretary to "promulgate standards to govern the humane handling, care, treat- 
ment, and transportation of animals by dealers, research facilities, and exhi- 
bitors." Section 21 of the Act, 7 U.S.C. 52151, authorizes the Secretary "to 
promulgate such rules, regulations, and orders •• he may deem necessary in order 
to effectuate the purposes of this Act." The Supreme Court has written: 

Where the empowering provision of a statute states simply 
tha the agcTTcy Day "make . . . such rules and regulations 
a may he necesmAry to carry out the provisions of this 
Act we hav« held hat the validity of the regulation 
y^ promulgated thereunder will be sustained as long as it 

is "reasonably related to the purposes of the enabling 
legislation." 

Mourning v. Family Publications Service, Inc. , 411 U.S. 356, 369 (1973). In 
short, the power of the U.S.D.A. to promulgate regulations under the Animal Wel- 
fare Act is very broad. Unless a regulation it promulgates contravenes a law, 
it is within the agency's authority if It may reasonably be deemed necessary 
to effectuate the purposes of the Animal Welfare Act. The purpose of the Act 
essentially is to Insure that animals covered by it "are provided humane care 
and treatment." 7 U.S.C §2131. Any regulation that is reasonably related to 
this purpose apparently would be found valid, if challenged in court. 

Applying this principle, we have examined the 14 provisions of H.R. 5725 
listed above and reached the following conclusions. 

Numbers (2) through (6), (8) through (10), and (12) apparently could b« 
implemented- by the U.S.D.A. under its existing authority. Specifically, proaul- 
gatlng standards requiring exercise for dogs, requiring research facilities to 



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consider alternaclves to painful experlmencs, requiring research facilities to 
establish animal research ccinmlttees, and Implementing the other provisions 
Included In these numbers would appear reasonably related to insuring the humane 
care and treatment of animals covered by the Act. A qualification to this 
statement should be made, however. Although U.S.D.A. apparently could estab- 
lish an Information service at the National Agricultural Library, since that 
Library is within U.S.D.A., it apparently could not require the cooperation of 
the National Library of Medicine, since that Library is within the Department 
of Health and Human Services. 

^ Numbers (1), (7), (11), (13), and (14) apparently could not be implemented 
without additional legislation. This is because the matters included in these 
numbers would change existing lav or affect courts or other agencies over which 
the U.S.D.A. has no jurisdiction. Specifically, to change a definition enacted 
by Congress, to authorize states to promulgate standards, to require other agen- 
cies to suspend or revoke federal support, or to establish crimes or causes of 
action would be to change the Act, not to implement it. 



Henry Cohen 
Legislative Attorney 
American Law Division 
October 24, 1984 



Addendum: Section 13(a) of the Animal Welfare Act provides: "Nothing in this 
chapter shall be construed as authorizing the Secretary to promulgate rules, 
regulations, or orders with regard to design, outlines, guidelines, or perfor- 
mance of actual research by a research facility as determined by such research 
facility.- This might limit the Secretary's power to implement (4). (5). and (6). 



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STATEMENT BY SENATOR BOB DOLE 
HOUSE SUBCOMMITTEE HEARINGS ON ANTMAI WEI FARE 

A TIMELY CONCERH 

THANK YOU CONGRESSMAN BROWN; IT IS A PLEASURE TO BE HERE TODAY 
AND PI€SENT TESTIMONY ON BEHALF OF THE SENATE ON LEGISLATION FOR THE 
HUMANE TREATMENT OF ANIMALS. I'M PLEASED THAT YOU INTRODUCED 
H.R. 5725. WHICH IS SIMILAR TO S. 657 WHICH SENATOR MELCHER AND I, 
ALONG WITH SEVERAL OTHER SENATORS. INTRODUCED MARCH 2ND. 1983 AND 
WHICH NOW HAS OVER 25 COSPONSORS IN THE SENATE. I WOULD STATE FOR 
THE RECORD THAT THE CHANGES INCLUDED IN THE HOUSE BILL ARE ACCEPTABLE 
TOME. 

ACTIONS. NOT WORDS 
AS I HAVE OFTEN SAID TO AUDIENCES INTERESTED IN OBSERVING 
CONGRESS. "DON'T LISTEN TO WHAT WE SAY. BUT WATCH WHAT WE DO." BECAUSE 
OUR ACTIONS SPEAK LOUDER THAN OUR WORDS. THE SAME IS TRUE FOR THE 
MEDICAL COMMUNITY AND THE ANIMAL WELFARE COMMUNITY. THE SAME APPLIES 
TO SOME FARM INTERESTS WHO ARE NOT AT ALL AFFECTED BY THIS LEGISLATION, 
BUT WHO HAVE NEVER THE LESS LOBBIED AGAINST IT. OUR LEGISLATION IS 
AN AMENDMENT TO THE ANIMAL WELFARE ACT WHICH HAS A SPECIFIC EXEMPTION 
FOR FARM ANIMALS. 

MR. CHAIRMAN. THERE WILL BE DETAILED TESTIMONY PRESENTED TODAY 
ON BOTH THE MERITS AND THE NEED FOR THIS LEGISLATION. BUT THERE ARE 
THOSE WHO SAY "WE BELIEVE IN THE HUMANE TREATMENT OF ANIMALS, EUI..." 



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AND YET AT EVERY CORNER TRY TO BLOCK RESPONSIBLE LEGISLATION. IT 
IS A NARROW VIEWPOINT THAT MAINTAINS THAT OUR PRESENT SYSTEM IS 
BASICALLY WITHOUT FAULT AND THAT TIGHTENING REGULATIONS TO PREVENT 
ABUSES SHOULD NOT BE ATTEMPTED. 

SOME HAVE QUESTIONED THE NEED FOR LEGISLATION SUGGESTING THAT 
ABUSES ARE INFREQUENT. HOWEVER, MATERIAL OBTAINED UNDER THE FREEDOM 
OF INFORMATION ACT SHOWS THAT ABUSES ARE A COMMONPLACE PROBLEM EVEN 
IN SOME OF OUR MOST PRESTEGIOUS INSTITUTIONS. I SUGGEST THAT IT IS 
TIME TO STOP WAVING THE BANNER ENTITLED "NO LEGISLATION" AND PUT 
ACTION IN PLACE OF WORDS TO ENSURE THE PIBLIC THAT AMERICA HAS AN 
ADEQUATE ANIMAL WELFARE SYSTEM. 

LET'S ASSURE THE TAXPAYERS WHO SPEND BILLIONS OF DOLLARS EVERY 
YEAR FINANCING MEDICAL RESEARCH THAT SAFEGUARDS NECESSARY TO PROTEQ 
ANIMALS FROM ABUSE ARE IN PLACE. LET'S ALLOW PUBLIC INVOLVEMENT 
THROUGH INSTITUTIONAL COMMITTEES AND REQUEST PERIODIC INSPECTIONS. 
l£T'S TAKE A UNITED AND SERIOUS LOOK AT HOW BETTER AND PRACTICAL 
ALTERfWTIVES CAN POSSIBLY REDUCE THE NUMBER OF ANIMALS USED OR AT 
LEAST REDUCE THE PAIN THEY EXPERIENCE. 

RFSPONSIRLF IFGISLATIQN 
MANY, MANY HOURS HAVE BEEN SPENT IN CONSULTATION WITH THE MEDICAL 
COMMUNITY AND THE ANIMAL WELFARE COMMUNITY IN AN EFFORT TO DEVELOP 
A BILL WHICH ADEQUATELY REFLECTS THE LEGITIMATE CONCERNS OF ALL 



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INVOLVED. HE HAVE EVEN INCLUDED FARM INTERESTS IN OUR DISCUSSIONS 
TO BE SURE THEIR INTERESTS ARE TAKEN INTO ACCOUNT. SEVERAL FARM 
GROUPS HAVE DECIDED TO REMAIN NEUTRAL BECAUSE THEY REALIZE THIS 
LEGISLATION DOES NOT AFFEQ THEM. 

THE SIGNIFICANT ROLE ANIMALS PLAY IN IMPORTANT RESEARCH AND 
TESTING AND THE VALUE THAT SUCH RESEARCH AND TESTING ADDS TO OUR 
SOCIETY IS GENERALLY RECOGNIZED. YET, EVERYONE AGREES THAT RESEARCH 
ANIMALS SHOULD BE TREATED HUMANELY SO THAT TEST RESULTS CAN BE 
ACCURATE AND TAXPAYERS' DOLLARS CAN BE SPENT IN A COST EFFICIENT 
MANNER. UNFORTUNATELY, WE HAVE NOT YET LEGISLATED A SYSTEM TO 
MAKE THIS TRUE. 

MR. CHAIRMAN, THIS IS A MODERATE AND REASONABLE BILL AND IT IS 
TIME IT BE ENACTED. 



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American Society of Mammalogists 

HUGH H. QENOWAYS. PmUm* ^^-^ "^^^ TER RY L YA TES. 

SKUonolMwnmali /iT^ H\. Dtpwtnwnt o« Bwogy 

Camagk MuMum ol Ntturaf HMoiy X II jf \ Ui*»««Ky o« Mpw Mwdoo 

saOOBMnBM. / A\ ^^ \ Atwquwque. N«w M«loo 87131 

Pttttburgh. Pwvwylvwia 15208 / \ik ■jF \ (506)277-3838 

(412)361-0684 / 'i^^v JK^ \ GORDON L KWKLANO. JR.. 8«0»twy-Ti««MW 

DONE.WItSON.nr«tVlo»J»rMld«it / ^^^^9^ I T1» V«i1ib»«» M 




W«rt*gton. DC. 20580 \ ^^JJm. J (717)632-1407 

(202)367-1930 \ ^^O^L J CLYDE XM 



JAMES L PATTON. Second VI ^^ 

MuMum 01 Vailibral* Zoology N. ^__^^B >^ TtM> Toch UnhwriHy 



24 September 1984 

Honorable George E. Brown, Jr. 
Chairnan, Suboonmlttee on Department 
Operations, Research, and Foreign Agriculture 
Room 2256 Rayburn 
Washington, D.C. 20515 

Dear Congressman Brown: 

As representatives of the American Society of Mammalogists, a 
professional society of over 3700 members, we had hoped to present 
testimony concerning the Improved Standards for Laboratory Animals Act, 
H.R. 5725 at the public hearing on 19 September 1984. Because of the 
time constraints of the hearing and the large number of witnesses already 
scheduled, we were not able to present testimony at the hearing. We 
would, however, ask that the attached testimony be Included as part of 
the written hearing record. We would appreciate receiving a copy of the 
hearing record when published. 

One of us (RCD) did attend the hearing and we will continue to monitor 
this legislation as It progresses. We would appreciate the opportunity 
to comment on this bill at a later time If necessary and thus would like 
to be kept Informed by your staff of future action on this bill. 

Thank you for this opportunity to submit this written statement of our 
viewpoints on H.R. 5725. 



Respectfully,. 




Hugh H. Genoways 

President 

American Society of Hammalogista 

Robert C. Dowler 
Chairman. ASM Committee on 
Legislation and Regulations 

HHG/kk 
Enc. 



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American Society of Mammalogists 



MUOM M. O i W OWAYS. P n mti m ^ " ^^^ TWWVLVATa. 






Statenent of Dr. Hugh H. Genoway8« President, American Society 
ManMloglats and Dr. Robert C. Dowler, Chalrvanr ASM Cooalttee on 
Legislation and Regulation for th« written record of the hearing of the 
Suboomnlttee on Uepartinent Opera tlanst R«»«arch^ and Foreign Agriculture 
concerning H,R^ 5725 , the Improved Standard* for Lnborfltory Anlffala Act, 

The Anerican Society of Hamnalogiats 1« a profess lonel society 
representing over 3700 namnB log lata worldwide with a ujorlty of our 
■eabers being froa the United StbteA. This society actively proivtea 
research on Bannals In the interest of advancing knowledge In all fields 
of biology. 

The Anerican Society of Mannaloglsts fully supports the huaane care and 
treatnent of all anlaals. However, we cannot support the passage of H.R. 
5725 as written. In general, nany of our conients below are concerned 
with the broad Units of coverage and undefined ternlnology used In H.R. 
5725. 

Many inainna log lata conduct bionedlcal research in a laboratory setting, 
but a large proportion conduct field studies of wild aninsLa that nay 
Involve such activities as collecting DaBnala taking routine 
neaaureaents and blootl sanplea, holding anlnals t<k^ various short tern 
observations, tagging or narking arrlnals for later Idetttiflcntlon If 
recaptured, attaching radio trananltters to anlnala to monitor their 
activities and nuvetnenta and relea^ln^ then where captured Such field 
situations are not generally ocnaldered to be * laboratories" There Is, 
In fact a tendency to aeparate laboratory biologists and field biologists 
as sonewhat distinct groups of research aclentiata. Although the title 
of H..R ST25 Is "the 'nproved Standards for Laboratory Anls^l Act* and 
the act la presuned to be alned prlsarlly at laboratory species used In 
bioioedloal research, a broad Interpretation of wording In several 
aeotlons could have an effect on field baAcd reaearch such ss that 
described above. In addition to any effects on marnnallan research In 
laboratories. The following specific conients are concerned wltb aspeets 
of H.R. 5725 that would affect BaoDaloglsts conducting research In both 
laboratories and In field situations. 



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The requireaent for •stablishaent of an aniaal researoh oowiittee to 
inspect *«t l«a3t senl annually «11 anlpal study areas. ••" p. 7 lines 
7-8) is caaentially unirorlcBble In w>at field research, K glveci "snlnal 
study qrftd" nay be a desert site In Arizona * b renote forest In A la ska » a 
river bank In Tropical foresta of Peru, or a nountaln side In India, 
Such study areas aay or nay not have formal structures nay he utilized 
for tloe periods of a year or less* and are often used only once, 
Requlrine a research facility to have suoh areas Inspected by an aniaal 
research comlttee sejil annually would be prohibitively expensive and we 
believe such requlrenents are not the Intent of this act. 

We are further concerned that many terns used in H.R. 5725 are either 
undefined or cannot be adequately defined, Aeferences to "pain* snd/or 
^distress* are Bade throughout the test but neither have been defined, to 
our know led Be, and in reality they represent a continuum that occurs as a 
natter of degree » Even anong hunan subjects what represents pain to 
one, pay be inperoeptible to another. This is not to suggest that 
painful procedures do not occur, but slnply that Judgenent as to whether 
certain procedyrea are painful is often tines subjective. For example, 
does taking blood sanples^ giving routine injections, or tagging animals 
oause pain? If Judged to cause pain under this act such procedures 
would require consultation with a veterinarian (p. 5, lines 11-12) and 
involvenent of the aninal research cooBittee (p. 7, lines 9-11). 

Another tern that appeara to be undefined is "najor operative procedure" 
(p, 6 ine 2), Again, if loosely defined, what is considered 3 sajor 
operative procedure to a nenber of the connlttee representing cQimmnlty 
Interests nay not be "naJor" to th« research aclentlat. Does anputation 
of a snail anlmal^s toe constitute a major operative proc«durfi? f so, 
this night result in the aninal beln^ euthanized because It could not be 
used in any other major operative procedure in that or any other 
laboratory. Use or research techniques, such as artificial inaenination, 
electroejaculfltlan, caesarean section fetal transplants, or eiutero 
enbryo culture, intended to preserve or Increase populations of a rare or 
endangered species night be inpeded if considered to be naJor operative 
procedures. 

Another provision of H.R. 5725 that would prevent nany legitinate studies 
and Increase the costs of others is that requiring separation by species 
Cp, % line 1) Where wild sningl species ^re brought into the 
laboratory for study, analyses may involve nany different species. 
Providing facilities to house each wild species in a separate room (in 
addition to separate areas for standard laboratory anlmsla) would be 
aitrenely expensive and often impossible tc Justify especially for 
analler facllltlea at snsll colleges and universities. Such requlrenents 
should be nade only when the potential for transnlsston of coDBunl cable 
health problems between the species in question has been denonstrated 
and/or la a potential threat. 



41-970 0-85-19 

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In conclusion, we, as representatives of the Anerioan Society of 
Mannalogists, believe that the language of H.R. 5725 is too inclusive and 
ill-defined at this tine and that passage of this act would iapede and 
prevent legitimate research by maonalogists as well as other groups 
involved in biological research. We would be happy to work with the 
subcoonittee in whatever way necessary to ensure that any legislation 
enacted is biologically sound. Thank you for this opportunity to state 
our views in H.R. 5725. 



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STATEMENT 

Leon C. Hirsch, President 
United States Surgical Corporation 

on H.R. 5725 

Before the 

United States House of Representatives 

Subcommittee on Agriculture 

September 19, 1984 



United States Surgical Corporation ("U.S. Surgical") 
is the leading producer of surgical stapling devices used to 
close wounds and reconstruct tissue during surgical procedures. 
Surgical staplers are standard equipment in operating rooms 
throughout the world and U.S. Surgical is continuing to 
develop new products and to refine our current devices. 

U. S. Surgical is a research facility under the 
provisions of the Animal Welfare Act (the "Act") and takes 
its responsibilities seriously — not just by meeting the 
standards of the Act, but by surpassing them. Our facili- 
ties are inspected by two Federal and two state agencies. In 
addition, we are accredited by "AAALAC" , the American 
Association for Accreditation of Laboratory Animal Care, and 
take great pride in the excellent reputation of our medical 
facility. 

We support efforts to assure humane treatment for 
laboratory animals; however, we are extremely concerned about 
amendments to the Act which can affect how we develop 
surgical devices. We are absolutely committed to patient 



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health and safety and believe it is absolutely essential to 
maintain our highly-specialized, technical salesforce to 
train surgeons and operating room personnel on conplex 
surgical devices before the surgeons use them on human 
beings. 

U. S. Surgical restricts the use of laboratory animals 
to the absolute minimum. We are extremely proud of the fact 
that we were the first medical device company to be issued 
PDA approval for performing a biochemical test as a substi- 
tute to using live animals in pyrogen testing. 

Our sales efforts utilize illustrated encyclopedias, 
films and demonstrations on foam rubber organs by our 
specially trained salesforce. Live tissue is only used in 
limited circumstances: essential product development, 
testing under circumstances necessary to obtain government 
approval, and for training of surgeons, operating room personnel 
and our reprsentatives. In this regard I want to make the 
following points: 

1. Surgical devices must undergo the most rigorous 
testing procedures during development, including 
live tissue testing for chemical body reaction 
and hemostasis (control of bleeding). There is 
no method of testing for control of bleeding 
other than testing on live tissue. 



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2. Surgeons must be thoroughly trained, including 
live tissue experience, before using medical 
devices on humans. When surgeons and operating 
room personnel are ready to use our surgical 
stapling devices, we are committed to the highest 
level of training in order to assure patient 
safety and proper procedures. This live tissue 
training with surgical stapling devices is per- 
formed either in our laboratory or, by invitation, 
in the laboratories of a teaching university in 
conjunction with the faculty. 

3. Medical teaching universities routinely call upon our 
highly trained technical salesforce to assist in the 
training of their residents and surgeons. Because 

of this, it is essential that we give our repre- 
sentatives adequate live tissue training in order 
to qualify them for teaching. 

4. In addition to teaching surgeons on live tissue, 
our representatives are trained and qualified to 
be present in hospital operating rooms to provide 
technical product assistance to surgeons during actual 
operations. This is an important facet of our 

work and requires the highest level of training 
and a solid familiarity with hospital operating 
room procedures and etiquette. 



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U. S. Surgical, as a facility that has the full 
accreditation and certification of AAALAC, operates under 
animal care standards that far exceed the current statutory 
and regulaltory "minimum" requirements. As stated earlier, 
we readily endorse the thrust of H.R. 5725. We wish the 
industry were free from violations or abuse, but recognize 
that sound laws are essential to assure humane treatment for 
laboratory animals. We believe that this objective is best 
obtained through legislation that rectifies problems or 
abuses where they actually exist. In this regard, we urge 
the Subcommittee to deliberate very carefully in considering 
H.R. 5725 in order to avoid any unintentional results which 
could hamper medical research, developing technology or 
essential training. 

H.R. 5725 incorporates some specific improvements 
over its companion bill, S. 657. While I appreciate those 
adjustments, I still want to express my concerns 
to the Subcommittee. We have already discussed some 
specific language with staff, so I will merely highlight 
our concerns in this statement. 

First, we believe it is important to provide the 
right incentive for facilities to voluntarily comply with or 
exceed the regulations and statutes. The federal government 



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simply cannot fully enforce all the provisions of the Animal 
Welfare Act and H.R. 5725 at all the animal research facili- 
ties. There are 3,300 research facilities across the 
country represented by 1,166 registrants (institutions or 
parent companies). In our opinion, any attempt to gain full 
compliance through enforcement alone is unrealistic and 
doomed to failure. 

We urge the Subcommittee to adopt an approach which 
fosters voluntary compliance. Give research facilities 
which meet or exceed statutory standards a "safe harbor". 
Reward voluntary compliance with a corresponding reduction 
in burdensome paperwork and duplicative inspections. Make 
penalties harsher for those facilities which certify compli- 
ance but fail to maintain it -- creating an incentive to 
provide and maintain the highest level of animal care. 
There are several ways in which such incentives can be 
incorporated into H.R. 5725. 

Second, we suggest there is an enormous distinction 
in the proprietary interests of government research and 
private industry and we are extremely concerned about the 
protection of trade secrets and other private proprietary 
rights under the provisions of H.R. 5725. Whereas in federally 
funded laboratories, information should be shared to reduce 
duplication and unnecessary animal use and expense, private 
laboratories are entitled to the exclusive rights in the 
fruits of their research and must assure complete confidenti- 
ality in order to protect their proprietary rights. We urge the 



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Subcommittee to consider carefully %rhether there is any need 
to include private research facilities in the proposed 
legislation. U. S. Surgical is currently subject to the 
inspection of two federal and two state agencies in addition 
to the more stringent requirements for AAALAC certification. 
We question whether an additional inspection by an institu- 
tional "animal research committee" is necessary, especially 
in light of the trade secrets-proprietary rights question. 

we recognize the attempt made to provide safeguards 
against disclosure in H.R. 5725 but suggest that they ignore 
the greater problem that the presence of an outside person 
represents. Besides, it is unrealistic to require an 
outside volunteer to serve on an animal research committee 
and to be subjected to extensive criminal penalties for 
even inadvertent disclosure. Simply enacting stiffer 
penalties against disclosure is not the answer — eliminat- 
ing the potential problem of the outside member is the proper 
solution. 

Section 4 of the bill requires at least one member 
of such a committee to have no association with the research 
facility and be primarily responsible for representing the 
community concerns regarding the welfare of animal subjects 
(page 6, lines 21-24). In private research facilities. 



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it is critical that certain business information be 
closely guarded, sometimes even from employees within the 
research facility. For example, in April, 1983, U.S. 
Surgical announced the development and marketing of the 
world's first absorbable surgical staple, representing a 
major surgical advance and an immense potential patient 
benefit. However, it was critical for competitive reasons 
that the mere existence of the project leading to this 
break-through be closely guarded. We are not convinced that 
bona fide trade secrets or confidential information of this 
kind would be adequately protected by the provisions of the 
bill. This kind of confidential information is the life 
blood of high technology industries and cannot be compromised. 

We respectfully suggest that the best solution is 
to have the "animal research committee" provision apply only 
to research facilities receiving federal funds. This is 
reasonable in light of the number of federal and state 
inspections facilities face each year. At the very 
minimum, all research and development activities of a 
proprietary nature must be exempt from inspection by any 
outside member of an animal research committee. We welcome 
all government inspectors, but strongly object to outside 
people who are not government employees conducting inspec- 
tions in our private facility. We do not object to the 



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inspection itself, but tre do object to the potential coapro- 
nise of our very basic and valuable rights that an outside 
member represents. 

Lastly, during hearings in the Senate on S. 657 Senator 
Dole stated his intent that the bill not impose significant 
additional costs on research facilities. He submit that both 
S. 657 and H.R. 5725 will significantly raise the costs to 
research facilities which make a good faith effort to comply 
with all provisions. To the extent there are costs required 
to comply with H.R. 5725, they will be passsed on somewhere. 
Federally funded research facilities will ultimately pass 
those additional expenses through as an increased cost of 
research and they will be borne by the taxpayer. In private 
research facilities, the cost can only be passed on to the 
consumer. This Subcommittee has a duty to evaluate the real 
cost of H.R. 5725 and assure that the legitimate intent of 
the legislation does not impose any more nonproductive costs 
than absolutely essential. 

In conclusion, we share the Subcommittee's concern 
for assuring proper treatment for laboratory animals. We 
believe our own facility far exceeds statutory and regulatory 
requirements and we invite the Committee and its staff to 
visit our laboratory in order to see first hand a private 
research facility covered by the Animal Welfare Act. 

We are available to work with the Subcommittee to 
develop legislation which addresses our concerns in a fair and 
equitable manner while also assuring proper treatment for 
laboratory animals. 



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AMERICAN SOCIETY FOR PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS 
9650 RockviUe Pike BHlMfda, Manrfauid 2M14 3tl.530-7«W0 

Cotmcil 

Marjorie O. Horning. President ^^ ^- ^^™*" 

WilUan K. Riker. Praidatt-EleGt 

Allan H. Conney. Put President 

Theodore Cooper, Secrcury-TreaMirer 

WUIiani L. Dewey, Secreury-Treasurer-Elect 

John P. Long. Past Secretary-Treasurer 

J. Richard Crout, Councillor 

Thomas F. Burks, Councillor 

Janice L. Stickney. Councillor 

n W. Ficaoiag, Board of PubiicatioBS Trustees 

Septenter 18, 1984 



Honorable George E. Brcwn, Jr. 
Ghariinan, House Agrlcultuz^ 
Subconnittee en Department Operations 
Research and Foreigyi Agriculture 
U.S. Hcxise of Representatives 
2256 Raybum Building 
Washington, DC 20515 

Dear \/ic. Chaixman: 

The Aoerican Society for Pharmacology and Experimental Therapeutics 
is appreciative of the opportunity to ccnment on HR 5725. We welcome the 
concerns expressed by the authors and supporters of HR 5725 for the qual- 
ity of life of animal subjects. We, by exaiple, have insisted upon and 
practiced care and consideration for animal subjects without the need for 
excessive regulatory pressures. We contend that flddiHonal restrictions 
that exceed the present requirements eoixxiied in the Animal Welfare Act 
are not warranted. We urge and si;>port the recannendatians of the Fed- 
eration of American Societies for E}q>erimental Biology that coc^gressicnal 
efforts be focused on a fact-finding study concerning research, testing 
and education involving the use of animals. A study conducted by a pres- 
tigous body such as the National Academy of Sciaices would s^arate po- 
lemics and confrontational hyperbole fran the specific issues of providing 
the best care, enviroment and protection for animal subjects. 



Sincerely yours, 

tferjorie G. Homing 
President, 




Keith F. llllam 
Chairman, Cnnnrittee on 
Professional Affairs 



Ehclosure 



JOURNALS: The Journal of Phannacoiofy ft Experimental Therapeutics. Pharmacological Reviews. Molecular Pharmacology. The Pharmacologist. 
Rational Drug Therapy. Clinical Pharmacology ft Thmpeutics. Drug Metabolism ft DIsposilioa 



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LixKia H. Ruber 
30 Sea View Avenue 
Piedkicnt, Ca. 94611 



Septeniber 17, 1984 

lb Menbers of the Subcxximittee on DepartniBnt Operations, Beaearch and FDireign Agri. 

Re: H.R. 5725 

Ify name is Linda Huber, and I am a neniber of Gsdifomians for Reaponsible 
Research, Fund for Aninals, Aninial Welfare Institute, Aninial Protection 
Institute of Anerica, People for the Ethical Tceatxnent of Aninals (PE^ 
and other organizations. In active affiliation vdth the Aniioal Rights 
Direct Action Ooalition, I have beocrae infomed of the University of Cali- 
fornia's Berkeley Gnnpus violations of the Aniinal Welfare Act with cbcur 
nented deficiencies in the humane handling, care and treatment of animals - 
^>ecificcdly USDA citations fron late 1979 to January, 1984 for inadequate 
disease control, inevSequate veterinary care, inadequate animed care and 
inadequate identification of animals. 

A recent KCBS radio editoricd broa d casted the ceise of a male primate suf- 
fering from necrotic and gangrenous skin in the perineal area, entire 
scrotum, feet and ears. In a letter dated 2/20/79 to Dr. DeValois (Professor, 
Psychology Department) fron David H. Sesline (D.V.M. , Senior Veterinarian, 
Laboratory Animal Medicine) , he writes, "This animal was in such diaoastfort 
that he could not cliinb to the lixit to drink and was observed by the ani- 
mal technicians and nyself to attenpt to drink his own urine. . .1 urge you 
to observe your animals frequently or aaperviae those who do. . . " 

Despite the existanoe of a Gonmittee for the Protection of Animal Subjects 
(CPAS estabUshed 1982), the ttiiversity was fined $12,000 in i^il, 1984 
by the USDA. Ohis same conmittee is on record as being against legislation 
designed to inprove or strengthen standards for animed care as documen t ed 
in a joint report issued by Csdifomians for Responsible Research and 
B udd h ists Oonoemed for Animals called Animal Care and Animal Care Policy 
at University of California, Bea^celey, Animed Research Facilities, Octoba: , 
1983 . 

In consideration that the Ikiiversity has proved an unwillingness to care 
for its animal subjects in ocnplianoe with the Aniiral Welfare Act plus the 
reedization that the USDA itself was delinquent in pressing a timely oonidednt/ 
fine against the Ikiiversity - despite the long history of repeated violations - 
H.R. 5725 particularly addresses this type of situation with improved mon- 
itoring and reporting of laboratory animal conditions. Acknowledging that 
this Uhiversity's (CPAS) peer review has failed, (information regarding the 
above prinete was never provided the USDA) , the presence of a ocRmmity 
animal welfare representative on committee to guarantee enforcement of the 
Animal Welfare Act is critical. Ihis as well as all other features of K.R.5725 
demands enactment. 

Sincerely, 

Linda H. Huber 

Member, Calif omians for Responsible Research 

attachment 



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"We haue uncouend what appears to be a pattern of expertirwitaUon 
usinganimals which often produces no usefid results other than miMaied 
or dead animals. 

There seems to be a mentality that what goes on at the Uniuersity is the 
Uniuersity's business and no one else's, and it seems to be that the 
academic community is immune from the public, and the (JniuersUy wUl 
take care of its own protMems. and tfiat's Che end of U." 

Bob Jimenez, Mewscasler 

KROMTV 

July?. 1982 



"This is to inform you thM U was necessary todt^ to euthanize one of your primates uih/c/i had 
apparently been severdyiryured for sornetirTie. I do not n^ake a practice of euthariizing research arUrnab 
without the corKurrence of the investigator but in this case the necessity was obvious. This animal had 
been ir^ured sometime (weeks?) ago ... The perineal area and entire scrotum were necrotic and 
gangrenous with full thickness skin death ... The animal was in such discomfort that he could not dlmb 
to the lixit to drink and was observed by the animal technician and myself to attempt to drink his own 
urine... This animal could probably haue been saved and his discomfort minlmiied if treated early." 

David H. Sesline. D.VM 
Senksr Veterinarian 
Laboratoiy Animal /Aecfidne 
aCBerittley 
Feb. 20. 1979 



'K is increasirigly obvious that while the carnpusveterirtartanseenis to haue die authority to prouUle 
veterinary care, the Departmmt ofPsychology is ignoriryg orchMenglng the matter.*' 

Veterinaiy Inspector 
a^-DeptofAgricuhure 
March 5. 1960 



"It would appear that cephalic dedrode impUuntatkxi and other experimental surgery ist)^igdone 
by researchers and graduate studerUs by "on thejob treUnlng" at the animals expense." 

R.F.V!BnCjelder.D.VM 
Animal Care Spedaist 
OS Dept of Agriculture 



"/ rememt)er seeing chronic brain implants with greei. amourUs of pus oozing from betwe&i the skin 
and the bone wax. I remanba- monkeys kqjt in Individual cages. exNbiting aU sorts of neurotic behavtor 
such as compulsive sdf<lutching and chmvirtg off the fingers ofmor\kajs in adjacent cages. I recollect a 
general ignorance or disregard for ascqjtk surgical lechrUque. I recall the resistarKX of MOST 
invesUgators to making chmtges in basic husbandry or experimented methoddlogy which would rdieve 
animid suffering." 

Bnjce MoK Feldman. D.VM 
C3iNcal Veterinaiy 
aCBerittley 
1969-1960 



"At the invitation of their director of animal facilities. Dr. Max Redfeam, I toured the present Ufe 
Science Building. I was appalled by the condltlor\s I observed. Rooms in whkh animals were housed 
were substandard. Many rooms were filthy with feces, feathers and other det)ris on the floors. ..hiany of 
the rabbits I saw had fUthy cages whkh had not been cleaned in severed days: these rooms were 
malodorous. Turtles were housed In filthy water with noproperfood or sunlight, and noplaceon uMch 
to haul out of the water. These particular turtles had had me^abdominad surgery after which they had 
been placed in the filthy condtttons I obeenjed. Two large roosters were housed in cages so small that 
they could riot stand uprigtU; they mere in poor bodily condition as welL A room in whk^ nu^surgay 
was af^^areritiy routindy paformed dUi r}ot have ariy provistoris for aseptic tecfvUque. Vetlwasshown 
anotha- room that had been designed for this purpose but had never been used according to Dr. 
Redfeam." 

NedBuyidoTMcVXD. 
Aas't F¥of. of Ophthatmology 
aCDavto 
AVvch 16. 1963 



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"Review of inspection reports. SepL 7. 1963 to Dec 1963 reueaksd repeated deficiencies, aome 
repeated every month for the four months. Moat of t/iese reports are apparmdy ignored. This uxMiid 
indicate a lack of concern for proper animal husbandry and a poor attitude regarding compiiarKX with 
not only USDA requirements, but also NIH and AAAIAC standards by some researchers. And a lade of 
any authority on campus to take corrective actiori or rductance by the authority to take actton on 
repeated deficiencies. " 

Homer E. Mdaby. Jr. D.VX 
Veterinaiy Medkai Officer 
CLSDeptofAgifcukure 
January 27, 1964 



'This is to respectfully ir^orm you that I am Irwoldng the Appeals f^ocedure for fion Senate 
Academic Appointees on the basis of arbitrary, caprick)us and unreasonable actions by aentor 
administratiue officers. .^Chancellor Heyman 's stMement in the press release of March 13. 1964. 'we need 
a type of expertise that we have up to now lacked...,' Is an irnndibleinexacttaklearvi an ouirtghtUautt 
to a member of the vetertr\aiy profession. 

The series of everUs leMlirig to my demotion I conskier to be inexcusable, imprindpled and 
indescribably urKonscionable." 

MMOweW S> Redfeam, D.VM^ MS, PhD., 
Campus Veterinarian 
aCBertcriey 
March 26. 1964 



'7 am writing in response to your false, misleading, and insultir^statentenisin theMarch I3ih, 1964 
press release from the UCB Office of Public Information. 

You state: ... "We need a ttffx of expertise that we have up to now lacked — a professional guidarnx 
based upon thorough knowledge of all actions needed to meet AAALACs requiremenis In the 
managemerU of animal care.' Eight or so laboratory animal veterinarians have worked In the UCB 
Division of^xlmal Resources during the past Wto J 5 years. During the swneperkxi, other veterinarians 
have worlced for or coTisuUed with various ca/npus departrnerUsaslaboratoryanlrnalveSer1nartans.lt Is 
particulariy inaccurate and InsuUing to Imply that theae veterinarians were Ignorant of or could not 
comprehend AAALAC requirements, for they are bask and fimdamentaL not sophisticated or technicaL 

The problem of CKB laboratory animal care has always been a lack of wlU or Interest on the part of 
those In authority This Inaction aver a period of decades has resulted In the scathing reports on animal 
care to which the campus has been subfed k Is appalling to see the UnkiersHy resporui by making 
reduTklarU persorvtel appoUiirnervts aid creatirig reduruiantcorrvrUttees.'' 

Bnjce Ate Fekknan, D.VM 
— ^— » - -■ »<- » - ■«--■»- ■ 
rofmer vjncai veiervianan 

aCBertcriey 

Match 31. 1964 

(From a letter to ire M. Heyman, 

ChanceBor, a.C Beriwley) 



CALIFORISIAN8 FOR RESPONSIBLE RESEARCH 

aiTHHlVlrtaBtad. 

Coitel%dew,CA 94923 

415/924-4454 

Fcxjnded in May of 1963 by members of the veterinary, medkal. educational, legal, and artistic 
communittes, Caltfbmians fbr Responsible fiesearch has groiMn in res p onse to the >Mate, neglgerKe, 
CAielty and dhhonesly occurring within the r cs e ar dil a boratp ri es of the University of CaBfomto 

Scandal and corruption occurring outside of the laboratory results primarily in monetary loss: >Nhen It 
happens within research laboratories, it is usually compounded t^ senseless pain, suffering, agony and death. 

Thb flyer focuses on the problem s involving non^iuman anim^ occurring 
within the bioiogical and medical laboratories of the University of Califbmia.lt 
wifl give you an overview of the p roblems we at CF RR ar e attempting to 
correct. arKl the reasons we believe it is essential that CFRR continue to act 



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MsoclatioH of Professors ofM^icitte 



J. WHJJS HURST. M.O. 



1319 F SMtl. N.W.. I 



September 25, 1984 



Honorable George E. Brown 
Chairman 

Subcommittee on Department Operations, 
Research and Foreign Agriculture 
House Committee on Agriculture 
1430 Longworth House Office Building 
Washington, O.C. 20515 

Dear Mr. Brown: 

The Association of Professors of Medicine Is the organization that represents 
the chairpersons of departments of internal medicine In the nation's medical 
schools. As chairman of the largest clinical departments, members of the 
Association have responsibility for a substantial portion of the teaching, re- 
search, and patient care programs of these institutions. 

We understand that your Subcommittee recently held hearings on H.R. 5725, the 
"Improved Standards for Laboratory Animals Act." We respectfully submit the 
enclosed statement and the attached brochure for inclusion in the hearing re- 
cord. 

Thank you for considering our views. 



Sincerely, 



r. Willis Hurst. M.O. 
President 



cc: Members, Subcommittee on Department Operations, 
Research and Foreign Agriculture 



UnnwfMy o( Teus HeaWi Scianc* 

C«nt«r at S«n Antonio 
7703 Floyd Curl Dnve 
San Antonw. TeMS 78384 

(512)691-6511 



NORMAN G. LEVINSKY, M.O. 

SvcfMary- Traasurar 
0«partm«nt ol Madicina 
Boalon Univefsily 

School o4 Medicina 
75 East r4awton Straal 
Boaton. Massachusetts 02118 



NORTON J. GREENBEROER. M.O. 



Univarsity ol Kansas Medical Cantsf 
39lh and Rainbow BoutevanJ 
Kansas City. Kansas 66103 
(913) 58»«001 



LAURENCE E. EARLEY. M.O. 

Pas» PrtfOtm 
Oepanmani ol Madone 
Hosprtal o( the Unmeraily 



HAROLO J. FALLON. M.O. 



Oapailmonlol Ma d i c ina 
MMlcal CoMga o( Virgmia 
Box 663. MCV Slahen 



3400 Si 

PhUadetphia. Pannsytvania 19104 
(215) 662-2402 



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J^ssociatloH of Professors ofM^diciHc 



J. WHJJS HURST. M.O. 



STATEMENT OF THE 

ASSOCIATION OF PROFESSORS OF MEDICINE 

REGARDING 

ISSUES RELATED TO THE 

USE OF ANIMALS IN RESEARCH AND TESTING 



LVNNN 

aptem Amman tor 



The Association of Professors of Medicine (APM) Is the organization that represents 
the chairpersons of departments of Internal medicine In the nation's medical schools. 
The Individual members of APM have direct responsibility for a substantial portion 
of the teaching, research, and patient care programs of these Institutions. We would 
like to offer our general views regarding the use of animals In research and testing 
as the Agriculture Subcommittee on Department Operations, Research and Foreign Agri- 
culture begins its consideration of H.R. 5725, the "Improved Standards for Laboratory 
Animals Act." 



As physician scientists extensively Involved In the conduct of biomedical research, 
members of APM are keenly aware of the essential role of laboratory animals. As 
noted In the attached brochure, animals are used as substitutes for humans In re- 
search regarding the diagnosis, treatment and prevention of human disease. Virtu- 
ally every major advance in medical science has depended upon research Involving 
animals. The following are just a few examples which demonstrate how knowledge 
gained from animal research has enabled millions to lead longer, healthier lives: 
• the development of Insulin - In 1923, Drs. Frederick Banting and John 
Macleod were awarded the Nobel prize In physiology and medicine for re- 
search involving dogs which lead to the development of Insulin. There 



JAY H. STEIN, M.D. 



NORMAN Q. LEVINSKV, M.O. 



Univwiily ol T«iM HMllh Scianca 

OiMr al San AfMomo 
7703 Floyd Curt Df ivt 
Swi Antonio. T«<at 78284 

(512)891-6511 

LAURENCE E. EARLEY. M.O. 

PMiPrmidtni 



DaparUnent of Madicina 
Boston UnivarMy 
School of MaOidna 



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are In the United States alone approximately 11 million diabetics, 
most of whom live normal lives with the aid of Insulin Injections. 
Previous treatment for diabetes consisted of starvation diet to delay, 
however briefly, the Inevitable death of the patient. 
§ the development of the polio vaccine - The polio vaccine, developed 
through research Involving animals, has resulted In the almost total 
eradication of the disease. Prior to 1955, polio victimized In this 
country alone approximately 30,000 people each year— most of them chil- 
dren. 

§ Improved cancer therapies - As a result of the development of chemo- 
therapeutic drugs which are evaluated In animal models. Increasing 
numbers of young and adult victims of cancer are being treated success- 
fully. The National Institutes of Health estimates that 17,411 fewer 
children died of the disease between 1965 and 1979 than expected at the 
1950 rate. A related development Is Improved treatment for Hodgkln's 
disease, which Is most common among the 15-34 age group. Thirty-five 
years ago, this malignancy was considered Incurable. 1980 statistics 
revealed the cure rate to be approximately 73% 

§ the pump oxygenator - Without this device, which maintains the circula- 
tion and oxygenation of the blood when the heart Is stopped, life-saving 
surgical procedures for the heart and major arteries could not have been 
developed. Coronary bypass operations, which extend the lives of over 
150,000 people each year In the United States, could not be performed. 
The pump oxygenator was developed In the 1950's by teams of researchers 
working here and In Great Britain. However, Initial testing on dogs, 
pigs, and calves was performed In this country because of the British 
government's restrictions on the use of laboratory animals. 



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These are just a few of the numerous examples of how mankind has benefitted from re- 
search Involving animals. In addition, animals are used to determine the safety and 
efficacy of drugs and vaccines prior to their approval for use In humans. It Is 
also Important to note that animals are used In research to Improve veterinary care 
for pets and livestock. 

The Association of Professors of Medicine strongly supports the humane use of ani- 
mals In biomedical research and testing. Along with the general public, we are ap- 
palled by any abuse of animals— whether In a scientific. Industrial or sporting en- 
vironment. For humanitarian reasons, and In the Interest of scientific Integrity, 
the Association believes that It Is Imperative for laboratory animals to receive 
appropriate care and treatment. Fortunately, as noted In the attached brochure, 
the humane treatment of animals used In research Is almost always assured by scien- 
tists themselves. In addition, most research Institutions maintain committees to 
Inspect animal care facilities and actively oversee the use of animals for scienti- 
fic purposes. In terms of external controls, the Federal government has established 
standards for laboratory animal care and facilities are Inspected by the Animal and 
Plant Health Inspection Service of the U.S. Department of Agriculture to assure com- 
pliance with these standards. 

Despite the essential role of laboratory animals and the safeguards that exist to 
assure their appropriate use, there are those who suggest that research Involving 
animals Is Inhumane and unnecessary. Some advocate legislation that would severely 
limit or totally prohibit the utilization of animals for scientific purposes. Others 
support the modification of existing laws regarding the care and treatment of labo- 
ratory animals. The Association of Professors of Medicine would like to call atten- 
tion to the fact that there Is a striking absence of data to suggest that these pro- 
posals are warranted . At present, there Is simply Insufficient Information available 



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to make an Informed determination of the need for— much less the content of— such 
legislation. This view is supported by a 1980 report of the General Accounting Of- 
fice stating that, "...more information is needed on the advantages and limitations 
of alternative methods and the extent of inappropriate animal experimentation before 
deciding whether legislation. ..is needed." 

Accordingly, the Association is on record in support of proposals which advocate a 
Congressional ly-mandated 18-month study of the use of animals in research and test- 
ing. A study by the National Academy of Sciences (NAS) of issues related to the care 
of laboratory animals and the development of non-animal methodologies would provide 
a much-needed data base on this subject. The Association has urged the Congress to 
authorize an NAS study and await the results of this effort prior to proceeding with 
additional— potentially premature or unnecessary— legislation regarding this impor- 
tant issue. Until the results of such a study are available, the Association can not 
offer its support for additional legislation related to the use of animals in re- 
search and testing. 

In addition to advocating a study, the Association has encouraged the Congress to 
provide adequate appropriations for the Department of Agriculture's Animal and Plant 
Health Inspection Service (APHIS). Under the auspices of this agency, animal care 
facilities are inspected by highly qualified veterinarians and other animal health 
experts. Unfortunately, in recent years the efficiency of APHIS has been hampered 
by insufficient funding. The Association believes that the objective of assuring 
the humane care of laboratory animals can be achieved most effectively if the Con- 
gress provides increased levels of support for APHIS programs. In addition, we sug- 
gest that the enactment of new legislation relevant to APHIS activities may prove 
ineffectual so long as funding limitations constrain the agency's ability to func- 
tion. 



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In suflinary, at present the Association of Professors of Medicine can not support the 
enactment of legislation regarding the use of animals In research and testing. In- 
stead, the Association urges the Congress to: 
§ authorize an 18-month study by the National Acaden^y of Sciences of the use 

of laboratory animals, and 
§ provide sufficient appropriations for the Animal and Plant Health Inspec- 
tion Service so that thorough Inspections of research facilities can be 
performed. 
The Association firmly believes that these steps should be taken before the Congress 
proceeds to enact additional legislation. 



(The brochure is held in the committee files.) 



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^otufMol Society for Mfdicat Keseareh 

lo raoMOir nmuc uNotusiMmNG or mt muHciPus and HtmANiTMiAN 

OOAIS Of MOMHMCAl AND BiHMnOHAL USiAKH 




claubkx obmms. mo. ph o 

•mm Untwwwiv ol Nmt Yoffc 



X>HN E BAEH. Ph.O 



HELENE CECIL. Ph.D. 



Tha Upiohn Company 
OMIGMT E HARKEN. M 




V^QMIAV WEIjDON.M.O 



SHBJXMM VMX^.MO 
Htm England Madi o l Cwiwr 



■eWtAM)CZOOK.OVM 
Qaora* WMhinaton IMiNnM 



WMLTCR A. FHCYBURGM. Ph 



VMLUAM M SAMUELS. CAE 



September 11, 1984 



Ms. Sara Rasmussen 
c/o Rep. George E. Bro%m, Jr. 
2256 Raybum House Office Building 
Washington, D.C. 20515 

Re: H.R. 5725 

Dear Ms. Rasmussen: 

We understand that Rep. Bro%m is planning 
hearings on the subject bill (H.R. 5725) for 19 
September 1984. 

The National Society for Medical Research has 
been working for 38 years to provide the public and 
the Congress with information on the importance of 
animals in biomedical research. We have recognized 
the importance of responsible care in the handling of 
research animals and have advocated awareness by 
scientists of the need for such care. On the other 
hand, we have cautioned against unnecessary restric- 
tions of research. 

We would like to have an opportunity to have our 
views presented at the hearings. In discussions with 
the Association of American Medical Colleges on this 
subject we have learned the AAMC has already applied 
to you for an opportunity to present its views, and 
we have found that those views of the proposed 
legislation are consonant with our own. In the 
interest of preserving the time of the committee, 
therefore, we wish to suggest that the AAMC 
representative be heard and that his/her testimony be 
understood to be endorsed also by NSMR. 



Sincerely, 



ICON JACOBS. PhO 




L^ J^c6bB, Ph.D. 
Sci^n€ific Consultant 



John F. Sherman, Ph.D. 
Melissa Brown, AAMC 



AAMC 



1029 VERMONT AVE.. N.W., WASHINGTON. D. C. 20005 (202) 347-9565 



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September 19. 1984 

TESTIMONY IN FAVOR OP H.R. S72S 

The Honorable George E. Brown, Jr. 

Chairman 

Subcommittee on Department Operations, Research and 

Foreign Agriculture 
U.S. House of Representatives 
Washington. D.C. 20515 

Dear Congressman 3rowni 

PAWS represents more than 10,000 people who believe that this 
Congress has a moral obligation to pass H.R. 5725. When you 
are spending some four billion dollars of our tax money on 
animal research every year, you ought to have the basic 
decency to provide for the humane treatment of those animals. 

So far. Congress has failed in its moral responsibility to do 
this, and millions of animals have paid a terrible price in 
suffering as a result. 

H.R. 5725 will not stop all cruel experiments, but it will be 
the first step in that direction — a step that should have been 
taken before the first dollar was ever appropriated for any 
kind of research on live animals. 

Thank you for holding hearings on this long overdue, legislation. 

Sincerely yours. 



C— -- Jeimiter Johnson 
Chairmaui 
PAWS Legislative Committee 



SEP24IMI 



Non-Proflt Humane Organization Since 1967 

Humane Bduoattxi V Animal Ou« GMttr 

PaB0Kl007 

lynimood. Wmihlngtnn 96046 

Caoe) 745«4B 7750661 



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TUFTS UNIVERSITY 



Jean Mayer 
President 



September 12, 1984 



The Honorable George E. Brown, Jr. 
U. S. House of Representatives 
2256 Rayburn House Office Building 
Washington, D. C. 20515 

Dear Congressman Brown: 

Re: H. R. 5725 

1 want to congratulate you and Senator Dole on the development 
of a useful and sensible bill on standards for animal experimentation. 

It is difficult for those of us who both care about animals 
and are committed to the need for animal experimentation in bio- 
medical research to maintain a position which is acceptable to 
the majority of our fellow citizens and is not constantly attacked 
both by scientists who see any regulation and any protection 
of animal rights as a reflection on their integrity and by radical 
"antivivisectionists" who would eliminate animal experimentation 
altogether . 

I think you have succeeded in this difficult task, and I 
think your bill deserves to be supported and passed. 

Sincerely yours. 



cc: Senator Robert Dole 




Medford, Massachusetts 02155 
(617) 381-3300 



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Dear Meirbers of Congress 




I'm a young blacdc male who grew ip in the inner city of Washington D.C., but 
frequent trips during my youth to places where nature flurished has given me great 
appreciation for our environment and the animals within it. Ihe fact that I real- 
ize the great need for people to assume their role as protectors of this environment 
is directly related to this. In response to this realization I have been attenpt- 
ing to establish an organization called The. Iteplenishment of Bidangered Species 
Conservation Union (RESCU) in order to put to work seme ideas I have for this 
purpose. 

I've been working at the Armed Faroes Institute of Dental Reseandi (U. S.A.I. D.R.) 
for the last year «rtiere I've been «n.tness to a large amount of ndsuse of animals 
in the name of research. People at this institute gained knowledge of my interest 
to save animals and saw me as a threat to their progress. I*m now being rail 
roaded out of my job here because I'm suspected of making a recent report to the 
American Society for the prevention of crulty to animals of e3^)erimentation being 
done on rabits here at U.S. A. I. D.R. 

That fact that I can write a letter such as this to be read« by the entire 
United States Congress is evidence that mankind is beginning to awakan to his self- 
ishness. Ttiere has always been individuals vrtio cared enou^ to wan't to do some- 
thing about mans mistreatment of the animals kingdom, but we've made up such a 
small portion of the worlds population that we could 't begin to effect the minds 
and ways of the vast majority. Even still today, we lack the ability to bring 
about an abrupt change due to the sensitive and peaceful nature of our being. 
You see it's this sensitive nature that we possess that allows us to feel for 
these animals, and it is also this sensitive nature that is needed to bring forth 
peace in the world. So you must listen to us now before I and those like me become 
extinct like so many forms of life before us that %«ere unable to survive in a 
changed environment not suitable for their existence. 

I'm dixiiafounded by the true meaning behind the vp conming. h ^a ring ^for animals 
rig^its in America. To pass legislation that guarantees the qp keep and conoem 
for pain of aninals used for eaqpermentaiton is like the laws passed in the 1800's 
protecting slaves fran mistreatment. It takes all the power within oe to keep 
from giving ip on the in power of the world today. I though tfaeit' Ocngress was 
finally about to do something good. But the truth of the matter is that Oongress 
is only scimming the surface of an injustice that needs to be scooped qp whole 
and thrown out as we do with radio active %«aste. For the product of this need- 
less research has more of a detramBnt2d effect of people than it does them good. 

With our animal experimentation we discover more things to be afraid of dying 
from rather than excepting the fact that we all must die. We can't change that 
fact and the more we try, the more causes of death we find. Now we can anticipate 
but we can't prevent it. We discovered that Cancer can cause death but we can't 
find, nor will we ever find a way to ciire it. The more we discover the more %« 
find there is to discover. Cancer has been around since life itself, and by 
discovering Cancer we discovered something to make our life more fearful not 
prolonged. 



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Msui has a tendency to think of animals as being inferior to him. TTuLs is 
because a man has the natural instinct to think of himself better than any other, 
but just because we think this doesn't make it so. We are no more iufxirtant 
to this vrorlds ecosystem than the giant redwood tree. We have no more control 
over our existence than does a tiny protozoa. We have been for ages trying to find 
ways to increase our life span by scientific research, but even today vAien we have 
advance far in these areas, the most primative scientificly advanced- civilizaticxi 
have been more content, more harmonious, and longer lived than the so called ad- 
vanced civilizations. Yet we called these people primative. We call these 
people savages, because they fic^t and continue to fic^ modem mans attenpts 
at districting their freedom and their harmmy with nature. We saw this in the 
Indians long past gone, we saw this in the Africans sold into slavery, we saw 
this in the animals that have been domesticated for mans benefits, we see this 
still today in their children and our children as well. We rebel against modernization 
not because we aren't intellegent not because we aren't educated, but because we 
have sorething within us, something that %d.thin us all, scmething described as God 
by some as instinct by others, but we all must agree that vAiat ever it is it 
gives us great will to be untamed by nankinds desire seize all things he admires. 
Like Abraham Lincoln knew when he wrote the Gettysburg Address, I too knew that the 
world will little note nor long remeber what I say here, but I hope some one %d.ll 
here my cry for freedom, not just for myself but for all life great and small and 
heJp me reach my God given goals. 

Soon I too may no longer be able to naintain my free will because of my need 
to survive. I must naintain my free will or die trying, or maybe some one will 
read this letter and come to my RESCU just as I seek to rescue others with a 
desire to be free. I soon will be without enplovnent because some people find rny 
will to be free, and my desire to help things in need something to be jelous of, 
and thus seek to destroy me, but I have faith that some will come to my RESCU 
and help me find a way to save whats left of the free world from mankinds desire 
to control all things he admires, and that have the will and the rig^t to be free. 



Yours Truly 




William L. Mondy 
President of RESCU 
4726 9th St. N.W. 
Washington D.C. 20011 



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Submission of 

Our Animol WARDS 

2225 Observotory Piece, N. W. 

Washington, D. C. 20007 



COMMENTS on H.R. 5725 
THE IMPROVED STANDARDS FOR LABORATORY ANIMALS ACT 
presented to the 
Committee on Agriculture Subcommittee on Department Operations, 
Research, and Foreign Agriculture 



We are grateful for this hearing . It proves that the shameful conditions for 
animals in research have begun to be examined again because the Subcommittee 
believes complaints of the present system are valid, in assessing what needs to be 
done, it is necessary to evaluate USDA-APMIS service for its usefulness in improving 
the care of animals in research. 

We believe that USDA is only parfially to blame for the present inadequacies 
in the Inspection program, its staffing, and the failure to require necessary improvements 
by the laboratories. In 1966 when USDA reluctantly accepted responsibility for policing 
the care of animals in research, we remember the struggle of the Secretary of Agriculture 
to resist the new assignment. Eighteen years hove proved that he was right. However, 
at that time, USDA had agents across the country, and the plan seemed logical. 

In retrospect, some factors were overlooked. We failed to anticipate that 
the medical establishment would be so insistent on, and successful in, maintaining the 
status quo for animals in research. Periodic inspection is unwelcome in many areas, 
and possibly USDA's difficulty could have been predicted. As a result of USDA's lock 
of success in effecting change, only a minority of the research centers are maintaining 
animal care standards set by the Public Health Service. We believe responsibility for 



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laboratory animal care should lie with PHS and the local Animal Care Committees. 
PMS has to be vitally concerned in this area because research funds for the National 
Institutes of Health hove grown from $l-billion in 1971 to $5-billion. The research 
community should accept the standards for care already outlined by PHS, and research 
professionals should insure that their research centers not fall below those standards. 
There is growing advocacy for decent care and concerns on the inside of research, backed 
by indignant pressure from the public, as reflected in press accounts of inspection 
inadequacies. 

As an example of a new sense of responsibility, NIH has taken its first steps 
to GO AND SEE conditions in ten of its research centers under very restricted circum- 
stances. It is logical and incumbent on PHS and NIH to be responsible for resources 
they allocate. To know the facts is NIH's real duty in facing the situation. Continuing 
USDA inspection of research centers is ineffective and sometimes duplicative of NIH 
services, which should clearly be PHS's sole responsibility. For eighteen years, USDA 
has engaged in hit and miss activity in this area, and now in ten brief visits, NIH has 
mode some important observations of where constructive changes should be made. 

The inspection service of USDA for laboratory animals was established in 
1966, and Section 13 of the Animal Welfare Act mandated a veterinary service in each 
research center. It was understood that these professional men and women were not to 
interfere with research but rather were to improve the environment of the animals and 
to advise better ways to avoid animal suffering. This is an invaluable service when it 
is clearly understood as on integral part of the established medical protocol with no 
implication of policing. It should be reerfiphasized for the practical organization of 



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care in local research centers. 

H.R, 5725 would duplicate the establishment of local Animal Care Committees 
initially proposed in the Wolgren bill in 1981 . That bill included the two essentials for 
relief of suffering of animals in laboratories — a clear system of care to ovoid all possible 
stress and the use of alternatives when possible. Probably all that is acceptable in this 
area at this time has already been approved by the House as an amendment to the Waxman 
bill/ now stalled for lack of a Conference Committee hearing. We believe the Wolgren 
proposal for mandatory Animal Care Committees in each research center is an essential 
way to have responsible recognition of the problems involved in professional handlir>g 
of animals in research. 

Another element of this legislation which duplicates activities already existing, 
is the proposal to create an information center for research in USDA. The five divisions 
of PHS, which includes NIH, already hove the largest accumulation of facts about 
animals in research in this country. The need to coordinate such information to moke it 
more useful is an important goal . USDA and other agencies of Government should 
recognize the economy of creating o single information center through a joint project in 
PHS in coordination with the Notional Library of Medicine. 

In short, USDA has on impossible set of responsibilities. Besides its authority 
over dealers, exhibitors, auctions, and transportation — where its power is more 
acceptable — research coverage has been added. Effective work with research centers 
requires a differently equipped agent and strong national relish for the job. These are 
lacking in USDA. We believe research coverage should be under PHS rather than USDA. 



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We have urged USDA to take the position that the Animal Welfare Act can 
best be strengthened by assessing the services which can be most effectively assumed 
with its limited funds, and then to clarify its organizational program to accomplish the 
assignment. Certainly one area where USDA has been overburdened inappropriately It 
the reform of care for animals in research. 

Since 1953, WARDS has searched for a way to spare suffering for animals in 
research. We hope this Subcommittee will see some merit in our new approach to 
change the duplicative system which results in unnecessary animal torture and adversely 
affects research findings. 



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t^- t,: »^ ' American 
xiAAferG^;^, Rsychdogical 
V^bib V ;. Asscx:iation 



Li' 



TESTIMONY OF 

Michael S. Pallak, Ph.D., Executive Officer 

AMERICAN PSYCHOLOGICAL ASSOCIATION 

Before the 

SUBCOMMITTEE ON DEPARTMENT OPERATIONS, RESEARCH, 
AND FOREIGN AGRICULTURE 

COMMITTEE ON AGRICULTURE 
UNITED STATES HOUSE OF REPRESENTATIVES 



On the subject of 



H.R. 5725, THE IMPROVED STANDARDS FOR LABORATORY ANIMALS ACT 



The Honorable George E. Brown, Jr. September 19, 1984 

Chair 



1200 Seventeenth St . N W 
Washington. D C 20036 
(202) 955-7600 



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SUMMARY 

o The American Psychological Association recomends to the House 
that, before any animal research legislation is enacted, a study 
be conducted as proposed H.R. 2350, The Health Research Extension 
Act. We believe It is necessary to address the numerous 
unanswered questions surrounding the use of animals in research in 
order to make effective and appropriate policy decisions in this 
area. 

o With regard to H.R. 5725, we believe that many provisions would 
increase the regulatory burden for researchers without necessarily 
improving animal welfare, and that this legislation may pose 
particular problems for behavioral research, which often cannot 
use alternative research subjects. 



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Mr. Chairman, and Members of the Subcommittee: 

My name la Michael S. Pallak. I am Executive Officer of the American 
Psychological Association (APA) representing 72,000 research and clinical 
psychologists. Thank you for the opportunity to comment on H.R. 5725, the 
"Improved Standards for Laboratory Animals Act** (Brown, D-GA). A substantial 
number of APA*s members are behavioral researchers whose studies Involve 
animals. 

The provisions of H.R. 5725 affect the whole range of animal 
experimentation from medical vivisection, to psychological observation of 
animals, to experiments In animal husbandry. While we are In full agreement 
with the bill's stated purpose — "to ensure the proper treatment of 
laboratory animals'* — we are concerned that some of the proposed mechanisms 
would create expensive and unnecessary bureaucratic Interference In animal 
research programs In hospitals, university research facilities and agriculture 
experimental programs. 

The American psychological community concurs with the general objectives 
of the proposed animal research legislation. However, we are concerned that 
there Is Insufficient Information on which to Judge whether the mechanisms set 
forth In ths legislation will have the desired results. We believe It Is 
essential to assess the Impact of these bills on productive research that Is 
of critical Importance to human welfare as well as their Impact on animal 
welfare. 



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One particular concern for behavioral researchers Is the fact that 
alternative methods of studying behavior for the most part are not feasible. 
Studying behavior requires studying live animals. Restrictions on the use of 
human subjects In research compel the use of other animals. The quality and 
momentum of this research have profound Implications for human health and 
well-being. 

Current research methods are not Immune to Improvement or change, but 
there must be a sound basis for rejecting them. The fact that alternatives 
are not now being used en masse does not signal a lack of awareness or 
sensitivity on the part of the research community. It may well reflect the 
necessarily slow process of developing such alternatives. 

We believe that legislation such as H.R. 5725 will not be effective unless 
It Is based on something more than assumptions about what will or will not 
Improve the care and welfare of laboratory animals. A study, such as that 
proposed In H.R. 2350, the Health Research Extension Act, will produce 
accurate Information about the number and type of animals being used, and 
about existing admlnstratlve and research practices that affect their 
welfare. Only with this Information will the most effective and appropriate 
policies and legislative mechanisms be developed for animal research. 

Our comments on H.R. 5725 follow. 



41-970 0-85-21 

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Alternatives to the Use of Animals 

In several instances, H.R. 5725 promotes the use of alternative methods of 
research or alternative research subjects. We support the objective of 
minimizing the number of animals being used, and minimizing any discomfort 
experienced by animals that are used. However, the emphasis on alternatives 
poses a problem for behavioral science in particular because alternatives are 
not as readily available for the study of behavior as they may be in other 
areas of science. 

Tissue cultures, computers and radioimmunoassays are often suggested as 
replacements for animals. We believe that many researchers in a variety of 
disciplines would prefer to use these adjunct methods, but substitutes such as 
laboratory cultures of cells, while useful for certain biological and medical 
tests, do not develop arthritis, heart disease, multiple sclerosis, mental 
disorders or drug addiction. Tissue cultures cannot be used co study the 
interactions or behavior of body organs — for example, the effects of 
cardiovascular changes on brain function or kidney physiology. It is 
virtually impossible to study the behavior of a whole organism through the use 
of alternatives. 

Despite these difficulties, behavioral as well as biomedical researchers 
are in active pursuit of alternatives to using laboratory animals. 
Alternatives are sought as a matter of routine in research, and their use is 
stressed whenever possible. However, this legislation offers little 
protection for research that cannot use alternatives to animals. Our concern 



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Is that such research would be subject to unnecessary delays or even 
unjustified rejection In federal review and funding processes. Problems 
caused by the demand for alternatives would be magnified for behavioral 
science, where, as noted above, fewer research alternatives are available. 

Animal Research Committees 

There Is a real need for a national study on the use of animals In 
research. Such a study could examine current practices In animal research, 
examine and disseminate the latest developments In substitute methodology, 
acquaint the research population with alternative methods, evaluate proposals 
for uniform national standards and. In general, provide much needed data about 
the care, costs and benefits of using animals In research. Without such a 
factual foundation, the animal research committee, as proposed In H.R. 5725, 
will be repetitious, and will flood the research field with numerous 
potentially contradictory rulings, thereby creating Increased ambiguity and 
reducing the number of objective criteria for decisionmaking In the research 
community. 

The proposal to require animal research committees at research 
Institutions In large part would legislate what Is already current practice at 
many. If not most. Institutions. The establlatqenC of animal review 
committees Is not a concern per se. Many research facilities already have 
Institutional committees that are charged with monitoring the care and use of 
laboratory animals. However, there are several problems Inherent In creating 
a legislative mandate for such committees. For example H.R. 5725 would create 



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an Inf lexibl*. rol« for the conmittees, igaoring the likelihood that different 
research programs and facilities have differing requireaents and 
capabilities. Further, it is likely that this provision of H.R. 5725 would 
increase the paperwork for research facilities and the federal agencies to 
which research institutions report, and could divert financial, administrative 
and personnel resources from supporting and conducting actual research. 

With regard to the composition of the animal research committees, we 
believe that the required participation of comnunity representatives and 
veterinarians, while well intended, could cause an undesirable shift in 
emphasis away from overall research concerns — but not necessarily in the 
direction of animal welfare — and could place less qualified individuals in 
the position of reviewing research. 

Many of the conditions to be addressed by the animal studies comitteas -* 
such as assessing comfort or distress — are behavioral in nature. For 
example, consider the fact that some species have different environmental 
needs. One type of primate may require a cage that allows vertical movement 
while another may require a horizontal layout. Without knowing this, animal 
research committee members may simply evaluate environmental conditions on 
quantitative bases, and in this instance would look only at the number of 
square or cubic feet per animal without considering the cage layout. It is 
difficult to imagine that inclusion of a veterinarian or lay person on an 
animal research committee would guarantee the committee's sensitivity to this 
type of requirement, which is overwhelmingly behavioral in nature. 



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Another consideration is whether a requirement that the comittee must 
Include individuals to represent specific aspects of animal welfare would 
create certain procedural problems. For example, would the number and 
frequency of meetings depend upon whether those persons could attend? If they 
were not in attendance, would action taken by the committee be legitimate? 
Could non-attendance at meetings be used to place the institution in a 
position of non-compliance with the legislation, and thus ineligible to 
receive federal funding? Would there be opportunities for recourse in the 
event that research is obstructed or rejected on the basis of actions by such 
persons? These questions raise serious doubts about mandating representatives 
on the committee. 

As a minimum, the structure and effectiveness of existing animal care 
committees should be studied before being locked into legislation. If it is 
determined that specific members of the committee will be responsible for 
specific aspects of animal care — such as requiring that a veterinarian be on 
the committee in order to ensure the clinical care of animals — then we would 
strongly urge that an individual scientifically trained in animal behavior 
also be required so that the psychological and behavioral needs of the animals 
will be adequately and appropriately monitored. 



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State— nts of Assurances 

In current practice, federal research proposals are required to include a 
number of the Justifications and assurances called for In H.R. 5725. However, 
this bill would also require additional Items which are not necessarily 
relevant to scientific merit or animal welfare, but which would constitute an 
additional burden on applicants seeking research support. 

Proposals for studies involving animals already are required by the 
research review system to provide detailed Information about experimental 
procedures and to Justify the selection of a particular methodology. A 
bibliography of relevant research, including research using alternatives, is 
also required. 

Consultation with a doctor of veterinary medicine is not currently 
required and could pose a problem in two respects. Such consultation would 
increase the cost of submitting research proposals, particularly for smaller 
institutions or others that might not have routine access to veterinarians. 
The other issue is that an assumption is being made about the effect of 
including a veterinarian in research planning. Specifically, it is assumed 
that the presence of a veterinarian will automatically enhance or ensure 
animal welfare. This is not necessarily the case. Rather, this assumption 
raises questions about whether the training and education of veterinarians 
qualifies them to be involved in research planning and other activities as 
indicated in H.R. 5725. Again, our concern is that this sort of information 
be in hand before legislation such as H.R. 5725 is enacted. 



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In sum, th« requirements for Justifications and assurances for the most 
part do not appear to establish new practices of care and use for laboratory 
animals. These provisions do, however, constitute a regulatory burden for 
research. Further, they could be restrictive by legislating the structure of 
research proposals. An equally important consideration is that these 
provisions are not necessarily going to enhance animal welfare. Hence, we 
believe that neither research nor improved care and use of animals will be 
well served by these requirements in H.R. 5725. 

Funding 

A final concern is that without additional funds to implement the 
provisions of H.R. 5725 or other animal research legislation, the net effect 
of such legislation will be symbolic rather than substantive. We believe that 
Congress would be more willing to provide funds for animal research 
legislation if it is demonstrated that such legislation is based on accurate 
data and would establish the most appropriate mechanisms. We believe it is 
possible and desirable to Improve animal welfare without jeopardizing progress 
in research, but that this balance will not occur without further study. 

Restatement of Summary Points 

o We recommend to the House that, before the animal research 

legislation is enacted, a study be conducted, such as the one 
proposed in H.R. 2350, The Health Research Extension Act, to address 
the numerous unanswered questions that surround the use of animals in 
research. 



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o With ragard to H.R. 5725, the Improved Standards for Laboratory 
Animals Act, there are a number of concerns regarding the bill's 
impact on research in general and on behavioral research in 
particular. Briefly, those concerns are: 

1. Several provisions in H.R. 5725 are based on assumptions rather 
than facts. 

2. Alternatives to the use of animals are difficult to find in the 
study of behavior, so the emphasis on alternatives in H.R. 5725 
may have particularly adverse consequences for behavioral research. 

3. Several provisions in H.R. 5725 pose a regulatory burden for 
research without assuring improvement in animal welfare. 

4. The fact that no funding is included in H.R. 5725 means that the 
entire financial burden would fall on researchers, and would 
divert resources from direct support of doing research. 

Again, we appreciate the opportunity to make these comments and would be 
pleased to provide further information or answer any questions Members of this 
Subcommittee might have. 



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TESTIMONY 

IN SUPPORT OF 

H. R. 5725 

presented by 
THE ANIMAL PROTECTION INSTITUTE OF AMERICA 

The Animal Protection Institute of America, representing over 100,000 
members natlonvrlde, supports H. R. 5725, the "Improved Standards for Lab- 
oratory Animals Act", as an Important step In upgrading the treatment and 
care of laboratory animals under the Animal Welfare Act and providing the 
Impetus for the careful rethinking of the current heavy dependence on 
animal "models" In research and testing. 

H. R. 5725 firmly commits the orientation of biomedical research towards 
reduction and replacement of live animal research through development and 
use of alternative, non-animal methodologies. The research community can- 
not fall to heed this kind of signal from the major supporter of biomedical 
research, the federal government. At the very least, passage of H. R. 5725 
would force many researchers to rethink their often uncritical reliance on 
animals . 

Furthermore, the need to establish animal research committees (ARCs) at 
all federally-funded research facilities Is effectively dealt %d.th In H. R. 
5725. The Animal Protection Institute recently provided testimony to the 
Public Health Service regarding Its proposed policy for establishing ARCs 
at research Institutions. Many of our concerns with that policy are 
adequately addressed In H. R. 5725. 

Notably', H. R. 5725 requires representation, on ARCs, of "community 
concerns regarding the welfare of animal subjects", a key element missing 



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from the original Public Health Service proposal. H. R. 5723 also: (1) 
restricts a research facility from heavily stacking its ARC with facility 
staff, who obviously have vested interests in the research being conducted; 
and (2) requires that minority views of the committee be made part of the 
committee's official reports. Another important aspect of H. R. 5725 is 
that it provides safeguards against the potential leak of confidential 
information and trade secrets as a result of ARC deliberations. 

In a number of important ways, H. R. 5725 directs the research conmunlty 
to take a fresh approach; by (1) requiring training sessions — of all per- 
sonnel handling or conducting research on laboratory animals — in the humane 
care of research animals and the ways and means of reducing animal use in 
research; and (2) establishing a national information service to help in- 
quisitive and innovative scientists looking for non-animal alternatives in 
biomedical research. 

H. R. 5725 is a first step that takes us in the right direction — reduc- 
tion, and eventual elimination, of the stress and suffering experienced by 
millions of animals in research and testing in laboratories throughout the 
country. The Animal Protection Institute urges the speedy passage of this 
bill, as well as strong support for the U. S. Department of Agriculture's 
effective implementation of its measures. 

Thank you. 



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statement on H.R.5725 

Ann Squire, Ph.D. (Blopsychology) 
Director of Research and Education; Scientific Advisor 

THE AMERICAN SOCIETY FOR THE PREVENTION OP CROELTY TO ANIMALS 



Subnitted to 
United States House of Representatives 

September, 1984 



The American Society for the Prevention of Cruelty to Animals, 
America's first humane society, strongly urges passage of H.R.5725 
to amend the Animal Welfare Act, (7 U.S.C. S2131-2156) . Animals 
do suffer. Animals do experience pain. Scientists have established 
this beyond any reasonable doubt. It is of the utmost importance, 
therefore, that immediate action be taken to find alternatives, in 
addition to those already existing, to the use of animals in 
experimentation. H.R.5725 addresses this crucial point by requiring 
research facilities to provide for annual training sessions for 
scientists, animal technicians and other personnel involved in ani- 
mal care and treatment. The sessions must include training in re- 
search and testing methods that minimize or eliminate the use of ani- 
mals and, when animals are used, limit pain and distress. Also re- 
quired is training on the use of the information service of the National 
Agricultural Library to prevent unnecessary duplication of ani- 
mal experimentation. To encourage the use of alternatives to 
animal experimentation, H.R.5725 further requires research facil- 
ities to specify in their report to the United States Secretary 
of Agriculture that the principal investigator has considered al- 



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ternatives to any procedure likely to produce pain or distress. 
In addition, H.R.5725 mandates the Secretary of Agriculture to 
establish an information service at the National Agricultural Li- 
brary, in cooperation with the National Library of Medicine, to 
provide information on improved methods of animal experimentation 
which could reduce or replace the use of animals, minimize dupli- 
cation and minimize pain and distress to animals. 

Research institutions must be made more accountable when 
using animals than is currently the case. They must provide 
greater scrutiny of the humaneness of experiments involving 
animals. H.R.5725 helps accomplish this by requiring that each 
research facility establish an animal research committee. This 
committee would include a person representing community concerns 
regarding the ethical treatment of animals. Each committee would 
be responsible for carefully inspecting its own research facili- 
ty at least twice each year, and reporting to the Onited States 
Secretary of Agriculture any violations of required standards 
that they might uncover. 

To improve research animal care further, H.R.5725 also re- 
quires that the Secretary of Agriculture promulgate standards for 
exercising research dogs. It also discourages the use of an ani- 
mal in more than one major operative procedure from which it is 
allowed to recover, and specifically provides that employees of 
research facilities not be discriminated against (i.e., lose 
their jobs) for reporting to the institution's animal research 



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committee any violations of the Federal Animal Welfare Act and 
its regulations. 

H.R.5725 is not an anti-science bill. Rather, its passage 
would assist scientists by providing for better training and 
easier access to resource material. By promoting the development 
of research alternatives, H.R.5725 would ultimately aid scienti- 
fic advancement at considerably less cost and suffering. Better 
trained, more knowledgeable scientists, and advanced scientific 
techniques on alternatives to animal use make this bill pro- 
science as well as pro-ethics. And scientists, like all of us, 
need to be reminded that in their pursuit of knowledge they, too, 
are bound by ethical norms and constraints. For many years. Con- 
gress has been considering a multitude of bills regarding labora- 
tory animals. Eighteen years ago a major humane achievement took 
place when Congress passed the Laboratory Animal Welfare Act. 
Oversight hearings have strengthened that act over the years, but 
not enough. This year, budget cuts have seriously eroded the 
Act's enforcement arm. H.R.5725 puts more emphasis on compliance 
by providing for surveillance within each research institution. 
With its many other strong, reasonable features, H.R.5725 de- 
serves Congressional support. The American Society for the Pre- 
vention of Cruelty to Animals urges passage of this legislation 
during this Congressional session. 



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1055 Cathcart Way 
Stanford, CA 94305 

September 13 , 1 984 



The Chairman and Members 
Subcommittee on Department Operations, 

Research and Foreign Agriculture 
United States House of Representatives 
House Office Building 
Washington, DC 20515 



Gentl emen : 



I appreciate the opportunity to comment on aspects of Congressman 

Brown's laboratory animal protection bill H.R. 5725, from the viewpoint of 

a biomedical scientist. 

I believe that animal experimentation will continue to be a regrettable 
necessity for the progress of medfcal science for the forseeable future. 
But I believe that the public in general, and the majority of biomedical 
scientists wish to limit such experimentation whenever appropriate alter- 
natives can be found, to apply strict humane standards and to minimize 
the distress of those animals that are to be used in the more severe 
procedures. Existing legislation is not adequate, in my view, to ensure 
that such standards are met. The country that leads the world In preventive 
and curative medicine can afford to lead also in humane treatment of its 
research animals. 

The bill's provision for establishment of an information service at the 
National Agricultural Library, and for encouragement of alternatives to 
painful animal procedures is much needed. Often researchers simply are 
too busy to dig out the information on alternatives that may be buried 
in the literature, and will welcome the improved access to such information 
that the bill provides. Often, the best species for studies on human 
disease is Homo sapiens; and the past year has seen remarkable and entirely 
relevant medical progress in studies using human volunteers only, in par- 
ticular the successful conclusion in January of the Lipid Research Clinics 
study on cholesterol and heart disease prevention. With adequate concern 
and planning, use of higher animals for painful experiments can be 
considerably reduced. 

I highly commend the bill's provisions for instruction of animal personnel 
in humane practices: if not required, it may not happen, frequently 
because of perceived lack of time. The requirement for a community 
representative sensitive to the welfare of animal subjects on Animal 
Research Committees is entirely appropriate. The issue of animal ex- 
perimentation involves very difficult philosophical and humanitarian 
decisions. As with so many social issues, the public should take 



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responsibility for some of these decisions, in cooperation - not 
confrontation - with scientists. Both sides need to learn the facts 
behind sometimes distressing choices. I have found little opposition 
among my colleagues to the "community representative" provision; some 
probably recall the trepidation when, some twenty years ago, lay members 
were first required on Institutional Human Experimentation Committees. 
These committees, to oversee research work on human subjects, are 
now accepted as the obvious, proper way to proceed. I doubt that anyone 
would claim that the presence of a lay member on such committees has in 
any way impeded medical progress. I believe many scientists would welcome 
increased public observation of their animal research activities. There 
should be nothing to hide. If animal welfare representatives are denied 
reasonable access to animal research activities, a growing segment of 
the public will suspect biomedical scientists of occult barbarism - a sad 
paradox, since these hardworking and dedicated people set great store 
by unfettered exchange of information and engrained compassion. 

H.R. 5725 provides a thoughtful, workable, modern framework for humane 
and parsimonious use of research animals. It is a bill that the majority 
of the concerned public and the biomedical research community can live 
with. It is important to note that it is a bill that research animals 
will continue to die with, but with reduced stress. It is a bill with 
which we can all sleep better. I earnestly solicit your support of H.R. 5725, 
and its rapid passage. 



1^^ d^, /JoTTt:L 

Peter D. Wood, D.Sc, Ph.D. 
Professor of Medicine (Research) 
Stanford University Medical School 
Associate Director, Stanford Center 
for Research in Disease Prevention 



o 



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