ML20033F852
| ML20033F852 | |
| Person / Time | |
|---|---|
| Issue date: | 09/30/1988 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20033D930 | List: |
| References | |
| REF-10CFR9.7 NUDOCS 9004030255 | |
| Download: ML20033F852 (15) | |
Text
{{#Wiki_filter:- - - -. e: ~ l[. s* Action: Beckjord, RES v* **4 UNittost its j Cys: Stello / NUCLE AR REGULATORY COMMISSION a wasunestow,p.c.seses -{ Thompson, NMS$ \\ ' " * *,/ ey RR September 30, 1988 - crece or TMs secastAny NEMORANDUM FOR: Victor Stallo, Jr. Executive Director for ions Samuel J. Chilk, Secretad ) FRON: Sulk 3ECT; STAFF REQUIREMENTS - SEC1 8 257, " PROPOSED CONNISSION POLICY STATENENT N EXEMPTIONS FROM REGULATORY CONTROL FOR PRACTICES WHOSE PUBLIC NEALTN AND SAFETY IMPACTS ARE BELOW REGULATORY CONCERN (BRC) i ? The Commission, with all Commissioners agreeing, requested that the draft Advance Notice of the Development of a Commission Policy on Below Regulatory Concern, as modified in the attachment, be made available to the participants prior to the International Workshop on the subject and placed in the Public Document Room. At the International Workshop, the staff should clearly focus on those issues where differences of opinion may I exist or specific comments are sought (see Commissioners' vote sheets at;d meeting SRM on the subject matter dated 9/29/88 for additional details). Following the International Workshop and other public workshops, the staff should forward for commission review a revised Federal Register Notice for public comment on the proposed BRC policy. (spe)-(RET) (SECY Suspense 1/27/89) l
Attachment:
As Stated cc Chairman Zech Commissioner Roberts Commissioner Carr Commissioner Rogers OGC l l 9004030533 900316 PDR-ORO NGPZ PDC 1--e e w-- m a. r-
.a ( i DRAFT \\ Advance Notice of the Develooment of a Proposed Comission Policy on Exemptions from Regulatory Control for Practices Whose Public Health. and Safety Impacts are Below Regulatory Concern J I. INTRODUCTION AND PURPOSE i Over the last several years, the Comissior ass become increasingly aware of the need to ptovide a general policy on the appropriate criteria for release of radioactive materials from regulatory control. To address this need, the Comission is expanding upon its existing policy for protection of the public l from radiation, currently expressed in existing regulations (Title 10. Code of Federal Regulations) and policy statements (30 FR 3462. Use of Byproduct Material and Source Material, dated March 16, 1965; 47 FR 57446, Licensing Requirements for Land Disposal of Radioactive Weste, dated December 27, 1982; and 51 FR 30839, General Statement of Policy and Procedures Concerning Petitions Pursuant to 6 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion-includes the prov4s4en develooment of an explicit pc'i:y on the exemption from regulatory control of practices whose public health and safety impacts are below regulatory concern. A practice is defined in this policy as an activity or a set or combination of a number of similar sets of coordinated and continuing etivities aimed at a given purpose which involve the potential for radiation exposure. Under this policy, the definition of " practice" is a critical feature which will assure that the formulation of exemptions from regulatory control will not allow deliberate dilution of nuterial or fractionation of a practice for the purpose of circumventing controls that would otherwise be applicable. 1 .- -.. Y
t The purpose of this policy statement is to establish the basis upon which the Comission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control persons who receive, possess, use, transfer, own, or acquire certain radioactive material. This policy is directed principally toward rulemaking activities, but may be applied to license amendments or license applications involving the release of licensed radioactive material either to the environment or~to persons who would be exempt from Comission regulations. It is important to emohesire that this colicy does not assert a_n absence or threshold of risk but rather establishes a baseline where further covcenment regulation to reduce risks is unwarranted. I The concept of regulatory exemptions is not nut. For example, in 1960 and ] 1970, the Comission promulgated tables of exempt quantities and concentrations for radioactive material which a person, under certain circumstances, could receive, possess, use, transfer, own, or acquire without a requirement for a license (25 FR 7875 and 35 FR 6427). Other exemptions allowing distribution of l consumer products or other devices to the general public, or allowing releases of radioactive material to the environment, have been embodied in the Comission's regulations for some time. More recently, the Low Level Radioactive Waste Policy Amendments Act of 1985 directed the Comission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the - disposal of slightly contaminated radioactive waste material that the Comission determined to be below r @ latory concern. The Commission responded to this t l 1egislation by issuing a policy statement in August 1986 (51 FR 30839). That e Y statement contained criteria which, if utisfactorily addressed in a petition l for rulemaking, would allow the Co m aion to act expeditiously in proposing [ appropriate regulatory relief on a " practice-specific" basis consistent with .the merits of the petition. The Comission believes that these " practice-specific" exemptions should be encompassed within a broader NRC policy which defines levels of radiation risk below which specified practices would not require NRC regulation based on l. public health and safety interests. For such exempted practices, the .Comission's regulatory involvement could therefore be essentially limited to l 2 i t ,, -- - _- a
i ^ 1 tl(l lg licensing, inspection, and compliance activities associated with the transfer of the radicactive material from a controlled to an exempt status. The Commission recognizes that, if a national policy on exemptions from regulatory control is to be effective Agreement $tates will play ah important implementation role. In the past, $tates have been encouraging findings that certain wastes are below regulatory concern and the Commission believes that $tates will support an expansion of these views to all practices involving exempt distribution or release of radioactive material. The Cosnission intends that rulemakings codifying regulatory control exemptions will be made a matter of compatibility for Agreement State.. Consequently, any rulaciskings that evolve from this policy will be coordinated with the States. Advisory and scientific bodies have offered diverse views to the Comission in anticipation of this Policy Statement. There is no clear consensus based on existing scientific evidence or research regarding the selection of numerical giteria for use in this Policy Statement. Further. the Comission is aware that there are differing views within the NRC staff on the selection of numerical-criteria for BRC. In-the absence of a scientific _ consensus, it is the Comission's task to assess the diversity of views in establishing a responsible BRC policy. The authority and responsibility to make the final selection of criteria rests with the Comission. Criteria selected must:
- 1) provide reasonable assurance that public health and safety will be protected, and 2) consistent with such assurance, p:;1 nit practices in the public domain which involve the use of radioisotopes for which society perceives a demand.
It is recognized that there is a del _icate balance here. Criteria can be set sufficiently restrictive such that there is absolute assurance that health ard safety will always be protected, no matter what events might transpire. However; in doing so, the regulator may then place undue and unnecessary restrictions on practices which should be permitted because of otherwise reasonable social, economic or industrial considerations. There is always the danger of over-regulation which results in effects that are felt in areas where the NRC does not have authority and responsibility. Moteover, I 3
1 l<' l the Atomic Energy Act does not reouire ab ulute assurances of safety in the use of radioactive material and licensed f acilities. J The numerical criteria ultimately selected will have significant impact on nuclear regulation here in the United States and potentially in the' international connunity. The values under consideration in this Policy Statement do not necessarily agree with those selected or under consideration by other countries. -The Connission has carefully reviewed those alternate criteria, and does not find significant scientific evidence that would dictate-preferential selection of any of those views over what is proposed in this Policy Statement. i ) 1 II. RADIATION PROTEC110N PRINCIPLES The Comission subser4bes-to recognizes that three fundamental principles of radiation protection 4n formv4at4ng-4ts-pe44e4es-and-regulat4 ens have historically guided the formulation of a system of dose limitation to protect workers and the public from the potentially harmful effects of radiation. They are (1) justification of the practice, which requires that there be some net i benefit resulting from the use of raciation or radioactive materials, (2) dose I limits, which define the upp?- boundary of adequate protection for a member of the public which should not be exceeded in the conduct of nuclear activities, and'(3) ALARA, which requires that radiation dose be as low as is reasonably achievable, economic and social factors being taken into account. The term, ALARA, is an acronym for As Low As is Reasonably Achievable. The Comissior, is interested in assessing how these principles should be applied in establishing appropriate criteria for release of radioactive materials from regulatory control. For-the-purpose-of-estab44sh4mg-the-stoehest(e-f4,evs-stat 4stiea44-health-r4sk assee4ated-with-4ts-rad 4644en-proteet4en pe44e4est-the-Gem 4ss4en-a4se subser4bes + n to-a-44near quadrat 4e-re4at4ensh4p-between dese-and-effeet-whfeh-4s-44near-ever the dese-range-for-wh4eh-th4s-pe44ey-app 44ese-4he-hypothes4s-spen-wh4eh-the mode 4-4s-based Because of the absence of observed health effects below 5 rem / year, scientific experts including the International Comission on 4
- ~. - .'s l Radiation Protection (ICRP) and the National Comission on Radiation l Protection (WC'9 make the assumption that the frecuency of occurrence of health effects per unit doy at low dose levels is the same as at high doses '( 10 Red) where health effects have been observed and studied in humans and animals. This' linear non threshold hypothesis assumes that the risk'of radiation induced effects (principally cancer) is linearly proportional to h dose, no matter how small the dose might be. The coefficient used in the model as a basis for estimatine statistical health risk is on the order of 2x10'4 j risk of fatal cancer per person rem of radiation dose rese4ved by an-4md4v4dva4 f I in-subser4bing-to-th4s-modely 4.T,he Connission recognizes that it is a j conservative model based upon data collected at relatively high doses and dose rates which is then extrapolated to the low dose and dose rate region where there are no statistically reliable epidemiological data available. j A4though.aA,1ternative hypotheses have been proposed and reevaluations of the data base at higher doses continue v-no-s4gn4f4eant-ehange-4s-ent4e4 pated-4n the-genera 44y-aseepted-44near-mode 4-and-4ta-numer4ea4-eeeff4e4 ente--it-4s therefere-the Ge m4ss4en s v4ew that-the-use-of-the-44 pear-mode 4-prov4deo-a a l. reasonab4e-basis-for-deve4ep4ng-enempt4en-pe44ey, The Comission, believes that L use of the linear non-threshold hypothesis allows the theoretical establishment of upper limits on the number of health effects that might occur at very low doses which are the subject of the exemption policy. l The risk of death to an individual, as calculated using the linear model, is shown in Table 1 for various defined levels of individual dose. A radiation exposure of 10 mrom per year for a lifetime corresponds theoretically to an increase of 0.15 'of the individual's annual risk of cancer death. The lifetime risk is based upon the further assumption that the exposure level is the same for each year of a 70-year lifetime. I 5
.g Table 1* Incronental Incremental Lifetime Risk from Annual Dose Annual Risk Continuing Annual Dose 100 wom*** 2 x 10 5 = 1 x 10*3 10 mrem ** 2 x 10-6 N 1 x 10-4 4 5 0.1 mrom 2 x 10*8 N 1 x 10 6 1 mrom 2 x 10 rwl x 10-Risk coefficient of 2 x 10*4 per rem based upon publications of the ICRP. For purposes of comparison, the risk to an individual of dying from cancer from all sources in the U.S. is 1 in 500. The additional risk to an individual of dying from cancer when exposed to 10 mrom is 2 in one million.
- Unless otherwise indicated, the expression of dose in mrom refers to the Total Effective Dose Equivalent. This term is the sum of the deep dose equivalent for sources external to the body and the comitted effective dose equivalent for sources internal to the body.
The Comission recognizes that it is impossible to measure risk to individuals or populations directly, and, that in most situations, it is inpractical to measure annual doses to individuals at the low levels implied by exemption decisions. Typically, radioisotope concentrations or radiation levels from the material to be exempted are the actual measurements that can be made, and doses are then estimated by exposure pathway analysis combined with othat types of assumptions related to the ways in which people might become exposed. Under such conditions, conservative assumptions are frequently used in modeling so that the actual dose is on the low side of the calculated dose. The Commission believes that this is the appropriate approach to be taken when determining if an exemption from regulatory controls is warranted. in-the-app 44 eat 4en-of-the-fundamente4-pr(ne4p4es-of-radiat4en-proteet4ent ee44eet4ve-dese-prov4 des-a-asefv4-way-to-express the-4mpaet-44,ery-detr4ments) L - of a-nue4 ear-set 4v4ty-en the-health-of-the-populat4en-subdeet-to-rad 4ation exposurer Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure. By assigning collective dose a monetary value, it can be used in cost benefit and other quantitative analysis techniques. _It is therefere-en-4mportant a, factor to consider in balancing benefits and societal detr4ments-for-praet4ee-dust 4f4 eat 4en-and-AkARA determ4 mat 4 ens,ig act. 6
1 e !!!. APPhiGATION-0F-RADIAfiON-PR07EtT10W-PRINfiPhEE-70-EMEMpileWS-FROM REGWhATORV-69NTR9b ] CONSIDERATIONS IN GRANTING EXEMPTIONS FROM REGULATORY CONTROL i The following sets-forth-guide 44nes about-how-the Gemm4se4en-w(44-app 4y-the fundamenta4-pr4ne4ples of rad 4at4en proteet4en-4n eene4 derat 4en-of elements are being considered by the Comission as a basis for evaluatine practices which are proposed to be exempt from regulatory control. These practices, if approved, would result in products containing low levels of radioactive' material being distributed to the general public and radioactive effluents and solid waste being released to areas of the publically-accessible environment. l. o Justification - The Comission seeks coment on the extent to which Eexposures resulting from any practice should be justifiedt thuss-even at-tr4v4a4-4 eve 4s-of-deser-the-praet4ee-eene4dered-for i L enempt4enshou4d-be-dust 4f4ed, As lower levels of radiation exposure are _ projected, should lower levels of benefit w(44 be needed reevired for { practice justification! Howeveer (In establishing its pe44efee-the so m4ss4en-w(44-eent4nue-ts-preh4b44 exemption policy. should the Comission exclude certain practices for which there 4e appears to be no reasonable justification! In considering proposals for exemptions. should the Conunission evaluate the social acceptability of practices? Should the Comission determine a practice te be un.iustified if nonradioactive economicc1 alternatives exist? o Dose Limits and Critertoj - Individual doses from practices exempted under this policy should not be allowed to exceed 100 mrom per year. This is the dose limit for members of the public specified in the final revision of 10 CFR Part 20. Standards for Protection Against Radiation. The dose limits in the final revision of 10 CFR Part 20 apply to all sources of radiation exposure under a licensee's control (natural background and medical exposures are excluded). Because of the small risks involved, a 10 mrom individual dose criterion is proposed as the basis for exemption decisions based on simple analysis and,iudgements. The Comission specifically seeks coment on the need for establishing I^ a collective dose limit in addition to an individual dose criterion. l 1 L 7
j i i i If such a collective dose criterion is needed, what is the basis for this need? If the Comission decides that a collective dose criterion is needed, what aoproaches allowing truncation of individual dose in calculation of collective _ dose or weighting factors for components of collective dose would be appropriate? What alternatives shouid be considered for assessina societal impact? o ALARA - The ALARA principle generally applies to determining dose levels below which exemptions may be granted on a cost-benefit basis. However, it is the purpose of this policy to establish criteria for-4pd4v4dwa4-and f ee44eet4ve dese which would in effect. delineate achievement of ALARA i without cost-benefit analysis. Although it is possible to reasonably project what the dose will be from a practice, and then take this information into account in controlling regulated practices so that the dose limits are not exceeded, exemptions imply some i i degree of loss of control. The Conunission believes that a key consideration in establishing a policy for exemptions, and subsequently in specific rulemaking or licensing decisions, is the poss4b444ty-that ouestion of whether individuals may experience radiation exposure approaching the limiting values through the cumulative effects of more than one practice, even though the exposures from each practice are only small fractions of the limit. The Comission f l specifically seeks consnent on the issue. By appropriate choices of exemption criteria and through its evaluations of specific exemption proposals in I implementing the policy, the Comission intends to assure that it is unlikely that any individual will experience exposures which exceed the 100 mrom limit. IV. PRINCIPLES OF EXEMPT!0N Onee-a-praet4ee-4s estab44shed es-dust 4ffedt-4:es,-there-4e-a-pos444ve-net ^ benef44-to-the-4ntrodwet4en-er use-of rad 4eae64ve-meteria4,-the-dee4s4en-of whether-or not-the-ent4re-prest 4eet-or-some-defined-subset-of-the-praet4eet-4s 6-eend4date-for-exempt (en A major consideration in exempting any practice from regulatory control hinges on the general question of whether or not l 8 1'~- .. l
} + application or continuation of regulatory controls arv necessary and cost effective in reducing dose. To determine if exemption is appropriate, the -Comission must' determine if one of the following conditions is met: j l 1. The application or continuation of regulatory controls on the practice does not result in any significant reduction in the 4nd4v4dva4-or-ee44eet4ve dose received by individuals within the '[ critical group and by the exposed population or .l -i 2. The costs of the regulatory controls that could be imposed f,,o,r, dose reduction to reduce-the-4mdiv4dua4-and-ee44eet49e-dese are [ not balanced by the commensurate reduction in risk that could be realized. i For purposes of-implementing its policy, the Commission recognizes that only I u under unusual circumstances would practices which cause radiation exposures approaching the 100 mrom limit be considered as candidates for exemption. The Comission will consider such circumstances on a case specific basis using the general principles outlined in this policy statement. However, as the doses and' attendant risks to mem6ers of the exposed population decrease, the need for ragulatory controls decreases and the analysis needed to support a proposal for axemption can reasonably be somewhat simplified. At a-suff4e4ently-4ew-4 eve 4 f of-4md4v4dua4-r(shs-dee4s4 ens-regard 4ng-enempt4 ens-f4,e,s-whether AbARA-has been-seh4eved)-ean-be redueed-to an-evaluat4en-of-whether-the-overa44-pub 44e r4sk-4s suff4e4ent4y-sma44, The Comission therefere-propeees that is evaluating the use of two numerical I criteria shov4d-be-estab44thed in defining the region where ALARA has been achieved. They are (a) a criterion for the maximum individual annual dose reasonably expected to be received as a result of the practice and (b) the l ee44ettive-dese-to the a measure of societal impact to the exposed population. in-temb4 mat 4 ens (These criteria are-eheten are beino considered to assure that, for a given exempted practice, no individual will be exposed to a significant risk and that the population as a whole does not suffer a significant impact. i 9 9 ---
,v 7, t If the individua1' doses from a practice under consideration for exemption are i .sufficiently small, the attendant risks will be ses11 compared with other societal risks. The Comission believes that annual individual fatality risks below approximately 10-5 (one in 100.000) are of little concern to most l-men 6ers of society. Providing for some margin below this level, tho' Commission propetos 10 mrom as the level of annual individual exposure 2 be4ew-wh4eh AkARA-een-be-demonstrated on the-bas 4s-that-ce44eet4ve-dese-4s e4se-suff4e4en64y-ome44, The incremental annual individual cancer fatality risk associated with an exposure level of 10 mrom per year is about tx10-6 (two in one-million) as indicated in Table 1 and of the order of 0.1 percent '(one in one thousand) of the overall risk of cancer death. In evaluating the need for a The collective dose criteriong proposed-4s-499 person-ree-per-year-per-praet4eet--Adopt 4en of-th4s-va4ee-prov4 des-essuranee that-the-number-of-4nd4v4due4-emposures-at-or-near-49-urem-w(44-be-ne e re then e-few-thousand-peop4e-and-that-for the-enempt-preet4ees-to-wh4eh-44-4s j app 44ed-e-fete 44ty emengethe-emposed popu4st4en-wou4d-be-very-en44ke4ye M Comission recognizes that this criterion could be the limiting consideration for practices involving very small individual doses to very large numbers of people. It is also recognized that in such cases the collective dose criterion would, in effect. apply the ALARA concept to individual doses less than the below regulatory concern level of 10 mrom per year to the individual. Conversely, where the collective dose criterion would not be limitine. it would The (omission requests conenents on this issue. including serve no purpose. comments on what the g ooitude of the collective dose criterion, if any. should be. If the ee44ee64ve dose end-4nd4v4due4-dese-fe44-be4ew-these-4 eve 4ss is less than the below regulatory concern criteria then the risk from a dest 494ed The practice 4e would be considered to be ALARA without further analysis. Comission stresses that adoption of the ind4v4dua4-end-ee44eet4ve-dese criteria should not be construed as a decision that smaller doses be4ew these-eriter4e are necessary before a practice can be exempted, while doses above the criteria would preclude exemptions. On the contrary. the criteria simply represent a range of risk which the Comission believes is sufficiently small compared to other individual and societal risks that a cost benefit analysis is not required in order to make a decision regarding the 10 gj
i acceptability of an exemption. Practices not meeting these criteria may be j granted exemptions on a case-by case basis in accordance with the principles j embodied within this policy. To further emphasize the Comission's recognition i that a rigid limitation on collective base-4s dose would be inappropriate, it l notes that for some practices, such as use of smoke detectors, appr'eciable l benefits can only be attained through extensive utilization and, hence, with a commensurate collective dose. The Commission is aware that existing regulations of the Environmental j Protection Agency establish criteria more restrictive than exemptions which l could otherwise be granted under this proposed polic). With regard to its own i regulations, the Connission will evaluate whether there are exemption criteria embodied therein for which modification, according to the principles of this policy, would be beneficial. o V. EXCLUSIONS FROM EXEMPTION $ [ i. The Comission's March 16. 1965. notice on the Use of lyproduct Mtterial and Source Material Products Intended for use by General Public (Consumer Products) (30 FR 3462) provides the basis for the Commission's approval of the use of these materials in consumer products without regulatory control on the consumer-user. This is accomplished by case by-case exemption of the i possession and use of approved items from applicable licensino requirements. Approval of a proposed consumer product depends upon an assessment of exposures of persons to radiation as well as an evaluation of the usefulness of the product. There-are-come-types-of Certain practices involving radiation or radioactive l' materials wh4eh-ares-pr4me fee 4e, have been judoed by NRC to be socially f L unacceptable regardless of how trivial the resulting dose might be and, derefore, shov4d-be have been excluded from exemption. Excluded practices we,w4d include, but not be are not limited to, the intentional introduction of radioactive material into toys and products intended for ingestion, inhalation or direct application to the skin (such as cosmetics). Exe4ws4 ens-wov4d-a4ee 4ne4mde-the-purposeful-and-fr4veiews-diste4bution-or release-of-rad 4eaet4ve g u-
\\ l mateP4a4s where there are-elearg-econom4ea4-a4ternat4ves-to eveh voe and-the pree44ee-4a not-dust 4ffed-beeswee there-are-no un4que benef4ts from se4mg the j rad 4eaet4ve-matee4a4s, In addition to socially unacceptable uses of radioactive materials, a question 'also arises regardine uses where there are clear economical alternatives, and no unique benefits exist from using radioactive material. Where risks are trivial. the reculatory prohibition of such uses could pose en unnecessary regulatory burden by interferine with the conduct of business. The Comission seeks consents on whether orectices should be categorically excluded based on the Comission's judeement regardine social acceptability or the existance of alternatives. Analternativetocategoricalexclusioncou'j be case specific determination based on a safety analysis. ] l Y!. PROPOSALS FOR EXEMPTION A proposal for exemption must provide a basis upon which the Comission can l I determine if the basic conditions described above have been satisfied. In i general, this means that the proposal should address the individual dose and ee44eet4ve-deses societal imoset resulting from the expected activities under the exemption, including the uses of the radioactive materials, the pathways I of exposure. the levels of activity. and the methods and constraints for assuring that the assumptinns used to define a practice remain appropriate as the radioactive materials move from regulatory control to an exempt status. i If a proposal for exemption results in a rule containing generic requirements, a person applying to utilize the exemption would not need to address justification or ALARA. The Comission decision on such proposals will be based on the licensee's meeting the conditions specified in the rule. The promulgation of the rule would, under these circumstances, constitute a finding .that the exempted practice is justified, and that ALARA considerations have been dealt with. This approach is consistent with past practice, e.g., t consumer product rules in 10 CFR Part 30. i 12 =w
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,c ) 1 ift after e praet(ee 4s determ4ned-to be-fust4 feed-end a e4mple assessment i end4eates-that-the-44he4y oonsequences of enempi4en ere-4md4v4due4 end ee44ee t4ve deses spprem4 mete 4y eque4+te-or-4ess then s,0 er4ter4e-ve4eest there-wou4d be h4gh 44ke44 heed-that-the opp 44eeteen-wom d 4:4 w epted-by the-Gem 4ss4en, a In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered with regard to the potential that some individuals may receive doses near the 100 mrom p,e2 m limit when doses from other practices are also taken into consideration. If exposures from multiple practices een occur which are sigiiificantly beyond the individual dose criterion (10 mrom), the exemption will not be granted without further analysis. As experience is gnined, this policy and its ] implementation will be reevaluated with regard to this issue to assure that the i exposures to the public remain well below 100 mrom. In addition to considerations of expected acttvities and paQveys, the l Comission recognizes that consideration must also be given to the potential i for accidents and misuse of the radioactive materials involved in the practice. A proposal for exemption of a defined practice must therefore also address the potentials for accidents or misuse, and the consequences of these exceptional conditions in terms of individual and collective dose. Vii,-GAkGWhAfiGN AND-W6E-9F-69hhEGTIVE DOSE ASSESSMENT The ee44eet4ve dese een serve es both e-measure-of the-4mpeet-44,es,-detr4 ment) f of-a preet4ee-en the-emposed-popu4ation-and-a-meehen4sm for-assess 4pg the benef4ts of reguietory tenstre4nts en the preet4ee-be4ng-enempted-from f regu4etery-contre 4,--in-the 4etter-ease, e monetary-vaise een be ass 4gned-te the ee44ee64ve-deoe-ee that-eest benef44 assessments een be-made w4th-respeet to the-usefu4 ness-of eentre4s-er eenstra4nts en e praet4ee-to further reduee l eo44eet4ve-dese, The Gem 4ss4en-be44 eves-the assessment of-the-eempenents of tete 4 ee44eet4ve i dese-must-be-made to-set 4sfy-Nat4ene4 Env4rennente4-Pe44ey-Aet requirements, Howevert when used-for esst-benef44-ene4yses-er-for-eve 4Wat4en age (not-the 1 ee44eet4ve-dese er4ter4en-proposed-4n-th4s-pe44eyr-severe 4-alternative 13 -sw=
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