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/ S. Hrg. 103-601

FEDERAL REGIMTION OF MEDICAL
RADIATION USES

Y 4, G 74/9: S. HRS. 103-601

Federal Regulations of lledical Radi.

HEARING

BEFORE THE

COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE

ONE HUNDRED TfflRD CONGRESS

FIRST SESSION

MAY 6, 1993

Printed for the use of the Committee on Governmental Affairs

AUG 1 f 1954

U.S. GOVERNMENT PRINTING OFFICE
68-495 cc WASHINGTON : 1994

For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-0A4575-2

i / S. Hrg. 103-601

\^ / FEDERAL REGIMTION OF MEDICAL

RADIATION USES

Y 4. G 74/9: S. HRG. 103-601

Federal Regulations of lledical Radi..

HEARING

BEFORE THE

COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE

ONE HUNDRED TfflRD CONGRESS

FIRST SESSION

MAY 6, 1993

Printed for the use of the Committee on Governmental Afffurs

AUG 1 1 t994

U.S. GOVERNMENT PRINTING OFFICE
6&-495CC WASHINGTON : 1994

For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-044575-2

^H.,>

COMMITTEE ON GOVER^fMENTAL AFFAIRS

JOHN GLENN, Ohio, Chairman

SAM NUNN, Georgia WILLIAM V. ROTH, Jr., Delaware

CARL LEVIN, Michigan TED STEVENS, Alaska

JIM SASSER, Tennessee WILLIAM S. COHEN, Maine

DAVID PRYOR, Arkansas THAD COCHRAN, Mississippi

JOSEPH I. LIEBERMAN, Connecticut JOHN McCAIN, Arizona

DANIEL K. AKAKA Hawaii
BYRON L. DORGAN, North Dakota

Leonard Weiss, Staff Director

Robert Alvarez, Profeaaiorud Staff Member

Christopher R. Kline, Professional Staff Member

Franklin G. Polk, Minority Staff Director and Chief Counsel

Michal Sue Prosser, Chief Clerk

(ID

CONTENTS

Opening statements: Page

Senator Glenn 1

Senator Lieberman 4

Prepared statement:

Senator Roth 59

WITNESSES

Thursday, May 6, 1993

Ivan Selin, Chairman, Nuclear Regulatory Commission, accompanied by Ken-
neth C. Rogers, James R. Curtiss, Forrest J. Remick, and E. Gail de
Planque, Commissioners 7

Dr. D. Bruce Burlington, Director, Center for Devices and Radiological
Health, U.S. Food and Drug Administration, accompanied by Ronald M.
Johnson, Director, Office of Compliance and Surveillance, Center for De-
vices and Radiological Health, FDA; Marvin Rosenstein, Director, Office
of Health Physics, Center for Devices and Radiological Health, FDA and
Donald Hamilton, Radiation Policy Advisor, Office of Health Physics, Cen-
ter for Devices and Radiological Health, FDA 33

Aubrey V. Godwin, Chairman, Conference for Radiation Control Program

Directors 49

Alphabetical List of Witnesses

Burlington, Dr. D. Bruce:

Testimony 33

Prepared statement 65

Godwin, Aubrey V.:

Testimony 49

Prepared statement 70

Selin, Ivan:

Testimony 7

Prepared statement 59

APPENDDC

Prepared statements of witnesses in order of appearance 59

Criteria for Adequate Radiation Control Programs (Radioactive Materials) 75

Criteria for Adequate Radiation Control Programs (X-Ray) 96

Criteria for Adequate Radiation Control Programs (Environmental Monitoring

and Surveillance) 110

Criteria for Adequate Radiation Control Programs (Nonionizing) 142

Office of Inspector General — Investigation of NRC Staff Actions Associated

with Oncology Services Corporation (OSC) 177

Office of Inspector General — Report of Investigation — Inadequate Inspection

and Mishandling of Allegations by Region I 203

Statement by the American College of Medical Physics 257

Resolutions submitted for the record by the American College of Medical

Physics 264

Recent Agreement State Reviews — Regional Results 274

Explanatory Information on Recent Agreement State Reviews Regional Re-
sults Chart Adequacy and Compatibility Findings 275

(III)

FEDERAL REGULATION OF MEDICAL
RADIATION USES

THURSDAY, MAY 6, 1993

U.S. Senate,
Committee on Governmental Affairs,

Washington, DC.

The Committee met, pursuant to notice, at 9:38 a.m., in room
SD-342, Dirksen Senate Office Building. Hon. John Glenn, Chair-
man of the Committee, presiding.

Present: Senators Glenn and Lieberman.

OPENING STATEMENT OF CHAIRMAN GLENN

Chairman Glenn. The hearing will be in order.

For a number of years, the Governmental Affairs Committee has
maintained an interest in the subject of medical radiation. Our in-
terest in this issue goes back a long way; and I am glad we are
back on this subject again, because there is a strong need for con-
tinued Congressional oversight.

There is little question that medical uses of radiation provide sig-
nificant benefits and have led to important medical discoveries.
Every year, many people lead better and more healthy lives be-
cause of this valuable medical tool.

However, it has been known for decades that medical radiation
misuse also poses risks of injury, latent disease and death, not only
to the patient but to the health care and research professional as
well as the community at large.

A recent accident that took place at a clinic in Indiana, Penn-
sylvania late last year is a case in point. A patient died £ifter a
highly radioactive source was accidentally left inside her body. The
source subsequently exposed unwitting workers and residents to
radiation doses that significantly exceed the annual limit allowed
for workers in the U.S. The radiation source also posed a potential
environmental risk because it was almost disposed of in a private
landfill.

Over the past several years, the uses of ionizing radiation in
medicine have experienced major growth. Various studies now indi-
cate— or, estimate — that over 170 million diagnostic radiation pro-
cedures and some 20 million radiation therapy procedures are
given each year in the United States. The estimated annual cost
for these procedures is about $12.3 billion.

With the recent dramatic growth in medical radiation use over
recent years, major questions have been raised as to whether Fed-
eral and State regulation provides an adequate margin of protec-
tion of public health and the rights of those who may be put at

(1)

risk. It is abundantly clear that if people become ill, they or their
families should not relinquish the basic right to know if unneces-
sary harm has been done to them. Unfortunately, the Nuclear Reg-
ulatory Commission and the Food and Drug Administration have
not taken action to assure that this basic right is guaranteed.

The Committee has been reviewing the role of Federal and State
agencies that regulate medical radiation uses for a long time, and
this review goes way back; it goes back into the seventies. In the
seventies, we had hearings, and I proposed legislation and a bill
that would have coordinated some of these activities and brought
a little more sense to them. At that time. President Carter sort of
preempted us, which was fine with me, by issuing an Executive
order, which did the same thing basically I was going to do with
the bill. After the change of administration. President Reagan can-
celled that Executive order. So that is where we now sit.

We have had a Coordinating Council on Ionizing Radiation, but
I think many would question whether their activities have been as
forceful and effective as they should have been.

So we have been reviewing these regulations for a long time. The
review was initiated after several disturbing disclosures were made
in the news media about patient deaths, injuries and
overexposures. Particularly the hearing today was triggered by a
series of articles beginning in December of last year, published by
the Cleveland Plain Dealer. I think Plain Dealer reporters Ted
Wendling and Dave Davis, I think have done an excellent job, and
their pointing out some of these matters to us is why we are here
today. We are glad to have Ted with us this morning over at the
press table.

I am pleased that the NRC has taken their reporting seriously
and is starting to address some of the problems identified by the
Plain Dealer.

During this period, the Committee has been contacted by several
people who have written about serious problems they experienced
from radiation procedures. The Committee is in no position to de-
termine the merits of these problems; however, I am submitting
copies of these letters to the NRC and the Food and Drug Adminis-
tration for their determination of whether any misadministrations
took place. I expect the two agencies to report to the Committee
about these disturbing letters.

Assuring the safe and effective use of radiation in medicine in-
volves a complicated web of relationships between the patient,
medical professionals, equipment manufacturers, health care and
research faciHties, and various State and Federal regulatory pro-
grams. With a few important exceptions, a great deal of medical ra-
diation regulation relies on the voluntary reporting of problems.
And as we know, not everybody is forthcoming enough to make
that system work.

Unfortunately, despite past scrutiny and recommendations by
this Committee and others, medical radiation regulation is scat-
tered, fragmented, and very inconsistent. Several Federal agencies
in all 50 States have regulatory responsibiUty, but not the pro-
grams to follow up on that responsibiUty. States have varying and
diff'erent programs which lack conformity with each other. One-
third of the population of the United States Uves in States— includ-

ing my home State of Ohio, I am sorry to say — that do not require
people who operate radiation devices to be trained and certified. It
was pointed out in the Plain Dealer articles that people with felony
convictions for medical radiation violations in one State can move
over to another State and serve as radiation protection officials in
other States, because they are not likelv to be discovered. In the
reporting, there were two cases exactly like that.

Let me just give some short -examples to illustrate how complex
this is. There are 27 States that license radiographers; 21 States
license radiation therapy technologists; 14 States license nuclear
medicine technologists; three additional States have legislation per-
mitting regulation of radiographers; five States have legislation au-
thorizing regulation of radiation therapy technologists; four States
have enabling legislation authorizing regulation of nuclear medi-
cine technologists. All States continue to license dental hygienists.
Of the 50 States permitting dental assistants to perform
radiographs, one State licenses, 29 States certify, and two States
register dental assistants. Now, that indicates how complex it is
and how the regulation goes all over the lot.

I would like to acknowledge the efforts of Senator Lieberman,
who is with us here this morning, in ensuring that the NRC fully
and thoroughly investigated allegations of safety and wrongdoing
by NRC licensees — for example. Senator Lieberman's diligence in
oversight of the NRC and the work of the NRC's Office of Inspector
General, which this Committee created. The OIG review resulted
in a reinspection and validation of a number of allegations raised
by Connecticut citizen Mr. Arnold Gunderson, which originally
were missed by a faulty NRC inspection.

After today's testimony, I will review the situation, and I may
consider the need for legislation to address some of these problems,
because obviously, something must be done. I don't know whether
it will be the same legislation I introduced back in the Carter
years, whether something new is necessary, or whether this admin-
istration will go ahead and t£ike action on their own, or whether
NRC and FDA can in their testimony this morning give us some
ideas about what direction we should go. They are the people who
should be on the firing line, so I would welcome their suggestions,
and we'll have some questions along that line after we hear testi-
mony.

A number of people have died from overuse of radiation. I think
there were 28 deaths in my home State of Ohio back through the
years that can be directly traced to some of these
misadministration of radiation. So while we are interested in see-
ing what happened and why people were not notified, we are even
more interested in seeing how we can prevent this in the future
and how we can tighten up this system so that the people of this
country are adequately protected, and that's the purpose of today's
hearing.

Prepared Statement of Senator Glenn

Over the past several years, the Governmental Affairs Committee has maintained
an interest in the subject of medical radiation. There is little question that medical
uses of radiation provide significant benefits and have led to important medical dis-
coveries. Every year, many people lead better and more healthy lives because of this
valuable medical tool.

However, it has been known for decades that medical radiation misuse also poses
risks of injury, latent disease and death, not only to the patient, but to the health
care and research professional as well as the community at large. A recent accident
that took place at a clinic in Indiana, Pennsylvania late last year is a case in point.
A patient died after a highly radioactive source was accidently left inside her body.
The source subsequently exposed unwitting workers and residents to radiation doses
that significantly exceed the annual limit allowed for workers in the U.S. The radio-
active source also posed a potential environmental risk because it was almost dis-
posed of in a private landfill.

Over the past several years the uses of ionizing radiation in medicine have experi-
enced major growth. Various studies indicate that over 170 million diagnostic radi-
ation procedures and some 20 million radiation therapy procedures are given each
year in the U.S. The estimated annual cost for these procedures is about $12.3 bil-
lion.

With the recent dramatic growth in medical radiation use over recent years, major
questions have been raised as to whether Federal and state regulation provides an
adequate margin of protection of public health and the rights of those who may be
put at risk. It's abundantly clear that if people become ill, they or their families
should not relinquish the basic right to know if unnecessary harm has been done
to them. Unfortunately, the Nuclear Regulatory Commission and the Food and Drug
Administration have not assured that this basic right is guaranteed.

The Committee on Governmental Affairs has been reviewing the role of Federal
and state agencies that regulate medical radiation uses. This review was initiated
after several disturbing disclosures were made in the news media about patient
deaths, injuries and overexposures — particularly a series of articles beginning in De-
cember of last year published by the Cleveland Plain Dealer. The Plain Dealer re-
porters, Ted Wendling and Dave Davis, have done a commendable job. I am pleased
that the NRC has taken their reporting seriously and is starting to address some
of the problems identified by the Plain Dealer.

During this period, the Committee has been contacted by several people who have
written about serious problems they experienced from radiation procedures. The
Committee is in no position to determine the merits of these problems. However,
I am submitting copies of these letters to the Nuclear Regulatory Commission and
the Food and Drug Administration for their determination if any
misadministrations took place. I expect the two agencies to report to the Committee
about these disturbing letters.

Assuring the safe and effective use of radiation in medicine involves a complicated
web of relationships between the patient, medical professionals, equipment manu-
facturers, health care and research facilities, and various state and Federal regu-
latory programs. With a few important exceptions, a great deal of medical radiation
regulation relies on the voluntary reporting of problems. And as we know, not every-
body is forthcoming.

Unfortunately, despite past scrutiny and recommendations by this Committee and
others, medical radiation regulation is scattered, fragmented and inconsistent. Sev-
eral Federal agencies and all 50 states have regulatory responsibility. States have
varying and different programs which lack conformity with each other. One third
of the population of the U.S. lives in states, including my home state of Ohio, that
do not require people who operate radiation devices to be trained and certified. Peo-
ple with felony convictions for medical radiation violations in one state, can serve
as radiation protection officials in other states.

I would like to acknowledge the efforts of Senator Lieberman in ensuring that
that the NRC fully and thoroughly investigated allegations of safety and wrongdoing
by NRC licensees. For example, Senator Lieberman's diligence in oversight of the
NRC and the work of the NnC's Office of Inspector General which this committee
created. The OIG review resulted in a re-inspection and validation of a number of
allegations raised by Mr. Arnold Gunderson which originally were missed due to a
faulty NRC inspection.

After hearing today's testimony, I will review this situation and I may consider
the need for legislation to address some of these problems.

I welcome today's witnesses and thank them for appearing for this important
hearing.

Senator Lieberman?

OPENING STATEMENT OF SENATOR LIEBERMAN

Senator LiEBERMAN. Thank you very much, Mr. Chairman.

I want to express my appreciation to you for conducting this
hearing this morning on the Federal regulation of the medical uses
of radiation, which is, as your statement has indicated, a very im-
portant issue affecting the health and the health care of millions
of Americans.

I understand that this hearing will look at the regulation of the
medical uses of radiation by the Nuclear Regulatory Commission,
the Food and Drug Administration, and the various States.

One major issue that I hope the witnesses will address is how
well these various regulatory bodies are coordinating their efforts;
are there any gaps, or inconsistencies, or duplications in the cur-
rent regulations? If so, how can these gaps be filled, and how can
these duplications be eliminated?

Mr. Chairman, I am particularly interested in this matter from
my perspective as chair of the Subcommittee on Clean Air and Nu-
clear Regulation of the Committee on Environment and Public
Works. In that capacity, I have recently been examining a related
matter, which is the NRC's enforcement practices and policies for
nuclear power reactors and for nuclear materials licensees. As you
have indicated in your statement, with respect to one of those is-
sues that I have been following, this Committee today is distribut-
ing two reports prepared by the NRC's Office of Inspector General
which address allegations by a Connecticut resident, Arnold Gun-
derson, concerning the actions of the NRC staff.

The first of these reports concerns allegations by Mr. Gunderson
that the NRC staff conducted a faulty inspection of his original al-
legations regarding the practices of a nuclear materials licensee, a
private company licensed by the Government, called Nuclear En-
ergy Services, or NES. The NRC's first investigation, the staff in-
vestigation of Mr. Gunderson's allegations, found no violations.

Mr. Gunderson then contacted my office, presenting us with alle-
gations that the original inspection was faulty, and we passed
those on to the NRC. The NRC Inspector General independently
began an investigation of the NRC staffs original inspection. Then,
the NRC staff, to its credit, reinvestigated Mr. Gunderson's original
allegations and found seven violations.

The second report which this Committee is releasing today con-
cerns allegations also made by Mr. Gunderson that the NRC staff
in one particular region. Region III, did not maintain an appro-
priate arm's-length relationship with personnel from Nuclear En-
ergy Services, this private company, licensee. The report high-
lighted several practices in Region III, such as the sharing of ex-
penses for meals and informal referrals of business, to the private
company, NES, by the NRC personnel that gave the appearance
that the NRC staff in Region III was not maintaining a proper reg-
ulatory relationship with the personnel of this private company.

Mr. Chairman, I have requested that the NRC's Inspector Gen-
eral report on the NRC's actions to correct the deficiencies that led
to the faulty inspection of Mr. Gunderson's original applications,
and I am also working through my subcommittee to monitor the
NRC's response to the Inspector General's second report, to make
sure that the Commission establishes clear policies and procedures
for its personnel at the regional level and nationally, to maintain
an appropriate arm's-length relationship with its licensees.

In response to the NRC's handling of the original Gunderson al-
legations and other whistleblower issues that have been brought to
my attention as chairman of this subcommittee, I have requested
the NRC's Inspector General to conduct a comprehensive review of
the way in which the Commission is handling whistleblower com-
plaints. The IG will in fact be looking at questions such as whether
NRC personnel are too trusting of statements made to their own
inspectors, made to themselves, by some of the Ucensees; whether
the NRC adequately protects the confidentiality of whistleblowers
who make allegations to the NRC, and whether the NRC discour-
ages whistleblowers by taking too long to investigate their allega-
tions.

I do all this and ask for this investigation not so much in the
spirit of accusation with the Commission, but in the spirit of co-
operation and attempting to work together to enable the Commis-
sion to fully perform the considerable responsibilities which we
have given them by law, and to keep vital the whistleblower func-
tion, which is one of our best allies, I suppose, our frontUne defense
against misuse of the peaceful uses of nuclear energy, including
those that you will be investigating today.

Mr. Chairman, I realize that the NRC's handling of these whis-
tleblower complaints is not the focus of this hearing, which is on
the regulation of the uses of radiation for medical purposes, but I
see it as a related matter, and since the Committee is issuing those
two reports, I wanted to indicate here for the record two things.
One is that I hope to continue to follow these problems from the
Subcommittee on Clean Air and Nuclear Regulation, and second,
that I certainly do look forward to working with you, Mr. Chair-
man, in responding to the specific problem of the medical uses of
nuclear energy and the extent to which we should better regulate
them.

Mr. Chairman, that concludes mv statement. I apologize to you
and the witnesses that the lottery has worked against my interest
here, and I must preside in the Senate at 10:00, but I look forward
to reading the testimony of the witnesses later in the day.

Thank you.

Chairman Glenn. Thank you very much.

Our first panel this morning will be the Nuclear Regulatory
Commission — Ivan Selin, Chairman; Kenneth C. Rogers, James
Curtiss, Forrest Remick, and Gail de Planque.

Mr. Chairman, if you'd lead off for us, we'd appreciate it very
much.

I would say to all of our witnesses this morning that if you have
lengthy statements, we would appreciate an abridgement thereof.
Your entire statements will be included in the record as though de-
livered; if you prefer to give the whole statement, that's fine, also.
We'll leave it up to you.

Mr. Selin, we are ^xappy to have you with us.

TESTIMONY OF IVAN SELIN,i CHAIRMAN, U.S. NUCLEAR REGU-
LATORY COMMISSION, ACCOMPANIED BY KENNETH C. ROG-
ERS, JAMES R. CURTISS, FORREST J. REMICK, AND E. GAIL
DE PLANQUE, COMMISSIONERS

Mr. Selin. Thank you very much, Mr. Chairman. Our written
statement, of course, is not lengthy, but I will summarize.

It is a pleasure for the Commission to be here. First of all, I'd
like to say that we certainly identify and accept the thrust of your
opening remarks. I'll address some of the specific points you raised,
and since I am not sure Senator Lieberman will be around at the
end of my statement, I would like to say that as far as his remarks
about the allegers in specific and the use of the IG in general, we
completely identify and agree with these points.

The IG is one of the many mechanisms that we have in place
now that we did not have in place 15 years ago, when the event
to which you referred took place. I believe that one of the tests of
the openness and the performance of our Commission will be just
how well we do reply and react to allegations and information in
general, and specifically to IG reports. So I agree completely with
your remarks, Senator.

Our testimony today will focus on radiotherapy, since this is the
area where the risks are the greatest, as you, Mr. Chairman, have
pointed out. In fact, even in radiotherapy, the NRC has only a
small slice of the pie. According to the rough estimates available,
there were about half a million new cancer cases in 1992 which
were treated using some form of radiation therapy. That is roughly
consistent with the figure used of 20 million procedures, since there
are old and new cases, and many of the procedures take fi*om 20
to 40 applications. But roughly is the best we can do with the qual-
ity of the statistics that are available to us — and that's one of the
problems that we address in the written testimony.

Sealed radiation sources made of byproduct material, which are
the subject of NRC regulation under the Atomic Energy Act, were
used in no more than 25 percent of these radiotherapy treatments.
Radiation produced by electronic devices not regulated by the NRC,
such as linear accelerators, was used in the other 75 percent of the
cases.

In order to give the patients the best chemce to survive, the ra-
diotherapy treatments normally deliver high doses of radiation,
close to the patient's limit of tolerance. Even when correctly deliv-
ered, a therapy dose of radiation may well have serious side effects
and may on occasion result in the death of the patient.

The NRC does not regulate the appropriateness nor the effective-
ness of the prescribed treatment. Our objective is to make sure that
the patient receives the dose of radiation prescribed by the physi-
cian, as well as to protect health care workers and members of the
public in this process.

The safety effect of misadministration appears to be rather small
compared to the intrinsic risks involved in using radiotherapy accu-
rately, but nevertheless that's our job, and we should be held to the
standards, Mr. Chairman, that you laid out to make sure that that
risk is kept at the lowest possible point.

^ The prepared statement of Mr. Selin appears on page 59.

The NRC directly regulates the medical use of byproduct mate-
rial in 21 States, a number of Territories, and in all Federal facili-
ties. There are approximately 2,000 NRC Ucenses authorizing the
medical use of byproduct material.

Under the Atomic Energy Act, the NRC is authorized to enter
into agreements transferring our regulatory authority to a State.
Twenty-nine such agreement States exist, and they have 4,500
medical use licenses.

Last year, our Office of State Programs, which oversees the
agreement State program, was moved from the Commission level
to go within the staf^ in order to foster a more consistent, well-co-
orchnated program between NRC and the agreement States. Never-
theless, there still exists considerable variability among the States
and between the agreement State and NRC medical use programs.
For example, reporting of misadministrations and other medical
events by agreement States is so uneven at this point that it is dif-
ficult to determine if the misadministration rates reported are ac-
curate or not.

Variations in jurisdiction over different sources of radiation--a
point to which you referred in your opening statement, Mr. Chair-
man— also give rise to a range of problems. Jurisdiction is shared
by the Federal Government and the States, and at the Federal
level, by the Food and Drug Administration and the NRC, and I
am forced to point out that any questions about notification of pa-
tients at the Federal level are really our responsibility; it is not the
FDA's responsibility to do that. So the responsibility that you out-
Uned in your statement falls clearly on our shoulders, at least at
the Federal level. But more generally, I think the jurisdiction prob-
lems between the Federal level, mostly represented by the NRC,
and the States are much more serious than intra-Federal-level
questions between us and the FDA.

The vast majority of medical radiation sources, such as natu-
radly-occurring and cyclotron-produced radioisotopes, diagnostic x-
rays, and electronic radiation-producing therapy devices, are not
subject to NRC regulation. Because regulation outside the byprod-
uct material area is entirely at the States' own discretion, there is
variability from State to State. Programs operated by the States
range from minimal to programs comparable to, or in some cases
even more extensive than that which we require.

In the example, Mr. Chairman, that you brought up in Ohio, ac-
tually, the next level is even more interesting — the technicians or
the radiotherapists that you referred to are in fact certified at a
rather high level of training to use the relatively simple Cobalt-60
devices, which we regulate, but to use the linear accelerator, an in-
finitely more complex device, they are subject only to the relatively
low level of regulation that you pointed out. So it is not just from
State to State, but from device to device that there is significant
variation in a way which does not look to the outsider as being a
particularly rational way.

Even the regulation of those medical devices that do use byprod-
uct material does require special attention because of the com-
plicated nature of the interface between the FDA and the NRC.
The FDA regulates product manufacture and distribution while the
NRC regulates radiation safety associated with the actual use of

the products. A simple way to paraphrase it is that the FDA's au-
thority is exercised at the product model, or at the wholesale level,
while the NRC and the agreement States work at the retail level.
We regulate not only the model, but each instance of each model
or device, directly on the basis of the individual licenses. So they
might have a comment, say, on the Ford Pinto, whereas we would
look at each vehicle in use to see if it is properly used.

The scope and level of detail required for NRC review obviously
go far beyond that required by the FDA. We are able to provide
this more detailed and focused review because while FDA has over-
sight responsibility for the entire universe of medical devices —
some 20,000 devices — NRC and the agreement States are con-
cerned only with the 300 types of devices that contain byproduct
material.

We are in the early stages of an effort to establish a memoran-
dum of understanding between the two agencies that will address
the FDA/NRC interface, concentrating on medical devices, and I am
quite sure that that effort will be successful.

Another area in which problems arise is the field of health statis-
tics. While we have information about the number of reported
misadministrations, there is evidence of underreporting.
Misadministration reporting by agreement States is inconsistent,
and we are not confident about projections of the total number of
administrations. Without more reliable data on the total number of
administrations, that is, on administrations of isotopes where the
doctors' orders were in fact carried out, we cannot accurately deter-
mine misadministration rates nor misadministration trends.

Turning to operations, one of the points that you covered in your
statement, Mr. Chairman, NRC's regulatory program consists of
three fundamental elements. First is the licensing process, second
is the inspection of current licensees, and third are the enforcement
actions taken against violators of NRC regulations.

Overall, we are reasonably comfortable with the licensing proc-
ess, although even there, a recent Inspector General report has
shown that some formalization of procedures would be useful.

With respect to inspections, a different focus may be needed. Our
current approach has been criticized as focusing too much on de-
tailed compliance with NRC requirements and not enough on over-
all radiation safety performance. Compliance is important; we
shouldn't have regulations if we don't expect people to live up to
them, but compliance is not enough. We really have to look at the
bottom line and see how well the programs are doing, and that
should be the ultimate focus of our inspections, I believe.

Turning to enforcement, a point that Senator Lieberman brought
up in a different context, this is really quite a complicated ques-
tion. An enforcement policy is intended to do two things. It is in-
tended to discourage repeat violations by the people who are found
to have violated our regulations, and it is intended to deter other
licensees from committing similar violations.

In the vast majority of cases, at least in the medical cases, NRC
enforcement sanctions have been effective in gaining lasting correc-
tive action. We have seen relatively few repeat violations for sev-
eral years after a civil penalty is levied. However, we do not know
whether the policy has been effective in deterring problems at

other licensees' facilities, and this is a question that we need to in-
vestigate.

Senator Lieberman's remarks about the enforcement process are
right on the nose. He has been handling the allegations that have
come to his office in a meticulous and proper way, and I agree with
his careful summary of the IG cases. We too are awaiting the IG
whistleblower report, due in June, that he mentioned, and we are
awaiting it with great interest. We have a number of things we
wish to do, and they depend on the IG report.

The series of stories in the Cleveland Plain Dealer to which you
referred, and which we agree were a very valuable piece of report-
ing, expressed a number of concerns, including problems in patient
follow-up. As a result, the NRG staff conducted a detailed review
of therapeutic misadministrations at NRC license facilities over the
past 3 years. This review indicated that the patients were notified
of misadministrations only 72 percent of the time. Although it is
true that the NRC permits not notiiying patients in those special
cases when a physician determines that it would be harmful to the
patient, this exclusion does not appear to be the cause of most of
the cases of non-notification.

Furthermore, of the patients notified, the 72 percent of the pa-
tients who were notified, only 56 percent of them were given a
written report — contrary to expUcit and longstanding NRC require-
ments. The staff is currently revievmig those cases in which the pa-
tients were not provided with a written notification to detennine
if enforcement action is called for.

I have gone through a rather long litany, and the written state-
ment has many others, pf places where we see that the program
is subject to review and perhaps improvement. But on the positive
side, we do believe that some recent steps have been taken which
will increase the effectiveness of our program.

Among the various steps that I could cite, I'd like to single out
the comprehensive rulemaking on quality management require-
ments in preventing and reporting misadministration, which I'll
call the "QM rule" in further discussion, which became effective a
little over a year ago. This is a performance-based rule that tells
the licensees what they have to do, not how they have to do it, so
it can be applied to a wide variety of programs, taking into account
specific variations from case to case. It is also designed to have the
greatest effect on those licensees that have weaker safety pro-
grams, since what it calls for is basically what the better programs
already do today.

In time, when the rules' reporting features are implemented, not
only for the NRC Hcensees, but in all the agreement States, it
should provide us with much more reliable data on
misadministration frequencies and causes than we have now.

In sum, Mr. Chairman, we beheve the situation is about as fol-
lows. The NRC has what we consider to be a reasonably good regu-
latory program for the medical use of byproduct material, at least
compared to the regulatory programs for other medical devices.
Areas for improvement in the design of the program have been
identified, especially in our relations with the agreement States, in
our interface with the Food and Drug Administration, in the gaps

we see in radiation health care data, and in our responses to the
rapid changes in medical technology.

We have also identified some weaknesses in execution, especially
in the area of patient notification and follow-up, and perhaps in a
tendency to inspect for compliance rather than directly for safety.
We believe that we have steps underway, especially a shift toward
performance-based rules and a regulatory regime which focuses
more effort on the weaker licensees, a set of steps which if carried
to their logical conclusion will remedy most of these problems.

The fact remains, however, that no matter what level of re-
sources we in the agreement States devote to improving the regu-
latory program for medical therapy, the effect will be confined to
no more than 25 percent of the radiation therapy treatment in the
country, while the other 75 percent is subject only to discretionary
and perhaps inconsistent regulation at the State level.

We question whether it makes sense to apply so much effort to
25 percent of the problem. It is a little bit like building a fort with
a big wall in the front, a couple of small walls on the sides, and
a river on the fourth side. So we have been giving some thought
to ways to address the issues of coverage. Among the options that
come to mind, we have thought of three. The first is to limit NRC's
regulatory purview just to the approval of sealed sources and de-
vices containing byproduct material, and leave it to the States to
regulate the medical use of these sources. The second possibility
would be for us to continue to write standards and guidelines and
provide the technical support, but turn over to the States all the
responsibility for inspection and enforcement. The third approach
would go the other way; it would extend the type of regulation we
do today for byproduct sources to all therapeutic radiation sources,
not just for the byproduct material, but in particular to the linear
accelerators. Such extension would, of course, require legislation.

Once we have completed our review and discussed it with the af-
fected agencies, we will of course report promptly back to the Com-
mittee, we will give you our recommendations, and then we will
leave it to the Congress to decide what to do with these questions.

Mr. Chairman, this completes our statement. We will be pleased
to answer any questions that you and members of the Committee
may have for us.

Chairman Glenn. Do other commissioners have comments they
wish to make at this time?

[No response.]

Chairman Glenn. OK, fine.

I referred earlier to the deaths that occurred back home in Ohio
at Riverside Hospital in 1975-76, where some 400 patients were
overexposed, and I think about 28 deaths occurred, 10 directly from
it, and 18 where the radiation was a contributing factor.

According to a memo to the Commission in February of this year
from the Office of General Counsel, the NEC staff stopped the in-
vestigation on the basis that, "there would be no useful purpose in
following up." And then: "Neither the then Chairman who made
the commitment to the Congress regarding patient follow-up, nor
any of the Commissioners, was advised of this decision."

What steps are you taking as far as dealing with the staff over
there to determine if any other deaths occurred fi-om overexpo-

sure — this is just one that came up — any other deaths from over-
exposure since 1980, when the NRC medical misadministration re-
porting rule was adopted; and next, to assure that deaths in the
future will be reported as well?

Mr. Selin. Mr. Chairman, that is a question that we put tc our-
selves quite strongly. In fact, you are really too gracious; the facts
are even less complimentary than you put it, because the then
chairman. Chairman Rowden, had in fact promised to Congress-
man Koch that all of the follow-up would be done, and thai was
not properly communicated to the region; neither the region nor
the people who were working with the region were aware of that
commitment.

But that was a watershed event. It was a terrible and a verj' un-
fortunate event, and we all would have preferred it not to happen,
but at least the Commission drew, I think, some very powerfisl les-
sons from that that led to a revolutionary change in the way we
went about the administration of the radiation therapy program.

First of all, there were a number of changes made to 10 CFR
Part 35, the part of the Federal regulations that control the pro-
gram. There was a policy statement issued in 1979, which I still
think is quite valid. As you pointed out, in 1980, a
misadministration reporting requirement was added; we didn't
even have the concept of misadministration reporting nor a clear
definition of misadministration. There were major revisions made
to Part 35 in 1987, and then the quality management program that
we talked about.

The second thing that was done in the time that came after that
was to change the way in which follow-up would be done. At that
time, the same people who were doing the licensing and were doing
the inspections and enforcement were in fact interpreting the situa-
tion after the fact. In part through the IG legislation that your
Committee has sponsored, and in part through a number of items,
the whole approach of the NRC to the review of these cases has
changed completely.

We now have a formal Office of Investigation, quite apart from
the people who have done the work, that looks at the health and
safety implications of these acts; we have the IG in the ultimate
case, to look at the situation themselves; and then there is a set
of intermediate steps that can go to the point of an independent in-
vestigative team which is composed of senior people outside the re-
gion, certainly outside the situation, to look at the facts. This is the
mechanism that we used in the Indiana, Pennsylvania case. In that
situation, also an unfortunate situation, the incident was much less
serious than the 1975-76 incident to which you refer. Nevertheless,
we traced down 92 different people who might have been subject
to radiation; each one of them got a letter fi-om the NRC, explain-
ing what their radiation exposure might have been and what they
should do about it.

The third area had specifically to do with patient notification. We
did not have clear procedures at that time about the obligations to
patients. We have had clear procedures, but not a very good prac-
tice for following up to make sure that they were carried out. Now,
we have, I believe, all of these in place at this point.

Chairman Glenn. How do you establish these agreements with
the States? Who initiates that agreement? Does the State have to
come in and request that, or do you go out to the State and say,
"We think you ought to have this"? How come we only have 29
States that have agreements?

Mr. Selin. Formally, the State has to request an agreement. In-
formally, we try to hold forth a very inviting aspect. We like the&3
agreements-

Chairman Glenn. So they have to ask you-

Mr. Selin. Yes, Senator. The Governor has to formally request
an agreement — ^but that usually comes at the end, not at the begin-
ning, of a long negotiating and discussion process.

Chairman Glenn. So do some of these States have their own reg-
ulations within the State that are satisfactory?

Mr. Selin. No, sir.

Chairman Glenn. In other words, if my wife or my kids were
someplace right now to get some sort of treatment or therapy, and
they are in one of these 21 States that do not have any regulation
worked out through you, are they just at the mercy of whomever
happens to be there?

Mr. Selin. No; it is actually quite the contrary. The 21 States
have quite uniform regulation because we run these programs our-
selves. The agreement State programs are unique in Federal-State
intercourse, as far as I know.

Chairman Glenn. So the other 21, then, you operate, you nin
them; is that correct?

Mr. Selin. Yes, sir. We do the inspections, we license the people,
we do the enforcement.

Chairman Glenn. The 29, though, where we have had some
problems are ones where they have just chosen to malce their
own

Mr. Selin. Well, we have signed an agreement with those 2'J
States. I have to tell you that we do not know if we have more
problems in the 29 States or the 21 States; that's one of the things
that we are trying to find out. It is very hard for us to put on a
comparable basis a bottom-hne evaluation of the health programs
in the different States.

These are not delegations of the Federal program. The State says
that they will install a program which is adequate, which is com-
patible in certain aspects to our program. We terminate our pro-
gram, and they start theirs, and then we continue in overview to
make sure their program remains adequate and compatible.

Chairman Glenn. Why do these States want their own pro-
grams?

Mr. Selin. Well, there are three reasons. The first question is
why do we want them to have the program, you might say. And
the reason is because there are 25 percent, roughly speaking, of
these radiotherapy cases that we regulate and 75 percent that we
do not. We are desirous — and I think you are desirous — that there
be a more uniform set of regulations over radiotherapy regardless
of what type of device it comes from. The States are already re-
sponsible for the naturally-occurring and artificially-generated ra-
diation, and so there is the possibility of a more holistic approach
that says all radiation, in fact all health supervision, in those

States will stay at the State level. This is highly desirable to us,
provided that they carry out the byproduct program as well as we
think we might carry it out. In fact, we even hope that it will bring
up the rest of their programs alongside that.

It is desirable for the States in three ways. First, it keeps there
from being an arbitrary distinction between one type of source and
another type of source. It allows them at least the possibility of a
uniform regulation.

The second, quite frankly, is their fees are lower. The licensees
pay lower fees to the State than they do to the Federal Govern-
ment. The reason is that the States charge licensees for all of the
things the State does, but they share in the overhead of running
the program for free. We do not charge the States an allotment for
our technical support and our scientific work, so there is a benefit
to the State in that respect.

And then the third is really a question, I believe, of sovereignty
more than anything else.

Chairman Glenn. Let me ask you this. It is my understanding
that only 19 out of the 29 States that you have agreements with
have demonstrated compatibility with NRC's regulatory program.
Now, given that situation, how do you know if there have been ad-
ditional deaths, or medical misadministrations even if there is no
follow-up?

Mr. Selin. Well, there is plenty of follow-up. The key thing is are
the programs adequate. Compatible is a very specialized function.
The Atomic Energy Act says the programs must be adequate and
compatible. The "adequate" is the key point — are they providing a
program which provides adequate health and safety. I will provide
information on the extent of compatibility and adequacy of the 29
Agreement State programs. ^

The fact is that we aren't sure. I mean, what we do is we review
their programs. We review the inputs of their programs — do they
have enough people, do they run enough inspections. And that
part, we are very comfortable about. But in our oversight of the
agreement State programs, we don't look at their results. We don't
ask are the morbidity or the fatality rates in States significantly
different in agreement States from what they are in our case. We
don't think they are, because we look at their programs very care-
fully, but we aren't sure, and that is one of the things that we will
do.

The compatibility is limited to those items which really should be
national level. They have more to do with standardization than
they do with direct health and safety. There are certain regulations
that they must adopt verbatim. They tend to be definitions, they
tend to be radiation limits, and they tend to be reporting require-
ments. So the fact that a State is not compatible will affect our
ability to run the National program, but it may not have much im-
pact on whether the State's program is responsible or not.

But on the other hand, in the long run, we cannot allow States
to run programs that are not compatible.

1 See pages (274-282).

Chairman Glenn. Does your agreement require certain levels of
training and inspection and qualification of people — to pass a board
test, or something like that

Mr. Selin. Yes.

Chairman Glenn. Are those agreed to? How do you pass that
kind of test?

Mr. Selin. Well, the agreement says that they will meet our
standards

Chairman Glenn. And do you check on that?

Mr. Selin. Yes, sir, we check on that. Now, the better question
is what happens if they don't meet these standards, and the an-
swer is we work an awful long time to try to bring them up oo
those standards before we come to the conclusion that the States
will not

Chairman Glenn. Is there any requirement under these agree-
ments that only people who pass these tests can administer treat-
ments, then?

Mr. Selin. I'm sorry — are you talking about the physicians?

Chairman Glenn. Yes — and/or technicians; either one, not only
doctors, but anybody who is authorized out there to give me a
treatment if I go in. Let's say I have cancer, and I'm going in to
get therapy. How do I know the person knows what he's doing?

Mr. Selin. I misunderstood your question. I thought you were
talking about the State personnel. I'm sorry. I misanswered tre
previous question.

Chairman Glenn. Well, I guess I'm tsdking about personnel
across the board. If I'm getting a treatment how do I know that
qualified people are giving it?

Mr. Selin. Well, the fact is that the overwhelming number, prob-
ably 90 percent, of the people who are delivering any type of ser^'-
ice are people who are certified by third parties, by joint commit-
tees on accreditation of hospitals, or physicians' boards. Most of the
people who are qualified are qualified by the professional groups.

We have standards for people who claim to be qualified who ha\ e
not gone through these groups, or for facilities that are not ho3-
pitals, that we carry out, and the States carry out these standards,
£ind we look quite carefully at how they carry out the standards.

I'd say the biggest weakness is in the radiation safety officer, bo-
cause that's a job which is not defined in other professional soci-
eties. It is something that is very specific to our regulations ar;d
the State regulations, and that's the area in which we have to look
a lot harder.

I don't think it is true that the quality of the people who are car-
rying out our programs are noticeably different in the agreement
States than they are in the places that we regulate directly.

Chairman Glenn. OK. You said you deal with licensing, inspec-
tion and enforcement.

Mr. Selin. Yes, sir.

Chairman Glenn. How many people do you find who aren't
qualified, who are doing something they shouldn't be doing?

Mr. Selin. Well, those are two separate questions. We rarely find
people who are not qualified, but we do find people who are quali-
fied who nevertheless are cutting comers, doing things that they
shouldn't do.

Chairman Glenn. What happens in that case?

Mr. Selin. It depends on three things — how serious the case is;
the long-term impact of what they are doing; and whether it was
inadvertent or whether they were really trying to fool us.

I would say quite frankly that in looking over the 10 most spec-
tacular cases of the last 10 years, the biggest questions have come
about differing professional judgments as to whether people were
doing things on an inadvertent basis, or they were really trying to
fool us. Therefore, the principal conclusion that we have drawn
from this is that we have to make our guidance much clearer as
to what tests we will apply and how tough we will be in follow-up
on people who don't seem to be carrying out their promises to us.

Chairman Glenn. I recall when we looked at Three-Mile Island
on which we had detailed follow-up including hearings one after
another in this very room. And yet we didn't lose anybody directly
out of Three-Mile Island. But here, we have radiation of a similar
kind, of course, but less concentrated in its overall danger to a
large population.

Mr. Selin. Mr. Chairman, if I might say something, there are on
the order of 30 to 40 therapeutic misadministrations a year in the
21 States that we monitor directly. We have not in the past been
tough enough on the agreement States in making sure that they
collect this therapeutic misadministration information, so we can't
speak with the same confidence.

But let's say just for the sake of argument that there were com-
parable numbers, so we are talking about roughly 70, 80, 90 thera-
peutic misadministrations a year, of which about 10 percent have
serious consequences-

Chairman Glenn. But how do we know that? How do we know
those figures are correct?

Mr. Selin. Well, I am reasonably comfortable about the
misadministrations in our area — we might miss one or two, but I'm
sure that there aren't major changes. It is a very serious violation,
a criminal violation, to change the records and lie about whether
there is a misadministration or not. And we do do an audit of our
licensees' records to see if they are reporting what they have in the
records.

So to be reasonably confident, they would have to do one of three
things. They would, number one, have to make sure that their
records don't show a misadministration — which I think is not im-
possible, but unlikely. The second, which I am more concerned
about, is that they would get a physician to say, "They did what
we told them to do; maybe we didn't tell them to do the right
thing" — in which case, by definition, it is not a misadministration,
and we have a couple of cases of that.

And the third would be where they have the information in the
records, don't report it to us, and hope we don't find it in an audit.

There is no risk-free operation in any of these areas, but the
risks of doing something like that are much greater than the risks
of shifting people, say, from a Cobalt device to a linear accelerator,
where the rules for reporting misadministration have been unclear
until 2 years ago.

So what we are concerned about is not so much the likelihood
that there will be a frontal assault on our regulations, but that peo-

pie will just get around the regulations at the comers, which is a
much greater source of concern to me and to the Commission.

Chairman GLENN. I know that some of the anecdotal material I
use here today is back before your watch, all of you who are with
us here this morning. Mr. Rogers, I think you came on in 1987; Ms.
de Planque in 1991; Chairman Selin in 1991, and Mr. Curtiss in
1988— is that correct?

Mr. Selin. Yes.

Chairman Glenn. OK, so some of these things occurred before
your watch — but I ask these questions here to find out what has
been done to correct these situations that did occur before.

Based on the Committee's investigation, in addition to being re-
peatedly opposed to the medical misadministration reporting rule,
in 1984 the NRC staff made changes in the rule that affected pa-
tient notification and recordkeeping requirements without the
knowledge of the Commission. Now, what kinds of safeguards do
you think are necessary to assure that the staff can be held ac-
countable for decisions made by the Commission?

Mr. Selin. Well, among others, the knowledge that we are going
to have to appear before you periodically has certainly sharpened
our focus on making sure that we do hear from the staff. I am quite
sure that the situations which have been reported in 1976 and
1984 and as recently as 1986, of the staff, going on unnoticed will
not be repeated. It is absolutely clear to the staff that the Commis-
sion has a great interest in these topics. Particularly in the notifi-
cation and misadministration definition topics, the organization
that supervises that staff, the Office of Nuclear Material Safety
and Safeguards, has been reorganized to bring the medical pro-
gram to a higher level. The outside follow-up on what goes on,
whether it is the Inspector General or our own reports, has just
greatly increased the amount of information and the interest of the
Commission in what the staff does.

I will give you two examples of things that are quite opposite
from the situation that you refer to. One has to do with the use
of the medical consultant. Before, the guidelines on using a medical
consultant were very foggy and murky. The guidelines now — just
recently, since Indiana, Pennsylvania, I have to admit — say very
simply if there is a medical therapeutic misadministration, we use
a medical consultant — no ifs, ands, or buts, no trying to estimate
dose rates or damage or what-have-you.

And the second issue has to do with the question of patient fol-
low-up. As pointed out in the statistics I brought up, that were
brought up by the Cleveland Plain Dealer, the performance was
just not consistent with our standards. Right now, we are inves-
tigating every medical therapeutic misadministration to see if the
patient has been followed up. It is unequivocally understood by the
staff that we will concentrate on the few high-dosage iodine mis-
administrations and then the medical therapeutic mis-
administrations, and absent an overwhelming concern for harm to
the patient, which our own advisory committee estimates is maybe
one to 3 percent of the cases, the patient will be notified in writing,
and furthermore there will be a short-term follow-up to see if the
deterministic effects have been assessed or not.

Chairman Glenn. We have a recent NRC/OIG report on the In-
diana, Pennsylvania accident, where NRC inspectors failed to re-
view records which showed that technicians were not trained to op-
erate the device in a portable mode, and as a result, mistakes were
made.

How do you explain that lapse? This is a recent incident.

Mr. Selin. Actually, they have come up with more than that.
The portable mode was probably not the cause of the accident. But
what we did find is that they were using the device at a number
of facilities that had not been included in the license; we found that
the analyst, the inspector who allowed the license to be extended,
got incomplete guidance from NMSS — more particularly, she didn't
have a particular person to deal with, and it was not clear to her
from whom she needed to get guidance and how to do it — and most
particularly, it was quite clear, the most important part, the most
serious failing, was that the RSO, the radiation safety officer,
didn't do his job from all that we can see. There were people at
these satellite clinics who had not gotten any effective supervision
or training from him.

It is clear that the first two things will not happen again — the
point of contact, the guidance, the inspectors, the sensitivity of the
inspectors on the licensing is very clear now, and I have no doubt
that the licensing part has been straightened out, and that we'll
have no problems with that.

But as far as the inspection part, that's harder to say. We can
say we will work harder, and will look more carefully for these
things, and we will, but I CEinnot guarantee to you that there will
not be other inspection lapses.

Chairman GLENN. In 1990, the NRC Office of Inspector General,
OIG, found that NRC headquarters staff, again, without the knowl-
edge of the Commission, provided improper assistance to medical
groups by helping them prepare a petition for rulemaking that
would weaken the current regulation. Now, if we had a nuclear
power lobby coming in, I'm sure people would be out the door be-
fore nightfall if they were writing regulations in-house over there
for the industry to submit to you. What has the NRC done to as-
sure that this problem will not be repeated?

Mr. Selin. That same IG report had another section which is
also quite damning. It said that essentially, in spite of the fact that
your intuition and your sense of what is right and what is wrong,
said these are the wrong things to do, we had no regulation which
these people violated, and it was another sign of the

Chairman Glenn. Except common sense.

Mr. Selin. Exactly, Senator.

Chairman Glenn. The staff doesn't, in my office or yours or any-
body else's, go off half-cocked on their own and make decisions to
weaken regulations or help the industry or whomever is out there
to weaken regulations. And they would be out of my office before
nightfall in my office if they did.

So I presume you have done something to make sure that they
are not doing that now without bringing it to the Commission's at-
tention.

Mr. Selin. We have done three things. We started at the top. We
fixed the internal guidance to make it absolutely clear that these

two types of things cannot be permitted to happen — either the staff
marketing a petition to outside groups, or the staff deaUng v/ith
outside groups in areas that would lead to a conflict.

The second thing is that the EDO issues not only once, but annu-
ally, a statement calling people's attention to this point. And the
third is the specific people who were involved in thus — it was dis-
cussed with them about what they should and should not do. But
we cannot retrospectively do more than that, because they did not
violate our written requirements. And as much as that goes against
common sense, we can't have ex poste facto justice. So we have
fixed the requirements; it is clear to the people that they did
wrong, and that particular thing will not happen again.

But it is a broader example of the fact that in these highly com-
plex and technical areas — which are very small, and the medical
one is not the only one — we have been going for too long, until
about 4 years ago, on common sense rather than formalizing the
regulations to make it clear in the letter that what you have so
aptly characterized as common sense will be expected.

Chairman Glenn. What is your requirement now for notifica-
tion?

Mr. Selin. Patient notification?

Chairman Glenn. Yes, where there has been some
misadministration. As an example, for more than 8 years, the NRC
failed to require the University of Cincinnati Medical Center to no-
tify a patient and her daughter — the daughter had been improperly
exposed — that a misadministration occurred. It was only after this
Committee initiated an investigation at the NRC in January of this
year, 1993, that they sent a letter to the hospital notifying them
of their obligation.

Are there other cases like this, and why are we taking so long?
What's the problem?

Mr. Selin. The big problem there wasn't the notification. It was
the reluctance of the staff, as you put it in a previous question, to
recognize that this was in fact a misadministration. Once it was de-
cided that it was a misadministration — which took far too long to
get to that point — the notification was fairly prompt.

I believe that that case is really not a notification problem, but
one of a number of cases that you have cited and that your staff
has cited in the past where the fact that the regulations and the
definition of misadministration were murky allowed for too broad
a set of arguments as to whether specific instances were
misadministrations or not. Now, the regulations are much clearer,
and our interpretation is much tougher about what is a
misadministration and what isn't.

As far as the patient notification is concerned, in the Riverside
case that you cited earlier, the staff was just very confused as to
why they were supposed to do this follow-up. They thought that the
only purpose of the follow-up was to get enough information to im-
prove our regulation £ind inspection procedures, and they were in-
sufficiently sensitive to the patient rights aspects of the piece.

I assure you, sir, that that is no longer the case and that the no-
tifications will be, and in fact are already much more thorough
than they were then.

Chairman Glenn. OK. Your agreement States, which are respon-
sible for regulating about 4,500 medical licensees, more than twice
the number regulated directly by the NRC, are supposed to have
programs that are compatible with the NRC. However, as I under-
stand it, only 19 have demonstrated they are compatible.

How do you know if any of these agreement States are requiring
that patients be notified if accidents occur?

Mr. Selin. Well, it is true that they have to have compatible pro-
grams, but we have changed our rules on notification, and they
have 3 years to catch up. So at this point, the States — and I am
confident that not 19, but all 29 — have in place a notification proce-
dure that is based on the notification procedure which has in fact
been superseded by our quality management rule.

So, starting in 1991 — that was the first year that we unequivo-
cally required that agreement States use our definition of
misadministration and notify the patients. We have been maiking
this topic a point of emphasis in our meetings with the agreement
States and in our reviews of their programs. Before last year, it
was not a major topic. We have plenty of reason to believe that the
States were far more laggard than we were in notifying the pa-
tients before 1991. We think that they have made a lot of progress
in 1992, but we aren't yet sure.

The second thing is that when our QM rule becomes binding for
the States, which is 1995, then the definitions will be clear, and the
notification will be clear. But there will be a period between now
and then when the States' process of notifying patients will be un-
even compared to the process in our 21 States — not because they
don't meet the compatibility rules, but because there is a natural
inertia when we change the groundrules for how long it takes for
the States to follow.

Chairman Glenn. Let me go back to the University of Cin-
cinnati. In 1986 the NRC officially declared the University of Cin-
cinnati incident a misadministration. Why did it take until Janu-
ary of 1993 to formally notify the University of Cincinnati?

Mr. Selin. Well, we declared it a misadministration, but the uni-
versity did not agree on that, .and there was a fairly long, drawn-
out discussion of what should happen by the time that that was
done unequivocally; then there was a second discussion about
whether it made sense to notify somebody so far after the case
about it being a misadministration. And then finally, in part be-
cause of your Committee and in part because of the perseverance
of a member of the NRC staff, the Commission finally said enough
of this — no more ifs, ands or buts — notify the patient's descendent,
and let's get on with the situation.

Chairman Glenn. That took 7 years.

Mr. Selin. That's true. What am I supposed to say? We didn't
do it right, and we wouldn't do it again. That's all I can say to that.

Chairman Glenn. Well, my concern is are there other cases out
there that haven't come to light yet, where we are hanging back
on the notification of somebody who may be in some danger, aind
they might be able to do something about their health. If it takes
7 years before we notify them, people will have died a long time
ago.

Mr. Selin. We found in the last 3 years that only 72 percent of
the misadministrations had been notified to the patients at the
time of the Cleveland Plain Dealer article. So the smswer to your
question unfortunately is there probably are some out there that
haven't been notified yet — a lot fewer now than a year ago, and a
lot fewer next year than now. We had not paid sufficient attention
to the notification procedures to make sure that was followed up.
The attention is being put, but there is a delay between the time
the attention is spent and the time the actions have been taken.

Chairman Glenn. Let me move on to a different area. According
to the Committee's investigation, the NRC staff again halted
probes by the NRC's Office of Investigations that found that physi-
cians may have falsified their license applications. The first situa-
tion involved several situations where phantom applications were
provided including floor plans for facilities to contain nuclear mate-
rials that never existed. Apparently, even after the NRC's Region
III disagreed, the NRC headquarters staff advised that this did not
constitute a violation — did not constitute a violation — and the case
had to be dropped by the Office of Investigation.

In the second instance, a physician for over 10 years was operat-
ing under a license where another physician, who was the only one
authorized to possess nuclear materials, was unaware he was even
on the license. Yet the NRC staff again halted an investigation by
the NRC's Office of Investigations on the grounds that there was
no apparent violation.

On the face of these facts, it would seem that at the minimum,
the NRC's Office of Investigation should have been allowed to pro-
ceed to determine whether these circumstances were willful viola-
tions; but under the current system, the NRC's Office of Nuclear
Material Safety and Safeguards can simply overrule the NRC Re-
gion and the 01 office on the basis of just a judgment call.

What kind of guidance and safeguards should the NRC have in
place to deal with this obviously troubling situation? Have you cor-
rected this?

Mr. Selin. Yes, sir. We have taken steps. I think time will tell
whether we have corrected it or not. But the key point is to sepa-
rate out the investigation and review of the investigation from the
control of the people who were involved in the situation in the first
place. It is not so much whether the staff can supervise 01 or not;
it's the question at what level the staff will supervise the Office of
Investigations. For too long, the medical area was thought of as
something that was so arcane and so complicated that nobody at
the general management level really could understauid it well
enough to get involved in these cases and see them out. I believe
that we all understand that that is not true and that that will not
continue.

The cases that you cite are really quite complicated cases, be-
cause we don't have an open and shut case to prove the statements
that you have made. They are more, as you said earlier, common
sense points. The fact that in one of those cases in particular, the
physician who was down as the supervising physician asked that
his name be withdrawn from the license. He didn't give us any rea-
son for withdrawing the name, but the supposition that he was em-
barrassed by being considered a supervisor, when perhaps he didn't

think he was going the supervision, is certainly a supposition that
comes up.

That doesn't come out of the investigation; that comes out of
high-level people sitting down and saying, "This doesn't pass the
'red face' test. We've got to do something different from what we
are doing." And the managerial changes have been made to make
sure that the people who can interact in the case you brought up
with 01 are not the same people at the same level whose actions
are indirectly being questioned by the 01 investigation. The idea
that the investigator should be independent and should be report-
ing to supervisors well above those who are implicitly involved in
the subject being investigated is a well-established principle, but it
wasn't carried out in practice as it should have been.

Chairman Glenn. In July of 1992, the NRC Office of Inspector
General reported that NRC Region I staff failed to identify safety
problems at a company in Connecticut that were brought to their
attention by a former employee. In April of this year, just recently,
the NRC OIG issued a second report which found that the NRC Re-
gion III staff were improperly recommending this SEime company to
licensees in Ohio who were having regulatory problems with the
NRC.

First, were any enforcement actions taken against this company,
and second, what is the NRC doing to assure that Commission em-
ployees don't engage in potential conflict of interest practices?

Mr. Selin. The first situation was much less serious than the
second situation. I looked at the first one in some detail, and it is
true — everything Mr. Gunderson said was absolutely right; he per-
formed quite a service. But the question was whether the licensee
was operating on his own license in a particular kind of case where
most times, the licensees operate on their customers' licenses. We
looked at the safety implications, and there was again a lesson to
be learned about being much clearer about what information is to
be available. The inspector was relatively inexperienced and did
not use information that was available from another region. But it
was a situation which, given the information at the time, was not
unreasonable.

The second situation, if you'll allow me to continue, is much more
troublesome because, to be frank, it's not just a question of who
was paying for the lunches, but why were these people having
lunch together in the first place. I mean, it was the familiarization
and the fraternization that was more worrisome than whether
somebody was picking up a check for $20 or not. We are very con-
cerned about this situation. We are sharpening our regulations, but
in this case there is no question that the actions happened as de-
scribed by the IG, people knew and should have known that they
should not have done these actions. There is a review going on at
the management level. The EDO has put two people in charge of
this review who are not directly or indirectly involved in the super-
vision of the situation at hand. But that is a very worrisome situa-
tion— both the fraternization with the licensee and then a well-
meaning but very dangerous practice of recommending people to li-
censees to help them solve problems.

Most of these material licensees are very small organizations. A
lot of them have radiography only as a sideline; if their program

runs into trouble, and they don't know where to turn to for help,
it is natural for them to turn to us and say, "OK, you're right, we
have a problem. How can we fix it?" But to say it is natural and
to say it is appropriate are not the same thing.

We are putting in a formal procedure to keep lists of people who
might be suggested— a large list that the licensee could take a look
at. Whether there will be enforcement actions against the licensee,
or what disciplinary actions might be taken against the NRC peo-
ple is just a bit early to report. But when those decisions are made,
we will of course report them to you, Senator.

Chairman Glenn. Another specific example, and I'd like to know
how you are handling this. In early April, the Northwest Ohio Re-
gional Sewer District filed a lawsuit against Advanced Medical Sys-
tems, AMS, Inc., a Clevelamd-based manufacturer of cancer treat-
ment equipment. The Sewer District claims that the company has
disposed of Cobalt-60 sources which have contaminated the south-
erly sewage treatment plant, and they are asking for assistance in
paying for the cleanup.

Congressman Stokes, Senator Metzenbaum and I have asked
both the GAO and the NRC to investigate this situation and look
at it. When did the NRC first become aware of this situation?

Mr. Selin. We became aware of this situation only inadvertently.
I fear that my answer may lead to another set of questions, but I
will bravely go ahead, regardless.

At a meeting in Newburgh Heights when we were talking to the
citizens of Newburgh Heights about the Chemetron site, we under-
took to take a broad survey not just of the site, but to have an aer-
ial survey taken of the area to see if there were other hot spots,
other sources of radiation. That aerial survey turned up contamina-
tion from the sewer lines connecting the site evidently passing
through the concentrating part of the sewer system. Investigation
of that radiation turned out that there was Cobgdt-^O, as you
pointed out, at the site. There was never any Cobalt-60 at the
Chemetron site, so clear, the Cobalt-60 did not come from the
Chemetron site

Chairman GLENN. When was this survey?

Mr. Selin. Two years ago. The aerial survey was 2 years ago,
and it was last year — I'll get the date for you, more specifically a
chronology of events — it was last year that the radiation was deter-
mined to be Cobalt-60 and where the contamination was.

INSERT FOR THE RECORD

Chronology of the Northeast Ohio Regional Sewer District

• During an April 1991 aerial gamma survey of the Cleveland, Ohio area several
areas of elevatea radiation were identified at the Northeast Ohio Regional Sewer
District's Southerly facility, following this identification, Region III conducted radio-
logical sampling at the site and determined that the site was contaminated with low
levels of coDalt-60. (Direct radiation levels ranged from 30-60 microroentgen per
hour with sampling concentrations ranging from 27-79 picocuries per gram of soil.)

• In order to obtain an understanding of the extent of the contamination, Region
III contracted with Oak Ridge Institute for Science and Education (ORISE) to per-
form radiological characterization studies at the site. These studies were performed
in September 1991 and March 1992 and confirmed the presence of cobalt-60 at lev-
els that do not represent immediate health and safety risks at the site. Based upon
this characterization, total cobalt>-60 at the site was estimated to be approximately
200 millicviries.

• Concurrent with the ORISE site characterization studies, Region III initiated
inspection efforts at the site to obtain information on the possible origin of the con-
taminant and to perform independent assessments of hazards of workers and radi-
ation levels in facilities. Based upon those efforts, it appears that a likely origin of
the cobalt-60 was from the Advanced Medical Systems (AMS) site in Cleveland.
Both AMS and its predecessor, Picker Corporation, manufactured cobalt-60 sources
for medical usage from the early 1970's to the mia-1980's. From the location of the
contaminants at the site and the Sewer District's operational history, it appears
that the contaminant most likely was deposited at the site sometime between the
late 1970's to early 1980's. The Sewer District has initiated litigation claiming neg-
ligence on the part of AMS and also has petitioned the Commission pursuant to 10
CFR 2.206 to reauire AMS to assume all costs resulting from the off-site release of
cobalt-60 from tne AMS facility and to also decontammate a sewer line from the
AMS property.

• NRC representatives have met on numerous occasions with Sewer District rep-
resentatives to discuss remediation plans for the site. The District has contracted
with a consultant to assist them in performing additional site characterization ac-
tivities, developing a remediation plan, and assessing potential personnel radiation
exposures to District employees. The Sewer District has fenced on the contaminated
areas and has provided adequate security and posting provisions for the contami-
nated areas.

• The NRC is in the process of reviewing the Sewer District's current plans which
consist of emptying three contaminated settling ponds and placing the material in
an isolated area on the Southerly property. It is essential that these ponds be
emptied in order for the Sewer District to continue operations. The NRC will have
onsite presence during this operation and future site activities to assure safety of
the workers and also to perform independent measurements so that an accurate as-
sessment of total activity at the site may be obtained. ORISE will assist the NRC
in some of these activities. The NRC will be reviewing all future characterization
and remediation plans proposed by the Sewer District.

We did a survey of all the licensees in the area, and the only one
that was conceivable as being a source of Cobalt-60 was AMS.
They had been doing a manufacturing process involving Cobalt-60
that terminated in 1987.

Then the problem gets interesting from there on in. We don't
know whether the manufacturer, AMS, was in fact putting more
Cobalt-60 into the water than their regulations allowed them to
put in; so there is a question of fact. But even if they were within
our regulation, the amount of Cobalt that they put in, when con-
centrated in the sewer system, could have led to these concentra-
tions.

It is pretty clear that the Sewer District has some cleanup to do,
and it is pretty clear that they were acting in an appropriate fash-
ion.

So in answer to your question, the first thing we are doing is try-
ing to help solve the problem, and that is to work with the Sewer
District, providing technical advice and support on how to decon-
taminate those ponds that have to be decontaminated. The second
thing that we are doing is looking at the generic basis and asking
if you are going to have emissions that go into concentrating sewer
systems instead of being dispersed into fluids the way we thought
when the regulation was passed, are these emission levels too high.
But the key question — it is not our question; it is really between
the Sewer District and the manufacturer — is what is the liability
of the manufacturer. There is a doctrine that says just because you
are within Federal regulations doesn't mean you have no tort re-
sponsibility for what goes on. So that is basically a tort case be-
tween the Sewer District and the manufacturer.

Chairman Glenn. Is this a problem in other cases?

Mr. Selin. Probably.

Chairman GLENN. I don't know whether you checked on this, or
how you check it, or does amybody check on it, but it seems to me
that when people have something they want to dispose of, they
quite often flush it down the drain, £uid it winds up someplace in
the sewer system. How do you check that, or do you just trust peo-
ple's good sense not to do that — Eind it probably occurs more than
we know.

Mr. Selin. It is worse, Mr. Chairman. They were within our
standards. Our standards did not foresee a sewer system at the
end. If a radioisotope is soluble, if it dissolves or it will disperse,
we set standards assuming that there will be a certain amount of
dispersal, and that the concentrations will not cause any problem.

But if you have a sewer system doing what it is supposed to do,
what it does is it concentrates the sludge and has an effect which
is just the opposite of dispersal. I should assure you that these con-
centrations are not at what we consider to be dangerous levels, but
there is clearly a lack of coordination between our standards as-
suming dispersal and the knowledge that there are sewer systems
which lead to concentration rather than dispersal.

Prospectively, we are changing the standards to fix this situa-
tion, but retrospectively, we don't know of other places, but I
wouldn't be surprised if there are other places. But this is where
people are within our regulations. This is in addition to the cases
where there would be illegal disposal of radioactive material.

Chairman Glenn. We could go on and on talking about the de-
tails of all these things and anecdotal examples. Let me get to the
bottom line. In 1980, President Carter established the Radiation
Policy Council, whose purpose was to coordinate the formulation
and implementation of Federal policy relating to radiation protec-
tion. The council was comprised of representatives of 13 Federal
agencies. It was also to advise on policy formulation, monitor im-
plementation of radiation protection policies, resolve jurisdictional
disputes, serve as a liaison with the States and Congress, and
serve as a public forum.

Now, it was not in place long enough to really know whether it
would have worked or not worked, and I don't know whether it
would have or not. What President Carter did was basically what
I had proposed here, and he sort of preempted that, and that was
fine; I was glad to see it in place. President Reagan came in and
abolished the council by Executive order soon after he was inaugu-
rated.

Now, I don't know where we go from here, but I'm interested in
answers. I know there has to be more close monitoring and coordi-
nation than in the past. That is obvious from all the information
we have talked about this morning, the Plain Dealer articles, and
the illustrations you have given and commented on.

I don't know whether a similar council to examine medical uses
of radiation is in order, or what will work. We have radioisotopes
that are produced in reactors, and those are regulated by you at
the NRC.

Then you have radioisotopes produced in accelerators. It is my
understanding there are some 2,000 accelerators now in this coun-
try. Is that a valid figure, about 2,000?

Mr. Selin. I don't know how many there are, but I know how
many procedures there are, and there are about

Chairman Glenn. But there are a lot of them, and they have
come into more common use; about 2,000 of them.

Mr. Selin. Yes, sir.

Chairman Glenn. Now, these aren't regulated at all, as I under-
stand it, by anybody.

Mr. Selin. Not by us, no.

Chairman Glenn. By whom?

Mr. Selin. The State department of health or State department
of radiation. And of course, as I'm sure you are aware, there is the
Conference of Radiation Control Program Directors which writes a
standards document, but it is completely voluntary. Fifteen States
have adopted those standards. They are comparable to our stand-
ards, but they don't have the Federal inspection and follow-up; they
are just standards for

Chairman Glenn. Well, I know we haven't had FDA up here yet,
but FDA has very tight regulations now for things like sun lamps,
tanning beds, television sets, and even airport surveillance, and
things like that, but we have no regulation for accelerators. This
just doesn't make any sense. We are supposed to have some inter-
national standards, but as I understand it, the international stand-
ards are not binding; they are advisory.

So I would appreciate your comments on what you think we need
to do, or you need to do, or somebody needs to do. Would a council
provide — and I am the last one in Washington who wants to set up
another commission, council, advisory group, committee-type thing;
that's the Washington solution to a problem — form a committee,
and draft a quick press release so people will think you've done
something. But I want to get to the bottom of how we regulate ra-
diation. Should it be a Federal law, with Federal standards that
have to be adhered to, that the States can't have any variation
from? Should we turn it over, as you said was one of your options?
Should the NRC and other Federal agencies set the standards in
all their wisdom, and then leave it up to the States on how they
comply? And we are getting complaints now — every time we do
that, the States want money-complaints as to how we require them
to do things and don't provide the money to do it. That's another
problem.

What is your best advice — all of you here. I'd like your individual
opinions — and I am asking for your opinions, not something pre-
conceived. You all have different views on some of these things,
and I want your personal opinion on what is best to get this whole
thing under control so we aren't endangering the people of our
States and our Nation.

Mr. Selin. Fine. First of all, we are flattered that you are asking
our advice on this. My own view is you have to start from the most
specific and then work out. We have identified that there are seri-
ous questions with respect to radiation therapy, so we would like
to see answers developed that deal specifically with radiation ther-
apy— not with x-ray machines, not with dentist diagnostics, et
cetera. So we would start at that level. We don't believe that some-
thing as broad as the council you are talking about is necessary,
nor would it do much good at that detailed level.

27 :!

We also don't think the main problem is between lis^and FDA;
it has to do with the inconsistent regulation from the Federal level
and the States and from agreement States to non-agreement
States.

I think we understand the options. We need to do some home-
work and get back to you on which of these we would recommend.
I personally feel that the one thing I would not recommend is the
current situation; I consider that to be quite illogiced, where a huge
£Lmount of resources is poured into, really, only a small part of the
problem. It would not surprise me that part of the growth in linear
accelerators is just because they are separately regulated, although
they have technical advantages as well.

So at the level of therapeutic radiation, I think it is within the
capability of us and the States, with the support of the Congress,
to figfure out what the best approach is there and where to go from
there.

On the broader question of the control or regulation of all ioniz-
ing radiation, that's resdly quite a broad issue. We take the view-
point that any of several approaches could work, and really, you
know much better than we do which ones would work. But I would
put the proviso that whatever does happen, the NRC has some spe-
cific responsibilities under the Atomic Energy Act, and we would
be very uncomfortable if we didn't have the authority to carry out
those responsibilities.

In other words, if, say, EPA, for instance, were given authority
to mandate that we do certain things that kept us from carrying
out our responsibilities, obviously, that would make us feel uncom-
fortable.

On the broader area of international stgindards, I think each of
us has a different view. I think basically, the problems in the use
of the devices — which is not a standards problem but an inspection
and enforcement problem — are much worse than the standards
problem. For instance, FDA does a reasonably good job in linear ac-
celerators; the big weakness is not can you meet the FDA stand-
ards, but do you use them the way you are supposed to use them,
do you maintain them the way you are supposed to maintain them,
do you do the daily, weekly, and monthly calibrations — and that's
far outside of their authority.

Chairman Glenn. Yet that's important.

Mr. Selin. It is very important.

Chairman Glenn. Who should do it?

Mr. Selin. Well, those are State responsibilities today, and they
could either be

Chairman Glenn. But don't they vary from one State to another,
or are those the same for all States?

Mr. Selin. No, sir; they vary from one State to another. Even
where there is some standardization, it has only to do with the reg-
ulations, not the inspection. Even those States that have adopted
the radiation officer standards are still monitoring themselves.
There is no outside monitor.

Chairman Glenn. What you are telling me, then, is there is a
big difference in how much you are protected, or whether you are
safe or not, depending on which State you decide to get your treat-
ment in; is that correct?

Mr. Selin. It is plausible; it is probably true. And that's why my
own view, and I think the Commission's view, is that whatever is
done, we would be better off putting our resources into making
some decision as to what level of Federal resources you and your
colleagues wish to apply, and apply them more uniformly over all
therapeutic radiation, and not concentrate so much on the sliver
that we have.

In all respect, in spite of all the points you brought up — and I
agree with every one of them — I still believe that we do a much
better job than what's done on the edges when you get outside of
byproduct regulation. For instance, there are no patient notification
standards anywhere that have to do with misadministrations
under linear accelerators. Your question to us is do we do a good
job of carrying out the rules, and the answer is that sometimes we
do, sometimes we don't. But in this other area, there are four times
as many devices, presumably there are at least four times as many
misadministrations, and there aren't any rules — at least, any na-
tional rules.

Chairman Glenn. That's what I'm getting at. Who should set the
rules? There should be some rules so that we don't have people in-
advertently being literally killed by some of these devices. It has
already happened — not just fi*om linear accelerators, but we know
that deaths have occurred. Now, how do we protect against this?
Who is the controlling factor — you, FDA, all of us, a council, or a
what? I don't quite buy this idea that we should go along the way
we are because we now have improved our act a little bit. I think
maybe there is a whole new organization of some kind

Mr. Selin. I'm absolutely saying that we should not go along the
way we are, but the Commission is not prepared to tell you what
we should do. We are hoping that we will have established enough
credibility with you that you will give us a little time to take a look
at this. We do have some machinery set up to look systematically
at these options, each of which would produce more standardization
than we have today, at increasing cost to the public, and be allowed
to come back to you with some recommendations when we have
done our homework, instead of trying to do the recommendations
without the study.

We are in agreement with your basic proposition, Senator.

Chairman Glenn. OK. When could we expect that advice?

Mr. Selin. We would do a first cut by the end of the year to
make sure we understand the options and that we're in the right
ball park; and then, depending on how hard this study was, it
might take another 6 months to a year to do properly. We want
some outside help on this. We aren't really qualified to do this
study internally.

I'm sure my colleagues have opinions on this topic as well, Mr.
Chairman.

Chairman Glenn. Yes. I want to get everybody's opinion on this.
Mr. Rogers, let's start with you — and I'd like these to be your own
personal opinions. I know you haven't sat down and taken a vote
on what you are going to say — or, I hope you haven't taken a
vote — this morning. I'd like for these to be your own opinions.

Mr. Rogers. No, we haven't voted — at least, not to my knowl-
edge.

Chairman Glenn. You've been there longer than any of the rest
of these people, so cut them out of the pattern and give me your
personal advice.

Mr. Rogers. I'd like to say that I really think the Chairman has
said very well what is a reasonable approach here. I don't think we
have considered all the possibilities. In my mind, there is a need
for a standard approach nationally; that doesn't exist. It makes no
sense to me at all that the same kind of radiation is regulated in
totally different ways depending upon how it is created — whether
it comes from a Cobalt source, or whether it comes from a linear
accelerator makes absolutely no difference with respect to how it
ought to be regulated from a health point of view, in my opinion.

Exactly what the best way to do that is, I really wouldn't want
to make a recommendation at this point. I think it does need con-
siderable study. But it is very clear that there is, in my view, an
absurd situation in the United States that is not common in other
places in the world where radiation is treated as radiation from a
health point of view, and regulated uniformly.

I myself have not come to a conclusion as to whether States or
Federal ways of regulating are best; I think the Chairman has ex-
pressed one very good argument for turning some of these things
over to the States. My own personal experience over the years in
dealing with State governments has been that there is a high vari-
ability in quality and competence in highly technical matters
among the different States; they have very different financial and
human resources, and very different abihties to deploy these re-
sources, depending on the size of the State, its technical sophistica-
tion, and so on and so forth.

I myself would favor some kind of uniform standards established
at the National level, but exactly how those would be administered,
I'd say is something I personally am not prepared to make a rec-
ommendation on.

Chairman Glenn. Mr. Curtiss?

Mr. Curtiss. I share the Chairman's view when it comes to the
regulatory jurisdiction over these activities. That is a fairly com-
plex subject, and I think the Commission's view is that we ought
to take a careful look at that question. There are several groups
that have an interest in this — the Conference of Radiation Control
Program Directors is the organization of State officials.

Picking up on your comment that a study in Washington can go
on and on and be an excuse for not doing anything, I do think there
are some things that can be done in the relatively near term. The
Chairman mentioned the discussion with FDA on the memoran-
dum of understanding. I do think we need to take a look at the
agreement State program and make sure that that current pro-
gram is functioning the way it ought to.

But over the course of the rest of this year, I think what you are
hearing is that the Commission is dedicated to focusing on what
the pros and cons are of the various options and bringing this issue
to a head.

Chairman Glenn. Ms. de Planque?

Ms. DE Planque. I'd like to make some general remarks in this
area. First of all, I think it is extremely important to depend on
international standards and internationally agreed-upon standards

when it comes to issues of radiation safety in general, and what is
safe. There are several standard-making bodies, but basically this
advice comes from the ICRP and is looked at in the United States
by the NCRP, the National Council on Radiation Protection and
Measurements. And I would agree with what some of the others
have stated. Commissioner Rogers in particular, that I personally
feel that radiation protection standards and what levels are safe
should be set at a national level.

Now, these don't involve just the area of health that we have
been talking about today, but they involve several complex areas —
as you mentioned earlier, cleanup of a contaminated site, for exam-
ple. So that setting what is safe covers many areas in addition to
health.

What we are seeing is that in the health area as in some of these
others, various government agencies are involved. In the past, we
had the Federal Radiation Council that set some of these stand-
ards. We don't have that now. We have had other groups like the —
CIRPPC is what it is called — which has not been effective as I
think many of us would have liked. These bodies need the strong
support of all the Federal agencies involved in order to make them
work.

Once you get past the concept of setting standards for what is
safe, be it for the worker, be it for the patient, be it for the public,
then we get into the problem of implementation. And here, I agree
with my colleagues, at least in the health area; we are looking at
a number of things right now, and I think it takes a good deal of
consideration to come up with a proposal that would be the best
in terms of implementation, implementation then being things like
notification, records, enforcement.

Here agEiin, add economics and resources into the picture as well
as exactly how you go about actually protecting the workers, the
public and the patients.

Chairman Glenn. Well, the reason I get a little short-fused on
some of this, with all due respect — and this goes back a long way —
but this is a letter from the NRC to me when I was Chairman of
the Subcommittee on Energy, Nuclear Proliferation and Federal
Services. To indicate how long ago this was, March of 1979, my
ranking minority member was Senator Jake Javits of New York.
The letter was to me as Chairman of that Subcommittee, and I
won't read the opening, but the second paragraph reads: "Following
an investigation of the teletherapy overexposures at Riverside
Methodist Hospital in Columbia, 1) NRC in agreement States noti-
fied all teletherapy licensees to check the csdibration of their units;
2) NRC in agreement States made independent checks on the cali-
brations of licensed teletherapy units; 3) NRC published proposed
and final rules requiring its medical licensees to a) calibrate each
teletherapy unit annually, b) perform monthly spot-checks on tliose
calibrations (NRC expects the agreement States to adopt similar
requirements for their licensees)" — and then says these apply only
to the ones in NRC agreement States, of course — "and in a not un-
related rulemaking procedure, NRC proposed that all medical li-
censees 1) keep records of all misadministrations of radiation mate-
rial and 2) promptly report potentially dangerous mis-
administrations to the NRC, to the patient's referring physician,

and to the patient or the patient's responsible relatives. We have
received approximately 150 comments, the vast majority opposed to
the rulemaking, and are presently analyzing these comments for
the Commission as part of the final rulemaking procedure."

Here we are in 1979, 14 years later, and we are analyzing the
process here as to what we should do. That's the reason why I get
so upset when something like this comes up. So I don't know where
we go with it now.

Let me go further. The legislation I referred to

Mr. Selin. Could I say something, Senator?

Chairman GLENN. Just a moment, and I'll ask you to comment
on this, too. This is just a little summary of what we proposed way
back. It was Senate Bill 1938 in 1979. "The Federal Radiation Pro-
tection and Management Act of 1979 ensures adequate protection
of workers, the general public, and the environment from harmful
radiation exposure; to establish mechanisms for effective coordina-
tion among the various Federal agencies involved in radiation pro-
tection activities; to develop a coordinated radiation research pro-
gram, and for other purposes." It was introduced on October 24,
1979 and referred back to this Committee, but because of Executive
order action at that time, we never went ahead with it.

I would like to trot this out and send it over to you and see if
you think it could be the basis for something — or maybe it could
be the subject of another Executive order now. I don't know, but
I want to do something, because I think we're all over the lot on
this right now.

Mr. Selin. Well, I just want to say three things. First of all, per-
sonally, I think the Commission is quite sympathetic with the gen-
eral thrust of your comments. As far as the specific 1979 letter you
read from, we fixed every one of those in terms of our standards
and our rules. We have not done as complete a job, but we will in
executing according to those. And there has been opposition every
step of the way. For instance, the Office of Management and Budg-
et refused to approve our quality management program, and we
just overrode them. We said we are going to do this in spite of that.
So there has been opposition, but on the other hand, it is possible
to make progress.

There are two points I would like to make, sir. First, I completely
agree with Commissioner de Planque's points about running off
international and national standards — but standards aren't the
problem here, whether we have a CIRPPC or a Federal radiation
policy. We already know how to do a lot better than we are doing —
we, the United States, including but not limited to the NEC. I'd say
90 percent of the problem is coordination and execution, not setting
standards.

So the question that I brought up on behalf of the Commission
in the testimony, which is what is the best way to integrate these
different areas of radiation therapy, I think is the critical question.
To the best of my knowledge, the NEC has never broached this
issue with the Congress before. It was broached in a number of
other places, including the newspaper articles. But we have taken
this to heart. We think this is the right question, and we can do
better. But we are polishing up the last 10 percent of improvement
on 25 percent or fewer of the procedures, and we think it is time

to spread the aggravation to the other practitioners, not just to the
people that we regulate.

Chairman Glenn. Well, how do we get all the aggrieved parties
together so we can protect the people out there? That's the prob-
lem. And I realize you go back and forth with turf problems and
things like that, but that's very little solace for someone out there
who has gotten overexposure or isn't protected when they go to the
hospital.

Mr. Selin. Mr. Chairman, three-quarters of our orders, two-
thirds of our enforcement actions agency- wide have to do with med-
ical regulation. If it were a turf problem, I would gladly turn it over
to somebody else. It is really what is the best way to protect the
general public, and as we said, there are a number of ways to do
it, all better than what we have now.

Chairman Glenn. All right. Thank you very much. I appreciate
your testimony. Let me do one other thing. I would hope we could
speed up the report between now and the end of the year. This has
been studied since 1979 by various and sundry people, and I hope
it isn't the end of the year before we can get your counsel and ad-
vice on this.

Mr. Selin. We will undertake to give you a preliminary report
probably in 3 months. Whether we have all the t's crossed and the
i's dotted — I am sure you are right that it is really not a question
of studying; it is a question of how much does the Federal Govern-
ment want to see invested in one of hundreds of areas of health
and safety, and that's really not our question to answer. So we'll
do the best we can.

Chairman Glenn. That would be by August 6th. Can we get
your report by August 6th?

Mr. Selin. Mr. Chairman, your will is our command. Of course,
you can.

Chairman Glenn. All right. I would like to get moving on this,
because if it turns out that we need legislation to do anything, then
I'd like to get it through this year. I don't want it to be next year.
Once we do get beyond the August break this year, being a non-
election year, it gets awfully tight to get things on the floor or even
though committee, because we're up against appropriations and au-
thorizations bills, and time gets tight over on the floor. So, I am
serious. If you can do it, or even if you can beat August 6th, I'd
appreciate it, because well have to get things going here if there
is to be any legislation in this regard.

Mr. Selin. What we can do is give you the first cut of the Com-
mission's deliberations on this point. If it is pretty much open and
shut, you may decide you have enough. But we need to talk to the
affected parties. We cannot have the NRC coming to the Congress
without talking to the States and the other agencies, telUng you
what we think you ought to do with them; that's just suicide.

Chairman Glenn. I understand. Thank you. I don't know what
day of the week August 6th falls on, but let's make it Friday of that
week; how's that?

Mr. Selin. Yes, sir.

Chairman Glenn. We look forward to working with you.

Mr. Selin. Thank you very much, Mr. Chairman.

Chairman Glenn. Thank you much.

Chairman Glenn. We'll hear next from Dr. Bruce Burlington, Di-
rector, Center for Devices and Radiological Health at the Food and
Drug Administration. Dr. Burlington, we welcoirre your testimony
this morning. Your entire statement will be included in the record
if you choose to give an abridged version thereof We understand
you are accompanied today by Ronald M. Johnson, Director, Office
of Compliance and Surveillance, Center for Devices and Radiologi-
cal Health; Marvin Rosenstein, Director, Office of Health Physics,
Center for Devices and Radiological Health; and Donald Hamilton,
Radiation Policy Advisor, Office of Health Physics, Center for De-
vices and Radiological Health.

We welcome all of you this morning, and Dr. Burlington, if you
would proceed, we would appreciate it.

TESTIMONY OF DR. D. BRUCE BURLINGTON,^ DIRECTOR, CEN-
TER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND
DRUG ADMINISTRATION, ACCOMPANIED BY RONALD M.
JOHNSON, DIRECTOR, OFFICE OF COMPLIANCE AND SUR-
VEILLANCE, CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH; MARVIN ROSENSTEIN, DIRECTOR, OFFICE OF
HEALTH PHYSICS, CENTER FOR DEVICES AND RADIOLOGI-
CAL HEALTH, AND DONALD HAMILTON, RADIATION POLICY
ADVISOR, OFFICE OF HEALTH PHYSICS, CENTER FOR DE-
VICES AND RADIOLOGICAL HEALTH

Dr. Burlington. Thank you very much, Mr. Chairman.

We are pleased to be here this morning. Mr. Chairman and mem-
bers of the Committee, I am here today to discuss the role of the
Food and Drug Administration in helping to ensure that radiation-
producing medical devices, particularly devices used in radiation
therapy, are safe and effective.

Before I begin my testimony, I would like to announce that 2
days ago, acting in behalf of FDA, the U.S. Attorney in Houston
carried out a mass seizure of Omnitron Model 2000 radiation ther-
apy devices. Our inspection of this firm in December of 1992 re-
vealed numerous violations of good manufacturing practices.

We acted promptly with the State of Texas to halt the shipments
of products from this firm. We carefully considered how to pros-
ecute this case, and in January we moved to seek seizure. This sei-
zure is clear evidence of how seriously we are taking violations of
medical device law. We will not tolerate the failure of manufactur-
ers of critical products such as radiation therapy devices to risk the
pubHc's health by ignoring basic quality control as they go about
making their products.

We are inspecting other radiation therapy device manufacturers,
and we are clearly telling them all to report promptly adverse
events to us.

As I begin my testimony, let me explain that I am new in the
position as Center Director, having served only a little oyer 2
months. So I am accompanied today by staff who can provide insti-
tutional memory and a deeper perspective on our Center's program.

With respect to radiation-producing devices, FDA's job is to be
sure that they are safe and effective, are properly manufactured,

1 The prepared statement of Dr. Burlington appears on page 65.

and perform their intended function. Once these products are mar-
keted, it is also our job to take action if they are found to pose un-
anticipated hazards.

Radiation therapy devices are the primary focus of this hearing
because when radiation treatment is not deHvered properly, the
consequences can be very serious, or even fatal, as the cases you
have brought to our attention illustrate.

Let me emphasize, though, that as a practicing physician, I un-
derstand radiation therapy is very useful in treating and some-
times even curing some cancers. It has real risks, but it also has
real benefits, and the benefits far outweigh the risks in general.

Nonetheless, several highly-publicized incidences in which pa-
tients have been injured have occurred over the past few years.
These have been caused both by device failures and more com-
monly, by user errors. I know these events have captured the at-
tention of the Committee, and they are of great concern to us as
well.

The jurisdiction over devices and their components of use extends
across two Federal agencies as well as each State Government, as
we have already heard this morning. Who does what with respect
to controlling radiation products has been discussed, and I don't
want to go into that in more detail. But let me point out that FDA's
role under the statutory scheme is to see to it that radiation-emit-
ting devices are designed, tested and manufactured to be safe and
effective.

In other words, our primary job is to regulate radiation therapy
equipment. We deal principally with the manufacturer of the de-
vice, both before the device is marketed and afterwards, if problems
should arise. I will briefly summarize what we do to help assure
the safety of radiation therapy devices. I will also point out where
we would like to strengthen our regulation of these products. Then
I will describe for you ways in which we are seeking to better as-
sure the safety of patients who are undergoing radiation therapy.

We engage in three basic activities related to radiation therapy
devices. First, before a manufacturer can market a new radiation
therapy unit, we require that they submit data to us demonstrating
that the device is safe and effective. This includes the computer
software and accessories intended for use with the product. Second,
we inspect firms who make devices, to be sure that manufacturing
processes and quality control are in place to assure a well-manufac-
tured product. And third, once the product is on the market, we
monitor problems that may occur in use, and as necessary, we take
action to correct them.

These corrective actions range from alerting physicians about po-
tential hazards to requiring product recalls, or even seizures, as is
appropriate. Problems are brought to our attention because manu-
facturers and now, more recently, users, are required by law to re-
port to us when serious mishaps occur.

Since other agencies have at least partial jurisdiction over radi-
ation therapy devices and also receive such reports, it is important
that we coordinate our efforts with them.

As I gmalyze our programs in this area, it is clear to me that
some have been more effective than others. I think we are doing
a sound job of evaluating the safety and effectiveness of new radi-

ation therapy devices before permitting them to go on the market.
Likewise, I think our inspection system is basically sound. We do
want to get into plants more frequently, but we have in place the
program for inspections and the authority to deal with problems in
manufacturing.

My chief concern lies in our ability to be informed about prob-
lems with these devices as they arise in the real world of radiation
therapy. We need more reports from manufacturers and users,
promptly identifying serious incidents.

Finally, our communication with other Government agencies at
the Federal and State level needs to be both rapid and comprehen-
sive. Communication is a critical area. When we review a new
product that a company wants to bring to market, we apply sound
engineering and scientific analysis to the data on its design and
performance — but new devices are often very complex systems, and
unforeseen risks will always be with us. We can never be sure that
life-threatening incidents won't occur once the product is in wide-
spread use. Therefore, we must rely on quick and efficient report-
ing of adverse incidents in order to take action before even more
serious or more frequent events happen.

With that in mind, Mr. Chairman, I would now like to turn to
several actions that we have taken to improve our ability to find
out about problems with radiation therapy devices at the earliest
feasible stage.

We are requiring new user facility reporting of adverse events.
These new regulations which, through notice and comment, are
nearly ready as final rules will now require that medical facilities
report device-related deaths, serious injuries or serious illnesses to
us. Up to this time, device manufacturers have had to report what
they knew, but we have actually had little information from the
point of use. The new requirement will also increase the informa-
tion content in reports.

We welcome the citizen reports you have received. This is the
type of input we need to find problems quickly. We will, of course,
analyze those reports and give you the results of that analysis.

At this point, I would also like to let you know that on June 3rd,
FDA will announce its new "Med- Watch" program. This is a
streamhned system that will enable radiation therapists and radi-
ologists, as well as the entire array of other health professionals,
to report adverse events for both drugs, biologies and devices to the
agency directly and expeditiously! We think that this will substan-
tially enhance reporting by practitioners.

As a second action, we will notify all dealers, importers, manu-
facturers, and distributors of radiation therapy devices about their
obligation under the law to report to us, and about the criteria they
must use in deciding when a problem is reportable.

Third, we are actively seeking a memorandum of understanding
with the Nuclear Regulatory Commission, which will cover medical
devices using NRC-licensed radiation sources. The memorandum
will address prompt problem notification, coordination of investiga-
tions, and information exchange between the two agencies.

Formalization of our longstanding relationship should improve
the speed and effectiveness with which our two agencies commu-
nicate about radiation therapy device problems.

Fourth, we will reassess our communicating with the State regu-
latory authorities. Although we have always worked with the Con-
ference of Radiation Control Program Directors, and directly with
the individual States in investigating cases in their jurisdictions,
we want to be sure we are regularly relajdng information to the
States on problems occurring elsewhere.

Our fifth action goes beyond these improvements in our ability
to receive and transmit information. Last year, we also stepped up
industry-wide inspections of radiation therapy manufacturers.
These inspections will include a check on whether manufacturers
are reporting problems to us which they have in their files, as they
are required to do.

In conclusion, Mr. Chairman, we share your concern about radi-
ation therapy accidents, and we are taking steps attempting to re-
solve that concern. The actions I have described today should give
us a better early warning system; they should also enhance com-
munication among FDA, NRC, and the States.

Let me note we are not taking these actions in isolation. They
are part of a larger, overall effort to improve the way FDA regu-
lates all medical devices. Our Center is sharpening the criteria for
new product evaluation. We are improving our surveillance system
to detect and evaluate marketed device problems. We are seeking
enhanced problem reporting, and we are taking swift and decisive
action against those who violate the law.

Thank you, Mr. Chairman. That concludes my prepared remarks.
We welcome any questions.

Chairman GLENN. Thank you very much.

Do any of the other gentlemen have any comments to make be-
fore we proceed with questions?

[No response.]

Chairman Glenn. All right. Thank you.

The FDA,, Dr. Burlington, defines "serious injury" as "an injury
that is 1) life-threatening, 2) results in permanent impairment of
a body function or permanent damage to body structure or 3) ne-
cessitates medical or surgical intervention."

But when a person is accidentally exposed to a dose of ionizing
radiation, it doesn't have an immediate clinical effect, but it none-
theless can likely contribute to cancer later in life. Does this clas-
sify as a "serious injury'7

Dr. Burlington. Mr. Chairman, that is a difficult way to work
through the definitions. Fortunately, under the statutory scheme,
we also have authority to require other significant events be re-
ported to us even if they are not immediate, palpable injuries.

In looking at our user reporting regulation, we are trying to find
a way to make sure that we get those over- £ind underexposures
reported to us through this additional authority.

Chairman Glenn. Well, is that classified then as "serious injury"
or not?

Dr. Burlington. Serious injuries are, as you have noted, broadly
classified by FDA to be cases that require intervention of some
type, or result in permanent disability or death. Rather than say-
ing that these are serious injuries, it makes sense to me for us to
say these are significant additional events that we need to know
about, and there is a probability that the patient may eventually

turn out to be injured, but that is not anything that is clear and
present today.

The effect of that will be to make sure that we get the informa-
tion so that we are in a position to analyze it.

Chairman Glenn. I understand the difference, and I won't press
it, but it is a difficult situation, because one is a danger now as op-
posed to "may be," and we don't know what may be down the line.
I would think there ought to be some way that that has to be con-
sidered, so we can make sure people are notified.

Dr. Burlington, Absolutely, we agree, Mr. Chairman.

Chairman Glenn. You are reorganizing, I believe, the Center for
Devices and Radiological Health; is that correct?

Dr. Burlington. Sir, we have undertaken a reorganization with-
in our Office of Compliance and Surveillance just recently, on a
pilot basis, and we will be continuing that, so that we are orga-
nized within this office along lines of business.

We do not have in process an overall reorganization of the Center
at this time.

Chairman GLENN. OK. I understood the Center for Devices and
Radiological Health is being reorganized in part to improve post-
market surveillance and to develop patient notification programs.
You are saying that isn't the case?

Dr. Burlington. We are in the process of looking very hard at
how to do a good job on that. Right now, we are organized in such
a way that those programs are integrated through a matrix involv-
ing four different offices. And we need to make sure that we cover
the functions, that we properly coordinate the information. Wheth-
er that will result in structural changes in organization, or whether
it will make sure that we have cross-structure reporting is not yet
decided.

Chairman Glenn. But whatever you do, I presume that this re-
organization will also address medical devices that produce or uti-
lize radiation.

Dr. Burlington. Absolutely.

Chairman Glenn. OK, What aspects of patient notification will
you also look at? How will this be coordinated with NRC's patient
notification of misadministration? Will you coordinate with them if
you are setting different standards, or reorganizing that group?

Dr. Burlington. Let me address that in two parts. In terms of
the question of what is an under- or overdose in terms of the ad-
ministration of radiation, we intend to coordinate that very closely
with the NRC so that we are using a uniform reporting standard
for practitioners so that they don't have to have different rules for
different Federal agencies and can understand that one level is the
threshold at which they need to be reporting.

The separate question in terms of how we will coordinate patient
notification, our statutory scheme provides us with authority to re-
quire patient notification where it is necessary and there are no al-
ternative methods feasible to mitigate the effects of the adverse
event. We have not routinely undertaken patient notification in the
past. Clearly, over the last couple of decades, with the changes in
practice of medicine, there is a changing expectation on the part of
patients and the medical community about getting the information
to patients. We have moved more toward patient notification. We

have done that in a number of cases where the patient needed the
information in order to take action that would affect their risk of
the adverse event. And we are carefully considering how we ought
to apply that in the case of inappropriate administration of radi-
ation.

We also have to be cognizant of the fact that we don't want pa-
tient notification to be a trip-wire or a signal that gives physicians
pause and reduces reporting to us of events, because if every doctor
thinks that I report to FDA, and I am immediately inviting a
bunch of lawsuits, then we aren't going to get the reports we need
to find out what is going on.

Chairman Glenn. Have misadministrations been followed on a
regular basis by lawsuits?

Dr. Burlington. I don't know the answer to that. Senator.

Chairman Glenn. Does anybody know?

Mr. Johnson. Frequently, it has, yes. Senator.

Chairman Glenn. Even though we don't know what the effect of
it may be.

Mr. Johnson. That's true.

Chairman Glenn. FDA has established radiation control per-
formance standards for television and diagnostic x-ray systems, la-
sers, microwave ovens, and even tanning beds. Why hasn't the
agency established such standards for linear accelerators, which
are far more dsuigerous?

Dr. Burlington. Somewhat over a decade ago, we established
notice of intent that we were going to do exactly that. We received
resoundingly negative input, and in fact were advised- —

Chairman Glenn. From whom?

Dr. Burlington. From the community, principally practitioners.

Subsequent to that, we have become aware that today, products
coming through for marketing approval are uniformly manufac-
tured in accordance with the lEC, the International Electro-
technical Standards, because they are in an international market-
place. If one should come through that did not meet that standard,
we would reinforce the standard by asking the same types of ques-
tions in the review process that the standard is designed to meet.

So we have de facto adopted that standard even though it is not
a required performance standard.

Chairman Glenn. You are saying, then, that you in effect have
adopted the international standards, £ind you want everybody to
adhere to that. Do you check, then, to see whether they do adhere
to those standards?

Dr. Burlington. We look at the applications that they submit to
us to ensure that they have committed to adhere to them. We have
an inspection system that addresses the manufacturing principles.
We also have a BIMO system that, in complement with our manu-
facturing system, is designed to assure that there is valid informa-
tion submitted to us.

In terms of do we go and do an engineering quality assessment,
engineering drawing level, no. We are not staffed at that level, and
we don't have the capacity to deal with every application.

Chairman Glenn. Well, if you have a doctor out there using a
linear accelerator to treat someone therapeutically, how do we
know that that machine is within the international standards? Is

there any checkup on this? Are there requirements for measure-
ments to be made or assessments to be made of individual pieces
of equipment over a certain period of time?

Dr. Burlington. As was addressed earUer in Mr. Sehn's discus-
sion and the colloquy, there is a network of regulations through
State authorities in terms of the user point administration of radio-
therapy; that principally, this is an activity regulated through the
States — it does vary, depending on the type of radiation being de-
livered; it is different for linear accelerators or naturally-occurring
sources than it is for byproduct sources. Obviously, for byproduct
sources, the NRC has an active role in assuring that the medical
device is performing appropriately on site. For the others, it is a
State responsibility.

Chairman Glenn. Well, do you think that's the best way to leave
it? Maybe you don't have the facilities right now, but do you think
you should be doing follow-up? Because the improper or unauthor-
ized use of these linear accelerators' safety bypass system in the re-
search mode has led to a number of serious injuries. Do you know
what the purpose of that safety bypass switch is?

Dr. Burlington. No, sir, I don't know.

Chairman Glenn. Mr. Hamilton?

Mr. Hamilton. Basically, in many of these linear accelerators,
the machine is capable of not only doing patient work, but also re-
search applications as well, and many times, what the manufac-
turer or the user would Hke to be able to do is to use that machine
to determine whether there is improved methodology for treating

patients.

So the machines have a bypass whereby you can actually get
more energy out of the machine for particular research. We are
aware of that. Again, one of the criteria we would want to see in
the applications that would come in to us would be ways to prevent
that bypass from being used, even accidentally, in treating a pa-
tient.

Chairman Glenn. There is no restriction on that now— you just
leave it up to the individual doctor?

Mr. Hamilton. Basically, it is left up to the user to use, again,
with the labelling instructions that we do review to show that there
is some way of not letting that thing accidentally happen.

Chairman Glenn. Are any of these machines designed so you
could cut out the research mode when it is being used on patients?
Is such a thing possible— because that is where the accidents have
occurred, as I understand it.

Dr. Burlington. Mr. Chairman, I don't know how it would be
possible for a machine to distinguish between whether it was being
turned on for patient use or for research.

Chairman Glenn. Well, it could be done any time it is being
used for a medical therapeutic purpose, though — you'd throw the
therapeutic switch, and that prevents anything else — I don't know.
I haven't even seen one of the machines — and I am not making
light of it at all, but there ought to be some way to do that, because
that is where some accidents have happened with these machines.

Dr. Burlington. Yes, sir. The operation of these machines is
fundamentally the responsibility of the unit and the institution in
which they are being operated. We rely on sound medical practice.

sound radiation safety practice on behalf of the professionals who
are operating them and the institutions that are overseeing that,
including the State licensing, to the extent that that is relevant, to
make sure that

Chairman Glenn. When you approve a machine like this to be
sold, Doctor, do you require any warnings that the research mode
on these machines not be used when the machine is being used for
therapeutic purposes?

Dr. Burlington. Let me again ask Mr. Hamilton to address the
labelling issue.

Mr. Hamilton. Again, we rely upon the user to determine how
the machine is to be

Chairman Glenn. No — do you give the user a warning that this
could be dangerous if it is used that way? That's the question.

Mr. Hamilton. Normally, you would find something like that in
the operator's manual, yes, sir.

Chairman Glenn. Do you require that kind of warning in an op-
erator's manual?

Mr. Hamilton. I don't know honestly whether it is required or
not, but it is something we know all the reviewers would be looking
for as they would go through that submission.

Chairman Glenn. It might not be a bad idea since we have had
problems in that area already.

When FDA is alerted to a serious problem with a medical device,
what steps are taken by FDA to alert other users of the device of
that problem?

Dr. Burlington. The first thing we do when we get a report is
take a look at it and analyze it and try to sort through whether
we have a user problem or whether we have a device problem, and
that leads us to a number of consequences in terms of developing
further information.

In terms of our network of how we communicate to other in-
volved parties, let me ask Mr. Johnson to address this.

Mr. Johnson. Generally, if we get a report, when we speak of
users, we are usually thinking of the health care worker or the in-
stitution. When we find that there is a problem that is deriving
from a defective device, our immediate concern is notifying, making
sure that the other users — hospitals, physicians, whatever — are
aware of those problems. That can take the form of what we call
"safety alerts" that are issued by the company; safety alerts that
are issued by us if it is a generic, across-the-board kinds of prob-
lem; or actually a recsdl notice that would involve both a notifica-
tion and a correction if there is a defect to the device.

Chairman Glenn. We have a similar problem on fluoroscopy x-
ray devices, similar to the linear accelerator. On the fluoroscopy x-
ray device, they have so-called "turbo switches," which allow the
user to drastically increase the dose to obtain a clearer image; but
as the dose increases, so does the risk to the patient. I don't know
whether you monitor things like that when you assess a machine.
Do you put limits on it, or redline it, or once again, provide instruc-
tions so that it can't be misused? I guess the purpose of a turbo
switch is to obtain a clearer image, but there should be certain lim-
its there so that you can prevent misuse. Is that something you get
into?

Dr. Burlington. Mr. Chairman, you are correct. The purpose of
these high-level energy switches is to allow a clearer image so that
certain diagnostic applications, principally in cardiology, can get
clearer images and can operate more efficiently. Because of concern
about this issue and the patient exposure involved, on the 3rd of
this month, we proposed regulations that would put limits on these
switches in order to enhance patient safety when they are used.

Chairman GLENN. OK. We have a February 20, 1992 GAO report
on FDA device inspections which found that, "FDA does not meet
its minimum statutory obligation to inspect manufacturers of me-
dium and high-risk devices at least once every 2 years." They con-
tinue, "GAO also found that the frequency of inspections has been
declining in recent years" — I don't know whether that is a budget
problem or what it is. "Further, foreign manufacturers must also
be inspected by the FDA, but they have only been inspected about
once every 8 years."

Do you agree with GAO's findings, and what is being done to ad-
dress this situation?

Dr. Burlington. Mr. Chairman, as I noted in my remarks, we
are concerned; we want to be in those plants more often. We need
to have the resources to get there. The administration, cognizant
of the growing responsibilities of our Center, has asked in the
President's budget for $20 million of additional funds. We need the
bodies and those dollars in order to fully implement our program.

I'd like to ask Mr. Johnson to respond more fully to your ques-
tion.

Chairman Glenn. Fine.

Mr. Johnson. Yes, I think those numbers probably are accurate.
In the domestic area, to address that issue, what we have tried to
do is identify some priorities for our field investigators so that they
are at least getting to the most problematic of companies on a regu-
lar basis, reasonably regular basis. We think that has worked very
well. We have developed a number of initiatives that look at cor-
porate profiles, chronic violators, repeat offenders, if you will, mul-
tiple recalls. So I think that is making as good a use as possible.

We have found that the time it takes to make an inspection has
significantly increase because the complexity of these devices is al-
ways increasing.

In the foreign area, we recognize that there is an obvious weak-
ness in there— it is very costly, and it is very difficult for us to get
there. But in this last year, we have doubled the number of inspec-
tions that we have asked our field ofilces to carry out, and we are
being much more aggressive in enforcing the rules, using some very
powerful authorities to bar products from coming into the country,
and that has proven to be very beneficial as well.

Chairman Glenn. That same GAO report also found that FDA's
inspections were not coordinated particularly with market intro-
duction, which is the time when product design and manufacturing
problems are most likely to appear. For example, during fiscal
years 1987-90, one-third of domestic manufacturers with recalled
devices had not received an inspection within 2 years of their prod-
ucts being recalled.

Is that a factor, do you think? Do we need to address that?

Dr. Burlington. We think it is a factor, Mr. Chairman, and we
are prepared to address it. We are moving to have a pre-market in-
spection program that will be applicable to the most risky devices
that are approved under this mechanism.

Chairman Glenn. We understand that FDA and the NRC were
planning on negotiating a memorandum of understanding to assist
each other in regulating medical devices that employed radiation
therapy technology. Has this been done?

Dr. Burlington. We have begun discussions on such a memo-
randum. We have talked about the principles of hat we want to ac-
complish in it. Because it requires coordination among the various
centers that use radiation in human diagnostic and therapeutic is-
sues— that is, biologies, drugs, as well as devices — we are in the
process of coordinating that.

We have not yet gotten that memorandum, but we have dis-
cussed it. I met yesterday with Dr. Selin, and we are committed
to see this process through expeditiously.

Chairman Glenn. OK. Like how expeditiously? Can you give us
a time frame or a date by which you expect to have this done?

Dr. Burlington. I can make a commitment to you to work very
hard on it. Given the complexity of the situation and the fact that
it involves people who are in other areas of responsibility and other
centers, I would hesitate to make a commitment for their actions.

Chairman Glenn. Well, this isn't all that complicated. I wonder
if we could have that same August 6th date as a target date for
getting the agreement?

Dr. Burlington. We will certainly try.

Chairman Glenn. Because staff just passed me a note that says,
"This has been ongoing since at least 1984." That gives us 9 years.
It seems to me we ought to be able to get it here by August 6th,
since we have been considering it for 9 years. We'll look for that
as part of our August 6th reporting.

August 6th is a Friday, so that's fine. Staff tells me August 6th
is also Hiroshima day.

You have already addressed Theratronics. Can you go into that
a little bit? They have been a manufacturer of linear accelerators
and other medical radiation devices. I think it would be fair to say
that they have had a rather checkered history with regard to the
performance and their compliance with your FDA regulations.

Is the Theratronics equipment that you and the U.S. Attorney
seized in Houston — was that the company we were talking about,
Theratronics?

Dr. Burlington. No, sir. The company in Houston was
Omnitron.

Chairman Glenn. Oh, OK.

Dr. Burlington. But you are absolutely correct about the check-
ered history of Theratronics.

Chairman Glenn. OK. Let me address that. Theratronics has in-
dicated that they do not plan to provide spare parts support any
longer. What are you doing about that? This was investigated by
the House, also, when Congressman Dingell got into this some time
ago. What is the status of Theratronics now, and does FDA have
the authority to insist that Theratronics meet its obligation to the
hospitals that originally purchased the equipment for spare parts?

Dr. Burlington. I would prefer to refer this question to the Di-
rector of our Office of Compliance and Surveillance, Mr. Johnson.
Chairman GLENN. Fine.

Mr. Johnson. We have had, as you know, a lot of problems with
Theratronics products over the years. They are a Canadian firm,
and they have a subsidiary here in the United States, and we have
inspected both of those over the last several years rather exten-
sively. We have barred all importations of products from
Theratronics since 1991, with some expectations; those exceptions
were for parts.
Chairman Glenn. Everything, the whole works.
Mr. Johnson. Everything. We have just completed inspection in
February of the Canadian facihty, and we are now going to permit
entry of selected products, but not other products that they are con-
tinuing to do validation work on and have still to get their good
manufacturing practices into shape.

They are in fact permitted to import parts for repair and service
for all of their units at this point.

Chairman Glenn. But it's not that they are permitted. They
have said they are not going to; they do not plan to provide spare
parts. Can you require them to do that, because this leaves some
of our hospitals and others high and dry.

Mr. Johnson. I don't think that we can compel them, but my un-
derstanding from what we know is that they are continuing not-
withstanding their notification that service and parts may ulti-
mately go away on some of their older units.

Chairman GLENN. I would think most contracts would have a re-
quirement for spare parts within a certain time period, don't they —
quite apart from this or any other type of equipment.

Mr. Johnson. Yes. The products that are subject of these parts
needs are 30, 35 years old. Another source of service and parts are
third party reconditioners and refurbishers. There are a number of
them that I know specifically are very interested in Theratronics
products and have an active business in that area.

Chairman Glenn. Are things like this a problem with foreign
suppliers, not just from Canada, but from other places? We have
medical equipment and all sorts of equipment sold all over the
world now; do we have any more problem with foreign suppliers
than we have here with our own people?

Mr. Johnson. From the standpoint of continuing to provide
parts?

Chairman Glenn. Well, I mean just the general acceptability of
the product, doing what it says it should do, parts, the whole thing.
Mr. Johnson. We think the bottom Une measure is whether they
comply with good manufacturing practices, and in our foreign in-
spection program, we find that compliance is a little less than it
is in the domestic market, but not significantly worse, in other
words. So we think the products that are coming in are comparable
to domestic products, and Dr. Burlington mentioned in response to
your question on the GAO report that we do in fact do an inspec-
tion of every product that is brought to market under the PMA
process before it is permitted on the market, and we are going to
begin to do that on even the 510(k) Class 3, or the most problem-
atic devices.

Chairman Glenn. When you have foreign devices, let's say a big
x-ray machine, and it's a new type, do you send people over to in-
vestigate it at the plant, or do you have a sample sent here for your
analysis? What process do you use when approving a machine?

Dr. Burlington. These are pretty big devices, by and large, and
we don't generally get samples shipped in. We do onsite inspec-
tions, and that allows us not only to look at the product, but also
to look at the manufacturing control processes.

Our inspection and good manufacturing practices is a systems
approach where the company has to have the quality control sys-
tems in place in order to produce a quality product.

Chairman Glenn. Last year, Mr. Benson, then director of CDRH,
indicated before Chairman Dingell's subcommittee that he has, "in-
vited a review of our device evaluation and pre-market approval
programs by the HHS IG." Additionally, he said that the agency's
Office of Management, which oversees internal controls, and au-
dits, conducted under FMFIA, will take, "an independent look at
the way you do business."

What has been the outcome of those reviews, with specific ref-
erence to our topic here today of radiation control?

Dr. Burlington. I have to apologize, Mr. Chairman, I don't
know. We'll have to look into that, and we can get back to you.

Chairman Glenn. All right. If you could get back to us with that
information for the record, we'd appreciate it.

The President's budget seeks increased funding for FDA device
activities, by 24 percent; I believe it is scheduled for $153 million.
Is that correct?

Dr. Burlington. Certainly, he has sought an increase in fund-
ing. I will take your word for the dollar amount.

Chairman Glenn. OK. I think it is $153 million. Reportedly, this
increase is for "monitoring and inspection coverage to improve mar-
ket surveillance and to employ new enforcement authorities."

The question is if you receive this increase, if Congress approves
it, how will it affect the regulation of the devices we are talking
about here today? That's supposedly an increase of 24 percent.
What will you use that money for?

Dr. Burlington. We'll use that to implement principally the au-
thorities given to us under the Safe Medical Devices Act of 1990
as amended in 1992, where we have a number of new authorities
that are going to make a difference. We will also be ramping up
our inspection program, as we have earlier alluded to, in addition
to which we will have an increased capacity to review applications
as they come through, both re-establishing timeliness of review of
applications as they come through, and as well looking with en-
hanced scrutiny to make sure that they are meeting applicable
standards.

Chairman Glenn. You have an Import Alert List that is main-
tained by FDA. When a product is placed on that list, it is effec-
tively barred from being marketed in the United States, as I under-
stand it; is that correct?

Dr. Burlington. That is correct.

Chairman Glenn. Do you have any idea how many radiation de-
vices are currently on the Import Alert List?

Mr. Johnson. I don't know the number.

Chairman Glenn. Is it a large number — or none?

Mr. Johnson. No — there clearly are. Theratronics is on that list,
and Mitsibushi is on that list, some of the larger ones that we have
recently had problems with. But there is a list that is maintained.
I honestly don't know the number.

Chairman Glenn. I presume most of those products barred
would be on specific pieces of equipment, not a bar against every-
thing a manufacturer produces; is that correct?

Mr. Johnson. It frequently can be either or both, but generaliy
it is a bar against things coming in from that particular facility.

Chairman Glenn. Do you have certain standards you apply
when you check it out? What causes a radiation device to be placed
on the list — that's my question.

Mr. Johnson. Well, principally, the same reason that any oth^^r
medical device would get placed on the list, and that is usually a
failure to comply with good manufacturing practices. If they a-e
not manufacturing in a state of control their quality assurance pro-
gram, that's usually the primary reason.

Chairman Glenn. What do you do to ensure that once a product
is placed on the Import Alert List that similar devices which may
already have entered the domestic market are located? Do you keep
a record of those, or do you require the company to keep a record?

Mr. Johnson. Companies are required to keep distribution
records, so if need be, we can go to the companies and determine
where the products are. The threshold, however, for putting a com-
pany on an import alert, the statutory authorities are different. So,
while we may bar a company from bringing in new product, the
threshold may not have been met for us to go out and actively take
some action against products that are already in the country. They
may have been, for example, manufactured perfectly in compliance
with good manufacturer practices, and our most recent e\ddence in-
dicates that current operations are not in compliance. So there m£iy
not be any applicability to domestic products.

Chairman Glenn. In other words, the equipment is all right, but
it is being misused — is that what you meant?

Mr. Johnson. No. I am talking about the systems and the con-
trols in the actual manufacture of the device, to make sure that
what is manufactured is what is intended to be manufactured, that
it meets the specifications, that that is what it is supposed to do.

Chairman Glenn. There was a linear accelerator used in a Span-
ish incident. Is that on the list now?

Mr. Johnson. It is not on the Ust. That was an event that was
reported to us by General Electric. The episode was the result of
a service problem. We did work with General Electric to determine
whether that kind of a problem might exist in any of their other
facilities, and it was determined that that problem was not one
that was generic to the product line. It was a unique circumstance
in Spain, based upon service.

Chairman Glenn. The problem was there, but nothing occurred
here. That was a very important one, I think, because some 20 peo-
ple, I believe, were killed; is that correct?

Mr. Johnson. Absolutely. Yes, it was very serious. The problem
was that they had an unqualified service person in Spain come m
and service the unit, and in the servicing created a situation where

the machine could actually overdose. That kind of problem — the
users in this country were notified of the event, but there really
wasn't anything they could do because it had been improperly serv-
iced.

Chairman Glenn. Are service people certified? That just points
out the difficulty of this. How do you certify a repairman who can
misadjust or maladjust a machine, and kill 20 people? How do you
check up on that? Does that come under your regulation and fol-
low-up? Somebody needs to be looking into this stuff. We had 28
people in Ohio, 20 in Spain.

Mr. ROSENSTEIN. The case in Spain was a service person who
was not qualified to repair the device

Chairman Glenn. I know, but who determines whether he is
qualified or not? That's the point.

Mr. ROSENSTEIN. He was qualified to fix the Cobalt therapy sys-
tems, and the staff there imposed on him to correct the other one,
and he should not have, so it was a misjudgment on his part to
even attempt to do something that he was not certified to do.

Chairman Glenn. Well, let's say the same thing happens right
here, in Kansas City. Do we have any regulations for controlling
that kind of thing here? How do we qualify repair people?

Dr. Burlington. We have FDA requirements for people who are
basically reprocessing and reftirbishing machines to put them back
in new condition and put them back on the market. In terms of the
service people for machines out on the market, that fundamentally
is the responsibility of the institution in which that machine is op-
erating and the States.

Chairman Glenn. Is that good enough?

Dr. Burlington. It leaves gaps, as you pointed out, Mr. Chair-
man.

Chairman Glenn. We have so many Federal regulations these
days that I'm hesitant to impose more. We just fought part of last
week on the floor over the EPA bill that I was managing on the
Senate floor, and part of the big debate last week was in this area
of rules and regulations. And I get more complaints about rules
and regulations from the Federal Government when I go back
home and have town meetings than almost any other complaint
that people have. So I am extremely sensitive to making more rules
and regulations, but it seems to me there ought to be some way
where machinery, maladjusted and misused by people with all good
intentions, can kill folks and should be regulated. We have already
had it at home in Ohio, and now we have 20 in Spain.

I would think that in your consideration and the NEC's consider-
ation of what system we are going to have in this country with re-
gard to use of radiation equipment, we have to consider some kind
of follow-up. Whatever we set up as a control program, I think it
has to include things like this — people maladjusting a machine,
which I presume was not obvious to the operators of the machine,
and wound up killing 20 people. I think that's something we have
to consider, too. I don't know how we do that. Do you have any sug-
gestions?

Dr. Burlington. It is a very difficult issue, and you are abso-
lutely correct; we get a lot of feedback as well that the American
citizens, the companies that manufacture these products, think

they are heavily burdened by the current regulatory system. Impos-
ing more requirements ought to be done on the basis of looking and
saying that this is a rational way to deal with the problem.

We have identified a problem, and we concur that this is a real
problem, and we share your concern about how to grapple with the
right answer.

Chairman Glenn. Well, first, you want to make sure the ma-
chines are as foolproof as possible, and then that the people are
trained, it seems to me, and then you don't want to make so many
restrictions that you can't use the machines for the very good and
beneficial purposes for which they are designed. So nothing is per-
fect. I had a background in aviation, and they used to joke that the
only way to never have an aviation accident is to keep everything
in the hangar and never get it out there and fly it. And that's a
little bit like where we are with this. There is a balance here that
has to be hit, but it seems to me that when people have already
been killed, that's a warning that we have to taJce some precaution-
ary measures.

You heard the discussion that I had with the NRC people a little
while ago about the Radiation Policy Council that President Carter
established, and I read off what I had proposed at one time. Is that
the way we should go? What is your advice on this? I'd like each
of you to address this as I did the previous panel. What do you
think we ought to do? Do we need some overriding authority on
this? When people have been killed, it is obviously a danger. This
isn't, "Take an Advil and call me in the morning"; this is really se-
rious. And it seems to me we have to have some kind of control,
and I don't know exactly what it is. You are the experts. What do
you propose?

Dr. Burlington. Mr. Chgiirman, the agency and the Departm.ent
to the best of my knowledge do not have a thought-through, consid-
ered opinion on this. We, like NRC, would be glad to grapple with
the question and see what we can come up with.

Chairman Glenn. Can you coordinate with them and hit thnt
August 6th date?

Dr. Burlington. We can certainly seek to have input to their do-
liberations and to coordinate with them.

Chairman Glenn. If you would, I'd sure appreciate that, because
if we are going to get something through this year, we have to have
your advice and counsel, I don't want to just pass something up
here from on high, as though we have all the magic answers. You
are the people who are going to have to make whatever we pass
work, so I want your advice on this, and any advice you can give
us this morning would be appreciated.

Dr. Burlington. We certainly will tiy. I must, of course, note
that we are at a relatively low level within the Department. We
have agency, Public Health Service, and then the Department ad-
ministrative structure above us. To develop a coordinated position
in that time frame is a commitment that, again, I would hesitate
to make on my own authority, but we'll provide our input to our
supervisors.

Chairman Glenn. Well, we sent the letter of invitation to the
Secretary over there, and she sent it to your level, so I presume
you speak for her. You can carry the word back that we expect the

Einswers by August 6th, along with NRC's answer, if you can pos-
sibly do that.

Dr. Burlington. We will certainly carry that word back, Mr.
Chairman.

Chairman Glenn. Thank you.

Mr. Johnson, what do you think — what do we need to do to cor-
rect this?

Mr. Johnson. I don't think I know the answer. I think you have
pointed out some very, very good questions on a lot of disconnects.
It is very frustrating for us, the one we were just talking about.
It is very frustrating for us to try to assure that a device is prop-
erly designed and then properly manufactured and will in fact per-
form safely and effectively, only to have it tweaked by somebody
who is unqualified, or used by someone who is unqualified. I think
that clearly is a gap that needs to be filled.

The disconnect between the level of user regulation for linear ac-
celerators versus Cobalt teletherapy is another obvious one that
needs to be addressed. I think some of that may be appropriately
addressed through legislation. I think a lot of it, because there is
always going to be overlay, can be done through some kind of a co-
ordinated effort — whether that is creation of a council on a tem-
porary basis to get the house in order, but not live forever; or per-
haps expansion and more formalization of the memorandum of un-
derstanding that we are developing with NRC to include some
other parties. That might be another way to do it.

Chairman Glenn. Mr. Rosenstein?

Mr. Rosenstein. Thank you. I am a representative from the De-
partment to the CIRPPC group, the Committee for Interagency Ra-
diation Protection and Policy Coordination. If you look at the char-
ter, the committee is limited to a coordination role. It serves a use-
ful purpose as a forum for discussion, but it does not supersede or
replace any authorities that the member agencies have. Therefore,
whatever authorities reside in the agencies are the authorities that
count, and they work together whenever they can to come to agree-
ment.

The issue of radiation therapy has not come before them, and in
my opinion would not be an appropriate issue for them, since it is
limited to a couple of agencies.

In my own personsd view — and this is all personal opinion — I
think the components for the regulation of these systems — and I
speak specifically of radiation therapy devices — exists. It exists be-
tween the NRC, the FDA's roles, and the State roles. They are the
parties that I think need to be brought together in some fashion.
I don't know how you do that through legislation, but the pieces
are there; they are just unsatisfactory.

So I would not look to the Radiation Policy Council or its current
version of that unless there is some major change in the charter,
and the committee or the council has authority to actually regulate
these devices, which is not the case at the present time.

Chairman Glenn. Mr. Hamilton?

Mr. Hamilton. I think that there are a number of authorities al-
ready present for the various agencies, both at the Federal and the
State levels, to utilize. I think that with perhaps improved coordi-
nation and communication between those agencies, a number of the

problems that have brought us here today may have been solved
beforehand, and we would not necessarily have been spending the
time.

Chairman Glenn. Yes, but I am a cynic on that approach, be-
cause we have been waiting since 1979 for this coordination that
we were told about in the letter that I quoted from. So I don't take
much solace, nor do I think the people out there who may get
overdosed are going to take much solace out of the fact that govern-
ment has to get together and coordinate. I think we may have to
push. I hope we don't. I hope this August 6th report gets some in-
formation on how we really can go at this and gives us some exam-
ples perhaps of what you are doing between now and August 6th
to hopefully get control of this thing.

Right now, there are just too many gaps. Just from the few anec-
dotal things we have pointed out this morning and some of the
comments, it is evident that something needs to be done to ensure
that people are better-protected out there. And like I said before,
I don't want to set up another committee or commission, and I
don't want to put in legislation — unless I have to. But we want
your advice on it. You are the ones who have to make it work.

Thank you very much. We may have additional questions for
you, and we'd appreciate your early reply so we can include it in
the record.

Dr. Burlington. We'll make every attempt. Thank you, Mr.
Chairman.

Chairman Glenn. Thank you very much, gentlemen.

Our last witness this morning is Aubrey Godwin, Chairman,
Conference for Radiation Control Program Directors.

Mr. Godwin, we welcome you this morning and look forward to
your testimony. I know you have been in the audience here all
morning, and I'm sure you have heard all the comments, so maybe
you can straighten out some of these things for us.

TESTIMONY OF AUBREY V. GODWIN,^ CHAIRMAN, CONFER-
ENCE FOR RADIATION CONTROL PROGRAM DIRECTORS

Mr. Godwin. Thank you, Mr. Chairman. I appreciate you and the
members of the Committee inviting the Conference to come and
offer some testimony.

You have my written testimony already, and I thought I might
go through and just hit some of the points that came up this morn-
ing.

Chairman Glenn. First, tell us what the Conference on Radi-
ation Control does. What is the organization, and what is its back-
ground?

Mr. Godwin. Each State that has a radiation control program,
the director of it is a former Conference member. The associate
members are people within the programs within the States. We
also have what we call affiliate members, who are other groups in-
cluding, in some cases, industry, in some cases, user groups, like
universities, for example, and some Federal people also appear in
that. But the actual voting members are the actual program direc-
tors for the radiation control programs in each State, which is typi-

' The prepared statement of Mr. Godwin appears on page 70.

cally in the health department, although in my particular case it
is a minor cabinet level.

Chairman Glenn. Thank you.

Mr. Godwin. Looking at some of the issues that came up this
morning, first of all, there were some comments relative to dental
assistants and their training. I think we need to recognize that the
training program in some cases is normally part of their dental as-
sisting training, and is not necessarily limited to radiation protec-
tion— and indeed in some cases, they can probably take the test for
dental assisting and fail all the radiation protection requirements
and still pass it. So you need to be aware of that.

Also, along the same line of training, with the exception of Wyo-
ming, all States have some requirement that says a general state-
ment of training for the users of ionizing radiation, i.e., they will
say the facility or the operator is required to train its workers. And
that's about as specific as it gets. So you do have that, and as we
address this, the numbers you were giving are probably those
States who certify additionally their qualifications; so there is cer-
tification and license, and it goes beyond that rather general state-
ment.

Chairman Glenn. But that's up to the State.

Mr. Godwin. That's up to the State. That is clearly-established
by the State.

Chairman Glenn. There are no national standards that

Mr. Godwin. Well, now, FDA had some authorities given to them
that they could put forward some advisory guidance that the States
could use, and they were to get back to Congress and make rec-
ommendations as to whether to make it stronger than advisory.
But I believe that is advisory; you might need to

Chairman Glenn. Well, I don't know if we need to go to Con-
gress— and I don't mean to interrupt your statement, but in some-
thing like this, I would think FDA would have full authority right
now to go ahead and put out an advisory as to what they think

Mr. Godwin. Oh, yes, they can put out an advisory, and they put
out a preliminary draft in the Federal Register, but I'm not aware
of it being finally finalized. It may have been, but I am not aware.

Chairman Glenn. OK. Go ahead.

Mr. Godwin. Another issue that came up was regarding individ-
uals who may have a record of not being fully open, or perhaps
even willfully violating regulations, or malpractice, if you would.
Even though the States, as a part of their general medical licens-
ing, chiropractic licensing and dental licensing, have the overall, if
you would, licensing authority, in some States the radiation pro-
gram, when they ask for a license to use radioactive material, they
do undertake to go back into the record and obtain information
from other States that they may be coming from, to see if they did
have a record of problems. And in the former State that I worked
with, Alabama, we would take a one- to 2-year prohibition perhaps
on giving them a license until they had established that they would
do things properly.

Chairman Glenn. But that is left up to the States, then; you can
do it or not?

Mr. Godwin. It is left up to the States. The NRC, I don't think,
has adopted that regulation. They could adopt that regulation

themselves and pick up information from States. For example, if
they were coming from an agreement State, they could ask about
it, but I am not sure they are doing that at the present time.
Again, that's related to the byproduct source and special nuclear
material.

Chairman Glenn. The Plain Dealer cases that I referred to ear-
lier, I think, are ones where they actually found two cases where
people had been felony violators in one State and just went over
to another State, got a job, and I think were in an official position
in the second State. We don't have any way of checking up on that.
Would your organization be one that could keep a centrsd file on
this sort of thing, or is that too voluminous?

Mr. Godwin. Well, we are looking at a similar operation relative
to industrial radiography. We discovered that you have to be very
careful to avoid the blacklisting characterization and character as-
sassination; you can pick up some interesting liabilities when you
approach this. And the only thing we would be able to do, I sus-

Eect, would be to pass on information where an official order had
een issued by some State, probably a court, and pass on a copy
of the court order. Otherwise, you are going out for character assas-
sination.

Along somewhat similar lines, compatibility issues came up.
Compatibility generates a lot of discussion within States because,
as always, the first question is. Do you mean "identical," or do you
mean "compatible"? Can a State adopt something more stringent,
then?

In relation to what came up this morning, you need to recognize
that in some cases, a State is ruled not compatible when it really
has nothing to do with health and safety. For example, my State
is found to be noncompatible. The issues involved, however, one of
them was a decommissioning bonding requirement, and the only fa-
cility involved was a university which nas to make a statement
rather than post a bond, and the statement says, "We will seek
funding if we have to decommission."

The other issue involved was emergency planning, and we have
no Hcenses that fall into that. So even though we are
noncompatible, it effectively has no meaning as far as health and
safety is concerned. Now, unfortunately, that is not true; there are
several States that do have some issues that need to be looked at.

Another area that we might want to look at is in the
nonagreement States, you may end up in a little worse situation
with regard to particle accelerators, because in the agreement
States, you do have a training program of some sort in existence.
In a nonagreement State, you have no assurance that there is a
training program of any type — in fact, in one State, there is no ra-
diation program. So there is less likely an opportunity to review
the use of a particle accelerator in a nonagreement State.

Now, turning to the particle accelerators for just a moment, part
of the problem in the use of particle accelerators is that the FDA
really licenses the device that has been installed in a room that is
not, if you would, part of the manufacture of the device itself. So
the bypass operation may take place as a result of the way it is
built into the room. It has nothing to do with the circuit diagram
of the piece of equipment that is installed, but has to do with the

way the safety equipment is connected to the doorways and things
that lead into the room.

Because of that, my testimony indicates that we see some real
need for the States to be closely involved in particularly looking at
the user end of it. In fact, I think the States in general would sup-
port things that would keep the States involved in looking at the
user end of it. We are very concerned that we don't lose that par-
ticular area. I think the States have a vital mission to play there,
and I think most of the States would also want to continue the gen-
eral licensing of the medical practice provisions, which is currently
the practice in this country.

You touched upon the service personnel. To elaborate just a little
on the situation you are going to find there, some States do regu-
late service personnel. Again, it is a State decision, as you heard
earlier. Service personnel may consist of people from the original
manufacturer; they may be a third-party supplier, or in some cases,
they may be the facility's own in-house service personnel. So you
then come into a real tangle of problems as to how to assure that
each one of those groups gets appropriate training before they actu-
ally do the work. And I think that, looking at the scope of it, you
can see it is a real tangle there that will have to be dealt with.

You also mentioned something earlier relative to the States com-
ing in and saying they need funding, and I will address this as my
personal thoughts rather than associate the Conference with it.

The approach that is being taken by NRC through their agree-
ment State program has some merit in that they say, "Look,
States, we don't give you a grant to be an agreement State, but you
can charge fees." And quite often, as you heard, the fees are less
than the NRC fees because of less overhead, less travel, and for
various reasons — less salary, too, I might add.

If, in establishing some proposal, you establish a requirement
that the States charge fees equal to some minimum floor value to
be used for those purchases, you in effect have guaranteed the
funding for the program without necessarily having a Federal pro-
gram established, but allow it to be handled through the State leg-
islature and be appropriated back to the program such that it
would be cheaper to run it at a State level, thereby again reducing
the overall cost at the Federal level.

Touching on those issues as a quick run-through, Mr. Chairman,
I am prepared to answer your questions.

Chairman Glenn. Thank you very much, Mr. Godwin.

It is my understanding that of the 29 NRC agreement States,
those States that have agreed under authority of the Atomic En-
ergy Act to assume regulation of byproduct material, only 16 States
have demonstrated their programs are fully compatible with the
NRC. Do you view that situation as serious, and what should we
do about it?

Mr. Godwin. Well, I think you almost have to look at it on an
individual, case-by-case basis. Some of them are serious, there is no
doubt about it, and I won't try to duck that issue at all. But as I
indicated in my earlier statement, in some cases, the items that are
noncompatible really have no effect because they don't address any-
thing that has taken place in the State. For a while, one State was
noncompatible because they didn't have certain import regulations.

The States don't really control import, but they didn't have that
particular general license, in effect. So you run into those kinds of
things. Others are far more serious.

Chairman Glenn. You could take the other tack, though, and
say that the public health and safety is impacted by the fact that
nearly half the agreement States don't have adequate radiation
protection programs, too.

Mr. Godwin. I think youll find that in most of the cases, al-
though they were noncompatible, that a finding of adequacy to pro-
tect public health and safety did exist.

Chairman Glenn. Well, OK I think unless you look at them,
though, and try to get them into compliance, you don't know.

Mr. Godwin. Yes. They need to be looked at, no doubt about it.

Chairman Glenn. You don't know whether someone is dangerous
out there or not, unless you look at it.

Mr. Godwin. You do have to look at it, that's absolutely true; I
agree.

Chairman Glenn. OK You mentioned this briefly, but according
to the Department of Health and Human Services, 27 States regu-
late radiographers, 21 States license radiation therapy tech-
nologists, 14 States license nuclear medicine technologists, 32
States certify or register dental hygienists to give x-rays. Is this a
logical way to protect the public health and safety? It is all over
the lot. I don't know what we should do about it. How do we get
this to become more standard? Who does it? Shall we leave it up
to the States and set some Federal guidelines and let the States
adhere to that, or what?

Mr. Godwin. I tend to think that the Federal Government sets
some general criteria and put it to the States to enforce it would
be the more logical way to go about it. I don't think involving the
Federal Government in day-to-day medical practice issues is the
way for us to do; I think that is really a State issue.

Chairman Glenn. Well, how consistent are the licensing proce-
dures? Let me just give an example. Do some States require that
radiographers pass a test or take a course before they apply for a
license?

Mr. Godwin. Some States do, some don't. It is not consistent.

Chairman Glenn. Let me ask this. Is it possible in some other
States for someone to just walk in off the street, apply for a
radiographer's license, and get it?

Mr. Godwin. I am not sure that they can get licensed, but there
are some States where they can walk in and start doing work.

Chairman GLENN. Do all States require a license to be a
radiographer?

Mr. Godwin. No, sir.

Chairman Glenn. They do not?

Mr. Godwin. They do not.

Chairman Glenn. So you don't need a license. I was putting an
extra step in there. You don't even need a license.

Mr. Godwin. Some States do not require a license; that's very
clear.

Chairman Glenn. Are you aware of any instance when a patient
has been harmed due to inadequate training on the part of a
radiographer or a radiation technologist? Are there examples?

Mr. Godwin. Well, other than the ones that have already been
mentioned, I'm not aware of any. When I was in Alabama, there
was a case where you'd have to decide whether it was inadequate
training or whether it was malpractice. We did have a patient who
was harmed by a technologist inappropriately doing some work,
and you'd have to make that evaluation as to whether you believed
that was malpractice or lack of training. She did not follow her di-
rectives, I'll say.

Chairman Glenn. What concerns me as much as anything else
is that we just don't know. We don't know the status of machinery
and people and training and their level of competency.

Is there a mechanism by which States can share data on medical
uses of radiation? For example, does a database even exist that is
accessible to both Federal and State regulators which lists medical
devices, for instance, that have been recalled, or should be sub-
jected to particular attention? Is this shared back and forth?

Mr. Godwin. On the byproduct source and special nuclear mate-
rial side, there is what we call a source and device catalog, in
which approved devices appear, and if something happens that it
gets disapproved, it will be pulled out of it. I was surprised to hear
this morning relative to the FDA having seized all these devices in
Texas. FDA does have a notification list. Unfortunately, they don't
get it to all the States. Arizona is one that we don't get their recall
lists; it is just one of the quirks of their system.

Chairman Glenn. Why do you not get their recall list?

Mr. Godwin. As I understand, it is shipped to another agency.
They have one agency in each State that gets all of their notices,
and if that agency cooperates, it will send them out to everybody,
and if it doesn't, you don't get them. And I don't know whom it
goes to in Arizona yet; I am still trjdng to find out. I have only
been there since September, and I am trying to find out where it \
goes so I can get the list.

Chairman Glenn. Dr. Burlington is still in the audience. Can
you get him the information on whom it goes to in Arizona?

Dr. Burlington. Yes, Senator.

Chairman Glenn. All right. You'll get it.

I think that's ridiculous, that they send it out, and a State orga-
nization would take something this important and not get it to the
people who should use it.

Mr. Godwin. Well, they don't recognize it as important quite
often, unfortunately.

Chairman Glenn. Well, maybe you can enlighten them when you
go back.

Mr. GopwiN. As soon as I find out, I'll get with them.

Chairman Glenn. Could you elaborate on your view of the con-
sistency of Federal regulations with respect to medical devices? For
example, in your written testimony, you state that "the two Federal
laws directly affecting medical devices have not been implemented
for radiation devices."

Mr. Godwin. With regard to users.

Chairman Glenn. Yes. And you go on to say, "These laws do not
adequately provide for State regulatory control."

How do we improve that situation?

Mr. Godwin. If you look at the particular laws involved, of which
one of them was the Medical Device Act Amendments of 1990, I be-
lieve, there is an application, and I read it as saying that they
could require the user to have certain minimum training, or maybe
even certain additional equipment. And to my knowledge, they
have not required anyone to have that particular type of equip-
ment.

The other one is the Mammography Quality Assurance A.ct,
which is in the process of being implemented, and it will require
specific user things whenever they implement it — October of 1994
is the current schedule.

Chairman Glenn. Do you think there is a need for Federal per-
formance standards for linear accelerators?

Mr. Godwin. I think we and the States need to know that they
are built to certain specifications with surety— whether they want
to do it by informally adopting international, or whether they want
to go with a formal program, we need to know that that equipment
meets these minimum design criteria, and we need to know what
they are so that when we go through and look at the user and how
he is going to use it, we know the starting point.

Chairman Glenn. Let's say you had a linear accelerator hke the
one in Spain. It has passed all the standards, FDA has approved
it, it's a good piece of equipment, and they send it out. How do you
make sure it isn't being misused?

Mr. Godwin. This is where I think the State has a particular
role to play, in that they should come in and look at how they are
going to set that piece of equipment up, particularly if they are
going to use it for something that I would call nonstandard, like
research, where they are perhaps going to bypass something, to
make sure they have the safeguards in place to prevent that situa-
tion from occurring as it did in Spain.

Chairman Glenn. But you think States can do that

Mr. Godwin. The States can do it— not all States do it, you un-

Chairman Glenn. Well, should there be just a general require-
ment that States do it and then let them decide how they do it and
how many people they put on it, and things like that?

Mr. Godwin. There should be some way to get the States to do
it, yes, or somebody needs to do it. I certainly agree with that.

Chairman Glenn. For what reason would States not do it— just
money for inspections?

Mr. Godwin. Resources are very tight, and you must recogmze
that the priorities given to this in the pohtical arena— these deci-
sions are made by elected officials, and medical issues are quite
often not what he is running on; he is probably running on the idea
that if he can keep high-level waste from coming across his county
or jurisdiction, and he can get a lot of money to keep the trucks
out that are carrying high-level waste — but he doesn't get any
votes for the other. .

Chairman Glenn. In Chairman Selin's written statement, he in-
dicates that the NRC may take over device approval from the
agreement States. Do you have any reaction to that?

Mr. Godwin. I don't see that that will result in a whole lot of
improvement where you have States that are operating under the

agreement program, where they have been reviewed and assured
that they are doing things in a relatively comparable manner, be-
cause if you look at track records, you can find problems that the
NRC has had in approving devices, and you can find problems that
the States have had in approving devices. So I don't see a whole
lot to be gained by that.

It works a little better on the user by having it at the State level
in that he doesn't have to truck over to Washington or some re-
gional Federal office to talk to people and show what he is doing.
So there are some advantages to having it at the State level.

Chairman Glenn. There was a 1992 study in the International
Journal of Oncology which says that linear accelerators are fast re-
placing radiation teletherapy devices. The study found that as of
1990, the number of Cobalt and accelerator devices were 504 and
1,893, respectively. In other words, the linear accelerators were
over triple the Cobalt devices. The study also noted that the num-
ber of facilities to treat cancer with radiation are increasing faster
than the number of new patients, almost.

With the exception of the FDA approval of manufacture and de-
sign, there is no Federgd regulation governing accelerator use.
States have advocated in the past that the NRC assume regulation
of accelerators. What are your views on that?

Mr. Godwin. I think that some agency would do well to assume
that because of very high-dose output. I also think that you need
to look very closely also at the turbo fluoro units, because they
have a relatively high-dose output. So really, let's look across the
board at all of it, rather than just strictly at the high things. Where
you get a lot of retakes because of poor equipment, you in effect
begin to build up in the population sense; maybe not on an individ-
ual basis, but in the population sense, you do build that dose.

Chairman Glenn. In your testimony, you mention there is no
central repository of national health care statistics that can provide
complete information about the number of procedures involving
medical radiation uses. I agree that without such data, regulators
cannot accurately know misadministration frequency and trends,
but I also don't know quite how that should be set up. It is a volu-
minous procedure, with everything that's going on.

Should that be a Federal Government procedure requirement?
How do you develop such a database?

Mr. Godwin. That's one that you may have to do sampling; you
may have to do something very limited. I don't have an offer on
how to go about that. As you noted from my testimony, I talked
about that. You need to compare what is the misadministration
rate for chemical treatments versus x-ray. You may find it's a
whole lot worse than chemical — you may find it's a whole lot bet-
ter. I don't know which way it will go. But it is really very vital
information to make an informed decision. But I don't have any ad-
vice on how we can go about doing that, I'm afraid, Mr. Chairman.

Chairman Glenn. The last question is the same one I asked pre-
vious witnesses. Give us your advice on this. It's obvious we have
a lot of gaps and holes and maladministration these things and dif-
ficulties that have resulted in deaths. And I know we all want the
States to have this and that and something else, and I don't want
to impinge the Federal Government into States any more than we

have to. But how do we deal with this? People are either being seri-
ously injured or dying. The Spanish incident is one; we had our
own in Ohio that has been reported, as I indicated earlier this
morning, and I don't know — there may be others.

How do we set up an adequate control to protect the people of
this country in this area?

Mr. (jODWIN. Well, as I indicated in my testimony, I think we
need an agency, set up — either existing or somewhere else; I'm not
sure exactly how you'd want to go about doing it, because there is
a lot of political give and take on which way that would have to
go — but you need someone who sets the overall criteria, standards,
design, whatever that the States must as a minimum follow. I
think the States need the capability to go beyond that where it is
necessary for their local conditions. It needs to have the ability for
the States to work as a partner with the Federal Government, par-
ticularly when you start looking at things like rural areas, where
you have local populations; you've got to be very careful that you
don't just completely eliminate care in some areas.

All of these are very vital issues that you need to address in set-
ting up

Chairman Glenn. Do you think the agencies in existence now
are adequate to do the job if there were better coordination be-
tween them? In other words, I think about whether we need some-
thing to replace existing authorities or whether we just need co-
ordination between existing authorities, if you get that difference.

Mr. Godwin. Well, if you take FDA and NRC as the two entities
we are primarily looking at, the NRC has the agreement State pro-
gram which works pretty weU in that it turns the authority over
to the States, the States then continue to meet it — the States need
some kicking along in some cases to make sure they maintain ade-
quate regulations. Part has to do with resources, which I addressed
earlier as a personal comment.

The FDA laws for the most part — with one exception that I am
familiar with, which is the mammography law— <io not allow a
similar transfer of authority, so you end up having sort of a glitch
there on how the States would go about enforcement. Now, the
FDA has been very good to come out with contracts to let the
States do inspections of their diagnostic x-ray equipment as a part
of their program, and the States interact there, but they have noth-
ing to do with the development of the regulations, they have noth-
ing to do with how they get what is important and what is not im-
portant on the inspection. And it only looks at the equipment end
of it; it does not look at exposure to the public, it does not look at
operator exposure per se. So those are some of the limitations on
the FDA.

Actually, there may be some need for legislative actions on one
side or the other.

Chairman GLENN. Do we need to change some of the authori-
ties— what I'm thinking about are some of the things that have
come up here this morning — NRC regulates Cobalt, but not linear
accelerators; FDA approves linear accelerators, but not their oper-
ation, not the standards for which they will be used.

Mr. Godwin. Right — and we've got radium out there, too, that
people are using, that needs to be looked at. Some of those on occa-
sion leak and cause sniff contamination problems.

Chairman GLENN. Can a coordinating group such as Jimmy
Carter had for a while in the Executive order bring some order out
of this, or do we need legislation that will change some of the juris-
dictions?

Mr. Godwin. Since the group didn't exist long enough, it's hard
to read whether that would work.

Chairman Glenn. Well, that's true.

Mr. Godwin. I think you need to get together and get the groups
working together and see what we can come up with as an overall
picture, because all the people are going to be affected. You've real-
ly just got to have a group before you get to the legislative, or the
other group; either one.

Chairman Glenn. We would appreciate your input to that, and
I'd ask you to have it in by August 6th; how about that?

Mr. Godwin. We'll work with them.

Chairman Glenn. Could you give us your advice on this? I am
serious about that.

Mr. Godwin. We'll work with those agencies. The Conference has
always worked with those agencies.

Chairman Glenn. All right. We've set sort of an arbitrary time
period for them to get the information in to us, and if you can work
with them, or give us your independent opinion of it on August 6th.
I would appreciate it.

Mr. Godwin. The Conference will work with them — I may not be
the one doing the work, but Conference will work with them.

Chairman GLENN. All right. We'd appreciate whomever wants to
give us advice in that area from the Conference.

Thank you. You have all been very patient with us this morning.
The hearing has gone about 3 hours, and we appreciate your input.
Obviously, there is a lot of work to be done, and we want to get
on with doing it, so we can get whatever needs to be done, done
this year.

Thank you. The Committee stands in recess subject to call of the
Chair.

[Whereupon, at 12:35 p.m., the Committee was adjourned.]

APPENDIX

Prepared Statement of Senator Roth

Mr. Chairman:

I certainly share your concern that Federal regulation must protect the consumer
of health care services. Nowhere is this more important than in the case of medical
uses of radiation because of the intrinsic danger represented by the high levels of
exposure needed to kill cancer.

Certain principles are clear from the onset: Substantive violations should not be
swept under the carpet as may have been the case in the past. Furthermore, respon-
sible agencies should co-ordinate their efforts in order to improve efficiency and pro-
ductivity.

Yet, I feel that a word of caution is needed. I would like to point out that medical
uses of radiation are among the moat sophisticated and effective technologies in
modem medicine. Many thousands of lives have been extended and improved as a
result of this technology. One can even make a good case for economic efficiency of
these technologies; but it is not my intention to place dollar values on lives.

Rather, I hope to draw attention to the fact that responsible regulation must con-
sider its impact on accessibility, its impact on cost, and its impact on the competi-
tive pressures needed to make high technology medical services safely available to
the largest possible number of Americans in need of them. Regulation must not be
a blunt instrument that slights the pressing national problem of affordable health
care.

I look forward to working with you to find the best ways to meet the expectation
of all Americans for safety, access, and quality of health care.

Thank you, Mr. Chairman.

Prepared Statement of Ivan Seun, Chairman,
United States Nuclear Energy Commission

Mr. Chairman, members of the Committee, it is a pleasure for us to be here today
to discuss the Nuclear Regulatory Commission's national program for regulation of

radiation medicine. xt^./-.

Two categories of radiation medicine use radioisotopes subject to NRC regulatory
jurisdiction. One is nuclear medicine, which employs radioactive drugs. These drugs
usually contain only very small quantities of radioactive materials, and are used pri-
marily for the diagnosis and mapping of disease. Nuclear medicine also includes the
use of radioactive drugs for therapy, especially for disease of the thyroid gland.

The other category of radiation medicine is radiation therapy. Larger quantities
of radioactive material are used in therapy. According to the rough estimates avail-
able, about 1.1 million new cases of cancer appeared in 1992. Of these, more than
500,000, or almost half, were treated using some form of radiation therapy. Sealed
radiation sources made of byproduct material (radioisotopes), which are regulated
under the Atomic Energy Act, were used in no more than twentv-five percent of
these radiotherapy treatments. Radiation produced by electronic devices not regu-
lated under the Atomic Energy Act, such as linear accelerators, was used in the
other seventy-five percent of these cases.

In order to achieve optimal cure and remission rates or to alleviate pain, radio-
therapy treatments normally deliver high doses of radiation, often close to the pa-
tient's limit of tolerance. Even when correctly delivered, a therapy dose of radiation
may well have serious side effects, and may on occasion result in death.

The objective of NRC's regulatory program is to assure that the patient receives
the dose of radiation or radioactive material that is prescribed by the physician, as
well as to protect health care workers and members of the public in the process.

(59)

NRC does not regulate the appropriateness or effectiveness of the prescribed treat-
ment.

Much, although not all, of the focus of our current concerns is on therapeutic
misadministrations — cases in which radiotherapy as delivered is different from that
which is prescribed. The information we have indicates that the misadministration
risk is very small in comparison with the intrinsic risk to the patient from radio-
therapy treatment; one of the problems I'll discuss is that there is some uncertainty
in our knowledge of the precise rate of misadministrations, but it is probably less
than one in several thousand. Misadministrations may or may not cause adverse ef-
fects to patients. NRC requires that each therapeutic misadministration be assessed
and the likely consequences communicated to the referring physician and the pa-
tient. This communication is another topic of our testimony.

Of course, all medical misadministrations are of importance to the NRC and we
set as an objective the avoidance of misadministrations to the greatest extent prac-
ticable. Our testimony will focus on radiotherapy since this is the area where the
consequences of potential errors are generally the greatest. However, many regu-
latory initiatives in radiotherapy also would apply to nuclear medicine where the
consequences of errors, in most cases, are much less.

1. HISTORY OF NUCLEAR MEDICINE REGULATORY PROGRAM

Under the Atomic Energy Act (AEA) the NRC regulates the use of byproduct ma-
terials, i.e., radioisotopes produced as a result of the nuclear fission process in a nu-
clear reactor. The NRC does not have authority to regulate radioisotopes produced
by other means such as cyclotrons, nor does NRC regulate electronic devices which
produce radiation, such as X-ray machines and linear accelerators.

The single most important use of byproduct material is probably for medical diag-
nosis and therapy. NRC directly regulates medical use of this material in 21 states,
the District of Columbia, Puerto Rico, Virgin Islands, United States territories, and
all Federal facilities through a system of regulations, licensing, inspection and en-
forcement. There are approximately 2,000 NRC licenses authorizing the medical use
of byproduct material.

Under Section 274 of the AEA, the NRC is authorized to enter into agreements
whereby a state assumes regulatory authority over most byproduct materials, in-
cluding medical use. To enter into an agreement, the state must have a program
which is adequate to protect the public health and safety, and which is compatible
with NRC's regulatory program. Twenty-nine states have agreements with the NRC
to regulate byproduct material. They have issued approximately 4,500 active li-
censes authorizing the medical use of byproduct material.

Over the years, and especially since the mid 1980s, the Commission has made a
concerted effort to improve and strengthen the medical use program. The Atomic
Energy Act of 1946 authorized the medical use program; the Atomic Energy Com-
mission initiated steps to regulate radioactive drug safety at that time. The first
medical use of byproduct material also occurred in 1946. In 1967, the AEC codified
its medical regulations into a new 10 CFR Part 35 which covered both the medical
use of radioactive drugs and the use of radiation from medical devices. Following
a 1976 report of hundreds of patient overexposures at Riverside Methodist Hospital
in Columbus, Ohio, NRC took actions to upgrade its regulation of radiation sources
in medical use. As a direct result, NRC amended its relations to require licensees
to conduct annual calibrations and monthly spot-checks of teletherapy units.

In 1979 NRC issued its "Medical Use Policy Statement," which stated NRC's in-
tent to regulate the radiation safety of patients while minimizing interference with
the practice of medicine. In 1980, NRC published a final rule requiring reporting
of misadministrations involving byproduct material. This rule also required tnat pa-
tients affected by misadministrations and their own referring physicians be notified
of misadministrations. Exceptions to patient notification requirements are allowed
only when the referring physician determines, based on medical judgement, that no-
tification would be harmful to the patient.

In 1987 a major revision to Part 35 codified many of the radiation safety practices
which had become standard in licensed medical use. In 1988 the NRC began devel-
oping a performance-based rule to improve medical quality assurance in using by-
product material. As part of the initiative to upgrade quality in the delivery of radi-
ation medicine, NRC increased resources in order to inspect medical licensees more
frequently.

We reached a milestone in the medical use program when we issued a new regula-
tion known as the "Quality Management Program and Misadministrations" (QM)
rule which became effective on January 27, 1992. This rule governs medical uses
of radioactive material; it requires NRC's medical licensees to develop and imple-

ment programs to provide high confidence that radiation and radioactive materials
will be administered as directed by an authorized physician. This rule also modified
the definitions and reporting requirements for misadministrations. The rule is a
performance-based standard rather than one which contains prescriptive require-
ments, and therefore it is more accommodating to medical innovation, technology
development, and varying hospital control processes. This rule has a decidedly
greater impact on licensees with weaker programs; it is intended to raise them to-
wards the level of the better performers. The staff will reevaluate the program after
three years of experience, to see if results are as intended.

II. AREAS OF NRC'S MEDICAL USE PROGRAM WHERE IMPROVEMENT IS NEEDED

The last several years have seen a number of reviews of NRC's medical use pro-
gram. These reviews have identified several systemic or jurisdictional problem areas
where improvement is clearly needed in our regulatory program for radiation medi-
cine, in addition to a number of specific weaknesses in the execution of this regu-
latory program. , , , ,

During the week of December 13, 1992 the Cleveland Plain Dealer published a
series of newspaper articles which focused increased attention on the medical use
of radiation. They raised several questions on the extent of NRC's and agreement
states' knowledge of misadministrations and on the follow-up with patients subject
to misadministrations. We have also found work by NRC's Office of Inspector Gen-
eral helpful in drawing attention to areas in our medical program in need of im-
provement.

The Commission had already initiated several efforts to reexamine our medical
regulatory program before the Plain Dealer series. In part because of the Plain
Dealer articles and in part due to a recent misadministration at Indiana, Pennsylva-
nia, we have accelerated these efforts. They include:

• performing two independent reviews of NRC's medical use program, one being
conducted by NRC senior management not currently associated with the medi-
cal program, and the other to be conducted by an outside group of qualified ex-
perts, such as the National Academy of Sciences;

• working with the food and Drug Administration (FDA) to clarify our respective
responsibilities to ensure that generic problems with radiation devices are ad-

• redefining the focus of NRC's Advisory Committee on Medical Uses of Isotopes
to reflect the change in the scope and type of advice sought by the Commission.
The Committee, originally formed primarily to assist the NRC staff on medical
technology issues, now often provides advice on policy and generic issues.

III. THE AGREEMENT STATE PROGRAM

Some generic problems arise in the agreement state program. Although the NRC
reviews agreement state programs to be sure they are adequate in terms of health
and safety protection, the degree to which state rules must be compatible with NRC
rules continues to be an important issue between agreement states and the NRC.
Currently, state compatability is required for generic standards, definitions, and
some reporting requirements.

Last year, the Office of State Pro-ams was assigned to the Executive Director
for Operations for direct control. This has fostered a more consistent, well-coordi-
nated program between NRC and the agreement states. This has improved coordi-
nation with other NRC offices in developing policies and guidance for implementa-
tion by both NRC and agreement states. Nevertheless, variability exists among the
states and between the execution of agreement states' and NRC s medical use pro-
grams. For example, there is currently such uneven reporting of misadministrations
and other medical events by agreement states that it is difficult to determine if the
misadministration rates reported are accurate; the staff is working to obtain better
and more timely information on misadministrations which occur in agreement
states in order to develop a clearer understanding of the total number and rate of
misadministrations. The agreement states should all have misadministration report-
ing requirements compatible with NRC's by January 1995, three years after the ef-
fective date of NRC's "QM" rule.

IV. JURISDICTIONAL ISSUES

A second set of problems arises from the variations in jurisdiction over different
sources of radiation. Jurisdiction over various aspects of the use of ionizing radi-
ation in medicine is exercised by the Federal Government and the states, and at
the Federal level, by FDA and the NRC. Within this regulatory framework the NRC
has jurisdiction only over medical use of byproduct material.

The vast majority of medical radiation sources, such as naturally occurring and
cyclotron -produced radioisotopes, diagnostic X-rays, and electronic radiation-produc-
ing therapy devices, are not subject to regulation by NRC. FDA regulates to assure
the safety of new devices and drugs, whether or not they use bjT)roduct material,
as they are placed in service. The states may regulate the use of nonbyproduct ma-
terial devices and drugs FDA approves. States exercise widely varying degrees of
regulatory control over radiation sources not subject to NRC jurisdiction, and pro-
grams operated by states vary widely.

Even the regulation of those medical devices that do use byproduct material re-
quires special attention because of the complicated nature of the jurisdictional inter-
face between FDA and the NRC. The FDA regulates the manufacture and distribu-
tion of radiopheuTTiaceuticals, biologies and medical devices for safety and efficacy,
while the NRC regulates radiation safety associated with the actual use of these
products. The FDA's authority is exercised at the investigational, premarket review,
and manufacturing site level, and in their post-market surveillance of the market,
which includes user facilities only when serious problems are reported.

FDA's premarket safety evaluation of radiation devices and materials does not, by
itself, assure the safe use of a specific device at a particular facility. For example,
safe use also requires that adequate operating and emergency procedures be devel-
oped and implemented, and that personnel be adequately trained and supervised to
assure that radiation safety requirements are met. Also, devices in service must be
properly maintained.

In addition to receiving a premarketing approval from FDA, medical devices con-
taining bjrproduct material must be approved for radiation safety by NRC or an
agreement state prior to use through a certificate of registration. The scope and
level of detail required for this approval go beyond that required by FDA; a request
for NRC review must include detailed information about installation, service and
maintenance requirements, operating and safety instructions, and any potential
hazards. We are able to provide the more focused review necessary to assure radi-
ation safety in service because, whereas FDA has oversight responsibility for the en-
tire universe of medical devices, NRC and the agreement states are concerned only
with about 300 types of devices that contain byproduct material.

We have identified three areas where the interface between FDA and NRC could
be improved: 1) coordination of the FDA and NRC reviews of medical devices; 2) co-
ordination of response to incidents involving device failures, such as occurred last
year in Indiana, Pennsylvania; and 3) coordination on the regulation of manufactur-
ing, compounding and use of radiopharmaceuticals and radiolabelled biologfics. We
are in the early stages of an effort to establish a Memorandum of Understanding
between the two agencies that will address these three areas.

V. HEALTH STATISTICS

A third area in which problems arise is the field of health statistics. While we
have information about the number of reported misadministrations, we are less con-
fident about projections of the number of administrations. There is no central repos-
itory of national health c£U"e statistics which can provide complete information about
the number of procedures involving the application of ionizing radiation. Without
more reliable data on the total numbers of administrations we cannot accurately de-
termine misadministration fi'equency and trends.

VI. COPING WITH TECHNOLOGICAL DEVELOPMENTS

A fourth problem area intrinsic to the regulation of radiation medicine is the chal-
lenge involved in keeping the regulatory program current with technological devel-
opments. Radiation medicine is a dynamic, high-technology field. New treatment
modalities and equipment appear frequently. Many cobaQt-60 teletherapy units,
which were once the ultimate state-of-the-art, are being replaced by linear accelera-
tors. Brachytherapy — the implantation of sealed sources m the patient's body — is
rnoving toward faster acting high-dose-rate sources which present much different ra-
diation safety concerns. The coming use of radiolabelled biologies for medical pur-
poses, particularly monoclonal antibodies, will open up an entirely new area of med-
ical applications with attendant radiological safety issues yet to be seen. This cut-
ting-edge technology is now being approved by the FDA for widespread use. In addi-
tion, efforts aimea at health care cost reduction and consolidation of services also
cause changes such as greater use of mobile nuclear medicine facilities. Emphasis
on out-patient treatment has given rise to specialized clinics which may not have
the review committees, eredentialing or quality assurance procedures equivalent to
those found in most hospitals.

NRC staff monitors these emerging technologies and trends in service delivery to
identify and prioritize radiation safety issues. However, due to the highly dynamic
nature of radiation medicine, the NRC staff is sometimes not able to evaluate fully,
and address with appropriate regulations and guidance, a)l the safety concerns asso-
ciated with a new technology application before its use. Even when we do address
these concerns a minimum of two years is needed to promulgate new regulations,
and another three years pass before agreement states are obligated to implement
regulations for which compatibility is required. In the interim, NRC can issue guid-
ance to address safety concerns in the form of NRC bulletins, information notices,
or generic letters to licensees. In such cases, NRC expects agreement states to follow
through by providing this guidance to their licensees.

VII. ASSESSMENT OF THE EXECUTION OF NRC PROGRAMS

NRC's regulatory program consists of three fundamental elements: 1) the licens-
ing process, which approves facilities and users of byproduct material for medical
purposes, based on anility to protect public health and safety; 2) inspections of cur-
rent licensees, to determme compliance with NRC regulations; and 3) enforcement,
to remedy deficiencies and act as a deterrent against future violations of NRC re-
quirements.

We are reasonably comfortable with the licensing process, although a recent In-
spector General report has shown that even here some formalization of procedures
would be useful. However, a further shift in the focus of inspections may be re-
quired. For years inspectors were generally asked only to ascertain whether a li-
censee is in compliance with NRC requirements. This is done by direct observation
of work activities, interviews with workers, and sometimes special demonstrations
by workers of work practices regulated by the NRC. Additionally, information in li-
censee records is reviewed to assess performance since the last inspection and deter-
mine compliance with recordkeeping requirements. This approach has led to criti-
cism that our inspectors focus too much on detailed compliance with NRC require-
ments, and not enough on overall radiation safety performance. In response, in re-
cent years NRC inspectors have been asked to broaden their inspection oversight
to search for safety problems, but more emphasis and further guidance in this area
may be needed.

The fundamental purpose of the enforcement policy is, of course, to promote and
protect the radiological health and safety of the public, including patients and
health care workers. This is accomplished in two ways: by encouraging the prompt
identification and lasting correction of deficiencies; and by deterring new violations
from occurring. In the vast majority of cases NRC enforcement sanctions have been
effective in gaining lasting corrective action. Our records indicate that in combina-
tion, the experience of appearing before NRC in an enforcement conference following
an inspection identifying significant violations, receiving a civil penalty, and the as-
sociated adverse publicity, have resulted in relatively few repeat violations for sev-
eral years after a civil penalty is levied. However, we do not know whether the pol-
icy has been effective in deterring problems at other licensees' facilities.

The staff is reviewing the size of the base civil penalties for various categories
of facilities, and evaluating the feasibility of other potential sanctions, such as pro-
bation for medical licensees.

VIII. IMPACT OF TRAINING, EXPERIENCE AND HUMAN FACTORS

The last problem area we will discuss here concerning the regulation of radiation
medicine is human factors. Radiation therapy often involves deliberate exposure of
patients to high levels of radiation for beneficial purposes, and the consequences of
mistakes can be grave. We cannot eradicate all human error, but we can look to
see whether there are ways to reduce the error rate significantly. Achieving and
maintaining a high level of safety in the use of byproduct material in medicine is
highly dependent on having properly trained personnel who follow procedures and
maintain equipment properly.

How to judge the adequacy of the training and experience of individuals respon-
sible for the medical use of byproduct material has been and will continue to be a
priority concern for the NRC. Currently, the NRC has specific requirements for
training and experience of authorized physician users, radiation safety oflficers, and
teletherapy physicists, and we are examining the need for training and experience
requirements for other personnel involved in the medical use of byproduct material.
However, we do not yet have in place a process for periodic reassessment of the
knowledge and understanding of individuals responsible for radiation safety.

A specific case illustrates the importance of the issues surrounding human factors.
In connection with the recent, tragic therapy misadministration and patient death

in Indiana, Pennsylvania in which a radioactive source was inadvertently left in a
patient, the NRC sent an Incident Investigation Team to investigate the cir-
cumstances surrounding the incident. The team found that human error was the
primary cause, while machine problems were also important.

The team did find a need for updated licensing and inspection guidance for high
dose rate brachytherapy devices, such as the one involved in this event, to make
more clear what safety requirements apply to the use of this type of device. In the
interim, NRC published two bulletins specifying additional controls to be imple-
mented by licensees using the technology involved in the incident, and revised the
inspection guidance for these facilities. Ultimately, rulemaking may be needed to
adaress some of the issues identified by this investigation.

IX. REPORTING TO PATIENTS AND PATIENT FOLLOW-UP

Following the Plain Dealer series, NRC staff conducted a review of therapeutic
misadministrations at NRC-licensed facilities over the past three years. This review
indicated that patients were notified of misadministrations only 72 percent of the
time. Although NRC permits not notifying patients when a physician determines it
would be harmful to the patient (in which case a responsible relative must be in-
formed), this does not appear to be the cause in most of the cases we have reviewed.
Furthermore, of the patients notified only 56 percent were given a written report,
contrary to explicit and longstanding NRC requirements. NRC is preparing an infor-
mation notice to alert the regulated community to these failures to comply with the
regulations, and to remind them of their obligations under the notification and re-
porting requirements. In addition, future NRC inspections will focus on assuring
that licensees comply with all the notification and reporting requirements in the
event of a misadministration. The staff" is currently reviewing the cases in which
the patients were not provided with a written notification, to determine if enforce-
ment action is warranted.

The Plain Dealer series also focused attention on the issue of patient follow-up
after misadministrations. NRC's current policies and guidance on patient follow-up
are being reexamined as a part of our ongoing program reviews. It is current agency
practice to consider the NRC medical consultant's opinion of harm to the patient m
the determination of appropriate enforcement actions, and of the probable con-
sequences to the patient to be reported, if required as part of the periodic report
on abnormal occurrences required by Section 208 of the Energy Reorganization Act
of 1974. We are now reconsidering this issue ft-om the perspective of the agency's
obligation to the patient, who needs medical follow-up which continues long enough
for any anticipated delayed deterministic effects to have appeared and been recog-
nized.

X. LONGER RANGE REGULATORY OPTIONS

The previous discussion has focused on the effectiveness of our regulatory pro-
gram from this agency's programmatic point of view. We must also look at the pro-
gram from the patient's point of view. In this regard, we note that NRC's regulatory
jurisdiction covers only approximately 25 percent of radiation therapy treatments.
The remainder, which involve identical radiation from different types of sources, are
covered under a range of state regulatory programs.

As long as the use of byproduct material in radiation medicine is subject to NRC
licensing and regulation, we will do the very best job we can of regulating that com-
ponent of radiation medicine. But at the same time it is fair to ask if there is any
public policy justification for the continuation of the present approach to regulation
of radiation use for medical purposes. It is also fair to ask if continuation of the ex-
isting scheme is the best way to use limited resources to achieve the goal of protec-
tion of the public. So we have been giving some thought to ways to address these
issues. Among the options that come to mind and that appear to warrant evalua-
tion—although this may not be an exhaustive list— are (1) limiting NRC's regulatory
involvement to approval for use of sealed sources and devices containing byproduct
material with the states then regulating their medical use, (2) NRC's continuing to
write standards and guidelines with the states assuming all responsibility for in-
spection and enforcement, or (3) extension of NRC regulation to all radiation sources
used for therapy, not just byproduct material. Such an extension would require leg-
islation.

These and other approaches require careful development, evaluation and consider-
ation by the NRC bewre the Commission would be in a position to make a decision
on this matter, including any eventual recommendation to Congress for possible re-
visions to our statutory authority.

SUMMARY

In sum, Mr. Chairman, we believe the situation is as follows:

The NRC has what we consider to be a reasonably good regulatory program for
the medical use of byproduct material. Areas for improvement have been identi-
fied— especially in our relations with the agreement states, in our interface with the
FDA, in the gaps we see in radiation health care data, and in our responses to the
rapid changes m medical technology. We have also identified some weaknesses in
execution, especially in the area of patient notification and follow-up. We believe we
have steps underway — especially a shift; towards performance-based rules and a reg-
ulatory regime which focuses more effort on weaker licensees — which, if carried to
their logical conclusion, will remedy most of these problems.

The feet remains, however, that no matter what level of resources is devoted to
improving NRC's regulatory program for medical therapy, the effect will be confined
to no more than about 25 percent of the radiation therapy treatment in the country,
while the rest, beyond the Federal-level regulation of devices exerted by FDA, is
subject only to discretionary and perhaps inconsistent regulation at the state level.

NRC's objective continues to be a vigorous program that fulfills all statutory re-
sponsibilities, one that provides adequate safety for patients, radiation workers and
tne general public; minimizes interference with the practice of medicine; and accom-
modates medical innovation and technology development. We will continue on this
path. However, the Congress may eventually want to consider some legislation in
the future which would bring more consistency to the regulation of radiation medi-
cine as a whole. Such legislation should not be considered until the indeoendent re-
views of the medical use program initiated by NRC have been completed and other
agencies such as the FDA and state regulatory authorities have been consulted.

Mr. Chairman, this completes our statement. We will be pleased to answer any
questions that you and the Committee may have.

Prepared Statement of D. Bruce Burlington, M.D.

Introduction

I am here today to discuss the Food and Drug Administration's regulatory pro-
gram for medical radiation devices, principally the radiation therapy devices. As
with all medical devices, the FDA program, administered through the Center for De-
vices and Radiological Health, encompasses the review of a device before it reaches
the marketplace and a postmarket surveillance of the device. When we approve a
device, the data submitted for our evaluation must demonstrate that the new device
is safe and effective and that its potential benefits outweigh any potential risks.

We must do our utmost to make certain that medical devices used by physicians
and consumers are safe and effective. We must all also understand that even with
careful design, manufacturing controls and clinical investigations; devices can have
unintended and unforseen effects during widespread use. Even with a quality con-
trol system that strives for "Zero" defects, we must accept that devices can fail and
user error can occur. FDA's job is to address, in advance, the safety and effective-
ness of devices, and to act quickly and decisively if an unanticipated failure or mal-
function of the device occurs after it is marketed.

Our concerns today focus on radiation therapy devices. The benefits of radiation
therapy treatment are great. The ACR estimates that nearly 20 million radiation
therapy procedures are performed each year. The American College of Radiology
(ACR) estimates that as a primary cancer treatment, radiation therapy has been
partially responsible for increasing the overall cure rate for cancer to more than 50
percent. Between 50 and 60 percent of all cancer patients are treated with radiation
at some point during their therapy. For some patients the use of radiation is the
major or sole way to achieve cures. In patients who have cancer that has spread
to bone or brain tissue, radiation therapy offers an irreplaceable treatment that im-
proves their lives. It is frequently the principle measure to relieve pain.

All radiation therapy systems, such as medical linear acclerators, Cobaltr-60 tele-
therapy units, computerized treatment planning systems, and the accessories used
in the provision of radiation therapy treatment, are regulated by the FDA. I would
like to discuss the legislation that the Congress has provided FDA and how FDA
implements it. Then I will address a deficiency the FDA sees in receiving reports
of adverse incidents and the actions that we are taking to improve the situation.

History of FDA Medical Radiation Device Regulation

The Food and Drug Administration has several legislative mandates for regu-
latory control of radiation therapy devices. These include:

• the Medical Device Amendments of 1976 to the Federal Food, Drug and Cos-
metic Act (P.L. 94-295),

• the Safe Medical Devices Act of 1990 (P.L. 101-629) and its amendments.

• the Radiation Control for Health and Safety Act of 1968 (P.L. 90-602), and

• the Consumer-Patient Radiation Health and Safety Act of 1981 (P.L. 97-35).

These laws and their implementing regulations provide a system of premarketing
clearance and manufacturing controls so that radiation therapy devices will be both
safe and effective when used as labeled.

The Medical Device Amendments and the Safe Medical Devices Act provide the
most extensive regulatory tools available to the FDA. While these authorities cover
all types of medical devices, I will focus on radiation therapy eauipment.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic
Act (the Act):

The Medical Device Amendments were enacted by Congress in 1976. This legisla-
tion requires device manufacturers to notify FDA of plans to market devices so our
staff may undertake premarket review of the product. This review permits the FDA
to determine the level of regulatory control necessary to assure that devices are
suitable for their intended uses. Each device is classified according to the knowledge
about the types of risks it raises and the level of regulatory controls needed to man-
age those risKs.

FDA addresses manufacturing problems through regulatory authority derived
from this Act with the Good Maniifacturing Practices (GMP) regulation. The GMP
regulation covers the methods, facilities, and controls used in manufacturing, pack-
ing, storing, and installing medical devices. It identifies the essential objectives that
must be included in a quality assurance system. Such a quality assurance program
will ensure that the marketed device meets specifications by reducing manufactur-
ing process variation that can lower quality. The FDA field staff conduct both rou-
tine and directed inspections of radiation therapy device manufacturers to ensure
compliance with GMPs.

The 1976 legislation also authorizes FDA to issue an order that requires manufac-
turers to notify certain health professionals that the device presents an unreason-
able risk of harm to the public health. The manufacturer's notification obUgation
may be extended, either directly or through health professionals, to include all indi-
viduals at risk. Manufacturers may be required to recall the devices from the mar-
ket or repair or replace this equipment, depending on the risk. One such example
occurred in June 1991 when the Agency asked one of the largest Cobalt-60 tele-
therapy manufacturers to notify all users of their teletherapy units of certain device-
related problems and that appropriate actions should be taken to correct the prob-
lems.

As a result of adverse incident reports and subsequent inspections, problems were
uncovered with the software controUing one brand of radiation therapy accelerators.
In April 1986, FDA directed all manufacturers of medical accelerators to conduct
thorough verifications of their software programs and, where necessary, make ap-
propriate modifications to minimize the risks of similar failures.

Similar to our inspection experience with all medical devices, 53 out of 71 (75 per-
cent) registered manufacturers of radiation therapy devices have been inspected, in-
cluding eight of the nine manufacturers of brachytnerapy devices, in whicn the radi-
ation source is in contact with the patient. This was the type of device involved in
the Indiana, Pennsylvania incident, where a patient died as a result of a broken ra-
diation source wire and multiple safeguard failures.

Our shortfall for medical device inspections is due to competing medical device
workloads and priorities for the inspection staff. For example, in December 1992,
FDA initiated new directed inspections of all firms engaged in the commercial dis-
tribution of linear accelerators and teletherapy systems used to treat patients and
radiation therapy treatment planning systems. Proportionate to the number of de-
vices regulated, this is approximately a two fold excess commitment of our inspec-
tion capacity.

The last authority under the Medical Device Amendments I would like to mention
is the mandatory medical device reporting program. The legislation requires manu-
facturers to report to the FDA any death, serious injury, or malfunction which could
lead to a death or serious injury. Each report received by the Agency is reviewed
and necessary action is taken. Since the inception of the program in 1984, the Agen-
cy has received 57 reports concerning deaths and serious injuries associated with
the use of radiation tnerapy devices. These reports refer to seven deaths and 236
injuries. The information in these reports has led to product recalls, notifications to
health professionals, and improvements in product design. We are reminding all
dealers, importers, manufacturers, and distrioutors of radiation therapy equipment

about reporting requirements and the criteria to use for reporting problems to the

FDA.

Safe Medical Devices Act of 1990

With the enactment of the Safe Medical Devices Act of 1990, Congress provided
several expansions of FDA's medical device authority, including the requirement for
mandatory reporting by user facilities. User facilities (e.g., hospitals, nursing homes,
and outpatient treatment sites) must file reports of deaths, serious injuries and seri-
ous illnesses associated with the use of medical devices with either the manufac-
turer of the implicated device or with the FDA. This will increase the opportunity
to learn about problems early and to permit the Agency to take quicker action to
avert major problems. The user facility reporting requirements became effective in
November 1991, but reporting is below anticipated levels. Final regulations are
under development. FDA personnel are developing a "universal reporting form" that
can be used by those that we regulate or anyone that wants to report a device prob-
lem. • i. 11

Other authorities that were expanded include: distributor renortmg for all types
of medical devices; authority for FDA to initiate recalls; and expanded
postmarketing surveillance.

Radiation Control for Health and Safety Act of 1968

The first FDA law to specifically address medical radation was the Radiation Con-
trol for Health and Safety Act of 1968. This act provided for the regulation of all
electronic products that produce radiation. Medical linear accelerators are an exam-
ple of a radiation therapy device covered by regulations promulgated vmder this law.
These electronic radiation devices are also subject to the Medical Device Amend-
ments. . L •.. U

Manufacturers of electronic radiation products are required to submit a number
of reports to FDA. Before marketing an electronic product, such as a linear accelera-
tor, an initial report must be submitted. When a manufacturer learns of any acci-
dental radiation occurrence or a radiation safety defect it is required to report that
information to FDA. In addition, manufacturers are required to submit annual re-
ports on the device. These reports contain information that is not required by the
premarket notification requirements under the Medical Device Amendments, such
as equipment maintenance schedules.

Consumer-Patient Radiation Health and Safety Act of 1981

Congress enacted the Consumer-Patient Radiation Health and Safety Act of 1981
to minimize unnecessary radiation exposures. The Act was a directive to provide
guidance. It was also a mechanism to have a continuing supply of adequately edu-
cated medical radiation technologists with appropriate accreditation and certifi-
cation. , T-. r xj uu

The Health Services and Resources Administration in the Department ot Health
and Human Services has responsibility for the implementation of Section 981 of the
Act. Section 981 provides for the promulgation of minimum standards for the ac-
creditation of educational programs to train individuals to perform radio logic proce-
dures and to assist the States in the certification of those persons.

FDA has responsibility for Section 982 of the Act. Section 982 du-ected various
Federal Government agencies to work together to promulgate Federal radiation
guidelines to minimize unnecessary radiation exposure from diagnostic procedures
and therapeutic applications.

The FDA developed a series of training videotapes; published a primer on the op-
eration of accelerators in radiation therapy; and began a regional workshop series
to encourage quality assurance. In addition, the FDA initiated a quality assurance
service at the University of Texas to check radiation therapy doses. This program
is still operational today and is self-supporting.

Relationships between FDA, NRC, and States

Nuclear Regulatory Commission ^u r

In 1983, an exchange of letters between the CDRH Director and the NRC s Chiet
of Materials Licensing Branch confirmed an agreement for:

• the notification to premarket applicants concerning other Federal agency re-
quirements; , , ■ 1- J

• the exchange of documents and other information on developing policy guides
and compliance pubUcations; periodic meetings between staff; and

• the identification of key contact persons in each Agency.

The most frequent contact with NRC, concerning regulated products, is at the
staff level. The Center's Office of Device Evaluation (ODE) routinely notifies manu-

facturers, at the premarket stage, of the need to meet other Federal requirements,
before marketing new medical devices. The Center's Office of Compliance and Sur-
veillance (OCS) has exchanged information with NRC in response to specific
postmarket problems with devices or use of the devices and facilitated coordination
of inspections and investigations by the two agencies. This relationship has allowed
FDA access to information regarding device problems before being reported through
other channels.

In December 1992, NRC notified FDA of the death of a patient m Indiana, Penn-
sylvania, resulting from a combination of a brachytherapy device malfunction and
a series of user errors. The FDA joined the NRC team at the site of the incident
and at the manufacturer's facility. The purpose was to coordinate Federal action in
the investigation of the event and to determine corrective action. This combined
team was able to complete the investigation quickly.

Representatives from the FDA and the NRC are working on a Memorandum of
Understanding (MOU). This MOU would address medical radiation devices that uti-
lize radioactive materials licensed by the NRC. The MOU would provide for prompt
problem notification, coordination of investigations, and exchange of information be-
tween the two agencies.

States

The Conference of Radiation Control Program Directors (CRCPD) is a professional
organization of State radiation control personnel which is supported, in part, by
FDA and several other Federal agencies. FDA maintains a liaison with the CRCPD
for the exchange of information on regulatory issues, technical items, training pro-
grams, resources, and incidents. FDA staff interacts with numerous CRCPD com-
mittees.

The Conference has guidelines for the evaluation and State licensmg of the use
of naturally occurring and accelerator produced radioactive sources not licensed by
the NRC. The FDA and the NRC cooperate in maintaining a catalog of such sources
for the Conference. The CRCPD has the responsibility to update and disseminate
the Suggested State Regulations for Control of Radiation (SSRCR). The Suggested
State Regulations represent a set of model regulations, for the control of electronic
product radiation and radioactive materials published to assist the States in devel-
oping their individual programs while maintaining a degree of national uniformity.
Various sections of the SSRCR specifically addresses radiation therapy devices.

It is vital that we work directly with appropriate State personnel at the site of
the radiation incident. It is also important to cooperate with the State in which the
manufacturer operates and where the device is registered. In a recent
brachytherapy incident where the radiation source was left in contact with the pa-
tient's body, the Agency worked with the States of Louisiana and Texas, where the
equipment was manufactured, as well as Pennsylvania, the site of the incident. This
cooperation is standard procedure in such cases.

FDA Initiatives to Lessen the Likelihood of Adverse Incidents Involving Radiation
Therapy Devices:

FDA's regulatory programs designed to ensure the safety of radiation therapy de-
vices include three areas: premarket review of new products, inspection of manufac-
turing facilities, and postmarket surveillance to detect problems in existing devices.
The types of incidents that have brought radiation therapy devices to the Commit-
tee's attention are largely unanticipated in the premarket review process. We must
rely on quick, accurate postmarket reporting of incidents in order to evaluate them
and limit the public health risk. Without these reports we lack the early warning
signals needed to act before serious events occur. We want to identify potential
sources of failure early enough to investigate and intercede. Many radiation inci-
dents are either caused by or accompanied by human error, which are events out-
side our immediate regulatory control. However, better product information and
training can reduce human error. With adequate information we can differentiate
human error from device failure and know whether the corrective action should be
directed to the operator or the device.

We have taken the following actions to improve our ability to identify problems
as soon as possible:

• User facility reporting regulations, as required by the Safe Medical Devices Act
of 1990, will issue later this year. User reporting regulations require medical
facilities to report a device-related death, serious injury, or serious illness to ei-
ther the manufacturer of the implicated device or to FDA. The information re-
ported will help identify problems as quickly as possible.

We are reminding dealers, importers, manufacturers and distributors of radi-
ation therapy devices about reporting requirements and the criteria to use for
reporting problems to FDA.

We are discussing a Memorandum of Understanding with the Nuclear Regu-
latory Commission that will cover medical devices using NRC-licensed radiation
sources. We expect the Memorandum to address prompt problem notification,
coordination of investigations, and information exchange between the two agen-
cies.

We will re-assess how we communicate information we receive on problems with
radiation therapy devices to the State regulatory authorities. Although we £ire
already working directly with the individual States to investigate cases in their
jurisdictions, we want to be sure we regularly relay information to the States
about problems occurring elsewhere. This serves as an early-warning system to
the States as they exercise their respective authorities and license users of var-
ious devices. We will also seek prompt notification from the States about prob-
lems reported to them so we may be more comprehensive in identifying prob-
lems.

Finally, beyond these improvements in our ability to receive and transmit infor-
mation about radiation problems, we are also conducting industry-wide inspec-
tions of radiation therapy device manufacturers. These comprehensive inspec-
tions will also help to determine whether the manufacturers comply with the
requirements for reporting device failures or malfunctions. These actions are
consistent with FDA's overall plan to improve the regulation of all medical de-
vices. In the entire medical device arena, FDA is committed to enhanced pre-
market review and postmarket surveillance, and to prompt action against those
who violate the law.

TESTIMONY OF AUBREY V. GODWIN

BEFORE THE U.S. SENATE COMMITTEE

ON GOVERNMENTAL AFFAIRS

APRIL 22, 1993

Good morning, and thank you Mr. Chairman and members of the Committee for inviting me
here to testify on the regulation of medical ionizing radiation uses. I am testifying as Chairman
of the Conference of Radiation Control Program Directors, Inc. (Conference). The Conference
membership is comprised of the Radiation Control Program Director for each State. The staff
of each state's program make up the associate membership of the organization. For example,
Mr. Robert E. Owen, of the Ohio Department of Health, is Ohio's representative, with four
members of his staff as associate members. Only one state, Wyoming, does not have a formal
ftill time radiological health employee. Several small states have only one or two people in their
program.

One of the issues of interest to all states is the proliferation of ionizing radiation agencies at the
federal level of government and the resulting overlap and gaps in enforcement. For example,
U.S. Bivironmental Protection Agency (EPA) has the authority to make recommendations to the
President, which, if accepted, become Federal Guidance which all Federal agsncies must take
into account in carrying out their responsibilities. EPA also develops ionizing radiation standards
under the authority of several pieces of legislation; these standards set limits on human ionizing
radiation exposure level or on quantities or concentrations of radioactive materials that may be
released to the environment. The U.S. Nuclear Regulatory Commission (NRC) implements these
standards for all users of byproduct, source, and special nuclear materials. The Safe Medical
Device Act of 1990 authorizes the establishment of special controls for Class n devices which
may include the qualifications of users. Further, P. L. 90-602 was used as the authority to initiate
a notice of intent to propose rules and develop guidelines for ionizing radiation therapy
equipment. It is my understanding, neither of the latter Acts have had final implementing actions
taken by the agency.

Prior to World War n, all medical uses of ionizing radiation were regulated by the States as a
part of the overall regulation of medicine. This followed the normal practice of the States being
the natural regulator of "Professions." With the passage of the "Pure Food and Dnig Act," the
federal authority began to extend to the manufacture of medical goods.

Other organizations which helped standardize the use of ionizing radiation were the National
Council on Radiation and Measurements, the National Bureau of Standards, and the professional
organizations such as the Radiological Society of North America and the American College of
Radiology. All of these were voluntary standards and the individual practitioner could elect not
to follow them at any time. A few states elected to use their professional regulatory powers or
the occupational safety powers to establish some regulatory standards. These were uncoordinated
and were the exception rather than the rule.

The Atomic Energy Act of 1954, as amended (AEA), provided for the regulation of individual
users of radioactive materials. This permitted the U.S. Nuclear Regulatory Commission (NRC),
formerly the U.S. Atomic Energy Commission, to directly regulate the individual physician
using those material covered by the Act, namely source, byproduct, and special nuclear
materials. This authority had several benefits;

1. The standardization of training and conditions of use for the users of these
radioactive materials.

2. Some organized consideration of the ionizing radiation dose being given to the
patient.

3. A standardization of equipment used for the administration of ionizing radiation
from radioactive materials covered by the AEA.

Perhaps the most important item to come from the AEA was the national ionizing radiation
standard in the form of 10CFR20. Prior to this, several different standards were in existence.
One amendment to the AEA provided for a State to sign an agreement with the U.S. Atomic
Energy Commission (now the U.S. Nuclear Regulatory Commission) thus becoming an
"Agreement State." The Agreement State status required the state to adopt radiation standards
consistent with 10CFR20. With the enactment of AEA, Suggested State Legislation for the
Control of Radiation was promulgated by the Council of State Governments. At present there
are 29 Agreement States.

Additionally, through the cooperative efforts of various federal and state agencies. Suggested
State Regulations for the Control of Radiation were develop)ed as a model for states. These
regulations are the foundation for all states regulations, i.e. both Agreement States and Non-
Agreement States. This in turn allowed the rapid development of nuclear medicine and ionizing
radiation therapy utilizing primarily byproduct material. The primary difference between federal
and state regulation is that states regulate Naturally Occurring and Accelerator Produced
Materials (NARM) and machine produced ionizing radiation at the user level. Most of the states
attempt to regulate NARM similarly to AEA materials. The states in regulating NARM have
found and corrected several problems. For example, radium sources were not routinely tested
to insure their integrity, they were not accounted for by the users, and often they were stored
such that the public was exposed to the ionizing radiation. For these reasons and the fact these
materials were not regulated by the AEA, the Public Health Service actively promoted the disuse
of radium.

In the early 1960s, the Public Health Service offered grants to the States to develop ionizing
radiation programs. These programs used the Suggested Sute Legislation and Suggested State
Regulations for the Control of Radiation to assist states to become Agreement States. In the
1980s, the Conference, in order to maintain the quality of State programs and to provide
guidance to elected officials, developed a series of guides for State Radiation Programs. These
guides were in the form of criteria for resources, procedures, and funding for an adequate
ladiation control program. Copies of these guides are provided for the Committee's information.
The Conference has begun a program to update these guides for future use.

In the 1970s, the States though the Conference and with the assistance of the Food and Drug
Administration began the Nationwide Evaluation of X-Ray Trends G^EXT). This was a project
to standardize the methodology and measurements of diagnostic x-ray units in the field. The
results of these tests are provided sq)arately to the Committee. The rather large ranges of
exposure values was and continues to be of concern. To assist the sutes in the reduction of both
patient exposures and public exposures, the Conference has prqjared example acceptable
exposure ranges for different diagnostic techniques so the user will have a basis to adjust their
technique. The NEXT project continues today and is providing data for the future.

Paritially as a result of NEXT, the states began to expand their regulation of the "Professions"
to include the technicians actually administrating the ionizing radiation to patients. Today, 26
sutes have some form of licensing or registration of x-ray technicians as well as technicians in
nuclear medicine and radiation therapy. All but one state have a requirement that technicians be
trained. California and Vermont have additional requirements for the primary medical care
professionals beyond the basic medical practice license to use ionizing radiation.

The regulation of the medical professionals by the Sutes has been a beneficial one for the
public. That is not to say that problems have not occurred. Among the problems are those cited
in the recent news articles relating to ionizing radiation injuries. For example, clearly several
misadministrations of ionizing radiation thenyjy have occurred; but, were they at a greater
incidence than for similar misadministrations of other therapeutic materials and were the
consequences greater than with other thenqjeutic materials? Another question that might be asked
is, "Should mpcax x-rays be considered misadministrations under some conditions?" After all,
this is exposure of rhe patient without a benefit to the patient. If the unit is one that has a higher
exposure per examination, this exposure may be significant. I believe that the investigations by
this Committee are jyjpropriate and are in the public interest. They should result in a better
understanding of the overall occurrence of misadministrations within the medical, care
community.

The NRC is the only active Federal medical user regulator of medical ionizing radiation use and
that is only for byproduct, source, and special nuclear material. The States are the exclusive
regulator of the remaining ionizing radiation uses in health care. When adopted by a sute, the
Conference's Suggested Sute Regulations for Control of Radiation are a powerful force in the
regulation of users. In adopting these regulations quite often Legislative or other officials
exercise a veto over the final wording of the regulation. Further, in every case, they control the
resources made available for use in the regulation of sources of ionizing radiation. For example,

the State and Territorial Health Officers goals for the year 2000 only mention radon in homes.
Nothing is mentioned about ionizing radiation safety for any other use. This is important since
most Radiation Control Programs are a subunit of the State Health Agency.

Some areas of concern are;

1 . The lack of a consistent radiation standard for all medical (and industrial) users and
devices in this country. The two Federal Laws directly addressing medical devices have
not been implemented for radiation devices. Further, they do not adequately provide for
state regulatory control. Most states feel that this is an area that should be implemented
at the state level. These laws do not address public exposures related to the devices
usage.

2. Rapid communication is needed to report problems with ionizing radiation equipment due
to the short half-life of the isotope. Both NRC and FDA have communication systems
in place. Unfortunately, they do not always function as well as might be desired. For
example, if there is a problem with a Technicium 99m generator lot, the manufacturer
may report it to FDA. FDA may report it to the states on a monthly report. This is for
a product which has a 10 day useful life. Receiving a report that is over 30 days old is
of little use. Further, some of the states are not on the routine distribution of the monthly
reports.

3. Another area of concern is the inhibitions of communications within the regulating
community. For example, if the Agreement States wish to establish a joint working group
with NRC to do the initial development work on regulations, policies, guides, etc. we
become advisors and are subject to the Federal Advisory Committee Act. We suggest that
this goes beyond the intent of Congress since full public comment will be received by
the agency prior to fmal rulemaking.

4. One other area, not related to the regulation of medical ionizing radiation use, but is of
concern, is the lack of a defined system to obtain prompt accurate information about
international events. For example the recent Tomsk-7 event the states, did not receive
information regarding the event. While it can be argued that nothing would reach the
U.S. Continent; therefore, the sates were not interested. Sutes have bands going to
Russia and they have returning citizens all of which are asking for guidance and
surveying. So even though the event is not widespread we still need some information.

My recommendation is that this Committee should consider the foUowmg:

1. Designate one agency to regulate all uses of ionizing radiation. This may or may not be
the same agency as the basic standard setting agency. This probably would include
transjKJrtation and defense issues. Provisions should be made to have something like the
Agreement State program of the AEA. The initial phase should allow states to certify that
they have adopted and can enforce the basic requirements of the "Suggested State
Regulations for the Control of Radiation." The program could require the pre-approval
of certain facilities and for conditions of operations.

ADVANTAGES.

A. One agency would have most of the expertise and regulatory control thereby
simplifying the coordination of national radiation control activities thereby providing the
public better access for assistance. Further, it would be easy to initiate a nationwide
information exchange program.

B. A single regulatory program modeled like the Agreement State program should
result in improving interstate commerce and possibly research and development.

C. With legislative authority, the federal government could regulate "orphan"
ionizing radiation sources such as NARM that are not regulated by the states in all cases
amoung the Non-Agreement States.

DISADVANTAGES.

A. This would remove some of the flexibility of local regulation.

B. Unless one agency sets the generic ionizing radiation standards and another
agency implements and enforces the standards there is some risk that one philosophy
(possibly not in the public interest) will develop.

C. By bringing NARM and X-Ray into the federal scheme the costs to Federal
Government of control may be too high. Fees for service may be the only practice
revenue for this program and care must be taken to kee[ the fees reasonible. Fees may
also be reduced if the plan is to allow states to collect fees since the sutes generally can
operate somewhat more efficiently. Start up funding may be an item of consideration.

NOTE. This proposal should include medical, academic, and industrial uses to
be adequate. Also mixed hazards, i.e. ionizing radiation and chemical, would
have to be addressed.

2. Extent federal control to include discrete sources and users of NARM and particle
accelerators which are not covered by the AEA. While many States have exercised
jurisdiction in these areas, we believe that nationwide consistency of regulation with the
resulting improved commercial development would occur if this were accomplished

Si&si?

Conference of Radfathn Control
Program Directors, Inc.

Con( Pubhcaiion «82-2

Criteria for Adequate Radiation
Control Programs
(Radioactive Materials)

A Report of Task Force E-3 (Formerly 2B)

Published bv

CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS. INC.

Conf Publication »82-:

CRITERIA FOR ADEQUATE RADIATION
CONTROL PROGRAMS (RADIOACTIVE MATERIALS)

A Report of Task Force E-3 (Formerlv 2B)

This work was performed under
FDA Cooperative Agreement 5 U01 FD 01201-02S1

Printed November, 1982

Prepared bv

Conference of Radiation Control Program Directors, inc.
65 Fountain Place. Frankfort, KY 40601

in cooperation with

The Bureau of Radiological Health and
The Executive Director for Regional Operations. FDA

The US Nuclear Regulatory Commission

The U S Environmental Protection Agency

The opinions and statements coniainedm this document are those j
of the Conference, and may or may not reflect the views of the j
cooperating federal agencies ^1

FORWARD

The development o< criteria for evaluating the adequacy of various aspects of state and local radiation control
programs has been given considerable attention by the Conference, the Bureau of Radiological Health |BRH|, the
Nuclear Regulatory Commission (NRC), and by the individual state programs

For those states which have become "Agreement States' ' under the provisions of the Atomic Energy Act. the Nuclear
Regulatory Commission has developed detailed criteria to evaluate the state's radiation control program for compatibil-
ity with federal regulatory requirements

In Apr 1 1 of 1981. the Conference prepared a document relating to criteria for an adequate radiation control program in
the area of x-ray This document similarly relates to criteria for an adequate radiation control program in the area of
radioactive materials, being particularly designed for those "Non-Agreement States " which regulate radioactive
materials not covered by the Atomic Energy Act This document closely parallels the criteria document of the NRC, and
can be used as a comparison document to the NRC criteria document for the evaluation of Agreement States

Wallace Hinckley ^ Heyward Shealy

linckley
Task Force Chairman

Conference Chairman

PREFACE

This guide has been developed bv the Task Force on Criteria for Adequate Radiation Control Programs (Radioactive
Materials) at the direction of the Conference of Radiation Control Program Directors Inc Adequate resources are
essential for the successful implementation of a program to protect the public health of our citizens from unnecessary
radiation exposure A guide, therefore, is needed that provides an outline of the basic needs and resources which should
be operational to properly carry out a radiation control program

This document presents the guidance of the task force as a result of its research and deliberations It presents a
method for determining the quality and quantity of the resources necessary for the successful operation of a balanced,
thorough and yet efficient radioactive materials program at the state level This report, in conjunction with the
document. "Criteria for Adequate Radiation Control Programs (X-Ray). should serve as the basis by which state
radiation control agencies, administrators, and legislative bodies, as well as the public, can make realistic evaluations
regarding the adequacy of a comprehensive program for the control of ionizing radiation

This guide embraces the "Licensing State Concept" for radiation control programs. The criteria assume that rules and
regulations have been adopted which are as effective as the "Suggested State Regulations for the Control of Radiation
(SSRCR) which have been prepared by the Conference of Radiation Control Program Directors. Inc . the US Nuclear
Regulatory Commission, the U S Environmental Protection Agency, and the Bureau of Radiological Health of the Food
and Drug Administration

CONTENTS

Page

Foreword m

Preface iv

Membership 1

History 2

Background assumption 2

Charge 3

Recommendations 3

Criteria for Adequate Radiation Control Program 3

I Legislation and Regulation 3

II Program Organization 4

III Program Planning and Management 4

IV Staff, Tra ning and Budget 5

V Licensing. Inspection, and Enforcement 7

VI Radiological Incident Response 9

VII Records, Office Equipment, and Clerical Support 9

VIII User Education 10

IX Transportation of Radioactive Materials 10

X Public Information 10

XI Radioactive Waste Disposal 11

XII. Special Studies 11

Appendix i Determination of Adequate Manpower 12

MEMBERSHIP

The following persons served on Task Force E-3

STATE PERSONS

Wallace Hmcklev. Chairman Maine
Michael McCann. Illinois (resigned)
Lynn FitzRandolph. Anzone (resigned)
Warren Jacobi, Colorado (assigned)
Nancy Kirner, Washington (assigned)

FEDERAL RESOURCE PERSONS

Bobby Dillard, EDRO-'FDA
Donald Thompson. DTMA/BRH
Joel Lubenau, OSP/NRC
DeVaughn Nelson. ORP/EPA

HISTORY

The need for guidance on adequate cniena was recognized by the Conference at its First Annual Meeting held m
Monigomerv Alabama in 1969 The first basic recommendations for an effective radiation control program were
presented in a workshop report from this meeting. Criteria and/or indices. Program Evaluation and treasures of
Progress '

At the Second Annual Meeting in 1970, a Program Criteria Committee recommended that to evaluate an x-ray control
program, five major areas should be addressed

1 Legislative Basis.

2 Administration,

3 Operations and Surveys.

4 Compliance, and

5 Education, Training and Public Relations

At the Third Annual Meeting held in 1974. a workshop was charged to consider methods to measure effectiveness of a
radioactive materials control program. This workshop recommended that the Conference establish a task force to
develop methods of how to measure radioactive material program effectiveness As a result of the recommendation, a
task force was formed, but not funded, and therefore never met

In 1 976. the Executive Committee clarified the charge to the Task Force on Criteria for Adequate Radiation Control
Programs, which only included the area of x-ray, radioactive materials being excluded

In 1979, a separate working group (Task Force 2 B I was formed for developing radioactive materials criteria but did not
meet In 1 980 this working group was charged by the Executive Board "to develop criteria for an adequate radiation
control program - radioactive materials

At the Thirteenth Annual Meeting in Little Rock, Arkansas, held in 1 981 , Task Force 2B submitted a draft of ■Criteria
for Adequate Radiation Control Program ■ Radioactive Materials' to the Executive Board The document was approved,
pending final refinements of one appendix

The final document with the refined appendix was completed in 1 982

BACKGROUND./ ASSUMPTIONS

Although the NARM Task Force and the SSRCR, Subpart C, Task Force have direct policy making charges related to
control of radioactive materials, the problem of developing adequate criteria for a radioactive materials program centers
on the need to consider the broad scope of the program and the interaction with the federal rules administered by NRC.
EPA, DOT, BHR. OSHA, DOE, etc The E-3 Task Force has considered the many requirements and constraints placed
upon licensing states and non-licensing states The following assumptions were made by the E3 Task Force

1 The "Suggested State Regulations for the Control of Radiation" (SSRCR) has been adopted by over 30 states
and forms the basis for licensing stale criteria Adoption of Part C for the licensing of radioactive materials is
assumed to be adequate criteria

2 The "Guides for Naturally Occurring and Accelerator- Produced Radioactive Materials (NARM)" is adequate
licensing criteria for NARM radioactive sources

3 The "Guides for Evaluation of State Radiation Control Programs Under Agreement with US NRC" is adequate
criteria for all slates and is essential for the Agreement Stales

CHARGE

To develop criteria to be used to evaluate the adequacy o( a radioactive materials program considering the variation
that exists among states m enforcement and administrative praciive. however, the following assumptions are to be
made by the task force

1 The Criteria shall endorse the licensing state concept for all radioactive materials

2 The Criteria shall assume that all states have adopted regulations equally effective as the SSRCR and
the provisions of Subpart C

3 The Criteria shall endorse, to the fullest degree possible without losing the flexibility needed for
application to all state programs, the state evaluation rationale for Agreement States

4 The Criteria shall be in a format suitable for inclusion with other task force recommended criteria

5 The Criteria shall consider federal authority, rules and guides, such as NRC. EPA. DOT. BHR. OSHA
etc

RECOMMENDATIONS

1 The Criteria should be distributed to each radiation control program for use in assessing program
adequacy

2 The Criteria should be used by program personnel to develop an understanding of the key elements of
a comprehensive radioactive materials program

3 The Criteria should be consistent with other "criteria" established for adequate radiation control
programs for other radiation sources, i e . x-ray, nonionizing, etc

4 Task Force E -3. having met its charge, should assume a monitoring role and revise criteria every three
(3) to five (5) years The chairman should maintain a file related to potential revisions

RADIOACTIVE MATERIALS PROGRAM CRITERIA
I LEGISLATION AND REGULATIONS

A The state radiation control program shall have enabling legislation essentially in conformity with the Council
of State Governments' "Suggested State Legislation," 1983 Edition. Volume 42 Likewise, the program
shall have regulations essentially m conformity with the "Suggested State Regulations for the Control of
Radiation (SSRCR) Note County or city programs for radioactive materials control may strike reference to
"state" in many instances Provision to set license fees by regulation is deemed desirable Statutory
authority should include a requirement for surety arrangements Issuance of civil penalties should be
included in legislation to support compliance, and authority to appoint an advisory committee is consistent
with development of program policy Legislation, consistent with the licensing state concept for radio-active
materials set forth in SSRCR and "Guides for Naturally Occurring and Accelerator-Produced Radioactive
Materials (NARM)," shall include authority to enable the state to license, inspect and enforce all radioactive
materials sources not preempted by federal authority The legislation should include authority for entering
into interstate and federal/state agreements
Federal-state arrangements include, but are not limited to

1 Granting state primacy for the enforcement of regulations for the control of radioactive materials This

includes the entering into agreements witti the US Nuclear Regulatory Commission (NRCl for the
control o( by-product, source and/or special nuclear materials Special authority may be needed tor
agreements related to the Uranium Mill Tailings Radiation Control Act (UMTRCA). and the regulation
of low-level radioactive waste

2 Approval of and preparation of stale emergency response plans

3 Training of stale staff in licensing, enforcement, laboratory radiochemistry, emergency response,
quality assurance, etc

4 Assuring sufficient funding, necessary support services and equipment to the slate radiation control
program

5 Interchanging of staff to assist state programs Legal staff should be assigned to assist the state
radioactive materials program in the enforcement of rules The legal staff should have a working
knowledge of all the laws, rules and procedures related to licensing, inspection and compliance

B Uniform regulations shall be adopted The egulations shall embrace reciprocal stale cooperation for
licensing inspection and enforcement of the shipment, manufacture, and product usage of radioactive
materials The state program shall adopt regulations for radioactive materials compatible with the provisions
of Part C, "Licensing of Radioactive Material,' of the SSRCR

C Regulations should be completely reviewed at least every two (2) years and the revision adopted withm one
(1) year thereafter A public hearing to allow review and comment by affected groups, and a review and
comment period of at least sixty (60) days prior to changes in the regulation, should be provided

II PROGRAM ORGANIZATION

A When responsibility for control of radioactive materials is divided among more than one state agency,
administrative letters of agreement should be effected to minimize duplication of services Agencies should
wo ■^ toward a common objective — radiation protection

B A radioactive materials program should be a separate and identifiable government unit with a single person
responsible for directing the work of the program When regional offices are utilized for program
administration, there should be clear lines of communication

C The program should utilize an Advisory Committee, consultants, or other outside resources to provide as part
of Its function, guidance and assistance for the radioactive materials program Note
See NRC Guide for Evaluation of State Radiation Control Programs

III PROGRAM PLANNING AND MANAGEMENT

The day-to-day operation of the radioactive materials program should be guided by the overall written
management plan of the program The Radiation Control Program Director shall be responsible for development
and implementation of the plan The plan should include the following basic components

A Problem — The problem ideniificaiion section of the plan should demonstrate that the promulgation of
rules IS justified based upon data showing the extent to which workers and the general population are
exposed to radiation

B, Obieciive — The long and short term objectives should be established with specific targets for priority and

accomplishment,
C Methodology - The strategy, including necessary fundings, should be detailed and include the services

provided by support agencies, such as laboratory, emergency response team, and licensing Activities

should be described that will fulfill stated objectives

0 Evaluation — The plan should include periodic evaluation of program effectiveness An important
component of evaluation would be a method to determine if changes have occurred in the hazards to
population groups

E Quality Assurance

1 Licensees' files should be selected on a predetermined frequency, for complete in-depth review of
license, inspection, and enforcement procedures for adherence to quality assurance criteria

2 Program personnel records should be selected, on a predetermined frequency, for review of time,
scheduling of inspections, expense records, accuracy of records, etc

3 The compliance program should be periodically reviewed to assess its effectiveness For example.
consideration should include escalated enforcement policies and effective use of staff Legal staff
should participate in the review

STAFF. TRAINING AND BUDGET

A Personnel - Professional Staff

1 Radioactive materials program licensing, inspection and enforcement staff should be experienced
Requirements for training and experience will be different for each state depending upon the types of
licenses administered by the state The following guidance may be used to develop a description of

positions

a Supervisor ■ Senior Level

Entry level qualifications should include.

(1) a tour year degree in science or engineering and supplemental college level training m
health physics and public administration.

(2) specific training in licensing, inspection and enforcement of radioactive materials
licensees, and

(3| at least four years of experience serving in a professional health physics position or eight
(81 years of equivalent training and experience in other civilian or military employment in
radioactive materials plus a record of progressive management responsibility within the
position
b Senior Level — Professional/Technical
Entry level qualifications should include

(1 ) a four year degree in science or engineering and course training in basic health physics.

(2) specific training in licensing, inspection and enforcement of radioactive materials
licensees; and

(3) at least one year of progressive experience in the roleof a Junior Level Professional/Tech-
nical or eight (8) years as a health physics technician in other governmental, civilian or
military employment related to radioactive materials

c. Junior Level — Professional/Technical
Entry level qualifications should include:

(1) college level training in mathematics, physics, and chemistry;

(2) two (2) years of progressive training in radiation protection, and

(3) specific training in inspection and enforcement of radioactive materials licensees or
equivalent training and experience In other government civilian, or military training

2 The supervisor should be part of the management team

3. Each employee should have an accurate, and up todate description of the position, detailing specific
responsibilities and tasks

4 It should be possible for any professional or technical employee to progress via a career ladder
through the various levels up to and including Director of the Radiation Control Agency

5 An organizational structure that supports promotion from within and salary levels adequate to retain
persons of appropriate qualifications should be the policy of the agency to minimize staff turnover and
maintain continuity

6. Personnel requirements for licensing, inspection and enforcement of radioactive materials licenses
should be 1 0 ■ 1 5 full-time equivalents per 100 licenses Additional staff would be required lor

a A major radioactive materials manufacturing facility

b A major milling/processing facility

c A low-level commercial waste disposal area

d Key emergency response activities

Small programs should assign responsibility between two (2) persons to insure continuous program
coverage and continuity in the event of sickness, promotion, etc (see Appendix I for example)

3 Training

1 Training should be included in the program plan This training should encompass initial and ongoing
training necessary to maintain technical competence and maintain the interest and involvement of
new and experienced staff At least five percent of program time should be allocated to training
and/or cross training

2 Training should be planned as available from universities, federal agencies, private companies, etc
to broaden the capability of the staff and to keep personnel informed of current developments m the
control of hazards related to radioactive materials

3 The radioactive materials program should have a planned policy of cycling all professional and
technical staff through a variety of training and retraining to periodically update and reinforce
previous knowledge

4 States should use training aids available from federal agencies and develop a comprehensive
reference library on radioactive materials and licensing

5 Interstate training agreements and exchange of information is desirable to utilize state training staff
C. Funding

1. The radioactive materials programs should be funded from sources that insure continuity of the
program

Note When states are authorized by legislation to adopt a fee structure to support the radioactive
materials program, the fee schedule in 1 0 CFR 1 70 may be used as a guide The authority to adopt a
fee schedule by regulation rather han by statute is advisable

2. There should be a funding mechanism for agency use of contractual services

V LICENSING INSPECTION AND ENFORCEMENT
A Licensing

1 The radioaciive maienals program shall license users of radioaciive materials in accordance with Pan C of
iheSSRCR The program shall obtain information about the proposed use of radioactive materials facilities
and equipment, training of personnel, radiation safety officer, operating and emergency procedures
appropriate for determining that the licensee can operate safely and in compliance with rules and license
conditions Pre-license visits for maior licensing actions should be considered

2 The radioactive materials program should adopt its own licensing guides, checklists and policy memoranda
to assure technical quality and uniformity in the licensing program NRC Guides. American National
Standards and Radioactive (Materials Reference Manual (RMRM) are appropriate for reference

3 The following administrative practices shall be considered

a Appropriate copies of rules, laws, guides and forms shall be printed and made available to each
licensee or prospective licensee

b The license should detail the type of radionuclide and form of the radioactive material, the
licensed quantity in curies, the authorized use. and all conditions attached to the license

c The license should be reviewed in light of current licensing practices at least every five (51 years
License expiration notices shoutd be sent 60 days prior to the due date

d Files should be maintained to provide for fast and accurate retrieval of licensee information,
licensee conditions. RMRM evaluation sheets, source data sheets, licensees consumer warn-
ing, licensee's calibration data, waste disposal contractor staff evaluations, pending enforce-
ment actions, general correspondence, personnel monitoring services, reports and miscellane-
ous information

e Issuance of licenses shall be based upon written guidelines Renewal of licenses should also be
based upon the history of compliance.

4 Quality Assurance (OA) and ALARA Programs for controlling exposure of patient and worker

a The radioactive materials program should have a plan to encourage licensees to implement OA
and ALARA Written guidance should be developed for evaluating QA and ALARA

b Calibrated test equipment should be used by inspectors in the evaluation of licensee's use of
radioactive materials

c Records of worker exposures maintained by licensee should be reviewed and evaluated as a
check (or a successful QA and ALARA program

B Inspection

1 Inspections shall be conducted by qualified staff It should be normal policy for senior level staff to
inspect licensees with higher priority frequency ratings and (unior level staff to inspect routine
licensees There should be communication and cooperation between the licensing and inspection
sections For states with separate inspection and licensing staffs, joint inspections for cross training
are desirable

2 Field and laboratory equipment in support f the radioactive materials program shall be adequate to
monitor all types of radioactive materials licensed by the agency

a Calibration schedules, procedures, and data should be maintained for all field and laboratory
equipment The agency's calibration of instrumentation, calibration records, and calibration

intervals should as a minimum, meet NRC guides

b The laboratory should participate in the US Environmental Protection Agency (EPA) or other
cross-check programs

3 Field Check Quality Assurance — Calibration should be vended, e g . calibration sources, flood
source, etc should be used by inspectors m the evaluation of the licensees program

4 The following administrative procedures should be followed

a An inspection schedule should be developed semiannually The inspection frequency should be
based upon the hazard and the inspection history The agency should have written procedures to
extend frequency .based upon compliance hisory See appropriate NRC guides

b Statistical data from inspections should be developed to permit program management to assess
the status of the inspection program on a periodic basis

c. Inspection guides and checklists should be used to maintain uniform compliance procedures

d A written policy should establish protocol for announced inspections (announced inspections
should not occur except under extenuating circumstances), unannounced inspections, follow-
up inspections, exit interviews, notification of violations, and obtaining agreements with licen-
sees on scheduling of corrections

e Procedures should be available for maintaining a sequential record of licensees' compliance
history to enable early identification of patterns of repetitive violations

f Inspection reports should be uniform and adequately describe

(1) scope of inspections.

(2) complete substantiation of all items of noncompliance.

(3) scope of licensees' safety programs.

(4) number and type of the inspector's independent measurements, and

(5) follow-up of previous violations

g Procedures should be established for quality assurance, including field review of inspectors

C Enforcement

1 The legal authority shall provide for prompt correction of items of noncompliance Written procedures
should be developed by the regulating agency for response to licensee noncompliance Appropriate
enforcement actions, should be progressive Options should include the following (not necessarily in
order listed)

a Remedy by administrative compliance letter per agreement with licensee at exit interviews with
licensee management.

b tVlanagement conferences

c Orders for correction of serious and imminently hazardous conditions, as defined in Section 1 3
(a) of the OSHA Act Section 5 (a)(l ) of the OSHA Act is a general duty clause which requires a
hazard-free place of employment

d Civil penalties

e Modification, suspension or revocation of licenses

-8-

f Impoundment of radioaciive materials
g Criminal penalties
2 The following administrative practices should be followed

a Issue "notice of noncompliance" letters within 30 days following the inspection. utili;ing
consistent regulatory language

b Specify all items of noncompliance, referencing the appropriate regulation or license condition
and establish a period of time for response, usually 30 days Recommendations thai may
improve licensees program should be in- eluded, but clearly separated from compliance items

c Respond promptly to all communication related to enforcement letters from licensees

d Establish a written review procedure that gives licensees the opportunity to appeal enforcement
actions

VI RADIOLOGICAL INCIDENT RESPONSE

A The State Radiological Incident Response Plan shall be written and should be updated annually This plan
should include
(Da telephone number for a 24 hour response contact,

(2) names, addresses, and telephone numbers of key personnel:

(3) lists of equipment thai is available.

(4) equipment calibration procedures, and

(5) Department of Energy (DOEI Regional Inter-agency Radiological Assistance Plan (IRAP| coordinator
and 24 hour telephone number

B A vehicle with multi-frequency statewide radio communication should be available for emergency
response

C The plan should be filed with other appropriate local, state and federal public health and safety offices

0 Prompt on-site investigations should be made of radiological incidents that require reporting to appropriate
authorities within 30 days per SSRCR. Part D. Lesser radiological incidents should always be followed up

E Results of investigations of radiological incidents should be documented, appropriate enforcement action;
taken, and cases followed up

F Federal, state and local agencies should be notified, when appropriate, of pertinent information abou
radiological incidents

G Information should be provided on failure of devices or sources to appropriate agencies responsible for
device or source approval

H Training should be given to local safety officials for responding to radioactive material incidents
I. Public information • see Section X

VII RECORDS, OFFICE EQUIPIVIENT, AND CLERICAL SUPPORT

Record-keeping is critical to program planning and evaluation and provides a means for demonstrating the public
health impact of the program Therefore, the data that is collected and retained should be selected to relate, a;
directly as possible, to the public health impact of the radioactive materials program

A The program should have a data managemeni system ihat provides ihe following

1 Accurate data thai is rapidly retrievable

2 Up-to-date list of licenses thai includes mailing addresses telephone numbers locations of use
possession limns, and the principal contact individual

3 Agency personnel monitoring records

4 Fiscal and other administrative records

5 Records o( incidents and investigations

6 An up-to-date list of qualified consultants and health physicists from whom the agency, radiation
safety officers and other persons may seek advice

B Office Equipment

The program should make maximum use of electronic data and word processing systems

C Secretarial and clerical

Adequate secretarial and clerical support should be provided

Vill USER EDUCATION

A The agency should encourage and promote continuing educational programs for radioactive material
users The agency should be prepared to conduct training in radiation safety and regulatory requirements

B Inspection personnel should provide information to the licensees related to the safe use of radioactive
materials to educate, assist and answer questions related to health physics

IX TRANSPORTATION OF RADIOACTIVE MATERIAL

A Transportation of radioactive materials shall be in accordance with Part C of Ihe SSRCR

B Where the state transportation or public safety agency has authority to regulate the transportation of
radioactive materials, there should be a written agreement to coordinate activities with the radiation
control program

C The radiation control agency should provide information regarding transportation to licensees

X PUBLICINFORMATION

A The radioactive materials program should make files available to the public consistent with State Freedom
of Information Acts A policy for protecting proprietary and 'or private information should be established in
accordance with state law

B The agency should have a designated Public Information Officer (PIOI Information for media distribution,
such as press releases and m-depth reports, should be prepared in conjunction with the Public Information
Office of the state agency The program should seek opportunities to inform the public in news releases, TV.
radio, incident reports, etc

C There should be a liaison with trade and professional groups leading to seminars, training courses and
public documents on radiation control of radioactive materials

D Public information procedures should be established lor notifying contiguous state directors and federal
agencies of radiological incidents and making all pertinent information available

XI RADIOACTIVE WASTE DISPOSAL

A The radiaiion control agency should develop a coniingency plan lo manage radioactive waste in the event
that current disposal sues are not available Reliance on a regional waste sue is not considered un op: on
unless (he regional sue is operational

B A periodic survey o( waste generated witlim the slate should be conducted to accomplish (A| above

C The agency should maintain information on viable disposal mechanisms (or use by licensees

XII SPECIAL STUDIES

Special studies should be performed of potential radioactive material exposures which may be the subieci ol
public concern These studies should assist the radioactive materials program m determining the scope o<
potential issues and problems developing regulations to control a potential hazard, and determining future
program needs

APPENDIX I

DETERMINATION OF ADEQUATE MANPOWER

For Agreement States, the US NRC has staffing requirements of 1 - 1 5 FIE (full time equivalents) per 1 00 active
RAM licenses The example below is based upon licensing state experience The assumptions listed below were used to
develop the example Both the example and assumptions may be used by a state program director to predict staffing
requirements for the establishment of a state materials licensing program

The following assumptions have been made for the example

1 One FTE is 225 work days

2 The ratio of licenses, by type, is similar from state to state, regardless of the number of licenses

3 A compliance ratio of 25% is assumed, i e 75% of licenses would need compliance letters, follow-ups and
legal actions

4 The total number of license actions, e g , amendments, renewals, and new applications processed each year,
equals the total number of the state programs licenses

5 The state program has developed an inspection frequency schedule, based upon license type, e g . specific
licensee. "Medical Institution." "Broad Scope." "Academic," "Industrial." "Non-Portable Gauge." etc (See
Table A for example)

6 Work day requirements

a Estimated work days necessary for inspection priority type (based upon state licensing experience)

I Specific licenses - 2 5 days
II Broad Scope - 7 1 days
III Follow-up (could include re-visit, letter, or legal action - 1 0 day

b Estimated work days necessary for license review and issuance activities - 0 6 days

c Estimated work days necessary for all other personnel duties, eg — staff training, public education,
emergency response, calibration, etc is 25°o of the sum of the estimated work days for inspections plus
the estimated work days for licensing activities (sum of 6a and 6b above)

d Estimated work days necessary for administrative activities associated with any licensing program, e g
budget preparation, program planning, personnel evaluation, etc is 25% of the Sum of the estimated
work days for inspection plus the estimated work days for licensing activities (sum of 6a and 6b above)

EXAMPLE

(The following example is based upon a new state program with an estimated potential for 100 licenses )

After reviewing his inspection priority schedule, (see example in Table A) the program director has determined
that the loliowing license types will require inspection each year
a No of specific licenses — 32

b Broad Scope licenses — 1

c Follow-up — 24

Based upon the above determined number of annual inspections and follow-up actions. Table B shows an
example of the method of determining the total work days per year required, and the calculation for determining the
annual FTE for the 100 licenses in this example

CATEGORY
1 Specific Institutional

2 Specific Private
Practice

3 Specific Gauge

4 Specific Research

5 Broad Medical

6 Broad Research
7. Broad Industrial

8 Manufacturer/Distributor
(Medical or Non-Medical)

9 Consultant/PhYSicist
10 In vitro General License
1 1. In VIVO General License

TABLE A

Inspection Prioriiy Schedule*
(SAMPLE)

EXAMPLE

Hospital

a Nuclear Medicine
b Therapy User
c Educational

{dependent upon use)

Office

a Nuclear Medicine
b Therapy User

a Moisture Density
b Level, etc.
c Non-specific

PRIORITY

2 years *
1 year *

1 to 3 years '

2 years *

1 year *

2 Years •

3 years *

2 to 3 years '

1 to 3 years
1 year
1 year
1 year
1 year

1 10 2 years

4 years
4 years

* Inspection frequency may vary depending upon individual state compliance history
+ The US NRC maintains guidance for inspection frequency which also may be used

13-

WORK ACTIONS

TABLE B

Oeierminaiion of Toial Work Days For a 1(X) License Program
(SAMPLE)

REQUmED
ACTIONS /YEAR

WORK DAYS
PER ACTION

TOTAL WORK
DAYS/YEAR

1 Inspection Actions

a Specific licenses
b Broad licenses
c Follow-up

2 Licensing Actions

3 Other Duty Actions

4 Administrative Actions

100

25'^i: of Subtotal
25°o of Subtotal

Subtotal

171

Grand Total Work Days

257

Once the total work days year have t>een determined, as shown above, then the required FTE to accomplish the
workload for this specific example is

Example

(257 total workdays/year] J FTE J

225 Work Days

1 14 Total FTE per year

This determined ratio of 1 1 4 FTE per year for 1 00 active licenses is an appropriate ratio when the total numt>er of
licenses is 100 or greater If the total number of licenses are less . 'an 100 and/or if the licenses include a large
manufacturer, a low-level radioactive waste site, or a milling operation, then the FTE ratio will usually have to be
adjusted higher

14.

PUBLICATIONS

•Firsi Annual National Conference on Federal-State Implementation of Public Law 90-602 September, 1969. ORO

69-4
•Second Annual National Conference on Radiation Control, The Quest for Quality Qctober 1 970. BRH/QRO 70-5
•Third Annual National Conference on Radiation Control, New Horizons. December 1971. DHEW Publication (FDA)

72-8021
•Fourth Annual National Conference on Radiation Control. Save a Rad. July 1 972. DHEW Publication (FDA) 73-8003

BRH OBD73-3
•Fifth Annual National Conference on Radiation Control. Planning for Protection, October 1973. DHEW Publication

(FDA) 74-8008
•Sixth Annual National Conference on Radiation Control New Challenges. Qctober 1974. DHEW Publication (FDA)

75-8010
"Seventh Annual National Conference on Radiation Control, Assuring Radiation Protection, February 1976, DHEW

Publication (FDA) 76-8026
•Eighth Annual National Conference on Radiation Control. Radiation Benefits and Risks Facts. Issues, and Options

April 1977. HEW Publication (FDA) 77-8021
•Ninth Annual National Conference on Radiation Control. Meeting Todays Challenges, April 1978. HEW Publication

(FDA) 78-8054
•Tenth Annual National Conference on Radiation Control. A Decade of Progress. June 1979. HEW Publication (FDA)

79-8054
•Thirteenth Annual National Conference on Radiation Control Problems. Trends, and Issues The Need for Redefinition.

HHS Publication (FDA) 82-8054. IVIarch 1 982
•Bonding and Perpetual Care of Nuclear Licensed Activities. January 1 975
•Credentialing Users of Ionizing Radiation in the Healing Arts — A Report of Task Force on Credentialmg of Radiation

Allied Health Operators. May 1982
•Criteria for Adequate Radiation Control Programs (X-Ray) A Report of Task Force 2A. HHS Publication FDA 81 -81 60.

April 1981
"Directory of Commercial Calibration Services for Ionizing Radiation Survey Instruments NBR GCR 80-296. April 1981
•Guides for Naturally Occurring and Accelerator-Produced Radioactive Materials (NARM). HHS Publication FDA 81-

8025. June 1981
•ionizing Radiation Measurement Criteria for Regulatory Purposes. NBS GCR 79-174 November 1979
•Natural Radioactivity Contamination Problems, EPA 520''4-77-015. February 1978
'Natural Radioactivity Contamination Problems Report No 2, A Report of the Committee, August 1 981
•Quality Assurance in Diagnostic Radiology A Guide for State Program Implementation. HHS Publication FDA 81 -81 47.

January 1981.

Conference of Badfation ConUoi
Program Dtractors, Inc

Criteria for Adequate Radiation
Control Programs (X Ray)

A Report of Task Force 2A

Published by i

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration

HHS Publication FDA 81-8160

Criteria for Adequate Radiation
Control Programs (X Ray)

A Report of Task Force 2A

This work was carried oul under PHS Contract Number 223-79-6010.

Printed April 1981

Prepared by

CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS. INC.

and

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administraiion

Bureau of Radiological Health

Rockville, Maryland 20857

The opinions and statements contained in this report are those of
the Task Force and may not reflect the views of the Department
of Health and Human Services (HH5).

FOREWORD

The development of criteria for evaluating the adequacy of various aspects of radiation
control programs has been given considerable attention by the Bureau of Radiological
Health (BRH), the Nuclear Regulatory Commission (NRC) and several State programs. In
one instance, the NRC has developed detailed criteria to evaluate Agreement States
compatibility with Federal regulation of byproduct materials. Therefore, in recognition of
the need in other areas of radiation control, the Conference of Radiation Control Program
Directors charged Workshop No. 1 at the 7th Annual Conference in 1975 to consider the
development of such criteria. The recommendation of the workshop called for the
formation of a Task Force to develop the actual criteria. On two separate occasions the
Executive Committee of the Conference established a Task Force to accomplish this task.
During this period, the charge has been refined to call for the development of specific
criteria for evaluation of a State radiation control program. The charge was divided
between two independent subgroups and this report reflects the work of Task Force 2A,
which was assigned to develop criteria for x-ray and nonionizing radiation control. It is
assumed that upon completion of criteria for other sources of radiation by future Task
Forces that it may be possible to integrate the criteria in a manner to enable the evaluation
of the overall adequacy of a comprehensive State radiation control program.

This document provides detailed criteria that State radiation control directors may use
to evaluate the adequacy of their x-ray control program. By identification of weaknesses
or deviation from nationally accepted criteria, individual directors will have more
justification for their budgetary or legislative requests.

^^Sc^r^ ^%uiifjfL.

Marshall W. Parrott, D.Sc.
Chairman

Conference of Radiation Control
Program Directors, Inc.

Dhn C. Villforth
director
Bureau of Radiological Health

100

PREFACE

This guide has been developed by the Task Force on Criteria for Adequate Radiation
Control Programs (X Ray) at the direction of the Conference of Radiation Control Program
Directors. The role of the radiation control program has changed over the years and
recently there b^s been concern raised in the press and in Congress regarding the adequacy
of the control of radiation in the United States. In general, these reports have been critical
of the programs but there has been very little discussion of the reasons for the problems.
Since adequate resources are fundamental to the successful implementation of any program,
there needs to be an outline of what should be expected of radiation control programs and
the resources needed to properly handle the problems.

This document presents the guidance of the Task Force as a result of its research and
deliberations. It presents, for the first time, a method for determining the quality and
quantity of the human resources necessary for the successful operation of a balanced,
thorough and yet efficient x-ray control program at the State level. This report should
serve as the basis by which State radiation control agencies, legislative bodies, as well as
the public can make realistic evaluations regarding the adequacy of x-ray control programs.

tf^v^P^y^

Edd 3ohnson, Chairman
Task Force 2A

William S. Properiio, Ph.D.
Director

Division of Training and
Medical Applications

101

CONTENTS

Page
Foreword ' '•''''

Preface • • • iv

Membership ^^

History ^

Background '

Charge ^

Conclusions and Recommendations 2

X-Ray Control Program Criteria 2

I. Legislation and Regulations 2

II. Program Organization 3

III. Program Planning and Evaluation 3

IV. Staffing 3

V. Registration, Inspection, and Enforcement 4

VL Survey Equipment ^

VII. Records \

VIII. User Certification P

IX. User Education ^

X. Quality Assurance °

XI. Public Information and Education 6

XII. Special Studies 7

Appendix I °

q
Appendix II '

Appendix III '

g
Appendix IV

102

MEMBERSHIP

Task Force 2A on the Criteria for Adequate Radiation Control Programs (X Ray)
consisted of the following members during the development of this document:

Edd C . 3ohnson , Chairman
Wyoming Division of Health and Medical Services

Warren Jacobi
Colorado Department of Health

Ernest Ranieri

Idaho Department of Health and Welfare

John W. Shaver - Consultant

Radiological Health Sciences Education Project
Walnut Creek, California

Bobby L. Dillard

Food and Drug Administration , Region VIII

Richard E. Gross

Food and Drug Administration
Bureau of Radiological Health
Division of Training and Medical Applications

103

CRITERIA FOR ADEQUATE RADIATION CONTROL PROGRAMS (X RAY)
A REPORT OF TASK FORCE 2A

HISTORY

Workshop No. 1 at the 7th Annual Conference in Hyannis, Massachusetts, was charged to
consider the development of criteria for an adequate State Radiation Control Program. In
its report to the Conference, Workshop No. 1 recommended the formation of a Task Force
to further study this matter. In September 1975, the Executive Committee implemented
this recommendation by forming a Task Force, however, support funds were not available.
In September 1976, the Executive Committee reactivated the Task Force, clarified the
charge, and allotted funding for meetings. Members of the original Task Force— 3ohn
Shaver, Chairman, Si Kinsman, 3im Hickey, Warren Dacobi, Bobby Dillard, and Charles
Showalter (representing Richard Gross)— met in Denver, Colorado, during April 1977.
Criteria developed at this meeting were presented to the Conference members for comment
at the 9th Annual Conference in Seattle, Washington.

In 1978 the Task Force was reconstituted to include the members mentionec above. The
criteria were again submitted to the Conference membership for comment in August 1978.
In November 1978, the Task Force met in Rockville, Maryland, to review the comments, and
revise the criteria document as indicated by the comments. A final version of the criteria
was submitted to the Conference and approved for publication.

BACKGROUND

The problem of developing suitable criteria for radiation control program adequacy has
surfaced on numerous occasions, and has been given considerable attention by the Bureau of
Radiological Health, Nuclear Regulatory Commission, and several of the State programs.
For example, in 1969, the BRH prepared a detaUed questionnaire as a part of a study to
evaluate the status of State radiation control programs. The questionnaire was carefully
developed with input from States, regional offices, and other Federal agencies, such as the
NRC. It was pilot tested in most regions, and revised and improved based upon these tests.

Other work in this area includes sending Federal and State survey teams, upon request,
to selected States to conduct detailed program evaluations. The Nuclear Regulatory
Commission has detailed criteria to evaluate Agreement States to ensure program
compatibility. In 1976, the Southern Interstate Nuclear Board conducted a study of
radiation control programs in the South. The Conference has also formed workshops to
consider the matter. The Task Force has taken full advantage of the previous work.

CHARGE

The charge that Task Force 2A worked under was to develop criteria that can be used to
evaluate the adequacy of a State x-ray and nonionizing control program. In carrying out
this assignment, the Task Force was reminded to consider mechanisms that would ensure

104

0. To minimize staff turnover and maintain program continuity there should be
an organization structure which provides for:

a. Promotion opportunities from junior level to senior level and
supervisory positions, and

b. Periodic salary increases which are commensurate with experience and
responsibility.

B. Training

1. A formal training program should be established for all new professional
employees. New employees should be provided with copies of and
instructions on the regulations and written program procedures which
include registration, inspection, and compliance requirements. New
inspectors should be accompanied by experienced personnel during initial
field surveys.

2. Personnel should participate in a planned continuing program of in-service
training consisting of seminars, demonstrations, lectures by consultants,
short- and long-term training and attendance at professional meetings
(Health Physics Society, Regional Training meetings, annual meetings of the
Conference, and so forth) to keep abreast of current developments in the

fit control of radiation hazards.

V. Registration, Inspection, and Enforcement

A. Registration. The program should have authority to require the registration of
all x-ray sources. The "Suggested State Regulations for the Control of Radiation
- Part B" may be used as a guide in developing the extent of the registration

t function.

B. Inspection Authority. The program should have authority to conduct its own
inspections. Survey reports from qualified private consultants or from radiation
safety officers employed by the owner of an x-ray installation may be useful in
augmenting the inspection program.

The program should have authority to set qualifications for private consultants
or radiation safety officers when the survey reports of such individuals are used
by the State to evaluate continuing compliance with its regulations in lieu
of installation inspections by program staff.

C. Inspection Procedures. The program should have written procedures to insure
that linif orm inspections are conducted. These procedures should provide for the
evaluation of the overall radiological performance of the facility. The
"Suggested Optimum Survey Procedures Manual" can be used as a reference to
develop wiStten procedures for machine parameter measurements.

D. Inspection Schedule. The program should have a written priority schedule which
sets routine inspection frequencies by type of x-ray installation. The schedule
should be reviewed annually and adjusted to reflect any changes in program
objectives. The irtspection priority should take into account the following
considerations:

1. Inspect every facility within a year of initiation of operation.

2. Utilize screening techniques, i.e., DENT, BENT, NEXT, and so forth,
whenever possible.

105

3. Utilize facility/machine workload information and other previous inspection
data, in addition to screening data, to develop specific inspection priorities.

I*. Inspect every facility (except dental) at least once every five (5) years (see
Appendix II). Facilities with higher priorities should be inspected more
frequently.

An example of a program-determined priority schedule is given in Appendix III.

E. Enforcement. The program should have written enforcement procedures. These
procedures should detail the steps to be taken within a specified time period to
accomplish compliance with the regulations. The Office of the State Attorney
(Attorney General) should be consulted in the development of these procedures.
Interpretations based on policy occasions should be accumulated and maintained
to ensure consistent enforcement policy.

•i-
VI. Survey Equipment

The Program should have sufficient field x-ray survey equipment and instrumentation
capable of detecting and measuring x-radiation exposure to determine compliance
with applicable guides and regulations, and to provide estimates of radiation doses to
patients, operating personnel, and the general public.

Ideally, a survey kit should be provided for each FTE in the field. (Refer to the
Optimum Survey Procedure Manual for a partial listing of the equipment, materials,
and supplies that can be useful to the field inspector. However, special equipment
will be needed for special studies, that is, low-energy detectors for evaluating
mammography equipment, and high-energy detectors for evaluating certain therapy
equipment.)

The x-ray control program should be capable of providing for the servicing and
calibration of all x-ray survey equipment and instrumentation. There should be a
written procedure and schedule for calibration and servicing of each radiation
detection instrument. The schedule should call for a calibration at least annually,
with calibration checks performed on a quarterly basis. Each instrument should bear
a tag stating the latest date of servicing and calibration, and a calibration curve or
correction factors for each detection range. Responsibility for calibration and
servicing should be assigned to one staff person. Calibrations may be done by the
radiation control pror,ram using its own calibration source(s), equipment, and
procedures, or by a commercial instrument calibration and repair service under
contract.

The complexity of the agency calibration program is dependent upon the purpose for
which the data was obtained and should be detailed in the written procedures.

VII. Records

Recordkeeping is critical to program planning and evaluation and provides an
objective means for demonstrating the public health impact of the program.
Therefore, the data that is collected and retained should be selected to relate as
directly as possible to this public health impact.

A. The program should have an efficient data management system that provides the
following:

1. Data accurately and rapidly retrievable.

2. A continuing integrated registration program.

106

3. Physical survey forms containing minimum uniform data, and compliance
and enforcement actions.

k. Agency personnel monitoring records.

3. Fiscal and other administrative records.

6. Records of x-ray machine transfers and vendor notifications.

, 7. Records of incidents and investigations.

B. The program should utilize the above records for;

1. Program planning.

2. Evaluation of program objectives.

3. Establishing priorities for x-ray inspections.

It. Carrying out field survey and inspection programs.

C. The program should make maximum use of available electronic data processing
systems.

VIII. User Certification

The program should establish a credentiaJing program for all users of x-ray
equipment. (See Appendix IV.)

IX. User Education

A. The program should encourage, sponsor, or conduct continuing formal education
programs for users or operators of x-ray sources.

B. The inspector should take advantage of his time in x-ray facilities to educate,
assist, and answer questions regarding radiation safety and good radiological
health practices.

X. Quality Assurance

The program should have a plan to encourage and assist healing arts registrants in
establishing quality assurance programs to ensure that all images are of a
consistent, high diagnostic quality, and that all treatments are properly
administered.

XI. Public Information and Education

A. The program should maintain liaison with professional groups, sponsor seminirs
and training courses, and develop/distribute public documents on radiation.

B. The program should provide x-ray registrants with current reference material,
guidelines, and standards as they are available.

C. The program should serve as a resource for technical information on
radiological health to the public at large (through newspaper releases, TV,
radio, incident reports, and so forth) and participate in public education efforts
at the State and local levels.

107

XII. Special Studies

The program should have adequate personnel, instrumentation, and initiative to
undertake special studies including x-ray protection; for example, identify new
problems that need investigation, develop more efficient procedures and
methodology, and cooperate with Conference and/or Federal programs.

is.

108

Appendix I

Staffing requirements can be determined using the following rationale. Clerical and
administrative/managerial personnel are not included.

A. The following assumptions have been made in this analysis:

1. For each 1,000 x-ray tubes, there will be approximately 10 percent annual
turnover or replacement.

2. For each 1,000 x-ray tubes, approximately 50 percent will be dental tubes.

B. Inspection, FoUowup, and Registration

Regardless of program size, an annual inspection workload of 500 x-ray tubes per
FTE is a reasonable figure.

1. Dental facilities (assume 50 percent foUowup,
to screening programs) 500 tubes X 0.2 (priority)
X 0.50 (followup) = 50 tubes/yr.

2. Other facilities
500 tubes X 0.5

(priority) = 250 tubes/yr.

3. New installations
1,000 tubes X 0.10

(turnover) = 100 tubes/yr.

400 tubes/yr. = 0.8 FTE

4. Other followup and registration 0.2 FTE

1.0 FTE per 1,000 tubes

C. Other Activities

Larger programs (larger number of x-ray tubes) can be more efficient with respect
to other aspects of program, that is, education and quality assurance, staff training,
special projects, and so forth. Other factors which will influence program efficiency
are geographical distributions of population, age and experience of program, and
possible regionalization of program operation. A range of staffing requirements
has been derived, based on these considerations for other program functions.

Education and Quality Assurance
Staff Training
Special Projects
Miscellaneous

Totals

•Values are for full-time equivalents (FTE) per 1,000 tubes.

D. Total staffing requirements, as derived above, will range from l.U to 2.1 FTE's
per 1,000 x-ray tubes.

"Program Size"
Larger* Smaller*

0.1

0.5

0.1

0.2

0.1

0.3
1.1

109

Appendix II
The rationale for this criterion is based upon the following considerations:

1. When operation is initiated, the dental facility will be surveyed and compliance
determined.

2. Dental x-ray equipment tends to stay in compliance. The major problem is
patient exposure, and while it is recognized that a screening program cannot
identify all problems, such a program can cost-effectively identify those
facilities that should be revisited. ■

3. DENT should be conducted on at least five (5) year intervals.

Appendix HI

Each radiation control program should have a written priority schedule for inspection
frequencies that will reflect the program's current objectives.

The following is only an example of such a priority schedule:

Hospital or Similar facility
Radiology Clinic
Other Medical facility
Chiropractic facility
Veterinary facility
Dental facility
Industrial facility

every year
every year
every 2 years
every 2 years
every 2 years
every 5 years
every 2-'f years

Appendix IV

All x-ray machine operators in the healing arts should demonstrate a minimal level of
competence in the use of x-ray equipment which is consiste .t with national criteria.

Conference Task Force No. 5 "State Credentialling Program for Allied Health
Operators" is currently working to develop recommendations and provide suggestions for
implementation.

The staffing requirements for implementing this program have not been included in
section IV.A.6.

u. 1. oovaiMUDiT ndMTmc orncc itii— ?M-w«/t>M

CRCPD Publication 86-«

Conference of Radiation Control
Program Directors, Inc.

Criteria for Adequate Radiation
Control Programs

(Environmental Monitoring and Surveillance)

A Report of Task Force E-1 0

Published by
CONPERENCE OE RADIATION CONTROL PROGRAM DIRECTORS. INC.

Printed May 1986

Ill

DISCLAIMER

.The Information contained in this document ^as been developed
by the Conference for consideration by radiation control
progtaras, and other interested parties.

The Implementation and use of the information and

recommendations contained in this document are at the

discretion of the user. The implications from the use of this
document are solely the responsibility of the user.

The opinions and statements contained in this document are
those of the Conference, and may or may not reflect the views
of the cooperating federal agencies.

112

CRCPD Publication 86-4

CRITERIA FOR ADEQUATE RADIATION CONTROL PROGRAMS
(ENVIRONMENTAL MONITORING AND SURVEILLANCE)

A REPORT OF TASK FORCE E-10

This work was perfonned under:
FDA Cooperation Agreement FD-U-000005-05-2

Printed May 1986

Prepared by

Office of Executive Secretary

Conference of Radiation Control Program Directors, Inc.

71 Fountain Place, Frankfort, KY 40601

in cooperation with

The Center for Devices and Radiological Health and
Office of Regulatory Affairs, FDA

The U.S. Environmental Protection Agency, and
The U.S. Nuclear Regulatory Commission

113

FOREWORD

The development of criteria for evaluating the adequacy
of various aspects of radiation control programs has been given
considerable attention by the Center for Devices and
Radiological Health (CDRH) , the Nuclear Regulatory Commission
(NRC), the Environmental Protection Agency (EPA) and by the
radiation control agencies for individual states. For those
states which have become "Agreement States" for the licensing
of certain radioactive materials, under provisions of the
Atomic Energy Act, the NRC has developed detailed criteria with
which to evaluate the compatibility of the States' regulations
with the Federal regulations of these materials. In response
to similar needs in other aspects of radiation control, the
Conference of Radiation Control Program Directors, Inc.,
(CRCPD) established task forces and committees to formulate
appropriate criteria.

In April of 1981, the Conference published "Criteria for
Adequate Radiation Control Programs (X-Ray)," in November of
1982, "Criteria for Adequate Radiation Control Programs
(Radioactive Materials)," and in April of 1985 "Criteria for
Adequate Radiation Control Programs (Nonionizing)." This
document presents the criteria for adequate programs of
monitoring ionizing radiation in the environment.

The CRCPD will utilize
Comprehensive Review Program.

these documents in its State

By identification of weaknesses or deviation from
nationally accepted criteria, directors of state and local
programs will have a basis to strive for improved programs.

Jarren eT (fl'acobi ^^
Chairman, Task Force on
of Criteria for Adequate Radiation
Control Programs (Environmental
Monitoring and Surveillance)

Eddie S. Tuente
Chairman, Conference
of Radiation Control
Program Directors,
Inc.

114

PREFACE

A program for monitoring radioactive materials and ionizing
radiation in the environment, both actual and potential, is
essential for the protection of the public health and of the
environment. Such a program is necessary, for a state, whether
or not the state licenses radioactive material, and whether or
not a major nuclear facility is Iccated within the state.
States that do license facilities which contribute to the
radiation environment should provide a monitoring program which
has at least the quality that is required of the facilities.

Adequate resources are essential for the successful
implementation of every program for the protection of the public
from unnecessary radiation exposure. Guides are therefore
needed which provide outlines of the specific needs and
resources of particular control programs.

This guide has been developed by the Task Force on Criteria for
Adequate Radiation Control Programs (Environmental Monitoring
and Surveillance), E-10, at the direction of the Conference of
Radiation Control Program Directors, Inc., (CRCPD). The
document provides guidance as to the resources required for a
balanced, thorough and efficient surveillance of ionizing
radiation and radioactive materials in the environment.

This report is the fourth in the series of "Criteria for
Adequate Radiation Control Programs," for X-Ray, for Radioactive
Materials, and for Nonionizing Radiation. These reports provide
guidance by which state radiation control agencies,
administrators, legislators and the public can make realistic
evaluations of radiation control programs. The CRCPD will
utilize these four documents in their State Comprehensive Rev ew
Program.

The criteria assume that rules and regulations have been adopted
which are as effective as the "Suggested State Regulations for
the Control of Radiation" prepared by the CRCPD, the U.S.
Nuclear Regulatory Commission, the U.S. Environmental Protection
Agency and the Center for Devices and Radiological Health.

115

TABLE OF CONTEUTS

Page

Foreword 1

Preface . li

Task Force Members iv

History & Charge 1

Recommendations 2

Legislation and Regulations 3

Program Organization 3

Program Planning and Management 4

Staff, Training and Budget 6

Quality Assurance 9

Program Records and Reports 13

Equipment 14

Sampling Criteria 14

Public Information 15

Special Studies 15

Table I-Surveillance Criteria for Ambient Environment. . 16

Table Il-Surveillance Criteria for Facilities 17

Appendix A-Staffing Requirements 24

Appendix B-Lower Limit of Detection 25

111

116

TASK FORCE MEMBERS

The following persons served on Task For
State Persons

Warren Jacobi, Colorado r^,o^
Nolan Bivens,'souJh?f?^U^f'^"'^"
Melanie Hamel, IlUnol

ce E-10

Robert Mooney, Washingt
Margaret Reillv. PennL

■ly, Pennsylvania
Federal Resource Pgr<=nnc

Robert Bores, NRG
Ronald Colle' NBS
Bobby Dillard,' ORa/FDA
Charles Phillips, EPA

117

CRITERIA FOR ADEQUATE RADIATION CONTROL PROGRAMS
(ENVIRONMENTAL MONITORING AND SURVEILLANCE)

HISTORY

The need for guidance criteria in the development,
organization and operation of an adequate program to control
radiation was recognized at the first annual meeting of the
Conference, in 1969. Since that time three guidance documents
have been developed by the Conference. These are:

1) "Criteria for an Adequate Radiation Control Program
(X-Ray),"

2) "Criteria for an Adequate Radiation Control Program
(Radioactive Materials)" and

3) "Criteria for an Adequate Radiation Control Program
(Nonionizing) ."

In 1982, the Conference also developed a program providing
a comprehensive review and evaluation of a state or local
radiation control program, upon request from a state. The above
three criteria documents were used as the primary basis for
making these reviews. It soon became apparent that one major
component of a radiation control program, that of environmental
monitoring and surveillance, had no established criteria with
which to conduct the reviews and evaluations.

As a result of this need, in 1983, the Executive Board of
the Conference established a committee for the development of
environmental monitoring and surveillance program criteria.
This report is the result of the work of this committee.

CHARGE

The committee is to develop a criteria document that can be
used in the evaluation of the adequacy of a state routine
environmental monitoring and surveillance program. Such
criteria will consider and recommend mechanisms whereby it is
assured that state programs are compatible with various federal
standards and programs of environmental monitoring and
surveillance .

118

RECOMMENDATIONS

1. The Criteria should be distributed to each radiation contr..!
program for use in assessing program adequacy.

2. The Criteria should be used by program personnel to develop
an understanding of the key elements of a comprehensive
program for environmental monitoring and surveillance.

3. The Task Force on Radon should develop criteria for
screening, sampling and assessment of radon levels in the
ambient environment.

4. The Task Force on Nonionizing Radiation should evaluate the
need to perform environmental monitoring of nonionizing
radiation.

5. The Conference should pursue, with the U.S. Nuclear
Regulatory Commission, the U.S. Environmental Protection
Agency and the Departme: : of Energy, the uniform reporting
of environmental radiological data.

119

CRITERIA FOR ADEQUATE RADIATION

CONTROL PROGRAMS -

ENVIRONMENTAL MONITORING AND SURVEILLANCE

LEGISLATION AND REGULATIONS

1. A state which has regulatory authority over sources of
ionizing radiation must have appropriate legislation and
regulations. An environmental surveillance program should
have specific legislation and regulations as a basis for its
authority and evaluations. However, the authority for
environmental monitoring may derive from more general
statutes.

2. The program should have authority to enter into interstate,
and Federal-State arrangements for training, travel, joint
inspections, equipment loans, and so forth.

3. The legislation and/or regulations should contain provisions
for reciprocity with neighboring States for the exchange of
monitoring data and reports.

PROGRAM ORGANIZATION

The environmental unit of a radiation control program
should have equal organizational status with other units of the
program. This will allow independent environmental assessments
distinct from the program's licensing and compliance function,
and will allow a greater degree of independence.

The environmental monitoring program should be in the
radiation control program. Persons responsible for sample
collection, analysis, and reporting should all be under the
chain of command of the radiation control program director.

Program functions should be assigned to two or more persons
to assure continuous program coverage and continuity in the
event of sickness, promotion, leave or other unavailability of
program principals. However, one person needs to have overall
responsibility for ensuring all aspects of the environmental
monitoring program are properly addressed.

When responsibility for different aspects of the
environmental monitoring program, e.g., sample collection,
radiochemistry , etc., are divided among more than one state
agency, administrative letters of agreement should be
established to document respective roles, responsibilities, and
understandings, and to promote coordination and cooperation in
conducting an effective program.

120

Provisions should be made for significant increases in
effort when emergencies occur. Details of those provisions
should be addressed as part of the state's emergency response
plan.

The program should utilize advisory committees,
consultants, and other resources, e.g., NRC , EPA, and CRCPD.

For facilities and activities that have a potential for
ma lor public health concerns, there should be a mechanism for
the exchange of environmental information among the states,
other appropriate organizations and interested individuals.

PROGRAM PLANNING AND MANAGEMENT

The day-to-day operation of the environmental monitoring
program shall be guided by the overall written management plan
of the program. The radiation control program director shall be
responsible for development and implementation of the plan.

PROBLEM

The plan should identify radiation sources and areas of
environmental radiation concern. It should also address the
need for background data to evaluate existing and potential
problems .

OBJECTIVE

The adequacy of an environmental monitoring program is
determined, in part, by how well the progr. .1 meets its
objectives. The objectives of a program will vary from state to
state and depend upon many factors, including:

1. The program's level of support;

2. The number of facilities which have a potential
environmental impact (the objectives may differ
between pre-operational , operational, and post-
operational activities, and may also differ between
facilities ) ;

3. The state's regulatory authority;

A. The need to either screen samples or provide detailed
analyses;

5. The desire or need to verify a facility's data or to
do independent environmental evaluation; and

6. The state's participation in national monitoring
programs .

121

As a minimum, the state program should meet the following

objectives :

1. Characterize the state's general radiological,
environmental profile, including ambient conditions as
well as the effect of any radiation facilities;

2. Obtain background data around nuclear facilities to be
used in evaluating operational effects;

3. Verify source terms and possible changes including
both natural and man-made sources;

4. Provide in-place monitoring for use, after-the-fact,
in the event of a facility accident or other
radiological crisis;

5. Assure the quality of data;

6. Evaluate public health and environmental impacts, if
any, due to radiation insults; and

7. Provide information on program activities.

METHODOLOGY

The plan should specify tht actions necessary to fulfill
the above objectives.

EVALUATION

The plan shall include periodic evaluations of program
effectiveness. Audits shall be performed annually by qualified
individuals who do not have day-to-day responsibillities in the
environmental monitoring program. Results of the audits shall
be reviewed by management and corrective actions shall be taken
where indicated.

Additionally, the radiation control program director should
annually review the environmental monitoring program to assure
that :

1. The program is continually meeting its objectives, and
that the quality assurance (QA) procedures are
followed; •*

2. Appropriate changes in methods, priorities and
agreements are made in accordance with administrative
procedures ;

122

3. Reports are timely; and

4. Program deficiencies and deviations are brought to
management's attention and appropriate action is
taken.

STAFF, TRAINING AND BUDGET
PERSONNEL - PROFESSIONAL STAFF

The environmental monitoring program staff should have
adequate experience in environmental monitoring. Requirements
for training and experience will be dependent on the job
classification and assigned responsibilities, e.g., training
needs for a health physicist vs a radiochemist . The following
guidance may be used to develop a description of positions.

Supervisor

Minimum qualifications should include:

1. A four (4) year degree in science or engineering, and
additional college level training in public
administration and health physics, chemistry, or
environmental science;

2. Specific training in environmental monitoring and
exposure pathways; and

3. At least four (A) years of experience in a
professional position in health physics, chemistry, or
environmental science; or eight (8) years of
equivalent training and experience in other employment
in health physics, radiochemistry , or environmental
monitoring, plus a record of progressive management
responsibility within the position.

Senior Level

Minimum qualifications should include:

1. A four (4) year degree in science or engineering and
course work in basic health physics, chemistry or
environmental science;

2. Specific training in their appropriate field - health
physics, radiochemistry, and/or environmental science;
and

123

3. At least one (1) year of progressive experience in the
role of a Junior Level Professional /Technical , or
eight (8) years employment as a health physics
technician related to radiological environmental
monitoring.

Junior Level

Entry level qualifications should include: , ^

^tlSt~ *■■"--:

1. A four (4) year degree in a science or engineering
field; or

2. Equivalent training and/or experience consisting of:

(a) College level training in mathematics, physics,
and chemistry;

(b) Two (2) years of progressive experience in
radiation protection, chemistry, or
environmental science; and

The supervisor should be part of the management

organization.

Each employee should have an accurate, current description
of the position, detailing specific responsibilities and tasks.

It should be possible for any professional or technical
employee to progress via a career ladder through the various
It levels up to and including Director of the Radiation Control
il xerogram. An organizational structure that supports promotion
It from within and salary levels adequate to retain persons of
appropriate qualifications should be the policy of the agency to
minimize staff turnover and maintain continuity.

124

Personnel requirements are shown in the
provides the range of staff required for an
monitoring program.

Figure which
environmental

18 -
16

« 12

i 8

2 6

OL i_

_1_

2 4 6 8

Number of Major Facilities

The graph relates staff requirements to the number of major
facilities which impact a state. (A major facility includes,
but is not limited to, a reactor site, a uranium mill, a low-
level radioactive waste facility, or a Department of Energy
nuclear facility.) This graph should not be interpreted as
indicating the number of Full-Time Equivalents (FTE) required to
monitor a major facility. Rather it is a convenient method of
relating staff needs to characteristics of a state. The FTE
include management, health physicists, chemists, field
personnel, and other professionals. It also includes any
individual from any other program or agency which assists in
sample collection, analysis, or any other environmental
monitoring function. A range has been provided because of
circumstances which differ from state to state. Appendix A
provides the basis for the graph in this Figure.

It is recognized that some states may not want to have a
complete environmental monitoring program, just as some states
do not control both HARM and by-product material.

125

TRAINING

Training should be included in the program plan. This
training should encompass initial and ongoing training necessary
to maintain technical competence and maintain the interest and
Involvement of new and experienced staff. At least five (5)
percent of program time should be allocated to formal training
and/or cross training.

Training should be planned as available from universities,
federal agencies, private companies, professional societies, and
the CRCPD to 1) broaden the capability of the staff, 2) provide
professional development, 3) to enable staff to progress up
their career ladders, and 4) to keep personnel informed of
current developments in environmental monitoring and the control
of hazards related to radioactive materials.

The environmental monitoring program should have a policy
of cycling all professional and technical staff through a
variety of training and retraining to periodically update and
reinforce previous knowledge. Individual development plans for
each staff member are encouraged.

States should use training aids available from federal
agencies and develop a comprehensive reference library on
radioactive materials and environmental monitoring.

Training agreements and exchange of information is
desirable between states, and between the state of 1) its
licenscLS, 2) federal facilities and 3) federal licensees.

FUNDING

The environmental program should be funded from sources
that assure continuity of the program. There should be a
funding mechanism for agency use of contractual services.

QUALITY ASSURANCE

The role of an analytical laboratory is to ensure that all
measurements being performed are precise and accurate and to
provide qualitative and quantitative data that will assist in
decision making. To be of value, analytical data must be
accurate and legally defensible.

POLICY STATEMENT

The program shall have a written statement of its QA
objectives. This should include:

126

1. A conuniCment of management; and

2. A statement of required precision and accuracy.

At least 10% of the overall program effort should be
voted to ensuring that analytical results are accurate and
ecise, and ensure that measurements reflect actual conditions,
e effort needed for particular types of analyses will be case
ecific.

One person shall be assigned the overall responsibility for
e quality assurance program.

OCEDURES

Procedures shall be written, approved, and followed for:

1. Sample collection and receipt. Sample size should be
sufficient to perform a second independent analysis.

2. Sample preparation and analysis, including the degree
of precision and accuracy and the lower level of
detection required for each type of analysis.

3. Health physics relating to the handling of samples and
the surveying of both the samples and the laboratory.

4. Calibration and operation of instrumentation.

5. Quality control.

6. Maintenance of standards.

7. Coding individual samples for the purpose of
identification and tracking through the analytical
process .

8. Computer program documentation, if applicable.

9. Reporting

10. Data analysis procedures, Including anomalous data
follow-up.

11. Prevention of cross-contamination. Samples with
different activity levels should be segregated into
separate laboratory areas.

12. Operating procedures under emergency condiclons which
address both operations and analysis.

127

13. Storage of samples before and after analysis.

14. Preventive maintenance schedules for each piece of
equipment .

15. Disposal of materials which must be treated as
radioactive waste and/or are regulated under RCRA.

STANDARDS

2
NBS or NBS-traceable standards and/or calibrated

instrumentation shall be used. The documentation of standard

sources and the certification of instruments must be maintained

by the radiation control program.

When available, standards should be in a similar chemical
and physical form to that of the samples to be analyzed. The
activity of the standard should be balanced between the activity
of the samples being counted and realistic counting times
necessary to assure adequate precision and accuracy.

CALIBRATION AND OPERATIONAL CONTROLS

The program shall have a sufficient number of check sources
and standards to verify the calibration of all instruments at
any time.

All instrumentation, radiological and nonradiological ,
shall be calibrated at least annually or at the manufacturer's
recommended intervals, whichever is more frequent. Check
sources should be used daily or before each use of the
i n s t rumen t a t i on .

Backgrcunds should be obtained daily or before each use.
When analysis requires very long counting times, a background
with the same counting time should be obtained at least monthly.

Blanks should be run with each batch unless otherwise
justified.

The isotopes used for gross alpha and beta counting should
be specified.

Satisfactory measurement assurance interactions between source
suppliers and NBS involve two (2) basic mechanisms: 1) The
supplier submits a calibrated radioactivity source to NBS for
confirmaton that the supplier's calibration value agrees with
NBS results within certain specified limits; or 2) NBS provides
calibrated radioactivity sources of undisclosed activity to a
supplier who is able to make activity or emission-rate
measurements on the source that agree within certain specified
limits with the measurements of NBS.

128

Control charts shall be maintained for background, check
and calibration sources. Operational checks shall indicate
results are within stated parameters. If they are not, the
instrument shall not be used until the problem with the
instrument has been corrected.

PERFORMANCE TESTING

Interlaboratory

States shall participate in interlaboratory performance
testing programs. Comparisons should be made with the
following:

1. Federal facilities - Environmental Protection Agency,
Department of Energy, and the Bureau of Mines for
radon;

2. Other states' radiation control programs; and

3. Facilities which have the potential to impact the
state's radiological environment.

For certain analyses, it is preferable to use cross-
comparisons rather than standards, e.g., radon.

Intralaboratory

Blind, spiked and duplicate samples should be used. At
least one (1) spiked sample should be analyzed quarterly for
each type of analysis routinely performed.

Contracts

If the radiation control program contracts for laboratory
and/or analytical services, the program shall ensure that the
laboratory's QA program is adequate to meet the program's needs.

COMPUTATIONAL CHECKS

A substantial fraction of any calculations and data
reductions shall be verified by a person other than the one
performing the original computation.

If calculations are performed by computer, the
computational program shall be verified before initial routine
use and after each modification of the program.

AHALYTICAL REPORTS

All measurement results should include an estimate of their
overall uncertainty. The uncertainty estimate should
incorporate "counting errors," and all other known sources of
uncertainty.

129

All analysis results should be reported. If an analysis is
questionable, it should be reported and "flagged" to indicate
the reason for questioning. If it is voided for the purposes of
averages, ranges, etc., reasons for the voiding should be
stated.

Records of quality assurance activities should be
maintained .

The method(s) used to determine the lower levels of
detection should be defined.

AUDITS

Analytical results should be reviewed within a period of
time consistent with sample stability and nuclide half-life.

PROGRAM RECORDS AND REPORTS

Record keeping and report publication is critical to
program planning and evaluation, and further provides a means
for documenting any radiological impacts on public health or the
environment. All data should be retained. Annual reports of
the data should include an executive summary stating the
radiological impacts on public health and the environment.

RECORDS

Records shall be accurate and rapidly retrievable. They
shall discuss all anomalies and permit trend analysis. All
units shall be clearly stated. The International System of
Units (SI) should be used. If both SI and conventional units
are used, the conventional units should be included in
parentheses .

Records should include an estimate of overall uncertainty
for all measurements. The uncertainty estimate should
incorporate "counting errors" and all ether known sources of
uncertainty.

REPORTS

Annual reports which include all routine analyses should be
completed within six (6) months after the year's end. These
reports should be published and include:

1. Maps identifying sampling locations;

2. Sampling procedures, and analytical procedures;

3. A discussion of data, including trends, anomalies, and
program deviations;

130

4. Documentation of any modeling;

5. A description of the QA program;

6. A discussion of any changes In previous data;

7. Dose projections, Including uncertainty estimates,
should be Included for actual and potential pathways;
and

8. The name of the person(s) responsible for the report.

Reports should not be released until they have been
reviewed by appropriate personnel.

RETENTION PERIODS

1. All sample data and annual reports should be
maintained indefinitely.

2. Samples should be maintained until the results of
their analysis have been reviewed. If a sample is
involved in a compliance action, it should be
maintained until the compliance action is complete.
For certain facilities, such as low-level waste
facilities and uranium mills, some samples, e.g., soil
samples, should be maintained until post-reclamation.

EQUIPMENT

A state shall have equipment which: 1) is capable of
performing the required analyses; 2) will facilitate the
required precision and accuracy; and 3) allows the state to
reach the recommended lower levels of detection.

There should be sufficient redundancy for a program to
continue to perform the routine analyses during Instrument down
time.

Both computerized analytical equipment and a computerized
data management system should be used.

SAMPLING CRITERIA

Tables I and II represent the minimum environmental
monitoring needs for ambient conditions (Table I) and for
certain facilities (Table II).

Other facilities, not listed, which have the potential for
er.'lronmental releases should be evaluated. If a net dose
equivalent of 0.1 mSv/yr (10 mrem/yr) at the site boundary might
occur, that facility should be appropriately monitored. If

131

after one (1) year of monitoring, results indicate that it it
unlikely for the hypothetical "highest exposed individual" to
receive a cise equivalent of 0.25 mSv/yr (25 mrem/yr).
surveillance r ay be reduced to quarterly screening unless
conditions cha'ge. ,-

PUBLIC INFORMATION

The environmental monitoring program should make reports
available to the public. However, information should not be
made available until it has been reviewed by appropriate program
personnel .

The radiation control program should have a designated
Public Information Officer. Information for media distribution,
such as press releases and in-depth reports, should be prepared
in conjunction with the Public Information Office of the state
agency. The program should seek opportunities to inform the
public in news releases, TV, radio, incident reports, etc.

There should be a liaison with public and professional
groups which leads to seminars, training courses, and public
documents on the radiological environment.

Procedures should be established to provide to contiguous
state program directors and federal agencies information on
environmental samples that contain radioactivity in excess of
specified reporting levels.

SPECIAL STUDIES

As resources permit, special studies should be performed of
potential radiological exposure pathways or situations which may
be the subject of public concern. These studies sho\ Id assist
the radiation control program in determining the scope of
radiation exposures, developing regulations to control a
potential hazard, and determining future program needs.

132

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139

FOOTNOTES FOR TABLES I and II

1. The intent of the criteria for the ambient environment is to
characterize the state's radiological environment, and not to
monitor the same locations every year.

2. Unless otherwise stated, the frequency of analysis is the same as
the sampling frequency.

3. As used in this document, LLD has the same definition as that used
in U.S. Nuclear Regulatory Commission Regulatory Guide 4.14,
"Radiological E- fluent and Environmental Monitoring at Uranium
Mills," Revision 1, April 1980. A Copy of this definition is
attached as Appendix B.

4. Gross alpha and beta analyses are for screening purposes only. If
elevated levels are observed, procedures should direct which
additional analyses may be required.

5. "Gamma" means gamma isotopic.

6. The LLD for gamma Isotopic analyses are to be determined for Cs-
137 unless stated otherwise.

7. TLD systems should meet the criteria of ANSI Standard N545-1975
and U.S. Regulatory Guide 4.13.

8. The criteria for radon monitoring are interim guidance until the
Task Force on Radon Monitoring can make a final recommendation.

9. Sample collection and analysis is desirable, but not required.

10. X is the short-term average centerline value of the ground
concentration in Bq/m , and Q is the rate of release of
radioactivity in Bq/sec.

140

APPENDIX A

STAFFING REQUIREMENTS

The personnel requirements Indicated below for an
environmental monitoring program provide the range of staff
required for an environmental monitoring program.

The graph relates staff requirements to the number of
major facilities which impact a state. (A major facility may
include a reactor site, a uranium mill, a low-level
radioactive waste facility, or a Department of Energy nuclear
facility.) This graph should not be interpreted as indicating
the number of Full-time Equivalents (FTE) required to monitor
a major facility. Rather it is a convenient method of
relating staff needs to characteristics of a state. The FTE
include management, health physicists, chemists, technicians,
field personnel, and other professionals. A range has been
provided because of circumstances which differ from state to
state.

The chart is based upon the fact that the base level of
an environmental monitoring program is 1.5 - 3 FTE. An
additional 1-2 FTE will be required if the state is impacted
by a major facility. For two to five major facilities, the
program will need an additional 1.5 FTE per facility. For 6
or more facilities, the program will need an additional 1 FTE
per facility.

# OF FTE REQUIREMENTS TOTAL FTE

FACILITIES PER FACILITY REQUIREMENTS

0 1.5-3 1.5 - 3.0

1 1.5-3 + 1-2 2.5 - 5.0

2 1.5-3 + 1-2 + 1.5 4.0 - 6.5

3 1.5-3 + 1-2 + 2 X 1.5 5.5 - 8.0

4 1.5-3 + 1-2 + 3 X 1.5 7.0 - 9.5

5 1.5-3 + 1-2 + 4 X 1.5 8.5 - 11.0

6 1.5-3 + 1-2 + 4 X 1.5 + 1 9.5 - 12.0

7 1.5-3 + 1-2 + 4 X 1.5 + 2 X 1 10.5 - 13.0

8 1.5-3 + 1-2 + 4 X 1.5 + 3 X 1 11.5 - 14.0

9 1.5-3 + 1-2 + 4 X 1.5 + 4 X 1 12.5 - 15.0
10 1.5-3 -^ 1-2 t- 4 X 1.5 + 5 X 1 13.5 - 16.0

141

AfPENOIX B
LOWER LIMIT OF DETECTION

For Iht purpoKi of Ihli fuldt, tlii Lo»«f Limit of Dtltc-
den (LLO) i> dcfuitd u lh« milleil eoaeintndoa of ndlo-
tcti'c miCeriaJ umpled tfati hu i 95% prebtbOitr of bcini
dcieclr'' with enir i S% probtbilltr thit t bluk lunpl*
vul rield • rctponn Intciprelcd le mtux that ndie«etiT«
mtierial ii prneac. (RadiotctiTt niceful is "deteetcd" tf it
ficldi an jnitrumnil nipansi that leadi (bf tnalyit to eon-
duda that actintr abort the tritam backpound a pmcnt.)

For a particular iiK«>urcmcnt iritaia (arhieh our
include radiochemical teparation):

LLD<

4.«« Sfc

3.7 « 10* EVY axp<-XAt)

whett
LLO

J.7 X 10*

ii the lower limit of detection (raicrocttriei
?er milUUter):

fa the itaadard danation of the Instrument
backcFOUnd ceuatin(ralc (eooats per lecend):

b the number of dianteprntioas pet aacond
per micTocucie;

it the counliiii efridencr (couna per disin-
tc (ration);

is the temple lolumc (millililers),

is the (ttetlaoal radiochemical yield (when
applicable):

is the ndieacti*« dcear constant for the
parbculai radionuclide; and

it the elaptcd time bctveea tample coUeciion
and countwi.

The value of Sl lued in the calculation of the LLD for t
ptrtkular measurement lytlem ihoald be bucd en (he
actual obaerrad eaiiance of the instrument backtround
eouollni rate rather than an antcrilled theoretically
predicted earianct.

Since the LLO is a function of sample folume, couniini
cflicieaer, radiochemical yield, etc., it may vary for differ-
cot sampUni and analytis procedures. Whenever there it a
(jfni/leaat ehanfe in the parameten of the measurement
fyttcm. tha LLO should b« recalculated.*

For • wnw con*(«n dbcvila* ef llw ILO. — ItASL tnct-
<■§« Maiiaal.- Jak*M. Hwltr. tailor. US£RDA.HASL)0O (niwa
»— i-'rl Ma Caita. t_A_ -Umlu (a> QwUnur* I><itcil«« •)•«
Q«a«tluil*« D«i«rBUM»uo»-Ar9UcaUan t* fiMdiachtmttirr." ■^"•I.
Olm. «0. I fas. >a. ia*-tl.«>d 0«mi. I. J.ua R. L. Wolk«. ^>ii
Sattllial Utarvrvun** •' Covnnnc 0«u (raw MtMunMMdU ol
L»-Lr^ Rtalouunlr.- Htmlm thftla. V"l. Jl. nn, »p. I-K.

142

Conf. Publication #85-2

Conference of Radiation Control
Program Directors, Inc.

Criteria for Adequate Radiation

Control Programs

(Nonionizing)

A Report of Task Force H-2

Printed April 1985

Published by

CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS. INC.

143

DISCLAIMER

The InforoiaClon contained In Chls document has been
developed by the Conference £or consideration by radiation
control programs, and other interested parties.

The implementation and use of the information and
recommendations contained in this document are at the
discretion of the user. The implications from the use of
this document are solely the responsibility of the user.

144

Conf. Publication #85-2

CRITERIA FOR ADEQUATE RADIATION CONTROL PROGRAMS
(NONIONIZING)

A REPORT OF TASK FORCE H-2

This work was performed under:
FDA Cooperative Agreement FD-U-000005-04-2

Printed April 1985

Prepared by

Conference of Radiation Control Program Directors, Inc.
71 Fountain Place, Frankfort, KY 40601

in cooperation with

The Center for Devices and Radiological Health and
Office of Regulatory Affairs, FDA

The U.S. Environmental Protection Agency

*:■■■

145

The opinions and statements contained in this document
are those of the Conference, and may or may not reflect
the views of the cooperating federal agencies.

146

FOREWORD

The development of criteria for evaluating the adequacy of various
aspects of radiation control programs has been given considerable
attention by the Center for Devices and Radiological Health (CDRH) ,
the Nuclear Regulatory Commission (NRC) , the Environmental Protection
Agency (EPA) and several State programs. In one instance, the NRC has
developed detailed criteria to evaluate Agreement State compatibility
with Federal regulation of byproduct materials. Therefore, in
recognition of the need in other areas of radiation control, the
Conference of Radiation Control Program Directors (CRCPD) charged
Workshop No. 1 at the 7th Annual Conference in 1975 to consider the
development of such criteria. The recommendation of the workshop
called for the formation of a Task Force to develop the actual cri-
teria. On two separate occasions the Executive Committee of the
Conference established a Task Force to accomplish this task. During
this period, the charge has been refined to call for the development
of specific criteria for evaluation of a State radiation control
program.

In April of 1981, the Conference prepared a document entitled
"Criteria For Adequate Radiation Control Programs (X-Ray)." In
November of 1982 the Conference prepared a document entitled "Criteria
for Adequate Radiation Control Programs (Radioactive Materials)."

This document provides detailed criteria that State radiation control
directors may use to evaluate the adequacy of their nonionizing
control program. By identif icaiton of weaknesses or deviation from
nationally accepted criteria, individual directors will have more
justification for their budgetary or legislative requests.

The CRCPn will utilize these three documents in their newly developed
State Comprehensive Review Program.

Robert M. Hallisey
Task Force Chairman

-H U-

111

147

PREFACE

This quide has been developed by the Task Force on Criteria for
Adequate Radiation Control Programs (nonionizing)) at the direction of
the Conference of Radiation 'Control Program Directors Inc. Adequate
resources are essential for the successful implementation of a program
to protect the public health of our citizens from unnecessary
radiation exposure. A guide, therefore, is needed that provides an
outline of the basic needs and resources which should be operational
to properly carry out a radiation control program.

This document presents the guidance of the task force as a result of
its research and deliberations. It presents a method for determining
the quality and quantity of the resources necessary for the successful
operation of a balanced, thorough and yet efficient nonionizing
program at the state level. This report, in conjunction with the
documents "Criteria for Adequate Radiation Control Programs (X-P.av) ,
and "Criteria for Adequate Radiation Control Programs (Radioactive
Materials) shall serve as guidance by which state radiation control
agencies, administrators, and legislative bodies, as well as the
public, can make realistic evaluations regarding the adequacy of a
comprehensive program for the control of ionizing and nonionizing
radiation. The CRCPD will utilize these three documents in their
newly developed State Comprehensive Review Program.

The criteria assume that rules and regulations have been adopted which
are as effective as the "Suggested State Regulations for the Control
of Radiation" (SSRCR) which have been prepared by the Conference of
Radiation Control Program Directors, Inc., The U.S. Nuclear Regulatory
Commission, the U.S. Environmental Protection Agency, and the Center
for Devices and Radiological Health.

148

CONTENTS

Foreword iii

Preface iv

Membership 1

History 2

Background 2

Charge 3

Conclusions/Recommendations 3

Criteria for Adequate Radiation Control Programs

(Nonionizing) 4

I. Legislation and Regulations 4

II. Program Organization 4

III. Program Planning and Evaluation 4

IV. Staffing 5

V. Registration, Inspection, and Enforcement 6

VI . Survey Equipment 7

VII. Records 8

VIII. User Education 8

XI. Quality Assurance 9

X. Public Information and Education , 9

XI. Special Studies 9

XII. Federal State Regulations 9

Appendix Determination of Adequate Manpower 10

149

MEMBERSHIP

The following persons served on Task Force H-2

STATE RESOURCE PERSONS

Robert M. Hallisey, Chairman, Massachusetts

Susie Kent, Texas

Danny McGlohorn, South Carolina

Michael Mays, Arizona

FEDERAL RESOURCE PERSONS

Bobby Dillard, ORA-FDA
Richard Gross, DTMA-CDRH
William Murray, NIOSH-CDC

150

CRITERIA FOR ADEQUATE RADIATION CONTROL PROGRAMS (NONIONIZING)

HISTORY

Workshop No. 1 at the 7th Annual Conference in Hyannis,
Massachusetts, was charged to consirier the development of criteria for
an adequate State Radiation Control Program. In its report to the
Conference, Workshop No. 1 recommended the formation of a Task Force
to further study this matter. In September 1975, the Executive
Committee implemented this recommendation by forming a Task Force;
however, support funds were not available. In September 1976, the
Executive Committee reactivated the Task Force, clarified the charge,
and allotted funding for meetings. Members of the original Task
Force-John Shaver, Chairman, Si Kinsman, Jim Hickey, Warren Jacobi,
Bobby Dillard, and Charles Showalter (representing Richard Gross) — met
in Denver, Colorado, during April 1977. Criteria developed at this
meeting were presented to the Conference members for comment at the
9th Annual Conference in Seattle, Washington.

In 1978 the Task Force was reconstituted to include the members
above. The criteria were again submitted to the Conference membership
for comment in August 1978. In November 1978, the Task Force met in
Rockville, Maryland, to review the comments and revise the criteria
document as indicated by the comments. A final version of the cri-
teria was submitted to the Conference and approved for publication.

The former Task Force 2A "Criteria for Adequate Radiation Control
Programs (X-Ray) " decided not to attempt to develop criteria for
nonionizing radiation control as part of their charge due to time
limitations. The Executive Committee, in turn, formed a new Task
Force to develop criteria for nonionizing radiation.

BACKGROUND

The problem of developing suitable criteria for radiation control
program adequacy has surfaced on numerous occasions, and has been
given considerable attention by the Center for Devices and
Radiological Health (CDRH) , Nuclear Regulatory Commission (NRC) , and
several of the State programs. For example, in 1969, the Bureau of
Radiological Health (BRH) prepared a detailed questionnaire as a pa:
of a study to evaluate the status of State radiation control programs.
The questionnaire was carefully developed with input from states,
regional offices, and other Federal agencies, such as the NRC. It was
pilot tested in most regions, and revised and improved based upon
these tests.

Other work in this area includes sending Federal and State survey
teams, upon request, to selected states to conduct detailed program
evaluations. The Nuclear Regulatory Commission has detailed criteria
to evaluate Agreement States to ensure program compatibility. In
1976, the Southern Interstate Nuclear Board conducted a study of
radiation control programs in the South. The Conference has also
formed workshops to consider the matter. The Task Force has taken
full advantage of the previous work. In addition, the Conference has
recently provided a comphrnsive review program of any state
reguesting such, and criteria for a adequate nonionizing program are
needed for such review.

151

CHARGE

The charge that Task Force H2 worked under was to develop criteria
that can be used in the evaluation of the adequacy of a State
radiation control program in the nonionizing radiation area. Such
criteria will also consider and recommend mechanisms whereby it is
assured that state programs are compatible with nonregulatory federal
programs in addition to those which address the enforcement of stan-
dards and regulations in the achievement of radiation protection.

CONCLUSIONS AND RECOMMENDATIONS

Following a careful review of available materials, the Task Force
concluded the following:

1. The charge could be best implemented by developing a
comprehensive list of criteria to be used by radiation
control program directors. The criteria should reflect
the needs of a comprehensive program and should be
detailed enough to assess staffing and funding needs,
but flexible enough to account for the wide spectrum of
individual program needs and resources.

2. Program directors should compare their program with
these criteria to determine deficiencies or weak areas.
Upon identification of a weakness, a director can empha-
size the deviation from nationally accepted criteria to
add support or justification for budget or legislative
requests.

3. Unlike other program areas, the members of this Task
Force had only their limited backgrounds and program
experiences to guide them in the development of these
criteria. There were not any available publications or
criteria to serve as a source document and very few
states have structured nonionizing programs; those that
do exist have not been in operation very long. In
addition biological risk information is more limited and
inconclusive than it is for its ionizing counterpart.

4. When the environmental radiation program criteria is
developed, it should be recognized that the environmen-
tal aspects of nonionizing radiation are covered in the
nonionizing criteria of this document.

5. These criteria should be combined into one document with
the criteria established for adequate control programs
for other radiation sources, i.e., radioactive
materials, environmental radiation, and X-radiation.

152

NONIONIZING RADIATION CONTROL PROGRAM CRITERIA

I. Legislation and Regulations

A. The radiation control program should have enabling

legislation and regulations essentially compatible with
the Council of State Governments' suggested legislation
and the "Suggested State Regulations for the Control of
Radiation. "

B. The program should have authority to enter into
interstate and Federal-State arrangements for the
control of radiation hazards. "Federal-State
arrangements" refer to formal or informal agreements
between the program and Federal agencies for training,
travel, joint inspections, equipment loans, and so
forth.

C. The legislation and/or regulations should contain provi-
sions for reciprocity with other States for coverage of
nonionizing radiation hazards.

D. At least every five (5) years, regulations should be
critically reviewed and updated as necessary. This does
not preclude individual programs from exercising their
own prerogative for more frequent revision of their
regulations. The appropriate affected groups should be
provided an opportunity to review and comment on pro-
posed changes.

II. Program Organization

A. The nonionizing radiation control program should be
located in the same agency as all other radiation
control activities. However, when responsibility for
control of nonionizing radiation is divided among more
than one State agency, administrative letters of
agreement should be effected to delineate responsibility
and to minimize duplication of services.

B. The program should have an established radiation advi-
sory committee which provides guidance on implementation
of the nonionizing radiation control program.

III. Program Planning and Evaluation

Each program should have a written action plan which should
include the following basic components:

A. Problem. The plan should define the problem, and should
identify radiation sources.

B. Objective. The long and short-term objectives should be
established with specific targets for priority and
accomplishment .

153

Methodology. The plan should describe those methods
necessary to fulfill stated objectives.

D. Evaluation. The plan should include periodic evaluation
of program effectiveness. An important component of
evaluation would be a method to determine if changes
have occurred in the hazards to population groups.

IV. Staffing

A. Personnel

1. Professional/inspection personnel for the
nonionizing radiation control program should
require a minimum of 0.5 Full Time Equivalent
(PTE's). Additional staffing requirements should
be based upon the number of sources and be derived
from guidance in the Appendix.

2. Nonionizing radiation control program administra-
tive and inspection personnel should meet one of
the following minimum qualifications of training
and/or experience in the field of nonionizing
hazards and control:

a. A bachelor's degree in engineering or physical
sciences from an accredited college or
university;

b. Two (2) years of study in an accredited insti-
tution plus two (2) years of job experience in
radiation activities;

c. Graduation from a two year approved program in
engineering or physical science areas plus two
(2) years job experience in radiation
activities;

d. Four (4) years of equivalent training and
experience.

3. Each permanent staff position should have an
accurate, up-to-date description which details spe-
cific responsibilities.

4. To minimize staff turnover and maintain program
continuity there should be an organizational struc-
ture which provides for:

a. Promotional opportunities from junior level to
senior level and supervisory positions, and

b. Periodic salary increases which are commen-
surate with exoerience and responsibility.

154

B. Training

1. A formal training program should be established for
all new professional employees. New employees
should be provided with copies, of and instructions
on, the regulations and written program procedures
which include registration, inspection, and
compliance reauirements. New inspectors should be
accompanied by experienced personnel during initial
field surveys.

2. Personnel should participate in a planned con-
tinuing program of in-service training consisting
of seminars, demonstrations, lectures by con-
sultants, short- and long-term training and atten-
dance at professional meetings ( Professional
Societies, Regional Training meetings, American
Industrial Hygiene Association, annual meetings of
the Conference, and so forth) to keep abreast of
current developments in the control of radiation
hazards.

V, Registration, Inspection, and Enforcement

A. Registration. The program should have authority to
require the registration of all nonionizing radiation
sources. The Suggested State Regulations for the
Control of Radiation may be used as a guide in devel-
oping the extent of the registration function.

B. Inspection Authority. The program should have authority
to conduct its own inspections. Survey reports from
qualified private consultants or from radiation safety
officers and safety and health professionals employed by
the owner of a nonionizing radiation installation may be
useful in augmenting the inspection program.

The program should have authority to set qualifications
for private consultants or radiation safety officers or
safety and health professionals when the survey reports
from such individuals are used by the state to evaluate
continuing compliance with its regulations in lieu of
installation inspections by proqram staff.

In some program areas (such as tanning booths, microwave
ovens, sun lamps, etc), adequate control may be effected
by use of local health personnel. Technical assistance
and direction should be provided by the State Radiation
Control Program.

Inspection Procedures. The program should have written
procedures to insure that uniform inspections are
conducted. These procedures should provide for the eval-
uation of the overall radiological performance of the
facility.

155

D. Inspection Schedule. The program should have a written
priority schedule for items in the Appendix, section B,
which sets routine inspection frequencies by type of
nonionizing radiation installation. The schedule should
be reviewed annually and adjusted to reflect any changes
in program objectives.

1. The inspection schedule should include initial
inspection of every facility within a year and
periodically thereafter.

2. In certain situations, such as production line or
manufacturing processes using RF heating, laser
welding, etc., nonionizing radiation exposure can
change frequently. In these applications, inspec-
tion frequencies may need to be increased.

E. Enforcement. The program should have written enforce-
ment procedures. These procedures should detail the
steps to be taken within a specified time period to
accomplish compliance with the regulations. The Office
of the State Attorney (Attorney General) should be con-
sulted in the development of these procedures.
Interpretations based on policy should be accumulated
and maintained to ensure consistent enforcement policy.

VI. Survey Equipment

The Program should have sufficient field survey instru-
mentation capable of measuring nonionizing radiation to
determine compliance with applicable guides and regula-
tions. The instrumentation should also be capable of
estimating radiation exposure to patients, operating
personnel, and the general public. The report of Task
Force GN-3 should be referred to for information on sur-
vey equipment.

The Radiation Control Program shall assure that all
nonionizing radiation survev equipment and instrumen-
tation is properly serviced and calibrated. There
should be a written procedure and schedule for calibra-
tion and servicing of each radiation detection instru-
ment. The schedule should call for a calibration at
least annually. Each instrument should bear a tag
stating the latest date of servicing and calibration,
and a calibration curve or correction factors for each
detection range. Resoonsibilitv for calibration and
servicing should be assigned to one staff person.

The complexity of the agency calibration program is
dependent upon the purpose for which the data was
obtained and should be detailed in the written
procedures.

156

VII. Records

Recordkeepinq is critical to program planning and eval-
uation and provides an objective means for demonstrating
the public health impact of the program. Therefore, the
data that are collected and retained should be selected
to relate as directly as possible to this public health
impact.

A. The program should have an efficient data manage-
ment system that provides the following:

1. Data accurately and rapidly retrievable.

2. A continuing integrated registration program.

3. Physical survey forms containing minimum uni-
form data, and compliance and enforcement
actions.

4. Fiscal and other administrative records.

5. Records on nonionizing radiation source trans-
fers and vendor notifications.

6. Records of incidents and investigations.

B. The program should utilize the above records for:

1. Program planning.

2. Evaluation of program objectives.

3. Establishing priorities for nonionizing
radiation inspections.

4. Carrying out field survey and inspection
programs

C. The program should make maximum use of available
electronic data processing systems.

D. The program should maintain agency personnel medi-
cal evaluation records, e.g., ophthamological for
eye injuries and dermatological for skin injuries.

VIII. User Education

A. The program should encourage, sponsor, or conduct
continuing formal education programs for users or opera-
tors of nonionizing radiation sources.

B. The Radiation Control staff should take advantage of
their time to educate, assist, and answer questions
regarding radiation safety and good radiological health
practices.

157

IX. Quality Assurance

The Program should have a plan to encourage and assist
nonionizing radiation users in the healing arts in
establishing quality assurance programs to ensure that all
treatments are properly administered and all diagnostic uses
are of consistent high quality.

X. Public Information and Education

A. The program should maintain liaison with professional
groups, sponsor seminars and training courses, and
develop/distribute public documents on radiation.

B. The program should provide nonionizing radiation
registrants with current reference material, guidelines,
and standards as they are available.

C. The program should serve as a resource for technical
information on radiological health to the public at
large (through newspaper releases, TV, radio, incident
reports, and so forth) and participate in public educa-
tion efforts at the State and local levels.

XI. Special Studies

The program should have adequate personnel, instrumentation,
and initiative to undertake special studies leading to expo-
sure reduction in the nonionizing radiation area; for
example, identify new problems that need investigation, devel-
op more efficient procedures and methodology, and cooperate
with Conference and/or Federal programs.

XII. Federal/State Relations

The Radiation Control Program should actively pursue a
working relationship with Federal agencies respc.sible for
licensing, authorizing or controlling nonionizing radiation
sources within the state. This is especiallv critical in
this area of radiation control due to the ubiquitous nature
of many nonionizing radiation sources.

158

APPENDIX

Staffing requirements can be determined usinq the following
rationale. Clerical and administrative/managerial personnel are not
included .

A. The following assumptions have been made in this analysis:

1. At a minimum, RF heaters, industrial microwave ovens,
fixed laser light shows and industrial and medical laser
installations will require routine compliance inspec-
tions in order to maintain standards and protect the
public health and safety. Therefore the normal
activities of registration, inspection, and follow-up
are essential. The remaining other sources (including
transient laser light shows) will be addressed under C.
(other activities) .

2. Most RF heaters will require a follow-up visit in the
same year and most industrial oven inspections will not.

3. Fixed laser light shows are those maintained in the same
location for an extended period of time. These will
require approximately 50% follow-up within the same year,

4. Stricter compliance with recommendations is presumed for
industrial and medical installations, since radiation
safety officers at these facilities are responsible for
compliance .

B. Inspection, Followup, and Registration

Regardless of program size, the personnel requirements are
based upon an annual compliance workload per source and do
not include program initiation activities.

1. RF heaters and industrial ovens

3 days/unit

2. Fixed lasers

5 days/unit

3. Industrial/Medical lasers

3 days/unit

4. Registration activities

1 day/month/100 sources

C. Other Activities

In addition to the above, the following other nonionizing
radiation sources were considered to demand program time.
These can vary in impact due to public health issues and per-
ceptions. Examples of such sources are: transient laser
light shows, merc+ary vapor lamps, tanning booths, ultrasound
devices, microwave ovens, NMR imaging devices, RF com-
munications systems, radar, high voltage transmissions lines,
medical microwave uses and noncoherent optical sources.

159

APPENDIX CONTINUED

Estimated Program Time:

Public education & information .1

Non-routine inspections .15

Special investigations .1

Staff training .1

Miscellaneous .05

. 50 FTE

D. Total staffing, as derived above, will require a minimum of
0.5 FTE. Additional staffing requirements should be based
upon the number of sources and derived from the guidance in
section B.

E. Example: State XYZ Annual Requirements;

20 Lasers x 5 days/unit = 100 days
30 RF heaters x 3 days/unit = 90 days
18 Industrial lasers x 3 days/unit = 54 days

21 Medical laser x 3 days/unit = 63 days

Registration (100 sources) 12 days

319 days
or

1.4 FTE

Other Activities (Sect. C.) 0.5 FTE

Total Program Need 1.9 FTE

Note: The /Task Force strongly recommends against cross-
training personnel between the X-ray and nonionizing
program, since they feel X-ray activities will always
have priority.

160

161

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162

THE PLAIN DEALER

a patient's distres
errors are"

m^nm At* irtpm^x ftmul NBC Offi-
: r^mU im«fcto«n Hitffv a gngtll ftt«l.

! iOr. A oBavattc teocb of tke.
< •eesqr'c oni (btafaot looted jutt

! thwiimds, bui that tiwy nitbr «re
J diiBuUxTttdbuuble to ruiiiTiftB be^
• coue iBiSitiaQ4adue«d okb* ii«
; indlsttxcutthabk fiom other cu-

I ^ _ Sootf of ine ncBstkux enon w
{ made in medieil luHiliilMii knoani
I to hare fKrrilfnt ndstioB st&ty
■ pngcuBs. But most oceui is faosp-
! tab vfaere mdiatbui aCetj b ne-
! gleeicd. nnrtrflitiiVd tad. is Kxae
I enes, openly flccQfid.
; *■ IkaFDfnfaeiixsiiaTastainjof

I mut&UydesnadtobchieBBiaqaan-
I tial TmVfT pattelita afaov irianwHate
I aipit of dis&MS.ThatnidT happens
bacause ndMoa toSaaa usaaliy
^ lakeyfrsyfwartff^rtrt^tDdeniop.
'The ED alab flwnd that tqmehat-
, ^tol-frfffrtalt ftll to wpoct adadbon
I ovenlpaex tote NBC and fiie& Sear
[ try Tft fTTTTTTTp TmHoar iiw fHiinrrrr
; aiaiii <Vfif IP1W m».OtnBrcawaigftaI

rftnrtnrt wbo wia narer disspBna^
.Andlsvil fines arc- ao Imr the; em- :

Some of tht natioa's best bospftils ;

ttave' oompUed -tiiE \rarst ladiaiffli ;

' aaSeiy-'.tecQRls. Ute^ . mrinrir the :

Qevi^aod flinT^ ■•ami Rjvexsidc '

; TTieNRC doesn't. do
anything to protect

-rpatients.

— WallerJ.WoblceJr.
CoUimtnis lawyer

taft^'<aSct.-_ii)d. i—^**"* bf;
had ^wim

.. ^K NBC has fined tiie diaic
$16^S75 ainee 1SS7. t. fisure that
tanks It Mo. 4 among aH 2^ NBC-
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^de was the-ale of the woist ndi»-
uoo calastzopha fai modectt^ar ncd-
jQne,^^ihi£u- oocoDed 'in use q^q-
yigjte.irtiej more- tbaa 400 patients
^^BcehfCd ■ cobsli ovcfdoscs ^^t'""^

At'laast B Biveiside patient: died
' of t^mies related to tb«r ovcnot^

..-'.-'^aeKBC doetntdo a^tfaiac to
.BOteciJpetieBb,' aid Waher J.

wdrte Jr.- a'Ontambig lawyer vho

iL|iiLJ(utsd more dian 'Vs Bireside
•jlrtJTO "Look at Birenide. Tht bot-

pttal tnnted all tliose pco^de up aod
.Ibe-ttBCdJdnt do tir^img to ttiem.
; Tbegr Ibund tm UctuaDy thne) mU.
! taf¥n, issj^nificant sbxEL One vas for
. a nuoiDi; sicn 001 a dooL "

. _-^bouti-— -^^- ,

m-'fi^T^iP""***"**'"' dniDt an'
TTTTT liiiaafliiligi fcmd-AlMomh
^^*_rnll'*'"*" ^**y nfffrwr aw i eon- .

of a fetar te &IBBf to leport

* boot he and the pten-

en tiie faaa^taTs staff

Is^SbooiBltt, a "w*^**^ moSdne
tedmdioKist ttUpterAtnj Medical

Qqttrpm a doae rf lacEdaetlve k>-
ODCiUi to Baady Phillip, wiio le-
ceatiy<bid tnto. faclh, but fbisot to
adc vbeltaar (be «as bRBMeaOng.

ndUc, daaUuylut the babj's grawtb-
ngnlltiBttltymid giand.

Attf ^ HwtT*"'. a Watt Honctss
VeSai. Onter tfrtmnlnptt de-

: ctnirea'SbiJen Wen's tfajnid vitfa
I W ndEemie oTlodine-ai. imaware
ItfaaT'tiK dose «as UXD -times
: cboBScr than the preacdbed dose of

l^i^ke fbe vior Siat inbably to
i ertOseseenttf ^pcooiawfaoate
1 tnatad ... leLBie a leva of cneve
: ifould'be «eiT pleaacd with.' aaid
; KBCCkaiBBan tvan SaB& *Oitr re-
■ spoBBfaiB^ is to tiy to tatcod that io
I 9Sor^^ifiiffifl

Aefaievinc thai poltal regalatoiT
I faalaoee may be impassible because
' the MBCs RSolatiqD of medicine
i p^ Tvr^ *TTtTaHy " "'^ ^*^wa — ■ neitber

; tbf^ifltilBS of '^'*^**g Kwgjw»»1 pjvc-
\ «wy B»r ♦>!» Ill II l»»i iMi<iriii» nuK.

1 msni^, vhjcb r''^]tf^ tl^ t^C of
' inraS^ the w^'*^ of the dodoi^
; patMRtTcMxBahip.

*%«' NEC is made up of a bnacfa

! of lefiover people £iuuj ttv nuacar

I pcmer'indisQy vbo dont have any-

I tUnrto dc* aid Dr. Carol S. Mar-

; msrficedar of the nuclear mwlirtnf

; oiipiiieit dinic at UCL&>Haibar

lledical CsBlEr aod one of the RBCs

raa^ «m<<j»i' njiw* TAB fhey do is

bab^itit IDO (actnaSy 118 4:^ nn-

daar poverpiantL

*7aD dont han a tedenl afula-
toiy.agBi^ letjilatinc cilliopedic
sarfOBS to Bake ame that evey.

bone thqrnt is oraed^btGod help
readidseif («ei]rfieldvcteto have a
bonch af nadaa Rcolatcn Eke the
NBC-

^Uany aeniiis ladiaticc in}unes
never coEoc ts the NKCi mentlaa.
In pan, tfaaf I because hoqteli drnit
tiavc to iepcrt,tfa8iapeutic oaardoKs
as long as iheintal dose the patient
receives doesn't ffu,Tfl1 tlie pn-
soibed dose by more than 20%. That

": 'The NRC Is. made up
■: of o Ixmcfi of leftover
■; people horn the
X nuclear power industry .
'' who don't have
anything to do.'

— Oi. Carol S. Harous, I
tX3AHait>erMe<6ca; Center |

is tnie even in cases vAieie ttie pie- {
soibei dose ■■'■—Ht «E reeaenbed ;
I mediealMududsofeare.

'. tds to report radiation "misadminis-
tratians" — NELC JiniD for ovasdoBts,
' underdoses and usintttided doses —
xc has no national data 00 hcsphalift-
i&ition eitirs because it dogat te-
qmrc ^t 29 tdfnsulated states to
fvpoittnPm

Data on the 21 afcacy-rapilated
states — .viildi '">*"<» Ohio — shov
ttiat about 473 patients a year aie vic-

~1iBs of snefa ndiation cnois. Scien-
tists at the National Council on BadS-
fttoB ftetaction and Huuuieiuuits,
an iadvendeat lawai^h agno', e»-
ttwirtu the msnber nationally at
dighily over 1,400 a year.
At best, that's a loogb esdoote,

aid TT»rT;»t T-.r»g<«nnle an NBC

"^e ioves'i come up with w '
oondusians *"''""» it's JmrmsiKlf,"
shstaid.

pftfV,4neinnc alsO aiC iujpu&ublc

because the NBC rqieatedty has dc-
dined ts regulate devices such as X-
zay madii&s and ni|)ervQlage lin-
ear aceeienBm,. which aie een-
mooly used la cancer tiierapy and
jBoduee tts saiae kind of radiation
ax the mfaaH unit that kSlad Dvigfat
0«i«t»i»i Ovodoaes iavolvisg Z-ny
iiiiii^ and acceleAtoES arc noc re-
qoiivd to be npoitad. acoept in a law
states, onles the enor invoh^s a

m%rMn» r[w)finv,tinn imil «\r patiegt
Aimc nr U — i lr«t«ly ll^jnrwL

13ie leported peiueutage of iBi£a-
tioi ecnus is small when compared
with the loagtaiy 7 mSUon diagnostic
procedures and 110,000 theran' pro-
<«„Tiiig,<. perfinaed aiintslly in tbe
United Sfy^ Bat oitics questJOD
the aecuiacy of NBC statistics be-
cause tbe afcn? don sndi a poOT
job of keeping data on the most sen-
ous enore — tiiose that result in
death.

"It's not Just thai they're not re-
porting the Bliarimimstiations;
L.i/rc no: reporting the deaths,"

163

Radiation mistakes

betwoen 19B9 and 1091 .

.xifi^'>^^-

DiwIHHinortil How)tel. BOit, WJVm.

:^-<>.*'.>v'<^^

r:".'- — •',-■•^-.-.%

<«e3?'^^'^'"''

*"""^ .ii-^f—i-

BidDavUU. ,-. „

- oa lb* """^^ SubeoBBilttee on £a<

Tfaaomiit, EDBCr aad Itataial Be-
' taincB. "At bat, tbe qnum tm't

vgdkiac. At iioat,'tii<r^ eoMdag

Dr. SUnr M. ▼oUl. diifittn- of
PobUe CUaB EtiBb BuuilL
Gtoiqi la Vuhmglon, Is among
.flxac «bo duilcDK tfae MBCs oon-
KggtigD ttut ima from medial
ofvnspofisvsof ndiAtimiBxcAz^ |

what the KBC Is UTisg s that so- ',
badrbai««vi!otteii&tiltci)leiidi- !
(tjon (idowss,'' Woib Bid. "^til, '
iMit of the pcDcle vlio die bom ndi-
vtioo cscpoEuie doi't die .faninfrti-
ttiir, othe- tbu the peoptB «bo
VBC is tbe doMit cinie of Eir>
«Wm« and Kagasald. Tliey don't
here aof valid data od fi*e or 10

/jcBS down the line, when ywi i*ait.

' feeing the tatsncy period drains
fir the adiatiao-bidDcid OBcen."

BepzesenlBtxves of' the AiiieiiJi*
CsOtfe of Badiokity and Society of ■
Nodear Uedidne ccue that heilth
eoDcenis aic oreitjloim and put of
an anti-imdeir irjttta^ "^ej an
paftieidez^ enphjiic when dis-
mim*nf ■li.gnncrir Artrs nf Mrtiatim

Edmd ^. Wetaster, a pfa^rSQSt
asd profkaor of mlioloor at Hamrd
Mtriiril SdK»l equates dogsostic
fata wtth 'grnnf an aqiinn to the
wicagpeaac."

UOABaiboi's Maiais Bid. "We
bam out bdneen ttio and fbur thy-
raids a year. So the pstienl has to
take thjmid hormoDC for rest of his
life Nobody dies tnm tt. Varitai
E^edicioe is probably the salest medi-
cal specially thzt tbeie is."
Despite those protests, the KBC
. and its predecessor, the Atomic £d-
eipt CcsnniissiQii, ba^e lone been
aitidad for faxvinc a coiy lelzlioD-
ship vltb the nislcar minrniinity.
The odtkasin led Conciess » abolish
the A£C in 1914 and replace it with
the NRC and fte Sne^ Beseaich
■od Denlopo»nt Adrmsistnlion,
a>w part of the Deparanent of Kn-
esgy.

But aBegatioas thai the vitcha is
too dose to the watched have oontiD-
ued.

A recent eaniple came &i>m the
MECs Office of the Inspector Gen-
oal, its intenial watdxioc unit

The IBM inresosition famd that
the NEC's Office of Nudear MalEiial
Safety emS S«fcgu»--« bad ipent
tjjtit months seceUy Q^afling a nile-
■».irmg pstitoD for ti.-o nodear med-
Idnesodetles.

The NRC rtaTrer? believed the
NEC bid been ovenegutetiBg nu-
dear phamiadsts. but wot con-
oauol that oomraissioncn wouldn't
dsnce the mlf if the rcquesl came
from wtthin the agencj' So the staff-
ers volujiteered to wnt* the proposal
to give It "a better chance ofsuLUtd-
ing because it would be vn^eii as
hevinc a br^ad consensus," accord-
ing to the in'9exngitive report

WWinB— uinontAnnyM>caMdCi<iBf. SBko, Tims 29
M»wMLilceeOot»ityM«aw<Ootntilax.Mft»«ufct» 23

I WBam Beaumont Hoapiiai, flcys/ Osfc Affitfi.
MgyoainicFoundallow.flotf>MCf,M>m.

- "~j- ■ '

H Wtihtri^UnKwfiay M«dlc«l Cwttr. St tuute

TlwrasJeBw»onUrtv»wftyMoepltal.'''>ifad«»»MB

B Washington HospM OBdttr. lV«s>iing>c)n. D.C.
Graduatt HoapBal, PiaaOe^ia
FoK ChBse Cahoer Canter. PMacto|>AiB
Yde-New Haven HospBal, N&wHamn, Com.
MtrsMeldCainic Ma/tfifcM', Mi^

IB Ohio SM» Unlveftfy Hcsptal. Columbus
Bl Oevetend COnlc. C^veland

19
19

18
18
IS
18
18

Q St Ffaneis-St Geotge Hospital, Ondnnati
Toledo Hoepltai. Toledo
Unlvwsi^ a Ctrtcinnall Medkal Cwiter, andvmS

awOdnt mi minion t»i<ip)'imttatssrwgul*tn)Oy tit NHC.
SOVnOE: US. NvdmrFliiJmay CUiwai**! _

After tiavcUng anond the ooonti^'
to meet with Maitsis and otiieix, the
NEC emploj«; drafted lie IS-pege
petition, did thv lepl review' and
tt4>mit>Bd it to commiisiooas on be-
Italf of the OBdear medidnc aooedes
vitfaout r^^rnn^tAgmg that tt was
their own wodL

AdiouCh the NBC Investigation
found the tt''«**~- iiuiuuper, no
djadjUrarj aeUan was talun be-
cause 'Oie KBC lad no leniladons
iimttrnf ctAfT gpstann' Tne NBC
passed such a rule in March 1S9L

Selin, tite NBC rtiairTTan, dis-
missed njcjestiani that fee NEC
was cosy with the nudeei mediane

We ivant to be more
in the position of an
auditor ratherthan in
the position of a record
keeper.'

— h«iS«£a
NRCxJainnan

^Tbese arc all reasonable things to
do' ^^1" said- "But tiiey're i«s
light But tes not because th«y^
cn^ with the indaaiy. I^s^*^"^*
it's sort of grewn tip a; a leasonahlj'
tespon^le vay to d: hintnfs^ ---
and I tttnk the commission has
p.~<» ttquitE dear to tfaestalTtha.
that's not what we'd lis:- to see in tie
fctUTt'

In keeping wi'Ja the »ntj-iegula-
tor/ tjend that de&oed the Beagarv-
Bush years. Sdin bdlc»cs the NRC
Aould be les didactic aiwajd hospi-
tals.

-The ceneral tie.-id Is to ge: away
from trfiai miny of us thitk has been
an orerb' prestrtptive approach to
the m»djcal side of things — that jou

most do tills, you may not do. that
..." tx said. "We wast to be more Is
the poationof an auditor ralherthan
In the posttloD of a record keeper."

Whatever the NRCs proper Jde
might be. if I isdevant to Baitam
GaMdn. Toiler, the NBC has faUed
to protect the putilic beshh.

Dwi^ltfs dodor and the Vat
Coast i^""*^ Foundatkm in San
fttaasBB. wtdcb <Sd the coinfiitrr
ralnilati""' for Dwighfs ladutiai
tiierapy. have paid SSOO^OOO to settle
izw^ts. Last tlonday. the last f.^
fcndant Alta Betes Medical Cei.:4ff,
KltJed for an undisdosed sum.

Dwigbt was aillxtlc and Ckd^eiD .
is partimlatiy bitter because the hoa-
piial'i lawyer qruesboaed her charac-
tsiatiim of the qoaliv of Dwigfats
Bfe and tfadr lelatiCDsldp.

•Tliey wanted to know howttWB I
could have as nonnal a relationship-
Tritli D»TAt as whh my other cha-
dien," said Colston, who b sla-
nted and has lour O&ib rhlkhen."
think what they^ tiying to ay is
Dwight was just this thing in the
dsaet. thai he was just thee and wc
fundioDed aeparatety."

Dwighfs final days aie etdied foi^
ever into hB' memocy.

ae icDemben ti>e TV bang an
and Dwigfat looking in that dlraetian.
bat die isn't sure whether the tato-
tion had already bUsded hhn. Be-
i~.». of Dwight's autisRi. they bad
devtioped a spcdai bond omi the
years that enabled her to fed his joy,
his pzln and his fear-

"I told Dwight before be died that
h wa« OK to leave OS," the said. "He
was DgMing hard- 1 told him that be
was going to go to heeven and live
with Jesus and tiiai it was betur for
him.

•Tjiree days lalar. be djec."

164

-.' •; i^'.o

niifs

fef?i

Ti sili||il|>iE
sC llflliliJ!;! !

^ HP «1 P

'I til B

iiH ff iiii I

iHiiilli <
U »lilflHl?lli!tlSl«

THE PLAIN DEALER

iYhowere
the 28
who died?

~fB£ .

^ at

as.1,—

^ iir lafcllili Mcn«.A Hiln

a Babid Balm. DM Jtac

Me £. M«iw ac e. (T Ran-

■itf. a Mtar of riK. Died ivtj i.

tut. ^

,K,cfVrftr*t»afm.

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-- S.lidV.6S.«rODkBbg<.

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ton. tt Baliwi ngSs""* """'

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aObtoMTilfphnniOn-
naAMv&VIC

^LOBbdctlbrW&Q S^nBi^BI
^j^n, J.Md» ar tkoKT Iitei-

rattUiX lirtki-41. tf BiKiakt:.

O. Hm^b^ Hd nBthe- of tat

BiidJkBcLllTt.

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Im-*--'*-' Jural. U7t.

OtHia L MiartBC 4&, of Catrnn-

ju^^afcir ndntfbcr aT bu:.

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B. afi. of . CinDDbB.
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iLTaom7.ai,orGn»c

Gtf'' 0. Onwrof CUaotaoi PsSoia:
IakCcI>MI>K.ta. WIS.

WfevrfteecOW JmeSC VK.

— ' m iCcfrhitrre-

buL Iktiztf iCDSuy s Ote Suie
UiidBBdlr. U^ Decs. U>E.
Uh iOMaddk. mcakatto.

Britoid dooar^ miMtai. OM Jan.
S.UT7.

Cta^ L WMddL a. Bf Cokim-
I ba.a«btedlnckd>Kv.nadJ(n.

I ¥i mir i. McHwy. W. of Ootnr-

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nun.

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' H^iitB B>»BdL..». af Jtai«>C>- Oc.'i

ta« Wrfn«*«r. «. of CoUmbuij..,,
llmwml— '^^""*« ^~-
jiBts 0. B«&<- C. "C CBtuataOk-.
OWc Bdl oewon omjjw ■* ;
fcB«Trf»»«LDiniAus.»l.jra- _;•

165

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COMING UP

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=r fiiill

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lit

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Eg- ■££

Tragedies
across Ohio

TOStORROir: A iei% of

bluaden at the Cleveland
Clinic in ^by iflsi led to a
record third flae ty the
NRC and pnmpted a top
dlnic official to call the in-
•tttuOoa'a tailiation aaft^
program an emlMiTaB*-
ment. So the cUnlc ftxed its
problem: It fired the radia-
tion safety oEEcer. ^o had
been oonplainin^ about vi-
olaiiont for years.

TUESDAY: The nations
vmsl radiation therapv-
disaster occumd at River-
side Methodist Hospitals in
Columbus in 1975-76. Al-
thou£b more than >100 (>eo-
ple received radiation over-
doses and at least 28 died,
the KRCs medicai consul-
tant shut doivn his lnquii>-
because he didn't u-anl to
expose the hospital to mal-
practice IcvkiulLS.

TTEaJNESDAT: Jeen
Maialik doesnt shori- up in
NHC records as a radiation
therapy casualty- l>ecause
Che took her oa-s life a/ier
tier doctor burned a hole in
her chest. Neither does
Stella Johnson. even
though a radiation over-
dose killed her. They ate
among hundreds of people
tho are overiosed in our •'
nation's hospitals each
>'ear.

THDSSDA^T: NHC im-es-
tigBtors have caught doz-
ens of hospilid oCCaais ly-
ing. bUtatsiag records and.
covering up zadiatior. over-
doses. Yet onK- three peo-
ple haw been convicted of
crimes and no one has eve-
fone to JaiL Some stm
work St the same faospltala.

>
D

'«!»•

166

THE PLAIN DEALER

jk^A

fyniAf.iiiis]p.fit

^ I

• ■■uwogmamumiDSl.

; In Qptobcr IMS, offidils ai b

tlBt^Ofpaticnts mddied iflvKd-
^ocntilly nostvBf ofcnioKS of o^

oDfiwuCr Im ' piQcsQ woo osdcr*
Mst ouiilun tfatony fer bnin cut-
nr ibo hid tBctnod doKs Vut at-
OMded.tbrir p— "''l*'""' by TO9b,

Omhfrimd told the Ifeyiipd De>

piifiiw^ftfth»ft>wtt;g^mQwt-

tients' dea

IfManiandhad been one of the 21 states —
indudSng Ohio — regulated bv the NRC, most of
the records pertaining tc the 20 deaths at Soared
Heaat would be aotmable under the federal
Freedom (^Information Act Medical consumers
then could decide whether Saared Heart and tfie
state acted re^Mxisibly.

^--^—iiUryiud hat « ipqlted
ay VS. NudMT BagoUbny Cam-

^3QR0& ^^ DiBBBBfl wW Stl[t£ fiuS ^^*

.NBC^ nfe in tiw tiMmtm^ gg^ {q.
toeetiaD of midar timmih otter
gmpowirplaaic— teitite'sfiaiii-

I ^nm did it find? Msylaad dti-
aa» will never kaev.

In wbat B fpokesnac fiar tiK Bnvi-
^raunaot Deputment called tte
inlidest thing Tn aeen staee Tve
ticeii here, tte Mexytand "'M'M'*y
gcoBaTs office agned u acteemeot
•with SK3«d Heert In 19B9 pMfiiis
that all raoHdc of the in«afdcttion
.would be wit&beid fiooi mj^joe who

vnota'teUcet'ofii

The state Authfer promiied not to
.DobUette the afreemcnt or a $8,500
\2hie of the '"'«[■"»' *nr ^jga^ id
'juuimiUy aport the twmlcar

• t Tb^ agieeBBest also raqaind that
"m the event • nqoest sader the
■■ttte^ ^ohBc Ialbiintia& Act fiBEed
'fllifioaiuc of tte aaefe CDStenoe of
, the agrcenent, the sSBtc would Botitr
..^Saaed Beait to allow the hospital to
:take •wiimuu aaka n deecg ly-
jwi|wtetopiDtBetitaiBtcie>L''

' The onlt h>i been a'oewi blade-
Alt of what afptaa ip be the most
■ardoBs rm^itit^ fnri^tfit in *^
)gm't hii6(7. SacndBaBtoOdals
JaoQldnatdikuai die oTcrdoBs, end
"'". Qutsicr. .the asiraBt

7— d at&jw sBietal wtio

• "aittifiarf with the aih»i».^ ^f
loocteonsBctiae.'*

Qointer would not diaeoar that
ft^ton." bat aaid the state new de-
teiiiljied whether, or bow njanj.
dosha were catwed by the bo^ital's

•Tft ^ueatiaiahle whether they
cootdbuted to the **—**'* of 20 pet>-
pie," he MBd. "Tbatis ooe of the an-
faigulUea of this casfc"

AlllMii^ the KitiooBl Governors*
has eaOed the MRCs
_-.- of the
ititaffwteil partr
iwTihlpByeteslalilliihfrt,*' tte fiiiinl
Rant sua poinis \ip what critics B)r
is Just one of die pcoctasi's inii^
pnUA&jL

inteTtand bad been one of the 21
fluigs — Indudlnf Ohio ^ leflttlatBd
' by tfac wuC post of tte iwudt pet^
tainiog to tte S) deaOs at Saorad
Bean would te avaOabte nadcr tte
fedcnl Ftaedoffl oflntenatioDAa.
Medical ooBEumvt tb«i eouid de-
cide wtiether Sacrad Haazt and tte
stale acted nspomSily.

Fatieats also are deptfved of in-
portaot ooosuBCr Bkteination be-
cause of a wide vnnoe io icgula-
tSoBS OQD atate to atat^iDd bebiwsi
afreetDCBt shdes and NBCfCgnlaied
stttes-Also. sates mdtteKgCoftBi
don't due faifoBBitian.

Fsr fnsme^ patienta at the Uaf-
oostic ^^twt^ of Honflm miiht waht
to ksow that tte cfinic's ™'*«**""
lafetr oIBcet, Or: Maynsrd -Line-
Ban, was canviaed in UM oafelei^
eoBBts relating Is cnoaaliBg evi-
4tBQa and faiBngtp npdcttwfiafaaa
ovBdoaes ai tte VetEnns Adninis-
tnttonMaficil Center la Bines, m.

But tter dooX aad neither does

trel, which nsfaoHUid FtBBm.

After being fited by die YA. Au
Ban moved tern Ilhnois. il NBC-
legnlaled atate, to Tan, an
ureeaiani stale that has witi tte
KRCcBBSiderscoeofttetopndial-

try. Tte Bineaa?Badiation Oaatxol
chedced Reeuiau's academic oualiS-
f^^pti fiaund than in order and is-
wed him a xadioaetiTe niHdals U-

ITnles grmrtaody inibnns tis of-

fldally thai aoBsfaody Ss a bad aelDr,
we dont dig into thi^ badcground,''
ca: -^^Btid Wood, a nidirtnn fioeits-
ing reviewer in Teas.

Not oaly does the bureau not dig '
mto applicants oaoQ^^oi^Dos* aopll- '
cants aren^t even' asked whether dKy -
have a oiBiiaal xacBd, Vood said. '
Aad tte NRC has bo iiiwliiiiimi to

<«— mlnaft4i»rmtt aWftn twaatg A

piii^^aiw Of iwEpTials, oooosdes Car- j
hon C> ^■■""'■'» djiema of tte ( ,
KBOs OfBcc of State ftogmms.

.*% oeitainly sounds to me Uks
we>d te delighted to abate that land .
of faubcBBalJOo,**- nid Kammeicr, a
fbrraer detinshre end bt the Wasfa-
uigtuu Bedsldns. 'There ni^ te a
dP there ttet needs to te flted."

Anetho- gap aadsts ha tte NBCs
fiifmrnnent of Its so<riled nasad-
aiaistxatio& xepocting rule.

tte nile sets strict '*«»^»'^ lUb
Qar w^uch ^oe^uc^x ^qsoomiods bbq^^*
ixport fpy«^'<'"*|"<^^**»'w^f — Qver-
dtaaes, iinderdoBts and other ladia-
ton enos Hie BBC gives stal^fwi
pragrams ttuce years IB pass ooopat-

BotslattE dootalwvs do it

CUBiaaila, lor iiislaim,', waited 10
yeais, mitU Oetobcr UtS. to pass a
ifpoftmg nl^ CoBsaQudDl^, tte
sate's Radlrangif Health Brandt
doesit know thai V^eap^ Owight
Golsteitt died tem a buje ladiaiiOD
ovetdoaa at Ate Bum Idadieal Ca-
ter in Bcricalay in U88.

Badido^e haabh ^^^^"'r said
thay were uaawaie of tte death but
bad DO le^oosifaifity to investigate It

it In eiEed then. Tbty said dieir
teaads diowed that nr ooe in Cdi-
fnraia t]^ ever (&CC of an ip^ med-
ical ovBdosp of ndlabOD.

There'i newer been a death that I
taiow ot and Tve been in the pro-

167

THE PLAIN DEALER

-ncPVAMoeA^n. auNDMT.

la^wfli^

'ADMTION'fflALr KILLS

gum SBEc 1N8.'* Mid Dckaalil Bunn,
tKnkffhMUbj

"Kt I oopflut," Dr. Sdmsr M.
Wolft, .dkcotcr of Poblic Otaea
Health Beaeaich (kvap, srid of the
HreaBgtf»<tii^pnyiiii ~TiiiiWItn,
fiir budfot nnobt, IS up fkr tutnicc
tfaic over to itHM. Aad the raoord of
hov the ctiteB do' Is piet^ dor
Some do «d od mae do tenftily.
And ftfll AoQjdiiot bo tobntBd.'*

In nccBt jcns, tho HBC fau faoec

pcQCZUQ ^liiTflvm. toMoy of whom
bdieve iheafBDcr is* (Smufftal BIc
Brotbtt. AMhoup NBCoocte hcve

CdtiOVd ItltOB fiv DOt |BHill< CUUi-

pttible tefDlations, the NBC has
oevcr dectftified a pracBm agitist a
tttt^flwilL

'^taparttnc mindrnmutntiaiis is
vst ""» of the tiHt^jc itates have
aearteno over," aid Gi^ ninii.
llry^V! nf Ai<iBima* DhrtsJoTi of Ba-
liatlott OontroL "But the probism is
QuK^' Dcoadar * ^^*^ * to^^ ^3ie
MgnBuslt itiies icgolate dor n-
dloaettvs ' matBoal than tiie NRC
does and ... hi lome sms, we be-
UsTc we hare more t^wli'vr than
the MBC does."

That may be, bnt mefical coostim-
eis Id Arkansas have cause to ques-
tjon tri* shite s QQBomiQBQBt to eo'
^m^^ nrtift*"" ■Cely ' xuIce
Arkansas, vfakfa has been an
eigreannt state stoce lfiC3, has
nem fined a himilial tor rarfiatiwx

Sbidaily. nunois, vfaidi has one

. of the luxer actcenentrstate jm^

' pams anduoBBses about 400 bmi£-

Qg[ jp^tittitttimr {as fiiHd jnst one

m&SB^ imUUUiou tu > TOTStinn vi-

sttteinJtinem?.

mBCDS SSDO^r BOUtS XdIX XftDSKuOQ

■t Adonsas hmpttali arc
rthsn dseMfaere.

^nwD we have had an iBddcnt It
a ho^iBt, tbey afaad tt'ts mocb as
we da" ifae said. *A fine is another
penalty on Um otwhaL has occurred.
we':e Ind^. we knoar the MBC fines
a lot, as do oiha- states, but we
baventhadta"

Radiation and you

Bris

RadaSon Is part of the envfaDfunant around i».nbombafda us- .
tttroughout our BvM at iovato ranghg Iron) hannlan to danBorouB
tolathaL : x .

SeianMs measure X-r^ or gamma radUDon in units cded -^-^
roan^jena. The unit und to ODqMasa ttw quan% of iscflBiion you .;
raoelwe is the rem (roantgan aqulvalent roan), me annual
pennisaSiid occupaUonardosa of wtnlB^xxiy radlaSon is S reih.

Whota-lMtity
In

<J001

Eff6Cte&

Qafflmareyai^osurelromTVper -.
year. «

jaa2.-M3 .'OamnBiByeipoflufB at Parry plant
ate boundary per yaar.

Dental X-ray.

25 Ufadme dose from natural bad^round.

fBdtation, including radon acposure.- ..

50 PoasUe radbUon sickness; rtaadache.

dizzinees. iralaise. nausea, vomBtng.
dtontiea. decrease in Mood prasure, •.
inttabiSty and insomnia.

2S0 Acute radiation acknecE, few or no ■

deaths and sigiulicant Bfe ^nrttning.
Qyrihitinn »wm»ac ircliides vomSing,
diarrhea, loss of hair, naiaea,
hemontni^ng. fever. Iocs of appeflts.
and gensiBJ malaisa. RecovenrOfno ,
oompilcafions) in about ttvee months.'.

1,000 DaethvdlhlnSOdays.

fiOunce MMiantf Couneff on flaeiBaan
tmBm/AodmayafSdanom

or a busL" said Dr. Bany A. Sesi^ a
SL Louis mdiolosist and chainum of
the VRCs Advisoiy Committee on
the Medical Uses of Isotopes. '^yoD
end tip with eolicbtetted tagokloa.
who are wQing to talk wUh the Docdi-
eal fatvg and icaDy undeistand their
jjjgtjlenu and try to ttave an appm-

priatp- Tpgnlatnry h«hifn«P thoi ...

]rou can ^licve a comftiftable atatas.

"Die Ixist part wotdd be if your
r.aie^ cot a linthsd bud|et and hires
people wiio am^ veiy quallCed, you
end up with a iiepelast urugium. It's
Tiot very eood and It doesn't do a
fDodJobof proRcttngtbepabhc Or,
'ignoDaxi stales can he a boon wmse yet, you gttpi»pic xtliaK only

•>D

approach is, 'I don't know wiiat's
nany coins on lee. txit let's icgo-
late the heU out of them.' They be-
come inattonaL*

Beprraantitivas of tiie
medicine coiiuuunity, most of wtsom
fcs^fxt Ax^ atznson hy fovemmcnt,
are split over whether the NRC or
the states do a better regulatory job.

KRC officials eveDtsaDy ■ would
Qce to see eveiy state beoome selT-
leculated, bol realUe some states
simply can't aQoid to operate strons

psOCLUUkS.

"What we say is, this isavaH-
able,' " Kanimenr said. "It is an op-
tion . . . tMt we're not out t>eatins the
bnsbes to tell eveiyhody to become
an acteemem. stale"

168

X-ray viclim

'safe^Bose

■am ._ .

tkat BugbHT deoer Mid fee
could d«r«p the V-^mr^Ut

fiat tne nor (Mfaer and I

,• raeneir wf ttrWifaioK
be Hid. b thMe%i, vten •

'dOOtOr frid aODMBUBg. tlitt

«H the Itad — «lth • ofAd

'Oaet ■'

: far about itc

iQi.M'tbcr'OoaKl'nand at
tbeboneiintfatgfcrt nnrtmt

'itR panou a fCapM oftbrir

nefa fiaodfd iope^vith «>■
rite and Ipnfnae taoliag the
«ODdes ^oirpaleBlbl hMtut
e{ n& in :a &*«(i)r9ad>iii«

•led Id bis oocfeof'a adoc be-
_ Und Sntaal TBptr. IBnle
'-JUlK QcMfaarvttiiad wilihyi Ifae
ftxnaad tbe X4v^ beam
of neboT^

OKbei Mner felt a Hang —
'it taatc not fir tbe fim decide.

■f .:«

aofe dose,

viclim of cancer

He wcat tc Cfama. BonraL md Ib-
Ida, :ateR be aamd In Anny Air
-EtiiaaalalelIlBBieedinin('WoddVar
<-II Um, xatbe tlOi. 'iAer ntamiBK
'to Oefdand. a doctor dboovend
y^ilB eaaoe titiitf aantr at bit noae.

.. Ttadv. BHR than 100 loixBiies
.■tats, g"ft*«' 7E, ennB .acm
i ^ fii;; eaoocr tet evtatualtr
T fab Boae and diaOsBitd fait
fto& Beiras ofBdflead wftfa to mcfa
{atfjuDfi aa a-jciffi^ ujau tfazt a^or
aiiiodiii 110V «- cvm from uauual
HAHvw ^ la potftitlally drngMtw^

. "Vtaen I facer tbe tcoB "aiie e^o-
aun.' I wisoe."^ «id. *I maiataln
tfava'a ao'aate evoaaieto nditflaB.
. .Qttl^ i^^ffaiift it*a anauiailvt.*

AhhoQ^ no other oafctDDfcn baa
been tfadied as lDteojtve|]r as adla-
"tioB, tdeEtiats diagne v tbst
■ point, pertieuUtiy aa U idales to iMr
"Icfds of ladatiDO. Whik sane be-
lieve low doaei poae ao dak obat-
auevei, othov are cuuwuiced — as is
.'tzqe or lead — ttiat tfaete Is a Jioaer
piQfKasiOD i& vffalcii tbe body's iflilr
burden increases vitt eedi dose

"Doctos bi*e aD aorls of RBsons

br gMoe X-nys, but tbere's no

%goaBBcr of tfaDutfft'Bnc idid this

• yiujetfc- 'Amldoingtius.pBrtratany

toadr' ^lid Dr. Allot Stavart, an

- cpUanloloclst at tbe Uoivexsi^ of

pir<wti^#hTt^ in 2D0axid- SIBWt c

.■iBdfflaifc naaanb la. tbe USDs

' louiidtfaateceaaneZartoaftaiis

. 'doofaied the lidc of uiiueiiluc Icu-

■Dodprs voold «|ue thai It's
vDitfa the risk ... tod licbt MW tbe
fpiii,f»» doctor It under ioKnse
pnsmetBOMrXaythepatiaiibe-
ceoc of (the fear eO atalpRaiee,*
arid SitHit 'ADd ilBet M aifflott
eectain that tbe oiDoeB are not eoiae
10 aorfboe itar naa? yiBS, the doe-
ton ere De«er CBbV to «tt the ao-
otnthofeBute."

Mott doebn, faamercr. tu tbc
beotfitt of TMBnlnp br oiiapBl«h

'Ve'R abnort deeliag vitii ml;/
beMfiL Tfae role I ttae it if (ta a fiag-
naK6c uat that^ jmiiatal, it should
he d»e «itfa the lemtt adiienhte
doae, but It ataeuld be dBM," aaid Dr.
Rb&P K. CkRade. a IGcfaiCBi ndol-
Qf]atand '*»■*■■ nuii of tie Aaann
nUagi ofBMBolapTt quaiitr ——
^QOt o^BSuBe& ^Tfase • so asnor^
l^in ILemMlil that can asy with eg-
laifitj hT?T'fHwir' *"'**^***i'*''y^
be iadueed la «aaeD over 40 by ec-
|w*<i^# thin to penodSc atansngn-
piv. But in our best Imoaiadge. '«e
♦hinfc' tfae 't*"*" outawtfi tbe

Hk people ai|ue the point tiiai
ijBOt tfae «■"»"*"[ dItco«ei7 oT "X-
Sght' bcr tfae QeDsan pliytiumt 'Wil-
faeja Boeit^a in IBS, odotiBD bat

^twQusioosBo ^be fae^Xfflg ^^^^ ^^y*

^otsaa use » MiuY*«»T»"-><*i»'"'^^
Aiucs le deteei eeiir '-f"*'^ and
Used etas. n>.i...^Mi^ iodiBe ta»
— "**^ iriaaifi tojion iiiigiij. a^
qy- tfaBapj,Bainc iBe^>ab*g^Gpeer

onee lecuUed in death or amputa-

tl#WI

"The (Sscorar7 of XnTS ans prob-
ably the thing Otf bad tfae single
gBBtttA ""I** * on iiwdirnie,* said
Jdd E. Ckir, a mtfial pb^sicst at
tfae Maya Osiic in Bocfaealer. Usm.
"Itk tfae onlr wtj yoB have of
loolmg inside tbe body wifiioat cnt-
tingltven."

But siDoe f^^*^ HbbTs etaatlon
of tfae first sDSlalnod unclear reect-
ioD at the Dui»uUlj of Chiea9> SO .
yen ago this mcDtfa, modePHiay
medical aJ»iiuucs l>ave bcQkaBBOO)-
ptpfffd by note Aiglili'iiing uses of
ndiatioQ i&tbeandflerweepoBS and
mil !■■! po^vr xodBtseL ^he ^V'-
iaiiai dat doaes of UMlkliop once
tfaoo^ Id be '"i ■■■<»' mH canse
nii«»« ilK hat gives oa ts aev
baa tued b psTt en pulp ceicnoc
Bi'^inr^ god tile powsftd nytiiolagy
tfaata

Hie tteoevnlent gesie^ftttehottle
diMjirtmA jD Tab Oitae}'s U6T Bm'
•Our Moid file Atom* bs bea 10-
sct by vUoos of the potentia] CKtiao-
tlon of human life in a availed nu-
etcar winter. Images of a gleaaaiag.
white atocoic utivia baKc been <fis-
pi«f»«< fay noUa-ay-faeekyinl feais '
tlBl noclflBr waste doceips and nxsa-
eetfon will leave a dcTttfating lec-
a^ofeBneer and gmftt* "■""*■*""

~I think oaoy of tfae TeaUemt
wc'fc having with iwfiatinn omes,
portieulatb' ^Btpecgl pnbleBt, it
ttatwahavan'tarta^iHalyiBftmad
tlB pohSc of the Jaanet,'* aid (km.
Oiaa. ifitedai of tfae Aikansas Oiiri-
«ii»i of ^afiatJOD OeBtm and past

cfaaiMnnan of an nsanraaw of
g^;i^ y'^***^^*' |v"ff w« ''UiepRib-
las -is. whan the pofaDc^ beed with
ondar Issues, tbcy iiiiiiiei'l I
think it has to do witti Ooae of OS in
the fiaid not doing a good job oftalk-
liigaboir tJDe&ctt.

*m)si we uarted usng tadiatloo
for Bnd things, we didnt make thai
cfcar."

IftilOoe ttie sBdes powv Industo',

ifiiinMii tract people place in

In irariirhlnr this scics. The
FUn Di^ii ftn^ —"»—"'« fat-
rims ft which padems sBveaci:
that doetOB or *"*"'''~^ we:2 ad
uuuimaiut doaes of Mdlattar<-;«JH
wieag areas of tbeir bodes, but al-
lond it becmiae tbe? atauBCd the
inAaaioatU kanr what ifaqr w«r*

"With pafboiti; yea get into a tiha-
alioD where it's atanost a lU mental-
Jty." said James A. Johnaoo. a laajv
In Rhhidandei. VU, who has rep-

lawsuits inv^nng — 'fWrgral et-
na. * ^hen do I go? Do you want
ae to lie dom on this table? '

Store's a lot of Onst that yott put
In tiiosedoctOBX.**

In other eaaas. Identity moMipt by
hoipita] ;rrrT~'"*' lad to patieaCi be-
ing Mated with ladioactive drugs
wfaen th^ were Kfaaduled (or an en-
tnb' dOcROt Badleal piucedme.
Agiic snne rf those palieots sever
questjooed the errors bciorchand.

169

■OHIU-i

•ir-Crir-tT-A

l>^KV^l.Ml

L*STOFkSBieS

LETHAL DOSES

RADI^ON THAT KILLS

ues,
crimes
— and
nobody
goes

to jail

ByTHJWENDUNG

and DAVE DAVIS I£C T 7

PUJN DEALER REPORTB^S

It's a long way from Eonce-
vcrte, TT-Va, to KctchUan,
AlMkn, and thats the -way Dr
TenyD.Lcsko likes n.

It Tras just orer two j-*ssrs
ago that iesbc was forced to
resign as the staff radiologia
zaa rariiytioTi safetj' officer at
Eamana Ea^lal-Greenbner
Valley in scenic ^rt^gm Wgs;
Virginia. The area is best
known for the Grecahricr bo-
te], a Imaiu' rcsort recentlr re-
VBalad as the site of B saiet
tmdBground bnnker mcmijers
ofCOnpias had bialtXbr thcT>-
seives in the event of a nudear
v.'ar.

. Ai Humana, just a fev miles
»wsiy, Leslo) was a cisual^- of a

.Whistle-blower

Afler btowjnf the whistle in
1990 an Eontana's <Htrri nii-
dear medidne <=f'Tvii] jj^
seven years, Lesko moved to
Alaska, 'sitere hcvnidcs e a Q-
dialogist at Eodnksn Gcnoal
Hospital Stm, be wcsxies ^jf
TiiBc uiD ie reprisals for hiv-
ing notified the US. Nuclear
Hcifulatoiy ConutuEoon ♦'h^»
tinlirmspd ph:«iciant «cie
pwfnnning imcicar medidzie-
piDcedures at HumazB.

"Humans is vsiy, very pov-
etful,'' Lesko said. "Jhey are
the single most powerjiil medj-
cal corporalinn m the cotmiry.
I have to be caiefal about what
I «(y."

Altfaoil£b fiaiSier 'HmwaTin

ExEOitiveDireclor Grtjory L.
Gibson an.' Asssdatt Director
SbeilQ' Wr.-: jr. also resigBec
after an ii.-wticstian by the
NRCs <TimiTini divisicii Ibtmc
that they hac "negitoed to
prov tie complete infosnation"
to the NEC the Humanj scan-
dal i'3s t^picul of NBC ixupital
p."ches in thar it produced far
rac -c «"i)nrt than Tcgul^toty
fuiT.

THE PLAIN DEALER

The piobe dircloial thatHu-
msns offiriuls provided inaccu-
rate and Cilse Infonnation and
withheld part of a physics con-
sutant's report thai recom-
jnended Humana's audear
mcdidne department be
closed unless stsious deDdcn-
dcs ■were corrected.

AdditJonally, Gibsan and
Waid admitted that four boxes
of adnttnisoalion fUes ^eze de-
stroyed dmiactbe probe, NEC
rccQids shoiv.

Showing a profit

For those violatioos and oth-
civ Bumana Inc. — whose
78-hospltal chain showed prof-
it^ of S2fl2 million during the
W9S. fiscal year — paid «
. $21,500 fine- It was tiie third
largest fine cN-er levied by the
NEC ajalnst a. tnedlcal instltu-

Tirm

HitmaiE spokesman 'WiUiam
ShJTcs vEould not discuss those
or pas viQlations. saying sim-
plj- that the hospital was "com-
miaeo to compljing with the
NBCs regnlftions."

Tvhile KRC investigations of
medial institutions have re-
peated! j stibstantialEd allega--
tions thzt hosphal penojmel
throughout the country ned,
falsiSid records or faBed to re-
port rariiarifrp oVCrdoseS, JiO

oat has ever gone to jaU as a
result of an KHC probe, a Plain
Bealc investigation has
found.

Since 1982, the NBC has re-
feiied 18 hospital investi^a-
• tjons to the Justice Depaiv
mcnt for criminal prosoanina
As a result, only Uirct people
have been proaculcd and all
Vticre convicted.

SEE DECEIVE/1»V\

Afaarth dcfendantTKrC&ute
E. 'Weinstcin, fnrmBj- chirf of ladi-
olojj- it Hnmana<jre«nhrier Val-
ley, had his record expunged In
1B89 by coiag tiuoueh i Seal
mogLjui for fiist-tsne oSbodos.
WeinstMn was chargedafter three
physicians told the KSC they falsi-
fied records at his leqnest to get
'Weinstein'i name ad^cd to Hu-
mana's nodear Twatgrhic Eaensg^
NHCiecordi show. Ihe three p)Q>-
sioans were not efaaised.

NRC investifaiois say tiie lade
of prosecutions is fnntuiif^ but
; undersandafale.

"Who's, going *j pn: a doctor in
jail?" said Roger A. Fortuas, dep-
uty director of the NRCs OSce of
Investigatioos.

In the place of rrtminai pnisccu-
tions, the NRC's tDvestJeaiToas and
en&iceinent ofHces have leaorted
to nsisg press releases and dvil
fines to punish mcdjcal lawiaxalc-
eis.

Tie first qoestian bospilE.' U-
cttisees ask is. 'Aie you going to
have a press retaoer"" said James
Liebcrman. director of the Office
of Eafbrcerr rit. "The second thing
the;' asl: is. '. jb you goiag to issue
a avil penalij:' They don't like
any lioe because tar fine pute the
hospital in the puislic nnmain

ood they want 10 be perceived at

th^ are in most cases — as aa in-
dus-jy that's trying tn serve tie
publir."

Of the tHti, liefaemaiTaSB'olti^
NBC oCRciaU consider the press re-
lease to have more pusitivt value,
in part because tines are CO knv.

Particularly embsmsEing to
' NBC ofTidals is a fine they Issued
In an industrial esse tn 1B90 —
S8?5 against Cenersl Motora Corp.
I for losing 2 ^Buge contsuiing ra-
dioactive eesjxun. Til bet that
; really broke the bank," quipped
NBC public af&uis ofOocV Diane
Scrend.

Among the 134 fines issued to
mediral Institutions benveen 1980
and September 1S92, 116. a- tl'i.
were &0OP or less. Penalbes
against opeotocs of "nfiyar power
plants, vtilcb the NRC also regu-
lates, are conaderably higher, in-
dodlng seven Ones of $100,000 or
more last year alone

"Most of our medical licensees
are non-profit organizatinns,'' said
NRC Chaiisian Ivan Selin.
"Thcy'ie having a tough time mak-
inc ends meet 'Xbu don't want to
Itne (2 hospital? a million dollais
.-. unless there's some malfea-
sance there, not just carelessness.

"On the other band, the
amounts do seem awfully smalL
Tb^ do' seem like a slap on the
wiasl"

Dr. £dwaid G. Allen, rsiiatian
safety officer at Alleghany Re-
gional Hospital in Low lioor, Va,
didn't even get a &lap on the wrist
wiicn. he jHi^itn^ feilafying Wan-
stein's Dcdendals at Humana. No

AOoi was cue of several pl^si-

Cians who tailed afaine ilngHiiml

lawyers when the. NBC Erst pro-
posed a rule tn the late ISTOs that
now retpnres bcsptals to report
certaixL radalion ^nnn. to patients
andtheNBC

*I feci that c report chmiirf not
be given to the paacnt ... as tiiis
would simplj' lead ID initiation of
malpiacticE stilts . . ." Allen 'wrote
in an aagrr July 27. IflTB. letter to
the NEC "Tiiderthls proposal and
the fY«edom of Tn formation law,
we sow Jia^ any lawyer that can
tin^jly request In tiie inibSc Inters
est a cop7 of such a report . . .' and
then proceed tc contatl the pe-
tten& mvoired tc r^ntij** ^oaiuuis
tice pcocedtjre^"

Bin. ATlrri wacat neaiiy as eoD*
coned about medica] ethics is .
1885, wlien IFeinstein asked a £»■
Tor of his "Tf^ frip^'d AHen ^^*^
out a £om in which he blseiy
dazmed that "Weinstein bad cas}-

p^^t»f^ ?9n bonis of '*^'"*'^1 tratn.

mg imder ADeit's tii^— mig^fTn,
NBC records diow.

"ItTs dosed sow as te as tiie
NBC is concemed.* Allen sad
when ccotaoed by The FD. "Sttne
it's a dosed rratter Tm not coiag
to discuss H."

Hair- lawyets whr speSaSz: in
niHira' majpractice '■m'"''"*" . tiie
NBC far being too lenieoL Btit al-
nost ■£ nndear med' :uie profes-
sionals CQn^derthea{-'3C7'iD0 ag-
gressive.

"I think one of the ke^ issues,
rightly or wrongly. Is tiial the NBC
is viewed by many people in tlie
medial commtinizy as being ex-
csssively advetssiial ic tarms of
Oie way they deal with people."
said Dr. Bairy A. Siegel B SL Louis
radiologist and chalncan of the
NRCs Advisory Comniaee on the
Mfxical Uses of Isotopes.

170

THE PLAIN DEALER

•J6-A

LETHAL DOSES R

White lies

Caught in the act

^-^5

y^' 1 T1S3?
tJnrverstty of Cincinnati .

Hospitais, rmrinnati

In 19S9. the unhtasilj- Gred radia-
tion safKT oITircr (ESC; Kcsuictt ^i.
Fritz aficr NEC invcstip rs found
numerous nducion aXcty vrolations.
indudio; Inaiicqiaic iraininf ofcra-
ployccs. toeing radioactive raiicrial
and improperly disposx; of rafiiosc-
UTC maicriai.

Ftia bad isucc a ttTiilai CJg or-
der. prohibilisE employees from con-
Ucung zny oulslOc a$cnr>- aboui ra*
diatior. saftty pmblons. One
icchniaon v.ts Ciroi for iaroimisc
the NHC of problems. NRC invcsliga-
tDrs found that Pticec Jason, the
depuTv- RSO. had orocred 3 icchni-
cian to hide recoms thai would have
jTvcoJcd tiot. the uaivtaaly ted lost
isome radjoadJTC nickd-Sl The in-
.vestigatioD also nt^^^i^r^^ t>ia? the ra-
nirtin.i salclj- oflicc mdudins Fritz

Snssell Connty Medical
Center, Lebanon, Va.

HarrcK C (Hal) Murray, former
diitr nudcar medjcinc lcainolo0si.
admitted to NRC invoticatsis that
bcui.'cc: Jddc 1SE2 and .\pnl I3SC.
he inlcntianally administered huge
ovcnloscs of diasnosilc lariiophar-

. mamniiralt to doiciu or r"'-*"*' to
speed up the iaz^z time and
lessen his workload. Miaiaj Ihca lal-
siTasi record lo indicale that pa*
ticnis had received the prcsaibcd
doses rather than the dclivcfod

. doses. MiLTay loji invcsUjaiore the
overdoses ivcre oee^ssao' f^" ii^fi^'

" patients "to overcome toe eflccts oT

'- fat tissue.' DoOors said the claim
has no medical [oundatior..

The NEC fined the hospital 53.730
OS I£aiel. iC. It'Jti. li\imy plc3dt:d

iT'L Hices Jr.
ospil2i lines.. UL

;::xjgatJor. in 1987

t-»6V

Edv
VA

four: thai Dr. I'jiyziri L Freeman,
tssii' It cfaicT cr ou=Ic^' mcdidoc,
' liile J) lepor. i\ra dia;i-.3$'Je orer
dose- asd then iicd to KZC invest!'
JOINTS, rit'^'.iiijwv^ and raiCTfirv^ pi«j.

the testimony of a tc^esi.

■ The NKC isued do Dne. Ftccznan
pleaded guilty July U. 19t8. m U.S.
Diinet Cotir. in Quopi lo xvi;.'fu;
fax; tire lo report miodministraUons
and conceding :nfo:mjtJon pertain-
ing u; rtis*draiDisva;jo:u. born felo-
nies. He rcccivK u-L-ee >-ea.-s pxba-
lio:t. a $10i)00 fine and was onacnd
to pcrfoTTT. 3O0 houTT of eommcrit.v
senriec. Tn« dinois Dcpaiimc.-.'. of
Prafessional Rxjgulatjoa. trhic.-. li-
censes doaon to prarticc. medicine.

pcnonal:^-. vras providiTif unautho-
lizEd lor-TOoHl seniccs, indtidinf ra-
diatioi>-lcal: testin£ and tuaste bro-
kerage ssviecs, to other NRC licms-
css.
The KRC fiacd the lEtii-cs::?

SS.T^O on Sept. 2C, 19S1. and another
SmtSO on Ma; 1, 1S92. The case in-
vohnog Jason was lefened lo the
Justice iDcpar'Oxez:!, xrhieh deoined
lo pxscaitc. Pna is nott- RSO ai the
Cioe:;Jiati vcifscs hospital

guiltj- Aug. 2'.. J989. in U-S. DistiiS
Court in Boanokc Va. to a felony
ojont ofvietolinj Uie .Momic Encrc

Ac He »asplarrri on five years' pro-

bat::..': and ardcrcd to pc^ona 300
hours ofcommuoityscnice.

issued Frecmaa a uriiien rephr.'uid
ir. Seplcstbe." 1S90. but tooi: nc ac-
tion eeaiar. his liceose. 'Basicall.v. it
was a slap or. the wnst," ssid a dc-
KL-tmcnt sDokcsn'omir. "We Jtinc o.'

oCJdaTjj- told hijo he did wronj."
Frccsiaa is novr liccascd to practice
naciear medicine in Tsas and is
RSO a: the Disgnosti: Clinic of
Houston.

171

THE PLAIN DEALER

Lafayette dinicTDetroit

A 1S89 investigiian br.th* NRC
deleusined thei Di: NitnJ Silamc,
s rtsosrcher, deliberatriy wlaied
tbe clinic's licsise by ardetlng tod
using ladjoictlve phospharaj5-32
vritiiDut certification. The tnvestigs-
Doo foimd th't the dlnic subse-
Queiatiy disoTjuiiiilficl a^zinst radtp-
tion safety ofliccr Dr. Lew M.
Hryhorezuk by fiHng him for hring-
inf safrtT problems, iscludiuE Stta-
rern^B violsdion, to the ots&Qtion of
his superiors aod tiic ICRC. Investi-
gators alsc concluded that Dr.
Tiomas M. SuJlJ^-zt. tbe clinic's for-
mer acting (iiector, "riHiherattly
misle<J" the KRC when he to! d invts-
ugators he was unaware that Hiy-
borcruk had been Cred es HSO. NBC
records show that li was Sulljvan

Virginia Heart Institute
Richmond, Va.

In 1990. zn NRC investigation
fouhr" that orcner Dr. Charles L
Baird Jr. had been routinely sdniin-
isKring radioph;iia2ceuticals since
197? TOhou: z llrenst. e\'eii though
he pre^iouslr b^ been idvised to
obtain cerJIicEtion. Bairc also pro-
nded false informatJOE to the NRC
by listing Br. 'SViUisn: S. Dingiediiie
as the heart insnrmE's only licensed
user or nuclear nEiehais despite the
fact tiia: Dingiedine never WTKed
Uicre. Dingiedine. who was em-
ployed in tbe medics] depcrnae^t of
V'irginiE Power Co, also stiaiaec
filse Qocuments to the KRC, certiiy-
ihg tnzt he supemsed Baird"s perfor-
mance of nuclear me<Jldne pmoe-
dnres. Sucb supervision *t)uln have

Lakeview Hospital,
Wam^Taosa, Wis.

An NEC inv-estigaliDn found thai
between 1976 and 1380, dozeas o! pa-
tianis were rcutinri.v given double
doses of radiocba.*Tnaccalicals &r di-
ognostK sczns of the brai:!. bones,
bvc, spleen and lungs. The over-"
doses xvere intended to deoene
scanning time and obtain hrig^itg '
images. Ttro technicians, v,^to w-ere
later fired by th; hospital, also falsi-
fied icoords to indrate tbat the
ptoper dosagec ware gives.

Cie NBC did no: issue a fine, sor
did il refer die case to the Justice De- '
parrmfnL

■vrtio fired Hr>-borczul-_ »ftr- which
Sullrv::: slsc appointed Sltaram to
the clinic's ndiati02 szSct^' Qommlt-
tee-

The NEC fined the rtmir SItSOO
on Oc 2, 1991, and birred Siaran

cud SuBiran torn being involved in
NRC-bcenscd activities for three
ycar^ Th:: agencj- also rt "med the
case to the Justice Department,
wni-'h dedined to prostcme. The
c--. Iw went out of biEiness in Octo-

ailovved Baird to legaB^' tise izdio-
p.^irmaceutical drugs evd thoagh
he bed be«= i^ecec for a bcease biy
the NRC becanse of insufficient

trailing.

Tr: NEC did not issue a fine, nor
did it refer the case to the Justice De-
Danment.

■■..-.■^\^C':.^.-

172

^<^

'IHEPOMOeUBt. THUfSDAY.

■17. 19!

nON THAT KILLS

•2:^Z4L,

Doctors deceive probers, hospitals
lide facts — and no one is jailed

Thpy seon tD be lateiesiea m
'kiliE'iTOl to fini the bad
loc toe tiiss, put tfaemoct of
iniM;^, paQish'theoi find Gcpose
a to pub&c Hf<tf^tp . tbroDgb
s ideasa — »s cs>posed ts be-
alMiabltmoiefnIlpginli ..

If I -were to pick » tii!g[€thiss
: has Irtad people . . . tt wmud
the notion UjHt by tiiniTnt on

yT>g^i|ptrni/ sCTcws, that soiDe-
.■ the KEtC 1000111 mike the
i^rf of nuclear medione fail-
i You ctat do IL Medicine
!•! be marti' failsafe."
■ithnifh hospttal oSkials feti
-denec by '±B pEpersrork the
.C imjioset, th« agency's recnrds
w it lardy tunis on the rej\da-
- screws. And even when it
s, bosprols often dont follow •
with adjnimstratire saactians.
X the three people wtio were
ivicffid as a result of KEC Ifflspi-

pnbes, two are s^ prariihne

one at the same hospttal at
jci hewurksdwben he'^as cnn-
".ec.

"nil dortor, Bene B. Malher,
.eotjoaally feOed to report four
-irdoses of radiopharmftcytrhcal
^gs because be thought it in-

ved 'Too much paperirark tnd
•; tape," aosmlia£ to a 1985 NEC

-v>r*-ig?finn report. Ttf^thpr was

•BCor a'' iraciear medidne and
; ndation safety aHiocr at

The Isvetieahon '^''^'"'»^ that ;

TfHP* TTIMT^P false ^^U'^MIP^ty

thheld records <nd instruetfid

iployees ts lie to NBC investlga-

■s to impede their probe.

it also found tiai hospilsl Presi-

jit Baland E. Kohr, who de-

aded Malhe- as a "roan of trueg-

T," previdcd false inlomisbon

2en askzd about one of the over-

ises.

Althonjh 'Mt^^^^'' pleadfid gmlry

1S89 m US. Diitdct Court in ]b-

arrapnn*: tp ft fClOI^ rmirYt of finl-

le to lepeirt sn oveidote. he tc-
■«''": a: BloamingtOD Hospital as

staff tadiobeist Be 'received a
.ispoided scDtencc and was fined
-.051

Kobr was not prssectttBd and is
JD presidmt

"Certainly, nothing's been kept
-OK anybody ,* said Bloomingios
wye." Janes L Whhijtrh wfao
jpresenls the hospitnl "Peoplfi at
le hospital are rw^re of what the
oarses wetc and Dr. MaihfT paid
.le debt he had to pay."

When a^ced why the hospital's
:aics policy didn't caD for Mather
.od Hnhr to be fired or disdplmed.

TTie first question
lospilal licensees ask
s, "Are you going to
lave a press
elease?". ' The
second thing they ask
s, 'Are you going to
ssue a dull
lenalty?" '

— iames Liebemnn,
Sredor. NRG OEce of

Enforeersent

■TOiitlaJch said: Thej-nndeaandl periale's rerooval «b the hospital
•jjx Wf)"^ made a ■"'«-°v-» and I ladiatiaa safety otBcerand Stt
ifte-he conectedii....Ieenab3ly Ipendcdhlroforaneytar, helsrai

donl think Mr. Kohr did aayflnne a taff rariioloEist Bl Meity- Admin
Iwitmc" [stiaiOTS there would not commei^.

■ AspokeswononforfljelniSana IbmimpedaiesaldthcTtooknoad-
jjaedical T.i><^c%if Boarc said no dltional distapliiiarj' action against

achoc was takm by the state htm He said be should have le-
Ijgainst Mather because no one had ported Uie mistake, bnt dldct be-
/ notifiei the board of his convjc- caose the dose "was really of no

tiofi-

EufeneT-PawUk, diisetorofthe
NECs regional 05ice of InvestifO-
tions in fti>T- EDyn, DL, said he
wasn't surprised to leam that
Mather still worked a: Bloom-
inginn Eospltal.

"Not reall>'. This Is Ampriia,'
Paalik sadd. Tve been ei this a i
'tr,n^ tinie. . . If I started wtjnymE

end hadn't harmpri

consequence
thcpatirnt

Ujresrtsc adrocnlstraJDis at MB-
ford Menorial Hospital in Milford,
D^ ncvc' disciplmed Radjaiion
Safe^- OfEcer D:. Santos F. Del-

■ gado and Julie E. Qreenly. a nu-

■ dear medionc technr.logis'^ after
Grccnl\- and another technologist
admitted in KRC mvesugaturs that

S-trt-whathappenedtothepi^- ^^.t^^t...^^;^^^
« mvestigate, it woula eat me ^'^''°jij°y igje ^ December

we investigate,
up."

Consequendy. hospitals whose,
anployees liave been impliczxed ip '
WTongdoing a2cn don't wu;ij ei-
ther. . . I

Al Gisnt M^^""^^ Hospital in
PetersbuiE. "K'.'Va, Dr. Kad J.
Eeckenthaier, the raniahon safety
offiffir, admiiled to NBC investiga-
TTT^ that he alio».-cd anothrr docso."
to crraie recordr of nerer-held rv .
dia-:35 safety aiectiiics for four
yean because he '-nmtW^p-w^ the :
rrmp/^aTnry rt\mMy\^ "just another
ijdjnjlous government leguls-
tion.' 1

' B°''<~'''>'=''"- is stin a staff radi-
ologist at G^ant, iriiich (Ssconti- I
uued its nudear tziedidne piogzam !
as a resuh of the NEC jnvestiga-
Ti:?r. Hf>*Tp'^' arimmigratrirRnhgrt
Hannan said he ja»' no need to
take disdplina^ icdon arainst
Becksnthaler hp'T"*** Hx. KKC

I DCTETdid.

Al Mercy Hospital in WHkes-
BariE, Pa_ an NEC inveshgahm
found Hal Dr. Salvatare 41. Impe-
hale, the radiation alety oSicer,
Tf\irt a nuclear modione trrhninr'
not to notify the NEC thzt a pa-'
ri>nt sdaeduled inr a diest ^iay
; had niistakeily been given a dose
. of a adiopiian&xcetiSical dnig
: used for Ihrer scans.

AlQioueit the KBC cadaed Itn-

1SB6. Tne technologists then falsi
fied lenjtds to indicate tiiat the
tests liad been done. ■

CalihWion tests, wliicli take less
•Jan a minute to perform, are de-
signed '.0 ensure tnat doses of ra-
dioactive drugs pven to patirng;
are accurate.

NRC urvestlgstors also leicned
that Dclgado had not held KKC-
nandaiEd radiaticn safSty meet-
ings for at least 14 years. Instead,
be hiui instmcied a seaetar>' to re-
type tlie same tnmutes over and
over for dis'aibntiaa tn ghost "xsj-
uezpants."

One cf those people vas Dr.
Abraham J. Strauss, who replacal
Ddgado when the KRC ordered
Deigado removed as ■ radiation
safely oScer. Strauss uild invest

Although the NBC commen^^s^
the onweislty for its prtaipt ax"'
j Mnr the agency allowed ?rttj to
I serve in the same capaciy at Mi-
! ami (Ohio) Uaivijiiiy and al the
i Veterans Administialion Mwtintl
Centsrln f^nrinnati
Fritz is Etill the radiation safety
,' of&cer at the Cinannati vHwuns
I botpitaL

. When Fritz was Ered m UBS, a
consultant wcsed tiniverjity oCi-
dals of serious defideodes in the
radiation safety program- Gsc con-
sultant also said there wai s sub-
stantial risk the uaivcrsty could
lose its nuclear matenais license.

Althou^ NRC investigalnrs de-
tetmined that Flritzs dep-Jty.
• Pnnce Jason, had <:oacealec re-
cords, th^- could not Tuijstanliate
. aHfigations by Jason that Fritz bad
i ordered Jason to mnrpp.; evidence
jfromtheKEC ItwasOEtlutbasis,
NRC ofSdals said, tha. taej- did
not prevent Fjitt from being li-
censed at Miami and DC

In an intcrvieu-, xiT2 dafended
his 20 years a: UC, saj-.ng he tsn a
good jadlanon safety program. He
said many of the university's prob-
lems occurred after he left and had
nothing to lio witl him.

"Zani in ""fi that thsy wt;re
fined (SiaTSO) a year or two after I
left and after they spent over a mil-
nr>T^ dollars .on a consulting firm,"
Friti sad. "^e were bever fined
wiiDe I was there. I sever bad a
piobleni with the NRC"

Jason countered; "He wis the

the falsified minnles becaa^ "it
was his (Delgado's) business and
responsibllrty."

' When asked why Deigado listed
.him as attendinE the meetings,
.Strauss told the NRC, "I dont
knov. Maybe he needed a quo-
ran."
Today, both Deigado and

S5^.^:nev^-c.mpi^nei«»£ I ^^j«^* g^^S
perioi."

Despite all the aitldJCi of the
NEC Ueberman, the tgenc/i ea-
■foreemoTl director, said the NSC Is
doing all it on to live up to its mis-
Tsion to "pmtBCt tbe public hMlth
land safety.*

• "Obviously, there are only so
-XDoay. '^■"^j:^^^ nanynsoSkandthisisatigte

fZ^ld^SrST:^'^ P -- inspect:.^ but in this
aS te moo- didnt warrant day and age jou cant have thaL
fartha-disdplijie by tiie hospital. ' "Tfhal concesjjs meisw dosdy

Z^^we hrve an*thio poUcy. 1^==*^ arreenlated?
but t*".? adminisnatian felt that the
NEC -)ok tbezr separate artinns on

In other cases, the NBC has per-

nnlied doctors it has accused of

wrongdoing to become ■licrnvd

elseriare.

In October 1SJ€. six months af-
ter the NRC Qideieri Mather re- ■ ^

moved as radiation safety frffirpr at

Bloomiagton Hospital, the agency

^licensed him at Marjan Oounty

ManceiaiEospial inMzittnsville,

Inc. . ■ ■
In another case, the Dniverntj-
. of Cinnnnati fired ouliztinn safety
- officer Kenneth M. Frit: aSer a se- . •

nes of NEC mvestigationi fotmd

oumcrous vialatioas, including
■ failure to adequaely train employ-
. #^< loains r^oadive malerul,

and hsproperiy disposing of iadi>
, a(3rve tnaierisj in sanityty sewere
' azidcash.

173

XHE PLAINDEAJyER

Letters to the editor

V..!

Clinic: Radiation story spread needless fear

-The splBfliBtWSoJrGevelaiid
Clinic" prodfilmed The Plain Dealer
(Dec 14} in froni-page double banner
bpafflines wanhy of flashing the
Chernobj'i disaster The accompany-
ing aniriffs, compieie ulth frontpage
diponoiogical illusirafloaL, feaiiired
e phiMphonis-32 spE :.- a non-pa-
tieat research laboiztory Tiore than
IV: years earlie:. The sjilll iiseir was
innocunui: the «posiire to those in-
vn>»ed ■w'as less tlian whal is reccrred
is one chest Xrs;, End. also time did
the spUl pose a risk to any jndivid-
nzl. Badinacrive phosphorus may be
desned up \rith soap and ■s.'stcr. The
utole episode vi'as repor.ec in Xhe
Plain Dealer-and other local De*Tps-
persinMay 199L

Ahhnngh the reputztjon" of the
Qeveland Chcic is oaoizged by such
hrrespmtiHie reporting, that is -of
little imporiznct in rel2.lion to the in-
calculable nam caused to patients
undergoing or r^oomniended to UE- i
dagD therapeoti!: Irrariiarimi at ths \
CJnuc and dsei'here. Aiaim e:;- '
pressed by oirrpatientsaad others ia ■
the several days fnHnwing publica-
tion oT the articles caused the Clinic
to reassure the prhlir through the re-
' die media and the estabSshacnt of e
' hot line CZl&-444-234ti that ramsoon
tbenp? is an enremely safe modal-
ity in tbe treatment of the nahnn's
, deadliest IdHer.

■While eaempting to inform the
public about so-calied "ladiztios thst
■ IdDs," The Plain Dealer appears to
have unneccssBrily elanned ths pub-
lic '"*" tiiinking tbzt radialiim Ae-
' rapyisungfempriirinf 'Wiattheai-'
, tide did not mention is thai 3533
patiems bare received 22S,Q30 ladia- -
tion therapy tieannents attheacve-
bnfi C5njc over tic pas 10 yeeis
with a total of siz misaaministiatians
Imported to the Nuciear Hegolaany
Comsnsiaii u tequired. or Qi]Q26%
of cli xadiatioo ibeiapy ticscoenzs.
"de nation gl misadmlnistiation rate
is (UltSc for all tekrierapy proce-
dures and OJIZS: of aU bia^iytbeiapy
tiiuLtiiiiies as repoclsdl^tiieOtrice
of Manafemezit and Budcet to the
K2C «Bdier this Tear.

"TfepLe this esEsDent safety re-
CDid, tiiire KRC fines for prtxsdnial
entr In &re years could notbett^er-
ated Et the Qeveland dime, where
supexiar qoait^ standee sze the
noun. Caxa^es ■wo* in order, among
wfaicb vni the npgrac'rtg of tiie qual-
Ifieztlons of the CLnic's ladiabon
ofafy o5cer poritajn. The Plain
Dealef s renni tliat "the ainic
fboed lis pyrJ-JiTP- it filed tiie radiz-
tioD "gfcy oScer, who baa been
complaining aboui violatians for
years" \ras a ^j1^» infoencs thar the
Clinic iDegaO)- retyfeTrd against a
whistle-hlattcr. This is nonsense. A
Labor D-partmcnt in(juii5' found no
ixopropc conduct by tiie Clinic.

These articieE published by The
Plain Dealer are the journalisac
equivalerc. of rociaessly yeDing
"Fire!" ia a corded theater Toe
Plain Dealer needs to lecngnize tiie
responsibflity Sbat comes ■^crth frcc-
i^<i4> of the piesiJ. and rriyiain tic
temptation to print iaztcmraie infor-
matian ^'•°* ■wili seil new^apeo le-
ganiless of the mTisi»Tnmrr;

TLOXDD.LOOP.llD.
Qeweland
Lew? is chcirmnE o,' inc. board of gov-
eiMi^ aa. extatacr dee prestoerit
of the aetelmid. Qinic

174

JNRC lifts
6 centers'
Hcenses

Gancer treatment
units lose pennits

<■ * ** ■ * -

^TB>WaiDUNG jAu

and DAVE DAVIS y* gg JeSS

PLAIN DEALER Re^RTEriS""

WASMNGTON

Tie 115. Kudear Hqgulatoiy Oom-
missioQ yesteitiay sijspended. tiie II*
cffises of six Pennsylvania cenccr
c^teis. JnclprifnE one in Indhoa,^
K, at which «i. 82-3rear-old woman
received 8 &tal xadiation. overdose in
November.

- .The su5pen»}ns do not shut down
tkie centers,. but. tfaey prevent them
' rrriTn • pArfnTTTiTTic hundreds of so>
called hrachytheiapy procedures tiiat
involve tiie use of iridlum-192," a
high-intensity radioactive .'inatiEdal
that is Bui;gjcall7 implanted • into
deq>«eatBdtupQors. ; . ''"',-:;.'." i'S.

The sbc^cenieis are owned by Qu:
cology Services Carp, of Harrisbug,
Pa. The centers came under sccunity
by the KBC following the death Nov.
21 of Sara MUdred rnlprn. The liRC
is' responsible fbr pnrtecSng the pub-
Ed fhmi ia(£stioa mishsps.

'ODlgah died a&er a doctor at the
Lidiana Regional Cancer Center acd-
dcjitally left a sliver of iririhun-192
inside on^ of her treatment cathe^
for about 91 homs, cimsing her
death. ^'BC officials estiniatird that'
t^ indium- ddlveied. a- lacSatioav
ddse of more than 1 mmipn rads Id
tfievaE of her bowti.

'In eddiHoo- to Colgan. aboot 90
pgjplff;" ftrchiriing hesuh. care'nork-
ciSt.* saJStation TTip]f|yn*» and,
fiiendf^i?^ o^iosed nMe the ii^
dmmjgiTyippd m Cdgan'^ Ixidy.and
afte^'^nas inadvurteuUy di^x>scd of
Kfotifiiiay medical waste.

rlndpffta County Coroner .Tbctmas
Stieczhs, who is Investigating Ool-
gan's destii tar evidence of possible

nriTTifT^til Ti^tgtigy pr»_ ha^ '.S^d Cot

gen's -radiation dose vasmoiie than
lOO times the letiial dose: ° Streams
said he was st3I awaiting; results of
ail aotop^ tiiat was xione after Cdl>
^'s body was disinteaied Dec. 18.

Diane P. Screnci, NSC Spokeswo-
man, said the order -was issued after-
NRC. investigaloa found a 't)reak-
dpws" in the six centeraV nnfi?rtiop
safety programs. "Oncology Services
nbvr has to prove to us that they can
use these materials in a safe man-
lier" she said.

Oncology Services has 20 days to
request a bearing on the suspension.
Executive Vice Prefddent B^y Caia-
van said the companyvi'ould appeaL
-.•^We're pretty . upset about this
whole tiling," Caiavan s^irf "The
NRG did it agun. They rtieased this
thing (the suspension oider) and
didn t send it to us. It is absdutety
loaded with inaccuiades, untruti^
and malicious comments."
- The tinannouneed NHC iospee-
tioDS on Dec 8 of two other Oooology
Sfervices centers the Exton Cancer
Center in Exton, Pa-, and the Mahon-
ing ValL^r Cancfr Center in Lchigb-
ton, I^ found that personnel -RTre
upaware of the requiiements and
procedures to protect themsebes
and otiiei? from radiation acddents.
• . So poor was the tiainuig that when
the bracbythetapy mamne being
used to treat Col^ gave numerous
^errur" messages followed bv an
alaim from the room's radiation
monitor, the tedmologists didn't
loiow how to use a survey meter that
would have shovin the radioactive
source was still In Colfan's body.

Ihe NBC was iBiticulariy critical
of Dr. David £L Cunningiam, who
serves as the radiation safety officer
faraHslxoaiters • .
-!NHC investigators said Cunning-
ham had denxmsttatcd that he was
*^t wiDlhg to be- responsible" for
the ceDters* radlatian safety fto-
garoi. Tbt sgromsinn order said
Qmnlogbam had not-vidted fte Le-
highton &dlity in the past ok to
i)ine moslfas end said the medical di-
rector-of the fadSty didnt even
ItpowitfaatQinninghamwas the ladi-
atioQ. safety ofSoer.
'-tThe JtlU; also Cmlted Cunmng-
ham firr seodlz]^ a lettfi- to five of the
Ontology ServKcs fanlltiw in which
i}c said tt was "not possible for cor-
jxBgte ■ adininistration to 'supervise
your ladiatidn safety progiam on a
lodtine basis."

^;: Caravan said the 528 bract^e
.n^:Pnxx>dores. done act Oncology
Services centers - last year ' lep-'
■jesmted fewer; than ISi of the cen-.-
"fets* cancer treatments. -

175

Wm ill II

Jala S%^ StE

^lill^lEiii Mi|||.

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\zmiimmhi%

■^ililBfll lip W

;il^41illl!il|

Htm ill 1*1

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miupr-^

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elf

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III ifit l^lHllli

ra- aa-:

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SCO

IPplpi'ifilililit

ilJif 111 iliPI

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r_ SSaTS'B'3 oC. B

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iiMiiil-

176

(Pjc toosftington post ^^^ ^ 9 1992

ClrcolallDB •J4,2«2

Md. Cancer Patients Received Radiation

Overdoses

By Deb RiechmBiin

BALTIMORE. Dec. 18— A state
investjgalion of radiation ovf rdoses
given to 33 brain cancer patients at
a Cumberland hospiul found some
patients suffered temporary deaf-
ness and skin problems after receiv-
ing doses 75 percent greater than
prescribe<l.

Investigation documents had
been sealed under an agieement
the state signed with Sacred Heart
Hospital. The state released the
documents today after several news
organizations requested them this
week under the Freedom of Infor-
mation Act.

Some of the terminally ill pa-
tients who received overdoses died.

but there was no conclusive evi-
dence to link the deaths to the ex-
cessive radiation treatments, which
occurred during a 13-month period
in 1987 and 1988.

The overdoses occurrw) because
a computer program used to control
the intensity of radiation released
was not changed when a depleted
source of radiation was replaced.
The oversight caused radiation
doses for brain cancer to be 75 per-
cent greater than prescribed.

The problems at Sacred Heart
Hospital could have been detected
earlier, investigators concluded.

The person in charge of the hos-
pital's radiation department, Cyn-
thia Brown, denied responsibility
and blamed the problem on a phys-
icist whom she trusted to conduct

all computer calculations of radia-
tion equipment.

1 responded by telling her that
she is the radiation safety officer."
state radiological inspector Carl E.
Trwnp Jr. said m his Nov. 23, 1988.
report. "Regardless of who loaded
the computer with data, her imme-
diate responsibihty was to confirm
that data to be current and accu-
rate, and that most of the blame in
this matter will be directed at her."
The hospiul was fined $9,500,
partly for not immediately report-
ing the overdoses. Sacred Heart
suspended Brown, who resigned
Dec. 14. 1988.

At the time of the problem. Sa-
cred Heart asked the state to keep
its investigation confidential.

"At the time, we really felt that
was the right thing to do," said Ro-
land Fletcher, administrator of the
state's radiological health program
"We had done a detailed investiga-
tion and were satisfied that a thor-
ough redirection of the hospitals
therapy program had occurred."

Twelve of the 33 patients being
treated for brain cancer were over
70 and three were over 80.

"Although the characteristics of
this group of patients may have
served to mask any consequences
of the overdosage, this in no way
condones the (act that they re-
ceived excessive radiation of the
order of 75 percent that would have
had catastrophic effects in almost
any other group," according to a
consulunt hired by the hospital,
who was quoted in the report.

177

OmCIAl USE ONLY

OFFICE OF THE INSPECTOR GENERAL
REPORT OF INVESTIGATION

INVESTIGATION OF NRC STAFF ACTIONS ASSOCIATED
WITH ONCOLOGY SERVICES CORPORATION (OSC)

CASE NO. 93-29A

kiiisTtair iNSPEcrot Date

General for Investigations

THIS REPORT IS THE PROPERTY OF THE OFFICE OF THE INSPECTOR

GENERAL. IT MAY NOT BE PLACED IN THE PUBLIC DOCUMENT

ROOM WITHOUT WRIHEN PERMISSION.

FREEDOM OF INFORMATION/PRIVACY KJ EXEMPTION (■) (S) (6) (7) (C) (D)

omciAi n OHIY

178

omcwmsEONiy

TABLE OF CONTENTS

SUBJECTS 2

STATUTES AND REGULATIONS. 3

EXECUTIVE SUMMARY 4

BASIS 5

BACKGROUND 6

DETAILS 7

ALLEGATION 1 8

FINDINGS - ALLEGATION 1 12

ALLEGATION 2 13

FINDINGS - ALLEGATION 2 16

ALLEGATION 3 16

FINDINGS - ALLEGATION 3 18

ALLEGATION 4 18

FINDINGS - ALLEGATION 4 ...21

ALLEGATION 5 21

FINDING - ALLEGATION 5 23

ALLEGATION 6 23

FINDINGS - ALLEGATION 6 2S

EXHIBITS 25

OFFICIAL list OMW

179

OFFICIAl USE ONir

SUBJECTS

OmCIAl USE ONLY

180

OFFIdUUSEONir

STATUTES AND REGULATIONS

10 CFR. Part 0
Conduct of Employees

10 CFR, Part 35
Medical Use of Byproduct Material

Management Directive 8.8
Management of Allegatioos

18 use 1001
False Statements

OFFICIAL USE ONLY

181

OmCIAl USE ONLY

EXECUTIVE SUMMARY

This investigation was bas«d on information developed during the NRC Incident
Investigation Team (IIT) examination of the therapy misadministration and loss of an
Iridium- 192 source at the Indiana Regional Cancer Center, Indiana. PA. This report
does not address the same issues discussed by the ITT in NUREG-14ao. This Office of
the Inspector General inquiry addressed the following areas related to NRC operations:
1) the NRC Region I handling of the bcensing actions associated with Oncology Services
Corporation (OSC); 2) the NRC evaluation of the Gamma Med U High Dose Rate
(HDR) afterloader device for use in a portable mode; 3) the September 1991 inq>ection
of OSC by NRC Region I staff; 4) alleged preferential treatment provided to OSC by an
NRC Region I staff member, 5) the NRC Region I bandling of an aDegation made
against OSC in March 1991; and 6) NRC Headquarters' responsiveness to requests for
policy guidance from the regions.

The investigation disclosed that the existing NRC policy guidance for the licensing of
remote afterloading devices was not followed by Region I in handling certain of the OSC
licensing actions. Additionally, some Lcense ameodments were issued despite the fact
that NRC staff was aware that the pobcy was either unclear or non-existent on the
matters involved in the amendments The investigabon confirmed an inappropriate
remark was made by an N'RCpBMMWW^oncemingjWytconfidence in the licensee
based on friendship with the ^ceasee s9l0tt/KttttttH9ltttH^The
investigation also disclosed defidenoes in the handling b> Region I of an allegaboo
against OSC in 1991. The shortcomings included the lack of documentation for
ii^ormatioD which was used to resolve the allegation as well as a lack of adequate issue
identificauon. Additionally, the existence of the aUegauoc wai inappropriate^ disclosed
to the bceosee ?HBpby an NRC staff member.

Questions concerning the OSC bcensc and transportability of the HDR device were
raised by three different individuals in 1991. The NRC staff cooduaed inadequate
inquiries into the concerns and allowed the bcensee to continue operating without
restrictioa The OIG investigation determined there was no evidence that OSCs HDR
device bad ever been evaluated for use in a ponable mode Additionally, the licensee's
RSO bad not received the required training to install the device following relocation
despite assurances made to the NRC that be bad received such training. This
investigation also discovered deficiencies in the NMSS system for tracldng requests from
the regions for policy guidance and technical assistance.

OFFICIAL USE ONLIT

182

OFFICIAL USE ONLY

BASIS

This invesiigatioD by the OfBce of the Inspector General (OIG). U.S. Nuclear Regulatory
Commission (NTIC), was initiated based upon information developed in connection with
the Incident Investigation Team (DT) at Indiana, Pennsylvania. This investigation
addressed the following issues: 1) the NRC Region I handling of the bcensing actions
associated with Oncology Services Corporation (OSC); 2) NRC evaluation of the
Gamma Med Ili HDR aftcrloader device; 3) the September 1991 inspection of OSC by
NRC Region I staff; 4) alleged preferential treatment provided to OSC by an NRC
Region I staff member; 5) the NRC Region I handling of in allegation made against
OSC in March 1991; and 6) NRC Headquarters* rcsponsweness to requests for policy
guidance from the regions. Issue (4) in this report was referred to the OIG for
^vestigation by the DT team leader at the direction of the EDO. The other issues were
developed by the OIG while serving in an observer role to the DT.

183

OFFICMl USE OHiy

BACKGROUND

A review of the U.S. Nuclear Regulatory Commission (SRC) Repon I licencing file for
the Harrisburg Cancer Center/Oncology Services Corporatioo (OSC) disclosed that an
Application for Materia] License (NRC Form 313) was receive^on or about June 4,
1990. j|WJMiWBBi^ was listed as the applicant 5 J^mHg|^gf|||i»
^//f^ and the point of contaa regarding the bcense. The Lcense appbcation requested
the use of a single Iridium 192 source in a Gamma Med Hi Hjgb Dose Rate (HDR)
afterloadcr at the Harrisburg Cancer Center. The HDR was designed for use in
brachytberapy which is a therapy procedure in which radioactive sources are placed near
or in contact with a tumor.

The OSC Kcense application was assigned for review by an hfRC Region 1 staff member
in the Licensing Section. A written request for additional infocpiadon, dated August 1,
i990, was sent to the bcensee b> <|pMPMHMHBiMMH^ihe NRC Region I
{■pi^PrtpH^ assigned to process the origioaJ bcense appGcation. Following receipt
"of the additional information on August 2, 1990. bcense Jiumbcr37-28450^1 was issued
by Region I on August 3, 19SK) bearing the signature o'i3VHVK0ttl|||W

^ —J

On Qgober 1. 1990. a bcense araendment request was submitted by^^l^
fmUBBHl^BK T^^ license amendment requested ibe addioon of five authorized
users with the locations of use expanded to include: Stoneboro. PA, Pittsburgh, PA;
Exton, PA Indiana. PA; and Lehigbton. PA. The amendment request did not contain
diagrams of the ueatment areas in these facibues. The cover letter from the bcensee
included a statement that tbe HDR therapy would comply wiib all. requirements of the
original bcense Tbe bcense amendment request was assigned tc ^■■■IflMmll from
NRC Region I for review. J

The OSC bcense file conjaincd a reconstructed record of a telephone conversation
between HIBHUI and fllBlHVl from NMSS/IMAfi on .November 1. 1990. (Note:
The year'on the previousK mentioned'record of conversation mcorrectly reflects 1991
rather than 1990.) Tbe issue discussed in the telephone conversation bctwcet ^
and 'il/tt^^o^^^^ ^^ transpoftabilit^of the HDR device

reconstructed record reflects tbai^^Pfli indicated that the portability /transportation of
the HDR device to remote sites was penEissible as long as tbe Department of
Transportation (DOT) requirejpe_nts were followed. On November 2, 1990, amendment
1 to tbe bcense was issued by |||[ti8ll^ which granted tbe addition of authorized users
and locations contained in tbe amendment request Of particular note b tbe fact that
condition 14 of this amendment authorized tbe licensee to tran^rt b'censed material in
accordance with tbe provisions of 10 CFR 7L

On June 20, 1991, a second license amendment request was submitted by^flU

Tbe request included tbe addition of an authorized user as well as

•♦-^m

V y^E ONLY

184

OFFICIAL USE MY

additional radioactive sources and HDR bracbytberapy units ououfactured by Nudetroo
and OmnitroD loterDational. Tbe supporting documents for this uneDdmeni request
included tbe shielding diagrams and layout of tbe treatment rooms for tbe sites
previously added by amendment 1. Tbe amendment request was modified by a letter
from OSC dated July 9, 1991, which indicated the corporation's intent to obtain
additional HDR units for use at some of tbe sites approved b> amendment 1.

Tbe amendment request was assigned for review to'<^|MHPBi^B^mNRC Region
I. On Augus^^4_l991, a request for additional informapoc was sent to^m|^

response to tbe NRC request
for~additiona] information was provided~on August 16. 199J On Augusijl. 1991, tbe
license amendment request was further modified by ^fHBMMMVm'^ include an
additional site and authorized user. Amendment 2 to tbe bcense was originally
forwarded to tbe Ucensee on December 26, 1991. Tbe cover letter incorrectly refers to it
as a 'renewal' of the license. Paragraph 3 of the amendment transmittal letter from
Region I states that due to pending policy questions regarding the use of HDR devices in
mobile services, a condition of the bcense had been added wfajcb required tbe HDR
device to remain at a fixed facility. Tbe autborizadon to transport Ucensed material
which bad been granted in an earber bcense aaioo (ameodmem 1) was being rescinded
bv amendment 2. Another version of amendment 2 was issued b) Region I on January
22, 1992, which restored the bcensee's abibty to transport the HDR device and iridium
source to other sites as long as it was done in accordance wiib 10 CFR 71.5 and DOT
regulations.

A third bcense amendment was issued on August 19, 1992. wbjcb added a stand-alone
HDR bracbytberapy shielded facihty at the Harrisburg. PA locanon. This amendment
bad no effect on the issues discussed in this repoa Gjpies of all pertinent documents
from tbe license file are included as Exhibits 1 (a) - l(m) lo tlus repon.

NRC Pohcy and Guidance Directive FC 86-4; Informatioc Required for Uceosing
Remote Afterloading Devices was issued on February 20, 198c It contained the most
recent guidance from NRC Headquarters on the bcensing of remote afterloading devices
which was a central part of tbe OSC bcense Enclosure 2 to the directive outlined tbe
information required to support a bcense request (Exhibit 2).

185

OTOMlBSEONiy

DETAILS

ALLEGATION • 1

This section addresses the NRC Region I handling of the licensing actions associated
with OSC.

i^lBMMHHHHfelHHflHBilHP (Medical Academic & Commerdal Use Safety
'Erancb (IMAB), Office of Nuclear Matcnal Safety and Safeguards (NMSS). NRC
reported that in about May 1991,Uwas assigned to review thg agency policy regarding
the bcensiog of mobile brachytherapy services. It was |^HB uoderstaodiog that the
issue had been raised during a meeting of the Advisory Xbjpniittee on the Medical Uses
of Isotopes (ACMUI). While looking at this quesbon. MWI^evigwed the actions
taken by Region I in connection with the Ucensing of (^CT^Hv compared the
information provided in the Ucense application with the Folic, and Guidance Directive
FC 86-4 which listed the information required to be submitted to support the issuance of
a license ^B|review disclosed that cenain information listed is the pobcy guidance was
not included in the original Ucense application. The informabon missing from the
original license applicauon package included a lack of data concerning tiie instructor who
was to provide training; incomplete shielding informabon on the treatment room; the
means of assuring that only one radiation-producing device would be in operabon at a
time; calculadoo of exposure rate in adjacent areas; independent verificabon of
treatment time calculations; and lack of off-duty telephone numbers for people to be
notified in the event of an emergency.

lanalysis also noted that the applicauon for amendment 1 to the license merely
stated that the five addibooaJ sites requested in the ameodmen: would comply with the
requirements of the existing bcense Sufficient data was not provided to support the
licensee's daini that the addibonal sites met NRC requiremenu 'JttfU^aho noted
that the Pohcy and Guidance Direcbve was in need of revision JifHPprepared two
briefing memoranda for JH management which reponed the resiJU ofjMreview
(Exhibits 3, 4 and 5).

A review of the ACMUI meeting minutes for May 9, 1991, disclosed that a committee
member raised the quesbon of a Pennsylvania firm conducting a mobDe brachytherapy
service and possibly transporting a remote afterloader device is a trailer to various
treatment sites. The member voiced a concern about the safety of shipping rad^active
sourgsby Federal Express from one hospital to another. NRC staff members M^|||P
^^^ flHlVHp ^^° weje to attendance at the meeting indicated no knowTedge of
sucb^ operation; Fowever,H||^0^eed that the matter should be explored (&chibit
6 at 96. 193-195).

jRegjon I, NRC, confirmed that|_

handled the initial OSC application for a materials b'cense which involved an HDR

OmCIAl «SE ONLY

186

«fterloader._.This

OFFICIAl USE ONLY

the first HDR license application processed byffl^
elieved thu^f^ay have relied more heavily on a draft
feletberapy Reg Guide rather than Pobg^and Guidance Directive FC 86-4 in
processing the OSC Ucense applicatiocL ^P^did not recall receiving any in-deptb training
on HDR bcensing matters.

^||||MHHBBtfHLreview of the initial application of OSC resulted in a request for
Additional information regarding the training of the authorized user and other minor
points Whcntbelicensee provided the requested informap^g the bcense was issued.
^^■■MMHflPwas aMIlMlHUi^at the tune. ^HHIMBMHIArecalled
during the processing of the original license request, OSCr _

inquired about the procedures for adding additionaL sites hrthe bcense and tra^fk>rting
the HDR device to various sitesjor ueatment IBIHHHHBHIIsaid thatj

informed I

^^ _lthat such a request would require pobcy guidance from

NRC Headquanerssince it was jot addressed in th^urrent regulations. After

'^^^ ■ ** '^"""''''^BWihai such a request would hold up

luc issumjwt V. »-v -, atV>H that the initial application be

processed and commented uai the addition of sites would be handled in a futwe
amendment request

During the OIG intervie\» of JlJJBIHI^BM^^he deficiencies in the original OSC
bcense application noted during the review by fttH^^^^ discussed.

reed that certain informabon discussed m Pobcy and Guidance
Ju^ective FC 86-4 was not included in the OSC bcense appbcabon. Most notable of the
deficient areas were shieldmg calculations; the means for assunng only one radiation
producing device was in operation at a time; independent verificau^H)f treatment time
calculations; and off-duty emergency telephone numbers ^m aied W^unfamiliarity with
bcensmg such devices as a contributing factor to the oversight id obtaining the correct
information.

^said that following the granting of thejgitia] bcense, W!

HoNkevet.flpdid recall suosequently

had no

le mioa

)tirther involvement^ any OSC bcense acuons Ho\fcevei.Hpdid recau suDsequenuy
seeing a copy of bcense amendment 1 shortly after the oh^iiaJ bcense was issued. pB
said that at the timej^was surprised the license amendment bad been issued so quickly
since it involved a maner which required policy guidance from NRC Headquarters (i.e..
the transportation of the source and device to various treatment locations).

ud that^ expected such a process would have taken at least one
Year to accomplish. ^'J^did not inquire further about the circumstances surrounding the
issuing dL amendment 1 (Exhibit 7).

^f|fl[|0||0|HHHBMHtiPH^R^8>o° ^ NRQ confirmed thattt^ bandied
\bt first amendment request to the OSC license which added several authorized users
and requested authority to transport the HDR afterloader device to vari^streatment
sites. Hflrecalled that it was handled as a routine amendment matter. ||p0m|said

omciAi IKE mi

187

OTOMi mom

Jpi^was coDcemgd about the proposed transportinc of the device tod coover
lelepbooe withMMBHHRIVErom tbe_NRQ^NMSS staff oo this issue,
recollection of tEe guidance provided by ^^Hffttwas thai any traospooiag oT Ume
material bad to be in accordance with DOT regulaboni Addibon^y^ ~^ "^
tbe issue of shielding in the treatment rooms at the various sites. ^^^BHWP^aid that
^^subsequently discussed tbe shielding issue wiin ^KHHmiJ0[|ppwBo informed
^li^that tbe HDR treatments would be conducted in rooms which housed either a linear
accelerator or cobalt therapy machine. It was^||0Hfl(HBHiife^beUef that this
meant that tbe shielding in the treatment rooimwas jufBcieni for use of an HDR device.
^|BiHiQsaid that^p^accepted the explanation of ftBMMBHflMand did not
Request diagrams or shielding calculatioos for the additional treatment rooms.
^■fHi^said that^i^did not discuss the ameodgient issue with any other Region I
manager prior to issuing the Ucense ameodmenL ^HHHB^indicat^ that at the time
of the f>ending amendment^l^was not aware of the NRC Policy and Guidance
Directive FC 86-4 on remote afterloaders (Exhibit 8).

■^Pi^HHHHIIH^BM^Medical, Academic & Commercial Use Safety Branch
^MAB). Division of Industrial & Medical Nuclear Safety (IMNS), Office of Nuclear
Materia] Safety and Safeguards (NMSS), NRC, recalled a telephone conversation with
^BMBflijC whjcb^lt questioned whether a Lcenseeo^JdDansport sources between
locations ^IMHflN^<^ ^^' ^^^ conversation with ||flliM^^as relatively short and
limited to'lhe issue of whether sources could be transported. ~^|P aclcnowledged
informing ^l^that transportation was permitted as long as it cotbplied with DOT
regulations. According to^p|||||||^be conversation did not include a discussion of
whether such a situation involved mobile bracbytberajjy services or whether a hcensee
could transpon HDR devices to multiple sitei>.. g^^^^ ^^ o^i maintain any record of
the telephone conversation wiib^BtHl^pBHPadded that the quesbon of mobile
brachytherap) services was subsequently ralsea by a Membej of thg^ Advisory Committee
on the Medical Uses of Isotopes jACKfUl). At that tune, ^^^BUssigaed HMHto
conduct a review of the issue ^BHIP^as later advised B> 4HPI ^^ certain
deSciencies in the handling of tBe OSC license and anaeodmelQi appTicauons b> Region I.

^mUll^also confirmed tbat^pylater directed Region I to restore the licensee's ability to
"transport the source ip the rj^vised amendment 2 to the bcense Exhibit 9 is a

bandwntien note of^||H|||Vhicb documents a conversaboo wit

MHHpm^on January 21,~f992 during which the issue was discuss^
IbatHI recSupended the restoration of the transpon condition after tbe^bcensee'sl
complaiced to^Mabout the earlier version of amendnoent 2 which revoked that ability.
|>kaid tbSjPQdid not believe it was proper to use a license amendment as a
(o remove an ability which bad be«n previously granted by the NRC Further,
P)feli that tbe pending poUqr issues concerning transportabiliQr <^ the HDR
Vevice did not raise immediate health andsafety issues which would have justifie<t^an
order to modify the existing license. ^MMB/eported that^pfeMBMBMHIsaid
^was qualified to perform the functions associated with tranqx>rtation of the HuR unit

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188

OTOAl USE ONiy

to the various sites. ^H^P^ddcd that the existing policy and guidance directive was
outdated and in need of revisioo. One of^l^taff members was currently working on
that project (Exhibit 10).

edical Licensing Section. Nuclear Materials Safety
ranch (NMSBj. Division of Radiation^ Safety and Safeguards, Regioi] l advised that|[||^

became the ipSHNHMMflMBBm^ Region I on February 2£, 1991. By that
time, the ori^al license and amendment 1 bad already been issued to OSC.

^HB^mPi recalled that in the March/ April 1991 time frame, questions were raised
Sbout the number of health care centers listed on the OSC Ucense, the lack of diagrams
for the facilities, and the licensee's plan to transport the HDR device to the various
treatment sites, fli^ew was thatsucb an operation was not permissibl^u^e^^
(ffect at that time. fllKidfl||lsaid that HH spoke wi,th WttKtm\

regulations in ef

about the transportation issue an

approved it.

lat sucb an opei

dicated than

rom NMSS bad

batflft realized in about March 1991, that policy guidance from

baid thatjl
TJMSS was geeded Jjj^ acknowledged having conversatioos begirming in June 1991,
v^-itb jj^jpfrom NMSSjegarding a lack of informanoo in the Ucense and ameodment
appbcatioQS i^MKPHi^aid thai^l^viewed the Lcensee's failure to provide shielding
informatioD iii me request for amendment 1 as a health and safety issue, however, since
the amendment had already been issued by Region I.^j^direcied thai the information
be obtained Js coonection with a subsequent amendment actioo m 1991 (ameDdment 2).

laclcDowlcdged that there was a delay between the tmie the issues were first

liscovered in March 1991 and the submission of the request for poUcy guidance to
i>JMSS in January 1992 The delay was due to a heavy workload as weU as the fad that
BBMflftdesired to condua an insp>ecuoo of the Uceosee m order to gain a better
^dcrst^dmg of the operation. That inspection was not copduciedjintiJ Sepiember
199- IflBiBiiSs^d that during that inspecuon.4H0iMBflMm||cbaraaerized
the mdvement of the HDR as "high risk," or words to that effea (Exhibit 11).

Exhibit 12 is a copy of the request for
in January 1991 According to
NMSS as of January 1993.

idapce from Region I which was sent to NMSS
**" no written response had been provided by

4uclear Materials Safety Branch (NMSB), DRSS, Region
.'advised that the OSC Licensing actions were bandied in a routine manner at Region L
^iBdid not rec^ any discussion in advance of the issuance of the L'ceitse and
amendmentl^^Hfint knowledge of a problem with the license occurred around the
th^tiiflHWHVsubmitted the January 1992 request for policy guidance to NMSS.

felt that it should have been brought tof^pttention at an earlier time
ubit 13)

nnnni^i H ONLY

189

OTOAlllSEDMiy

FINDINGS -AT J FfiATinNI

1. Tbe NRC Policy and Guidance Directive (FC 86-4); Information Reouired for
Licensing Remote Afterloading Devices was not foUo>*ed by Region I in the
issuance of the original license to OSC in August 1990.

2. The Region I licensing inspector responsible for the handling of amendment 1 to
the OSC license was not aware of the NRC Pobcy and Guidance Directive (FC
86-4). The Lcensee should have been required to submii diagrams of the
treatment rooms and shielding calculations for the sites added by this amendment.

3. Insu£5cient information was provided by(pHKBburing|jAtelephone
conversation witb^|||^|wn November 1990 in which U>e issue of transportation
of licensed material was discussed. Moreover, flHfliB^hould have submitted a
formal request for guidance so thai NMSS could have made a decision based
upon adequate information from the Ucensee. As a result, all pertinent issues
associated with the OSC amendment request were noi identified or addressed
prior to issuance of Ucense amendment 1.

4 Pobcy issues related to this bcense were first raised in Region I in March 1991.

In May 1991. the NMSS staff was aware thai pobcy questions bad been raised.
The Region I written request for NMSS pobcy guidance was not submitted until
January 1992. As of March 1993, pobcy guidance on the matter bad not been
provided to Region I.

5. The NRC Pobcy and Guidance Directive (FC 86-4) is outdated and in need of
revision.

6. Amendment 2 to the bcense which was initially issued in December 1991, revoked
the bcensee's abibty to transport HDR devices and bcensed material pending

»' tion of the mobUe services issue. At the duecuoD of an NMSS^HP
a revision to amendment 2 was issued in January 1992, which restored the
Jjcensee's authority to transport the device and radioactive sources. The NMSS
iPmi0^took no action to assure that the mobile services issue was resolved
^rior to restoring the bcensee's abibty to resume transporting the device and
sources.

7. The Region iMHtfftH^said thatflkbelieved in March/April 1991 that the
bcensee's operation was not permissible under the existing NRC regulations and
there were health and safety concerns associated with the lack of documentation
providedbytbe Ucensee in the agpbcation for_amendnient 1. Additionally, the
bcenseeWWrepprtedly told the^HMMH^uring a September 1991
inspection that ^viewed the operation as "high-risk.* Despite this, the licensee

was permitted to continue operating without restrictioa

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190

O^IALmOHLY

^T T Fr.ATlON • 2

This section of the OIG report addresses whether the traosportability of the Gamma
Med Hi HDR afterloader was properly evaluated prior to the gnnting of Uceose
ameodmeot 1.

As indicated in the previous discussion of the licensing of OSC amendment I'was issued
by NRC Region I on November 3, 1990. That amendment added five authorized users
and five additional treatment locations to the original license. The amended license still
listed only one Gamma Med Qi HDR remote afterloading brachytherapy unit
Condition 14 of amendment 1 gave the licensee tbe authority to transport bcensed
material in accordance with 10 CFR 71, Tackaging and Tran^x>rtatioD of Radioactive
Material* Section 19 of the Nuclear Medicine Inspection Field Notes prepared by tbe
NRC Region I inspectors in September 1991, reflect that tbe source was transported
approximately 40 times between April and August 1991.

jcjetron Corporation, was contacted in
''connection with this investigation. QHHlBfadvised that Nudetron Corporation
manufacmres HDR remote afterlp^dep for sale to medical institutions. ;)0iH^said
thai jl^ approached ^hMtfHflBftfrom the NRC sometime in about May 1991,
with questions concerning OSCs plan to transport a Gamma Med Qi HDR afterloader
to various treatment sites iffKtlflfiexp\ainc6 that the maoufacrurer of the Gamma
Med HDR afterloader was V competitor of Nucletron Corporation and^||||sa]esaieo
were being questioned as to wby Nucletron would not a3icr* tbeir HDR units to be
transported to different locations for use in treatments.

i^|fl||||||§[said that during ppjneeting at NRC.^BflMM^'^ °ot aware that tbe
^practice of movin| HDR devices between treatment sites ba'd been approved by the
NRC ^PMHpthen provided jffKttM^^^ a copy of the OSC bcense which bad
been obtained bv^Nucleiro^hrough tbe Freedom of Information Act (FOIA).

n>indicated to |i|BHflpthat tbe matter would be addressed by tbe NRC

said that>m^ubsequently beard from a source whose identity^P|couJd not

Tecall tbaf OSC hadvoluiu^y ceased transporting the Camina Med Ili device between

anspor
treatment sues, ^w^^explained that^|^coocem with tbe transport of the Gamma
Med ni device centered around ^jj^belief that the issue of frequent transportation of the
device was not considered when the device was originally designed. Althougbf||bad no
specificjmowledge asto whether tbe transportation issue was ooosidered during design,
~ jd tbat^ is quite familiar with HDR units and believed that the issue was

it considered when the device was designed about 14 years ago (Exhibit 14).

ISesJe^ouTtt Safety Section, IMNS, NMSS,

^lifinned that^^bad a conversation with ■pmH from Nudetron concerning a
Ucensee's use of a Gamma Med Qi HDR device in ui operation which required
transportation of tbe device between locations. Af tbe time of^fi conversation with tbe

nmniAi. USE OMIY

191

omciAiusEMr

represenutive from Nudetron/lMtBKbelieyed that the NRC bafl
the use of an HDR in such an Operation. WbeojH|[|||||Mprovided

Id not appros
locations of

copy of the OSC bcensc which indicated a single device aii3 multiple

urmiscd that the device was being .transported between locations,
said that he brought the matter to the attenuon of his '

roved of
with a
use,

who was

At OIG request, ^HPHViprovided a copy of the New York Sute registration for the
Gamma Med Di HDR device (Exhibit 15) After reviewing the registration document,
(flJIlHIJ^advised that there was no indication that the Gamma Med Qi device bad
^eo evaluated for suitabihty of use in an operation requiring frequent transportation.
The New York registry was sOent on the issue of transportation of the device.

Vindicated that it should not be presumed that a sensitive piece of equipment

^uch as an HDR can be transponed on a regular basis and set up for use. Tests and
evaJuatioo of the device for thai type of use should be conduaed ^BHHUlbaid that
the manufacturer of the equipment normally provides the necessary data for the
evaluatioa ^[^deschbed faaors which must be considered including the effect of
vibrations on the equipment and a discussion of whether the sealed source will be
transponed inside the device or external to the unit.

'fUlfimi^believed that Region I 'should have submitted a Technical Assistance
Request (TAR) to the Sealed Source Safety Sectiop when the bcensee appbed to
transport the HDR to various sites for treatment ^J^section would then have reviewed
the device to determine if it could be used m such a manner ^HHIB advised that a
later transportable model of the Gamma Med HDR aherloader has been under
evaluation by^Jisection, however, J^bcbeved it was significantly different from the
model being used by OSC (Exhibit 16).

When interviewed,
issue to^Pl attention

Ijhad jio^sp
However

dfic recoUectioD of ^HflBV bringing this
'said it was quite possible tbat|||^did so, ^H
did not feel that the requested aaion to ttanspon the HDR was a major departure from
the manufacturer's intended use of the device 4HHHftsaid that the conditions of use
did not appear to differ from those which could nave been originaUy anticipated for the
device (Exhibit 17).

■(^Division of Industrial and Medical Nuclear Safety
'tIMNS), said^was not fully awafe of all the developing issues surrounding the OSC
license. However,^ acknowledged that the staff should have reviewed the issue of
transportabibty of the HDR device prior to issuing amendment 1. It wotild have been
reasonable for the NRC staff to question whether the device was intended to be
transported and to review whether it bad been approved for tise in a portable mode. In
addition, the staff should have reviewed whether the state had evaluated the device for
transportability. If there was no record of a review, it would have been appropriate for

OmCIAI. IKE ONlY

192

DFFICiAL USE DNIT

either the sute or the NRC Sealed Sources aod Devices staff to evaluate the device.
According to^lftaB^iVA^^ effects of transportuic tjtedevice and its operability
after frequent transportation should have beeo considered. ^^ added that the precediiig
comments were provided retrospectively (Exhibit 18).

itfllHMMiWm)^'^ Technology, inc.. reported that ft^ompany was a
^bsidiaiy of the German firm which manufactures the Gamma Med HDR ^erloader.

Jij^dentified the manufacturer as Isotopen-Technik Dr. Saueofcein GmbH. '^HIP^
said that a U.S. firm by the name of Mick Radio-Nuclear handled the Mlesand service
of medical devices at the time the Gamma Med IL was sold to OSC. iSMR)^^ ^^'
RTS has submitted a more recently developed model of the Gamma Med HDR to the
NRC for evaluation of use in a transportable mode. {]P)descnbed this oew^^^l as
significanUy different from the Gamma Med Ili which was sok) to OSC ^flM^sud
that tofllmowl^S^ ^ i°<^^ ^'^ ^ ^^^ ^*^ °^^ speciScaDy designtil to be used in
a transportable mode J||||added that he did not believe the idea of transportm^be
HDR unit was considered at the time the Gamma Med Di wa5 designed. JBHiS^^
that the unit was never advertised as being suitable for use in a mode which required
frequent transpon ^MBHllwas not aware of any testing performed on the Gamma
Med ni to determine how ifWould hold up under frequent transportation from site to
site (Exhibit 19).

lUdl^MHiflHttl^cl' Radio-Nuclear, Inc., reported thai^[|;^firm bandied the
Initial installation of tR_Gamma Med Hi HDR afterlpader at jj[arTisburgi_PA in
September 1990. ^Mlbdvised,that^de^i with JUMMMtMUliPdyiSg ^^
installation of the^evicc" ^m^|said tbain||||^B|Bi^HPinfonDeda|^f the
firm's intent to move the Gamma Med IL device to different kxabons for treatment of
patients ^(tj^fiid tbatf|[\told J^feflMBBBMIi that the Gamma Med IL was
not designed as a portable device ^d that '^JBp^had concerns about OSCs plan.
iHH^said tbat^lTfirm conduaed only the initiaT installaDoo of the device at
Harrisburg. PA. ■^never installed Gamma Med devices at an> other facilities operated
by OSC. Any movement ofthe dcvicefrom the OSC Harrisburg location was done
without the knowledge of^Blto In ^PIU^ opinion, anytime the HDR device was
moved to another location for tfeatment, the person maldng the mov^h^d have
followed the same procedures as used at tb^dijM of an installaoon.3BV said that

yas not certified b> flBRfor installabop oLthe GammaMed IL

IDR afterloadet. ^^f^mmented that the only exposure^^fkflHPHSSAl)^

in the installation ^ the Gamma Med Ili afterloader would^have been what"^"^^

iUujl^iW

observed on the one occasion whenJ|M|iQStaOed the device at
advised that oo training in installing the d

^uTucu iuai uu uouiiu^ uj — -g, tuc dcvice was provided t(M|f^

however, ^j^was provided an installatioo manual Representatives
from ^^tf^ were present during a few source exchanges at the Harrisburg site following
the imtil^mstallation. Source exchanges involved the replacement of a depleted
radioactive source with a new radip^ctive source. ^BHMMHHHK^^^ authorized
to perform that task; bowever,4B|^eiterated that a source exdiange wis different
from an installation procedure (ExhiSit 20).

(R)

mm n ^

193

Cfnctti BSEONiy

OSC license anjendment 1 indicates that licensed material may be transported in
accordance with the provisions of 10 CFR 71 (Exhibit 1(^)); however, the amendment is
silent on the issue of the transporution of the HDR device. Condition 13 on license
amendment 2 which was issued in January 1992, requires that any installation, relocation
or removaJ of the HDR device containing sources shall be performed only by persons
specificallv licensed by the NRC or an Agreement State The condition further states
that fMfBmPIHHBimay perform any of the above services 'for which he has
received specific training from a licensed manufacturer's reprcsenutive" (Exhibit l(m)).

Licensee uaining records were not reviewed during the NRC inspection on September 4,
1991. That matter is discussed in more detail under aUegation 3.

FINDINGS • AlJFr.ATinN 7

1. No evaluation of the Gamma Med IL HDR afterloader was conducted in order to
determine if it was suitable for use in an operation which included frequent
transportation of the device.

vis not specifically trained by a Ucensed manufacturer's

"representative on thelhstallauon or relocation of thf Gamma Med Hi HDR.
Therefore. Hfdid not meet the criteria listed in condibon 13 (c) of license
amendment 2 as being qualified to instaU the device following relocation.

3. Licensee uaining records were not reviewed during the September 1991

inspection bv NRC Regon 1 Had the staff reviewed Ucensee training records
during the mspecuoii,^BMM|||fHBHHMitlack of training in the ascas
required to move/remstall'thc HDR device may have been detected.

ALLEGATION - 3

This section of the repon addresses the issue of whether the September 1991 inspection
of OSC by NRC Region I was adequate and conducted in accordance with NRC
procedures.

A Region I inspection of OSC was conducted by^pButfMHIHMPflBflBBl^and
^ ""TBDrd September 4, 1991. The inspection site was

uted to the OSC operation at the Harmburg Cancer Center. 77S South Arlington
Ave., Hanisburg, PA. An inspection report was issued on September 26, 1991, (Exhibit
21), which identified two severity level IV violations. One of the violations dealt with
deficiencies in the paperwork required in connection with the transportation of the
radioactive source to the various treatment sites. The violation indicates that the
licensee had transported radioactive material approximate^ 40 times between Aprfl and
August 1991. The second violation dealt with the fact that the ^/f^bid not been
suppb'ed with a whole body badge by the Ucensee. The licensee responded to the Notice

OmCIAl USE ONLY

194

OFnctuosEONir

of Violatioo and indicated what corrective action bad been taken. Tbe NRC
acknowledged tbe corrective action in January 1992.

Section 2800-04.03 of Manual Chapter 2800, Materials Inspection Program states that
initial inspections 'shall be conducted of licenses in InspectioD Priorities 1 through 5
within su months after material is received and operations under the license have begun*
(Exhibit 22) Tbe Ucense was issued in August 1990, and the initial inspection was not
conducted until September 1991, a period of 13 months.

[Region 1, NRC confirmed tbat|||§

jcipated in tbe inspection of tb^OSCj^cflity in Harrisburg. PA, along witb_
flmilBUki September 1991. ^HfllB explained that^Bworkedfor^^
in the Region I Licensing Section at tbe time of tbe iiispectionTjjpHllttf was aware
that a Ucense amendment for OSC was pending at the time whicF may have influenced
tbe timing of the inspection as well as tbe fact that it was being conducted by
represenutives of the licensing section. Additionally, j|^ was aware that bcensing
questions had been raised previously concerning whether OSC was operating a mobile
brachyiherapy service as well as tbe issue of ownership for tbe various sites where the
OSC ueaunents were being performed.

> recalled reviewing the license file at Region I in advance of the inspection.

lasked to see tbe training records during tbe inspection at OSC; however, for
^-romc reason the records were never reviewed J(|beUeved that ^|^ may have been
diverted to some other aspect of tbe inspection and never returned to look at tbe
training records.

itnessed a cobversatioo berweeDBHHIHMpaDd]_

jntioned that an allegation had been madf against OSC
represenutives trom ^^pBMHBHHH|^HHB^^^u]d not recaU u'l
meDUoned the alJeger bv name id^flflfBtt/BSf^^ ^' allegation is discussed^
more detail in allegation 5 of this report 4HMHB&aJ3 that the inspection identified
three violations; however, one of the violations was corrected immediately and not listed
on the subsequent Notice of Violation (NOV) jUlMlftprepared tbe inspection
report which was subsequentiy sent to tbe bcensee (ExhibifZB).

flH|y||[|0^ confirmed thgt §fti was present during tbeSeptember 1991 inspection at
OSCi^anisburg. PA fl^BH^P^xpIaioed tbat^|[)bad been anxious to conduct
tbe inspection due to tbelact that questions bad been raised concerning the nature of
the OSC operation. Tbe questions which bad been initially raised in tbe
February/March 1991 timeframe centered around the issue of mobile brachytherapy
services and the transportation of tbe HDR afterloader to various treatinent locations.

flerloader was going ^

reportedly had agreed to notify
I be used at one of tbe other O:

vhen the HDR
' sites so that an inspection

nmriai m nNlY

195

o^rmmmY

could be coDducted while the machine was being operated away from the Harrisburg
Cancer Center A sigqjfiant time bad elapsed without any such notification, so the
decision was made byPBMfll^to conduct the inspection at the Harrisburg clinic.

supervisor

the

^primary involvement in theinspectioD was to obscfvel
llspectioD abilities This stemmed from^jl^duties a^MBHCT
requirement to periodically review assigned inspectorVwork. ^MMM^said thatJB
assistedjiflflBJ^^ertaLO reviews of records JpHMHI^ acknowledged that^^T
told <^PlBi^HMMH£durinj| the inspectioD that an aileron bad been made
against OSC. 4Hi^*^ uncertain if ^j^provided the alleger's name to JtB^

»-ir Jul belieyedjhatj^'more than ykdy* mentioned the adeger's name

^affihatioD witT a certain WflftfliBBM|HHfl|BBMHHP^d that 0B^
'"^'frrorjbortly after making the comment to^BHMlSHHliHPBHHtlaQd

b'ere in ageement on the two violations which were
'acknowledged that ^|Pwas surprised during the inspection to learn of t)E
of times that the kDR device had been transponed by OSC.

large

attempt to uiterview ^^pp^^HHBSHBI^egarding this matter was unsuccessful,
rjdeclined to be interviewed due to a separaTe ongoing invesngatioo involving OSC

nNDINGS • Al I Fr.ATION -^

During the inspectior^plBlllHv'o'd'^BHiMMHRHii^f the filing of an
allegation against OSC. It could not be determined if the identity of the alleger
was divulged, however, ^■■MJlPbelieved thai^l^'more than likely*
mentioned the alleger's name or affiLation with a certaic medical association.

2. The inida) inspection at OSC was not conducted within the six month period
specified in Manual Chapter 2800.

ALLEGATION ■ 4

This section addresses the issue of whether an NRC Region I
preferential treatment to OSC in the handling of Ucense actiou.

provided

A file containiQg copies of various Ucensing documents related to OSC and maintained
at NMSS was reviewed by members of the ITT during the invesngatioo into the incident
at I^iana. PA Contained in the NMSS file were the handwnnen notes of^PHiH|§
;, relating to J^^eview of the OSC Ucense file and conversations
Region JliMMPMMfcWBWBBg) The notes enumerated ccqain defidencies
detected bynKS^^ licensing of OSCjctiyitica. Additionally, ^^MBl notes
reflected a tetephone conversation in which M||||||||Preportedly made reference to
the lack of need for Region 1 to request ad<fflonaI supporting documents from OSC due
to^[|^nfidence that ■BHMHHVi||^operated a safe program. According to

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196

OTOIAL USE ONLY

nuDeai to

However, based oo^f^past es>erieaa with

regarding the

stcjroer

^__^^^^__^^ not feel there was any basis for believing that tf|would provide
preferential tr'eatmeot to any licensee (Exhibit 24).

A revigw of the educational and work experience o{fli

vere both at ibeU

Pand^
lisdosed that theypyere both at tb€~University~of Delaware, Newark,
Delaware, inj974. At that time. ^iBHlQlSwas employed at the university while
as enrolled in a Ph.D. program at the university.

;n interviewed by OIG^HH^PP)denied any preferential treatmenttowardMJPJpj
'Jin connection with the licensing actions for OSC ^BHHfl^^^°^
safMdid not know HMMlBfllMwhile at the Universtyjof DeUware and
was not even^awareJhatTbey were there at^e same time in 1974. |B|explained^|
comment to KJH^^egarding personal friendship with HP^tfflflBHHi as
stemming frspn theiTmutuaJ involvement in professionaTEealtb physics sodet

^ jenied anv unofficial involveroent with^jMWWJi^^BBB outside of

activities associated with the societies. ^MflHIIbeUeved thai^Pcomment to ^^
^BliiUboncenung the quality of the operation at OSC would have been based oajUl^
^^^^^ of ^lifeMBBSHHft^rofessional credendads combined with the

knowledge of
physics society

a person which was gained through their association with the health

specbon in the early logo's of a
land found it to be adequate in
jflbc

jd tbatjipbad conducted a previous^
f^cilit>' wherejJttpBMMft^served as the_
all respecu B^denicd any attempt" to rebev<

requirement to submit full documentation in suppon of license acuons

said that ii was^^ decision during the processing of Uccnse amendment^ to require
OSC to submit the shielding diagrams for the treatment rooms whic^ had been omitted
during the initial processing of license amendment 1. AddjnoDaIl>.^||HKBCpointed
(odjJLattempt in license amendment 2 to revoke OSCs abihry to transport material as
evidence ofjj(|lack of preferential treatment (Exhibit 11).

P/eported that jfBMB^i^^^<^ Vk ^ resppnsibflity for

'''aaaiing amendment 2 to the OSC Ucense in Ifie sununer of 1991. ^mMprecalled
|batfliMB0^irected^||to review the entire OSC bceose file in"order to_
determine if the previous licensing actions met the NRC re<iuirements. ^P|||fP|viewed
this as somewhat unusual since license amendment review were usually lunitedto the
issues associatwl with the jpending amendment request ^Hfeiftfclt ^2< ^ review
requested byi^lMHfll^A^ laoit thorou^ ihanwould have been done under normal
cifcumstance^BHlQlBalso infonned |RMi|^\liat the shielding diagrams for the
added treatment rooms hadnot been submitted during an earlier amendment and^|^
t0)(]ft|[|to ensure that the diagrams were requested from the b'censee at this time
(Exhibit 2S).

OFFICUl USE ONir

197

Bmamim

MTOofidence in the safe operation of OSC
Quotes contain tbe
fa a persona] fheod o(J|BMMBft and

the notes of tb^onversation, ;
was based on JH friendship witbj
following statement:
Jjj^bas a great deal oT confidence mj

When interviewed by OIG, JlH|||||advi5ed that in about Ma> 199l,|Pwas assigned to
conduct a review of the NRc policy on brachytberapy with specific emphasis on the
question of mobile brachytberapy services. As previously rcponed, it was(ttiMi
understanding that the issue of mobile brachytberapy services had been raised at a
meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) which
had included reference to the Ucense held by OSC. y'0/ft^deiernaned that there was
no existing NRC guidance on the allowability^ mobile brachytberapy services and 10
CFR Part 35 was silent on the matter J|^|||Nva]uated the OSC license file using
NRC Pobcy and Guidance Directive FC"86-4ras' the guide for the procedureswhich
should have been followed by Region I in issuing the bceosc to OSC (JHBC^^ysis
showed several areas where Region I did not follow the Pobcv and Guidance Directive
FC 86-4.

Following review of the licensing actions associated with OSC which disclosed several
discrepancies with the existing Pobcy and Guidance Directive. ^flUAcontacted
(t/^0ttf^ Region I to discuss the deficienaes^lt was inioally determined that the
licensing actions in quesbon had occurred prior to |BM|0fl||P assignment

repptied that during the conversatjot^ #BpB^^commented that]
was confide n^aijHHMHHHHRHBu as doing a goog job beause Hfc*, knew!
personal!) ^j^BflBiP^neponedly indicated to^f^j^ ihatjhe disaepancies did not
need to be pursued suTccJJl^jhad coiiBdeoce IE ^ '

impression was thai BBHHHUconsidered the maner as Vater under the bridge' since
the Ucense bad already been issued f|0hB^repared two bnefing memoranda
£ontainjn|_tbe^ results ofijl^nalysis of the bcensing package as well as a report of

cpnunents. The memoranda^ ere provided to^H|||^flM||j||P||||||||P

(Exhibits 3 and 4") ~X briefing for J)ivisi6n
jn the matter was scheduled and postponed approximately
times; it was never beld'(Exhibit S).

ree

During^ OIG interview, ^^^^i^clmowledged that fPl^lixiformec

> comment cohcemingQ|0persona] frien^hip wit

reed the comment was inappropriate; however,^ did not beliej
Jwould have provided preferentialjjeatmeni to ai^^"
lieved the comment meant that ^HMMJI^j^ confidence in I
technical ability was based, in |i iil ii'll|^Pi in i~iiii il liii ml lii|i 9m0&aid thatflVdid
not discuss the comment with any ofi^ftMttltffhsMpehors at Regjon I. Additionally,
the matter was not referred to the OIG for investigation (Exhibit 10).

OmRlAl list OHIY

198

OWJAl IKE OHIY

An attempt to intcfview^pipliiBB^BPyegafdin« this matter was unsuccessful.
fl| declined to be interviewed by the NRC OIG due to coDcems about a separate
o^oing investigation involving OSC.

FINDINGS • A' ' FfiATlON 4

I made an improper commentregarding licensing decisions based on
"personal friendship with the Ucensee's^Plp

4M0Hfl|kin)proper comment was reported to NMSS managers by a staff
^Sbw/Howcver, the NMSS managers failed to repori the matter to
~ ' ^management or the OIG.

While the OIG investigation did not sulsiantiateany oven preferential treatment
having been provided to the bcensee b>p|||0BP the bcensee benefited as a
result of NRCs issuance of the license and amendminis without full compliance
with the existing regulations.

AT 1 Fr.ATlON • S

This section addresses the NRC Region I handbng of an allcgaooD regarding safety
concerns associated with the transportation of HDR afterloaders.

A review of the Region I AUegation File concerning allegation number
revealed a letter dated March 1. 199K trom^

J DRSS. Region L The letter

q Jesuoned the adwabihty of transporting an HI5R aJicrloader between various
institutions for ueaiments. The letter expressed concern over the transport of high
intensity radioactive seeds in a mobile unit in which adequate protectiOD procedures
would be dif5cult to follow. Additionally, the potential for an accident with resulting
damage to the treatment machine was cited. No specific bcensee was mentioned in the
March 1. 1991 letter (Exhibit 26).

An Allegation Receipt Report was prepared by Region I which contained the following
summary of the aDegation: 'Questions whether transport of HDR and use of the device
at a number of facibties is a good idea. Is it safer (Exhibi^TiAa Allegation Panel
was convened atRc^n J on March 21. 1991. to discus^M^aD^tio^he panel
chairman wasSHlliH^Other panel members included^PBVHVHHlB

^^^^^H|Mf^ The notes of the paoelmeebng reflect that the following
action should be taSen to resolve the allegation; ^■HM^*^ ^ co"**** ■
represenutive from NUCLETRON (a manufectiucr of HDR afteriwdeirito determine
if they had any knowledge of the situationjWBgwMio contact(^min an
attempt to identify the facility involved; and1^P|g0iSwas to obtain pdCcy guidance

OfflCIAl USE ONir

199

iwcMi m am

from NMSS if a licease bad already been issued whicb pennined such ao operation
(Exhibit 28).

Dented an

The allegation fiie included a me morandma, dat^edfJhMIPBP whiclt d^gcymenl
earber telephone conversation betuee[lflp|||Pkj33^BiBK£SfvhjchMf§jp
provided bmiied and incomplete informajion. regarding the idenbty of tn^iceSc in
question. This memorandum reiterated ^JKHj^coocero about the hazards associated
with transporting radioactive sources as well as tBe possible adverse effects on the HDl
device such as misalimment of the machine during shipmenu^ According to tbe^HI^
memorandumJHBArequested confidentiality during the /April 29, 199r)telepbone
conversation. ^H^El^cted that the issue of confidentiahty be addressed in a
subsequent letter toJ^pHf^ Exhibit 29).

^ _ _ _ _

^eallegatioo file also contained a copy of a Region I letter to^BBHMflBlMiJfe
miPH which reported the results of the completed inquiry into ibe allegation. The
resfJffnsc confirmed that OSC had been bcensed by ?^C and allowed to transport the
remote afterloading device between specifically Licensed facihiies while complying with
DOT and NRC regulations The allegations of ^flB^^cre essentially found to be
without merit The letter of response also informed wBMl that ^p[jidentirv would not
be disclosed to the licensee or the public (Exhibit 30).

KlDR^ Region I NRC recalled a meeting withV^
^to disou^enain aspeas^f'JBHMHHAMH|<^''atioa At some point
m the meeiing.^|||[||||||§voice(SPcoocem aboiij mobile ra^abon therapy which was
reportedly being provided by an NRC bcensee ^HMIrecalled that 4||^|||1 did not
provide a greai deal of detail due to perceived personallUbiLry ODlhispan. _
was uncertain if at any point in the allegation jrpcess^BMliP ever identified the

bcensee being refened to m(bi5ial)egatioti ^^BBP^'as not cognizant of the inquiries at
Region I whicb ultimately led to the identification of OSC as the bcensee in question.

4(BPsaid tbar^pwas generally aware of the facts whicb formed ibe basis for
^solution of the allegation. The region's inquiries established that the treatments were
not being provided inside a van. Further, the bcensee bad indicated compliance with all
Department of Transportation (DOT) requirements in the transfer of the device to the
other sites )09bad no knowledge of any Technical Assistance Request (TAR)
asking for NMSS policy guidance on issues associated with this matter (Exhibit 31).

fl|BHp[||advuedthatM^as present during ^^pBBflHk^MlA^t with^
flH|Band|Bit0HBiwhicb included a meeting with ^^H^lHHHMHBfi did
^ot^participate in any discussion of^MjIm^WlcgatioD wide at the hospital However,
_ Subsequently filled out the Allegation Receipi Report and anended the AQegation
'ane! meeting at the Region I office. ^HpMlK'^ould not recaD ever contacting a
representative from NUCLETRON Corporation concerning the allegation as was
indicated among the planned actions of the allegation panel (Exhibit 32).

OFFICMl USE ONlir

200

OfFiCIAlUSEONir

>rted that ^ftprepared the notes of the AUegatioo Panel mee^s on
lIHBp) which included the planned staff action to resolvf
legation^ ^^acknowledged adding certain informationio T
letter to H|[[[|^ concerning the resolution of the allegation.
thatMKontacted a representative from the Commonwealth of Penfisylvania in order to
determine if any licenses had been issued which allowed treatments outside of a
specifically Ucensed facihty. ftHHH||^<^ that^Aprepared no notes of the
conversation and was not cenS^vnomljBcontactea^H^provided two names of
representatives m may have contacted on the matter

Ladvised thatfl^ forwarded an allegation to the NRC after
I^afnmg that an NRC licensee was plaimmg to transpor^^fl>R afterl^er to various
sites and conduct brachytherapy treatments in a van. HHB| ^d that^ was deeply
concerned about a licensee's ability to exerc^adequat^ate^ and quality control of
medical treatment over such an operation, ^^escribed the HDR afterloader as a
sensitive instrument which could be adversely affected by frequent transfers over the
road from site to site. ^MMl^&lso questioned the manne^^vhic^the radioactive
sources were going to be transferred between locations. In^^^^^popinion, the above
op>eration was a 'disaster waiting to happen.' This feeling v^^ue^n part, t(>^HHB(
past involvement with the Ucensee in question on other matters concerning theqinm^r
medical care.

luld not recall receiving a letter from the

ICex

umceiving a letter trom tne iNKt^ explaining the results of their
Inquiry into the matter. Uphad a conversation withH|||||i||Bfromthe Advisor
Committee on the Medical Uses of Isotopes ( M H1 1| iii iiliii liBp|||fciiiliiiiiii
that the NRCs position was that the Department of Transportation (ixfi ) regulated tne
transportation of the radioactive source. ^flPIBs^d thatfl|has bad no contact with
any representatives from OSC since the allegation was made (Exhibit 34).

isory.
sedfB^
ilated the

An attempt to interviev^HHjjIHHHHi^ regarding this matter was unsuccessful,
fljpjeclined to be interviewed by the NRC OIG due to concerns about a separate
ongoing investigation involving OSC.

FINDING AI J FOATtONS

There is no indication thatV||||||m|concem over the potential adverse effects caused
by the frequent transportation of the HDR device was considered or evaluated by
Region I in resolving the allegation.

i^LLEQAHQIi • 6

This section addresses whether NMSS is responsive to Regional requests for policy
guidance and technical assistance.

OTICIAI USE ONLY

201

OTCIAlllSEONir

As previously reported io Allegation #1, Region I submitted a request to NMSS seeking
pobcy guidance on a number of issues associated with the licensing of OSC. The Region
I request was forwarded to NMSS in January 1992, and bad not been responded to by
March 1993.

OIG attempted to determine if the lack of a timely response in the above case was an
isolated instance or if it was indicative of a widespread problem in this area. In pursuing
the above issue. OIG conducted a limited review of the systems in place to see if
Technical Assistance Requests (TARs) and similar requests for policy guidance from the
regions are effectively tracked within NMSS.

reported that a manual tracking system for all action items
Including TARs was initiated sometime in 1990. A computer based sysjgm was
develoged in 1991 and has been partially implemented in the branch. ^HfAsaid that
tbeHlJMMMBII^s responsible for logging in each TAR and assigning a sequential
number ijffHf^ turn, forwards the TAR to the appropriate section leader who
ultimately assigns the work to the staff member. The TAR is normally assigned to the
staff member who possesses expertise in the subject area in question. The staff rebes on
corporate memory to determine if the particular issue has been addressed in a previous
TAR or other related document.

According to^^l^Pthere is an informal goal for responding to TARs within 60 days
of receipt. This deadline is not followed closely, however, due to the complexity of
issues associated with many of the TARs and the requirement for study as well as
coordinatioD with otb^r jjffices. Seaion Leaders are responsible for the tracking of the
pendmg TARi flUIBIestimated that 100 to 200 TARs are received in IMAB on an
annual basis The current procedure calls for the TAR responses to be coordinated with
the Office of the General Counsel (OGC) which adds time to ine process flSBJ^
explained thai copies of the TAR responses are rouiineiv provided to all NRC Repons
(Exhibit 35)

^|P[9lflHBH0MiVflHlHHiflHMMilHKHt^MA£. stated that pendmg
TARs are discussed during general section meetings as well as with the individual staff
member assigned to work on a particular TAR flHBv^d that several times each
monlh^^ personally reviews a computer listmg oT pendin|T"ARs m^^sectjon. i$H|
typicaUy assigns a due date of 30 days following receipt of a TAR; bowever^|
acknowl^eed that deadline is not strictly followed ^^jadded that whenfjjP initially
assumed Imposition, TARs were logged but not tracked to completioa As a result,
some ite^Hiad been pending for as long as five years (Exhibit 24).

The Nuclear Material Safety Branch in each of the Regions was contacted and requested
to provide a listing of the pending TARs in their respective ofiBces as of March 1993.
IMAB was also requested to provide a list of the pending TARs being tiracked within tbe

nmciw n ONW

202

OfFICIAl USE ONLY

Branch at NRC Headquarters. A comparison of the Region submissions with the Branch
listing disclosed significant discrepancies.

The information provided by the Regions reflected a total of 62 pending TARs as of
March 1993. including several from 1990 and 1991. The IMAB computer listing
reflected only 30 pending TARs as of March 17, 1993. Eighteen TARs did not appear
on the list of pending TAR's but were being tracked in another action item list
maintained by the Branch. Some TARs appeared as pending on the IMAB list but were
not included on the Region submission. Approximately seven TARs reflected a 'dosed'
status on the IMAB listing but were being carried as pending issues by the Regions.
Exhibits 36 and 37 are a summary of the review conducted by the OIG regarding this
issue.

FI>fDING • AI 1 FnATIQN f,

There is no effective system in place within NMSS for the tracking of requests from
NRC Regions for policy guidance or technical assistance Some of the requests have
been pending since 1990. There is signi6cant disagreement between the Regions and
IMAB as to which TARs are, pending.

OmriAl USE ONIY

203

OFFICE OF THE INSPECTOR GENERAL
REPORT OF INVESTIGATION

IHADEQUATE INSPECTION AND M1SHAN0LIN€
OF ALLEGATIONS BY REGION I

CASE HO.r 91-076

THIS REPORT IS THE PROPERTY OF THE OFFICE OF THE INSPECTOR

GENERAL. IT HAY NOT BE PLACED IN THE PUBLIC DOCUHENT

ROOM WITHOUT WRITTEN PERMISSION.

FREEDOM OF IKrORKftTION/PRIVACY ACT EXEWTION <">M<** "' '•^'

204

TABUS or COVTEMTf

PAGE

SUBJECT 3

STATUTES AND REGULATIONS 4

SYNOPSIS 5

BACKGROUND 7

BASIS «

DETAILS 8

FINDINGS 19

LIST OF EXHIBITS 19

205

SUBJECT

206

4
STATUTES AND REGULATIONS

10 CF.R. Part 0.735-3
Responsibilities and Authorities

NRC Inspection Manual Chapter 2800
Materials Inspection Program

NRC Manual Chapter 0517
Management of Allegations

207

SYSOPSIS

This investigation wasjnitiatedbvjhe Office of the Inspgnor Genera] (OIG) based upon
allegations made by|H9mBBBHiil^H^HHHHBMof Nuclear
Energv Services (NES). a consultiag sejvices finn. that aS^pecaEew^e handling
and iranspon of radioactive material. ^|^||H|stated that on June 26. 1990. he
presented his concerns of radiological safety violations dL<<t)vered during ^

>'ES to HB^HE^^^fl^E^HBH^HB^^^M, Region I and2_

, legion I. Specifically,

_ Ireponed to Region 1 that KES did not have a"Radiation Safety Officer

(RSO), failed to post its license and NRC Fonn 3s (Nodce of Rights and Protection as
Licensee Employees) at the Danbury, Cotmecticui facility, and improperly stored
radioactive material. On July 24, 1990, a team from Region I conducted an inspection at
NES Headquarters, Danbury, Connecticut to address |B^^H|Hl|^concems. The
inspection determined there were no radjologicaj safe^ violations at NES. Upon
receiving this information, ij^^^^Hjpurported that the Region I inspection was
inadequate and incomplete.

The OIG investigation disclosed that^^S^Qm§allegatioQs as presented to Region
I were not fully and adequately examined. in the July 24. J990 inspection. Further, the
inspectors did not inierview witnesses toBIB^^^j^^BalJegations, other than the
president of MES and one other NES employee^Q^BBlBaclcnowIedged that

t provided names of witnesses who could corroborate his claims, however,

[did not contact those individuals. The OIG investigation also determined

lat ine inspection failed to address JISQUI^^^ concern regarding improperly
stored radioactive material.

The OIG investigation deiemuhed that the RcgionlinspeCTion report (No. 90-001)
provided limited findings due to the belief oHjI^^B^and the inspeaors that no licensed
activities had taken place at N'ES. There were issues which were not examined in detail
because the inspectors believed KES was not working under the authorization of its
license, but rather under the Ucc^^f clients for whom the) were shipping or handling
radioactive material. Neither{fl£mnor the inspectors made an attempt to
substantiate the NES claim that they were not performir,g licensed activities under the
NES license.

OIG obtained documents that verified NIES bad^^aa, performed services under the
auspices of its license contrary to the belief oOPHH^iand the inspectors. Some of
these documents were located in the NRC docket file on KES, at Region I. Two of the
documents which showed Jhauhe N^ES b'cense bad been activ^g^ted of
correspondence between(P^lB^°<^ NES. In addition,n^^|BB[jmentioned one
event in which NES had utilized its b'cense in his Allegation Interview Report, dated «
June 20. 1990.

208

A second inspection by Region I, conducted from Jaoua/y to June 1992, examined NES
Ucense activities as tbey related to radiation safety and coropUaoa with NRC regulations
and the license conditions. The second inspection revealed that the July 1990 inspection
incorrectly stated there had been no use of radioactive material under the NES license.
Further, it was disclosed that NES committed seven violations.

209

BACKGROUND

On August 30. 1985. the NRC issued NES a Ucense to possess specified quantities of by-
product materia] and source material. The license authorizes use of these materials for:
1) performing maintenance, repair and/or decontamination of tools, equipment, and
containers; 2) analyzing samples; 3) checking instnxments; and 4) packaging and
transporting of licensed materials. Use of the license is restriaed to temporary job sites
of the licensee an)'\*bere in the United Sutes where the NRC maintains jurisdiction for
regulating the use of licensed material. In addition, the Lccosee is restriaed from the
fwssession or use of licensed material at licensed customer facilities or licensed customer
temfX)rary job sites except as speciBcally authorized under that customer's license. The
licensee is required to notify NRC Region I, in writing, three days prior to the
establishment of a temporary job site and to submit surveys to the NRC prior to release
of the job site for unrestricted use.

210

BASIS

This iuvestigaljon was initiated by the Officej)f the Inspector Genera] (OIG) ^ased upon

information by^HHHU^HWHHHi^HH^^^HI^H Nuclear

Energ) Services (NES) to the OIG hotline in November 1990^^^H^^H advised
OIG that he bad reponed safety concerns, at NES to Region I via letterv telephone
conversations and a forma] meeting v>i\.

Region'! ■BSH^^tfTclated that an inspecuoD was conducted to address biT
concerns. W^B^BB^sHicgtd that the Region I inspection was inadequate and did
not compleTely address his allegations (Exhibit 1).

DETAILS

advised thai be reported to Region I three primary concerns discovered
lunngpig^B^^^N^S: 1) NES did not have a Radiation Safety Officer (RSO) for
approximately eight months; 2) NTS failed to post its license and KRC Form 3s, at the
NES Danbury facility, 3) N'ES had radioactive material stored in unsecured locations oe
at least two occasions resulting in exposure to untrained staff personnel.
beUeved these anions by NTS were in violation of the Ucense issued by the NTIC
(Exhibits 2. 3 and 4).

As a result of JB^E^HIB original allegations, an inspeaion >^-as conducted by
Region I on July 24, 1990. Subsequently, Jhb3bB^| received a letter and inspection
report (No. 90-001), dated Oaober 26, 1990, from Region I, which indicated that no
violations were found at KES (Exhibits 5 and 6). ^^I^^^^Hstated that he severely
questioned the conclusions of the inspection and its thoroughness. After reviewing
inspection repon no. 90^oHEBE^^BBB concluded that the N'RC ignored his safety
concerns. According to^^^^lSBvhis knowledge of NTS indicated a disregard of
safety procedures and f^C regulations.

I advised that be learned from a former NTS colleague that the July 24,
1990 Region Ilnspectio^wa^a "mosquito bit€*Jasiin^nly four hours. After receiving
this informationJ8i^8BI^^<elephoned/BiKl^B\to inquire about the inspeaion.
According to'jBM&jfe^l^^^8BByQ°^IP^^ that jbe inspection lasted four
hours. In addition[|9^g^B^Hn^3ted that(ll^^l^^]m^S5ed^ersof^ frustration
about the scope of the inspecuon. According to^^Hj^B^BM^^^H^^^'^*^ '^^^
NTS bad not conducted any regulated activities under its license, therefore the scope of
the KRC inspection was limited. ^B^B^JB^not^ that thej^egion I inspection
report contained a similar statement as that made by)H|B[m The inspection report
stated: The bcensee has not performed any services nor has it possessed any licensablc
radioactive material under this L'cense."

211

[staled that be disagreed with the .inspection repon coDCcming the lack of
activity by NES under its bcense. fHHHBlprovided three letters dated February
28, 1989. May 31. 1989, and March 27. 1990. respectively as examples of correspoDdence
between NES and the NRC documenting that the NES license h^d been active (Exhibits
T^^n^^He added that two of the letters were addressed toBBBM|
P^^HHHBicn'ph^ized that the NES violations covered approximately five years and
was during a period that he believed the NES bcense was active.

ihat the July 1990 inspection repon did not address his ptimary
^ocemsr^^^BV^i3d^c<^ ^3t ^"^ ^"^ without an RSO from September 1989
to April 1^0. He related that during the period when NES had oo RSO, radioactive
materials were received by NES and improperly storej. in an acco""iing safe used to
store payroll and employment records. According to ^[^I^^SHIthe NES Ucense
requires that any radioactive tnaterials received by N'ES at the Danbury facijLty be

l^tated that since the previou5iQ|H^

verified bv the RSO. Further

[■acate

>.%

sition with NES. time hadj.apsed before
as appoLDied_^B^BBiMaddeji thalf
was improperly appointed by |Ji^^^^@B^^H^9PllHB\for NES. He
explained that the NES policy and procedures manual, approved by the NRC, required
that the RSO be appointed by the Radiation Safety Committee.

maintained that the NRC inspection report did not cite NTES with a
jlaiio^o^ie period NES did not have an RSO or for the improper appointmemof
I The inspection repon stated that: "During the perioij of time that^|
Vacated the position and^^^^^^^Hassumed the duties there was no work
be ing conduaed under this lice ose/^^HI^^HBIreite rated the NES license was
active during this timeframe and he stated that the Itegion I inspectors appeared to
accept NES ansv^ers without questiotL

With regard to his allegation, that NES failed to post NRC Form 3s and its license,

^idvised that Seaion 2.5 of the repon sj;ated: Inspectors saw the
required notices, such as Form NRC-3, were posted.* |pESBE9B explained that he
leA^g^NESposted the required forms after he was fired on May 2iri990. According
toJ^BH^KPAhe notified ^SHBBIS^S^HBK^HI^^^I^HH
^^■^■^HfRigion I by letter that NTS posted the required forms after his
termination and prior to the July inspection (Exhibit 10). Additionally, 'J
offered to provide names of witnesses who could corroborate his sutement that the
forms were not posted prior to his iiptiMn^JE^bat they were in violation of their
license requirements. According to^l^m^^l Region I did not contact him to
obtain the witnesses' names. """^

jstated that the allegation that radioactive material »-as beinf

unsecured locations seemed to be completely ignored by Region L

advised that NES* own procedure, approved by the NRC, stated that all calibration'

212

jources which xoutinely are less thao Uc«nsc limits must be stored is a controDed area.
(^dmHj^^aid that one^mplove^ouod at least a gallon of radioactive material in
ibe parking lot In addition, ||BHHiQir^<l ^^t he found wba^ppeare^o be four
calibration sources in an uncontrolled accounting safe. Funher.^HIHI^Hl^dvised
tbatQPH^^employee discovered the radioactive material in the accouotiiig safe.
Section 2.2 of the in5f>eaion report stated: Tbe licensee's evaluation of this incident
concluded that the sources were exempt from Ucensing. No violations were identified.*

Region
contacted ReeioD I with

^4.^

1 recalled thai approximately two years
allegations against NES. At that ume

^ being informed of Jj^E^^^^^^BI concemsiPI|accepted
offer to meet and discuss the allegations. After listening to

1 concerns. l^BlHsaid thattti immediately assessed that there were no

bealih and safety concerns present (EjJiibits 11 and 12).

jstated that as a result of^i^^^^^^^ allegations and the fact that NES bad
loot been impeded for sometime,,an iiispection was scheduled at the NES headquarters
office in Danbury, Connenicuu (g^^Bsaid tbatfciwaslargely responsible forjhe
decisions made concerning the handling of feM^^^B^M allegations.

allegations and to veri^ whether or not NT^ was acting in accordance with all license
requirements.

ar)d9B8BBi|^conducted an inspection on July 24,
}s?d ^ be unannounced. However,^P|IP|B|beIieved that
3ma\ have surmised that an JisBection ^-as forthcoming
'as there were telephone contacts witbQmHMt^ after receipt of^BHJHVttV
allegations. The purpose of these comans was to establish whether there »-as recent
activity by NES under its Lcense. pl^P^nformed that the inspectors did not tell
^felMWethe reason for the inspectiotL According lo^^j^j^f^ "What we did y>-is
essentially did the inspection to verify to a reasonable extent, to a reasonable ability,
whether or not there was any substance to those allegations and close (them] out*
(Exhibit 11 Pg. 37).

iMWBVjstated thatsometime during the inspectio^^JEflMHl^andBBiSliVc^^^
iMjgfor advice. ^PHRdid not recall the specifics of the conversation, bowever{Hp
remembered providing direction to the inspeaors concerning N'ES' Ucensed activity,
^mmi^told the inspectors to continue conducting a routine inspection andverify that
NES had not performed any acuviiies under the Ucense. According to^|HMVthe
inspectors were instructed to verify whether or not there had been any licensejj_activity
by NES through an examination of records and by talking to the NES staff. MBMlit
maintained that^j|was not aware of any documentation which indicated Ucensed

213

activities took pTace at ibe NES Daijbun,' faciLty. MHUDdid not recall reviewing ihc
NRC Region I docket fiJc on NES. ^Wadded tbalMdid oo( personally check the NES
records because that was the responsjblDty of the inspectors.

^ advised that the inspectors objervgdtbeNK facility, reviewed NES files and

spoke with NTS employees regardingV^nHnnJconcerns. AccordinEtoj
the inspeaion did not reveal any evidence of NTS' license being active. iWii^
acknowledged thai^HjftBSHVprovided names of uiinesses to support his
allegations, boweveJ^^plUEdid not know if those individuals were conucted by the
inspectors. ^$0Bstated that the inspectors determined that while NES bad a bcense
and it provided for possession, use and b-iidling of radioactive material, NES never
really exercised the Lcense. Further, the inspectors purported that any work NTS did
involving radioactive material was done under the auspices of clients' licenses.
Consequently, no radiological health and sa^tyji^equades were found. These findings
were documented in the Lnspeaion report. Mp|^ maintained that ^^AflMHllltfV^
concerns were not valid since NES had not performed any work under the auspices oTits
own license.

5j(||P_<mphasi2ed that the pnmaA^focus of the in5peciioD was on immediate health
and safeiv issues and thai ^^{|S@MMtti|b concerns did not fall into this category. The
inspection report reOected^at since no bcensed aciiviiies were performed at the NES
DanbuA facility, there was no need for NXS to establish an RSQor to post NRC Form
3s. ^SBi^^dvised that the radioactive materiaJ^ESBMMWMii^identiGed as
improperly stored was determined to be exempt from bcensing. 300^d that the
inspcaors reported that the sources in the accounting safe were not bcensable quantities
of radioactive material.

Id further re^nse to;VWBi@PIMr allegation that Form 3s were not being posted at
N'ES.^HMfBstated that Form 3s, b,> regulation, a^e required to be posted at the job
site where bcensed aaivities taJce place. HoweverJ||rtfvplained no bcensed activities
took place at ibe KES Danbury site, therefore Form^ were not required to be posted.
Title 10 Code of Federal Regulations 19.11, "Posting of notices to workers," states in
paragraph (d), "Documents, notices, or forms pwsted pursuant to this section shall appear
in a sufCdent number of places to permit individuals engaged in bcensed activities to
observe them on the way to or from any particular bcensed activity locauon to which the
document appUes, shall be conspicuous, and shall be replaced if defaced or altered*
(Exhibit 13). ^^HHVJinterpreted this to mean that Form 3s were only required at the
place of work where bcensed activities were being performed.

||H|i^3cknow]ed£ed that the inspection report indicated Form 3s were posted as
rcquirea However^jjflbebeved that the statement in the report was erroneous because
Form 3s were not required. Accordincto 3BHH the inspectors observed R^nn 3s
posted at the Danbury facibty. ^fH/Kli^ opined that some time after fll^BPMttp
made allegations and before the July inspection, the Form 3s were probably posted.

214

HoweverniiylexplaiDed that: There were no licensed activities taking place at that
locatioD so it was not required by regulauoos so the fan that Pons 3s were posted there
is iDcidentaJ" (Exhibit 1 1 Pg. 20).

gatioQS were completely and

^__ ^said that infl|\view,j_

adequately addresseoiD the July 1990 inspectioD. ^pHHfelcoDcl-jded that the inspection
findings were accurate sinceQ|||^was npt awar_e of any documeniadon indicating NES bad
performed work utilizing its license, mt/ttt^^^^^^ ^^' ^^ inspection report was
factual ancq^ concurred with the findings.

OIG sbowednSPI^opies of three letters regarding NES aoivities during the period
covered by the uispeciion. The letters, dated February 28, 19S9. May 31, 1989 and
March 27, 1990, were purported byJHi^MBHlko show NES bad performed various
acu'vitJes under the auspices of their license (Exhibits 7, 8 and 9). After reviewing the
I^<*^^ SBd^^'^'^^^^^^^ °*^' ^^° aware of their existence.

With respect to the February 28, 1989 lettcr,^WH||\said ibaiJUdid not bebevg the ^
letter indicated thcNES bceo^uas aajvc. ilSe Mji)^31, 1989 letter was from^BHP'

ma?e it appear that activity authorized by tbe f^ES license had occurred. However,
f^lmiM^tated the letter j^d not reference what type of work occurred or which NES job
sue was involved. nSHMP^tated that the a/oresaid was also t-Oie of the March 27, 1990
letter by'^j^^f^SSf^lf^i^i tha^^^^L'eved the letter referred to work NES
perfonneT under a cLent s license. However, ^S^Blrelated that the letter did not
state what type of activity required NES to possess radioactive c-aterial or the job site
where the material was located.

occurred mder the N'ES license
«Tis signjtjcant to me mspecuon process ijigjexplained that if uo.'k referenced in the
May 1989 and March 1990 letters was performed at tbe NES Dijbury facihty then the
inspectors should have uncovered tbe activities. Vp£Sl{^lie>ed that the work most
likely was performed at an NTS off-site facility.

fl^informed that the job site in which activities
significant to tbe inspection process [J(jjexplaine

OIG discussed the three letters wit

were all standard forms written by e
authorized by tbe NRC Ucense (Exhibit 14).

elated that the letters
refcrencag recent NES activities

Regarding the February 28, ^89Jeller,|j|^glB^stated that the details of this letter
were somewhat ambiguous. Sf0(tliHKS^^O'*f]edgcd that tbe phrase '...please be
advised that Nuclear Energy Services will use it's Ucense to ship one (1) Co-60 Irradiator
within the Model No. NES-5 Shipping Cask, Certificate of Compliance No. 9193," gives
the appearance that work was performed under the bcense. Howeverjjjjexplained that
the licensed activity could have taken place at another facility, Arthur dTij 11 iJE

215

(ADL), ^AcoraP^ Cambridge Massachusetts, which also has a bcense for such
activity. "QfBBBMIPlstated that the work Krformed could have been conducted under
either the KES license or the ADL hcensc. '^tfHHli^tated that further review of
the actual activity was necessary in order to know whose license was used.

In discussing the May 31, 1989 Ictte^
letter were not clear. According t
activity occurred at NES.

isaid that the activities outlined in the
the letter does not state if any Ucensed

^iJteBBipt^dyiseo t^^at the MarcbJ7^990. letter was the result of a telephone

respect to tbe details of the March ietterT^SCN^mi^tated the letter indicates the
NES license was active. He noted that KES indicated they were in possession of
radioactive materials as of the date of the telephone call.

OIG obtained tbe technical services agreement between ADL, the company referenced
in tbe February 2&, 1989 letter, and KES (Exhibit 15). The February 1989 agreement
indicated KES would provide con.<;ulliDg, licensing support, technical and cask rental
services as requested by ADL Section 2.7, NES' BY-PRODUCT MATERIALS
LICENSE USAGE of the agreement stated: "KES will acuvate its License No. 06-20775-
01 in accordance wth license condition No. 17, and uill perform the required shipment
brokerage services under the subject bcense.' Further, Section 2.7, FIXED PRICE:
License Usage Fee: $12,500.00, stated: 'Above fee is inclusive of all costs associated with
the activation, notification and upkeep procedures of NES' By-Product materials bcense.'

for ADL, recalled tbe period when KES performed the
foremenlioDcd work for ADL |g||0mKArelated that at the time, ADL did not have
an approved Quality Assurance (QA) program ai;ihoriiing them to handle the Co-60
irradiator shipment. According xojSfttfti^ SES ^hjd an N'RC approved QA program
so they were used to ship the Co-60 inadiator. ^|9HHB!maintained that a spedal
condition and expense was placed in the N^ES proposal to ADL because of ADL's
shipping restriction (Exhibit 16).

OIG obtained the 'Chronology of communjcations

from
on I

docuroe

^^^_^_^ conCnning that work done under tbe NT5 bcense at the

.^'ewburgh Heights, Ohio site (Cheroetron) would not involve open containers of
material. Tbe May 10, 1989 letter referred to in the May 31st letter was frorqjl

JlBtilliMlJIt'uIJJWIi^i'' Ii0"l ^^^ ^^ ^^^' '^'^°' '° utilize its bcense at the
Chemetron site in Newburgh Heights, Ohio (Exhibit 18). Exhibit 19 is the tele^one
inquiry referred to in tbe May 31, 1989 letter. The telephone call was made by

^gfUJli^jKi^NES, to an unknown KRC inspector regarding two uses of the NES
license.

216

[Region 1, recalled rnaking the telephone inquiiy to NES referenced in the March
27, 1990 letter. In^pMi^view the NES license was active and believed the letter
verifies that NES used its license. Q|f}explained that if the information contained in the
letter was incorrect, NES would have written back to NRC Region I correcting the
information (Exhibit 20).

^egion_I advised that be initially receiyed
> allegations cooceming NES. /HftmriBdocumemed W&JHtttttKf
formation in an 'Allegation Interview Report' (Erhibit 21). ^Hrecalled

leged that NES was in^violation of several NRC codes and reeulaUons,
some for tbepast five years^S^HSMEinunediately informedf^supervisor jj[^
•dHp^of the allegations. WBIP^Sj^A-as directed to fonn an allegation panel to
discuss bowRegion I was joing to proceed regarding the allegations. During this period,
Imm^liiSSSt met wtbjJpHBBP^and jWBBRand documented his concerns in a
formal presentation. According to^H^Bmigtbe panel dedded that an inspection of
NTS was needed to pursue any health and safety issues (Exhibit 22).

IfMMIIi^SM^statedthat in preparation for the inspection[j|^eviewed the NRC docket file
Tor~NES. ^jlSSIMi^sdvised that the file revealed that KLS bad not be^n inspected in
several years, although NES was due for inspection on an annual basis.^p|[iiii^P
explained that NES bad not been inspecte<^ecau5e they had not performed any work
under the auspices of the license. ^BwRHft'^c'^lcd that the file contained a few
letters docu men ti ng projects N'ES conducted utilizing the licenses of others.
Consequently, ffi^HM^^pproacbed the inspection believing that the NES license was
not active.

In July 1990,M3QB||^a£dj|^SB||jl}conducted an inspection of the NES Danbury,
Connggjcut facility. WWWBP^'^ted that upon a/riving at the NTS facility they spoke

information during the inspection. ^^BBB)oldtbe inspectors that NES had not
performed any work under their license, instead NES had worked under the auspices of
their clients' licenses.

^stated that the inspection ended relatively soon after receiving confirmation
rom 9RB^pthat NES did not have to adhere tojhe^nditiotis of its hoense^if no work
had been performed under the Ucense. I nJMMWB^g^'^WWWPBj^ concerns
bad been fully examined within the context of the inspectioa However^HMMMdid
001 rccalls^aMng to anyone who had been with NES five years ae^o confinn
ipJiflSBlfiil' ^legations, {jll^iiiii^acknowjedged that ^iKBUfcjIJiftjrovided
witnesses who could corroborate his claims, but|j|^plSMH^id not contact those
individuals.

217

>riefedgB||||§oo their inspectioo Gcdiogs. Accordinf to
recommended that NES' clients be contacted to confirm
that NES ba? workedlTnder iKe clients' bcenses. However, there wa^jo effort made by
SRC maiiagement to contact NES' clients nor was it suggested thaijSMMIlBMlflk
sbouJd do so. ^QHpHB|advised tbai|H||HMW|lland^BlB|rwere m agreement
with the inspection Gndings and that 4fiBHNH|^B|c^ais coul3 not be supported,
^jjfjstated that based on the conversations vkitb^^SHH^ a re\'iew of the NES records,
^d the^fact that NES bad not conducted work under the auspices of its license,
"l^cgstions could not be substantiated.

jacknowledped tbat||0concurTed uitb Region I ma£a|ement's
reconimendatioD not to make the RSO allegation a violation, ^^ppined that this
decision was due to the section being over-worked and understaffed, the lack of any
health and safety signiCcance and th^natler being identified by the licensee.
lf^||||SMi&t3ted that in reuospec^P^should have documented NES^ lack of an RSO as
a violation because the issue arose as an allegation.

^^^gfl^^''P^^^^^3^^^M^Kf^^^'°° ^ ^ '^ interviewed. flBHRH^'d
ma^Bilbecame aware ofHB^gl^J^Kllegations from attending the allegation
panel n^eetineJB^necall^d the allegation panel dedded that an inspection u-as needed
to address SBaiHI^ft concerns. jfJ^Pflvpoted that a full inspection was
recommended since there wereotber elements to be examined in addition to

Lconcerns. ^HV^'ecalled revies^-ing the docket file on NTS prior to the
inspecuon.'^B^^^wJid not recall seeing any documents in the file indicating that the
N'ES license was actjvc (Exhibits 23, 24 and 25).

mStf^>stated that upon arriving at NES.y^and^^SHiiiC^P^^^ '°j

/^gj§Hconfronied tbc irtspectors stating: "l know why you are here.*

rboLc^hat the inspection u as difficult to conduct because many documentsrequested
were not located at N'ES, and few KES employees were present. Further^fllPPMft
indicated that N'ES bad not uu'Iized its Ucense.

^ > recalled that the NTS records initially reviewed (jurin^tbejnspection

"mdicated the NES Lcense bad not been utilized. However.^JPBPJB subsequently
found som^ N'ES (Jpcuments that indicated NTES had performed work in NRCs Region
ID area. MSW noted that the NES work performed in the Regonig^area was
comjuaedunder the auspices of NTS* client's license. In addition, l|0iPllB*as told
by JMMWwDthat tbc work conducted by N'ES was under the auspices of their client's
Ucense and therefore NES did not have to adhere to its wj^iccnse requirements.
^ Imaintained thaflj|]:ontactedjJsj^ervisoJp^B^ of

_JstatemenL According to^^HH^^^KtatedtbatlMM^was

"correct.

218

ud tLat wbeDr|||^d|pflHH^ere advised NES did not have to adhere
to its hcenic requirements, they basicaUy termioated the inspectioa. ^HMH^
acknowledged that there were a nuiDber of issues which were oot examined is detail
tbey believed NES was not worldng under the authorization of its license.

?Dclujied that the NES license bad not been active ^)ased primarily on
Hscussions wiibjiBlHMMfiflKBiC'saicnMwasnotaware SCHMHflcPi'Ovided
names of witnesses to suppon his al]egatioas!^S|[[0|^6aid tbat^H^v^ aware of the
alleged incident involving radioactive material m the parking lot, however^AVJ^id not
recal] reviewing this matter during the inspection.

With regard toiPHBQHBH^allegation of improper storage.iQHIBQst^tc^' ^^^^
ie sources found injhc accounting safe were exempted quantidel. According to

provided the information about the caL'bration sources, which led
\o conclude that the sources were exempt from the NRC licei^e requirements.

^elated that survey meters were used to check the area where the^ radioactive
rnaTeriaJ was stored and nothing was found in the sturounding area. ^^MA^dded
thadtl^did not beb'eve there wercanyradiological problems at the ume.
^flllWy"'^ ihaiMl^nd l^^jJMBsubsejquently brie fe^lBBftoP the l^fES

inspeaioQ. According to ^BBBMQIi^ aj)d^|HMMlHR''^0'™<^<^^9lil^^' ^^^^
had performed work under their chentsMj^censes, most of which were located in NRCs
Region IH area. ^^||B0H|( advised ^HHeof the limited inspection due to the NES
license not being active and recommendedhaving a Region III inspcclor confinn NES'
work under their clients' licenses. ^flBHJBadded that to the best of^^[)aiowledge
the recommendation was not acted upon.

[had frequent telephone conversations with
(advised that duri.-:g the period -li^

allegations were

stated

(^^ ..^_^ . -, ^Region

I maintained thai

concerning NES

madeiras '^ _

thatPpimme lately exarm'ned^ allegations to discern whether there

were any safety implications, anc^ ibelieved there >kere nooci^PSSS&MIKmKltttf^

decided with other Region I oEDdals that an on-site inspection was appropriate, however

the inspection was of low priority due to the low safety concern (Exhibit 26).

explained that the inspection was limited because NES had not
jssessed sufficient quantities of radioactiveroaterial during the timeframe of
^^tfiMM0| allegations. fBHHiiMlbeb'eved that NES had not performed
any activities under its Ucense, except for asmall shipment of materials to the Um'versity
of Cincinnati. According to^jBHMlHlMW^ there was no reason to doubt the
inspectors' observations and findings, thus(|P^as satisfied with the conclusions of the
iiispediori. jHHRiiBlliSH said that the main concern of the inspection was to ^^^^^
determine whether there was any safety significance. ^HHMVBHMIV said that ii^Sttk
opimontbcallegations had no safety significance and Region 1 bad be?n responsive ta
liOSlfeilW^ncerns.

tjhej[u|y 1990 inspection of NES was cooducted to addrcsslj^ ^

^Sf//t^bc\ieve<i the inspection w-as sufBcicnt and noted it did not detect

' suted thai
allegations
any health and safety violations (Exhibit 27).

flPpiil^dvised that great emphasis was placed on the observatioos of the inspectors
diiring the July 1990 inspection. ipFyelated that the inspector wTgtcJheir findings
based on their observations and DRSS management concurred M|||||pjbelieved the

jg July 1990 inspection were

done again, given the same circumstances and^itfMMilkiMrallegations^jHwouId be
satisSed with the manner in which the inspecuon was conducted! Hojveverl^^
said: 1 would have liked a more thorough inspection.'

jpined that a mo£e thorough inspection w-a^ecdc^^esplve a couple of
issues. "One of the is&ues^||S|f|^eferred to w-aslHHHBI^Vallegation that NES
had not posted Form 3s for the past five years. |^^^Ktate^||would have liked the
inspectors to pursue the issue further. HoweveriaHii(said|J^believed the concern of
whether or not the Form 3s were posted at NES in the past was an integrity issue and if
the Form 3s were not posted in the past it would not necessarDy be a violation.

Wf/ISHfad\TScd that a second inspeaion at NTS begaii in January 1992.
mat the January inspection was prompted by conere^onal interest inH

tated

January inspection was prompted by congessjonal ii
original allegations against NES. According tQjBB^BB(«B^^^ Region I management
rlieved a second^ inspection was needed to ?.i<^er quesoons posed by Congress and

^ JaHH^H ihati^j^Vanied this JJanuary^l992] inspecuon to be as
thorough as possible to address any future problems l^^Pi0SHH|may bring up*.

Region I, stated that in

ations against SES.

d in the matter regarding ^^^^^^B^P allegations due
that congressional intefest caused
issues in a more in-depth manner

of 1991

^became inv
^o congressional interest.
Region I to examine NTS and
(Exhibit 28).

?rovided OIG with a briefing regarding the January 1992 inspection
conclusions. ^ilH^BBifel3tc>J that a major finding of the Januarii inspection jvas
that b'censed activities were discovered to have taken place at SES. HIBlHiM&^'d
that the statement contained in the July 1990 inspection report, "The licensee has not
performed any services nor has it possessed any licensable radioactive material under
this license* was a 'major mis-statement' ^^HMMw^dded that the July 1990
inspection was limited in scope because the inspectors reported no Ucensed acu'vities bad
taken place at NTS.^d^ncIuded that the inaccurate sutcment set the tone for the
rest of the conclusions of the inspection.

220

^^ acknowledged that some of the issues alleged b>wHHHMVM>>t were

not ideDtified as violations in the pn\ inspe^on were found to De violations in the
second inspection. According to^lHHMHl^tbe January 1992 inspection at NES
revealed seven violations. One of the violations disclosed ^^-as the lack of an RSO at
NES for a period of time.

taied that ^ftlUJSfltl/SKfi allegation that Pons 3s were not posted a^
NES in "the past was neither confirmed nor dtnied by the January 1992 inspeclioa Jfi^
informed that the NES staff interviewed by Region I related differing stories about the
posting of Form 3s. TTierefore, the January 1992 inspection did not find conclusive
evidence to substantiate whether or not Form 3s were posted at NES. in the past

wa^ been that^PKMBKHHallegations
tijipu-as concerned with the adequacy of the

jadvised tbat(pBjConcero has alwa
"were not fully examined. Jjj^Taaintained tba

July 1990 inspection. i|pi^Bii0P[jStated that the inspectors took a 'snapshot* of NES
on the day of the inspection, therefore they could not have addressed
concerns regarding past incidents.

Although ISiSii&MBsaic^llBhelieved the July 1990 inspection was not thorou^t
believed tK"e J^e^on l.jUjT followed the proper procedures in handling |_
allegations. iB^BttM^lated that the staff complied with Manual Chapter 0517,
'Management of Allegations.'

^oduaed the January 1992 inspeaion at NES^pl^BH related thatQI^was not
involved with the July 1990 inspection and had no knowledge of it until assigned to
conductlbe second inspection. Upon being assigned theJaiiuary 1992 inspection,
MHSMHllto^e viewed the NRC docket file on NES. SHHSooted there were a few

oacumenL' that indicated N^ES had conduaed work under the auspices of its license
(Exhibit 29).

^^I^BI^stated that the major difference between the July 1990 inspection andthe
tranuajy 1992 inspection w as bow NES license requirements were interpreted. QHl -^
opined that the July i^pection oversimplified the license requirements in the 'Scope of
Activiues Seclioa''fij^maintainedlhanhc NRC approved license provisions were
complicated and very restrictive. "^OSllPiliadded that it was ^t plain error that they
thought the Lcense hadn't been used.'

The second inspection of the activities of NES License No. 06-20775-01 was conduaed
rom January 9 until June 11, 1992. The inspection consisted of observations by

'_ ^ interviews with N^ES personnel, and a review of selerted NES records. The

inspection report (No. 92-001) concluded: 'Based on the results of the January
inspection, it appears that your activities have not been conducted in full compb'ance ^
with NRC requirements.' The report identified seven violations at NES. One of the

221

violauons dted was a failure of NES to have an NRC approved RSO from September 2,
1989 until June 9, 1990. In addition. NES was cited because ibe Radiation Safety
Committee did not review all NES activities. Specifically, the committee did not review
the ADL project in Cambridge. Massachusetts and the Chemetron project in Newburgh
Heights, Ohio, prior to initiation of licensed activities (Exhibit 30).

FINDINGS

The OIG investigation disclosed that j9WM|MN|)al]egations as presented to Region
I were not fully and adequately cj^ned in the July 24, 1990 inspectioa The inspection
did not consider JMiSMB^lWl^egatio^ as they related to the past The msoection
did not consider >^itnessestol|MBHHMMKallegations^otber thaivSHSMdid one
other >fES employee. IplKHSackDowIedged tbaiJ|UgB|0MH|lfprovided a list of
witnesses who could corroborate bis claims, bowever.ffipHlMdid not contact those
individuals.

The inspection neglected to address |0MHI|^3PHB concern of improperly stored
material. The inspection did not veri^ whether or not the radioactive sources stored in
the NES accounting safe were exempt quanu'ties. The inspection concluded the sources
were exempted from licensing based solely on the licensee's evaluation of the inddent

OIG obtained documents indicating that NES had performed services under the auspices
of its license. These are documents which were located in the NRC Region I docket file
that the inspectors stated ihe^ad reviewed. T*vo of these documents were
correspondence between^PPQ|Kmd NES.

The January 1992 inspection disclosed that the July 1990 inspection incorrectly stated
"laj^therejbad t'^fo nouse of radioactive material under the NES bcense. ^tHKHt^

indnttMHIl! thought that since NES did not possess radioactivcmaterial
under its L'censel^'TES did not have to fulfill all bcense requirements. ^MHHbi
maintained that fMBBWBWM^coocerns were not valid since NES had not performed
any work under the auspices of its license. ^HRBMi'acknowledged that there were a
number of issues which were not examined in detail because NES was not working under
the authorizatioo of its bcense.

JThe Re^onlinspection at NES in July 1990 did not adequately address
|flHHnMMH9allegations. This failure was due to inaccurate assumpdons by Region I
managers and inspectors as to the stattis of the NES bcense. Documents contained in
the Region I docket file on NES contradicted the assurances made by the NES President
to NRC inspectors.

C/S

222

223

omcwiosfOHiv

OFFICE OF THE INSPECTOR GENERAL
REPORT OF INVESTIGATION

CONFLICT OF INTEREST INVOLVIW HK EMPLOYEES
AND NUCLEAR ENERGY SERVICES

CASE NO. 91-72A

THIS REPORT IS THE PROPERTY OF THE OFFICE OF THE INSPECTOR

GENERAL. IT HAY NOT BE PUCED IK THE PUBLIC DOCUMENT

ROOM WITHOUT WRITTEN PERMISSION.

FREEDOM OF INFORMATION/PRIVACY ACT EXEMPTION (s) (5) (6) (7) (C)

OFFICIAL USE OlY

224

OmCIAl KE ONLY

TABLE OF CONTENTS

PAGE

SUBJECTS 2

STATUTES AND RE6UUTI0NS 3

EXECUTIVE SUMMARY 4

BACKGROUND S

BASIS «

DETAILS/ALLEGATION I 6

FINDINGS/ALLEGATION I 23

DETAILS/ALLEGATION II 24

FINDINGS/ALLEGATION II 31

EXHIBITS 32

225

OmClftl U3E CIILV

SUBJECTS

.- r-- •• *t

226

OmCIAl USE ONLY ]

STATirrES AND REGUIATIONS

18 use 208
Conflict of Interest

10 CFR. Part O
Conduct of Employees

5 CFR, Part 2635.702
Government Ethics

Execuiive Order No. 11222
Section 201 (c) (2). Part D
Standards of Conduct

NRC Inspection Manual Chapter 1201
Conduct of Employees

nrnrifti mi ONIY

227

e?R?!Ai u?E c:ay

EXECUTIVE SUMMARY

This iovestigation by the OCEice of the Inspector General (OIG). U.S. Nuclear Regulatory
Conunission (SRC) was irujiated based upon inforraatioo provided by^|||pl

"3^^"^'**^ Energ» Services. Nuclear Energy
Services (NES) is a broad-based engineering and technical suppwrt service contractor is
the nuclear industr\ AjHWHl^sdvised OIG that during the period he worked for
NES. the IBHMHH'^^ expresseB^ having received business referrals from NRCs
Region I^^MBjM|beUeved that NES|$|i|««BHHM^MMpMbad
developed a^endship witF^members of the Region ID stafi. 6^//fMSS\^cgtd
that there was an improper relationship between NES and Region ID stafL

The OIG investigation revealed that Region III
recommended NES to three licensees: Case Western Reserve Univera
Clinic, and the University of Cincinnati. OIG obtained evidence tbatfll
recommended solely NES to the University of Cincinnati.

Lafayetti

The investigation disclosed lhat(jB|0MHQ|maintained continuous and substantial
contact with NES, consequently establishing a familiar relationship with certain NES
managers.

The investigation disclosed that most Region HI inspectors routinely referred the names
of certain consultants to licensees. Region UI management was knowledgeable and
encouraged this practice by instructing the regional staff to provide at least three
recommendations as an unoCBcial policy.

The investigation disclosed that there was not an established system in place for the
manner of referring consultanu to bcensees. There was no oniform list o( consultants
and most inspectors apparently relied on their own opinions. In addition, there were oo
criteria or guidance for making a judgement on what constituted a competent consultant.
Further, there was no indication that Region III managers or inspectors considered
whether the praaice of recommending consultants might compromise the NRCs ability
to conduct inspections of the work such consultants performed

^ on jcparate OQ^ions

Wli,\dined with

Further, the investigatipCLrevealed , ._ . _

' ^ odljMHniflHBBUdiQed with^PlPI^ The

employees suted that momes were given for thei^ortion of the meals, however, the
employees* testimonies were not consistent wiih99|||^ Weekly Business and E;q>ense
Reports submitted to NES for meals with the respective employees.

The investigation did

while

at develop sufBdent evidence to determine whether I

^Office of Nuclear Materials Safety and Safeguards, dined with
"I was an NES employee.

r— ;-.••! {"C r'!iy

228

OmCIALUSEOHlY

BACKGROUND

Nuclear Energy Services (NES) was developed by[^l|BHBMB^2iii 1973 as a broad-
based engineering and technical suppon service contraaor to the Dudear industry. NES
is beadquanered m Danbury. Connecticut, with another oCBce in Boston, Massachusetts.
NTS is a subsidiary of Penn Central Corporation located in Cincinnati, Ohio. Presently,
NES has approximately 150 full-time employees. NTS provides engineering and
technical suppon services to nuclear utilities. Further, NES is involved in consulting
services for radiological waste management and other NRC Uceosees.

In addition, NES maintains an NRC license to possess specified quantities of by-product
materia] and source material. In 198S, the NRC issued NES a license authorizing use of
materials for: (1) performing maintenance repair and/or decontamination <^ tods,
equipment, and containers; (2) analyzing samples; (3) checking instruments; and (4)
packaging and transporting of licensed materials. Use of the license is restricted to
temporary job sites of the bcensce anywhere in the United States where the NRC
maintains jurisdiction for regulating the use of licensed material

OFRCISl USE ONLY

229

OFFICIAL USE ONLY

BASIS

This investigation by the OfBce of the Inspccior General (OIG). U.S. Nuclear Reeulatorv
ComxTUSsiOD (NRC), wasjnitiaied based upon information provided by MMB
^MM^MHaHMMMBBaa^Nuclear EnerpServices. Nuclear Energy
Services (NES) is a consulting firm to many NRC Uc^nsees. MBtHMfladvised
OIG that during the period be worked for NES. ihe[J||^j|^NES auSj to
receiving referrals from NRCs Region ID fMBMBISaUeged that there was an
improper relationship between NES and the Region ID staff.

DETAILS/ALLEGATION I

,]4MPVHBHMHi(HlM0BHttiM||^^''^'^^ Energy Services, advised that
there was an iipproper relationship between Region ID staff aod NES rcprescnutives.

on at least two occasions during the period 1989-1990, NES

_ — ^jdiscussed at monthly managemeni meetings surprise awards

"to the Plant Servicgs Unit that were initiated by referrals from the Region 10 staff. On
the two occasions. |MCBVMW>«lJeved the referrals cooceroed two NRC bcensees in

Ohio^jTase Wesiera Reserve University and the University of ClocinoatL

^■■^^■'^'■^B '■*c^*<^ 1^3' *' ooe meeting (J0|p0||p| stated.

_ God for

fEC^andma

maintained thatMp4lll|^Qever mentioned the namefs) of the NRC/Region ID staff
members who referred business to NES. ^i||fl4d|B added that^MMtWi
MBOMfetfOSMi^at tbe tuDC> was the contact between NES and Region ID
(Exhibit 1 ).

mends at the NgC* and made the sign of ibc cross aficrvards.

lJB0MSA|J suted that he did not have any docixmentation to sup^rt his belief of a
'cozy relationship* between NES reprcscnutives and the Region ID staff. However,
iHUMMl^beLeved that internal NES correspondence produced during the period
^989-1990 contained information addressing this relationship ber*een NES and Region
QI. Specificai]y.^jyiWimm suggested that OIG examine: (I) notes from the
monthly staff meetings; (2) |pfl)HBi|j monthly reports to NET parent company; (3) the
weekly marketing contact rego'rts; and (4) the Sales Marketing Pan for the October-
November 1989 timeframe. JPBBm0ii^related that the Sales Marketing Plan
mentioned NES' close relationship with the Region ED staff aod bow NES hoped to
enhance it

RECORDS OBTAl>fED FROM NES:

In response to ao OIG subpoena, NES provided records pertaining to its business
activities during the period fi^om January 1988-Deccmber 1991. The foDowing
documents: (1) Plant Services Monthly Reports, dated June 2, 1988, September 28,
1988, December 1, 1988, February 7, 1989, April 20, 1989 and August 8, 1989 (Exhibits 2

230

•tf» *'^»

C."'V

thru 7); (2) Monthly Staff Meeting Minutes, dated September 1 1, 1989. March 14, 1989
and October 18, 1989 (Exhibiu 8 thru 10); and (3) Telephone log of calls made by
(■ijimivia his AT&T Long Distance credit card duho| the period of 1988 to 1991
(Exhibit II). indicate frequent contacts between NES and the Regioo ID staff. The
AT&T telephone log of iMUl^listed numerous calls to Region ID inspectors.

Terminology used in the Plant Services Monthly Reports and Monthh Meeting Minutes
implied a relationship between KES and Regiots Dl Certain NES monthly reporu and
meeting minutes contained phrases such as 'continue to foster relabonship with NRC
Region IH' and 'relations with NRC inspeaors continues to be excellent with mutual
trust exhibited towards NES.* Further, the NES documents impUed that Region ID staff
recommended NES to Lcensees. Induded is the NES documents were the statements,
'maintain contact with NRC headquarters,' foster NRC relationships for
recommendations,' and that NES received a verbal award to oooduci as audit at the
University of Cincinnati in response to Region ID advice. The records provided by NES
indicated Region ID recommended NES to three bcensees within Region ID juris<fictioa
Case Western Reserve University in Geveland, Ohio; Lafayette Clinic in Detroit,
Michigan; and the University of Cincinnati in Cincinnati, Ohio.

GIG requested that NESj>rovide the personnel records and all documents pertaining to
the business activities of^ '^ ^

since 1978. resigned from the NRC in January 1989. ___^

' junder the supervision

Subsequent to MBHWlfe^'g°^^°^ ^ ^'^^ ^ed by NES in
March 1989. RecordTprovided by NESiodicatod{|PmBliworked from his home in
Chicago. Illinois and v^-as responsible for marketing among ^-product materials licensees
of the NR^ in the Region ID area. Further, NES records izxhcated that one of
JHBlHk&rst projects with NES was the work conducted at the Univer^ty of
CincinnatL

DsfTER VIEWS OF NRC UCENSEES INVOLVED WITH NES:

_^ ICasc Western

"Reserve University (CWRU), advised that faOures within CWRU*s radiation safety
program prompted Region III inspections in 1987 and 1988. As a result of the 1987
inspection, CWRU was prohilnted from continuing radiatiofi research worL He advised
that Region DI inspectors informed CWRU that there were problems with the program,
but the inspectors did not explain how CWRU could resolve the problems.
(JMgOlJIPgsiated that the NRC requested that CWRU submit a proposal of bow
the university planned to fix the problems in addition to periodic progress reporis
(Exhibit 12).

irecaPed that CWRU was Tn a crisis' because the staff did not know hofw

^Holve its problems, and CWRU decided to hire a consultant for this purpose.

prp?>:Ai [15^ p»i|^

231

m!\ 'J?f ONLY

,^^^,^^„^,^^ advised that he and the radiatioD program staff caOed around to other
fadlities and colleagues for names of consulting firms that could assist with the
development of their radiation program. Subsequently. NES was selected to assist
CWRU with its radiatioD program IMBRVHCi^'^ ^^ ^^ ^^^ Of ^^ N^S was
selected. He bebeved that a few finns were considered in addiboo to NES.
■mPHllPIPt said be was not directly involved with the selecboo process, but was
Evolved with the hinngofNES at the finandaJ and policy level. According to
jPUPp^WMMMStfL administered to the day-to-da) responsibilities and
managed all contacts and negotiations with the various competing consulting firms.

I believed that due to NES* immediate assistance CWRU was able to

a month after being shut down by the NRQ albeit on a

conduct research wi ^^^^^^^^
probationary status. if||tflHBH9recalled that
contact at I^ES and performed most of NES* wort
approximately six months.

jwas CWRlTs main
NES consulted with CWRU for

^ ^ jof CWRU, recaUed that Region ID shut down

'^WRU's radiatioD program, requiring the university to resolve its programmatic
problems. ^S^/ffjoiiniiincd that be telephongd the region for advice regarding the
hiring of a nuclear consultant to assist CWRU .^^HlH^ did i>ot recall with whom be
spoke, but believed it was an NRC official at the management level (Exhibit 13).

I l^mi^ stated that the Rj:gion ID employee recommended three or four firms to him
Nttiat could assist CWRU ^jflKldid not believe the Region IB employee
recommended any of the firms more strongly than the othei. According to(|H|||||^^
first firm j>e called was located in Oeveland, Ohio He did not remember tbe'name of
the firm ^flV^ informed OIG that the Oeveland firm did ixx have the necessary
resources to assist CWRU, so be contacte<) the t>ext recommeoded firm on his list, NES.
t'said be spoke with SRHj^^^^o claimed NES could begin immediately.

^advised that in December 1987, NES was hired a5 consultant to resolve
WRU's radiation programproblems and assist with the developmeoi of the university's
radiation program ^lipm^aedited NES*Drompt efforts for the reiostatement of
CWRU's radiation research worL ^MflH0did not observe a "cozy relationship*
between NES and the Region III staff, but sensed that NES representatives knew and
talked to the Region ID staff He explained that the NES staff knew the NRC
regulations and requirements well enough to l^ow wha^t would be expected of the
CWRU radiation program to pass inspection. ^VHi]said that NES" famibarity with
Region ID staff and the inspection program was an advantage to CWRU. In February
1989, NES completed their work at CWRU.

rm^0ggggUi0ttK9lf6MBK$ff9fStt9lf$9^ Clinic,

explained that in June 1988, there was a minor spill of radioactive material at the clinic.
According toisiHitRegion III was notified that the clinic had some internal

rrc«'

r'"v

232

omeiAi USE m

problems with its radiation safety profram, one of which was the June radiatioo ^riD,
and was attempting to resolve these problems. Subsequent to the clinic notifying the
NRC a letter was received from Regiop ID ordering the clinic to cease work within its
radiation safety program ^ilBlAadvised that Region ID shut down the clinic
primarily because Lafayette Ginic had no RSO (Exhibit 14).

After Lafayette Qinic's radiatioo program was shut dowp^mj^ %t-as appointed as the
tfIB He stated that after his appointment as ^^ an inspection was conducted hy
Region ID. He named |iSpnHH8MHMMHHVHB|BB0ii!^d^||||pl
KB|mM|as some Region ID membeji that he dealt witt concerning the clinic's
problems. According to^fffgfggtKtttttt^^ni very bejpfij in ejylaining how the
clinic could get its radiation safety program "back on track.' ^HPHf^^dvised that
liMMnJK^SS^s^^ several sources the dinic could contact who were capable of
providing assistance the clinic needed. (MBt^^^^^lVlBi^ recommended three
consulting firms, one of^whicb was NES. He did not recall tbenam^^the other two

firms recommcDded by^ttUttttt ^ 9VH|pi^^c^<^PHP''flH^*^
professional and very impartial wben'recommendmg''tbe consulting firms.

I informed that Lafayette Oinic was under pressure to resoNe its problems and

Return to its radiological work as soon as possible. Due tojhe engent circumstances he
decided on NES because of tbeimmediate response from^mUJwben he was
contacted byttSBM'HNMI^^^^^ ^*< almost immediately after NES began
working, the ^nTc was able to perform radiation work again. He noted that NES
reconstructed the dinic's radiation safety program, and due to NES* efforts the program
was much improved and passed the Region ID inspection.

« advised that throughout this period of time, he had direct contact with the
I staff and there should not have been any NES contact with the region. He
recalled that Regjon ID inspectors visited the clinic the same time the NES staff was
presen'w. Ho^ikever,^|fmi|pdid not believe that the RegjppjD. staff and NES
representatives met with one* another on these occasions SMilK;'^*^^' ^^^ ^ ^'^
not get the impression there was an improper relationship bet>heeo the NES staff and
the Region ID stafL

^University of Gncinnati (UQ, advised that during 1989 a series of problems devel
within UCs radiation safety progranL He explained that technicians within the program
bad made serious allegations against the RSO and the radiatioo safe^ propam. Due to
the gravity of the accusations and his inabtUty to ascertain the truth;^||||Bdecided to
hire an outside consultant to examine the aDegations and conduct a thorough review of
the university's radiaUon safety program (Exhibit 15).

said be required assistance in identifying a consultao|
br suggestions. AHll3<lvised that he knew

he contacted

om prior UC

233

••• - l}'i\Ll

iovol^meoiw^i^^ Regioo m. According to(]m|| oo August 3 or 4, 1989, be spoke
with IHMlflWabout the nged for aMistance with the university's radiation safety
j)rogram. Jj^j^ recalled that fPMWH^j specifically suggested jjjjBicontact
0/lt^ and provided a telephone number for^|||||H|at NES jHftf maintained that
M^IPtlJPt] cUJmed NES performe^jbc type of service UC required, and NES would
do a goodjoB. (^Htaf reiterated that ^■■pi|^|g(^^ recommended only NES.

^D August 12. 1989. NES began consulting for the univenit). JQHrecalled that
^Wp[|^iand J||[|0i|pwere the principal NES representatives responsible for assisting
uC witi its radiatioD safety program problems. NES conduaed a review of the
radiabon safety program and found many problems and possible JJRCviolatioos. As a
result of the NES audit, the RSO was suspended and replaced. AJjji|ftsaid NES.assisted
the university witb the placement of a new RSO. SubsequeDtlyJ^^BbmHjIwas
nominated for this positioo pending the approval of the NRC M|KrecaOed that be
and other VC faculty members Joined^HBip meeting with tLe Region IH staff
coDceming the appointme£tofJMIM^^^^did not recall who attended the meeting
OD behalf of Region IH ^■Ksaid that |||||m^must have met the Region III staff
before because be introducedUC faculty members to them.

. i|[j,,jadvised that NES consulted for UC for nearly a year. He maintained that as
NES discovered safety problems, he immediately informed Region IH of the problems.
Consequently, Region BD inspertors visited UC to examine the simation to formally
dooxment these safety problems. On those occasions Region ID inspectors visited UQ
^^Bpisaid^be did not observe tb^m^ctors meeting with the NES representatives.
However. ^m^ advised tbai?|PJJfcwas very friendly with the Region in inspectors.
Topined tbat^HMM^elationship with the inspectors was normal considering
^,was a fomoer Region ID inspector.

UC related that be interacted with NRC Region ID staff
during the 1989 inspectip^ftbe university's radiation safety program JKttMlt0Ktt§\
recalled being told that jBj^desired a consulting firm^o resolve some allegations and
other problems associated with UCs program. He said ll^tt reported that be

; Bnns aj

contacted Region ID for recommendations of consulting
name. According to

UcDuid not recall who

and was provided NES'
^ |b< Region Dl staff recommended only NES.
fjspoke with at Region ID (Exhibit 16).

claimed that he thought it was 'strange* tbata^l^Bonly received a
single recommendation from Region DI, and believed this was agamst NRC rules. He
explained that be was familiar with the NRCs rules and regulations from his past
mployment widi the Atomic Energy Commission (AEQ, NRCs predecessor.

^ lOted that UC acquired NEys services on a sole source procurement
^asis and be wrote a letter explaining the circumstances to UCs procurement
department (Exhibit 17).

OFRDiAl m. Giiiy

234

OFFICIAL USE ONLY

suted thai be did not have any evidence to suppoft (bat tbere was an
unproperrelationsbi£. between NRC_and NES, however, he believed (here was an
appearance of one. (BBPWim^ speculated that there may have been a leak frogg

Region in to ^jtttj^^ someone else at NES According to f^PHHHHHHHf
knew of NRC results prior to the NRC informing the university of them. He recaDed a
message iH^tfic^ 'o^ ^*^ which referred to 'unofiSciaJ informatioB' {Exhibit 18).
Mlpm^^pBpsaid be bad the impression that jH|ft^<l ^HVS had constant
contact witb the Regi0D.ni staff. He surmised tbatj^^f iearnedoT certain
information because of^Smi^past experience as an Region ID inspector and
knowledge of NRC regulations.

INTERVIEWS OF NES MANAGEMENT:

%|||pgHMMMiiMiH|^ ^^^' ^^^^^^ ^ai during 1988-1991. NES conducted woit
^ three fpa»n areas: Engineering. Technical and Waste Management. ^(BH^
explained that within NES* Engineering Division, procedures were written for nuclear
plants that bad recently started-up, and NES modiSed certain nuclear plant procedures
that bad become antiquated. NES also conducted in-service inspections and qualiQr
control work for nuclear plants under the Technical Division, in addition to radiological
field work conducted by NES' Waste Management Division. Under the scope of these
three areas, NES began marketing to commercial utib'ties (Exhibit 19).

' **^*^maintained that NES acquired its clients during 198S-1991 mainly through

*word of mouth.' (mp0Bfadvised that NES bad a repuution as a quality company in
certain respects. In order to build upon its reputation, NES began to seek others within.
the nuclear industry to inform them of NES and the services it could provide. iflUplSB
stated that NES iaitially sought out Region I to assist NES in this effort Hc^explained
that NES approached Region I because I^ES b headquartered is Region L 0mttlt^
related that NES attempted to meet with Region I to descnbe the company and its
services and to obtain a published list of troubled Ucensees in Region I Hovk>-ever.
the Region I staff rebuffed NES and claimed there was no such list of bcensees.

■■■mipsaid he did not beUeve NES tried the same approach witb any of the other
"NRt regions as it did witb Region I. He believed that Regioo jD recogaiied NES for
the quality work NES had previously performed in the regJoL |BBH|[(^stated that he
had beard Region ID compiled a list of quality firms, whicb included NES. JHHHl
heard that the Ust was provided jo Regioo ID licensees requiring services the firms could
provide. According toHpHftthe Region III stafi^ never gave preference to any of
the firms on the list. Heldded that be did not have direct knowledge of any Uccnsec
requesting assistance and Region ID referring companies from the list

dviscd that NES has received referrals from Region III in the sense that NES
was namcjj amongjother compam'es that could provide certain services in a timely
manner. flKlJiJjil^'^'^^^^ ^^^' ^"^^ acquired work at CWRU by being named among

235

• • ft

many Gnns by the Region m staff. He recalled the situation with CWRU because the
university was is troublj^^nd needed immediate assistance, which NES was able to
provide. According to^|pH||( he never considered Region QTs referral procedure as
providing NES with an improper advantage over competitors.

JUM^psaid that he touted NES' success to his employees afier NES received the
CWRU consultini projea ^JHUT reaped that he told the NES staff that good work
can lead to more projects According' to JIPPflA he did not aedit Region ID for this
success, but the NES staff responsible for doing the quality work which led to the
CWRU projea Regarding the alleged statement Thank God for our friends at NRQ"
flpmi^doubted that he ever made such a statement He added that be probably told
Eis staff '..thank God we're doing good work* (Pg 18).

OIG asked pilpfl^ about the comments contained in the Plant Services Monthly
Reports an^ Monthly Staff Meetin£ Minutes, which implied a relationship with Regloo
ID (Exhibiu 2 thru 10) ^|Pp||'stated that commeou like "relationship with NRQ'
what ii means is that the quality of work permits NRC to look at us as somebody that's
not a shoddy performer but somebody that's there to stand behind a good product* (Pg
22). ^SMi^cxplaioed that proper interpretation of the Monthly Staff Meeting
Minutes inferring a relationship between NXS and Region ID was that NES must
continue to dp good ^rk to give the region reason to place NES on a reference Est, if
so inclined jM|flM informed that NES did not ask the Region ID to be placed on
such a list. ^IHBHi^ maintained that if NES was recognized for the quality of its work,
he would accept any recommendation and assume that it was done in a fair and proper
manner by the NRC ^||pMi|§ advised that he had no oonuct no'th the Region III staff
and had not visited Region ID.

Concerning SES employment of vJ^PBm»BBi|y [informed that JP^BH and

Thired him. ^ffHRW^t^t^t' ^^t be ii>et.fBPH^ prior to him being hired

and he was aware j

know whether NES approached

approached NES.

;was a former inspertor for RcgioD III

about employment at NES dri

did not

^^^^^^ jNES,was

interviewed by OIG. JHH^HH^ recalled that sometime in 19S5 NES' first
encounter with the RegjonUl staff was dujing consulting work the NES performed for
the SOHIO Chemical Plant located in Lima, Ohio (Exhibit 20).

According xc(^
wmle

inspectors while NES worl
SOHIO called Region III
acceptabiUty of many issu
regarding certain projects

maintained a continuous dialogue with the Region III
at SOHIO. He noted that the NES site manager at

^a few tin>es to determine the
he personally dealt withlf
nagcd involving Region ID. He eiqplained

236

OmCIAl USE OUT

that discussioos be had with Regioo HI staff were of two types: (1) fonnal
communicatioos such as reports and letters to tbe refioo from the dieot were drafted by
NES; and (2) informa] coaununications with ihe region to asceruio tbe NRC
requiremeots for a particular task.

SitlfKftMti advised thai subsequent to tbe SOHIO project. NES worked at other
facilities in Region HI that were the focus of NRC inspections^ such as CWRU, Lafayette

Ginic. and tbe University of Qncinnati (DC). iPHBIHHiP did not have direct
knowledge that Region jl recommended NES as a service consultant to these facilities.
However. jHHRIitfill said be was aware of a Region ID practice of providing a list
of several companies that did quality work to licensees is need of assistance.
MHHpm^|suted that his impression was that Region QI did not refer NES
specifically to ai^ faciliQr.

f believed that NES was placed on the Region in list of quali^ companies
because of their good performance record. In faci,|p|p^HflQ related that Region
ni's recognition of NES^strong performance vt-as diyussed numerous timesJig managers'
meetings with fjiiPMHflBHlM^HlPMBfllpdid not recall bearing ffpMU
make tbe allegid statement. Thank God for our friends ai the NRC* He noted that
'...we bad absolutely no relatjonshio with Region m that I know of other than on a
purely professional basis..* (Pg S). ^mBPS^m^said that NES had a veiy stroiig
professional relationship with Region m.

With respect to NES' hiring of |f0IH|pMflH|||i| stated that(|HQ||pwas
qualified for his position at_NES and would have been hired whether there was a
published vacancy QrooLjflpp||H|fl^ did not believe there was a published^
announcement for fMliSlP, position. Accordmg to JMBBM^WIMMMi^ hiring
was not a^rprise/He explained that when NES hiredJ^||PP|^the company was
rowing fl||iMH|li^u^o'™^<I ^^t ^^^^ employees were hired during the time
rwas retained.

"advised that prior to beinehired by the NRC be was employed by NES between r982-

1990 /'MJiiowas tbe fiMWiiiw<wi^^MWWiB<— iiw>ip>wi

and later became ^|p0P''HVMtMMivnPn9BV9HHHHiBHpstated
that NES began seeking decontamination projects. In this Tcg^iMffg/ff^d be
visited NRC beadmiartets to find out which hcensees were in neeo^of NES* services.
According lO'^^QlPH^NRC headquarters staff informed him that tbe Ucensee
information NES sought was handled by the individual regions (Exhibit 21).

^■MHfiadvised that NES eventually approached Regions I and III to acquaint the
^ponaSaff with NES. He said NES visited Regions I and m because NES was
beadquartcrcd within Region I jurisdiction, and the majoriQr of materials licensees were
in Region ID. ^KKKtm^'^^ *^* ^^ regional staffs immediately told NES they did

omcitt list oHi'^

237

OfFICIAl llSt 0^?."

Dot recommend consultants to licensees. However.ymi|||psai<I Refioo in maintained
that if a licensee had a problem and.needed assistance, they wouM govide a list of
firms, of which NES would be one. j|[||||||m|i}recalled spealdnf to ImilljJlJIlP
concerning this matter.

ymiUp, said be did not believe Region ID ever referred NES as the only consultant to
a bcensee fPflHV^^''^'^'^^ '^^' ^' beUeved the Region m staff recomffiended_
severaJ consufiing firms to include NES to any Ucen&ee requesting assistance. ^
stated that through this referral system NES received the CWRU project He didnoT
know whether NES^ceived the Lafayette Ginic and UC projects via the Region Dd
referral system ^ Vpi^P|||§view, the Region ID staff was confident NES was doing a
good job.

^advised that NES and the Region ID staff developed a prcrfessiona]
Telanonship and did not believe any NES representative was invoKed in an improper
relationship with an NRC staff member. He acknowledged that be kaewjbe late Lee
ROUSE. a^NRC headquarters employee,_and consider_ed hip ^iend. wttlK^
suted iha^pHpilfjfrequeotiy spoke v^thJ|pP^mi|rbut|||[^|||did not consider
the two to be friends.

Concerrung NES' hiring of J^pMMgg|||p§was not sure bow NES came to hire
■JJU^BMipilBl^beheved that^|Bi|§|por someone ODjflmMli^half
approacbedUfBUlabout a_ position^ with NES. ^Ipm^aid be knew^
wanted to leave the NRC fiflB^^^^^j^^ tbaiMB|[M>adva}uaUe experience
which would be an asset to NES^^[|imPmaintamed ihatjmHHHwas very familiar
with NRC regulations and the Region ID area.

(NES, was interviewed by OIG 4|mi^informed that during_i$88- 1991. be was

^ reporting to^|§^

said his responsibilities were to develop business opponunities in the non-

reactof decommissioning services market and with nuclear power plants He added that
NES was very much involved with fuel clean-up services during this timefr'ame (Exhibit
22).

omftstated that in 1985 while conducting work at the SOHIO facility, later known as
B^^emical, NES first encountered the NRC V^Hjll advised that Regarding the
SOHIO project, NES bad to negotiate with NRc headquarters staff. ^Hli recalled '
dealing with ye^OUSE at NRC and as a result, be became the prindpal NES contact
to the NRC ^HfBBnoted that the inspection of the SOHIO Jacflity^was conducted by
Region III sja& Punng_the Region HI inspection <rf SOHIO.^|B|^$aid be met two
inspectors, HHdHlVand [

CfFICI/i' m ONLY

238

omoi?.'. n r:r.t

believed JbatNES was recognized by Region ID afier tbeir exceDeot work at the

Hid facility. MHlOsuted that due to NES' efforu at SOWO. Repy ip placed
NES OD as "000^033 list of qualified vendorv* developed by^UpMH^of Region
m (Exhibit 23) ^BBPl^'aimed that if a licensee with problems contacted Region EQ
asking for the names of consultants. Region ID provided the Ucensee with a minimum of
three firms AWtf added that when Region ID provided the three names background
on each firm was also provided iMBPadvised that Repoo ID Ucensees were given
this assistance, however, those in other regions were not provided with NRC assistance.

jSflHiistated, 'Of all the regions that you have, the one that is closer to your licensees

^Spon ID.-' (Exhibit 22 pg 8).

^jjMHi|maintained that NES definitely did not solicit the Region ID staff to be
T^^^ended to NRC licensees. (|||p0 reiterated his belief that NET good
performance was recognized by the Region ID staff resultiM in tbeir referral of NES
among other companies to licensees. According to4p|mNES received referrals to
CWKU, Lafayette Ginic, VC and two others that nES did not acoepu pim^psaid be
knew NES was recommended tojhe three aforementioned Ucensees b) Region ID staff
because each representative^told\M|iy)of this J^m^noted that pH|ffpB^P^
CWRy.^lBHBflVMHIi^^dfllBVHHMHfl^th Lafayette Qim^. a^d^HH^fl
MJIH o^C contacted him for theu respective consulting oe^ds. ^g/fff^sSSaewti
posiove that CWRU and Lafayette Ginic received the oam^of three companies from
the Region ID staff. However, JfejJpS^was no^ce rtain PJ|yof UC received three
referrals ^JBJJIjtated that h^ just assumed ^ll§fffjftlfl^Te<x>miDcoded three
fomp?n'g< to^m because that was the normal procedure for Region UL

flBM^suted that NES' familiarity with the Region ID staff did not provide an unfair
^mpetitive advantage for NES. He explained that any similar consulting firm oouk)
have gone to Region ID and requested infonnatioo on a bcensee or ask to be
recommended 40 bcensees <^nPiQr^^ "^ ^'^^^'^ ^^^ I can go and sit down wit
^■HMtfflpthe foUovkring day and say, 'What's new? Tve heard that we have
^roblcmsiMSs kind of bcensee. What's the siams''~ (Pg 44> ^fffff^s^d be took
pride in knowing how to deal with the Region ID staff He advised that NES' cLents
expected NES to interf.'ice with the region on their behall ^mm noted that the many
telephone calls to Region by him were done on behalf of clients to find out if the Region
ID approved of certain efforts by a bcensee. He maintained that a lot^f issues were
resolved by telephone, ^//f/j^iddcd that his calls were primarily to|^

Regarding NES' emplofflent o(J

left Region JD iWB> speculated that

hiring sQHVh^cause be recalled
at health physics and a good writer. In

nth^uch_va]uable experience. ^BBUdemed that

5 providing NES as a sole referral According to^

I advised that be hired him after be
_ eceived NES* name from his former
have contacted jBfJBBl^about
I stating (iiH^/ff/g0jns very good
' f, it made sense to hire a person
hired^inexchange for
^gave

OFFICIAL USE ONLY

239

OfnCIAl BSE ONLY

SES insight oo how Regioo ID inspected licensees. He ooied ihatllBHQleft NES
because be did not wish to move to NES headquaners in CooDeciicttL

OIG discovered that|mm^resigned from NES in 1992. OIG's effons to locate
]were to oo avail. Consequent!) ABH^wss not interviewed by OIG.

INTERVIEWS OF REGION HI INSPECTORS:

_ JNuclear Materials Safety Brandi

"tNMSB), advised thai be first becagje famihar wi^NES when |||fl|Mwent to work
for NES in 1989. He related tbajjBf^^^was employed by NESdurinf a Ren^^D
inspection at UC ^HHUm^believed be met anodier NES representative, iflmiP
during a meeting at Re^ob ED at approximately the same time (Exlul«t 24).

ig||d|iSB|^stated that be occasion|Py referred the names of firms to licensee when
be was a Section Chief and Inspector. pmmiBHVooted that be provided a Ust <tf at
least three names when asked for recommendations, lie provided the names of
companies that were listed^in the Radiadon Protection Professiooals Directory and
Handbook. According tOi^H^Wiiphe normally reconuneoded conq>anies in the
directory /handbook, companies be was familiar with, and/or companies be knew as good
performers^ He added that other Regon staffjiembers referred companies from their
own Ust& flUPlMfl^Pptated ihat^JUmHlBalso maintained a list of medical
consultanu. He added that there are many different lists held by tbe various sections of
Region m.

suted that the procedure of referring the names of consultants to
^censees was an informal regional policy. Heated that tbe pobcy was shared within
Region ID by "word of mouth.* According to JPIHBH^ tbe Repqp 03 staff knew

it was improper to recommend one company to a bcensee.

acknowledged that a company would be unfairly advantaged~if not on tbe ut of
recommended companies. He advised that so many companies are available that not all
can be kno«n to the regional staff.

JgMtagBBB^said that the issue of referring consultants concerned him. He said be
was unsure whether it was the region's responsibility to assist licensees in finding a
consultant to resplve their problems However, if tbe regon did not provide sud)
assistance, the NRC might be ignoring safety concerns. jMBHfl^helieved that
legion ID ha<La tendency to be problem-oriented and tried to help licensees.

^nnMRnoted that he has in the past discussed issues with consultants on behalf
oi tne licensee to resolve problems, although most knowledgeable consultants did not
contact the region.

^gH0|0M0MiM|li^MfiNMSB. informed that be joined tbe NRC in 1981
^ afilHMMHiiHBMiMKptated that be first became aware of NES while

f.—T'- •-.• .* • fll

T rv'Y

240

OmCIAl USt ONlY

working on a decontamination project involving ChemetroninQeveland, Ohio. He
recalled that Cbemetron's consultant, NES, tmp\oycd^fff//f}(Ejibibit 25).

jd that he 'probably recommended' NES along with four or five other
insulting' firms to various licensees. ^^[^iHl|padvised that there was a list of
consultants us^d for referrals, which had been prepared by4|MHMBlf^E)^^t 23).
According to iMfeflM^^^ ^^ unaware of any written poLcTfor NRC inspectors when
providmg bcensees with the names of consulting firms. However, be said that Section
Chiefs and Branch Qiiefs routinely instructed Region III inspectors to provide at least
three or four names and to never recommend any particular oompanty. (VHftH^^^^
that he routinely communicated with consultants who requested guidance on behalf of
the licensee.

^was generally unaware of any contact between NRC staff and lHBflil|||afler

"went to work for NES However,^mi||Mbelieved thatM^Hl^used Repon ID
inspection information to develop a 'paclcage' That would be aovantageous to gaining
employment with NES. He explained that VC technicians had been senjling allegations
left and right* to Region m, which were not being acted upon prior^togBBMPWeaving
NRC. He added that {tMBWUHMBBMBBV^ the ^MMBimi0and should have
been acting on (them)^B^jB^p)said that one of his recommendations to
|[MHBipB||f and flpiH^for solving a UC safety concern was used ^mHt0KI^^
an NES promotionaTservice to UC.

OIG interviewed seven other inspectors assigned to the Division of Radiation Safety and
Safeguards (DRSS), Region ID who were familiar with NES. The inspectors were
familiar with NES as a constiltant to various Ucensees in the Region ni area. None of
the inspectors claimed to know how NES acquired the work at CWRU, Lafayette dijiic
or UC The inspectors were familiar with NES' work at UC mostly due to ■
being part of NES" consulting team at UC (Exhibits 26 thru 32).

The inspectors concurred with wtfUfSttl^ ^(^ JIKHiM^'hai there was no formal
Region III policy regarding recommendations to bcirSees The inspectors advised that
Ucensees requesting reconunendations were provided with the names of at least three
consultants. The inspectors stated that there were different uooffidal vendor lists used
within the division (Exhibits 33 thru 35) The inspectors related thai they were
instructed not to give preference to any firm. The inspectors did not know of this
procedure ever being compromised b: a Region ID inspector.

Further, the inspectors stated that no specific instructions were given for dealing with a
licensee's consultant who made inquiries to the region. When this occurred, most
inspectors said they would participate in discussions with the consultants. Certain
inspectors noted they would not receive quesUons fi^om a consultant and would refer to
the b'censee's management However, the inspectors collectively agreed that consultants
could not replace licensees at Region III meetings.

241

'J!! (!«IY

jNudear MaiedalSafetv Braocb (NMSB). befaa his career witb

ion ID in 1979. FrQm L91M989.iii9Mi0|^was theiflpBIHll

_ advised thai io July 1989 be was reassiped
^to tbe Director of DRSS (Exhibit 36).

jUtated that be first eocountered NES in 1985 duriD| ajt allegation review
of SOHIO/BP Cbeoiicals facility, where NES was a subcontractor. llHiMBil
^mroepted that be was impressed with tbe quality of NES" work at SOHIO.
jUmPmHllksuted that NES subsequently requested a meeting with RegioB ID
maoagemeni and inspection stag to imroduce themselves and inform Region ID of tbe
services NES provided JniPHH|Jinformed that ^HBtnMMMHH^
DRSS, approved the meeting. Hedid not remetnbcLwben tbe meeting occurred. Jle
recalled NES representatives, fK^^and Sp|[HiP^iog present
maintained thai be later interacted with NES~ at three facflities. CWRU, Lafoyette Ginic
aodUC

_ p^recaUed that CWRU was experiencing proj^lems at some of its various

jabora(orie$ which used radioactive materials. M||piflSf informed that Regioii ID

sent to CWftU to conduct an inspectioa Based on

findings, a Confirmatory Action Letter suspending the universiQr's

Tadiation activnies was issued.^Qonsequently. j^WMBBK said that bg. receive^ a
telepbooe oU from ipp0M|Fpf CWRU. MBMMBt^^t^ thatPHHwanted
some assistance witb^d^eloping CWR Us radiation safety program andasked for
recommeodabons. MSMHHKtated that be recommended ||||0HH|||||||gPIBi of
Geveland Hospital; Nuclear Medicine Associates in Geveland, Ohio; NES; and Applied
Health Physics, which was already conducting work at CWRU.

at NES because
IjycaPed that

(stated that be was aware^Hflpncontac
|i\toid him of this after receiving^lPmi^'caL.

helepbooed him asking for a summary of CWR Us problems. MKKHtKKiXoM
^about the Confirmatory Anion Letter and explained that O^^U i>eeded an
ovefbaul of their entire radiation program He maintained that the information be
provided |flp^ was public information available at tbe NR Cs pubUc documeai room.

Stated that be dealt with tbe^i^ES staff at Lafayette Ginic in the same
did at CWRU. ^/fgtt$/t^expiaiDe6 that Lafayette Clime's RSO bad
iving the dinic without a qualjyd person to manage tbe radiation safely
iassigDedJKttttt^xo inspect Lafayette Clinic Accordiitg to
Jcontended there were a lot of regulatory problems at tbe clinic
iibsequen^, Region Dl issued a Confirmatory Action Letter requestingjbe^clinic to^
suspend its ficensed acti'viQr and to appoint a new NRC-approved RSO. i
said after the letter was issued, be received a telephone caD firomr

manner as

resigned,

jtfogram.

-.».»».*

242

OFFICUl USE ONLY

laiotained tbatHB%jand^Q|||P(Qasked him to suggest whauftcy

should do to put their prografloback into operatioo. According to jjlMIIMB "^ ^^Id
them that if I was in their situationJ would conai^r a third party audit qtibe enfce
radiation safety program* (Pg 16). ^||||P|WBj||suted that he providedgMH^ilj^^
[pMiH^'^^^ sources: ^j|H|BMHHH|§&om Wayne Sute University, Medical Physics
Consultants in Ann Arbor, Kfichigan; and

jJpH0BM( explained that^following >fES' work at Lafayette Clinic, the firm was
contracted at UC. ^MHMHlQmaintained that UC wasaproblem facility for many
years dating back to the early 1980s. According to^pHHfltolBl Region III had
received nuiqerous allegations concerning UCs radiation safety program. In ^ril 1989,

^mBMMU prepared a memorandum concerning the recent allegations he had
received (Exhibit 37). Subsequently, the region conducted an insi>ection at UC

ymml^MPl explained that he was not invohred with the inspection at UC because he
was transferred from NMSB to tbegpMMiMMhmmHgin July 1989.

^■iMtHtWstated that he recewedatelephone call from/^WtWBWMWof UC
after July 1989. He recalled thataMBEwanted Repon ID jy investigate the numerous
allegations and resolve UCs safety problems.^MfMMBt/toldWiSthat the NRC
encourages bcensees to identify and correct violations whenever possible, so UC should
take the initiative. According to pUBPWWWPjjpjCasked hjm to re<»nimetid _ ^
someone. gMBBBWJ^lsaid^je^recot^endedflBBB^ntacl^fclMilii^tfciWMiill/
with Applied Health Phvsia^flj^Mlifi^th Radiation Safety Servicesjncorporated; and
\jp|n^]witb NES. (jJUlPlMUBiremembered that he provided9hl|^with the
telephone number of\|PJHAat NES, but was not positive be gave him telephone
numbers to the other firms.

•Jraa

maintained that he did not recommend only NES tojjWBB He recaUed
that bis telephone call wiib9MCwas quite lengthy. ^HlfeflHiiK&tated that he did
not emphasize NES to^Srjmore than the other firms recommended. Although,
QH^^BiMVil^tated that^e gave^mp^a little background on NES and not the other
comparuesTHpBHMBsaid he toldHM^of NES' good work at CWRU. According
to pttHNMoT-.I would say because of my statement about Case Western that
probably that was the thing that really made his^H^fj^^decision mentaUy' (Exhibit 36
Pg92).

[maintained that he has never recommended one firm to any licensee.

stated thathe kept a list of consulting companies be recommended to
licensees upon request. ^BBHSMUprepared the list himself of companies be dealt
with during past inspections ba^d on their performance and geographic location (Exhibit
38). According toMhP'iliMl other Region lU inspectors recommended consulting
firms to licensees. Jfe stated Jhat recommending three companies was standard practice
within the region. |||||P$||B|0 recommended three companies so that he could not be
accused of favoritism to any one of them. He added that be tried not to recommend
the same companies repeatedly.

omciAi (i>E f :;iy

243

OFFICUl USE ONLY

advised that there wa^oo written
of outside consultants to licensees.

tlicy cDoceniim ^ reoommeodatioos
acknowtedfed that it was not his

respoosibilitv for assisting the license^ with finding a eoosultaat, but be did so as a
courtesy. According to ^mpmUpT^Pubiic health and safety b the number one thing
and by turning your back on tbein (hcensees) and telling tbcm that's your problem not
mine, you get it fixed, that is sort of a bureaucratic cavalier approad) that I would never
take- (Exhibit 36 pg 31).

l^mmBlP explained that be bad frequent contact with hcensees and their
consultants. He^Jnformed that much of his contact was answering licensees' questions via
the telephone jp^pBMBl%atfl that be treated licensees' cootracton the same as be
did the licensees. For example, HHHHtfnoted that be interacted with NES
regarding their work at Lafayette Clinic. CWRU, and to some eitent UC

ijHlglPHlp stated that hji interaction with NES did not create a unique or co^
^relationship. 'According to JWMll^ be treated NES as be would any other
consulting firm He explained that his dealings with NES and any other consulting firm
was to assure that the hcensees had programs in place thai were in compliance with
NRC rules and which provided a safe and healthy environmeoL

Jlegarding Region ID inspector
^■Pabout ~
(egioo in. be mentioned to

ecaOed talking to
" esieoed from

^^^^ ^ aat be may want to co^ider

provided «||mif^ telephone numSer. flBBBHHfttold '
thorough job onmspections and investigations. Subsequently,
learned that |IQHl^^^ biitd by NES.

_ } informed that not long afterjjfpgpwas hired by NES, be saw him at

be regional o£5ce. According to1|HflHMpQ|ii'iejep^n^him to explain that
0ltflU§*'^ going to represent NES at tbeUC projecC'^lBBBgM^told ^
that be did not anticipate a problem with flim^^jwor king at the univer^iy.
WtftJttttffl^^^^ °^' cheeky with his superiors' concemiog the accura^of the
information be provided to|^m^ ^^^'URBlAleft Repoo ni|HHHH|§said
he spoke yitb him on only two other oc^jms. He continued that oo one of these
occasions MPHif'^'^P^°^ to ebcit^||pmmi||| opinion of the repon NES wrote
^Deeming IjC afte'r tbe^ UC problems Jiad been resolved. The secood,occasion
^|HPBim|»met with (^ifPiJl^ and 9HB^^ ^ regional office. ^HBHMl^
advised that NES had developedlajiealtb physics computer appEcatioa training program
and demonstrated the program to j|||||pMHt|liHHVi^said that be did not
have the decision maldng authoriQr concerning training equipment, but met with
^ 'landfflB^because be was personally interested in the coinputer program.

mm\ rr miY

244

tm'}. ir: Fsit

INTERVIEWS OF REGION m MANAGEMENT:

"Region II. advised tbat^he was i^jJBWi—ll ^Wm>BlB^BM8|. Regioo ID
from 1S§7;1990_ ^gfff/jlf^fidormcii that be was famUia; with NES is a consultiQg
firm JJMMMyfinrencouDter with NES occuned wbeo NES decommissiooed tbe
SOHIO/BP Coemica] faciLi) pMHHIP noted that be became aware of NES again
wben NES worked for CWRV. a facility Regioo ED discovered to have bad many safely
concerns. According t<yflHB|v ^^ '^' ^^^ ^ beard of NES was during tbe firm's
involvement with UC jSPSVycould only recall NES serving as a constiltant to three
facilities: BP Chcmicais; CWRU; and UC (Exhibit 39).

^ recalled a questionable incident regarding tbe recommeodation of NES to a

Ucensee. Hc^did not remember which licej&ee was involved, but informed that
^PUmmilKvas implicated {^KtB^^explained that a questioo^jvas raised of
Whether or noiJBMHpM^P
discussed the situation wiib
conversation. He did not recall whether,^
incident, "^
region.

solely reconunend NES to a licensee.

" but did not recall tbe details of tbe
. ya^ officially counseled about tbe

^unnised that since the matter was not o£5ciaJly pursued in the
;>lanationof tbe situation must have been satisfactoiy to him
___^_^ Although IfSllllQflH^ concluded tbe situation was not significant, be

^lievcd'be probably discussed the matter with Division I^ector j|||mymPH|^

acknowledged that some employees in his branch refeaed companies to
and in fact there was a list maintained by Region ID of firms to be referred.

brmed that as Materials Licensing Section Chief be kept a list and wben

asked be would recommend companies from his hst (Exhibit 40). He explained that

ere were often licensees with safety concerns wbo would caD the Region ID for help.
.^■mm^dvised that the Region ID staff provided tbe names of aO companies they
could think of in the regioiL !t|H0mP^ stated that his specific instructions concerning
recommendations was to always provide a Ucensee with the names of more than one
consultant, and if possible, to refrain from recommeoding any fins. According to
(pmUPmfi, he cautioned against rec£>inmeodia| one company because be did not want
anyone to be accused of favoritisiD. iHBRNH|QO<cd that the procedure of
rccommendiDg more than one consultant was not a writiecpolicy. but it has been an
informal Region ID poUcy for some time Tofi/fffSjg^jjio^itdgt, the Regional
Counsel was never advised of or queried concerning this unoffidal policy.

policy on working with licensees and their consultants, be

With respect tn

advised that licensees were to be dealt with directly. He sutcd that Ccgnse«werc
always recognized as tbe first line of contact for the Region HI staff. MHJHtfi
recalled that often Lcensees' consultants called the region requesting information,
meetings and approval status on issues. fWWBHltadvisgd bis staff not to deal with tbe
b'censees' consultants on these types of issues. MHHi|[|maintained that telephone

nrr.fMf1 I'-? p^;iY

245

ofncuiusEONir

calk bad to beanswered, of course, but the staff was instructed oot to answer spcdBc
questions. ig0f/fHtfj^d that be made his instructions known to the region's section
chiefs and expected tbe information to be disseminated to the inspectors.

RegardiogJHBmBBMPBiMHBiistated that
section and tbe two were close friends prbfessiooall^\
relationship outside the ofBce. He informed thai
1989, after tbe NRC learned of inappropriate cooduct

worked in ' „,^pB^^
d oot know of a
resigned from tbe NRC in

, r^w^^- J, , »<»^MJ^ Regioo m.

Told OIG that NE5 was knows to him as a consulting firm, which bad represented
several Regioo ID bcensees. His personal dealings with NES staff was limit^ to a
ffuple of n^etinp at Region m, in which >|ESrepresentativd^||H|||was a partidpant
^IHBjtfmf^ecalle^situadoo in which iHM^^eooffimeodedNES solefy to
UC. According tci^p|j||f[|flHW the situation arose during an enforcement conference
when a UC represenutive maintained tba:^iHHHBfeoIel> recommended NES as
the consultant to resolve UCs program deficiencies (Exhibit 41).

following jbe enforcement conference, ||mpm^said be discussed the matter with
MKittftt^ who claimed be provideod>e names of three or four consulting firms to
UC However .^IB0HI''^'^t^<^ that pHHm^ckDowtedged having told UC,
>ou should get NES* or 'they (NES) are the best. ' ^Siitttif0 counseled
_ ithat the NRC was not in the business of recommeDding a specific

consultant to a licensee. According to||Mp^^ftMHWmi|^cknowledged that
doing so was poor judgement on his parL^^H||M|^4dvised that C
actioD did oot warrant a personal reprimand, but h
OIG (Exhibit 42).

cided to forward tbe matter to

With respect to providing referrals to Ucensees, fflBM^psuted there was general
knowledge "b) some within the business,* that when bcensew so requested, Regioo ID
provided tbe names of three or four consultants without recommending a particular one.
He explained that licensees were typicaUy at a loss to resolve their inspeoioo problems
witboutoutside assistance, so the Region ID provided a selecboo of consultants.
Wtttfttf. advised that be knew of no written procedure, but be suongly suspected
that other NRC regions followed tbe^oCScial procedure of providing several
consultants to a requesting Uceosee ^MpRHi^was unav^-aie of an unoCBcial vendor
list and did not bebeve such a hst existed. He stated that his penonal instruction to
subordinate staff was that the NRC was not in the consulting business and should not
attempt to resolve problems for licensees. However, if outside consultants were needed,
Region IH inspectors could help Ucensees learn which compam'es might be available to
them.

Jstated that hcwasnot familiar with NES untO

l^went to work at NES. Subsequent to||||m|||pieaving tbe NRC for

nmriiii ||<JF ONlY

246

f- •"• ^•••%f

iploymeoi with NES,^ll|||Pii|Vas asked to provide guidance oo bow to treat

^ and any ^tber former NRC employee who works for a licensee or contractor.
' bebevedilBP^BJiJplUPIB^lBjrequested the counselling session.
KecalJed inf ormi "sIMHHH^ branch that former NRC employees were to
be^eated as a member of the public and not to provide them any privileged information
(Exhibit 43).

..^^^i^, advised that be was aware inspectors provided lisjsj)f consulting firms to
^censees who requested assistance is finding a consultant. jBlHPsuted that be was
not aware of an inspector recommending only one consulting firiD to a licensee. He
explained that recommending three or more compyiies to a licensee was allowed,
although this procedure was not a written policy. WUtfKI^^^^^'^ '^^ ^ neither
had knowledge of the list of recommended firms nor that the recommendations actually
occurred. PUUBt^^^ ^^^^ "^^ ^^^' ^^^ ^°^ discussion regarding the inspectors
providing recommeDdations and he vaguely remembered pursuing the point with the
Office of the General Counsel (OGC).

_ fhad some concern with the recommending of three ox more consulting firms
^beD^theire are several others available from which to choose. He stated that the
recommendations posed a fairness question since congpanies not recommended or listed
are placed at a disadvantage. According to^mdP recommending three or more
firms was a possible conflict of interest because preference was given to the firms
recommended. JMHM^P^^ ^^^ ^^ "^^^ scenario would be to give whomever the
list and say choose from the list without ever providing three names * ^HflHl did not
know how the other regions operated with respect to this informal procedure.

FLNDLNGS/ALLEGATION I

The OIG investigation revealed that JVBBHMQBHHHI^cferTed NES among other
companies to Case Westem^Reserve University and Lafayette Clinic Although there is
conflicting testimony abou;.jlH|iBimtrgcoP"PePdiflg only NES to the University of
Cincinnati, it is clear that^HHSMAP^''ecommeodatioD of NES to the University of
Cincinnati was interpreted as an endorsement of NES' servjces.

^mgPI^Bil as well as other Region III staff made referrals to Ucensees. Region ID
management wa& knowledgeable and encouraged this practice by instructing the staff to
provide at least three referrals. By memorandum of February 23, 1993, NRC General
Counsel advised that it would be a violation of government regulations for a NRC
employee to recommend the services of a particular entity for a particular project, which
is subject to NRCs regulatory jurisdiction.'

The investigation disclosed that (fMRPBHI maintained continuous and substantial
contact with NES^^ consequently establishing a familiar relationship with certain NES
employees. §fftKBtt0^^^ repeated interaction with NES via telephone caDs,

^-ri'^'v i-r A**: 7

247

crF;^:.'i s:e caY

meetings and with fomterRe^oo HI inspector _

tdfflitted tecotamtodiag^f/j/g^to NES as a poteotial employee.

Tbe investigation disclosed that there was not a fair system in place for the manner of
referring consultants to licensees. There was no uniform list of consultants, and most
inspectors apparently relied on their own opinions. Further, there were no procedures
established to ensure fairness and to avoid charges of favoritism.

DETAILS/ALLEGATION II

As previously mentioned in this report, NES provided OIG documents pertinent to. its
busing activities in response to an OIG subpoena. Upon review of these documents,
OIG discovered expense accounts of two SES represenutivc thaijndicated ineah were
bought for NRC employees. The two NES representatives,^ISPMHI^and.
reported on their expense accounts dining with NRC cmployet

3d ^Hf^MIIB) In addition.
I^expense account indicated that he bought a meal foi^m^Hpafter
Jbecame an NRC employee The meals occurred on the following dates:
October 17, 1988; February 8, 1989. March 23, 1989; April 4. 1989; and July 21, 1991.

MONDAY. OCTOBER 17. 1988 AND THURSDAY. MARCH B. 1989 MEALS

^^^^ _. , advisory Comminee on Nuclear Waste

^ACNW) w3i z'gfmamtMgmf^th NES until 1990.3HMH^WeeUy
Business & EtpensePlepon indiotedihat on October 17, 1988, be baoa business dinner
with^HPHpand LC ROUSE at E>oininique's in Baltimore, Maryland (Exhibit 44).
t|iA|Mt reported on the expense account that the cost for tbe dinner w^jS6.70.
"Xnother expense report of JBBMH^dicated that on March 23. 1989.pHm||had
breakfast with L ROUSE ^d^flim^at Tbe Golden BuS is Gailhersburg. Mao'land
(Exhibit 45) and (Exhibit 21).

^said thatbeprobably had meals with some of the NRC staff and assumed be
^paid'for tbem. timUliexpIained that be ^often visited an NRC employee, Lee
ROUSE, who was an olofrieod from wbepjBH|^worked for the Atomic Energy
Commission. ROUSE is now deceased ^■Bd^continued that when be visited
ROUSE, other NRC employees were usually present and all would go out to dine
together ^HRRidid not recall what was discussed on the two occasions be dined
withjiill and ROUSE

^^Mttpi^tated ihat*if I bought lunch foT^fgj/flff^l would hope that nothing
nap^nstoMNPIii0because I probably said don't wony about it, ni_take care of h
or you can pay me back the next time or something" (Exhibit 21 pg 56). MHin
acknowledged that his lunches with the NRC employees may have ^iven the appearance

"Sf

248

OmCIAL USE Mr

of a conflict of interest, but be did not believe tbere was • coDflict wi
A^HiUHview, tbe recipients of tbe inexpensive luncbes did not fee
NES reprcsenutive, was trying to "buy* them.

Ltbe situation. In
las an

^__ _ ^ _ i)Office of Nuclear

Materials Safety and Safeguards (NMSS). stated^that be was introducedtoU^HHIJ^
during MdHlJI^visit to NRC beadquanen>. ^l^l^dnfonDed ibat^[H|||pPwas
visitingiPl^^^pervisor. Lee ROUSE. ChieT Field Cycle Safety Branch. According
toflMlp59VMllvisited ROUSE j)n several occasions, sometimes unannounced.
■(jj^Bbadtbe impression tbat l|pfl|[pvisited to renew acquaintances and to
information tbat migbt be useful to NES. He recalled two occasions tbatf
visited at NRC for business meetings (Exbibit 46).

^m^denied having any meals with HRHI^ He majptained tbat be consistently
brougEt a brown bag hmch to work and ate at his desk, im^informed tbat be was
neither familiar with nor bad been to E>ominique's Restaurant in Baltimore, Maryland.
IjQH^had beard of Tbe Golden Bull in Gaithersburg, Maryland, but claimed 1
certainly wasn't there withJH|||Bl|p||^and Lee ROUSE' j^g2)^|(|j|im^k:ategorically
denied ever going to the restaurants mentioned above withf

WEDNESDAY FEBRUARY 8. 1989 MEAL WITH _

^NES was interviewed UH|H|^.Weekly Busjpess & EJipense Report indicated

tbat onTebruary i^ 1989. be baodinoer with^fUHHI^Px "^op of ^ Town in
Geveland, Ohio. l^|||^eported on his expense account tbat tbe cost of tbe diiuer
was $85.67 (Exhibit 47).

Pstated that be and'JdfPl^fllHP'and J|MflMHB||PBwere at Case
'Westerp Reserve University (CWRU)^ on the'^above'Jate. According
invited irittfll^^<^ftHBMHvt<^ dinner with bim. He recalled tha
elected^not to go because be had friends or relatives in the area be wanted fo visit
iflHlpi advised that the dinner was at a restaurant on top of a building He did not
recall tbe name of tbe restaurant (Exbibit 22).

:))|BHhktated that during the dinner be aod^HMIH|||^discussed quality and
performance factors and tbe current misadministratioo problems at some fac
According to^llHRrhc paid for tbe nijtal with bis aedit card, aoc
reimbursed him with cash for his meal. PMB^explained that fbe reason tbe money
HllpBllj^paid was not reflected on tbe expense report was due to NES' difficult
^ccountingpTocess. He claimed tbat a cash advance form would have to have been
completed in order to reflect cash received during a trip. ^Im^ continued that "We
are very loose sometimes on other meals, so ;M)metimes what I remember in some cases I
am not that specific but I may have used bis^MflHHB'°<^°^y ^^ P"^ ^^ '^P ^^

nrcT'Af ircp^'iy

249

OfffOJiL BSf OKIY

Iheo 10 balaoce I just expense it afainst other things and it didn't show op in the end"
(Pf30).

request in May 19fi be later
>aid cash for hi& meal. ^IBd^said
concerned with the

acknowledged that upon
wrotj^ on his expense account that
that^HHI^. trusted him and did not believe

manner in which be prepared his expense report

I Nuclear Materials Safety Brancb (NMSB), stated that
be met with(imi|M> discusslhe Lafayette QinicJCet Well Progran* over dinner,
formed that the dinner with^HB^ocoured oe Febniary 8, 1989,
during a visit to C^i^ in Geveland, OHIO. |l(t^m{0b7lained that be and
m^prilMHHMfli^^^^^ ^^^^ *' CWRU coiKeming^some administration
problems the university was experiencing. He added that ^R|||Mvas the NES
representative responsible for assisting CWRU with their radiation safety progr^
^jtllfflttij^eahed that jB|B|^wanted him to review some documents ht^f/jf/Mi
had concerning Lafayettg Oinic. jJMUHBl^told j^BB^thai his schedule was fuU
with CWRlTs issues so|pm|suggested they have dinner to discuss the documents
(Exhibit 36).

frecaOed that he had a fish dinner with one scotch and water drink and

maybe^ad~sbme coffee, which cost approximately S12-SI4. He infonned that b; did not
see the acnial biL According to JHV'iHSilK'^^^o the bill arrived, I askedSlr.
mB^hat is my portion and his comment was^ oh, don't wony about it, and I said,
no, Tm not able to accept a meal from a hcensge or anyone wbo represents a licensee*
(Pg 37), and JWflH^P^^^PHS^S^S. JB^j^Bisuted that be assumed that
the S25 was adequate to cover his meal and dnnk. He noted thai^H|||^paid the bill
with his American Ejq>ress oedit card.

d the dinner with^^^Hv '^'^'^ ^^^ approximately two^ hours.

bnned that during tbedinner he reviewed documents JiHl^presented
to hiniL ^PBI^BI^oted that the documents penained to the corrective action for
violations identjSed by Region ni during the past inspection of Lafayette Ginic. He
explained that^imipbroughi the document

egion ni and

to him for review because they were going
wanted to make sure the documents

to be submitted to the

would be accepuUe. |mpmH^ added that the review of these draft documents by

MRC personnel prior to the documents being submitted to the NRC was permissible and

done oftea He stated that at the coiKlusion of the dinneri^|||||p)drove him to bis

bold.

stated that be was aware of NRC policies on employee conduct and
^nflJcToflnteresL He noted that be kept a spedal CQe of the NRC announcements oo
conflict of bterest and other documents pertaining to employee conduct regulations.

OFFICIAL USE ONLY

250

OmCIAL UV- CK./

^did not b«Iiev^ having a meal with

portion was a problem. Id ^

any conflict of inwrest rules. However
the situation again be would not dine wilb

TITFiSDAY. APRfL 4. 1989 MEAL WITH

w^cfa be paid for hb
eal with||^Bpdid not violate
mainuiried if he were placed in

LMC

',WcckJy Business & Expense Re

jrt indicated that on Aprfl 4, 1989, be bad
dinner withflPBHHBV^i^d ^jf^ffttf^^ ^^ Holiday Inn in Detroit, Michigan,
reported that the cost for the dinner was SS636 (Ejihibit 48).

^jecalled tbatM||pi^^^Kand|0HHSwere in [>etroit conducting an

mspecm>n at Lafayette Ginicfl|||f)advised that be and the two inspectors

temporarily resided at the sameboteland met for dinner in the hotel restaurant During

the dinner, W^ff^^^''^^ ^^^ discussed the currentjiolaaons at Lafayette jQinic and

tbe progress of |HMMBi'(''^'^S According to ^[|||^WMi|BlB^^
paid him cash for their meals. He did not recall ho« much each inspector paid

22). -

With respect to^
the inspectors, ^

^expense account not reflecting the monies provided to him by
ive the same explanation as be did for his dinner with
eiterat^d that_the NES accounting process for cash received was

itgdinaM
complicated and cumbersome. (|HHpt emphasized that ^■■MHI^^B was not

" moncyne

concerned with the amount of moneybe spent on a trip, out with the success (^ his trip.

fSB, Region IH, suted that be was ^miliar

with~NES as a health physics consulting firm to some NRC bceosecs. ^^MBIHHIPwas
aware that NE$ was involved with two NRC licensees, Lafayette Clinic and Univer^ty of
Cincinnati ^ftfttttf'^^^^^^ ^^' ^^ came in contact with NES while conducting an
inspection at Lafayette Clinic in April 1989 (Exhibit 31).

On April 4, 1989,|H|B0HiPrecalled dininEwithNES representative,!

\ He maintamed that the dinner withj^BHAoccuried after work hours.

trainee mspecto; were sittmg in
Upproacbedhim andP^PHPl and
sUeved iba^^^ppwas staying at tbe same
I while tbe three ate dinner they

^explained that be and!

ioliday Inn Hotel restaurant when
asked if be could join Ibem.
hotel as be andgHPlI According
discussed tbe radiation protection indtisti>.

6bMHH| stated that each person paid for their meal, and be and^HttVpaid
^sb^c^rding to^MpMH^'My geoeral practice is to pay for tbe meal myself
using my own cash as opposed to giving the mottfy to_jQmeooe else and letting them
pay" (Pg 11). He claimed that be did not aflowf^Pl^lo pay for tbe meaL

\rrrK

• -.T

«^•••. \^

251

r— -•.. ,v.- ff%»y

lid Dot bebeve there was anythinf improper about be aodHHUJ^ dining
witb^^^^iocluding tb: appearance of any improprie^^|||||PSMrstatedtbat be
^^HilPH^^^''^ ^^^ '^^^ '^'^ inspectors could not accept any meals, fratuities, or
gifts from licensees or contractors. He added that as an inspector b< was taugbt to
decline meajs with bj^ensees or contractors. However, IflBflHiPinformed tbat be did
not decline fliipmi request because be 'did not feel ibere was any problem with him
joining us for a casual dinner' (Pg IS).

iDivisioo of Radiation Safety and

Safeguards (DRSSj, Re^n n. began his career wjtb Regioo ID in 1989. Upon
raduating from coUegeMi^[|pwas hired as ai ~

informed tbat bis initial supervisor w:

ioNMSB.
ibit32).

St inspection trips was to Lafayette Clinic witb(

, _ __, Jin April 1989 SpHmiPi advised tbat be acoompanied!^|pp^lPPin a

training capadt>' and was not mtimately acquainted with the issues of the in^ctioa.
""^ believed NES was the consultant to Lafayette Ginic, but was not positive <rf
f role'

bad dinner with
^^^^bappeoed to meetij^
the lobbvoftbe hotel, where all three were staying~pii|||||fl|oontim)ed that after
meeting pmi^in the hotel lobby, they all went to the hotel restaurant and sat at the

acknowledged that on April 4, 1989, be
explained that be aod{
ibv of the hot

same uble. He did not recall anyone ^king whether tbe other wanted to eat with one
another. (p|H||^ reiterated that b^> AVHBBMpaod||pHI|h)appeDed to meet and
sit down togetnerai tbe same table. ^'

_ .maintained that each person paid for their meal He did OM recall how much
be paid, but suggested SlO, S 12 or S 15 in cash. (Jimm^did not recall what was
discussed at the dinner, althoyeh. ly stated that informaboD cooceming tbe inspection at
^e clinic was not discussed flBBilPbelieved tbat each perv>o bad a separate bilL
^Pl^jJIJ^did not recall specuicali> requesting a separate bill but maintained that be
typically did so.

f did not believe that be bad been fonnaHy advised of the conflict of interest

rules at this point in bis career. According ^<><|H0B|^^twas probably more or less
I was running off common sense type stuff* (Pg 16)l^QHl^uted tbat be did not
think there was a conflict of interest problem if a dinner with a consultant concerned
business.

252

{■fiiNDAY nny 21 1991 meal wtth^

The Weekly Business & Expense Reponof||Hp indicated that on July 21, 1991. be
bad luncb witb^HmMfiP*<igWB||at a resuurani (oaxDC unknown) in
Washington, DC^^j^j^cponed tbai tbe cost for tbe luncb wa& S64i4 (Exhibit 49).

|MB|#itold OIG tbat be and his wife had brunch witbymHBknd his wife in
Annapolis, Maryland, instead of Washington. D.C. He advised tbat tbe brunch was
purely a social event. According ^oi^j/flf^he and lus wife anended a Health Physics
show in Washington, D.C. and stopped by to visit tbe^mp[||||§ He informed that the
foursome went to brunch at a restaurant on tbe waterfront in Annapolis (Exhibit 22).

^MPI^did not recall wbetber{||pdBm|MM^paid for their meaL However,
sBESstated tbat be did not mind gaymtlorjfBPJpbecause be believed a bruodi
was tbe least be could do for^flpHHHVHPcxplained thatp|^||m|i>as^

(^■■MjjAat NES for many yean, and theyhad developed » good friendship.

Ijdn^believe his friendship witb^Q^p^ilposed a problem to the NRC because
Iwork at the NRC did not relate to NES.

_^^^^_^___^_^^ jtcd that subsequent to his being hired by tbe N^C in February
^990, be dined witb^||0WM0|#informed that be jus kaovi^BBlftfof
approximately JJj'ear^. having worked witb_him at NES. §PP|piVrecaOed one
occasion when 9|V^<^ ^ ^^ visiied^gHm^^nd his wife. According to
(jMBHl^tbelSBi^^''^^ ^ ^^ Maryland area visiting tbe Annapolis Naj^^^
Academy in anticipation of their so^sfuture enrollment ai tbe academy. pHHHP
noted tbat be and his wife took tbe iBBM^o bruncb_»i the Middleton Tavern and
later gave them a tour of tbe naval academ>~pil|m0fdid not recaD tbe date of the
jrunch, but believed it occurred on a Sunday during the warm weather season.
lid not recall who paid for brunch (Exhibit 21).

kiatfd that he was aware of the NRCs policies on confLa qfjnterest and
Employee conduct codes, but did not bebeve bj violated any niles. LoMMPview.
there was not a problem with his brunch wiit^HH^because tbey bad a friendship that
was estabUsbcd prior toj|(||B||S>vorkin|attbeNRC He noted that his work at the
NRC did not effect NES in any manner JlSHiadded that neither the business of
the NRC nor NES was discussed at the brunch.

CARDING THE MEALS

INTERVIEW OF NES'i
WITH REGION ffl:

0/tttKl^tggtflttttMlttMtAf^^ stated that NES bad a practice of not paying for
^ve^ent employees' mealf1>ecaiise his employees knew it was against the
government's regulations. j^HMV^^^^^ (bat be did not implement (his practice as a
written policy. M9||H||)^Iicv^(I <^^ ^ ^^^ employees understood that government

ntnniv. m ^

253

OFFICIAL USt ONLY

employees were not to be takeo out and entertained. However.fipflH^maintained
that sitting down and splitting the cost of a meal with a government employee was
accepuble (Exhibit 19).

Jstated thatupoD receipt of an OIG subpoena for NES documents on May
1992, he DoucedJgBH expense accounts reported m^ with NRC/Region ID
inspeaors. gHWPi|^d>jsed that be questioned JUPIMb regarding the meals and
believed him whenBSI^Ss^d the Region m inspeaors paid cash for their meals.

[piiBjg noted thaMhere were not many occurrences of meals with Region ID
bispectors. and PMiS bad been very scrupulous in the past so he believed him

JPflHHBexpiained that he probably gave a cursory examination of ^Jifefll expense
account and left the accounting particulars to the NES* Accounting Department

^MKKttt^tzted that NES w^ked on the honor system He acknowledged that be
would have preferred \bat JUpWflreduce the amount the inspectors paid him for the
meals. He added thai jBIWi should n^have "pocketed* any money paid to him by the
inspectors gjHHiplrancluded that if glMH received money _from the jnspectors and
did not account for it on his expense reports thenjt was g^ong 9MHB^'^<' ^^^ ^^
was not overly concerned about the disparities in^lM|^^xpense report because he
was primarily interested in the how productive his employees' business trips were for
NES.

INTERVIEWS OF NRC/REGION HI MANAGEMENT REGARDING
THE MEALS WITH NES:

- E)RSS, stated that he was not aware any inspector had

3ed with NES representatives. JjpMlB^advised that approximately a week prior to
his interview with OIG^jitBPHHtold him that he had gone out to dimier with an
NES representative oo one occasion. jmUl^noted that ft|BBi^^|ilinsisted he
paid for his portion of the meal. He added that g|MMHi^rovidedthL information
unsolicited (Exhibit 50).

[stated that "Conflict of Interest* training for Region m inspectors began in
1989 and continues. He infonned that the inspectors were given scenarios that were
applicable to avoidingjneals or^ngaging in social activities with Ucensees or licensees'
contractors. Further.gBBNHS stated that after the various scenarios were discussed
the inspeaors were queried for the correct response to ensure that they were cognizant
of appropriate conduct by NRC employees. ^IBMP^ added that NRC/RegjoD ID
inspectors were trained and quizzed on Title 10 Code of Federal Regulations (CFR) SO
Part 0. Certification of such training is documented by having each inspector im'tial and
date his Training Qualification Card periodically.

_ [ DRSS. Region n, advised that he was not aware of

ai^ Region HI inspector having a meal with NES during his tenure as a Region in

OFFICIAL USE ONLY

254

OfncMiBSEcmr

\ indicated had he knowo an inspector bad dinner with a
consultant, whether the inspector paid for the meal or tkot^jlfllflfll0woaid have
counseled the individual. tMl0H|^>eUeved that a mea] with licensees and/or
consultants posed an appearance of a confliq of interest. Further JMUBBpstated
that there was a more serious problem vrnhmptH^^dininf witb a consultant
because as a^MHpmSP'^VW ^^^ power to make decisions affecting the
licensee (Exhibit 39).

jjmjj^said that he^utioned his inspectors not to have hincb with Ucensees.
According to ipPHH(^ each inspector was given a Training OualiScations Journal
upon being hired in the region, which provided instruction oooceming conduct codes for
inspectors. tS0|ff||||||[^continued that after receiving the appropriate jastnictiom. an
inspector must sign the journal certifying that instructions were given. ^HHflP^^^^
that at least once a year during his tenure be bad meetings or discussions regarding
conflict of interest rules.

advised that as pan of his responsibilities as

_^^ ae reviewed the 'Conduct of Employees,* Part Ooftbe Code of

Fede^Regulations (CFR) with all new Region ID employees, ipmi^said he
explained to the employees that peals should not be taJcen and to be disaete about pre-
existing friendships. In addition, gUmp^reviewed the Fundamentals of Inspection
with all new inspectors to Region ni^J^BH^oted that the region has received the
conflict of interest announcements generated &y NRC headquarters throughout the years.
According to fM^PJlli Region ID employees, espedaUy the inq>ectots are well versed
in conflict of interest rules (Exhibit 43).

In addition to the NRCs period announcements and regulabons contained in CFR Pan
O, Region ID inspectors were provided guidance in the NRC inspection Manual,
Chapter 1201. "Conduct of Employees ' The NRC Inspection Manual 1201-07 (b)
Ideals., sutes: 'Employees shall not go to places of entertainment or out to eat with an
employee of a licensee or its contractors when the NRC emplovee is normal!) assigned
to work on, or is responsible for, matters directl) affeaing that bcensee or contractor.
This restriction applies even though the NRC employee pays his or her own way*
(Exhibit 51). The manual further instructed employees to discuss with their immediate
supervisor aO cases of actual or potential conflicts of interest or simations which might
lead to the appearance of a conflict of interest

FLNDINGS/ALLEGATION II

Tbe^IG investigation disclosed tha| NRC emptoyees.(liMBPWBMWyBBBli#

3^<^^!iP0BHMi»^u>^ ^'(b NES representative,

>n different occasiott/nowever, the investigation did not

etennine whether the NRC employees received a gratuity in the form of
Tbe employees stated they paid otsb for their portion of the meals,

255

^ - V:UT

however, the employees' testimonies were not consisteot witb%|^||||pl^
and Expense Reports.

submitted expense

Tbe investigatJOD disclosed that on iFffCT separate occasions

reports reOectioi that be incurred the full cost of tbe NRC emplc^es' meals. |

testimony^doot adequately address his claims represented on his expense reports.

Eitberi^llllll^ubmitted false expense reports to NES or was untruthful to OIG. In

either situation, the perception exists that the government employees received free meals

fromf

Tbe investigation revealed that :
were not sufBciently sensitive to their responsibility to^
or CTeate the appearance of a conflict of interest As^

fl^MRmiP aJod^l^l^MS^^'^^ directly involved with tfie regulatory activities that
affected SES, as a contractor. These inspectors should have been aware of tbe
restriction for accepting meals with a Ucensee or its contractor, including meak that were
paid for by them.

Tbe investigation didnotdevelop sufficient evidence to determioe ^^tVBfMHV
dined with9^ptfMMM^^hedHMB|l0fwas an NESemployec. ■BHp^^tated
that be dined witMMB||||on two occasions._in whichH|iP^|^^Week^ Business and
Expense, Reports reflect the two occasions, ^im^ categorically denied having a meal
wi

|0D either occasion.

ExhibiU:

OFFlGia USE V^

256

257

American College of Medical Physics

1891 Preston White Drive • Reston, Virginia 22091
(703)648-8966 • (703) 648-9176 FAX

June 2, 1993

The Honorable Senator John Glenn
United States Senate
Washington, D.C. 20510

Dear Senator Glenn,

On behalf of the American College on Medical Physics, I wish to
thank you for the opportunity to provide testimony to the Senate
Committee on Governmental Affairs hearing on federal regulation of
medical radiation uses. Enclosed you will find a copy of our
testimony to be included in the official records of this hearing.

Certainly, The American College of Medical Physics is willing and
anxious to provide to your Committee any additional information
which you require. Thank you again for the opportunity to submit
this testimony.

Michael T. Gillin, Ph.D
Associate Professor

MG/keo

Executhw Committee: Michael T. GiDin, Ph.D., Chairman • David L. GoH, Ph.D.. Immediate Past Chalnnan
Stephen W. Nagy. Ph.D., Vicc-Chairman • Alexander P. Turner, Ph.D., Secretary • Alan L Huddleston, Ph.D., Treasurer

Board of Chancellor*: Herbert W. Mower, Sc.D.
Roy E. Landers, Jr., Ph.D. • Faiz M. Khan, Ph.D.

Edward L NickobH, Sc.D.
Vernon Joe Fickcn, Ph.D.

' Larry D. Simpson, Ph.D.
Benjamin R. Archer, Ph.D.

Suresh K. Agarwal, Ph.D.
• Melissa C. Martin, M.S.

Executive Director: Laura Fleming Jones

258

Statement to the Senate Governmental Affairs Committee
by the American College of Medical Physics. May, 1993

The American College of Medical Physics(ACMP) appreciates the opportunity
to express to the Senate Governmental Affairs Committee its positions on federal
and state regulations on "Medical Radiation Protection' and associated topics.
The ACMP is an organization of senior, clinically experienced medical physicists
in the United States who are especially interested in the contributions their
professional expertise can provide toward patient care and safety. Medical
physicists are the board certified, non physician, medical specialists who bear the
responsibility for ensuring the specific quantity, quality, and placement of
radiation doses in any medical imaging or therapeutic procedure involving
ionizing radiation. The ACMP agrees with the concerns expressed by Senator
Glenn relative to the scattered, fragmented, and inconsistent regulations on the
medical use of radiation. In addition, the ACMP is concerned that future cost
containment pressures may result in the reduction of the existing standards with
a subsequent increase in risks to the public health.

The risks to the public health from the use of ionizing radiation have been well
studied. The National Council on Radiation Protection and Measurements
(NCRP), an organization chartered by the U.S. Congress, and its predecessor
national committees have been involved with this topic since 1 929. The NCRP
has published over 100 reports which contain detailed recommendations on
medical and non-medical uses of ionizing radiation. There have been multiple
reports of the Advisory Committee on the Biological Effects of Ionizing Radiations
(BIER) of the National Academy of Sciences. From the public health perspective,
the diagnostic use of ionizing radiation exposes a much larger portion of the
population than does the therapeutic use of ionizing radiation. To avoid the
fragmented situation noted by Senator Glenn, the ACMP recommends that any
federal initiative address both diagnostic and therapeutic uses of ionizing
radiation. To focus on the one thousand linear accelerators in the U. S. and to
ignore the hundreds of thousands of diagnostic x-ray tubes would indeed be
inconsistent. In April, 1992, the ACMP held a symposium entitled Current
Regulatory Issues in Medical Physics. The symposium addressed the following
topics:

1 . Suggested State Regulations for Radiation Therapy

2. Suggested State Regulations for Diagnostic Radiology

3. Licensure of Medical Physicists

4. The NRC Quality Management Program and Misadministrations

5. The New 10CFR20 Radiation Exposure Limits for Personnel and the

Public

6. Mammography Equipment Performance Requirements

7. Equipment and Software Requirements for Radiation Oncology.
(A copy of that symposium accompanies this report.)

259

Regulatory issues and public health concerns and patient health concerns
have been addressed by numerous scientific, professional, educational private
and public organizations. The ACMP urges the Committee to review the
recommendations of the various organizations while considering the drafting of
any new legislation.

The American College of Medical Physics has passed several resolutions
which speak directly to the concerns raised by Senator Glenn. One resolution
"urges that federal regulatory responsibilities for medical devices including the
use of ionizing radiation be consolidated into one agency which by virtue of its
comprehensive regulatory position will be in a better position to protect the public
health and insure patient safety and will be better positioned to coordinate with
the individual states to implement their oversight responsibilities, and that this
agency be the Food and Drug Administration" (adopted March, 1993). The FDA
through the Center for Devices and Radiological Health (CDRH) has a long and
basically successful history in protecting the public health from both diagnostic
and therapeutic medical applications using ionizing radiation. They have
developed good working relationships with the states, with industry, and with
users. The Nuclear Regulatory Commission, on the other hand, spends less than
5% of its budget to regulate less than 2% of the medical uses of ionizing
radiation. They have been very slow in dealing with new technology, such as
remote afterloading devices. The relationship between the NRC and others,
including the states and the NRC licensees, tends to be more legalistic than
constructive. Chairman Ivan Selin of the U. S. Nuclear Regulatory Commission
in his statement to this Committee acknowledged that there are areas where
improvement is needed in the NRC's medical use program. Certainly, the
weaknesses of the NRC's programs have been long apparent to those being
regulated by this agency. It must be noted that the NRC's Advisory Committee
on the Medical Use of Isotopes met directly with the Commissioners JoUtlfiJilSl
time ever in 1992. One question which should be faced by the Committee on
Governmental Affairs is can the NRC cast off its history of isolation and refocus
itself from "detailed compliance with NRC requirements" to "overall radiation
safety performance" in the medical environment, as was suggested by Chairman
Selin.

Another ACMP resolution "recommends that the Radiation Safety Officer
(RSO) named on the license for each medical institution should be independent
of the direct clinical use of the radiation producing equipment and the radioactive
material, and should report directly to the institution's management for the
purposes of radiation safety". As part of the same resolution, the ACMP has also
stated that "the institution's management must assure that the RSO named
possesses appropriate and sufficient training in radiation safety for the
responsibilities imposed by the type of medical procedures being performed and
has the necessary experience in radiation safety in the medical environment to
manage the radiation safety program in a safe and efficient manner" (adopted
March, 1993). The current practice in many institutions is to name a physician
who is an authorized user for the medical use of radiation producing equipment
and radioactive material as the radiation safety officer or the chairman of the

260

oversite committee to which this officer reports and this results in the user being
the evaluator of the radiation safety program. Title 10 CFR Part 35.21 , 22, and
23 and 35.900 (copies attached) contain the pertinent details of the NRC's
requirements for the RSO and permit this real or perceived appearance of this
conflict of interest in the supervision of the radiation safety program.

Another ACMP resolution "urges the USNRC and appropriate state licensing
agencies that appropriately trained and experienced medical physicists be named
on the license for each use of radioactive materials, including afterloadlng units,
and that such individuals be charged with the responsibility of insuring patient
safety for the treatments delivered with such units", (adopted March, 1993). The
NRC in Part 35.961 (copy attached) lists the training for a teletherapy physicist.
The NRC has yet to develop any regulations describing the minimum training
requirements for any aspect of brachytherapy including remote afterloadlng
devices. As recent tragic events have indicated, it is prudent and wise to
supplement the medical focus of the physician with the safety focus of the
physicist. The failure to address staffing and training needs for brachytherapy
procedures must be corrected soon.

It must be noted that the Nuclear Regulatory Commission currently requires a
license for an individual to handle teletherapy sources. A NCR license is also
required to calibrate a Geiger counter, to calibrate a nuclear medicine dose
calibrator, and to possess the sources used in such calibrations. All of these
licenses are granted by the Nuclear Regulatory Commission or an agreement
state. In the 1 980's the NRC required that the teletherapy physicist be named on
the license. Why has the NRC chosen not to require licenses to calibrate cobalt
teletherapy units or sealed sources used in brachytherapy? Both of these
applications of radioactive material have been used for decades. Apparently it
required the Indiana, Pennsylvania accident with a high activity source used in a
remote afterloadlng device to force the NRC to address issues associated with
this new technology.

The American Association of Physicists in Medicine Report 45 states that a
medical radiation oncology physicist should be on-site during operational hours of
a radiation therapy clinic. The Report of the Inter-Society Council for Radiation
Oncology, Radiation Oncology in Integrated Cancer Management. November
1986, contains the following description of medical radiation physics activities:

The ultimate objective of the medical radiation physics activities
is to insure the delivery of high quality treatment. This requires
quality control of the physical components of treatment. Necessary
surveillance includes:

1 . equipment functioning and safety

2. treatment planning

3. treatment application

4. dosimetry

5. personnel radiation safety.

261

From the information gathered on the high dose rate remote afterloading accident
in Indiana, Pennsylvania, it appears that the institution did not have a full time,
on-site physicist. Perhaps one reason why there was no qualified medical
radiation oncology physicist present is related to recent changes in the HCFA
reimbursement policies for physics services, namely that for free standing centers
the global fee for medical physics services is paid to the physician. The absence
of federal and state regulations requiring that qualified medical radiation oncology
physicists be on-site during operational hours and the difficulties associated with
institutions being appropriately reimbursed for physics services has partially lead
to the current concerns expressed by Senator Glenn and others. Qualifications,
staffing, and appropriate reimbursement are all issues which the Committee
should explore.

In the diagnostic area, HHS has published regulations specifying the
qualifications of physicists who can calibrate mammography units. This is the
only such requirement for the calibration of diagnostic ionizing radiation devices.
The JCAHO does require annual calibration of diagnostic units for those
institutions who seek their accrediation. The appropriate calibration of the tens of
thousands of x-ray units in private offices is substantially less certain.

The question of appropriate qualifications for individuals who are given the
responsibility for insuring the public health with respect to the use of ionizing
radiation is a very important one. Two different specialty boards currently certify
the minimum qualifications of most medical physicists in the United States,
namely the American Board of Medical Physics and the American Board of
Radiology. There are now over 1 ,000 board certified medical physicists in the
United States. Licensure of medical physicists is now required in the State of
Texas. There is movement towards licensure in some other states.

The NCRP has published a definition of a qualified expert for several decades
which is based upon board certification. The American College of Medical
Physics has adopted the following definition for a qualified medical physicist:

A qualified medical physicist is an individual who is competent to practice
independently in one or more of the subfields of medical physics.

1 . At the present time, the subfields of medical physics are:

a) Therapeutic Radiological Physics is that branch of medical physics
which deals with (1) the therapeutic applications of roentgen rays, of gamma
rays, of electron and charged particle beams, of neutrons, and of radiation from
sealed radionuclide sources, and (2) the equipment associated with their
production and use.

b) Diagnostic Radiological Physics is that branch of medical physics
which deals with (1) the diagnostic applications of roentgen rays, of gamma rays
from sealed sources, of ultrasonic radiation, of radiofrequency radiation, and (2)
the equipment associated with their production and use.

262

c) Medical Nuclear Physics is that branch of medical physics which
deals with (1 ) the therapeutic and diagnostic applications of radionuclides (except
those used in sealed sources for therapeutic purposes), and (2) the equipment
associated with their production and use.

d) Medical Health Physics is that branch of medical physics which
deals with the safe use of roentgen rays, of gamma rays, of electron and other
charged particle beams, of neutrons, of radionuclides, and of therapeutic
purposes, and (2) the instrumentation required to perform appropriate radiation
surveys.

Additional subfields may be added as required.

2. An individual will be considered competent to practice one or more of the
subfields of Medical Physics if that individual is certified or licensed in that field by
any of the following organizations:

a) The American Board of Medical Physics.

b) The American Board of Radiology.

c) The American Board of Health Physics.

d) The American Board of Science in Nuclear Medicine.

e) The Canadian College of Physicists in Medicine.

Additional certifying organizations may be added as they are recognized.

3. It is expected that an individual will not hold him/herself out to be qualified
in a subfield for which he/she has not established competency according to the
requirements of paragraph 2 above.

4. The American College of Medical Physics regards board certification, in
the appropriate medical physics subfield, and state licensure, in those states in
which licensure exists, as the appropriate qualification for the designation of a
Qualified Medical Physicist (adopted July 17. 1986; revised May 1 , 1993).

The specification of the minimum training and experience of the regulators has
never been comprehensively addressed. Thus in some inspection situations the
high school graduate inspector is evaluating the work of the physician and the
Ph.D. physicist. The substantially greater expertise of those being inspected
diminishes the inspection process.

263

In summary, the ACMP salutes Senator Glenn and other members of the
Senate Govemmental Affairs Committee for the identification of problems in the
area of medical radiation protection. The ACMP shares Senator Glenn's
concerns about the current regulatory situation, which is not only scattered,
fragmented, and inconsistent, but Is also very expensive. The American College
of Medical Physics wishes to emphasize the following points:

1 . The entire spectmm of the medical uses of ionizing radiation should be
reviewed to adequately address all public health concems.

2. The Center for Devices and Radiological Health of the Food and Dnjg
Administration be the appropriate federal agency in which to center all federal
activities involving the medical use of ionizing radiation.

3. There should be both federal and state regulations which define a qualified
medical physicist and which require a qualified medical radiation oncology
physicist to be on-site during operational hours for radiation oncology clinics.

4. HCFA should be requested to develop appropriate reimbursement regulations
which insure that adequate funds are available to support all medical physics
activities and that such funds are only paid when there are appropriately qualified
medical physicists associated with the services provided to the Medicare patient.

5. The NRC be instructed to:

A. License medical radiation oncology physicists to calibrate Co-60
teletherapy units and brachytherapy sealed sources.

B. Name medical physicists on the license of each institution who wishes
to perform brachytherapy procedures.

C. Develop regulations to require that the radiation safety officers at
medical institutions be independent of direct, clinical responsibilities

6. The Department of Health and Human Services be instructed to issue
regulations that require all diagnostic radiology units, which image Medicare
patients, and not just mammography units be calibrated by a qualified medical
physicist.

The American College of Medical Physics will be pleased to provide the
Committee with any additional information which the Committee would require
and is grateful to the Committee for the opportunity to express its opinions.

264

American College of Medical Physics

Executive Committee:

David L. Goff, Ph.D.

Chairman

Jimmy O. Fenn, Ph.D.

Immediate Past Chaimian

Michael T. Giliin. Ph.D.

Chaimnan Elect

Stephen W. Nagy. Ph.D.

Secretary

Alan L. Huddleston. Ph.D.

Treasurer

Board of Chancellors:

Hertwrt W. Mower, Sc.D.

Edward L. Nickoloff. Sc.D.

Alfred R. Smith. Ph.D.

Suresh K. Agarwal. Ph.D.

Roy E. Landers. |r.. Ph.D.

Falz M. Khan. PhD

David W. Switzer, M.S.

Benjamin R. Archer. Ph.D.

F. Eugene Holly. Ph.D.

Executive Director:

Laura Fleming )ones

April 16, 1993

The Honorable Senator John Glenn

Chairman

Government Affairs Committee

United States Senate

Dear Senator Glenn,

The American College of Medical Physics, a professional
organization consisting of the senior medical physicists in the
United States, has recently adopted three resolutions pertaining
to regulatory aspects of the use of ionizing radiation for medical
purposes. Enclosed find copies of those resolutions. It is my
request that they be included in the record of the hearings which
the Governmental Affairs Committee is going to conduct next week
with representatives of the U. S. Nuclear Regulatory Commission.

0hank you very much for considering this request. Clearly, I would
be happy to expand in these issues with you or a member of your
staff. It is my hope that your hearings go well.

Michael T. Giliin, Ph.D
Chairman, ACMP

MG/keo

1891 Preston White Drive. Reston. Virginia 22091
(703) 648-8966

265

Whereas,

Radiation safety is an important aspect of every medical
application which uses ionizing radiations in patient diagnosis or
treatment, and

Whereas

the public, medical personnel, and the patient have a right to
be safeguarded from the mis-use of ionizing radiations whether
produced from equipment or from radioactive materials, and

Whereas

The current practice of medical institutions is to name
aphysician who is an authorized user for the medical use of radiation
producing equipment and radioactive material as the radiation safety
officer (RSO) or the chairman of the oversite committee to which this
officer reports and this results in the user being the evaluator of the
radiation safety program.

Whereas

It is necessary to avoid real or perceived appearances of any
conflict of interest in the supervision of the radiation safety program,
and

Whereas

Assuring that appropriate trained and experienced staff
necessary for the proper performance of the duties of a radiation
safety officer is the responsibility of the medical instituion's
administration, therefore

Be It Resolved that the American College of Medical Physics
recommends that the Radiation Safety Officer named on the license
for each medical institution should be independent of the direct
clinical use of the radiation producing equipment and the radioactive
material, and should report directly to the institution's management
for the purposes of radiation safety. Be it further resolved that the
institution's management must assure that the RSO named possesses
appropriate and sufficient training in radiation safety for the
responsibilities imposed by the type of medical procedures being
performed and has the necessary experience in radiation safety in
the medical environment to manage the radiation safety program in
a safe and efficient manner.

266

Whereas

The duplicative efforts and oversight functions of the various
federal, state, and local regulatory agencies or departments
pertaining to the medical use of ionizing radiation are costly,
wasteful, and a dilution of the limited, specialized talent contained
within these various agencies or departments

Whereas

One federal agency by virute of its comprehensive regulatory
position will be in a better position to protect the public health and
insure patient safety and will be better positioned to coordinate with
the individual states to implement their oversight responsibilities

Be It Resolved that the American College of Medical Physics urges
that federal regulatory responsibilities for medical devices including
the use of ionizing radiation be consolidated into one agency who by
virtue of their comprehensive regulatory position will be in a better
position to protect the public health and insure patient safety and
will be better positioned to coordinate with the individual states to
implement their oversight responsibilities and that this agency be
the Food and Drug Administration.

Whereas,

High dose rate, remote afterloading units are inherently
complex electro-mechanical devices which contain high activity
radioactive sources that are transported by mechanical means into
and from the patient

Whereas,

Recent events have demonstrated the potential for great harm

to patients from these devices.

Be It Resolved that the American College of Medical Physics urges
the USNRC and appropriate state licensing agencies that
appropriately trained and experienced medical physicists be named
on the license for each use of radioactive materials, including
afterloading devices, and radiation beams, as is currently done for
Co-60 units, and such individuals be charged with the responsibility
of insuring patient safety for the treatments delivered with such
units.

267

1101 Connecticut Avenue, N.W. • Suite 700 • Washington, DC. 20036

American
College of
Nuclear
Physicians

(202)429-5120

Fax (202) 223-4579

The Society

of Nuclear

r\/ledicine

STATEME>fT SUBMnTED TO THE

U.S. SENATE GOVERNMENTAL AFFAIRS COMMFTTEE

Regarding

MEDICAL RADIATION PROTECTION

On Behalf of

The American College of Nuclear Physicians

and

The Society of Nuclear Medicine

May 13, 1993

For More Information Contact:

Kristen D.W. Morris

ACNP/SNM Director of Government Relations

(202)429-5120

268

The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine
(SNM) are submitting the following comments to the Senate Committee on Government
Affairs to describe the medical practice of nuclear medicine and to clarify the distinction
between it and radiation therapy. We will discuss the inherent safety of the radioactive
tracer materials used in nuclear medicine, the counterproductive nature of duplicative
regulation, and the burden of increasingly costly regulation which we believe will not
significantly improve medical care or radiation safety.

As the two largest voluntary health care organizations dedicated solely to the practice of
nuclear medicine, we will always support reasonable efforts to improve the safety and quality
of medical care provided to patients. It is unfortunate when public attention to medical care
involving the use of radioactive materials is communicated by the media in a sensationalistic
or confusing manner, or in a way that is not fully informative. We have concerns that this
kind of reporting may in some cases cause patients to delay or even avoid necessary medical
testing for lifesaving treatments.

We appreciate the opportunity to provide information which will put into perspective the
relatively few, unacceptable, untoward medical events involving radiation in nuclear
medicine. In contrast, approximately 10 million properly performed diagnostic and/or
therapeutic procedures each year in nuclear medicine have individually and collectively
improved health care in a cost-effective, safe manner.

Specialty Background

The College (ACNP) and the Society (SNM) have approximately 15,000 physician,
pharmacist, scientist, and technologist members dedicated to the si}ecialty of nuclear
medicine. There is a separate medical Board certification for physicians (American Board
of Nuclear Medicine), as well as independent Board certification for nuclear pharmacists
(American Board of Nuclear Pharmacy), for nuclear medicine scientists (American Board
of Science in Nuclear Medicine), and for nuclear medicine technologists (Nuclear Medicine

269

Technology Certification Board). Prior to the establishment of these Boards, members have
completed approved training programs meeting strict standards.

Nuclear Medicine is a medical specialty in which tracer amounts of radioactive drugs are
used to diagnose a large variety of illnesses in patients being evaluated by practitioners in
primary care and most of the medical and surgical specialties and subspecialties. Examples
of the types of medical or surgical conditions diagnosed include coronary artery disease,
infections, metastatic prostate and breast cancer, sports "shin splints" or stress fracture
injuries and gallbladder disease. Nuclear medicine physicians administer a lesser number
of treatments to patients using larger amounts of radioactive drugs for cancerous and
serious, non-cancerous medical conditions. Thyroid cancer, painful cancerous bone
metastases from prostate cancer, life threatening blood disorders and hyperthyroidism are
a few of the disorders which often are eliminated or improved as a result of treatment with
radioactive medicines.

Nuclear Medicine is distinguished from other medical specialties by the expertise in using
radioactive drugs which are "unsealed sources." That is, radioactive drugs which are usually
injected, swallowed, or inhaled and concentrate in specific organ tissues or abnormalities
such as tumors. This differs from other medical specialties using radiation such as diagnostic
radiology or radiation oncology which use sealed sources of radioactive material or radiation
producing machines.

Approximately 10 to 11 million patient procedures are performed in nuclear medicine each
year. Additionally, about 100 million tests analyzing body fluids by "radioimmunoassay"
(RIA) are performed each year using tracer amounts of radioactivity. In these RIA tests the
radiation has no contact with the patient. Most of us know someone who has benefited from
a pregnancy test (beta-hCG), prostate cancer tumor marker PSA, ovarian cancer tumor
marker CA-125, thyroid function tests, etc. Most of these tests have involved the use of
radioactive materials in radioimmunoassay.

270

WhDe the Senate hearing on May 6, 1993, very clearly described the difference between
nuclear medicine and other specialties, the definition was lost on other members of the
public. Following the hearing several stories appeared in the media which perpetuated a
misunderstanding regarding nuclear medicine' K Our specialty has suffered due to the
assumption that nuclear medicine is a generic term for all medical radiation procedures. We
hope that as Congress continues to review this issue that this distinction in nomenclature is
maintained.

Safety Aspects

It is estimated that the average citizen in the United States receives about 300 mrem per
year of background radiation. This compares favorably with the small amount of radiation
received by patients from a diagnostic nuclear medicine procedure. The National Council
for Radiation Protection and Measurement (NCRP) has indicated that this average effective
radiation dose for a nuclear medicine imaging test is 440 mrem per year. To put this small
patient radiation discussion into perspective, please consider the NRC (Nuclear Regulatory
Commission) guidelines allowing a radiation worker to receive up to 5000 mrem per year
or ten times more than a patient receives from the nuclear medicine test. Radioactive drugs
used in nuclear medicine tests are used in such minute amounts that it is truly rare for a
patient to experience any allergic reaction, side effect, or untoward results. In fact, a
pregnant woman with chest pain or shortness of breath who is thought to have a significant
risk of life-threatening blood clots in the lungs (pulmonary emboli) is deliberately sent to a
nuclear medicine physician for testing with radioactive drugs.

About 200 million Americans have benefitted from these radioactive drugs during the past
half century. A testimony to the cost-effective, medical benefit and safety of the procedures
is exemplified by the increased utilization and reliance on nuclear medicine procedures by
physicians expert in other medical specialties such as primary care, cardiology, surgery,
urology, etc. A recent publication in CA: A Cancer Journal for Qinicians the highlights
from the National Cancer Data Base: 1993 were discussed '. This article indicates that

271

bone scans in men with prostate cancer increased from 21.5% in 1974 to 73% in 1990.
Treatment for these men depends in significant part on information proved by these tests.

Commitment to Quality

Our members have a strong commitment to quality in the nuclear medicine profession.
Annually for the last 40 years the Society (SNM) has held a national education meeting to
advance the quality practice of nuclear medicine. A monthly scientific journal for nuclear
medicine professionals is published by the SNM. The ACNP has a mature, peer review
practice certification program to foster the delivery of safe, quality nuclear medicine services
in hospitals and clinics in the United States. These voluntary peer-review inspections are
growing in number and we hope that more practitioners will participate in the future.

We are encouraged by the stated willingness of the hfRC to consider accepting peer review,
nuclear medicine practice certification programs to be an alternative to NRC inspections of
the quahty management aspects of a practice. We also support the recently instituted NRC
Visiting Medical Fellow Program which included a nuclear medicine physician and a nuclear
pharmacist at NRC for the first time in NRC's history. The pending NRC contract with the
National Academy of Sciences or Institute of Medicine, which would study the role of NRC
in the medical use of byproduct material, should provide excellent, independent insight into
present problems. We look forward to the swift initiation of this much needed project.

Regulation

Nuclear Medicine is more regulated than any other medical specialty. In addition to the
normal medical regulatory controls, inspections, and paperwork (from the Health Care
Financing Administration, the Joint Commission on Accreditation of Healthcare
Organizations, the Occupational Safety and Health Administration, etc.), multiple Federal
agencies have a responsibility for oversight of some aspect of the activity in nuclear
medicine. NRC regulates radiation safety, the Food and Drug Administration (FDA)

272

regulates radiopharmaceuticals, the Environmental Protection Agency (EPA) regulates
radiation in relation to the environment, the Department of Transportation (DOT) regulates
transportation of radiopharmaceuticals across State lines, and the Federal Trade Commission
(FTC) regulates by preventing us from restricting practice to Board Certified individuals.

At a time when the cost of health care is critical to the public, there is no significant effort
on the part of these agencies to control or reduce costly paperwork. There is not enough
interagency cooperation to reduce overlapping or duplicate regulation. There is no practical
requirement for agencies to prove the significant benefit of a regulation in relationship to
outcome and cost of the regulation.

It is understandable that agencies make an effort to carry out legal mandates. Many of
these agencies are beginning to charge "users" for "services." This is becoming a significant
burden to the public as part of the cost of health care.

Summary

The ACNP and SNM believe that nuclear medicine is being practiced safely and with quality
by the vast majority of practitioners. Distinctions exist between us and other medical
specialties, in terms of quantities of radiation used and the relative risks. Our organizations
will continue to work with practitioners to minimize the relatively few, unacceptable
untoward medical events involving radiation in medicine. We do not believe that new
regulation will add to the safety or quality of nuclear medicine practices. In fact, efforts to
reduce or coordinate the regulation of different Federal agencies allows practitioners more
time to care for patients, and thereby increase quality.

Recommendations

1. The NRC is apparently evaluating its Agreement State Program. We welcome efforts
to give States more authority to manage and monitor radiation safety in medicine just

273

as State Medical boards monitor medical practices.

2. Congress should consider ways to reduce health care costs by the coordination of
overlapping and duplicative regulation by Federal agencies.

3. Congress should consider urging the President to appoint to the NRC a physician to
the NRC Commission. This person should be Board certified in nuclear medicine or
a specialty expert in the use of radiation in medicine.

4. Congress should consider ways to require a review of existing regulation in order to
eliminate those that do not contribute to the public health and safety.

Thank you for the opportunity to comment on this most critical subject. We are available
as a resource and hope to work with the Committee to address the issues presented during
this hearing.

1. ABC Evening News, May 6, 1993.

2. "Nuclear Medicine's Risks Unreported, Most Patients Not Warned of Radiation
Overdoses", Associated Press; Washington Post: Health Section, May 11, 1993, page
8.

3. Mettlin C. Jones GW, and Murphy GP: Trends in prostate cancer care in the United
States, 1974-1990: Observations from the patient care evaluation studies of the
American College of Surgeons Commission on cancer. In Murphy GP. CA: Cancer
Journal for Clinicians 43:83-91, March/April, 1993.

274

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EXPLANATORY INFORMATION ON RECENT

AGREEMENT STATE REVIEWS

REGIONAL RESULTS CHART

ADEQUACY AND COMPATIBILITY FINDINGS'

REGION I

Maine
(1992)

5 Agreement States

States found to be both adequate and compatible - 2

Maine became an Agreement State In April 1992. The first
review was conducted April 26-30, 1993. The report
documenting the results of that review has not been
completed at this time.

Rhode Island The last review was completed in November 1991 and the next
(1991) review is scheduled for November 1993.

States for which a finding of compatibility was withheld - 2

Maryland The last review was completed in April 1991 and the next
(1991) review is schedule for August 1993.

Regulations overdue (and date due):

Waste disposal requirements (1/86)

Transportation safety requirements (9/86)

Waste classification standards (12/86)

Waste shipment & manifest requirements (12/86)

Remove exemption glass enamel & freud (9/87)

Industrial radiography surveys & audits (7/89)

Notification of filing for bankruptcy (2/90)

Well logging safety requirements (7/90)

Medical misadministration reporting (4/90)

Certification of dosimetry processors (2/91)

Funding of decommissioning plans (7/91)

STATUS - A review visit was conducted of the State on
June 9-10, 1992. The visit revealed that the State
regulations continued to be seriously out-dated. In view of
this, the results of the visit were sent to the State in a
letter dated September 16, 1992 in order to bring this issue
to the State's attention.

' The Office of State Programs' Director, upon signing of the letter
documenting the results of the review, routinely calls the Agreement State
management. During this call, the Director indicates the results of the
review with emphasis being placed on areas needing improvement.

276

New York The review of the New York radiation control programs wa^
(1992) completed in November 1992 and the next review will be

scheduled for November 1994.

Regulations overdue (and date due):

New York Department of Environmental Conservation

The regulations regarding low-level waste were determined to
be compatible with NRC regulations. However, a finding of
compatibility cannot be offered until the regulations become
effective.

New York State Department of Health

Funding of decommissioning plans (7/91)

New York City Health Department

Certification of dosimetry processors (2/91)
Notification of filing for bankruptcy (2/90)
Funding of decommissioning plans (7/91)

New York Department of Labor

Funding of decommissioning plans (7/91)

State for which findings of both adequacy and compatibility were withheld - 1

New Hampshire The New Hampshire review was complete in June 1992 and the .
(1992) next review will be scheduled for June 1994.

Regulations overdue (and date due):

Funding of decommissioning plans (7/91)

STATUS - The radiation control program (RCP) is in the
drafting stage of the rule adoption procedure. Adequacy was
withheld for two reasons. First, legal opinions were issued
that indicated the RCP did not have the authority to (A)
require licensees to clean-up contaminated facilities or (B)
impound sources of radiation when necessary to protect
public health and safety. Secondly, the RCP indicated it
would need to relax its inspection effort in order to reduce
a backlog of licensing actions. Efforts to resolve these
issues are proceeding. These efforts have included
assistance by the NRC and the Conference of Radiation
Control Program Directors, Inc, (CRCPD) in reviewing
licensing actions. This has allowed the State to reduce its
backlog of licensing actions.

277

REGION II - 8 Agreement States

States found to be both adequate and compatible - 5

Florida
(1993)

Georgia
(1991)

North Carol ina
(1991)

South Carol ina
(1993)

Mississippi
(1991)

The review was completed on February 26, 1993 and the
next review will be scheduled for February 1995.

Next review October 1993
Next review December 1993

The last review was completed on March 24, 1993
and the next review will be scheduled for March 1995. The
State of South Carolina has continued to have a strong
radiation control program since it became an Agreement State
on September 15, 1969. The program has undergone nineteen
reviews by NRC, and has remained adequate and compatible
during this period.

Next review September 1993

Alabama
(1991)

States for which a finding of compatibility was withheld - 2

The last review Alabama was completed in June 1991 and
the next review is scheduled for July 12-16, 1993.

Regulations overdue (and date due):
Certification of dosimetry processors

(2/91)

Kentucky
(1992)

STATUS - The rule was inadvertently omitted during the last
rules update and a proposed rule is in the adoption process.

The last review of Kentucky was conducted in April 1992.

Regulations overdue (and date due):

Funding of decommissioning plans (7/91)
STATUS - A proposed rule is In the adoption process.

278

state for which findings of both adequacy and compatibility were withheld - 1

Tennessee The Tennessee follow-up review was completed in September
(1992) 1992.

Regulations overdue (and date due):

Well logging safety requirements (7/90)

STATUS - The well logging rules were adopted effective in

November of 1992. Note: There is a slight difference

between the NRC decommissioning rule and the equivalent

Tennessee rule. The question of the compatibility of this

rule is on hold pending a Commission determination of the

"compatibility" issue. Adequacy was withheld due to a
serious shortage of trained staff combined with a large
backlog of overdue inspections.

REGION III - 2 Agreement States

State found to be both adequate and compatible - 1

Illinois The Illinois review was completed in January 1992.

(1992) However, the finding of compatibility is contingent on the
Commission's evaluation of the State's regulations involving
1 millirem per year dose limit at the boundary of a low-
level radioactive waste disposal facility, financial surety
requirements for site reclamation and medical
misadministrations.

STATUS - The compatibility issues with Illinois are still
under consideration by the NRC. The 1 millirem issue is
being discussed at the Commission level. A NRC and Illinois
management meeting is scheduled for June 1993 to discuss the
other compatibility issues.

State for which findings of both adequacy and compatibility were withheld - 1

Iowa A follow-up review of the Iowa radiation control program was

(1993) conducted in February 1993.

STATUS; Both adequacy and compatibility were withheld

because the overall program was deficient due to management

and programmatic deficiencies, which included: maintenance

of adequate staffing levels; completion of technical

training for inspectors/reviewers; and quality assurance

reviews of licensees and reports by management. Corrective

actions are underway, with reports from the RCP to NRC

monthly. As the State has not yet reestablished an adequate

and compatible program, the NRC has offerred continued

short-term assistance to the State. This assistance has

included licensing and inspection training, accompaniments ^j

of inspectors and the review of licensing case work. <l

279

REGION IV - 9 Agreement States

States found to be both adequate and compatible - 5

Arkansas The 1993 review has been completed and the report

(1991) win be issued shortly.

Colorado The last review was completed on April 9, 1993 and the next
(1993) review will be scheduled for April 1995.

North Dakota A review is scheduled for June 21-25, 1993.
(1991)

Utah The last review of the Utah program was completed during

(1992) the week of April 13-17, 1992. The findings of adequacy and
compatible were contingent upon a satisfactory resolution of
the technical quality of the licensing actions taken by
State for the Envirocare low-level radioactive waste
dispos.ll license including the exemption of land ownership.
The next review of the State will be scheduled in April
1994.

STATUS - The land ownership exemption issue is currently
under review at the Commission level.

Texas
(1993)

A follow-up review was conducted in January 1993. The last
routine review was conducted in March 1992 and the next
routine review will be scheduled for March 1994.

STATUS - On March 1, 1992, the Texas radiation control
program was reorganized whereby the primary regulatory
responsibility for the disposal of uranium mill tailings and
low-level waste was statutorily assigned to the Texas Water
Commission (TWC). This authority was previously assigned to
the Texas Department of Health (TDH) . In view of this
reorganization, a follow-up review was conducted the week of
January 25, 1993 to evaluate the transfer of authorities to
the TWC. Although the follow-up review revealed that the
program was adequate and compatible, the review disclosed
that TDH was proposing the deletions of those sections in
its regulations that pertain to the disposal of radioactive
waste; thus, the TWC would have to adopt these same sections
of the regulations, concurrently, in order to have
continuously effective radioactive waste disposal
regulations in the state of Texas. We recommend to the
State that a coordinated effort between TWC and TDH be

280

established to ensure the continuance of the appropriate
regulations for the disposal of radioactive waste in Texas.

States for which a finding of compatibility was withheld - 3

Kansas The Kansas review was completed in February 1993

(1993) and the next review will be scheduled for February 1995.

Regulations overdue (and date due):

Funding of decommissioning plans (7/91)

Industrial Radiography surveys & audits (7/89)

Notification of filing for bankruptcy (2/90)

Well logging safety requirements (7/90)

Certification of dosimetry processors (2/91)

Medical misadministration reporting (4/90)

STATUS - The Kansas RCP has proposed rules to adopt the
above; these proposed rules are currently undergoing legal
review by the State Attorney General. In addition, a
special visit was made to the State on May 4, 1993 by NRC
management to encourage the expeditious adoption of
regulations by the State. A commitment was made by Kansas'
management to have all regulations promulgated within the
next 30 to 60 days.

Louisiana The last review of Louisiana was completed in August 1991

(1991) and the next review is scheduled for August 1993.

Regulations overdue (and date due):

Well logging safety requirements (7/90)
Medical misadministration reporting (4/90)
Funding of decommissioning plans (7/91)

STATUS - The State completed the adoption of these rules in
January 1992.

New Mexico The last review of the New Mexico program was conducted in

(1992) August 1992 and the next review will be scheduled in
August 1994.

Regulations overdue (and date due):

Industrial radiography surveys & audits (7/89)

Notification of filing for bankruptcy (2/90)

Well logging safety requirements (7/90)

Certification of dosimetry processors (2/91)

Funding of decommissioning plans (7/91)

281

STATUS - In letter dated November 16, 1992, we urged the
State to take actions to adopt the above indicated rules.
The State has hired a contractor to develop its rulemaing
packages. All of the above indicated regulations are
scheduled for adoption by January 1994.

State for which findings of both adequacy and compatibility were withheld - 1

Nebraska
(1992)

Regulations overdue (and date due):
Funding of deconrmissioning plans

(7/91)

STATUS - A proposed rule is in the adoption process.
Adequacy was withheld due to a significant backlog of
overdue inspections combined with a staff shortage. The
Office of State Programs' management hand delivered the
report to Nebraska to emphasize the need for corrective
actions. The new Health Officer committed to turn the
program around.

REGION V

Oregon
(1993)

Washington
(1992)

5 Agreement States

States found to be both adequate and compatible - 2

The Oregon review was completed on April 2, 1993 and
the next review will be scheduled in April 1995.

The Washington review was completed on July 17, 1992
and the next review will be scheduled for July 1994.

Arizona
(1992)

Nevada
(1993)

States for which a finding of compatibility was withheld - 2

Regulations overdue (and date due):

Funding of decommissioning plans (7/91)

STATUS - A proposed rule is in the draft stage.

A review of the Nevada program was completed in March
1993.

Regulations overdue (and date due):

Funding of decommissioning plans

(7/91)

STATUS - The State is in the process of adopting this
regulation.

BOSTON PUBLIC LIBRARY ^

llllli

282

3 9999 05982 981 0

state for which findings of both adequacy and compatibility were withheld - 1

California The review of the California program was completed in
January (1993) 1993.

Regulations overdue (and date due):

Funding of decommissioning plans (7/91) ' |

.] i

STATUS - Adequacy was held because of backlog of inspections
(over 50% of inspection frequency) of byproduct material
inspections in priorities 1, 2 and 3. In addition, some
escalated enforcement was not adequately handled. In view
of these deficiencies, upon dispatching the report to
California, a special management meeting was held with the
State on May 24, 1993.

•^ ;

•!

ISBN 0-16-044575-2

9 780160"44575

0000

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Full text of "Federal regulation of medical radiation uses : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Third Congress, first session, May 6, 1993"

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