ML20043C091
| ML20043C091 | |
| Person / Time | |
|---|---|
| Issue date: | 09/23/1988 |
| From: | Carr K NRC COMMISSION (OCM) |
| To: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20042C963 | List:
|
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006040023 | |
| Download: ML20043C091 (22) | |
Text
{{#Wiki_filter:. ,,,,,, - = = = =., d!,T NOTAT10N V0TE cc: Stello Taylor _ t V. 7;. i. RESPONSE SHEET FYI: Beckjord._ RES' ' WLahs, RES-9 ~ JHoyle TO: SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM: COMMISSIONER CARR L
SUBJECT:
SECY-88-257 - PROPOSED COMMISSION POLICY STATEMENT-ON EXEMPTIONS FROM REGULATORY CONTROL FOR PRACTICES WHOSE PUBLIC HEALTH-AND SAFETY IMPACTS ARE BELOW REGULATORY 3 CONCERN (BRC) l APPROVE w/ comment-DISAPPROVED ABSTAIN l .NOT PARTICIPATING REQUEST DISCUSSION i COMMENTS: 1 approve issuing the attached draft as t.dvance notice of the Comission's intent _to issue a policy statement on below regulatory concern. i This advance notice should be made available te participants prior to the International Workshop to clearly focus on those issues where differences of opinion may exist or specific comments are sought. Also, the advance notice should be published and public workshops held to seek comment on those issues of particular interest to the Commission prior to the staff forwarding a proposed policy on bolow regulatory concern to the Commission for review and action. I agree with Commissioner Rogers that the issues of " justification of use" and "need for collective dose criterion" should be thoroughly explored and I have included specific questions on these issues in my revision. I believe that it is particularly. important on this complex issue for the Commission to clearly set out its questions and concerns at the outset so that public involvement in the development of the policy is maximized { n% m On ~ SIGNATURE 9,2'4.It $$$6 $ 023 89213o DATE CHP1 53FR49886 pdc YES !LO. ENTERED Oh "AS" / / / / NPC-SECY Fo w MAY, 1987
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l l DRAFT [. L 4 l Advance Notice of the Development of a Proposed Comission Policy on Exemptions from Regulatory Control for Practices Whose Public Health and Safety Impacts are Below Regulatory Concern 3. INTRODUCTION AND PURPOSE Over the last several years, the Comission has become increasingly aware of the need to provide 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 e 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 Waste, dated December 27, 1982; and 51 FR 30839, General Statement of Policy and Procedures Concerning Petitions. Pursuant to 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29, 1986). The expansion includes the prev 4s4em development of an explicit policy on the exemptica 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 contin'uing activities 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 material or fractionation of a practice for the purpose of circumventing controls that would otherwise be -applicable. 1
~~ Y Y 'A. l= , ',4 / M g ' 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 regulatery 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 rac'ioactive material either to the environment or to persons who would be exenpt from Commission regulations. It is important to emphasize that this policy does not assert an absence or threshold of risk but rather establishes a baseline where further covernment reculation to reduce risks is unwarranted. The concept of regulatory exemptions is not new. For example, in 1960 and L 1970, the Commission 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 corsumer 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 [ precedures for expeditious handling of petitions to exempt from regulation the l disposal of slightly contaminated radioactive waste material that the Comission i determined to be below regulatory concern. The Comission responded to this l 1egislation by issuing a pelicy statement in August 1986 (51 FR 30839). That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow the Comission to act expeditiously in proposing appropriate regulatory relief on a " practice-specific" basis consistent with .the merits of the petition. l l The Comission believes that these " practice-specific" exemptions should be enccmpassed within a broader NRC policy which defines levels of radiation risk below which specified practices would not require NRC regulation based on public health and safety interests. For such exensted practices, the Corrission's regulatory involvement could therefore be essentially limited to 2
.m .).% - Qk.i licensing, inspection, and compliance activities associated with the transfer of the radioactive material from a controlled to an exempt status, i l L The Commission' recognizes that, if a national policy on exemptions from L regulatory control is to be effective, Agreement States will play an important implementation role. In the past, States have been encouraging findings that certain wastes are below regulatory concern and the Comission believes that States will support an expansion of these views to all practices involving exempt distribution or release of radioactive material. The Comission intends that rulemakings codifying regulatory control exemptions will be made a matter of compatibility for Agreement States. Consequently, any rulemakings that l evolve from this policy will be 'oordinated with the States. c 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 criteria for use in this Policy Statement. Further, the Comission is aware that there are differing views within the NRC staff en the selection of numerical criteria for BRC. l '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 respnnsibility 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, permit practices in the public domain which involve the use of radioisotopes for which society perceives a 8$t7r It is recognized that there is a delicate balance here. Criteria can be set sufficiently restrictive such that there is absolute assurance that health and 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. Moreover, 3
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the Atomic Energy Act does not reouire absolute assurances of safety in the use of radioactive material and licensed facilities. The numerical criteria ultimately selected will have significant' impact on nuclear regulation here in the United States and potentially in the jnternational comunity. The values under consideration in this Policy Statement do not necessarily agree with those selected or under consideration by other countries. The Comission 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. l II. RADIATION PROTECTION PRINCIPLES The Comission subser4bes-te recognizes that three funderrental principles of radiation protection 4n-fermulating-4ts-pe44eies-and-regulatsens have historically guided the formulation of a system of dose limitation to protect workers ar.d the public from the potentially harmful effects of radiation. They are (1) Justification of the practice, which requires that there be some net benefit resulting from the use of radiation er radioactive materials, (2) dose limitt, which define the upper 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 Comission is interested in assessing how these principles should be applied in establ~ishing appropriate criteria for release of radioactive materials from regulatory control. Fer-the-purpese-ef-estab44sh4mg-the-steehest4e-(4rety-stat 4st4ea44-hea4th-risk assee4ated-with-4ts-rad 4at4en-preteet4en-pe44e4est-the-Ge m4ss4en-alse-subser4bes t e-e -44 ne a r-q u a dr a t 4e-rela t 4 e ns hip-between-de s e-a nd-e f f e e t-wh 4 eh-4 s-44 mee r-e ver the-dese-Parge-fer-wh4eh-th45-pe44ey-app 44est--The-hypethesis-upen-wh4eh-the mede 5,-{eed Because of the absence of observed health effects below s re,/ year,;#*Tertific experts including the Internatieral Comission on sc ~ I,
... _. _. ~. op .efga 57 s m Raciation Protection (ICRP) and the National Comission on Radiation Prctection (NCRP) make the assumption that the frequency of occurrence of health effects per unit dose at low dose levels is the same as at high doses (10A'aYwherehealtheffectshavebeenobservedandstudiedinhumansand arimals." This linear non-threshold hypothesis assumes that the risk of raciation induced effects (principally cancer) is linearly proportional to dese, no matter how small the dose might be. The coefficient used in the model as a basis for estimating statistical health risk is on the order of 2x10 risk of fat (al canIeEw e n.rson rem.of) radiation dose received by an-4nd4v4dua4 per pe A,vo- - v. n.< rt a pepulations. in-subser4bing-te-this-mede4, Qhe Comission recognizes that it is a conserv^ative 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. A4though aAlternative hypotheses have been proposed and reevaluations of the data base at higher doses continue. v-ne-s4gn4f 4eant-ehange-4s-ent4e4 pated-4n the-genera 44y-seeepted-44near-mede4-and-4ts-numerica4-eeeff4e4 ente--it-4s the=efere-the-Gepm!4ss4en s-v4ew-that-the-use-ef-tht:-44meer-mede4-prev 4 des-a a reasonable-bas 4s-fer-develep4mg-exempt 4en-pe44ey, The Comission believes that use of the linear non-threshold hypothesis allows the theoretical establishment g upper limits on the number of health effects that might occur at very low ^ doses which are the subject of the exemption pelicy. The risk of death to an-individual, as calculated using the linear model, is i shewn in Table 1 for various defined leve s of individual dose. A radiation \\ o./ m3v gav e excesureof10mremperyea(r.forali[etmecorrespondstheoreticallytoan increase of 0.1% 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 iifetime. 5 J
v* }} a& ll. 4: s . Table 1 V -Incremental Incremental ' Lifetime Risk from Annual Dese Annual Risk- _ Continuing Annual Dose I 5 1 x 10-3 arebCosaU 4) 2 x 10 6 [1x10'4 ~ 100 10 2 x 10 7 C mre 1 mrem /n 2 x 10'8
- 1 x 10-5 0.1 mrem b J 2 x 10~
d a 1 x 10-6 I Unless otherwise indicated, the expression of dose in mrem 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. U* ^~9 2 Risk coefficient of 2 x 10-4, per rem, based upon publications of the ICRP. 1 The Comission recognizes that it is impossible to measure risk to individuals or populations directly, and, that'in most situations, it is impractical 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 other types'of 4 assumptions related to the ways in which people might become exposed. Under such conditions, conservative assumptions are frequuntly 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-ef-the-fundamente4-pr4me4ples-ef-rad 4at4en-preteet4ent ee44eet4ve-dese-prev 4 des-a-usefu4-way-te-express-the-4mpaet-f4:ert-detriments) of-a-nue4 ear-net 4v4ty-en-the-hea4th-ef-the-pepu4at4em-subdeet-to-Pad 4ation expesurer Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure. By assigning collective dose a moretary value, it can be used in cost benefit and other quantitative analysis techniques. It is therefere-en-4mpertant a, factor to consider in balancing -ber.efitsandsocietaldetr4ments-fer-praet4ee-fust4f4 eat 4en-and-AJARA f determ4 mat 4 ems impact. 6
illg& f 48 l )). APPhlGAil0N-GF-RABIATEGN-PROTESTION-PRINGiPhES-TG-ENEMPTE9NS-FR9M [ REGWhATORV 69NTR9k CONSIDERATIONS IN GRANTING EXEMPTIONS FROM REGULATORY CONTROL The following sets-ferth-guide 44nes-about-how-the-Gemission-w(44-app 4y-the fundamenta4-pr4ne4p4es-of-rad 4at4en-protee44en-4n-eems4 derat 4en-of elements are being considered by the Comission as a basis for evalutting 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. o Justification - The Commission seeks comment on the extent to which Ee_xposures resulting from any practice should be justifiedt. l thus,-evem-at-tr4v4a4-4 eve 4s-ef-deser-the-prae 64ee-eems4dered-for l. exempt 4en-sheb4d-be-dust 4f4ed, As lower levels of radiation exposure are projected, should lower levels of benefit w(44 be needed required for practicejustification] Wewevert41nestablishingitspe44efes-the Gem 4ssien-w444-eent4mue-te-preh4b4t exemption policy, should the Comission exclude certain practices for which there.4s appears to be no reasonable justification! In considering proposals for exemptions, should the Commission evaluate the social acceptability of practices? Should the Commission determine a practice to be unjustified if nonradioactive economical alternatives exist? o Dose Limits and Criterion - Individual doses from practices exempted under this policy should not be allowed to exceed 100 mrem per year,.,5viney U* l This is the dose limit for members of the public specified in the final l-revision of 10 CFR Part 20, Standards for Protection Against Radiation. l The dose limits in the final revision of 10 CFR Part 20 apply to all l sources of radiation exposure under a licensee's control (natural backgroundandnedicalexpo,s,regareexcluded). u Because of the small risks involved, a 10 mrem, individual dose criterion is proposed as the basis for exemption decisions based on simple analysis and judgements. The Comission specifically. seeks comment on the need for establishing a ecliective dose limit in addition to an individual dose criterion. 7
a a ~+-a .~.,.a a =+ --a a s yfw _;.xL 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 approaches allowing truncation of individual dose in calculation of collective dose or weightino factors for components of collective dose would be appropriate? What alternatives should be considered-for assessing societal impact? l 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-4md4vidua4-and ee44eet4ve-dese which would in effect, delineate achievement of ALARA 2 without cost-benefit analysis. Although it is possible to reasonably proiect 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 degree of loss of control. The Comission believes that a key consideration in establishing a policy for exemptions, and subsequently in specific rulemaking or licensing decisions, is the pess4b444ty-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 [ specifically seeks coment on the issue. By appropriate choices of exemption criteria and through its evaluations of specific exemption proposals in implementing the policy, the Comission intends to assure that'it g unlike1( that any individual will experience exposures which exceed the 100 mIm imit. l IV. PRINCIPLES OF EXEMPTION L l p Gnee-a-praet4ee-4s-estab44 shed-es-dustif 4edr-4terg-there-4s-a-pes 4t4ve-net bene f 44-te-the-4 nt reduct ie n-er-u se-ef-rad 4eae t 4 ve-mat er4 air-t he-dee4 s 4en-of I-whether-er-net-the-ent4re-preet4eet-er-seme-def4med-subset-ef-the-praet4eer-4s e-eend4dete-fer-exempt (en A major consideration in exempting any practice fren regulatory control hinges on the general question of whether or not l-l- l 8 n. I 2
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} s. l application or continuation of regulatory controls are necessary and cost 1 L effective'in reducing dose. To determine if exemption is appropriate, the Comission must determine if one of the following conditions is met: i 1. The application or continuation of regulatory controls on the practice does not result in any significant' reduction in the 4nd4vidwe4-er-ee44eet4ve dose received by individuals within the critical group and by the exposed population or; 2. The costs of the regulatory controls that could be imposed for h-dose reduction to-redwee-the-4nd4v4dwa4-and-ee44eet4ve-dese are not balanced by the commensurate reduction in risk that could 1 i be realized. o .For purposes of implementing its policy, the Comission recognizes that vnly underunusualcircumstanceswouldpgagtic,eswhichcauseradiationexposures 7 ,j approach $ng' the 100 inrem)[mit be considered as candidates for exemption. The Cort 91ssion 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 members of the exposed population decrease, the need for regulatory controls decreases and the analysis needed to support a proposal for exemption can reasonably be somewhat simplified. At-a-suff4eient4y-4ew-4 eve 4 ef-a d4v4dwa4-r4ek -dee464ene-regard 4mg-exempt 4 ens-f 4 ert-whether-Al: ARA-has n t bee n-ae h 4 evee )-e a n - be -red we ed-te-e n-e va 4 w a t 4 e n-o f-whe t her -t he-e vera 44 -pub 44e P4sk-4s-suff4e4ent4y-sma44r The Comission therefere-preposes-that is evaluating the use of two numerical' criteria shew 43-be-esteb44shedindefiningtheregionwhereAl.ARAhasbeen achieved. The'y are (a) a criterion for the maximum individual annual dose reasonably expected to be received as a result of the practice and (b) the ee44eet4ve-dese-te-the a measure of societal impact to the exposed population. in-eemb4 mat 4ent tThese criteria are-ehesen are being 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 ir' pact. 9
g i u, Lf.' f ,8e4. \\ f I i If the individual doses from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared with other L societal risks. The Comission believes that annual individual fatality risks i below approximately 10-5 are of little concern to most menbers of society gg l I Previding for some margin below this level, the Commission proposes 10 mrem,as the level of annual individual exposure; below-wh4eh-AkARA een-be-demonstrated en-the-basis-that-ce44eetive-dese-4s-alse-suff4e4ent4y-sma44 The incremental anrual individual cancer fatality risk associated with an exposure level of 4 10 mrem per year is about 2x10 as indicated in Table 1 and of the order of 0.1 percent of the overall risk of cancer death. In evaluating the need for a The collective dose criterion 2 preposed-4s-499 g persen-rem-per-year-per-pract4eer--Adept 4en-ef-this-value-prov4 des-assuranee that-the-number-ef-4md4v4dve4-expeswees-et-e*-near-49-mrem-w(44-be-ne-mere . t h e n-a-few-t he w s a nd-p eep 4 e - a n d -t h e t -f o r -t h e-exemp t -p rae t 4 ee s -to-wh 4 eh-4 t - 4 s a pp 4 4 e d-a-f a ta 44ty-ameng-t he-expe s ed-pep w4 at 4en-wew4d-be-very-un44ke4y, the Comission recognizes that this criterion could be the limiting consideration for practices involving very small individual doses to very large numbers of peeple. 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 reoulatory concern level of 10 mrem per yeafto Ne lndYidual. '~ / Corversely, where the collective dose criterion would not be limiting, it would serve no purpose. The Commission requests comments on this issue, including coments on what the magnitude of the collective dose criterion, if any, shculd be. If the ee44eet4ve dose and-4md4v4dwa4-dese-fe44-belew-these-4 eve 4sr is less than the below reoulatory concern criteria, then the risk from a dvstif4ed practice 4s would be considered to be ALARA without further analysis. The Comission stresses that adoption of the 4md4v4dva4-and-ee44eetive-dese criteria should not be construed as a decision that smaller doses-belew these-er4ter4a are necessary before a practice can be exempted, while doses abcVe the criteria would preclude exemptions. On the contrary, the criteria sirply represent a range of risk which the Cu.dssion believes is sufficiently sma.1 compared to other individual and societal risks that a cost benefit are'ysis is not required in order to make a decision regarding the 10
p x x acceptability of an exemption. Practices not meeting these criteria may be w. granted exemptions on a case-by-case basis in accordance with-the principles embodied within this policy. To further eghasize the Comission's recognition ) that a rigid limitation on collective base-4s p se would be inappropriate, it notes that for some practices, such as use of smoke detectors, appreciable benefits can only be attained through extensive utilization and, hence, with a comensurate collective dose. The Commission is aware that existing regulations of the Environmental Protection Agency establish criteria more restrictive than exemptions which could otherwise be granted under this proposed policy. With regard to its own regulations, the Comission will evaluate whether there are exemption criteria embodied therein for which modification, according to the principles of this policy, would be beneficial. V. EXCLUSIONS FROM EXEMPTIONS The Commission's March 16, 1965, notice on the Use of Byproduct Material 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 possession and use of approved items from applicable licensing 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-seme-types-of Certain practices involving radiation or radioactive materials wh4eh-ares-pr4ma-fee 4er have been judged by NRC to be socially unacceptable regardless of how trivial the resulting dose might be and, therefore, sheuld-be have been excluded from exemption. Excluded practices wow 4d include, but net-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). Exelvs4 ens-would e be 4 Pe 4 ede-t he-purgesef u 4-a nd-f r 4 ve 4eu s-d4s tr 4b ut 4en-er-re 4eese-ef-rad 4eset 4ve 11
. - -. - ~ - Y mater 4a4s-where-there-are-elearr-eeenom4ea4-alternat4ves to sveh-use and-the b;; praet4ee-4s-net-fwst4f 4ed-beeavse-there are-no-wn(qwe-benef 4ts-from-us4ng-the "g red 4eact4ve-meter 4alst l In addition to socially unacceptable uses of radioactive materials, a question aise arises regarding uses where there are clear eccnomical alternatives, and no unique benefits exist from using radioactive material. Where risks are trivial, the regulatory prohibition of such uses could pose an unnecessary reculatory burden by interfering with the conduct of business. The Comission seeks coments on whether practices should be categorically excluded based on the Comission's judgement regarding social acceptability or the existance of alternatives. An alternative to categorical exclusion could be case specific determination based on a safety analysis. VI. PROPOSALS FOR EXEMPTION A proposal for exemption must provide a basis upon which the Comission can determine if the basic conditions described above have been satisfied. In general, this means that the proposal should address the individual dose and ee44eet4ve-deses societal impact resulting from the expected activities under the exemption, including the uses of the radioactive materials, the pathways of exposure, the levels of activity, and the methods and constraints for assuring that the assumptions used to define a practice remain _ appropriate as the radioactive materials move from regulatory control to an exempt status. 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 prerulgation of the rule would, under these circumstances, constitute a finding that the exempted practice is justified, and that ALARA considerations have bee-dealt with. This approach is consistent with past practice, e.g., consuner product rules in 10 CFR Part 30, 12
b t If -after-a-practiee-4s-determined-to-be-fust4f4ed-and a-simple-assessment T 4nd4eates-that-the-44hely-eensequenees-of-emempt4en-are-4nd4v4dve4-and-ee44ee 44ve deses-apprex4 mate 4y-equa4-to-or-4ess-than-the-eriter4a-values,-there-wov4d be-h4gh-44ke44 heed-that-the-app 44 eat 4en-wov4d-be seeepted by-the-Gemm4ss4en, In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered with regard-t. to thc Op tential t) hat some individuals may receive doses near the 100 mrem m r m yar t l ye,a r_ imit when doses from other practices are also taken into consideration. D If. exposures from multiple practices e e significantly beyond theindividualdosecriterion(10mreh, age,ugwgigh,theexempti$nwi without further analysis. As experience is gained, this policy and its implementation will be reevaluated with regard to this issue to assure that the exposures to the public remain well below 100 mrem.y y (/mSv r" year)- In addition to considerations of expected activities and pathways, the Cortnission recognizes that consideration must also be given to the potential 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 corditions in terms of individual and collective dose. Viir-GAkGWEATiGN-AN9-WSE-9F-GGkkEGTIVE-B9SE-ASSESSMENT Th e - e e 44 e e t 4 v e -d e s e - e a m - s e r v e - a s -b e t h - a -me a s u r e -e f-t h e - 4 mp a e t - f i v e r t -de t r 4me n t ) of-a-praet4ee-en-the-expesed-pepv4atien-and-a-mecham4sm-for-assess 4ng-the benef4ts-ef-regulatery-eenstra4mts-en-the-praet4ee-being-exempted-from regulatory-eentre4*--in-the-4atter-easer-a*menetary-Va4We-een-be-ass 4gned-te t h e -ee 44 e e t 4 v e - de s e - s e -t h a t -e e s t - b e ne f i t - a s s e s sme n t s - e a m - b e -ma de -w4 t h - re s p ee t te-the-usefu4 ness-ef-eentreis-er-eenstraints-en-a-practiee-te-further-reduce ee44eet4ve-deser The-Gemmissien-believes-the-assessment-ef-the-eempements-ef-teta4-ee49eet4ve dese-must-be-made-te-sat 4sfy-Net 4enal-Env4remmente4-Fe44ey-Aet-requ4rements, Hewevert-when-used-fer-eest-benef 4t-analyses-er-fer-eva4uet4en-aga4Pst-the ee4 eet4ve-dese-er4terien-prepesed-4m-this-pe44eyr-severa4-alternat4ve 13
l ~. W7:- 4 i app *esehes-een-a44ew-truneat4 ens-er-weight 4ng-feeters-to-be app 44ed --For example,-the-ee 44 ee t 4 ve -de se - 4 s -of ten -u sed-te-d 4 ser4minate-between-a 4 ternat ive s or-eptionst--The-ee44eet4ve-dese-4n-such-eases-shou 4d-be ea4eu4ated-to-the j; pe4nt-where-a-ehe4ee-between-opt 4 ens-4s-e4eart--Gemp4y4ng-w4th-th4s-requ4rement L w444-often-a44ew-the-traneat4en-of-the-ee44eet4ve-dese-assessment-4n-44me a nd /or-spe e e t -- A4 se,- 4 a rge-u ns e r t a 4 n 64 e s -a s s ee 4 a t ed-w 4 t h -do se r-pa rt 4eu 4a r 4y-a t 't very-4ew-dese-or-dese-rates-may-render-eertain-eempenents-of-the-assessment ne*-usefu4-4n-the-eemper4sen-of-alternatives,--Furthermorer-en-4nd4v4dua4-dese es t ef f-eeu 4d-a l se-be-ee n s 4dered-en-t he-ba s i s -tha t-t he -suma t ion-of-sma 44 4md4v4dua4-deses-ferger-4ess-than-Gr4-mrem-per-year)-represent-en-4ns4gn4f4eent see4ete4-risk-er-that-the-ee44eetive-dese-attributed-te-these-sma44-deses-4s l. Very-sma44-4n-eemper4sen-te-the-rema4n4ng-ee44eet4ve-dese-from-the-enempted p praet4eer--Fina44yr-very4ng-menetary-ve4mes-eeu4d-be-assigned-to-compements-of l ee44eet4ve-dese,-erger-64000-per-persen-rem-fer-ee44eet4ve-dese-eemposed-of 4md4v4 dual-deses-4n-exeess-ef-4-mrem-per-year-and-$400-per-persen-rem-for-4 ewer 4md4v4dua4-deses,--The-Gemissien-be44 eves-that-the use-of-ene-or-mere-of-the abeve-approaehes-eevid-be-apprepriate-depending-en-the-praet4ee-under-eens4 der 'at4en-fer-exemptien-frem-regulatery-eentre4r VIli. VERIFICATION OF EXEMPTION CONDITIONS The Commission believes that the implementation of an exemption under this bread policy guidance must be accompanied by a suitable program to monitor and verify that the basic considerations under which an exemption was issued remain valid. In most cases, the products or materials comprising an exempted practice will move from regulatory control to the exempt status under a defined set of conditions and criteria. The monitoring and verification program must therefore be capable of providing the Comission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being observed. The Commission will determine compliance with the specific cercitions of an exemption through its established licensing and inspection procram and will, from time to time, conduct studies as appropriate to assess the impact of an exempted practice or combinations of exempted practices. 14
l/bO /k U- .4 state et causeneer.-eeAttu Ane weteAat Aeswey hmnARTMENT OF HEALTH SERYlCES pQ3 DEP a>suset ' SacRAangeno, CA 9M14 p (9.16) 445-0498 L l To: Icoal Health Officers Envircenantal Health Directors b FICM Envircenantal Management Bran t 714 P street, Roasn 616 P. O. Box 942732 1 Sacramento, CA 94234-7320 sUB7B:T: selow Amplatory C2noern In response to qJestions frtz many of you, the Divircree.14 Management i Branch has prepared a position paper on the below regulatory concern (BRC) radioactive waste issue. Currently, there is no lower or " cut-eff" level balw which radioactive material could not be considered re;rdated radioactive waste, except sme l. lower levels for discharge into the sanitary newer systam. The purpose of a policy being considered by the U. S. Nuclear Regplatory c:nmissian 0m0) is to clearly define this lower level in a nanner consistant with current L envie.=eital regulations. The preposal by the NRC to set a lower limit en materials which wculd be censidered regrdated radioactive waste is not deregulation. Ic is a clarification of the point where the risk of health affects frutn radioactive material has been detartined to be minimalg g y.. w is known as risk based reqplaticn; it is not a new w @. .pc.h m kH. An attated position paper Mm-this issue in more detail. De staff are also available for consaltation. If yem have any questions regarding this natter, please call me at (916) 323-3019. Y' s 3. Enclosure
2 4 m j= EEtts umtnxmRY MCERN 10ME PQEmCH MPER l i The califomia Departaant of Health services (DIS) twirureantal mm;-- % acerch (me) has roomived several impiries fra local goverrmants iw.aiing a proposed adaragulation" of omrtain radioactive waste designated as "below regulatory conosm" (me). seen counties have, by resolution or cetiinanos, bemed dWi of ary low-level radioactive wastas, regardless of the minimal aucunts of radioactivity in acme wastas, prohibited acceptance of such wastas at county-operated waste d4W1 facilities. Their actions were taken in response to offorts by the L U. 5. maclear Regulatory Ozmission (NRC) to develop a consistant policy E on exemption of wastas fra regulatory control, DS has reviewed the county actions, the escisting radiation control regulations, and the NRC's www4 policy stataments. DS has also L reviewed the scientific litareture and the reoczimendations by the %dzad scientific ard medical organizations on the effects of exposure to ionizing radiation. Based on this review, DS believes that NRC's p s,--_x ' policy statement is consistant with the recoronandations of the scientific and medical organizations and is consistant with other risk based regulations. As such, DS sgports the w-r. of establishing a lower limit of cenaam for cartain radioactive wastas. BACIGROUb'D In 1980, Cw% s pamd the low-Laval Radioactive Waste Policy Act (LINPA), whid was amended in 1985. The Act was precipitated by conoam expressed by the three states (South Carolina, Washirgtan and Nevada), 1 facilities, that they were the with operating low-level wasta d_4& "du:tpire ground" for the nation's icw-level wasta. the runnining disposal capacity at these fa.111 ties was gaickly being depleted, but there were no new dW1 facilities under
- m. auction or in the plannirg stage anyWhere in the nation. The Act required the establishment and aparation of regional facilities for the dia:==1-of low-level radicactive waste.
The Act made each stata responsible for providing, either for itself or in coeparation with other states (in organizaticra celled ocupacts), for the dimi of low-level waste ganareted within the state or compact. In response to the Act, a number of carpacts were formed including the Southwestam ompact consisting of California, North Dakota, south Dakota
==1 site for this cartpact ard Arizona. % p.W low-level waste d4=:dastaly 25 miles west of is located in San Bernardino county, -wm i Nestles. The 1985 amendants regaired the NRC to establish stan$ards and sw.2dres within six months and to develop te&nical capabilities for considering and acting upon petitions to mounpt specific very low-level radioactive waste streans frtan regulaticas. The NRC not its charge to develop standards; the current proposal is in respense to its nardate to exer:pt cartain waste streams fim regulatory control.
1 ~ l'. the -califamia mediaticri control magulations (califamia case of d 4 L' Regulations (ccR), Title 17) as well as the lac regulations do rot speci f". a lower limit en the
- h. dan of radioactive unterial in lw-1 L
radiomative wasta. This absenos of a lower cutoff level requires the A4 1 of waste with any detectabla licensed relicactive material as loelevel radioactive wasta unless specifically emosytad by the L 'this lower level was ret intentionally left opent at the time these regulations were written, it was not possible to measure as low a level of radiation as is cassoonly done today. 'the lower limit was ( w#ad by J the measurement vi=='1t utilises. At the time these regulations were L issued (early 1960s), potentially contaminated items were considered l "clona" een they were "less than two times Wwand" as measured with hand-held survey instrumentation. '!he NRC w.hi to the 1985 requi.
- a. by issuing a Policy Statement on Radioac*.ive Wasta Balow Regulatory concer7 (IRC) on August 29, 1986. The policy statament contained 14 criteria whids taast be addressed in a petition regaesting h.yden.
The 14 critaria required that the petitioners denenstrate that the proposed activities will rot result in a. significant risk to an individual or to the general population, that the proposed activities will result in net benefit to the society, and that g the stLaty is based on actaal data fram study of iW'ide practices. These 14 criteria are 6.yv-W balew: u L 1. Di - =*1 and treatment of the vaste as specified in this petition will result in insignificant inpact on the gaality of the human envi - n. 2. '!he -!== expected effective dose equivalent to an iniividual I member of the public does ret exceed a few r.illirem per year for normal cperstions and anticipated events. 3. The oc11ective doses to the critical population and general M = tion are small. 4. The potential radiological ocnnequences of accidents or agaignent malfunction involving wastes and intrusion into di-==1 sites after loss of instituticmal control are ret significant. I 5. The emeption will result in a significant reduction in societal j l costs. - l 6. The waste is ocupatible with the preposed treatment and disposal options. 7. The exeeption is useful en a national scale, i.e., it is likely to be used by a category of licensees or at lanst a significant portion of a u,. 4 f. l 2
i 4: ? -l5+r ,~ - u' 8. 1he ndiological r W ies of the wasta stnam have been earectarised: on a national basis, the variability has been projected, ard the range of variation will not invalidate the opporting analysis. 9. The wasta charactarization is based on data en real wastes. )
- 10. The disposal ften of the waste has negligible W.i.ial for recycle.
- 11. -Licensens can establish effective, licensable, and inspectable programs for the wasta prior to tansfer to denumstrate aanplianoa.
- 12. - The offsita treatment or did medium does not need to be monitored for radiatico protection purposes. 13._ The methods ard reates uses to manage the wastes ard to assess 6 the impacts are no different from those that would be applied to the con +niing uncontamiratai materials..
- 14. There are no regulatory or legal obstacles to the use of the rvy ed treatment or disposal methods.
To provide a more censistant basis for eacunption, the NRC Comnissioners dire: tad the NRC's Office of Nuclear Regulatory Researt:h to expand the ERC L effort beyond sinply wasta disposal. This was to include the development of a broad policy on exenption from regulatory centrol for practices whose health and safety inpa t could be considered balw regulatory conoarn. The swy sd policy statament was published in the Federal Registar on December 12, 1988. l' UWE FnCF~u POLTcY EMMD?T ON EXDGTICH FEE PMfIA7tStY CnmtDL the "Damption frtan Regulatory 0:rstrol" policy defines the transition point at which the amount of radioactivity in a wasta material or prtduct represents auch a small. hazard (risk) that specific controls an not regaired of the next recipient of the material or product. The criteria stipulate that the. licensees establish effective, licensable, and inspectable programs, ard that the radiological impact be icw enough such that the offsite treatment or dispesal site does not need to be monitored. Regulatory ocntrol continues to be in effect on the generator of the antarial or product since that person is still bound by all the l regairements of the regulations ard tne specific license which prescribes the asthod of release of this material to others. l r L Deanptions frtan radiation control ruralations are not new. The following is a partial list of current exemptions: 1. There are tables of %L quantitles of radioactive material which a person, under certain cizouestances, can magaire, possess, use, transfar, cwn, or dim of without a license (CCR, Title 17 Section 30235 Schetale A). 1 3 l l
~ Juy-27-1ge9 14157* FROW. DHS ENV PGT BR44CH TO_ 914109722233 P.86 4 -s: i 4 S., 2. There 'is a blankst eenption for sedical wastes containing very small gaantities of ese radio-mclides used for in vitro testing, e.g., c-14, H-3, etc. (03t, Title 17 Section 30236 S & edule 3). 3. There are ensuptims for esospeed radioactive materials whie are eeninistered to patients as a part of medical diagnosis anyor therapy and h*=1 ped into sanitary eswer systes (05t, Title 17 Section 30247(b)). 4. 1here are tables of canoentrations of radioactive materials below which a possemear of licensed radioactive natorials any release these materials into the annitary sewer system (cat, Title 17 o Section 302G7(a) and 30355 Appendix A). 5. Other exenptions allow distribution of censumer products or other { devices whis contain radioactive material to the general public (i.e., smoke detectors, wat &es, optical
- epm, static i
eliminators, exit signs, gas lantern aantles, etc.) (0:R, Title 17 Section 30180). 6. There are case tr<mse eqdons granted by D15 after determination that there will not be a public health inpact (CCR, Title 17 Section 30104). NRC's proposed policy statement is intem$ed to enocupans all-exerpted activities, including the distribution of consumar products, under one uniform set of critaria. The critaria for exemptions proposed are: 1. .7ustification of the ' practice, which requires that there be a net benefit resulting fra the use of radiation or radioactive material; 2. Dome limits, which define the q:per boundary of adequate protection ' for members of the public whie should not be exceeded in cxrdact of nuclear activities; and l 3. AIARA, which requires that radiation dose shall be As' Iow As amasonably Achievable (AIARA), provides for soonemic and social factors to be taken into acomunt. i j Under no circumstance will practices such as intentional introduction of E radioactive material into toys and products intended for ingestion, inhalation or direct application to skin be emnopted. 2HE RISK BMED RMUIATIWS the basis for the safety regulations,m-M policy statment is that, as with all other the regulatory control should be connensurate with the level of potential risks. Mhare there is little or no risk to an iniividual or to the general public, it is appropriate that there should be minirum regulation. CNer-reirulation would divert regulatory resources fra other higher priority work. 4 l
my; -g rm - ....n.,<- Y
- 4..
Q The radiation centrol segulations were erected to protect radiation ", l. weehere and the ganaral public frien potertially hartaful effects of sediatian. Ikamrver, same radiation anarcas have not been subject to regulatory control, either because they are not. emanable to control (souh as natural bedspround radiation), or kannuma they represent such a low hasard that the regulatory effort cannot be $ustified. Other regdatory egsreies have also applied the "-tion trem regnatory controla concept in their cwn risk based regulations. the twiaw e.a1 Protection 's tauicity test for certain chemical and artal contaminents wastas define levels below eich the waste is no 1 considered toxic and therefore is not considered hasaresas wasta Departaart of Transportation has set lower limits for concentration of radioactive natorial, below Wich it no longer considers the antarial radioactive. The NRC's i.M anxiasan irdividal radiation dose limit for an h/dble activity or practice is 10 minirun par year (one chest X-ray is equal to ab:st 20 milliruu 1 transcontinental flight adds about 10 tilliam to an iniividal's cost.ic ray eMposare). NRC derived this limit bened on the evaluation of the rulemaking proomsses by other regulatory agencies and the rveisw of the racemnandations frurn wall respected scientific organisationa. In a normal rulemakirq process, it is aarmed that the annal individal fatality risk below one in 100,000 is of little conomrn to nest nectiers of the society. This risk 1real by itself nay seen high until it is cor1 pared against the other socially acoopted risks. The 10 millirm par year limit was derived based on considerations of the follcuing factors: 1. Linear dama response modelt For the purpoem of radiation protection, it is accepted that a lowar dose leads to lower risk of harr.. '!his is the mest conservative of the currently m-::d models for radiation dose resy.iae. This model estinatas that there is 0.0002 risk of fatal cancer par parson-run of radiation dose. A person-ram is equivalent to one person receiving 1,000 milliturn, or to 1,000 pareens reoniving one millirm. 2. Amosptable societal risk: Frtan the linear done response arreal above, it was detarzinm3 that the radiation exposare level of about 10 milltrum par year, eich is eqpal to a risk of about two in one minion, is an moneptable risk lem1. This risk level is taken fran the Ir.tarnational crmr4 anion on Radiation Protection, Publication No. 26 (Annals of the ICRP Vol.1 Ho. 3). The 10 milliran par year ** dose limit is about 8 of the average background radiation done. The average annal par-capita niiation dose frtra natural and samade ocuroes (oosmic ray, natural radicartivity in soil, kuildfigs, feod, air and water) is about 300 r,illiren. The level of exposure tae to an exeytad a::tivity to any one iniivital is no Icw that 5 l i
Gx \\ h
- j it will ret be pensible to esparate it cast from the engeoted statistioni l
fluotnastions in the hedgetmand radiaticm level. i net 2ieaer to nn: sTME or mLmann marzently, there are abonat 1,100 licensed institutional (escols and I hospitals) and about 1,200 licensed itubastrial users of radiation and radioactive antarials. Additionally there are six pressurised water ranclear reactors generating electricity an$ one boilurg water reactor awaiting hianiming in California. l Because of the large industrial base of radioactive estarial users in California, the industrial users genersta nearly half of the total low-level waste volume, and the largest traction (to to 95 percent) of the l total activity in low-level waste.1he utilities, the escols and the i hospitals ganarate the roaminder. The availability of the icw-level wasta I dimw= mal C4pacity is critical to the Viability of M AFMRQstries, 3 Cst l heepitals, schools and the utilities. Without the m.pdon frtza radiation control. regulations for very Icw-level waste, the industries, the s & ools, the hospitals and the utilities in onlifomia will be faced with an increased operational cost. The future Scuthwestern cecpact low-level vaste facility will be faced ^ i with redaoed operational life, and the Ctzpact may regaire a new MM facility years socnar than anticipated. l Dans on ERC are egacted to be inpractical to enforce. Monitoring sanitary newers, for exanple, will be a senumental tank if it becomes neossanzy to ascertain that no radioactive petarials enter the systam. M Radiation is a highly anotional issue. %en dealing with potential risks outside of one's control or experienoa, it is easy to lose perspective en the meaning of the potential risks expressed in obtuse mathematical probabilities. However, in order to seku a rational, scand judgment on i safety mattars, it is critical to make a distinction between an activity with significant risk and an activity with risk ss Icw that any effort to control it is not justified. The NRC's pt-- M policy statanant on aseseption fra regulatory centrol is an attempt to take that distinction between an acceptable risk and a risk W i e must be centre 11ed. NRC's rW policy statament is consistant with the turenendations of scientific and undiomi t organizations and is consistant with other risk based regulations. The rW policy is not a change, but a clarifiantion of limits in a technoicgically advarcing world. I ( 6 l i ,..-L~.- , - -,.,., -}}