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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"



/ 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. 



6 

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. 



8 

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 



9 

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 



10 

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 



11 

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- 



12 

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. 



13 

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 



14 

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). 



15 

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. 



16 

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- 



17 

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. 



18 

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 



19 

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. 



20 

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. 



21 

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 



22 

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 



23 

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. 



24 

• 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. 



25 

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? 



26 

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? 



28 

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. 



29 

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 



30 

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, 



31 

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 



32 

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. 



33 

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. 



34 

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- 



35 

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. 



36 

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 



37 

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 



38 

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 



39 

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. 



40 

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? 



41 

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? 



42 

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? 



43 

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. 



44 

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. 



45 

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 



46 

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 



47 

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 



48 

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 



49 

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. 



50 

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 






51 

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 



52 

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. 



I 



53 

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? 



54 

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? 



55 

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 



56 

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 



57 

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. 



58 

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.] 



I 



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) 



60 

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- 



61 

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. 



62 

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. 



63 

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 



64 

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. 



65 



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: 



66 

• 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 



67 

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- 



68 

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. 



69 

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. 



70 



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. 



71 



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. 



72 



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, 



73 



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. 



74 



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 



75 




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. 



76 



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 



77 



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 



78 



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 



79 



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 



80 



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 



81 



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 



82 



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 



83 



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 



3- 



84 



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 



85 



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 



86 



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 ■ 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 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 



y 



87 



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 



88 



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- 



89 



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 

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 



90 



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 



10 



91 



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 



11 



92 



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 day 

b Estimated work days necessary for license review and issuance activities - 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 



12 



93 



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- 



94 



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 



32 

1 

24 

100 



25'^i: of Subtotal 
25°o of Subtotal 



25 


= 


80 


71 


= 


7 


10 


= 


24 


06 


= 


60 




Subtotal 


171 




= 


43 




= 


43 



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. 



95 



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. 



96 




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 



97 



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 



98 



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). 



11 



99 



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 



m 



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 



1v 



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 



VI 



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 


0.1 


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 



no 




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 



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. 



11 



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 



on 



■ly, Pennsylvania 
Federal Resource Pgr<=nnc 

Robert Bores, NRG 
Ronald Colle' NBS 
Bobby Dillard,' ORa/FDA 
Charles Phillips, EPA 



iv 



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 

(c) Specific experience in radiological 
environmental monitoring. 

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 

14 



« 12 



3 



10 



E 

i 8 



2 6 

V) 




OL i_ 



_L 



_L 



_L 



_1_ 



2 4 6 8 

Number of Major Facilities 



10 



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. 



8 



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. 



10 



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. 



7 

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. 



11 



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. 



12 



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; 



13 



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 

14 



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. 



15 



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. 



23 



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 

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 



24 



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* 

E 



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); 



At 



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. 



25 



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. 



XI 



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. 



iv 



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. 



1 



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. 

8 



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. 

10 



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. 



11 



160 




161 



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aaTvaci Miv^i ai"' 



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 luHili i lM i i 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 
^ lakeyfrsyfwa rtff^rtr t^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 

rftn rtnr t 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- 
l«gala]Bd rae<£cal butStotiQns. Bitn^ 
^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 J r.- 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. 
! t af¥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, da aUu y lut 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^ ^ i fi i ffifl 

Aefaievinc thai poltal regalatoiT 
I faalaoee may be impassible because 
' the MBCs RSolatiqD of medicine 
i p ^ Tv r ^ *TTtTaHy " "'^ ^*^wa — ■ neitber 

; tbf^ifltilBS of '^'*^**g Kwgjw»»1 pjvc- 
\ «wy B »r ♦>!» Il l I I 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 B ake ame th at 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 d ogat 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 Jm rmsiKlf ," 
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 
iiii i i ^ 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 l e p or t ed peiueutage of iBi£a- 
tioi ecnus is small when compared 
with the loagtaiy 7 mSUon diagnostic 
procedures and 110,000 theran' pro- 
<«„ Ti ii g, <. 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 A i ii e i iJi* 
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- 
o auol 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 



ao 

so 



19 
19 



18 
18 
IS 
18 
18 



17 



15 



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 C Uiwa i**! _ 



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 
iimttrn f 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 
NRC xJainnan 

^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 c o i nf i itrr 
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 rhlk hen." 
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 



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THE PLAIN DEALER 

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the 28 
who died? 

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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. 



m 

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D 

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'«!»• 



166 



THE PLAIN DEALER 



jk^A 



fyniAf.iiiis]p.fit 




^ I 





• ■■uwogma mumi DSl. 



; In Qpto bcr IM S, 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, 

Omhfrim d tol d the I feyiipd 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. 



^ --^—ii Uryiud 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 
' fllifio aiuc of tte aaefe CDStenoe of 
, the agrcenent, the sSBtc would Botitr 
..^Saaed Beait to allow the hospital to 
: take •wiimu u aa ka n deecg ly- 
jwi|w tetopiDtBetita iBtci e >L '' 

' The onlt h>i been a'oewi blade- 
Alt of what afptaa ip be the most 
■ardoBs rm^itit^ f nr i ^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>- 
pi e," h e 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 
sttte s-Also . s ates m dtteKgCoftBi 
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 
KRCcBBSidersc oeof ttetopndial- 

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 
f b rra er detinshre end bt the Wasfa- 
uigtuu Bedsldns. 'There ni^ te a 
dP there ttet needs to te flted." 

Anetho- gap aadsts ha tte NBCs 
fiifmrnnen t 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, ii nderd oB ts 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 i p^ 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 te nftily. 
And ftfll AoQjdiiot bo tobntBd.'* 

In nccBt jcns, tho HBC fau faoec 

pcQCZUQ ^liiTflvm. toMoy of whom 
bdieve iheafBDcr is* (Smufftal BIc 
Brotbtt. AMhoup NB Coocte 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^j c 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 stat e sto ce 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^ imUUUi o u 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 



i 



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. 



H 



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 op erate 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 ev eiyhody 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 of tbrir 

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 T Bptr. IB nle 
'-JUlK QcMfaarvttiiad w il i h y i Ifae 
ftxnaad tbe X4v^ beam 
of neboT^ 



OKbei Mner felt a Hang — 
'it taatc not fir tbe fim decide. 



■f .:« 




aofe dose, 



k^ 



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 

• yiuj e tfc- 'Amldoingtius.pB rtrat any 

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 ' *» ■* ■■ nu ii of tie Aaann 
nUagi of BMBo lapTt quaiitr —— 
^QOt o^BSuBe& ^Tfase • so asnor^ 
l^in IL em Mlil 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*"* " o ut a wtfi 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 D ui»uUlj of Chiea9> SO . 
yen ago this mcDtfa, m od ePH iay 
medical aJ » iiuu c s l>ave bcQkaBBOO)- 
ptpfffd by note Aiglili'iiing uses of 
ndiatioQ i&tbeandflerweepoBS and 
mil !■■! po^vr xodBtseL ^he ^V'- 
iaiiai dat doaes of U M lkli o p once 
tfaoo^ Id be '"i ■■■<»' mH canse 
ni i«»« 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 gmf tt* "■""*■*"" 

~I think oaoy of tfae TeaUemt 
wc'fc having with i wfi a tinn 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', 



ifi i i nMi i 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 Rhhid andei. 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.** 



1 



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 p iuce dm e . 
Agiic snne rf those palieots sever 
questjooed the errors bciorchand. 



169 



■OHIU-i 



•ir-Crir-tT-A 



l>^KV^l.Ml 



L* STOFkS BieS 

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 
1B8 9 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 fn n t u i i f^ 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 nnma in 

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 ^ n nn. 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^ fri p^'d AHen ^^*^ 
out a £om in which he blseiy 
dazmed that "Weinstein bad cas}- 

p^^t»f^ ?9n bonis of '*^'"*'^1 tr atn. 

mg imder ADeit's tii^— m ig^fT n, 
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 



d 



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 u aiv ta a ly 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 



P 



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 "m ed 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 t ii n iTnt 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." 
■i thnifh 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 hos pttal 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- 

arra pnn*: tp ft fClOI^ rmirYt of finl- 

le to l e p e irt 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 Ampri ia,' 
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>*T p'^' 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 patir n g ; 
are accurate. 

NRC urvestlgstors also leicned 
that Dclgado had not held KKC- 
nandaiEd radiaticn safSty meet- 
ings for at least 14 y ears. 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) Ua iv ij iii y 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 ■ l i crnvd 

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 Nu c i ear 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 
t i iuLtii i ii e s as repoclsdl^tiieOtrice 
of Manafemezit and Budcet to the 
K2C «Bdier this Tear. 



"T fepL e 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-J iTP- it filed tiie radiz- 
tioD "gfc y 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 pi es iJ. 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- 
e i Mi^ 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^t g ti gy 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 fe wer; tha n ISi of the cen-.- 
"fets* cancer treatments. - 



175 




Wm ill II 

Jala S%^ StE 

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elf 



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III ifit l^lHllli 



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IPplpi'ifilililit 



ilJif 111 iliPI 

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176 



(Pjc toosftington post ^^^ ^ 9 1992 



ClrcolallDB •J4,2«2 



Md. Cancer Patients Received Radiation 

Overdoses 



By Deb RiechmBiin 



tL 



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. 



50 



177 

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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 
Conduct of Employees 



10 CFR, Part 35 
Medical Use of Byproduct Material 



Management Directive 8.8 
Management of Allegatioos 



18 use 1001 
False Statements 



3 



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 amendment s The in vestigabon 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. Additio nally, 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. 



4 

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. 



'1 



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 
Applicatio n for Materia] License (N RC 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, 
i99 0, 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 . 199 0. 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 b cense fil e co njaincd a recon structed 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 
rathe r than 19 90.) Tbe issue discussed in the telephone conversation bctwcet ^ 
and 'il/tt^^o^^^^ ^^ transp oftabilit^o f 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) requir ejpe_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 

O n June 20, 1 991, 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 req uest for addition al i nforma poc 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 



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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 r eview 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 Advisor y Xbjpniit tee on the Medical Uses 
of Isotopes (ACMUI). While looking at this quesbon. MW I^evigw ed 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 'Jttf U^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 
sou rgsby Federal E xpress 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 Po bg^a nd 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 requ ested inform ap^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 additi onaL sites hrthe bcens e 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 j ot 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 ap plication no ted 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 r eques ted 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 coDce mgd about the propo sed transportinc of the device tod coover 
lelepbooe withMMBHHRIVErom t be_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 th e various sites. ^^ ^BHWP^aid that 
^^subsequently discussed tbe shielding issue wiin ^KHHmiJ0[|ppwBo informed 
^li^that tbe HDR treatments would be condu cted in rooms which h oused 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 dia grams or shielding calculatioos for the additional treatment rooms. 
^■fHi^said that^i^did not discuss the ameo dgient 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] Sa fety and Safeguards (NMSS), NRC, recalled a telephone conversation with 
^BMBf lijC 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 transpo rtation wa s 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 bracb ytberajjy 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 Memb ej of thg^ Advisory Committee 
on the Medical Uses of Isotop es jACKfU l). At that tune, ^ ^^BU ssigaed 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 recSu pend ed 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 whi ch wou l d 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 

10 





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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 ope ration was not permissibl^u^e^^ 
(ffect at that time. fllKidfl||lsaid that H H 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 
TJMS S was geeded Jjj^ acknowledged having conversatioos begirming in June 1991, 
v^-itb jj^jp from NMSSj egarding 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 copduci edjintiJ Se piember 
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 ^ an y 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) 



11 



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 infor mation 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 auth ority 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 a gpbcation for_a mendnient 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 

12 

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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 Co rporation 
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 b etween tr e atment 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 



a nspo r 
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 

U 




nmniAi. USE OMIY 



191 



omciAiusEMr 

represenutive from Nudetron/lMtBKbelie yed that the NRC bafl 
the use of an HDR in such an Operation. WbeojH|[|||||Mprovided 




Id not appro s 
locations of 



copy of the O SC 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 
Gam ma 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. Tes ts 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 Secti op wh en the bcensee appbed to 
transport the HDR to various sites for treatment ^J^section would then h ave 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 th is 
'said it was quite possible tbat|||^did so, ^H 
did not feel that the requested aaion to ttansp on 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 

14 



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192 



DFFICiAL USE DNIT 

either the sute or the NRC Se aled 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 neve r advert ised 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_G amma Med Hi HDR aft erlpader at jj[arTisburgi_P A in 
September 1990. ^Mlbdvised,that^d e^i with JU MMMtMUliP dyiSg ^^ 
installation of the^evicc" ^m^|said tbain||||^B|Bi^HPinfonDeda|^f the 
firm's intent to move the Gamma Med IL device to diffe rent 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 

ya s not certified b> flBRfor install abop oLthe GammaMe d IL 

IDR afterloadet. ^^f^mmented that the only exposure^^fkflHPHSSAl)^ 

in the installation ^ the Gamma Med Ili afterloader would^have been what"^"^^ 



i Uujl^i W 



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^ 

h owever, ^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 replacem e nt of a de pleted 
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). 



15 



(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 
specifica llv licensed b y 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 R egon 1 Had the staff r eviewed 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 inspectio n of OS C w as condu cted 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 



16 



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|||§ 

jci pated 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. 

l asked to see tbe training records d uring 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 allega tion h ad 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 t hgt §fti was pr esent 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 



17 



nmriai m nNlY 



195 



o^rmmmY 



could be coDducted while the machine was being operated away from the Harrisburg 
Cancer Center A sig qjfiant time b ad 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 obs cfvel 
llspectioD abilities This stemmed from^jl^duties a^MBHCT 
require ment to perio dically review assigned inspe ctorVwork. ^ 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 belie yedjhatj^'more than ykdy* mention ed 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 NMS S file were the handwnnen notes of^PHiH|§ 
;, relati ng to J^^evi ew of the OSC Ucense file and conversations 
Region JliMM PMMfcWBWBBg) The notes enumerated cc qain defid encies 
detected bynKS^^ licensing of OS Cjctiyitica. A dditionally, ^^MBl notes 
reflected a tetephone conversation in which M||||||||Preportedly made reference to 
the lack of need for R egion 1 to request ad<ffl onaI supporting documents from OSC due 
to^[|^nfidence that ■BHMHHVi||^operated a safe program. According to 



18 



OmCIAl USE ONLY 



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 revig w of the ed ucational and work experience o{fli 

vere both at ibeU 



Pand^ 
lisdosed that t heypyere 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 wit h the lice nsing actions for OSC ^BHHfl^^^°^ 
safMdid not know HMMlBfllMwhile at the Universtyjof DeUware and 
was not even^ awareJh atTbey were there at^e same ti me in 1974. |B|explain ed^| 
comment to KJH^^egarding personal friendship with HP^tfflflBHHi as 
stemming frspn theiTmutuaJ involvement in professi onaTEealtb physic s s odet 

^ jenied anv unofficial involvero ent with^ jMWWJi^^BBB outside of 

activities associated with the societies. ^MflHIIbeUeved thai^Pcomment to ^^ 
^BliiUbonce nung the q uality 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 condu cted 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 whi c^ had been o mitted 
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 ^ re sppnsibfli ty for 

'''aaaiing a mendme nt 2 to the O SC 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 associat wl with the j pending amendment request ^Hfeiftfclt ^2< ^ review 
requested byi^lMHfll^A^ laoit thorou ^ ihanwo uld 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). 



20 



OFFICUl USE ONir 



197 



Bmamim 



MTOofidence in the safe operation of OSC 
Q uote s 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 I sotopes (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 
li censi ng actions in quesbon had occurred prior to |BM|0fl||P assignment 

re pptied that during the conversatjot^ #BpB^^commented that] 
was confide n^aijHHMHHHHRHBu as doing a goo g 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 BBHHHUco nsider ed 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 

cpnun en ts. The m emora nda^ 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 




of 




During^ OIG interview, ^^^^i ^clm owledged that fPl^lixiformec 

> comment cohcemingQ|0persona] frien^hip wit 

reed the comment was inappropriate; however,^ did not beliej 
Jwould have provide d preferentialjj eatmeni 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). 




19 



OmRlAl list OHIY 



198 



OWJAl IKE OHIY 



Ck 



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. 



3. 



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 concer ning allegation number 
revealed a let ter dated M arch 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 

21 



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 inform ajion. regard ing 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 t he HD l 
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 f acihiies 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 re called a meeting withV^ 
^to disou^enain aspeas^f'JBHMHHAMH|<^''atioa At some point 
m the meeiing.^|||[||||||§voice(SPcoocem ab oiij mob ile ra^abon th erapy whi ch was 
reportedly being provided by an NRC bcensee ^HMIrecalled that 4||^|||1 did not 
provide a greai deal of detail due to perceived perso nal l UbiLry ODlhispan. _ 
was uncertain if at any point in the allegati on jrp cess^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 
Departmen t of Trans portation (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 i ncluded a m eeting with ^^H^lHHHMHBfi did 
^ot^participate in any discussion of^MjIm^WlcgatioD wide at the hospital However, 
_ Subsequently filled out the Allegat ion 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 
l egation^ ^^ 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 ha d bee n issued which all owed 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 i NKt^ expl aining 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 De partment o f 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). 



iso ry. 
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 FOATtON S 

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. 



23 



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 sy sjgm wa s 
de veloged in 1991 an d has been partially implemented in the branch. ^HfAsaid that 
tbeHlJ MMMBII^ 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 wit h otb^r jjf fices. 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 meet ings 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 rec eipt o f 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 



24 



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 w asjnitiatedbvjhe Office of the Inspgnor Genera] (OIG ) based upon 
allegations made by|H9mBBBHiil^H^HHHHBMof Nuclear 
Energv Services (NES). a consultiag s ejvices finn. that aS^pecaEew^e handling 
and iranspon of radioactive material. ^|^||H|stated that on June 26. 1990. he 
present ed his concerns of radio logical sa fety violations dL<<t)ver ed 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 conducte d an inspection at 
NES Headquarters, Danbury, Connecticut to address |B^^H|Hl|^concems. The 
inspection determined the re were no radjo logicaj 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 examine d. in the July 24. J 990 inspection. Further, the 
inspectors did not inierview witnesses toBIB^^^j^^BalJegations, other than the 
president of ME S and one other NES employee^Q^BBlBaclcnowIedged that 

t provided names of witnesses who could corroborate his claims, however, 

[did not contact those in dividuals. The OI G 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 

8 

BASIS 

This iuvestigaljon was initiated b y the Offi cej)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 concern s, at NES to Regi on 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 

a dvise d 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 a llegations, an ins peaion >^-as conducted by 
Region I on July 24, 1990. Subsequently, Jhb3bB^| received a letter and inspection 
report (No. 90-001), dated Oaober 26, 1990, fro m Region I, which indicated that no 
violations were found at KES (Exhibits 5 and 6). ^^I^^^^Hstated that he severely 
questioned the conclusions o f the in spection 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^^<elephone d/BiKl^B\to inquire about the inspeaion. 
According to'jBM&jfe ^l^^^8 BByQ° ^IP^^ that jb e 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 regu lated activities u nder 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 dis agreed with the .i nspection 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 ac tive (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 stor ej. in an acco""ii ng safe used to 
store payroll and employment records. According to ^[^I^^SHIthe NES Ucense 
requires that any radioactive t naterials received by N'ES at the Danbury faci jLty be 

l^tated that since the previou5iQ|H^ 




ve rified b v the RSO. Further 

[■acate 



>.% 






sition with NES. time hadj. apsed before 
as ap poLDied_^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 tha t: "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: Inspecto rs saw the 
required notices, such as Form NRC-3, were posted.* |pESBE9B explained that he 
leA^g^NESposted the require d forms after he was fired on May 2iri990. Accordin g 
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 



10 

jources which xo utinely 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 d iscuss 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). 

n 





jstated that as a result of^i^^^^^^^ allegations and the fact that NES bad 
loot been impeded for sometime ,,an iiispe ction was scheduled at the NES headquarters 
office in Danbury, Connenicuu (g^^Bsaid tbatfciwaslargely responsi ble forjh e 
decisions made concerning the han dling of fe M^^^B^M allegations. 

allegations and to veri^ whether or not NT^ was acting in accordance with all license 
requirements. 

ar)d9B8BBi|^conducted an insp ection on July 24, 
}s?d ^ be unannounced. However,^P|IP|B|beIieved that 
3ma\ have surmised that an Jis Bection ^-as fort hcoming 
'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 ins pectors 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 thats o metime 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 licen sejj_activit y 
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 



11 



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 no t r eveal any e vidence 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 fac i lity, there was no need for NXS to establish an RSQor to post NRC Form 
3s. ^SBi^^dvised that the radioactive materiaJ^ESBMMWMii ^identiGe d 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 observe d 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 



12 



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). 



gatioQ S 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, da ted Febru ary 28, 19S9. May 31, 1989 and 
March 27, 1990, were purported byJHi^MBHlko show NES bad performed various 
acu'vitJ es un der 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 beb evg the ^ 
letter indicated thcNES bceo^uas aajvc. ilSe M ji)^31, 1989 letter was from^BHP' 

ma?e i t appear that activity authorized by tbe f^ES license had occurred. However, 
f^lmiM^tated the l etter 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 



13 

(ADL), ^AcoraP^ Cambridge Massachusetts, which also has a bcense for such 
activity. "QfBBBMIPlstated that the work Krformed c ould 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 Ma rcbJ7^990. letter was the re sult 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 
in quiry r eferred 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, r ecalled rna king 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 a dvised that be initiall y receiyed 
> allegations cooceming NES. /HftmriBd ocume med W&JHtttttKf 
formation in an 'Allegation Interview Report' (Erhibit 21). ^Hrecalled 

leged that NES was in^v iolation 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 pr oceed 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 insp ected in 
several years, although NES was due for inspection on an annual basis.^p|[iiii^P 
explained that NES bad not been inspe cte <^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 n g 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, 
Con nggjcut facility. WWWBP^'^ted that upon a/ri ving 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 ad here tojhe^ nditi otis of its hoen se^if no work 
had been performed under the Ucense. I nJMMWB^g^'^WW WPBj^ conce rns 
bad been fully examined within the context of the inspectioa However^HMMMdid 
001 rccalls^aMng to anyone who had been with NES five y ears ae ^o confinn 
ipJiflSBlfiil' ^legations, {jll^iiiii^acknowje dg ed that ^iKBUfcjIJiftjrovided 
witnesses who could corroborate his claims, but|j|^plSMH^id not contact those 
individuals. 



217 




IS 

>riefedgB||||§oo their inspectioo Gcdiogs. Accordinf to 
recommended that NES' clients be contacted to confirm 
that NES ba? workedlTnder iKe clients' bcenses. However, there w a^jo effort m a de 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. 



j acknowledped 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^Bilbecam e awa re of HB^ gl^J^Kllegations from attending the allegation 
panel n^eetineJB^necall^d the allega tion p anel 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^tbej nspection 

"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 Re gonig^are a 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 



u 



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. 

?Dcl ujied that the NES lice nse 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 wh ere the^ ra dioactive 
rnaTeriaJ was stored and nothing was found in the sturounding area. ^^MA^dded 
thadtl^did not beb'eve there wercanyradiological problem s at the um e. 
^flllWy"'^ ihaiMl^nd l^^jJMBsubs ejquently brie fe^lB Bft oP t he 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 



J 



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' observati ons and findings, thus(|P^as satisfied with the conclusions of the 
iiispediori. jHHRiiBlliSH said that the main conce rn of the inspecti on 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 wTgtcJhe ir findings 
based on their observations and DR SS ma nagement concurred M|||||pjbelieved the 

jg July 1990 inspe ction 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 m o£e thorou gh 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 m atter 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 Janua rii inspection jv as 
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 lic ensab le 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 



IS 

^^ 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 
ti ji pu-as concerned with the adequacy of the 



jadvised tb at(pBj Concero has alwa 
"were not fully examin ed. Jjj^ Taaintained tba 

July 1990 inspection. i|pi^Bii0P[jStated that the inspectors took a 'snapsh ot* of N ES 
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^o n 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 



19 

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 adeq uately cj ^ned in the July 24, 1990 inspectioa The inspection 
did not consider JMiSMB^l Wl^egatio^ a s they related to the past T he m soection 
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 
"la j^therejb ad 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 n o t h ave to fulfill all bcense requirements. ^MHHbi 
maintained that fMBBWBWM^coocerns wer e not v alid 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. N uclea r Regulatory 
Conunission (SRC) was irujiated based upon inforraatioo provided by^|||pl 

"3^^"^'**^ Energ» Services. Nuclear Energy 
Services (NES) is a broad-based engin eering 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 



I 



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 jc par ate OQ ^ions 

Wli,\dined with 



Further, the investiga tipCLrevea led , ._ . _ 

' ^ 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 Servic gs Unit that wer e initiated by referrals from the Region 10 staff. On 
the two occasions. |MCBVMW>«lJeved the referrals cooceroed two NRC bcensees in 



Ohio^jTase We siera Reserve University and the University of ClocinoatL 

^■■^^■'^'■^B '■*c^*<^ 1^3' *' ooe meeting (J0|p0||p| stated. 



_ God for 

fEC^andma 

maintained thatMp4lll|^Qever mentio ned 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 Ng C* an d 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 relationsh ip* between NES reprcscnutives and the Region ID staff. However, 
iHUMMl^beLeved that internal NES correspondence produced during the period 
^989-1990 conta ined information addressing this relationship ber*een NES and Region 
QI. Specificai]y.^jyiWi mm su ggested 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 re go'rts; and (4) th e 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 



e; 



•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 fr equent co ntacts 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>rovid e the per so nnel record s and al l documents pertaining to 
the business activities of^ '^ ^ 

since 1978. resigned from t he N RC in Janu ary 1989. ___^ 

' ju nder the supervision 

Subsequent to MBHWl fe^'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 t he inspect ors 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 prog ram. Subsequen tly. NES was selected to assist 
CWRU with its radiatioD program IMBRVHCi^'^ ^^ ^^ ^^^ Of ^^ N^S was 
selecte d. He be beved 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 r adiatioD p rogram, requiring the university to resolve its programmatic 
problems. ^S^/ffjoiiniiincd that be teleph ongd the re gion 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 receive d from Re giop 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 con duc ted hy 
Region ID. He named |iSpnHH8MHMMHHVHB|BB0ii!^d^||||pl 
KB|mM|as some Region ID membeji that h e dealt witt concerning the clinic's 
problems. According to^fffgfggtKtttttt^^ni very b ejpfij in ej ylaining how the 
clinic could get its radiation safety program "back on track.' ^HPHf^^dvised that 
liMMnJK^SS^s^^ several sources the dini c co uld contact who were capable of 
providing assistance the clinic needed. (MBt^^^^^lVlBi^ recommended three 
consulting firms, one o f^whicb was NE S. 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 t ojhe eng ent circumstances he 
decided on N ES be cause 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 Regjo n ID inspe ctors visited the clinic the same time the NES staff was 
presen'w. Ho^ikever,^|fmi|pdid not believe that the Reg jppjD. sta ff 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 saf e^ prop am. 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 assista nce in i dentifying 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 aMista nce with the universit y's radia tion safety 
j)rogram . Jj^j^ recalled that fPMWH^j s pecificall y suggest ed jjjjB icontact 
0/lt^ and p rovided a telephone number for^|||||H|at NES jHftf maintained that 
M^IPtlJPt] cUJmed NES performe ^jbc type of s ervice UC required, and NES would 
do a goodjoB. (^Htaf reiterated that ^■■pi|^|g(^^ recommended only NES. 



^D Augu st 1 2. 1989. N ES 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 JJRC violatioos. 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 th e approv al 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 
^^Bpisai d^be di d not observe tb^m^ctors meeting with the NES representatives. 
However. ^m^ a dvised 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< Re gion 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). 



i 



10 



OFRDiAl m. Giiiy 



234 



OFFICIAL USE ONLY 



13 



suted thai be did not have any evidence to suppoft (bat tbere was an 
unproperrelationsb i£. between NRC_a nd NES, however, he believed (here was an 
appearance o f one. (B BPWim^ speculated that there m ay have been a leak frog g 

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 ' unofiScia J inf ormatioB' { Exhibit 18). 
Mlpm^^pBpsaid be bad the impression that jH|ft^<l ^HVS had constant 
contact witb the Regi0D .ni staff. H e 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 H c^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 recogai ied NES for 
the quality work NES had previously performed in the regJoL |BBH|[(^s tated that h e 
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 



Ci 



dviscd that NES has received referrals from Region III in the sense that NES 
was namcj j amongjo ther compam'es that could provide certain services in a timely 
manner. flKlJiJjil^'^'^^^^ ^^^' ^"^^ acquired work at CWRU by being named among 

11 



235 



C 



• • ft 






many Gnns by the Region m staff. He recalled the situation with CWRU because the 
university was is trou blj^^nd need ed 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 tout ed NES' su ccess to his employees afier NES received the 
CWRU consultini projea ^JHUT re aped 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 pro jea 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 pe rformer 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 r ecommen dation 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 em ployment o f vJ^PBm»BBi |y [i nformed 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 tha t the NES site manager at 

^a few tin>es to determine the 
he personally dealt withlf 
nagcd involving Region ID. He eiqplained 




12 



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 Regi on 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 t he 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 time sJig manag ers' 
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 a t_NES and would have been hired whether there was a 
published vacancy QrooLjflpp||H|fl^ did not be lieve the re was a published^ 
announcement for fMliSlP, position. Accordmg to JMBBM ^WIMMMi^ hiring 
was not a ^rprise/He ex plained 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 t hat prio r to beinehired by the NRC be was employed by NES bet ween r982- 

1990 /'MJiio was 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 Reg ion I jurisdiction, and the majoriQr of materials licensees were 
in Region ID. ^KKKtm^'^^ *^* ^^ regional staffs immediately told NES they did 



13 



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 an d.needed a ssistance, they wouM govide a list o f 
firms, of which NES would be one. j|[||||||m|i}recalled spealdnf to ImilljJlJIlP 
concerning this matter. 

ymiUp, s aid 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 kae wjbe late L ee 
ROUSE. a ^NRC h eadquarters employee ,_and con sider_ed hip ^iend . wttlK^ 
suted iha^pHpilfjfrequeotiy spoke v^thJ|pP^mi|rbut|||[^|||did not consider 
the two to be friends. 

Concerrung NES' hiri ng of J^pMMgg|||p§was not sure bow NES came to hire 
■JJU^B MipilB l^beheved that^|Bi|§|por someone O DjflmMli^half 
approacbedUfBUlabout a_ position^ w ith NES. ^I pm^a id 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. 



i^ 



(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 w ork at the SOHIO facility, later known as 
B^^emical, NES first encountered the NRC V^Hjll advised that Regardin g the 
SOHIO project, NES bad to negotiate with NRc headquarters staff. ^Hli recalled ' 
dealing with ye^OU SE at NRC and as a result, be became the prindpal NES contact 
to the NRC ^HfBBnoted that the inspection of the SOHI O Jacflity^w as conducted by 
Region III sja& Punng_t he Region HI inspection <rf SOHIO.^|B|^$aid be met two 
inspectors, HHdHlVand [ 



14 



\ 



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 S OWO. 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 Re gion 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 de finitely 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 recei ved refer rals to 
CWKU, Lafayette Ginic, VC and two others that nES did not acoepu pim^psaid be 
knew NES was recommended to jhe three afore mentioned Ucensees b) Re gion ID staff 
because each represe ntative^ 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 n o^ce rtain PJ|y of UC received three 
referrals ^J BJJIjt ated 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 an d requ ested 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 h eard 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' emploffl ent o(J 

left Region JD iWB> speculated that 

hiring sQHVh^cause be recalled 
at health physics and a good w riter. In 

nth^uch_va]uable experience. ^BBUdemed that 

5 providing NES as a sole referral According to^ 



15 




I advised that be hired him after be 
_ eceived NE S* nam e from h is former 
have contacted jBfJBB l^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 fr om 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 Saf ety Brandi 

"tNMSB), advised thai be first bec agje famiha r wi^NES when |||fl|Mwent to work 
for NES in 1989. He related tbajj Bf^^^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 re f erred 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 liste d^in the Radiado n 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 a dded tha t other Re gon staffjiem bers 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. He ated 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 r esplv e their problems However, if tbe r egon did not pro vide 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 



16 



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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 recom mended' NES along with four or five other 
insulting' firms to various licensees. ^^[^iHl|padvised t hat there was a lis t 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 a t 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 NR C 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 se njling alleg ations 
left and right* to Region m, which were not being acted upon prior^ togBBMPWeaving 
NRC. He added that {t MBWUH MBBMBBV^ the ^MMBimi0and should have 
been acting on (th em)^ 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, La fayette dij iic 
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. 

17 



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). 

j Utated that be first eocountered NES in 1985 duriD| ajt allegation re view 
of SOHIO/BP Cbeoiicals facility, where NES was a subcontractor. llHiMBil 
^mro epted that be was impressed with tbe quality of NES" work at SOHIO. 
jUmPmHllksuted that NES subsequently requested a meeting with RegioB ID 
maoagemeni and inspe ction stag to im roduce thems elves and in form Region ID of tbe 
services NES provided JniPHH|Jinformed that ^HBtnMMMHH^ 
DRSS, approved the meeting. Hedid not remetnbcLw ben 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 experi encing proj^lem s 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 Acti on Letter suspending the universiQr's 

Tadiation activnies was issued.^Q onsequently. j^W MBBK said that bg. receive^ a 
telepbooe oU from ipp0M|Fpf CWRU. MBMMBt^^t^ thatPHHwanted 
some assistance wit b^d^eloping C WR 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 withou t a qualjy d 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. 



-.».»».* 




18 



242 



OFFICUl USE ONLY 

laiotained tbatHB%jand^Q|||P(Qasked him to suggest whauft cy 

should do to put their prografloback into operatioo. According to jjlMIIMB "^ ^^Id 
them that if I was in their situationJ w o u l d cona i^r a third party audit qtibe enfc e 
radiation safety progra m* (Pg 16). ^||||P|W Bj||suted that he providedgMH^ilj^^ 
[pMiH^'^^^ sources: ^j|H|BMHHH|§&om Wayne Sute University, Medical Physics 
Consultants in Ann Arbor, Kfichigan; and 



jJpH0BM( expl ained that^follo wing >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 wa s 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 thataMBEwan ted Repon ID j y investigate the numerous 
allegations and resolve UCs safety problems.^MfMMBt/toldWiSthat the NRC 
encourages bcensees to identify an d cor rect violations whenever possible, so UC should 
take the in itiative. Acco rding to pUBPWWWPj jpjCa sked hjm to re<»nimetid _ ^ 
someone. gMBBBWJ^lsaid ^je^recot^ endedflBBB^ntacl^fclMilii^tfciWMiill/ 
with A pplied Health Phvsia^flj^Mlifi^th Radiation Safety S ervicesj ncorporated; and 
\jp|n^]witb NES. (jJ UlPlM UBiremembered 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 tojjW BB 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 lit tl e 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 s tatemen t 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 tha the ke p t a lis t 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. 




19 



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243 



OFFICUl USE ONLY 



C* 



advised that there wa^oo written 
of outside consultants to licensees. 



tlicy cDoceniim ^ reoommeodatioos 
acknowtedfed that it was not his 



respoosibilitv for assisti ng 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. H e^Jnformed that much of his contact was answering licensees' questions via 
the telephone jp^pBMBl%a tfl that be trea ted 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 h ji interaction w ith 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 I D insp ector 
^■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 l ong afterjjfpgpwas hired by NES, be saw him at 

be region al o£5ce. According to1|HflHMpQ|ii'iejep^n^him to explain that 
0ltflU§*'^ going to represent NES at tbeUC pr ojecC'^lBBBgM^told ^ 
that be d id not anticipate a problem with flim^^jwor king at the univer^iy. 
WtftJttttffl^^^^ °^' chee ky with his supe riors' concem iog the accura^of the 
information be provided to|^m^ ^^^'URBlAleft Repoo ni|HHHH|§said 
he spoke yitb him o n only two other o c^jms. He con tinued that oo one of these 
occasions MPHif'^'^P^°^ to ebcit^||pmmi||| opinion of the repon NES wrote 
^Deeming IjC afte'r tb e^ UC prob lems Jiad bee n resolved. The secoo d,occ asion 
^|HPBim|»met with (^ifPiJl^ and 9HB^^ ^ regional office. ^HBHMl^ 
advised that NES had developedl ajiealtb physics computer appE catioa training program 
and demonstrated the program to j|||||pMHt|liHHVi^said that be did not 
have the d ecis ion mald ng authoriQr concerning training equipment, but met with 
^ 'landfflB^because be was personally interested in the coinputer program. 



ao 



mm\ rr miY 



244 



tm'}. ir: Fsit 



INTERVIEWS OF REGION m MANAGEMENT: 




"Region II. advised tbat^he wa s i^jJBWi—ll ^Wm>BlB^BM8|. Regioo ID 
from 1S§7;1990_ ^gf ff/jlf^fidormcii that be was famUia; with NES is a consultiQg 
firm JJMMMyfinrencou Dter with NE S occuned wbeo NES decommissiooed tbe 
SOHIO/BP Coemica] faciLi) pMHHIP noted that be became aware of NES again 
wben NES worked for CWRV . a fa c ility 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 remembe r 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 n ot a writiec policy. 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 re gion requesting information, 
meetings and approval status on issues. fWW BHltadvisg d bis staff not to deal with tbe 
b'censees' consultants on these types of issues. MHHi|[|maintained that telephone 



21 



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 limi t^ 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 situati on arose during an enforcement conference 
when a UC represenutive maintained tba:^iHHHBfeoIel> recommended NES as 
the consultant to resolve UCs program deficiencies (Exhibit 41). 

follo wing jbe enforcement conference, ||mpm^said be discussed the matter with 
MKittftt^ who claimed b e provideo d>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 b usiness 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 tb e^oCScial pr ocedure 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 employ ee 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 li sjsj)f consu lting 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 com pyiies 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 s ince cong panies 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 Weste m^Reserve Univ ersity and Lafayette Clinic Although there is 
conflicting testimony abo u;.jlH|iBimt rgcoP"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^^ consequ ently establishing a familiar relationship with certain NES 
employees. §fftKBtt0^^^ repeated interaction with NES via telephone caDs, 



23 



^-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 represenutiv c thaijndicated ine ah were 
bought for NRC employees. The two NES representatives,^ISPMHI^and. 
reporte d on th eir expense accounts dining with N RC cm ployet 

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 visit ed 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 



24 



"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). state d^that b e 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 ROU SE j)n se veral 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 ma jptained 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 Gold en 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|^.W eekly Busjpess & E Jipense Report indicated 

tbat onTebruary i^ 1989. b e 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 Rese rve U nive rsity (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 an d tbe current misadministratioo problems at some fac 
According to^llHRrhc paid for tbe ni jtal 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 1 9fi be later 
>aid cash for hi& meal. ^IBd^said 
concerned with the 



acknowledged that upon 
wrot j^ on his ex pense 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 coiKemin g^some a dministration 
problems the university was experiencing. He added that ^R|||Mvas the NES 
representative responsible f or assist ing CWRU with their radiation safety progr^ 
^jtllfflttij^eahed that jB|B |^wanted him to r eview som e documents ht^f/jf/Mi 
had concerning Lafayet tg 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 c ost approximate ly 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 me al from a hce nsge or anyo ne 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 tw o^ 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 ide ntjSed 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 th e 

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 p aid for hb 
eal with||^Bpdid not violate 
mainuiried if he were placed in 



LMC 




',WcckJy Business & Expense Re 



jrt i ndicated 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 cu rrentj iola aons at Lafay ette 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). - 




It 




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 invo lved 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; w ere s ittmg 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 resta urant when 
asked if be coul d 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 mo ttfy to_jQ meooe else and letting them 
pay" (Pg 11). He claimed that be did not aflowf^Pl^lo pay for tbe meaL 



27 



P 



\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 me ajs 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. beg an his career wjtb Re gioo ID in 1989. Upon 
r aduati ng from coUegeMi^[|pwas hired as ai ~ 




informed tbat bis initial supervisor w: 




ioNMSB. 
ibit32). 

St ins pection 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 
^ ^^^bappeo ed 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 ub le. He did not recall anyone ^king whe ther 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 fo r thei r 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 w as 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 f onnaH y 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. 



r 






252 



{ ■ fiiNDAY nny 21 1991 meal wtth^ 




The Weekly Bu siness & Expen se Reponof||Hp indicated that on July 21, 1991. be 
bad luncb witb^H mMfi P*<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 Wa shington. D.C. He advised tbat tbe brunch was 
purely a social event. According ^oi^j/flf^he and lus wife anen ded 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 no t mind gaymtlorjf BPJpbecau se be believ ed a bruodi 
was tbe least be could do for^flpHHHVHPcxplained thatp|^||m|i>as^ 

(^■■MjjAat NES for many yean, and theyh ad 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 Fe bruary 
^990, be dined witb^||0WM0|#informed that be jus kaovi^ BBlftfof 
approximately JJj'ear^. having worked wi tb_him at NE S. §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 iBB M^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). 

k iatfd that he was aware of the NRCs policies on confLa qfjnterest an d 
Employee conduct codes, but did not bebeve bj violate d any niles. LoMMPview. 
there was not a problem with his b runch 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' m ealf1>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 

29 



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 repo rted m^ with NRC/Region ID 
inspeaors. gHW Pi|^d>js ed that be questioned JUPIMb regarding the meals and 
believed him whenBSI^Ss^d the Region m inspeaors paid cash for their meals. 

[piiBjg note d thaMh ere were not many occurrences of meals with Region ID 
bis pectors. 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 JUp Wflreduce the amount the inspectors paid him for the 
meals. He added thai j BIWi should n^have "pocketed* any money paid to him by the 
inspectors gjHHiplrancluded that if glMH received money _ from the jn spectors and 
did not account for it on his expense reports then jt was g^o ng 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 represe ntatives. Jjp MlB^advised that approximately a week prior to 
his interview with OIG^jitBPH Htold him th at he had gone out to dimier with an 
NES representative oo one occasion. jmUl^not ed 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 avoidin gjneals 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 



30 



OFFICIAL USE ONLY 



254 



OfncMiBSEcmr 




\ indicated had he knowo an inspector bad dinner with a 
consultant, whether the inspecto r paid for the meal or tkot^jlfllflfll0woaid have 
counseled the individual. tMl0H|^>eUeved that a mea] with li censees and/o r 
consultants posed an appearance of a confli q of interest. F urther JMUBBpstated 
that there was a mor e serious prob lem vrnhmptH^^dininf witb a consultant 
because as a^MHpmSP'^VW ^^^ power to make decisions affecting the 
licensee (Exhibit 39). 

jjmjj^s aid that he^ utioned his inspectors not to have hincb with Ucensees. 
According to ipPHH(^ each inspector was given a Training OualiScations Journal 
upon being h ired 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 shou ld not be taJcen and to be disaete about pre- 
existing friendships. In addition, gU mp^review ed the Fundamentals of Inspection 
with all new inspectors to Region ni^J^BH^oted that the region has received the 
conflict of in terest annou ncements 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 investigati on disclos ed tha | NRC e mptoyees.(l iMBPWBMWyBBBli# 

3^<^^!iP0BHMi»^u>^ ^'(b NES representative, 

>n different occasiott/nowever, the investigation did not 

etenni ne whether the NRC employees received a gratuity in the form of 
Tbe employees stated they paid otsb for their portion of the meals, 



31 



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 th e app earan ce 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 su fficient evi dence to determioe ^^tVBfMHV 
dined with9^ptfMMM^^hedHMB|l0fwas a n NESe mployec. ■BHp^^tated 
that be dined witMMB||||on two occasion s._in whic hH|iP^|^^Week^ Business and 
Expe nse, Repor ts reflect the two occasions, ^im^ categorically denied having a meal 
wi 



|0D either occasion. 



ExhibiU: 




OFFlGia USE V^ 



256 




33 



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 
Re gulatory 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 





'k 



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 

5 



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. 



I 



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 com patible - 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 ^ 

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282 




3 9999 05982 981 



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. 



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ISBN 0-16-044575-2 




9 780160"44575 




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