ML20217M588

Responds to Re Natl Academy of Sciences,Institute of Medicine Rept, Need for Regulatory Reform

ML20217M588
Person / Time
Issue date:	08/12/1997
From:	Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM)
To:	Bartlett R, Ehlers V, Largent S, Rohrabacher D, Salmon M HOUSE OF REP.
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ML20217M595	List: ML20217M588 ML20217M604
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NUDOCS 9708250066
Download: ML20217M588 (115)

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..

pa anc% UNITED STATES e- -t NUCLEAR REGULATORY COMMISSION n j

• ' I WASHINGTON, D.C. 2055f4001 ,1 g

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\ , , , , , *,[ August 12, 1997 CHAIRMAN ,

The Honorable Roscoe G. Bartlett l United States House of Representctives  ;

Washington, D.C. 20515

! Mar Congressman Bartlett:

On April 26,1996, you wrote concerning the National Academy of Sciences, Institute of Medicine report entitled, " Radiation in Medicine: A Need for Regulatory Reform." On June 13,1996, I provided an interim reply. Since then, the Commission has taken action to evaluate the Nuclear Regulatory Commission's (NRC) future role in regulating the medical use of radioactive material.

Based on the findings of NRC's strategic assessment and rebaselining efforts, which considered the findings of the National Academy of Sciences, Institute of Medicine report and comments from the regulated community, professional organizations, NRC's Agreement States, other Federal agencies. and the public, the Commission decided to retain its regulatory authority for the medical use of byproduct material, and directed the staff to modify the current program.

On June 30,1997, the Commission approved the staffs plan for revising 10 CFR Part ^E associated guidance documents, and, as necessary, the Commission's 1979 Medicai Policy Statement, following.a risk-informed, more performance-based apprcach to regulation. The staff recently pubiished a Federal Reaister notice and press release announcing the initiative.

I have enclosed background documents associated with this issue, if I can be of further assistance to you, please contact me.

Sincerely, b

Shirley Ann Jackson I h#7-

Enclosures:

1. DSI Nos. 7 and 12

2. COMSECY-96-057

3. SECY-97-115

- 4. SECY-97-131 -

,r.

5. SRM-SECY-97-115 .... UJI 6.12/6/96 ltr. to Senator Faircloth, with enclosures g

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%, *....f August 12, 1997 CHAIRMAN The Honorable Vernon J. Ehlers United States House of Representatives 1

1. ashington, D.C. 20515

Dear Congressman Ehlers:

l On April 26,1996, you wrote conceming the National Academy of Sciences, Institute of Medicine report entitled, " Radiation in Medicine: A Need for Regulatory Reform." On June 13,1996, I provided an interim reply. - Since then, the Commission has taken action to evaluate the Nuclear Regulatory Commission's (NRC) future role in regulating the medical use of radioactive material.

I Based on the findings of NRC's strategic assessment and rebaselining efforts, which considered the findings of the Naticnal Academy of Sciences, institute of Medicine report and -

comments from the regulated community, professional organizations, NRC's Agreement States, other Federal agencies, and the public, the Commission decided to retain its regulatory authority for the medical use of byproduct material, and directed the staff to modify the current program.

On June 30,1997, the Commission approved the staff's plan for revising 10 CFR Part 35, associated guidance documents, and, as necessary, the Commission's 1979 Medical Policy Statement, following a risk-informed, more performance-based approach to regulation. The

. staff recently published a Federal Reoister notice and press release announcing the initiative.

I have enclosed background documents associated with this issue. 'If I can be of further assistance to you, please contact me.-

Sincerely, J P Shirley Ann Jackson

Enclosures:

1. DSI Nos. 7 and 12

2. COMSECY-96-057

3. SECY-97-115

4. SECY-97-131

5. SRM-CECY-97-115 6.12/6/96 Itr. to Senator Faircloth, with enclosures

. _ . -_ - - _ _ ____..-.-__.m_.____._._ - _ _ _ . _ . _ . _ _ . _

[ia nam '*e UNITED STATES NUCLEAR REGULATORY COMMISSION g- ,[ WASHINGTON, D.C. 20 % 0001

• Q,,,,,l August 12, 1997 CHARMAN f'

l l

1 The Honorable Steve Largent

i. United States House of Representatives j Washington, D.C. 20515 j

Dear Congressman Largent:

On April 26,1996, you wrote concerning the National Academy of Sciences, Institute of Medicine report entitled, " Radiation in Medicine

A Need for Regulatory Reform." On June 13,1996, I provided an interim reply. Since then, the Commission has taken action to evaluate the Nuclear Regulatory CommiF 3n's (NRC) future role in regulating the medical use of radioactive material.

Based on the findings of NRC's strategic assessment and rebaselining efforts, which considered the findings of the National Academy of Sciences, Institute of Medicine report and -

comments from the regulated community, professional organizations, NRC's Agreement

!~ States, other Federal agencies, and the public, the Commission decided to retain its F regulatory authority for the medical use of byproduct material, and directed the staff to modify

. the current program.

, On June 30,1097, the Commission approved the staff's plan for revising 10 CFR Part 35, j - associated guidance documents, and, as necessary, the Commission's 1979 Medical Policy i Statement, following a risk-informed, more performance-based approach to regulation. The j- staff recently published a Federal Reaister notice and press release announcing the initiative.

I have enclosed background documents associated with this issue. If I can be of further assistance to you, please contact me.

Sincerely, 1

b j Shirley Ann Jackson i

i

Enclosures:

. - 1. DSI Nos. 7. and.12

- 2. COMSECY-96-057 4

3. SECY-97-115

4. SECY-97-131'

~ 5. SRM-SECY-97-115 6.12/6/96 ltr. to Senator Faircloth,

. with enclosures -

..... ___m _. m.- ._._ _ -- - - ~ _ ~ ~ _ _ . - - _ . _ - - . . - . - . - . - - _ _ - - - -

4 1

% UNtTED STATES

/,:"P . 4 NUCLEAR REGULATORY COMMISSION TJ( WA$HINGToN, D.C. 20666-0001

~ 1, g

• August 12, 1997 CHAIRMAN F

The Honorable Dana Rohrabacher

_ United States House of Representa4ves

! Washington, D.C. 20515 j Dear Congressman Rohrabacher; On April 26,1996, you wrote conceming the National Academy of Sciences, Institute of

! Medicine report entitled, " Radiation in Medicine: A Need for Regulatory Reform." On

- June 13,1996, I provided an interim reply. Since then, the Commission has taken action to evaluate the Nuclear Regulatory Commission's (NRC) future role in regulating the medical use of radioactive material.

Based on the findings of NRC's strategic assessment and rebaselining effons, which

considered the findings of the National Academy of Sciences, Institute of Medicine report and comments from the rogulated community, professional organizations, NRC's Agreement

! States, other Federal agencies, and the public, the Commission decided to retain its regulatory authority for the medical use of byproduct material, and directed the staff to modify the current program. ,

On' June 30,1997, the Commission approved the staff's plan for revising 10 CFR Part 35, k

! associated guidance documente, and, as necessary, the Commission's 1979 Medical Policy

i. Statement, following a risk-informed, more performance-based apptoach to regulation. The j- staff recently published a Federal Reoister notice and press release announcing the initiative.

l 'I have enclosed background documents associated with this issue. If I can be of further assistance to you,~ please contact me.

Sincerely,=

i .

.i Shirley Ann Jackson

Enclosures:

1 1. DSI Nos. 7 and 12 l 2. COMSECY-96-057 4 3. SECY297-115-I < 4. - SECY-97-131

5. SRM-SECY-97-115 C. '12/6/96 ltr. to Senator Faircloth,

with enclosures i

1

1. 4 UNITED STATES

[' g NUCLEAR REGULATORY COMMISSION g WASHINGTON. D.C. 20 % 5-0001 g

s  !

% ,,,,** August 12, 1997 CHAIRMAN The Honorable Matt Salmon United States House of Representatives Washington, D.C. 20515

Dear Congressman Salmon:

On April 26,1996, you wrote conceming the National Academy of Sciences, institute of Medicine report entitled, " Radiation in Medicine: A Need for Regulatory Reform." On June 13,1996, I provided an interim reply. Since then, the Commission has taken action to evaluate the Nuclea- Regulatory Commission's (NRC) future role in regulatin] the medical use of radioactive r,.merial.

Based on the fin 6ngs of NRC's strategic assessment and rebaselining efforts, which considered the findings of the National Academy of Sciences,instituta of Medicine report and comments from the regulated community, professional organizations, NRC's Agreement States, other Federal agencies, and the public, the Commission decided to retain its regulatory authority for the medical use of byproduct material, and directed the staff to modify the current program.

On June 30,1997, the Commission approved the staffs plan for revising 10 CFR Part 35, associated guidance documents, and, as necessary, the Commission's 1979 Medical Policy Statement, following a risk informed, more performance-based approach to regulation. The staff recently published a Federal Reaistel notice and press release announcing the initiative.

I have enclosed background documents associated with this issue. If I can be of further assistance to you, please contact me.

Sincerely, AC Shirley Ann Jackson

Enclosures:

1. DSI Nos. 7 and 12 ,

2. COMSECY 96-057  !

3. SECY-97-115 l

4. SECY-97-131 l S. SRM-SECY-97-115 6,12/6/96 Itr. to Senator Faircloth, i I

with enclosures 1

4

t l

Enclosure 1:

Direction Setting issues Papers Numbers 7 and 12

i

,4 l

STRATEGIC ASSESSMENT ISSUE PAPER l l

(

DSI 7: NATERIALS/MEDICALOVERSIGHT L ,

INTRODUCTION In August 1995, the Nuclear Regulatory Connission (NRC) staff initiated Strategic Assessment and Rebaselining Proje,.

j_ take a new look at the NRC by conducting a rg ;essment of NRC activiti  :

l l which that. Work is accomplished, and to apply to t l

i rigorous screening process to produce (or rebaseline) a new set ofThe r assumptions, goals, and strategies for the NRC.

l are. intended to provide an agency-wide Strategic Plan which can be d l end implemented to allow the NRC to meet the current and future chall l

A key aspect of.this pro,iect was the identification These issues fall into three categories, The this work is accomplished.

l first category includes broad issues defined as Directio Subsumed issues are those that

(DSIs).

' The second category includes subsumed issues.

i should issues.

be considered along with the DSIs. The thir Also, as part of the project, other l a decision on the option (s) for a DSI. These are not strategic

issues of an operational nature were identified. issues and the issue papors.

l Following the reassessment of NRC activities, issue papers were p

provide a discussion of DSIs and subsumed issues, and to these broad, high-level issues.

discussion of the options as well as sumoaries of the consequences options related to-the DSIs. Final decisions related to the DSIs will 4

influence the related issues which are listed, but not discussed, in l issue paper. As part of the Strategic Assessment and Rebaselining Proje the issue papers are being provided to After interest 4

t

! to provide a forum to discuss and receive commen decisions concerning the DSIs and options. In suussary, the Strategic Assessment to develop a Strategic Plan for the NRC.

and Rebaselining' Project will analyze where the

' forward in a changing environment.

W DSI 7

+

SEPTEMBER 16, 1996 RELEASE DATE:

r

< , a i

i 4

DSI 7 MATERIALS / MEDICAL OVERSIGHT i

i I. SufWlARY '

1 l

3 A. Direction-Setting Issue ,  ;

1 The Nuclear Regulatory Commission (NRC) Bypro@ct Materials Program current 1y' L

regulates approximately 6,400 specific and 35,000 general licenses for the possession and use of- nuclear materials in medical, academic, and industrial

(' applications. The Materials Program includes licensing and inspection activities, primarily administered br the NRC regional offices, and exempt l distribution licenses and sealed source and device (SS&D) reviews, which are handled by NRC Headquarters. The various regulated products and uses range l

from large quantities of radioactive materials in complex devices or in the manufacture of radiopharmaceuticals to small quantities in radioactive-tracer L

i studies-or in simple devices. The NRC is evaluating the level of control and

regulation needed to oversee its diverse Nuclear Materials Program.- Many of the applications pose similar risks-and could be regulated by other Federal i and State agencies. Specifically, the NRC has been considering whether to j

L continue to regulate or to revise its oversight of the medical uses of nuclear i byproduct materials. To obtain input on the medical regulation issue, the NRC contracted with the National Academy of Sciences (NAS), Institute of Medicine l

(IOM), to perform an external review and to assess the adequacy and report, The IOM final

- appropriateness of the current regulatory framework.

L " Radiation in Medicine: A Need for Regulatory Reform," provides recommendations to give regulatory authority over medical uses to the States,

! with a Federal agency other than the NRC providing leadership and guidance'.

l

• A decision on the Medical Use Program may effect a rethinking of the NRC's fundamental philosophy on the extent to which it should regulate other nuclear l

materials. This-issue paper provides nptions associated with the Direction-Setting Issue (DSI) of what should be the future role and scope of the NRC's

[ Nuc1, ear Materials Program, and in particular, NRC's regulation of the medical use of nuclear material; -The options include expanding; retaining and l-revising, retaining in part, or eliminating the Nuclear Byproduct Materials l Program with particular emphasis on medical use.

j

[ B. Options

Option 1: Increase. Regulatory Responsibility With Addition of X-Ray, L

' Accelerators, and Naturally Occurring 'and Accelerator-Produced Radioactive i Materials i-This option would transfer the regulatory responsibility for non-Atomic Energy 4

Act of 1954, as amended (AEA), sources of ionizing radiation, such as x-ray, linear accelerators, and naturally occurring and accelerator-produced l

I 1 See Attachment, " Regulation of Radiation in Medicine - IOM issues" i DSI 7 SEPTEMBER 16, 1996 2 RELEASE DATE:

l-I

i i DSI 7 MATERIALS / MEDICAL OVERSIGHT radioactive materials (NARM), from other Federal agencies and the States to the NRC. An Agreement States Program would continue. Legislation would be 1 required to implement this option. ,

Option 2: Continue Ongoing Program (With Improvements)

This option would maintain the current regulatory responsibility of the NRC

and the States, while making continual improvements to increase efficiency and revising regulations to be more risk-informed and performance-based rather than prescriptive. Some of these improvements are currently ongoinn (business process reengineering [BPR)) or are on temporary hold (revision of Part 35 of Title 10 of the Code of Federal Reculations (10 CFR Part 35}). Legislation 4

would not be required.

Option 3: Decrease Oversight of Low-Risk Activities With Continued Emphasis of High-Risk Activities This option would decrease regulatory responsibility for all materials that pose a low risk to the workers and the public. Examples of these materials include diagnostic nuclear medicine, gas chromatographs, some portable gauges, 1

and so on. The NRC would retain oversight of SSLD reviews, manufacturers and distributors, and high-risk applications, such as medical therapy,

raditsgraphy, and large irradiators. Specific regulations and guidance in the high risk area would be revised to make them more risk-informed and performance-based.

i Option 4: Discontinue Regulation of All Medical Activities Except NRC Oversight of Osvices and Manufacturers (National Academy of Sciences Recommendation)

In this optien, the regulatory authority over all medical user of byproduct material would be given to the States, with a Federal agency (not NRC) in a guidance leadership role. The NRC would retain authority for SS&D reviews, manufacturers and distributors, and all nonmedical applications. Findings under Section 81 of the AEA for exemption or legislation would be required to discontinue NRC responsibilities over medical uses. Legislation would be required to give authority to the States and to name a lead Federal agency.

Option 5: Discontinue Materials Program In this option, the regulatory authority for byproduct material applications

' would be given to another Federal agency or the States, with the assumption that an acceptable level of safety would be maintained. The NRC would have no

• remaining authority for any byproduct materials oversight. Legislation would be required.

I SEPTEMBER 16, 1996 3 DS1 7 RELEASE DATE:

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I f MATERIALS / MEDICAL OVERSIGHT

.DSI 7-II. DESCRIPTION OF-ISSUES t

A. Background / Bases

' The key considerations in reexamining the role and scope of NRC's Byproduct Naterials Program, and specifically its regulation of the medical use of byproduct material, are NRC's responsibilities as defined by the AEA tu L protect public health and safety, the common defense, and the environment.

" Although the Byproduct Materials Program must be-performed in response to the AEA, the AEA also provides NRC with broad authority regardingThis the issue standards and processes that it applies in luplementing this responsibility.

paper addresses the extent or scope of a Byproduct Materials Oversight Program l

L necessary to ensure adequate protection in the use of byproduct materials.

Section 81 of the AEA directs the NRC to regulate the manufacture, production, transfer, receipt in interstate commerce, acquisition, ownership, possession, Among other things, Section 81 import, and export of byproduct material.

authorizes the NRC 'to issue general or specific licenses to applicantsB

. seeking to use byproduct material."

11e(1) of the AEA as nuclear materials created or made radioactive by exposure As provided '

to the radiation during the fissioning process in a reactor. The under, the AEA, the NRC also regulates Federal licensees in all States.

NRC has only limited responsibility, however, for regulating uses of nuclear material by the Department of Energy or the Department of Defense.

The nuclear materials licensees can be categorized into several major groups covering various products and uses regulated by the NRC and the Agreement States,-under either a specific license or a general licease.'

1. Specific Licensed Nuclear Materials-These groups include (1) broad-scope materials licenses; (2) manufacturers an distributors; (3) hospitals, clinics, nuclear pharmacies,.and private '

physicians; (4) limited research and development ope All of these licensees are regulated under

-(g) other material: licenses.

applicable provisions in 10 CFR Parts 19, 20, and 30 fo some activities, such as medical, ~ radiography, and irradiators.

2 In addition, the Commission has exempted Thecertain most widelynuclear material exempted uses, activities,. and products from regulation. products are r americium-241. ..

DSI 7 SEPTEMBER 16, 1996 4 RELEASE DATE:

n N - DSI 7 - MATERIALS / MEDICAL OVERSIGHT Presented below are descriptions of the major groups of nuclear materials licensees regulated by NRC and the Agreement States that require a specific license. ,

a. Broad-Scope Materials Licenses The broad-scope licensees include universities, medical schools, large medical centers, large manufacturers, and research and development facilities that cannot operate under a more limited specific license without seriously disrupting their programs. These licensees use nuclear materials for a wide variety of activities, including research and development, laboratory testing,

-and medical diagnosis and therapy. Broad-scope licenses authorize the use of any byproduct material by anyone in accordance with review and approval Under procedures and criteria established by the radiation safety conmiittee.

the broad-scope license, the NRC places significant reliance on the organization's radiation safety cosmiittee and radiation safety officer to ensure that NRC's regulations are met. At present, the NRC regulates about 300 broad-scope licensees.

b.. Manufacturers and Distributors

!: Manufacturers and distributors of nuclear materials include those that fabricate SS&Ds- (e.g., brachytherapy sources, portable gauges, radiography cameras), as well as those that make radiopharmaceuticals. The manufacturers usually use unsealed nuclear materials that must be controlled to a greater extent than sealed materials. Currently, NRC licenses 12g manufacturers and distributors under 10 CFR Part 32. Twenty of these manufacturers also have received broad-scope licenses from the NRC.

c. - Hospitals, Medical Clinics, Nuclear Pharmacies, and Private Physicians The Medical Use Program represents approximately one-third of NRC's nuclear materials licensees and includes uses of byproduct material in medical

-diagnosis, therapy, and research. Currently, there are approximately-2,000 NRC licenses authorizing the medical use of byproduct material- under 10 CFR Part 35,

d. Limited Research and Development Operations Research and-development licenses are issued for possession and use of specifically designated radionuclides in academic institutions, industrial facilities, and medical institutions for nonnedical use. The NRC regulates.

1 approximately 500 limited research' and development licensees under applicable sections of 10 CFR Parts- 20 and 30.

5 DSI 7

. RELEASE DATE:- SEPTEMBER 16, 1996 l

i I

DSI 7 MATERIALS /hE RAL OVERSIGHT

, e. Measuring Systems. .

Measuring system licenses are issued for the possession and use of measuring

devices and are regulated under applicable sections of 10 CFR Parts 20, 30, i

and 70. Measuring systems include fixed gauges for measuring or controlling

parameters, such as material density, flow,' thickness, or weight; portable gauges, such as moisture-density gauges used at fixed locations; x-ray

! fluorescence analyzers; gas chromatographs; and others. The NRC regulates approximately 2,200 measuring system licensees. l

f. Irradiators i

Irradiator licensees use radiatic, for purposes such as sterilizing blood products, disposable medical supplies, and food and polymerizing compounds in

, wood finishes. Irradiators are also used for some research applications.

Approximately 40 irradiator licensees are authorized, pursuant to 10 CFR Part 36,_to possess radioactive material in excess of 10,000 curies each for use in irradiation activities. Several comercial NRC-licensed irradiator licensees use more than 6 million curies to process materials in their facilities. The

! NRC regulates 204 irradiator licensees.

I

g. Industrial Radiography In industrial radiography, radiographers use sealed radiation sources to make ,

x-ray-like pictures of metal objects such as pipes and valves. Radiography is /

a form of nondestructive tes; ting that uses radiation from sealed sources (principally iridium-192 and. cobalt-60) to examine the internal structure of objects. The portable radiography devices may contain radioactive sources ,

with as much as 200 curies of iridium-192 or 100 curies of cobalt-60. The NRC l

has issued about 160 industrial radiography licenses pursuant to 10 CFR part 34.

I Well Logging

h. i In well logging, sealed nuclear sources, unsealed radioactive trace material, and radioactive markers are used for subsurface surveying to obtain geological information. The testing procedures are primarily used in oil, gas, and mineral exploration to identify subsurface geologic formations. NRC licenses about 60 firms for well logging under the provisions of 10 CFR Part 39,

i. Other Material Licenses The other types of materials uses that require a specific license include such diverse activities as nuclear laundries, which clean protective clothing contaminated with radioactive material; leak test and other service companies that provide services to other licensees to leak test sealed sources or SEPTEMBER 16, 1996 6 DSI 7

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s DSI 7 MATERIALS / MEDICAL OVERSIGHT-

~ devices containing sealed sources, to analyze leak test samples, to calibrate radiation-survey or monitoring equipment, or to repair devices containing sealed sources; waste disposal services;- and others. The NRC

• has about 900 licensees performing these remaining diverse activities.

2. General Licensed Devices Although specific licensees must submit a license application to the NRC and receive a written specific license, this is not the case for most general licensees.. An NRC general license becomes effective on the basis of the general-license provisions in NRC's regulations. In most cases, a general license is effective without the filing of an application with the Commission or the issuance of a licensing document to the license holder. An example would be the acceptance cf a nuclear materinis product at the point of sale, which would make the buyer a general licensee.

General license' provisions authorize a variety of- activities, such as holding title to licensed material, _as well as use of licensed material contained in a device. The generally licensed devices must meet regulatory star.dards for design and manufacture so that they may be used by persons with minimal instruction in their proper use.- (As previously discussed, manufacturers and distributors of devices--intended for use under a general license must be specifically licensed for this purpose.)

Examples of these devices include static eliminators, nuclear gauges, and self-luminous signs. An NRC database indicates that there are approximately 35,000 general licensees that use about 600,000 regulated devices.

3. -Exempt Distribution Licenses In addition to specific and general license products and uses, the Commission has exempted certain nuclear material products, quantities, or concentrations from the requirements for a license and from the regulations. These exemptions have been made with prior findings-that such exemptions will not constitute an unreasonable risk to the common defense and security and to.the

~ health and safety of the public. Exemptions have been authorized for products such as gemstones, watches with tritium peint, and smoke detectors, once there has- been an' initial transfer or distribution of the product.-

-4. Sealed Source and Device Reviews The NRC further exe-cises-its statutory responsibilities by the certification oc registration of SS&Ds.-.-SS&D manufacturers submit specific information on manufacturing techniques, prototype test results, and other data related to engineering and radiation safety to the NRC-or the appropriate Agreement State. These data are evaluated and an SS&D certificate is issued after a RELEASE DATE: SEPTEMBER 16, 1996 7 DSI 7

e ,

MATERIALS / MEDICAL OVERSIGHT DSI 7 The NRC determination-is made that the product is safe for the proposed uses.

maintains a registry of SS&Ds approved by the NRC and the Agreement States.

S plicants for specific licenses can reference these apprgved-products in their applications.

B. External Factors Notwithstanding the aforementioned oversight process, the operational history and bowledge base inherent in the current nuclear materials Theindustry nuclear allows opportunitigs for streamlining NRC's Regulatory Program.

materials industry, with an operational history exceeding 40 years, has a firm foundation in the knowledge and understanding of the properties of nuclear materials and the applicable handling and radiation safety procedures, as well

' as the metallurgical and engineering requirements for fabricating SS&Ds.

However, evnen with such an operational history, some factors, such as technological advances and aging equipment, may affect streamlining considerations.

1.. Technological Advances '

l The nuclear materials industry has been and will continue to be af"e-ted by technological advances in other fields. For example, advanced conap:ter technology and devices.

has been combined with the use of sealed sources for new p advent of the ganea knife (used for brain radiosurgery) and remote Technological enhancements are not afterloading brachytherapy devices.As the SS&Ds are affected by more limited to radiation medicine.

sophisticated nonnuclear technology, the regulations, review process, and qualifications of NRC technical staff required to review these applications may change. In the case of the gamma knife, for example, there are no specific medical use requirements in 10 CFR Part 35, although the regulations do address procedures for conventional cobalt-60 teletherapy devices.

2. Aging Equipment Additionally, with a mature industry, some licensed nuclear material devices One result may be increased mechanical and are accoming matulurgical old and/or obsolete. Aging devices may warrant special consideration when problems.

and if the NRC undertakes to streamline its Regulatory Program, especially in the areas of routine-inspections and guidance to licensees.

3. External Interest i . Unlike the organized opposition to nuclear reactors or nuclear waste disposal, the public (in most cases) has been supportive (at times, by remaining Theresilent) on the use of nuclear materials in medicine, industry, ad columwee.

DSI 7 8

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DS! 7 MATERIALS / MEDICAL OVERSIGHT 3

}

have been. times, however, when the public has expressed concern about new uses of nuclear radiation (e.g., opposition to irradiation of fresh foods).- For

- the most part,- the external interests in the Materials Program have involved a

- few concerned citizens, licensees and their associations and professional societies,_and the news media.-The print media have published in-depth articles on issues such as radiation medicine misadministrations that have resulted in deaths; radioactively contaminated sites whose licenses have been terminated; and reconcentrated radioactive sewage sludges found at sewer treatment facilities. Additionally, Congress has shown'and continues to show interest in.the Nuclear Materials Programs of both NRC and the Agreement States.

An example of this external interest is found in the medical use of byproduct materials. During the past several years, the medical connunity, regulated by NRC and Agreement States, has been very vocal on specific requirements of Part 35. In general, this medical community, including physicians, physicists, pharmacists, hospitals, professional associations, and others, regards the detailed prescriptive requirements of Part 35 as unnecessarily burdensome. A specific target has been the regulation on " Quality Management Program and Misadministrations" (the QM rule), which became effective on '

January 27, 1992. The medical community has asserted that the requirements are an intrusion into medical practice, are cost-ineffective, and have no utility. The QM rule was strongly opposed by several professional societies, which made their. views known to the Office of Management and Budget-(OMB). In June 1992, OMB disapproved the record collection requirements of the QM rule on the basis that the NRC had not demonstrated that the rule would yield nignificant benefits. The NRC Commissioners overrode ths OMB determination, citing the necessity of the information collection requirements for public health and safety. In addition, the American College of Nuclear Physicians and the Society of Nuclear Medicine took the NRC to court to overturn the QM rule. The court ruled in favor of the NRC. Shortly after, in November 1992, a patient in Indtana, Pennsylvania, died as a result of a therapy misadministration. A month later, the Cleveland Plain Dealer ran a week-long series entitled " Lethal Doses: Radiation That Kills." These events resulted in congressicnal hearings = on NRC's Medical Radiation Program and its Agreement States Program that raised questions about the adequacy of control of the medical use of byproduct material by the NRC and the Agreement States. As a result of the two opposing, strongly held views of the regulated medical community, and Congress and the media, the Commiission directed the staff to reevaluate the Medical Use Program with the assistance and advice of the NAS.

To that end, the staff contracted with the Institute of Medicine of the NAS to perform the external review mentioned earlier in this issue paper. The report of that review, " Radiation in Medicine: A Need for Regulatory Reform," is discussed in the Attachment to this paper,'" Regulation of Radiation in Medicine .10M Issues" RELEASE DATE: SEPTEMBER 16, 1996 9 DSI 7 1

MATERIALS / MEDICAL OVERS!GHT DSI-7

, 4.. Full Cost Recovery .

j Another significant external factor is the Omibus- Budget ,Recoi.ciliativ Act of 1990,- which requires that the NRC recover almost 100 percent of its budget authority. The number cf NRC licensee: has declined since about This declining trend1990will due i

l I

Primarily to the requirement for full fee recovery. continue, with-the number of that are currently negotiating agreements (Massachusetts, Pennsylvania, Ohio, and Oklahoma) become Agreement States and additional States continue to pursue

,this status, The reduced number of NRC licensees will further compound the

- full-fee-recovery cost issue, even though the BPR efforts Also,will State likely_ reducein interest licensing fees for s ~.s categories of NRC licensees.

buoming an Agreement State may be reduced by NRC changes in funding for Agreement State training and technical assistance.

t C. Internal Factor In addition to the described external factors, an ongoing internal initiative could affect any decision on the role and scope of the Nuclear Materials Program.

Business Process Reengineering In 1gg4,.the staff began a major reevaluation of the regulatory process in out NRC's oversight of licensed materials. This reevaluation is being carried This

-as part of a BPR effort.

Phase I was completed in the ;pring of 1995. phase was directed ~

licensing designed to (1) perform at least an order of magnitude faster than the current system; (2) be supported by clear, consistent, and. timely ensure that no adverse effect on public health

and regulatory safety guidance; results from andits(3) implementation.The new process will use modern The new approach focuses on information technology to streamline operations.

including performance requirmeents in NPC's regulations, discontinuing the current practice of incorporating licensee practices and procedures in license As conditions, and considering changes to the duration of materials licenses.

part of these efforts, a rulemaking has been promulgated to extend qualified materials licenses for an additional 5 years, it is envisioned that the BPR will have a significant impact on the entire-The number of Nuclear Raterials Program during the next several years.

. licensing actions should significantly decrease, as should the amount of required review time. Inspections for certain-materials licensees will be Overall, as a result of the reengineering efforts, streamlined or eliminated.

the MC's Materials Program should be significantly Duringmore the past efficient and-years, several responsive to both the public and: licensees.the RC's Materials Program.has re DSI 7 SEPTEMBER 16, 1996- 10 RELEASE DATE:

DSI 7 MATERIALS / MEDICAL OVER$1GHT staff and resources. However, in fiscal year 1997 the program will begin to decisase in both staff and technical assistance contractual support. This decrease is due, partially, to the increased efficiencies in licensing and

-inspection anticipated from BPR, and partially from additi,onal Agreement States.

III. DISCOSSIONS A. Discussion of Direction-Setting Issue The key considerations in reexaminin!1 the role and scope of N'tC's Byproduct Raterials Program, and specifically its regulation-of the medical use of byproduct material, are NRC's responsibilities as defined by the AEA to protect public health and safety, the common defense, and the environment.

Although the Byproduct Materials Program must be performed in response to the AEA, the AEA also provides NRC with broad authority regarding the standards l

and processes that it applies in implementing this responsibility.

Also to be considered is the interpretation that the Commission has adopted and implemented that medical patients are included in the "public."

The options on the role and scope of the Nuclear Materials Program are the result of management and staff review and subsequent initiai.ives such as the Medical Management Plan, BPR, and planned revisions to 10 CFR Parts 34 and 35.

Other factors influencing the development of options included resource limitations, growth in the number of-Agreement States, a desire for increased efficiency and effectiveness, and the recoassendations of the 10M.

Although the primary focus of the Byproduct Materials Program is on protecting public health and safety,.it must also ensure that the extent of centrol is tempered by the risk to the public. The focus should be on the safety-significant issues and on~providing timely and consistent guidance and licensing that will allow licensees to meet the regulations and standards in the most efficient and economic way. In turn, these considerations need to be viewed in terms of a broader, changing environment. For example, it is -

anticipated that the number of Agreement States will increase over the next 5 years, significantly reducing the number of NRC licensees. The NRC will need to consider what steps to take to account for the anticipated reduction in--

resources. - Although the BPR process is a step in the right direction, additional steps need to be initiated. The NRC may also have to consider--

changes in how it regulates areas of low public risk. This issue paper addresses the extent or scope of a Byproduct Materials Oversight Program necessary to ensure adequate protection in the use of byproduct materials.

. RELEASE DATE: SEPTEMBER 16, 1996 11 DSI 7

DSI 7 MATERIALS /MEDIrAL OVERSIGr(1 8.

Discussion of Subsumed Issue typroduct Materials ProgramAs.a-part of selecting an option on considered and resolved as a, result of this issue paperthe follow Issue: .

What should be the role of NRC in regulating nuclear material? the medical us e of Under the AEA, NRC has responsibility for two categorie use.

Regulation of these two broad catego third of NRC's Nuclear Materials Program. riessrepreser's approximatelyofone- radiation medi is nuclear medicine, which espioys radio 2ctive drugsOne category These material drugs usually contain only very small quantities (radiopharmace of radioactive Nuclear m,edicine. occasionally includes quantities of thee. use of la unsealed thyroid gland radioactive material 'for therapy, especially for disea (radiation onc.ology).

The other category of radiation medicine ses- of the is radiation the In radiation therapy lar apy material, treatment. usually in the form of sealed sour,ces,ger-quantities of radioactive to and within a patient. Sealed quantities of radioactive material are use external used in about 25 percent of radiotherapy treatments. Sealed radiatio electronic devices not linear accelerators,:is usedregulated under in the other 75 the AEA, such percent q pmentofand t as x-ray Therapeutic 6,000 curies radiation devices, such as a gamma knife reatatnts.

microcurie or, millicurie quantities.whilemay contain more than diagnostic nuclear medicin By authority of the AEA and Commiission policy workers and-the general public.use of nuclear on - materials safety of as necess patients when hstified by the risk to patients, but minimizNRC-also r intrusion into medical judgments affecting patients and into es the agency's traditionally considered to-be the practicee.of medicin other areas that physicians have primary respor.sibilityThe patients.

e forNRC the pr N recognizes-appropriateNRC traininregulations assume that authorized phy w an userstion of

, with of their patients. g and experience, will'make decisions in the best interest Over the' years, the Commission has m

-strengthen the Medical Use Program. ade a concerted' effort to improve and took action to upgrade its regulation Also . in February 1979, NRC i o umbus,ofOhio, radiation NRC spatie Progr,am in the medict1 area. ssued aources policy in medical use.

statement to guide its A fundamental tenet in the policy statement-is RELEASE DATE: SEPTEMBER 16,.1996 12 DSI t

-DSI 7 MATERIALS / MEDICAL OVERSIGHT the commitment to protect patient safety without intrusion into the practice of medicine. However, there has been frequent tension with the regulated medical =cce.nuaity on a number of medical use regulatory initiatives that have been opposed by members of the regulated community as an intrusion into the practice of medicine. This. tension and opposition to NRC's regulation of the medical uses of byproduct material have been a continuing problem.

Additional problems arise from the jurisdictional responsibilities for the different sources of radiation. Jurisdiction over various aspects of the regulation and use of ionizing radiation in a6dicine is exercised by both the Federal Government. primarily through the Departwt of Healtn and Human Services, the Food and Drug Administration (FDA) and the NRC, and the States.

Within this regulatory framework, the WRC has-jurisdiction over the medical 1 use of byproduct and special nuclear material and regulates radiation safety associated with the actual use of these products. The FDA regulates the manufacture and distribution of radiopharmaceuticals, biologics, and medical devices for safety and efficacy. For the most part, FDA does not regulate at

.the user level. The 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 AEA material, which is tegulated by the NRC. The States control most of radiation medicine, but the degree to which they exercise control varies from State to State.

In 1992, the staff began to develop a Medical Management Plan to guide the conduct of the Medical Use Regulatory Program. Although delayed as a result of staff actions in response to a radiation therapy misadministration and the associated patient fatality, media interest, and congressional hearings, the plan was subsequently completed and ir.itiated. In parallel, the staff was directed by the Commission to initiate an external review of the Medical Use Regulatory Program.

As a result, NRC contracted with the NAS in 1994 for the 10M to conduct that external review, addressing not only the role of the NRC bC also the roles of the FDA and the States in this area. The 10M has completed its review and recommended-that regulatory authority over medical uses of byproduct material be given to the States. The 10M also recommended that only licensed users have access to byproduct material and identifies the Department of Health and Human Services (DHHS). as the agency that should exercise a-leadership role in the radiation safety community. Further, the report suggests that DHHS assist in developing recomunended State laws' and regulations, act as an information clearinghouse, and distribute resources for training and research.

The NRC has reviewed the IOM recommendatinns at length and has held several public meetings on them. As of August, 1996, the NRC had received 41. consents on the subject. Although some commentors supported the reconenendations, the CRCPD expressed concern about the elimination of the entire medical use SEPTEMBER 16, 1996 13 DSI 7 RELEASE DATE:

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MATERIALS / MEDICAL OVERSIGHT ,

DSI 7 l program and the absence of. Federal authority in the medical 'ise area. . D stated that it could not : upport the recommendation that it provide the leadership role suggested by 10M, A more extensive summar,y of the

-l recommendations and comments appears in the Attachment to this paper,

" Regulation of Radiation in Medicine - 10M Issues' IV. OPTIONS In this section, the five options described earlier are detailed, including, if applicable, required regulatory or legislative changes, impacts, resource implications, and the reaction of stakeholders.

Option I: Increase Regulatory Responsibility With Addition of X-ray.

Accelerators, and Naturally occurring and Accelerator-Peoduced Radioactive Materials option Under this option, the NRC would continue with its ongoing program and  !

improvements and seek legislation for regulatory oversight of other source ionizing radiation, including x-ray, accelerators, and discrete NARM. Discrete sources of NARM include radium-sources used in medicine and industry a '

wastas resulting from cyclotrons and linear accelerators. An wastes from the mining and processing of radium or other radionuclides.

This option would significantly Agreement States Program would continue.

increase NRC's jurisdiction in the control of ionizing radiation; it would result in responsibility being taken away from other Federal agencies and the

>- States. Variations of this option could include consideration of limiting oversight to specific applications, such as industrial and commercial 'uses, or to only those applications that pose a high risk (Option 3).

Regulatory Changes Legislation would be neded to remove the responsibility for the regulat these sources of radiation from other, Federal agencies transfer it to NRC.

statements, such as the 1979 Medical Policy Statement, memoranda-of understanding with other Federal agencies, and agr or revision of the companion guidance documents for the NRC staff and licensees would be necessary.

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-4 Ds! 7_ MATERIALS / MEDICAL OVERSIGHT Impacts .

' This-. option would ensure increased uniformity and consistepcy in the regulation of all . sources and uses of ionizing radiation. It would avoid substantive differences in regulations and o'versight between AEA and non-AEA sources of radiation. Also, it could eliminate regulatory advantage of one radiation modality over another for a given application (e.g., x-ray radiography versus gamma' radiography). This option would require an ' expansion of NRC's technological base to include specialists in x-ray and accelerator equipment,._and the medical and commercial uses of this equipment. It would result in a significant increase in the number of NRC licensees (which would multiply 5 to 10 times), especially in the medical area. This increase would require additional personnel and physical resources, including the possibility of additional regional offices. Such wide-sweeping legislation may be

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

The resources required to develop the necessary legislation would include s

resources from the other Federal agencies currently providing some radiation

" protection or source and-device-oversight (e.g., FDA, the Environmental-Protection Agency l: EPA)), as well as NRC. A comprehensive program that would implement such legislation, that is to regulate all discrete _NARM, including promulgation of regulations,- guidance development, and inspection at frequencies comparable to those of similar NRC licensees,_ could require

- several hundred full-time equivalent (FTE) positions.

The Advisory Committee on Medical Uses of Isotopes (ACMUI) would need to be expanded to include other areas of expertise such as diagnostic and ,

interventional radiology.

Reaction of Stakeholders As described in more detkil in Option 4. the Agreement States that now have ,

authority for non-AEA sources support the approach for a single Federal agency to be responsible for all radiation use.

Option 2: Continue Ongoing Program (With Improvements)

Option Under this option, the current regulatory responsibility of HRC and the States would be maintained. However, there would be continual improvements to increase efficiency and revision of regulations to make them more risk-informed and performance-based rather than prescriptive. Some of these improvements are ongoing or are on temporary hold (e.g., BPR and Part 35 revisions). ,

RELEASE DATE: SEPTEMBER 16, 1996 15 DSI 7

MATERIALS / MEDICAL OVERSIGHT

.DSI 7 The ongoing 8PR of the licensing process will result in the use of modern infomation technology to streamline operations. The envisioned new licensing (1) a Regulatory Froduct Design process is composed of three major concepts: Center in which technical members of-community can interact face to face or by way of the computer, to design and prepare the regulatory products necessary to support, maintain, and enhance the new licensing process; (2) improved processing of licenses through reviewer-performed and computer-assirted licensing, using a graded approach commensurate with the safety hazards the application poses; and (3) a new way of working in agency-wide teams. The agency-wide team concept, based on BPR philosophy, will include such attributes as collaborative team-based decisions and parallel concurrences.

I In addition, NRC is identifying regulations that are obsolete, unnecessarily burdensome, too prescriptive, or that overlap or duplicate the regulations of other agencies. As part of this effort, NRC is reviewing Part 35 to evaluate whether it can be revised to reflect a more risk-informed, performance-based regulation. To this end, the staff has requested input from the ACMUI and the Agreement States on what revisions should be made to Part 35 if NRC were to retain its current statutory authority and also if NRC were to ramp down in the regulation of patient safety. Examples of staff-identified and staff-j suggested requirements needing revision or possible rescission include the As Low As-it Reasonably Achievable (ALARA) Program, the Quality Management Program, the misadministration definitions and reporting, dose calibrator checks, surveys, calibration of devices (using industry standards where

- possible), and training and experience requirements. Other sections of the regulations-pertaining to materials are also being reviewed for appropriate revisions.

Regulatory Changes No legislative changes are needed to implement this option. However, rulemaking would have to be initiated to revise the byproduct materials regulations, such as Part 35. In addition, internal guidance documents (e.g.,

inspection procedures, standard review plans, etc.) as well as several regulatory guides, including Regulatory Guide-10.8, would have to be revised to reflect the proposed changes.

Impacts This option would result in the development of more risk-informed, performance-based regulations and increased agency efficiencies obtain4:d by implementation of BPR initiatives.

SEPTEMBER 16, 1996 16 DSI 7 RELEASE DATE:

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+ .J 1

Amending

the regulations and modifying guidance documents and associated 1

! regulatory guides has already been budgeted as part of the' Medical Management plan. No additional- resources would be necessary for the i

' Also, an overall reduction'in needed materials resources s anticipated t'wdical over use area the next 5 years. This reduction is predominantly due to the increased efficiencies anticipated with the implementation of planned BPR initiatives, i

i as well as anticipation that there will be an increase in the number of Agreement States within the next 5 years. This possibility could result in a l reduction of approximately 20 FTEs by the year 2000.

I- Reaction of Stakeholders L

Based on- 10M interviews and coments on the 10M report, many medical licensees l

would continue to support NRC's divesting itself of responsibilities in the medical area.

Decrease Oversight of Low-Risk Activities With Continued Emphasis

~

Option 3:

of High-Risk-Activities

l. Option

This option places priority on the tenet that the regulation of byproduct

!.- materials should be consistent with the risk involved. Although the NRC has

effectively regulated areas of high risk (e.g., nnufacturers,

large

irradiators, etc.), it may be overregulating areas that involve low-risk activities or sources. Low-risk activities could inclu6e the use of devices such as gas chromatographs and certain gauges, and diagnostic nuclear 4 medicine. The oversight of these low-risk activities may be an unnecessary

, expenditure of resources because of the limited additional protection it F provides. ,

l Under this option, the NRC would modify its existing regulatory responsibility i of low-risk sctivities and maintain its current responsibility (with some i program modifications) for high-risk activities. This could be accomplished

' through-policy decisions on decreasing or discontinuing oversight in certain areas, rulemaking, or an agreed-upon definition of. low risk established and coordinated with other Federal agencies, the States, and the conduct of a

,f public comment process. This option would encompass the overal1~ Materials

- Program-and would affect medical as well as nonnedical- programs. The low-risk applications could-be placed in a category of licenses-(such as general f licenses) that warrants minimal regulatory oversight with no formalized-1 inspection frequency and minimal licensing requirements. However, some audit activity might have to be established to periodically assess the general licensee's byproduct material possession and performance.

1 r 3_ . ._ ,. ..+.,-...m-, ..~

y . ..

DSI 7- MATERIALS / MEDICAL OVERS BHT Once low risk has been defined, this' option would necessitate reevaluation of those licenseesmurrently licented by the general license provisions,-as well as those activities previously determined to be_ exempt- frpm regulation.- A reassessment of these licensing categories may result in moving activities and uses from one category to another.

In this option, the NRC would probably maintain its current level of regulatory oversight for the manufacturers of radiopharmaceuticals and sealed sources because these activities would most likely be considered higher risk activities.. The NRC would also maintain its current -level of regulatory <

oversight for other high-risk applications, such as-therapeutic uses of byproduct material, large .irradiators, and industrial radiography. For the high-risk applications, the existing specific regulations would be revised to.

be more risk-informed and performance-based, or consideration may be given to limiting oversight to_ Part 20 compliance only.

Regulatory Changes The transfer of some of the current specific licenses to general licenses or to some other category that warrants minimal regulatory oversight would not I require legislative changes. .The transfer of low-risk activities to general licenses would require modifications to current general license regulations in Part 31, as well as modifications to current licensing regulatory guides, l

j internal standard review plans, and inspection procedures.

Impacts This option would result in increased efficiency and effectiveness within the L agency by focusing NRC's limited resources on higher risk activities and those l

. licensees that warrant enhanced oversight because of poor performance. This

! option might result in the elimination of approximately 50 percent of the -

NRC's current specific licensee base. For the remaining high-risk licensees,.

the NRC would revise the applicable regulations-and guidance documents using a risk-informed, performance-based approach.

It is anticipated that.a few FTEs over about a year would be required to complete an analysis and recategorize licensees. If NRC- completely discontinues its oversight of the low-risk activities, associated legislative efforts may also require several:FTEs over several years.

With NRC either completely discont 'uing its regulatory oversight of lower risk activities or reducing its oveisight, the current specific licensee. base could be decreased by about half. Allowing for some resources to track and audit general licensees, _ a reduction of approximately 50 FTEs from current licensing, inspection, and other materials activities might be' realized. This reduction includes those FTEs-eliminated by the BPR.

L DSI 7 RELEASE DATE: SEPTEMBER 16, 1996 18 f:~

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A DSI 7 - MATERIALS / MEDICAL OVERSIGHT Option 4: . Discontinue Regulation of all Medical Activities Except NRC Ovetsight of: Devices and Manufacturers (National Academy of Sciences Institute of Medicine Recommendation) ,

Option Under this option, the NRC would request that Congress (1) discontinue NRC's regulatory authority over all medical uses of byproduct material (including biomedical research), (2) give this regulatory authority to the States, and- .

(3) name another Federal agency (not-NRC) to a guidance leadership role. The 10M report has recommended that this Federal agency be the DHHS. Tha l

leadership role would be nonregulatory and would assist in developing recosmonded State laws and regulations, act as an information clearinghouse, and distribute resources for training and research. In this option, the NRC would retain responsibility for cversight of the manufacture and distribution l

of byproduct-material (including SS&Ds) used in medicine. Further,- NRC would condition these licenses to require that products could only be distributed to users who were licensed by a State. Also, the Conference of Radiation Control Program Dirsctors (CRCPD) would continue to develop its model regulations for adoption by the States. The CRCPD would be expected to continually reevaluate its regulations to maintain congruence with any scientific advances in knowledge on radiation bioeffects, and benefits and risks of the medical uses of ionizing radiation. The NRC's ongoing program for nonmedical licensees would remain as in option 2.

Regulatory Changes

- Legislation would be needed to remove responsibility for the regulation of the medical uses of byproduct material from the AEA. In lieu of legislation, if IRC made the requisite findings under Section_81 of the AEA, the NRC could by

" exemption" eliminate this aspect of the Mate'ials- Program._ Rulemaking to-rescind or modify regulations in Parts 30, 33, and 35, among others, would follow. This route would require public notice and coament rulemaking.

Coupled with these actions would be a revision or rescission (in'whole or in ,

part) of the 1979 Medical policy Statement, the enforcement policy, agreements with the 29 Agreement States, and the memorandum of understanding with the '

FDA, as wel1 as NRC regulatory guides, manuals, and-directives.

Impacts-This option would result in the elimination of approximately one-third of the NRC's current specific licensee base. The States would be responsible for all radiation medicine applications, which would result in the potential for increased uniformity of the regulation.of all radiation medicine within a xgiven State. Ho*'ever, the level of oversight may vary considerably from State

'.to State because currently some States provide oversight (licensing and 19 DSI 7

, RELEASE DATE: -SEPTEMBER _16, 1996

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MATERIALS / MEDICAL OVERSIGHT DSI 7' inspection) through. State radiologic health personnel, and others by a simple registration process. Additionally, inconsistencies could develop between regulation of basic radiatio.1 safety in medical and nonnedical applications.

Finally, DMis does not support the 10M's reconnendation that DHHS be given a leadership role.

Some of the non-Agreement States may lack the resources, including qualified personnel, to set up-their_ own safety programs and decide not to regulate in this area and both the Agreement States and the non-Agreement States may view I the action ps an unfunded mandate. Also, revision of the agreements Additionally, the with each event l uf the 29 Agreement States would bq necessary. a database would no longer include misadministrations or events involving overexposures to workers or members of the public (non-patients) as a result of the. medical use of byproduct material. Federal facilities would be responsible for self-regulation of the medical uses of byproduct material.

l proposed legislation would need to address State regulation of Federal authorities or facilities.

For those facilities conducting both biomedical and nonmedical research, there would continue to be a dual system of regulation.

Resources associated with efforts for legislation and rulemaking would entail a few FTEs for a period of about 5 years.

The Medical Use Program includes approximately 50 FTEs, which would be

-eliminated. The majority of these FTEs, approximately 70 percent, come from '

the regional materials licensing, inspection, and event evaluation activities.

Also, the number of medical consultants under contract to NRC could be reduced from approximately 12-(current) to less than half that number. These consultants are used on an as-needed basis in response to medical misadministrations resulting in an overexposure, as well as nonnedical events that might require the services of a physician or a scientist consultant to Currently, the assess radioactive dose estimates and possible consequences.

majority of provided services is in response to. medical misadministrations.

Reaction of Stakeholders As of the end of August 1996, the staff had received 50 written coursents on the 10M report. The two major categories of responses are either in support of, or opposition to, the overall reconnendations of the IOM couaittee.

However, within each_of these-major categories, there are subsets with respect j to the specific direction or focus of the comments. None of the comments received specifically indicated that there should be no Federal involvement.

SEPTEMBER 16, 1996 20 DSI 7 RELEASE DATE:

MATERIALS / MEDICAL OVERSIGHT DSI 7 The Secretary of the Department of Health and Human Services (DHHS), the Federal agency that would be most directly affected by the IOM recomendations, indicated that the report does not make a compelling public Furthermore, health agreement for DHHS to assure the recommended new roie.

DHHS raised a concern that Congress would not provide resources comensurate with the added responsibilities.

The majority of coments received (32 out of 47) did not endorse the full

• ange of recomendations put forth by the ION comittee. Four of the 15 respondents .that supported the recomendations indicated that the The recomendations should encompass ali uses of byproduct materials.

Department of Veterans Affairs, in its support of the IOM report, indicated that legislative initiatives should ensure that Federal facilities are not subject to State and local regulations.

The comments that did not support all the ION recomendations varied The degree of dramatically in the focus of their viewpoints and opinions.

regulatory re. form perceived to be necessary ranged from simply recognizing the merits of the issues raised by the ION comittee to a need for a com;;1ete restructuring of the regulatory program. The non-Agreement States that responded were particularly concerned about the substantial financial impact of the recommendations and the issue of this being, in effect, an unfunded Federal mandate. For example, as indicated in the response from Hawaii, public health and safety could be jeopardized in those States with insufficient resources or capability to adequately implemsnt the regulation of byproduct materials. The Department of Defense response, .nich sumarized the responses from the three Service Medical Departments (Army, Navy, and Air Force), supported the need to re-evaluate the current regulatory structure, but emphasized the need for a uniform regulatory authority. There were several responses that recomended the need for Federal oversight for all uses of radiation.

The Organization of Agreement States response provided a sumary of the consensus of the participants of the NRC and Agreement State technical workshop conducted March 5-6, 1996, which included that all radiation use (medicalThe and non-medical CRCPD prepared auses) should position be consolidated paper, which supported the under one Federal leadership agency.

role of a single federal agency for all forms of ionizing radiation, at their May 6 meeting. The comments of these organizations are summarized in Appendix 3 to the Attachment to this Issue Paper.

21 DSI 7 RELEASE DATE: SEPTEMBER 16, 1996

'DSI 7 MATERIALS / MEDICAL OVERSIGHT I0ption 5: Discontinue Materials Program Option ,

Under this option, the NRC would request that-Congress-discontinue NRC's

= regulatory authority over all byproduct material uses, give this regulatory authority to the States, and name a Federal agency (not NRC) to a guidance role for all sources of radiation, as discussed in Option 4. This option presumes that an acceptable level of safety would be maintained by the States.

The NRC would have no remaining authority for any byproduct materials oversight. This option is an extension of the previous option to all materials uses.

Also, there would be no change in the proper disposal of byproduct materials at low-level waste disposal sites.

Rugulatory Changes This might be viewed as subject to the procedures of the Unfunded Mandate legislation. Legislation would be needed to remove responsibility.for the regulation of all uses of byproduct material from the AEA. Rulemaking would be needed to rescind the regulations in 10 CFR Parts 30 through 39, and 1

.certain policy statements and memoranda of understanding would have to be rescinded or drastically revised. Also, all agreements with the 29 Agreement states would have to be rescinded.

Impacts In addition to the impacts ' described in Option 4, this option would result in elimination of NRC's oversight of all specific and general byproduct materials licenses, thereby dramatically decreasing the resources of the Office of

- Nuclear Material Safety and Safeguards (NMSS) and the Office of State Programs. The States would be responsible for all medical, academic, and commercial: applications of- byproduct materials.

The lead Federal agency could possibly serve as a safety backup if a State requested assistance. The lead- Federal-agency role could be filled by an existing Federal agency such as the EPA, .DHHS,.or the Occupational Safety and Health Administration, with legislation modifying its authorities and.

responsibilities. Alternatively, a new agency or office within an existing agency could be created, thereby consolidating activities currently vested among saveral agencies. Greater uniformity might be achieved by consolidating a guidance role. in one federal agency. However, because each State would be responsible for. implementing =its regulatory program as it deems appropriate, there could potentially be quite-diverse programs among' the 50 States.

SEPTEMBER 16, 1996 22 DSI 7 RELEASE DATE:

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05! 7 MATERIALS / MEDICAL OVERSIGHT Resources associated with efforts for legislattun and rulemaking would entail sev6 cal FTEs over a period of 5 to 7 years.

The number of budgeted FTEs for the Byproduct Materials Pr'ogram is approximately 140 FTEs in Headcuarters and the regions. These FTEs include Nearly all of all managers and technical, administrative, and support staff.

these FTts could be eliminated or redirected, in part, to other activities, l

recognizing that a few FTEs would be needed to handle residual activities.- In l addition, staff from other NRC offices who support the NMSS Byproduct l Materials Program could be reduced by the current number of FTEs that handle byproduct m:,terials issues or provide support to this NMSS Program.

React' + of stakeholders Reaction from the regulated community could depend on whether consensus develops among the States to follow the guidance established by the federal agency. Manufacturers of some sources and devices could be particularly concerned about the possibility of br.v!ng to comply with a multiplicity of State requirements.

The Agreement states might support this option to the extent they find it consistent with their consensus view described in Option 4.

Federal agencias would self-regulate. _ Some indicated in their comments on the ION report that they did not have the resources necessary to develop and implement an oversight program, as indicated in the Department of Defense's consents on that report.

V. RELATED ISSUES

- After the Commission has made decisions concerning the Direction-Setting and Subsumed Issues discussed above, additional issue (s) such as those related to implementation details will be addressed as the Strategic Plan is implemented.

The Related Issues are listed in this section to provide a more complete tlMerstanding of the higher level- Direction-Setting and subsumed Issues.

A. Is escalated enforcement-effective in preventing future violations by materials licenseest Would it be more effective to augment the inspection process than to impose civil penaltiest This is a Commission issue because it involves the commission's reconsideration of its policy on its Enforcement program for materials licensees and may lead to rulemaking. It is related to the 051 because NRC's enforcement policy for materials must reflect the philosophy established by the 051. It is a related issue rather than a subsumed issue because it will SEPTEMBER 16, Igg 6 23 DSI 7 RELEASE DATE:

DSI 7 MATERIALS / MEDICAL OVERSIGHT reflect the extent to which the materials licensee comunity follas NRC's enforcement activities and will be addressed in more detail than is appropriate for the DSI. ,

B. What should be the NRC's policy relative to the need for and the frequency of renewals for materials licensees?

This is a Cossaission issue because a change to the current frequency of renewals will involve policy and >erhaps rulosaking. This issue is related to the DSI because the DSI will esta>11sh how important materials license rer.awals will be in the future. It is a related issue rather than a subsumed issue because different classes of materials licensees may require different renewal policies. Such differentiation will lead to more detail than is appropriate for the DSI. The staff is actively engaged in addressing this issue.

C. What should be NRC's policy relative to frequency of renewals for fuel fabrication facility licenses?

This is a Coenission issue because a change in the current frequency of renewing fuel fabrication facility licenses will involve policy and perhaps rulemaking. The issue is related to the DSI because the philosophy for renewing fuel fabrication facility licenses should be consistent with the philosophy for renewing materials licenses to be developed here. It is a related issue rather than a subsumed issue because it will reflect such aspects of fuel fabrication facility regulation as criticality concerns, which are beyond the scope of this DSI.

D. Does NRC have an acceptable program, given that history and operating experience have required revocation of very few licenses? Is there a set of licensees that NRC should be regulating difforently?

Rather than revoke licenses or reject applications, NRC generally helps bring weak licensees and applicants up to acceptable standards. Such activities are often very staff-intensive and include multiple deficiency letters, pre-licensing meetings, and site visits; confirmatory action letters; increased itspect 'on frequencies; enforcement conferences; and imposition and monitoring of "Get Well Programs." Although such activities generally bring weak licensees up to acceptable standards, this may not be the most cost-effective use of NRC's limited materials resources.

This issue, originally a subsumed issue, goes beyond the question of whether NRC should regulate a certain materials area and concentrates on the "how" or the methodology of regulation. As such, this issue will be directed by the decisions made on the Byproduct Materials Program and will require an in-depth RELEASE DATE: SEPTEMBER 16, 1996 24 DSI 7

A m D51 7 MATERIALS / MEDICAL OVERSIGHT i

evaluation that is beyond the-scope of the current issue paper. For these reasons, and depending on decisions by the Commission, this subsumed issue will be addressed as a related-issue. ,

E. Should a single Federal agency regulate radiation safety?

This issue is directly linked to the Agreement States' comments on the 10M recommendations in which the Agreement states technical staffs said that 'All radiation use (medical and nonnedical uses) should be consolidated under and machine-produced Rat radiation. J Federal agency to include NARN, AEA material ConsensuswasnotreachedastowhichFederalagencyshguldhave-the authority, or whether it should be an existing agency.'

It appears most appropriate to consider the issue of single agency jurisdiction from several perspectives. As stated above, a single agency could be responsible for radiation regardless. of source, to include AEA material, NARM, and machine-produced radiation. Alternatively, a single agency could hold all authorities, to include such authorities as standard- '

setting (now vested in EPAD, approval of medical devices and radiopharmaceuticals (now $n DHHS),and applications (now in NRC).

This is a Comunission issue because it involves policy concerns that are fundamental to NRC's mission, that in fact go beyond NRC's regulation of materials to include its regelation of nuclear reactors as well. It is-clearly a related, rather than a subsumed, issue, because it is well beyond the scope of this 051.

V. ColWil5510N'S PRELIMINARY V!EWS staff actions regarding the various options should be held in abeyance pending the Comunission's final decision on this issue paper.

The Commission preliminarily favors a combination'of option 2 (Continue the Ongoing program with Improvements) and Option 3 (Decrease Oversight of Low-Risk Activities with Continued Emphasis of High-Risk Activities).- In implementing Option 3, the NRC would utilize the risk-informed performance based approach, as discussed in D51 12, to determine which activities in the materials area, and specifically in the medical area, are low-risk activities.

-The general approach described in Option 3 of this 051 appears to be a reasonable starting point for identifying the types of activities that can be affected by this process. .

3 Seport of Joint NRC/ Agreement' State technical workshop, March 5-6. 1966 SEPTEMBER 16, Igg 6 - 25 DS! 7 RELEASE DATE:

8 4 MATERIALS / MEDICAL OVERSIGHT DS! 7 In implementing these options with regard to the NRC's medical program, the NRC would consult with its Advisory Committee on the Medical Uses of Radioisotopes (ACMUI) for guidance on low-risk medical activities, revisions to 10 CFR 35, and possible implementation methods. The NRC would also evaluate the feasibility of using professional medical organizations and societies as a potential source for developing professional standards and guidance that would be adhered to by NRC medical licensees and could be adopted by the NRC as regulatory requirements.

In the publje comments on this issue, the NRC particularly solicits the viewt.

of other affected organizations such as the Organization of Agreement States and the CRCPD on applying a risk-informed performance based apsroach to NRC's oversight of medical activities. The NRC also solicits the pu)11c's views on the feasibility and desirability of NRC's striving to have the remaining non-In Agreement States acquire Agreement State authority for medical-use only.

addition, the Commission solicits the public's views on whether a single agency should regulate radiation safety. Finally, the NRC specifically seeks consents on the Attachment to this issue paper titled " Regulation of Radiation in Medicine - 10M Issues."

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s DSI 7 MATERIALS / MEDICAL OVER$1GHT

(

- ACRONYMS ACMUI Advisory Committee on Medical Uses of Isotopes AEA Atomic Energy Act ALARA As Low as is Reasonably Achievable BPR Business Process Redesign CFR Code of Federal Reaulations CRCPD Conference of Radiation Control Program Directors DHHS Department of Health and Human Services DS! Direction-Setting Issue EPA Environmental Protection Agency FDA Food and Drug Administration FTE Full-Time Equivalent 10M Institute of Medicine NARM Natu' rally Occurring and Accelerator-Produced Radioactive Materials ,

NAS National Academy of Sciences NMSS Office of huclear Material Safety and Safeguards NRC Nuclear Regulatory Commission DMB Office of Management and Budget QM RULE Quality Management Program and Misadministrations S$hD Sealed Source and Device 27 DSI 7 RELEASE DATE: SEPTEMBER 16, 1996

.-.~ _ _ _ _ _. __ _ . _ _

D51 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT REGULATION OF RADIATION IN MEDICINE lOM ISSUES' I INTRODUCTION Under the Atomic Energy Act (AEA), the Nuclear Regulatory Commission (NRC) regulates the medical use of reactor - generated radioactive materials to provide for the radiation safety of workers and the general public. It also regulates the radiation safety of patients when justified by the risk. NRC's responsibilities include the regulation of radiopharmaceuticals and sealed sources, but not machine-produced x-rays nor naturally occurring or accelerator produced radioisotopes.

Over the years, NRC has had a concerted effort to improve and strengthen its Medical Use Program. In these efforts, it has repeatedly addressed two difficult issues; how can it best protect patient safety without intruding into the practice of medicine; and how can it best deal with the numerous jurisdictional responsibilities for different sources of radiation? To obtain external advice on these and other issues, in 1994 the NRC contracteo with the Institute of Medicine (10M) of the Nationa; Academy of Sciences (NAS) to review NRC's Medical Use Program and to address the roles of the regulatory agencies in this area. In December, 1995, the 10M provided NRC with a prepublication copy of its report, " Radiation in Medicine - A Need for Regulatory Reform." The final report was issued in March 1996.

The report documents the committee's consideration of seven alternative regulatory systems, ranging from no regulation (laissez-faire) to Federal control of all aspects of medical care. Between these extremes the committee considered a variety of Federal and State regulatory systems. The committee concluded that the Federal government should relinquish regulation of radiation in medicine to the States, with the. Department of Health and Human Services (DHHS) providing support, coordination, and guidance to them. To bring about this change, the committee made eight recommendations; two to Congress, three to the NRC, and three to the Conference of Radiation Control Program Directors and the States.

This document provides an overview of the committee's report, including issues identified by the NRC staff about each of the recommendations, and a summary of the public comments received to date.

' Some of the text in this paper closely parallels text in the Institute of Medicine report which is the subject of this paper.

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. DS! 7 ATTACHMENT The second section of this report, " Background," briefly discusses the use of radiation in medicine, the regulatory authorities of the Federal and State agencies, NRC's particular responsibilities, regulations, and activities, and a sumary of the history of the NRC program which led the agency to seek a review of its Medical Use Program. ,

I The third section of this report sumarizes the 10M comittee's view of the  !'

present situation, and describes the seven alternative regulatory systems considered by the comittee. It describes each alternative and presents the comittee's views of the positive and negative aspects of that alternative.

~

It concludes with the committee's basis for selecting its preferred alternative, State Regulation with Federal Guidance.

' The fourth section of this report addresses the comittee's recommendations associated with the preferred alternative. It contains a brief description of ,

each recomendation, a sumary of the comittee's rationale for the recomendation, the NRC staff's principal issues, and some pertinent public coments.

The fifth section documents NRC actions on the report to date and provides a 4

general surnary of the 47 coments received so far. Lists of specific comentors and brief sumaries of their comments appear in appendices.

J  !! BACKGROUND This section contains a brief description of the ways ionizing radiation is used in medicine, followed by a discussion of the Federal and State regulatory authorities over that radiation, it then sumarizes NRC's medical use program including its applicable regulations, its licensee comunity, and its activities. It then sketches the history of NRC's efforts to improve the prograt, including the events and issues that led NRC to seek a review by the NAS. Finally, the section documents NRC's goals for the study and the recomendations NRC requested from NAS.

Ionizing radiation is used for both diagnosis and treatment. Diagnostic uses are classified under two basic headings; radiology and nuclear medicine. In radiology, (such as the use of x-rays) the radiation administered is external Nuclear medicine employs to the patient; in nuclekt medicine, it is internal. When used for diagnosis or radioactive drugs (radiopharmaceuticals).

followup, these drugs usually contain only very small quantities of radioactive material.

Ionizing radiation used for treatment is also typically classified into categories depending on whether the source of radiation is external or internal to the patient. These areas are called teletherapy (external SEPTEMBER 16, 1996 2 DSI 7 ATTACHMENT RELEASE DATE:

o .

DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT sources), brachytherapy (internal) and therapeutic nuclear medicine (internal). Brachytherapy and teletherapy use sealed sources; therapeutic nuclear medicine uses radiopharmaceuticals. In radiation therapy, larger quantities of radioactive material, usually in the form of sealed sources, are used primarily in cancer treatment. Sealed radiation sources regulated under the AEA are used in about 25 percent of radiotherapy treatments. Radiation produced by devices not regulated under the AEA, such as linear accelerators, is used in the other 75 percent of therapy.

Regulatory authority over ionizing radiation in medicine is widely dispersed among several government agencies at the Federal, State, and local levels.

At the Federal level, by authority of the Atomic Energy Act (AEA) and Commission policy, the NRC regulates the medical use of byproduct material to provide for the radiation safety of workers and the general public. NRC also regulates the radiation safety of patients when justified by the risk to patients.,NRC's as cobalt or iodineregyp), so ittory authority does is limited not regulate tooccurring naturally byproduct or material (such accelerator produced materials (NARM), or accelerator produced radiation. For example, NRC does not regulate the use of radium or x-ray equipment in medicine.

The food and Drug Administration (FDA) in the Department of Health and Human Services (DHHS) oversees the approval of radiation-producing devices (including x-ray equipment) and radiopharmaceuticals (including NARM). In addition to these approvals, FDA's regulatory program includes review of problem reports, enforcement actions including product removal and recall, and civil prosecution of manufacturers. The Department of Transportation (DOT) regulates the transportation of radionuclides. The Environmental Protection Agency (EPA) sets generally applicable environmental standaros to protect the public from radiation. and the Occupational Health and . Safety Administration (OSHA) is responsible for worker safety.

States have broad regulatory authority over the general public health and safety of their residents, including authority over all sources of ionizing radiation excep the authority preempted by the Federal Government as discussedabove}. The AEA does permit States to obtain authority to regulate byproduct material by becoming one of NRC's Agreement States. In that case, a Byproduct material is defined as nuclear material created or made radioactive by exposure to radiation during the fissioning process in a reactor.

3 Although Federal pre-emption applies to source and special nuclear material as well as byproduct material, regulation of those materials is beyond the scope of this document SEPTEMBER 16, 1996 3 051 7 ATTACHMENT RELEASE DATE:

T ____--_0

DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT the NRC formally relinquishes its regulatory authority to a State based on the NRC's determination that the State's program is adequate and compatible with NRC's.

authority over Federal l(As provided icensees underPresently in all States.) the AEA, theare there N[tC29 retains regulatory Agreement States.

The degree to which States exercise control over all medical uses of radiation varies from State to State. The Agreement States normally apply the standards which they have developed for NRC materials to other sources of radiation within thei,r State, although there is no requirement that they do so.

Likewise, there is no requirement for non-Agreement States to reg"'t.te the sources of radiation for which they are responsible. This situation has led to inconsistencies in the regulation of other sources of radiation in those States.

NRC's (and its Agreement States') regulation of radiation in medicine is based principally on two parts of the Code of Federal Regulations (CFR); 10 CFR Part 20, Standards for Protection Aaainst Radiation, and 10 CFR Part 35, ligdical Vse of Bvoroduct Material. These regulations limit the amount of radiation that a worker or member of the public may receive, establish the controls that a licensee must exercise over radioactive materials, establish training and experience require'nents for users of the materials, set quality management and reporting requirements, and provide a number of technical and administrative requirements for the possession and use of the materials.

NRC's medical program constitutes about one-third of its Nuclear Materials Program. Currently there are about 2,000 NRC licensees authorized for the medical use of byproduct material under 10 CFR Part 35. In addition, the 29 Agreement States have issued about 4,500 licenses authorizing the medical use of nuclear material. These medical-use licensees include hospitals, clinics, and physicians in private practice.

NRC's regulatory program consists of developing regulations and guidance, issuing new licenses, and ensuring compliance. NRC promulgates new regulations and modifies existing ones through staff-initiatives or in response to petitions. NRC provides guidance to its staff and licensees by issuing regulatory guides for licensing and procedures for inspection. NRC's medical licensing activities include issuing about 85 new licenses a year, and approving about 1,400 amendments. NRC ensures compliance with its regulations by comunicating safety issues to licensees, inspecting them to observe their performance, and exercising its enforcement authority over licensees who are in violation.

Over the years, and especially since the mid 1980s, the Commission has made a concerted effort to improve and strengthen the medical use program, in 1967 the Atomic Energy Commission codified its medical regulations into 10 CFR Part

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35. . Following a 1976 report.of hundreds of patient overexposures at Riverside Methodist Hospital in Columbus, Ohio, NRC took action to upgrade its regulation of radiation sources in medical use. In February 1979, NRC issued a policy statement to guide its regulatory program in the medical area. A key issue in the policy statement is NRC's commitment to protect patient safety without intrusion into the practice of medicine. NRC regulates the radiation safety of patients when justified by the risk to patients, but minimizes the agency's intrusion into medical judgments affecting patients and into other areas traditionally considered to be the practice of medicine. The NRC recognizes .that physicians have primary responsibility for the protection of their patients. NRC regulations assume that authorized physician users, with appropriate training and experience, will make decisions in the best interest of their patients. Since then, the tension inherent in NRC's commitment has arisen in a number of key medical-use regulatory initiatives that have been opposed by members of the regulated community as an intrusion into the practice of medicine. The doctor / patient relationship and NRC's regulation of medical use of nuclear material has been a continuing problem, up to the present.

A second set of problems arises from the jurisdictional responsibilities for the different sources of radiation. As discussed above, jurisdiction over various aspects of the use of ionizing radiation in medicine is exercised by a number of agencies in the Federal Government and by the States. Because of the diversity of, and occasionally overlapping, responsibilities, dual regulation or gaps in regulation may occur.

In 1992, the staff began to develop a medical management plan to guide the conduct of the medical use regulatory program. The plan was delayed as a result of staff actions in response to a radiation therapy misadministration and the associated patient f atality, media interest, and congressional hearings on administrations in both the Senate and the House. The staff subsequently completed the medical management plan, and, in parallel, was directed by the Commission to initiate an external review of the NRC's and the Agreemen States' medical use regulatory program.

As a result, in January 1994, NRC contracted with the IOM to conduct that external review, including a review of NRC's regulations, policies, practices, and procedures. NRC set three goals for the study; 1) examination of the overall risk associated with the use of ionizing radiation in medicine; 2) examination of the brsad policy issues that underlie the regulation of the medical uses of radioisotopes; ar.d 3) a critical assessment of the current framework for the regulation of the madical use of byproduct material. The NRC sought specific recommendations on two major issues. First, it requested reconsnendations on a uniform national approach to the regulation of ionizing radiation in all medical applications, including consideration of how the regulatory authority and responsibility for medical devices sold in interstate SEPTEMBER 16, 1996 5 OSI 7 ATTACHMENT RELEASE DATE:

DS! 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT commerce for application to huaan beings should be allocated among Federal Government agencies and between the Federal and State governments. Second, the NRC requested recommendations on appropriate criteria to measure the effectivensss of regulatory programs needed to protect public health and safety.

!!! ION REPORT - ALTERNATIVES This section presents 10H alternatives and recomendations. It begins with the IOM broad view of the regulation of radiation in medicine to provide insight into the basis for ION decisions on the regulatory alternatives it considered and the recomendations it made.

1) -10M comittee's View of the Curcent Situation fhe IOM comittee noted that NRC regulates only 10% of all ionizing radiation found in medicine, and that-public health and safety would be better served by uniform regulation of all such use. It therefore concluded that NRC's current system of regulation and enforcement should be revised and that regulation of all radiation uses in medicine should be conducted by the States.

The comittee examined the existing regulatory system and identified several problems that it concluceo needed to be addressed. in particular, it judged the NRC's present set of regulations and its approach to regulation to be burdensome, costly, and unduly prescriptive. In addition, it found that actions taken by the NRC against user institutions, in its public announcements arid its unrealistic paperwork demands, tended to be disproportionate to the violations.

The committee determined that the benefits resulting from the NRC's efforts to reduce adverse events may not be comensurate with the constraints imposed, it stated that the NRC's regulatory policy, although seemingly effective, might have gone beyond the point where "an additional dollar spent on regulation achieves an equivalent dollar benefit to patients or the public."

The committee judged that, given the strength and leadership of the Conference of Radiation Control Program Directors (CRCPD) and the Suggested State Regulations for the Centrol of Radiation (SSRCR) which the CRCPD promulgates, that State programs would remain intact and expand to cover byproduct use if Federal regulation were to be relaxed. The committee believed that all sources of ionizing radiation would be-treated more uniformly, in that they would all be subject to State regulation.

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The comittee's recomendation would eliminate NRC's medical use program, but retain the basic structure of federal regulation and responsibility. In particular, the comittee would have federal agencies retJtin responsibility for the generation, transport, non-medical use, and disposal of radionuclides and for the approval of radiopharmaceuticals and of equipment that generates .

ionizing radiation. A Federal agency would assume a guidance role for the States.

2) Alternative Regulatory Systems The comittee considered NRC's request for recommendations on a uniform tational approach to regulation broadly. It examined a wide spectrum of alternative structures through which all ionizing radiation in medicine might

>e regulated. The comittee report discusses seven alternatives, which are l

A Continue the Existing Situation B Laissez-Faire (No Regulation)

C State Regulation Only 0 State Regulation with Federal Guidance E State Regulation with Reserve Federal Authority F Centralized Federal Regulation G Health Finance Agency After considering the alternatives, the comittee found Alternative 0, State Regulation with Federal Guidance, to be its preferred choice. Brief descriptions of the seven alternatives, and the basis for the comittee's choice follow.

A- Continue the Existing Situation The comittee considered two ways to continue the existing situation, which it describes as A1, Status Quo, and A2, Status Quo Modified. Alternative Al,-

Status Quo, would be for the NRC to continue to operate exactly as it does or today. Alternative A2, Status Quo Modified, would have the NRC eliminate announce that it will not enforce, its requirements for quality management programs (10 CFR Part 35.32) and for notifications and records of misadministrations (10 CFR Part 35.33). -The comittee's considered this modificatior, because NRC has received considerable criticism from the medical comunity for promulgating these requirements.

The consnittee found no positive aspects to the Status Quo. It found a positive aspect of the Modified Status Quo in that this Alternative would not require legislative change and thus would be the easiest way to change the existing system to address the medical comunity's concern. Further, in the committee's view,- the NRC could make useful changes to its work culture. The comittee found-the negative aspects of the Status Quo to be that this SEPTEMBER 16, 1996 7 DSI 7 ATTACHMENT RELEASE DATE:

DS! 7 ATTAC9 MENT MATERIALS / MEDICAL OVERSIGHT alternative did not address .two of the comittee's concerns; first, that ionizing radiation in medicine is not treated consistently - sources used regularly in the practice of medicine are treated unevenly. The comittee raised the issue of whether NRC regulation is necessary, given that NARM and machine-produced regulation has been left to the States and the FDA. Second, this alternative does not address the comittee's concern that safety can be maintained at lower cost.

B Laissez-Faire (No Regulation)

In this Alternative, all forms of regulation, Federal and State, wodd be eliminated and responsibilities for radiation safety would be left to medical practice, medical societies, and the marketplace.

The comittee found that a positive aspect of Laissez-Faire would be the cost savings resulting from an absence of regulation. The comittee found negative aspects of this Alternative to be that not everybody is conscientious about radiation protection, and the comittee had little expectation that the marketplace, the malpractice system, and the professional societies could, by themselves, weed out incompetent practitioners and ineffective procedures.

Further the committee noted that most States now regulate ionizing radiation ,

to some degree and it seemed unlikely that they could all be convinced to follow this alternative. This approach would be unwieldy, as the existing federal regulatory structure for radiation control of non-medical applications would continue unchanged.

1 C State Regulation Only This Alternative would eliminate NRC control of medical uses of byproduct material and would give regulatory authority to the States. Under this alternative, byproduct materials would be regulated the same way x-ray machines, linear accelerators, pharmaceuticals and other medical devices and materials are currently regulated. Under this alternative, Federal agencies would still have a number of responsibilities; FDA would continue to regulate safety and efficacy of radigharmaceuticals' ano radiation devices, 00T would continue to regulate the transportation of byproduct material, and NRC would license the manufacture of byproduct material. The comittee noted that this alternative would permit States to choose the laissez-faire approach.

However, the comittee expected that under this Alternative, the CRCPD would encourage States to adopt its Suggested State Regulations for Control of Radiation (SSRCR).

-The committee found the positive aspect of this Alternative to be the assum) tion that all States with existing programs would continue and expand them 3ased on the SSRCR and thu:, reinforce the movement toward greater uniformity. The comittee found negative aspects to be that it had no RELEASE DATE: SEPTEMBER 16, 1996 8 DSI 7 ATTACHMENT

DS! 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT assurance that States want this responsibility, that not all States currently have strong regulatory programs in place for NARM and machine-produced radiation, and that some State legislatures might be respqnrive to strong antiregulatory interest groups. The committee also felt that the lack of Federal leadership under this Alternative would make it difficult to encourage States to adopt CRCPD guidelines and that States might abandon the radiation safety programs now in place without the incentive from a Federal agency to continue operating them.

D State. Regulation with Federal Guidance i

This Alternative modifies Alternative C by identifying a Federal Agency, other than the NRC, to exercise a leadership role in the radiation saf6ty community, with DHHS as a suggested agency. This is the committee's preferred Alternative.

As the comittee has developed this Alternative, the Federal agency would assist in developing recommended State laws and regulations fcr all ionizing radiation in medicine. It could work with CRCPD to enhance the existing SSRCR l

i and promote their adoption. The committee felt that development of guidelines through a collaborative process with the Federal agency, the States, the CRCPD, and professional organizations would result in successful implementation by all participants. Additional functions of the Federal Agency could include assisting States, investigating crises, educating the public, collectir.g risk data, conducting research, and monitoring the effects of shifting responsibility for regulating radiation in medicine to the States.

Under this Alternative, States would have to establish a regulatory program that includes byproduct material. Since, under this Alternative, the NRC and Agreement States would continue to regulate the manufacture of byproduct material, manufacturers would not be able to distribute byproduct material to their users unless the users were licensed by their States. Consequently this requirement would provide an inducement to States to expand or revise their existing radiation control programs to include byproduct material. Federal facilities would be encouraged to either expand their existing procedures for NARM to include byproducts or adopt the SSRCR for byproduct material.

The committee found several positive aspects of this Alternative, it includes the advantages of Alternative C, State Regulation Only, with the additional advantage of a Federal agency to provide non-regulatory oversight and leadership. The committee would expect the Federal agency to assume a leadership role for the Federal government as a wholu. In addition, this Alternative would ensure that a State would be required to have a regulatory program for byproduct material for that material to be used in the State. The RELEASE DATE: SEPTEMBER 16, 1996 9 DSI 7 ATTACHMENT

DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT comittee found negative aspects of this Alternative to be the costs of the Federal agency, and that the egency could not guarantee either the quality of any State program or the safety of ionizing radiation in, medicine.

E State Regulation with Reserve Federal Authority This Alternative would go beyond Alternative D, State Regulation with Federal Guidance, and empower the Federal agency identified in that Alternative to exercise regulatory authority over any State unwilling or unable to enact a regulatory structure that encompasses ionizing radiation in medicine, i

This Alternative would be identical to Alternative D, with the exception that l

if a State did not have a radiation control program it would become subject to the regulations for byproduct material devised for Federal medical centers.

The Federal agency would enforce its authority only if the State did not assume any responsibility to adequately protect public health and safety.

This authority would be analogous to the NRC's present authority to resume regulatory control over an Agreement State.

The comittee found this alternative to have all of the positive aspects of Alternatives C and D, with the advantage that placing DHHS in the leadership role would, in the comittee's view, yield more reasonable regulations if they are needed. The comittee found negative aspects to be the need to set minimum standards for State programs and the need to assess those programs.

This would have the effect that all States would become similar to NRC's present Agreement States. The committce was also concerned about funding, and Federal authority over what it expected to be a minority of States.

F Centralized Federal Regulation This Alternative would make a Federal agency responsible for regulating medical uses, not only of byproduct material, but of NARM and machine-produced radiation as well. The Alternative would federalize regulation of all ionizing radiation in medicine, including standard-setting, licensing, and ir.spection. If this Alternative were to be adopted, the comittee would recomend centralization within DHHS rather than NRC because the comittee

~

cons.idered it best suibd to atminister public health programs and because it already has various levels of authority over ionizing radiation in medicine.

If NRC were to be the lead federal agency, its legislative authority would need to be expanded beyond byproduct materials.

The comittee found positive aspects of this alternative te include promotion of uniformity in regulation of radiation in medicine, provision for States who do not want responsibility for radiation control programs, and the development of national standards. The comittee noted that the positive aspects of the Federal role described in Alternative D, State Regulation with Federal REl. EASE DATE: SEPTEMBER 16, 1996 10 051 7 ATTACHMENT

s 051 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Guidance, also apply to this. Alternative. The comittee found negative espects to include the increased Federal costs of such a role, and the difficulty in' achieving uniformity due to the regulatory involvement of a number of Federal agencies (DOT, EPA, OSHA) in addition to the committee's proposed DHHS. Finally, the committee noted that since NRC would continue to be responsible for the non-medical useA of byproduct material, it would be necessary for NRC and DHHS to work very closely together to avoid inconsistencies.

G Health Finance Agency This Alternative would place regulatory authority for all health care into a single, centralized agency to counter inconsistency and inefficiency. The new agency would acquire the regulatory power now held by the medical components of the NRC and by parts of DHHS. The agency would have the power to regulate l health care, broadly eliminating practices that were shown not to be effective or beneficial. The comittee considered this Alternative an extreme approach for addressing a very specific issue and recognized that it had not been developed to its full logical extent. The comittee considered an advantage to this approach is that it could improve minimal standards and define the goals of safety and high quality care. However, such a centralized system would mean a large increase in bureaucracy and reduce provider incentives and responsibility.

3) Assessment of Alternatives The committee documented its consideration of the above alternatives by examining the extremes and moving toward its preferred alternative, it rejected Alternative A, Continue the Existing situation, because it did not address the comittee's concern that all . ionizing ractation in medicine be administered and regulated more consistently. It rejected Alternative B, i.aissez-Faire, because many comittee members were not convinced that the marketplace, the malpractice system, and the professional societies could, by themselves, weed out incompetent practitioners and ineffective procedures. The ,

committee rejected Alternative G, Health Finance Agency, because it was an all-encompassing and overwhelming solution to a very specific problem. The committee rejected Alternative F, Centralized Federal Regulation, because from a cost-benefit perspective the comittee as a whole saw little reason to pursue this alternative. Thus the committee focussed on Alternatives C, State Regulation Only, D, State Regulation with Federal Guidance, and E, State Regulation with Reserve Federal Authority.

While the comittee found Alternative C, State Regulation Only, attractive, it was concerned that State regulation evolve with technical advances, that Non-Agreement States be assisted in any transition from NRC regulation, and that information sharing be enhanced, so it rejected this alternative. The RELEASE DATE: SEPTEMBER 16, 1996 11 051 7 ATTACHMENT

051 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT comittee found that Alternative E, State Regulation with Reserve Federal Authority, could result in a program very much like NRC's present Agreement State program which would not resolve the comittee's congerns about that program's funding characteristics and practical drawbacks. The comittee therefore arrived at its preferreo choice, Alternative D, State Regulation with Federal Guidance.

As discussed above, Alternative D would give re0ulatory authority over medical uses of byproduct material to the States. The States would expand their existing radiation control programs that apply to NARM to include byproduct material as well. The comittee recomends that a Federal agency, DHHS, The leadership exercise a leadership role in the radiation safety community.

role would be non-regulatory and would assist in developing recommended state laws and regulations, acting as an information clearinghouse, and distributing resources for training and research. The Federal agency would work in conjunction with the CRCPD and other professional organizations to develop recomended state laws and regulations for all ionizing radiation in medicine.

The NRC would retain responsibility for the manufacture and distribution of byproduct material (including sealed sources and devices) used in medicine.

Further, NRC would condition these licenses to require that products could only be distributed to users who were licensed by a State.

I IV 10M REPORT - RECOMMENDATIONS f

To implement its preferred alternative, the comittee made a total of eight specific recomendations; two to Congress, three to the NRC, and three to the CRCPD and States. First, the committee recommended that Congress: 1) eliminate all aspects of the NRC's medical use program to include 10 CFR Part 35 and applicable activities conducted under 10 CFR Part 20; and 2) direct the Secretary of Health and Human Services to support, coordinate, and encourage activities involving regulation of all ionizing radiation in medicine including support the operation of the CRCPD, assist States in implementation of regulations, oversight of State programs, enhance training and standards for health care personnel, and investigate future significant radiation medicine incidents.

The recomendations to the NRC were to: 1) immediately relax enforcement of 10 CFR 35.32 and 35.33; 2) if Congress fails to act within 2 years to the comittee's recomendations above, initiate formal steps under the Administrative Procedures Act to revoke 10 CFR Part 35 in its entirety; and 3) separate the costs of formulating regulations from costs of administering those regulations.

The recommendations to the CRCPD and the States were to: 1) incorporate into the SSRCR any relevant concepts from 10 CFR Part 35; 2) enact legislation to incorporate the regulation of reactor-generated byproducts into existing state SEPTEMBER 16, 1996 12 051 7 ATTACHMENT RELEASE DATE:

D51 7 ATTACHMENT MATERIALS /MED! CAL OVERSIGHT regulatory programs; and 3) continually reevaluate regulations and procedures to ensure congruence with evolving scientific understanding of radiation bioeffects and associated risks and benefits. .

The comittee did not reach total unanimity on the final recomendations. A comittee member stated that federal regulatory authority should be reformed, not repealed. This dissenting opinion is included as a separate Appendix to the report.

The following sections discuss the recommendations individually. Each section contains a brief description of the recommendation, a summary of the committee's rationale for the recornendation the NRC staff's principal concerns, and some pertinent public comments

& RECOMMENDATIONS TO CONGRESS A1. The comittee recomends that Congress elintnete all aspects of the NRC's Medical Use Program,10 CFR Part 35, and those regulatory activities conducted under 10 CFR Part 20 that are applicable to medical uses.

DESCRIPTION Cy this action, Congress would relinquish responsibility for regulation of byproduct material used in medicine to each state. NRC would retain regulatory authority over manufacturers of byproduct material used in medicine. Other federal agencies, such as the FDL, the 001, and the EPA, would retain their regulatory authority over radiation.

ION RATIONALE The intensity with which the byproduct area of radiation medicine is being regulated at the federal level far exceeds the rest of ionizing radiation used in medicine and most of the rest of medical practice and has little if any justification, in fact, the concentration of resources spent to reduce adverse events involving byproduct material, although seemingly effective, appears to have gone beyond the point at which the additional dollar spent on regulation achieves an equivalent dollar benefit.

' A list of comentors organized by commentor affiliation, a list of comentors by general view, and a summary of specific comments appear in Appendices 1, 2 and 3, respectively.

SEPTEMBER 16, 1996 13 051 7 ATTACHHENT

. RELEASE DATE:

MATERIALS / MEDICAL OVERSIGHT 051 7 ATTACHMENT All lonizing radiation, with the exception of byproduct material, is currently regulated or subject to regulat '9n at the State level.theStates Although have the

,comittee cannot ability to regulate radiation effectively.

guarantne that states will effectively _ regulate byproduct material, it believes they will. Further, States with insufficient resources could join a

' consortium of states for the purposes of implementation and oversight.

Rescission of authority at the federal level for regulation of the medical use of byproduct material has three benefits: 1) it eliminates prescriptive and costly regulations that yield marginal risk reduction; 2) it shifts Wing respnsibslity, s.foty of their citby Izens; state and 3) governments it promotes authority uniform treatment, in thatover tre health and radienuclides and machine-produced radiation are regulated by a single level of government at equal intensity, regardless of their source.

NRC STAFF ISSUES

1. The comittee recognizes that not all states currently have strong I regulatory programs in place for NARM and machine-produced radiation.

In fact, not all States currently regulate ionizing radiation used in medicino. What assurance does the comittee, or Congress or the NRC, have that all States will assume the responsibility for medical use of byproduct material?

2. This recomendation assures that federal facilities will expand the scope of their existing regulations to cover all ionizing radiatt - in medicine - what existing regulations currently apply to federal facilities (other than those of the NRC)7

3. How would the gotl of "unifor:a treatment" and regulation by a single level of government at " equal intensity"' be achieved through legislation and rulemaking giving responsibility to the States.

PUBLIC Col 9 TENTS NRC has received 47 coments on the comittee's report. About one third of the comentors support this recomendation and the rest of the comittee's recomendations as well. These comentors included the Department of Vcteran's Affairs, several State agencies, four professional societies Several associated with the use of radiation in medicine and six individuals.

of these comentors not only supported this recommendation, but believed that NRC should discontinue all of its regulation of byproduct materials, and give that responsibility to the States.

SEPTEMBER 16, 1996 14 0517 ATTACHMENT RELEASE DATE:

DSI I ATTACHMENT MATERIALS / MEDICAL OVERSIGHT A second ib'rd of the commentors supported the concept of regulatory reform, bu'. with retention of Federal authority. These commentors included three Federal agenc195, three professional societies involved in radiation 1.i DedMnc,10 States and NRC's Advisory Committee on the Medical Uses of isotopus (AWUI). Nine of these co;sentors favored continued regulation by the NRC, eight wers not specific on which Federal agency should have authority, and two, the State of Californit and the ACMUI would vest authority l with DHHS.

Four comentors, including the State of New Jersey favored regulatory reform, but only after additional analysis.

l l

Nine commentors supported the concept of uniform regulation for all radioactive materials, including NARM, with Fedt.al oversight.

Several specific comments are of interest. The EPA felt that the report reflected the concerns of the regulated community more than those of the public at large. The Department of Defense indicated that the Federal regulatory authority over medical use of byproduct material should be reevaluated and perhaps relaxed and restructured, but not abolished. The States of Utah and Virginia were concerned that State legislatures might view this as an unfunded mandate and would need additional Federal support. The CRCPD does not support the recommendation. "CRCPD is concerned that elimination of the entire program, as recommended, could have immediate and undesirable consequences on citizens in non-Agreement States which cannot or will not have developed a state program consistent with the national model prior to Congressional action, in addition, the absence of federal authority in the redical use area may also have long terin consequences for Agreement States as they try to maintain a nationally consistent, program in the face of budget cutbacks and t changing regulatory philosophy." Several non-Agreement States indicated that they had neither the resources nor the capaMlity to develop a program to adequately protect public health and safety.

A2. Congress direct the Secretary of Health and Human Services to support, coortlinate, and encourage the following activities involving regulation of all ionszing radiation in medicine:

a. supporting the cperation of the CRCPD;

b. providing a venue for the review and evaluation of Suggested State Regulations for Control of Radiation; 5 CRCPD position on the NAS repnrt, reached at their meeting in Albuquerque, New Mexico, on May 8,1996

.-RELEASE DATE: SEPTEMBER 16, 1996 15 DS17 ATTACHMENT

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DS! 7 ATTACHMENT MATERIALS /MEDlCAL OVERS!GHT

c. assisting states in implementation of their regulations;

d. siding in assessment of the effectiveness of state programs through the collectton and analysis of data; ,

e. helping develop survey methods by which the rate of adverse events for a wide range of procedures and devices afght be measured;

f. nonitoring the effects of deregulation; 9 enhancing training and standards for health care personnel; and

h. Investigating future significant radiation medicine incidents.

DESCRIPTION ,

In addition to the above, DHHS would educate the public for the primary purpose of "... putting radiation risk in a more accurate and balancod perspective." Adverse events for investigational drugs and blood products must be reported to FDA as are adverse events involving radiation devices resulting in serious injury or death.

As noted in the previous recomendation, NRC and Agreement States would continue to regulate the manufacture of byproduct material for use in radiation devices and radiopharmaceuticals; thus manufacturers would not be able to distribute radioactive byproduct material to users unless they were licensed by their states.

10M RATIONALE A Federal agency, such as DHHS, would assist states to establish regulatory programs; train state radiation control personnel; build liaisons between smaller states that wish to dare regulatory systems; develop survey methodology; and monitor the success of regulatory programs.

DHHS has an extensive history in regulating radiation in medicine. Within DHHS, FDA exercises direct authority to determine the safety and effectiveness, and to approve the marketing, labelling, and manufacture of all radiation products used in medicine. FDA has promulgated regulations establishing quality control standards and a certification program for medical facilities that provide mamnography services. FDA has issued guidelines and recomendations regarding public exposure to ionizing and non-ionizing radiation.

The NRC should not regulate the education and training of health care personnel - it should be done by professional organizations and by the states.

NRC STAFF ISSUES

1. Would DHHS have any regulatory responsibility for Federal facilities other than the Public Health Service? If not, who would have authority over Federal facilities?

SEPTEMBER 16, 1996 16 DS1 7 ATTACHMENT

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MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHMENT Current reporting requirements for FDA are not identical to those of NRC

2. /

- they only require reporting adverse events resulting in serious bodily injury (to manufacturer) or death (to FDA). There gre no reporting requirements for radiopharmaceuticals other than investigational drugs except on a voluntary basis. To what extent should administration errors be reported?

3. In view of the overall reduction in federal spending, whether DHHS would be provided any appropriations to carry out these additional responsibilities cannot be predicted. With the reduction in federal spending and with the knowledge that the NRC is supported by user fees rather than taxpayer dollars, would Congress appropriate sufficient funds for even the minimal expenses of this agency?

4. How would the effects of deregulation be monitored? The report states l

that the committee did not possess the requisite-expertise to address l

the issue of appropriate criteria for measuring the effectiveness of regulatory programs, i PUBLIC COMMENTS As mentioned above, about a third of the comentors support this recomendation along with all the committee's recomendations. A number of comentors support the role of a Federal agency described in this recommendation, but do not necessarily endorse DHHS. Many of these latter comentors believe that the Federal agency should have at least some authority and that it should be responsible for at least NARM as well as byproduct material. The CRCPD view is illustrative. CRCPD supports the concept of a single federal agency with a strong leadership role, and believes that consolidation of authority presently found in several agencies including NRC, DHHS, OSHA, and EPA is very desirable. Howev'er, CRCPD, in addition to several states, do not support the automatic selection of DHHS as the lead agency, but consider that radiatign protection should be a major responsibility of the lead agency. The OAS recomended a revision to recomendation A2 to include that a single federal agency should be directed (by Congress) to support, coordinate, and oversee specified activities involving regulation of all ionizing radiation in medir.ine. The OAS did not reach consensus on which agency should have the responsibility.

The agency most affected by this recomendation is DHHS, who does not support it. DHHS does not find the comittee's arguments compelling andFurther, does notin the consider the legislation recomended by the comittee likely.

' The OAS comment provided the recomendations of and consensus reached at a NRC' and Agreement State technical workshop conducted on March 6,1996.

SEPTEMBER 16, 1996 17 DSI 7 ATTACHMENT RELEASE DATE:

O OSI 7 ATTACHMENT MATERIALS /ME01 CAL OVERSIGHT

- event of >such legislation, DHHS :onsiders the probability low that it would receive funding from Congress commensurate with its additional I responsibilities.- ,

I BECOMMENDATIONS TO THE NRC E1. The NRC should inmediately relax enforcement of 10 CFR 35.32 and 35.33 through its present nechanisms.

DESCRIPTION l

j NRC's 10 CFR Part 35.32, Ouality Mannagment Proaram, requires, among other

! things, that medical licensees have written procedures to ensure that I direction for a therapeutic administration is made in writing, that the ,

patient's identity is verified by more than one method, that unintended deviation from the written directive is evaluated, and that the licensees review this program at least once every 12 months.

NRC's 10 CFR Part 35.33, Notifications. Reports. and Records of Misadministrations, requires, in part, that medical licensees notify the NRC within one calendar day of the discovery of a misadministration, and that they submit a written report within 15 days, and that they retain a record of each misadministration for five years.

The information required by 10 CFR 35.33 would not be entirely abandoned. NRC could continue to cooperate with the FDA as provided in their M00 to obtain data on devices, drugs, and biological products-that relate to device malfunction, serious injury, or death.

IOM RATIONALE NRC's Quality Management (QM) rule lacks the basic elements of a QM program:

comprehensive process and outcomes data, feedback mechanisms for health care providers, education of clinicians to achieve continuous improvement, and follow-up measurement to monitor change / improvement.

The regulation of byproduct material greatly exceeds the regulation of chetaotherapy, surgery, anesthesia, and-the use of general pharmaceuticals exct t for controlled substances, all of which are unregulated at the federal level.

A lower rate of adverse incidents in radiation medicine is not a result of stricter regulatory oversight. The more detailed reporting and enforcement systems required for byproduct materials do not seem to result in even a marginal decrease in risk to providers, patients, or members of the public.

SEPTEMBER 16, 1996 18 DSI 7 ATTACHMENT

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DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT The level at which the NRC currently enforces 10 CFR 35.32 and 35.33, through detailed and voluminous documentation, reporting, and penalties, is inconsistent with the NRC's Medical Policy Statement, which favors minimum regulatory intrusion into the practice of medicine.

The Joint Comission on Accreditation of Healthcare Organizations (JCAHO) has A performance standard which requires intensive assessment when performance varies from recognized standards, but does not specifically require reporting of medication errors except in accordance with written procedures of the hospital.. .

Elimination of the QM rule would not lessen the radiation protection of the public, occupational worker, or the patient.

The regulated community has expressed reservations about seeking advice from the NRC, fearing that they might become the target of punitive reprisals.

l When the NRC levies a fine, the agency also issues a press release describing l

the violation and the fine. Licensees assert that adverse economic impact of l such press releases is considerable.

NRC STAFF ISSUES

1. The lack of data for comparing byproduct material, NARM and machine-produce radiation limited the scientific basis of the committee's findings. How can we achieve improved data collection on actual incidence and rates of adverse incidents and misadministrations? Is there a need for improved databases?

2. What is the rationale or basis for the necessity for immediate action?

3. Assuming that NRC were to immediately relax enforcement, NRC would be in the position of having a regulation for which there would have been no monitoring or enforcement. If NRC were to follow this recommendation, what followup actions should NRC conduct in the event of a misadministration resulting in serious injury or death?

4. If NRC lacked statutory or regulatory authority governing the medical and biomedical researth use of byproduct material, why should NRC continue to gather data on user errors, drugs, and biological products to share with FDA under the MOU (unless reimbursed by another Federal agency)?

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051 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT l

PUBLIC COMENTS A number of comentors supported the concept that many of, NRC's requirements are overly prescriptive and burdensome. CRCPD supports rei.=xation of these requirements because it finds them overly prescriptive and unnecessarily burdensome. The Organization of Agreement States believes that NRC should immediately relax enforcement of these requirements, and further considers that the Quality Management Rule should not be an item of Agreement State compatibility.

52. The comittee recomends that the NRC initiate formal steps under the ,

Administrative Procedure Act to revoke Part 35 in its entirety, if .l Congress fails to act within two years in response to the two recomendations to Congress stated above. j DESCRIPTION NRC's 10 CFR Part 35, Medical Use of Bvoroduct Material, contains technical and administrative requirements that apply specifically to medical applications. It sets quality management and reporting requirements, and establishes training and experience criteria for users of byproduct material.

It sets requirements including dose calibration, leak testing, source inventory, patient release, instructions to nurses, and survey requirements as well as use of syringe shields and storage of waste for decay.

10M RATIONALE in addition to NRC's overly stringent enforcement, the regulations themselves are excessive and duplicative. 10 CFR Part 35 covers areas that either are already regulated at the institutional level or are best left to the states,

-to professional societies, and to patients in consultation with their doctors.

States regulate the medical uses of other forms of ionizing radiation and, could easily fold byproduct material into their regulatory programs.

The CRCPD could add byproduct material to its suggested state regulations.

These additions could incorporate relevant concepts currently in Part 35.

Doctors have ethical obligations, codified in professional standards, for infoming patients of medical errors. The relatively low misadministration rate could be maintained by less stringent programs _that are administered at the state level by professional societies, and by existing liability law.

RELEASE DATE: . SEPTEMBER 16, 1996 20 DSI 7 ATTACHMENT

=- .. . -. . - - . - . ._ -. . _- - . . - - .

MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHMENT The FDA collects data on adverse effects of radiopharmaceuticals and incidents of failure of radiation-emitting medical devices, and it could assume the monitoring responsibilities of the NRC. ,

Public safety in the medical use of ionizing radiation would yet exist in the fact that the NRC would still retain responsibility for the licensing of manufacturers and, consequently could ensure that byproduct material was withheld from any state that failed to license users and regulate the use and safety of byproduct material.

The comittee strongly endorses the formal route of notice and comment rulemaking, subject to the Administrative Procedure Act, to accomplish the rescission of all of part 35.

NRC STAFF ISSUES

1. This recomendation presupposes Congress wil. not act, and therefore will not vest DHHS with a leadership role. This could result in the laissez faire or state control regulatory structures, both of which were rejected by the comittee. How would this recommendation achieve the goal of the preferred alternative?

2. With the lack of data cited in the report, on what scientific basis might NRC make a finding that there is no u.4.easonable risk to public health and safety, and thereby exempt medical use of byproduct material from the requirements of a license, as set forth in Section 81 of the Atomic Energy Act?

PUBLIC COMMENTS Many comentors, to include professional organizations, State agencies, and individuals, were in favor of the need to revise Part 35. While CRCPD considers that a major revision to 10 CFR Part 35 is needed, it does not support this recommendation. 0AS believes that 10 CFR Part 35 should be revised significantly, but that it should not be revoked in the abst.nce of legislation. 0AS believes that a minimum level of radiation protection must be available.

83. The connittee recommends that the NRC separate the costs of formulating regulations from the cost of administering those regulations.

21 0517 ATTACHMENT RELEASE DATE: SEPTEMBER 16, 1996

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DS! 7 ATTACHMENT MATERIALS /MEDlCAL OVERSIGHT  :

DESCRIPTION The Omnibus Budget Reconciliation Act of 1990 requires NI}C to recover 100% of its budget by charging fees to NRC applicants and licensees. As a result, NRC licensees bear all of the agency's costs both of developing its regulations and of administering them. Separating these costs would enable NRC to recover development costs from its licensees differently than it recovers its administrative costs.

IOM RATIONALE Only NRC-licensed institutions should bear the NRC's costs of licensing and inspection, whereas the costs of developing standards should be borne by all institutions, whether or not they are located in NRC-regulated states.

Licensing fees charged to health care facilities to meet the cost of the existing NRC program are becoming more expensive as more states become Agreenent States.

Several individuals interviewed during site visits voiced concern that excessive costs force laboratories to stop using radionuclides, which in turn delays or prohibits the development and implementation of new uses of radionuclides in medicine.

NRC STAFF ISSUE If NRC were to separate the costs of formulating regulations from the cost of administering these regulations, how would the Agreement State licensees bear

.the cost of developing standards?

PUBLIC COMMENTS CRCPD supports this recommendation and recommends that Congress provide 0AS general funds to support development of essential regulatory standards.

idt tified the issue of how Agreement States would bear the costs of developing standards if NRC were to accept this recommendation.

G RECOMMENDATIONS TO THE CRCPD AND THE STATES .

C1. The connittee recommends that the Conference of Radiation Control Progran Directors incorporate into its Suggested State Regulations for Control of Radiation any relevant concepts from 10 CFR Part 35 that are not already integrated in those suggested regulations, ,

RELEASE DATE: SEPTEMBER 16, 1996 22 051 7 ATTACHMENT

a .

MATERIALS / MEDICAL OVERSIGHT 051 7 ATTACHMENT 10H RATIONALE All states will be able to provide regulatory oversight fqr AEA material in a manner similar to that provided for non-AEA material through the adoptions of CRCPD's Suggested State Regulations for the Control of Radiation. *[T]he comittee expects that byproduct materials can be accomodated in the state systems."

Although State laws, regulations, and administrative practices vary, States can and do achieve a level of uniformity in many areas through cooperative. 4 voluntary, and informal arrangements. l Although States cannot be compelled to accept the voluntary guidelines or the SSRCR, a variety of forces can greatly influence them to do so such as a collaborative effort, professional peer pressure, consumer groups and the i l

media, and State medical societies.

CRCPD will continue to provide SSRCRs of the current level of quality without the assistance of the NRC, but with another federal agency providing

" voluntary guidelines and model regulations for states" NRC would continue to fund the CRCPD's efforts with respect to all nonmedical uses of byproduct material.

NRC STAFF ISSUES Will the states voluntarily adopt the CRCPD's SSRCR in the absence of any real compelling mandate placed on either CRCPD or the states? For 1

example, in the case of the recently passed mamography law, Congress provided a compelling reason for hospitals and clinics to meet the quality standards: 1.e., in order to be reimbursed for mamography services, the hospital or clinic must be certified as meeting the standards.

2 The level to which the states currently adopt the SSRCR varies from state to state. Would there be greater uniformity under the proposed recomendation?

PUBLIC COMMENTS CRCPD considers that it already has accomplished this.

C2. The comittee recomends that all state legislatures enact enabling legislation to incorporate the regulation of reactor-generated byproducts into existing state regulatory programs.

SEPTEMBER 16, 199G 23 DSI 7 ATTACHMENT RELEASE DATE:

4 MATERIAL 5/ MEDICAL OVERSIGHT DSI 7 ATTACHMENT 9

10M RATIONALE States have effectively regulated naturally-occurring any NARM in the past and Therefore all States can regulate the medical use of continue to do so.

byproduct material effectively.

Congress will modify the AEA to revoke the NRC's authority to regulate the medical use of byproduct material, give another Federal agency the responsibility for providing guidance, and allow all States, at th All States will devote the additional necessary resources to provide :dequate protection of the public health and safety related to the medical use of byproduct materials with "little", if any, additional federal funding.

The possibility of precluding users from obtaining byproduct material from manufacturers in those " states that did not include byproduct material into their existing regulatory programs" would be acceptable to Congress and the public.

NRC STAFF ISSUE Will all States in fact have the will, the resources, and the competence to regulate the medical use of all sources and uses of ionizing radiation safely?

PUBLIC COMMENTS OAS endorses this recommendation, but as applied to all ionizing radiation.

CRCPD endorses the recommendation, although it recognizes that not all States will choose to establish comprehensive programs that include bypro materials.

radiation protection standards nationwide and believes that this can be best accomplished by having all radiation programs in a single state agency which can deal comprehensively with all forms of ionizing radiation within the state.

C3. The committee recommends that the Conference of Radiation Control Program Directors and the states continually reevaluate their regulations and procedures pertaining to radiation medicine to ensure >

congruence with evolving scientific understanding of radiation bloeffects and to be in accord with advances in knowledge regarding benefits and risks related to medical and biomedical research uses of ionizing radiation in medicine.

24 DSI 7 ATTACHMENT RELEASE DATE:

SEPTEMBER 16, 1995

MATERIALS / MEDICAL OVERSIGHT  ;

OSI-7 ATTACHMENT t

-ION RATIONALE Continual reevaluation and maintaining congruence is a necessary step for

_providing adequate protection of the public health and safety.

The CRCPD and all states will devote the necessary resources to maintain congruence with evolving scientific. understanding of radiation bioeffects and be.in accord with advances in knowledge regarding the benefits and risks of the medical use of-ionizing radiation.

NRC STAFF ISSUE Many states have adopted regulations for non-AEA materials that are similar to those that NRC implements for AEA materials and requires Agreement States to adopt as items of compatibility (e.g., NRC's QM. rule for cobalt teletherapy "versus State regulations for accelerator teletherapy). Will the CRCPD be able to effectively " ensure congruence" of the States' regulations and procedures to "be _in accord with_ advances in knowledge regarding benefits and risks ..." '

by using voluntary mechanisms in.the absence of the regulatory presence and resource support of NRC?

PUBLIC COMMENTS Both OAS and CRCPD endorse this recommendaten.

V NRC ACTIONS AND COMMENT

SUMMARY

I i

A 'NRC Actions to Date The IOM provided NRC with a-prepublication copy of the comittee's report in December 1995. The NRC provided copies of the report to all Agreement States knd non-Agreement States and Territories, appropriate Federal agencies, CRCPD,

.0AS, Congressional Oversight Comittees and NRC's Advisory Comittee on the

Medical Uses-of Isotopes (ACMUI). In addition, the NRC published a Federal

!Reaister notice (61 FR 1648) on January 22, 1996, and issued a press release acknowledging receipt of the report and requesting coments on the possible impacts of the report, to include any views on; policy, legislative,

rulemaking,'and guidance issues. The Comission ' directed the staff to consider the report and coments received within its Strategic Assessment and

_Rebaselining efforts. While the report is being consi4 red, the NRC is continuing to implement the ongoing medical use progtha.

SEPTEMBEP. 16, 1996 25 DSI 7 ATTACHMENT

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DSI 7 ATTACHMENT MATERIAL 5/ MEDICAL OVERSIGHT Several public meetings have been held to discuss the report. The ACMUI met on February 21-22, 1996 and subsequently briefed the Comission on May 3,1996 to discuss their recomendations. Briefly, the ACMul diq not recommend any of specified alternatives. They reached consensus that the medical use regulatory program should be rebuilt, reassessing the objectives of the regulations-and ercompassing all uses of ionizing radiation in medicine, and that States should be federally mandated to administer the program, with appropriate incentives to encourage States to comply. State programs should be monitored by a Federal agency with an overall medical use perspective (e.g.,DHHS).

The OAS and the members of the 10M committee briefed the In addition, theCommission report was on discussed February 26 and 27, 1996, respectively.

at a joint NRC and Agreement State technica'i workshop on March 5-6, 1996. The workshop included representatives of 18 Agreement States and two non-Agreement States. More recently, the report was discussed with the Conference of l

Radiation Control Program Directors on May 6,1996.

B COMMENTS ON 10M REPORT As of the end of August 1996, the staff had received 47 written coments on the report. The two major categories of responses are either in support of, or opposition to, the overall recomendations of the 10M committee. However, within each of these major categories, there are subsets with respect to the specific direction or focus of the comments. None of the coments received specifically indicated that there should be no' Federal involvement.

The Secretary of the Department of Health and Human Services (DHHS), the Federal agency that would be most directly affected by the IOM recomendations, indicated that the report does not make a compelling public health agreement for DHHS to assure the recomended new role, Furthermore, DHHS raised a concern that Congress would not provide resources commensurate with the added responsibilities.

The majority of coments received (32 out of 47) did not endorse the full range of recomendations put forth by the 10M comittee. Four of the 15 respondents that supported the recomendations indicated that the recomendations should encompass all uses of byproduct materials. The Department of Veterans Affairs, in its support of the IOM report, indicated 1 that legislative initiatives should ensure that Federal facilities are not subject to State and local regulations.

The coments that did not support all the 10M recomendations varied dramatically in the focus of their viewpoints and opinions. The degree of regulatory reform perceived to be necessary ranged from simply recognizing the SEPTEMBER 16, 1996 26 DSI 7 ATTACHMENT P.ELEASE DATE:

DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT e

merits of the issues raised by the IDM committee to a need for a complete restructuring of the regulatory program. The non-Agreement States that responded were particularly concerned about the substanti l l financial impact of the recommendations and the issue of this being, in effect, an unfunded Federal -mandate. For example, as indicated in the response from Hawaii,

' public health and safety could be jeopardized in those States with insufficient resources or capability to adequately implement the regulation of byproduct materials. The Department of Defense response, which summarized the responses from the three Service Medical Departments (Army, Navy, and Air Force), supported the need to re-evaluate the current regulatory structure, but emphasized the need for a uniform regulatory authority. There were several responses that recommended the need for Federal oversight for all uses of radiation.

The OrDanization of Agreement States response provided a summary of the consensus of the participants of the NRC and Agreement State technical workshop conducted March 5-6, 1996, which included that all radiation use 4.

(medical and non-medical uses) should be consolidated under one Federal agency. The CRCPD prepared a position paper, which supported the leadership role of a single federal agency for all forms of ionizing radiation, at their May 6 meeting. The comments of these crganizations are summarized above under the specific recommendations to which they apply.

The NRC will continue to evaluate comments as part of the strategic assessment and rebaselining efforts. A summary of the comments is provided in Attachments 1-3, 4

4 SEPTEMBER 16, 1996 27 DSI 7 ATTACHMENT RELEASE DATE:

DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT

(

. Categories of Responses Received on IOM Report Federal Aaencies:

Department of Defense (D0D) - consolidates views for three services Department of Health and Human Services (DHHS)

Department of Labor, Occupational Safety and Health

-Administration (OSHA)

Department of Veterans Affairs (DVA)

Environmental Protection Agency (EPA)

Aareement States:

Arkansas C911fornia Florida (Office Radiation Control) - R Florida (State Health Office) - H lilinois Kentucky

} Marylar.d j New Mexico New Ycrk (Dept. Environmental Conservation) - E New York (Dept. Health) - H New York (Dept. Labor) - L Tennessee Texas-Utah Vermont Washington Non-Aareergat States / Territories:

Alaska American Samoa Delaware Hawaii Massachusetts New Jersey Virginia Wyoming 28 Enclosure 1

MATERIALS / MEDICAL OVERSIGHT

. DSI 7 ATTACHMENT Oraanizations/ Committees: .

AmericanAssociationofPhysicistsinMedicine(AAPt))

American College of Cardiology (ACC)

American College of Medical Physics (ACMP)

American College of Nuclear Physicians / Society of Nuclear Medicine (ACNP/SNM)

American College of Nuclear Physicians - California chapter (ACNP-CA)

American College of Radiology (ACR)

American Pharmaceutical Association (APHA)

American Society of Nuclear Cardiology (ASNC)

Conference of Radiation Control Program Directors (CRCPD)

NRC's Advisory Committee on Medical Usps of Isotopes (ACMUI)

Organization of Agreement States (OAS)

Other Resoondents:

CBeasley : St. John's Regional Health Center, Springfield, M0 MHafermann, Virginia Mason Cancer Center, Seattle, WA DJones, Northwest Medical Physics Center, Lynnwood, WA CMarcus, University of California, Los Angeles, CA CPerez, Washington University, St. Louis, M0 GPoteat, OH JRieke, Virginia Mason Cancer Center, Seattle, WA DSchumacher, Northwest Medical Physics Center, Lynnwood, WA MSelikson, RSO, University of Pennsylvania, Philadelphia, PA St. John's Hospital, Jackson, WY 1

7 The OAS comment provided the recommendations of and consensus views reached at the NRC and Agreement State Technical workshop. The session on the SC, NV, NAS report included representatives from 18 Agreement States (CA, NY IL, WA, TX, MS, TN, GA, NE, CO, KY, KS, NYC, FL, AR, AZ) and two non-Agreement States (OH, PA).

29 Enclosure 1

^ ,

f

_ DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT

. General Comments on 10M Report Respondentt in favor'of ION recommendations: ,

Support 10M report / recommendations as written:

AAPM ACNP/SNM ASNC DVA ,

NM MHafermann ('.;rginia Mason Cancer Ctr)

DJones (Northwest Medical Physics Ctr)

CMarcus (UCLA)

CPerez-(Washington Univ)

JRieke (Virginia Mason Cancer Ctr)

DSchumacher (Northwest Medical Physics Ctr)

Support IOM report / recommendations, but as applied to all materials:

FL (R)

NY (H)

NY (L)

ACNP-CA 6'

30 Enclosure 2

. DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Respondents not in aareement.with 10M recommendations:

Support concept of regulatory reford but retain Federal Authority2 :

DHHS oversight: ACMUI, CA NRC oversight: EPA, ACMP, ACR, Hi, KY, NY(E), UT, WA, GPoteat(OH)

Unspecified oversight: DHHS' , D00, ACC, AK, DE, TN, VA, WY

^'

Support concept of reg;;1atory reform, but after additional analysis:

CBeasley (St John's Regional Health Center)

MSelikson (RSO, Univ, of Pennsylvania)

NJ St. John's Hospital

- Support concept of uniformity for all radioactive materials regulation with Federal oversight:

CRCPD OAS APHA AR (NRC as lead agency)

FL (H)

Il MA MD TX 8 -It should be pointed out that the degree of regulatory reform perceived to be necessary by different respondents varied from recognizing the concerns raised by the IOM to a drastic change in the approach to regulation of medical uses.

Some States (e.g., VA, WY, DE) were primarily concerned with the substantial financial impact of the NAS recommendations and the issue of unfunded Federal mandates, rather than more specific concerns on the overall approach for regulation.

'O DHHS did not address the issue of regulatory reform, Federal authority, or concerns raised by the IOM, but focussed on the implications of the recommendation to DHHS.

31 Enclosure 2

~'

MATERIALS / MEDICAL OVERSIGHT.

DSI 7 ATTACHMENT-ge gondents indicatina report under review DOL AS VT 1

'M 32 Enclosure 2

MATERIALS / MEDICAL OVERSIGtT DSI 7 ATTACH'iENT Specific Coments on ION Report Category of Re-r g R@st WHeEms 3ESPONDENTS IN AGAEEMENT WITN IGN REcopWENDATIONS DVA The Veterens Neelth Administration gmeretty twcurs with eruf endorses the firdiras styport 10M report / and recoMtions of !DM. Principet concern is teck of sincif fes regarding recomumendation es written regulation of Federe! ent! titles and etso the reputation of serfical research programe.

New Mesico Agtees with IGN recuamendation that Congress remapwe regutetten of possession and see of asteriet sebject to AEA from NEC's purvier. 5tgiports teedership role of DWNS so long es ett states c:J ntain i regulatory programs that measure comprehensive standards of perfonmence and ef feetIveness.

.ggpg AAPM faruloser.tetty st5pports pos! tion, cervetuelens, and recomumendations of the itse report. WRC should be removed from its current regulatory role for medical t:se.

Estabtish progrene for implementing states' regutettons eenitored ty agprop-late federet heetth egency with essisterce of tser caummity and professional orgenIretiens.

ACNP/SWN The ACNP and SNN be4Ieve & report preposes e seuruf and thouAtful approach to the regulation of nutteer smedicine ente urges WRC to laptement the ItWE recomumendations, t

ettouing for comment on specific acans to echten 1 9 ementation.

ASWC Concur with the 10R's conclusions erst sagport their recmamendations for a satifone ,

policy to be set et federet levet inhich can be enforced by tfWr states. DWNS should include medical radiatien safety es port of its heetth core sensgement plan. l Mnefermann Endorses recomumendations of 10N. Does not agree with sentiments of Robert Adler in Appendir.L. ,

{

1 33 Enclosure 2

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\ i MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT Speelfic Causents Cataw of -- --

1. - e " . .:

gESPOISENTS NOT IN ACREDENT Wiin ION REtseqEISATIONS ADeft Indicated a prefennce for a werf en+ of the 30st preferred etternettwe in idhich AOtif there would be sehetentlet Federet oversight of State progress with a saechanime to Sepport concept of regulatory reform but reteln Federet ensure cesptlance of States and usere. State progress should be eenitored by a M W itY Federet m.ap wlth e. rett medical use perspective fgNNS).

Report does not meta e cespetting gehtic heetth ersionant for suRE taking on a OnWS steetontist riew role. Ylee probability is low that Congress would provide adegante resources. DWNS does not -mt the receousendetfan. 1 Federal reputatory authority over suedicet use of byprothset meterlet should be m reevetuated and perhaps retened and restructured, but not abolished in fewer of e votimtery or State-eperstad system.

E' Port reflects the concerns of the reguteted ccesamity score tfien tfie pietic et i EPA There may be espects of MRC's program thet een be leproved, test NRC should large.

continue to ensure putdic is protected.

Transfer of overslWit of the seedical e se of footopes to the States seems reesonable.

ACC Roosever, strensty encourage Federet oversight of this state initiative. An obvious drenesek would be If att States had seperate reguistions for ticensure and comptlance.

Sets the rieed for e drestic change in regutetten of redletlen in medical use AOIP including use of Advisory Penets (cesprised of users, manuf acturers, and pittic) to detensine the regulatory frenework to te opptled isniforely in seedical profession.

Current regutetIone shoutd be modif eed.

in tjeu of Congressionet action to eliminate spC's medical use program, the Act ACR bellewes that NRC's medical e.se pregrem must be rebuilt and its objectives thoroughty reessessed.

35 Enclosure 2

i j

MATERIALS / MEDICAL OVERSIGHT \

DSI 7 ATTACHNENT l

- Specific Comments Category of - m  ; R-v . int RESPOISEutt NOT IN AGREENENT UtTN 1018 REU35ENDATIONS (contirased)

Atoske This would not be e cost effective nor efficient reform for 7teske. It is in the sigport concept of reguletory best interest of the State to stcport the enleting method of regulating nucteer reform but retain Federet medicine tiema; by a Federet egency.

euthority (contlnued) in view of spilt reputatory authority at federet levet and apparent reluctance of Nec Collfornie to expend jurisdiction, agree that Congress remove NRC's authority. DWNS should be given authority to ensure that every str*e maintelne a redletten program that meets minismm, comprehensive, consensus standerde of performance end effectivenees.

The tapect of the ION recousmendations teould be stestentlet in terne of our. Increesed Delsmere  ;.;d for funding, staf fing, trefning and Infrastructure reyf rements.

Does not have resources or capability to adequately laptement reputetton of bypredset novell meterials, without assistence (training and development) to states, ti.e removat of Nac's authority any significantly Jeoperdire pt6 tic heetth and safety.

A better pprooch would be to have NRC revise its medical proprem to go along with Kentucky the rec _ _. i ttens the institute has given in preferred etterretive D.

plany unforeseen consepences may occur if ACA le modified. Commission should proceed New York cautieusly in pursuing ION recommerdstions that may etter the present AEA.

(Dept,' Environ.

Corservation) mile the findirge of the Consmittee have some smerit, there is no conclusive styport Termessee provided to doctsment them. Sweeping changes are not asett thought out erxf may result in cheon.

State legistetures may view this as another tefunded federet anndete end may provide t?teh no additionet sipport to the state program. feedical causemity should- work with NRC, States, and other perties to resetve the reguletten leeue.

36 Enclosure 2

ljl{llIll) jI 1 s

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1-MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT i - Specifle rwe Catewxy of Weepense 2~

NESPOISENTS NOT IN AGREf9ENT WITN list RECIBOIEseATIONS (continued)

New Jersey If NJ chose not to became en Agreement State, pddic may not be ensured of edegante Syt concept of reguletory protection. If adapting the recomemdetions, IIRC and Congress should not act reform, but ef ter additieret Precipitounty, but attou the States to prepere for eseusing reputatory progrees in onetysis orderly feeblen.

University of gefore moving in the direction of a state-based decentretired systmo, e tietter-Penneytvanie evetuotten of potentist both for increased risk to the pd41c and increased cost to the medical leuksstry is necessery.

St. John's Ursees WRC to give every consideration to ION report, porticuterly the revleu of risk pospitet essessment.

cgesegey The report missed port of its stated intended poet to revleu the current system of regutetten (the leeues of miformity seens states uns not futty emptored). Preposes revleu in more detell the reguletten of non-nutteer medicine redletogy and geestion of asniformity betaseen states.

At NRC/ Agreement State Technicet workshop, c,. r_r na reached thet ett radiation 04S Sqqsort concept cf tesiformity use (reguteted currently under NRC, FDA, EPA, and O5WA) should be coneotidoted taider for ett radioective meteriets * 'I"'I* I I 8"CY' regutetton uith Federet oversidt Atwence of federet authority in medicat use eres may have laserdiste and undesirstate CRCPD cenoegsences en citirens in non- Agreement States and tone term consegsences for Agreement States trying to mainteln a nettenetty consistent program. CaCPS does not engiport automatic selection of DIsts as the agency to provide teedership rete.

Att lanizing radietlen should be grouped together under e ef form regulation.

APHA Trarisfer responsibility for medical uses of any lenfrine redietion to the states.

Some Federet autherity should remain over the suedical uses of lenizing radiation (NRC or a simiter fe& ret agency).

38 Enclosure 2 e

m_

MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT Speelfic Comemts Category of R m _ - L w-- -. .: -

mESPOISENTS NOT IN AGREE 9ENT Ut18 fist set 0WIENDATIONS (continued)

The mRC should consider etternettwe A2 (stetus eso modified). If enjer d . . are  ;

Arkanses to be mode, centretiration of reedtetlen within one Federet egency (uRC) umuld be the w t conc $ of testformity for all M

• h W wg,gs best egyrooch for ett tsees of radiation. Concrees esould be required to espond the

• " "

• role of met and a change in the egency would be necessary. Espend current Agreement g

State program.

Sepport ideo thet regulatory euthority of eli agreement meteriets be turned over to Floride the states with consolidation of federet radietlen oversight, guldence, and (neelth regulatory functions into one agency, not necenserity Days.

Office)

,,tidetion Prefer CRCPO preposed neu orgenlrationet concept that recommends some c Ittinois of att redietlen regulatory functions et federot tevet. Revise est and edienmecy rules. Prepare aatte paper to use as e policy bests to eteerly detineote t%

r+tlwe authority and responsibilities of verlous Federal and State agry.

Rather then revoke meC's authority and repeet the Federet regutettons, euch authority Iteryland should be esprnded to incorporate naast, and the Federot regutettons should te thoroughly revleued and amended to clarify regulatory responsibility. Dans does not have necessery empertise.

Do not stoport eliminetton of ett espects of WRC's medical progrese, tsut steport stessochusetts retenetton of overty prescriptive and tsinecesserity costly requirements. Steport intent of single Federet egency providing a single teedership role Inst do not sigport automatic selection of OWNS.

T!ie bests for the report's recommendations do not seem to be siestantiated. The Texas serrging of att federet radietlen control oversight into e single regutetory program should be considered. The NRC should eteence the partnership with the Stein to jointly determine competibilley rewirements. .

39 Enclosure 2

l.

~

STRATEGIC ASSESSMENT ISSUE PAPER J

'DSI 12: RISK-INFORMED, PERFORMANCE-BASED REGULATION INTRODUCTION In August 1995, the Nuclear Regulatory Comission (NRC) staff initiated aThis p Strategic Assessment and Rebaselining Project.

take a new look at the NRC by conducting a reassessment which that work is accomplished, and to apply to these redefined activities a rigorous screening process to produce (or rebaseline) a new set ofThe results of this pro assumptions, goals, and strategies for the NRC.are intended to provide a and implemented to allow the NRC to meet the current and future challenges.

A key aspect of this project was the identification and classif These issues fall into three categories. The this work is accomplished.

, first category includes broad issues defined as Direction-Setting Is l (DSIs). Subsumed issues are those that l

The second category includes subsumed issues.The third category includes related should issues.

be considered along with the DSIs.These are issues that should be cons a decision on the option (s) for a DSI.

Also, as part of the project, other These are not strategic issues of an operational nature were identified. issues and are appropr the issue papcts.

Following the reassessment of NRC activities, issue papers were prepared to provide a discussion of DSIs and subsumed issues, and to obtain a r

' these broad, high-level issues.

' discussion of the options as well as suunaries o'f the consequences of the Final decisions related to the DSIs wil't options related to the DSIs. influence the related issues which are listed, but no issue paper. As part of the Strategic Assessment and Rebaselining Project, the issue papers are being provided to interested After parties to provide a forum to discuss and receive comment on the decisions concerning the DSIs and options. In suusary, the Strategic Assessment to develop a Strategic Plan for the NRC.and Rebaselining Project will ana internal and external factors, and outline a path to provide direction to move forward in a changing environment.

DSI 12 SEPTEMBER 16, 1996 RELEASE DATE:

RISK-INFORMED, PERFORMANCE-BASED REGULATION

-DSI 12 I.

SUMMARY

-A. Direction-Setting Issue .

The Commission has established the policy that, to the extent practical,Asrisk a insights shall be incorporated into all nuclear regulatory activities.

result of this policy, the staff has developed a framework for applying probabilistic risk assessment (PRA) methods and techniques in reactor regulation (SECY-g5-280, " Framework for Applying Probabilistic Risk Analysis in Reactor Regulation") in order to ensure consistent and appropriate application of PRA methods. The staff has also identified a number of regulatory applications associated with reactor regulation that appear amenable to the expanded use of PRA - such as inservice testing of pumps and valves, inservice inspection, technical specifications, and graded quality assurance. In these areas, the staff is developing PRA standards and guidance to help clarify and facilitate the use of risk-informed, performance-based regulation for both the NRC and the industry.

Industry and NRC efforts to develop and apply similar approaches to nuclear materials programs are not as advanced as reactor programs. The complexity of power reactors and-the potentially severe consequences of a reactor accident led to the development of analysis methods to provide-better estimates of risk. The consequences of an accident in the nuclear materials area would be less severe and the event sequences would be less complex than the l

consequences of an accident in the reactor area. The need for a better understanding of risk for commercial power reactors resulted in detailed development of reactor risk analysis methodology before such methodology was developed for the relatively simpler, but more diverse, nuclear materials area. Also, power reactor risk analysis techniques are more developed than nuclear materials risk analysis techniques because the coamercial nuclear power industry'is actively seeking regulatory relief in numerous areas using risk-informed, performance-based insights to help justify the request for relief.

Considering the general direction provided by the Commission and Congressional directives to various Government agencies to proceea to use risk-based and cost-benefit criteria,- and recognizing the resources needed to implement risk-informed, performance-based approaches to regulation the following direction setting-issue (DSI) was identified:

What criteria should NRC use in expanding the scope in applying a risk-informed, performance-based approach to rulemaking, licensing, inspection, and enforcement?

SEPTEMBER 16, 1996 2 DLI 12 RELEASE DATE:

RISK-INFORMED, PERFORMANCE-BASED REGULATION DS! 12 The Commiission's decision on this issue will be used t framework for "how fast" and "how far" the agency wil approaches.

This paper provides four options for moving toward more risk-informed, performance-based regulatory approaches.

Sample criteria for expanding the scope within the context of the stra direction are discussed in Appendix A.

B. Options.

0; tion 1: Continue Currot Process The current process for pursuing risk-informed, performance-based Priority and scope in i d regu could be characterized as an incremental process.

applying risk-informed, performance-based regulatory Priority approaches are d by balancing external and internal goals and available resources.

criteria (Appendix A) are Thisapplied and approcch covers the scope of ac both reactor implementation, and available resources.

and nuclear materials areas but there is more activity the PRA Implementation Plan (SECY-95-079).

Option 2:

More Rigorously Assess Relationship to Public Health and Safety Before pursuing risk-informed, performance-based approaches, this I

require that for new initiatives, the NRC determine that there is the potential for a substantial increase in overall protection to public he and safety that would justify the level of resources necessary to pursue Priority additional risk-informed, performance-based regulatory initiatives.

and scope in applying Many risk-informed, intangibles would haveperformance to be benefit to the public health and safety. Priority criteria are weighted toward greatest qualified safety benefit.

before proceeding.The scope of risk-informed, performance-based ll approache would be primarily determined by considering the cost / benefit, the overa This impact on the NRC and regulated industry, and available resources.

option would provide additional focus for moving toward risk-informed, performance-based regulation and potentially move I

DSI 12 SEPTEMBER 16, 1996 3 REl. EASE DATE:

RISK-1: MORMED, PERFORMANCE-BASED REGUL' TION DSI 12 Option 3: - Perform 's Comprehensive Assessment of NRC Regulatory Approaches This is a proactive, aggressive option for moving toward r,isk-informed, This option wocid maximize internal performance-based regulation.self-assessment and include exploring all regulatory area whether risk-informed, performance-based regulatio'i should be pursued in that area. This approach would require a comprehensive review of our regulations and regulatory processes to determine areas that couldPriority be improved for through risk-informed, performance-based regulatory approaches.

regulatory activities are established based on consideration The scope ofof the cumulative impacts on safety, burden reduction, and efficiency.

risk-informed regulatory approaches u;1 der this option would be determined by considering agency responsiveness to stakeholder initiatives, the safety benefit / significance of the approach, and the effect on NRC and licensee efficiency. Ease of implementation and available resources are secondary scoping considerations (i.e., if the activity is determined to be a state-of- the-art to the level necessary to support the desired goal).

Option 4: Consider Risk-Informed, Performance-Based Approaches Primarily in Response to Stakeholder Initiatives This option is the most responsive to industry and stakeholder initiatives.

Priority and scope in applying risk-informed, performance-based regulatory approaches would be primarily determined by stakeholder demand and ease of implementation. Priority would be weighted toward hidustry initiatives to use The risk-informed, performance-based approaches to reduce regulatory burdens.

scope of risk-informed regulatory approaches under this option would beEase of implemen primarily determined by nature of the initiative.

cost / benefit play a major role in defining the scope of the regulatory approach.

II. DESCRIPTION OF ISSUES A. Background Since the ea=1y 1970s, the NRC has expended significant resources This included in the the ground-development and application of PRA technology.

breaking work of the Reactor Safety Study (documented in WASH-1400) in 1975.

On January 18, 1979, the NRC issued a policy statement entitled "NRC Statement ,

of Risk Assessment and the Reactor Safety Study Report (WASH-1400) in Light of the Risk Assessment Review Group Report" [ Risk Assessment Review Group Report, In addition to addressing specific criticisms of WASH-1400, NUREG/CR-0400).

the 1979 policy statement articulated limitations in the use of PRA in the regulatory arena. Many of these limitations have been addressed, however, Primary among these limitations is the some still remain pertinent today.

DSI 12 SEDTEMBER 16, 1996 4 RELEASE DATE:

RISK-!NFORMED, PERFORMANCE-BASED REGULATION  :

DSI 12

./

characterizationPRA of methodologies uncertainties associated with calculated probabilities o have, however, provided a better.means reactor accidents.

for identifying and characterizing the range of uncertainty.

l The Three Mile Island accident in 1979 substantially changed the charac the analysis of severe accidents worldwide. In addition, both major program on severe accidont phenomenology.

investigations of the accident (the Komony and Rogovin studies) recomme that PRA techniques be used more widely to augment the traditional In 1984, the NRC nonprobabilistic methods of analyzing nuclear plant safety.

analysis techniques.

An In early 1991, the NRC published NUREG-1150, " Severe Accident Risks:In NURE

. improved Assessment for techniques PRA Five U.S. Nuclear to assessPower the Plants."

risk associated with five nuclear po plants.

This study was a significant turning point in the use of risk concepts in the regulatory process and enabled The methods developed for, the C initiation and subsequent accident progression.and results from, the risk techaiques.

PRA methods have been applied successfully in several regulatory activitie I

and have proved to be a valuable complement to traditional det engineering approaches.

t enhancement of traditional regulation rather than a separate and different technology. Several recent Commission policies or regulations have been based, in part, _on PRA methods and insights. Th 21,1986),the Operation of Nuclear. Power Plants," (61 FR 30028; August i

Commission's " Policy Statement on Severe Reactor Accidents Regarding Fut Desigr.s and Existing Plants" .(50 FR 32138; August 8,1 1993). PRA methods also

- for Nuclear Power Reactors" (58 FR 39132; July 22,ient without scram (ATWS) were used effectively during the anticipated Additionaltransand benefits have station blac

-generic _ issue prioritization and resolution process.

been found in the use of ' Risk-Based Inspection Guides" to focus NRC rea inspector efforts and make more efficient use of NRC inspection resources Probabilistic anelyses were extensively used-in the development of the recently proposed rule change to reactor siting criteria in 10 CF (59 FR 52255; October-17, 1994), Shutdown Earthquake ground motion fo DS1 12 5

RELEASE DATE: SEPTEMBER 16, 1996 l

RISK-INFORMED, PERFORMANCE-BASED REGULATION DSI 12 Currently; the NRC _is using PRA techniques to assess the safety importance of operating reactor events and-as an integral part of the design In addition, certification the Individual review process for advanced reactor designs.

Plant Examination (IPE) program and the Individual Plant Examination -

External Events'(IPEEE) program (an effort resulting from the implementation  ;

of the Comunission's " Policy Statement on Severe Reactor Accidents Regarding Future Designs and Existing Plants") have resulted in cownercial reactor licensees using risk- assessment methods to identify any vulnerabilities needing attention.

The Commission has been developing performance assessment methods for low-level and high-level waste since the mid-1970s, and these acth: ties intensified using performance assessment techniques in the 1980s and early 1990s. - This work involved the development of conceptual models and computer codes to model the disposal of waste. Because waste disposal systems are passive, certain analysis methods used- for active systems in PRA studies for 7 power _ reactors had to be adapted to provide scenario analysis for the performance assessment of the potential geologic repository at Yucca Mountain, Nevada.- In regard to high- level waste, the NRC staff participates in a variety of international activities (e.g., the Performance Assessment Advisory -

Group of the organization for Economic Cooperation and Development, Nuclear Energy Agency) to ensure that consistent performance assessment methods are used to the degree appropriate.

In mid ~1994, the NRC staff proposed a PRA policy statement to the Conunission in SECY 218, " Proposed Policy Statement on the Use of Probabilistic Risk Assessment Methods in Nuclear Regulatory Activities." In that Conunission paper, the staff proposed that in overall policy on the use of probabilistic risk assessment (PRA) methods in nuclear regulatory activities thould be established and-that the use of PRA technology in NRC regulatory activities The staff also forwarded SECY-94-219, " Proposed should be-increased.

Agency-Wide Implementation Plan for Probabilistic Risk Assessment (PRA)," to the Commission.

The NRC established its regulatory requirements to ensure that nuclear facilities can be operated and nuclear _ materials can be used without undue-risk to the health and safety of the public. These requirements are largely

- based on deterministic engineering criteria, involving the use of multiple barriers and application of a defense-in-depth philosophy. Beyond its deterministic criteria, for cosamercial power reactors,~ the NRC has

- additionally formulated guidance, as in the safety goal Thepolicy safetystatement, goal policythat utilizes-quantitative, probabilistic risk measures.

statement establishes top-level objectives to help ensure safe operation of nuclear power plants. The safety goals provide guidance 'on where plant risk Also, is sufficiently low so that further regulatory action is not necessary.

6 DSI 12 RELEASE DATE: SEPTEMBER 16, 1996

DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION s

as noted above,-the Coassission has been using PRA in performing regulatory ,

analyses for backfit of cost-beneficial safety improvements at operating ,

reactors (as required by 10 CFR 50.109) fcr a number of yo rs.

The application' of PRA to nuclear regulatory activities has evolved with improvements in PRA techniques and data bases. PRA techniques can be used to derive valuable insights, perspectives, and general conclusions as a result of the integrated and comprehensive examination of the plant design and a structured examination of plant and operator response to events. For a nuclear power plant, a plant-specific PRA can_ be used to derive plant-specific insights and conclusions where appropriate plant-specific modeling and data are available and used appropriately. PRA sensitivity studies are particularly useful-in focusing designers, operators, and regulators on important aspects of design, operation, and-maintenance.

The Commission has considered recent improvements in nuclear technology and accumulated experience with risk assessment methods, and concluded that increased use of these techniques as an integral- part of the regulatory decision-making process is now justified. Consequently, in its policy statement, "Use of Probabilistic Risk Assessment Methods in Nuclear Regulatory Activities" (60 FR 42622, August 16,1995), the Commission adopted the policy that the use of PRA should be encouraged and the scope of PRA applications in nuclear regulatory matters should be expanded to the extent supported by the state-of-the-art methods and data.

Bases The bases for rules and standards issued by the NRO are the Atomic En6rgy Act of 1954 (AEA), the Energy Reorganization Act, the Administrative Procedures Act, and other legislation. The AEA generally requires that the NRC establish regulatory standards to govern its licensing determinations. The AEA (section 161(b)) provides NRC with broad authority regarding the standards and processes that the NRC must apply in exercising its licensing and regulatory responsibilities.

In the reactor area, the AEA (sections 101 and 103) requires a license for each utilization facility and requires technical specifications (section 182) to be part of the license. The AEA allows for amendments to the licenses

-(section 187) and includes requirements for holding hearings in the amending of licenses -(section 189). -Under the Energy Reorganization Act of 1974, NRC is responsible for these licensing and regulatory functions. The procedures and requirements governing issuance and modification of these licenses are

contained in the NRC's regulations- (primarily in 10 CFR Parts 2 and 50).

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In the. nuclear materials area, the AEA requires general or specific licensing for distribution-and use of special nuclear material (section 53), source As a material- (sections 62 and 63), and byproduct material (see, tion 81).

consequence of the statutory responsibilities for licensing the distribution and use of nuclear materials and the use of utilization and production facilities, the NRC regulates medical, industrial, academic, and other commercial uses of nuclear materials.

The AEA provides the broad authority for inspection to ensure compliance with the' provisions of the Act. NRC inspections provide an independent verification of licensees' activitiesInspections to ensure are thatprimarily the activities are in discussed in10 compliance with agency regulations.

CFR Parts 19, 30.-and 50..

The AEA authorizes the NRC to undertake enforcement activities relating to '

violations of the licensing requirements, such as notices of violations and the imposition of civil monetary penalties. The NRC is also authorized to issue Orders that may lead to the suspension, revocation, or amendment of licenses. 10 CFR Part 2 describes the procedures for issuing notices of violation and orders, and imposing civil penalties.

- 8. External Factors

1. Executive Branch and Congress Congressional and Executive requirements regarding regulatory reform, changes in international standards, and advances in understanding risk and the biological: effects of radiation may affect the regulation of the nuclear industry. As late as 1995, Congress-was considering legislation concerning risk assessment (Title III of H.R. 9, the Risk Assessment and Communication Act of-1995).

2. Standards-Setting Organizations -

International and national standards-setting coassittees may influence the transition toward risk- informed, performance-based regulations. Translations In the between dose and risk usually use international consensus factors.

nuclear materials area, NRC has traditionally used radiological That is, indose as- the certain endpoint for rulemaking and compliance. assessment.

nuclear materials areas, regulatory decisions are related to the acceptability  ;

of dose as a -surrogate for risk. The International Coannission on Radiological Protection (ICRp) dose limits = reflect ICRP recosseendations for acceptable risk selections- for radiation workers and the public. The NRC makes use of

. recommendations- from the ICRP,- the National Council on Radiation Protection, and the National Academy of Sciences.

8 DSI 12 RELEASE DATE: SEPTEMBER 16, 1996

- RISK-INFORMED, PERFORMANCE-BASED REGULATION s DS!.12 J.

3. Federal Agencies The Environmental Protection Agency (EPA) has undertaken a, number of regulatory initiatives under its authorities-that affect activities licensed or otherwise regulated by the NRC. Substantial' differences have arisen between the two agencies and have included the underlying bases and approaches used to develop standards. In 1995, the NRC and the EPA developed a joint paper entitled " White Paper on Risk Harmonization" to help explore

, assessment methodologies to assess radiological risk.

As-previously discussed, the Paperwork Reduction Act of 1995Itisrequires tl., basis for agency and OM8 activities related to information collections.

controls to limit and reduce the: burden on the public for collecting agency information. In 5 CFR 1320, which implements- the Paperwork Reduction Act, OMB requires agencies to submit plans for..new, revised, and extended information collections to OM8 for approval. However, the NRC, as an independent regulatory agency, may override OM8 decisions.

4. ' Nuclear Industry In the reactor area, commercial nuclear power utilities and-industry ,

organizations-are using risk insights to identify and-reduce unnecessary burdens. Where NRC review and approval is necessary before reducing the In the  ;

burden, the industry is actively engaging the staff to seek relief.

nuclear materials area, there is less demand for regulatory change based on risk insights than in the reactor area. In some instances the nuclear materials industry may not be supportive of risk-informed,-performance-based initiatives due to perceived high cost, impact on small number of licensees, and little perceived ~ additional- safety benefit.

Si Public The public will-likely pisy a substantial role in the transition toIn order to maintain public risk-informed, perforzar.ce-based regulation.

confidence, the bases for and implications associated with risk-informed, performance-based regulatory approaches should be well defined and easily-.

' understood.-

C. Internal Factors

21. Nuclear Materials Initiatives The Commission's decision on the future role and scope of the NRC's nuclear materials program (in particular NRC's regulation of the medical use of

. nuclear material) will potentially affect tne priority and scope-for pursuing 9

DSI 12

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risk-infomed, performance-based regulatory approaches in nuclear materials program areas. The National Academy of Sciences recommended that the NRC reduce or eliminate its oversight of the medical uses of-quelear material.

The basis for a decision regarding NRC oversight of the-medical uses of-nuclear material may affect the oversight and regulation of other materini licensees and, consequently, the extent to which the agency may pursue risk-informed, performance-based approaches. The Business Process Reengineering effort is examining ways to gain efficiencies in licensing of nuclear materials and the results of this effort may t.ffect the extent to which risk-informed, performance-based approaches could improve the effectiveness and efficiency of the licensing process.

2. Commission's PRA Policy Statement The Commission's PRA Policy Statement encourages the use of PRA and seeks-to expand the scope of PRA applications in all nuclear regulatory matters to the extent supported by the state- of-the-art in terms of methods and data.

Performance-based regulation is an implicit element of the Policy Statement.

Depending on the Commission's decision for procee' d ing toward risk- informed, performance-based regulatory approaches (e.g., mere aggressive (Option 3) or less aggressive (0ption 4)), activities associated with the PRA Policy Statement and the companion PRA Implementation Plan may be refocused and staff resources may be redirected.

3. Defense-in-Depth The Commission has recognized that reliance for safety- should not be placed on any single element of design, construction, operation, maintenance, training or other activity associated with nuclear facilities or the use of nuclear materials. Our current regulations are generally deterministic and were

-constructed around this concept of defense-in-depth. Risk insights provide a more structured way to' assess relative .importance of the levels of defense-in-depth and can lead to enhanced defense-in-depth. Risk-informed, performance-based regulations may need to consider the potential adverse ctumulative effect of reducing conservatism and providing additional flexibility on defense-in-depth. Perfor:aance-based initiatives are considered for activities where failure to meet the performance criteria results in tolerable conditions for which appropriate corrective action will' be taken.

Therefore,- a key element of' a transition toward risk-informed, performance-based regulation is maintaining " defense-in-depth" for risk-informed, performance-based approaches by appropriately balancing deterministic- based and performance-based requirements so.that defense-in-depth is not compromised.

RELEASE DATE: _ SEPTEMBER 16, 1996 10 DSI 12

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4 4. Policy and Legal Issues: . Compliance with Performance-Based Regulations -

1 Substantive policy and legal issues are likely to emerge aj; increased reliance -

- is placed on probabilistic- and performance-based approaches to support regulatory requirements and licensing decisions. Issues such as using risk to

assess the severity level of-an. enforcement action or utermining compliance i with performance-based regulations will need to be addassed to ensure that there is an appropriate balance between deterministic-based and performance-based regulations so-that defense-in-depth is not compromised.

! III. DISCUSSIONS-4-

A. Discussion of Direction-Setting Issue I The Commission's decision on' this direction-setting issue will be used to establish the overall framework for expanding agency activities in applying j risk-informed performance-based regulatory approaches. After deciding on the overall approach for pursuing risk-informed, performance-based regulation, criteria for expanding the scope in applying a risk-informed, performance-based approach to rulemaking, licensing, inspection, and i

enforcement Lctivities can be applied in the context of the overall Consission -

i direction. In order to provide agency focus, these criteria can be sufficiently broad so that the criteria can be applied to both the reactor and j- nuclear materials areas. However, given the diverse nature of nuclear materials applications and the differences between ccamercial nuclear power i and other nuclear materials areas-in regard.to-their ataenability for..

t risk-informed, performance-based regulaticas,_ these criteria may need to be i

applied differently for different regulatory activities. Appendix A contains sample " priority and scoping" criteria that can be applied to better focus

- agency activities once the Commission decides' the overall approach for j pursuing risk-informed, performance-based regulatory approaches.

8. Discussion of-Subsumed Issues l

Aftur the Counission decides on the overall approach for pursuing risk-informed, performance- based regulatien, six subsumed strategic issues l

will be resolved in the context of the oven 11 direction. Four of these l

subsuntd issues-can be directly resolved through resolution of the-

-direction-setting issue. The resolution for the two other subsumed issues

! will- be greatly influenced by the Commission decision on this direction

[ setting issue.

The four issues most-directly resolved through implementation of the Commission decision for "how fasta and "how far" the agency will go'in j

expanding activities in the application of risk- informed, performance-based j' regulatory approaches are:

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_DSI 12

• - What should be NRC's , strategy and philosophy with respect to changing NRC"s responsibilities and authority in areas of little public risk?

l

• What- approach should NRC take in modifying the materials regulations to move toward risk-informed, performance-based regulation, recognizing the requirements will vary as a result of the range of products and the divergence of the licensees that use or possess byproduct nuclear material?

• Should NRC revise its regulations to address the uses of materials- If resulting from technological advances and changing human factors?

so, to what extent should NRC articulate objectives to prevent or limit the effects of equipment failures and human factors / human performance?

• What should be the approach for licensing material uses with various levels of inherent risks?

The first two issues should be completely resolved by the Comission's decision on this direction-setting issue and the Comission's decision on the  :

direction-setting issue concerning the future role and scope of-the NRC's nuclear materials program (in particular, NRC's: regulation-of the medical use of nuclear material).

The agency is required by the Atomic Energy Act of 1954 (AEAD, as amended, to provide reasonable assurance of _ an. adequate level of protection of_ the public health and safety, as well- as to promote the comon defense and security, in its regulatory activities. Although the scope of actions necessary to attain this level of protection from the use of AEA materials is relatively clear in areas of high risk, it is not so easily defined for those activities and types of material that generate a relatively small risk to the public from their use.- such areas include, but not limited to, the use of generally licensed devices, exempt distribution of consumer products, the _ definition and.

regulation of source material, review of formerly licensed sites As -and the agency stabilization and'1ong-term control of uranium mill tailings.

seeks- to improve the efficiency and effectiveness of its regulatory programs, these low risk activities will be scrutinized in order to make informed decisions about how the agency should pro'.eed, The Commission's- philosophy for considering changes to its regulatcry activities, including areas of responsibilities and authorities for-areas of little public risk is, in part, contained in the Commission's Final Policy Statement on the use of probabilistic risk assessment in nuclear regulatory _

activities. In the Final policy Statement, the Comission conveys an open-minded approach for considering strategic-type changes associated with using risk insights and states that two explicit implications associated with the policy statement are:

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RISK-INFORMED, PERFORMECE-BASED REGULATION l- -A D3! 12 i

t

, ) i i

First, that the NRC staff, licensees, licensee applicants, and  :

Commission must be prepared to considar changes to regulations, to -

and to,the inspection  ;

' guidance program. documents, to the licensing IrocessSecond,theNRCstaffand16 i

a shift in the application of resource , over a period of time based on  !

risk findings.

i i

l The current a6ency-wide strategy for increasing the use of risk assessment and i

risk management in regulatory decision-making s captured in the agency's PRA '

! Implementetkn plan. Therefore, the commiss on decision on 'how fast" and

]

'how far' the agency should go in axpanding activities associated with the i application of ris' . informed, performance-based regulatory approachel, will  ;

further define the approach and support the bases for considering changes to  !

regulations, responsibilities and authorit %s. '

The third issue ex>iteitly recognizet ..e diverse nature of nuclear materials l= applications snd _ tie differences between reactor and nuclear materials areas-i in regard to their amor. ability for risk- informed, performance-based

• l l

regulations. For example, events assceinted with industrial and medical uses -

i of nuclear materials generally involve a simple system, involve radiation gecause of  :

overexposures, and result from human error, not equipment failure.

these characteristics of medical and in:tustrial events, analysis of these l'

events using relatively simple tuhniwes may yield useful results. These results may lead to the establishment of standards with broad risk-informed, performance-based objectives and criteria. Conversely, these results may lead l

to a conclusion that more prescriptive requirements for equipment design and .

J Procedural compliance are appropriate. In these cetes, risk insights lead to i

risk-informed, deterministic regulations not rist-informed, performance-based

, regulations. Similar to the first subsumed issue, this subsumed issue will i also be resolved by the commission's decision on this direction-setting issue  :

i and the aforementioned direction-setting issue concerning regulation of

nuclear materials. .

I The fourth subsumed issue :onec ns licensing' for nuclear materials when there is determined to be a wide range of inherent risks because of the diverse use +

of the materials. These risks vary from very low-risk smoke detectors to i- relatively high-risk irradiators. Although the Commission must license all of i j these uses in response to the AEA, the Commission has flexibility in how it approaches the licensing. Currently, the Commission provides for three types

j. J of licensing: (1) exempt distribution. (2) general licenses, and (3) specific i

{- licenses. For exempt distribution devices (e.g., smoke detectors), the 4 Commission oversees and controls their manufacture and distribution by issuing specific licenses to the manufacturers and distributors. The individual users of these low-risk devices are not licensed. A review of the internal and i

external factors and ongoing activities has not identified any strategic l '

' issues associated with exempt distribution devices.

i >

i SEPTEMBER 16, 1996 13 D$1 12 RELEASE DATE:

4

,e a, ~ y er w y , e e e ,t, gry mm m,  %-e -. v. wav--,es,,r- c,,-y,n.wn,- +mw+-+,..mm-wrr,,es-es..wm.,,e.--,-w,,- _ m -ew%,,eemw-w ,,a-ceei enw

I-3

~

f RISK-INFORMED, PERFORMANCE-BASED REGULATION 0$! 12 The generally licensed devices consist of radioactive material contained in sealed sources that are designed with inherent radiation safety features.

Approximately 1.5 million generally licensed devices are under theNRC's regulation jurisdiction of the Agreement states and the NRC.

devices is essentially limited to the maintenance of a general license database, which contains the names of the general licensees and the products they possess. For general Ifeenses, issues associated with control and which reports that many poneral accountability were discussed in SECY- g5-139,ies under the general license.

licensees are not aware of their responsibilit The staff has previously.noted that there are inconsistencies inFor terms of. in example, risk, both among and acr:ss these three levels of activities.

SECY-go-175, the staff identified certain generally licensed gauges that may be better controlled through specific licensing and also identif' ed certain  !

generally licensed devices that are suitable for exemption from regulation.  !

En this regard and in accordance with reconnendations-contained in l 3ECV-g5-139, the staff has established a joint Agreement State-NRC working group to evaluate the current regulations concerning generally andA rep specifically licensed devices. )

June 1996.- ,

As previously mentioned, issues associated with determining an approach for - '

considering risk in.the licensing of material uses will also be resolved in '

the context of the overall cosmission decision on this direction-setting issue '

and the direction-setting issue concerning the future role and scope of the NRC's nuclear esterials program (in particular, NRC's regulation of the medical use of nuclear material). I A fifth subsumed issue concerns-the information necessary for_ developing and l The subsumed issue implementing risk-infor ed, performance-based regulation.

is, stated as follows:

• Given the new Government-wide goals for reducing Federal information  :

collections, how should the agency prepare for possible reductions in its budget ceiling for information collectica without compromising public health and safety? 4 The paperwork Reduction Act of 1995 is the basis for agency and OMB activities It requires-controls to limit and reduce related to information collections. In 5 CFR 1320, the burden on the public for collecting agency information. '

which implements the paperwork Reduction Act, OMB requires agencies to submit -

plans approval.

for new, revised, and extended information collections t By majority vote, the Commission can choose not to abide by i

by OMB decisions.

an 0M decision.

DSI 12 SEPTEMBER 16, 1996 14 RELEASE DATE:

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RISK-INFORMED, PERFORMANCE-BASED REGULATION 051 32 i

O The new paperwork keduction Act sets a goal of 10-percent annual reduction in l information collections for 1996 and 1997 followed by a 6-wrcent reduction 1 i

sach year in 1998, 1999, 2000, and 2001. It is uncertain now OMS will l

implement this goal. Depending on individual agency plans to achieve the reductions, OMB could assign specific reduction goals to each agency. NRC '

could be required to reduce its information collection burden before imposing '

]

i any additional burden through new or amended collections. This could affect j the rulemaking process, especially since risk-informed, performance-based -

l-regulatory approaches-may well require licensees to collect more information

)

for the NRCs >

The Commission's decision on expanding agency activities in applying l risk-informed, performance-based regu'atory approaches will influence the i extent and impact of additional information requirements. In response to l

several consents concerning the potential data collection implications of the Cmanission's PRA Policy statement, the Cossaission agreed that it should make  ;

- every effort to avoid any-unnecessary regulatory burdens in connection with collecting reliability and availability data (60 FR 42622 at 4F626). The i

Commission also indicated that, in the context' of risk-informed regulation, i

' this was an implementation issue and that data and information collection will j be addressed in connection with proposed data collection requirements when the 4- requirements are published for cosament.

! In a strategic sense, information collection requirements and burdens should not define the direction that the agency takes regarding risk-informed,

[ performance-based approaches. Regardless of the option selected for l

i:  !

proceeding toward risk-informed, performance-based regulatory approaches, the j- Commission could consider information collection options independently. The Commission may (1) look for efficiencies in.information collection and storage methods and identify areas that could be made more efficient (2D wait until i

[ OMB publishes its guidance to agencies for implementing the prov1sions of the ,

new paperwork Reduction Act and address any issues on a case-by-case basis with each rulemaking, or (3) report NRC's case to OMB now and request a level j j

j vr increased ceiling to accommodate future information collection needs astociated with risk-informed, performance-based regulatory approaches. ,

[

i i

' Finallys a sixth subsumed issue concerns interagency implications associated with moving toward-a more risk-informed, performance-based regulatory

~

framework. $PectfIcally:

• Hw should a risk-informed, performance-based regulatory philosophy

! influenn NRC's handling of dual regulationt l

As=t,eeviously mentioned, the Environmental protection Agency (EPA) has j undettaken a number of regulatory initiatives under its authorities that ,'

affect activities licensed or otherwir.e regulated by the NRC. Substantial- t i

i 15 D5! 12

. RELEASE DATE: SEPTEMBER 16, 1996 e.,..,<_ ~,r.. .y4,,,,.,m..,+  %.m-wm,.,,em,-_.,,,w..e..q-.--v.,,,,,~.ym-_v--._,~. ~mm-.g.e.-,w..v.,.,..J,_,m,.-.-#,,, ,.-twe,,m.,,~.,..,,y-..,.

RISK-!NFORMED, PERFORMANCE-BASED REGULATION D5! 12 differences have arisen between the two agencies and have included differences associated with the underlying bases and approaches used to develop regulatory In 1995, the standards and acceptable methods for meeting these standards.

NRC and the EPA developed a joint paper entLtled " White paper on Risk Harmonization

• to help explore ways to " harmonize' risk goals and to develop mutually agreeable approaches-for risk assessment methodologies to assess radiological risk.

As the NRC and other government agencies move toward more risk-informed, performance-based regulatory approaches, the use of risk insights should help promote a common understanding of the technical bases for regulatory approaches. The cc ..en desire for increasing the use of risk in all government agencies helps define the common goals, but there is substantial l

interagency work necessary to ensure that there is a systematic interrelatedness among approaches and mutual understanding and agreement on the underlying bases for the reguistory approach, including agreement on key policy issues, such as agency safety goals, and technical issues confronting the agencies. The Commission decision on 'how fast' and 'how far* the agency should go in expanding activities associated with the application of risk-informed, performance-based regulatory approaches will further influence the level of agency resources devoted to reconcile differences in conflicting ,

interagency regulatory approaches.

C. Important Aspects of Risk-Informed Performance-Based Regulation Three important aspects of expanding agency activities in applying risk-informed, performance- based approaches concern establishing a coasson understanding of what is meant by ' risk- informed, performance-based,' dealing with uncertainties in regulatory decision-making _ and strategically considering how to ensure regulatory coherence during the transition from deterministic-based regulations to risk-informed, performance-based regulations.

1. Discussion of terms ' Deterministic-tased,' ' Risk-Informed.

Deterministic-Based ' ' Performance-Based,' and " Risk-Informed, performance-Based

• Deterministic-based. The NRC has generally regulated the use of nuclear material (including nuclear materials and reactors) based on deterministic approaches. Deterministic approaches to regulation consider a set of challenges to safety and specify how those challenges should be mitigated, simply stated, the deterministic approach establishes requirements for use of nuclear materials and for engineering margin and quality assurance in design, manufacture, construction, and operation of nuclear f acilities.

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RISK-INFORMED, PERFORMANCE-BASED REGULATION

( 08! 12 N

The NRC established its regulatory requirements to ensure that a facility is designed, constructed, and licensed to operate without undue risk to the health and safety of the public. These requirements are Isrgely based on deterministic engineering criteria. In addition this approach assumes that adverse conditions can ex i st (e.g., equi pmentfalluresandhumanerrors)and establishes a set of design basis events. It then requires that the licensed facility design include safety systems capable of preventing and/or mitigating the consequences of those design basis events to protect the public health and safety, The deterministic approach contains implied elements of probability.

For example, reactor vessel rupture is considered too improbable to be included as an accident to be analyzed. However, the likelihood that a single emergency core cooling system or system train would not function was o

' cons'dered high enough that safety train redundancy and protection against single failure where required.

Riskoinformed, deterministic-based. A risk-informed, deterministic apprsach to regulation enhances and extends this traditional, deterministic approach, by: (a) allowing consideration of a broader set of potential challenges to (b

safety,liho)od and risk significance, and (c) allowing consideration of aprov on like broader set of resources to defend against these cha'lenges. A risk-informed approach can be used to focus deters nistic regulations by considering risk in a more coherent and comprehensive manner, gy considering risk insights, operating experience, and engineering judgment the NRC and its licensees can focusregulatoryapproachesandlicenseeactivItiesonthoseitemsmost important to public health and safety. Where appropriate, a risk-informed regulatory approach can be used to reduce unnecessary conservatism in deteministic approaches or can be used to identify areas with insufficient conservatism and provide the bases for additional: requirements.

Deterministic-based regulations have been successful in protecting the public health and safety and risk insights are most valuable een they serve to focus the deterministic- based regulations and support the dafense-in-depth philosophy.

performance-based. A performance-based regulatory appronc' h requires at least four key elements:

• There are measurable parameters to monitor acceptable plant and licensee performance.

• Objective performance criteria are established to assess performance.

• There is licensee flexibility to deterc.ine how to meet' established performance criteria.

17 DSI 12 RELEASE DATE: SEPTEMBER- 16,1996

051 12 kISK-INFORMED, PERFORMANCE-BASED REGULATION

• Failure to meet a performance criterion must not result in unacceptable consequences.

In theory, a performance-based approach can be implemented without the use of risk insights. This type of performance-based approach would require that objective performance criteria be based on deterministic analysis and performance history. This approach would provide additional flexibility to the licensee to determine how to meet performance criteria. However, the not impact on public health and safety would be difficult to determine.

Risk-informed, performance-based. Risk-informed, performance-based approaches use risk insights, together with deterministic analyses and performance i

history, to develop measurable parameters for monitoring plant and licensee performance, as well as for developing criteria for performance assessment, and focus on the results as the primary means of regulatory oversight.

-Similar to a risk-informed, deterministic-based approach, a risk-informed, performance-based regulatory approach can be used to reduce unnecessary conservatism in deterministic approaches or can be used to support additional regulatory requirements. In addition, a risk-informed, performance-based approach can further focus performance-based approaches by defining the goal or purpose of the approach in terms of performance characteristics and safety significance and permitting the licensee additional flexibility in meeting the regulation. Performance-based initiatives can be considered for activities where objective performance criteria can be established for performance monitoring. Additional evaluation of performance-based approaches may result in a determination that a number of functional areas are not amenable to performance-based treatment.

The NRC Inspection Manual-has tailored the concepts of " risk-infomed" and

" performance- based" for inspections into a single-definition of

" performance-based inspection." According to Insoection Manual Chapter 0610, performance-based inspection is inspection that focuses' on issues of safety and reliability,.with an emphasis on field observation rather than in-office procedural or records. review. The emphasis on safety and reliability borrows from risk studies, incorporating PRA and individual plant examination insights to structure inspections that focus on systems or components most important to plant safety, in addition, performance-based inspection tends to focus more on results than on process and method.

2. Uncertainties in Regulatory Decision-Making The treatment of uncertainties is an important issue for regulatory decisions. .

Uncertainties exist in any regulatory approach and these uncertainties are derived from knowledge limitations. These uncertainties and limitations existed during the development of deterministic regulations and attempts were made to accommodate these limitations by imposing prescriptive, and what was

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RISK-!NFORMED, PERFORMANCE-BASED REGULATION s D51 12 s

hoped to be, conservative regulatory requirements. A probabilistic approach has exposed some of these limitations and provided a framework to assess their significance and assist in developing a strategy to accommpdate them in the regulatory process.

Human performance is an important consideration in both deterministic and i

probabilistic approaches. Assessing the influence of errors of commission and organizational and management issues on human reliability is an example that illustrates where current PRA methods are not fully developed. Although this lack of knowledge contributes to the uncertainty in estimated risks, the PAA framework offers a powerful tool for logically and systematically evaluating the sensitivity and importance to risk of these uncertainties. Improved PRA techniques ano models to address errors of connission and the influence of organizational factors on human reliability are currently being developed.-

Given the-dissimilarities in the nature and consequences-oi--the use of nuclear materials in reactors, industrial situations, waste disposal facilities, and medical applications, the Commission has recognized that a single approach for incorporating risk analyses into the requintory process may not be appropriate. However, PRA methods and ' nsights will be broadly applied to ensure that the best use is made of.available techniques to foster consistency in NRC risk-informed decision-making. Activities that lead to re9ulatory coherence will also reduce uncertainty in regulatory decision-making.

~

3. Regulatory Coherence Regulatory coherence is essential in order to vnsure that the direction the Commission-takes in expanding agency activities in applying risk-informed, performance-based regulatory approaches promotes a stable and predictable regulatory environment. Regulatory coherence is achieved when the regulatory programs or processes are well understood and proceed in a logical and orderly fashion. In this paper " regulatory coherence" means:

-(a) integration of risk-informed, regulatory approaches based on a consistent pattern or framrvork (b) implementation of risk-informed, performance-based approaches in a suitable or orderly way that promotes and ensures mutual understanding (c) development of risk-informed, performance-based approaches that are verned by rational principles and that ensure systematic nterrelatedness.

The commission has recognized the importance of coherence for increasing the use of PRA and the Co.inission's policy statement on the use of probabilistic risk assessment methods in nuclear regulatory activities (60 FR 42622)

SEPTEMBER 16, Igg 6 19 DSI 12 RELEASE DATE:

1 RISK-INFORMED, PERFORMANCE-BASED REGULATION DSI 12 1

promotes regulatory coherence. Through the 'PRA Implementation Plan' the f

staff monitors PRA-related activities and helps ensure consistent application )

of PRA methods and techniques. The PRA Implementation P14n explicitly )

l contains activities that have, as a principal goal, the achievement of i regulatory coherence. Recently, the schedule for completing several I J

i activities in the PRA Implementation plan dealing with regulatory guides and standard review plans (SRPs) for reactor pilot applications Arguably, have beenthe l

l

[ accelerated to improve and promote regulatory coherence. l increased use of PRA methods and techniques itself promotes regulatory I

] coherence by integrating regulatory decisions using risk, allowing systematic  ;

comparisons of approaches, and enhancing mutual understanding of those items  ;

that are most important to safety.

j Another way that the Cosmiission is promoting regulatory coherenceThe for safety i operating reactors is through the safety goal policy statement. i j' goal policy statement uses quantitative, probabilistic risk measures and  :

j establishes top-level objectives to help ensure safe operation of nuclear I power plants. The safety goals provide guidance on where risk is sufficiently low that further regulatory action is not necessary. The concept l of a " safety goal" has not been firmly established for NRC licensees, other '

than commercial power reactor licensees.

{j j Eventually, the Cossaission could consider rulemaking, adoption of a. national standard for performing PRAs, or more detailed regulatory guidance to help j

i ensure uniformity in the quality and application of risk-informed, performance-based regulatory approaches. The Commission and senior NRC i

management could define staff requirements more precisely for moving toward risk-informed, performance-based regulatory approaches and could more strongly articulate =its expectations for industry use of risk-informed, performance-l' based approaches to support regulatory decision-making.

Finally, regulatory coherence for a risk-informed, performance-based approach may not be achieved unless there is a cohesive approach that can be used as i

guidance for both the NRC and the regulated industry. The Commission could encourage industry /stakeholders to develop solutions or processes that help ensure regulatory coherence. To help ensure regulatory coherence for industry ,

1 processes or industry application of a risk-infonned, performance-based approach, a part of the burden could be assumed by the regulated industry.

jl For example, if the varying levels of quality for individual PRAs contribute >

L

-to regulatory incoherence, the industry could develop a PRA " certification" process-or develop criteria for detailed peer reviews.

As discussed above, regulatory coherence is essential-in order to ensure that the direction the Commission takes to expand agency activities in applying risk-informed, performance-based regulatory approaches promotes a stable and i

predictable regulatory environment.

i SEPTEMBER 16, 1996 20 DSI 12 RELEASE DATE:

9 I

RISK-!NFORMED, PERFORMANCE-BASED REGULATION l

! x D5! 12

. s i IV. OPTIONS Option 1: Continue Current Process ,

This option would continue the current process for determining priority and '

scope of risk- informed, performance-based activities. The Commission's final .

policy statement on 'Use of Probabilistic Risk Assessment in Nuclear  !

Regulatory Activities

• establishes an overall policy on the use of PRA methods 4 in nuclear regulatory activities so that the many potential applications of ,

PRA can be implemented in a consistent and predictable manner that would

promote regulatory stability and efficiency. The priority and scope for regulatory activities under this policy statement are captured in the agency's PRA Implementation Plan.

There is flexibility associated with the PRA Implementation Plan. NRC Program Offices principally determine the priority and scope in applying risk-informed, performance-based regulatory approaches. The PRA Implementation Plan is periodically updated to reflect progress for plan activities, to indicate areas that are determined to be not yet amenable to risk- informed approaches, or to add new areas where the staff is pursuing .

risk-informed approaches. Under the current process, the priority and scope '

in applying risk-informed, performance-based approaches are determined by t balancing external and internal _ goals with available resources. Priority 1 criteria are applied and the scope of activities is primarily determined by considering the industry demand, the safety benefit, the ease of implementation, and available resources.

The current process is responsive to industry initiatives in reactor-related areas. In part, this is because the potential benefits for reducing '

unnecessary industry burden, enhancing safety decision-making,- and improving staff efficiency are more readily apparent.. Consequently, resources in the I reactor area are focused on developing additional regulatory guidance and-

• supplementing the Standard Review Plan to address areas such as inservice inspection, inservice testing of pumps and valves, graded quality assurance, and technical specifications. .

There is no widespread industry demand to consider risk-informed approaches in many of the nuclear material areas and it is not apparent whether some nuclear material areas will significantly benefit from implementation of risk-informed approaches. As a result, in the PRA Implementation Plan, there is less )

emphasis on incorporating risk-informed approaches in the nuclear materials areas.-

A performance-based approach is an implicit element for some PRA Implementation Plan activities and a necessary element for other activities in the plan. For example, there have been several performance-based initiatives SEPTEMBER 16, 1996 21 DSI 12 .

RELEASE DATE:

i l l  !

I .i 1 -

RISK-INFORMED, PERFORMANCE-BASED REGULATION 05I 22 such as risk- informed j discussed in the PRA Implementation Plan,leaka9e requirements, fire protection i

performance based changes to containment The PR$ Implementation requirements, and maintenance rule implementat<on. As data from plan pilot appl

,l inservice inspection contain performance-based aspects.

perfomance monitoring of structures, systems and components are accumulated and made available to the agtncy, the staff evaluates the performance data, where appropriate, to determine the effectiveness of the approach.

Under this, option, the modification of rules and regulations to move toward performance-based regulation would proceed at a pace consistent with the-l activities-under the PRA Implementation Plan. As areas amenable to 4

j risk-informed, become available performance-based regulation are. identified and as r..ou l l areas, technological changes and changing human factors may affect the In speed t and scope of risk- informed, performance-based revisions to regulations.

j-areas involving dual regulation, the current emphasis and level of activity devoted to resolving issues affected by dual regulation would continue and the #

i

! pace of these activLties would be consistent with the safety benefit, the ease i of implementation, and available resources.

Since this option is the current process, no change in-resource allocation is 4 l

necessary to implement it. The resource and progrannatic consequences are ,.

3 gradual and incremental.

4 l Option 2: More Rigorously Assess Relationship to Public Health and safety Similar to the continue current process option discussed above, this option b

! would primarily continue the current approach for moving toward more-However, under  ;

risk-informed, performance-based regulatory approaches.

l option, the relationship of new activities to public health and safety would i L

' need to be more rigorously assessed. The results of this safety assessment In other words, would determine whether the agency would pursue the activity.

l -those activities where there could be a substantial increase in overall  ;

protection to public health and safety will be given the highest i#tority. '

l Underlying both this option and the continue current Process option is the  !

assumption that our regulations and current regulatory processes are adequate, The l

l and will continue to be adequate, to protect public health and safety.

Continue Current process option pursues enhancement to current regulatory

processes through risk-informed approaches to regulation, is exploratory inThis  ;

nature and applies a threshold for pursuing such activities. $

i. pursues enhancements However, .to our current regulatory processes through risk-inf ,

this option is more narrowly focused than F

approaches to regulation.

Option 1 and applies a higher threshold for pursuing activities.

1 I

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RISK-!NFORMED, PERFORMANCE-BASED REGULATION

- DS! 12 Under Option 2, priority and scope in applying risk-informed, performance-based regulatory approachos would be primarily' determined by the projected cost of the approach compared to benefit to the public health and safety. Many intangibles would have to be analyzed, at least qualitatively, and a methodology developed in order to provide a meaningful assessment.

Priority criteria are weighted toward greatest safety benefit. The scope of risk-informed, performance-based approaches is primarily determined by considering the cost / benefit, the overall impact on the NRC and regulated industry, and available resources.

For example,' consider some of the current activities in the reactor regt% tion area. Several of these activities are in response toThe industry demand and have safety benefit of these as a principal goal to reduce unnecessary burden.

activities is not well defined. There has been an assumption that, once burden has been reduced, those resources made available through that reduction in burden would be made available to focus on activities that are of greater safety importance. However, this safety benefit is difficult to quantify.

In the nuclear materials area, there is less industry demand to reduce unnecessary burden through risk-informed, performance-based approaches to regulation than in the reactor area. The nature of the interaction between the NRC and its materials licenses is different from the interaction between the NRC and commercial power reactor licensees. Material licensees often deal with simple systems and the primary contributor to risk is human error. Any safety benefit associated with a risk-informed, performance-based approach may also be difficult to quantify. Under option 2, the current emphasis on reconciling regulatory differences arising from dual regulation may be reduced.

Priority criteria for new initiatives are used as a threshold but weighted toward greatest safety benefit. Scoping criteria from Appendix A most useful in this approach are cost / benefit, safety significance, largest impact, and available resources.

Option 3: Perform a comprehensive Assessment of NRC Regulatory Approaches This approach would involve a comprehensive review of our regulations and regulatory processes to determine areas that could be improved through risk-informed, performance- based regulatory approaches. The agency priority for activities would be established based on consideration of the cumulative impacts on safety, burden reduction, and efficiency.

This is the most proactive, aggressive option for moving toward risk-informed, performance- based regulation. This option would maximize internal self-assessment and include exploring all regulatory areas to determine whether risk-informed, performance-based regulation should be pursued in that SEPTEMBER 16, 1996 23 051 12 RELEASE DATE:

RISK-!NFORMED, PERFORMANCE-gASED REGULATION D5! 12 area. The purpose for the review under Option 3 is not just to enhance our deterministic regulations. The purpose of this assessment is to fundamentally change, in a comprehensive manner, the bases to our regulations and process for those areas that are amenable to a risk-informed, performance-based approach.

Under Option 3, priority for regulatory activities would be established based on consideration of the cumulat've impacts on safety, burden reduction, and j

efficiency. The scope of risk-informed regulatory approaches under this option would be determined by considering agency responsiveness to stakeholder l

i initiatives, the safety benefit / significance of the approach, and the effect en NRC and-licensee efficiency. Ease of implementation and available resources are secondary scoping considerations (i.e., if the ;ctivity is determined to be a high priority then resources will be made available and efforts made to improve the state-of-the-art to the level necessary to support the desired geal).

In the reactor area, the staff and industry have already identified several areas that may be conducive to risk-informed, performance-based regulatory approaches. The Commission has already performed a systematic review of the many current rules and regulations to identify opportunities for eliminating unnecessary regulations. In 1993, the NRC established the Regulatory Review troup [RRS) to conduct a structured review of power reactor regulations with specia; attention on the opportunity to reduce unnecessary regulatory burdens.

The RRS recomunendations to reduce the regulatory burden included the suggestion to use more risk- based ap+ roaches in quality assurance, inservice inspection, and inservice testing.. Tie RR6 reconnendations were documented in SECY-g4-003. Option 3 would build on the RRG review results with a more tightly focused assessment on the bases of those regulations and on identifying and prioritizing regulations that are amenable to a risk-informed, performance-based approach.

In the nuclear materials area, a similar systematic assessment of rules and regulations has not been conducted. However, several recent initiatives, including an materials licensee regulatory impact study and the gusiness process floengineering initiative, may result in changes to nuclear materials regulatory approaches. Option 3 would-initiate a thorough review of the bases for nuclear materials regulations and process and would identify and performance-based prioritize approach. those areas that are amenable to a risk-informedAs a result of this asse framework for applying PRA in reactor regulation in $ECY-g6-280, could be developed for other nuclear materials uses.

Because the purpose of Option 3 is to change the bases of our regulations and

_ process for those areas that are amenable .to a risk-informed, perfomance-baswl approach, this option is the most resource intensive option.

SEPTEMgER 16, 1996 24 051 12 RELEASE DATE:

s DS! 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION

\j Additional resources would be needed to train the staff, develop a strategy 1 i

for review, complete the assessment, and implement rulemaking or procedural  !

changet. ,

Under Option 3, the staff would likely intensify its efforts to resolve issues

> associated with dual regulation. The agency would more aggressively pursue a systematic interrelatedness among approaches and mutual understanding and

agreement on the underlying bases for the regulatory approades, inc uding agreement on key policy issues, such as agency safety goals, and technical issues ernfronting the agencies.

Because it is the most resource intensive, this option would alsc be the most costly to licensees in the form of fees to pay for the reviews, guidance

! development, and rulemakings to be undertaken. Their participat'on in and i support for such activities could well depend on the extent to which they perceived near term, concrete benefits accruing to their own operations.

' Option 4: Consider Risk-Informed. Performance-Based Approaches Priitarily in Response to Stakeholder Initiatives ,

This option is the most responsive to stakeholder interests. The agency would determine for new initiatives the priority and scope in applying risk-informed, performance-based regulatory approaches through consideration of stakeholder demand and ease of implementation. The scope would be primarily established to meet the demand or request.

Under this optinn, reducing industry burden would be the primary result. The

< safety review for proposed risk-informed, performance-based approaches would be to ensure that the proposed approach maintains an acceptable level of safety. Staff and industry efficiency may be collateral benefits of this >

approach.

i Another potential consequence of selecting this option is that the agency

could be perceived to be reactive and not making the best use of ava lable information and technology to reach decisions. The agency's expertise in risk-informed regulatory approaches may be limited by the demand for that expertise. Therefore, in tie future there might be a substantial burden associated with " ramping-up to speed" to deal with emergine safety issues.

. V. RELATED ISSUES After the Commission has made decisions concerning the Direction-Setting Issue discussed above, additional _ issue (s) such as those related to implementation 4

details will be addressed as the Strategic Plan is implemented. The related issues are listed in this section to provide a more complete understanding of -

the higher inval Direction-Setting Issue.

4 4

SEPTEMBER 16, 1996 25 DSI 12

. RELEASE DATE:

l 05I 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION i i

• 'Jhat is the appropriate level of resources that the NRC should devote  !

ever the next few years to reduce the number of licensing requirements t no longer required for safety and to. develop risk-teformed,  !

performance-based approaches in order to achieve long-term reductions in  :

the resource burden of both the licensee and the NRC? j

• W 4t levels of residual radioactivity are acceptable for decommissioning  !

a saterials licensed facility?  !

VI. C0lWII55 ION's PRELIMINARY VIEWS ,

Staff actions regarding the various options should be held in abeyance pending  !

-the Commission's final decision on this issue paper. The Commission's  ;

! preliminary views are:  !

The consission recognizes that, in order to accomplish the principal mission  !'

of the NRC in an efficient and cost effective manner, it will in the future have to focus on those regulatory activities that pose the greatest risk to i the public. This can be accomplished by building upon probabilistic risk  ;

assessment concepis, where applicable, or other approaches that would allow a  :

risk-graded approach for determining high and low risk activities. In  ;

general, those activities that are of a higher risk should be the primary  !

focus of the agency's efforts and resources. The level of staff activity - '

associated with lower risk activities should be determined based on a  !

consideration of the cumulative impacts on safety, stakeholder initiatives and burden reduction, and the effect on agency and licensee efficiency. j The staff should continue with the current efforts, in cooperation with the l industry (0ption 1),_ including pliot programs. The objective of this initiative is to obtain additional information regarding the appropriateness of a risk-informed, performance-based approach for-the subject activities.  :

.These activities and their schedule, are presently captured in the agency's '

PRA Implementation plan. As data from performance monitoring of structures,  ;

systems and components are accumulated, the staff should evaluate the -

i performance data to determine the effectiveness of the approach on the subject ,

activity.-  ?

The staff should proceed-in the direction of enhancing the pRA Implementation plan by building on the(i.e., moving towards implementation of elements Regulatory Review Group's (RRG) results, which were initial of option 3)ly focused on reducing the regulatory burden, with a more. focused assessment of those  !

regulations which are amenable to a risk-informed, perfomance-based approach.

4 In determining the priority and scope of regulatory activities to be included  ;

~

in moving in the direction of partial implementation of option 3, the staff should consider the cumulative impacts on~. safety, stakeholder initiatives and burden reduction,- and the effect on NRC and licensee efficiency. This RELEASE DATE: SEPTEMBER 16. 1996 26 D51 12 f I  ;

-- --___ - - - - - - =

RISK-INFORMED, PERF0PMANCE-BASED REGULATION DSI 12

..s approach should result in a further focusing of resources, on the various areas that the Commission regulates, that is consensurate with its risk significance, potential burden reduction and effect on eff,1ciency.

The staff should evaluate and clarify'any technical and/or administrative issues associated with performance-based approaches to regulation (e.g.,

inspection activities, enforcement, etc.). The staff should also perform a thorough review of the basis for nuclear materials regulations and process, and should identify and prioritize those areas that are either now, or can be made with. minimal additional offort/ resources, amenable to a risk-informed, performance-based approach. This assessment should e entually lead to the development of a framework for applying PRA to nuclear materie.1 uses, similar to the one developed for reactor regulation (SECY-9F-280), where appropriate.

In the public connents on this issue, the NRC particularly solicits how NRC should deal with dual regulation when applying a risk-informed, performance-based regulatory philosophy.

27 DSI 12 RELEASE DATE: SEPTEMBER 16, 1996

DS! 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION Appendix A Saiple criteria for Determining the priority ,and Scope Within the Context of the Strategic Direction

1. Applying the criteria The weighting of criteria to datermine the priority and scope associated with applying 4. risk- informed, performance-based approach to rulemaking, licensing, inspection, and enforcement for new initiatives will be governed by the option that the Consission chooses for proceeding toward a risk-informed, performance-based regulatory framework.

Several sample critoria for establishing the scope and priority in applying a risk-informed, performance-based regulatory are discussed under this issue paper. Except as noted, the criteria can be applied to reactor and nuclear materials areas.

The staff notes that the expected benefit of an activity may elevate its priority. However, if the scope of the activity necessary to explore that expected benefit is resource intensive, then the priority may be lowered.

!!. Priority criteria priority criteria can be broadly defined by the relationship of the activity or proposed acti/ity to the agency's commitment to good regulation. Pricrity criterta also reflect a balance between the need for a revised approach and an assessment of whether the revised approach is achievable. The priority for applying a risk-informed, performance-based regulatory approach can be illustrated by assessing an activity or proposed activity using the following high-level criteria:

Safety Impact: To what extent will the activity result in enhanced safety decision- making or increase the level of public health and safety? Conversely, to what extent will the activity potentially reduce the level of public health and safety?

Burden Reduction: To what extent will the activity reduce unnecessary burdens on the staff or the industry by eliminating unnecessary requirements?

Efficiency: To what extent will the activity promote a bettar use of staff or industry resources by focusing on those activities that are more important to safety?

. RELEASE DATE: SEPTEMBER 16, 1996 28 DSI 12

RISK-INFORMED, PERFORMANCE-BASED REGULATION s DS! 12

.J

!!!. Scoping Criteria Scoping criteria can be broadly defined by ti.e extent and, timing of the resource commitment necessary to achieve a certain goal. The scope defines the nature and character of the activity and conveys an agency resource commitment. The scope in applying a risk-informed, performance-based regulatory approach for new initiatives can be determined using a criterion or combinations of criteria. Sample criteria are listed below.

Responsive to Scope is determined by the extent needed to be responsive to Stakeholders t stakeholder initiatives.

Safety Benefit: Scope is determined by the extent needed to achieve the desired impact on reduction in risk or positive impact on public health and safety.

Efiiciency: Scope is determined by the extent needed to achieve the desired impact on staff efficiency.

Cost /Senefit Scope of an activity is pursued to the extent that is supported by a cost / benefit analysis. The scope of an activity may be established to optimize the cost / benefit ratio.

Public Scope of an activity is limited to those areas that the Confidence: public is willing to support.

Largest Impact: Scope is determined by the extent needed to provide a large-scale programmatic or systemic impact.

Available Scope is determined by the extent supported by available NRC-Resources: and licensee resources.

Ease of Scope is determined by the maturity of the technology and Implementation: how easily the technology can be incorporated into the regulatory framework.

SEPTEMBER 16, 1996 29 USI 12

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l

i RISK-INFORMED, PERFORMANCE-8ASED REGULATION DS! 12

- ACRONYMS 4

e Atomic Energy Act of 1954 AEA ATWs anticipated transient without scram business process reengineering BPR D$1 direction-setting issue Environmental Protection Agency EPA International Commission on Radiological Protection ICAP IPE Individual Plant Examination IPEEE Individual Plant Examination-External Events office of Management and Budget OMB PRA probabilistic risk assessment RRG Regulatory Review Group 580 station blackout SNM special nucigar material SRP standard review plan 9

l l

DSI 12 SEPTEMBER 16, 1996 30 RELEASE DATE:

1

9 8 Enclosure 2 COMSECY 96 057

. __ ~ .__ . _ . _ . . _ . _ ~ , _ _ . _ _

______m __ __._____.

• [' UNITED STATtS

/ NUCLEAR REGULATORY COMMISSION I  ;

WASHWQTON,OC 20665 0001 '

$,,,,, March 20, 1997 MCAf7 ART i

1-MEMORANDUM TO: L. Joseph callan

Exe ut ve D rector for Operations i FROM

Job C. oy b

e, Secretary

)

SUBJECT:

S AFF REQUIREMENTS - COMSECY-96-057 MATERIALS / MEDICAL OVERSIGHT (DSI 7) t With respect to the overall materials program, the Commission i continues to support its preliminary views on this issue which j

were a combination of two options - Continue the Ongoing Program  ;

with Improvements (Option 2) and Decrease oversight of Low-Risk Activities with Continued En.phasis in High-Risk Activities (Option 3). For the longer term, the Commission also believes that consideration should be given to broadening NRC's regulatory oversight to include one or more of the higher risk activities identified in Option 1.

With respect to the medical program, the Commission was not '

persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report that recommends that NRC should not be the Federal agency involved in the regulation of ionizing radiation

, in medicine. The Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued.

The Commission continues to support the use of ACMUI and professional medical organizations and societies in developing regulatory guides and standards as was proposed in the Commission's preliminary views. In the longer term, the commission would be willing to cot. sider taking on broader '

regulatory responsibilities for higher risk activities involving other sources of ionizing radiation but such efforts should not divert resources from the 10 CFR Part 3b rulemaking discussed below.

In lieu of a-rulemaking plan in the context of Management >

Directive-6.3 the staff should submit a program for Commission approval for revising 10 CFR Part 35, and associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary. The program should describe how 10 CFR Part 35 can be restructured into a risk-informed, more performance-based regulation by a suspense date of 6/30/99. In developing the -

program the staff should consider the following g 0 @l'8N 5#

,. n ,,,,n- - - . - . , , - . , , n.,.n - ~ . . , . . , ,n , . - . - . , . , , . - ,- . - - . - . ~ -

.. . k i

(1) Focusing Part 35 on those precedures that pose the highest risk.

l (2) For diagnostic pr.cedures, staff should consider l regulatory oversight alternatives consistent with the lower overall risk of these procedures.

(3) The staff should address how best to capture not only relevant safety-significant events, but also precursor events.

(4) Chanping the nomenclature from " misadministration" to a

madical event" or comparable terminology.

(5) Part 35 should be redesigned so that it can i.. corporate necessary regulatory requirements for new treatment modalities in a timely ranner.

(6) The Quality Management Program provisions (10-CFR Part 35.32) should be re-evaluated and rctised to focus on those requirements that are essential-for patient safety, e.g., confirming patient identity, requiring written prescriptions and verifying dose. To the maximum extent possible, the requirements should be revised to be risk-informed. Given this objective, a mixed approach of performance-based rules and otherwise prescriptive regulations should be pursued.

(7) The staff should consider the viability of using or referencing available industry guidance and standards within Part 35 and related guidance to tne extent that they meet NRC needs.

(8) The staff ~hould consider a rulemaking process that provides mt a opportunity for. input from potentially .

affected parties than is provided by the normal notice and comment rulemaking process but would be less consumptive of resources and time than the process recently used in the development of NRC's rule on radiologi;&l criteria for license termination.

The staff's program to implement the abov:.-should be submitted to the Commission for its consideration no later than June 6, 1997.

The program should target June 3b, 1999 as-the date for  !

. completing tha rulemaking process, This rulemaking and Lassociated.guidanco development is a ve y high priority for the i Commission. The Commission is prepared to provide additional resources-to the extent necessary to complete the rulecaking process on this schedule.

(NMSS/RES) (EDG - - Program) (SECY Suspense: 6/6/97) 970006!

(NMSS/RES) (EDO - Complete Rulemaking) (SECY Suspense: 6/30/99) 970006!

n

. c 1

3 1

cci Chairman Jackson Commissioner Rogers Commissioner Dieus

. Commissioner McGaffigan Commissioner Diaz K. Cyr D. Rathbun H. Bell A. Galante R. Scroggins W. Beecher 4

s

Enclosure 3 SECY 97-115

it.....sh

- I r 1

\,...../

RULEMAKING ISSUE i (Notation Vote)

June 5, 1997 SECY-97-115 EQB. The Commissioners FROM: L. Joseph Callan Executive Director for Operations

SUBJECT:

PROGRAM FOR REVISION OF 10 CFR PART 35," MEDIC ,L USES OF BYPRODUCT MATERIAL

• AND ASSOCIATED FEDERAL REGISTER NOTICE PURPOSE:

To obtain Commission approval of: (1) the staffs proposed program for revising 10 CFR Part 35, associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary; and (2) a Federal Reoister notice (FRN) of proposed rulemaking for publication to solicit public comments regarding 10 CFR Part 35 restructuring into a nak-informed, more performance. based regulation.

CATEGORY:

This p. aper addresses significant rulemaking issues requiring Commission consideration and approv%.

DA.C. XGROUND:

Toe Commission, in its " Staff Requirements Memorandum (SRM) - COMSECY 96-057, Materials / Medical Oversight (DSI 7)," directed the staff to submit a progras, for Commission approval, for revising Part 35, associated guidance documents, and, as necessary, the Commission's 1979 Medical Policy Statement (Attachment 1).

CONTACTS: Catherine Haney, NMSS/IMNS SECY NOTE: TO BE MADE PUBLICLY AVAILABLE AT COMMISSION BRIEFING (301) 415-6825 ON JUNE 13, 1997 Susanne Woods, NMSS/IMNS (301) 415-7267 m c676L M ^ 6 f?

I The Commissioners 2 The staff was also directed to describe how Part 35 could be restructured into a  !

risk informed, more performance based regulation, in addition, a listing of issues was provided for staff consideration during development of the program. The staff reviewed the [ ;

i Commission's direction and is prepared to move forward with the revision to Part 35 and il associated guidance documents. I 3

' DISCUSSION.

~

The staff plans to establish a steering group and a working group, This approach is desenbod in Management Directive 6.3, "The Rulemaking Process." The steering group will l be comprised of representatives, at the Division Director level or higher, from the following s

2 offices: Office of Nuclear Material Safety and Safeguards (NMSS); Office of Nuclear Regulatory Rese.rch (RES); Office of the General Counsel (OGC); Office of Enforcement (OE){ and Office of State Programs (OSP). The Director, Division of Industrial and Medical 7

j i Nuclear Safety, NMSS, will chair the steering group. In addition, the steering group will l

i inclurie an Agreement State Program representative, The working group will be comprised of Nuclear Regulatory Commission staff and representatives from both an Agreement State and a non Agreement State.' Representation willinclude NMSS, RES, OGC, and OSP. The '

nominated Agreement State representative is also a member of the Conference of Radiation 1 Control Program Directors (CRCPD), Inc., Suggested State Regulation Committee (SSR) on

- Medical Population. The staff plans to work toward parallel development of the NRC rule and the CRCPD suggested state regulations to facilitate state development of their corresponding rules.

o Attachment 2 describes the staff's proposed program for the revision to Part 35 and associated documents. The staff plans to use a fresh start approach, soliciting initialideas i i  !

end suggestions from the medical community and the public. Previously identifioo issues will l

also be factored into the revision, including: recommendations of the Indiana, Penasylvania, ,

]-  ;

incident investigation Team; recommendations from intomal staff audits; open rulemakings - '

, and results of analyses in medicalissues papers,

't The staff plans to use a process for revising Part 35 and associated guidance documents that '

provides more opportunity for input from potentially affected parties than is provided for by _

the typical notice and comment rulemaking process. This process includes solicitation of-public comment on several occasions, The first opportunity begins with the publication of an ,

FRN (Attachment 3) that solicits initial loput into the development of Medical Policy Statement options and regulatory attematives, To the extent possible, commentors will be asked to provide specific examples of draft rule language. During this period, two public meetings are planned to further solicit the initial public input. The second opportunity for public input will include a public comment period and a set of facilitated public meetings based upon draft 1

t rulemaking attemptives. The staff plans to provide the draft rule attematives to the d Commission prior to soliciting comment,' During these meetings the staff will work with

participants to review and refine the details of the proposed rule, Based upon the results of these public interactions, a proposed rule, regulatory analysis, and environmental assessment '

p

'The _ Organization of Agreement States recommended that the non Agreement States  !

be represented on this working group, -

.. = - _ . . - - . - - - - . - .. - ..- _ - - - .a - . - , - _ . - .- . - -

The Commissioners 3 will be prepared, along with draft guidance documents. Following Commission approval, th proposed rule will be published for comment, and a second set of facilitated public meetin would be completed. The meetings are expected to be focussed upon areas of controversy, and upon the draft guidance, as a mechanism to refine the rule and guidanos into final form.

The revision of the medical regulations will be a complex and controversial process, because of the diversity of activities, modalities and risk that fall within the umbrella of medical use, the corresponding diversity in medical community positions, and the varied availability of professional codes and standards. Given these facts, the proposed program represents an aggressive schedule. The staff emphasizes that the proposed plan does not account for any possible requests for extensions on public comment periods associated with the initial FRN, the notice requesting comment on the rulemaking altamatives, or on the proposed rule.

Requests for comment extensions annot be granted without causing a change to the end dates for the final rulemaking. The staff projects that the final rule will be published in April-2000 (Attachment 2).

The staff plans to provide NRC's medical licensees, professional medical societies, and the Agreement States (for distnbution to their licensees) with copies of the initial FRN of proposed rulemaking. The staff plans to meet with and solicit comments from several professional societies, including, among others: (1) Society of Nuclear Mec" cine;

- (2) American College of Nuclear Physicians; (3) Health Physics Society; (4) American

. Association of Physicists in Medicine; (5) the American College of Cardiology; and (6) the American College of Radiology. The staff will also attempt to identify patient's rights groups and forward them copies of both the FRN and applicable documents for their comment. To this end, the staff arranged for a two-hour discussion with the American College of Nuclear-Physicians and Society of Nuclear Medicine at their combined meeting in San Antonio, Texas, on June 4,1997. The staff intends to make documents pertaining to this rulemaking and electronic comment submittal available on the Intemet, using a separate page within the current RES rulemaking bulletin board.

Contractors and consultants are expected to assist the staff during the rulemaking process.

Contractors, in particular, will be used to consolidate public comments and prepare the regulatory analyses for the revised rule. In addition, the staff will pursue the use of techn medical experts as consultants to the working group. Specifically, the project is expected to enlist experts for diagnostic and therapeutic uses of radioactive material. Ft"ther, the us contracted facilitators for public meetings is being considered, in addition te w support of the OGC Special Counsel for Public Llason and Agreement State Progran...

The staff believes that, at this time, providing the Commission with a description of how Part 35 can be restructured, without the benefit of public comment, is premature and that it may lead stakeholder groups to believe that the staff has already decided on a particular approach ideas generated at the first stages of comment will be validated and tested the subsequent facilitated public meetings planned for spring igg 8 and earfy iggg. The result will be the staff's proposed rule and associated guidance for Commission consideratio in December 1998.

The staff used the guidance in the Strategic Assessment Direction Setting issues Papers

. Number 7, " Materials / Medical Regulations,' and Number 12, " Risk informed, Performance

The Commissioners 4 Based Regulations," as well as the SRM (COMSECY 96-057) to prepare a proposed FRN and associated press release (Attachments 3 and 4). The FRN of proposed rulemaking contains a list of issues, presented in the form of questions, for consideration by the public.

The staff recognizes that the question, are te astist with the formulation of comments and that the commentary received need not be limited as response to the questions presented.

Rather, the overriding issues are both the identification of necessary changes (additions and deletions) to Part 35 requirements and the assessment of risk for a risk informed, inore performance based regulation with sufficient oversight of public health and safety. The staff also poses the question of whether quantitative or qualitative enteria should be considered in determining the " risk" for each modality. Public comments, the Commission SRM issues, and the staff reports on medicalissues (as previously noted) will t,a used for developing the framework and associated text of the proposed rule.

The staff discussed revision of Part 35 with the Advisory Committee on the Medical Uses of Isotopes (ACMUI) at the April 1997 Committee meeting As a mechanism for generating discussion during the last two public meetings of the ACMUl, the staff identified a possible approach for restructunng Part 35 by modality (e.g., teletherapy, radiopharmaceutical therapy), based upon risk. ACMUI comments addressing the Part 35 revision are summarized in the proposed FRN (Attachment 3). The ACMUl's discussion will be available as additional background information for public commentors, and will be conside'ed by the working group in preparing rulemaking proposals. The staff intends to continue active involvement of the ACMUIin the ongoing development process, including Committee meetings, additionni reviews of guidance documents developed during the Part 35 revision process, and possible supplemental technicalinput from ACMUI subcommittees.

RESOt> ACES:

The Offices of Nuclear Material Safety and Safeguards, Research, General Counsel, and State Programs have identified the following resource requirements for this effort in their recent budget submissions. These resource levels will be considered in the FY 1999 budget review process.

FY 1998 FY 1999 FY 2000 Office m .EIg g .EIE E FTE NMSS 39 30 60 3.0 0 0.3 RES 150 1.9 50 1.0 OGC* O 0.3-0.6 0 0.3-0.6 OSP O 0.5 0 0.5

'OGC effott includes any process design and the possible option of facilitation support for the public meetings from the Special Counsel for Public Liaison and Agreement State Programs.

NI,1SS management will monitor resource use closely for this rulemaking.

. t The Commissioners 5 BE.QQMMENDATION:

That the Commission approve the following: (1) the proposed Part 35 revision program:

(2) issuance of the attached FRN; and (3) the attached press release.

COORDINATION: ,

OGC reviewed this paper and has no legal objection. The Chlef Financial Officer has no objection to this paper. The Office of Chief Information Officer has reviewed the plan for information management implications and concurs in it; however, since the revision to 10 CFR Part 35 contains information collection requirements, it must be submitted to the Office of Management and Budget for review no later than the date the proposed rule is published in the Federal Reaister.

L.Jo' ph Callan Executive Director for Operations Attachments: 1. SRM dated Mar 6. 20,1997

2. Program for Revising 10 CFR Part 35 and Associated Documents

3. Proposed Federal Reaister notice

4. Press Reler9 DISTRIBUTION:

Commissioners OGC OCAA OIG OPA OCA CIO CFO EDO SECY Commissioners' comments or consent should be prov:.ded directly.

June 20, 1997.

to the Office of the Secretary by COB Friday, Commission staff office comments, if any, should be submitted to the Commissioners NLT June 13, 1997, with an information copy to the Office of the Secretary. If the paper is of the such a nature Commissioners that it requires additional review and comment, and the Secretariat should be apprised of when comments may be expected.

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UNITE D STATE S NUCLE AR REGUL ATORY COMMISSION jordan

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ucam m M-ch 20, 1997 Ross, AEOD 4

MEMORANDUM TO: L. Joseph Callan Exe ut ve D' rector for Operations b

FROM: Job C. oy e, Secretary

' S AFF REQUIREMENTe COMSECY-96-057

SUBJECT:

MATERIALS / MEDICAL OVERSIGHT (DSI 7) the Commission With respect to the overall materials program, continues to support its pre.iminary --

views on this issue which Contir.ue the Ongoing Program were a combination of two options with improvements (Option 2) and Decrease oversight of Low-Risk Activities with Continued Emphasis in High-Risk Activities (Option 3). For the longer term, the Commission also believes that consideration should be given to broadening NRC's regulatory oversight to include one or more of the higher-risk activities

' idantified in Option 1.

With verpact to the medical p::;"s , the Commission was not Institute of pers 209+ by the National Academy of Sciences,NRC should not be the Medic;rg D.>M) report that recommends that Federal agency involved in the regulation of icnizing radiation

~

the in medicines The Commission continues to oelieve that conclusions in the report were not substantiated and that the recommendations should not be pursued.

The Commission continues to support the use of ACMUI and professional medical organizations and societies in developing regulatory guides and standards asInwas the proposedlonger term,in thethe Commission's preliminary views.

Commission would be willing to consider taking on broader regulatory responsibilities for higher risk suchactivities efforts involving should not

, other sources of ionizing radiation but35 rulemaking discussed divert resources from the 10 CFR Part below.

In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a pregram for Commission 35, and associated guidance ,

if approval for revising 10 CFR Partand the Commission's 1979 Medical Policy Statem The program should describe how 10 CFR Part 35 can be documents, necessary.

l restructured into a risk-informed, more performance-based regulation by a sv9 pense date of 6/30/99. In developing the i

program the staff should consider the following:

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_ _ _ _ _ _ _ _ . . . . . ~ . - _ _ . _ _ _ . _ _ . . _ . . . _ . . _ _ _ _ _ . _ _ _

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- ;f Focusing Far: 2~ :n :n:se .tr::+ .r+s .

h:ghest r:sk.

staff should :ent; der i (2) For diagnostic procedures, regulatory oversigi.c alternatives consistent with the lower overall risk of these procedures.

, to capture not only (3) The staff should address howevents, best but also precursor '

relevant safety-significant events.

l 3

(4)

Changing the nomenclature from " misadministration" to "mectical event" or_ comparable terminology.

it can incorporate ,

(5) Part 35 should be redesigned so that necessary regulatory requirements for new treatment modalities in a timely mannu..

l Pr: gram provisions (10 CFR Part i .6) The Ouality Manage:..entshould be re-evaluated and revised to focus en i

35.32) those requirements'that are essential for patient safety, e.g.,

confirming patient identity, requiring To the

-written prescriptions end verifying dose.the requirementsashould be maximum extent possible, Given this objective, revisedapproach mixed to be risk-informed. of performance-based rules and otherwd.se ians shoeld be pursued.

prescriptive regulat (7)

The-staff should consider the viability of using or referencing within-Part available indust y guidance and standar they meet NRC needs.

(8). The staff-should consider a rulemaking process thatfrom potentially provides more opportunity fer inputaffected less parties than is and comment.rulemaking process but would'be consumptive of resources and time than the process recently used in the development'of NRC's rule on radiological criteria for license termination.

b should be submitted 6, 1997.

to The staf f's program to implement the a ovethe Commission for The program should target June 30, This rulemaking and completing the rulemaking process.is a very high priority for the casociated guidance developmentThe Commission is prepared to provide addition Commission.

resources to the extent necessary to complete the rulemaking process on this schedule. 6/6/97) '970006!

(SECY Suspense: 970006!

(NMSS/RES):(EDO> - Program) (SECY Suspense: 6/30/99)

DmSS/RES) (EDO ~ Complete Rulemaking)

PROGRAM FOR REVISING 10 CFR PART 35. ASSOCIATED GUIDANCE DOCUMENTS. AND 1979 MEDKAL P 4 7/97 PtA*sh Endea!' Begrzler notre for earty mput wWh 90 day commert pened ACMUt anput, pro 8essacnal society rneebngs, and two putic meetmgs Pubhc Input Working group. Steenng Commatee, and consumant develop doeurnents weh m g7 rewsw and approval from Steenng ComnTee Staff Develops

1. Medcal Pohey Staterient Rn-...Json 2 Rule ARemathres 3 Associated Commmson s Paper Commnsion renew and approval of Medcal Pokey Statemerd recommendsbons and 2

' rule .;;,,ir.:: for putAc release and put*cahon in Eedetal Reorslw r Commission Rev6ew and Approval Proposed rule ane nabwes put*shed in fiqargl Regester for 9% commert penod g

Oa ' Two facihtsted putte meetings to examine anernahves in detad Pubhc input Wortang Group. Steenng Commatee, and censutants develop documents, with review y and approval of Steenng Committee o 7/98 Prepara6an of oms clearance and supporhng documents Q4 Renew with ACMUI and Agreement States

[

o l Additional coordinahan as necessary Staff Develops :s

1. Proposed RtAe. OMB Clearance.

Regulatory Analysm, Envtrenmertal *>

Assessmerd

2. Draft Guidance Documents

3. Associated C . nh Paper I

?ROenans FOR REVISING to CFR PART 35. AgenCIATED OUIDANCE DOCUMENTS. AND 19M ME(NCAL PQLICY STATE 88ENT* W. ..

Commmeion revew and approval for Federal Reguer paar=a m and pese cenweiere

-O 4 129s Commiselon Review and Approval ef PrW Rule and Guidance Peheh proposed rute and enounce W of draR ymfonce in Federal Ramster.

O '" 2.>99 encheng 90 day comment pened Two facetated edec n'eeengs focumng on tugh nok scarvenes ceneroversed teoues and r ed.e ined Waremg Group, Steenng Commmee, and consumarts dewtop documerts, wah review and approves or Steenne Commme.

5/99

-Q d Preperson of OMB chance and *W documeres Review wth ACl#J1 and Agreemere States Adehonal coort9nsman as necessary Staff Develops

1. Fhel Rule. OMB Casarance. Coontnason for Rule Approval

2. Final meneerice Documeres

3. AW Comnuosion Paper Commmeian rewteur and approwse of Anni tule and Anal guusence for h h h m Q+ 11/90 C_._. _ ^ - Re*w and Approwel of Fined Ride and Final nemmce 4/2000 Putteh Final Rule

.Q 4

• The program presented represents ongoing efforts of theWorkmg Group, Steermg Committee. and protect consultants including extensive NRC Office coordmation ACMUI consuRation. Agreement and non-Agreement State interaction. and numerous meetings with professional organizations, stakeholders, and the pubhc

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' ATTACHMENT 3 ,

[7590 01-P]

NUCLEAR REGULATORY COMMISSION

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! RIN 3150-Af74 Medical Use of Byproduct Material:

Issues and Request for Public Comment

[

5

! AGENCY: Nuclear Regulatory Commission

? . ..

ACTION: _ Notice of Proposed Rulemaking

SUMMARY

The U. S. Nuclear Regulatory Commission (NRC) is developing a program for revision ~of 10 CFR Part 35, " Medical Use of Byproduct Material." The decision to revise i

Part 35 resulted from the NRC Strategic Assessment and Rebaselining initiative (SA), a j- process involving identification of the direction setting issues and associated options for the future of NRC activities. Specifically, the SA effort included medical use regulation. With this l

notice, the Commission is initiating a proposed rulemaking action which will culminate in the developement of a final rule for approval in late 1999. This notice describes issues proposed

to be included in this rulemaking. The Commission plans to further propose specific

~

rulemaking text for public comment during 1999 (approximately February 1999).

f in order to provide the public the most effective opportunity to participate in' developing the rule text, the Commission is requesting public comment on the issues identifed by the questions in this notice within 90 days of the issuance of this notice. Comments received after this initial 90 day period will be considered along with the comments received on the

proposed text anticipated for publication in 1999. However, because of schedule

! requirements, it may not be practicable for the Commission to consider those comments received after the 90 day period in preparing the detailed proposed rulemaking text.

DATES: . The comment period expires (90 days after the FRN is issued).

ADDRESSES: Send written comments and suggestions to Secretary, Nuclear Regulatory Commission, Washington, DC 20555-l

! 0001, Attention: Docketing and Service Branch. Hand-Deliver comments to 11555 Rockville Pike, Rockville, MD, l

between 8:00 a.m. and 4:00 p.m. on Federal l - workdays.

Written comments may also be submitted electronically on the Intemet via NRC's interactive rulemaking web site, through the NRC home page l

(http://www.nrc. gov). This site provides the ability to upload comments as j files (any format), if your web browser supports this function. For information about the interactive rulemaking site, contact Ms. Carol

[ Gallagher, (301) 415-5905; e-mail CAG@nrc. gov.

i i

i

i o-..

FOR FURTHER INFORMATION REGARDING THIS NOTICE CONTACT:

h Catherine Haney, Omce of Nuclear Material Safety and Safeguards, Nuclear i

Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6825 or Susanne Woods, Omce of Nuclear Material Safety and j

Safeguards, Nuclear Regulatory Commission, Washington, DC 20555-0001,

!- telephone (301) 415 7267, t

! SUPPLEMENTAL INFORMATION:

n ,

Background

NRC examined the issue of its medical use program in great detail during the last four years.

This process started with NRC's 1993 intomal senior management review report; continued with the 1996 independent extemal review report by the National Academy of Sciences, i institute of Medicine; and culminated in NRC's SA process. In particular, medical oversight

- was addressed in the Strategic Assessment Direction-Setting issue Paper. Number 7 (DSl 7) _

4 (released September 16,1996).

In their Staff Requirements iAemorandum (SRM) - COMSECY 96-057, Materials / Medical l ,

l

- Oversight (DSI 7)," dated March 20,1997, the Commission directed staff to revise Part 35, n

associated guidance documents, and, if necessary, the Commission's 1979 Medical Policy

' Statement. Further, the SRM stated, 'Wlth respect to the medical program, the Commission >

! was not persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report '

that recommends that NRC should not be the Federal agency involved in the regulation of L

l ionizing radiation in medicine. The Commission continues to believe that the conclusions in

!- the report were not substantiated and that the recommendations should not be pursued."

The Commission SRM specifically directed the restructuring of Part 35 into a risk-informed, more performance-based regulation.- Further, during development of the rule and associated 2 guidance, as well as during review of the Medical Policy Statement, the NRC staff was

, directed to consider the following issues:

1. - Focusing Part 35 on those procedures that pose the highest risk.

2.' Regulatory oversight attematives, for diagnostic procedures, that are consistent with the lower overall risk of these procedures.

3. The best way to capture not only relevant safety-significant events, but also precursor events.

4. The need to change from the term " misadministration" to " medical event" or other comparable terminology.

5. Redesigning Part 35 so that regulatory requirements for new treatment modalities can 1

-be incorporated in a timely manner.

,L 6. Revising _the requirement for a quality management program (10 CFR 35.32) to focus on those requirements that are essential for patient safety,

7. The viability of using or referencing available industry guidance and standards, within Part 35 and related guidance, to the extent that they meet NRC needs.

The NRC staff discussed items 1-7 and solicited preliminary views from the Advisory

}~ Committee on the Medical Uses of isotopes (ACMUI) at the April 1997 Committee meeting.

[ Transcripts of this meeting are available by contacting the NRC Public Document Room and

L ,

1 4

on the Intemet (as specifed in the reference information provided).]

The ACMUI discussed their views and recommendations during a briefing of the Commission on May 8,1997. The ACMUl concurred with NRC's position to continue the ongoing medical program with improvements, and to decrease oversight of low-risk activities with continued

[ , emphasis of high risk activities. The committee supported the use of professional medical organizations and societies in developing a performance based regulation. The ACMUI i

recommended consideration of a quality improvement approach as an altamative to the

_ present Quality Management Program. Further, the committee recommen e , od d t the

. Commission, that the 1979 Medical Policy Statement be revised to reflect that NRC will regulate radiation safety of patients only where justified by the risk to the patients and only where volu_ntary standards or compliance with the standards are inadequate. The ACMUl believed that the assessment of the risks justifying regulations should reference comparable '

risks and comparable modes of regulation for other types of medical practice, in addition, they believed that the NRC should not intrude into medical judgments affecting patients and

. into other areas that the ACMUI considered to be traditionally a part of the practice of medicine.

This notice initiates a proposed rulemaking action which will culminate in the development of a final rule for approval in 1999. In order to provide the public the most effective opportunity to participate in developing the rule text, the Commistion is requesting public comment on 4 the issues identified by the questions in this notice and on the ACMUI re ,,nmendations -

within 90 days of the issuance of this notice. Comments received after this initial 90 day pe'iod will be considered along with the comments received on the proposed text that is anticipated for publication in 1999. However, because of schedule requirements, it may not be practicable for the Commission to consider those comments received after the 90 day period in preparing the detailed proposed rulemaking text. Further, the staff recognizes that the questions are to assist with the formulation of comments and that the commentary received need not be limited as response to the questions presented. Rather, the overriding issues are both the identification of necessary changes (additions and deletions) to Part 35 requirements and the assessment of risk for a risk-informed, more performance-based regulation with sufficient oversight of public health and safety. The NRC staff is interested in '

-ideas, proposals, and comments on the structure and content of a revised Part 35, given the Commission guidance and direction as described above, To the extent possible, commentors are asked to provide specific examples of draft rule language.

Reauests for Comments on General Considerations NRC has identified the following areas of Part 35 for consideration and is seeking comments on these issues, as well as any others, offered for consideration during the revision to Part 35:

1. How should the Part 35 requirements be revised to be risk-informed and more performance-based? How should performance be measured to provide both NRC licensees and NRC with an objective basis for determining regulatory compliance?

2.- -How should risk be assessed for medical uses and the regulation be modifed to focus on procedures posing the highest risk? What quantitative or

C 9

qualitative enteria should be considered ir, determining the " risk" for each ,

1 modality?

3. What oversight should exist for diagnostic procedures that is commensurate

with the associated risks?

. 4. What specific events or incidents should be reported to NRC?

2- [e.g., machine failure, leaking source, software failure, hardware failure] What criteria should be used for determining if the event is reportable (e.g.,

threshold)? Are there modality specific events that should be reported?

Should the term " misadministration" be changed to " medical event" or comparable terminology?

5. How should the regulation be redesigned to incorporate necessary regulatory requirements for new modalities? Should Part 35 be structured such that requirements for a particular modality are g'ouped together?

4

- 6. Which Quality Management Program provisions should be re evaluated and >

revised to focus on requirements that are essential for patient safety? Are different provisions appropriate for each of the different modalities? ,

! 7. Which standards and guidance developed by professional societies and other organizations are applicable to NRC-regulated medical uses of radioactive matenal and how could they be incorporated within the regulatory framework of Part 35 and/or associated guidance?

8. How should the issues of training and experience be addressed? What individuals or groups thould be subject to such requirements?

9. Which new issues / modalities should be incorporated into Part 357

- 10. Should the 1979 Medical Policy Act Statement (44 FR 8242) be modified to increase flexibility for a nsk-informed, more performance-based approach to medical regulation?

Refersace information

1. Strategic Assessment Direction-Setting issues Paper Number 7 is available by writing to the U.S. Nuclear Regulatory Commission. Attention: NRC Public

' Document Room, Washington, DC 20555-001. [ Telephone: (202) 634-3273; fax: (202) 634-3343].

2.' The memorandum " Management Review of Existing Medical Use Regulatory Program (COMIS92-026)" (dated June 16,-1993) is available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-001. [ Telephone: (202) 634-3273; fax: (202) 634-3343]; .

3. Radiat: , in Medicine: A Need for Regulatory Reform (1996) is available from

'1

- . -- , --.-,.w , -- - . . , ,,,,,% - - - - - e . . - -

l the National Academy Press at 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055.

4. Summary minutes and transcripts of the ACMUI April 1997 meeting or-transcripts of the May 8,1997, Commission briefing are available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document 1

Room, Washington, DC 20555 001. [ Telephone: -(202) 634 3273; fax: (202) 634 3343), .

I Transcripts of the May 8,1997 briefing are also available by Intemet at http://www.nrc. gov.

5. The NRC Medical Policy Act Statement of 1979 was published in the Federal Register, Volume 44, page 8242, on February 9,1979, Dated at Rockville, Maryland, this day of May,1997, For the U. S Nuclear Regulatory Commission l John C, Hoyle, Secretary of the Commission

6 4 I

Enclosure 4 SECY-97-131

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~

RULEMAKING ISSUE

] (Information) i June 20, 1997 SECY-97-131 i

FOR: The Commissioners i

FROM: L. Joseph Callan l Executive Director for Operations

SUBJECT:

OUPPLEMENTAL INFORMATION ON SECY-97115, " PROGRAM FOR REVISION OF 10 CFR PART 35, ' MEDICAL USES OF BYPRODUCT j MATERIAL,' AND ASSOCIATED FEDERAL REGISTER NOTICE" l

l PURPOSE:

l To provide the Commission with supplemental information and an alternative program for

. the revision of 10 CFR Part 35.

2 I

CATEGORY:

i This paper addresses significant rulemaking issues requiring Commission consideration and

! approval.

l l BACKGROUND:

On June 5,1997, in SECY-97-115, the staff requested Commission approval of: (1)its

! proposed program for revising 10 CFR Part 35, associated guidance documenta, and the Commission's 1979 Medical Policy Statement, if necessary; and (2) a Federal Reaister notice

! (FRN) of proposed rulemaking, for publication, to solicit public comments about restructuring

, Part 35 into a risk-informed, more performance-based regulation.

CONTACTS: Diane S. Flack, IMNS/NMSS NOTE: TO BE MADE PUBLICLY AVAILABLE (301) 415-5681 IN 5 WORKING DAYS FROM THE DATE OF

', THIS PAPER l Susanne Woods, IMNS/NMSS l (301) 415-7267 d

4 l

gQt'k{ySbYOSS Yft i

l I

The Commissioners 2 On June 13,1997, the staff briefed the Commission on its proposed program for revising Part 35 as described in SECY 07-115 In addition, the staff and the Commission discussed an attemative approach to revising the regulation. The Commission requested that the staff supplement SECY 97115 with a description of the attemative approach, as well as with the estimated resources,to complete the rulemaking, if this attemative were implemented.

DISCUSSION:

Attachment i describes the staffs attemative approach for revising Part 35 and the associated guida' ice documents. Under the attemative, the staff would immediately begin preparing proposed rule language and altematives using a " modality' approach (Attachment 2),- The attemative differs from the program recommended in SECY 97115 in several respects, First, there would be no fomial public opportunity for comment at the beginning of the process. The staff would consider comments and rule language attematives beginning immedia'ely, but the first more formal opportunity for public interactions would be during facilitated public meetings in the fall of 1997. The staff would, under the attemative, provide a proposed rule; associated documems such as the regulatory analysis, environmental assessment, and finding of no significant environmental impact; and the Office of Management and Budget clearance package to the Commission in May 1998'. At that same time, the staff would expect to provide the Commission with draft guidance documents for each of the proposed rule modalities, and its recommendations regarding the need for any changes to the 1979 Medical Policy Statement. Following Commission approval, the proposed rule and draft documents would be published for public comment. The legal minimum time for public comment on a p oposed rulemaking is 75 days. The staff would expect to provide a fina! rule, associated documents, and final guidance documents for Commission approval in May 1999.

Under the attemative, there would be more public interactions than the usual rulemaking and comment process of the Administrative Procedure Act, in the following respects, First, public input would begin immediately and continue throughout the development of the rule attematives and facilited public meetings in the fall of 1997, Consideration of comments would be cut off at a point approximately two-three months before providing the material to the Commission for approval. Rulemaking attematives and drafts would be made publicly available on an ongoing basis, including posting them on an INTERNET page, and the staff would make available the comments received, both in the PDR, and to the extent possible, electronically in the INTERNET. If the attemative revision program described in this supplemental information is approved, staff would revise the Federal Reaister notice in SECY-97-115 to notify the public of the approved prograrn and the availability of documents on the INTERNET. The staff would continue, as proposed in the original program outlined in SECY-97-115, to solicit comments and specific rule text proposals from various professional societies, The staff would also continue its proposal to use both consultants, and a working group and steering group approach to the development of the documents. The staff would particularly look into obtaining consultants or other information sources that can provide an indication of the current trends in medical practice, in addition to vigorously using the -

'As the staff proceeds with this rulemaking, the staff will be alert to issues or areas where more immediate rulemaking is appropriate.

The Commissioners 3

- Advisory Committee on the Medical Uses of Isotopes.

J RESOURCES:

Resource projections associated with revising Part 35 and associated documents for fiscal years (FY) 1998. FY 1999, and FY 2000 were provided to the Commission in SECY 97115.

Staff does not anticipate any change in the resources needea, in FY 1998 and FY 1999, to complete the rulemaking effort by May 1999. The primary resource needs are based upon development of the rule, associated documents, and corresponding guidance. Since this task

. is unchanged, the resource estimates are unchanged. Since the rulemaking effort would be completed in FY 1999, the resources identified in SECY-97115 for FY 2000 would be used in other areas of the medical program.

RECOMMENDATION:

That the Commission approve the Part 35 revision program described in the attachment to this document.

7 COORDINATION:

The Office of the General Counsel reviewed this paper and has no legal objection. The Chief

Financial Officer and Chief Information Officer hr.ve no objection to this paper.

, . seph Callan Ex cutive D; rector i for Operations l Attachments:

1. Attemative Program for Medical Revision j 2. Modality Outline for 10 CFR Part 35 i DISTRIBUTION:

Commissioners OGC OCAA OIG OPA

. OCA

CIO CFO i EDO SECY-

-, -- m -- , - a -, -- a w

ALTERNATIVE PROGRAM FOR MEDICAL. REVISION The following is an attemative program for the revision of 10 CFR Part 35, as discussed with the Commission on June 13,1997.

The attemative consists cf the following program elements.

1. The staff wo'uld immediately initiate development of draft language and rule

, attematives, and make these materials publicly availab'e on an ongoing basis, including posting them on an INTERNET page, and would consider comments, suggestions, and other altematives that result from these interactions. Public input would begin immediately and continue throughout the development of rule attematives, facilitated public meetings in the fall of 1997, and development of the proposed rule. The staff would interact with professional societies and the public to solicit, on an informal basis, comments and rule text. In addition, staff would prepare a Federal Reoister notice to notify the public of the approved Part 35 program and the availability of documents on the INTERNET.

2. Per Management Directive 6 3, the staff proposes to conduct this rulemaking using a group approach. Development of rule text attematives, incbding draft guidance documents, would use a working group (or groups) and steering group approach. The staff proposes to enhance the State participation in the process through the inclusion of State individuals in both the working group and the steering group. This participation would facilitate the Conference of Radiation Control Program Directors' (CRCPD's) development of corresponding rules in its suggested State regulations, and would allow the State staff to focus on potentialimpacts of Nuclear Regulatory Commission draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treatment, or research in the States.

3. Facilitated public round table me6 tings in the fall of 1997 would be used to focus discussion on specific rule text and attematives. Discussions would also be held in meetings with the Advisory Committee on the Medical Uses of Isotopes (ACMul), and with the Organization of Agreement States, The exact timing of the meetings would depend on the process to convene and facilitate these meetings, but it is expected that the meetings could be conduc'ed in the late September to November 1997 timeframe.

4. Based on the informal and formal public interactions, the staff, using the working group and steering group approach, would develop the proposed rule and associated documents including the regulatory analysis, environmental assessment, finding of no significant environmental impact, and Office of Management and Budget clearance for Commission review and approval. The staff would also develop draft guidance documents for each medical modality of the proposed rule, for publication as drafts for comment, in parallel with the proposed rule, and would provide for Commission consideration, any recommendations regarding changes to the 1979 Medical Policy Statement. During the development process, the staff would continue to make drafts publicly available, but would need to cut off consideration of comments at a point approximately two-three months before providing the material to the Commission for approval. Comments received after that time would be considered as part of the ATTACHMENT 1 e

, . . l l

t 2

[ ongoing interaction process, and as part of the comments received during the formal F _p ublic comment period on the proposed rule after Commission approval.

5. Following Commission approval'. the proposed rule and draft documents would be

- published fot public comment.= The legal minimum time for public comment on a - ',

proposed rulemaking is 75 days. The staff would make the drafts available on the

i. INTERNET, and would acce,nt comments electronically The staff would also hold two '

l public meetings, during the formal comment penod, to facilitate comments.

6. Development of the final rule, associated documents, and final guidance would be throagh the working group and steering group. The staff would continue to make draft documents available, but would not be able to consider further extemal input

' beginning approximately four months before the submission of the final documents for c

Commission approval The staff would discuss the final documents with the ACMUI, ,

and wi* the Agreement States, prior to submission to the Commission. The staff l

would expect to provide the final documents for Commission approval in May 199g.

4 1-i 4

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ATTACHMENT 1

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- , , - - . .- , , ,,e. , .,, - -, . . + ,,a ,

ALTERNATIVE PROGRAM FOR REVISING 10 CFR PART 35, ASSOCIATED GUIDANCE DOCUMENTS , AND THE 1979 MEDICAL POLICY STATEMENT ,

2Q97 3Q97 4Q97 1Q98 2098 3098 4Q98 1Q99 2099 May l Jun Jul l Arg,l Sep Oct l Nov l Dec Jan } Feb l Mar Apr l May l Jun Jul l Aug l Sep 0;.t l Nov l Dec Jan l Feb l Mar Apr l May Task Name Staff Development of  ; y Staff Development of Proposed Rule and Draft Guidance Documents Proposed Rule and Draft  ;

informal Public Interactions ____________ _ . . . . _ . _ _ _ . _ _ _ - Informal Public Interactions Facilltated Public Meetings Facilitated Pubile Meetings

" Commission ReviewtApproval Draft Rule R

Pubtle Comerent-Proposed Ruts Staff Development of Final Rule and Guidance  :

Staff C;.;;-r.. era of Final Rule and Guidance Documents y y Submit to Commission for Approval Submit to Commission for Approval 5

I a

f MODALITY OUTLINE FOR 10 CFR PART 35 1

in developing the rev_isions to.10 CFR Part 35, the staff proposes to move the rule to an entirely modality based approach, as discussed with the Commission on June 13,1997 - This approach is described briefly below.

Part 35 is currently a mixture of modality specific requirements, and generally maplicable f requirements. The staff proposes to reexamine the current divisions, and, baser on risk, j

l develop a set of requirements that are specific to each modality. At this time, the staff l anticipates that the following modalities would be addressed:

. 1. Iow-dose unsealed materials (diagnostic nuclear medicine);

2. high-dose unsealed materials (nuclear medicine therapy);

3. Iow-dose sealed source applications; 4, teletherapy; 5, high dose rate remote afterloaders;

6. gamma stereotactic surgery; and 7, emerging technologies.

The above list is not viewed as all-inclusive. Additional categories may be developed,-

depending on the breadth of the areas to be covered, and the simitanty of requirements in a given area.

The modality approach envisioned would place all requirements for a given type of treatment into a single section of the regulation, including who or what organization is heensed; what type of license is issued; the necessary technical requirements, such as surveys and calibration; the training and expe ence requirements; the event recording and reporting .

requirements; and the qua!ity imp ovement and management objectives, Thus, requirements can be tailored more specifically for each modality (as listed above), with those posing lower risks having fewer or simpler requirements, and those posing higher risks having correspondingly more stringent requirements.

The advantage of organizing Part 35 to be entirely modality-driven is that the rule can be modified to incorporate new modalities by simply adding a new subpart to address the activity. The staff envisions that new approaches would initially.be licensed under the emerging technologies modality, where the rule requirements would be general in nature, and the specifics would be contained in license conditions. As experience was gained in the regulation of that modality, a rulemaking to add a new subpart to address the specific modality could then be undertaken, and there would be no need to revise the regulations for the other modalities.

Tne downside of the modality approach is that there would need to be some repetition between the subparts, since some of the requirements would be similar for at least some of the modalities. However, the staff believes at this time that this type of organization would make for a more flexible and usable regulation.

ATTACHMENT 2

f 1

-4 2

i The following is a set of questions that have been developed for determining the contents of each modahty section. This list is not intended to be all-inclusive.

1. Who and/or what (e.g., facility) should be licensed?

2. What type of license (e.g., is registration a possibility)?

3. What terms should be defined?

t 4. Should there be an operational definition of " adequate protection,'such as performance criteria or a ' safety goal *?

5. What are the ' technical issues

• that should be addressed (e.g., surveys, calibration, access controls, etc.)?

6. What training and experience (T&E) is necessary for what types of personnel involved in the modakty?

i

a. Should T&E include not only physicians and radiation safety officers, but associated professional personnel (e.g., medical physicists)?

b. Should the focus of T&E be radiation safety or extend to medical or other credentials? Is it sufficient to simply require the requisite licensure and credentials required by the State, for the medical specialty being practiced?

c. Are there needs to maintain qualifications and undertake periodic requalifications?

7. What duties and responsibilities should be set forth, and for which personnel?

8. What reports of ' safety significant" medical events or " precursor" events should be required?

9. What should be the necessary Quality Management objectives that are essential for patient safety? Are there any additional specifications needed in addition to the basic objectives?

10. What records should be kept?

11. What provisions relative to enforcement should there be?

12. What provisions for amendments, renewals, exemptions, etc., should be included in the rule?

- 13. What, if any, provisions are needed for the protection of human research subjects?

14. Are there industry guides and standards available that either the regulation or guidance can rely on?

15. What interactions are there with other regulations, particularly 10 CFR Parts 20,30, 32, and 337-ATTACHMENT 2 w .. e , a . - , - . - , e

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4 8 f

Enclosure 5 SR-SECY-97-115

- . ~ . . ~ _ - . . - - . - - - . . - - - - . - - - _ _ - - . - - - - . - - . . _ - - . _ - . -

_ Action: Paperiello, NM,SSi

] ~

y.g* UNITED STATES

' Cys: Callan

' 3"

• NUCLE AR REGULATORY COMMISSION o pson

'- wasmNotoN. o e 20ss6-0001

{  ;

9 Norry

\ ,,,,, June 30. 1997 Blaha Thadani, RES

-omes or ts Bangart, SP

"'""* Shelton, CIO 4 Meyer, ADM CHaney, NMSS 1

SWoods NMSS MEMORANDUM TO: L. Joseph Callan l E;-ec 'v D4fe tor for Operations i '

! C j: FROM: John' . Hoy e, ecretary j

SUBJECT:

STAFF REQUIREMENTS - SECl-97-115 - PROGRAM r

FOR REVISION OF'10 CFR P..AT 35, " MEDICAL USES

] OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL

- REGISTER NOTICE 9

The Commission has approved the staff proposal to rev'.se 10 CFR ,

Part 35 consistent with the alternative program proposed in

. SECY-97-131 and subject to the following comments. ,

1. The staff should not only consider what regulations will be 4 affected by the change to Part 35, but should also take a -

close look at existing guidance and draft guidance to determine-what changes would be needed. To ensure that all regulatory rulemaking and guidance development potentially affecting medical uses will be consistent with the Commission's direction in DSI 7,=the staff should identify in the public meetings and Federal ~ Register notices all regulatory actions and proposed actions relating to or affecting Part 35 licensed activities. When appropriate, public comment should be invited.

2. The staff should continue to solicit input from members of L the - b..alic . to - ensure , to the degree possible, that all interests are represented. The staff should include groups representing radiopharmacists and medical technologists, and

other experts, as appropriate.

i 3.- The staff should_ prepare alternatives with specific rule-

' _ text to help focus the discussion during the first-round of l

facilitated meetings and assist the staff in developing.

draft' rule' language for publication and comment.

i

SECY NOTE

SECY-97-115 WAS RELEASED TO THE- PUBLIC ON JUNE 17,-

1997. THIS SRM, SECY-97-131, AND THE COMMISSION VOTING-RECORD CONTAINING THE VOTE SHEETS'OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING" DAYS FROM THE DATE OF THIS SRM.

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4. The staff should look for potential. resource savings (FTE, consultants, and funds) that can be achieved through use of the internet, teleconferencing, etc. In making documents available over the internet, some caution should be exercised to ensure that the number of and versions of available documents for comment are not so large and varied that they will overwhelm commenters and lead _to confusion on

, the part of the staff and management responsible for the rulemaking.

A Federal Recister notice and press release should be issued

< reflecting the approach outlined in SECY-97-131, attachments 1 and 2, and published in time to support the facilitated public meetings.

-(-5904- (NMSS) (SECY Suspense: 9 /5 /.E1) 9700065 8/29/v/

cc: Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC CIO i

CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

{ PDR DCS

- - .. - . . . . . - . ~ . . . . . . ~ . . _ . - - - _ - ._ _ .-_ - _ .- -._ - .-

/ So, UNITED STATES y

, NUCLEAR REGULATORY COMMISSION WASHINGTON, D C Ml66-f 001 g.' .

g, ' e e * ,e June 30,.1997

- OF71CE OF THE

- SECRETARY COMMISSION VOTING RECORD

DECISION ITEM: SECY-97-115

. TITLE

PROGRAM FOR REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT

! I?ATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE i

The Commission (with all Commissioners agreeing) disapproved the i staff proposa) as contained in this paper, but instead approved

the alternative approach provided in SEC'l-97-131, as recorded in the Staff Requirements Memorandum (SRM) of June 30, 1997.

Tnis Record contains a summary of voting on this matter together with the individual vote sheets, views and comments of the Commissioners, and the SRM of June 30, 1997.

4 i

t .s 4

g45hn C. Hoyl6 Secretary of the Commission i

i attachments:

1. Voting Summary

2. Commissioner-Vote Sheets

3. Final SRM cc: Chairman Jackson Commissioner-Rogers-

. Commissioner Dicus Commissioner Dia:

Commissioner McGaffigan OGC i EDO PDR DCS

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~ - - - -- . _ . . _ __ _, . - - . . _ . . , _ . . _ _ . ~ _ _ _ _ . . . _ _ . _ . _ . . . _ . _ . _ _ . _ _ _ . _ . _.

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VOTING

SUMMARY

- SECY-97-115 3-RECORDED-VOTES NOT APRVD DISAPRVD ABSTAIN PARTICIP COMMENTS DAlt CHRM. JACKSON X X 6/27/97 COMR. ROGERS- X X .X 6/25/97 4

COMR. DICUS X X 6/30/97 i

COMR. DIAZ X X 6/26/97 COMR. McGAFFIGAN X X- 6/26/97 COMMENT RESOLUTION In their vote sheets, all Comissioners approved alternative approach provided in SECY-97-131 with some additional coments.

Subsequently, the _ coments of the Comission were incorporated into the guidance.to staff as reflected in the SRM issued on June 30, 1997.

4 N OT ATION VOTE ,

, RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: CHAIRMAN JACKSON

SUBJECT:

SECY-97115 - PROGRAM FOR REVISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT l

MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE Disapproved _ xx Abstain Approved Not Participating Request Discussion COMMENTS:

I disapprove the original program to revise 10 CFR Part 35,' Medical Uses of Byproduct Material" proposed in SECY 97-115; however, I approve the aMernative program propesed in SECY 97131.

' b '

SIGNATGRE June 27, 1997 Release Vote /xx /

U^

b;11770D7N /A Withhold Vote / /

NOT ATION VOTE

1. RESPONSE 5HEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER ROGERS

SUBJECT:

SECY-97-115 - PROGRAM FOR P2 VISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE m

Approved"ib*it!

• Disapproved"rayfAbstain Not Participating Request Discussion COMMENTS: sse n rrs uc u e*>7 O-SIGNATURE Q Release Vote / x / Q u 2_C M 7 DAT1.)

!y17ntMLL1pp.

Withhold Vote / /

x No Entered on"AS" Yes

.I Commissioner Rogers' comments on SECY-97-115 and SECY-97-131:

I approve the. staff's program for revision of 10 CFR Part 35 as described in-the attachment to SECY-97-131 and subject to the following comment:

The facilitated meetings should be focussed not so much on alternative rule text as on concrete, alternative approaches for resolving discrete, specific,- long-standing areas of controversy related to Part 35. The meetings should be preceded by distribution of a paper which identifies and, in an even-handed way, discusses these issues and alternatives for resolving-them in a rulemaking context. The paper should convey the_ sense that the NRC is open to alternatives that may develop during workshop discussions.

To illustrate my thinking, I would appeal to the same example that I mentioned in my ecmments on SECY-97-054.

Specifically, It seems clear that an essential aspect of a QM program is a set of procedures to assu.e that the patient is  !

given -the 'right' dose . What~is not so clear and has been an area of contention is how close the delivered dose inust that-we I believe be to the prescribed dose for it to be the 'right' dose .

might learn some important considerations from a full airing of this issue in a facilitated meeting.

I would expect that actual ruls text could be developed quite quickly after the meetings and I would hope that the meetings could be moved forward in-time by focussing them on issue resolution rather than the detailed wording of draft text.

In any case, I believe the discussions would be more fruitful for NRC.

I= disapprove publication of the Federal Register notice.

8CIL

/ ; Artt7 i

o N0TATION V0TE RESPONSE SHEET T0: John C. Hoyle Secretary of the Comission FROM: COMMISSIONER DICUS

SUBJECT:

SECY 97 115 PROGRAM FOR REVISION OF 10 CFR PART 35, "HEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE 1

Approved XX Disapproved Abstain Not Participating Request Discussion L . COMMENTS:

l SEE ATTACHED

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,.gl @ f0RE <

Release Vote /J_7 d/St>/97 DATE Withhold Vote / /

Entered on "AS" Yes )(_ No 9% Ale *T22- 2;v-

l COMMENTS OF COMMISSIONEis DICUJ_91L5ECY.97115 ,.

f I approve staffs program to revise Part 35 as modifed by the supplemental information in SECY.97131 subject to tne followin actions:

1

1) The staff should not only consider what regulations would be affected by the ,

revised Part 35, but should also take a close look at existing guidance and +

draft guidance to determine what changes would be needed. To ensure that  ;

all regulatory rulemaking and guidance development potentially affecting medical uses will be consistent with the Commission's SRM on DSI 7, the staff should identify in their public meetings and Federal Register notices all regulatory practices end propnsed actions relating to or affecting Part 35 licensed activities. For example, draft Regulatory Guides for licensing of the production and distribution of radioactive materials used in maoicine may need

. revision. When appropriate, public comment should be Invited.

2) When soliciting comments, the staff should include groups representing radiopharmacists and medical technologists.

NOT ATION VOTE RESPONSE SHEET l

TO: John C. Hoyle, Secretary i

l FROM: COMMISSIONER DIAZ

SUBJECT:

SECY 9'i 115 PROGRAM FOR REVISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE Disapproved Aostain Approved \,Jl

, Not Participating Request Discussion COMMENTS:

I concur with the approaches presented in SECY 97-131 with the proviso that staff should look for resource savings (FTE. consultants, and funds) that can be achieved through the use of the internet, teleconferenci g. ect.

J l$

SIGNA 70RF V h

/ /

ReleaseVote / V / C,- 2 b~97 DATE Withhold Vote / /

Entered on "AS" Yes No oTfDTf0073f )7,

a O

. i N OT ATION VOTE RESPONSE SHEET TO: John C. Hoyle, Secretary i

FROM: COMMISSIONER MCGAFFIGAN l

SUBJECT:

SECY 97115 PROGRAM FOR REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL BEGISTER NOTICE g SE c V 'l 7 -13d Approved i Disapproved Abstain Not Participating Request Discussion COMMENTS: g g&LD ,

Y d b // ,

SIGNATURE (v u V Release Vote /x / b JG f 9 7 DATE Withhold Vote / /

Entered on"AS" Yes x No A 4 M i 6 9 + 3 3. ] p ,,,

• a i

i . a lM41SS10NER McGAFFIGAN'S COMMENT' ON SECY 97115 AS SUPPLEMENTED i l W 5ECY 97 131:

! I approve of the staff's plan (including the modality a i

) time line for revising Part 35 as described in SECY131 97 since pproach) andthe it meets proposed '

time line and goals established by the Comission in the SRM on DSl 7 while

providing enhanced opportunities for participation by licensees, professional '

organizations, the Agreement and non Agreement States, the public, and the

/.CMul. Indeed, the new staff plan provides more meaningful opportunities for -

public ccanents than the previous plan despite saving n1no months because it

1- will focus the process earlier on real issues as opposed to general discussion I which has already gone on for years, r i 1

' I agree with Comissioner Dicus' coments, but I disagree with those of i Comissioner Rogers. During the facilitated public meetings. I believe that- l specific rule text and alternatives, couched to encourage a free flow of ideas, will hel rule language. p focus the discussion and assist the staff in developing draftW a ,

j meetings.

1  ! also believe that we need to go forward with a Federal Reaister notice and 1 press release modified to reflect the SECY.97 131 approac1. The heart of

} these documents would be attachments 1 and 2 to SECY 97 131.

l The staff should continue to try and to identify sources of input from members '

i of the public to ensure, to the degree possible, that all interests are j represented. As I have noted previously. I found the candid remarks of Robert 4 Adler, a mfmber of the National Academy of Sciences comittee that conducted I the medical >rogram study, useful and worthwhile for the Commission as it 4 considered tie NAS findings. I suggest that we include Hr, Adler among the

individuals from whom we will specifically solicit comments.

I commend the staff for identifying non traditional methods to solicit public coments such as making documents available over the Internet. However. Some caution should be exercised to ensure that the number of, and versions of, availeble documen+.s for coment are not so large and varied that they vill overwhelm comenters and lead to confusion on the part of staff and management responsible for LLe iulemaking.

i 1

L

-/ p ueg UNITED STATis NUCLEAR REGULATORY COMMIS$10N

[ *****"'""'"""

5 r

% ,, June 30. 1997 optics of tut stenevany MEMORANDUM TO: L. Joseph Callan Exec v D e tor for Operations FROM: Jo . Hoy e, ry

SUBJECT:

STAFF REQUIREMENTS - SECY-97-115 PROGRAM--

FOR REVISION OF 10 CFR PART 35, ' MEDICAL USES-

, OF BYPRODUCT MATERIAL" AND ASSOC".TED FEDERAL REGISTER NOTICE The Comission has approved t.he staf f proposal to revise 10 CFR Part 35 consistent with the. alternative program proposed in SECY-97-131 and subject to the following coments.

1. The staff should not only consider what regulations will be affected by thu change to Part 35, but should also take a close look at existing guidance and draft guidance to determine what changes would be needed. To ensure that all regulatory rulemaking and guidance development potentially affacting medical uses will be consistent with-the Comission's direction in DSI 7, the staf f should identify in the public meetings and Federal Register notices all regulatory actions and proposed actions relating to or affecting Part 35 licensed activities. -When appropriate, public coment should be invited.

2, The staff should continue to solicit input from members of the pablic to ensure, to the degree possible, that all interests are represented. The stati should include groups representing radiopharmacists and medical technologists, and other experts, as appropriate.

3.- The staff should prepare alternatives with specific rule text to help focus the discussion during the first-round of facilitated meetings and assist the staff in developing draf t rule language for publication and coment.

SECY NOTE: SECY-97-115 WAS RELEASED '!V THE PUBLIC ON JUNE 17, 1997. THIS SRM, SECY-97-131, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE'OF THIS SRM.

WYu yQg Zj)jQ

9 2-

4. The staff should look for potential resource savings (PTE, consultants, and funds) that can be achieved through use of the internet, teleconferencing, etc. In making documents available over the internet, some caution should be exercised to ensure that the number of and versions of available documents for comment are not so large and varied that they will overwhelm commenters and lead to confusion on the part of the staff and management responsible for the rulemaking.

.A Federd5..Jf % 3fM notice and presW release should be issued reflectin3 fer 1pproach outlined in SECY 97-131, attachments 1 and 2, and pehtished in time to support the facilitated public nestings.

(EDO) (SECY Suspense 9/5/f7) cc Chairman Jackson Commissioner Rogers Commissioner Dieus Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OCA OIG Of fice Directors, Regions, ACRS,_ ACNW, ASLBP (via E Mail)

PDR DCS

l l

Enclosure 6:

12/6'96 ltr to Senator Faircloth, with enclosures

.