ML20055D033
| ML20055D033 | |
| Person / Time | |
|---|---|
| Issue date: | 06/29/1990 |
| From: | Curtiss J NRC COMMISSION (OCM) |
| To: | Geoffrey Miller HOUSE OF REP., INTERIOR & INSULAR AFFAIRS |
| Shared Package | |
| ML20055D034 | List: |
| References | |
| FRN-53FR49886, RULE-PR-CHP1 CCS, NUDOCS 9007030124 | |
| Download: ML20055D033 (8) | |
Text
{{#Wiki_filter:t > ~ + ? o { (4,p>p un s q{' jo UNITED STATES y NUCLEAR REGULATORY CGMMISSION g, t-WASHINGTON, D. C. 20066 ?%,,, g$ June 29, 1990 CHAIRMAN The Honorable George Miller 3: Committee onnInterior and Insular Affairs United States; House-of Representatives: Washington D.C. 20515 i
Dear Congressman Miller:
As promised dn Chairman -Carr's letter of June 22, 1990', I-am providing the information and documents you requested relative to the development of NP.C's policy-statement on below _i regulatory. concern.(BRC). 1 s Enclosed are copies of the Commissioner notation votes on i SECY-89-360;icopies of all drafts of the policy statement developed since January 1, 1990; a copy of IAEA Safety-y Series 89, " Principles for~ the Exemption ~of Radiation Source.s-1 and Practices'from. Regulatory Control"; and.a list of all'NRC-professional' staff who worked on the BRC-policy since January 1, 1986. 1 Also enclosed is a narrative which describes the staff's l preparation of;the BRC' policy for Commission review. The origin of the change in the individual dose criteria from 1 millirem to 10Emillirem per year and the individuals involved in this aspect of the-policy's. evolution are_addr.essed-i i I trust that this information is fully responsive to your request.- i Sincerely, i 12.Dbs l 1 mes R. C'urtiss l Acting Chairman
Enclosures:
As stated cc: Rep.-Morris Udall Rep.' Don Young. I e c o9ei g 7 y n Lg X
4: f t DEVELOPMENT OF BRC-POLICY STATEMENT Three offices were involved in development of the BRC Policy Statement.. These were the Office of Nuclear Regulatory Reseirch (RES), the Office of Nuclear Materials Safety and Safeguards (NMSS), and the Office of Nuclear Reactor Regulation (NRR). At the time the proposed policy was developed in 1988, the Directors of these offices were, respectively, Mr. Eric Beckjord, Mr. Hugh Thompson, Jr., and Dr. Thomas-L. Murley. The 0ffice-of Research had the lead for preparation of the policy statement, and NMSS and HRR provided technical support, and reviewed and concurred in the-proposed policy. Mr. Beckjord's principal advisor was Dr. Bill Morris, Director, Division of Regulatory Applications. Dr.' Morris directed Mr. William Lahs, Acting Chief of the Regulatory Development Branch, in the preparation of the policy. Dr.- Themis Speis, one of the Deputy Directors of RES, also had oversight' responsibility for the effort. Dr. Murley's principal advisor was Mr. Frank Congel, and Mr. Thompson's principal advisors were Mr. Robert Bernero, Mr. Richard Cunningham, and Dr. Donald ' Cool. These individuals agread that 1 millirem per year. (mrem /yr) was an-i acceptable value for the individual dose-criterion of the policy; that is, a dose level at which it could automatically be concluded that no further-1 effort, including cost-benefit analysis, would be needed.to' reduce exposures.- In doing so, it was-also agreed that exemptions could be granted on the basis of higher individual doses provided the dose was .I below' the dose limits in 10 CFR Part 20 and was as low as reasonably achievable. ) When the proposed policy in this form was forwarded to Victor Stello~ Jr., then Executive Director for Operations, Mr. Stello. called a: meeting to discuss the proposal. He questioned whether the proposed individual dose-H criterion value of 1 mrem /yr would provide sufficient flexibility,in practical application of the policy.' The question of whether higher values, including 10 mrem /yr, would constitute a threat to health -and safety of the public was also ~ discussed. Some at the meeting. thought that selection of dose criteria nearer 1 mrem /yr would be more consistent with existing or proposed dose criteria' of other organizations both within and'outside:the U.S..and hence less controversial as a policy element. At that. meeting, the only possible safety basis for selecting 1 mrem over 10 mrem identified was the possibility that exposure to 10-mrem doses from multiple practices could result in doses approaching or perhaps exceeding the 100-erem/yr_ public-. dose limit in. proposed revisions to 10 CFR Part 20. However, no one could identify plausible ways for this to happen. Mr. Stello directed the staff to modify the policy to adopt a 10-mrem /yr individual dose criterion. The Office of Research did this and transmitted the policy to NRR and NMSS for concurrence. P f
4 'NRR concurred but Robert Bernero, Acting Director of HMSS in the' absence of-Mr. Thompson, wrote a memorandum to Mr. Stello expressing his concern'that. under the policy, exposure to sources of radiation for multiple exempted practices could lead-to doses approaching 100 mrem /yr, the public dose limit in proposed.10 CFR 20. Mr. Bernero did not concur with the policy on that basis. A meeting was then held by Mr. Thompson with NMSS and RES in order to understand the-safety concern and, if appropriate, develop-a revision to the policy that would resolve concern. A revision to the policy was developed which included. specific policy elements, such as broad definition'of practice,, implementation of a collective dose criteria, and the commitment to review each exemption to assure that the effects of multiple practice were thoroughly evaluated prior to approval:of.a'new practice. This change provided assurance that significant' exposures _to-multiple practices would be unlikely. On that basis, Mr. Thompson-concurred:in the policy for NMSS, and Mr. Bernero and the other staff mentioned above,also concurred. 'It is worth noting that the final BRC policy is a further evolution'of the numerical criteria that provides even. greater protection than the proposed version of the policy. f r
9 NRC PROFESSIONAL STAFF WHO HAVE WORKED ON THE BRC SINCE 1986 EDO James. Taylor James Sniezek r Hugh Thompson-Lidia Roche George Pangburn Kathleen Black Mat Taylor Victor Stello (left Agency) Research' Donald Cool o William Lahs Donald Hopkins Catherine Mattsen ~ Shlomo Yaniv Frank Costanzi StanleyNeuder(leftAgency) Eric Beckjord Themis Speis Clemens Heltemes Bill Morris Zoltan Rosztoczy (sabbatical) Robert Alexander--(left Agency) James Malaro Alan Roecklein Carl Feldman NMSS Robert Bernero Guy Arlotto i Richard -Cunningham Glen Sjoblom John Austin ^ John Hickey - Regis Boyle Mike Bell (IAEA)- LelandRouse:(deceased) Jerry Swift Ed Shua Chad Glenn Mike Lamastra Pat Vacca Cynthia Jones 3.- John Greeves Richared Bangart I a 4 --~
_j j l NRR Thomas Murley-Frank Miraglia Charles Willis. Frank Congel Lemoine Cunningham . John Buchanan WayneMeinke(retired)- Ollie' lynch (leftAgency)) Ed Brannagan (left Agency RichardStarostecki(leftAgency) OGC William Parler. ' 1 Stuart Treby Jane Mapes Martin Malsch Robert Fonner Joseph Scinto s 4 { 4 Governmental and Public Affairs Harold Denton-Sheldon Schwartz Carlton Kamerer Fred Combs Vandy Miller Donald Nussbaumer (retired) Kathleen Schneider Cardelia Maupin Sprios Droggitis Rosetta Virgilio Office of Congressional Affairs Dennis Rathbun Tom Combs Advisory Comittee on Nuclear Waste Dade Moeller Martin Steindler William Hinze Clifford Smith (left Consnittee) Richard Major Raymond Fraley ' Richard.Savio Owen Merrill (left Comittee) i
y i '9 f Regional Offices' l Region I i Tim Martin I Malcolm Knapp Ron Bel 1any Marlene Taylor Region'II' - Phil:Stohr Doug Collins-Bob Trojanowski -Region III' N Carl Paperiello Chuck Norelius ~ Bill Axelson Roland Lickus I Region IV Bill Beach Bill Fisher Charles Hackney Region V s Ross Scarano Greg Yuhas l l' Dean Kunihiro N t c {; t . i i'.;
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.1 'a l j, COMISSION OFFICES' T' Kenneth Carr i ' Margaret Federline u Michael Weber L Karen Cyr Stephen Burns George Felgate (left Agency)- Thomas Roberts. Maria Lopez-Otin ' Charles Ader ~ t Forrest Remick. 1 " Rob MacDougall Brad Jones (left Agency) Kenneth Rogers ~Gail Marcus Susan Bilhorn - James Curtiss Joe Gray. Kitty Dragonette . Janet Kotra Lando'Zech Dennis Rathbun Janice Dunn-Lee SECY- . t - Samuel'Chilk - I John' Hoyle Andrew Bates l - Ann Tipton r 1 s i F .. ~, m-4
s. q ff'ag,; NUCLEAR REGULATORY COMMISSION UNITED STATES f;, j f i WASHINGTON. D. C. 20035 l j. a ~ July 9,: 1990 L o,,,,, o, yg, t SECRETARY - o NOTE FOR: Document Control' Desk FROM: Correspondence & Records Branch I The enclosedidocument(s) fare.-to be entered h j into the OCS. -An advanced has'been sent to the Public Document Room.o r z. PLEASE PROCESS AS ONE. DOCUMENT i f t-i 1 .k t -i I ~ .1 .q 4 l f 5 i 3 l ll Y--
-:A FLF I R M A T-I'0 N 'V 0 T E-s,- RESPONSE SHEET 1 TO: SAMUEL J. CHILK, SECRETARY OF THE COMISSION ~ FROM: CHAIRMAN CARR
SUBJECT:
SECY-89-360 - COMISSION POLICY STATEMENT ON EXEMPTIONS FROM; REGULATORY CONTROL i APPROVED w/ comment DISAPPROVED - ABSTAIN Nor PARTICIPATING REQUEST DISCUSSION COMENTS: Seeattachedcommentsh' l a i i $m SIGNATURE +. 0 % DATE ENTERED ON "AS" YES k No e r. m. l d9 k 0/
1 C Chairman Carr's comments on SECY 89-3603-I approve of.the revised version of the Commission's BRC' policy-statement included as an attachment to this vote. The policy statement has been revised to (1) clarify my views and address staff concerns about' justification of practice, (2) summarize the-need for the BRC policy, (3) describe my concept of an exemption from regulatory control in accordance with the criteria in the i policy, (4) clarify my position on the need for establishing.a uniform and consistent framework for' regulatory exemptions of radioactive materials, (5) incorporate staff's recommended revisions to reflect consideration of BEIR V, (6) incorporate. revisions suggested by Commission staff and-Dr. Moeller of the ACNW, and (7) improve the general clarity and presentation of the policy statement. I agree with staff that certain practices, such as the purposeful introduction of radioactive materialLinto children's toys, should not be considered acceptable candidates for exemption because of the' increased risks and uncertainties associated with the resulting doses. I_also believe that the j Commission's BRC policy is consistent with the three funde. mental 1 tenets of radiation protection-as appropriate for the low doses and dose rates typically associated with' exempted practices. Justification decisions involving. complex social and cultural. value judgments suould rightfully be made by affected elements of society because they involve considerations.that. fall outside of - the' Commission's health and safety and environmental protection
- purview, once the commission has completed its deliberations on the BRC policy statement, I urge staff to_ proceed expeditiously with its program for disseminating information on the BRC policy to Congress, media representatives, other Federal agencies, State and. local authorities, Indian Tribal organizations, and the public.. The success of the BRC policy will.be determined,'at.
least in-part, by NRC's ability to communicate the basis and need L for the policy with these groups. Accordingly, I;believe that a l working group of NRC managers should be established-to develop and implement a comprehensive strategy'for releasing'the BRC 6 policy. The working group should include-representatives of all involved Commission and staff offices.
- In addition to such activities as conducting pre-release. briefings for CongressiBeal staff and other Federal and. State _ agencies (including; EPA, DOE, j
FDA, CPSC, Agreement States, and affiliated organizations), the i i l working group should arrange internal workshops to prepare NRC L Headquarters and Regional' staffs for responding to inquiries t about BRC. The working group should also coordinate the' 1 development and release of information about BRC, such aus the BRC-r pamphlet already developed by Public Affairs. I look forward to staff's rapid progress in implementing the BRC. policy, including establishment of interim residual radioactivity criteria for decommissioning and assessing existing exemptions for consistency with the BRC policy. These efforts will not only enhance the coherence-of NRC's regulatory framework, but may also
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encourage the use of a consistent rick basis in other' areas of the Federal government's regulatory framework for protecting-the i i .public and the environment'from a var ety of r sks. Staff should also_ develop a program for systematically assessing existing NRC exemptions (as directed in the October 13, 1989 SRM) to evaluate their consistency with the criteria and provisions of'the BRC-policy and for developing a framework of new regulations aml guidance to implement the BRC policy (e.g., residual i radioactivity limits-for decommissioning, waste exemptions, i ~7 regulations to establish a framework for exempting consumer-products).id w4S-)%o i I i.
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b (7590-01) 4 NUCLEAR REGULATORY COMMISSION Below Regulatory Concern; Policy Statement AGENCY: Nuclear Regulatory Commission. ACTION: Policy statement,
SUMMARY
This policy statement establishes the framework withi which the Commission will make decicions to exempt from some n all regulatory controls certain products and, activities invol i or small quantities of radioactive material-that are below v ng regulatory concern. The exemptions may involve 1the release of ) licensee-controlled radioactive material either to th \\ e generally I accessible environment or~to persons who would be' exempt f rom Commission regulations.- Activities for which, exemptions may be [ granted include but are not limited to (1) the rel( .e for 1 unrestricted public use of lands and structures containingl i resioaal radioactivity, (2) the distribution of consumer products containit.7 small amounts of radioactive material (3) the disposal of very low-level radioactive-waste at oth ~ er than licensed disposal: sites, (4) the recycling o'f slightly contaminated equipment and materials,~and (5) g the release of effluents from licensed facilities. As described'in'this policy 1 i
a statement,-NRC intends to exempt specific practices'from regulatory control if the practice results in;small doses to { individuals and the population'at large and if availabl e controls cannot achieve reductions in-these doses-that are commen with the public and private resources needed to implement the controls. The policy statement defines the dose-criteria and other considerations that-will be used1by NRC in making exemptioj decisions. n The policy establishes individual-dose: criteria (l' and 10 mram per year (0.01 and 0.1 millisieverts per year)) and collective dose criterion (1000 person-rem per year (10 person a Sieverts per year)). These criteria, coupled with other considerations enumerated in the policy statement,will be major factors in the Commission's determination on whether ex emptions from regulatory controls will be' granted.-.The policy statement-is.needed to establish a consistent risk' framework f exemption decisions, or: regulatory to ensure an adequate and consistent level of protection of the public in their use'of radioactive materials, and to focus the Nation's resources ~on reducing the most significant radiological risks from practices under NRC' jurisdiction. s The average U.S. citizen should benetit from implementation of the BRC policy through- (1) timely cleanup of contaminated sites; (2)' increased assurance that adequate-funds are available to decommission operating nuclear faciliti es; (3) potential improvements in madical treatment and other servi that_use radioactive mater.als resulting'from optimal ces use of Federal, State,_and licensee resources; 1 (4) enhanced low-level radioactive waste management practices commensurate with potential risks; and (5) increased assurance that consumer 2
b' 1-1 i " products containing radioactive material under thel Commission's fjurisdiction-are safe' 5 EFFECTIVE DATE: (Insert, Publication Date.) FOR FURTHER INFORMATION CONTACT: Dr. Donald A. Cool, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, telephone:.(301) 492-3785. j SUPPLEMENTARY INFORMATION: i Statement of Policy l I. Introduction. l Ionizing radiation is a fact of life. From the day we,are l~ born until the day we die, our bodies are exposed to low. levels i of radiation emitted from a variety of natural and man-made l sources, including the cosmos, earth,. building materials, i, l industrial facilities, clothing, medicine, food, air,'and:our own bodies. All matter' exhibits some degree of radioactivity. -The consensus belief among scientists is that even low levels of radiation typical of the natural environment. pose some correspondingly-low risk of adverse health effects tonhumans. . Recognition of the risk due to radiation exposure from natural sources provides perspective on the risks associated with human 1 uses of radioactive materials. o i 3
4 Natural and man-made radionuclides:are used'injtoday's-society in.many forms for:a variety ofl purposes,-such as~ medical -therapy and diagnosis, materials. analysis, and power generation. In-general, the existing regulatory framework' ensures that radioactive materials are controlled. consistent with the degree of risk posed to'the public?and the environment. Some products like smoke detectors.and lamp mantles contain small quantities of radioactive materials that pose such a low risk'that they have been widely distributed without continuing regulatory controls. H To require that all radioactive materials'be' controlled'in the same' strict manner regardless of'the risks they pose would not be a sound use of scarce National resources. Such: strict control i could also deprive society of_the numerous benefits already derived-from appropriate uses of radioactive materials and radiation. In addition, such control:would not significantly reduce the risks associated with radiation exposure from controlled sources compared with risks associated with natural ~ background radiation. Therefore, responsible decisions need to be made on how radioactive materials are controlled based on a judgement about the levels of risk they pose. Over the last several years, the Commission'has pursued development of a risk threshold to distinguish those radioactive materials that do not require the same. stringent level of regulatory control as that imposed on potentially more hazardous materials. The Commission recognized throughout this process that the threshold would need to be low enough to ensure adequate l l protection'of the public. The Commission also recognized that 4 i,,-
r the threshold should be compatible with technological and measurement capabilities so it could be readily implemented in NRC's regulatory program for nuclear materials. In addition, the Commission identified the need to balance incremental reductions in risk below.the safety threshold with the attendant expenditure of private and public resources. 1 In today's notice, the Commission establishes a policy to guide decisions on which radioactive materials are "below regulatory concern" (BRC).because the low levels of risk they pose do not warrant regulation to the same degree as other radioactive materials to ensure adequate-protection of the'public i and environment. .This policy translates the Commission's judgement on acceptable risk jnto explicit and implementable criteria on which to base decisions to exempt nuclear materials l from the full scope of NRC's regulatory framework. The BRC i criteria'are necessary to ensure adequate and cot.sistent decisions on acceptable risks posed by decontaminated and i decommissioned nuclear facilities, consumer products containing' i radioactive materials, and very low activity radioactive wastes. These decisions will be implemented by the Commission through rulemakings an'd licensing-decisions based on careful and thorough analyses of the risks associated with exposure to ensure that the public is adequately protected.. Under the regulatory approach used by the U.S. Nuclear Regulatory Commission (NRC), the use of radioactive materials is subject toLlimits and conditions that ensure the protection of
I the health and safety of both workers and members of the general public, and'the environment. For' example, radioactive material is controlled by NRC-and Agreement State-licensees to ensure that dose limits are not exceeded. In addition, sources of radiation are designed, used and disposed of in a manner that ensures that exposures to radiation or radioactive material are as low as is reasonably achievable (ALARA), economic and social factors being taken into account. NRC has endorsed the ALARA provision in regulatory practice for a number of years (10-CFR Part 20). However, NRC has not yet provided criteria that would establish the basis for' defining the level of residual risk at-which further regulatory control is no longer warranted. A major provision of this policy involves the definition of criteria that delineate conditions under which additional expenditures of regulatory and licensee resources are not-necessary,to1further reduce radiation exposures from a given i practice. Application of these criteria by_NRC will promote ( consistent decisions on the need to require further reductions in radiation exposure at dose levels that are-comparable to incremental radiation doses associated with routine activities such as cross
- country air travel.
The policy statement in today's notice provides a. unifying risk framework for making decisions about which radioactive materials can be exempted from the full scope of NRC'O comprehensive regulatory controls. Under the criteria and principles of this policy statement, exemptions of radioactive 6
materials from regulatory controls would involve the transfer of very small quantities of the materials from a regulated to an unregulated status. NRC will analyze such proposed transfers to ensure that doses resulting from exposure to exempted practices will be sufficiently low that the public health and safety and the environment will-remain adequately protected. The licensed activity producing the exempt material would continue to be subject to the full range of regulatory oversight, inspection, and enforcement actions up to and including the point of transfer to an exempt status. The Commission also intends to conduct periodic research to evaluate the effectiveness of the Exemption Policy and to confirm the safety bases that support-the exemption-decisions. l Through appropriate rulemaking actions-or licensing decisions, the Commission will establish constraints, requirements, and conditions applicable to exemptions of radioactive materials from NRC's regulations.- The NRC will verify that licensees adhere to:these exemption constraints and conditions through NRC's licensing, inspection, and enforcement programs. For example, the-Commission may promulgate regulations that would require some type of labeling so that consumers could i-make informed decisions about purchasing a product containing exempted materials. Such labeling is presently required by the Commission for smoke detectors containing radioactive material (see 10 CFR 32.26). The NRC ensures that manufacturers label the- . detectors in compliance with the labeling requirement through licensing reviews and inspections. Specific source controls and 7
1, h exemption conditions are not discussed further in this policy because they will be more appropriately addressed ~in: developing the exemption requirements for-specific exemption proposals. TheLeoncept of regulatory exemptions is not-new. The 1 Atomic-Energy Act of 1954, as amended, authorizes the Commission:to exempt certain classes, quantities, or:uses of radioactive L material when it finds that,such exemptions will not constitute an unreasonable risk to common' defense'and security and to the_- '{ i health and safety-of the public. -In the 1960s and 1970s, the { Atomic Energy Commission used this authority to promulgate tables' l of exempt quantities and concentrations for radioactive material. 1 These exemptions allow a person or a licensee, under certain l circumstances, to receive, possess, use, transfer, own, or acquire radioactive material without a requirement for a license j (30 FR 8185; June 26, 1965 and 35 FR 6425; April 22, 1970). Other exemptions allowing distribution of consumer products or a devices to the general public or allowing: releases of radioactive material to the environment have been incorporated in the Commission's regulations for some time. For exan. ole, regulations [' currently specify the conditions under which licensees are I i allowed to dispose of small quantities of radioactive material into sanitary sewer systems-(see-10 CFR 20.303). These existing regulations specify-requirements,- conditions, and constraints that'a licensee must meet if~ radioactive material is to be " transferred" from a regulated to an exempt status. More recently, Section 10 of the Low-Level Radioactive Waste 8
Policy Amendments Act (LLRWPAA) of 1985 directed the Commission to develop standards and procedures and act upon petitions "to exempt specific radioactive waste streams from regulation... due to the presence of radionuclides... in sufficiently low concentrations or quantities to be below regulatory concern." The Commission responded to this legislation by issuing a policy statement on August 29, 1986 (51 FR 30839). That policy 1 statement. contained criteria that,'if satisfactorily addressed in a petition for rulemaking, would allow the Commission to act j expeditiously in proposing appropriate relief in-its regulations on a " practice-specific" basis consistent with the merits of the petition. Federal and State agencies have also developed'and implemented similar exemptions based on evaluations of their risks to the'public and the environment. The Food and Drug Administration (FDA), for example, has applied sensitivity-of-method, risk-based guidelines in connection with the regulation of animal drugs, food contaminants, and trace constituents in some food additives. Similarly, the Environmental Protection Agency (EPA)' established exempt' ion or threshold levels based on individual risks in the regulation of pesticides and other toxic L and carcinogenic chemicals. For example,~ EPA employs such a l concept in defining hazardous waste under the Resource Conservation and Recovery Act through the Extraction Procedure (EP) Toxicity Characteristic and the Toxicity Characteristic ~ Leaching Procedure.in 40 CFR Parts 261 and 268. These testing procedures yield concentrations of carcinogenic and toxic l 9
j -l constituents in leachate, which!are then compared with threshold concentrations to determine whether solid wastes / Ore hazardous I wastes and'to evaluate the adequacy of treatment processes. Wastes whose leachate concentrations fall below the threshold levels established byL EPA may be " exempted" from compliance with the comprehensive hazardous ~ waste regulations or allowed to be disposed of in permitted land disposal facilities, respectively. For certain practices involving ~ minimal public health-and safety concerns, the imposition of undue or unnecessary. regulatory controls could prohibit:a practice that.should otherwise be permitted because of reasonable societal (including - public health and safety) benefit.s. In addition, with the-necessary national focus on fiscal. responsibility, resources expended for regulatory control of practices with minimal health and safety impacts could be used to address more significant radiological and nonradiological health and-safety concerns. To address this need, the Commission, in this policy, is establishing a framework for expanding on its existing-regulations for protection of the public from radiation which currently define a number of longstanding exemptions from regulatory control. This policy will also be used'by the I Commission as afbasis for reevaluating existing NRC exemptions to ensure that they are consistent with the criteria defined herein. Because this policy provides a consistent risk basis for exempting the use of byproduct and source material in consumer products, this policy supersedes the Atomic Energy Commission's i 10 _~
'a l . March'16,'1965,- policy statement on this subject (30 FR 3462). 1 i The Commission believes that the Below Regulatory Concern policy is needed to establish a consistent, risk-based framework for making exemption decisions. Specifically, the~ policy is= needed to (1) establish residual. radioactivity criteria and requirements for decommissioning and cleanup of radioactive contamination at licensed and formerly-licensed nuclear .i facilities,.(2) ensure that licensee decommissioning funding plans provide adequate funds to cover the costs of cleanup of these facilities-to protect people and the environment, (3) i ensure that the public'is being adequately and consistently protected from consumer products that contain radioactive materials under the Commission's jurisdiction; (4) provide decision criteria for reviewing petitions to exempt very low level radioactive wastes in accordance with=the Low-Level Radioactive Waste Policy Amendments Act of 1985,-(5) focus the resources of NRC, Agreement States,.and licensees on more significant risks posed by nuclear materials,.(6) establish a risk-based threshold'to ensure.that the potential benefits of additional reductions in risk are commensurate with the costs of' attaining the reductions and.of performing the analyses to . achieve and confirm the reductions, and (7) review NRC's i n regulatory framework to ensure that existing exemptions involving, radioactive materials are consistent and adequate to protect.the public. The average U.S. citizen should benefit'from implementation of-the BRC policy through: . increased assurance that consumer products containing radioactive material under'the -11 i
Commission's jurisdiction are safe;= timely' cleanup of contaminated sites; increased assurance.'that adequate funds'are. available'to decommission currently operating nuclear facilities; potential improvements in medical treatment and other services that use radioactive materials resulting from the optimal use'of. J the Federa'1, State,' and licensee-resources; and-focus of Federal and State efforts and resources on reducing the most significant -l radiological risks from practices under their jurisdiction. The Commission's BRC policy establishes an explicit and ] uniform risk framework for making regulatory exemptilon decisions. 'In lieu of such a policy, the Commission could continue the current practice of exempting practices on-a case-specificLbasis.. Such an approach, however, does not necessarily ensure censistent evaluation and control of risks associated..with exempted practices. For this reason and the reasons discussed above,'the Commission has established the BRC: policy. Statement. i I The Commission recognizes that Agreement States will play an important role in the implementation of'the Below Regulatory concern policy, specifically in the areas of developing and j enforcing compatible State regulations, regulating cleanup and decommissioning'of certain types of.-contaminated nuclear facilities, and exempting certain low-level radioactive wastes from requirements for disposal in licensed low-level waste disposal facilities. The Atomic Energy.Act of 1954, as amended, j gives to the~ Federal government the exclusive. authority to ] regulate source, special' nuclear, and byproduct materials to-1 12
~ 1 l ensure protection of the public health and safety. While Congress subsequently provided for Federal-State agreements under Section 274b of the Atomic Energy Act through which States could assume regulatory responsibilities in lieu of Federal regulation for certain classes of nuclear materials, it required that State 'i radiation protection standards be coordinated and compatible with the Federal standards for radiation protection. NRC regulations exempting BRC wastes will not affect the l -i authority of State or local agencies to regulate BRC wastes for. i purposes other than radiation protection in accordance with j Section 274b of the Atomic Energy.Act. The Commission intends that rulemakings which codify exemptions from the regulatory requirements applicable to certain types of radioactive materials will be matters of strict compatibility for Agreement States to i the extent that States, under the terms'of their Section 274b Agreements with NRC, have assumed regulatory responsibility for these classes of materials. The Nation will benefit from the application of a uniform policy, thereby avoiding conflicting, overlapping, and inconsistent standards. This is particularly significant for articles containing radioactive materials which receive widespread distribution, such as consumer products, where inconsistent regulations could unduly restrict and~ burden interstate and international commerce. In initiating; proceedings-to implement NRC's BRC policy, the Commission will continue to consult with and seek the advice of the States. Some States have expressed concerns that economic and. 13 j
4 - institutional-impacts of the Commission's BRCl policy'may undermine their efforts to develop new disposal facilities for low-level radioactive waste-in accordance with.the Low-Level' Radioactive' Waste Policy Amendments Act of 1985. These States i would prefer to establish their own' standards for determining which wastes should be exempted from regulatory cont.ol rather than adopting standards that are compatible with uniform Federal standards. The Commission has developed the BRC policy'to' provide a uniform and consistent health and safety framework for exemption decisions. In so doing, the Commission recognized the' concerns expressed by Congress when it enacted the Low-Level Radioactive Waste Policy Amendments Act of 1985 that. health, safety, and environmental considerations should take precedence - over economic'or institutional concerns (see Senate Report 99-199 that accompanied S. 1517, Senate Committee on Energy and Natural Resources, November 22, 1985, 99th Congress, 1st Session at page i 9). The Commission is confident that waste exemption-decisions made in accordance with requirements that implement its BRC-policy will be adequate to ensure protection of the public health and safety. The Commission also believes that inconsistent regulation of BRC waste exemptions could not only result in-increased risks-to the public'and the environment but.coul'd also p i impede State efforts to develop low-level waste disposal facilities. The policy described in this document is intended to provide the public health and safety framework that would apply to a wide ~ spectrum of Commission exemption decisions. As such, it provides 14 4
l 1 individual and collective dose criteria, and_ discusses other important elements of.the exemption decisionmaking process. Section-II provides definitions of key terms and concepts used in s the policy statement. Section III presents the basic elements of the policy, while Section IV discusses how the policy will be implemented through rulemakings and licensing actions and describes how the public will~have an opportunity to comment on the' Commission's exemption decisions. .This section also discusses NRC plans to review past exemption decisions _to ensure f connistency with the provisions of the BRC policy. Section V describes, in general terms, the information-needed to, support-l the: exemption decisionmaking process. II. Definitions. " Activity," when used to describe radioactive material in this policy statement, is the rate of disintegration (trans formation) or decay of radioactive material. The units of, activity are the curie (1 Ci = 3.7 ' x 10" disintegrations per. second) and the. becquerel (1 Bq = 1' disintegration per second). l "ALARA" (acronym-for~"as low as is reasonably achievable") means making every reasonable effort to maintain radiation-exposures as far below applicable dose limits as is practical, consistent with the purpose for which the licensed activity is I undertaken taking into account the state-of technology, the economics of improvements in relation to benefits to the public-health and safety, and other societal and socioeconomic 15
considerations and in relation.to, utilization of nuclear: energy and licensed materials in the9public' interest. i " Agreement State" means any State with which the Commission has entered into an: effective agreement under subsection 274(b) of the Atomic Energy Act of 1954, as amended. "Byprc0uct material" means -- (1) Any radioactive material (except special nuclear l material) yielded;in,,or made. radioactive by, exposure to the radiation incident to the process of producing or utilizing special nuclear material; and (2) The tailings or wastes, produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including' discrete = surface wastes resulting from uranium solution extraction processes. Underground ore bodies. depleted ~by.these solution i extraction operations do not constitute " byproduct material" within this definition. " Collective dose" is the sum of the individual. doses (total effective dose equivalents) receivedLin a given period of time by t a specified population from exposure to a.specified source of' radiation (or practice involving the use of radioactive ~ material). Note: The calculated collective dose used to determine compliance with the criterion of this policy need not i 16
include-individual dose contributions received at a rate of less than 0.1 mrem per year. " Committed effective dose equivalent" is_the sum of the products of weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to those organs or tissues as defined in 10 CFR Part-20. " Deep dose equivalent" is the dose equivalent at a tissue depth of 1 cm. i { " Dose" or " radiation dose" in this policy is the total effective dose equivalent. .j 1 " Exemption from regulatory control" refers to a decision i process that may allow radioactive material to be transferred j from a regulated status to an unregulated status,.in-which the material will no longer be subject to NRC requirements.- t t Decisions to grant exemptions.will-be based upon findings that the radioactive material poses a small risk to-public health and safety and the_ environment and that-the small-magnitude"of the risk does not warrant expenditure of-additional-resources?of regulatory agencies and the regulated community in-attempting to further reduce the risk. " Exposure" means being exposed to ionizing radiation or to radioactive material. 17
~.. " Licensed material" means source material, special nuclear material, or byproduct material that is received, possessed, used, transferred, or disposed of under a general or specific license issued by the commission or an Agreement State. " Licensee" means the holder of an NRC or Agreement State license. " Natural background dose" means the dose received from naturally occurring cosmic and terrestrial radiation and radioactive material but not from source, byproduct, or special nuclear materialt "No-threshold hypothesls" refers to the theory that, at the small dose levels considered in this policy, there continues to be a risk without threshold for exposure to radiation and that there is a relationship between dose and the statistical probability of the occurrence of a health effect (such as latent cancers and genetic effects). I "Practico" le L broadly defined activity or a sat or combination of a number of similar coordinated and continuing activities aimed at a given purpose that involves the potential for radiation exposure. Disposal of very low level radioactive waste; the release for unrestricted public use of lands and structur?s with residual levels of radioactivity; th) distribution, use, and disposal of specific consumer products 18 n
Y l i I containing small amounts of radioactive material; and the recycle j and reutt of residua 11y contaminated materials and equipment are { examples of practices for which this policy will have potential applicability. " Rem" is the special unit of dose equivalent (1 rem = 0.01 sievert). " Risk," for purposes of this policy, means the annual or lifetime probability of the development of fatal cancer from exposure to ionizing radiation and is taken as the product of the dose received by an exposed individual and a conversion factor based upon the linear, no-threshold hypothesis. The conversion ' factor for dose to risk is taken to be 5 x 10" fatal cancers per rem of radiation dose. The fatal cancer risk is considered, in general, to be either more likely or have more severe outcome than the potential genetic and nonfatal cancer risks and the potential risks of developmental anomalies in fetuses. While the Commission recognizes that the risks from exposure to radiation are greater for children than adults and that-there are increased risks from exposure to the embryo / fetus, the estimate of fatal cancer risk for all ages and both sexes is considered to be an appropriate measure of risk from practices being considered for i exemption'in accordance with this policy statement (see Appendix). " Source material" means -- i h 19
a \\ l (1) Uranium or thorium, or any combination of uranium j and thorium in any physical or chemical formt or (2) Ores which contain, by weight, one-twentieth of one percent (0.05 percent), or more, of uranium, thorium, or any combination of uranium and thorium. Source material does not include special nuclear material, j 1 "Special nuclear material" means -- (1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material which the Commission, pursuant to the provisions of Section 51 of the Act, determines to be special nuclear material, but'does_not include source material; or I (2) Any material artificially enriched by any of the foregoing but does not include source material. " Total effective dose equivalent" means the sum of the deep dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures) expressed in-rems or sieverts. III. Policy Elements. J The purpose of this policy statement is to establish the 20
basis upon which the Commission will initiate the development of appropriate regulations or make licensing decisions to exempt i certain practices from some or all regulatory controls. This policy is directed principally toward rulemaking activities but i may be applied to license amendments or license applications involving the release of>1icensed radioactive material either to the environment or to persons who would be exempt from Commission regulations. 1 It is the Commission's intent to broadly define speciric practices so that the effect of an exemption decision on any individual or population will be evaluated in its entirety and not in a piecemeal fashion. At the same time, the practice must, be identified and described in terms that will facilitate i reasonable impact analyses and allow imposition of appropriate constraints, requirements, and conditions as the radioactive material passes from a regulated to an unregulated status (i.e., the material is no longer required to be under the control of a i licensec). Under this policy, the definition of a " practice" in any specific decision (rulemaking or licensing action) is a critical feature. The NRC will ensure that formulation of exemptions from regulatory control will not allow deliberate dilution of material or fractionation of the radiation or radioactive material for the purpose of circumventing controls that would otherwise be applicable. The definition of the practice in any specific. exemption decision will also provide the framework for taking into account the possible consequences of 4 accidents or misuse or the potential for other nonstochastic-21
b i +- F radiological impacts associated with the exemption. In formulating this policy statement, the Commission deliberated at length on the need to consider whether practices must be rigorously justified in terms of societal benefit i regardless of the level of risk they pose. Justification of practice is recognized by health physics professionals and national and international organizations as one-of the three fundamental tenets of radiation protection (justification, dose limits, and ALARA). The Commission has prepared this policy i statement in conformance with these basic tenets as appropriate for exemption decisions. Consisten.t with the position of the f International Atomic Energy Agency in its Safety Series Report i No. 89, the Commission believes that justification decisions usually derive from considerations that are much broader thsn radiation protection'alone and that fall outside of the context' of the Commission's regulatory authority to ensure the protection of the public health and safety and the environment. The Commission recognizes that justification decisions involving social and cultural value judgments should rightfully be made by I affected elements of society. Consequently, at the low levels of risk associated with practices eligible for exemption in accordance with this policy, the Commission will.not consider whether a practice is justified in terms of not societal benefit. Nevertheless, the commission may determine on the basis of risk estimates and associated uncertainties that certain 22 i
i practices should not be considered candidates for exemption, such as the introduction of radioactive materials into products to be l ? consumed or used primarily by children. Such practices should be i specifically evaluated to determine if they could result in 1 greater risk levels to exposed members of the public than the levels found acceptable by tue commission in formulating this i i policy. Unlike justification decisions involving complex trade-offs between cultural and societal values, these decisions clearly fall within the Commission's purview to orotect the health and safety of the public, t A. Principles of Exemption. A major consideration in exempting any practice from some or l all regulatory controls hinges on the general question of whether the application or continuation of regulatory controls is necessary to protect the public health and safety and the environment and is cost effective in further reducing a small risk (i.e., a commensurate dose reduction). To determine'if exemption is appropriate from this standpoint, the commission must determine if one of the following conditions is met: 1. The application or continuation of regulatory controls on the practice does not result in any significant reduction in dose received by individuals within a critical group (i.e., the. group expected to receive the highest exposure) and by the exposed population; or 23
I ) 1 I I 2. The costs of the controls that could be imposed for 1 further dose reduction are not balanced by the ] commensurate reduction in risk that could be realized. 1 At a sufficiently low level of risk, the Commission believes the decisionmaking process for granting specific exemptions from some or all regulatory controls can be essentially reduced to an i evaluation of whether the overall individual and collective risks from each particular practice are sufficiently small. The commission believes that individual and population dose criteria should be basic features of its overall policy to define the region where the expenditure of Commission resources to enforce requirements for further dose reductions or licensee resources to comply with such requirements is no longer warranted. These specific criteria include (1) values for the individual annual dose reasonably expected to be received as a result of the practice (e.g., an average dose to individuals in a critical I group) and (2) a measure of radiological in. pact to the exposed population. In combination, these criteria are chosen to ensure that, for a given exempted practice, no individual will be exposed to a significant radiological risk and that the population as a whole does not suffer a significant radiological impact. It is important to emphasize that, in this policy, the Commission does not assert an absence or threshold of risk at low radiation dose levels but rather establishes a baseline level of risk beyond which further government regulation to reduce risks 24
is unwarranted. As described in the Appendix to this policy statement, the technical rationale for the Commission's BRC criteria is explicitly based on the assumption that the risk from exposure to radiation is linearly proportional to the dose to an individual. The presence of natural background radiation and variations in the levels of'this background have been used to provide a perspective from which to judge the relative significance of the radiological risks involved in the exemption decisionmaking process. B. The Individual Dose Criterion. l If the doses to individuals from a practice under ecnsideration for exemption are sufficiently small, the attendant risks will be small compared to other societal risks, and there would be little merit in expending resources to further reduce this dose or risk provided that sound radiation protection principles have been applied in the design, development, and proposed implementation of the practice. The Commission believes the definition of this risk or dose level can be developed from 4 two perspectives. The first of these is related to quantitative risk levels. Based on analysis of voluntary and involuntary risks commonly l accepted by the public without significant concern, the Commission believes that most members of society will not expend resources to reduce an annual individual risk of fatality below-j approximately 1 chance in 100,000 (1 x 105; this is equivalent 25
i I 4 to a lifetime risk of 7 chances in 10,000 or 7 x 10). The 10 annual risk level is greater than-that selected by the Commission in the development of its safety goal policy for nuclear power 1 reactors (i.e., 2 x 10). The safety goal risk level equals one one-thousandths (0.1%) of the sum of cancer fatality risk from all other causes. The Commission compared this risk to the i lifetime risk of developing fatal cancer of about 2 chances in 10 d (2 x lo ) and the lifetime risk associated with natural background radiation generally ranging from 3 chances in-1,000 to 1 chance in 100 (3 x-10'3 to 1 x 10 2), The second perspective is based on variations in dose, and hence risks, knowingly or unknowingly tolerated by individuals because of factors such as their lifestyle or place of residence. The Commission notes that resources are not expended.to reduce differential exposures associated with variations in natural background radiation (e.g., the 60-70 mrem per year difference between annual doses received in Denver, Colorado, vs. Washington, DC.). In addition, individuals are generally not concerned about the difference in doses between living in a brick I versus a frame house, the 5 mrem dose received during a typical roundtrip coast-to-coast flight, or incremental doses from other activities that involve a small fraction of background radiation. In developing the BRC policy, the Commission is faced with l the issue of how to characterize the individual and population risks associated with low doses and dose rates. Although the uncertainties are large, useful perspective on the bounding risk l 26 l ol
associated with very low levels of radiation can be provided by 4 continued use of the linear, no-threshold hypothesis, comparison of the low risk from very low doses with the potentially more significant risks from higher doses associated with other i activities which the NRC regulates provides additional perspective. In this context, the risk to an individual as calculated using the linear, no-threshold hypothesis is shown in Table 1 for various defined levels of annual individual dose. The values in the hypothetical lifetime risk coltm.n are based on the further assumption that the annual dose is continuously received during each year of a 70-year lifetime. To provide further perspective', a radiation dose of 10 mrem per year (0.1 mSv per year) received continuously over a lifetime corresponds to a risk of about 4 chances in 10,000 (3.5 x 10) or a hypothetical increase of about 0.25% in an individual's lifetime risk of fatal cancer. The i Commission prefers to use factors of ten to describe such low individual doses because of the large uncertainties associated with the dose estimates. The Appendix to the policy statement provides a more ecmplete discussion of the risks and j uncertainties associated with low doses and dose rates.- 4 27
1. l o Table i Hypothetical Hypothetical Incremental Incremental Lifetime Risk From Annual Dose
- Anrrual Risk **
Continuino Annual Dose ** 4 4 100 mrem (1 mSv) 5 x 10 3.5 x 10 4 4 10 mrem (0.1 mSV) 5 x 10 3.5 x 10 1 mrem (0.01 mSv) 5 x 10'7 3.5 x 104 4 4 0.1 mrem (0.001 mSv) 5 x 10 3.5 x 10
- The expression of dose refers to the Total Effective Dose Equivalent.
This term is the sum of the deep (whole body) dose equivalent for sources external to the body and the-committed effective (whole body) dose equivalent for sources internal to the body. 4
- caleg' lated using a conservative risk coef ficient of 5 x 10 per rem (5 x 10 per SV) for low linear energy transfer radiation based on the j
results reporteo in UNSCEAR 1988 (Footnote 2) and BEIR V (see also l NUREG/CR-4214, Rev. 1). l In view of the uncertainties involved in risk assessment at low doses and taking into account the aforementioned risk and R dose perspectives, the Commission finds that the average dose to individuals in the critical group should_be less than 10 mrem per i year (0.1 mSv per year) for each exempted practice. -In-addition, an interim dose criterion of 1 mrem per year (0.01 mSv per year) average dose to individuals in the critical group will be applied to those practices involving widespread distribution of radioactive material in such items as consumer products or recycled material and equipment, until the commission gains more j 1 experience with the potential for individual exposures from multiple licensed and exempted practices. These criteria' provide i 28
i individual dose thresholds below which additional regulatory. controls are unnecessary and unwarranted to require further reductions in individual doses. The Commission considers these criteria to be appropriate given the uncertainties involved in estimating doses and risks, and notes that these criteria should facilitate straightforward implementation of this policy in i future rulemakings or licensing decisions. i The Commission believes that, notwithstanding exemption of practices from regulatory control under these criteria, it still has reasonable assurance that exposures to individual members of the public from all licensed activities and exempted practices l will not exceed 100 mrem per year (1 mSv per year) given the Commission's intent (1) to define practices broadly, (2t to evaluate potential exposures over the lifetime of.the practice, (3) to monitor and verify how exemptions are implemented under this policy, (4) to impose a companion individual and collective dose criteria, (5) to verify dose calculations through licensing reviews and rulemakings with full benefit of public review and i comment, and (6) to inspect and enforce licensee adherence to specific constraints and conditions imposed by the commission on exempted pracbices. The Commission intends that only under unusual circumstances would exemptions be considered for practices that could cause continuing radiation exposure to individuals exceeding a small fraction of the 100 mrem per year (1 mSv per year) public dose i limit. In rare cases, exemptions of such practices may be i 29 s
granted if, after conducting a thorough analysis of the proposed exemption, the Commission determines that doses to members of the public are ALARA and that additional regulatory control is not justified by further reductions in individual and collective doses. C. The Population Dose Critecion. The Commission believes that the collective dose (i.e., the sum of individual total effective dose equivalents) resulting from exposure to an exempt practice should be ALARA. However, if the collective dose resulting from an exempted practica is less i than an expected value of 1000 person-rem per year (10 person-Sv i per year), the resources of the Commission and its licensees could be better spent by addressing more significant health and safety issues than by requiring further analysis, reduction, and confirmation of the magnitude of the collective dose. The Commission notes that, at this level of collective dose, the number of hypothetical health effects calculated for an exempted practice on an annual basis would be less than one. l The National Council of Radiation Protection and 1 Measurements recommends in its Report No. 91 that collective-dose assessments for a particular practice should exclude consideration of those individuals whose annual effective dose ' Recommendations on Limits for Exposure to Ionizing Radiatiott, NCRP Report No. 91, National Council on Radiation Protection ar d Measurements, June 1, 1987. Available for purchase from NCI P Publications, 7910 Woodmont Ave., Suite 1016, Bethesda, MD 20814. 30
equivalent is less than or equal to 1 arem per year (0.01 mSv per year). Taking this recommendation into account and considering the practicality of dose estimation techniques and uncertainties associated with such low dose and dose-rate estimates, the commission concludes that individual doses less than 0.1 mrem per year (0.001 mSv per year). need not be considered in calculating collective doses. As a practical matter, consideration of dose rates in the microrem per year range and large numbers of hypothetical individuals potentially exposed to an exempted practice may unduly complicate the dose calculations that will be used to support demonstrations that proposed exemptions comport with the criteria in this policy. The Commission believes that inclusion of individual doses below 0.1 mram per year introduces i unnecessary complexity into collective dose assessments and could j inpute an unrealistic sense of the significance and certainty of i such dose levels. 4 In the sensitivity-of-measure, risk-based guidelines used by i 4 EPA and FDA, a 10 lifetime risk of cancer has been used as a quantitative criterion of insignificance. Using an annual risk coef ficient of 5 x 10 health ef fects per rem (5 x 10 2 per sievert) as di'scussed in the Appendix, the 10 lifetime risk. 4 value would approximate the risk that an individual would j i hypothetically incur from a continuous lifetime dose rate in the range of 0.01 to 0.1 mrem (0.0001 to 0.001 mSv) per year. For { the all of these reasons, the Commission believes that 0.1 mrem 3 per year is an appropriate truncation value to be applied in the - ] assessment of collective doses for the purposes of this policy.. I a 31 J l
i 1 j The Commission notes that adoption of the individual and I collective dose critoria does not indicate a decision that doses ] below these criteria are necessary before a practice can be i exempted or that doses above the criteria would necessarily preclude exemptions. The criteria simply represent a range of risk that the Commission believes is-sufficiently small compared to other individual and societal risks that further cost-risk reduction analyses are not required in order to make a decision regarding the acceptability of an exemption. Practices not meeting these criteria may nevertheless be granted exemptions from regulatory control on a case-by-case basis in accordance with the principles embodied within this policy, if (1) the potential doses to individual members of the public are sufficiently small or unlikely, (2) further reductions in the doses are neither readily achievable nor significant in terms of-protecting the public health and safety and the environment, and (3) the collective dose from the exempted practice is sufficiently small. IV. Implementation. 1 The Commission's BRC policy will be implemented principally through rulemakings; however, exemption decisions could also be implemented through specific licensing actions. I In the first case, a proposal for exemption, whether initiated by the NRC or requested by outside parties in a pet'. tion for rulemaking, must provide a basis upon which the 32
i petition for rulemaking, must provide a basis upon which the Commission can determine if the basic policy criteria have been satisfied. The Commission intends to initiate a number of rulemakings on its own (e.g., to establish a dose criterion for decommissioning) and may initiate others as a result of NRC's ] review of existing codified exemptions (e.g., consumer product exemptions in 10 CFR Parts 30 and 40). Rulemakings may also be initiated in response to petitions for rulemaking submitted by outside parties, such as a BRC waste petition submitted in accordance with Section 10 of the Low-Level Radioactive Waste Policy Amendment Act of 1985. In general, rulemaking exemption proposals should assess the potential individual and societal impacts that could result if the exemption were to be granted. The proposal should consider the uses of the radioactive materials, the pathways of exposure, the levels of radioactivity, and the methods and constraints for ensuring that the assumptions used to define a practice remain appropriate as the radioactive materials move from a regulated to an unregulated status. Any such rulemaking action would follow the Administrative Procedure Act, which requires publication of a proposed rule in order to solicit public comment on the rulemaking action under consideration.' The rulemaking action would include an appropriate level of environmental review in accordance with the commission's regulations in 10 CFR Part 51, which implement the' National Environmental Policy Act. If a proposal for exemption results in a Commission regulation containing specific requirements for a particular 33
n exemption, a person using the exemption would no longer be required to apply the ALARA principle to reduce doses further for the exempted practice provided that the licepsee meets the conditions specified in the regulation. The promulgation of the regulation would, under these circumstances, constitute a finding that the practice is exempted in accordance with the provisions of the regulation and that ALARA considerations have been adequately addressed from a regulatory standpoint. The Commission in no way wishes to discourage the voluntary application of additional health physics practices which may, in fact, reduce actual doses significantly below the BRC criteria or the development of new technologies to enhance protection to public and the environment. This is particularly pertinent in the area of decontamination and decommissioning, where the commission anticipates that emerging technologies over the next several decades should enhance existing technical capabilities i and further reduce doses to workers and the public. The second means of policy implementation could involve exemptions that would be granted through licensing actions, such as site-specific determinations that a site has been sufficiently decontaminated to be released for unrestricted public use. The NRC intends to develop guidance regarding the implementation of the BRC criteria to ensure that such site-specific actions adhere to the criteria and principles of this policy statement. These licensing actions may be subject to a public hearing process and, 1 depending on the specific action taken, may be required to be noticed in the Federal Register. .1 34
i One of the principal benefits of the policy is that it provides a framework to evaluate and ensure the consistency of past exemption decisions by the Commission. With ths adoption of this BRC policy, the NRC will initiate a systematic assessment of exemptions currently existing in NRC's regulations to ensure that the public is adequately and consistently protected from the risks associated with exempted practices. In addition, the NRC will, on a periodic basis, review the exemptions granted under this policy to ensure that the public health and safety continue to be protected adequately. V. Information To Support Exemption Decisions. A. General. The information required to support an exemption decision in i a rulemaking or licensing action should provide the basis for the proposed exemption in accordance with Section III of this policy. In addressing the radiological health and safety impacts, potential individual and collective doses attributed to the practice under consideration should either ruent the' policy's dose criteria or otherwise be demonstrated to be low enough to ensure protection of the public health and safety and ALARA. In addition to the impacts of routine exposures, the impacts l resulting from potential misuse or accident scenarios should also I be evaluated and demonstrated to be insignificant. The NRC may reject proposals for exemptions if they do not p'rovide a sufficient technical basis to support analysis of the benefits and impacts associated with the potential exemption. 35
l e Practices should be defined with respect to the geographic and demographic areas to which the exemption will apply. In some cases, an exemption will be limited to one particular locality or area. However, nany practices will have national applicability f and should be characterized accordingly. Information on these l issues will be necessary for determinations regarding which individual dose criterion should be applied. I j The Commission believes that the implementation guidance provided with its " General Statement of Policy and Procedures Concerning Pet!*.,: s Pursuant to $2.802 for Disposal of Radioactive Woo Streams Below Regulatory Concern," published August 29, 1986, 51 FR,1,0839, generally defines the types of information needed to support an exemption decision.
- However, not all of the information may be applicable to the broader range of practices considered for exemption under this policy.
l Applicants should examine potentially relevant guidance-available at the time the exemption proposal is being prepared and provide the information which is relevant to the particular type of exemption decision being requested. B. Material Characterization. r 1. Radiological properties. The radiological properties of the materials to be exempted should be described, including, as ' appropriate, the concentration or contamination levels and the half-lives, total quantities, and identities of the radionuclides i 36
1' associated with the exempted practice. The chemical and physical form of the radionuclides should be specified. All radionuclides l present or potentially present should be specified. The distribution of the radionuclides should be noted (e.g., surface or volume distribution). Mass-and volume-averaged concentrations should also be presented. The variability of radionuclide concentration, distribution, or type as a function ) of process variation or variations among licensees should be { addressed and bounded, as appropriate. 2. Nonradiological properties. The nonradiological properties of the materiale to be exempted should be described to + Pt% ensure complete characterization of the properties of the material and consideration of any afverse impacts associated with these properties. An NRC exemption, based on radiological impacts, would not relieve licensees from compliance with applicable rules of other agencies which cover nonradiological properties. A description of the materials, including their origin, chemical composition, physical state, volume, and mass' should be provided. The variability and potential changes in the materials as a function of process variation should be addressed. The variation among licensees should be described and bounded, as applicable. C. Practice Characterization 1.. Total impact. A regulatory action taken under this policy is likely te be. generic and may be nationwide in scale. 37
ii Therefore, to the extent possible, an estimate of the number of NRC and Agreement State licensees that possess the radioactive material considered for exemption, the annual volumes and masses, and the total quantities of each radionuclide that would be a part of the exempted practice should be given. The estimates should include the current situation and the likely variability over the reasonably foreseeable future. A geographical distribution would be a helpful tool in characterizing the radioactive material involved in-the exemption decision. Such distribution, submitted as part of the practice characterization, should be used to assess realistic impacts of the practice in addition to conservative bounding estimates that tend to overestimate human exposures and doses. In any case, the typical quantities produced per practice (e.g., number ef units of a particular consumer product) and an estimate of the geographic distribution of the practice should be described. The potential for short-and long-term recycle or reuse of the product containing the exempted radioactive material should also be i l addressed. Both the resource value (e.g., salvageable metals) and the functional usefulness (e.g., usable tools) should be examined. 2. Basis for assessment. A description of bases for the materials and practice characterizations should be provided. Monitoring and analytical data and calculations should be specified and provided in support of the characterization. Actual measurements or values that can be related to measurements to confirm calculations.are important and should be provided. 38
The description should address the quality assurance program used 1 in data collection and analysis and supporting information. If j l any surveys were conducted, they should be described. Market information may be useful in characterizing a practice on a national basis. 3. As low as is reasonably achievable (ALARA). An analysis should be provided that demonstrates that radiation exposure and radionuclide releases associated with the exempted practice overall will be ALARA. The ALARA principle referred to in 10 CFR Part 20 applies to efforts by licensees to maintain radiation exposures and releases of radioactive materials to unrestricted areas as low as is reasonably achievable. Appendix I to 10 CFR Part 50 describes ALARA for radioactive material releases from ' light water reactors I, nuclear power plants). Exemption proposals should describe how ALARA considerations have been applied in the design, development, and implementation of controls for the . proposed practice. Licensee compliance with the ALARA principle must remain in effect up to and including the point at which the materials are transferred to an unregulated status in accordance j with an exemption granted under this policy. D. Impact Analyses. To support and justify a request for exemption, each petitioner or licensee should assess the radiological and nonradiological impacts of the proposed exemption. The analyses should be based on the characterizations described previously and 1 39
'i \\ l i should cover all aspects of the proposed exempt practice, including possession,.use, transfer, ownership, and disposal of the material. NRC consideration of the exemption proposal and any environmental assessments and regulatory analyses required to implement the exemption will be based on the impact analyses and-supporting characterizations. 1. Radiological impacts. The evaluation of radiological impacts should clearly address the policy's individual and collective dose criteria or provide a sufficient ALARA evaluation supporting the exemption. In either case, the following impacts ? should be assessed: 1 Average doses to the critical population group; collective doses to the critical population group and the total exposed population (under conditions defined'in Section III); The potential for nonstochastic radiological impacts; and The potential for reconcentration of radionuclides. The collective population exposure should be estimated and sunaed in two parts: total dose to the critical population group and total dose to the population. The critical group is the relatively homogeneous group of individuals whose exposures are likely to be the greatest and for whom the assessment of doses is likely to be the most accurate. Average doses to this group are the controlling factors limiting individual doses and risk, and i should be compared with the individual dose criteria, as 40 .~..
) ] 1 appropriate. The critical group should be the segment of the ) population most highly exposed to radiation or radioactive materials associated with the use of radioactive material under unregulated conditions. The second part of the population l exposure is the general population exposure, exclusive of critical group exposure. For this group, the individual exposures should be smaller, and the assessment will of ten be less precise. The impacts analysis should present an estimate of l the distribution of doses within the general population. In situations where truncation of the collective dose calculation is done under the provisions of this policy, the basis for applying the truncation provision and the uncertainty in dose estimates should be provided. The evaluation of radiological impacts should distinguish between expected and potential' exposures and events. The analysis of potential exposures in accident or misuse scenarios should include all of the assumptions, data, and results used in the analysis in order to facilitate review. The evaluation should provide sufficient information to allow.a reviewer to independently confirm the results. The_ potential for reasonable interactions between the exempted radioactive material and the t public should be assessed. 2. Other impacts. The analysis of other radiological impacts such as those from transportation, handl'ing, processing, and disposal of exempted materials should be evaluated. Nonradiological impacts on humans and the environment should also 41
r be evaluated in accordance witM NRC requirements in 10 CFR Part 51. The analysis should also ceneider any adverse impact of the measures taken to provide nonradiological protection on radiation exposure and releases of radioactive material. Any NRC action to exempt a practice from further regulatory control would not relieve persons using, handling, processing, owning, or. disposing of the radioactive material from other requirements' applicable to the nonradiological properties of the material. E. Cost-Benefit Considerations (as required). ? A cost / benefit analysis is an essential part.of both environmental and regulatory impact considerations. The analysis f should focus on expected exposures and realistic concentrations or quantities of radionuclides. The cost / benefit analysis should l compare the exposures and economic costs associated with the regulated and unregulated alternatives. Benefits and costs should be considered in both quantitative and qualitative terms. Costs of surveys and compliance verification discussed under I' tem f V.G. should also be covered. Any legal or regulatory constraints that might affect an exemption decision should be identified. 3 For example, one such constraint.might stem from Department of Transportation (DOT) requirements for labeling, placarding, and manifesting radioactive materials in 49 CFR Part 173. 42
l F. Constraints, Requirements, or Conditions on Exemptions. i In most cases, the characterizations of the material and the assessment of impacts will be based on either explicit or implicit constraints, such as limitations on the amount of l radioactive material in a consumer product. In order for.an exemption decision to take credit for these constraints, the exemption proposal should specifically identify appropriate constraints, such as quantity limits, concentration limits, and f physical form characteristics. The bases on which these j constraints are to be ensured should also be discussed. In i' general, constraints should be inspectable and verifiable in order to provide the basis for an exemption decision. G. Recordkeeping and Reporting. l This portion of the exemption proposal should be tailored to l either a generic petition for rulemaking or specific proposal for a license amendment. For generic petitions for rulemaking,.the proposal should provide and justify feasible, generic requirements for record keeping and reporting for Quality Assurance / Quality Control and Reporting. Such proposals should include example requirements and show their effectiveness and feasibility. For site-specific license amendments, the exemption proposal should provide specific requirements for Quality Assurance / Quality Control and Reporting that have been tailored to the licensee's program. 43-i _-~ _
1. Quality assurance / quality control. The program to ensure compliance with specific exemption constraints, requirements, or conditions should be defined. The records of inventory, tests, surveys, and calculations used to demonstrate compliance with the exemption constraints should be maintained for inspection. Such programs are necessary to provide the NRC-and the public reasonable assurance of conformance with the constraints and of adequate protection of human health and the environment. 2. Reports. Annual reports may be required from licensees who, by rule or license, are permitted to release materials exempted from regulatory control. Associated recordkeeping to generate tho-reports should be defined. Minimum information in the annual reports could include volume and curie content.. More detailed recordkeeping and reporting requirements may-be imposed to address uncertainties in projecting future volumes or amounts of exempted materials and to consider-the cumulative impacts of multiple excmptions. F 44
c_ 4 O APPENDIX - DOSE AND HEALTH EFFECTS ESTIMATION I. Dose Estimation In estimating the dose rates to members of the public that might arise through various practices for which exemptions are being considered, the Commission has decided to apply the concept of the " total ef fective dose equivalent." This concept, which is-based on a comparison of the delayed health effects of ionizing radiation exposures, permits the calculation of the whole body i dose equivalent of partial body _and organ exposures,through use of weighting factors. The concept was proposed by the International Commit ", ion on Radiological Protection (ICRP) in~its j Publication 26 issued in 1977. Since that time, the concept has l been reviewed, evaluated, and adopted by radiation protection organizations throughout the world and has gained wide acceptance. ICRP plans to update the concept by publishing a-new, revised report in 1990. The " total effective dose equivalent" concept is incorporated in " Radiation Protection Guidance to Federal Agencies for Occupational Exposure - Recommendations Approved by the President," that was signed by i the President and published in the Fedenal Register en January 27, 1987 (52 FR 2822). The Commission recognizes t'.4at, in considering specific exemption proposals, the tota?, cffective dose equivalent must be taken into account. j i l 45
L o II. Estimating Health Effacts From Radiation Exposure m A.<LIndividual Risks. f I In the establishment of its radiation protection' policies,- \\ \\ the' Commission has considered the three major types of stochastic' I health effects + Sat can be caused by relativelyLlow doses'of i radiation:- cane a, genetic offacts, and' developmental-anomalies-in fet'uses. The NRC principally focuses on the risk of-fatal' 1 cancer development because, at relatively high radiation [ doses,' _(1)-the mortality risk represents a more severe outcome than the nonfatal cancer risk, and-(2) the mortality risk is thought"to be higher than the risk associated with genetic and developmental ef fects on fetuses.2.However, even though radiation has been shown to be carcinogenic, the development of a risk factor applicable to continuing radiation exposures at levels equal to 3 natural background requires a significant extrapolation from the 2Further discussion of these topics'is provided in " Sources, Effects'and Risks of Ioni::ing Radiation,_" United Nations Scientific - Committee.on the Ef fects of Atomic Radiation (UNSCEAR), -1988: Report to the; General Assembly with Annexes., 3Natural background radiation.can vary with. time and location. In Washington, D.C., natural background radiation (excluding ' radon)- results.in individual doses of about 90 mram per year: (0.9 'mSv/yr), while in Denver, Colorado,1 the value is about 160 mrem per year (1. 6 J mSv/yr) '. In both cases, naturally occurring radioactive-material in the. human _ body contributes approximately 40 mrem per year. Radiation from inhalation of the daughter products of! radon contributes an ' average additional dose of - 200 mrem'per year, (2 mSv/yr) to members of the U.S. population (NCRP Report No.!93, " Ionizing: Radiation Exposure of the Population of the United
- States").
46
a 1 f observed-effects at much higher doses and' dose rates.' This results in significant uncertainty in risk estimates as reflected
- (
by the views of experts in the field. For~ example,Lthe Committee on'the Biological Effects of Ionizing Radiation (BEIR III) of the' National Academy of Science cautioned that the risk values are ... based on incomplete data and involve.a large degree of uncertainty, especially in the low dose region." This Committee l9 also stated that it "...does not know whether dose rates of gamma [ 4 or x-rays (low LET; low linear _ energy transfer radiation) of about 100 mrads/ year (1 mGy/ year) are detrimental to man." More ~ recently, the BEIR V Committee of the National Academy of Science / National Research Council' stated that it " recognizes that its risk estimates become more uncertain when applied to very low. doses. Departures from a linear model at low doses,,however, could either increase or' decrease the risk per unit dose." The Commission understands that the Committees' statements reflect the uncertainti
- ed in estimating the risks of radiation.
exposure cnd de not imply either the absence or presence of detrimental ei vers at low dose levels. t The Unitet bat.o-4entific Committee on the Effects of Atomic Radiation (UNSCEAR) stated in their 1988~ Report 1to the 'The health-ef fects clearly attributable ' to radiation have occurred principally among early. radiation' workers, survivors. of the atomic bomb explosions at; Hiroshima and Nagasaki, individuals exposed for medical purposes, and laboratory animals. Natural background radiation causes an annual dose that is at least two orders of magnitude-less
- than the dose received by human populations from which the cancer risks'are derived.
Experiments at the cellular level-however, provide similar indications of~ biological effects at low doses. 47 ~
i .) l General Assembly'thatl"....there was a need for a reduction factor j to modify the risk's. (derived at high doses and dose rates)..for low doses and dose rates...an appropriate range'(for this factor). L to-be applied to total risk for low dose and dose rate should be f between 2'and 10." This factor would lead to a risk coefficient i value between 7 x 10 and 3.5 x 10 per-rad (7 x 10*3 and 3.5'x 4 4 i 10 2,per Gy) by914;on an UNSCEAR risk coefficient of 7.1 x 10 per rad-(7414:por gray) for ler end (1 gray) organ absorbed doses i at high dose rates. -The report also stated, "The product of the' l risk coefficient. appropriate for individual risk and the relevant collective dose wil'l'give the expected number of cancer deaths in .the exposed population, provided that the collective dose is at 1 l least of the order'of"100 man-Sv (10,000 person-rem). If the collective' dose is only a few person-Sv (a few hundred person-rem), the most likely outcome is zero deaths." 1 In December.1989, the BEIR V Committee published.a report i entitled " Health Effects of Exposure to Low Levels of Ionizing Radiation," which contained risk estimates that-are, in general,
- l similar to the findings of the 1988 UNSCEAR report.
-The BEIR V i a report's estimate of lifetime excess. risk of death from' cancer i following an acute dose of 10 rem (0.1~Sv) of low-LET radiation L 1 l was 0.8%. Taking into account a dose rate effectiveness factor of 2 for doses occurring over an extended period c2 time, the 4 risk coefficient is on the order of 4 x 10.per rem, consistent with the upper level of risk estimated by UNSCEAR. 48 .~
. ;b: ( i In view of.this type of information,..the NRC,:the Environmental Protection Agency, and-other national and i international radiation protection authorities have established radiation protection standards: defining recommended dose limits for radiation' workers and individual members of the public. 'As a matter of regulatory prudence, all these bodies have derived the value presumed to apply at lower doses and dose rates associated . with the radiation protection standards by extrapolation from values derived at higher doses and dose rates. The extrapolation-is frequently referred to as the linear no-threshold -hypothesis, in which the risk factor at low' doses reflects the straight-line (linear) dose-effect relationship at much higher doses and dose 1 rates. In this' respect, the BEIR Vereport notes that "in: spite. 4 of evidence that the molecular. lesions which give rise to somatic l and genetic damage can be repaired to a considerable degree, the i new data do not contradict the hypothesis,~at least with respect' to cancer induction and hereditary genetic effects, that the frequency of such effects increases with low-level' radiation'as a y linear, nonthreshold function of the~ dose." l { The Commission, in the development.of the BRC policy, is j faced with-the issue of how-to characterize the individual,and' population risks associated with low. doses and dose rates. .Although the uncertainties are large, useful perspective on the bounding risk associat'ed with very low levels of radiation can be provided by continued use of the linear no-threshold hypothesis. ] Consequently, such risk estimates have beenta~ primary factor in establishing individual'and collective dose criteria associated 49 a ____L____.___._____._.___.__.___,_
.j .. e ' l with this-policy. The estimations of the~1ow risk frca I J potentially exempted practices can be-compared to the'relatively L higher potential' risks associated with other: activities or 1 decisions over which the NRC has regulatory responsibility. Through such comparisons, the Commission can ensure that its i o radiation protection resources and those of its licensees are expended-in an optimal manner to accomplish its public health and safety mission, o In this context, the risk to an individual as calculated: using the linear no-threshold hypothesis is shown in Table 1 for' various defined levels of annual individual dose. The values in -i t the hypothetical lifetime risk column are based on the further assumption that-the annual dose is continuously. received ~during each year.of a 70-year lifetime.- To provide further perspective, a radiation dose of 10' mrem-per year (0.1 msv per: year)-received continuously over a lifetime corresponds to a' hypothetical increase of about 0.25% in an individual's lifetime-ri'sk of cancer death. Ten millirem'per year (0.1 mSv per year)~ is also a dose rate that is a small fraction of naturally occurring- -) background radiation and comparable to the temporal variations in natural background radiation due to. fluctuations that occur at any specific location. t I f i 50 1
I .. e l i a. Table 1 } r Hypothetical Hypothetical. Incremental Incremental Lifetime. Risk From Annual Dose
- Annual Risk **
'Continuina Annual Dose ** .100 mrem' (1 mSV) 5 x 10 5 3.5 x 10'3 ~ 4 4 10 mrem (0.1 mSv) . 5' x L 10 3.5-x 10 1 mram (0.01 mSv) 5 x 10'7
- 3. 5 x 10 5 l
4 4 j. 0.1 mrem (0.001.mSv) 5'x 10 3.5 x 10 t
- The expression of dose refers?to the Total Effective Dose Equivalent.
This term is the sum of the deep (whole body)rdose-equivalent for'_ 'i sources external-to the body and the committed. effective ~(whole-body) j. dose equivalent for. sources internal-to the body. l 4 I
- Risk coefficient of 5 x 10 per rem -(5 x 10 2 7,ar SV) for low ~ linear energy-transfer radiation has beenLconservatively based on the results.
s.. . reported in UNSCEAR 1988 (Footnote 2) and BEIK V -(see also. NUREG/CR-4214, Rev. 1). The Commission prefers to use factors of ten-to describe such low individual doses because of the large uncertainties-associated with the dose estimates. Use of values'such1as 0.7 or l 12 imputes a significance and sense of certainty that is not i r L justified considering the. levels of uncertainty in the dose.and risk estimates at these low levels. Thuse order of magnitude values such as 1 and 10 are preferable to avoid providing ~ analysts and the public with a sense of certainty and significance that is not commensurate with the actual' precision and certainty of the estimates. i 51
v. .o j 4 1 B. Collective or Population Risk l In the application of the-fundamental principles of. l radiation protection, collective dose provides a useful way to express the radiological impact (i.e., potential detriments) of a. nuclear activity on the health of the exposed population., t Because of the stochastic nature of_ risk, analysis of exposures of large groups of: people to very small doses may result lin-calculated health effects in the population-at large. Collective i dose is the sum of the individual total-effective dose equivalents resulting from a practice or source:of, radiation exposure. It is used'in comparative cost-benefit and other' 1 quantitative analytical techniques and, therefore,His an important factor to consider in balancing 1 benefits and societal detriments in applying the ALARA principle. For; purposes of this policy, individual total effective dose equivalents 11ess than 0.1 1 mrem'per year-(0.001 mSv per year) do not need toLbe' considered in'the estimation of collective doses. The Commission believes consideration of individual doses below 0.1 mrem per year imputes I a sense of significance and certainty of.their magnitude that.is not justified considering the inherent uncertainties [in dose and risk estimates associated with potentially exemptedfpractic'es.- The Commission also notes that doses in'the range of 0.0ltto 0.1 s mrem per year correspond approximately to lifetime risks on the order of one in a million. The NRC has used collective (dose, including rationales for its truncation, in a number of L J ft 52 5 ..a -. ~~
~ a ....-o rulemaking decisions and in resolving a variety ofLgeneric safety issues. III. Dose and' Risk Estimation The Commission recognizes that it is frequently not possible to measure risk to individuals or populations dire,ctly and,Ein most situations, it is; impractical to measure annual doses to individuals at the low levels associated with potential exemption decisions. Typically,.radionuclide concentrations or radiation dose rates can only be measured before the radioactive material. is released from regulatory. control. Estimates of doses to: members of the public1from the types of practices that the commission would consider exempting from regulatory control must be based on input of these measurements into exposure pathway models, using assumptions related to the ways <in which people might become exposed. These assumptions' incorporate sufficient-conservatism to accountifor uncertainties so that any. actual. doses would'be expected to be lower than the calculated doses. The Commission believes that this is an appropriate approach to be taken when determining if an exemption from some or~all-regulatory controls is warranted. Dated at Rockville, Maryland, this day of , 1990. For the Nuclear Regulatory Commission. Samuel J. Chilk Secretary of the Commission. 53
E AFFIRMATI0N V0TE RESPONSE SHEET T0: SAMUEL J. CHILK, SECRETARY- 0F TNE COMISSION FRON: .00mISSIONER ROBERTS
SUBJECT:
SECY-89-360 - COM4ISSION POLICY STATEMENT 0N-- EXEMPTIONS FROM. REGULATORY CONTROL APPROVED x DISAPPROVED ' ABSTAIN NOT PARTICIPATING REoUEsT: DISCUSSION' CW44ENTS: I agree with the Chairman's revised Below Regulatory Concern Policy Statement..I do recommend.:that-it be modified at places to clarify that the BRC individualEdose criteria is 10 mrem with an interim 1; mrem for widespread use practices. (See for example the attached pp;12 and 28.) ( W l 1. l l l. I 1 'v. SI E Ad [0 'DATE' / i ENTERen nu "AS" YEs _ No U ? ?. E :.-..
L statement, NRC intends to exempt specific practices from regulatory control if the practice results in'small doses to individuals and the population at-large and if available-controls cannot achieve reductions in these doses that are commensurate. l with-the public and private resources needed to implement the Y controls. The~ policy statement defines the dose criteria and other considerations that will be used by NRC in making exemption decisie w The policy establishes individual dose criteria.v(1 1 0 mrem per yearJ(0.01 and 0.1 millisieverts per year)]-. and a and collective dose criterion (1000 person-rem per year (10 person-( Sieverts per year)]. These criteria,-coupled with other? considerations enumerated in the policy statement, will beimajor factors in the Commission's determination on whether exemptions i
- from regulatory controls will be granted.
The policy-statement is needed to establish a consistent risk framework for regulatory exemption decisions, to ensure an adequate and consistent level 'of protection of the public in their use.of radioactive l materials, and to focus the-Nation's resources on. reducing the, most significant radiological risks from practices under NRC's jurisdiction. The average U.S. citizen should benefit from t implementation of the BRC policy through (1) timely cleanup of i contaminated sites; (2) increased assurance that adequate, funds 'are available to decommission operating nuclear facilities;- (3) potentialLimprovements in medical-treatment and other services that une radioactive materials resulting from optimal use of-Federal,' State, and licensee resources; (4) enhanced low-leveli ' radioactive waste management practices commensurate with potential risks; and (5) increased assurance that consumer i m _ _ _... ~.. _.. _. _ _ _ _ _ _ _ _ _. _ _ _. _. _ _.. _.. _.., ...m
l 1 Table 1 Hypothetical Hypothetical-Incrementcl Incremental Lifetime. Risk From Annual Dose
- Annual Risk **
Continuina Annual Dose ** 100 mram (1 mSv)- 5 x 10 '3.5 x 10'3 10 mrea (0.1 mSv)' 5: x.10**I-3.5 x 10 1 , area (O.01 mSv)- 5 x 10' .3. 5 x 10 5 0.1 area (0.001 mSV), 5 x 10s' 3.5 x 10 l
- The expression of dose refers _to the Total'. Effective Dose Equivalent-
!~ This term is the. sum of the deep;(whole body) dose; equivalent for sources external to the body and the committadieffective (whole body]- dose equivalent for sources-internal to the body.
- Caleg' lated using a conservative risk coefficient of 5 x 10 p'er rem '
L (5 x 10 per SV) for~ low linear energy. transfer radiation based on the -results reported in UNSCEAR 1988 (Footnote 2)'and'BEIR V-(see also NUREG/CR-4214, Rev. 1). I In view of the uncertainties. involved in risk assessment at 1 low doses and taking into account the aforementioned risk and dose perspectives, the Commission-finds (that:the. average dose to L individuals in the critical group should be.semandduse-10 mram Der er issb yearg (0.1 mSv per _ year) for.each exempted' practice. In addition, an interim dose criterion of-1 area perfyearf(0.01 mSv:perfyear) average dose to individuals in the critical ~ group will be applied to those practices involving widespread' distribution of radioactive material in such items as. consumer products or . recycled material and' equipment,7until the Commission gains more experience with the: potential.for individual exposures from multiple licensed =.and exempted practi-cas. These criteria provide:
A F F I R'M A T I 0 N V O T E RESPONSE _ SHEET L l TO: SAMUEL J. CaILK, SECRETARY OF THE CONMISSION FROM: C0lHISSIONER ROGERS
SUBJECT:
SECY-89-360 - 00lWISSION POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL' l-i i APPROVED Wla ame"Ts DISAPPROVED ABSTAIN It C9t NOT PARTICIPATING REaussT-DISCUSSION COMENTS: Approve with the following' comments.- I endorse the policy statement offered in Chairman Carr's vote, with the changes noted in the initialed' pages of _ the attached copy. I also strongly. support the Chairman's gauggestion regarding the establishment of. a working _ group to develop and -implement a comprehensive strategy for releasing'the BRC policy. This effort should be initiated as soon as possible;and take:a high priority. j WW P1D SIGNATUR'E Q bM.~3 6, ( ? ? o-DATE-q ENTERED ON "A%" Y=s NO 4 70 6 2 9 C 2 JA 63g
R: .,i' b hverI'pt M e.uSvo.ad w d v d c.en d W hhx 4 3 'V^5% o G'~@co du ced >#ctc.Nv a dd' c4 av d bdog, Gho,'pc.As ed s%v L6 % w &w3 0(< &oac.Vn <<+WO" (V.A' M h e h 3L.). -{ & 9 op hL% b4 [759 - ll u um woukhaou" h), 'w sed %%u f " Poyok% do%" (Sea. M' U lf U"t' J NUCLEAR REGULATORY COMMISSION Below Regulatory Concern;~ Policy. Statement i -i ~ t AGENCY: Nuclear Regulatory Commission. -N m, .N ACTION: Policy statement. l'-YP .i a;n u yevr6u;i aw.wek. etw W /{h' win. / i
SUMMARY
This policy statement establishes the framework within' . W m W or ua.M eu 6 which the Commission willieeke decisions.to %xempt from some or p<ae nw 1 all regulatory controls certain pr: ducts .r.d ::tivities involving i ,1 v small quantities of radioactive material,that are hel s - -re;"12Mry rencerr, The exemptions may-involve the= release of .l 7 licensee-controlled. radioactive material either to the generally accessible environment or to persons who would be exempt from % h* Commission regulations. ?.:::// :.w. g ; for which exemptions may be granted include but are not limited:to'(1) the release for l 1 unrestricted public use of lands-and structures containing residual radioactivity, (2) the distribution of consumer products containing small amounts of radioactive' material,- (3) the disposal of very low-level radioactive waste at other than licensed disposal sites, (4) the recycling of slightly contam4nated equipment and. materials, and (5) the release of effluents from licensed facilities. As' described in this policy i 1 1 s: g
a A 9hMm cc ecounwo On ok (<c k 1, ; h co+ ms5W 4o growed +W.g\\oAccsf e%% 9 3vh W W W QA y M %L. 4.wirewe w ca.nnow v.4 c:M. g QtMn 6 pc&W rui Q ccg.. statement, NRC intends to exempt specific ~ practices from \\ I "^="Its ia cr:11 deree to regulatory control if they* 4 "- f indifidurl: nd the pepul:ti:n :t 1 rg: :nd if evcil ble centr:1:_ j I
- nn:t schie'!: r:d a lva. in th::: der : th:t :re e.rurate _
i -) w it!
- h=
F3blic :nd pri/ste ::::urce: n::d:d to implere* the - rentr:1c. The' policy statement defines the dose criteria and other consideratio". that will be used by NRC in making exemption decisions. The policy establishes individual dose criteria (1 ] and 10 mrem per_ year (0.01 and 0.1 millisieverts per year)) and a collective dose criterion-(1000 person-rem-per year (10 person- .i Sieverts per year)). These criteria, coupled with other 1 considerations enumerated.in the policy statement, will be major q f actors in the commission's determination on whether exemptions ' r from regulatory controls will be granted. JPThe, policy statement 4 iseerdedtrestablish[aconsistent.riskframework.forregulatory [ 5 8 exemption decisions, -te ensure,an adequate and consistent level of protection of the public in their use of' radioactive as materials,. nd te focus the Nation's resourcesfon reducing the r 3 a most'significant radiological risks from practices'under NRC's jurisdiction. The average U.S. citizen.should. benefit from implementation of the BRC policy through, (1) timely cleanup of contaminated sites; (2) increased assurance that adequate funds i are available to decommission operating nuclear facilities; (3)
- 1 potential improvements in medical treatment and other services that use radioactive materials resulting.from optimal use of Federal, State, and licensee resources; (4) enhanced. low-level i
radioactive waste management practices commensurate with l l potential risks; and (5) -. increased assurance that. consumer
k products containing radioactive material under the Commission's jurisdiction are. safe. L l L EFFECTIVE DATE: (InsertTPublication Date.) l Y FOR FURTHER INFORMATION CONTACT:: Dr.. Donald A. Cool, Office ofl -l \\ i Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, -l i l Washington, 0;c. 20555, telephone:.(301)' 492-3785. i t i SUPPLEMENTARY INFORMATION: i Statement of' Policy i 1 I. Introduction. l l Ionizing radiation is anfact ofs life. From the day..we are j l born until the day we die, our bodies:are exposed to. low levels of radiation emitted from a variety'of natural and man-made-4 J sources, including the1 cosmos, earth,. building materials, industrial facilities, clothing,-medicine,. food, air, and our own I rneurc.omr e m M s bodies. 7.11 ;;tter exhibitK some degree.of radioactivity. The. g consensus belief among. scientists iscthat even low levels of-q radiation typical of the natural' environment pose some correspondingly low risk of adverse health effects to humans. Recognition of the risk duaito radiation exposure-from natural. sources provides~ perspective on the risks associated'with human uses of radioactive materials. 5 h L w
l Natural and man-made: radionuclides are used inltoday's society _ in many forms. for a variety of purposes, such as medical therapy and diagnosis, materials: analysis, and. power generation. In general, the existing regulatory framework ensures that radioactive materials are controlled consistent with the degree of risk posed to the public and the environment. Some products ~ swow as 44 der smoke detectors and ' lamp mantles. contain small ' quantities ' of l radioactive materials thatLpose such a' low risk that they have' .I i-l been widely distributed without continuing regulatory controls. j i l j To require that.all radioactive. materials be controlled in the r (~ same strict manner regardless'ofithe' risks they pose'would not be a sound use of scarce' National 1 resources. Such strict control- ] i could also deprive society of the numerous; benefits already derived from appropriate uses'of radioactive materials and radiation. In addition, such control would not significantly
- y reduce the risks associated with radiation exposure from a
controlled sources compared with risks associated with natural. background radiation. Therefore, responsible decisions need to f be made on how radioactive materials are-controlled based on a ] judgement about the. levels of risk they pose. j 1 i over the last several_ years,'the Commission has pursued 1 development of a risk threshold to distinguish those radioactive L materials that do not require the same stringent level of regulatory control as that imposed on potentially more hazardous i materials. The Commission recognized'throughout this process ~ can u a 4. that the threshold would need to~be low enough to ensure adequate 3 protection of the public. The Commission also recognized that l A.
the threshold should be compatible with technological and vsse measurement capabilities so it could be-readily'in;1-==n+=d in NRC's regulatory program for nuclear materials.- In addition, the Commission identified lthe need to balance incremental reductions l in risk below the safety ~ threshold with the attendant expenditure of private and public resources. In today's notice, the Commission establishes a-policy to 145 guide decisions on which ::dib ;tive mai.si.. #are "below. 3 regulatory concern" (BRC).because the low levels:of risk they' ] pose do not warrant regulation to the same degree as other I radioactive materials to ensure adequate protection of.the public h and environment. This policy translates the commission's p p e H cs.k judgement on acceptable risk into explicit and imple=="ttbl. criteria on which to base decisions to exempt =""1=pru_.hcis - ="==tericis-P'o from the full scope of NRC's regulatory frz % w:tv
- Ucr The BRC criteria are necessary to ensure adequate and consistent l
decisions on acceptable risks posed by decontaminated and decommissioned nuclear facilities, consumer products containing radioactive materials, and very low activity radioactive wastes. These decisions will be implemented by the Commission through i rulemakings add licensing decisions based on careful and thorough se d 6 es pr e i o _ analyses of the risks associated withgeayv ute to ensure that the public is adequately protected. Under the regulatory approach used by the U.S._ Nuclear Regulatory Commission (NRC), the use of radioactive materials is subject to limits and conditions that ensure the protection.of \\ \\ 5
.- + k 1 the health and safety of both-workers and members of the general .public, and the environment. For example, radioactive material is controlled by NRC-and Agreement State-licensees to ensure e that dose limits,are not exceeded. In addition, sources of radiation are designed,-used and disposed of in a manner-that i ensures'that exposures to radiation or radioactive' material are as low as is reasonably achievable (ALARA), economic and social factors being taken into account. NRC has endorsed.the ALARA . provision in regulatory practice for a' number of years _(10 CFR Part 20). However, NRC has not yet provided' criteria that would establish the' basis for defining the level of' residual risk at' which further regulatory-control.is no longer warranted. W \\ I A. major provision of this policy involve 'the definition of criteria that delineate conditions under ich additional expenditures of regulatory and licen e resources:are not i necessary to further reduce rad tion exposures from a given practice. Application of ttese criteria by NRC Will promote ~ consistent decisions on he need to require further reductions in radiation exposure-dose levels that are comparable.to / r incremental rad tion doses associated with routine' activities / l such as crops
- country air travel.
e 'W / / The policy statement in today's notice provides a unifying-risk framework for making decisions about which radi;;;tiv; PNu
- tcricla can be exempted from the full. scope of NRC's comprehensive regulatory controls.
Under the criteria and-principles of this policy statement, exemptions of radioactive-6 .i _j
ft materials from regulatory controls would involve the transfer of very small quantities of the materials from a regulated to an p t unregulated status. NRC will analyze such proposed transferA to 3 ensure that doses resulting from exposure to exempted practices i will bw sufficiently low that the public health and safety and the environment will remain adequately protected. C e licensed ons activity producing Aaw> exempt material would continue to be subject to the full range of regulatory oversight, inspection, and enforcement actions up,to and including the point of transfer to an exempt status.. The Commission also intends to conduct povsodiea0Iy j
- icdic research to evaluate the effectiveness of th.y x
- ; tier 3
Policy and to confirm the safety bases that support the exemption decisions. Through appropriate rulemaking actions or licensing decisions, the Commission will establish const_raints, 5(*4c.> requirements, and conditions applicable to exemptions of g radioactive materials from NRC's regulations. The NRC will verify that licensees adhere to these exemption constraints and conditions through NRC's licensing, inspection, and enforcement programs. For example, the Commission may promulgate regulations that would require some type of labeling so that consumers could make informed decisions about purchasing a product containing exempted materials. Such labeling is presently required by the Commission for smoke detectors containing radioactive material (see 10 CFR 32.26). The NRC ensures that manufacturers label the detectors in compliance with the labeling requirement through licensing reviews and inspections. Specific source controls and 7
f Policy Amendments Act (LLRWPAA) of 1985 directed tho' Commission to develop standards and procedures and act upon petitions "to exempt specific radioactive waste streams from regulation... due to the presence of radionuclides... in.sufficiently-low concentrations or quantities to be below-regulatory concern." The commission responded to this legislation by issuing a policy l i statement on August 29, 1986 (51 FR 30839). That policy statement contained criteria that, if satisfactorily addressed in a petition for rulemaking, would allow the Commission.to act expeditiously in proposing appropriate relief in its regulations- ~ on a " practice-specific" basis consistent with the merits of the petition. Federal and State agencies have also developed and t l implemented similar exemptions br.ded on evaluations of their risks to the public and the eavironment. - The Food and Drug Administration (FDA), for example, has applied sensitivity-of-method, risk-based guidelines in connection with the regulation of animal drugs, food contaminants, and trace constituents in some food additives. Similarly, the Environmental Protection Agency (EPA) established exemption or threshold levels based on individual risks in the regulation of pesticides and.other toxic L and carcinogenic chemicals. For example, EPA employs such a [ concept in defining hazardous waste under-the Resource o Conservation and Recovery Act.through the Extr::ti;n pr;;; dure 'EP) T;xicity Characteristi: and the T:xicity Ch:r:ct:ri.tiv i = w 4 4 e e l. aprc::durer yield cencentrations cf car"inogenic and tcMic 9 l
hi p ~ constituents in leachate, which are then compared with thr,S M id I concentrations to determine whether solid was are hazardous 1 l wastes and to evaluate the adequac treatment processes. Wastes whose leachate co trations fall below the threshold levels established y EPA may be " exempted" from compliance with the comp ensive hazardous waste regulations or allowed to be d osed of in permitted land disposal facilities, respectively. 1 For certain practices involving minimal public health and safety concerns, the imposition of undue or unnecessary regulatory controls could prohibit a practice that s ld otherwise be permitted because-of reasonable sop #etal (including j public health and safety) benefits. In ad tion, with the necessary national focus on fiscal re onsibility,_ resources expended for regulatory control practices'with-minimal health and safety impacts could be sed to address more significant - radiological and nonra.ological health and safety concerns. To address this nee the Commission,-in this policy, is establishin framework for expanding on its existing regulat ns for protection of the public from radiation which \\j cur ntly define a number of longstanding exemptions from i egulatorycontrol.]Thispolicywillalsobeusedbythe MW N@h Commission as a basis for reevaluating existing NRC exemptions to E ensure that they are consistent with the criteria defined herein ' "ecou-thi; p:licy previdee e cer.eistec* *iek b::i: for ~
- p.o 9
y erptia.g the use of byproduc* "A e""ce : teri:1 in consuncr--- g 'j prcducte, this policy supersedes the Atomic Energy Commission's c 10
/ 1 hrch16, 1965, policy, statement on'this subject (30 FR 3462).-~j 3 _- / q# The Commission-believes that the Below RegulatoryTConcern policy is needed to establish a consistent, risk-based-framework l for making exemption decisions._ Specifically,thhf$ffEE"Is needed to (1)~ establish residual radioactivity criteria and j requirements for decommissioning and: cleanup of radioactive contaminationLat licensed and.formerly-licensed nuclear facilities, (2) ensure that licensee decommissioning funding - plans provide adequate funds to cover the costs of cleanup of these' facilities to protect people and the environment, (3) ~ j-ensure that the public is t:ing d quitely'="A -^neietently uph+ wvh riu. protected from consumer products that contain radioactiva g materials under - the Commission's jurisdiction, (4) provide decision criteria for reviewing: petitions to_ exempt very low level rad.'oactive wastes in accordance with the Low-Level 1 Radioactive Waste Pol. icy Amendments'Act'of,.1985, (5) focus;the: addros6 g l resources of NRC, Agreement States, and' licensees on more g significant risks posed by nuclearimaterials,'(6)- establish a ( risk-based threshold to ensure that the potential 1 benefits of . additional reductions in risk are. commensurate with the' costs of i attaining the Teductions and Of p;rfer;in; th: an:ly::: t:-- l-
- hie"r :nd confira the reductienF, and (7) review NRC's regulatory framework to ensure that existing exemptions involving radioactive materials'are consistent ~andJadequate to protect the 3
Mord 5 public. The avereg: " C. citizer ehe"ld benefit from i g 'inA d.c implementation of the BRC policy through; increased ~ assurance Ethat consumer products containing radioactive material under the l l 11 u.- m.. ,4
fQJ[ J Commission's jurisdiction are safe; timely cleanup of contaminated sites; increased assurance that adequate funds are available to decommission currently' operating nuclear facilities potential improvements in' medical treatment and other services. that use radioactive materials resulting from the optimal use of the Federal, State, and licensee resources; and focus of Federal' and State efforts and resources on reduc'ing the most significant -[ radiological risks from practices under their jurisdiction. ( t I -The Commission's BRC policy establish'es an explicit and
- uniform risk framework for making regulatory exemption decisions.
y In lieu of such'a policy, the Commission could continue the current practice of exempting practices on a case-specific basis. Such an approach, however, does not r.cr::::rily_ ensure consistent evaluation-and control of risks-associated with exempted practices. For this reason and the= reasons discussed above,'the' Commission has established the BRC policy Statement. $ % \\ON The Commission recognizes that= Agreement. States will play an important role in the implementation of tha' Below Regulatory
- i concern policy, specifically in the areas of developing and enforcing compatible State regulations,, regulating cleanup _and q
decommissioning of certain types of contaminated nuclear i facilities, and exempting certain low-level radioactive wastes L-from requirements for disposal in licensed low-level waste disposal facilities. The Atomic Energy Act of 1954, as amended, gives to the Federal government the exclusive authority to ~ regulate source, special nuclear, and byproduct materials to i 19L u s.
/rW ensure: protection of the public-health and safety. While Congress subsequently provided for Federal-State agreements under Section 274b of the Atomic Energy Act through which States could assume regulatory responsibilities'in lieu of Federal regulation 'for certain classes of nuclear' materials, it required that State I radiation protection standards be coordinated and compatible with } the Federal standards for radiation protection. 1 1 NRC regulations exempting BRC wastes will not affect the authority of State or local agencies to regulate BRC wastes for purposes other than radiation protection in accordance with Section 174b of the' Atomic Energy Act. The Commission intends i that'rulemakings which codify exemptions:from the regulatory requirements applicable to certain types'of radioactive materials will be matters of strict compatibility for. Agreement States to the extent that States, under the terms of their'Section~274b 1 Agreements with NRC, have assumed regulatory responsibility for these classes of materials. The Nation will' benefit from the i application of a uniform policy, thereby; avoiding conflicting, overlapping, and inconsistent standards. This11s particularly significant for articles containing radioactive. materials which receive widespread distribution, such as consumer products, ""^-- inecneietent regu1=*iene could unduly r::trict end hurdea .?nt s=Loi. end internati n:1 ::rmerce: In initiating proceedings to implement NRC's BRC-policy, the Commission will continue to consult with and seek the advice of the States. Some States have expressed concerns that economic and U
^ Ntr' l institutional. impacts of-the Commission's BRC policy may undermine their ef forts to-develop new disposal f acilities for low-level radioactive waste in accordance with the Low-Level Radioactive Waste Policy Amendments Act of-1985.. These States j would prefer to establish their own standards for determining which vastes should be exempted from regulatory control rather than adopting standards that are compatible with uniform Federal standards. The Commission has developed the BRC policy to provide a uniform and consistent health and safety framework for l exemption decisions. In so doing, the Commission recognized the concerns expressed by Congress when it enacted the Low-Level 1 Radioactive Waste Policy Amendments Act of 1985 that health, i safety, and environmental considerations should take precedence over economic or institutional concerns (see Senate Report 99-199 that accompanied S. 1517, Senate Committee on Energy and Natural Resources, November 22, 1985, 99th Congress, 1st Session at page 9). The Commission is confident that1 waste exemption decisions made in accordance with requirements that implement its BRC i policy will be adequate to ensure protection of theLpublic health and safety. Th: Cerricri n 1.v Leliev : that incenri tc... - rrgul Lien Of SRC '?sete ex :pticn: ::ald not only ::: ult in - _incres :d riche te the public :nd the erviren=:nt but eculd 01: imp:de state effort: t develop lev-leual '?::t di:p:::1 -f acilitiee. The policy described in this document is intended to provide pro u c Ni m the public health and safety framework that would apply to a wide spectrum of Commission exemption decisions. As such, it provides . 14
' individual and collective dose criteria, and discusses other important elements of the exemption decisionmaking process, e 'Section II provides definitions of key terms and concepts used in I l the policy statement. Section III presents.the basic elements of the policy, while Section IV discusses how the policy will be implemented through rulemakings.and licensing actions and describes how the public will have an opportunity to comment on the Commission's exemption decisions. This section also $;;;; NRC plans to review past exemption decisions to ensure consistency with the provisions of the BRC policy.. Section V describes, in general terms, the information needed to support the exemption decisionmaking process. M )'M 4 II. Definitions. " Activity," when used to describe radioactive material-in this policy statement, is the rate of disintegration' (transformation) or decay of radioactive material. The units of activity are the curie (1 Ci = 3.7 x 10" disintegrations per (second) and the becquerel (1 Bq.= 1 disintegration per second). - "ALARA" (acronym for "as low as is reasonably achievable") means making every reasonable effort to maintain radiation exposures as far below applicable dose limits as is practical, consistent with the purpose for which the licensed activity is undertaken taking into account.the state of technology, the economics of improvements in relation to benefits to the public i health and safety, and other societal and socioeconomic .15
B ~ containing small amounts of radioactive material; and the recycle ] spac ' 6 t., Hon o b and reuse ofgresidually, contaminated materials and equipment are-examples of' practices for which this policy.will have potential applicability. ($44 N'" TD b9 ty. +w dssc dshi ob i mus'd r " Rem" is the special unit of dose eqN valent.(1 rem = 0.01 i sievert). " Risk," for purposes of this pol-icy, means the annual-or lifetime probability of the development of fatal cancer from exposure to ionizing radiation and is taken as the product of..the. dose received by an exposed individual and a conversion factor based'upon the linear, no-threshold hypothesis. The conversion factor for dose to risk is taken to be 5 x 10 fatal. cancers per. rem of radiation dose. The fatal cancer risk is considered, in general, to be either more likely or have more severe outcome than the potential genetic and nonfatal cancer risks and the potential risks'of developmental anomalies in fetuses. While the Commission recognizes that.the risks from exposure:to radiation are greater-for children than adults and that.there.are-increased t risks from exposure to the embryo / fetus, the estimate of fatal cancer risk for all ages and both sexes is considered to be an appropriate measure of risk from practices being' considered for exemption in accordance with this policy statement (see i Appendix). " Source material" means -- 19-
WOR-basis upon which the Commission will initiate the development of appropriate-regulations or make licensing decisions.to exempt certain practices from some or all regulatory controls. This l policy.is directed principally toward rulemaking activities but may be applied to license amendments or. license applications involving the release of licensed radioactive material either to the environment or to persons who would be exempt from Commission regulations. %or 40% p pbGc corny Mh htM 6 h f e dACA % M. f Labh &c W J It is the commission's intent to broadly define specific j practices so that the effect of an exemption decision on any individual or population will be evaluated in its entirety and not in a piecemeal fashion. At the same time, the practice must be identified and described in terms that will facilitate reasonable impact analyses and allow imposition of appropriate constraints, requirements, and conditions as the radioactive material passes from a regulated to an unregulated status ('i.e., a the material is no longer required to be under the control-of a licensee).. Under this policy, the definition of a " practice" in any specific decision (rulemaking or licensing action) is a critical feature. The NRC will ensure that formulation of exemptions from regulatory-control-will net allow deliberate => dilution of material or fractionation of the radiation or radioactive material for the purpose of circumventing controls that would otherwise be applicable. The definition-of the practice in any specific exemption decision will also provide the framework for taking into account the possible consequences of accidents or misuse or the potential for other nonstochastic 21
MCW practices should not be considered candidates for exemption, such. as the introduction of radioactive materials into products to be consumed or used primarily by children. Such practices should be specifically evaluated to determine if they could result in greater risk levels to exposed members of the public than the levels found. acceptable by the Commission in formulating this policy. Unlike justification decisions involving complex trade-offs between cultural and societal values, these decisions clearly fall within the commission's purview to protect the health and safety of the public. A. principles of Exeuption. 71v.pe:nc[ poi % ::jer consideration in exempting any practice from some or n all regulatory controls hinges on the general question of whether the application or continuation of regulatory controls is necessary to protect the public health and safety and the environment.;nd i: :::t effecti'/ 1.- furth-r ::durin; Om:11 dA a ri:% (i.e.,. ;;;;;neuret; d::: ;;ducti n)_ To d:::;;in; if exemption is appropriate f-a= *"i- =*- dprint, the Commission must determine if one of the following conditions is met: 1. The application or cont.inuation of regulatory controls on the practice does not result in any significant reduction in dose received by individuals within a critical group (i.e., the group expected to receive the highest exposure) and by the exposed populations or 23
i 2. The costs of the controls that could be imposed for l further dose reduction are not balanced by commensurate reduction in risk.th;0 ;;;1d b:
- li:cd.
I i l At a sufficiently low level of risk, the Commission believes j the decisionmaking process for granting specific exemptions from ) ) some or all regulatory controls can be essentially reduced to an i evaluation of whether the overall individual and collective risks-1 l i from each particular practice are sufficiently small. The i concission believes that individual and +tantch9t..yo..i.er, dose criteria i should be basic features of its overall policy to define the j region where the expenditure of Commission resources to enforce l requirements for further dose reductions or licensee resources to comply with such requirements is no longer warranted. These ~ specific criteria include (1) values for the individual annual i dose reasonably expected to be received as a result of the l practice (e.g., an average dose to individuals in a critical t t group) and (2) a measure of radiological impact to the exposed population. In combination, these criteria are chosen to ensure I that, for a given exempted practice, no individual will be exposed to a significant radiological risk and that the population as a.whole does not suffer a significant radiological impact. t It is important to emphasize:that, in this policy, the commission does not assert an absence or threshold of risk at low radiation dose levels but rather establishes a baseline level of risk beyond which_further-government regulation to reduce risks i 5 ^~
A h As described in the Appendix to this policy is unwarranted. the technical rationale for the Commission's BRC ctatement, criteria is explicitly based on the assumption that the risk from oxposure to radiation is linearly proportional to the dose to an The presence of natural background radiation and individual. variations in the levels of this background have been used to i provide a perspective f rom which to judge the relative significance of the radiological risks involved in the exemption decisionmaking process. ( %r4 yvm W T2, The Individual Dose Criterion. B. 1 If the doses to individuals from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared to other societal risks, and there would be little merit in expending resources to further reduce this dose or risk provided that sound radiation protection and principles have been applied in the design, development, The Commission believes proposed implementation of the practice. the definition of this risk or dose level can be developed from two perspectives. The first of these is related to quantitative risk levels. Based on analysis of voluntary and involuntary risks commonly accepted by the public without significant concern, the Commission believes that most members of society will not expend resources to reduce an annual individual risk of fatality below approximately 1 chance in 100,000 (1 x 104; this is equivalent I l QD
i I individual dose thresholds below which additional regulatory controls are unnecessary and unwarranted to require further t reductions in individual doses. The commission considers these criteria to be appropriate given the uncertiinties involved in estimating doses and risks, and notes that these criteria should facilitate straightforward implementation of this policy in future rulemakings or licensing decisions. i The Commission believes that, notwithstanding exemption of I practices from regulatory control under these criteria, it still has reasonable assurance that exposures to individual members of the public from all licensed activities and exempted practices will not exceed 100 mrem per year (1 mSv per year) given the commission's intent (1) to define practices broadly, (2) to evaluate potential exposures over the lifetime of the practice, ( ) to monitor and verify how exemptions are implemented under 3 be4h this policy, (/) to impose : ::rpenic-individual and collective dose criteria, (5) to verify dose calculations through licensing reviews and rulemakings with full benefit of public review and comment, and (6) to inspect and enforce licensee adherence to specific constraints and conditions imposed by the commission on exempted practice *s. t The commission intends that only under unusual circumstances would exemptions be considered for practices that could cause continuing radiation exposure to individuals exceeding a small fraction of the 100 mrem per year (1 mSv per year) ose limig. In rare cases, exemptions of such practices may be 6 +s to CJ cc. Yu.oso 29
b J l granted if, after conducting a thorough analysis of the proposed exemption, the Commission determines that doses to members of the l public are ALARA and that additional regulatory control is not j justified by further reductions in individual and collective l l doses. buuAvo C. The.":pulatian Dose criterion. t r i The Commission believes that the collective dose (i.e., the-t sum of individual total effective dose equivalents) resulting from exposure to'an exempt practice should be ALARA. However, i f l the collective dose resulting from an exempted practice is less than an expected value of 1000 person-rem per year (10-person-Sv per year), the resources of the Commission and its licensees could be better spent by addressing more significant health and [ safety issues than by requiring further analysis, reduction, and confirmation of the magnitude of the collective dose. The i 1 Commission notes that, at this level of collective dose, the number of hypothetical health effects calculated for an exempted practice on an annual basis would be less than one. i The National Council of Radiation Protection and .t Measurements recommends in its Report No. 91' that collective dose assessments for a particular practice should exclude consideration of those individuals whose annual effective dose ' Recommendations on Limits for Exposure to Ionizing Radiation, NCRP Report No. 91, National Council on Radiation Protection and-Measurements, June 1,- 1987. Available for purchase from NCRP Publications, 7910 Woodmont Ave., Suite 1016,.Bethesda, MD 20814. 30 -m 3----#- a y- -e+ g y g- --vsr-.-m + ey 9 p m-1
'(f[. } k equivalent is less than or equal to 1 arem per year (0.01 mSv per year). Taking this recommendation into account and considering i the practicality of dose estimation techniques and uncertainties associated with such low dose and dose-rate estimates, the Commission c:n:lud:: th:t individ 01 desee lee; th:n 0.1 ;;;; per year (0.001 efv p:: y r; n;;d net be ceneidered ir celewlating ec1'=ce4u= desee. '. : a practical
- tter, ceneiderati;n of dca;
[ mad ler;e: r-5 :: of i r=*== 4a +h-m!: :::: per y-er r*aga hypotheticel individuel; petentially :x; ::d te en er pted practi:; moi unduly vvmelivai-ib avus waivuloiien; th:t vill be ] reed t; ;uppert de;;neti Liene th:t-prepered ex;;pti;n; ce; pert-ul t h *ke critei-i. in--thi; p;1 icy. T5: Cerrieelee believes that s (o.coi msv pu yeAe; l inclusion of individual doses below 0.1 mrem per year introduces g unnecessary complexity into collective dose assessments and could impute an unrealistic sense of the significance and certainty of such dose levels./. i In the sensitivity-of-measure, risk-based guidelines used by 4 EPA and FDA, a 10 lifetime risk of cancer has been used as a l quantitative criterion of insignificance. Using an annual risk coef ficient of 5 x 10 health ef fects per rem (5 x 10 2 per 4 sievert) as discussed in the Appendix, the 10 lifetime risk value would approximate the risk that an individual would hypothetically incur from a continuous lifetime dose rate in the range of 0.01 to 0.1 mrem-(0.0001 to 0.001 mSV) per year. For the all of these reasons, the Commission believes that 0.1 mrem per year is an appropriate truncation value to be applied in the assessment of collective doses for the purposes of this policy. i ~. 31
[CM 49 y. The Commission notes that adoption of the individual and / collective dose criteria does not indicate a decision that doses 5:1:e th;;; es d.si... nece;;;ri b;fe;; ; p;;;tice-4 e he l
- ;;pt.
e; ',h t d;;;; above the criteria-would necessarily preclude exemptions. The criteria simply represent a range of risk that the Commission believes is sufficiently small compared to other individual and societal risks that further cost-risk-reduction analyses are not required in order to make a decision regarding the acceptability of an exemption. Practices not meeting these criteria may nevertheless be granted exemptions 4 from regulatory control on a case-by-case basis in accordance i with the principles embodied within this policy, if (1) the potential doses to individual members of the public are i sufficiently small or unlikely, (2) furt' er reductions in the l doses are neither readily achievable n' r significant in terms of l l protecting the public health and safecy and the environment, and (3) the collective dose from the exempted practice'i's 1 sufficiently small. -~ IV. Implementation. The Commission's BRC policy will be implemented principally through rulemakings; however, exemption decisions could also be implemented through specific licensing actions. 1 In the first case, a propcsal for exemption, whether l initiated by the NRC or requested by outside parties in a petition for rulemaking, must provide a basis _upon which the
(.k exemption, a person using the exemption would no longer be j i required to apply the ALARA principle to reduce doses further for the exempted practice provided that the licensee meets the conditions specified in the regulation. The promulgation of the regulation would, under these circumstances, constitute a finding that the practice is exempted in accordance with the provisions } of the regulation an6 that ALARA considerations have been l adequately addressed from a regulatory standpoint. The i commission in no way wishes to discourage the voluntary arplication of additional health physics practices which may, in fact, reduce actual doses significantly below the BRC criteria or the development of new technologies to enhance protection to This is partiqu1 r1 artinbtin i, 4 ob h\\o,$ecciecu h Nublic and the environment. 9 devel63 Dylfy'. Po(c% e Sb4 heareaofdecontaminationanddecommissioning,Awherethe Commission anticipates that emerging technologies over the next i several decades should enhance existing technical capabilities and further reduce doses to workers and the public. I l l The second means.of policy implementation could involve exemptions that would be granted through licensing actions, such i as ;it; specific determinations that t has been sufficiently decontaminated to be released for unrestricted public use. The NRC intends to develop guidance regarding the implementation of the BRC criteria to ensure that such site-specific actions adhara to the criteria and principles of this policy statement. These licensing actions may be subject to a public hearing process and r was the-speelfic setien taken, ii.ey be r.wi..a i.g e b d:;..ndiny un noticed in the Federal Register. i 34 i
b 1 l The description should address the quality assurance program used (- in data onllection and analysis and supporting-information. If I any surveys were conducted, they should be described. Market l information may be useful in characterizing a practice on a national basis. l 3. As low as is reasonably achievable (AIARA). An analysis i should be provided that demonstrates that radiation exposure and radionuolide releases associated with the exempted practice-overall will be AIARA. The AIARA principle referred to in 10 CFR Part 20 applies to efforts by licensees to maintain radiation I l exposures and releases of radioactive materials to unrestricted areas as low as is reasonably achievable. Appendix I to 10 CFR d I Part 50 describes AIARA for radioactive material releases from 1 light water reactors (nuclear power plants). Exemption proposals I should desctibe how AIARA considerations have been applied in the L l design, development, and implementation of controls for the l proposed practice. Licensee compliance 'with the AIARA principle r must remain in effect up to and including the point at which the materials are transferred to an unregulated status in accordance t 'm L @M,w,, a?s. e~AL. with an exemption gented under this policy.1, L
- A L; nM n;-
n }e g},n,b. $ naawill be prMnenT b hed prochtes. G_ T.'T;3 h t i'f' JF r-u-w ra c e C ' \\ 4 " q = ' df-T "-';, w '- {,' - h _,. i i ' ~ ~ TD. ImpactIAnalys$s. ~ ~ ~ " l To support and justify a request for exemption, each l-petitioner or licensee should assess the radiological and nonr'adiological impacts of the proposed exemption. The analyses should be based on the characterizations described previously and 39 l
should cover all aspects of the proposed exempt practice, including possession, use, transfer, ownership, and disposal of the material. NRC consideration of the exemption proposal and ( l any environmental assessments and regulatory analyses required to implement the exemption will be based on the impact analyses and supporting characterizations. 1. Radiological impacts. The evaluation of radiological i impacts should clearly address the policy's individual and collective dose criteria or provide a sufficient ALARA evaluation supporting the exemption. In either case, the following impacts should be assessed: Average doses to the critical population groupt Collective doses to the critical population group and the total exposed population (under conditions defined in Section III) The potential for nonstochastic radiological impacts; and-The potential for reconcentration of radionuclides, ciowa The collective ;r?"1 2' --T
=="a should be estimated and i summed in two parts: total dose to the critical population group ofewd and total dose to the4 population. The critical group is the relatively homogeneous group of individuals whose exposures are j likely to be the greatest and for whom the assessment of doses is likely to be the most accurate. Average doses to this group are the controlling factors limiting individual doses and risk, and should be compared with the individual dose criteria, as
[; ) i i i F. Constraints, Requirements, or Conditions on Fxemptions. J ~ In most cases, the characterizations of the material and the i l assessment of impacts will be based on either explicit or { implicit constraints, such as limitations on the amount of radioactive material'in a consumer product. In order for an [ exemption decision to take credit for these. constraints, the t exemption proposal should.specifically identify appropriate constraints, such as quantity limits, concentration l'imits, and t physical form characteristics. The bases on which these t constraints are to be ensured should.also be discussed. In general, constraints should be inspectable and verifiable in order to provide the basis for an exemption decision. l l h %ev Cin e w G.
- dkeeping and Reporting, t
This portion of the exemption proposal should be tailored to j either a generic petition for rulemaking or specific proposal for a license amendment. For generic petitions for rulemaking, the l proposal should provide and' justify J;; iblef generic requirements for ::cerd 6 eping ec.4 ::;:r*in; *er Quality Assurance / Quality Control and Reporting. Such proposals should include example requirements and show their effectiveness and -feasibility. For site-specific license amendments, the exemption proposal should provide specific requirements for Quality Assurance / Quality Control and Reporting that have.been tailored l l to the licensee's program. f as
? L B. Collective or Population Risk In the application of the fundamental principles of radiation protection, collective dose provides a useful way to express the radiological impact (i.e., potential detriments) of a pro 4M w - I -" 1;;; uivity on the health of the exposed population. Because of the stochastic nature of risk,-analysis of exposures of large groups of people to very small doses may result in calculated health effects in:the population at large. Collective dose is.the sum'of the individual total effective dose j equivalents resulting from a practice or source of radiation exposure. It is used in comparative cost-benefit'and other quantitative analytical techniques and, therefore, is an important factor to consider in balancing benefits.and societal i detriments in applying the ALARA principle. For purposes of this policy, individual total offactive dose equivalents less'than 0.1 mram per year (0.001 mSv per year) do not need to be considered in the estimation of collective doses. The Commission. believes consideration of individual doses below 0.1 mrem per year imputes a sense of significance and certainty of their magnitude that is i not justified considering the inherent uncertainties in dose and risk estimates associated with potentially exempted practices. The Commission also notes that doses in the range of 0.01 to 0.1 mram per year correspond approximately to lifetime risks on the order of one in a million. The NRC has used collective dese, including rationales for its truncation, in a number of n
3 i AFFIRMATION V0TE ) RESPONSE SHEET i l T0: SAMust J. CHILK, SECRETARY OF THE COMMISSION i FROM: C0mISSIONER CURTISS-i
SUBJECT:
SECY-89-360 - Co MISSION POLICY STATEMENT ON EXEMPTIONS FROM REGUl.ATORY CONTROL 1 X X , APPROVED in part DISAPPROVED in part AssTAIN Nor PARTICIPATING RaouEsr Discussion L COMENTS: 'l l l See attached comments. ( l l ) ( i l i J NM U SIGNATURE l 05/11/90 DATE ENTERED ON "AS" YEs x No i i 0 $i0 ~
ls 1 v l; i' Commissioner Curtiss' comments on SECY-89-360: I strongly endorse going forward with a comprehensive policy that 1 will establish a disciplined and consistent fran.swork within ) which the Commission can define those practices that, from the standpoint of radiological risk, we consider to be below l regulatory concern (BRC). The principal advantage of such a l policy, in my view, is that it will bring much-needed discipline and technical coherence to the patchwork of BRC regulatory I decisions that have been rendered to date, providing a clearly-i articulated, risk-based approach for reaching these decisions in the future. Accordingly, I strongly support this initiative. With the foregoing comments by way of general background, I endorse the Chairman's revisions to the policy statement, subject j to the following comments and modificationst Individual Dose Criteria I support the individual dose criteria of 10 millirem / year for practices involving potential exposures to limited numbers of the [ public and 1 millirem / year for widespread practices that involve potential exposures to large numbers of the public. In view of l the potential for multiple exposures from widespread practices, however, and in the interest of administrative finality, I think l it would be prudent to establish the 1 mrem criterion as a final criterion, rather than an interin value. On the question of which activities fall within which category (12g2, limited populations subject to the 10 mrem standard vs. widespread populations subject to the 1 nrem standard), I would ' recommend that we direct the staff to develop more detailed guidance to address this question. The guidance should be drafted in a manner that will enable those responsible for implementing this policy to sort through'the complex situations that might arise. To take one example, it is not obvious under i the policy Statement how we would approach a decommissioning action that involves some pathways that affect only a few people (gigt, fixed residual radioactivity), with others that might affect large numbers of people (gig 2, major ground water sources). To address this and other similar situations that might arise, the guidance should focus on defining what types of activity fall within which category, with representative examples cited where appropriate. Finally, while it is conceivable that the need may arise on a case-by-case basis to-permit exemptions where doses exceed the levels established in the policy Statement, it is not clear to me what the basis is for designating the level of 100 mrem / year. Since these decisions will be based on the merits of specific ~, cases and since it is difficult to project what dose levelsLabove 1 or 10 mrem / year might be appropriate, I do not believe that itL t is necessary to explicitly reference doses up to 100 mrem / year. e . ~.. ..-.1
i 1 , l Accordingly, I would delete the reference to 100 mrem from the Policy Statement, leaving the decision to be made on a case-by-case basis. (I do endorse the notion that such cases would be i the rare exception, rather than the rule.) i Collective Dose Criterion I would support a collective dose criterion of 100 person-rem. A i collective dose criterion of 1000 person-rem is an order of magnitude higher than the level recommended in IAEA Series No. i 89, as well as the level recommended by most other international groups. Furthermore, it is an order of magnitude higher than the 1986 collective dose to members of the public due to effluents t I from all operating reactors (Eng Memorandum from James M. Taylor to the commission, December 14, 1989). Finally, if the collective dose criterion is to be defined as the floor to ALARA (as I would propose below), a more conservative approach to i establishing a collective dose criterion seems to be warranted in view of the fact that doses may be truncated in the calculation of collective dose; additionally, the collective dose criterion' may be applied to single licensing actions. For these reasons, I am not comfortable with a collective dose criterion of 1000 person-rem. In view of what appears to be the prevailing technical view on this matte criterion of 100 person / rem.p, I would endorse a collective dose ALARA Iwoulddefinetpeindividualandcollectivedosecriteriaas floors to ALARA. If we intend to say, as I think we do in this Policy Statement, that those practices that fall within the individual and collective dose criteria established in the policy can be designated _below regulatory concern, we only confuse our intention (as well as our conviction) on this matter by nevertheless going on to say that we expect certain steps to be taken to keep exposures ALARA. This is not to say that I object ' I would point out that the Policy Statement allows higher collective doses if analyses show that the collective dose is ALARA for a given practice. Therefore,' adoption of the lower IAEA value of 100 person / rem based on dollar estimates of resources to do detailed ALARA analyses would not eliminate the option to approve practices such as smoke detectors that involve large numbers of potentially exposed, members of the public. 2 l By " floor to ALARA", I mean that the petitioner and the staff are relieved from the regulatory obligation to perform further ALARA analyses below these levels if individual doses are 1 mrem and the collective dose is 100 person-rem. e -e -e s,,. w e-wn- +
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to the ALARA concept. I support the notion that collective dose l and ALARA analyses should be performed in a manner that is consistent with basic national and international radiation protection principles. But to say on the one hand that the individual and collective dose criteria reflect levels below which no regulatory resources should be expended, while at the same time encouraging voluntary ALARA efforts to achieve lower doses strikes me as regulatory equivocation. For the sake of l regulatory clarity, I would treat the individual and collective dose criteria as floors to ALARA. i Justification I endorse the language proposed by the staff in SECY-89-360 on justification of practice. While I concede that the principle of justification of practice calls upon the Commission to make decisions involving so-called questions of " societal value", that is not a sufficient reason to step back from this widely-accepted health-physics principle. Indeed, we already take such considerations into account, either explicitly or implicitly, in many of the decisions that we render. With regard to the alternate approach suggested by the Chairman for addressing those practices involving children,. it seems to me that this approach poses the very.real potential that we could, on the one hand, reject a practice involving children (32g2, baby food, pacifiers, and the like) on the' ground'that the risk posed.by such a practice is too high, yet authorize a practice directed at the general public that could, coincidentally, expose an even greater number of children, even though the practice itself is not specifically directed at children. For these reasons, I would staff in Alternative 2 of SECY-89-360 [inciple recommended by the retain the justification of practice p Truncation I support the truncation of collective dose summations at 0.1 millirem / year. I am sympathetic, however, to the staff's concerns that truncation at this level may result in the loss of some information that might be useful in differentiating between options. Accordingly, the Policy Statement should be sufficiently flexible on this point to accommodate those rare occasions where there may be a compelling need to sum doses below this truncation value in order to make a sp0cific decision. P 3 Such an approach, if adopted, would supercede the approach set forth in the 1965 policy Statement on Consumer Products. i ,. _,.. ~,,
) l e i -4 Preemption / Compatibility e I do not believe that we'should take the position in this Policy Statement that the approach that we have established will be considered a matter of compatibility for Agreement States in the i area of low-level waste disposal; nor do I believe that we should i take the position that we consider the approach set forth in this Policy Statement to be preemptive on matters involving low-level waste disposal. My concern with such an approach is twofold First, I am not aware of any public health and safety rationale involving low-level waste disposal that has been advanced as a basis for the NRC to insist that the Commission's position on BRC should be a matter of compatibility for Agreement States and, in a more general way, a matter of preemption. The argument, as I understand it, for making the Commission's position a matter of compatibility (and preemptive) is that States should be 1 foreclosed from departing in any way from the approach established by the Commission. To take the most visible and l controversial example that has arisen to date, this would lead to the result that a State could not require that low-level waste streams designated BRC by the Commission nevertheless be disposed of in a licensed low-level radioactive waste disposal facility. As I indicated above, I am at a loss to understand the health and safety basis for taking this position. One hears the anecdotal information about reducing exposures to truck drivers by allowing BRC waste streams to be. disposed of in local landfills, rather than requiring such waste to be trucked across the country to a licensed low-levil waste disposal facility. If examples such as this constitute the basis for declaring that we have a health and safety concern that, in turn, requires us to prohibit a State from requiring such waste to be disposed of-in a licensed low-level waste disposal facility, then we need a more disciplined preseptation of the argument. To date, I have yet to see such a case. In the absence of a health and safety concern, it strikes l me as incongruous to say that the risk from a particular waste stream can be so insignificant as to be "below (NRC's) regulatory i concern", but at the same time insist that we nevertheless have a sufficient interest to dictate how a State might otherwise wish i ' This kind of information may well be a part of the waste stream petition that the nuclear utilities are reportedly l preparing for submission. If so, I would hold open the option of revisiting this question if and when the petition is filed. But at this point, I have yet to see a health and safety justification that would support a decision on our part that States should be preempted from the option of requiring waste streams designated BRC under this Policy Statement to be disposed of in licensed low-level radioactive waste disposal facilities.
. to handle that waste stream.' Second, as the General Counsel has pointed out, we cannot resolve the compatibility / preemption issue in a legally-binding way through a Policy Statement such as this. That can only be done through rulemaking. Accordingly, I see nothing to be gained by addressing the compatibility / preemption issue at this stage, if our actions here have no binding effect. But beyond that, there is a considerable disadvantage to raising the issue now! The question of whether a State or locality will be able to prohibit BRC waste streams from being disposed of in local landfills and, instead, insist that such waste be disposed of in licensed low-level waste disposal sites is perhaps the singlemost controversial concern that the general public has about our BRC policy. If we take that issue on at this stage, it will inevitably become a lightning rod for criticism, further hampering our efforts to communicate with the general public on the broader rationale for going forward with a BRC Policy Statement. For the foregoing reasons, I would delete any discussion on the i ' Beyond the health and safety concern, the argument has been made that permitting States the option of requiring BRC waste streams to be disposed of in licensed low-level waste disposal facilities would use up scarce disposal capacity and otherwise have an adverse impact on the compacting process. Indeed, this appears to have been one of the principal concerns advanced in the Commission's 1986 Policy Statement on BRC, wherein the Commission expressed the view that low-level waste generators would "be competing for space in the existing (LLW disposal) sites and the (BRC) concept should be applicable nationwide" in order to ensure "that the system works on a national basis and that it remains equitable." It was in part for this reason that the Commission declared in the 1986 policy Statement that future "(rjulemakings granting petitions (on BRC) will be made a matter of compatibility for Agreement States." (Policy Statement, 51 Fed.Rea. 30839, 30840 (August 29, 1986)). Whatever merit that approach might have had at the time, I disagree with it for two reasons: (1) Congress has vested States with the responsibility for developing and managing disposal capacity for low-level waste and, in view of this, decisions i about how best to proceed, including decisions about whether l States prefer to require BRC waste streams to be disposed of in licensed low-level waste sites rather than sanitary landfills, are best left to the States. (2) There is an abundance of l disposal capacity under development at the present time and, for this reason, the concern about husbanding limited disposal capacity no longer appears to be relevant. Indeed, if anything, States are concerned that there won't be enough waste to make it economically feasible to develop disposal sites. L
1 Q 6-compatibility / preemption issue from the proposed Policy statement. 1986 BRC Policy While the 1986 Commission policy on waste petitions is not explicitly superceded by this Policy statement, its status should be addressed. Where any inconsistencies exist, it should be made clear that the new generic policy constitutes the relevant Commission guidance. Compatibility is the only provision that I would obviously take issue with. Public Information Campaign I strongly concur with the recommendation of the Chairman and Commissioner Rogers that a comprehensive public information program should be in place prior to the release of this Policy Statement. In this regard, I would place special emphasis on internal workshops for those NRC staff (including Commissioners and Assistants) who will be called upon to address questions and concerns from the general public and others regarding the philosophy behind this Policy Statement, as well as the more detailed questions concerning implementation of the policy. Beyond the development of the BRC pamphlet and Qs and As, consideration should also be given to the production and use of video materials, as well as the use of videoconferencing, as a means of ensuring widespread dissemination of information to the general public and other interested parties. A supply of briefing materials (12g2, slides and vugraphs) should be developed for use in making presentations, with special care taken to ensure that such materials are distributed to those who will be speaking for the agency on this matter. Conclusion I reccmtend that the policy' statement be returned to the staff for modification and editing, along the lines reflected herein, and then resubmitted for Commission approval. In the interim, the public information campaign should be pursued as a matter of high priority and should be submitted for the Commission's review and approval as soon as possible. l l l l
s 1 AFFIRMATION V0TE RESP _0NSE_ SHEET j l TO: SAMUEL J. CHILK, SECRETARY OF THE COMMISSION ) FROM: C0l44ISSIONER REMICK l
SUBJECT:
SECY-89-360 - Col 441SSION' POLICY STATEMENT ON EXEMPTION FROM REGULATORY CONTROL i APPROVED X/w/cmts DISAPPROVED X/w/cmts ABSTAIN Nor PARTICIPATING REQUEST DISCUSSION i C0l44ENTS: PLEASE SEE ATTACHED COMMENTS i 4 { \\ ,- ~ l y/4IGNATURE RELEASE VOTE /X/ 4/24/90-DATE WITHHOLD VOTE / / 1 ENTERED ON "AS" YES 1._ No 4D2T3 .56.P.. Q' u 6 V.
.t. l i Comments to Accompany commissioner Remick's Vote Sheet on SECY-89-360 I recognize that there are sound technical arguments for the exemption policy in its present form, but I believe we can address the considerable public concern about exempted waste disposal in a way that would promote the survivability of the overall policy at a lower price in public and intergovernmental good will. I Accordingly, I would revise our proposed' exemption policy to: 1) defer promulgation of the waste disposal portion of the. statement until the completion of a final rule or final guidance to-implement it, and mount an aggressive but interactive public information effort, as Chairman carr has racommended, during the development of the rule or guidance; 2) make the 10-mram individual dose criterion for the release of. decontaminated sites an interim criterion pending the promulgation of either a final NRC implementation rule for decommissioning or a final set of applicable EPA standards, whichever occurs first; and 3) provide additional encouragement to licensees to strive for the lowest reasonably achievable doses at license termination to reduce the i risk of having to undertake additional decontamination efforts to meet a future EPA standard that may be more stringent than our interim criterion. In addition, I believe that the risk coefficient at the heart of this Policy Statement should be the same as those derived from the latest studies of authoritative national and international radiation protection bodies. In its April 11, 1990 memorandum evaluating the BIER V and UNSCEAR 1988 r,eports, the staff recommends that the Commission use 5x10' fatal cancers ?ar person-rem of radiation dose as the lifetime-risk coeft:.cient for fatal cancer. The BIER V and UNSCEAR conservative risk coefficient of 4x10',1988 reports arrived at a fatal cancers per person-rem for low-LET radiation. Other than noting that our number is " consistent" with.the coefficients in these reports, the staff l does not explain the basis for its recommendation to stick with l 5x104 Unless the staff provides clear reasons for this view, I believe we should conform to BIER V and UNSCEAR 1988 as independent national and international radiation protection authoritbes. L I see several strategic benefits in modifying our Policy Statement as I have proposed. Adopting the BIER V and UNSCEAR risk coefficients should enhance ~; public understanding of our action. Applying the modifier " interim" to both the 1-mrem and the 10-arem dose criteria would i make it clear that we recognize the differences between our approach and that of other nations and international-bodies of l l
cxpert opinion. Meantime, we should encourage licensees to r3 duce actual doses below our interim dose criteria pending the future promulgation of EPA standards. (See the attached markup r of the chairman's proposed revised policy statement.) Deferring promulgation of the disposal-related portion of the policy will enable us to get on with further implementation of the decommissioning rule and other portions of our policy without the distraction of having to defend the most unpopular and misunderstood part. We cannot be sure when we will get a petition to exempt a waste stream, but we need an exemption limit for D&D decisions now. We should not let the future possibility encumber our efforts to meet the present need. Nor should the less controversial parts of our guidance, such as those on consumer product and material recycle exemptions, be subject to uncertainties arising from opposition to the most controversial part. If carefully explained, a short-term deferral need not prejudice the case for a waste exemption policy on the technical merits. It would simply emphasize that we take the public's concerns about this policy seriously, and want to strike a balance of protectiveness, feasibility, and benefit. Such sensitivity might help gain the acceptance of a reasonable public. t i l-l l w-m w w r e-p+- v p m-w--- t f
t exemption, a person using the exemption would no longer be required to apply the ALARA principle to reduce doses further for the exempted practice provided that the licensee meets the conditions specified in the regulation. The promulgation of the regulation would, under these circumstances, constitute a finding that the practice is exempted in accordance with the provisions of the regulation and that AIARA considerations have been adequately addressed from a regulatory standpoint. The commission in no way wishes to discourage the voluntary 4 application of additional health physics practices which may, in j fact, reduce actual doses significantly below the BRC criteria or the development of new technologies to enhance protection to gg ob ekm\\ Menuet wt n %ublic and the environment. 9 deoeWm3 This is pa iulprl{kh(Npartingtin S 40 3 d D .22$ 4 fo(c4 8 he area of decontamination and decommissioning,fwhere the I commission anticipates that emerging technologies over the nex* several decades should enhance existing technical capabilities and further reduce doses to workers and the public. i The second means of policy implementation could involve exemptions that would be granted through licensing actions, such as site-specific determinations that a site has been sufficiently decontaminated to be released for unrestricted public use. The NRC intends to develop guidance regarding the implementation of the BRC criteria to ensure that such site-specific actions adhere to the criteria and principles of this policy statement. These licensing actions may be subject to a public hearing process and, depending on the specific action taken, may be required to be ] noticed in the Federal Registor. 34
I The description should address the quality assurance program used l in data collection and analysis and supporting information. If i i Market any surveys were conducted, they should be described. information may be useful in characterizing a practice on a l national basis. i 3. As low as is _ reasonably achievable (ALARA). An analysis should be provided that demonstrates that radiation exposure and radionuclide releases associated with the exempted practica overall will be ALARA. The ALARA principle referred to in 10 CFR Part 20 applies to efforts by licensees to maintain radiation exposures and releases of radioactive materials to unrestricted areas as low as is reasonably achievable. Appendix I to 10 CFR Part 50 describes ALARA for radioactive material releases from light water reactors (nuclear power plants). Exemption proposals should describe how ALARA considerations have been applied in the design, development, and implementation of controls for the proposed practice. Licensee compliance with the ALARA principle must remain in effect up to and including the point at which the 4 j materials are transferred to an unregulated status in accordance In etolchb even Achr Meek with an exemption gkanted under this policy.qn eump%en &nc _ ; n A > %t e, Q b escend rochtes c( W o,.l3 geendecks ega. ahences$ar0be%pehen Mn,),3 y L2 e in
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Impact Analyses. 3 To support and justify a request for exemption, each petitioner or licenses should assess the radiological and nonradiological impacts of the proposed exemption. The analyses should be based on the characterizations described previously and -..___._,_.}}