ML20057B962

Final Task Force Rept on Medical Radiation Protection

ML20057B962
Person / Time
Issue date:	09/15/1993
From:	NRC OFFICE OF POLICY PLANNING (OPP)
To:
Shared Package
ML20057B956	List: ML20057B955 ML20057B962
References
OPP-93-04, OPP-93-4, NUDOCS 9309240208
Download: ML20057B962 (50)

Text

I l_

Insk Force neoort on Medical Radiation Protection l

OFFICE OF POLICY PLANNING I

l TASK FORCE REPORT ON MEDICAL RADIATION PROTECTION g

OPP-93-04

.l FINAL g

SEPTEMBER 15,1993 I

I 4

I I

gBREG 9 g

I

+f g'2 i

co 0

l Wb7/

r %o+ e I

I na":8aans8e g

conneseanocuce eon..

I Task Force Report on Medical Radiation Protection ii g

CONTENTS I

INTRODUCTION AND BACKGROUND 1

RESULTS 3

i Findings 3

Current Regulatory Framework 3

I Data to Assess Need for Reallocation of Regulatory Responsibilities 3

Views of the Public Interest and Health Care Advocates 4

Health and Safety Implications 4

Improvements Within the Current Regulatory Framework 4

I Options for the Regulation of Medical Radiation 6

Current Framework with Improvements 7

Federal Regulation with Agreement State-Type

.g Implementation.

7 5

Federal Standard Setting with State Implementation.

8 Limited Federal Radiation Safety Oversight 9

DISCUSSION 10 I

Task Force Approach 10 Characterization of the Problem 11 Discussion and Analysis of Comments on Regulatory Issues 12 Uniformity and Regulatory Oversight 12 Database and Health and Safety Implications.

13 Training and Experience.

14 I

Communications 15 Discussion of Comments from Public Interest and Health Care Advocates 15

- I Analysis of Misadministration Data Currently Available.

17 Evaluation of Options 20 APPENDICES A

Federal & State Control Over Medical Radiation Uses B

Issues Relative to Radiation Safety in the Medical I

Uses of Ionizing Radiation t

C Contact List D

Summary Report - Meeting of the ACMUI - July 8, 1993 I

E Pollycove Memo F

Definition of Misadministration G

Members of the Task Force I

I

I Insk Force Report on Medigd Radiation Protection l

INTRODUCTION AND BACKGROUND I

Medical radiation is regulated at the Federal level by the Nuclear Regulatory Commission (NRC) and the Food and Drug Administration (FDA).

NRC and the 29 Agreement States regulate the use and users of byproduct materials for both therapeutic and diagnostic medical purposes.

FDA regulates the safety and effectiveness of drugs, biologics, and medical devices, including those that utilize or produce ionizing radiation, by controls applied to manufacturers.

States have broad authority and responsibility for the protection of their citizens from a public health perspective, but as a practical matter, the implementation I

of individual State programs for medical use of ionizing radiation varies widely.

The Conference of Radiation Control Program Directors (CRCPD) helps to coordinate State programs in this area and has developed suggested State regulations for the I

control of radiation (SSRCR) for all sources of radiation.

i Adoption of the SSRCR by the States is voluntary, and currently only 15 States, including both Agreement and non-Agreement States I

have adopted these regulations.

A summary of Federal and State regulatory controls regarding the medical uses of ionizing radiation is provided in Appendix A.

At the May 6, 1993, hearing before the Senate Committee on Governmental Affairs concerning the regulation of medical radiation, Senator Glenn, Committee Chairman, raised questions as to whether Federal and State regulations related to medical radiation provide an adequate margin of protection of public health and the rights of those who may be put at risk.

Although I

this Committee has maintained an ntorest in the subject of medical radiation for a number ot years, this particular hearing was triggered by a series of articles in the pinyeland Plain Dealer which primarily addressed patient deaths, injuries, and I

overexposures.

He noted the Committee's longstanding interest in the role of Federal and State agencies that regulate medical radiation, and in that context, stated that medical radiation regulation is scattered, fragmented, and very inconsistent.

Testifying at the hearing on behalf of NRC, Chairman Selin I

noted that the bulk of the radiation therapy treatment in the country uses non-byproduct material sources and is subject to only discretionary and perhaps inconsistent regulation.

He also noted that although NRC regulation only affects about 25 percent I.

of the radiation therapy treatment in the country, the NRC has given thought to suggested approaches to address issues of l

regulatory coverage of all radiation therapy treatment in the country.

In response to Senator Glenn's request to speed up the NRC's consideration of these issues, Chairman Selin committed to provide the Senate Committee on Governmental Affairs a I

I

I Task Force Report on Medical Radiation Protection

?

I preliminary report in three months.

Subsequently, an NRC Task Force, including FDA representation, was formed.

This report is the result of the Task Force's effort to look at issues and options which address radiation protection of the public health I

and safety from all medical sources of ionizing radiation, that is, from machine produced and naturally-occurring and accelerator-produced radioactive materials (NARM) sources of radiation as well as byproduct material which is currently regulated by the NRC.

The Task Force approach to this assignment was to gather

-data, information, and views from the regulated community, public interest and health care advocate groups, and Federal and State regulators to assess the scope and magnitude of the problem and identify and assess options which have the potential to result in a more effective allocation of authority and responsibility among Federal and State regulatory bodies to ensure adequate medical I'

radiation protection.

We are providing our best judgments and perspectives, based on the information gathered and regulatory experience of FDA and NRC.

We recognize that, in the timeframe allowed and with insufficient data available, we are unable to I

provide a rigorous analysis of whether a significant problem exists and possible remedies.

However, we have attempted to characterize the issues important to adequate medical radiation I

protection, indicate (without the benefit of definitive criteria) the general magnitude of misadministrations (see Appendix F for definition of misadministration), and assess various options for the regulation of byproduct, machine-produced, and NARM sources I

of medical radiation.

This report focuses only on the medical uses of for. zing radiation.

The sources of ionizing radiation considered are machines such as x-ray machines and linear accelerators, NARM, and radioactive materials regulated under the Atomic Energy Act I.

(AEA).

This report does not consider non-ionizing radiation.

Finally, those sources of radiation regulated by the NRC for medical uses under the AEA are generally referred to as byproduct material or byproduct sources in this report.

I I

I

Iask Force Report on Medical Radiation Protection 3

l RESULTS

-l Findings Based on the comments received from the regulated community, public interest and health care advocate groups, and Federal and State regulators, as well as our review of regulatory experience of FDA, NRC, and the States with their medical programs, the Task Force findings are as follows:

Current Reculatory Framework I

The regulation of medical radiation is implemented by two Federal government agencies and by the individual States.

Some of the regulations focus on medical radiation device I

efficacy and others focus more directly on user activities and resultant patient protection.

These different focuses have contributed to inconsistencies in regulations and their implementation through licensing and inspection programs.

I These inconsistencies have the potential to affect the overall adequacy of protection of the public health and safety.

There are also inconsistencies in reporting requirements which result in insufficient data to assess the I

effectiveness of the current regulatory framework to protect the public health and safety.

Data to Asserts Need for Reallocation of Reculatory ResDonsibilities Sufficient data are not available to assess the level of I

protection for all sources of medical radiation provided by the current regulatory framework.

More needs to be learned to assess whether a health and safety problem exists, and its magnitude, as well as to identify the weaknesses within I

the current regulatory framework before committing resources to the reallocation of Federal and State responsibilities.

To rigorously assess this issue would be costly and may I

require legislation; however, acquisition of selected performance data could provide the insights needed for consideration of appropriate regulatory changes.

The Task Force notes that the Commission has requested that the National Academy of Sciences (NAS) examine the overall risk associated with the use of ionizing radiation in I

medicine and provide recommendations for an overall national regulatory approach and criteria for measuring the effectiveness of medical radiation programs.

Based on our I

i i

Task Force Report on Medical Radiation Protection 4

I experience in developing information for this report, we believe that reliable data to assess risk and program effectiveness will be difficult to acquire, especially for non-byproduct sources of radiation.

Views of the Public Interest and Health Care Advocates A number of consumer interest and health care advocate groups were contacted and briefed on the issues under Task Force review.

These groups indicated that their members or constituents had not expressed much, if any interest or concern in the safety of the medical uses of ionizing radiation.

While they could offer no specific recommendations on changing the existing regulatory I

framework, most of the groups indicated as a general principle that they would support improvements in the safety of medical radiation but acknowledged that such improvements

.I would require significant expenditures that might be better spent in some other areas of health care.

Health and safety Implications Although there is a lack of definitive data, especially for non-byproduct sources, it is not clear that the current i

regulatory framework for all sources of radiation does not adequately protect the public health and safety.

Neither the public interest and health care advocates nor the i

Federal and State regulators contacted for this report have I

concluded that the current framework is inadequate for public protection.

Federal and State programs in effect, j

combined with professional medical practices and voluntary I

professional standards, appear to serve the public health and safety.

Improvements Within the Current Reculatory Framework Improvements can and are being made within the current g

regulatory framework resulting from insights gained from i

g internal agency studies, scientific studies, and enhanced cooperation among agencies regulating the medical uses of ionizing radiation.

The current activities within FDA and I

NRC as well as the recent Memorandum of Understanding (MOU) between FDA and NRC should be fruitful in this regard.

Enhanced communication among all participants and a strong I

partnership among Federal and State agencies will be beneficial in both the implementation of any improvements and development of future regulations if needed.

)

As a result of these findings, the Task Force faced a dilemma.

Neither criteria for assessing the adequacy of the current regulatory framework nor adequate information on its ll i

I

I Task Forte Report on Medical Radiation Protection 5

I performance exiat for all sources of ionizing radiation in medicine.

Therefore, we were unable to quantify the adequacy of today's framework or fully evaluate the effect of changing to any I

of the other regulatory options.

We are only able to indicate that if problems exist in a certain area; for example, radiation therapy, then a specific option may be best for addressing these problems.

To overcome this, the Federal government needs to establish what it wants to achieve in medical radiation protection.

For I

example, the Federal government may wish to provide a specific level of protection in the medical use of all sources of ionizing radiation.

This would require an operational definition of adequate protection such as performance criteria or a safety I

goal.

Such measures do not currently exist in the AEA or the current regulations of FDA or NRC.

Next, the Federal government and the States would have to agree on a definition of " adverse I

impacts" (e.g.,

severe injury).

The NRC's definition of misadministration, for example, appears to be too inclusive for this purpose since not all misadministrations result in adverse health impacts.

Agreement would also have to be reached on the definition of administration (e.g.,

this could be the number of new therapy patients) to be used in determining the rate of adverse impacts.

I Alternatively the Federal government may simply wish to achieve equivalent levels of public protection for all sources I

and uses of ionizing radiation used for medical purposes without establishing performance levels or a safety goal.

However, this would also require establishing and implementing the definitions discussed above.

Next, there needs to be a system for acquiring performance data for all sources to determine whether the performance I

standards are being met and if not, what regulatory changes would be beneficial.

The accumulation of this data would be necessary to quantitatively evaluate the options discussed below and choose I

the most cost-effective path for the regulation of medical radiation.

We have considered the effort that would be necessary to obtain information to evaluate the current regulatory framework.

To accurately identify the magnitude of adverse I

impacts in the medical uses of ionizing radiation and to determine if there are differences in public protection due to treatment modalities or different regulators (NRC, Agreement I

States, or FDA) would require a nationwide study.

A thorough definition of such a study is beyond the scope of the Task Force effort, however, it is clear that it would be costly and may require legislation.

To indicate the general magnitude of data collection requirements, we have outlined two possible alternatives for I

Task Force Report on Medical Radiation Protection 6

obtaining the data.

The first and more complete would be a survey of all licensees.

This would need Congressional legislation to require the States to collect data on adverse I

impacts from all sources of radiation.

There are currently about 6000 NRC and Agreement State licensee facilities.

A collection period of perhaps two years would be necessary because of the apparently low rate of occurrence.

Finally, the results would I

need to be analyzed and compared for each treatment modality, source of radiation, and regulator.

I' A less costly and less accurate approach for obtaining data would be by sampling.

To avoid the need for legislation, this could be a voluntary approach which would require Office of Management and Budget (OMB) approval.

A sample, on the order of 50,000 new patients would be needed with a collection period of at least one year because of the apparently low rate of occurrence.

The sample would need to be partitioned to cover the obvious differences, that is, large vs. small States or licensee facilities, treatment modalities, urban vs. rural areas, and types of facility or ownership.

Only after these efforts are completed can the current regulatory framework be evaluated or any options for change be considered.

Therefore, the options discussed below are treated I

qualitatively.

We have indicated what qualitative benefit each option will produce and at what qualitative cost.

It is clear that any of the options except the first will cost additional I

real resources in terms of legislation, programs, training, and inspection.

What is not clear is the benefit in terms of injury reduction or decrease in unnecessary dose.

I Options for the Regulation of Medical Radiation A broad range of options for the allocation of regulatory responsibilities for medical radiation, and their underlying advantages and disadvantages, were considered by the Task Force.

We considered these options both as seen from the regulator's perspective and with the benefit of input from the States, other Federal agencies, and the private sector.

Our range has covered I

options under which the Federal government would assume broader responsibility for both regulations and implementation to those which would not involve the Federal government in any implementation at the user level.

The Task Force notes that if I

legislation is warranted to reallocate regulatory responsibility for medical uses of radiation, providing uniform regulatory oversight for all similar uses of radioactive materials (e.g.,

industrial, academic, research, and medical) would be beneficial.

i I

i

I Task Forre Report on Medical Radiation Protection 7

I We have focused in this report on those options which appear viable, would likely resolve identified issues, or received endorsement from commentors.

They are analyzed in more detail in the Discussion section of this report and are summarized below.

Current Framework with Improvements I

This option would maintain the current regulatory responsibility of FDA, NRC, and the States, recognizing that I

there are initiatives now in place which are intended to address and make improvements in several of the identified problem areas.

Under the Agreement State program, NRC would continue to regulate sources and uses of byproduct material I

and FDA would continue to regulate the safety and effectiveness of drugs and devices but their use would be regulated by the States without Federal requirements.

I Current initiatives are expected to enhance communication and working relationships among Federal and State agencies concerned with medical radiation and bring about more recognition of problem areas.

Some of the advantages of this option are that it would not require significant additional resources nor legislation, and the States generally favor continuing this approach.

l Some of its disadvantages are that it does not address in a i

comprehensive way the problems with the current regulatory framework, principally the lack of consistent requirements at the user level for byproduct, machine, and NARM sources of ionizing radiation in medicine, both from State to State and within States.

Federal Regulation with Agreement State-Type Implementation l

l If after evaluating the current regulatory framework, it is determined that consistency in national requirements and additional Federal regulatory oversight is needed, then this i

option should be considered.

Therapy only Under this option, a Federal agency (or agencies) would develop and implement the regulations for ionizing radiation therapy from all sources and have the authority to establish an Agreement State-like program for their implementation.

This option-would focus on therapeutic treatments which have the greatest potential for causing harm to the patient.

States would have the authority to develop and implement

~I regulations for the diagnostic uses of medical radiation.

Flexibility within this option would result from the selection of compatibility requirements, that is, the extent I

1

Task Force Report on Medical Radiation Protection R

to which specific regulations and their implementation need to follow Federal regulations and guidelines.

I This option would ensure a high degree of uniformity and consistency in the regulation of radiation therapy and would eliminate any regulatory advantage of one treatment modality over another.

Also, the extent to which the Federal I

regulations controlled activities at the user level could also be varied.

However, it would be costly and time consuming to implement arid would require 1cgislation.

In I

addition, State and professional receptivity to such regulation might be low if the compatibility requirements extended down to the user level activities.

Diagnostic and Therapy This option would be similar to the option described I

immediately above except that both the diagnostic and therapeutic uses of medical radiation would be regulated.

An argument for including diagnostic uses is that these I

result in a larger collective dose to the public than therapeutic treatments because of the larger number of diagnostic radiation procedures.

The principal advantages for this option are the same as above for therapy and the disadvantages, beyond those for therapy, are that it would be very costly to implement and I

oversee and State and professional receptivity would likely be very low.

Federal Standard Settinct with State Implementation If after evaluating the current regulatory framework, it is determined that consistency in national requirements is I

needed but there is confidence that State implementation could provide acceptable public protection, then this option should be considered.

This option would have the Federal government develop regulations for the use of all sources of ionizing radiation used in therapy with State responsibility for I

implementation.

The Federal government would have no responsibility for oversight of the States.

The general principles of this option could be applied to diagnostic and I

therapeutic uses or to therapy alone.

The extent to which the Federal regulations controlled activities at the user level could also be varied.

~

The principal advantage of this option would be the degree of uniformity in medical radiation regulation and the elimination of any regulatory advantage of one treatment I

I Task Force Report on Medical Radiation Protection 4

modality over another.

However, differences in program implementation may still occur from State to Stato unless there was some group to oversee uniformity.

The principal I

disadvantages are the additional State resources necessary to establish and implement this option and the requirement for legislation.

Limited Federal Radiation Safety Oversicht If after evaluating the current regulatory framework, there I

is no apparent difference in public health and safety protection due to the differences in how byproduct and non-byproduct sources are regulated, then this option should be considered.

This option would have the Federal government provide NRC-type regulations for the radiation safety aspects of the I

sources and devices used in medicine but would not have Federal involvement in their application.

Federal oversight of the regulated activity would be conducted in a fashion similar to FDA's oversight program.

The principal advantage of this option would be the reduced need for Federal resources for medical radiation protection.

The disadvantages would be the potential for further inconsistencies in the regulation of medical radiation at the patient level, reduced ability to collect data for I

evaluating regulatory effectiveness, and the possible concern of health care advocates over Federal disengagement.

Another potential but unquantifiable disadvantage of this or any other option where the NRC withdraws its regulation of I

byproduct sources at the user level could be the unintended effects caused by an apparently diminished concern for radiation protection in the medical use of these sources and I

the withdrawal of standards for protection that could be adopted for non-NRC regulated activities.

I I

I I

I

I Task Force Report on Medical Radiation Protection 10 l

DISCUSSION Task Force Approach NRC formed a Task Force, including a representative from I

FDA, to examine these issues in response to the request from Senator Glenn.

The members of the Task Force are listed in Appendix E.

The Commission provided guidance to the Task Force in Staff Requirements Memoranda (SRM) dated June 10 and August 9, I

1993, regarding the scope of this study.

The Commission stated that the fundamental objectives for this effort should be to characterize the problem to the greatest extent possible based on currently available information, to identify options that should be closely evaluated, and to characterize the database necessary to allow a productive evaluation of the options.

Further, the I

Task Force was asked to examine the data currently available from Agreement and non-Agreement States to more accurately assess the magnitude (and its uncertainty) of the risks of misadministration.

The Commission also noted that the object of I

this effort was to develop a preliminary report on the issues but should not recommend final resolution of the issues.

Such recommendations would be left to the independent review of the medical use program by NAS.

The Task Force viewed the central question addressing concerns raised by Senator Glenn to be:

"Does the current I

allocation of authority and responsibility among Federal and State regulatory bodies meet the nationwide goal of ensuring adequate protection of the radiological health and safety of the I

public, including patients and health care workers, in the medical uses of ionizing radiation?"

From this, a number of issues were identified which the Task Force felt needed to be I-addressed in order to respond to the central question.

These issues, discussed in detail in Appendix B, are categorized as follows:

• Uniformity of requirements and regulatory oversight

• Database and health and safety implications

• Training and experience of radiation users and associated I

professional personnel in radiation safety i

• Communication among Federal and State agencies I

The allocation of regulatory responsibilities in medical radiation was discussed at a public meeting for the States on May 20, 1993.

Input from that meeting, as well as guidance from the Commission, meetings with the NRC staff, review of the transcript I

of the May 6 hearing, and Task Force members' experience was used to help define the issues identified above.

I I

I Task Force Report on Medical Radiation Protection 11 i

I Input on the question of whether these were, in fact, the issues that should be addressed, was sought from the States, the NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI),

I FDA, and NRC as well as selected Federal medical licensees, professional societies, medical equipment and radiopharmaceutical manufacturers, and a voluntary health organization.

Appendix C is a list of those contacted.

The Task Force reviewed the comments received from the respondents to determine if the key issues had been appropriately identified and whether options for resolution of identified problems could be determined.

l 5

The Task Force reviewed the data currently available from Agreement and non-Agreement States on the number of reported

, g therapy misadministrations from NRC-regulated sources of

g radiation.

In addition, we attempted to identify the number of therapy misadministrations involving use of NARM and machine sources of radiation which are outside of NRC's regulatory 4

purview but constitute more than 75 percent of therapeutic j

treatments.

To do this, we surveyed by telephone 22 Agreement and non-Agreement States for their applicable data.

4 We also contacted a number of public interest and health care advocates, identified in Appendix C, to determine their views and concerns relative to the medical use of ionizing radiation and its regulation.

,g Characterization of the Problem The current framework for the regulation of medical I

radiation is not uniform, either at the Federal or the State I

level.

NRC regulates the safety of the use of byproduct material t

at the user level while FDA regulates the safety and i

~

effectiveness of drugs, biologics, and medical devices, primarily g

5 at the manufacturer level.

NRC has mandatory reporting of adverse events and misadministrations at the user level for its I

licensees.

FDA has mandatory reporting requirements for device I

malfunctions from manufacturers and user facilities, and a system of voluntary reporting for health care providers and patients.

At the State level, medical radiation safety programs may vary I

from State to State or within States for differing sources of radiation.

Because the regulations in this area have different focuses, do not use the same terminology to describe patient incidences involving misadministrations, and collect data under different criteria there is no common basis for developing the data needed I

to assess the safety of medical radiation.

Thus, the database necessary to determine if there is a health and safety problem does not currently exist and there is not a process in place for I

i 1

e i

Task Force Reoort on Medical Radiation Protection 12 I

its generation.

Finally, there are no comprehensive regulatory systems in place to ensure adequate training and experience in radiation safety of those health care professionals involved in I

the medical application of radiation or formal systems to ensure communication among Federal agencies and States on their respective responsibilities, and to share technical guidance, and event information.

Therefore, the problem could be characterized I

as a lack of a fully coordinated regulatory effort as well as a lack of sufficient data to evaluate the effectiveness of this effort, across Federal and State agencies, for providing protection of the public health and safety in medical radiation.

Discussion and Analysis of Comments on Regulatory Issues Input was received from 22 States, CRCPD, six professional societies, three manufacturers, three Federal medical licensees, I

numerous FDA and NRC officials with responsibilities in this area, one voluntary health care organization, and ACMUI.

Most of the States and professional organizations provided written comments, while oral discussions only were held with some other respondents.

This section of the report contains a summary discussion of the comments and issues based on the input received.

Appendix D is a copy of the summary of the public I

meeting held by ACMUI on these issues.

The bracketed listings indicate the sectors providing the stated comments.

Uniformity and Reaulatory Overficht Some level of national uniformity in regulations and I

standards, to avoid substantive differences in regulations on medical radiation among the 50 States, was identified as being desirable by all respondents.

Suggestions on this issue included (1) regulations that would cover all sources of ionizing I

radiation and both diagnostic and therapeutic procedures [ Federal medical licensees, some States and professional associations, CRCPD, and a voluntary health organization]; (2) regulations that cover only radiation safety issues for all sources of radiation

[ACMUI and some professional societies and States]; (3) regulations that are limited to activities involved in interstate commerce (some Federal regulators and manufacturers]; and (4) limiting regulations to the area encompassing teletherapy byproduct sources and machine radiation sources [some Federal medical licensees].

lI There were several suggestions offered on how such uniform i

regulations could be established.

Most of these related to I

mandating national adoption of some existing radiation protection regulations or standards rather than the development of new regulations.

The adoption of the CRCPD's SSRCR was often I

e

i l

Task Force Remirt on Medical Radiation Protntion 13 1

suggested as well as the many voluntary practice standards and guidelines established by the professional associations [some professional societies, States, and Federal regulators].

In I

addition, there were several reasons why these regulations should address the diagnostic area, including (1) an option for therapy

(

alone addresses only relatively low probability, high consequence events and ignores the greater collective population dose from I

diagnostic radiations; (2) the issue remains the application of standards to the most troublesome configuration, that being the diagnostic imaging device in the private office; (3) the Federal I

government should require that minimum standards be implemented

)

for Medicare patients for all diagnostic and therapeutic

)

}

procedures involving ionizing radiation, such as it has for I

mammography; and (4) the misadministration of x-rays could be extended to the ordering of unnecessary or non-beneficial exams

[CRCPD and some professional associations and States].

In addition, there was agreement that there should be some regulatory structure, whether a single Federal agency, a pair of I

Federal agencies, or a network of Federal and State agencies, to be the focal regulatory authority for all sources of ionizing radiation.

A need for a single Federal agency to control the introduction of products containing ionizing radiation and their manufacture and distribution by the private sector was identified

[some manufacturers, Federal regulators, and Federal medical licensees].

Implementation (licensing, inspection, and enforcement) was generally identified as a State responsibility but should allow for flexibility (some States, Federal regulators, professional societies, and manufacturers).

In the event where a State did not want this responsibility or sufficient funding was not available to the State, implementation could be accomplished by the NRC Regions [some Federal medical licensees, and manufacturers).

Suggestions on the organization that should be responsible for all regulatory oversight ranged from CRCPD, FDA, NRC, an entirely new Federal agency, or a combination of these.

p Database and Health and Safety Implications Since there is currently no database on the frequency of administration of ionizing radiation for diagnostic and therapeutic purposes or on the accuracy of delivery, many respondents were positive on the need to develop such a database in order to determine whether there is a problem in the regulation of the medical uses of ionizing radiation that requires additional regulatory oversight.

The respondents also were in general agreement on the desirability of establishing common terminology for regulations and reporting for data analysis [all sectors).

The States, in general, as well as some respondents from other sectors did not see the need for collecting additional data and making health and safety

Task Force Report on Medical Radiation Protection 14 comparisons because of the perceived current low frequency of occurrence of adverse events or because the cost of obtaining i

additional information could not be justified within budget constraints.

Comments on which comparisons should be made to identify important health and safety considerations fell into one of two fairly distinct groups.

One group suggested that there is a need l

for comparison of the risk of the medical uses of ionizing l

radiation with other medical procedures.

These comparisons were I

favored because (1) they could demonstrate that a public health and safety problem does not exist with respect to the medical use l

of ionizing radiation or (2) could identify an allocation of scarce Federal, State, and health care resources in accordance I

with actual patient deaths and injuries [some professional l

societies, some Federal regulators, and ACMUI].

The other group suggested that the usefulness of these comparisons may be of limited value because (1) modalities cannot be lumped together, (2) relative risk is like comparing " apples and oranges," (3) certain risks may be unacceptable regardless of other considerations, and (4) the public has clearly demonstrated a low tolerance for radiation related occurrences, [one professional society, one manufacturer, some Federal regulators, some Federal medical licensees, some States, and a voluntary health organization].

There was nearly unanimous consensus of the ACMUI that getting better data to characterize the problem should be the highest priority and should be done before the other issues are addressed (see Appendix D).

Additionally, of those respondents who commented on the safety goal, some responded positively and others recommended caution on the use of a safety goal because of the difficulty of defining what to measure, such as deaths, misadministrations, or j

serious injuries; and a potential undesirable outcome of a safety goal having a negative influence on the use of one medical technology over another [some professional societies and some Federal regulators].

Training and Experience There was general agreement that minimum national standards were appropriate regarding the training and experience criteria of physicians, radiation safety officers, and associated professional personnel [all sectors).

There was also general I

agreement on the need to maintain qualifications and for periodic requalification by the certifying group or agency [some Federal regulators, professional societies, Federal medical licensees, and one manufacturer].

However, the States indicated that Federal regulations in this area could conflict with existing State statutes or regulations if they cover diagnostic and therapeutic x-ray machines.

As in other areas, there are

L

)

l L

Ta<k Force Report on Medical Radiation Protection 1 85 r

L differences in the capabilities and resources of the States to pursue this issue, therefore, differing levels of Federal e

[

involvement may be warranted [some States].

ACMUI reiterated its belief that the focus of licensure for use of ionizing radiation in medicine should be radiation safety and that training and f

experience criteria should be closely linked to the type of use j

and associated hazards.

[

Suggestions on who should develop the minimum national L

training and experience criteria included the professional organizations, the medical advisory groups of NRC and FDA, the J

States, Department of Health and Human Services, and NRC.

Communications f

It was generally indicated [all sectors] that better L

communication was needed and would serve both the regulators and the regulated.

In fact, some commentors indicated that more regulations were not needed, but rather more cooperation and more communica' ion were needed in carrying out existing regulations.

4 Examples L ways to improve communications included having all States roatinely report all extraordinary events to a central Federal agency and having that agency share the details of the causes of those events with all appropriate licensees, and establishing a formal written agreement between FDA and NRC.

Discussion of Comments from Public Interest and Health Care Advocates The Task Force contacted by phone the Executive Directors or other high level staff of over 25 national and local consumer interest groups and patient, health care, or malpractice advocates (see Appendix C).

The groups contacted were identified through consultation with FDA's Office of Consumer Affairs, various NRC staff and Commission representatives including the NRC's Office of Public Affairs, the CRCPD, ACMUI, staff of the Senate Committee on Governmental Affairs, and by referral from groups contacted.

[

These groups were briefed on the issues under Task Force review, and we requested their views on whether the medical use of radiation in therapeutic or diagnastic procedures presents a risk to the public health and safety that is of concern to their organization.

They were asked if they had concern that patients were being seriously injured by overdoses of medical radiation, whether they believed that existing regulation of medical radiation was adequately protecting the public health and safety, and if their organization had formal positions on these issues.

4

Task Force Report on Medical Radiation Protertion 16 Although referring parties indicated that these groups were l

the most likely to have concerns on this issue, none of the l

groups indicated medical radiation protection is an issue that is

,3 currently receiving much, if any, attention by their

5 organizations.

Most groups admitted to not being well informed on this issue even though it could be of concern to their g

constituents.

In general, they indicated that they had received

g few if any complaints about errors in the administration of j

medical radiation and were not receiving reports of such incidents, their constituents had not expressed interest or concern on the subject, and the issue did not have high visibility with their organization.

As a consequence, the groups l

contacted have no programs for dealing with the medical radiation issue or opinions on changing the existing regulatory framework.

While none of the groups contacted have positions on the issue, the American Association for Retired Persons (AARP) does l

have a formal position supporting FDA's efforts in the regulation of medical devices in general, and specifically on the Safe l

Medical Devices Act of 1990.

The AARP has not, however, been I

specifically concerned with the safety of medical devices which produce or utilize radiation.

Physicians for Social Responsibility has also been con:erned about the FDA medical device approval process in general, advocating testing rather I

than merely a paper review for approval, but is not focusing specifically on radiation medicine devices.

The groups contacted i

I were also specifically asked about NRC's regulatory efforts and none had either positive or negative comments.

l When asked to speculate if there were reasons, other than

'g there is not a problem in this area, which would explain why 5

Patients and consumers have not been expressing concern, the contacts offered seme insights.

The contacts indicated that, in I

general, the public/ consumers have to trust that the government is regulating for their safety.

The contacts also indicated that most people are not concerned about the possible problems from l

diagnostic or therapeutic procedures involving radiation until they or someone they know requires those procedures.

And once people are confronted with a diagnosis of cancer, many of them are so emotionally and physically drained from coping with such a life threatening disease that they become passive, almost

I apathetic, and unlikely to pursue questions on errors in the l

administration of radiation doses.

l Most of the groups indicated they would support improvements in the regulation of medical radiation but acknowledged that such improvements would require significant expenditures which might be better spent in some other area of health care.

I l

[

lI L--__ _ _

I I

i Task Force Rmort on Medical Radiation Protection 17 ll Analysis of Misadministration Data Currently Available I

The Task Force examined the data currently available from I-Agreement and non-Agreement States to more accurately assess the magnitude (and its uncertainty) of the rate of l

misadministrations.

The data that we used for this assessment I

were (1) the NRC data on misadministrations as compiled in the Office for Analysis and Evaluation of Operational Data (AEOD) l Annual Reports; (2) data reported by the Agreement States on

'a misadministrations as compiled in the AEOD Annual Reports; and g

(3) analyses performed by the NRC's Visiting Medical Follow on the rate of radiotherapy misadministration.

The above data only l

represents patient misadministrations from sources of radiation I

under NRC's regulatory purview (Atomic Energy Act material) and does not include misadministrations from machine-produced or NARM l

radiation sources.

NRC has required that its licensees report misadministrations since 1980.

But it was not until 1986, with

~

the revision of 10 CFR Part 35 (effective April 1987), that misadministration reporting was made a requirement for Agreement States, to be fully effective April 1990.

In 1991, the first full year for Agreement State misadministration reporting, a

~

number of Agreement States did not provide a report to the NRC on reported medical misadministrations involving NRC-regulated material.

All Agreement States did provide reports for 1992 on misadministrations reported to them by their licensees.

However, the total of their reported therapeutic misadministrations was only about half that reported by the Agreement States for 1991 L

and was not consistent with what would be expected based on presumably equivalent data from NRC licensees for the same yehrs.

g A possible contributing factor for the inconsistency of the 1992 l

Agreement State data with either the 1991 data or its relation to g

NRC licensee data is that the " Quality Management Program and g

Misadministration" rule became effective on January 27, 1992.

l This rule revised the definition of, and reporting requirements for, diagnostic and therapeutic misadministrations of byproduct I

material and will not become a requirement for compatibility for Agreement States until January 1995.

This currently results in j

the use by some Agreement States of a misadministration I

definition that is different from that used by NRC licensees.

While the available data on therapy misadministrations suggest f

differences exist between rates of reports by NRC licensees versus Agreement State liccnsees, tne actual numbers are I

relatively small and the statistical significance of the differences is uncertain.

For these reasons, caution should be exercised when comparing NRC and State data.

This data shows that, in 1991, 2094 NRC licensees reported 19, and 4524 Agreement State licensees reported 18, therapy I

I

I Task Force Report on Medical Radiation Protection 18 misadministrations.

In 1992, 2228 NRC licensees reported 29 (of

~

these, several occurred in previous years), and 4944 Agreement State licensees reported 10, therapy misadministrations.

Since I

this data only includes patient misadministrations from sources of radiation under NRC's regulatory purview (Atomic Energy Act material), it excludes machine-produced radiation and NARM sources which account for more than 75 percent of therapeutic I

applications of radiation.

There were about 1900 linear accelerators and about 500 cobalt machines in use in 1990.

The number of linear accelerators in use is increasing and the number of cobalt machines in use is decreasing.

The Task Force also attempted to identify the number of therapy misadministrations involving use of NARM and machine I

sources of radiation from both Agreement and non-Agreement States for 1991 and 1992.

While recognizing that the reporting of this information for machine sources of radiation is not required by I

any Federal Agency and may not be generally available, a number of sources indicated that in some Agreement States, the machine and NARM sources of medical radiation are regulated in a manner similar to byproduct material sources.

We surveyed by telephone 15 Agreement and 7 non-Agreement States to ascertain if the States have misadministration reporting requirements for non-byproduct sources comparable to that for byproduct material, and if so, if report data were available for comparison purposes.

Of the 22 States surveyed, 11

,I indicated that they had reporting requirements (three of these only since october 1992) which are equivalent to those for byproduct material, either through State regulations or license conditions.

However, only five of the eleven States were able to I

provide the number of reports for the requested years within the timeframe available.

The principal reason for this is that many States review and follow up on the misadministration reports on a I

case-by-case basis and file them in individual licensee files rather than in a misadministration database.

Therefore, to determine total numbers of misadministrations would require a g

search of individual licensee files.

The total number of M

reported therapy misadministrations in 1991 and 1992 from machine produced radiation for the five States who provided numbers was eleven.

These same five States had a total of twelve reported

,I nisadministrations from byproduct material.

Assuming the byproduct radioactive material I

misadministration total, which is based on NRC reporting requirements, is correct, we are not confident that the machine misadministration total can be used for further evaluation because the number of States (5) with data is too small to draw

'I conclusions.

In addition, two of the five States expressed lack of confidence in the data because of their belief that licensees were not aware of the requirements and the State inspections were iI i

llI

i

- I Task Force Repor1 on Medical Radiation Protection 19 I

resource limited and did not focus on reporting requirements.

_We have previously learned that most of the therapy misadministrations reported to the NRC resulted from miscommunication among the licensee staff, errors and oversights I

in the treatment planning process and patient identification and set-up, failure to follow procedures, and inadequate supervision.

These errors are not machine or source of radiation dependent and would be expected across all radiation therapy treatment sources.

Therefore, the number of reported machine misadministrations is much lower than expected.

As a result of this telephone survey to the State offices responsible for receipt of misadministration or similar data from machine and NARM sources of radiation, we are able to make some I

tentative observations:

l Many States do not compile a collective database of e

I this misadministration information, but rather handle such information on a case-by-case basis and maintain it in individual licensee files Many States do not have the resources to devote e

inspection efforts to ensuring compliance with reporting requirements only about half of the States surveyed have reporting e

requirements for NARM and machine sources which are I

similar to the NRC's for byproduct radiation misadministrations Regarding an assessment of the magnitude (and its I

uncertainty) of the rate of misadministrations, we considered the 1991-1992 data described above and the information received from the 22 State survey.

For NRC-regulated material, a method I

similar to that used by Myron Pollycove, M.D.,

NRC Visiting Medical Fellow, in his March 8, 1993, memorandum (Appendix E) could be followed to estimate the number of national i

misadministrations per patient treatment.

This approach I

estimates the national rate of therapeutic misadministrations from byproduct material by using the NRC-licensee data and extrapolating to the total U.S.

population.

Dr. Pollycove has estimated the rate of therapeutic misadministrations from byproduct material to be approximately 3 per 10,000 patients.

He also estimates the rate of serious injury from these I

misadministrations to be approximately 3 per 100,000 patients.

Dr. Pollycove notes that the data is approximate and unlikely that error would more than triple these totals.

We believe that Dr. Pollycove's approach is reasonable for NRC-regulated material I

because NRC's reporting requirements are relatively well defined and enforced.

However, to extend this analysis to the Agreement States requires the assumption that there are no effects i

I I

I Task Forte Report on Medical Radiation Protection 20 resulting from differences in the licensing, inspection, and enforcement programs among the Agreement States and the NRC.

Uncertainties in these rates may also exist because of the lack I

of sufficient data on the number of patients for all treatment modalities, non-detection of misadministrations, and underreporting.

Comparison of the risk of serious injury from misadministrations with the normal risks associated with properly I

administered therapy (which have been estimated by Dr. Pollycove as 1% for deaths and 10% for morbidity) would provide perspective.

Finally, the Task Force considered whether the information received from our survey of 22 States could be used to assess the magnitude (and its uncertainty) of the rate of misadministration I

from machine-produced and NARM sources of radiation which constitute over 75 percent of therapeutic treatments.

For the reasons discussed above, we concluded that the data could not be I

used to make such an assessment and that extrapolation of data for NRC-licensed material to machine-produced and PARM sources of radiation would not be prudent.

Anecdotal information and the Task Force's expertise leads us to believe that the rates of misadministration per therapy treatment would not be less for machine-produced or NARM sources than for byproduct sources of radiation because the procedures and processes are much the same.

Information received during the course of our survey also suggests that NRC's requirements, I

inspections, and enforcer at result in greater attention to the details of administratio:

Therefore, we would not expect that the rate of misadministration from NARM and machine sources would be less than for NRC-regulated sources.

I i

Evaluation of Options j

I l

Regulation of medical radiation is currently being provided by NRC, FDA, and the States.

This has resulted in differing

_I requirements based on the source of the radiation being I

administered and on where in the United States the administration takes place.

Since the public health and safety is the principal I

goal of these regulatory programs, an important issue is an allocation of regulatory responsibility that would most effectively accomplish this goal.

The Task Force considered a broad range of options for the allocation of regulatory responsibility based on their potential I

impact on health and safety.

The options were developed to I-address the problems and issues identified by the regulators, the States, Federal agencies, and the private sector.

Other options J

have advantages which are attractive but, on balance, did not l

I i

I

I Task Forre Report on MedicM Radiation Protection 21 I

lI appear to the Task Force to be viable at this time.

For example, an option where the Federal government would be totally l

responsible for regulations and implementation (without an l

Agreement State program for implementation) would likely be the l

most uniform approach but would most likely be very costly relative to the enhancement of public health and safety.

Conversely, having the Federal government be responsible for only I

basic radiation protection could save Federal resources but may not accomplish the desired goal of protection of public health and safety or of uniformity.

Also, within every option, the I

extent of Federal involvement could be varied.

For example, if the goal is to provide, for all sources, regulation equivalent to that for NRC-regulated byproduct materials, then regulations for

{

non-byproduct materials, which are similar in scope to the NRC i

l regulations would need to be promulgated.

If on the other hand, I

regulatory oversight equivalent to that provided by FDA is the goal, then the Federal government could change (through I

legislation or policy) the regulation of byproduct materials accordingly. Recognizing that there is a large number of possibilities, and with the short time available, we have I g selected for discussion those options which received endorsement 3

from commentors, could be solutions to identified problems such as lack of uniformity and fragmentation, or were extensions of these.

I Option 1 - Maintain the current framework for the regulation of medical ionizing radiation with recognition of planned and potential improvements.

This option would be chosen unless a basis for another option is developed from a thorough study of nationwide scope to I

determine the magnitude, if any, of a health and safety problem.

Also, this option would be chosen if it is concluded that the nationwide study should not be performed, for example, because of I

resource limitations.

Since this option would not disrupt the current regulatory system including the improvements underway, it may also be preferred if, from the nationwide study, no I

significant differences were found in public protection among the various treatment modalities and regulators (NRC, FDA, Agreement States, and non-Agreement States).

It would maintain the regulatory responsibility of FDA, NRC, and the States, recognizing that currently there are significant initiatives, discussed below, which are intended to address certain of the identified problems.

These initiatives would provide additional information to better understand the impacts of medical radiation on public health and safety.

This option would not require new legislation, costs would not be I

substantially impacted by the new initiatives, and regulatory agencies would continue in their current roles.

Therefore, while this option would have the least effect on the issues that we I

I Task Force Report on Medical Radiation Protection 22 have identified, its impact on resources and the inner workings of the current regulatory system would be minimal.

I This option would also accommodate the significant initiatives that have been made in recent years and are being made to improve regulatory oversight in the existing regulatory programs.

Additionally, new information that will be gained as a result of the full implementation of the "QM" rule and the other initiatives over the next few years, as well as additional efforts to evaluate risks associated with medical I

misadministrations could provide some of the data needed to better determine whether the allocation of resources among

)

Federal and State agencies should be changed.

These program j

changes and studies are described below.

A senior management review of the NRC program has been l

completed and the results of that review will be combined with other initiatives into a comprehensive plan to improve the NRC's medical regulatory program.

Planned action items include new and revised inspection and licensing guidance, a

comprehensive revision to Part 35, review of the enforcement I

policy, and continuing research efforts to evaluate risks associated with therapy procedures, and the human error component of misadministrations.

I NRC is pursuing a study by NAS for a comprehensive review and evaluation of the adequacy of the NRC's regulatory I

program for protecting public health and safety from undue l

risk attendant to the medical use of byproduct material.

The statement of work for this study specifically identifies interest in an examination of the broad policy issues which I

underlie the regulation of medical uses of radioisotopes, the overall risk context associated with the use of ionizing radiation in medicine, and the current framework for the regulation of medical uses of byproduct material.

An MOU, between NRC and FDA, provides for increased sharing I

of information between the two agencies.

It addresses coordination in the areas of notification of product I

l.

complaints, misadministrations or emergency situations, coordination of investigational activities, information exchange, and the NRC licensee and Agreement State Notifications.

I FDA has included, in its pending Medical Device Reporting regulation for user facilities and manufacturers, criteria for a " reportable radiation therapy device event."

The reporting criteria are consistent with those used in the I

NRC's misadministration definition in Part 35.

While the revision of the reporting criteria and its extension to user facilities improve on the information to be reported, I

I Task Forre Repod on Medical Radiation Protection 23 reporting is still limited to events resulting from device problems and does not include those resulting from user errors alone.

Also, there is no reporting requirement for errors involving the use of naturally occurring and

.I accelerator-produced radioactive material (NARM) radiopharmaceuticals.

Even with the improvements identified above, this option does not address the fragmentation and inconsistencies of State regulatory programs for non-byproduct sources of radiation and I

its impact on protection of the public.

In the current framework, the NRC-Agreement State program provides a substantial degree of consistency in the regulation of byproduct naterial between NRC and each of the 29 Agreement States.

The Agreement I

States generally look favorably on this program.

However, there is some lag in adoption by the States of the NRC requirements, and variation in implementation (licensing, inspection, and I

enforcement) from State to State.

Further, questions have been raised as to differences between Agreement State and the NRC regional program implementation.

NRC staff is developing a program to provide more consistent oversight of its regional I

offices and the Agreement States.

Option 2 - The Federal government develops and implements I

regulations for all sources of ionizing radiation used in medical therapy.

Under this option a Federal agency (or agencies) would develop and implement the regulations for ionizing radiation therapy with all States developing and implementing regulations for medical diagnostic uses.

This option may be preferred if I

results of a thorough nationwide study showed that significant differences exist in the frequency of adverse impacts among radiation treatment modalities because of differences among the I

regulators.

Therefore, one overall Federal regulator or closely coordinated regulation among agencies may be desirable.

Federal legislation would be required to combine or coordinate regulations.

If it is found from the nationwide study that there I

are no significant differences in frequency of adverse impacts between NRC regulated states and Agreement States then under this option, the Federal agency could be given the authority to I

establish an Agreement State-like program for implementation of the medical radiation therapy regulations.

I This option would ensure a high degree of uniformity and consistency in the regulation of ionizing radiation therapy and avoid gaps in the application of these regulations which should lead to smaller differences in frequency of adverse impacts among I.

treatment modalities.

It also would eliminate any regulatory advantage of one radiation treatment modality over another.

Also, it concentrates efforts and resources in the area that has I

I Task Forre Report on Medical Radiation Prviection 24 the greatest potential for causing harm to the patient.

One advantage of this option is that individual users would only have to deal with one regulatory authority regarding implementation of I

medical ionizing radiation therapy.

Each State would have flexibility to meet their unique interests and to be innovative in their programs to achieve public_ health and safety for diagnostic medical ionizing radiation.

On the other hand, such expanded Federal authority would be costly, and therefore, unlikely to gain acceptance in times of I

budget cutbacks.

The extension of Federal authority, even to this limited area of medical therapy, would likely be met with oppositicn from the States who now have authority for NARM and machine sources.

Thus, the goal of uniformity in implementation I

in all probability would not be achieved.

Funding to ensure the States' ability to implement the regulations could be a problem in times of tight budgets.

Also, differences in program I

implementation in this area may still occur from State to State in the diagnostic area unless there was some group to help maintain uniformity.

Further, any change in legislation may be I

difficult to support in the absence of a compelling safety problem.

Therefore, completion of some of the studies discussed in Option 1, including a nationwide study, may be required to make a case for the new legislation required by this option.

I Option 3 - The Federal government develops and implements regulations for all sources of ionizing radiation used in medical diagnosis and therapy.

Under this option a Federal agency (or agencies) would develop and implement the regulations for ionizing radiation used I

in diagnosis and therapy.

This option may be preferred if results of a thorough nationwide study showed that significant differences exist in frequency of adverse impacts among medical I

diagnostic and treatment modalities because of differences among the regulators.

Therefore, one overall Federal regulator or closely coordinated regulation among agencies may be desirable.

I Federal legislation would be required to combine or coordinate regulations.

If it is found from a nationwide study that there are no significant differences in frequency of adverse impacts between NRC regulated States and Agreement States then under this I

option, the Federal agency (or agencies) could be given the authority to establish an Agreement State-like program for implementation of the radiation medicine regulations.

This option would ensure increased uniformity and consistency and avoid gaps in the application of the regulations which should lead to smaller differences in frequency of adverse I

impacts.

Also, this option would eliminate any regulatory advantage of one radiation modality over another.

Another I

I

I

~

Task Force Report on Medical Radiation Protection 25 1

advantage is that individual users would only have to deal with one regulatory authority.

As with Option 2, this approach would likely be met with i

opposition from the States who now have authority for non-AEA sources.

Also, such expanded Federal authority over all uses, including the large number of diagnostic applications, would be very costly and therefore, unlikely to gain acceptance in times of budget cutbacks.

Further, any change in legislation may be difficult to support in the absence of a compelling safety

-I problem.

Therefore, completion of some of the studies discussed in Option 1, including a nationwide study, may be required to I

make a case for the new legislation required by this option.

pytion 4 - The Federal government develops regulations for all sources of ionizing radiation used in medical therapy with states responsible for implementation.

{

This option may be preferred if results of a nationwide study led to the conclusion that there are significant differences in public protection due to differences among NRC, I

FDA, and State regulations for all therapy uses, and, there is j

confidence that State implementation of the regulations for j

medical therapy would provide an acceptable level of public I

protection.

The general principles of this option could be applied to diagnostic and therapy uses or to therapy alone.

I This option would provide a high degree of uniformity in radiation therapy regulations and would eliminate any regulatory advantage of one radiation treatment modality over another.

An advantage of this option is that individual users would only have I

to deal with their State regarding the implementation of the regulations in diagnostic and therapeutic uses of ionizing radiation.

Each State would have flexibility to meet its unique I

interests and to be innovative in their programs to achieve public health and safety.

I States currently exercise control over the public health and safety for NARM and machine produced ionizing radiation therapy, and it is only because of Federal preemption over byproduct materials that control in this one area was given to the Federal government, with a provision to relinquish certain authority to the States.

Thus, the extension of Federal authority, even to this limited area of medical therapy, would likely be met with I

opposition from the States who now have authority for NARM and machine sources.

Funding to ensure the States' ability to implement the regulations could be a problem in times of tight budgets.

Differences in program implementation may still occur from State to State unless there was some group to help maintain I

I i

Task Forte Report on Medical Radiation Pn)tection 26 l

uniformity.

An additional issue which would have to be addressed is who would have authority to take action should a State choose not to implement the regulatory program or operate at a level

-l which would raise serious questions as to the protection of 3

public health and safety.

Funding to ensure the States' ability to implement the regulations could be a problem in times of tight

.g budgets.

Fragmentation and inconsistencies among State g

regulatory programs would be viewed negatively by manufacturers and suppliers who do business in multiple States.

Further, any change in legislation may be difficult to support in the absence I

of a compelling safety problem.

Therefore, completion of some of the studies discussed in Option 1, including a nationwide study, may be required to make a case for the new legislation required by this option.

Option 5 - The Federal government develops NRC-like regulations for the radiation safety aspects of the sources and I

devices used in medicine but retains no involvement in their application.

I This option may be preferred if results of a nationwide study led to the conclusion that there are no significant differences in public protection due to differences among NRC, FDA, and State regulations and implementation for byproduct, I

NARM, and machine sources of radiation.

This option would have the Federal government provide NRC-I type regulations for the radiation safety aspects of the sources and devices used in medicine but would not have Federal involvement in their application.

Federal oversight of the regulated activity would be conducted in a fashion similar to I

FDA's oversight program.

The principal advantage of this option would be the reduced I

need for Federal resources for medical radiation protection.

The disadvantages would be the potential for further inconsistencies in the regulation of medical radiation at the patient level, I

reduced ability to collect data for evaluating regulatory effectiveness, and the possible concern of health care advocates over Federal disengagement.

Another potential but unquantifiable disadvantage of this or any other option where the NRC withdraws

.I Its regulation of byproduct sources at the user level could be the unintended effects caused by an apparently diminished concern for radiation protection in the medical use of these sources and the withdrawal of standards for protection that could be adopted for non-NRC regulated activities.

I I

I Task Force Report on Medical Radiation Protection APPENDIX A FEDERAL & STATE CONTROL OVER MEDICAL RADIATION USES At the Federal level, regulatory control is exercised by the I

Nuclear Regulatory Commission (NRC) over medical use of byproduct material, including the adequacy of the radiation safety properties of sources, devices, and radiopharmaceuticals used in I

medicine, and by the Food and Drug Administration (FDA) over the safety and effectiveness of drugs and devices.

The NRC oversight is limited to the use of byproduct, source and special nuclear material, which represents less than 25% of the total radiation I

sources which are used in medical radiation.

NRC is also proposing to amend relevant regulations to allow properly qualified nuclear pharmacists and physicians greater discretion in preparing radioactive drucis containing byproduct material.

The FDA oversight for radiation therapy devices is not limited by the source of radiation.

These agencies have maintained close communication over the years, although prior to this time, there has not been formal documentation, such as a Memorandum of Understanding (MOU), to I

scope out the extent of this communication.

A general description of the Federal end State regulatory programs is set forth below.*

The principal statutes under which NRC regulates byproduct, source, and special nuclear material are the Atomic Energy Act (AEA) of 1954, as amended, and the Energy Reorganization Act of 1974.

Within the scope of its coverage, the NRC has broad regulatory authority, and carries out an active program of licensing the uses of materials for medical use, inspecting users, requiring reports of radiation safety problems and medical I

• Detailed information on the NRC responsibilities and interfaces regarding medical uses are set forth in an April 15, 1992, memorandum from the Office of the General Counsel (OGC) to the Commission titled " Regulation of Nuclear Medicine," a I

September 10, 1992, memorandum from OGC to the Commission titled

" Response to SRM Dated June 23, 1992 RE: Practice of Medicine,"

and a February 10, 1993, memorandum from OGC to the Commission titled "The Effect of the Safe Medical Device Act on NRC Jurisdiction Regarding NRC Review of Source Devices Used in l

Medicine."

A description of the FDA's regulatory responsibility for the safety and effectiveness of medical devices, particularly radiation therapy devices, is given in D.

Bruce Burlington's testimony at the May 6, 1993, Senate Governmental Affairs Committee.

I

I Task Force Report on Medical Radiation Protection I

misadministrations and taking enforcement action for regulatory violations.

FDA's regulatory programs have focused on the approval of devices or drugs for clinical use, review of voluntary or mandatory problem reports, enforcement actions including product removal and recall, and prosecution and civil penalties against manufacturers.

Within FDA, regulatory control over the safety and effectiveness of drugs and device uses is carried out by the Center for Devices and Radiological Health (CDRH), the Center for I

Drug Evaluation and Research (CDER), and the Center for Biological Evaluation and Research (CBER).

The principal statute under which FDA/CDRH regulates devices is the Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, I

the Safe Medical Devices Act of 1990, and the Medical Devices Act of 1992.

The principal statute under which FDA/CDER regulates drugs for human use is the Food, Drug, and Cosmetic Act, as I

amended.

FDA/CBER regulates all biological products.

They are either drugs or devices, and are regulated under both the Food, Drug, and Cosmetic Act and the Public Health Service Act.

States have broad regulatory authority over the general public health and safety of their residents.

This includes authority over the use of all sources of ionizing radiation except for that which is preempted by the Federal government --

byproduct, source, and special nuclear material which is controlled by NRC.

However, NRC has signed agreements with 29 States, as provided for in Section 274 of the AEA, in which it has formally relinquished its regulatory authority to those States.

NRC has a program in which it periodically assesses the Agreement States' programs to assure adequacy and compatibility I

with the NRC program.

Agreement States have three years to update certain designated regulations promulgated by NRC to maintain compatibility.

One of these regulations is the requirement to report misadministrations to NRC.

The degree to which States exercise control over all medical I

radiation uses varies from State to State.

The Agreement States normally apply the standards which they have developed for the NRC materials to other sources of radiation within their States, although there is no requirement that they do so.

In addition, I

there is no requirement that non-Agreement States regulate other sources of radiation by applying the standards for the NRC materials.

This has led to inconsistencies in the regulation of I

other sources of radiation in these States.

Further, FDA has also contracted with certain States to perform inspections of diagnostic x-ray machines within their States.

I

^~

I I

I Task Force Report on Medical Radiation Protection APPENDIX D ISSUES RELATIVE TO RADIATION BAFETY IN THE MEDICAL USES OF IONIZING RADIATION The central question:

Does the present allocation of authority and responsibility among Federal and State regulatory bodies meet the nationwide goal of ensuring adequate protection of the radiation health and safety of the public, including patients and health care workers in the medical uses of ionizing radiation?

Set forth below is a list of issues which require further study or resolution prior to making recommendations on the central question.

These issues have been grouped into four broad categories.

(1)

UnifoImity of Recuirements and Regulatory Oversicht (a) need for national uniformity in regulations (including reporting requirements) and their implementation (including effective enforcement) for each source of I

ionizing. radiation (i.e., byproduct, naturally occurring and accelerator-produced radioactive material (NARM), and machine produced)

(b) need for one national regulatory authority to ensure uniformity in areas that are now handled by multiple agencies (e.g.,

certification of sealed sources and I

devices and notification of referring physicians and patients of a misadministration and the likely consequences)

(c) need for a national program to monitor uses of ionizing radiation (including emerging technologies and new I

trends) and identify radiation safety issues that need new or additional regulatory oversight (d) need to identify source of funding for regulation I

development and implementation (E)

Database and Health and Safety Implications (a) need to develop common terminology and definitions of administration, misadministration, and serious injury for each source of ionizing radiation B-1 I

I Task Force Report on Medical Radiation Protection I

(b) need to determine the number of administrations and misadministrations for each source of ionizing radiation (e.g.,

drugs, devices) and the uncertainty in each estimate (c) need to determine the number of misadministrations for each source of ionizing radiation and the uncertainty in each estimate (d) need to determine the frequency of occurrence of I

serious injury related to the use of each source of ionizing radiation and the uncertainty in each estimate (e) need to compare the individual frequencies of I

occurrence developed in (a) above, and compare the frequency of occurrence of serious injury related to all ionizing radiation therapy procedures versus other I

individual cancer therapy procedures (e.g.,

surgery, chemotherapy)

~g' (f) need to compare frequency of occurrence of adverse g

outcomes from misadministration versus properly conducted administrations for each source of ionizing radiation (g) need to establish a safety goal for the medical uses of ionizing radiation (3)

Traininct and Experience (a)

Physicians need to have a regulatory authority establish e

training and experience criteria for physician I

authorized users for each source of ionizing radiation need to have a regulatory authority implement physician authorized user training and experience criteria, including history of regulatory and legal compliance need to have a regulatory authority periodically e

reassess the qualifications of each physician authorized user I

m I

1 Task Force Report on Medical Radiationfrotection (b)

Associated Professional Personnel need to have a mandatory licensing or e

I certification program for activities utilizing each source of ionizing radiation need to have a regulatory authority establish and implement the training and experience criteria for associated professional personnel I

need to have a regulatory authority periodically reassess the qualifications of. associated professional personnel (c)

Radiation Safety Officer need to have a regulatory authority establish the I

duties, responsibilities, and authorities to include each source of ionizing radiation need to have a regulatory authority establish and I

implement minimum training and experience requirements to include each source of ionizing radiation need to have a regulatory authority periodically reassess the qualifications of each radiation safety officer (4) pommunication (a) among Federal agencies (primarily in this case, the i

Nuclear Regulatory Commission (NRC) and the Food and Drug Administration (FDA))

need to clarify respective responsibilities e

need to coordinate device reviews e

need to coordinate regulations for the manufacture e

and distribution, compounding, and use of radiopharmaceuticals and radiolabelled biologics, and the manufacture and use of radiation therapy devices need to share information on events and incident e

reports and coordinate the responses I

I I

Task Force Repor1 on Medical Radiation Protection I

(b) among States and between each State and the Federal government I

need to share information on topics including e

event reports, proposed and final regulations, regulatory guides, information notices, enforcement cases, and product recalls I

I I

I I

I I

3 I

I I

I lI I

B-4 1

1 I

l

Task Force Report on Medical Radiation Protection APPENDIX C CONTACT LIST Groups Sent Letters Reauestino Comments on Issue Characterization (Appendix B):

All 50 States (22 responded)

Advisory Committee on the Medical I

Uses of Isotopes Food and Drug Administration Society of Nuclear Medicine (SNM)/

American College of Nuclear Physicians (ACNP)

American Association of Physicists in Medicine (AAPM)

Professional Council American College of Medical Physics (ACMP)

American College of Radiology (ACR)

DuPont Merck Pharmaceutical Company Varian Associates Nucletron Corporation Johns Hopkins Medical Institution (declined to respond)

Department of Veteran Affairs Department of the Air Force Department of the Navy American Cancer Society I

I

~'

I I

I Task Forte Report on Medical Radiation Prottetion States Called Recardina Misadministration Data:

New Jersey Maine Michigan Pennsylvania I

Missouri Ohio Virginia North Carolina Mississippi South Carolina Texas I

Georgia Tennessee Arizona Illinois 1

Arkansas Massachusetts Kentucky Florida New York California I-Alabama I

"~

I I

I Task Forte Report on Medical Radiation Protation Public Interest and Patient Care Advocate Groups Called:

Public Citizer Health Research Group s

U.S. Pharmacopeia Cancer Care Physicians for Social Responsibility American Association of Retired Persons (Public Policy, Devices, and Health Care Areas)

Center for Patients Rights Hospice Care National Consumer League National Council of Senior Citizens Center for Medical Consumers Health Care Information National Coalition for Cancer Research National Alliance for Breast Cancer Organizations People's Medical Society Radiation Research Society Issues and Policy Safe Medicine for Consumers National Coalition for Cancer Survivorship National Association for Cancer Research New York State Office of Health Systems Management Office of the Attorney General, State of Ohio Office of the Attorney General, State of Pennsylvania Maryland Attorney General's Office / Department of Consumer Affairs I

C-3 I

I Task Force Report on hfedical Radiation Protection Kansas Attorney General's Office / Department of Consumer Affairs Kansas Board of Healing Arts Utah Attorney General's Office / Fair Business Consumer Affair Coordinator Washington Consumer and Business Practice Affairs Office Washington State Medical Association Florida Office of Health Care Administration ll f

Groups offerina Unsolicited comments:

American College of Radiation Oncologists American Society of Radiation Therapists I

lI l'I I

!I

'I l

i I

C-4 I

.________d

ll-

- ~ ~

~

ena l

!ps n,%

l '

[ ' i +-

k UNITED STATES i'

NUCLEAR REGULATORY COMMISSION g

g s,

j wAssisotow. o.c. rosss-oooi E

!I MEMORANDUM FOR:

Carl J. Paperiello, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:

Barry A. Siegel, M.D., Chairman I

Advisory Committee on the Medical Uses of Isotopes

SUBJECT:

CERTIFICATION OF THE

SUMMARY

REPORT OF THE JULY 8, 1993, TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF IS0 TOPES

!I I hereby certify that to the best of my knowledge and belief, the enclosed Summary Report for the Jely 8,1993, teleconference meeting are an accurate record of the proceedings for that meeting.

lI W h ~o Barry A. Siegel, M.D., Chairman (Date)

Enclosure:

As stated I

I I

~

I I

l-l D-1 I

lpa ancyh I

[t'i+() $

UNITED STATES i ~ ' i,

3. !

NUCLEAR REGULATORY COMMISSION g..,,If WASWNGTON, D.C, 20m-0001

~

HEMORANDUM FOR: Carl J. Paperiello, Director Division of Industrial and Medical Nuclear Safety, NMSS I

FROM:

Barry A. Siegel, M.D., Chairman Advisory Comittee on the Medical Uses of Isotopes

SUMMARY

REPORT - MEETING OF THE ADVISORY COMMITTEE ON I

THE MEDICAL USES OF IS0 TOPES, JULY 8, 1993 The Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a special teleconference meeting on July 8, 1993.

Comittee members who took part via telephone included:

I Barry A. Siegel, M.D., Chairman i

Peter R. Almond, Ph.D.

I' s Judith I. Brown g

Melvin L. Griem, M.D.

Joan A. McKeown Carol S. Marcus, Ph.D., M.D.

For FDA:

David H. Woodbury, M.D., FDA [via telephone)

Donald R. Hamilton [present)

Present were: John E. Glenn, Ph.D, Nuclear Regulatory Comission (NRC),

(Designated Federal Official for the panel), and Larry W. Camper, Section Leader, Medical and Academic Section, NRC, and Richard Vollmer, Director of Policy and Planning, NRC.

John E. Glenn, Ph.D., opened the meeting at 11:40 a.m.

Richard Vollmer of the NRC's Office of Policy and Planning initiated the discussion and provided background information to the ACMUI.

I He indicated that the Senate Committee on Governmental Affairs met on May 6, 1993, to consider the allocation of regulatory responsibility for the medical uses of ionizing radiation. This Comittee requested a report from the Commission l

that would delineate the options for improving the current regulatory program.

Chairman Selin comitted to provide a preliminary report by August 6,1993.

Accordingly, a task force consisting chiefly of NRC staff, but including I

liaison representation from FDA, was convened to develop this report for the Comission.

The task force was charged by the Comission with the principal objective of characterizing the problem, to the fullest extent possible, based on currently available information. The task force also was asked to identify I

those legislative and regulatory options worthy of careful evaluation and to identify the data base that would be necessary for a critical evaluation of rI D-2 I

I Carl J. Paperiello 2

those options.

Mr. Vollmer further indicated that the object of this I

preliminary effort was not to recommend specific, final solutions to any perceived problems. Rather, the Commission had instructed that recommendation of solutions should be delayed until completion of the independent assessment of the medical use program to be performed by the National Academy of I-Sciences.

Mr. Vollmer stated that what the task force seeks from the ACMUI is its views I

on the characterization of the issues as presented in the task force's draft document, entitled " Issues Relative to Radiation Safety in the Medical Uses of lonizing Radiation."

During the ensuing discussion, the ACMUI did not provide commentary on each and every item in the draft list of issues compiled by the task force.

Rather, the ACMUI focused its attention on the following issues.

I The Health and Safety Implications of Radiation use in Medicine. and Data Ba_s.1 Needed to Assess These implications.

It was the nearly unanirous consensus of the ACMUI that the wisest thing the task force could recommend would be a critical scientific evaluation of I

adverse events in all areas of medicine in order to determine whether adverse events associated with uses of ionizing radiation in medicine warrant more regulation, less regulation, or about the same level of regulation for nuclear medicine and radiation oncology as for the rest of medicine. Getting better I

data to characterize the problem should be the highest priority and should be done before the other issues are addressed. The ACMUI recommended that the Hational Academy of Sciences would be the best organization to perform such a I

study, which should be accomplished independently of any particular Federal t

agency.

Ms. Brown, while agreeing with the need for better data, cautioned that I

getting such data would be difficult given the wide variability in data collection by the states. Accordingly, she favored requiring that the reporting by the Agreement States of misadministrations in a form compatible I

with NRC regulations should be accomplished before 1995.

Dr. Almond noted that the evaluation of the problem does not require every bit of data from both NRC-regulated and Agreement states; sampling methods are available that I

will allow for statistically reliable conclusions without access to all data.

Ms. Brown further dissented by indicating her concern that comparing outcome and injuries in nuclear medicine and radiation oncology with those occurring in other areas of medical practice does not seem a useful exercise; the goal I

of regulatory agencies should be to achieve high quality in all areas of medical care.

Other Committee members retorted that the regulatory approach cannot ignore costs and, thus, comparative data were appropriate to insure wise allocation of the nation's limited resources for healthcare.

Uniformity The ACMUI expressed the general consensus that uniform national standards for radiation protection were appropriate, but uniform prescriptive regulations I

D-3

I Carl J. Paperiello 3

governing medical practice were unnecessary and would limit medical l

flexibility.

There also was consensus that, if there were uniformity by way of a single national regulatory authority, such authority should be vested within a department or agency that has responsibility for regulation of all E

medicine and not within an agency that has " tunnel vision" as a consequence of 5

its narrowly constructed responsibilities for radiation safety.

Lack of a global medical perspective has the potential to result in increasing and inappropriate over-regulation of nuclear medicine and radiation oncology I

without clear benefit to the general public welfare.

Ms. Brown dissented and advocated the need for a single national regulatory authority in order to allow for concentration of the highest level of expertise within a single organization and to allow for easiest access of the general public to such expertise.

Trainino and Experience The ACMut recommended that the task force study the minutes and transcript of I

the Committee's May, 1993 meeting. At that meeting, the ACMUI discussed the need for a " paradigm shift" in the approach to establishing training and experience criteria for licensure and in validating the training and I

experience of authorized users.

The Committee reiterated its belief that the focus of the NRC and States with respect to licensure for use of ionizing radiation in medicine should be radiation safety, and that training and experience criteria should be closely linked to the type of use of ionizing radiation and hazard posed by such use to patients, occupational workers, and members of the general public.

l Communication The Committee agreed that the task force had identified the appropriate issues I

in this area, and that it would be hard to argue against the need for improved communication.

Written comments submitted to Dr. Siegel by several ACMUI members prior to the

.I teleconference were accepted into the record. Dr. Glenn invited other Committee members to submit supplementary written comments.

-l Dr. Glenn declared that the meeting was closed at 1:15 p.m.

I I

L a Q ~o Barry A. Siegel, M.D., Chairman 1

2l $0(y (%3 (Da'te)

'I I

j o"

/'p a,n

..,,.. ~..

o UNITED STATES g

E i' y,

g NUCLEAR REGULATORY COMMISSION S

1

.E WASHING 70M, D. C. 20$55

[

g svf

_l March 8, 1993 MEMORANDUM FOR:

John E. Glenn, Chief Medical, Academic, and Comercial Use Safety Branch, IMNS FROM:

Myron Pollycove, M.D.

Visiting Medical Fellow I

SUBJECT:

RATE OF RADIOTHERAPY HISADMINISTRATION I

Pending future receipt of better data concerning the annual rate of radiotherapy misadministrations occurring with use of byproduct material, I

a current estimate of the annual rate of radiotherapy misadministration is enclosed.

I These rates are based upon 1) total administrations received from the American College of Radiology and Radiopharmaceutical Manufacturers and Distributors, and 2) misadministrations obtained by tripling the number of misadministrations disclosed in the 21 NRC states with slightl han one-third I

ofthepopulptionoftheUnitedStates. NRC states population / S population

- 86.56 X 10 / 248.71 X 10' - 0.348.

1/0.348 - 2.87.

I Though this data is approximate, it is improbable that it is in error by more than 200%. A 200% error

• would triple the total an misadministrations rates to 7.8 X 10 and 6.9 X 10'g serious

, respectively.

W l

Myr b ilycove, Visiting Medical Fellow g

Enclosure:

As stated I

I

• Hypothetical example: A 200% error could be obtained by doubling the misadministrations (only half reported and detected) and reducing patient procedures to two-thirds (50% overestimat, ion by ACR and Radiophamaceutical Suppliers). Corrected rate R - R X 2+2/3 -3R E-1 I.

1 -

~

The following infomation was obtained from David F. Flynn, M.D., Radiation Oncologist member of the ACMUI and of the American College of Radiology:

g Manpower Comittee, Patterns of Care Study, and Comission on Human Resources.

19R 1,100,000 new cases of cancer I

49.6% treated with radiotherapy 545,600 patients (1.1X10' X0.49) treated with radiotherapy Brachytherapy 30,000 I

Teletherapy 100,600 - average of 22 administrations each.

Linear AcceleratorR, 415.000 545,600 Patient Procedures Annual National of Sealed Source Radiotherapy Procedures Brachytherapy and Teletherapy - 30,000 + 100,600 - 130,600 Brachytherapy: ~10 misadministrations/yr.

1-2 have serious consequences.

- I Teletherapy:

~30 misadministrations/yr.

- 3 have serious consequences.

Total:

~40 misadministrations/yr 4-5 serious -10% of total.

l Annual Scaled Source Misadministration Rate Brachytherapy and Teletherapy - 40/130,600 - 3.1 per 10' Patient Procedures Annual Scaled Source Serious Misadministration Rate 5

Brachytherapy and Teletherapy - 4/130,600 - 3.1 per 10 Patient Procedures I

Data obtained by the NRC from Radiopharmaceutical Manufacturers and Distributors.

I Annual Nationg1 of Unsealed Source Radiotherapy Procedures Radioiodine ( 'I) - 40,000 Radioiodine: - 4 misadministrations/yr.

- 0 have serious consequences.

Annual Unsealed Source Misadministration Rate - 4/40,000 - 1.0 per 10' Patient Annual Unsealed Source Serious Misadministration Rate - 0 Procedures I

Annual Scaled and Unsealed Source Radiotherapy Procedures - 170,600.

Annual Sealed and Unsealed Source Radiotherapy Misadministrations

- 40 + 4 Annual Radiation Misadminjstration Rate Sealed and Unsealed Sources

- 44/170,600 - 2.6 per 10 Patient Procedures I

Annual Serious Misadministration Rate Sealed and Unsealed Sources 5 Nuclear Medicine and Radiation Oncology - 4/140,600 - 2.3 per 10 Patient Procedures I

- I E-2 I

l I-APPENDIX F

,3 COMPARISON OF PART 35 DEFINITIONS OF MISADMINISTRATION

'5 BEFORE AND AFTER THE EFFECTIVE DATE OF THE QUALITY MANAGEMENT RULE 35,2, ' DEFINITIONS

• Prior to 1/27/92 Effective 1/27/91

>30 microcuries I-125/I-131:

!B' Wrong Patient; E

1. Involving either the Wrong radiopharmaceutical or wrong patient; or radiation from a sealed source wrong radiopharmaceutical OR I

other than the one intended;

2. when both the administered dosage differs from the Wrong route of administration; prescribed by more than 20%

I of the prescribed, and that difference exceeds 30 uCi.

Diagnostic radiopharmaceutical Diagnostic dosage of a radiopharmaceutical differing from dosage, other than > 30 uCi the prescribed by more than 50%;

sodium iodide I-125/1-131; both

1. involving either the wrong patient, wrong route, wrong radiopharmaceutical, or when I

the admin. dosage differs from the prescribed; and

2. the dose to the patiant exceeds 5 rems effective dose I

equivalent or 50 rems dose equivalent to any organ.

I Therapy radiopharmaceutical Therapy dosage of a radiopharmaceutical differing from dosage, other than sodium iodide:

I the prescribed by more than 10%; or

1. Involving either the wrong patient, wrong route, or wrong radiopharmaceutical; or

2. when administered dosage

,I differs from prescribed by more than 20% of prescribed dosage.

i I

F-,

I Prior to 1/27/92 Effective 1/27/92

• Therapy radiation dose from a sealed Gamma stereotactic radiosurgery:

I source such that certain errors

1. Involving either the result in a calculated total wrong pat.ent or wrong treatment dose differing from the treatment site; or I

final prescribed dose by more than 10%.

2. when the calculated total administered dose differs from the prescribed by more than 10% of the total prescribed.

Teletherapy:

1. Involving either the l

wrong patient, wrong mode of treatment, or wrong site;

2. when treatment is s 3 I

fractions: administered dose differs from the prescribed by more than 10% of prescrib.;

3. when calculated weekly admin. dose is 30% greater than weekly prescrib. dose; or

4. when the calculated total I

admin. dose differs from the total prescrib. dose by more than 20% of total prescrib.

Brachytherapy:

1. Involving either the wrong patient, wrong radio-I isotope, or wrong treatment site; or sealed source that is leaking; I

2. when, for temporary implant, one or more sealed sources are not removed upon completion of the procedure; or I

3. when the calculated admin.

dose differs from the prescrib. by more than 20% of I

the prescribed.

I I

I i

F-2 I

4

I Insk Force Report on Medical Radiation Protettion r

APPENDIX G I

Members of the Task Force Richard H. Vollmer, Director Office of Policy Planning Lloyd A. Bolling, Health Physicist I

State Agreements Program Office of State Programs Donald R. Hamilton, Radiation Policy Advisor Offlce of Health Physics Center for Devices and Radiological Hcalth Food and Drug Administration Janet A.

Lambert, Senior Technical Assistant Office of Policy P1anning Darrel A Nash, Senior Policy Analyst office of Policy Planning I

Charles E. Norelius, Director Division of Radiation Safety & Safeguards Region III Josephine M. Pi ccone, Section Leader Commercial Section Medical, Academic & Commercial Use Branch Office of Nuclear Material Safaty & Safoguards Maria E. Schwartz, Attorney I

Rulemaking and Fuel Cycle Section Office of the General Counsel John L. Telford, Chief I

Rulemaking Section Regulation Development Branch office of Nuclear Regulatory Research I

I G-1 I

e ENCLOSURE 2 NRC VIEWS 0% 8.

1938 THE FEDERAL RADIATION PROTECTION MANAGEMENT ACT OF 1979 This responds to your request for the views of the Nuclear Regulatory Commission (NRC) regarding S.

1938, the " Federal Radiation Protection Management Act of 1979," as introduced in 1979.

This bill would have established a Federal Council on Radiation Protection to develop a coordinated radiation research program.

After the bill was introduced, President Carter issued an Executive Order establishing a similar Federal Council on Radiation Protection (FRCP), and as a result Congress did not enact S.

1938.

The Council was abolished by President Reagan in 1982.

Title I of the proposed bill would establish a Federal Council on Radiation Protection which would, among other things, advise the President with respect to radiation matters affecting health and safety; review the authority of any Federal agency to regulate in areas concerned with radiation; and identify research needed to assess risks to human health from radiation exposure.

Title II would establish the Conference on Federal Research into the Biological Effects of Ionizing Radiation, which would advise the President with respect to related Federal research activities; formulate an annual Federal agenda for such research; and recommend review standards and information dissemination procedures.

During the May 6, 1993 hearing before the Senate Committee on Governmental Affairs, you requested that the NRC take a fresh look at the legislation to determine whether we believe that it has merit today.

Based on that review the commission has concluded that carefully tailored legislation could enhance interagency coordination on radiation related matters, but that legislation is not needed to reduce radiation exposures from NRC regulated facilities.

It is this latter conclusion that we turn to first.

Certain of the assumptions in the bill imply that a new Federal initiative is needed to reduce radiation exposure.

This needs to be reexamined in light of the developments which have occurred' during the 13 years since the bill was first introduced.

President Reagan issued Federal Guidance on Occupational Exposures in 1987.

The aim expressed in S.

1938 to " ensure the highest practicable protection against harmful radiation exposure" is, in essence, another way of expressing the "as low as reasonably achievable"

(" ALAR) ')

requirement that is already a part of the 1987 guidance.

The NRC implemented that guidance in a revision to 10 C.F.R. Part 20 which became effective in June, 1991, with mandatory implementavion by NRC licensees on

o

. January 1,

1994.

The revised Part 20 explicitly requires all NRC licensees, including power plants and inaustrial ano medical licensees, to operate programs which will maintain occupational and public doses as low as reasonably achievable.

This ALARA principle has been sperative in the nuclear industry for many years, and significant reductions in occupational and public exposure have been achieved.

The revised Part 20 reduces the occupational exposure and public dose limits, and explicitly requires all NRC licensees, including power plants and industrial and medical licensees, to establish radiation protection programs and to establish procedures and engineering controls to achieve occupational and public doses that are ALARA.

In addition, the Commission has been active in amending its regulations dealing with radioactive materials to further reduce exposure.

Recent revisions to 10 C.F.R. Part 35 are expected to reduce significantly unnecessary radiation exposures to patients caused by human error in medical administrations of byproduct material.

With respect to the Executive Branch organizational structure for addressing radiation-related issues, the NRC believes that there is some merit in having an interagency coordinating body to develop Federal radiation protection policy, similar to the former Federal Radiation Council.

After the abolition of the FRCP, President Reagan in 1984 created the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC).

Like the FRCP, CIRRPC has high-level representation on its Policy Panel, and is responsible for both policy coordination and radiation research coordination.

This body has experienced varying degrees of success in carrying out its mission.

In the area of policy coordination, CIRRPC has played a relatively limited role with respect to how agencies solve particular problems, although it has served as a forum for discussion.

In the area of science and research coordination, CIRRPC has met with somewhat more success.

The Science Panel has been continuously active, and has provided a number of reports on various topics.

Nonetheless, coordination has historically been relatively weak, due in part to a relatively low emphasis within the agencies and a lack of a strong mandate to force coordination and investment of resources.

The Commission believes that, to ensure that significant research issues are addressed, there is a need for better interagency exchange of information about research topics of immediate and future importance, interim and final research results, and methods and levels of research support.

Similarly the Commission believes that to ensure more uniform regulation, there is a need for better interagency coordination of policy on setting and implementing radiation protection standar s that uses various approaches such as risk harmonization.

o.

-. The Commission believes that, although legislation may be useful in improving interagency coordination and in ensuring its continuation, strong Congressional encouragement of informal, voluntary mechanisms might be able to achieve the same results more efficiently.

We also note that in the Report of the National Procram Review, the Administration has pledged to reconstitute the Federal Coordinating Council for Science, Engineering, and Technology as the National Science and Technology Council to strengthen coordination of Federal science and technology programs and policies.

If the Committee pursues legislation, the Commission would be pleased to comment on the proposed bill.

It would be our preference that any new legislation provide a mechanism to strengthen coordination of existing entities, rather than create a new federal entity to carry out the responsibilities described in S.

1938.

Such legislation would affect a number of agencies and interests and there are a variety of approaches, such as an inter-agency task force, to provide additional insights and information which could be useful in the development of such legislation.

The NRC would be pleased to couperate in any such effort to address the important issues you have raised.

i

• -