ML20217M551
| ML20217M551 | |
| Person / Time | |
|---|---|
| Issue date: | 08/12/1997 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Faircloth L SENATE |
| Shared Package | |
| ML20217M555 | List: |
| References | |
| REF-10CFR9.7 SECY-96-056-C, SECY-96-56-C, NUDOCS 9708250033 | |
| Download: ML20217M551 (99) | |
Text
jM % UNITED STATES Ok O* 4 NUCLEAR REGULATORY COMMISSION E o WASHINGTON, D.C. 20555-0001 Olb.
u :* l p@pfp August 12, 1997 k ..... /
CHAIRMAN The Honorable Lauch Faircloth UnitM States Senate Wasr'ington, D.C. 20510-6175
Dear Senator Faircloth:
On October 8,1996, you wrote concerning the National Academy of Sciences, Institute of Medicine report entitled, " Radiation in Medicine: A Need for Regulatory Reform."- On December 6,1996, 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 essessment and rebaselining efforts, which considered the findings of the National Academy of Sciences, Institute of Medicine report and comments from the regulated community, piofessional 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 guldrance documents, and, as necessary, the Commission's 1979 Medical Policy
- Statement, following a risk-informed, more performance-based approach to regulation. The I 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, _ ,.
fo i./
L .L _
Enclosures:
- 1. DSI Nos. 7 and 12 -
- 3. SECY-97-115
- 4. SECY-97-131
- 5. SRM-SECY-97-115 9708250033 970812 -
PDR COMMS NRCC CORRESPONDENCE PDR p+ b c. U 'J 11
s s i
Enclosure 1:
Direction Setting issues Papers Numbers 7 and 12
1 4
.c. t i
L i
STRATEGIC ASSESSMENT. ISSUE PAPER
-n DSI 7: MATERIALS /NEDICAL OVERSIGHT J
INTRODUCTION-In August 1995, the Nuclear Regulatory Coesnission (NRC) staff initiate l Strategic Assessment and Rebaselining Project.
take a new look at the NRC by conducting a reassessment of NRC act l
i which that, work is accomplished, and to apply to i rigorous screening process to produce (or rebaseline) a new set of.The
- assumptions, goals, and strategies for the NRC.
l- are intended to provide an agency-wide Strategic Plan which can be d l and implemented to allow the NRC to meet the current and future challe l
i
[
A key aspect ofThese this-project was the identification issues fall into three categories.
The this work is accomplished.
i first category includes broad issues defined as Directio Subsumed issues are those that
! (DSIs).
The second category includes subsumed issues.The third category includes related should be considered along with the DSIs.
l i issues. The i are issues that shculd be considered after the Also, as part of the project, other a decision un the option (s) for a DSI.
issues of an operational nature were identified.
the issue papers.
j Following the reassessment of NRC activities, issue d to obtain papers a review of were provideadiscussionofDSIsandsubsumedissues,anThese papers are intended to these broad, high-level issues.
discussion of the options as well as summaries of the consequence j
options related to the DSIs. Final decisions related to the DSIs will i
influence issue paper.
the related issues which are listed, but n lic.
- the issue papers are being provided to intereste After l
l to provide a forum to discuss and receive commen
~
t decisions concerning the DSIs and options. In summary, the Strategic Assessmen j to develop a Strategic Plan for the NRC i
and Rebaselining Project will analyze where th ,
' forward in a changing environment.
(
r 051-7 SEPTENBER 16, 1996
) RELEASE DATE: i
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MATERIALS / MEDICAL OVERSIGHT DSI 7
SUMMARY
A. Direction-Setting Issue ,
i The Nuclear Regulatory Consission (NRC) Byproduct Materials Program currently 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 by the NRC regional offices, and exempt distribution licenses and sealed source and device (SS&D) reviews, which are handled by NRC Headquarters. The various regulated products and uses range from large quantities of radioactive materials in complex devices or in the manufacture of radiopharmaceuticals to small quantities in radioactive tracer studies or in simple devices. The NRC is evaluating the level of control and Many of regulation needed to oversee its diverse Nuclear Materials Program.
the applications pose similar risks and could be regulated by other Federal and State agencies. Specifically, the NRC has been considering whether to continue to regulate or to revise its oversight of the medical uses of nuclear byproduct materials. To obtain input on the medical regulation issue, the NRC contracted with the National Academy of Sciences (NAS), Institute of Medicine (IOM), to perform an external review and to assess the adequacy The IOM andfinal report, appropriateness of the current regulatory framework.
" 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'.
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 materials. This issue paper provides options associated with the Direction-Setting Issue (DSI) of what should be the future role and scope of the NRC's Nucl. ear Materials Program, and in particular, NRC's regulation of the medical use of nuclear material. The options include expanding, retaining and revising, retaining in part, or eliminating the Nuclear Byproduct Materials Program with particular emphasis on medical use.
B. Options Option 1: Increase Regulatory Responsibility With Addition of X-Ray, Accelerators, and Naturally Occurring and Accelerator-Produced Radioactive Materials This option would transfer the regulatory responsibility for non-Atomic Energy Act of 1954, as amended (AEA), sources of ionizing radiation, such as x-ray, linear accelerators, and naturally occurring and accelerator-produced
' See Attachment, " Regulation of Radiation in Medicine - 10M issues" SEPTEMBER 16, 1996 2 DSI 7 RELEASE DATE:
6 i DSI 7 MATERIALS / MEDIC?.L OVERSIGHT radioactive materials (NARM), from other Federal agencies and the States to the NRC. An Agreeme..t States Program would continue. Legislation would be required to implement this option. ,
Option 2: Continue Ongoing Program (With Improvements)
Th's 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 (M:siness process reengineering (BPR)) or are on temporary hold (revision of PP.'t 35 of Title 10 of the Code of Federal Reculations (10 CFR Part 35]). Lesslation would not be required.
Option 3: Decrease Oversight of Low-Risk Activities With Continted 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, and so on. The NRC would retain oversight of SS&D reviews, manufacturers and distributors, ar.d high-risk applications, such as medical therapy, -
radiography, and large irradiators. Specific regulatiens and guidance in the high-risk area would be revised to make them more risk-informed and performance-based.
Option 4: Discontinue Regulation of All Medical Activities Except NRC Oversight of Devices and Manufacturers (National Academy of Sciences Recommendation)
In this option, the regulatory authority over all medical uses of byproduct material would be given to the States, with a Federal agency (not NRC) in a guidance leadership role. The NRC wou',d 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 nadical 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.
RELEASE DATE: SEPTEMBER 16, 1996 3 DSI 7
I J MATERIALS / MEDICAL OVERSIGHT DSI 7 II. DESCRIPTION OF ISSUES A. Background / Bases The key considerations in reexamining the role and scope of NRC's Byproduct l Materials Program, and specifically its regulatinn 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 This issue and processes that it applies in luplementing this responsibility.
paper addresses the extent or scope of a Byproduct Materials Oversig".t Program 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,Among acquisition, ownership, other things, Section possession, 81 import, and export of byproduct material.
authorizes the NRC *to issue general or specific licenses to applicantsBypro seeking to use byproduct material."
lle(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 license.'
- 1. Specific Licensed Huclear Materials These groups include (1) broad-scope materials licenses; (2) manufacturers and distributors; (3) hospitals, clinics, nuclear pharmacies, and private physicians; (4) limited research and development operatio All of these licensees are regulated under (9) other material licenses.
applicable provisions in 10 CFR Parts 19, 20, and 30 for byp some activities, such as medical, radiography, and irradiators.
2 In addition, the Commission has exempted Thecertain nuclear most widely material exempted uses, activities, and products from regulat, ion.
products are residential smoke detectors that contain small quantities of americium-241.
DSI 7 l SEPTEMBER 16, 1996 4 RELEASE DATE:
N DSI 7 MATERIALS / MEDICAL OVERSIGHT Presented below are descriptions of the ma.jor 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 procedures and criteria established by the radiation safety constittee. Under l
the broad-scope license, the NRC places significant reliance on the l organization's radiation safety committee 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 129 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 lit.enses are issued for possession and use of specifically designated radionuclides in academic institutions, industrial facilities, and medir ai ir.;titutions for nonnedical. use. The NRC regulates approximately Sn3 6imited research and development licensees under applicable sections of 10 Cr? Parts 20 and 30 9
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- 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, 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 The NRC regulates fluorescence analyzers; gas chromatographs; and others.
approximately 2,200 measuring system licensees.
- f. Irradiators Irradiator licensees use radiation 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.
- 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 testing 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 has issued about 160 industrial radiography licenses pursuant to 10 CFR Part 34.
- h. Well Logging 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
. RELEASE DATE:
~ 051 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 poneral 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.of a nuclear materials product at the point of sale, which would make the buyer a general licensee.
I 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 standards for design and manufacture so that they may be used by persons with minimal l
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.
4
- 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 paint, and smoke detectors, once there has been an initial transfer or distribution of the product. 4
- 4. Sealed Source and Device Reviews The NRC further exercises its statutory responsibilities by the certification
.or 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 l State. These data are evaluated and an SS&D certificate is-issued after a t
RELEASE DATE: SEPTEMBER 16, 1996 7 DSI 7
l.
MATERIALS / MEDICAL OVERSIGHT DSI 7 The NRC determination is made that the product is safe for the proposed uses.
l maintains a registry of SSADs approved by.the NRC and the Agreement States.
l Atplicants for specific licenses can reference these apprgved products in twir applications.
B. External Factors -
Notwithstanding the aforementioned oversight process, the operational history and knowledge base inherent in the current nuclear materials industry allows The nuclear opportunities for streamlining NRC's Regulatory Program.
materials industry, with an operatienal 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, even with such an operational history, some factors, such as technological advances and aging equipment, may affect streamlining considerations.
- 1. Technological Advances The nuclear materials industry has been and will continue to be affected by technological advances in other fields. For example, advanced computer technology and devices.
has been combined with the use of sealed sources for new p advent of- the gauna knife (used for brain radiosurgery) and remote
. afterloading brachytherapy devices. Technological enhanceeents are not As the SS&Ds are affected by more limited to rsdiation 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 gamaa 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 nature industry, some licensed nuclear material devices One result may be increased mechanical and
- .are becomingproblems.
metallurgical old and/or obsolete. Aging devices may warrant-special consideration when and if the NRC undertakes to streamline its Regulatory Program, especially in the areas of routine inspections and guidance to licensees.
- 3. External Interest unlike the organized opposition to nuclear reactors or nuclear waste disposal, the public (in most cases) has been supportive (at times, by remainingThere silent) on the use of nuclear materials in medicine, industry, and commerce.
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3 DSI 7 MATERIALS / MEDICAL OVERSIGHT 1
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 cosmiunity, regulated by NRC and Agreement States, has been very vocal on specific requirements of i j Part 35.- In general, this medical conmiunity, including physicians, physicists, pharmacists, hospitals, professional associations, and others, regards the detailed prescriptive requirements of Part 35 as unnecessarily l burdensome. A specific target has-been the regulation on " Quality Managunent i Program and Misadministrations" (the QM rule), which became effective oti l January 27, 1992. The medical community has asserted that the require'.aents 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, OM8 disapproved the record collection requirements of the QM rule on the basis that the NRC had not demonstrated that the rule would yield significant benefits. The NRC Cossiissioners overrode the OM8 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 Indiana, 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 congressional 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 Casuiission 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 - IOM Issues" RELEASE DATE: SEPTEMBER 16, 1996 9 DSI 7
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- 4. - Full Cost Recovery .
Another significant external factor is the Omnibus Budget , R The number of NRC licensees has declined since about 1990 dueThis declin u authority.
primarily to the requirement for full fee recovery.
continue, with the number of licensees decreasing by about one third if States that are currently negotiating agreements (Massachusetts, Pennsylvania, Ohio, and Sklahoma) become Agreement States and additional States continue to pursue this status, The reduced number of NRC licensees will fur licensing fees for s ms categories of NRC licensees.becoming an Agree Agreement State training and technical assistance.
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 Igg 4, the staff began a major reevaluation of the regulatory process inThis NRC's oversight of licensed materials. Phase I was completed in the This spring of 1995.
as part of a BPR effort.
phase was directed toward proposing a fundamentally new approach to materials licensing designed to (1) perform at least an order of magnitude faster than the current system; .(2) be supported by clear, consistent, and timely regulatory guidance; and (3) ensure that ~no adverse effect on public healthThe and safety results from its implementation.
information-tachnology to streamline operations. ;The new approach focuses on including performance requirements in NRC's regulations, As d 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 theofentire The number Nuclear Materials Program during the next several years.
licensing actions should significantly decrease, as should the amo required review time. Overall, as a result of the reengineering efforts,
- streamlined or eliminated.
the MtC's Materials Program should be significantly more During the pastefficient several and years, responsive to both the public_and licensees.the NRC's Materials Program DSI 7 SEPTEMBER 16, 1996 10 RELEASE DATE:
DSI 7 MATERIALS / MEDICAL OVERSIGHT staff and-resources. However, in fiscal year 1997 the program will begin to declease 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 additional Agreement States.
III. DISCUSSIONS A. Discussion of Direction-Setting Issue The key considerations in reexamining the role and scope of NRC's Byproduct Materials 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 conunon defense, and the environment.
Although the Byproduct Materials Progrr.m must be performed in response to the AEA, the AEA also provides NRC with broad authority regarding the standards 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 "pslic."
The options on the role and scope of the Nuclear Materials Program are the result of management and staff review and subsequent initiatives 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 afficiency and effectiveness, and the recoassendations of the 10M.
Al . 'h the primary focus of the Byproduct Materials Program is on protecting e -, alth and safety. it must also ensure that the extent of control is
- 'the risk to the public. The focus should be on the safety-su ~
issues and on providing timely and consistent guidance and licon. , 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 / MEDICAL OVERSIGHT B.
Discussion of Subsumed Issue Byproduct Materials ProgramAs a part of selecting an option on the the following strategic iss s considered and resolved as a, result of this issue paper.ues should be Issue:
What should nuclear material? be the role of NRC in regulating the medical use of Under
-use. the AEA, Regulation of these NRC hascate two broad responsibility for two categories c ne of ra l third of NRC's Nuclear Materials Progras:gories represents approximately one-is nuclear These dru medicine, which employs radioactive drugsOne category of radiat material,gs usually contain only very small quantities (radiopharmaceuticals).
of radioactive Nuclear medicine occasionally includes the use of la .
unsealed thyroid gland.radioactive material 'for therapy, especially for diseases of The other category of radiation medicine is radiation thera (radiation oncology).-
In radiation therapy lar 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 used b used in about P5 percent of radiotherapy treatments. Sealed radiation s electronic devices not regulated under the AEA, such as x-ray eq linear accelerators, is used in the other 75 percent of treatments '
Therapeutic radiation devices,'such as a ganna knife,an may contain .
6,000 curies, microcurie or millicurie whilequantities.
diagnostic nuclear medicine procedures m e to may be By authority of the AEA and Commission policy, thee NRC medical regulates th use ofand,the:
workers nucleargeneral materials public. as necessary to provide for the radiation s NRC also regulates the radiation safety o patients when justified by the risk to patients, but minimizes ys the ag intrusion into medical judgments affecting patients and into other a traditionally considered to be the practice of medicine reas that physicians have primary responsibility for the protectionThe patients.
of their NRC rec NRC regulations assume that authorized physician users
, with.
appropriate training and experience, will make decisions of their patients. in the best strengthen the Medical Use Program.Over therove years, and the Commis took action to upgrade its regulationmedical of radiation
, Ohio, NRC use.
sour Also, inin February program the medical area. 1979, NRC issued a policy statement to guide its Re A fundamental tenet in the policy statement isgulatory RELEASE DATE: SEPTEMBER 16, 1996 12 DSI
DSI 7 MATERIALS / MEDICAL OVERSIGHT s
the commitment to protect patient safety without intrusion into the practice of medicine. However, there has been f equent tension with the regulated medical connunity 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 medicine is exercised by both the Federal Government, primarily through the Department of Health and Human Services, the Food and Drug Administration (FDA) and the NRC, and the States.
Within this regulatory framework, the NRC has jurisdiction over the medical
! 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 "
regulated 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 initiated. 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 ION to conduct that external review, addressing not only the role of the NRC but 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 (DetlS) as the agency that should exercise a leadership role in the radiation safety community. Further, the report suggests that DHHS assist in developing recommended State laws and regulations, act as an information clearinghouse, and ' distribute resources -for training and research.
The NRC has reviewed the 10M recommendations-at length and has held several public meetings on them. As of August,1996, the NRC had received 41 comments on the subject. Although some consentors supported the recommendations, the-CRCPD expressed concern about the elimination of the entire medical use-SEPTEMBER 16, 1996 13 DSI 7 RELEASE DATE:
MATERIALS / MEDICAL OVERSIGHT DSI 7 DHHS program and the absence of Federal authority in the medical use area. ,
stated that it could not :upport the recommendation that it provide the leadership role suggested by 10M. A more extensive sunsar,y of the recommendations and comments appears in the Attachment to this paper,
" Regulation of Radiation in Medicine - ION 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-Produced Radioactive Materials option Under this option, the NRC would continue with its ongoing program and l improvements and seek legislation for regulatory oversight of other sources of ionizing radiation, including x-ray, accelerators, and discrete NARM. Discrete sources of NARM include radium sources used in medicine and industry They and do n;t the include wastes resulting from cyclotrons and linear accelerators. An wastes from the mining and processing of radium or other radionuclides.
TMs option would significantly Agreement States Program would continue. increase NRC's jurisdiction in 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 needed to remove the responsibility for the regulation of these sources of radiation from other Federal agencies and the States and to transfer it to NRC. Coupled with this action would be new and revised policy statements, such as the Ig79 Medical Policy Statement, memoranda of understanding with other Federal agencies, and agreements with the Agreement States. Rulemaking to expand and modify existing regulations and generation or revision of the companion guidance documents for the NRC staff and licensees would be necessary.
DSI SEPTEMBER 16, 1996 14 RELEASE DATE:
. DSI 7 MATERIALS / MEDICAL OVERSIGHT Impacts .
This option would ensure increased uniformity and consistepey in the regulation of all sources and uses of ionizing radiation. It would avoid substantive differences in regulations and oversight 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 gamaa 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 wauld 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 legisla; ion may be difficult to support in the absence of a compelling safety problem.
! The resources required to develop the necessary legislation would include resources from the other Federal agencies currently providing some radiation protection or source and device oversight (e.g., FDA, the Environmental i
Protection Agency LEPA)), as well as NRC. A comprehensive program that would l
implement.such leg'islation, 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.
l-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 detail 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 NRC 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). i RELEASE DATE: SEPTEMBER 16, 1996' 15 DSI 7
MATERIALS / MEDICAL OVERSIGHT The ongoing BPR of the licensing process will result in the use of m (1)- a Regulatory Product Design process is composed of three major concepts: Center in which technical members community can interact face to face or by way of the computer, to design and prepare the regulatory products necessary to support, maintain, and enhence the new licensing process; (2) improved processing of licenses through reviewer-performed and computer-assisted 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.
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-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 obtained by implementation of BPR initiatives.
16 DSI 7 RELEASE DATE: SEPTEMBER 16, 1996
, OSI 7 MATERIALS / MEDICAL OVERSIGHT Amending the regulations and modifying guidance. documents and associated regulatory guides has already been budgeted as part of the Medical Management Plan. No additional-resources-would be necessary for the pdical use area.
Also, an overall reduction in needed materials resources is anticipated over the next 5 years. This reduction is predominantly due to the increased efficiencies anticipated with the implementation of planned BPR initiatives, 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 reduction of approximately 20 FTES by the year 2000.
Reaction of Stakeholders I
-Based on ION interviews and comments on the 10M report, many medical licensees would-continue to support NRC's divesting itself of responsibilities in the medical area.
Option 3:- Decrease Oversight of Low-Risk Activities With Continued Emphasis of High Risk-Activities 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., =anufacturers, large irradiators, etc.), it may be overregulating areas thtt involve low-risk activities or sources. Low-risk activities could include the use of devices such as gas chromatographs and certain gauges, and diagnostic nuclear ;
medicine. The oversight-of these low-risk activities may be an unnecessary '
expenditure of resources because of-the limited additional protection.it provides.
Under this option, the NRC would modify its existing regulatory responsibility of low-risk activities and maintain its current responsibility (with some 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 public comment process. This option would encompass the overall 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 licenses) that warrants minimal regulatory oversight with no formalized inspection frequency and minimal-licensing requirements. However, sone audit
-activity night have to be established to periodically assess the general licensee's byproduct material possession and performance.
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DSI 7 MATERIALS / MEDICAL OVERSIGHT.
10nce low risk has been defined, this option would necessitate reevaluation of
-those licensees currently licen:ed 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 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, internal standard review plans, and inspection procedures.
Impacts This option would result in increased efficiency and effectiveness within the agency by focusing NRC's limited resources on higher risk activities and-those 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 docuraents= 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 discontinuing its regulatory oversight of lower risk activities or reducing its oversight, 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 imludes those FTEs eliminated by the BPR.
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-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-leadership role would be nonregulatory and would assist in developing recommended 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 oversight of the manufacture and distribution of byproduct material (including SS&Ds) used in medicine. Further, NRC would condition these licenses:to require that products could only be distributed to l users who were licensed by a State. Also, the Conference of Radiation Control l
Program Directors (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
.NRC made the requisite findings under Section 81 of the AEA,-the NRC could by
" exemption 5 eliminate this- aspect of the Materials Program. Rulemaking to rescind or modify regulations in Parts 30, 33, and 35, among others, would follow. This route would require public notice and comment 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 well as NRC regalatory guides, manuals, and directives.
Impacts This option would result in the elimination of approximately one-third of the IRC'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 given State. However, the level of oversight may vary considerably from State to State because currently some States provide oversight (licensing and
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1 MATERIALS / MEDICAL OVERSIGHT l
DSI 7 i
inspection) through State radiologic health personnel, and others by a simple registration process. Additional'y, inconsistencies could develop l between regulation of basic radiation safet', in medical and nonseiical applications.
Finally, DHHS does not support the 10M's recomunendation that DHHS be given a leade n hip role.
Some of the non-Agreement States may lack the resources, including qualified persannel, to set up their own safety programs and decide not to regulate in this area and both the Agreement States al.d the non-Agreement States may view the action ps an unfunded mandate. Also- revision of the agreements with each of the 29 Agreement States would bq necesJary. Additionally, the event database would no longer include misadministrations or events involvir.g 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, 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.
Retources associated with efforts for legislation and rulemas. ng 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 ac+.tvities.
Also, the nuwiber 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 assess radioactive dose estimates and possible consequences. Currently, the 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 comments on the 10M report. The two major categories of responses are either in support of, or opposition to, the overall recomunendations of the 10M coasmittee.
However, within each of these major categories, there are subsets with respect to the specific direction or ir.us of the conuments. None of the comunents received specifically indicated that there should be no Federal involvement.
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The Secretary of the Departrent of Health and Human Services (DHHS), the Federal agency that would be most directly affected by the IOM j recommendations, indicated that the report does not make a com Furthermore, health agreement for DHHS to assure the recoemended new roie. p i DMS raised a concern that Congress would not provide resources commensurate with the added responsibilities.
The majority of consents received (32 out of 47) did r;ot endorse the full .
range of reconnendations put forth by the 10M connit;ee. Four of the 15 respondents ,that supported the reconnen:fations indicated that the recommendations should encompass all uses of byproduct materials. The Department of Veterans Affairs, in itt, support of the IOM report, i!dicated that legislative inhiatives should ensure that Federal facilities are not subject to State and local regulations.
The comuments that did not support all the IOM recomendations varied dramatically in the focus of their viewpoints and opinions. The degree of regulatory reform perceived to Le necessary ranged from simply recognizing the merits of tFe issues raised by the IOM coenittee to a need for o complete restructuring of the regulatory program. The non-Agreement States tnat 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 implement the regulation of byproduct materials. The Department of Defense response, which suussarized the ts".ponses from the three Service Medical Departments (Army, Navy, and Air Force), supported the need to re-evaluate the current regulatory nructure, but emphasized the need for a uniform regulatory authority. 1here were several responses that recommended the need for Federal oversight for all uses of radiation.
The Organization of Agreement States response provided a summary of the consensus of the part'cipants of the NRC and Agreement State technical workshop conducted March 5-6, Igg 6, which included that all radiation use (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 coussents of these organizations are sunenarized in Appendix 3 to the Attachment to this !ssue Paper.
SEPTEMBER 16, 1996 21 DSI 7 RELEASE DATE:
OSI 7 MATEP.!ALS/ MEDICAL OVERSIGHT Option Es. 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 matcrials at low-level waste disposal sites.
Regulatory 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 3g, and certain policy statements and memoranda of understanding would have to be rescinded or drastically revised. Also, all agreements with the 2g 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 materints 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 letd Federal agency role could be filled by an existing Federal agency such as the epa, OHHS, or the Occupational Safety and Health Administrat' on, 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 several 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.
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[
i Resources associated with efforts for legislation and rulemaking would entail '
sev6ral FTEs over a period of 5 to 7 years. ;
The masber of budgeted FTEs for the Byproduct Materials Pr'ogram is approximately 140 FTEs in Headquarters and the regions. These FTEs include j all managers and technical, administrative, and support staff. Nearly all of ;
4 these FTts could be eliminated or redirected, in part, to other activities, recognizing that a few FTEs would be needed to handle residual activities. In i
addition, staff from other NRC offices who support the NM55 Byproduct '
- Materials Pnogram coulet be reduced by the current number of FTEs that handle byproduct materials issues or provide support to this NM55 Program.
J l deaction of Stakeholders ,
i Reaction from the regulated connunity could depend on whether consensus j 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 having to comply with a multiplicity i of State requirements.
The Agreement States might support this option to the extent they find it i
consistent with their consensus view described in Option 4.
Federal agencies would self-regulate. Some indicated in their coments on the ION report that they did not have the resources necessary to develop and 1 l
implement an oversight program, as indicated in the Department of Defense's l comments on that: report.
V. RELATED ISSUES After the Commission has made decisions concerning the Olrection-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. i t
The Related Issues are listed in this section to provide a more complete understanding of the higher level Dirsction-Setting and subsumed Issues.
I 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 l t
b This-is a Cosmission issue because it involves the Comission's-reconsideration of its policy on its Enforcement program for materials i licensees and may lead to rulemaking. It is related to the D51 because NRC's enforcement policy for materials must reflect the philosophy established by the DSI. It is'a related issue rather than a subsumed issue because it will
+
23 DSI 7 REL. EASE DATE. SEPTEMBER 16, 1996
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051 7 MATERIALS / MEDICAL OVERSIGHT l
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reflect the extent to which the materials licensee connunity follows 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 commission issue because a change to the current frequency of renewals will involve policy and perhaps rulemaking. This issue is related to the D$1 because the DSI will-establish how important materials license renewals 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 Cosnission issue because a change in the current frequency of renewing fuel fabrication facility licenses will involve policy and perhaps
-rulemakung. The issue is related to the 051 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 differently?
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 inspection 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 Naterials Program and will require an in-depth RELEASE DATE: SEPTEMBER 16, 1996 24 DS! 7 i
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_ = - _ - _ _ _
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051 7 MATERIALS / MEDICAL OVERSIGHT l evaluation that is beyond the.. scope of the current issue paper. For these reasons, and dependint, on decisions by the Commission, this subsumed issue
- will be addressed as a related issue. ,
i l
- E. Should a single Federal agency regulate radiation safety?
2 l This issue is directly linked to the Agreement States' comments on the 10M j
recessmendations in which the Agreement States technical staffs said that "All .
4 radiation use (medical and nonnedical uses should be consolidated under ont i Federal agency to include NARM, AEA matori 1, and machine-produced radiation. '
- Consensus was not reached as to which Federal agency shguld have the authority, or whether it should be an existing agency.' >
ency '
It appears most appropriate to consider the issue of single afn91e agency-jurisdiction from several- perspectives. As stated above, a s j 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-l setting (now vested in EPA), approval of medical devices and ,
i
- radiopharmaceuticals (now in DHHS),and applications (now in NRC). '
) This is a Commission 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 regulation of nuclear reactors as well. It is
- clearly a related, rather than a subsumed, issue, because it is well beyond t the scope of this DSI.
V. C0fflIS$10N'S PRELIMINARY VIEWS Staff actions regarding the various options should be held in abeyance pending the Comunission's final decision on this issue paper.
4 j.
s.
The Commission preliminarily favors a combination of Option 2 (Continue the l
- j. Ongoing Program with Improvements) and Option 3 (Decrease oversight of Low-Risk Activities wlth continued Emphasis of High-Risk Activities). In implementing option 3. the NRC would utilize the risk-informed performance
- ' based approach, as discussed in DSI 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 OSI appears to be a p
reasonable starting point for identifying the types of activities that can be 4 affected by this process. ,
1 k
i 3 . 8eport of Mnt NRC/ Agreement State technical workshop, March 5-6, 1966 j
SEPTEM8ER 16,1996 25 DSI ?
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MATERIALS / MEDICAL OVERSIGHT D5! 7 In implementing these options with regard to the NRC's medical program, the NRC would consult with its Advisory Committee on the Neoical Uses of Radioisotopes (ACMUI) for guidance on low-risk medical activities, revisions to 10 CFR 35, and wssible implementation methods. The NRC would also evaluate the feasi sility 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 public comments on this issue, the NRC particularly solicits the views of other affected organizations such as the organization of Agreement States and the CRCpD on applying a risk-informed performance based approach to NRC's oversight of medical activities. The NRC also solicits the public'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 comments on the Attachment to this issue paper titled " Regulation of Radiation in Medicine - 10M Issues."
SEPTEMBER 16, 1996 26 DSI 7 RELEASE DATE:
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. Dl! 7 MATERI ALS/ MEDICAL OVERSIGHT
- . ACRONYMS ACMUI Advisory Connittee on Medical Uses of Isotopes l
l 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 DMS Department of Health and Human Services DSI Direction-Setting Issue EPA Environmental Protection Agency FDA Food and Drug Administration FTE Full-Time Equivalent 10M Institute of Medicine NARM Naturally Occurring and Accelerator-Produced Radioactive Materials ,
NAh National Academy of Sciences MSS Office of Nuclear Material Safety and Safeguards NRC Nuclear Regulatory Commission OMS Office of Management and Budget QM RULE - Quality Management Program and Misadministrations SS&D Sealed Source and Device SEPTEMBER 16, 1996 27 DSI 7 RELEASE DATE:
MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT REGULATION OF RADIATION IN MEDICINE IOM 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 contracted with the Institute of Medicine (10M) of the National 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 IOM 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 To Services (DHHS) providing support, coordination, and guidance to them.
bring about this change, the comittee 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.
1 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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. OSI 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.
The third section of this report sumarizes the 10M committee's view of the present situation, and describes the seven alternative regulatory systems considered by the committee. It describes each alternative and presents the committee's views of the positive an1 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 committee's recommendations associated with the preferred alternative, it contains a brief description of each recomendation, a summary of the committee's rationale for the I
recomendation, the NRC staff's principal issues, and some pertinent public comments.
l The fifth section documents NRC actions on the report to date and provides a general summary of the 47 comments received so far. Lists of specific commentors and b-ief summaries of their comments appear in appendices.
II 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 summarizes NRC's medical use program including its applicable regulations, its licensee community, and its activities. It then sketches the history of HRC's efforts to improve the program, including the svents 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.
lonizing 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 nuclear medicine, it is When internal.
used for diagnosis or radioactive drugs (radiopharmaceuticals).
followup, these drugs usually contain only very small quantities of radioactive material.
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lonizing radiation used for treatment is also typically classified into j categories depending on whether the source of radiation is external or j
internal to the patient. These areas are called teletherapy (external 4
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. brachytherapy (internal) and therapeutic nuclear medicine sources)l).
(interna Brachytherapy and teletherapy use sealed sources; therapeutic nuclear medicine uses radiopharmaceuticals. In radiation therapy, larger quantities of radioactive material, usually in the form o/ sealed sources, are used primarily in cancer treatment. Sealed radiation sources regulated under Radiation the AEA are used in about 25 percent of radiotherapy treatments.
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 .
Comission policy, the NRC regulates the medical use of byproduct material' to provide for the rcdiation 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 iodine regg)iory authority
, so it does not regulate is limited naturallyto occurring byproduct or material (su accelerator produced materials (NARM), or accelerator produced radiattor.. 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 ofll, and ,
problem reports, enforcement actions-including product removal and reca civil prosecution of manufacturers. The Department of Transportation (DOT) regulates the transportation of radionuclides. The Environmental Protection Agency (EPA) sets generally applicable environmental standards 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 authorit/ preempted by the Federal Government asThi discussed above .
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byproduct material by becoming one of NRC's Agreement States. In that case, 3 Byproduct material is defined as nuclear material created or made radioactive by exposure to radiation during the fissioning process in a reactor.
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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. C retains regulatory authority over Federalicensees l(As provided in all States.) Present the @ly there are 29 under the AEA, 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 their State, although there is no requirement that they do so.
Likewise, there is no requirement for non-Agreement State; to reg"1cte the sources of radiation for which they are responsible. This bituation 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 i 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, Medical Use 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 requirements 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 communicating 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 kELEASE DATE: SEPTEMBER 16, 1996 4 DSI 7 ATTACHMENT
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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 tensi n inherent in NRC's commitment has arisen in a number of key medical-use regu'atory 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 l number of agencies in the Federal Government and by the States. Because of l the diversity of, and occasionally overlapping, responsibilities, dual regulation or gaps in regulation may occur.
l In 1992, the staff began to develop a medical management plan to guide the i conduct of the medical use regulatory program. The plan was delayed as a l
result of staff actions in response to a radiation therapy misadministration and the associated patient fatality, 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 Agreement 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 broad policy issues that underlie the regulation of the medical uses of radioisotopes; and 3) a critical assessment of the current framework for the regulation of the medical use of byproduct material. The NRC sought specific recommendations on two major issues. First, it requested recommendations 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 i
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DSI 7 ATTACHMENT MATERIALS /ME0lCAL OVERSIGHT comerce for application to human beings should be allocated among Federal Government agencier and between the Federal and State governments. Second, the NRC requested recomendations on appropriate criteria to measure the effectivenessofregulatoryprogramsneededtoprotectpublichealthand safety.
III 10M REPORT - ALTERNATIVES This section presents 10M alternatives and recommerdations. It begins with the IOM bro,ad view of the regulation of radiation in medicine to provide insight into the basis for 10M decisions on the regulatory alternatives it considered arid the recommendations it made.
- 1) IOM comittee's View of the Current Situation The 10M committee noted that NRC regulates only 10% of all ionizing radiation found in medicir,e, 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 concluded needed to be addressed. In particular, it judged the NRC's present set of regulations and its approach to regulation to be t burdensome, costly, and unduly prescriptive. in addition, it found that l
actions taken by the NRC against user institutions, in its public announcements and its unrealistic paperwork demands, tended to be l 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.
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might have gone beyond the point where "an additional dollar spent on I regulation achieves an equivalent dollar benefit to patients or the public."
The comittee judged that, given the strength and leadership of the Conference
' of Radiation Control Program Directors (CRCPD) and the Suggested State Regulations for the Control 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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DSI 7 ATTACHMENT MATERIALS /ME0lCAL OVERSIGHT The comittee's recommendation 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 retpin responsibility l
for the generation, transport, non-medical use, and disposal of radionuclides and for the approval of radiopharmaceuticals and of equipment that generates .
l ionizing radiation. A Federal agency would assume a guidance role for the States.
- 2) Alternative Regulatory Systems The committee considered NRC's request for recomendations on a uniform
. national approach to regulation broadly. It-examined a wide spectrum of alternative structures through which all ionizing radiation in medicine might be regulated. The comittee report discusses seven alternatives, which are A Continue the Existing Situation B Laissez-Faire (No Regulation)
C State Regulation Only D State Regulation with Federal Guidance E State Regulation with Reserve Federal Authority F Centralized Federal Regulation G Health Finance Agency f
f 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 Al, Status Quo, and A2, Status Quo Modified. Alternative A1, Status Quo, would be for the NRC to continue to operate exactly as it does today. Alternative A2, Status Quo Modified, would have the NRC eliminate, or knnounce 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 modification because NRC has received considerable criticism from the medical comununity for promulgating these requirements.
The comittee 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 comittee'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 RELEASE DATE: SEPTEMBER 16, 1996 7 DSI 7 ATTACHMENT t
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031 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT alternative did not address two of the committee'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 HARM and machine-produced regulation has been left to the States and the FDA. Second, I 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.
l The comittee found that a positive aspect of Laissez-f aire would be the cost savings retelting from an absence of regulation. The committee 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 inconipetent practitioners and ineffective proceduros.
Further the comittee 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.
C State Regulation Only e
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 radiopharmaceuticals and radiation devices, DOT would continue to regulate the transportation of byproduct material, and NRC would license the manufacture of byproduct mitterial. The comittee noted that this alternative would permit States to choose the laissez-faire approach.
However, the committee expected that under this Alternative, the CRCPD would encourage States to adopt its Suggested State Regulations for Control of Radiation (SSRCR).
The comittee found the positive aspect of this Alternative to be the assumption that all States with existing programs would continue and expand them based on the SSRCR and thus reinforce the movement toward greater uniformity. The comittee found negative aspects to be that it had no RELEASE DATE: SEPTEMBER 16, 1995 8 051 7 ATTACHMENT
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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 respgnsive 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 This Alternative modifies Alternative C by identifying a Federal Agency, other than the NRC, to exercise a leadership role in the radiation safety community, with DHHS as a suggested agency. This is the committee's preferred Alternative.
1 As the committee has developed this Alternative, the Federal agency would ashist in developing recommended State laws and regulations for all ionizing radiation in medicine. It could work with CRCPD to enhance the existing SSRCR and promote their adoption. The committee felt that development of guidelines through a collaborative process with the Federal agency, the States, the CP.CPD, 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, collecting 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 usurs 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 bysroduct material. Federal facilities would be encouraged to either expand t1eir 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 whole. 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 committee 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 j any State program or the safety of ionizing radiation in, medicine. 1 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.
1 This Alternative would be identical to Alternative D, with the exception that 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 conmiittee 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 committee 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 or.ly 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 inspection. If this Alternative were to be adopted, the comittee would recoassend centralization within DHHS rather than NRC because the comittee considered it best suited to administer 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 committee found positive aspects of this alternative to include promotion of unifomity 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 Feder i role described in' Alternative D State Regulation with Federal SEPTEMBER 16, 1996 10 DSI 7 ATTACHMENT RELEASE DATE:
DS! 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Guidance, also apply to this. Alternative. The comittee found negative aspects to include the increased Federal costs of such a role, and the difficulty in uhieving uniformity due to the regulatory involvement of a number of ederal agencies (DOT, EPA, OSHA) in addition to the committee's proposed fIHS. Finally, the comittee noted that since NRC would continue to l
be respon.ible for the non-medical uses 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 p0rts of DHHS. The agency would have the power to regulate 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 minirral :,tandards and define the j 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 comittee 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 radiation in medicine be administered and regulated more consistently. It rejected Alternative B, Laissez-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 comittee rejected Alternative G, Health Finance Agency, because it was an -
all-encompassing and overwhelming solution to a very specific problem. The comittee 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 comittee 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 infomation sharing be enhanced, so it rejected this alternative. The RELEASE DATE: SEPTEMBER 16, 1996 11 DSI 7 ATTACHMENT Wf
DSI 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 conperns about that program's funding characteristics and practical drawbacks. The committee therefore arrived at its preferred choice Alternative D, State Regulation with Federal Guidance.
As discussed above, Alternative D would give regulatory 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 committee recomends that a Federal agency, DHHS, exercise a leadership role in the radiation safety community. The leadership 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.
l l Further, NRC would condition these licenses to require that products could only be distributed to users who were licensed by a State.
IV 10M REPORT - RECOMMENDATIONS To implement its preferred alternative, the committee made a total of eight
! specific recomendations; two to Congress, three to the NRC, and three to the l 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 recomandations 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 fonnulating 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 l
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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 recommendations. 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.
i The followicig scetions discuss the recomendations individually. Each section contains a brief description of the recommendation, a summary of the t
comittee's rationale for the recommendation, the NRC staff's principal l concerns, and some pertinent public comments
& RECOMMENDATIONS TO CONGRESS A1. The com2f ttee recweends that Congress eliminate all aspects of the NRC's Medical Use Program,10 CFR Part 35, and those regulatory activitles conducted under 10 CFR Part 20 that are applicable to medical uses.
DESCRIPTION By 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 FDA, the DOT, and the EPA, would retain their regulatory authority over radiation.
IOM 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 niost 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 comantors by general view, and a summary of specific coments appear in Appendices 1, 2 and 3, respectively.
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All ionizing radiation, with the exception of byproductStates material, is currently have the regulated or subject to regulation at the State level.Although the ,comittee cannot ability to regulate radiat<on effectively.
guarantee alieves they will. that states will effectively regulate byproduct material, i 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 eliminatos prescriptive and I
- 2) it shifts costly regulations- that yield marginal risk reduction; responsibi s.fety of their citizens; and 3) it promotes uniform treatment, of government at equal intensity, regardless of their source.
NRC STAFF ISSUES
- 1. The comittee recognizes that not all states currently have strong -
regulatory programs in place for NARM and machine-pr medicine. What assurance does the comittee, or Congress or the NRC, '
have that all States will assume the responsibility for medical use of oyproduct material?
- 2. This recomendation assumes that federal facilities.will expand the scope of their existing regulations to cover all ionizing radiation in medicine - what existing regulations currently apply to federal facilities (other than those of the NRC)?
- 3. How would the goal of " uniform treatment" and regu and rulemaking giving responsibility to the States.
PUBLIC ColeENTS About one third of NRC has received 47 comments on the committee's report.the co These comentors included the Department of reconnendations as well.
Veteran's Affairs, several State agencies, four professional societies- Several associated with the use of radiation in medicine and.six individuals'.
of these commentors not only supported this recomme that responsibility to the States, I 14 DSI 7 ATTACHMENT SEPTEMBER 16, 1996 RELEASE DATE:
DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGli A second third of the comentors supported the concept of regulatory reform, but with retention of Federal authority. These comentors included three Federal agencies, three professional societies involved ir} radiation in
-medicine,10 States and NRC's Advisory Comittee on the Medical Uses of Isotopes (ACHUI). Nine of these comentors favored continued reaulation by the NRC, eight were not specific on which Federal agency should have authority, and two, the State of California and the ACMUI would vest authority with DHHS.
Four comentors, including the State of New Jersey favored regulatory reform, but only after additional analysis.
J Nine comentors supported the concept of unifcrm regulation for all ,
radioactive materials, including NARM, with Federal oversight.
Several specific comments are of interest. The EPA felt ' hat 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 recomendation. "CRCPD is concerned that eliminction of the entire program, as recomended, 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 medical use area may also have long term consequences for Agr6ement States as they try to maintain a nationally consistent, program in the face of budget cutbacks and a changing regulatory philosophy " Several non-l Agreement States indicated that they had neither the resources nor the capability to develop a program to adequately protect public health and safety.
Congress direct the Secretary of Health and Human Services to support, A2.
coontinate, and encourage the following activities involving regulation of all ionizing radiation in medicine:
- a. supporting the operation of the CRCPD;
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- c. assisting states in laplementation of their regulations;
- d. siding in assessment of the effectiveness of state programs through the collection and analysis of data; ,
- e. helping develop survey nethods by which the rate of adverse events for a wide range of procedures and devices alght be measured;
- f. nonitoring the effects of deregulation;
- p. enhancing training and standards for health care personnel; and
- h. Investigating future significant radiation medicine incidents.
I DESCRIPTION in addition to the above, DHHS would educate the public for the primary purpose of "... putting radiation risk in a more accurate and balanced perspective." Adverse events for investigational drugs and blood products i
must be reported to FDA as are adverse events involving radiation devices resulting in serious injury or death.
As noted in the previous recommendation, 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 share 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 ir. 1dicine. FDA has promulgated regulations establishing quality contro, standards and a certification program for medical facilities that provide mammography 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?
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- 2. Current reporting requirements for FDA are not identical to those of HRC 1
- they only require reporting adverse events resulting in serious bodily injury (to manufacturer) or death (.J FDA). There gre no reporting requirements for radio)harmaceuticals other than investigational drugs except on a voluntary ) asis. 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 agi.acy?
- 4. How would the effects of deregulation be monitored? The report states that the comittee did not possess the requisite expertise to address the issue of appropriate criteria for measuring the effectiveness of regulatory programs.
PUBLIC COMENTS As mentioned above, about a third of the commentors support this reconmendation along with all the comittee's recomendations. A number of comentors support the role of a federal agency described in this <
recomendation, but do not necessarily endorso 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 CRCPD supports the concept of a material. The CRCPD view is illustrative. .
single federal agency with a strong leadership role, and believes that consolidation of authority presently found in several agencies including NRC.
However, CRCPD, in addition to several DHHS, OSHA, and EPA is very desirable.
states, do not support the automatic selection of DHHS as the lead agency, but considerthatradiatignprotectionshouldbeamajorresponsibilityofthere lead agency. The OAS that a single federal agency should be directed (by Congress) to support, coordinate, and oversee specified activities involving regulation of all ionizing radiation in itedicine. 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 committee's arguments compelling andFurther, does notin the consider the legislation recomended by the comittee likely.
' The OAS comment provided the recommendations of and consensus reached at a NRC and Agreement State technical workshop conducted on March 6,1996.
17 DS1 7 ATTACHMENT RELEASE DATE: SEPTEMBER 16, 1996
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! 051 7 ATTACHMENT l
event of such legislation, DHHS considers the probability low that it would receive funding from Congress commensurate with its additional-3 responsibilities.
I REC 0fulE@ aTIONS TO THE NRC I
- 51. The NRC should inmediately relax enforcement of 10 CFR 35.32 and 35.33 through its present sechsnisms.
DESCRIPTION NRC's 10 CFR Part 35.32, Duality Mannaement Proaram, requires, among other things, that medical licensees have written procedures to ensure that 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 rFR Part 35.33, Notifications. Reoorts. and Records of Misadminiitt.Aljni, requires, in part, that medical licensees notify the NRC within ont 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.
NRC The information required by 10 CFR 35.33 would not be entirely abandoned.
could continue to cooperate ytth 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.
10M RATIONALE NRC's Quality Management (QH) 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 chemotherapy, surgery, anesthesia, and the use of- general pharmaceuticals except 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 0S17 ATTACHMENT
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DSI 7 ATTACHMENT P.ATERIALS/ MEDICAL OVERSIGHT The level at which the NRC currently enforces 10 CFR 3S.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 comunity has expressed reservations about seeking advice from the NRC, fearing that they might become the target of punitive reprisals.
When the NRC levies a fine, the agency also issues a press release describing the violation and the fine. Licensees assert that adverse economic impact of 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 imediate action? P
- 3. Assuming that NRC were to imediately 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 recomendation, what followup actions should NRC conduct in the avent of a miskdministration resulting in serious ink ry or death?
- 4. If NRC lacked statutory or regulatory authority governing the medical and biomedical research use of byproduct material, why should NRC continue tc gather data on user errors, drugs, and biological products to share with F0A under the MOU (unless reimbursed by another Federal agency)?
SEPTEMBER 16, 1996 19 DSI 7 ATTACHMENT RELEASE DATE:
1 051 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT PUBLIC COMMENTS A number of commentors supported the concept that many of, NRC's requirements are overly prescriptive and burdensome. CRCPD supports relaxation of these requirements because it finds them overly prescriptive and unnecessarily burdensome. The Organization of Agreement States believes that NRC should imediately relax enforcement of these requirements, and further considers that the Quality Management Rule should not be an item of Agrecment State j j
compatibility.
- 82. The committee recommends that the NRC initiate formal steps under the l Administrative Procedure Act to revoke Part 35 in its entirety, if (
Congress fails to act within two years in response to the two l recommendations to Congress stated above.
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 I
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 i
l are excessive and duplicative. 10 CFR Part 35 covers areas that either are
! already regulated at the institutional level or are best left to t.he states, l 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 informing 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.
i RELEASE DATE: SEPTEMBER 16, 1996 20 OSI 7 ATTACHMENT
DS! 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT 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 coment rulemaking, subject to the Administrative Procedure Act, to accomplish the rescission of all of Part 35.
NRC STAFF ISSUES
- 1. This recommendation presupposes, Congress will 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 whi_ch were rejected by the committee. 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...easonable risk to puolic 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 reccamendation. 0AS believes that 10 CFR Part 35 should be-revised significantly, but that it should not be revoked in the absence of-Llegislation. 0AS believes that a minimum level of radiation protection must i be availab'.e.
- 83. The committee reconnends that the NRC separate the costs of formulating regulations from the cost of administering those regulations.
SEPTEMBER 16, 1996 21 DSI 7 ATTACHMENT RELEASE DATE:
DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT-DESCRIPTION .
The Omnibus Budget Reconciliation Act of 1990 requires NFJC to recover 10G4 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.
10M 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 t Agreement States.
Several individuals interviewed during site visits voiced concern that excessive costs force laboratories to stop using radionuclides, Wich in turn i dolays or prohibits the development and implementation of new uses of radionuclides in medicine.
b 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 recomends that Congress provide general funds to support development of essential regulatory. standards. 0AS identified the issue of how Agreement. States would bear the costs of developing standards if NRC were to accept this reccmendation.
G. RECOMMENDATIONS TO THE CRCPD AND THE STATES .
C1. The coanittee recommends that the Conference of Radiation Control Program 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 DSI 7 ATTACHMENT
DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT ION RATIONALE All states will be able to provide regulatory oversight fgr 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, voluntary, and informal arrangements.
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 metila, and Stcte medical societies.
l CRCPD will continue to provide SSP.CRs 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 d iad the CRCPD's efforts with respect to all nonmedical uses.of byproduct material.
NRC STAFF ISSUES 1
Will the states voluntarily adopt the CRCPD's SSRCR in the absence of any real compelling mandate placed on either CRCPD or tho states? For example, in the case of the recently passed mamography law, Congress 1 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 C0tmENTS CRCPD considers that it already has accomplished this. ,
1 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, 1996 23 DSI 7 ATTACHMENT RELEASE DATE:
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- DSI 7 ATTACHMENT ION RATIONALE States have effectively regulated riaturally-occurring and NARM in the past and continue-to do so. Therefore all States can regulate the medical use of 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 their option, to exercise regulatory authority over the medical use of byproduct materials.
All States will devote the additional necessary resources to provide :dequate l arotection of the public health and safety related to the medical use of
)yproduct 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.
a 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 byproduct materials.- However, the CRCPD continues to support consistent application of radiation protection standards nationwide and be'lieves 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 connittee-reconnends-that the Conference of Radiation Control Progran Directors and the states continually reevaluate their regulations and procedures pertaining to radiation medicine to ensure congruence with evolving scientific understanding of-radiation bioeffects and to be in accord with advances in knowledge regarding benefits and risks related to atdscal and biomedical research uses of ionizing radiation in medicine.
SEPTEMBER 16, 1996 24 DSI 7 ATTACHMENT-RELEASE DATE:
DSI 7 ATTACHMENT _ MATERIALS / MEDICAL OVERSIGH1 4 . .
-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 NRC7 :!
PUBLIC' COMMENTS.
Both OAS and CRCPD endorse this recommendation.
V NRC-ACTIONS AND COMMENT
SUMMARY
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
' and non-Agreement States and Territories, ? appropriate- Federal kgencies, CRCPD, OAS. Congressional Oversight Committees and NRC's Advisory Committee on the Medical Uses of Isotopes (ACHUI). In addition, the NRC published a Federal Recister notice-(61 FR 1648) on January 22, 1996, and issued a press release acknowledging. receipt _ of the report and requesting comments on the possible impacts of the report, to include any_ views on policy, legislative. ~!
- rulemaking, and guidance issues. -_The: Comission: directed the staff to- -
t consider the report and comments' received within~its Strategic. Assessment-and-
.Rebaselining efforts. While the report is being considered, the~NRC is continuing to implement the ongoing medical use program.
. RELEASE DATE:. SEPTEMBER 16, 1996 25 051'7 ATTACHMENT
_ 1
DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Several public meetings have-been held to discuss the report. The ACHUI met c4 February 21-22, 1996 and subsequently briefed the Commission on May 3,1996 to discuss their recomendations. Briefly, the ACMul diq not recomend any of specified alternatives. They reached consensus that the medical use regulatory program should be rebuilt, reassessing the objectives of the regulations and encompassing all uses of ionizing radiation in medicine, and that States should be federally mandated to administer the program, with appropriate incentives tc encourage States to comply. State programs should be monitored by a Federal agency with an overall medical use perspective (e.g.,DHHS).
The CAS and the members of the 10M committee briefed the Comission on February 26 and 27, 1996, respectively. In addition, the report was discussed. .
at a joint NRC and Agreement State technical 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 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 oppositicr. to, the overall recoa:mendations of the IOM committee. However, within each of these major categories, there are subsets with respect to the f
-specific direction or focus of the comments. None of the comments 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 10M recommendations, 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 IOM comittee. Four of the 15 respondents-that supported the recommendations indicated that the
- 1 recomendations should encompass all uses of byproduct materials. Tne Department of Veterans Affairs, in its support of the 10M 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 IOM 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 RELEASE DATE: SEPTEMBER 16, 1996 26 DSI 7 ATTACHMENT l
l
DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT merits of the issues raised by the IOM committee to a need for a complete restructuring of the regulatory program. The non-Agreement States that responded were particularly concerned about the substantigl financial impact of the recommendations and the issue of this being, in effect, en 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 impleir.ent the regulation of byproduct materials. The Department of Defense response,-which summarized the responses from the three Service Medical Departments (Army, Navy, ana Air Force), supported the need to re-evaluate the current regulatory structure, but emphasized the need for a uniform regulatory authority. There ware several responses that recommended the need for Federal oversight for all uses of radiation.
The Organization 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 radiatinn use (medical and non-medical uses) should be censolidated 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 organizations are summarized above under the specific recommendations to which they apply.
The NRC will continue to evaluate comments as part of the strategic assessment l
and rebaselining efforts. A summary of the comments is provided in
! Attachments 1-3.
SEPTEMBER 16, 1996 27 DSI 7 ATTACHMENT
. RELEASE DATE:
DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT
- Categories of Responses Received on 10M Report Federal Acencies:
Department of Defense (D00) - 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)
Envitonmental Protection Agency (EPA)
Aoreement States:
Arkansas-California Florida (Office Radiation Control) - R Florida (State Health Office) - H Illinois Kentucky Maryland New Mexico New York (Dept. Environmental Conservation) - E New York (Dept Health) - H New York (Dept. Labor) - L Tennessee Texas Utah Vermont
. Washington Non-Aoreement States / Territories:
Alaska American Samoa
-Delaware Hawaii 1 Massachusetts New Jersey.
Virginia Wyoming 28 Enclosure 1 1
I l
- ~_ _ __ .
^
w DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Oraanizations/Committeet:
AmericanAssociationofPhysicistsinMedicine(AAPtj)
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 Us OrganizationofAgreementStates(OAS)psofIsotopes(ACMUI)
Other ResoondenJn CBeasley, St. John's Regional Health Center, Springfield, MC MHafermann, Virginia Mason Cancer Center, Seattle, WA DJones, Northwest Medical Physics Center, Lynnwood, WA <
CMarcus, University of Ca'lifornia, 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. Jnhn's Hospital, Jackson, WY 7 The OAS comment provided the recommendations of and consensus views reached at the NRC and Agreement State Technical workshop. The session on the NAS report included representatives from 18 Agreement States (CA, NY, SC, NV, IL, WA, TX, MS, TN, GA, NE, CO, KY, KS, NYC, FL, AP., AZ) and two non-Agreement States (OH, PA).
' .29 Enclosure 1
1 DSI 7 ATTACHMENT . MATERIALS / MEDICAL OVERSIGHT-
- General Comments on ION Report Respondents in favor of 10M recommendations: ,
Support 10M report / recommendations as written:
AAPM ACNP/SNM ASNC DVA ,
NM MHafermann ('i;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 ION report / recommendations, but as applied to all materials:
FL (R)
NYL(H)
NY (L)
ACNP-CA t
t i-4 E
j-J 30 Enclosure 2
- DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT RelDondents not in acreement with IOR recommendations:
Support concept of regulatory reformI but retain Federal Authority :
2 DHHS oversight: ACMUI, CA NRC oversight: EPA, ACMP, ACR, HI, KY, NY(E), UT, WA, GPoteat(OH) 4 Unspecified oversight: DHHS10, D00, ACC, AK, DE TN, VA, WY Support co$ cept of regulatory reform, but af ter additional analysis:
CBeasley (St John's Regional Health Center)
MSelikson (RSO, Univ, of Pennsylvania)
NJ St. John's Hospital Support con:ept of uniformity for all radioactive materials regulation with Federal oversight:
CRCPD OAS APHA AR (NRC as lead agency)
FL (H)
Il MA MD TX
- 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 inpact of the NAS recommendations and the issue lof 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 10M, but focussed on the implications of the recommendation to'DHHS.
31 Enclosure 2
MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHMENT tes m . dents indicatino' report under review 00L-AS
- VT t
-k 32 Enclosure 2
MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT Specific Comments on ION Report .
nespedme Specific Ce===t*
Category of : ~ _
mESPCISENTS fe AGREEEEEur WITE 8018 EECENOEEut'Af f0NS _
Dyg The Veterans meetth Administretten generetty concurs ulth and endorses the fisatings Sepport f(Nt report / and recommendations of left. Principet concern is teck of specifics regardig recomumdation es wittm reputetten of Tederet entititles and etso the regutetten of mdical research programs.
IIew Itemico Agrees ulth itNE recememdation that Congress ranswe reputation of poseecolon and use of meteriet sehject to AEA frem NRC's purvieu. Sigports teederehlp rete of DENS so long es ett states maintain regulatory programs that measure comprehensive standards of performance and effectiveness.
gappe Aaret fiedsmentotty supports positten, concluelens, and recourimdstiene of the taq report. NRC shoutd be removed fren its current regutetory rete for anilcet use.
Establish progream for implementing States' regulations monitored by appropriate Federal heetth egency uith assistance of user comunesity and professionet orgenfretiens.
acupfgIse The ACIIP and SIst intieve the report preposes a soiend and ttroughtfut approach to the regulation of nutteer medicine and urges IIRC to leptement the ItBE recommendations, ettewing for commuest en speelfic means to achieve lapteamntetten.
Concur uith the 150's canctuslens and sigport their recommendetions for a wilfonn ASIIC peticy to be set at Federet levet edilch can be enforced by the States. DINIS should inrtude medical radiatien safety es part of its heetth care management plan.
pulefenmann Endorses recommendations of 1011 Does not agree uith sentiments of Robert Adler in Appendia L. .
33 Enclosure 2
MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT Specific Canummes Ra m- 1.4 Cet;m y of R x- - ;
RESPOISENTS IN AGREEMENT WITN IDE RECIDGENDAt!ONS Endorses recanummdetions of I(34. Does not agree with sentiments of Robert Adler in DJones Steport 10M report / -.
IR L-recomenmdetion es written Cnercus Supports the ION report enri empresses disegrecomt with statements made try Robert Adler in his styptementet statement (Appendia L)
CPerez Empresses strong sigport for many of reemenendations.
Endorses rer,assemdetions of 15. Does not agree with sentimmts of Robert Adler in JRieke
,, :in L.
DSchismecher s' pts reconsumdetions proposed try IOM casumittee.
Floride styport idea of delegating regutetton of medical byproduct smoteriet to states in Support IGO report / addition to att agrecuent meteriets.
receranendations, but as applied (Red. Control) to att meteriets New York Sigport the 10M's conctmlen that the reputation of asedical use of bypredtset (Dept. Meetth) meteriets should be corried out at the state tevet. Encourages the mRC to not limit its response to the ION report ,to the notrew medical focus of the report.
new York Supports the 10M's recessmendetion that NRC discentinue regulation of medical use of (Dept. Labor) byproduct meterials, but considers it litonical to limit the recomummdetion to this one area (should incitak nucteer gAermecies, samnufacturers, distritmstors, and Inchsetriet users)
NRC's entire meteriets program should be given to the Sts.tes and Federal entitles ACNP-CA
__ ~
e 34 Enclosure 2 -
k .1 MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT Specific Comumeetts
- 4 .:
Ca*ecory of Rev. ;
- RESPONDENTS NOT IN AGREEMENT WITN ION BECOMOOATIONS ADall fruficated a preference for a verInnt of the ION preferred attemative in elch t concept of regulatory Acast there would be enhetantlet Federet oversight of State prograue with a enchenfee to ,
orm but retain Federet ensure compliance of States and users. State programm eheutd be monitored by e I authority Federet wy with overett medical we perspective (DaNS).
DPMS Report does not de e compeltIng pielic heetth ersissent for Da#S taking on a sthetentlet new role. The prebebility is low that Congress would provide edespmte resources. DEWS does not espport the recourmendetian. l Federet reputatory authority over medical use of byproduct materiet should be
'900 reevetuated and perhaps retamed sawf restructured, but not abottshed in fewer of a votimtery or State-ope.eted system.
Report raf tects the concerns of the reguteted community more then the pihtic et
[PA large. There soy be espects of MC's progree that con be leproved, but WRC shculd centinue to eseure pibile is protected.
l Transfer of oversight of the medical use of isotopes to the States secues reesenebte.
ACC Newever, strongly ercourage Federet oversight of this state initletive. An obvious dreseeck would be if att States had seperate reputettons for ifcensure end
- ,,tience.
St@ ports the need for e drastic change in regulation of radiation in smedical use ACMP including use of Advisory Penets (comprised of users, seresf acturers, and putdic) to determine the regulatory frenework to be opptled uniformly in suedical profession.
Current regutettene should be modified.
/
In lieu of Congressionet action to eliminste NRC's pedical use program, the ACE ACg believes that WRC's sedical use progreat must be rebuilt and its objectives thoroughly reessessed.
35 Enclosure 2
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l MATERIALS / MEDICAL OVERSIGHT t
DSI 7' ATTADMENT' Category of :_ ,- ; m-il
_ M 'ICC # 8'
.j
~
hESPouBEW1S NOT la ACAEEMENT WITN 10N RECmWIENDA?lon? (contisused)
I Aleste This would not be e cost effective nor efficient referse for Ateeks. It is in the best interest of the state to support the esisting urthed of reguteting rescteer I l y lci e ii. n.ees isy e feder.i - . :
- e -,,,,,,,,,,e,,,,,o,e,,
In vleu of split regutetery wherity at federet tewel and eggsscent retwtowe of (twC f Cellfornia to empend jurisdiction, spree that Congress remove uRC's authority. eenis should bc l given authority to enese that every state anInteine a redletten progree that ameti j
] minisass, Ocupreiwnsive, canoensue standerde if performerite and effectivenees.
eefeuere Yhe lapsect of tha FA rehtlons amould be sidiotentist in terne of our. lacreased need for funding. stof fing, trefning and Infrastrisettsre regelreme ets.
geuegg Does ret have resources or capabilitg' to adetesetely igtement requistten of tyypractact noterials. Without sosistence (treining and development) to states, the renewet of met's authority may significantly jeeperdire pihile heetth and safety. _
Kentucky A better approech escutd be te have NEC revise its medicot program to se elong with the recausendations the Institute hos given in preferred e.tternative D.
many inforeseen ecmasysences sney occur if ACA is modified. Consissten should proceed seu York cautieunty in gesrsuing Icst recommendations that may atter the present #EA.
(Oept. Environ.
C_.._,wtisn) y ,n,,eese.
White the findings of the Comelttee have rene amerit, there is no cwtushwe sepport provided to doctament these, $eseeping changes are riot well thought cut and may result in chase. ,
State legistetures may view this es another smfunded federet seendete and samy provide Utah no additlenet saggiert to *be State program. seedical c=umeenity should isort with rtC, States, and other porties to resotwe the regutetlen leaue.
36 Ecclosure 2
MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT Specific Commer.te Cet;; W of R- ~4 E-. 1 .t NESPO8 DENTS N0Y IN 4 CREE 9EENT WITN ION RECOMMENDAf toms (contirami) the commonweetth is in swa position to esstsee any ediltienet omft 4.,0 Federet Virginia siendetes. Could only assume regulatory responsibility if WRC prowldes itsda to 5typort concept of regutetery reform inst retain f ederet M Y C' *I N '"""' I I"8
- N""-
outherIty (cent (nued)
Weshington mRC should focus en radiation safety of worker and non-pettent ptMic (oversight of prodLaction, distribution, and handling of twr.dset meteriets) dite protection of patient is best handled through State boerde of medicine and phersecy, The conetunions of the report nestect the corwiderstde herdship to be inct.sred by w ing smetter, less populous, and less effluent states. Only through continued Federet regulatory participetten con the goets of smiformity and pihtic eccess to tefe medical procedures be achieved.
Potentist decrease in safety may result freen a transfer to State regulatort of WRC's CPotest authority. Minor changes are necessary but overett WRC's regutettens batence tSe need to protect workers, patient and the pibile v8th the requirements of medical practice.
37 Enclosure 2 l
L_.._____._____ .. . . _ . . . . . . . . . .. . .. . . . . . . . . . . . . . . .
l MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACMENT
-; ^ - Speelfle Casaments Category of R A _ ; #~ '
RESPOISENTS NOT IN ACAEEEENT WITE tel REtcieEngaTious (continued) '
l tieu Jersey If NJ chose not to become en Agreement State, ge6LIc seer not 2ie eseured of edeepsete Sq port concept of regulatory Protectlen. If adapting the recesammdations, IIRC emi Congrees should not act reform, but ef ter additlenet precipitounty, but allou the States to prepare for erenedne regutetery programm in
,gy,g, orderly fashlen.
University of Before moving in the direction of a State-tmed decentralized system, e tYetter Pennoytvcnis evoluetten of potentist both for increased risk to the pietic and increened cost to the medicet inthsstry le neccesery.
St. John's Urges tutC to give every considerstlen to IGN report, particularly the review of risk Isospitet essesement.
CSeesley The report m!ssed poet of its stated intended geel to revleu the current system of regutetten (the leeues of smiformity among states esse not futty emptored). Preposes revleu in more detait the regutettan of non-nutteer medicine radiology and questien of uniformity betiseen states.
At NRC/Agr_c.t State Technicet Work-2. q, consensus esos reached that ett radietion OAS une (reguteted currently under NRC, FDA, EPA, and OSIIA) should be consetidoted smder Steport concept of unifonelty -
for ett redleective meterfots e ainste W el w a.r regutetten uith federst Absence of federal authority in medical use aree umy have laumedlete end tedesirable mes@t cacpp consegsences en citizene in non- Agreeusmt States and long term consequences for Agreement States trying to maintain a nettonetty ceneistent progree. CRCPg does not eigport automatic selection of D11115 as the egency to provide feederehty rete.
All lenialns radietlen should be grouped together ender e imiform regulation.
APHA Transfer respanolbility for esedical uses of any ionizing radietlen to the Stetes.
Some federet authority should remain over the medical tases of fenizing
~
radiation (estC or a simiter federet egency).
38 Enclosure 2
i
. l l
^
MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTAQ MENT speelfic temmente eespondent Category of messense -
NESPOWENTS WOf IN AGREBEWF tflis leN SEC5WEtBaitems (continued) the NRC should consider etterne e lve A2 (stetus gas modified). If enjer J J ere .
t concept of wifemity Artenses to be sede, centrollection of reedtetten within one Federet omancy (anC) usutd be the ,
I redleective meteriets best esproach for ett uses of redletten. Congrees usutd he e 4gsfred to empend the '
regutetlen with Federet M e d WRC W e % in h esency W k m . E % m W .l everel@t (contimed) . state p..wam. i tierfde Sippert Ides that regutetery authority of 314 agreement esteriets he turned over to the states with connotidotten of federet redletten overeiget, guldence, and
-(Rootth reguistory fiemetiene inte one esency, not necesserfly suus.
office) _u Prefer CaCPD preposed new orgentretlonel concept thet recommendo samur ceneetidetten Itiinsis of ett redletten reputetery functlene et federet towet.. Revise em and f _,
rules. Propere edelte paper to use es e potley boele to cieerty defineote the respective authority isnd reopenolbilities of worious Federet and State agencies, Nether then revoke NRC's authority and repeet the Federot rep 4etions, such authersty' norytend should be empended to incorporate mRAM, and the Federet regulatione should be J timorsuply rewleved and amended to clarify regutetery reopensibility. Dans doec_ ret have piecessary espertise.
se not aipport elleinstion of ett espects of mRC's audical progreer, but seppert nossachusetts retesetien of overty prescriptlwe end __ a.wlty coetty regstrements. Sippert intent of single Federet egeecy providing a single teedevehlp role but de not sigpert-autemetIc setactten of SENS.'
The bests for the report's recessmendatione de not seem to be sidsstantleted. Ilie g ,,ee merging of att federot radiation centrot eversight late a sinate reputatory program should be considered. The set should cedience ttie partnerehtp uitti tfie states to jointly detenmine campatibility requireements.
39 Enclosure 2
s STRATEGIC ASSESSMENT ISSUE PAPER
,J
'DSI 12: RISK-INFORMED, PERFORMANCE-BASED REGULATION INTRODUCTION In August'1995, the Nuclear Regulatory Comunission (NRC) staff initiatedi aThis p <
Strategic Assessment and Rebaselining Project.take a new look at the NR order to redefine the basic nature of the work of the agency and tha means by 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 The and classific this work is accomplished. These issues fall into three categories.
first categcry includes broad issues defined as Direction-Setting Tss (DSIs). Subsumed issues are those that 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 consid a decision on the option (s) for n DSI. Also, as part of the project, other These are not strategic issues of an operational nature were identified. issues and are appropria the issue papars.
.Following the reassessment of NRC activities, issue papers were prepared to provide a discussion of DSIs and subsumed issues, and to obtain a re
'these broad, high-level issues.
discussion of the options as well as susunaries of the consequences of the Fir,a1 decisions related to the DSIs will options related to the DSIs. influence the related issues which are listed, but not dis issue paper. As part of the Strategic Assessment and Rebaselining Project, the issue papers are being provided to interested After parties a to provide a forum to discuss and receive coassent on the decisions concerning the DSIs and options. In sumunary, the Strategic Assessmen*.
to develop a Strategic Plan for the NRC.and Rebaselining Project will anal internal ar.d external f actors, and outline a path to provide direction to move forward in a changing environment.
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t I.- 5UMMARY-A. Direction-Setting Issue ,
The Commission has-established the policy that, to the extent practical, risk insights shall be incorporated into all- nuclear regulatory activities. As a result of this policy, the staff has developed a framework for applying probabilistic risk assessment (PRA) methods and techniques in reactor regulation (SECY-95-280, " Framework for Applying Probabilistic Risk Analysis in Reactor Regulation") in order to ensure consisttnt 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 pr 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 andithe event sequences would be less complex than the 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 commercial nuclear 4
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 proceed 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?
t s
RELEASE DATE: SEPTEMBER 16, 1996 2 DSI 12
- -- _ - -- - =_ . - . . . .- - -
RIGK-INFORMED, PERFORMANCE-BASED REGULATI DSI 22 ll The Commission's decision on this issue will lt ybe used t framework for "how fast' and "how far* the agen This paper provides four options for moving toward more approaches.
risk-informed, performance-based regulatory approaches. i Sample criteria for expanding the scope within the context of th direction are discussed in Appendix A.
B. Options.
0; tion 1: Continue Current Process The current process for pursuing risk-informed, Priority and scopeperformance-in determined could be characterized as an incremental process. Priority applying risk-informed, performance-based regulatory i approaches ily
, by balancing external and internal goals and available resources. f criteria (Appendix A) areThisapplied and approach covers boththereactor scopo o implementation, and available resources. in and nuclear materials areas but there is more a
' the PRA Implementation Plan (SECY-95-079). ,
More Rigorously Assess Relationship to Public Health and S Option 2: ld Before pursuing risk-informed, performance-basedhealth approaches require that for new initiatives, the NRC determine that there is potential for a substantial increase in overall Priority ches pr additional risk-informed, performance-based regulatory initiatives. d to and scope in applying risk-informed, performa benefit to the public health and safety. Priority criteria are weighted toward greatest qualified before proceeding.The scope of risk-informed, performance-bas all safety benefit. This/ benefit, t would be-primarily determined by considering the cost impact on the NRC and regulated industry, and available d resource option would provide additional focus for moving toward risk-in d performance-based regulation and potentially m DSI 12 3
SEPTEMBER 16, 1996 RELEASE DATE:
RISK-INFORMED, PERFORMANCE-BASED REN LATION OSI 12 Option 3:-
Perform-a Comprehensive Assessment of NRC Regulatory Approaches This is .a proactive, aggressive option for moving toward r,isk-informed, This option would maximize internal performance-based regulation.
self-assessment and include exploring all regulatory areas-to determine-whether risk-informed, performance-based regulation should be pursued in that area. . This approach would require a comprehensive review of our regulations and regulatory processes to determine areas that could Priority for be improved through risk-informed, performance-based regulatory The-scope of approaches, regula impacts on safety, burden reduction, and efficiency.
risk-informed regulatory approaches under this option would be determined by considering agency responsiveness to stakeholder initiatives, the safety benefit efficiency.
/ significance of the approach, and the effect on NRC and scoping considerations (i.e., if the activity.is determined to be a-high h
-priority then resources win be made available and efforts made to improve t e 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.
l This option-is the most responsive to industry and stakeholder initiatives.
- Priority and scope in applying risk-informed, performance-based *egulatory approaches implementation.
would be primarily determined by stakeholder The dem risk-informed, performance-based approaches to reduce regulatory burdens.
scope of risk-informed regulatory approaches under this option would beEase of im
[
primarily determined by nature of the initiative. cost / benefit play a approach. .
II. DESCRIPTION OF ISSUES A.--Background Since the early 1970s, the NRC has expended significant resources in theThis inc development and application of PRA technology.
breaking work of the Reactor Safety StudyLight (documented of of Risk Assessment and the Reactor Safety' Study Report (WASH-1400) in' the Risk Assessment Review Group Report" [ Risk Assessment Review Group Re NUREG/CR-0400). .In addition to addressing specific criticisms of WASH-1400 the 1979 policy statement articulated limitations in the use of PRA in the regulatory arena. Many of these limitations have been addressed, howevu, Pr some still remain pertinent today.
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characterizationPRA of methodologies uncertainties associated with calculated probabilities bye, however, provided a better means reactor accidents.for identifying and characterizing the range of uncertaint,y.
The Three Mile Island accident in 1979 substantially changed tne chara the analysis of severe accidents worldwide. In addition both major program on severe accident phenomenology.
investigations of the accident (the Kemeny and Rogovin studies) recosmo that PRA techniques be used more widely to augment thethe In 1984, traditional-NRC nonprobabilistic methods of analyzing nuclear plant safety analysis - techniques.
An In early 1991, the NRC published NUREG-1150, " Severe Accident Risks:In NU Assessment improved PRA for Five U.S. Nuclear techniques Powerthe to assess Plants."
risk-associated with five nuclear plants.
This study was a significant turning-point in the use of risk concepts in the regulatory process and enabled the Comnission to greatly improve its methods for assessing containment performance given core d initiation and subsequent accident progression. ~ The risk techniques.-
PRA methods have been applied successfully in several regulatory activit and have: proved to be a valuable complement to traditional d engineering approaches.
enhancement of traditional- regulation rather than a separate and different technology. Several recent commission policies-or regulations have been-These based, in part, on PRA methods and insights. Sft Goals for the
.(10 CFR 50.10g, "Backfitting"), the Policy Statement on " a e y Operatior, of Nuclear Power Plants,"d the(51 FR 30028; A
- Designs and Existing Plants" (50 FR 32138; August 8, '1985), an ;
Consission's " Final Policy Statement on Technica1' Specifications Impro PRA methods also for' Nuclear Power Reactors" (58 FR 39132; July 22,1993).h m (ATNS) were used effectively during the anticipated transient wit out scra l in-the and station blackout (580) rulemakings, and have beenbenefits Additional used have extensive y generic issue prioritization and resolution process.
been found in the use of " Risk-Based Inspection Guides" to focus NRC inspector efforts and make more efficient use of NRC inspection resource Probabilistic analyses were extensively used in the development of the recently proposed rule change to reactor siting criteria in 10 CF (5g FR 52255; October 17,1994),
' Shutdown Earthquake ground motion for a nuclear reactor site.
DSI 12 5
RELEASE DATE: SEPTEMBER 16, 1996 l
u
RISK-INFORMED, PERFORMANCE-BASED REGULATION DSI- 22 Curreni.ly; the NRC is Using PRA techniques to assess the safety importance of
.operattug reactor events and as an integralInpart of thethe addition, design certification 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 Commission's " Policy Statement on Severe Reactor Accidents Regarding Future Designs and Existing Plants") have resulted in connercial 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 acti'.' 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.
-power reactors had to be adapted to provide scenario analysis 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 Counission in SECY 218. " Proposed Policy Statement on the Use of Probabilistic Risk Assessment-Methods in Nuclear Regulatory Activities." In that Commission paper, the staff proposed that an overall policy on the use of probabilistic risk assessment (PRA) methods in nuclear regulatory activitias should 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 P,nd 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 coanercial power reactors, the NRC has additionally formulated guidance, as in the safety goal Thepolicy statement, safety 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.
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, DSI 12 _ RISK-INFORMED, PERFORMANCE-BASED REGULATION es noted strove, the Commission has been using PRA in performing regulatory analyses for backfit of cost-beneficial safety improvements' at operating reactors (as required by 10 CFR C0.109) for a number of yepts.
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 NRC are the Atomic Energy Act <
of 1954 (AEA), the Energy Reorganization Act, the Administrative Procedurcs 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 respon:;ible 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).
RELEASE DATE: SEPTEMBER -16,1996 7 -DSI 12-
- J
RISK-INFORME0, PERFORMANCE-BASED REGULATION DSI 12 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' activities Inspections to ensure that the activities are primarily are inin 10 discussed 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.
B. 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 committees may infmence the transition toward risk- informed, performance-based regulations. Translations between dote and risk usually use international consensus factors. In the nuclear materials area, NRC has traditionally used radiological dose as the endpoint for rulemaking and compliance assessment. That is, in certain nuclear materials areas, regulatory decisions are related to the acceptability of dose as a surrogate for risk. The International Commission on Radiological Protection (ICRP) dose limits reflect ICRP reconnendations 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.
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- 3. Federal Agencies The Environmental Protection Agency (EPA) has undortaken a, number of regulatory initiatives under its authorities that effect activities licensed or otherwise regulated by the NRC. Substantial cifferences have arisen between the two agencies and have irsluded 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 ways to
" harmonize" risk goals and to develop mutually agreeable approaches for risk assessment methodologies to assess radiological risk.
As previously discussed, the Paperwork Redu: tion Act of 1995 isIt tl.a basis for requires agency and OMB activities related to information collections.
controls to limit and reduce the burden on the public for collecting agency information. In 5 CFR 1320, which traplements the Paperwork Reduction Act, OMB requires agencies to submit plans for new, revised, and extended information collections to OMB for approval. However, the NRC, as an indepenoent 4
regulatory agency, may override OMB decisions.
- 4. Nuclear Industry In the reactor area, consnercial 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 burden, the industry is actively engaging the staff to seek relief. In the 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 en small number of licensees, and little perceived additional safety benefit.
- 5. Public The public will likely play a substantial roleIninorder the transition to-public to maintain risk-informed, performance-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
- 1. Nuclear Mav.ials Initiatives The Commission's decision on the future role ared scope of the NRC's nuclear materials program (in particular NRC's regulation of the medical use of nuclear material) will potentially affect the priority and scope for pursuing 9
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DSI 12 l
L risk-infomed, performance-based regulatory approaches in nuclear materials program areas. The National Academy of sciences recomended that the NRC i
)
reduce or eliminate its oversight of the medical uses of quclear material.
The basis for a decision regarding NRC oversight of the medical uses of
- nuclear material may affect the oversight and regulation of other material ,
licensees and, consequently, the extent to which the agency may pursue risk-informed, performance-based approaches. ine Business Process Reengineering effort is examining ways to gain efficiencies in licensing of nuclear materials and the results of this effort may affect the extent to
' which risk-informed, performance-based approaches could improve the effectiveness and efficiency of the licensing process.
- 2. Commission's PRA Policy $tatement 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 proceeding toward risk- informed, performance-based regulatory approaches (e.g., more 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 i The Commission has recognized that reliance for safety should not be placed on-any single element of bs'gn,-construction -operation, maintenance, training or other activity assM ted 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 .
cumulative effect of reducing conservatism and providing additional flexibility on defense-in-depth. Performance-based initiatives are considered ifor 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.
_p erfomance-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.
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- 4. Policy and Legal Issues: . Compliance with Performance-Based Regulations Substantive policy and legal issues are likely to emerge as increased relisnte 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 determining compliance with performance-based regulations will need to be addressed 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 Discussion of Direction-Setting Issue
' A.
The Commission's decision on this direction-setting issue will be used to establish the overall framework for expanding agency activities in applying 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 enforcement activities can be applied in the context of the overall Commission 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 nuclear materials areas. However, given the diverse nature of nuclear materials applications and the differences between connercial nuclear power and other nuclear materials areas in regard to their amenability for risk-informed, performance-based regulations, these criteria may need to be 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 pursuing risk-informed, performance-based regulatory approaches.
I B. Discussion of Subsumed Issues After the Commission decides on the overall approach for pursuing risk-informed, performance- based regulation, six subsumed strategic issues will be resolved in the context of the overall direction. Four of these subsumed 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 Coenission decision on this direction setting issue.
The four issues most directly resolved through implementation of the Commission decision for 'how f ast* and 'how far" the agency will go in expanding activities in the application of risk- informed, performance-based regulatory approaches are:
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- What should be NRC's strategy and philosophy with respect to chPnging NRC's responsibilities and authority in areas of little public risk?
- What approach should NRC take in modifying the materials regulations to seve 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 technolog< cal 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 Commission'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 (AEA), as amended, to provide reasonable assurance of an adequate level of protection of the public as well as to promote the coamen defense and security, in health its regulatory-act and safety,ivities. Although the scope of actions nscessary to attain this level of protection from the use of AEA natorials 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 contumer products, the definition and regulation of source material, review of fomerly licensed sitesAs and the agency stabilization ard long-term control of uranium mill tailings.
seeks to improve the efficiency and effectiveness of its regulatory programs, these low risk activities will bt scrutinized in order to make informed decisions about how the agency should proceed.
The Counission's philosophy for considering changes to its regulatory 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 Commission 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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First, that the NRC staff, licensees, licensee applicants, and Commission must be prepared to consider changes to regulations, to l
to the licensing process, and to,the inspection guidance documents,he NRC staff and the Commission must be committed to program. Second, t a shift in the application of resources over a period of time based on risk findings.
The current agency-wide strategy for increasino the use of risk assessment and risk management in regulatory decision-making us captured in the agency's PRA Implementathn Plan. Therefore -the commission decision on "how fast" and
'how far" the agency shculd go in axpanding activities associated with the application of risk-informed, performance-based regulatiry approache:, will '
further define the approach and-support the bases for considering changes to regulations, responsibilities and authorities.
The third issue explicitly recognizes the diverse nature of nuclear materials applications and the differences between reactor and nuclear materials areas in regard to their amenability for risk- informed, performance-based regulations. For example, events associated with industrial and medical uses of nuclear materials generally involve a simple system involve radiation overexposures, and result from human error, not equipment failure. Because of these characteristics of medical and udustrial events, analysis of these events using relatively simple techniques may yield useful results. These results may lead to the establishment of standards wth broad risk-informed, performance-based objectives and criteria.- Converr.41y, these results may lead to a conclusion that more prescriptive requirements for equipment design and procedural compliance are appropriate. In these cases, risk insights lead to risk-informed, deterministic regulations not risk-informed, performance-based regulations. Similar to the first subsumed issue, this subsumed issue will also be resolved by the Commission's decision on this direction-setting issue and the aforementioned direction-setting issue concerning regulation of nuclear materials.
The fourth subsumed issue concerns 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 relatively high-risk irradiators. Although the Commission must license all of these uses in response to the AEA, the Commission has flexibility in how it approaches the licensing. Currently, the Commission provides for three types of licensing: (1) exempt distribution.-(2) general licenses, and (3) specific licenses. For exempt distribution devices (e.g., smoke ditectors), the 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 external factors and ongoing activities has not identified any strategic issues associated with exempt distribution devices.
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The ponerally 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 regulatio jurisdiction of the Agreement states and the NRC. devices is essential :
database, which contains the names of the general licensees and the products they possess. For general licenses, issues associated with control and accountability were discussed in SECY- g5-139, which reports that many general licensees are not aware of their responsibilities under the general license.
The staff has previously noted that there are inconsistencies in terms ofFor example,-
l 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 tionidentified certain from regulation.
-fenerally n this regardlicensed and in accordance deviceswith that are suitable contained recossmendations for exemp in :
-5ECY-95-13g, the staff has established a joint Agreement State-NRC working t group to evaluate the current regulations enncerning generally andA 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 Commission decision on this direction-setting issue and 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).
A fifth subsumed issue concerns the information necessary -
for developing and The subsumed issue ,
implementing risk-informed, 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 collection without compromising public health and safety?
The paperwork Reduction Act of 1995 It requiresis thecontrols basis for to limit agency and OMB activi 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, OM8 requires agencies to sub plans approval.
for now, revised, and extended information collection By majority vote, the Commission can choose not to abide by by OM decisions.
an OMB decision.
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i The new Paperwork Reduction Act sets a goal of 10-percent annual reduction in information collections for '1996 and 1997 followed by a 5-preent reduction each year in 1998, 1999, 2000, and 2001. It is uncertain now OMB will 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 any additional burden through new or amended collections. This could affect i
the rulemaking process, especially since risk-informed, performance-based L regulatory approaches may well require licensees to collect more information for the NRC.
The Commission's decision on expanding _. agency activities in applying risk-informed, performance-based regulatory approaches will influence the extent and impact of additional information requirements. In response to several comments concerning the potential data collection implications of the Commission's PRA Policy Statement, the Commission 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 42626). The Cosmission also indicated that, in the context of r'.sk-informed regulation,ill this was an implementation issue and that data and information collection w l be addressed in connection with proposed data collection requirements an the '
requirements are published for consent.
I In a strategic sense, information collection requironients and burdens should not define the direction that the agency takes regarding risk-informed, perfomance-based approhches. Regardless of . the option selected for proceeding toward risk-informed, performance-based regulatory approaches, the 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, (2) wait until.
0MB puMishes its guidance to agencies for implementing the provisions of the new paperwork Reduction Act and address any issues on a case-by-case basis with each rulemaking. -or (3) rept,rt NRC's case to OMB now and request a level or increased ceiling to accommodate future information collection needs -
associated with risk-informed, performance-based regulatory approaches.
Finally, a sixth subsumed issue concerns interagency implications associated with moving toward a more risk-informed, performance-based regulatory framework. Specifically:
- How should a risk-informed, performance-based reguistory philosophy influence NRC's handling of dual regulation?
As previously mentioned, 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
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RISK-INFORMED, PERFORMANCE-BASED REGULATION D$! 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 entitled ' White paper on Risk Hansenization' to help explore ways to ' harmonize' risk goals and to develop mutually agreeable approaches for risk assessment methodologies to assess l
radiological risk.
As the NRC and other. government agencies move toward more risk-informed,
' performancebased regulatory approaches, the use of risk insights should help promote a common understanding of the technical bases for regulatory approaches. The cc . son desire for increasing the use of risk in a11 yovernment agencies helps define the common goals, but there is substantial interagency work necessary to ensure that there is a systematic interrelatedness among approaches- and mutual understanding and agreement on the underlying bases for-the regulatory approach, including agreement en key policy issues, such as agency safety goals, and technical issues confronting the agencies. The Counission decision on "how f ast" and "how far" the agency should to-in expanding activities associated with the application of risk-informed, performance-based regulatory approaches will further influence the l
' level of agency resources devoted to reconcile difforences 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 common 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-Based," " Risk-Informed, Deterministic-Based,' " performance-Based," and " Risk-Informed, performance-Based
- Deterministic-based.
The NftC has generally regulated the use of nuclear material (including nuclear materials and reactors) based on deterministic a>proaches. Deterministic approaches to regulation consider a set of esallenges to safety and specify how those challenges should be mitigated.
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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 facilities, t
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i RISK-INFORMED, PERFORMANCE-BASED REGULATION x DSI 12 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 recuirements are largely based on deterministic engineering criteria. In adcition, this approach assumes that adverse conditions can exist (e.g., equipment failures and human errors) and establishes a set of design basis events. It then requires that tha 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 exampler reactor vessel rupture is considered too improbable to be included as an accident to be analyzed. However, the litelihood that a single emer pncy core cooling system or system train would not function was considered high enough that safety train redundancy and protection against single failure where required.
Risk-informed, deterministic-based. A risk-informed, deterministic approach to regulation enhances and extends this traditional, deterministic approach, by: (a) allowing consideration of a broader set of potential challenges to safety,-(b) providing a logical means for prioritizing these challenges based on likelihood and risk significance, and (c) allowing consideration of a broader set of resources to defend against these challenges. A risk-informed approach can be used to focus deterministic regulations by considering risk in a more coherent and. comprehensive manner. By ct,nsidering risk insights, operating experience, and engineering judgment, the NRC and its licensees can focus regulatory approaches and licensee activities on those items most important to public health and safety. Where appropriate, a risk-informed regulatory _ approach can be used to reduce unnecessary consorsatism in deterministic approaches or can be used-to identify areas with insufficient conservatism and provide the bases for additional. requirements.
Daterministic-based regulations have- been successful in protecting the public health and safety and risk insights are most valuable when they serve to' focus the deterministic- based regulations and support the defense-in-depth philosophy.
Performance-based. A performance-based regulatory approach requires at least four key elements:
- There are measurable parameters to monitor acceptable plant and licensee performance.
- Objective performance criteria are established to asses,s performance.
- . There is licensee flexibility to determine how to meet established performance criteria.
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- Failure to meet a performance criterion must not result in unacceptable consequences.
- In theory, a performance-based approach can be impicmented without the use of t risk insights. This-type of performance-based approach would require that objective performance criteria be based on deterministic analysis _ and f
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 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 1 significance and permitting the licensee additional flexibility in meeting the regulation, performance-based initiatives can be considered for activities l where objectivo performance criteria can be established for performance monitoring. Additional. evaluation of performance-based approaches may result i
in a determination that a number of functional areas are not arenable to ~
- performance-based treatment. ,
The NRC Inspection Manual has tailored the concepts of-' risk-informed" and
" performance- based" for inspections into a single definition of j
" performance-based inspection." According to Inspection 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 accosmodate these limitations by imposing prescriptive, and what was l SEPTEMBER 16, Igg 6 18 DSI 12
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hoped to be, conservative regulatory requirements. A probabilistic approach has exposed some of these limitations and provided a framework to assess their i
significance and assist in developing a strategy to accommpdate them in the regulatory process.
Human performance is an important consideration in both deterministic and probabilistic approaches. Assessing the influence of errors of commission and organizational and management issucs 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 PRA framework offers a powerful tool for logically and systematically evaluating the sensitivity and importance to risk of these uncertainties. Improved PRA techniques and models to address errors of commission and the influence of organizational factors on human reliability are currently being developed.
Given the dissimilarities in the nature and consequences of 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 regulatory process may not be appropriate. However, PRA methods and insights 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 regulatory coherence will also reduce uncertainty in regulatory decision-making.
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- 3. Regulatory Coherence Regulatory coherence-is essential in order to ensure that the direction the Commission takes in expanding agency activities in applying risk-informed, performance->ated 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 consnstant pattern or framework-(b) implementation of risk-informed, performance-based approaches in a suitable or orderly way that promotes and ensures mutual understanding (c) development of risk-informedi performance-based approaches that are governed by rational principles and that ensure systematic Enterrelatedness.
The commission has recognized the importance of coherence for increasing the use of PRA and the Commission's policy statement on the use of probabilistic risk assessment methods in nuclear regulatory activities (60 FR 42622)-
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- e RISK-INFORMED, PERFORMANCE-BASED r.EGULATION DS! 12 Through the "PRA Implementation Plan" the promotes regulatory coherence. staff monitors PRA-related activities and helps ens of PRA methods and techniques. The PRA Implementation P14n explicitly contains activities that have, as a principal goal, the achievement of regulatory coherence. -Recently, the schedule for completing several activities in the PRA Implementation Plan dealing with regulatory guides and standard review plans (SRPs) for reactor pilot applications Arguably, have been the accelerated to-improve and promote regulatory coherence.
increased use of PRA methods and techniques itself promotes regulatory 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.
Another way that the Cornission is promoting regulatory coherenceThe for safety operating reactors is through the safety goal policy statement.
goal policy statement uses quantitative, probabilistic risk measures and establishes top-level objective; to help ensure safe operation of nuclear power plants. The safety goals provide guidance on where risk is sufficiently low that further regulatory action is not necessary. The concept ,
of a " safety goal" has not been firmly established for NRC licensees, other 1 than commercial power reactor licensees.
Eventually, the Commission could consider rulemaking, adoption of a national standard for performing PRAs, or more detailed regulatory guidance to help ensure uniformity in the quality and application of risk-informed, performance-based regulatory approaches. The Commission and senior NRC sanagement 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-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 guidance for both the NRC and the regulated industry. The Commissi n could encourage industry /stakeholders to develop solutions or processes that help -
ensure regulatory coherence. To help enscre regulatory . coherence for industry .
processes or industry application of a risk-informed, performance-based -
approach, a part 6f the burden could be assumed by the regulated industry.
For example, if. the varying levels of quality for individual PRAs contribute 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 4 the direction the Comission takes to expand agency activities in applying risk-informed, performance-based regulatory approaches promotes a stable and predictable regulatory environment.
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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 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 balancing external and internal goals with available resources. Priority 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 banefits for reducing unnecessary industry burden, enhancing safety decision-making, and improving staff efficiency are more readily apparent. Consequently, resources in the 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 nucitar material areas will significantly benefit from implementation of risk-informed approaches. As a result, in the PRA Implementation Plan, there is less amphasis 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 RELEASE DATE: SEPTEMBER 16, 1996 21 DSI 12 4
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discussed .in the PRA Implemntation Plan, such as risk- informed performance-based changes to containment leakage requirements, fire protection requirements, and maintenance rule implementat' on. The PR$ Implementation plan pilot applications dealing with inservice testing of pumps and valves and inservice inspection contain performance-based aspects. As data from :
performance monitoring of structures, systems and components are accumulated and made available to the agency, the staff evaluates the performance data, where appropriate, to determine the offsetiveness cf 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 activities under the PRA Implementation Plan. As areas amenable to '
risk-informed, performance-based regulation are. identified and as ruources become available the staff may initiate rulemaking. In the nuclear materials areas,technologIcalchangesandchanginghumanfactorsmayaffectthespeed and scope of risk- informed, performance-based revisions to regulations. In areas involving dual regulation, the current emphasis and level of activity devoted to resolving issues affected by dual regulation would continue and the ,
pace of these activities would be consistent with the safety benefit, the ease
-of implementation, and available resources, since this option is the current process, no change in resource allocation is ,
necessary to implement it. The resource and programatic consequences are .
gradual . and incremental .
Option 2: More Rigorously Assess Relationship to Public Health and Safety ,
similar to the continue current Process option discussed above, this option would primarily continue the current approach for moving toward more risk-informed, performance-based regulatory approaches. However, under this 1 option, the relationship of new activities to public health and safety would i need to be more rigorously assessed. The results of this safety assessment In other words, would determine whether the agency would pursue the activity.
those activities where there could be a substantial increase in overall protection to public health and safety will be given the highest priority.
Underlying both this option and the continue current Process option is the asstamption that our regulations and current regulatory processes are adequate, and will continue to be adequate, to protect public health and safety.- The Continue Current Process option pursues enhancement to current regulatory processes through risk-informed approaches to regulation, _ is exploratory in nature and app 1tes a threshold for pursuing such activities. This option also pursues enhancements to our current regulatory processes through risk-informed approaches to regulation. However, this option is more narrowly focused than Option 1 and applies a higher threshold for pursuing activities.
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RISK-INFORMED, PERFORMANCE-BASED REGULATION s DS] 12 Under Option 2, priori.ty and scope in applying risk-informed, performance-based regu?dtory approaches woulo De priniar;ly ' determined by the projected cost of the approar.h comparwd to benefit to the public health and safety. Many intangibles would have to te anal / zed, at Isast qualitatively, and a methodology developed in order to provide a raeaningful 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 regulation 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-inforsed, 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 counercial 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, pe formance-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, perfonaance- based regulation. This option would maximize internal self-assessment and include exploring all regulatory areas to determine whether risk-infomed, performance-based regulation should be pursued in that SEPTEMBER 16, 1996 23 DSI 12 RELEASE DATE:
l RISK-INFORMED, PERFORMANCE-SASED REGULATION 0$! 12 area. The purpose deterministic regulations. for the review under Option 3 is not just to enhance our change, in a comprehensive manner, the bases to our regulations and process for those areas that are amenable to a risk-inforr.ed, performance-band approach.
Under Option 3, priority-for regulatory activities would be established based .
on consideration of the cumulative impacts on safety, burden reduction, and efficiency. The scope of risk-informed regulatory approaches under 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 ileplementation and available resources are secondary scoping considerations (i.e., if the activity 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 goal).
In the reactor araa, the staff and industry have already identified several areas that may be conducive to risk-informed, perfermance-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 Group (RRG) to conduct a structured review of power reactor regulations with special attention on the opportunity to reduce unnecessary regulatory burdens.
The RR4 recommendations to reduce the regulatory burden included the suggestion to use more risk- based approaches in quality assurance, inservice inspection, and inservice testing.
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 Business process Reengineering 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 prioritize those areas that are amenable to a risk-informed, performance-based approach. - As- a result of this assessnont, a framework, similar to the
-framework for applying PRA in reactor regulation in SECY-95-280, 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.
performance-based approach, this option is the most resource intensive option.
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Additional resources would be needed to train the staff, develop a strategy
< for review, complete the assessment, and implement rulemaking or procedural changes. ,
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 approaches. including agreement on key-policy issues, such as agency safety goals, and technical issues confronting the agencies.
Because h 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 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 Primarily in i- 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 option, 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 maintaint an acceptable level of safety. Staff and industry efficiency may be collateral benefits of this approach.
Another potential consequence of selecting this option is that the agency could be perceived to be reactive and not making the best use of available 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 the future there might be a substantial burden associated with
- ramping-up to speed" to deal with emerging 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 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 level. Direction-Satting Issue.
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- What is the appropriate level of resources that the NRC should devote over the next few years to reduce the number of licensing requirements no longer required for safety and to develop risk-informed, performance-based approaches in order to achieve long-term reductions in the resource burden of both the licensee and the hMCf
- What levels of residual radioactivity are acceptable for decommissioning a materials licensed facility?
VI. COMMI6510N'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 viewe are:
The Commission '.ecognizes that, in order to accomplish the principal mission of the NRC i,i an efficient and cost effective manner, it will in the future have to focus on those regulatory activities that pose the greatest risk to the public. This can be accomplished by building upon 1robabilistic risk assessment concepts, 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.
The staff should continue with the current efforts, in cooperation with the industry (Option 1), including pilot programs. The objective of this initiative is to ottain additional information regarding the appropriateness of a rfsk-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 performance data to deterwine the effectiveness of the approach on the subject activity.
The staff should proceed in the direction of 6nhancing the PRA Implementation Plan (i.e., moving towards implementation of elements of option 3) by building on the Regulatory Review Group's (RRG) results, which were initially focased on reducing the regulatory burden, with a more focused assessment of those regulations which are amenable to a risk-informed, performance-based approach.
In detemining the priority and scope of regulatory activities to be included in moving in the directioil of partial implementation of option 3, the staff i should consider the cumulative impacts on safety, stakeholder initiatives and burden reduction, and the effect on NRC and licensee efficiency. This
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. .s approach should result in a further focusing of resources, on the various areas that the Cossaission regulates, that is cormensurate with its risk significance, potential burden reduction and effect on eff,1ciency. r The staff should evaluate and clarify any technical and/or administrative j
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 minissi additional effort / resources, amenable to a risk-informed, performance-pased approach. This assessment should eventually lead to the development of a framework for applying PRA to nuclear material uses, similar to the one developed for reactor regulation (SECY-95-280), where appropriate.
In the public consnents on this issue, the NRC particularly solicits how NRC should deal with dual regulation when applying a risk-informed, Performance-based regulatory philosophy.
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- Appendix'A sample Criteria for Determining the Priority And Scope Within the Context of the strategic Direction l- I. Applying the criteria p The weighting of criteria to determine 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 Commission chooses for proceeding toward a risk-informed, performance-based regulatory framework.
Several sample criteria for establishing the scope and priority in applying a risk-informed, performance-based regulatory are discussed under this issue paper. Except as noted, the criterta 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 activity to the agency's connitment to good regulation. Priority criteria 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 unnecess.ary requirements?
Efficiency: To what extent will the activity promote a better use of staff or industry resources by focusing on those -
activities that are more important to safety?
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!!!. Scoping Criteria l
l Scoping criteria can be broadly defined by the extent end, timing of the I 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: 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 saftty.
Efficiency: Scope is determined by the extent needed to achieve the desired impact on staff efficiency.
Cost / Benefit: Scope of an activity is pursued to the extent that is supported by a cost / benefit analysis. The scope of an activity may be estabitshed to optimize the cost / benefit ratio.
Public Scope of an cctivity is limited to those areas that the confidence: public it willing to support.
Largest Impact: Scope is determined by the extent needed to provide a large-scale programmatic or systemic impact.
Avail 4ble 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. J
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- ACRONYMS e
AEA Atomic Energy Act of 1954 ATWS anticipated transient without scram BPR business process reengineering DSI direction-setting issue EPA-Environmental Protection Agency ,
ICRP international Commission on Radiological Protection IPE Individual Plant Examination IPEEE Individual Plant Examination-External Events OMB Office of Management and Budget PRA probabilistic risk assessment RRG Regulatory Review Group
$80 station blackout SNM special nuclear material SRP standard review plan 4
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