ML20129F443
| ML20129F443 | |
| Person / Time | |
|---|---|
| Issue date: | 06/22/1990 |
| From: | Chilk S NRC |
| To: | |
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9610010343 | |
| Download: ML20129F443 (23) | |
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NUCLEAR REGULATORY COMMISSION
- Below Regulatory Concern; Policy Statement AGENN:3 ~ uc0$[r'Eeg'u$a' tory Commission. waste in a manner commensurate with their low radiologi-cal risk; and (5) increased assurance of a consistent level ACTION: foh. tatemqot.; of safety for consumer products containing radioactive SUMM :' ins' policy statement establishes the frame. material under the Commission's jurisdiction.
work within which the Commission will formulate rules or make licensing decisions to exempt from some or all regu- EFFECTIVE DATE: July 3,1990 latory controls certain practices involving smal1 quantities ADDRESSES: Documents referenced in this policy state-of radioactive matenal. Opportunity for pubh,c comment will be provided with each rulemaking and each heensing ment are available for inspection in the NRC Public action where generic exemption provisions have not al- Document Room,2120 L Street, N. W. (Iower Level),
ready been established. The exemptions may involve the Washington, DC-release of licensee-controlled radioactive material either FOR FURTHER INFORMATION CONTACT:
to the generally accessibic environment or to persons who would be exempt from Commission regulations. Practices The appropriate NRC Regional Office:
for which exemptions may be granted include, but are not limited to, (1) the release for unrestricted public use of Region I- Dr. Malcom Knapp, King of Prussia, lands and structures containing residual radioactivity;(2) Pennsylvania; telephone (215) 337-5000 the distribution of consumer products containing small amounts of radioactive material; (3) the disposal of very Region II- Mr. J. Philip Stohr, Atlanta, Georgia; telephone (4G4)331-4503 low-Icvel radioactive waste at other than licensed disposal sites; and (4) the recycling of slightly contaminated equip- Region III - Mr. Charles E. Norelius, Glen Ellyn, i ment and materials. As described in this policy statement, Illinois; telepl(one (708) 790-5500 NRC intends to continue exempting specific practices from regulatory controlif the application orcontinuation Region IV- Mr. Arthur B. Beach, Arlington, Texas; of regulatory controls is not necessary to protect the pub. telephone (817) 860-8100 :
lic health and safety and the environment, and is not cost-Region V - Mr. Ross A. Scarano, Walnut Creek, effective m further reducing nsk. The pohey statenient . , California; telephone (415) 941-3700 I defines the dose enteria and other considerations that will - - -
be used by NRC in making exemption decisions. The Federal and State Government Officials may contact:
policy establishes individual dose criteria (1 and 10 mrem Mr. Frederick Combs, U.S. Nuclear Regulatory Commis-per year [0.01 and 0.1 millisievert per year]) and a collec- sion, Washington, DC 20555, Office of Governmental tive dose criterion (1000 person-rem per year [10 person- and Public Affairs, telephone (301) 492-0325.
sievert peryear]).These criteria, coupled with other con-siderations enumerated in the policy statement, will be Questions may also be directed to the following major factors in the Commission's determination on individuals at the U.S. Nuclear Regulatory Commission, whether exemptions from regulatory controls will be Washington, DC 20555.
granted.
Dr. Donald A. Cool, Office of Nuclear Regulatory
'Ihe policy statement establishes a consistent risk frame. Research; telephone (301)492-3785 work for regulatory exemption decisions, ensures an ade-quate and consistent level of protection of the pubbe in Mr. John W. N. Hickey, Office of Nuclear Material their use of radioactive materials, and focuses the Na- Safety and Safeguards; telephone (301) 492-3332 tion's resources on reducing the most significant radio- ' Mr. L J. Cunningham, Office of Nuclear Reactor logical risks from practices under NRC's jurisdiction.The ' Regulation; telephone (301) 492-1086 average U.S. citizen should benefit from implementation of the BRC policy through (1) enhanced ability of NRC, SUPPLEMENTARY INFORMATION:
Agreement States and licensees to focus resources on more significant risks posed by nuclear materials; (2) timely and consistent decisions on the need for cleanup of Statement of Policy l i
contaminated sites; (3) increased assurance that funds . i available to decommission operating nuclear facilities will I. Introduction.
be adequate; (4) reduced costs and overall risks to the public from managing certain types of slightly radioactive Ionizing radiation is a fact oflife. From the day we are born until the day we die, our bodies are exposed to y"
010047 9610010343 900622 OM4 Mk) 0 r- I !
PDR PR CHP1 53FR49886 PDP h h e/) q f
IIRC Policy Statement Iow levels of radiation emitted from a variety of natural policy translates the Commission's judgement on accept-and man-made sources, including the cosmos, carth, able risk into explicit and practical criteria on which to building materials, industrial facilities, clothing, medi- base decisions to exempt practices from the full scope of cine, food, air, and our own bodies. All materials exhibit NRC's regulatory program.1he BRC criteria are neces-some degree of radioactivity.The consensus among scien- sary to ensure adequate and consistent decisions on ac-tists is that even low levels of radiation typical of the , ceptable risks posed by decontaminated and decommis-natural environment pose some correspondingly low risk sioned nuclear facilities, consumer products containing of adverse health effects to humans. Recognition of the radioactive materials, and very low activity radioactive risk due to radiation exposure from natural sources pro- wastes.These decisions will be implemented by the Com-vides perspective on the risks associated with human uses mission through rulemakings and licensing decisions of radioactive materials. based on carefut and thorough analyses of the risks associ-ated with specific practices to ensure that the public is Natural and man-made radionuclides are used in adequately protected.
today's society in many forms for a variety of purposes, such as medical therapy and diagnosis, materials analysis, Under the regulatory approach used by the U.S.
and power generation. In general, the existing regulatory Nuclear Regulatory Commission (NRC), the use of radio-framework ensures that radioactive materials are con- active materials is subject to limits and conditions that trolled consistent with the degree of risk posed to the ensure the protection of the health and safety of both public and the environment. Some products such as workers and members of the general public, and the envi-smoke detectors contain small quantities of radioactive ronment. For example, radioactive material is controlled materials that pose such a low risk that they have been by NRC and Agreement State licensees to ensure that ;
widely distributed without continuing regulatory controls. dose limits are not exceeded. In addition, sources of radia-To require that all radioactive materials be bontrolled in tion are designed, used and disposed of in a manner that :
the same strict manner regardless of the risks they pose ansures that exposures to radiation or radioactive mate- l would not be a sound use of limited National resources. rial are as low as is reasonably achievable (ALARA),
Such strict control could a!so deprive society of the bene- economic and social factors being taken into account.
fits already derived from appropriate uses of radioactive NRC has endorsed the ALARA provision in regulatory j materials and radiation. Intddition, such control would practice for a number of years (10 CFR Part 20). How- j not significantly reduce the risks associated with radiation ever, NRC has not yet provided criteria that would estab-exposure irom controlled sources compared with risks , lish the basis for defining the level of residual risk at which associated with natural background radiation.Therefore,' further regulatory control is no longer warranted.
responsible decisions need to be made on how radioactive materials are controlled based on a judgement about the The policy statement in today's notice provides a levels of risk they pose and the effectiveness of regulatory unifying risk framework for making decisions about which control to reduce those risks. practices am be exempted from the full t: cope of NRC's comprehensive regulatory controls. Under the criteria Over the last several years, the Commission has and principles of this policy statement, exemptions of pursued development of a risk threshold to distinguish radioactive materials from regulatory ccatrols would in. I those radioactive materials that do not require the same volve the transfer of very small quantities of the materials i stringent level of regulatory control as that imposed on from a regulated to an unregulated status. NRC will ana-potentially more hazardous matcrials. The Commission lyze each proposed exemption to ensure that doses result-recognized throughout this process that the threshold ing from the proposed transfer will be sufficiently low that would need to be low enough to continue to ensure ade- the public health and safety and the environment will quate protection of the public.The Commission also rec- remain adequately protected. A licensed activity produc-ognized that the threshold should be compatible with ing an exempt material would continue to be subject to technological and measurement capabilities so it could be the full range of regulatory oversight, inspection, and readily used in NRC's regulatory program for nuclear enforcement actions up to and including the point of materials. In addition, the Commission identified the transfer to an exempt status. the Commission also in-need to balance incremental reductions in risk below the tends to conduct research periodically to evaluate the safety threshold with the attendant expenditure of private effectiveness of this policy and to confirm the safety bases and public resources. that support the exemption decisions.
In today's notice, the Commission establishes a pol- Through appropriate rulemaking actions or licens-icy to guide its decisions on which radioactive materials ing decisions, the Commission will establish constmints, are "below regulatory concern" (llRC) because the low requirements, and conditions applicable to specific ex-levels of risk they pose do not warrant regulation to the emptions of radioactive materials from NRC's regula.
same degree as other radioactive materials to ensure ade- tions. The NRC will verify that licensees adhere to these quate protection of the public and the environment.1his exemption constraints and conditions through NRC's li-2
1 1
- , BRC Policy Statement i
censing, inspection, and enforcement programs. For ex- their risks to the public and the environment. He Food ample, the Commission may promulgate regulations that and Drug Administration (FDA), for example, has ap-would require some type of labeling so that consumers plied sensitivity-of-method, risk-based guidelines in con.
could make informed decisions about purchasing a prod- nection with the regulation of ammal drugs, food con-uct containing exempted materials. Such labeling is pres- taminants, and trace constituents in some food additives.
ently required by the Commission for smoke detectors Similarly, the Environmental Protection Agency (EPA) containing radioactive material (see 10 CFR 32.26). He established exemption or threshold levels based on indi-NRC ensures that manufacturers label the detectors in vidual risks in the regulation of pesticides and other toxic compliance with the labeling requirement through licens- and caremogenic chemicals. For example, EPA employs ing reviews and inspections. Specific source controls and such a concept in defining hazardous waste through the exemption conditions are not discussed further in this new Toxicity Characteristic rule in 40 CFR Part 261 [55 policy because they will be more appropriately addressed FR 11798; March 29,1990).
in developing the exemption requirements for specific exemption proposals. The Commission believes that the Below Regula-tory Concern policy is needed to establish a consistent, He concept of regulatory exemptions is not new. risk-based framework for making exemption decisions.
'The Atomic Energy Act of 1954, as amended, authorizes Specifically, this framework is needed to (1) focus the the Commission to exempt certain classes, quantities, or resources of NRC, Agreement States, and licensees on uses of radioactive material when it finds that such ex- addressing more significant risks posed by nuclear materi-emptions will not constitute an unreasonable risk to com- als; (2) ensure that beyond the adequate protection mon defense and security and to the health and safety of threshold potential benefits from additional regulation the public. In the 1960s and 1970s, the Atomic Energy outweigh the associated burdens; (3) establish residual Commission used this authority to promulgate tables of radioactivity criteria and requirements for decommission-exempt quantities and concentrations for radioactive ma- ing and cleanup of radioactive contamination at licensed l terial.These exemptions allow a person or a licensee, and formerly-licensed facilities; (4) ensure that licensee l under certain circumstances, to receive, possess, use, decommissioning funding plans provide adequate funds transfer, own, or acquire radioactive material without a to cover the costs of cleanup-of these fac^ ties to protect requirement for a license (30 FR 8185; June 26,1965 and people and the environmBnt; (5) ensure that the public is 35 FR 6425; April 22,1970).The Commission currently consistently protected against undue risk from consumer allows distribution of consu mer products or devices to the products that contain radioactive materials under the general public and allows releases of radioactive material Comnussion's jurisdiction; (6) provide decision criteria I to the environment consistent with established regula- ..for reviewing petitions to exempt very low-level radioac- (
tions. For example, regulations currently specify the con- tive Wastes in accordance with the low-Level Radioactive l ditions under which licensees are allowed to dispose of Waste Policy Amendments Act of 1985; and (7) ensure I small quantities of radioactive material into sanitary that existing exemptions involving radioactive materials sewer systems (see 10 CFR 20.303).These existmg regu- are consistent and adequate to protect the public.
lations specify requirements, conditions, and constraints that a licensee must meet if radioactive materialis to be The Commission's BRC policy establishes an ex-
" transferred" from a regulated to an exempt or unregu. plicit and uniform risk framework,for making regulatory lated status, exemption decisions. This policy will also be used by the Commission as a basis for reevaluating existing NRC ex-More recently, Section 10 of the Low-Level Radio- ernptions to ensure that they are consistent with the crite-active Waste Policy Amendments Act (LLRWPAA) of ria defined herein. In lieu of such a policy, the Commis-1985 directed the Commission to develop standanis and sion could continue the current practice of evaluating procedures and act upon petitions "to exempt specific exemptions on a case-specific basis. Such an approach, radioactive waste streams from regulation .. due to the however, does not ensure consistent evaluation and con-presence of radionuclides ... in sufficientlylow concentra- trol of risks assocated with exempted practices. For this
. tions or on~atities as to be below regulatory concern." . reason and the reasons discussed above, the Commission ne Corr wission responded to this legislation by issuing a ' has established the BRC Policy Statement. His policy policy statement on August 29,1986 (51 FR 30839).That supersedes the Atomic Energy Comrmssion's policy policy statement contained criteria that, if satisfactorily statement on this subject [30 FR 3462; March 16,1965).
addressed in a petition for rulemaking, would allow the .
l Commission to act expeditiously in pioposing appropriate The Commission recognizes that Agreement States relief in its regulations on a " practice-specific" basis con- will play an important role in the implementation of the i sistent with the merits of the petition. Below Regulatory Concern policy, specifically in the ar-eas of developing and enforcing compatible State regula-Federal and State agencies have also developed and tions, regulating cleanup and decommissioning of certain I implemented similar exemptions based on evaluations of types of contaminated nuclear facilities, and exempting (
3
BRC Policy Statement
]
j certam low-level radioactive wastes from requirements sites.The Commission is also concerned that inconsistent for disposal in licensed low-level waste disposal facilities. regulation of BRC waste could in fact undermine State The Atomic Energy Act of 1954, as arnended, gives to the and Federal efforts to manage low-level waste safely. A
) Federal government the exclusive authority to regulate uniform framework for exemption decisions is needed source, special nuclear, and byproduct materials to en- now to avoid disrupting State and compact development
. sure protection of the public health and safety. While - of new disposal facilities close to Congressional mile-Congress subsequently provided for Federal-State agree- stones in 1993 and 1996. Such a framework may also i ments under Section 274b of the Atonuc Energy Act facilitate the resolution of the mixed waste issues for j through which States could assume regulatory responsi- these BRC wastes.
i bilities in lieu of Federal regulation for certain classes of
- nuclear materials, it required that State radiation protec- The policy described in this document is intended to
- tion standards be coordinated and compatible with the provide the public health and safety protection frame-i Federal standards for radiation protection. work that would apply to a wide spectrum of Commission i exemption decisions. As such, it provides individual and NRC regulations exempting BRC wastes will not collective dose criteria, and discusses other important i
- affect the authority of State or local agencies to regulate elementsof theexemptiondecision-makingprocess.Sec-BRC wastes for purposes other than radiation protection tion II provides definitions of key terms and concepts used in accordance with Section 274b of the Atomic Energy in the policy statement.Section III presents the basic Act. Under the Atomic Energy Act, Congress intended elementsof thepolicy,whileSectionIVdiscusseshowthe that there be uniformity between the NRC and Agree- policy will be implemented through rulemakings and li-
, ment States on basic radiation protection standards. Fu. censing actions and describes how the public will have an
- ture BRC Rulemakings will establish basic radiation pro . opportunity to comment on the Commission's exemption ,
tection standards below which regulatory overs @ht is no't decisions. This section also notes NRC plans to review i
} needed. The Commission will address compatibility is- -past exemption decisions to ensure consistency with the l sues in future rulemakings. In initiating proceedings to risk framework described in the BRC policy.Section V l
implement NRC's BRC policy, the Commission will con. describes, in general terms, the information needed to l
- tinue to consult with and seek the advice of the States. support the exemption decisibn-making process.
l j Some States have expressed concerns that economic II. Definitions.
I and institutional impacts of actions resulting from the' .
Commission's B RC policy may undermine their efforts to . "ALARA" (acronym for "as low as is reasonably
! achievable")aneans making every reasonable effort to
- develop new disposal facilities for low-level radioactive , ,
maintam radiation exposures as far below applicable dose l waste in accordance with the Low-Irvel Radioactive ,
limits as ts practical. consistent with the purpose for which i Waste Policy Amendments Act of 1985. These States the hcensed activity is undertaken taking mto account the 1 would prefer to establish their own standards for deter-state of technology, the economics of improvements m
! mining which wastes should be exempted from regulatory ,
relation to benefits to the public health and safety, and
! control rather than adopting standards that are compat- ,
other societal and socioeconomic consideratjons and in i ible with uniform Federal standards.The Commission has relation to utilization of nuclear eneygy and bcensed ma-d developed the BRC policy to provide a uniform and con, terials m the pubhc mterest.
l sistent health and safety framework for exemption deci, I sions. In so doing, the Commission recognized the .
, Agreement State,, means any State with which the concerns expressed by Congress when it enacted the Iow- Commission has entered into an effective agreement un-Level Radioactive Waste Policy Amendments Act of 1985 der subsection 274(b) of the Atomic Energy Act of 1954, that health, safety, and environmental considerations as amended. ,
j should take precedence over economic or institutional concerns.(see Senate Report 99-199 that accompanied " Byproduct material" means-l S.1517, Senate Committee on Energy and Natural Re-sources, Novembec 22,1985,99th Congress,1st Session (1) Any radioactive material (except special nu-
, at page 9). clear material) yielded in, or made radioactive l by, exposure to the radiation incident to the The Commission is confident that waste exemption process of producing or utilizing special nu-decisions made in accordance with requirements that im- clear material; and plement its B RC policy will be adequate to ensure protec-tion of the public health and safety. 'Ihe Commission is (2) The tailings or wastes produced by the extrac-concemed that inconsistent regulation of BRC wastes tion or concentration of uranium or thorium could result in differing levels of risks to the public and .- from ore processed primarily for its source ma-the environment through the application of different re- terial content, including discrete surface wastes sidual radioactive criteria in the cleanup of contaminated resulting from uranium solution extraction i
4 i
- ," BRC Policy Statement d.
processes. Underground ore bodies depleted " Natural backgroend dose" means the dose received by these solution extraction operations do not from naturally occurring cosmic and terrestrial radiation constitute " byproduct material" within this and radioactive material but not from source, byproduct, definition. or special nuclear material.
" Practice" is a defined activity or a set or combina-
" Collective dose"is the sum of the individual doses (total effective dose equivalents) received in a given pe- tion of a number of similar coordinated and continuing activities aimed at a given purpose that involves the po-riod of time by a specified population from exposure to a specified source of radiation (or practice involving the use tential for radiation exposure. Disposal of specified types of radioactive material). Note:The calculated collective of very low-level radioactive waste; the release for unre-dose used to determine compliance with the criterion of stricted public use of lands and structures with residual this policy need not include individual dose contributions levels of radioactivity; the distribution, use, and disposal received at a rate of less than 0.1 mrem per year (0.001 of specific consumer products containing small amounts of radioactive material; and the recycle and reuse of spe-mSv/ year).
cific types of residually contaminated materials and
" Committed effective dose equivalent" is the sum of equipment are examples of practices for which this policy the products of weighting factors applicable to each of the . . will have potential applicability. (See Section III for fur-body organs or tissues that are irradiated and the commit-ther discussion of practice).
ted dose equivalent to those organs or tissues.
" Rem"is the special unit of dose equivalent (1 rem
" Deep dose equivalent" is the dose equivalent at a - 0.01 sievert).
tissue depth of I cm. " Risk,"forpurposesof thispolicy,meanstheannual
" Dose" or " radiation dose" in this policy is the total or lifetime probability o,f the development of fatal cancer from exposure to nomzmg radiation and is taken as the effective dose equivalent. product of the dose received by an exposed individual and a conversion factor based,upon the linear, no-threshold
" Exemption from regulatory control" refers to a de- hypothesis.The conversion factor for dose to nsk is taken cision process that may allow radioactive material to be to be 5 x 1Watal canceu penem of radation doseme transferred from a regulated status to an unregulated fatal cancer n,sk i,s considered, m general, to be more status, in which the material will no longer be subject to, likely than other radiation mduced health effects and to NRC requirements. Decisions to grant exemptions wilftse be the most severe outcome to an mdividual. While the based t*pon findings by reason of quantity or concentra. A Commission recogmzes that the risks from exposure to tion that the radioactive material poses a small risk to radiation are greater for children than adults and that public health and safety and the environment and that the em are inaeased nsks from exposure to the embryo /
small magnitude of the risk does not warrant expenditure fetus, me estimate Watal cancenisMor aH ages &di of additional resources of regulatory agencies and the sexes is considered to be an appropriate measure of risk regulated community in attempting to further reduce the from Practices being considered for exemption m accor-risk. dance with this policy statement (rce Appendix).
" Exposure" means being exposed to ionizing radia- " Source material" means -
tion or to radioactive material.
(1) Uranium or thorium, or any combination of "I kancad material" means r,ource material, special uranium and thorium in any physical or chemi-nuclear material, or byproduct material that is received, cal form; or '
p=aaad used, transferred, or disposed of under a gen-eral or specific license issued by the Commission or an - (2) Orcs which contain, by weight, one-twentieth
, Agreement State. of one percent (0.05 percent), or more, of ura - !
' ~
. nium, thorium, or any combination of uranium "Ucensee" means the holder of an NRC or Agree- and thorium. Source material does not include ,
ment State license. special nuclear material. l
.. 4 "Unear, no-threshold hypothesis" refers to the the- "Special nuclear material" means -
ory that there is a proportional relationship between a given dose of radiation and the statistical probability of (1) Plutonium, uranium-233, uranium enriched in the occurrence of a health effect (such as latent cancers the isotope 233 or in the isotope 235, and any and genetic effects), and that there is no dose level below other material which the Commission, pursu-which there is no risk from exposure to radiation. ant to the provisions of Section 51 of the Act, 5
BRC Policy Statement determines to be special nuclear material, but Such practices should be spmfimlly evaluated to deter-does not include source material; or mine if they could result in greater risk !cvels to exposed ruembers of the public than the levels found acceptable (2) Anymaterialartificiallyenrichedbyanyof the by the Commission in formulating this policy.These deci-foregoing but does not include source material. sions clearly fall within the Commission's purview to pro-
- tect the health and safety of the public.
' Total effective dose equivalent" means the sum of In formulating this policy statement, the Commis-the deep dose equivalent (for external exposures) and the sion deliberated at length on the need to consider committed effective dose equivalent (for internal expo- whether practices must be rigorously justified in terms of sures) expressed in rem or sievert. societal benefit regardless of the level of risk they pose.
Justification of practice is recognized by health physics HL Policy Elements. professionals and national and international organiza.
tions as one of the three fundamental tenets of radiation ne purpose of this policy statement is to establish protection (justification, dose limits, and ALARA). He the risk framework'within which the Commission will Commission has prepared this policy statement in confor-initiate the development of appropriate regulations or mance with these basic tenets as appropriate for exemp-make licensing decisions to exempt certain practices from tion decisions. Consistent with the position of the Inter-some or all regulatory controls. This policy is directed national Atomic Energy Agency in its Safety Series principally toward rulemaking activities but may be ap- Report No. 89, the Commission believes that justification plied to license amendments or license applications in- decisions usually derive from considerations that are volving the release oflicensed radioactive material either much broader than radiation protection alone.ne Com-to the environment or to persons who would 12 exemli t mission believes that justification decisions involving so-from Commission regulations. In either case, opportunity -tial and cultural value judgments should be made by af-for public comment will be provided with each rulemak- fected elements of society and not the regulatory agency.
Ing and each licensing action where generic exemptions Consequently, the Commission will not consider whether provisions have not aircady been established. a practice is justified in terntiof net societal benefit.
s It is the Commission's intent to broadly define spe- A. Principles of Exemption. 1 cific practices so that the effect of an exemption decision The principal consideration in exempting any prac-on any mdividual or population will be evaluated m, its tice from some or all regulatory controls hinges on the entirety nnd not in a piecemeal fashion. At the same time, generalhuestion of whether the application or continu-the practice must be identified and described in terms
, ation of regulatory controls is necessary to protect the that will facilitate reasonable impact analyses and allow
, public health and safety and the environment. To decide imposition of appropriate constraints, requirements, and if exemption is appropriate, the Commission mast deter-conditions as the radioactive material passes from a regu- mine if adequate protection is provided and one of the lated to an unregulated status (i.e., the material ts no following conditions is met-longer required to be under the control of a hcensee). j Under this policy, the definition of a " practice" in any 1. De application or continuation of regulatory i specific decision (rulemaking or licensing action)is a criti- controls on the practice does not result in any '
cal feature. The NRC will ensure that formulation of significant reduction in dose received by indi-I exemptions from regulatory control will not allow delib- viduals within a critical group (i.e., the group crate dilution of material or fractionation of the radiation expected to receive the highest exposure) and or radioactive material for the purpose of circumventing by the exposed population; or controls that would otherwise be applicable. He defini-tion of the practice in any specific exemption decision will 2. The costs of the controls that could be imposed also provide the framework for taking into account the for further dose reduction are not balarced by l potential effects of aggregated exposure from that prac- the potential commensurate reduction in risk. j tice together with other exempted practices, as well as the i possible consequences of accidents or misuse or the po- At a sufficiently low level of risk, the Commission tential for other nonstochastic radiological impacts asso- . believes the decision-making process for granting specific ciated with the exemption. exemptions from some or all regulatory controls can be essentially reduced to an evaluation of whether the over- l De Commission may determine on the basis of risk all individual and collective risks from each particular estimates and associated uncertainties that certain prac- practice are sufficiently small. The Commission believes tices should not be considered candidates for exemption, that individual and collective dose criteria should be basic ;
such as the introduction of radioactive materials into features of its overall policy to define the region where products to be consumed or used primarily by children. the expenditure of Commission resources to enforce re- ;
6 f
, BRC Policy Statement quirements for further dose reductions or licensee re- accepted as a fact of life and are identical to the kinds of sources to comply with such reouirements is no longer risks posed by radiation from nuclear materials under warranted. These specific critena include (1) values for NRC jurisdiction.These facts provide a context in which the individual annual dose reasonably expected to be to compare quantitatively the radiation risks from various received as a result of the practice (e.g., an average dose practices and make radiation risk especially amenable to to individuals in a critical group) and (2) a measure of the use of the approach described below to define an radiological impact to the exposed population. In combi- acceptable BRC level.
nation, these criteria are chosen to ensure that, for the average dose to members of the critical population group The Comnussion believes that if the risk from doses from a given exempted practice, mdividuals will not be to m. dividuals from a pract. ice under consideration for exposed to a significant radiological risk and that the exemption is comparable to other voluntary and myolun-population as a whole does not suffer a significant radio-logical impact
- tary risks which are commonly accepted by those same individuals without significant efforts to reduce them, then the level of protection from that practice should be It is important to emphasize that, in this policy, the adequate. Furthermore, for risks at or below these levels Commission does not assert an absence or threshold of there would be little merit in expending resources to 1 risk at low radiation dose levels but rather establishes a reduce this risk further. The Commission believes the l baseline level of risk beyond which further government definition of a B RC dose level can be developed from this regulation to reduce risks is unwarranted. As described in perspective. I the Appendix to this policy statement, the technical ra-tionale for the Commission's BRC criteria is explicitly Variations in natural background radiation appar .
based on the hypothesis that the risk from exposure t
, , ently play no role in individuals' decisio~ns on common radiation is imearly proportional to the dose to an individ-matters such as places to live or work (e.g., the 60-70 ual. However, the presence of natural background radia- rnrem differences between average annual doses received tion and variations in the levels of this background have m Denver, Colorado versus Washington, DC). In addi-been used to provide a perspective from which to judge ,
tion, individuals generally dd not seem to be concerned the relative significance of the radiological nsks involved about the difference m doses between hymg m a brick in the exemption decision-making process.
versus a frame house, the 5 mrem dose received durmg a typical roundtrip coast-to-coast flight, or incremental The Commission notes that adoption of theindivid.. doses from other activities that fall well within common ual and collective dosC Criteria does not indicate a deCi- jvariat[ OMS in natural background radiation. These factors sion that doses above the criteria would necessarily pre. lead to the conclusion that differential risks correspond-clude exemptions. The criteria simply represent a range ing to doses on the order of 5-10 mrem (0.05-0.1 mSv) are of risk that the Commission believes is sufficiently small well within the range of doses that are commonly ac-compared to other individual and societal risks that fur- cepted by members of the public, and that this is an ther cost-risk reduction analyses are not required in order appropriate order of magnitude for the Commission's to make a decision regarding the acceptability of an ex- BRC individual dose criterion.
emption. Practices not meeting these criteria may never- ,
theless be granted exemptions from regulatory control on Although the uncertainties in risk estimates at such a case-by-case basis m accordance with the principles low doses are large, the risk to an individual as miculated embodied within this pohey, if (1) the potential doses t using the linear, no-threshold hypothesis is shown in mdividual members of the pubhc are sufficiently small or Table 1 for various defined levels of annual individual unlikely; (2) further reductions m the doses are neither dose.The values in the hypotheticallifetime risk column readily achievable nor significant in terms of protecting are based on the further assumption that the annual dose the public health and safety and the environment; and (3) is continuously received during each year of a 70-year t collective dose from the exempted practice is lifetime.To provide further perspective, a radiation dose
. of 10 mrem per year (0.1 mSv per year) received contmu-ously over a lifetime corresponds to a risk of about 4 B. The Individual Dose Criterion. chances in 10,000 (3.5 x 10-d) or a hypothetical increase of about 0.25% in an individual's lifetime risk of fatal cancer.
The Commission has noted that, although there is The Commission prefers to use factors of ten to desenbe significant uncertainty in calculations of risks from low- such low individual doses because of the large uncertain-level radiation, in general these risks are better under- ties associated with the dose estimates.The Appendix to stood than the risks from other hazards such as toxic the policy statement provides a more com plete discussion chemicals. Moreover, radiation from natural background of the risks and uncertainties associated with low doses poses involuntary risks (primarily cancers), which must be and dose rates.
7
BRC Policy Statement Table 1 Ilypothetical Incremental Ilypothetical Lifetime Risk Incremental Annual Dose
- Annual Risk ** From Continuing Annual Dose **
100 mrem (1.0 mSv) 5 ic 10-8 3.5 x 10 4 10 mrem (0.1 mSv) 5 x 10 4 3.5 x 10-4 1 mrem (0.01 mSv) 5 x 10 4 3.5 x 10-8 0.1 mrem (0.001 mSv) 5 x 10 4 3.5 x 10 4 Re expression of dose refers to the Total Effective Dose Equivalent.nis 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.
- Calculated using'a conservative risk coefficient of 5 x 10" per rem (5 x 104 per Sv) for low linear energy transfer radiation based on the results reported in " Sources, Effects and Risks of Iomzmg Radiation," United Nations Sci-entific Committee on the Effects of Atomic Radiation (UNSCEAR),1988 Report to the General Assembly with Radiation, BEIR V," 1990, Committee on Annexes and "ofHealth Biological Effects IonizingEffects of National Radiation, Exposures to Iow Ilesearch Levels of Ionizing (see also NUREG/CR-4214, Council R In view of the uncertainties involved in risk assess- straints and conditions imposed by the Commission on ment at low doses and taking into account the aforemen- exempted practices.
tioned risk and dose perspectives, the Commission finds that the average dose to individuals in the critical group ,. De Commission intends that only under unusuti should be less than 10 mrem per year (0.1 mSv peryear) circumstances would exemptions be considered for prac-for each exempted practice. In addition, an interim dose tices that could cause contm, umg radiation exposure to criterion of 1 mrem per year (0.01 mSv per year) average individuals exceeding a small fraction of 100 mrem per dose to individuals in the critical group will be applied to yect (1 mSv per year). In rare cases, exemptions of such those practices involving widespread distribution of radio- Practices may be granted if, after conducting a thorough i active material in such items as consumer products or analysis of the proposed exemption, the Commission de- l recycled material and equipment, until the Commission termines that doses to members of the publicare ALARA gains more experience with the potential for individual and thatadditional regulatory control is not warranted by exposures from multiple licensed and exempted prac- further reductions'in individual and collective doses.
tices. These criteria provide individual dose thresholds .
below which continued regulatory controls are unneces. C. The Collective Dose Criterion.
sary and unwarranted to require further reductions in The Commission believes that the collective dose individual doses.The Commission considers these criteria (i.e., the sum of individual total effective dose equiva-to be appropriate given the uncertainties involved in esti- lents) resulting from exposure to an exempt practice mating doses and risks, and notes that these criteria should be ALARA. However, if the collective dose re-should facilitate straightforward implementation of this sulting from an exempted practice is less than an expected policy in future rulemakings or licensing decisions. 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 !
The Commission beh.e~es that, notwithstanding ex- health and safety issues than by requiring further analysis, emption of practices from regulatory control under these
, reduction, and confirmation of the magnitude of the col-criteria, it still has reasonable assurance that exposures to lective dose.The Commission notes that, at this level of individual members of the public from all licensed actm- collective dose, the number of hypothetical health effects ties and exempted practices will not exceed 100 mrem per calculated for an exempted practice on an annual basis year (1 mSv per year) given the Commission's intent (1) to would be less than one. I define practices broadly; (2) to evaluate potential expo-sures over the lifetime of the practice;(3)to evaluate the The National Council on Radiation Protection and potential for aggregated exposures from multiple ex- Measurements recommends in its Report No. 915 that empted practices; (4) to impose both individual and col- collective dose assessments for a particular practice lective dose criteria; (5) to monitor and verify how exem p-tions are implemented under this policy;(6) to verify dose ' Recommendations on timits for Exposure to Ionizing Radiation, calculations through licensing reviews and rulemakings NCEP Report No. 91. National Council on Radiation Protection ,
II with full benefit of public review and comment; and (7) to $p*p*5y'$"'ni$*o{yM^,;[*[jg"[$5'k*
o 5
inspect and enforce licensee adherence to specific con. Beihesda. MD 2u814.
8
i o' BRC Policy Statement t )
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i i should exclude consideration of those individuals whose ing that the assumptions used to define a practice remain l
annual effective dose equivalent is less than or equal to appropriate as the radioactive materials move from a regulated to an unregulated status. Any such rulemaking
- 1 mrem per year (0.01 mSv per year). In the sensitivity-of-measure, risk-based guidelines used by EPA and FDA, a action would follow the Administrative Procedure Act, <
. - 104lifetime risk of cancer has been used as a quantitative which requires publication of a proposed rule in order to f
. criterion of insignificance. Using an annual risk coeffi- solicit public comment on the rulemaking action under 1 2
cient of 5 x 10-* health effects per rem (5 x 10-2 per consideration. De rulemakmg action would include an !
sievert), as discussed in the Appendix, the 10" lifetime appropriate level of environmental review in accordance
' risk value would approximate the calculated risk that an with the Commen's regulations in 10 CFR Part 51,
, individual would incur from a continuous lifetime dose which implement the National Environmental Policy Act.
rate in the range of 0.01 to 0.1 mrem (0.0001 to 0.001 mSv) per year. If a proposal for exernption resultsin a Commission ,
' regulation containing specific requirements for a particu-As a practical matter, consideration of dose rates in lar exemption, a licensee using the exemption would no l
)
- the microrem per year range and large numbers of hypo- longer be required to apply the ALARA principle to I thetical individuals potentially exposed to an exempted reduce doses further for the exernpted practice provided j l
i practice may unduly complicate the dose calculations that that it meets the conditions specified in the regulation. j will be used to support demonstrations that proposed The promulgation of the regulation would, under these circumstances, constitute a finding that the practice is exemptions comport with the criteria in this policy. The Commission believes that inclusion of individual doses exempted in acconlance with the provisions of the regula-3 i below 0.1 mrem per year (0.001 mSv per year) introduces tion and that ALARA considerations have been ade-unnecessary complexity into collective dose assessments quately addressed from a regulatory standpoint. The and could impute an unrealistic sense of the significance Commission in no way wishes to discourage the voluntary
- and certainty of such dose levels. For all of these reasons, application of additional health physics practices which the Commission concludes that 0.1 mrem (0.001 mSv) per may, in fact, reduce actual doses significantly below the
, year is an appropriate truncation value to be applied in BRC criteria or the development of new technologies to
! the assessment of collective doses for the pur sesofthis enhance protection to 114 piiblic and the environment.
j policy. This is particularly pertinent in the area of decontamina-tion and decommissioning, where the Commission antici-pates that emerging technologies over the next several IV. Implementat. ion. / decades should enhance existing technical capabilities
- ne Commission's BRC policy will be implemented . -and fyrtber reduce doses to workers and the public principally through rulemakings; however, exemption and where other Federal agencies are in the process of i
decisions could also be implemented through specific li- developing standards which may affect those receiving censing actions, exemptions.
l 4
i in the first case, a proposal for exemption, whether The second means of policy implementation could
- I initiated by the NRC or requested by outside parties in a involve exemptions that would be granted through licens-
- petition for rulemaking, must provide a basis upon which ing actions, such as determinatiops'that a specific site has
- the Commission can determine if the basic policy criteria been sufficiently decontaminated to be released for unre-a have been satisfied.Re Commission intends to initiate a stricted public use.De NRC intends to develop guidance number of rulemakings on its own (e.g., to establish a dose regarding the implementation of the BRC critcria to en-j criterion for decommissioning) and may initiate others as sure that such site-specific actions adhere to the criteria j a result of NRC's review of existing codified exemptions - and principles of this policy statement. New licensing (e.g., consumer product e.emptions in 10 CFR Parts 30 actions that transfer radioactive material to an unregu- !
and 40). Rulemakings may also be initiated in response to lated status will be noticed in the Federal Register if they petitions for rulemaking submitted by outside parties, differ from previous generic exemption decisions.
such as a BRC. waste petition submitted in accordance <
with Section 10 of the Low-Level Radioactive Waste Pol- One of the principal benefits of the policy is that it icy Amendment Act of 1985. In general, rulemaking ex-
~
provides a framework to evaluate and ensure the consis-
- .. emption proposals should assess the potential health and tency of past exemption decisions by the Commission.
safety impacts that could result if the exemption were to With the adoption of this BRC policy, the NRC will
' be granted. initiate a systematic assessment of exemptions currently existing in NRC's regulations to ensure that the public is
- The proposal should consider the uses of the radio- adequately and consistently protected from the risks asso-active materials, the pathways of exposure. the levels of ciated with exempted practices. In addition. the NRC will, radioactivity, and the methods and constraints for ensur- on a periodic basis, review the exemptions granted under 9
. BRC Policy Statement ,
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this policy to ensure that the public health and safety volume distribution). Mass- and volume-averaged con.
continue to be protected adequately. centrations should also be presented. The variability of radionuclide concentration, distribution, or type as a V. Information To Support Exernption function of process variation or variations among licen-sees should be addressed and bounded, as appropriate.
Decisions.
A. General. 2. Noaradiological properties. The nonradiological The information required to support an exemption .Pmperties of the materials to be exempted should be esen t ensure complete charactenzadon d &c decision in a rulemaking or bcensing action should pro- PmPenies of &c material ami conMeration of any as vide the basis for the proposed exemption in accordance vme impacts assodated wie dese propedies. An NRC with Section III of this pobey. In addressing the radiologi- exemption, based on radiological unpacts, would not re.
cal health and safety impacts, potential individual and heve licensees imm compliance with applicable rules of collective doses attributed to the practice under consid-cration should either meet the policy's dose criteria or """8.encies which cover nonradiological pmperties. A descriptionof thematerials,m, cludingtheirongin,chemi-otherwise be demonstrated to be low enough to ensure ,
Cal Composition, physical state, volume, and mass should protection of the public health and safety and ALARA. In be provided. The variability and potential changes in the addition to the impacts of routine exposures, realistic ma er als as a function of process vanation should be impacts resulting from potential misuse or accident sce- addressed.The variation among bcensees should be de-narios should also be evaluated and demonstrated to be scribed and bounded, as. applicable.
insignificant. The NRC may reject proposals for exemp-tions if they do not provide a sufficient technical basis to C. Practice Characterization support analysis of the potential exemption.
L Totalimpact Aregulatoryactiontakenunderthis Practices should be defined with respect to the geo- Policy is likely to be generic and may be nationwide in scale.nerefore, to the extent possible, an estimate of the graphic and demographic areas to which the exemption number of NRC and Agreement State licensees that pos-will apply. In some cases, an exemption will be limited to sess the radioactive reaterial considered for exemption, one particular locality or area. However, many practices the annual volumes and hiasses, and the total quantines will ha ve national applicability and should be character-of each radionuclide that would be a part of the exempted ized accordingly. Information on these issues will be nec, essary for determinations regarding which individual dose Practice should be given. The estimates should include
/ the current situation and the likely variability over the criterion should be applied.
reasonably, foreseeable future. A geographical descrip-The Commission believes that the implementation tion Would be a helpful tool in characterizing the distribu-tion of radioactive. material involved in the exemption guidance provided with its " General Statement of Policy decision. Such distribution, submitted as part of the prac-and Procedures Concerning Petitions Pursuant to 92.802 tice characterization, should be used to assess realistic i for Disposal of Radioactive Waste Streams Below Regu.
latory Concern," published August 29,1986, 51 FR impacts of the practice, in addition to conservative bound-l ing estime tes that tend to overestimate human exposures a 30839, generally defines the types of information needed and doses. In any case, the typical quantities produced per i to support an exemption decision. However, not all of the information may be applicable to the broader range of Practice (e.g., number of units of'a particular consumer practices considered for exemption under this policy. Ap- Product)and an estimate of the geographic description of
, plicants should examme potentially relevant guidance the practice should be described.The potential for short-available at the time the exemption proposal is being and long-term recycle or reuse of the product contammg prepared and provide the information which is relevant to the exempted radioactive material should also be ad-dressed. Both the resource value (e.g., salvageable met-i the particular type of exemption decision being re-quested. als) and the functional usefulness (e.g., usable tools) should be exammed.
B. Material Characterization. 2. Basisforassessment A description of bases for the L F"3alproperties. He radiological properties materials and pmctice characterizations should be pro.
of the materials to be exempted should be described, vided. Monitoring and analytical data and calculations i including, as appropriate, the concentration or contami- should be specified and provided in support of the charac-nation levels and thc half-lives, total quantities, and iden- terization. Actual measurements or values that can be tities of the radionuclides associated with the exempted related to measurements to confirm calculations are im-
, practice.nc chemical and physical form of the radionu- portant and should be provided. The description should L clides should be specified. All radionuclides present or address the quality assurance program used in data collec-potentially present should be specified. He distribution tion and analysis and supporting information. If any sur-i of the radionuclides should be noted (e.g., surface or veys were conducted, they should be described. Market 10
.m -m. .--, .. ,-r m , i-
o" BRC Policy Statement information may be useful in characterizing a practice on accurate. Average doses to this group are the controlling a national basis. factors limiting individual doses and risk, and should be compared with the individual dose criteria, as appropri-
- 3. As low as is reasonably achievable (ALARA). An ate. The critical group should be the segment of the :
analysis should be provided that demonstrates that radia- population most highly exposed to radiation or radioac.
, tion exposure and radionuclide releases associated with tive materials associated with the use of radioactive mate- .
the exempted practice overall will be ALARA consistent rial under unregulated conditions.The second part of the !
I with the criteria in this policy. The ALARA, principle population exposure is the general population exposure, referred to in 10 CFR Part 20 applies to efforts by licen- exclusive of critical group exposure. For this group, the sees to maintain radiation exposures and releases of ra- individual exposures should be smaller, and the assess-dioactive materials to unrestricted areas as low as is rea- ment will often be less precise. He impacts analysis sonably achievable. Appendix I to 10 CFR Part 50 de- should present an estimate of the distribution of doses ,
5 scribes ALARA for radioactive material releases from within the general population. In situations where trunca-light water reactors (nuclear power plants). Exemption tion of the collective dose calculation is done under the proposals should describe how ALARA considerations provisions of this policy, the basis for applying the trunca-have been applied in the design, development, and imp- tion provision should be provided.
lementation of controls for the proposed practice. Ijcen-see compliance with the ALARA principle must remain The evaluation of radiological impacts should distin-in effect up to and including the point at which the materi- guish between expected and potential exposures and l als are transferred to an unregulated status in accordance events. The analysis of potential exposures in accident or -
with an exemption granted under this policy. misuse scenarios should include all of the assumptions, data, and results used in the analysis in order to facilitate ,
D. Impact Analyses. review.The evaluation should provide sufficient informa- i tion to allow a reviewer to independently confirm the To support and justify a request for exemption, each results. De potential for reasonable interactions be-petitioner or licensee should assess the radiological and tween the exempted radioactive material and the pubhc nonradiologicalimpacts of the proposed exemption.The analyses should be based on the characterizations de-should be assessed. y scribed previously and should cover all aspects of the ,. ;, gg 9g proposed exempt practice, mcluding possession, use, g g g transfer, ownership, and disposal of the material. NRC' I processing, and disposal of exempted materials should be consideration of the exemptton proposaland any envir6n-evaluated, Nonradiological impacts on humans and the mental assessments and regulatory analyses required to '
- envirofiment should also be evaluated in accordance with implement the exemptton will be based on the impact NRC requirements in 10 CFR Part 51. The analysis analyses and supporting characterizations. should also consider any adverse impact of the measures taken to provide nonradiological protection on radiation L Radiologicalimpacts. The evaluation of radiologi- ,
exposure and releases of radioactive material. Any NRC l cal impacts should clearly address the policy's individual action to exempt a practice from further regulatory con- 1 and collective dose criteria or provide a sufficient trol would not reheve persons usmg, handling, process-ALARA evaluation supporting the exemption. In either tng, wnmg,ordisposingof the ra'dioactive material from case, the following impacts should he assessed: other requirements applicable to the nonradiological Average doses to the critical population group; PmPerties of the material.
E. Cost Benefit Considerations (as required).
- Collective doses to the critical population group and the total exposed population (under A cost / benefit analysis is an essential part of both i conditions defined in Section 111); and environmental and regulatory impact considerations.He analysis should focus on expected exposures and realistic He potential for and magnitude of doses asso-concentrations or quantities of radionuclides. De cost / ;
ciated with accidents, misuses, and recon- benefit analysis should compare the exposures and eco- ;
centration of radionuclides. nomic costs associated with the regulated practice and {
alternatives not subject to regulation. Benefits and costs The collective doses should be estimated and should be considered in both quantitative and qualitative summed in two parts total dose to the critical population terms. Costs of surveys and compliance verification dis-group and total dose to the exposed population. The cussed under Item V.G. should also be covered. Any legal critical grou p is t he relatively homogeneous group of indi- or regulatory constraints that might affect an exemption viduals whose exposures are likely to be the greatest and decision should be identified. For example, one such con- l for whom the assessment of doses is likely to be the most straint might stem from Department of Transportation 11
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(D(7T) requirements for labeling, placarding, and mani- example requirements and show their effectiveness and ,
festing radioactive materials in 49 CFR Part 173. feasibility. For site-specine license amendments, the ex. J emption proposal should provide specine requirements F. Constraints. Requirements, or Conditions on for Quality Assurance / Quality Control and Reporting i that have been tailored to the h,censee's program.
Exemptions. l In most cases, the characterizations of the material A Quahty assurance 4aality coobol The program to and the assessment of irupacts will be based on either ensure compliance with specific exemption constraints, explicit or implicit constraints, such as limitations on the requirements, or conditions should be defined. The re-amount of radioactive materialin a consumer product. In cords of inventory, tests, surveys, and calculations used to i order for an exemption decision to take credit for these demonstrate compliance with the exemption constraints constraints, the exemption proposal should specifically should be maintained for inspection. Such programs are identify appropriate constraints, such as quantity limits, necessary to provide the NRC and the public reasonable concentration limits, and physical form characteristics. assurance of conforrrance with the constraints and
'Ihe bases on which these constraints are to be ensured of adequate protection of human health and the should also be discussed. In general, constraints should be environment. ,
verifiable in order to provide the basis for an exemption j decision. 2. Reports. Reports may be required from heensees who, by rule or license, are permitted to release materials i I
G. Quality Assurance and Reporting. ***".Pted from regulatory control. Associated record-keeping to generate the reports should be defined. Muu-This portion of the exemption proposal should be mum information in the reports could include volume, tailored to either a generic petition for rulemaking or isotope and curie cont:nt. More detailed recordkeeping specific proposal for a license amendment. For generic and reporting requirements may be imposed to address petitions for rulemaking, the proposal should provide and uncertainties in projecting future volumes or amounts of justify generic requirements for Quality Assurance / Qual- exempted materials and to consider the cumulative im-ity Control and Reporting. Such proposals should include pacts of multiple exemptpas.
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1 APPENDIX-DOSE AND HEALTH EFFECTS ESTIMATION i
I, Dose Estimation from the observed effects at much higher doses and dose ratesms resuhs in signincant uncd@ sk esS In est.imating the dose rates to members of the pub- mates as reflected by the views of experts in the field. For
. lic that,might arise through various pract.ces for which example, the Committee on the Biological Effects of exemptions are being considered, the Commission has IonizingRadiation(BEIRIII)of theNational Academyof
] l j decided to apply the concept of the " total effective dose Science cautioned that the risk values are " . based on equivalent."His concept, which is based on a companson incomplete data and involve a large degree of uncertainty, i j of the delayed health effects of somzmg radiation expo- especially in the low dose region." This Committee also l sures, permits the calculation of the whole body dose stated that it " .does not know whether dose rates of l '
equivalent of partial body and organ exposures through gamma or x-rays (Iow LET; low linear energy transfer use of weighting factors. ne concept was proposed by the radiation) of about 100 mrads/ year (1 mGy/ year) are det- l International Commission on Radiological Protection rimental to man." More recently, the BEIR V Committee
,. ]
(ICRP) m its Publication 26 issued in 1977. Since that of the National Academy of Science / National Research 1
- j. time, the concept has been reviewed, evaluated, and Council stated that it " recognizes that its risk estimates I adopted by radiation protection organizations throughout become more uncertain when applied to very low doses.
the world and has gamed wide acceptance. The " total Departures from a linear model at low doses, however, i effectivedoseequivalent conceptisincorporatedin Ra.
could either increase or decrease the [ estimation of] risk diation Protection Guidance to Federal Agencies for Oc-per unit dose." The Cn-mluinn understands that the j cupational Exposure-Recommendations Approved by Comminees' statements reflect the uncertamties in-the President," that was signed by the President and pub- volved in estimating the risks of radiation exposure and do i lished in the Federal Register on January 27,1987 (52 FR not imply either the absence or presence of detrimental j 2822). De Commission recogmzes that, m considenng effects at such low dose levels.
specific exemption proposals, the total effective dose i equivalent must be taken into account. De United Nations Scientific Committee on the
! Effects of Atomic Radiatied(UNSCEAR) stated in their j H. Estimating Health Effects From Radiation 1988 Report to the General Assembly that "...there was a
- Exposure need for a reduction factor to modify the risks (derived at
' high doses and dose rates). for low doses and dose 1
A. Individual Risks * '
l , rates....(A]n appropriate range (for this factor) to be ap- l In the establishment of its radiat,on i protection poh,- .-'pliedio tot'al risk for low dose and dose rate should be l l cies, the Commission has considered the three major between 2 and l'0." nis factor would lead to a risk coeffi-cientvaluebetween7x 10-8and3.5x 10d perrad px 10-8 types of stochastic (i.e., random) health effects that can be
,. caused by relatively low doses of radiation: cancer, genetic and 3.5 x 10-2per Gy) based on an UNSCEAR risk coeffi-effects, and developmental anomalies in fetuses. De 4 t
cient of 7.1 x 10 per rad 01x 10-2per gray)for100 rad NRC principally focuses on the risk of fatal cancer devel- (1 gray) organ absorbed doses at high dose rates. The opment because (1) the mortality nsk represents a more report also stated,'The product of the risk coefficient severe outcome than the nonfatal cancer risk, and (2) the appropriate for individual risk and the relevant collective mortality risk is thought to be higher than the risk associ- dose will give the expected number of cancer deaths in the 4 ated with genetic effects and developmental effects on exposed population, provided that the collective dose is at 4
fetuses.2 However, even though radiation has been shown least of the order of 100 person-Sv (10,000 person-rem).
i to be caremogenic, the development of a risk factor appli- If the collective dose is only a few person-Sv (a few hun-i cable to continuing radiation exposures at levels equal to dred person-rem), the most likely outcome is zero
. natural background 3 requires a significant extrapolation deaths."
d In December 1989, the BEIR V Committee pub-
- comminee 7g;,g,@"*hfect of Atomic Radiation (UNSCEAR)ID;,'d*.* ~1ished a report entitled " HealthhM,$DEnech on we E .
- Effects of Exposure to 1988 Report to the General Assembly with Annexes. I_ow Levels of ionizing Radiation," which contained risk
' ' #*' estimates that are, in general, similar to the findings of IaN E."na'tYrIIYg"rMNiatN(*excludinsY
, .. don) results in individual doses of about 90 mrem per year (0.9
- mSv/yr). while in Denver Colorado, the value is about 160 mrem
- De health effects clearly attributable to radiation have occuned per year (tf mSv/yr) In both cases. naturally occurring radioac- piincipally among early radiation workers, survivors of the
. live material in the human body contributes approximately 40 atomic bomb ex at liiroshima and Nagasaki, individuals mrein r ar. Radiation from inhalation of the daughter prod- exposed for cal purposes. and laboratory ammals. Natural ucts r in contributes an average additional dose of 206 background radiation causes an annual dose that is at least two
- mrem per year (2 mSv/yr) to members of the U.S. population orders of magnitude les than the dose received human popo-lations from which the cancer risks are derived. - riments at
.- (NCRP PopulationReport No. 93.
of the United "lonizing) Radiation Exposure of States the the cellular level, however, provide similar indications of biologi-cal effects at low doses.
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B$tC Policy Statement ,#
the 1988 UNSCEAR report. De BEIR V report's esti- based on the further assumption that the annual dose is mate oflifetime excess risk of death from cancer follow- continuously received during each year of a 70-year life-ing an acute dose of 10 rem (0.1 Sv) of low-LET radiation time.To provide further perspective, a radiation dose of was 8 x 10-2.Taking into account a dose rate effectiveness 10 mrem per year (0.1 mSv per year) received continu-factor for doses occurnng over an extended period of ously over a lifetime corresponds to a hypothetical in-time, the risk coefficient is on the order of 5 x 10-4 per crease of about 0.25% in an individual's lifetime risk of rem, consistent with the upper level of risk estimated by cancer death. Ten millirem peryear (0.1 mSv peryear) is UNSCEAR. also a dose rate that is a small fraction of naturally occur-ring background radiation and comparable to the tempo.
In view of this type of information, the NRC, the tal variations in natural background radiation due to fluc-Environmental Protection Agency, and other national tuations that occur at any specific lomtion.
and international radiation protection authorities have eaablished radiation protection standards defining rec- De Commission prefers to use factors of ten to ommended dose limits for radiation workers and individ- desenbe such low individual doses because of the large ual members of the public. As a matter of regulatory uncertainties associated with the dose estimates. Use of pmdence, all these bodies have derived the value pre- values such as 0.7 or 12 imputes a significance and sense 1 sumed to apply at lower doses and dose rates associated of certainty that is not justilled considering the levels of l with the radiation protection standards by a linear ex- uncertainty in the dose and risk estimates at these low I trapolation from valt.es derived at higher doses and dose levels.nus, order of magnitude values such as 1 and 10 i rates. His model is frequently referred to as the linear, are preferable to avoid providing analysts and the public j no-threshold hypothesis, in which the risk factor at low with a sense of certainty and significance that is not com-doses reflects the straight-line (linear) dose-effect rela- mensurate with the actual precision and certainty of the tionship at much higher doses and dose rates. In this estimates.
respect, the BEIR V report notes that "in spite of evi-dence that the molecular lesions which give rise to so- B, Collective or Population Risk matic and genetic damage can be repaired to a consider-able degree, the new data do not contradict the hypothe- In the application of,the fundamental principles of sis, at least with respect to cancer induction and heredi- radiation protection, coll &ctive dose provides a useful way tary genetic effects, that the frequency of such effects to express the radiological impact (i.e., potential detri-increases with low-level radiation as a linear, non-thresh- ments)of a practice on the health of the exposed popula-old function of tne dec." -
tion. Because of the stochastic nature of risk, analysis of
. exposuges of large groups of people to very small doses The Commission, in the development of the BRC ' may Ybsult in calculated health effect::in the population at policy, is faced with the issue of how to characterize the large. Collective dose is the sum of the individual total individual and population risks associated with low doses effective dose equivalents resulting from a practice or and dose rates. Although the uncertainties are large, use- source of radiation exposure. It is used in comparative ful perspective on the bounding risk associated with very cost-benefit and other quantitative analytical techniques low levels of radiation can be provided by the linear, and, therefore, is an important factor to consider in bal-no-threshold hypothesis. Consequently, such risk esti- ancing benefits and societal detdments, in applying the mates have been a primary factor in establishing individ- ALARA principle. For purposes o'f this policy, individual ual and collective dose criteria associated with this policy. total effective dose equivalents less than 0.1 mrem per The estimations of the low risk from potentially exempted year (0.001 mSv per year) do not need to be consulered in practices can be compared to the relatively higher poten- the estimation of collective doses. The Commission be--
tial risks associated with othe~r activities or decisions over lieves mnsideration of indmdual doses below 0.1 mrem which the NRC has regulatory responsibility.Brough per year imputes a sense of significance and certainty of such comparisons, the Commission can ensure that its their magnitude that is not justified considering the inher-radiation protection resources and those of its licensees ent uncertainties in dose and risk estimates associated are expended in an optimal manner to accomplish its .with potentially exempted practices. The Comnussion public health and safety mission. also notes that doses in the range of 0.01 to 0.1 mrem per year correspond approximately to lifetime risks on the in this context, the risk to an individual as calculated order of one in a million. The NRC has used collective using the linear, no-threshold hypothesis is shown in Ta- dose, including rationales for its truncation, in a number
- ble 1 for various defined levels of an'nual individual dose. of rulemaking decisions and in resolving a vadety of ge-l The values in the hypothetical lifetime risk column are neric safety issues.
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, BRC Policy Statement Table 1 Ilypothetical Incremental Ilypothetical Lifetime Risk Incremental Annual Dose
- Annual Risk" From Continuing Annual Dose **
' 3.5 x 10-2 100 mrem (1.0 mSv) 5 x 10-8 10 mrem (0.1 mSv) 5 x 10-' 3.5 x 10-4 1 mrem (0.01 mSv) 5 x 10-7 3.5 x 10-8 0.1 mrem (0.001 mSv) 5 x 10-8 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.
" Risk coefficient of 5 x 10-4per rem 5 x 10-2 per Sv) for low linear energy transfer radiation has been conserva-tively based on the results reported (m UNSCEAR 1988 (Footnote 2) and BEIR V (see also Rev.1).
III. Dose and Risk Estimation Commission would consider exempting from regulaton control must be based on input of these measurements The Commission recognizes that it is frequently not mto exposure pathway models, using assumptions related possible to measure risk to individuals or populations to the ways in which people might tjecome exposed.These directly and, in most situations, it is impractical to meas, assurnptions incorporate sufficient conserYatism to ac-ure annual doses to individuals at the low levels associ.
ated with potential exernption decisions. Typically, count for uncertainties so that any actual doses would be radionuclide concentrations or radiation dose rates can expected to be lower than the calculated doses.'Ihe Com-only be measured before the radioactive material is re- mission believes that this is an appropriate approach to be leased from regulatory control. Estimates of doses to taken when determiningif,an' exemption from some or all members of the public from the types of practices that the regulatory controls is warranted.
The additional views of Commissioner Curtiss and Chairman Carrr's comments are attached.
$diy of .iti n e ,1990.
[
Dated at Rockville, Maryland, this i I
F r the Nuclear Regulatory Commission. ,-
S-r,ofpC-g.
i l
I 15
l 1
. BRC Policy Statement / l
.? !
Additional Views of Commissioner Curtiss i I strongly endorse going forward with a comprehensive high, when viewed in the context of other risks that we policy that will establish a disciplined and consistent regulate and in view of the fact that the purpose of this )
framework within which the Commission can define those Policy Statement is to establish a framework for identify- l practices that, from the standpoint of radiological risk, we ing those practices that the Commission considers to be i consider to be below regulatory concern (BRC).ne prin- below regulatory concern.
cipal advantage of such a policy, in my view, is that it will bring much-needed disciplirie and technical coherence to Beyond this, if the collective dose criterion is to be de-the patchwork of BRC regulatory decisions that have fined as the floor to ALARA(as I would propose below),
been rendered to date, providing a clearly articulated, a more conservative approach to establishing a collective risk-based approach for reaching decisions on matters dose criterion is warranted in view of the fact that doses such as-(1) the release for unrestricted public use of may be truncated in the calculation of collective dose and lands and structures containing residual radioactivity,(2) the collective dose criterion may be applied to single the distribution of consumer products containing small beensing actions.
amounts of radioactive material, (3) the disposal of very .
For these reasons, I do not support a collective dose Iow-level radioactive waste, and (4) the recycling of ,
cntenon of 1000 person-rem. Instead, m, view of what i slightly contaminated equipment and materials A coher- ,
appears to be the prevailing techmcal view on this matter, l ent, risk-based policy is urgently needed to provide the I w uld endorse a collective dose criterion of 100 person- l foundation for future regulatory actions in each of these rem >
areas. Accordingly, I strongly support this initiative.
Dere are certain aspects of this policy, however, with AIARA ' 1 i
which I must reluctantly disagree. My views on these I would define the individual and collective dose criteria matters follow. as floors to ALARA.2 Unfortunately, the Policy State-ment is equivocal on this issue, suggesting at one point Individual Dose Criteria that the individual and cQ Mective dose criteria should be construed as floors to AIARA -
I support the individual dose criteria of 10 millirem per year for practices involving potential exposures to limited [ A) licensee . . . would no longer be required numbers of the public and I millirem per year for wide- to apply the ALARA principle to reduce spread practices that involve potential exposures to large . l f oses further for the exempted practice numbers of the public. In view of the potential for multi- provided that it meets the conditions speci-pie exposures from widespread practices, however, and in fled in the regulation.
- the interest of administrative finality, I believe that the Commission should establish the 1-millirem criterion as a but then going on to send what I consider to be a conflict-final criterion, rather than an interim value. ing and confusing message about what the Commission expects -
Collective Dose Criterion De Commission in no wdy wishes to dis-I do not support the establishment of a collective dose courage the voluntary application of addi-
- criterion at a level of 1000 person,-rem. This level is an tional health physics practices which may, in order of magnitude higher than the level recommended fact, reduce actual doses below the BRC cri-in IAEA Series No. 89, as well as the level recommended teria or the development of new technolo-by most other international groups. Furthermore, it is an gies to enhance protection to the public and order of magnitude higher than the 1986 collective dose the environment (emphasis added).
to members of the public due to efHuents from alloperat-ing reactors, the most recent year for which figures are If the Commission intends to say, as I believe it does in available. .
' this Policy Statement, that those practices that fall within mttha of 9a A collective dose criterion of 1000 person-rem would e cjen e nt vea mean, for example, that if, pursuant to this Policy State-
' !;y*,"M"jnaY apven practice. erefore, adoption of the lower IAEA value of ment, the Commission were to exemEt on the order of luu person-rem based on dollar estimates of resources to do
. . detailed AIARA analyses would not climinate the option to fifteen separate practices with collective doses at or near approve practices such as smoke detectors that involve large the exemption level of 1000 person-rem-not an unrea- numbers of potentially exposed members of the public.
titioner i staff sonable expectation, given previous practice-we would ' ,87,M'jg^yQ',3 m*ani,,9,y th t the project somewhere between 5 and 10 excess health ef- AIARA analyses below these levels ff individudoses are t fccts annually. I consider this level to be unacceptably millirem /to millirem and the co.iective dose is 100 person-rem.
16
,' BRC Policy Statement l
s l the individual and collective dose criteria can be desig- from all other practices, will inevitably lead to confusion.
nated below regulatory concern, it is unclear why the Moreover, this approach poses the very real potential Commission would then go on to say that it expects addi- that the Commission could, on the one hand, reject a tional steps to be taken to keep exposures ALARA. As a practice involving children (e.g., baby food, pacifiers, and l geneml matter, I do not object to the ALARA concept. the like) on the ground that the risk posed by such a !
, Indeed, I support the notion that collective dose and practice is too high, yet authorize a practice directed at ALARA analyses should be performed in a manner that the general public that could, coincidentally, expose an is consistent with basic national and international radia- even greater number of children, even though the prac-tion protection principles. But in the context of a Policy tice itself is not specifically directed at children.
Statement on Below Regulatory Concern, for the Com-mission to say on the one hand that the individual and In my view, this ambiguity should be resolved in favor of a collective dose criteria reflect levels below which no regu- clear and unequivocal statement endorsing the principle latory resources should be expended, while at the same of justification of practice. While I acknowledge that the time encouraging voluntary ALARA efforts to achieve principle of justification of practice calls upon the Com-lower doses, sends a confusing regulatory message.3 For mission to make decisions involving so-called questions of the sake of regulatory clarity, I would explicitly identify " societal value," that is an insufficient reason, in my view, the individual and collective dose criteria as floors to to step back from this widely accepted health-physics ALARA. principle. Indeed, the Commission already takes such considerations into account, either explicitly or implicitly, Justification of Practice in many of the decisions that it renders.
On the issue of justification of practice, the Policy State- Accordingly, in view of the central role that the justifica-ment is unclear as to when and under what circumstances tion of practice principle has played in health physics the justification of practice prmciple would be applied. At practice, as well as the complexity and confusion that will one point, the Policy Statement provides that: nyatiably result from the approach set forth in the Policy Statement, I would state explicitly in this Policy State-The Commission believes that justification ,
ment that the Commission rptains the prerogative to de-decisionsinvolvings( 'aland culturalvalue termme that specific practkes may be unsuitable for cx-judgments should be made by affected ele- *mption, regardless of risk, documenting such determma-ments of society and not the regulatory .
tions on a case-by-case basis.
agency. Consequently, the Commission will '
not consider whether a practice is justified -
Agreemeni m terms of net societal benefit. ~,g State Compatibility With olie exceptioh, I concurin the general approach that At another point, the Policy Statement indicates that: this Policy Statement takes on the issue of Agreement State compatibility. The one area where I disagree in.
The Commission may determine on the ba- volves the treatment of matters involving low-level radio-sis of risk estimates and associated uncer- active waste disposal.
tainties that certain practices should not be considered candidates for exemption, such As I understand the position of the rgajority, the approach as the introduction of radioactive materials established in this Policy Statement, and to be imple-into products to be consumed or used pri- mented in the context of subsequent rulemaking initia-marily by children, tives, will be considered a matter of strict compatibility for Agreement State programs. As a consequence, the ap-This bifurcated approach to justification of practice, proach taken by individual Agreement States on BRC which appears to distinguish practices involving children issues must be identical to the approach taken by the Comnussion. I disagree with this approach for the follow-reasons:
ch to AtARA set forth in
- Ithe amPohcy alsoStatement concerned thatto the aYmotivated,in part, by a '
appears concern that the.Favironmental Protection A may at some When Congress enacted the Low Level Radioact,ve i tm gent criteria for B pa icular Waste Policy Amendments Act of 1985 (LLRWPAA), it I",',"gP
, _ ,s ,
vested in the States the responsibility for developing new
- His [ approach to ALARA] is particularly pertinent low-level radioactive waste disposal capacity. Indeed, the ja the area of decontamination and decommission- Congress recognized at the time that the States were mg .where other federal agencies are in the process .
of developing standards which may affect those re-Uniquely equipped to handle th. .is tmportant responsibil-ceiving exemptions, ity. Accordingly, the States were given a great deal of latitude in deciding how best to proceed with the develop-
^ ment, construction, and operation of new low. level waste jecti to muka so$nWn fen 7bUe 'p rat e disposal facilities. To take one example, Congress than with an eye towards trying to anticipate what p icy EPA might estabhsh in the future.
17
BRC Policy Statement I
?'
recognized that some States may decide to construct fa- rather than requiring such waste to be transported across !
cilities that, from a technical standpoint, go beyond the the country to a licensed low-level waste disposal facility.
requirements established in 10 CFR Part 61 for shallow If examples such as this constitute the basis for declaring land burial facilitiest for this reason, Congress directed that a health and safety concern exists such that the Com- l the NRC to develop guidance on alternatives to the shal- mission should, in turn, prohibit a State from requiring i Iow land burial approach reflected in Part 61 (see Sec- such waste to be disposed of in a licensed low-level waste 1 tion 8 of P.L 99-240). Similarly, should a State decide to disposal facility, then a more disciplined and persuasive require radioactive wastes beyond those defined by the presentation of the argument is needed.To date, I have NRC as Class A, B, and C wastes to be disposed of in a yet to see such a case.5 In the absence of a health and regional disposal facility, the Act permits the States that safety concern, it is incongruous, in my judgment, to say option as well (see Section 3(a)(2) of P.L 99-240).4 In that the risk from a particular waste stream can be so short, the 11RWPAA grants States a great deal of lati- insignificant as to be "below [NRC's) regulatory con-tude in deciding what kind of facility to build and what cern," but at the same time insist that we nevertheless types of waste will be disposed of in that facility, so long have a sufficient interest to dictate how a State might as-(1) the facility complies with the requirements of otherwise wish to handle that waste stream.' i 10 CFR Part 61 and (2) the State provides disposal capac-ity for Class A, B, and C wastes. For the foregoing reasons, I would not treat the Federal policy on below regulatory concern, as set forth in this If one interprets the 11RWPAA in this manner, as I do, Policy Statement and subsequent rulemakings, as a mat-then in my judgment it is consistent with this general ter of compatibility for Agreement States when it comes approach to conclude that this Policy Statement (and the to issues involving commercial low-level radioactive waste subsequent rulemaking initiatives implementing the Pol. disposal. .
icy Statement) should not be considered matters of com-patibility.The result of such an approach would be that
- nis kind ofinformation may.well be a part of the wasie stream f
individual States would be allowed the option of deciding petition,that nie nuclear utilities are upwadly prgparin5 " .
whether low-level wastes designated BRC by the Com- '"N@
q Nw'Nhe'd No.P[s"dd.Nt th poi .I mission under this Policy Statement should nevertheless t josiification that would support a gt to see a health and be disposed of in a licensed low-level radioactive waste Ci'iP "$C **' ;o, g [e pth(t stata ,,, e e, g,,
dtsposal facility. hC uraler this Poli tatement to b disposed of in licensed low-level radioactive waste disposal facilities.
The argument, as I understand it, that is advanced in
- ne argument has been made to that p;rmitting states the option of pmd a low support of the approach taken in the Policy Statement- , QuggCwasg,a , , , c,p c ,y that the Commission's positton on BRC should be a mat- and otherwise an adverse impact on the compactmg procen.
Indeed. this a ars to have been one of the principal concerns ter of compatibility - is that States should be foreclosed *d' ' 8'
- from departing in any way from the approach established ,heIi the Cr e that I ".'$"cl e by the Commission.To take the most visible and contro- generators would %e competin8 or f space in the exis [11W d concept tion-versial example that has arisen to date, this would lead to gdl%%8h*1,B ,
the result that a State could not require that low-level basis and that it remains equitable.Nt was tt' for this reason that the C= ' N declared in the 19 P Statement that waste streams designated BRC by the Commission never-
- theless be disposed of in a licensed low-level radioactive l 8'jgeNSEies." "i" sta n, waste disposal facility.
$,",,~o[I"3*"*h".@3b0 51 red. Reg. 39 (August 29.1986)) W that approach have had at the time, t disa I am not aware of any public health and safety rationale involving low-level waste disposal that has been advanced g'o, de e H }an d mana and,in view of this, deci
'"" '"donthow 'h*c'a*@* for 1[iw*i' Ee gee w to proceed, includ-e d fer to re as a basis for the NRC to insist that the Commission's position on BRC should be a matter of compatibility for ia8 "~san**i'
'than fishions about Ie best left whether to ividuNta StatyN' quire B Agreement States. One hears the anecdotal information ot at about reducing exposures to truck drivers by allowing nere is an abundance gd 'i"" *" AN"oI 'h* * "**Nieva of disposal cap. city u BRC waste strdams to be disposed of in local landfills, y" deed, theD to pernut the Iri dispose of radium waste in iis regional o tin o eserm 1 facility seems to ty j
- Indeed, the Commission 5d not object when the Rocky Moun- @t that the og eve ,,,,ed ,d tam compact proposed te dispose of radium waste in the Rocky conside Mountam compact site.
e 18
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- , BRC Policy Statement s .' -
7 Chairman Carr's Response to Commissioner Curtiss' Views on the BRC Policy
! Statement l' I am proud of the Commission's accomplishment in Interim Individual Dose Criterion completing a comprehensive Below Regulatory Concern Onthefirstissue,Comm. .issioner Curt.iss would pre-i policy statement. I appreciate Commissioner Curtiss' en-thusiasm and strong support for the policy. Commission fey to establish the 1 milhrem-per-year criterion as a final
!' cnterion, rather than an mterun value.
deliberation of such views has helped to forge a compre-
- hensive risk framework for ensuring that the public is protected at a consistent level of safety from existing and As stated in the BRC policy, the Commission is l establishing the 1-millirem-per-year criterion as an in-
- future exemptions and releases of radioactive materials to the general environment.The framework should also be terim value until after it develops more experience with l
helpful in allowing NRC, States, and the public to focus the potential for indmdual exposures from multiple li-i resources on reducing the more significant risks under censed and exempted practices.The widespread practices i
i NRC's jurisdiction. I offer the following response to to which this criterion applies are primarily consumer
' Commissioner Curtiss* thoughtful views in the spirit of products, which could involve very small doses to large i
d~ the constructive process that has culminated in the BRC numbers of people.De 1-millirem criterion was selected policy. specifically to address the possibility that members of the j public may be exposed to several exempted practices.
l As with many of the issues that the Commission Simply put, exposure of an individual, to a handful of l
i deals with, there were very few right and wrong solutions exempted practices could result in annual doses close to
- to the issues associated with the BRC policy. He Com. 100 millirem if each practice were allotted individual
- mission reached its decisions on the policy by selecting doses up to 10 millirem per year. His is highly improb-
- preferred solutions from among a spectrum of possible able given the Comnussion's plans to closely monitor any policy options.These decisions were made based on the overlap of exposed populatibns from exempted practices Commission's technical analysis of the issues associated as well as the aggregate dose to the public from exemp-with regulatory exemptions, legal interpretation of gov- tions. Nevertheless, NRC does not presently know how ]
l erning legislation, and regulatory experience in approving- many exemption requests will be submitted by the public,
- exemptions since the birth of civilian uses of nuctsar how many will be approved, and what types of doses will l
}
materials in the 1950's. I believe Commissioner Curtiss' > be assec'Tated with the exemptions. If few exemptions are views on selected issues constitute part of the continuous requested and g' ranted, the probability of multiple expo-
] sures from exempted and licensed practices exceeding a 4 spectrum of policy options. However, for the reasons articulated below, I affirm the Commission's decision to substantial fraction of 100 millirem per year is consider-i approve the policy statement in its present form and ably reduced. Herefore, the 1 millirem-per-year crite-reject the differing views put forth by Commissioner Cur- rion may be too restrictive and the regulatory resources
- associated with its implementation may be better spent to tiss.
control more significant risks. C,onsequently, the 1-mil-j lirem-per-year criterion was selected as an interim indi-
- Commissioner Curtiss clearly endorses the policy _ vidual dose criterion to ensure that the sum of all expo-i- and the concept of establishing a comprehensive frame. sures to an individual from exempted practices does not work for making decisions on regulatory exemptions. exceed a substantial fraction of 100 millirem per year.
his criterion will remain an interim value until after the However, he takes issue with five elements of the policy:
. (1) the interim nature of the 1. millirem-per-year criterion Commission gains experience with the potential for mul-
! for practices with widespread distribution, (2) selection of tiple exposures to exempted and licensed activities.
l the 1000-person-rem-per-year criterion for collective "
dose. (3) the manner in which the Comnussion views the ' The initial rulemakings to implement the policy,
, BRC criteria as a " floor" to ALARA, (4) onussion of the particularly in the area of consumer product exemptions, 4
Pnaciple of justification of practice, and (5) making BRC should provide valuable insights into the validity and ap-e' rules an item of compatibility for Agreement State pro- propriateness of the 1-millirem criterion in terms of its 4 grams.%ese issues were fully considered by the Commis- need to protect the publi'c against multiple exposeres to
< sion and the NRC staff in the course of developing the nuclear materials. Although I agree with Commissioner j BRC policy. Indeed, Commissioner Curtiss voted in Sep- Curtiss that a final criterion would be desirable from the
, tember 1989 to approve the BRC policy, the essence of standpoin t of " administrative finality," it would be prema-
- which is preserved in the final BRC policy in today's ture to establish the 1-millirem criterion as a fm' al crite-notice. rion until after the Commission gains more experience f
i 19
J BRC Policy Statement i,
- . a-with exemptions of practices with widespread distribu. constrain decisions on exemptions without an adequate tion. health and safety or environmental basis.
}
. Collective Dose Criterion Based on these provisions, the Commission selected the value of 1000 person-rem / year as a level of collective j Comm..issaoner Curtiss would have preferred to dose that ensures less than one health effect per practice, q adopt a collective dose en}erion of 100 person-rem / year In selecting this value, the Commission relied on contem-j because of his view that this value is more consistent with porary recommendations of expert national and interna-the prevalent techmcal view on this matter. tional bodies.These included the 1988 conclusions of the United Nations Scientific Committee on the Effects of For the reasons discussed below, I beh. eve that a
] Atomic Radiation (UNSCEAR) that collective dose cal-l collective dose enterion of 1000 person-rem / year is more culations only provide reasonable estimates of health j consistent with the prevalent technical view on this mat- risks if the collective dose is at least of the order of 10,000
- ter and provides a sounder regulatory basis for making
, person-rem. This value is an order of magnitude greater
- exemption decisions. De Commission considered two than the value of the collective dose criterion selected by fundamental questions associated with the collective dose the Commission. UNSCEAR also stated that the most 4
cnterion: (1)is there a need fcr a collective dose enterion likely outcome of collective doses on the order of a few and,if so,(2)what should the value of that criterion be? hundred person-rem is zero deaths.
- ne Commission initially questioned the very need he Commission also considered the magnitudes of 1 for a collective dose criterion for the types of practices collective doses associated with practices, primarily con-i that would be considered as potential candidates for ex- sumer products, that have already been exempted by the emption. This questioning was based on a number of Commission. This was done to provide.a benchmark for factors that indicated that the Commission may not need the value of the collective dose criterion based on histori-i to consider collective dose in making exemption deci- cal decisions that the public found acceptable. The Com-
- sions.These factors included
- mission found that the magnitudes of the collective doses for these exempted practices fell in the range of the 1000 l 1. Thereisconsiderableuncertaintyassociatedwith person-rem / year dose. Specific examples include 1200
- the validity of risk estimates based on projections of col- person-rem / year from watches whose dials are adorned 3 lective doses composed of small to very small doses to with paint contaimng tritium,800 person-rem / year from j large numbers of people. , smoke detectors containing radioactive materials, and f 8600 person-rem / year from gas mantles for lanterns that j ^
- 2. De individual dose en.teria of 1 and 10 millirem - contaiii thi>rium (NCRP Report No. 95).
j per year, coupled with the other provisions of the policy
- (e.g., broad definition of practice), should ensure a consis- In addition, the Commission considered the magni-
- tent and adequate level of protection of members of the tude of collective doses associated with licensed activities, j public from all exempted and licensed practices. such as discharge of effluents from nuclear power plants.
- ne Commission established ALARA design objectives
- 3. Although collective dose has been considered in for effluent treatment systems for power plants in Ap-i evaluating environmental impacts and in assessing the pendix I to 10 CFR Part 50. The Commission noted that effectiveness of licensee ALARA programs, NRC's regu- the dose values established in 'the design objectives are
+
latory program has not traditionally placed specific con- generally consistent with a collective dose criterion with a straints on collective doses associated with regulated ac- magnitude of 1000 person-rem / year. However, the Com-j tivities. mission also recognized that licensees have performed j better than required in accordance with Appendix I by
- 4. Based on comments submitted to the Commis- reducing estimated collective doses from reactor plant
- sion on its proposed BRC policy, including comments effluents to 110 person-rem peryear in 1986, which is the
) presented by the Health Physics Society, the prevailing most recent year for which the data have been completely technical view opposed adoption of a collective dose crite- . assessed (see NUREG/CR-2850, Vol. 8).
rion in the BRC policy.
Finally, the Commission and its staff are only begin-
- Despite these considerations, the Commission also ning to evaluate specific details of how the BRC policy
- recognized the benefit of a collective dose criterion in will be implemented through subsequent rulemakings limiting the total population dose associated with ex- and licensing decisions. Even at this preliminary stage,
~
! cmpted practices and in evaluating environmental im- the Commission has identified substantive implementat-pacts and the effectiveness of ALARA programs. Conse- ion issues pertaining to the application of the collective quently, the Commission decided to establish a collective dose criterion. For example, an issue has txen identified .
- ' dose criterion as a part of the B RC policy, provided that it regarding how the collective dose criterion would be ap-was based on valid scientific analysis and that it did not plied in making decisions about appropriate levels of 4
, 20 f
4
, n . - - . . , - -- , . - - - - - - , - .- . , . ~ - - -
a . ,
BRC Policy Statement s .^
cleanup for contaminated sites. Specifically, does the col- practice. In this regard, I agree with Commissioner Cur-lective dose criterion apply generically to the practice of tiss because the truncation of further efforts to reduce decommissioning or would it be applied on a site-specific doses is one of the priacipal regulatory motivations for basis? Similarly, ho,w should the coWetive dose criterion establishing the BRC policy.
be applied in cases where nuclear operations have con.
l taminated groundwater resources that could potentially However, I disagree with the rest of Commissioner supply municipal drinking water systems? Resolution of Curtiss' view on this issue. It would be inappropriate to these and other issues could cause the Commission to tell the regulated community that they cannot reduce revise its selection of the magnitude of the collective dose deses below the BRC criteria. In short, although we will i criterion through future rulemakings and development of not require licensees to reduce doses further, we do not generic guidance, flowever, based on the technical infor. want to discourage their efforts to do so either.This would mation and recommendations currently before the Com- be tantamount to telling a licensee how to operate his or mission,1000 person-rem / year appears to be an appro. her business regardless of whether any health or safety priate magnitude for the collective dose criterion. issues are involved. Such a direction would be inappropri-ate because it clearly falls outside of the health and safety For all of these reasons, the Commission established focus of the NRC.
a collectiv dose criterion of 1000 person-rem / year for In formulating the BRC policy, the Cornmission rec-l ognized that new technologies being developed today Promise to reduce doses, and therefore risks, at lower M RA costs than present technologies. Indeed, technological Commissioner Curtiss would prefer to define the and cost considerations are explicitly recognized in the individual and collective dose criteria as " floors" to definition and application of the term "ALARA." Thus,I
! ALARA, that is, that the regulated community and NRC believe it would be inappropriate to tell licensees that are relieved from the regulatory obligation to perform they cannot implement new technologies and health further ALARA analyses below these levels if individual physics practices to further r. educe doses if they want to.
doses are 1 millirem /10 millirem and the collective dose is v
- 100 person-rem. Specifically, Commissioner Curtiss be- Justification of Practice j lieves that the BRC policy sends a confusing message by Commissioner Curtiss would prefer to endorse the
- encouraging voluntary efforts to achieve doses below the. principle of justification of practice (i.e., whether the BRC critena. / potentialimpacts of a practice are justified in terms of net
. ~societatteilefits) and retain the prerogative to reject ap-in responding to Commissioner Curtiss' view on this plications for exsmptions regardless of the risk they pose.
, issue, it is important to begm from the definition of the term ALARA. ALARA is the regulatory concept that I disagree with Commissioner Curtis' view on this radiation exposures and effluents should be reduced as matter because it puts the Commission in a position of low as is reasonably achievable taking into account the making decisions in areas outside the normal arena of its i state of technology, and the economics of improvements expertise, where the agency would be especially vulner-in relation to the benefits to public health and safety and able, perhaps justifiably so, to criticism. Consistent with other societal and socioeconomic considerations, and in the mission of the NRC, the Codimission should base its relation to the utilization of atomic energy in the public judgments on an explicit, objective, and rational consid-interest (10 CFR 20.1(c))."Ihe ALARA concept is one of cration of the health, safety, and environmental risks the fundamental tenets of radiation protection and has associated with practices, rather than on what many been a keystone in NRC's regulatory framework. Public would perceive as personal preferences of the Commis-comments on the proposed BRC policy statement and on sioners. Such an approach fosters long-term stability in proposed revisions to 10 CFR Part 20 urged the Commis- regulatory decisionmaking on potential exernptions.
sion to define " floors" to ALARA or thresholds below which NRC would not require further reductions in doses Decisions on justification of practice involve social or effluents. and cultural considerations that fall outside the Commis-sion's primary focus and expertise for ensuring adequate The Commission responded to these comments in protection of the public health and safety from the use of the policy by stating that ". . . a licensee using the exemp- nuclear materials. Such decisions should be made by af-tion would no longer be required to apply the ALARA fected elements of society, such as residents near a con-principle to reduce doses further for the exempted prac- taminated site, potential customers, suppliers, and other tice provided that it meets the conditions specified in the members of the general public, rather than NRC. I be-regulation" established for a particular exemption. In lieve that this position is consistent with regulatory prac-other words, the BRC criteria and implettenting regula- tices of other Government agencies that generally do not tions will provide " floors" to ALARA for the exempted regulate en the basis of whether a particular practice is 21
i 1
BRC Policy Statement "
i s .' -
justified in terms of net societal benefit. For example, to The Iow-Leni Radioactive Waste Policy Amend-the best of my knowledge, the Environmental Protection - ments Act did not change the regulatory framework ap-Agency does not question whether the generation of haz- plicable to Atomic Energy Act materials. On the contrary, ardou c wastes is justified in terms of net societal benefit, . the Act specifically recognized the importance of that even though the agency promotes the minimization and framework by including provisions such as the following:
elimination of such wastes to reduce risks.
Sec. 4(b) . . . (3) EFFECT OF COMPACTS ON I believe that Commissioner Curtiss misinterprets FEDERAL LAW.-Nothing contained in this Act the BRC policy when he claims that it embodies a bifur- or any compact may be construed to confer any new cated approach on the principle of justification of prac- authority on any cornpact commission or State-tice. As clearly indicated in the policy, the Commission
"(A) to regulate the packaging, generation, may determme that certain practices should not be con-treatment, storage, disposal, or transporta- l sidered candidates for exemption on the basis of risk I tion of low-level radioactive waste in a man-estimates or associated uncertainties. Rejection of such nerincompatible with the regulations of the an application should be based on the risks posed by the Nuclear Regulatory Commission ...;
practice, zather than whether the practice is justified m terms of net societal benefit. The types of concerns he "(B) to regulate health, safety, or environ- i raises about risks to children and the general public would mental hazards from source material, I be critically evaluated by the Commission in rulemakings byproduct material, or special nuclear ma- l to determine whether particular practices should be ex-terial*- l empted. Therefore, I believe that the Commission has l established an appropriate BRC pony that does not con- ,,,,,
sider whether a prcposed practice is justified in terms of i societal benefit. "(4) FEDERAL AUTHORITY.-Except as ex- 1 pressly provided in this Act nothing contained in this Agreemeist State Compatibility Act or any compact may be construed to limit the j
. . . applicability of any.Ftileral law or to diminish or Commissioner Curtiss also disagrees with the Com-otherwise impair the jurisdiction of any Federal mission majority view on the need for umformity between "E*"'I' "
basic radiation protection standards established by NRC and Agreement States. He indicates that he would,not' Unlike the Uranium MillTailings Radiation Control treat the Commission's policy on below regulatory con- . Act .gf4978, as amended, the low-Level Radioactive cern as a matter of compatibility for Agreement States Waste Policy Act, as amended, does not authorize States with respect to disposal of commercial low-level radioac- to establish more stringent standards. The Act also spe-tive waste. He reaches this conclusion in part because he cifically directed the Commission to establish standards reads the low-level Radioactive Waste Policy Amend- for exempting specific radioactive waste streams from ments Act of 1985 as giving States a great deal oflatitude regulation due to the presence of radionuclides in such in deciding how to proceed with the development, con- waste streams in sufficiently low concentrations or quan-struction, and operation of new low-level waste ('isposal tities as to be below regulatory concern. If, in response to facilities. Drawing upon this interpretation, he concludes a request to exemp' a specific wiste stream, the Commis-that individual States should be allowed the option of sion determines that' regulation of a radioactive waste deciding whether tow-level waste desipated BRC should stream is not necessary to protect the pub'ic health and be disposed of in a licensed low-level radioactive waste safety, the Commission is directed to take the necessary disposal facility. steps to exempt the deposal of such radioactive material
. from regulation by the Commission. Thus, the Act did This policy statement in and of ituf does not make not, in my view, grant any particular latitude to the States any compatibility determinations; as indicated in the to determine which waste streams were of regulatory statement, compatibility issues will be addressed in the -concern Rather, it reaIlirmed the existing roles of the context of individua! rulemaking, as they occur. But I NRC and the States in determining regulatory standards believe it is important to ; pond to Commissioner Cur- for low-level waste and specifically defined the Commis-tiss on this issue in two respects. First, I do not read the sion's authority in this regard as including designating low-Level Radioactive Waste Policy, Amendments Act as waste streams which are below regulatory concern.
giving the States particular latitude let alone specific authority in the area of waste to establish radiation stan- The respective roles of the Commission and the dards different from those of the Commission. Second, I States with respect to the licensing and regulation of do not believe that the issue of BRC for waste disposal Atomic Energy Act materials, including the disposal of can easily be divorced from BRC in other areas such as low-level radioactive waste received from other persons, dccommissioning. are governed by the provisions of Section 274 of the 22
1 BRC Policy Statement
, i i
I Atomic Energy Act of 1954, as amer.ded. Absent the The potential problems from conflicting standards execution of a Section 274b Agreement with the NRC, a identified by the JCAE in 1959 are fully apparent in the State is preempted by Federallaw from exercising regula- context of BRC and demonstrate why the scope of com-tory authority over the radiological hazards of these mate- patibility findings to be made by the NRC cannot be '
rials. The Commission is authorized to enter into an drawn to exclude low-level radioactive waste disposal. (
agreement with a State only upon a finding that the State For instance, the Commission intends to use the risk I program is compatible w1h the Commission's program
, criteria identified in the policy statement to enablish for regulation of radioactive materials and cdequate t
, decommissioning criteria, that is, the level at which a protect the public health and safety. Section 274d.(2).
The legislative history of Section 274 stresses throughout formerly licensed rite may be released for unrestricted the importance of and the need foi continuing compati, use. if the States are permitted to require that low-level bility between Federal and State regulatory programs. In waste streams designated BRC by the Commission be comments on the legislation, the Joint Committee on disped of in a low-level waste facility, it could result in a l Atomic Energy (JCAE) statt.d that site in one state being released for unrestricted use, while l
. soil or materials in an adjacent State at that level would be l 5.The Joint Committee beh.evesit.important t required to be confined in a low-level waste facility, if a emphasize that the radiation standards adopted .
Patchwork of disposal criteria were to develop, it would bc by States under the agreements of this bill should , ,
virtually unpossible to establish decommissionmg funding either be identical or compatible with those of the Federal Government. For this reason the requirements that would be adequate to assure that all ,
committee removed the language 'to the extent licensed facilities will set aside sufficient funds over the i feasible'in subsection g. of the original AEC bill life of a facility to pay for decommissioning. The resulting considered at hearings from May 19 to 22,1959. confusion from these conflicting standards could well re-The committee recognizes the irnportance of the sult in delays in adequate decommissioning of contami-testimony before it by numerous witnesses of the nated sites and certainly in unnecessary concern on the dangers of conflicting, overlapping and inconsis- part of the public. I continue to believe that reserving to tent standards in different jurisdictions, to the the NRC the nuthority to establish basic radiation protec- i hindrance of industry and je wrdy of public tion standards, including designating which waste streams l
safety. are below regulatorj concern, is fully justified to ensure Sen. Rept. No. 870, September 1,1959,86th Cong.,1st. an adequate uniform and consistent level of protection of Sess. f the public health, safety and the environment.
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