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APR 101989
'MEMEANVUM FOR: Thomas E. Murley, Director, Office of Nuclear Reactor Regulation Robert M. Bernero, Ofrector, Office of Nuclear Materials Safety and Safeguards Harold R. Denton, Director. Office of Governmental and Public Affairs-William C. Parler, General Counsel FROM:-
Eric S. Beckjord, Director, Office of Nuclear Regulatory Research
SUBJECT:
PROPOSED COMMISSION POLICY STATEMENT ON EXEMPTION FROM REGULATORY CONTROL The staff is expected to submit the subject proposed policy statement for Commission consideration by June 2, 1989.
This schedule necessitates submission of a Commission paper to the EDO by May 19, 1989.
In order to meet this schedule, RES rrust receive comments from affected Offices and resolve -
outstanding' differences in an expedited manner.
In order to move forward to accomplish this task, the RES staff-has prepared a preliminary draft proposed policy statement which is attached as Enclosure 1.
This draf t has included consideration of coments received (1) at the October 1988 workshop of regulator 12,1989, and (3) y authorities (2) from the public meeting held January through.the 220 coment letters received in response to the solicitation made in the December 12, 1988 Federal Register Advance Notice. We are.also using.this preliminar the U.S. Envirot-ental Protection Agency (y draft policy in discussions withEPA) to iden
-Our objective is to identify any outstanding issues, not only with EPA but among NRC Offices, so that the colicy statement can be revised as eppropriate.
In parallell with Office review, RES intends to complete a package which will (11 sumarize comments received on the advance notice proposal and (2) provide proposed Comission responses. To assist you in your review, Enclosure 2 contains responses to EPA coments while Enclosure 3 provides a sumary of the major comments received in response to the advance notice.
I request that written Office coments or concurrence on the enclosed policy statement be submitted by April 28, 1989. RES is, of course, mainly interested 1
in comments on the major policy principles and criteria, but we would welcome any suggestions for editorial changes you may find appropriate.
The contacts within the Offices who have, to date, assisted in the development of this policy l
are listed below:
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Eric S. Beckjord, Director Office of Nuclear Regulatory Research
Enclosure:
1.
Prelim. Draf t Prop. Pol. St (ement 2.
Responses to EPA comments N
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Sumary of Major Comments Received L
P "wnonse to the Advance Notic l
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particularly in documenting the changes you propose.and the reasons for them, would be appreciated.
ORIGINAL SIGN 3D IT Eric S. Beckjord, Director I
Office of Nuclear Regulatory Research
Enclosure:
1.
Prelin. Draft Prop. Pol. Statement j
2.
Responses to EPA-coments 3
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Summary of Major Comments Received s
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J. M.-Taylor. OEDO H. L. Thompson, Jr., OEDO I
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l APR I 9 jgg MEMORAN0lM,FOR: Thomas E. Murley, Otractor, Office of Nuclear Reactor Dimetor, Office of Nuclear Materials Safety and Safeguards Harold R. Denton, Director Office of Governmental and Public Affairs William C. Parler, General Counsel
-FROM:
Eric S. Beckjord Director, Office of Nuclear Regulatory Research
SUBJECT:
PROPOSED COMMISSION POLICY STATEMENT ON EXEMPTION FROM REGULATORY CONTROL I
u The staff is expected to submit the subject proposed policy statement for Comission consideration by June 2,1989. This schedule necessitates l~
submission of a Comission paper to the ED0 by May 19,1989. In order to meet this schedule, REE must receive comments from affected Offices and resolve L
outstanding differences tri an expedited manner.
4 In order to move forward to accomplish this task, the RES staff has prepa md a preliminary draf t proposed policy statement which is attached as Enclosure 1.
This draft has included consideration of coments received (1) at the October 12,1989, and (3) y authorities.-(2) from the public meeting held onthroug 1988 workshop of regulator January to the solicitation made in the December 12, 1988 Federal Register Advance Notice. We are also using this preliminar the U.S. Environmental Protection Agency (y draft policy in discussions withEPA) t
.Our objective is to identify any outstanding ' issues, not only with EPA but among NRC Offices, so-that the policy statement can be revised as appropriate.
In parallell with Office review, RES intends to complete a package witch will i
(1) sumarize coments received on=the advance notice proposal and (2) provide proposed Commission responses. To assist you in your review. Enclosure 2 L
contains responses to EPA coments while Enclosure 3 provides a stamary of the L
major coments received in response to the advance notice.
I request that written Office coments or concurrence on the enclosed policy statement be submitted by April 28, 1989. RES is, of course, mainly interested in coments en the major policy principles and criteria, but we would welcome any suggestions for editorial changes you may find appropriate. The contacts within the Offices who have, to date, assisted in the development of this policy are listed below:
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R. Cunningham D. Cool K. Dragonnette NRR F. Congel' L. J. Cunningham OGC 'r R. Fonner SPA K. Schneider In early May, a meeting will be scheduled with the ED0 to discuss any RES disposition of Office coments'on the major policy issues.
Your efforts.
particularly in documenting the changes you propose and the reasons for them, would be appreciated.
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Eric S. Beckjo
, Director Office of Nuclear Regulatory Research j
Enclosure:
1.
Prelim. Draft Prop. Pol. Statement 2.
Responses to EPA coments
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3.
Summary of Major Coments Received L
in Response to-the Advance Notice cc:
J. M. Taylor. OEDO
-H. L. Thompson, Jr., OEDO L
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v 4D PRELIMINARY RES DRAFT I
Proposed Commission Policy on Exemptions from Regulatory Control 1.
INTRODUCTION AND PURPOSE Over the k[st siveral years, the comission has become increasingly aware of the need to pmvide a general policy on the appropriate criteria for release of certain radioactive materials from the full extent of existing regulatory The first The need has been driven by two recurring realizations.
controls.
is the recognition that, for certain practices involving minimal public health and safety concerns, the imposition of undue and unnecessary regulatory controls could prohibit a practice which should otherwise be permitted because of reaso social, economic, or industrial benefits. The second results from the nation's focus on fiscal responsibility and the knowledge that resources expended for '8j regulatory control of practices with minimal radiological impacts could be
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To better used to address more significant radiation protection concerns.
address this need, the Comission is expanding upon its existing pof fey for protection of the public from radiation, currently expressed in existing regu (Title 10, Code of Federal Regulations) and policy statements (30 FR 3462, Use of Byproduct Material and Source Material (Consumer Products % dated Mar 1965; 47 FR 57446, Licensing Requirements for Land Disposal of Radioactive j;
27,1982; and 51 FR 30839 General Statement of Policy Waste, dated December and Procedures Concerning Petitions Pursuant to i 2.802 for Disposal of Radi Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion includes the development of an explicit exemption policy for those Commission-regulated practices which involve minimal public health and safety impacts.
The Comission, however, recognizes the benefits of uniforin regulation and -
therefore, supports the development of broader Federal Guidance regarding In doing so, the Comission realizes that, when signed by.
exemption policies.
the President, the Federal Guidance could supplant this policy.
In this policy, a practice is defined as an activity or a set or combination of a number of similar sets of coordinated and continuing activities aimed at a Disposal of given purpose which involve the potential for radiation exposure.
very low level radioactive waste; the release for unrestricted public use of lands and structures with residual levels of radioactivity; the distribution, use, and consumer products containing small amounts of radioactive material
and tho' recycle and reuse _of residua 11y conta:inated materials and equipment: Asm8. R
.i are'exemplesofclassesofpracticesforwhichthispolicyisjudgedtohave h
potentialappUtability.'I is the Commissien's intent to broadly define L
specific practices in terms whic ill preclude any individual or population being sienificant1.y affected by sistla ices within a given class while, W g
at the same time, identifying and describing the pra n terms which will L
facilitate. reasonable impact analyses and allow taposition of ap ate constraints as the radioactive material passes from controlled to exempt statu,
Under this' policy, the definition of a " practice" is a critical feature which will assure that the formulation of exemptions from regulatory control will not I
allow deliberate dilution of material or fractionation of a practice for 'the The purpose of circumventing controls that would otherwise be applicable.
definition will also provide the framework for taking into account the possible i
consequences of accidents or misuse associated with exemption decisions.
The purpose of this policy statement is to establish the basis upon which L
Commission may initiate the development of appropriete regulations or make Ifeensing decisions to exempt from regulatory control persons who receive.
This possess, use, transfer, own, or acquire certain radioactive material.
policy is directed principally toward rulemaking activities, but may be applied to license amendments or licen:.e 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 emphasize that this policy does not assert an absence or threshold of risk but rather establishes a baseline where further government regulation to reduce risks is unwarranted.
I The concept of regulatory exemptions is not new. The Atomic Energy Act of L
1954,'as amended, authorizes the Comission to exempt certain classes, quantities, or uses of radioactive material when it finds that such deregulation will not constitute an unreasonable risk to comon defense and In 1960 and 1970, the security and to the health and safety of the public.
Comission used this authority to promulgate 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 2
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public. or allering releases of radioactive material to the environment, have -
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been embodied)fh the Commission's mgulations for some ties. For example.
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regulations currently specify conditions under which licensees are allowed to-L dispose of radioactive material into a sanitary sewer system (Title 10. Code of Federal h guletlons. Part 20, Section 303). That is, the regulations specify requirements which a' licensee must meet if radioactive material is to be
transferred" from a controlled to an uncontrolled status.- More recently.
L Section10oftheLow-LevelRadioactiveWastePolicyAmenhentsAct(LLRWPAA) of 1985 directed the Commission to develop standards and procedures for I
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expeditious handling of petitions "...to exempt specific radioactive weste streams froin. regulation... due to the presence of radionuclides... in 4
i' sufficiently low concentrations or quantities to be below regulatory concern The Connission responded to this legislation by issuing a policy statement i August 1986 (51 FR 30839). Thatstatementcontainedcriteriawhich,jf I
satisfactorily addressed in a petition for rulemaking, would allow the f
Cosmission to act expeditiously in proposing appropriate regulatory relief on a
" practice-specific" basis consistent with the merits of the petition.
The Commission believes that these " practice-specific" exemptions should be encompassed within a broader NRC policy which defines levels of radiation risk l
- below which specified practices would require only minimal, practice-specific NRC regulation based on'public health and safety interests.
For such.
practices, the Connission's regulatory involvement-could be essentially limited to licensing, inspection, and compliance activities associated with the transfer of the radioactive material from a controlled to an exempt status.
That is, the Commission would define constraints which must be adhered to by NRC licensees if radioactive material is to be transferred from a controlled to an uncontrolled or exempt status.
The Consission recognizes that, if a national policy on exemptions from regulatory control is to be effective Agreement States will play an important implementation role. Pursuant to the LLRWPAA, States am responsible for
- providing, either alone or in cooperation with other States, for disposal of certain low-level radioactive wastes.
In the past States have been encouraging findings that certain wastes are below regulatory concern and the 3
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Cassission believes that States will suppurt the application of a national policy on exemptions for specific practices involving distribution or release of radioactive.hsterial. The Commission intends also that rulemakings Coenission believes that States will support the application of a national policy on exemptions for specific practices involving distribution or release
-of radio $dtive material, The Commission intends also that rulemakings codifying exemptions in all areas will be made a matter of strict compatibility Consequently, any rulemakings that evolve from this for Agreement States.
policy will be closely coordinated with the States.
The Commission recognizes that-its policy will potentially have a significant The approach and impact on nuclear regu ation in the international community.
criteria in this policy differ in some respects fess those selected or under consideration by other countries.
It is the Commission's intent to continue its dialogue with the international community in order to resolve, or foster mutual understandings of the rationales behind, differences in exemption policies.
II. RADIATION PROTECTION PRINCIPLES The Three Fundamental princioles of Radiation protection The Commission recognizes that three fundamental principles of radiation protection have historically guided the formulation of a system of dose limitation to protect workers and the public from the potentially harmful They are (1) justification of practice, which requires effects of radiation.
that there be some net societal benefit visu1*.ing from the use and disposition of radiation or radioactive materials (2) dose limits, 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 The tets, ALARA, is an acronym for As Low As factors being taken into account.
is Reasonably Achievable.
Dose-Estimation In estimating the dose rates to members of the public that might arise through the use of various practices for which exemptions are being considered, the f
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P Commission has decided to apply the concept of-the ' effective dose equivalent."
This concept, which is based on a comparison of the delayed mortality effects of ionizing rediation exposures, permits through use of weighting factors, the This calculation of-'the whole body dose equivalent of partial body exposures.
approachwasproposedbytheQnternationalCommissiononRadiological Protect & in its Publication 26, issued in 1977. Since that time, the concept has been reviewed and evaluated by radiation protection organizations throughout the world and has gained wide acceptance.
Estimatino Health Effects From Radiation ExDosure 4.
Individual Risks In the establishment of its radiation protection policies, the Cosatission hasconsideredthethreemajortypesofdelayedhealtheffectswhichcan}
be caused by exposures to radiation: cancer, genetic effects, and developmental anomalies in fetuses. Regulatory agencies, including the This is done NRC, focus on the risk of fatal cancer development.
(1) the best data principally because, at relatively hiah radiation doses:
base exists for cancer mortality. (2) the mortality risk represents a more severe outccme than the non-fatal cancer risk and (3) the' mortality risk is higher than the risk associated with genetic and fetal effects, However, even though radiation has been shown to be carcinogenic, the
. development of a risk factor applicable to continuing radiation expcsures I
at levels equal to or far below natural background roquires a significant extrapolation from the observed effects at much higher doses.2 The result is a significant uncertainty reflected by the views of experts in the field. For example, the National Academy of Science's Committee 'on the Natural background radiation can vary with time and a person's location.
In Washington, DC natural background radiation (excluding redon) results 1
in individual doses of about 90 arem per year, while in %nver, Colorado the value is about 160 mrem per year including, in both cases, a 4 '"""'
contribution of about 40 mese per year from natura1gradioactivity contained in the human body.
The health effects clearly attributable to radiation have ocurred principally among early radiation workers, survivors of the atomic bomb 2
explosions at Hiroshima and Nagasaki, individuals exposed for medical Natural background causes a dose over a purposes, and laboratory animals.
one year period which is at least two orders of magnitude less than the dose received by populatforis from which the cancer risks are derived.
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> Biological Ef ects o d involve a large degree of f
. values att "... based on incomplete data an This Committee also hf ;Ak uncertaint), especially in the low dose region."
stated.that it "...does not know whether dose rates of gas f
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are detrimental to man."
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.:n Q '"? c' th e M sf W ;;;..fons, the NRC, the Environmental t, e.o d international radiation l
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. Protection Agency, and other national an defining protection authorities have estabitsbed radiation standards l members or recomended dose limits for radiation workers derived the value presumed to apply at lower dose and dose rate the public.
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is-values derived at higher doses and dose rates. The extrapo at o frequently referred to as the no-threshold hypothesis, i faced The Comission, in the development of an exemption policy, is with the issue of how to charactertre the individua t i ties are associated with low doses and dose rates. - Although the unc i
large, useful perspective en the bounding risk associated b
low-levels of radiation can be provided by con threshold. hypothesis.
i d with in establishing individual and collective dos this policy.
l higher potential risks
. practices can be compared to the relative y NRC has associated with other activities or decisions over regulatory responsibility.
f its licensees, assure that its radiation protection resources and those o health and are expended in an optimal manner to accomplish its public L
safety mission.
the no In this context, the risk to an individual, as calculated usin L
d levels of annual threshold model, is shown in Table 1 for vario
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individual dose.
i d during further assumption that the annual dose is continuously rec
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each year.of a 70-year lifetime. To provide further perspective, s.
radiation dose of 10 mrom per= year (0.1 m5v per year) received continuously over s' lifetime corresponds to an estimated hypothesized
' increase of about 0.255 in an individual's lifetime risk of cancer death.
"'-4 Table 1 Hypothesized Hypothesized Incremental Incremental Lifetime Risk from 2
2 Annual Dose Annual Risk Continuine Annual Dose I
5 x 10-5 3.5 x 10*3 100 mrem 10 mrem '
5 x 10-6 3.5 x 10~4 5 x 10~7 3.5 x 10-5 1
mrem 5 x 10-8 3.5 x 10-6 0.1 mrem IUnless otherwise indicated, the expression of dose in arem refers to the Total-Effective' Dose Equivalent. This terin is the sum of the deep dose equivalentfor-sourcesexternaltothebodyandtheconnittedeffective}
dose equivalent for sources internal to the body.
2 Risk coefficient of 5 x 10 ~4 p r m for W lin ar o g transfer radiation based upon BEIR V. g g
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Collective or Pooulation Risk In the application of the fundamental principles of radiation protection, collective dose provides a useful way to express the radiological impact (i.e.. potential detriments) of a nuclear activity on the health of the population subject to radiation exposure. 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 p
in comparative cost benefit and other quantitative analysis techniques.
It is therefore an important factor to consider in balancing benefits and
..%f societal detriments for practice justification and in the carrying out of w~+ '
h[h ALARA dete4minations. The NRC has used collective dose in this manner in a number of rulemaking decisions and decisions involving resolution of a variety of generic safety issues.
Derivation of Measurable Quantities from Dose / Risk-Estimates The Comission recognizes that it is impossible to measure risk to individuals or populations directly, and, that in most situations, it is impractical to 7
. : measure annual-doses to individuals at the low levels ~potentially associated 5h.-
n,. c, with its exemption decisions. Typically, radioisotope concentrations or radiation leven from the material to be exempted are the actual measurements that can be made, and doses are then estiasted by exposure pathway analysis combined with other types of assumptions related to the ways in which people f
might bec6me exposed. Under such condi.tfons, conservative assumptions are g,,/ frequently used in modeling so that any actual dose would he expected to be
/.c ;' lower than the calculated dose. The Comission believes that this is the
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appropriate approach to be taken when detemining if an exemption from a
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regulatory controls is warranted.
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!!!. APPLICATION OF RADIATION PROTECTION PRINCIPLES TO EXEMPTIONS FROM REGULATORY CONTROL The following sets forth guidelines about how the Commission will apply the fundamental principles of radiation protection in consideration of practices.'
which are proposed to be exempt from certain regulatory controls. These l
practices, if approved, would result in low levels of radioactfve asterial in products being distributed to the general public and radioactive affluents and i
solid waste being released to areas of the publically-accessible environment.
Justification - Decisions regarding justification of practice usually derive from considerations which are much broader than those based on radiation protection alone. Therefore, these decisions may be made in a broader context before the need for regulatory control is addressed (or the need for exemptions from certain aspects of control, as addressed in this policy). The Comission continues to believe that any practice causing a' potential radiation exposure should be justified; however, as lower levels of indfvfdual and population dose are projected, lower levels of benefit will be needed to achieve a positive balance although other societal impacts of a practice must also be considered. The Cossnission will continue to identify or characterize certain practices for which benefits are l
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justift. cation. -
yte Dose Limits - Individual doses'from practices exempted under this
. -f policy-should generally not be allowed to exceed a small fraction of-
~ *190 mrom. per year (Im$v per yeaE). This is the non-occupational dose i
limit recomended by the International Comission on Radiological Protection and the National Council of Radiation Protection and l
Measurements for continous exposure from man-made sources of radiation other than medical.
It is also.the value.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 kJ
- apply to all sources of radiation exposure 'under a Itcensee's contre 1' (natural background and medical exposures are specifically excluded ALARA-Onceapracticehasbeenjustifiedandcontrolsareinplacd to assure that dose limits are not exceeded, it is necessary to L
design and plan the. subsequent use and disposal of the sources of n
l radiation in a manner which ensures that exposures are as low as
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l reasonably achievable, economic and social-factors being taken into-L account. As a result. this principle applies when considering a
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practice for possible exemptions from some or all regulatory controls. This requirement that doses be ALARA has been a part of
.NRC regulatory practice for a number of years and is now.femally embodied in the revisions to Title 10. Code of Federal Regulations.
Part 20. However, no policy or criteria have been provided which would establish the bases for defining a generic
- floor" to ALARA. A major purpose of this policy is to establish criteria which'would delineate when further regulatory and licensee resources need not be spent to further reduce radiation exposures from a practice for which L
an exemption decision is being considered.
1 Although it is possible to 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 involve a reduction or elimination of some or all controls.. In view of this, the Comission believes 9
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that a key objective in establishing a' policy for exemptions, is to provide adequate assurance that individuals will not experience radiation exposure-l approaching 100'erem per year (1mSv per year) through the cumulative effects of f
. more than one exempted practice even though the e.xposures from any single p
exempt practice would be expected to be a saml1 fraction of this value. By L
appropriate chojces of exemption criteria and constraints, and through its evaluations of specific exemption proposals, the Commission intends to assure that it'is unitkely that any individual will experience continuing exposures which approach or exceed 100 arem per year (1mSv per year) from all exempted practices.
L IV. PRINCIPLES OF EXEMPTION A major consideration in exempting any practice from some or all regulatory
- controls. hinges on the general question of whether hnet' application or j
continuation of regulatory controls s'rie'necessary and cost effective in L
reducing dose. To determine if exemption is appropriate, the Commission must
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determine if one of the following conditions is met:
E 1.
The application or continuation of regulatory controls on the practice does not result in any significant reduction in dose i
received by individuals within critical groups and by the exposed L
population or; 2.
The costs of the regulatory controls that could be imposed for dose reduction are not balanced by the connensurate reduction in risk that could be realized.
l For purposes of implementing its policy, the Consission recognizes that only l
under unusual circumstances would exemptions be considered for practices which could cause continuing radiation exposure to individuals exceeding a small fraction of 100 mrem per year (1mSv per year). The Consission 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 i
to members of the exposed population decrease, the need for regulatory controls l
decreases and the analysis needed to support a proposal for exemption can l-10 l
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. reasonably be somewhat simplified. At a sufficiently low level of individual risk, decisions justifying the distribution to or use of radioactive material by individuals hot controlled by NRC licenses, or decisions granting specific exemptions-from regulatory control for a justified practice may be reduced to an evaluation of whether the overall individual and public risk is sufficiently-small. "
The Commission therefore proposes that two numerical criteria should be
. established in defining the region where the risk reduction does not warrant the expenditure of Commission or licensee resources,to bring about a further incremental compliance with the ALARA principle. They are (a) a criterion for the maximum individual annual dose reasonably expected to be received as a result of the practice and (b) a measure of societal impact to the exposed population.
In combination, these criteria are chosen to assure that, for a,
given exempted practice, no individual will be exposed to a significant f
radiological risk and that the population as a whole does not suffer a significant impact.
The Individual Dose Criterion If the individual doses from a practice under consideration for exemption are j
sufficiently small, the attendant risks will be small compared to other
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societal risks and the merit of expending resources to further reduce the dose or risk from a justified practice can_be seriously questioned. The Commission believes the definition of this risk or dose level can be developed from two perspectives. The first is the risk perspective. The Cossnission believes that most members of society will not expend resources to reduce an annual.
individual fatality risk below approximately 10-5 (i.e., I chance in 100.000).
This risk level is comparable to that (i.e. 2x10 )selectedbytheCommission in the development of its safety goal policy - (i.e., a risk level equal to 0.1%(1/1000) of the sum of cancer fatality risk from all other causes). Using the no threshold hypothesis, the incremental continuing annual individual exposure level associated with this " safety goal" risk level can be estimated as 4 mrem per year. The second perspective is based on those variations in dose tolerated by individuals because of ' actors'such as their lifestyle or f
place of residence. The Comission notes that resources are not expended to 1
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e reduce differential exposures associated with variations in natural background l
radiation (e.ga.'the 70 mrom per year difference between annual doses received in Denver, Colo' ado vs Washington DC). Nor are resources spent to reduce the l
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Lh 7-10 mrom dose which an individual would receive during a single round trip coast-to-coast aircraft flight or the dose from other activities which involve h
doses rejifesenting'a small fraction of background radiation.
,1 In view of the uncertainties involved (such as, the applicability of the no-threshold model itself and its input data) and taking into account the results of analysis from both the risk and dose perspectives, the Commission finds an-individual dose of 10 mrem per year to be appropriate for use as one I-of two boundary criteria which would define whether or not additional resources need be spent to comply further with the ALARA principle. The Commission considers this value to be appropriate given the uncertainties involved and notes-that, at this value, implementation of this policy in future tvlemakingsk I
~
or licensing decisions shou 1d be a practical undertaking.
The Societal impact Criterion g
In proposing criteria which would demonstrate practical achievement of ALARA.
the Consnission ' seriously considered whether the imposition of the individual dose criterion would also provide a sufficient meas ue to judge societal impact, and.- thus, could stand alone as a basis for detemining when further resources need not be expended to further comply with the ALARA principle. The Conurission finds that the individual dose criterion should not stand alone and believes the need for a companion collective dose erf terion has two bases.
First, these criteria are being put forward as a means of demonstrating l
practical compliance with the ALARA principle. The ALARA process involves, b
among other considerations, the trade-offs between cost of dose or risk reduction and the magnitude of the reduction in population dose achieved.
Furthermore, since the individual dose criterion is not claimed to represent 'a negligible or de minimis individual dose, the sum of the individual doses from a given practice cannot be considered negligible.
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Second the Commission believes a collective dose criterion is necessary to
. rovide reasonable assurance that total doses to individuals from all exempted p
practices wil1@ot approach 100 mrom per year (1m5v per year). This
[
consideration specifically applies to the potential exposure of some few l
individuals to multiple practices and in particular to those practices or classes if practices involving potential widespread.' direct distribution of radioactive material to members of the public (i.e..' in the fom of consumer.
products, or recycled equipment or materials containing residual levels of l
radioactive contamination). The Cossnission notes that-the uncertainties in
. establishing reasonable scenarios through which the public may interact with these products, equipments or materials, creates unchrtainty in the calculation 4
of individual doses, and as a result argues for a compensatory prevision of collective dose as a matter of regulatory prudence. Furtherwore, for these practices, effective dose reductions may be possible at relatively saal1 costs.
As a result, a practice must also result in a collective dose of less than 50f person-rem per practice per year in order for the Cosatssion, based on these I I
criteria alone, to agree that further resources need not be expended to comply.
with the ALARA principle.
The Comission stresses that adoption of the individual and collective dose criteria should not be construed as a decision that doses below these criteria j
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 further cost-risk reduction analyses, or more broadly, ALARA analyses) are not required in order to make a decision regarding the acceptability of an exemption, practices not meeting these criteria may be granted exemptions on a case-by-case basis in accordance with the principles embodied within this policy. To further emphasize the Commission's recognition that a rigid limitation is inappropriate, it notes that for some practices, such as use of smoke detectors, collective doses have been estimated to exceed 500 person-rem per practice per year, yet appreciable benefits can only be attained through extensive utilization and, hence, with a commensurate collective dose.
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The Commission is aware that existing and future regulations of the Environmental Pestection Agency for environmental protection (e.g.. the Clean AirAct) mayo';tablishcriteriaforspecificpracticessorerestrictivethan e
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exemptions which may be granted under this proposed policy. Any affected NRC regulations developed on the foundations of this policy may need to be reviewed i
g and. if necessary, revised, to ensure compatibility. With regard to its own regulations, the Cosnission 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 Since it is not possible to foresee every possible use of radioactive material that may be proposed in the future, the Commission does not believe'it is possible to prejudge any class of practices as innately unjustiffable. I.'
However, the Cosmission continues to believe that there are certain classes oS' practices involving radiation or radioactive materials which potentially have little or no benefit to society (e.g., consistent witii the policy statement on consumer products. March 16, 1965. 30 FR 3462). These practices could include.
1 but.are not be limited to, the intentional introduction of radioactive material into toys novelties, and non-medical products intended for ingestion.
inhalation er direct application to the skin (such as cosmetics). The Commission's determinations regarding the justification of these practices will also include consideration of any non-radioactive alternatives; that is, there q
should be a net benefit of the radioactive over the non-radioactive alternative.
i VI. PROPOSALS FOR EXEMPTION l~
A proposal for exemption must provide a basis upon which the Commission can-L determine if the basic conditions described above have been satisfied.
In general. this means that the proposal should address the individual and societal impact (i.e., benefits and detriments) resulting from the expected activities under the exemption, including the uses of the radioactive j
materials, the pathways of exposure, the levels of activity, and the methods and constraints for assuring that the assumptions used to define a practice l
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remain appropriate'as the radioactive materials move from regulatory control to an exempt states.
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If a proposal for exemption results in a rule.containing specific requirements, a person applying to utilize the exemption would not need to address justifi(ation 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.,
consumer product rules in 10 CFR Part 30.
In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered withregardtothepotentialthatscoeindividualsmayreceivedosesfromothfr practicts.
If exposures from multiple practices can occur which are significantly beyond the individual dose criterion (10 arem per year (0.1 mSv per year)), the exemption will not be granted 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 individual members of the public from exempted practices remain well'below 100 arem.
In addition to considerations of expected activities and pathways, the Commission 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 conditions in terms of individual and collective dose.
VII. VERIFICATION OF EXEMPTION CONDITIONS The Commission believes that the implementation uf an exemption under this broad policy guidance must be accompanied by a suitable program to monitor and verify that the basic conditions 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 15
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.y set of conditions and criteria. The monitoring and verification program established by licensees, who propose to release materials under the provisions of regulations hr licensing conditions developed from this policy, must therefore be capable of providing the Commission with the appropriate assurance that the conditions for the exemption maain valid, and that they. ore being observedu.The Connission will determine compliance with the specific conditions of an exemption through its established licensing and faspection program and will, from time to time, conduct studies as appropriate to assess the impact of an exempted practice or combinations of exempted practices.
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CONCEPTS FOR ESTABLISHING BRC LEVELS EPA Comment There are two essential elements of any decision to limit regulation of a
-practice'that, while bene icial[ justified),cancauseradiationexposureto f
the general public. The first is that the deleterious impact of the practice on health in the exposed population, taken as a whole, is small enough that the effort and expense of regulation of the radioactive hazard is not warranted.
The second is that the risk to any. person is small enough that the majority.of individuals would not consider it of concern. Neither element is adequetely addressed by the proposed policy [ advance notice of a proposed policy
' statement].
NRC Response On the contrary, we believe the discussion in the advance notice reflected our appreciation of these elements. A major purpose of the proposed policy would be to establish criteria which would, in effect, delineate achievement of indicating when a licensee need not expend ALARAforajustifiedpracticei.e.(cost-riskreduction) efforts.
The advance.
further resources for cost-benefit notice stated that the Commission is evaluating the use of two numerical criteria in defining the region where ALARA has been achieved: a) a criterion for the maximum individual annual dose reasonably expected to be received as a An individual dose criterien was proposed (i.e., 10 mrem per year) populatio result of the practice and (b) a measure of societal impact to the but coments were solicitec on whether, or in'what form, a societal impact criterion should be proposed.
The Commission recognized that a collective dose criterion could be used to address societal impact but questioned whether alternative approaches could be devised to define a minimal societal impact for a given practice (e.g.
setting different. individual dose criterion on the basis of the number of people potentially exposed and the distribution of the expected individual Therefore, although the Commission has-questioned how to characterize doses).
the societal impact criterion (including consideration of the argument that the societ61 impact of the total of all trivial or negligible individual risks should be treated as being negligible), conceptually, the need for such a criterion has not been rejected. As a result, we believe both of the two essential elements have been addressed for the purposes you describe.
epa Coment The proposed policy'could be considered arbitrary since, without definition of a practice, an optimization assessment can nct be performed. Sufficient-experience should be gained with individual case from which a trend may emerge permitting generalization to a single set of generic numerical criteria for BRC.
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NRC Response The NRC believes the approach described in IAEA Safety Series 89, can be followed. ThisJapproach would involve the definition of both an appropriate individual risk and a minimal societal-impact. The value of the societal.
impact would be such that most reasonable people'would agree that the broad societal cost of.any regulation would be greater than the value chosen,-and.
that regulatory resources would be better spent on the control and regulation of moretisk significant radiological activities. As the discussion in the advance notice indicates, the individual criterion could be based on a fatality risk judged to be of-little concern to most members of society (e.g., a risk which the
..dividual would not spend resources to avoid). The importance attached ta optimization assessments was also reflected in our recognition that
.there could be situations in which the optimization evaluation for a specific even though practice could indicate that an exemption should be granted calculatedindividualandcollectivedosesmayexceedtheaforementionedcriterion values. The discussion in the advance notice, however, does need to be o
L improved since we have received many coments indicating that many readers L
believed that the Commission was proposing that practices causing potential individual exposures approaching public dose limits would be routinely exempted from regulation.
This is not the case,and in developing a proposed policy fo Comission consideration, the NRC staff. intends to rewrite and clarify this point.
THE EXEMPTION LEVEL FOR INDIVIDUAL DOSE EPA Comment At the international workshop in October 1988, there appeared to be virtual
. unanimity that a 10 mrem / year value was too high as a criterion for establishing when licensees need not expend further resources on ALARA or optimization l
efforts.
NRC Response On review, we believe your conclusion is somewhat overstated. Our view was that most participants considered individual effective dose equivalents in the rar.ge of 1-10 mrem per year to be " trivial." The discussion at the meeting L
revolved around the issue of how this number should be " fractionalized" to I
apply to a single practice.
Our approach was to establish the individual dose criterion on the basis of-a risk level which the Commission believes most individuals would not spend I
.their resources to avoid. This represents a slightly different approach than the trivial risk basis used internationally. However,theNRCis'stillactiveli considering what individual dose criterion should be proposed and what rationale should be used to defend the selected value.
Your comments on this issue will receive serious consideration.
EPA Coment Consideration of exemptions involving the possibility of exposures as high as 100 mrem per year is totally inappropriate.
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'NRC Response As stated in the advance notice, the intent of the policy is to assure that individual exposures to the public remain well below 100 mrom per year.
~The intent of the discussion in the advance notice was to reflect flexibility
'in> the regulatory decision-making process regarding exemptions. For example, there may be rare instances where exemptions,.on tte basis of an optimization evaluation,.could be granted for practices where a few individuals could receive % ses above-10 mrem per year. Our intent is to clarify this point in the proposed policy statement.
EPA Coment The individual risk levels associated with doses in the 10-100 mrem / year range are not consistent with many Congressional and regulatory actions being taken relative to other environmental contaminants.-l.
NRC Response The NRC is aware of this issue and is concerned that all of the many factors important in establishing acceptable health risk levels be considered for each environmental contaminant.
Populations impacted, distribution of individual 1 impacts, uncertainties in health impacts, persistence of the purported hazardf the potential for multiple exposures, and other issues -- all must be addressel in establishing " risk-based" regulatory policy. Our intent is to discuss this issue of consistency further in the development of the proposed policy.
EPA Comment The dose to risk conversion factor used in the advance notice is out-of-date.
NRC Response The NRC was aware of the impending recomendations regarding dose-to-risk l
conversion factors as the proposed policy was being developed.
In lieu of speculating on the implication of unpublished data, the discussion in the l
advance notice indicated that the Comission included a margin-of-safety in establishing an appropriate individual dose value.
However, with the iminent publication of the BEIR V report and the recent publication of the 1988 report by the United Nations Scientific Comittee on the Effects of Atomic Radiation, the NRC staff will include consideration of these developments in its recommended I
proposed policy.
i' COLLECTIVE DOSE EPA Comment Any decision to exempt a practice from regulatory control needs to include an evaluation of the total impact of the exemption on public health.
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l NRC Resoonse l
As mentioned previously, the discussion in the advance notice recognized
- that the totah.fapact of any exemption decision on public health and the L
environment needs to be considered. The NRC staff is currently evaluating tic L
efficacy of using collective dose, or some other alternative, to address total social impacts.
EPA Conment.,.
There is no valid scientific basis for truncations in the assessment of collective dose in the exemption decision-making process.
r NRC Resoonse Although the Commission asked for coments on this subject, I would emphasize 3
that neither,the advance notice nor the staff's original draft proposed policy included a decision regarding truncations. On this point. I would further note that an assessment of the total societal impact of an exemption decision does not necessarily preclude the usefulness of a truncation provision in the numerical-process of evaluating collective dose.
n IMPLEMENTATION EPA Comment Upper limits for doses to populations cannot be assured if exemptions we m pemitted to cause potential exposures approaching 100 mrem / year.
NRC Response d
This.would be true if such exemptions involved widespread individual exposures at this elevated level or were routinely granted. However, as discussed previously, this is not the intent of the policy. While it may be possible to grant an exemption involving doses above 10 mrem in some cases, these would be rare and would involve special measums to assure that the individual doses for the limited population involved would not exceed 100 mrem per year.
EPA Coment How would there be assurance that some source-specific limits are not exceeded as a result of exemption decisions?
NRC Response The advance notice made reference, and we are aware, that certain existing or proposed regulations may impose additional rutrictions on exemption decisions, if this is the case, the effect of compliance with these more restrictive regulations would be to further assure that no individual member of the public is likely to approach an annual exposure of 100 stem per year from all sources, 4
E
,g ICON 51STENCY WITH INTERNATIONAL AND NRC p0LICY
" ~ ~
EPA Comment i
Theproposedpolicy[advancenoticediscussion)isnotconsistentwith international recommendations.
NRC Response The NRC staff it familiar with IAEA Safety Series 89, " Principles for the
. Exemption of Radiation Sources and Practices from Regulatory Control" and its forerunner drafts and, in fact, attempted, in many cases, to use this document as'a model for certain sections of the draft proposed policy originally presented to the Comission. As you correctly point out, a major difference involves the
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selection of-the individual dose criterion which, when coupled with other requirements, would delineate when a licensee need not expend further resources to minimize. radiological im The international approach uses the concept oftrivial(ornegligible) pacts. individual risk while the Comissions' proposal is 1
tied to a Comission policy judgement on the level of risk below'which an 1
individual would not expend resources to avoid. Although the NRC staff believes i
this is a significant distinction, we are reevaluating all our alternatives for i
establishing criteria for defining a " floor" for ALARA evaluations.
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' EPA Coment
(
The discussion in the advance notice is inconsistent with the Commission's own policy on BRC for low level waste issued in August, 1986.
l NRC Response The NRC does not believe there is an inconsistency. The 1986 policy involved the achievement of regulatory expediency; that is, the policy provided the criter_ia which must be met, if a petition for rulemaking on "BRC disposals" was to be treated by NRC in an-expeditious manner. The implication of expeditious treatment was that the NRC could publish a proposed rule within 6 or 7 months of receipt of the petition, but does not imply that exemptions would be granted only if the criteria of the policy were net. As stated in the advance notice, the Comission will evaluate whether there are exemption criteris embodied
[within its own regulations) for which modifications according to the principles of this policy, would be beneficial.
4 5
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tuuower J COMMENTS ON ADVANCE NOTICE General In response to the publication on December 12,1989 of an advance notice regarding the subject policy 203 coment letters were received, most during the renth of February and many in March, after the official January 30, 1989 comment closing date. The issues raised in these letters have been categortred into 33 subject areas which include the subjects for which coment was explicitly solicited in the advance notice. The comment lettert were almost evenly split, with slightly more than half supporting the need for a Cassission exemption policy. The comment letters included about 135 from individuals, of which about 1/5 identified themselves as health physicists. Two of these letters frcm individu61s were petitions. expressing opposition to policy i
development. There were 21 letters from public interest groups,18 from t
utilities or their representatives,11 from industry, 7 from state or local government organtrations, 3 from professional societies 2 from sombers of the National Council on Radiation Protection and Measurements (NCRP), one from the U.S. Environmental Protection Agency, and two from sombers of Congress.
Coment Sumery A sumary of the substance of the major coments is as follows:
' Support /0ppcsition to Policy Development Those opposed to policy development generally stated that any health risk should not be the subject of deregulation. Post of these commenters focused on LLW disposal and believed that disposal of radioactive material in licensed facilities shculd be considered a cost of doing business. The pessibility that implementation of the policy could lead to abuses or accidents was also sited in several letters. Many of these comenters were not aware that exemption regulations exist and that case by-case licensing decisions involving exemptions have been made.
A large number of these comenters believed an exemption policy completely eliminated NRC regulatory involvement in the exempt practice.
Those favoring policy development focused on the issue of optimum use of licensee and regulator resources, believing resources spent to control small or negligible risks could be batter directed at more significant problems.
' Criteria (Criterion) For Establishing 'T1oor" For ALARA Most comenters agreed that a criterion feriteria) should be included to estabitsh a ' floor" below which it should be unnecessary to expend resources to further comply with ALARA principles. Several stated that, to be effective, numerical criteria were needed and not broadly defined ranges (e.g. a few
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I eren). Most mflected the Health Physics Society position, believing the i
" floor" could be defined through use of an individual dose criterien alone I
without the need for a collect've dess or societal impact criterien. The argument used by many of these consenters was that protection of the fadividual assured-pro,tection of society. Others specifically related their opposition to L
the uselessness"of a collective dose criterion when considering esemptions ir,volving LLW disposal practices. A number of these cessenters recognised that in addressing other practices, such as consumer products, the magnitude of the e
population exposure wculd have to be a consideration. A few ceanenters, including the EPA ar,d former Commissioner Kennedy, presented arguments for including a societal impact critarion which together with the individual dose criterion, would respectively, determine if an esemption could be granted or define the " floor" below which further ALARA afforts would not be required.
Both these comenters, believed that some assessment of societal ispect ses mandatory to the decision process regarding an exemption for regiatory cuntrol.
'Value Selected for Individual Dose Criterion Almost all comenters in favor of an exemption policy believed that 10 mrem / year was a conservative but acceptable value for the individual dose criterion. Other values, as high as several hundred millirem / year were suggested, with many proposing 20 mrem / year.
Notable exceptions to these views ine uded the EPA, the DOE, fomer Connissioner Kennedy, a pro nuclear interest 4
i group (California Radiation Materials Management Forum), the Conference of Radiation Control Program Directors and responders from the NCRP, who believed 10 mrom/ year may be too high a value, and that a lower value, consistent with international views, would result in greater acceptance of the policy as a whole.
' Applicability of the " Justification of Practice" Principle On the applicability of the justification of practice principle to exemption decision making, opinions were split with many believing that this principle Should not be applied to practices meeting the 'ALARA f,oor" criterion (wnich comenters frequently referred to as, " meeting the '8RC" criterion').
Many utility commanters believed that the discussion in the advance notice confused justification of practice with ALARA. These comenters stated that since practices such as nuclear power have already been justified, the issue of exempt vs controlled cisposal of LLk' is simply an optimitation of protection or ALARA issue. A few recognized that, because of the broad nature of the p91tcy, justification of practice can be an issue in the context of the distribution of new consumer products containing small amounts cf radioactive material.
Although not completely logical, many comenters agreed that certain practices could be precluded from exemption but statec that NRC should not become involved in judging social acceptability of specific practices.
' Maintaining Flexibility in the Exemption ' Decision-Making Process"
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Essentiallye11supbertersoftheneedforapolicybelievedthatflexibility should be maintainedh that is, if a pmper ALARA analysis supports an exemption for a practice in wh4ch an individual dose could esteed the criterion value (e.g.10 orem/ year), this practice should not be precluded from exemption EPA, however, believes that, as a condition for exemption, no consideration..ld receive a dose which is a significant frection of existing individual shou public dose 110tts.
'Campatability with Agreement States i
A number of coerenters stressed the need for making any exemption regulation a i
matter of exact compatibility with Agreement States. Other cementers.
including two representing tocal governments, stated their belief that the few level waste sites, being created as a result of state compacts mandated t,y the 1
Low Level Radioactive-Waste Policy Amendments Act of 1985, should be the repository for all Icw-level waste, and that there is no need for the Comission to define '8RC" waste. These latter comenters often stated that allowing radioactive material to be disposed at local landfills would si6nificantly complicate the already complex task of siting these facilities.
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Several comenters opposed to the development of an exemption policy, and one comenter favoring a policy, stated their belief that, based on most recent data, the risk coefficient cited in the advance notice was too low.
'Need for Perspective A number of comenters believed that far more perspective was needed to i
- indicate the magnitude of the dose and risk levels being discussed in the Several mentioned the differences in risk leve used by NPC and other policy.
federal agencies (e.g.. EPA), noting that the NRC values were less mstrictive by almost two orders of magnitude.
Ponitoring of Exempt Practices 4
All comenters who favored the development of the policy, and addressed the monitoring question, supported the need to monitor and enforce Itcensee's compliance with any developed exemption regulations. Many, however, stated opposition to any requirement for licensee monitoring once the material was transferred from controlled to exempt status. These comenters believed such monitoring would be perceived to contradict the underlying basis for the policy.
' International Consistency All who comented on the issue believed international consistency was detirable, but not necessary.
A few agreed that consistency would be an element which would be helpful in gaining acceptance for a policy.
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APR 19193g i
MEMORANDUM FOR: Thomas E. Murley, Director, Office of Nuclear Reactor l
Regulation
.asbeM. temers. Dire? tor, Office of Nuclear Materials Safety and Safeguards Harold R. Denton, Director, Office of Governmental and Public Affairs William C. Parler, General Counsel e
FROM:
Eric S. Beckjord Director, Office of Nuclear Regulatory Research h
SUB.1ECT:
PROPOSED COMMIS$10N POLICY STATEMENT ON EXEMPTION f?ON I
REGULATORY CONTROL f
The staff is erpetted to submit the subject proposed policy statement for I
Comisticn consideration by June 2,1989. This schedule necessitates subr.f ssion of a Comission. paper to the ED0 by May 19,1989.
In order to meet chis schedule. RES must receive comments from affected Offices and resolve outstanding differences in an expedited manner, t-i' In order to move forward to accomplish this task, the RES staff has prepared a l
preliminary draft proposed policy statement which is attached as Enclosure 1.
This draft has included consideration of coments received (1) at the October i
1988 workshop of regulator 12,1989, and (3) y authorities, (2) from the public meeting l
January through the 220 coment letters received ' n response i
to the solicitation made in the December 12, 1988 Federal Register Advance Notice. We are also using this preliminar the U.S. Environmental Protectic'n Agency (y draft policy in discussions withEP Our objective is to identify any outstanding issues, not only with EPA but among NRC Offices, so that the policy statement can be revised as appropriate.
(1)parallell with Office review, RES intends to complete a package which will In sumartre consrents received on the advance notice proposal and (2) provide proposed Comission responses. To assist you in your review, Enclosure 2 contains responses to EPA coments while Enclosure 3 provides a sumary of the major comments received in response to the advance notice.
I request that written Office coments or concurrence on the enclosed policy statement be submitted by April 28, 1989. RES is, of course, mainly interested in comments on the major policy principles and criteria, but we would welcome any suggestions for editorial changes you may find appropriate. The contacts within the Offices who have, to date, assisted in the development of this policy are listed below:
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R. Cunningham D. Cool K. Dragonnette NRR F. Congel L. J. Cunningham OGC R. Fonner GPA K. Schneider In early May, a meeting will be scheduled with the ED0 to discuss any RES disposition of Office comments on the major policy issues. Your efforts, 3
particularly in documenting the changes you propose and the reasons for them, would be appreciated.
R$ (5' ij
,, ), BEN Eric S. Beckjo. Of rector Office of Nuciaar Regulatery Research
Enclosure:
1.
Prelim. Oraf t Prop.. Pol. Statement 2.
Responses to EPA comments 5.
Sunmary of Major Comments Received i
in Response to the Advance Notice cc:
J. M. Taylor, OEDO H. L. Thompson, Jr., OEDO l
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PRELIMINARY RES DRAFT Proposed Comission Policy on Exemptions from Regulatory Contr >1 1.
INTRODUCTION AND PURPOSE Over the last several years, the Comission has become increasingly were of
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the need to provide a general policy on the appropriate criteria fo release of certain radioactive materials from the f xtent of existing regt story controls. The need has been driven by curring, realizations.Y The I
is the recognition that, for certait practices involving minimal public health
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and safety concerns, the imposition of undue and unnecessary regulatory controls l
could prohibit a ptactice which should otherwise p rmitted because of raascnabic.
social, tcenomic, or industrial bentfits. The esults from the nation's Y
focus on fiscal responsibility and the inewledge that rezovrees expanded for l
regulatory control of practices with mt wral radiological impacts could be
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L better used to address more significant radi6 tion protection concerns.* To c)*.
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address this raed, the Comission is expanding upon its existing policy for protection of tre public from radiation, currently expressed in existing regulatio i
(Title 10, Code of Federal Regulations) u d policy statements (30 FR 3462, Use
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of Byproduct Material and. Source Material (Consumer Productsi, 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 i
and Procedures Concerning Petitions Pursuant to i 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion includes the development of an explicit exemption policy for those Commission-regulated practices which involve minimal public health and safMy impacts.
The Comission, however, recognizes the benefits of uniform regt.a ation and therefore, supports the development of broader Federal Guidance regarding A
exemption policies.
In doing so, the Comission realizes that, when signed by A' the President, the Federal Guidance could supplant this policy.
In this policy, a practice is defined as an activity or a set or combination of a number of similar sets of coordinated and continuing activities aimed at a given purpose which involve the potential for radiation exposure. Disposal of very low level radioactive waste; the release for unrestricted pubite use of lands and structures with residual levels of radioactivity; the distribution, use, and consumer products containing small amounts of radioactive material;
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A and the recycle and reuse of residua 11y contaminated materials and equipment are examples of classes of practices for which this policy is judged to have potential appitcability.
It is the Comission's intent to broadly define specific practices in terms which will preclude any individual or population being sientficantly affected by similar practices within a given class while, at the same time, identifying and describing the practice in terms which will fact 11 tite reasonable impact analyses and allow imposition of appropriate constraints as the radioactive material passes from controlled to status.
Under this policy, the definition of a " practice" is a critical feature which g
will assure that the formulation of exemptions from regulatory control will not allow deliberate dilution of material or fract'onattan of a practice for the
purpose of circumventing controls that would otherwise be applicable. The definition will also provide the framework for taking into account the possible consequences of accidents or misuse essociated with exemption decisions.
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4 Ths purpose af this policy statement is to establir.h tht barit upon which the Comrission may initiate the '!evelopment of appropriate regulations or rake Itcensing decisions to exempt frort regdatery eentrol persons who receiw, possess, use, transfer, own, or acquire certain radioactive material. This policy b ciu cted principally toward rulemakfng activities, but m y be applied to license ' amendments or licente e'ppiteetions involving the release of ifcensed I
radioactive material either to the environ;nent or to persons who would be exempt from Comission 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 government regulation to reduce risks is unwarranted.
The concept of regulatory exemptions is not new. The Atomic Energy Act of 1954, as amended, authorizes the Comission to exempt certain classes, quantities, or uses of radioactive material when it finds that such deregulation will not constitute an unreasonable risk to common defense and security and to the health and safety of the pubite.
In 1960 and 1970, the Comission used this authority to promulgate 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 64271 Other exemptions 2
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allowing distribution of consumer products or other devices to the general
- pubite, or allowing releases of radioactive material to the environment, have been embodied in the Connission's regulations for some time.
For example, regulations currently specify conditions under which Itcensees are allowed to dispose of radioactive material into a sanitary sewer system (Title 10 Code of Federal Regulations, Part 20, Section 303). That is, the regulations specify I
requirements which a licensee must meet if radioactive material is to be
- transferred' from a controlled to an uncontrolled status. More recently, Section 10 of the low Level Radioactive Waste Policy Amendments Act (LLRWPAA) of 1985 directed the Commission to develop standards and procedures for f
expeditious handling of petitions "...to exempt specific radioactive waste streams frotoregulation... due to the presence of radionuclides... in sufficiently low concentrations or :;uantities to be below regulatory concern.
The Comission responded to this legislation by issuing a pnlicy statomsnt in i
August 1906 (51 FR 30829).
That stateeent conteined criteria which, if l
satisfcctertly addrened in a petition for ruletrakit.g, nuld allow the Commissien to act expeditiously in prcposing appropef 3*e rtsulatory relief on a
- prtcti:e-specific" btsts consistent with the W rits of the petititn.
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The Commission believes thrt these " practice-specific" exenttions 0o91d k encomper. sed within a broader NRC policy which defines levels of radiation risk below which specified practices would require caly minimal, prsetut+ specific NRC regulation based on public health and safety interests.
For such practices, the Comission's regulatory involvement could be essentially limited to licensing, inspection, and compliance activities associated with the transfer of the radioactive material from a controlled to an exempt status.
That is, the Comission would define constraints which must be adhered to by rom - cont 11ed to NRC licensees if radioactive material is to be transferred an uncontrolled or exempt status.
64WMMEL The Commission recognizes th
, if a national policy on exam tions rom regulatory control is e effective, Agreement States will play an important implementation role. Pursuant to the LLRWPAA, States are responsible for l
l providing, either alone or in cooperation with other' States, for disposal of certain low-level radioactive wastes.
In the past, States have been encouraging findings that certain wastes are below regulatory concern and the 3
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- m Consission believes that States will support the application of a national policy on exemptions for specific practices involving distribution or releap of radioactive insterial. The Comission intends also that rulemakings Comission believes that States will support the application of a national j policy on exemptions for specific practices involving distribution or release of radioactive material. The Comission intends also that rulemakings ccdifying exemptions in all areas will be made a matter of strict compatibility for Agreement States. Consequently, any rulemakings that evolve from this I
policy will be closely coordinated with the States.
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The Comission recognizes that its policy will potentially have a significant impact on nuclear regu ation in the international community. The approach and criteria in this policy differ in some respects from those selected or under consideration by other countries.
It is the Comission's intent to continue its diat0Dce with the international comunity in order to resolve, or foster g[
i butuel understandings of the rationales khind, differences in exemption j
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I policies.
II, RA0!ATION FROTECTION FRINCIPITS The Three Fundariental Price]Qes of Cadiation Protection The Comission recognizes that three fundamental principles of radiation protection have historically guided the fomulation of a system of dose limitation to protect workers and the public from the potentially harmful effects of radiation. They are (1) justification of practice, which requires that there be some net societal benefit resulting from the use and dis'oosition of radiation or radioactive materials. (2) dose limits, which define the upper boundary of adequate protection for a member of the public which should not be exceededintheconductofnuclearactivities,and(3)ALARA,whichrequires that radiation dose be as low as is reasonably achievable, economic and social factors being taken into account. The tem. ALARA, is an acronym for As low As is Reasonably Achievable.
Dose Estimation In estimating the dose rates to members of the public that might arise through the use of various practices for which exemptions are being considered, the 4
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Commission has decided to apply the concept of the
- effective do equivalent."
This concept, which is based on a comparison of the delayed nor ality effects of ionizing radiation exposures, permits through use of weigh factors, the calculation of the whole body dose equivalent of partial bod exposures. This
. approach was proposed by the International Commission on Radiological Protection in its Publication 26, issued in 1977. Since that time, the concept has been reviewcd and evaluated by radiation protection organi ations M h)-.m.
throughoutthewor1g/dand has ga ned ide acceptane A
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M Estimatino Health Effects From Radiation Exposure h
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Individual Risks 4' #
In the establishment of its radf ation protection policies, the osmission $N.
has considered the three major types of delayed health effects which can be caused by exposures to raClat %nt concer, Genetic' effects, and developmental anomelies in ietuses. Regulatory agtncies, including the NPC, focus on the risk of fatal cancer developmert. Tnts is done principally becausa, at relt tively high radiation doses: (1) the bast data
-base exists for cancer mcrtality, (2) the mortclity rist repmsents a more severe outcome than the non-fatal cancer risk and (3) the rertality risk is higher than the risk associated with genetic and fetal effects.
However, even though radiation has been shown to be carcinogenic, the development of a risk factor applicable to continuing radiation exposures I
at levels equal to or far below natural background roquires a significant extrapolation from the observed effects at much higher doses.2 The result is a significant uncertainty reflected by the views of experts in the field. For example, the National Academy of Science's Conriittee on the 1
Natural background radiation can vary with time and a person's location.
In Washington, DC natural background radiation (excluding redon1 results in individual doses of about 90 mrem per year, while in Denver, Colorado the value is about 16 n : K year including, in both cases, a contribution of abou 40 mrem p.7 year from natural radioactivity-contained in the human
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2 The health effects (1early attributabledo radiation have ocurred 77 principally among early rectation workers, survivors of the atomic bomb explosions at Hiroshima and Nagasaki, individuais exposeo Tor moical purposts, and laboratory animals.
Natural background causes a dose over a one year period which is at least two orders of magnitude less than the dose received by populatforis from which the cancer risks are derived.
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pg Biological Effects of Ionizing Radiation, has cautioned that the risk values are "... based on incomplete data and involve a large degree of uncertaint), especially in the low dose region." This Committee also stated that it "...does not know whether dose rates of gasma or x-rays (Iow LET) [ low linear energy transfer radiation) of about 100 strads/ year are detrimental to man."
In the face of this and similar cautions, the NRC, the Environmental Protection Agency, and other national and international radiation protection authorities have established radiation standards defining recomended dose limits for radiation workers and individual members or the public. As a matter of regulatory i*udence, all these bodies have derived the value presumed to apply at lower dose and dose rates associeted with the radiation protection standards by extrapolation from,
values dnived at higher deses and dose rates. The extrapolation is L
freopently referred to as the no-threshold hypothesit.
l The Comission, irt this development of an exemption policy, (A again faced with the in ue of how to character 1re the individual and population risks l
as",nciated with icw tbses and dose rates. Although the uncertainties are j
large, useful perspective en the bounding risk assectated with very low-levels of radiation can be provided by continued use of the no threshold hypothesis. Consequently, such risk estimates will be a factor in establishing individual and collective dose criteria associated with this policy. The estimations of the low risk from potential exempted l
practices can be compared to the relatively higher potential risks associated with other activities or decisions over which the NRC has regulatory responsibility. Through such comparisons, the Comission can assure that its radiation protection resources and those of its licensees, I
are expended in an optimal manner to accomplish its public health and safety mission.
In this context. the risk to an individual, as calculated using the no threshold model, is shown in Table 1 for various defined levels of annual individual dose. The values in the lifetime risk column are based on the further assumption that the annual dose is continuously received during 6
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.e each year of a 70-year lifetime. To provide further perspective, a radiation dose of 10 mrem per year (0.1 m$v per year) received continuously over a lifetime corresponds to an estimated hypothestred increase of about 0.25% in an individual's lifetime risk of cancer death.
Table _1 Hypothestred Hypothestred Incremental Incrementa1 Lifetime Risk from 2
2 Annual Dose Annual Risk Continuine Annual Dose I
5 x 10-5 3.5 x 10~3 i
100 mrem 5 x 10-6 3.5 x 10*4 10 mrem 5.x 10'8 3.5 x 10-5 7
1 mrem 0.1 mrem -
5 x 10-3.5 x 10-6 IUnless otherwise indicated, the expression of dose in mrem refers to the Total Effective Dose Equivalent. This tenn is the sum of the deep dote i
equivalent for sources external to the body end the committed effective dose equivelent for s')urces internal to the body.
Risk coefficient ci S x 10
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In the applicaticr. of the fundsmental principles of radiation protectio
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collective dose provides a uteful way ic express the radiological imp t (i.e., potential detriments) of a nuclear activity on the health population subject to radiation exposure. Collective dose is sum of the individual doses resulting from a practice or source radiation -
exposure. Ry m TM N"~t'": i ;; : [ n;;: ;; ' S I can be used M in comparative cost-benefit and other quant.itative analysis techniques.
k It is therefore an important factor to consider in balancing benefits and p
societal detriments for practice justification and in the carrying out of ALARA determinations. The NRC has used collective dose in this manner i a number of rulemaking decisions and decisions involving resolution of a variety of generic safety issues.
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Derivation of Measurable Quantities from DeM/ Risk Estimates f
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The Commission recognizes that it is possible to measure risk to individuals #-
L or populations directly, and, that in most situations. it is impractical to y:
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measure annual doses to individuals at the w levels potentially associated with its exemption decisions. Typically, adioisotope concentrations or radiation level's from the material to be azempted are the actual measurements that can be maqe and doses are then estimated by exposure pathway analysis M-^*N
- p # assumptions related to the ways in which peop1 sight become exposed.
Linder such conditions, conservative assumptions are frequently used in modeling so that any actual dose would be expected to be Iower than the calculated dose. The Comission believes that this is the appropriate approach to be taken when detemining if an exemption from M
regulatory controls is warranted, h
!!I APPLICATION OF RADIATION PROTECTION PRINCIPLES TO EXEMPTIONS FROM PEGULATORY CONTROL I
TM fo11cwing sets fceth guidelines about how the Comission will apply the funcamental principles of rsdf ation protection in tensidersticn of practices j
uhtch are proposed to be exempt from certain regulatory conteels. Tl:ese practices, if approved, would result in low levels of radioactive material in products being distributed to the general public and radioactive affluents ant solid waste t>eing released to areas of the publically-accessible envircrant.
l-a Justification - Decisicos regarding justification of practice usually derive from considerations which are much broader than those based on radiation protection alone. Therefore, these decisions may be made in a broader context before the need for regulatory control is addressed (or the need for exemptions from certain aspects of control, as addressed in this policy). The Comission continues to believe that any practice causing a potential radiation exposure should be justified; however, as lower levels of individual and population dose are projected. Iower levels of benefit will be needed to achieve a positive balance although other societal impacts of a practice must also be considered.
The Comission will continue to identify or characterize certain practices for which bene'its are 8
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-considered marginal and for which there appears to be no reasonable
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justification.
Dose Limits - Individual doses from practices exemp d under this g
policy should generally not be allowed to exceed small fraction of 100 mrem per year (1msv per year). This is t non-occupational dose limit recommended by the International Comi ton on Radiological Protection and the National Council of Ra ation Protection and Measurements for continous exposure f n-made sources of radiation other than medical.
It is also 4he value specified in the final revision of 10 CFR Part 20, Standards for Protection Against 4
Radiation. The dose limits in the final revision of 10 CFR Part kJ apply to all sources of radiation exposure under a licensee's control (natural background and medical exposures are specifically excluded's, l
3 a. q,hai) een justified and_c9ntrois are in place ALAR,5 - 0 i
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'1 to assure that dose limits are not eAceedtd, it is nacaksary to design and plan the subtequent use and raisposal of the sources of
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radiation in c menner which ansters that exposures are as low as 4
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- reasonably achievable, economic and social factors being taken into l
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As a result, this principle applies when considering a
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practice for possible exemptions from some or all regulatory g
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,, j controls. This requirement that doses be ALARA has been a part of 6
NRC regulatory practice for a number of years and is now fonnally l
embodied in the revisions to Title 10. Code of Federal Regulations, Part 20. However, no policy or criteria have been provided which would establish the bases for defining a generic " floor" to ALARA. A
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major purpose of this policy is to establish criteria which would delineate when further regulatory and licensee resources need not be g
7 spent to further reduce radiation exposures from a practice for which an exemption decision is being considered.
Although it is possible to project what the dose will. be from a practice, and then take this infonnation into account in controlling regulated practices so that the dose limits are not exceeded, exemptions involve a reduction or elimination of some or all controls.
In view of this, the Commission believes 9
p that a key objective in estabitshing a policy for exemptions, is to provide adequate assurance that individuals will not experience radiation exposure approaching 100'erem per year (im$v per year) through the cumulative effects of more than one exempted practice even though the exposures from any single exempt practice would be expected to be a small fraction of this value. By
-appropriate choices of exemption criteria and constraints, and through its evaluations of specific exemption proposals, the Coswission intends to assure that it is unlikely that any individual will experience continuing exposures j
1 which approach or exceed 100 arem per year (!mSv per year) from all exempted practices.
IV.
PRINCIPLES OF EXEMPTION A major consideration in exempting any practice from some or all regulatory controls hinges on the general quettion of whether or not application or contiruation of regulatory controls are necessary and cost effective in reducing dose. To detemine f f *Famption is appropt f ate, the Commission must determine if or,e of the following conditions is met:
1.
The application or continuation of regulatory controls on the prectice does not result in any significant reduction in dose
. received by individuals within etitical groups and by the exposed population or; 2.
The costs of the regulatory controls that could be imposed for dose reduction are not balanced by the commensurate reduction in risk that could be realized.
For purposes of implementing its policy, the Comission recognizes that only under unusual circumstUces would exerptions be considered for practices which could cause continuing radiation exposure to individuals exceeding a small fraction of 100 mrem per year (ImSv per year). 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 members of the exposed population decrease, the need for regulatory controls decreases and the analysis needed to support a proposal for exemption can 10
G reasonably be somewhat simplified. At a sufficiently low level of individual risk, decisions justifying the distribution to cr use of radioactive material by individuals hot controlled by NRC licenses, or decisions granting specific exemptions from regulatory control for a justified practice may be reduced to an evaluation of whether the overall individual and public risk is sufficiently sull.
The Comission therefore proposes that two numerical criteria should be established in defining the region where the risk reduction does not warrant the expenditure of Comission or licensee resources to bring about a further incremental compitance with the Al. ARA principle. Theyart(a)acriterionfor the maximum individual annual dose reasonably expected to be received as a l
result of th2 practice and (b) a measure of societal impact to the exposed l
populaticn.
In combination, these criteria are chosen to assure that, for a given exeropted practice, no individual will be exposed to a significent ndiclogical risk and that the population as a whole does not soffer a L
l significant impact.
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4h if the vidualuloses f practice under consideration for exemption are sufficiently small, t ttendant risks will be small compared to other societal risks and
' merit of expending resources to further reduce the dose or risk from a justified practicei= h ;a Leb ;n;t;vi.. '
The Comission believes th( definition of this risk or dose level can be developed from two The first is the risk perspective. The Comission believes that perspectives.
most members of society will not expend resources to reduce an annual individual fatality risk below approximately 10-5 (i.e., I chance in 100,000).
This risk level is comparable to that (i.e. 2x10'0) selected by the Commission in the development of its safety goal policy - (i.e., a risk level equal to 0.1% (1/1000) of the sum of cancer fatality risk from all other causes). Using the no threshold hypothesis, the incremental continuing annual individual exposure level associated with this " safety goal" risk level can be estimated The second perspective is based on those variations in as 4 mrem per year.
dose tolerated by individuals because of factors such as their lifestyle or
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place of residence. The Comission notes that resources are not expended to 11
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b reduce differential exposures associated with variations in natural background radiation (e.g.
the 70 arem per year difference between annual doses received in Denver, Colo'rado vs Washington, DC).
Nor are resources spent to reduce the 7-10 mrom dose which an individual would receive during a single round trip coast-to coast aircraft flight or the dose from other activities which involve doses representing a small fraction of background radiation.
Inviewoftheuncertaintiesinvolved(suchas,theapplicabilityofthe no-threshold model itself and its input data) and taking into account the tvsults of analysis from both the risk and dose perspectives, the Comissien finds an individu&1 dose of 10 mrem per year to be appropriate for use as one of two boundary criteria which would define whether or not additions? resources need be spent to comply further with the At. ARA principle. The Comission enstders tMs value to be appropriate given the uncertHnties involved and actes that, at this value, implementation of this policy in future rulemakings or licensing decisions should be a practical undertaking.
The Totietal Dipact Criterion In proposing criteria which would demonstrate practical achievement of ALARA, the Comission seriously considered whether the imposition of the individual dose criterion would also provide a sufficient measure to judge societal impact, and, thus, could stand alone as a basis for detemining when further resources need not be expended to further comply with the ALARA principle. The Comission finds that the individual dose criterion should not stand alone and believes the need for a companion collective dose criterion has two bases.
First, these criteria are being put forward as a means of demonstrating practical compliance with the ALARA principle. The ALARA process involves, among other considerations, the trade-offs between cost of dose or risk reduction and the magnitude of the reduction in population dose achieved.
Furthermore, since the individual dose criterion is not claimed to represent a negligible or de minimis individual dose, the sum of the individual doses from a given practice cannot be considered negligible.
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l Second, the Comission believes a collective dose criterion is necessary to provide reasonable assurance that total doses to individuals from all practices will hot approach 100 mrem per year (1m$v per year). This l
consideration specifically applies to the potential exposure of some few l
l individuals to multiple practices and, in particular to those practices or classes of practices involving potential widespread, direct distribution of radioactive material to members of the public (i.e., in the fem of consumer products, or recycled equipment or materials containing residual levels of radioactivecontamination). The Comission notes that the uncertainties in establishing reasonable scenarios through which the public may interact with these products, equipments or materials, creates uncertainty in the calculation of individual doses, and as a r'esult argues for a compensatory provision of collective dose as a matter of regulatory prudence. Furthermore, for these practices, effective dose reductions may be possible at relatively small cestsu As a result, a practice must also result in a collective dose of less thak $00
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person-rem per practice per year in order for the Comission, based on tt ese criteria alone, to agree that further resources need not be expended to e omply #
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I with the AlkRA principle.
n.pogs Tne Comission stresses that adoptinu cf the individual and collective dose criteria should not be construed as a decision that doses below these criteria go are necessary before a practice can be exempted, while doses above the criteria would preclude exemptions.
On the contrary, the criteria simply represent a
,p range of risk which the Comission believes is sufficiently small compared to other individual and societal risks that further cost-risk reduction analyses, ['
or mere broadly ALARA analyses) are not required in order to make a decision
_g regarding the acceptability of an exemption.
Practices not meeting these V*
criteria may be granted exemptions on a case-by-case basis in accordance with the principles embodied within this policy. To further emphasize the JD Comission's recognition that a rigid limitation is inappropriate, it notes that for some practices, such as use of smoke detectors, collective doses have been estimated to exceed 500 person-rom per practice per year, yct appreciable benefits can only be attained through extensive utilization and, hence, with a comensurate collective dose.
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The Consission is aware that existing and fu re regulations of the Environmental Protection Agency for enviro ntal protection (e.g., the Clean Air Act) may establish criteria for spect ic practices more restrictive than exemptions which may be granted under t s proposed policy. Any affected NRC regulations developed on the foundati of this policy may need to be mytowed and, if necessary, revised.
am n ;M*5"'*]" With regard to its own mgulations, the Comission wi.1..1..w....mer there are exemption criteria embodied therein for which modification, according to the principles of this policy,,would penficial,
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since it is not possible to foresee every possible use of radioactive material that may be proposed in the future, the Comission does not believe it is possible to prejudge an/ class of practices as innately unjustifiable.
However, the Comissten continues to believe that them are certain classes of practices involving radiation or radioactive materials which potentially have I
little or no benefit to society (e.g., consistent with the policy statement on consumer products, March 16,1965,30FR3462). These practices could include, but are not be limited to, the intentional introduction of radfoactive material into toys, novelties, and non-medical products intended for ingestion, l
inhalation er direct application to the skin (such as cosmetics). The Commission's determinations regarding the justification of these practices will also include consideration of any non-radioactive alternatives; that is, there i
l should be a net benefit of the radioactive over the non radioactive L
alternative.
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VI. PROPOSALS FOR EXEMPTION l
A proposal for exemption must provide a basis upon which the Comission can detemine if the basic conditions described above have been satisfied.
In general, this means that the proposal should address the indivit,al and societal impact (i.e., benefits and detriments) resulting from the expected activities under the ecmption, including the uses of the radfoactive materials, the pathways of exposure, the levels of activity, and the methods and constraints for assuring that the assumptions used to define a practice 14 i
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remain appropriate as the radioactive materials move from regulatory control to an ETWpt s
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If a proposal for exemption results in a rule containing specific requirements.
i e 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.,
consumer product rules in 10 CFR Part 30.
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 from other practicts.
If exposures from multipla practices can occur which are significantly beycnd the individual dose criterion (10 mrem per year (0.1 mSv As per year)), the exemption will not be granted withcut further analysis.
experience is gained, this policy and its implementation will be reevaluated f
with regard to this issue to assure that the exposures to individual members of f
the public from exempted practices remain well below 100 mrem, l
In addition to considerations of expected activities and pathways, the Commission recogni:es 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 conditions in tems of individual and collective dose.
VII. VERIFICATION OF EXEMPTION CONDITIONS The Commission believes that the implementation of an exemption under this broad policy guidance must be accompanied by a suitable program to monitor and verify that the basic conditions under which an exemption was issued remain valid.
In most cases, the products or materials comprising an exempted practice will move f rom regulatory control to the exempt status under a defined 15
56 e
i set of conditions and criteria. The monitoring and verification program established by licensees, who propose to release materials under the provisions of regulations or Itcensing conditions oeveloped from this policy, 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 Comission will determine compliance with the specific conditions of an exemption through its established itcensing and inspection program and will, from time to time, conduct studies as appropriate to assess the impact of an exempted practice or combinations of exempted practices.
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Enctosure Z
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CONCEPTS FOR ESTABLISHING BRC LEVELS EPA Comment There are two essential elements of any decision to limit regulation of a j
practicethat,whilebeneficial[ justified),cancauseradiationexposureto j
the general public.
The first is that the deleterious impact of the practice on health in the exposed population, taken as a whole, is small enough that the effort and expense of regulation of the radioactive hazard is not warranted.
The second is that the risk to any person is small enough that the majority of individuals would not consider it of concern.
Neither element is adequately addressed by the proposed policy [ advance notice of a proposed policy statement).
NRC Response On the contrary, we believe the discussion in the advance notice reflected our appreciation of these elements.
A major purpose of the proposed policy would be to establish criteria which would, in effect, delineate achievement of ALARAforajustifiedpracticei.e.(cost-riskreduction) efforts. indicating when a licensee n further resources for cost-benefit The advance i
notice stated that the Commission is evalutting the use of two numerical criteria in defining the region where ALARA has been achieved:
a) a criterion for the maximum individual annual duse reasonably expected to be received as a result of the practice and (b) a measure of societal impact t3 the population.
An individual dose criterion was proposed (i.e.,10 mrem per year) but comments were solicitee on whether, or in what form, a societal impact criterion should be proposed.
The Commission recognized that a collective dose criterion could be used to address societal impact but questioned whether alternative approaches could be devised to defit s a minimal societal impact for a given practice (e.g.
setting different individual dose criterion on the basis of the number of people potentially exposed and the distribution of the expected individual l
doses). Therefore, although the Commission has questioned how to characterize the societal impact criterion (including consideration of the argument that the societal impact of the total of all trivial or negligible individual risks should be treated as being negligible), conceptually, the need for such a criterion has not been rejected.
As a result, we believe both of the two I
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epa Comment The proposed policy could be considered arbitrary since, without definition l
of a practice, an optimization assessment can not be performed.
Sufficient l
experience should be gained with individual case from which a trend may emerge permitting generalization to a single set of generic numerical criteria for BRC.
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]Q NRC Response The NRC believes the approach described in IAEA Safety Series 89, can be followed. This approach would involve the definition of both an appropriate individual risk and a minimal societal-impact.
The value of the societal impact would be such that most reasonable people would agree that the broad societal cost of any regulation would be greater than the value chosen,lation and that regulatory resources would be better spent on the control and regu of more risk significant radiological activities.
As the discussion 'n the advance notice indicates, the individual criterion could be based on a fatality risk judged to be of little concern to most members of society (e.g., a risk which the individual would not spend resources to avoid). The importance j
attached to optimization assessments was also reflected in our recognition that there could be situations in which the optimization evaluation for a specific practice could indicate the.t an exemption should be granted, even though calculated individual and collective doses may exceed the aforementioned criterion values.
The discussion in the advan:e notice, however, does need to be improved since we have received many comments indicating that many readers believed that the Commission was proposing that practices causing potential individual exposures approaching public dose limits would be routinely exempted from regulation.
This is not the case,and in developing a proposed policy for Commission consideration, the NRC staff intends to rewrite and clarify this point.
THE EXEMPTION LEVEL FOR INDIVIDUAL DOSE EPA Comment At the international workshop in October 1988, there appeared to be virtual unanimity thet a 10 mrem / year value was too high as a criterion for establishing when licensees need not expend further resources on ALARA or optimization efforts.
NRC Response l
On review, we believe your conclusion is somewhat overstated. Our view was that most participants considered individual effective dose equivalents in the rhnge of 1-10 mrem per year to be " trivial." The discussion at the meeting revolved around the issue of how this number should be " fractionalized" to apply to a single practice.
Our approach was to establish the individual dose criterion on the basis l
of 6 risk level which the Commission believes most individuals would not spend l
their resources to avoid.
This represents a slightly different approach than the trivial risk basis used internationally.
However,theNRCis'stillactiveli considering what individual dose criterion should be proposed and what rationale should be used to defend the selected value.
Your comments on this issue will receive serious consideration.
EPA Comment Consideration of exemptions involving the possibility of exposures as high as 100 mrem per year is totally inappropriate.
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NRC Response As stated in the advance notice, the intent of the policy is to assure that individual exposures to the public remain well below 100 mrom per year.
The intent of the discussion in the advance notice was to reflect flexibility in the regulatory decision-making process regarding exemptions.
For example, there may be rare instances where exemptions, on the basis of an optimization evaluation, could be granted for practices where a few individuals could receive doses above 10 mrem per year. Our intent is to clarify this point in the proposed policy statement.
epa Coment The individual risk levels associated with doses in the 10-100 mrem / year i
range are not consistent with many Congressional and regulatory actions being l
taken relative to other environmental contaminants.
NRC Response The NRC is aware of this issue and is concerned that all of the many factors important in establishing acceptable health risk levels be considered for each environmental contaminant.
Populations impacted, distribution of individual impacts, uncertainties in health impacts, persistence of the purported ht:ard, the potential for multiple exposures, and other issues -- all must be addressed in establishing " risk-based" regulatory policy.
Our intent is to discuss this issue of consistency further in the development of the proposed policy.
EPA Cement The dose to risk conversion factor used in the advance notice is out-of-date.
NRC Response The NRC was aware of the impending recomendations regarding dose-to-risk conversion factors as the proposed policy was being developed.
In lieu of speculating on the implication of unpublished data, the discussion in the advance notice indicated that the Comission included a rargin-of-safety in establishing an appropriate individual dose value.
However, with the iminent publication of the BEIR V report and the recent publication of the 1988 report by the United Nations Scientific Comittee on the Effects of Atomic Radiation, the NRC staff will include consider & tion of these developments in its recomended proposed policy.
COLLECTIVE DOSE EPA Coment Any decision to exempt a practice from regulatory control needs to include an evaluation of the total impact of the exemption on public health.
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NRC Response As mentioned previously, the discussion in the advance notice recognized that the total in. pact of any exemption decision on public health and the environment needs to be considered. The NRC staff is currently evaluating the i
efficacy of using collective dose, or some other alternative, to address total i
social impacts.
EPA Comment There is no valid scientific basis for truncations in the assessment of collective dose in the exemption decision making process.
I NRC Response Although the Commiss n asked for oree on this ct. I woul mphes e
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that neither the adva notice nor staff's or.
1 draft posed policy {
included a decision reg ing tru ons. 'On s po uld further note that an assessmer.t of th oto octet im ft of an e ndecisiondoes,0)l the numetsel not necessarily preclude th sefulness trunct provis fq process of evaluating coil ve dose x
IMPLEMENTAT!ON EPA Coreent Upper limits for doses to populations cannot be assured if exemptions were persitted to cause potehtial exposures approaching 100 mrem / year.
NRC Response This would be true if such exemptions involved widespread individual exposures at this elevated level or were routinely granted. However, as discussed previously, this is not the intent of the policy. While it may be possible to grant an exemption involving doses above 10 mrem in some cases, these would be rare and would involve special measures to assure that the individual doses for the limited population involved would not exceed 100 mrem per year.
EPA Coreent How would there be assurance that some source-specific limits are not exceeded as a result of exemption decisions?
NRC Response The advance notice made reference, and we are aware, that certain existing or proposed regulations may impose addittohol restrictions on exemption decisions, i f this is the case, the effect of compliance with these more restrictive regulations would be to further assure that no individual member of the public is likely to approach an annual exposure of 100 mrem per year from all sources.
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EPA Comment Theproposedpolicy[advancenoticediscussion)isnotconsistentwith international recommendations.
NRC Response The NRC staff is familiar with IAEA Safety Series 89, " Principles for the Exemption of Radiation Sources and Practices from Regulatory Control" and its forerunner draf ts and, in fact, attempted, in many cases, to use this document as a model for certain sections of the draft proposed policy originally prewsted to the. Comission. As you correctly point out, a major difference involves the selection of the individual dose criterion which, wh,en coupled with other requirements, would delineate when a licensee need not expend further resources to minimize radiological im The international approach uses the concept
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of trivial (or negligible) pacts. individual risk while the Commissions' proposal is tied to a Commission policy judgement on the level of risk below which an
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individual would not expend resources to avoid. Although the NRC staff believes this is a significant distinction, we are reevaluating all our alternative establishing criteria for defining a " floor" for ALARA evaluations.
s EPA Comment The discussion in the advance notice is inconsistent with the Commission's own policy on BRC for low level v tste issued in August,1986.
NRC Response The NRC does not believe there is an inconsistency. The 1986 policy involved the achievement of regulatory expediency; that is, the policy provided the criteria which must be met, if a petition for rulemaking on "BRC-disposals" was to'be treated by NRC in an expeditious manner. The implication of expeditious treatment was that the NRC could publish a proposed rule within 6 or 7 months of receipt of the petition, but does not imply that exemptions would be granted only if the criteria of the policy were met. As stated in'the advance notice, the Commission will evaluate whether there are exemption criteria embodied (within its own regulations) for which modifications according to the principles of this policy, would be beneficial.
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COMMENTS ON ADVANCE NOTICE General In response to the publication on December 12, 1989 of an advance notice regarding the subject policy, 203 coment letters were received, most during the conth of February and many in March, after the official January 30, 1989
-comment closing date. The issues raised in these letters have been categorized into 33 subject areas which include the subjects for which coment was explicitly solicited in the advance notice. The comment letters were almost evenly split, with slightly more than half supporting the need for a Commission exemption policy. The comment letters included about-135 from individuals, of which about 1/5 identified themselves as health physicists. Two of these letters frcm individu61s were petitions expressing opposition to policy development.
There were 21 letters from public interest groups,18 from utilities or their representatives,11 from industry, 7 from state or local government organizations, 3 from professional societies, 2 from members of the National Counct) on Radiation Protection and Measurements (NCRP), one from the.
U.S. Environmental Protection Agency, and two from members of Congress, gment Summary A sumary of the substance of the major comments is as follows:
' Support /Oppcsition to Policy Development Those opposed to policy development generally stated that any health risk should not be the subject of deregulation. Most of these commenters focused on LLW disposal and believed that disposal of radioactive material in-licensed facilities should be considered a cost of doing business. The pcssibility that implementation of the policy co9ld lead to abuses or accidents was also sited in several letters. Many ei these commenters were not aware that exemption regulations exist and that case-by-case licensing decisions involving exemptions have been made.
A large number of these comenters believed an exemption policy completely eliminated NRC regulatory involvement in the exempt practice.
Those favoring policy development focused on the issue of optimum use of licensee an regulator resources, believing resources spent to control small or negligible risks could be better directed at more significant problems.
' Criteria (Criterion) For Establishing " Floor" For ALARA Most commenters acreed that a criterion feriteria) should be included to establish a ' floor" below which it should be unnecessary to expend resources to further comply with ALARA principles.
Several stated that, to be effective, numerical criteria were needed and not broadly defined ranges (e.g. a few
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arem). Most reflected the Health Physics Society position, believing the
" floor" could be defined through use of an individual dose criterion alone r-b without the need for a collective dosa or societal impact criterion. The argument used by many of these comenters was that protection of the individual assured protection of society. Others specifically related their opposition to the uselessness of a collective dose criterion when considering exemptions involving LLW disposal practices. A number of these comenters recognized that in addressing other practices, such as consumer products, the magnitude of the l
population exposure would have to be a consideration. A few comenters.
~ including the EPA and former Comissioner Kennedy, presented arguments for-including a societal impact criterion which together with the individual dose criterion, would respectively, detemine if an exemption could be granted or define the " floor" below which further ALARA efforts would not be required.
Both these comenters, believed that some assessment of societal impact was mandatory to the decision process regarding an exemption for regulatory L
cuntrol.
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'Value Selected for. Individual Dose Criterion Almost all comenters in favor of an exemption policy believed that
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10 mrem / year was a conservative but acceptable value for the individual dose
. criterion. Other values, as high as several hundred millirem / year were I
suggested, with many proposing 20 mrem / year. Notable exceptions to these views included the EPA, the DOE, fomer Comissioner Kennedy, a pro-nuclear interest
. group (California Radiation Materials Mar.agement Forum), the Conference of Radiation Control Program Directors and responders from the NCRP, who believed 10 mrem / year may be too high a value, and that a lower value, consistent with inttrnational views, would result in greater acceptance of the policy as a whole.
' Applicability of the " Justification of Practice" Principle L
On the applicability of the justification of practice principle to exemption l'
decision-making, opinions were split with many believing that this principle should not be-applied to practices meeting the "ALARA floor" criterion (which comenters frequently referred to as, " meeting the "BRC" criterion").
i Many utility comenters believed that the discu:sion in the advance notice l
l confused justification of practice with ALARA. These connenters stated that l-since practices such as nuclear power have already been justified, the issue of eFempt vs Controlled cisposal of LLk' is simply &n optimization of protection or
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l ALARA issue. A few recognized that, because.of the broad nature of the policy, justificttion of practice can be an issue in the context of the distribution of L
new consumer products containing small amounts cf radioactive material, Although not completely logical, many comenters agreed that certain practices l
could be precluded from exemption but statec that NRC should not become involved in judging social acceptability of specific practices.
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Essentially all supporters of the need for a policy believed that flexibility t
should be maintained; that is, if a proper ALARA analysis $Upports an exemption for a practice in which an-individual dose could exceed the criterion value (e.g.10 mrom/ year), this practice should not be precluded from exemption consideration.
EPA, however, believes that, as a condition for exemption, no individual should receive 'a dose which is a significant fraction of existing public dose limits.
'Compatability with Agreement States A number of commenters stressed the need for making any exemption regulation a matter of exact corrpatibility with Agreement States. Other commenters, including two representing local governments, stated their belief that the low level waste' sites, being created as a result of state compacts mandated by the
. Low Level Radioactive Waste Policy Amendments Act of 1985, should be the repository for all low-level waste, and that there is no need for the Commission to define 'BRC" waste. These latter commenters often stated that allowing radioactive material to be disposed at local landfills would significantly complicate the already complex task of siting these facilities.,
'Value Used For Risk Coefficient Several commenters opposed to the development of an exemption policy, and one commenter favorine a policy, stated their belief that, based on most recent date, the risk coefficient cited in the advance notice was too low.
'Need for Perspective A number of commenters believed that far more perspective was needed to indicate the magnitude of the dose and risk levels being discussed in the policy. Several mentioned the differences in risk level used by NPC and other federal agencies (e.g., EPA), noting that the NRC values were less restrictive by almost two orders of magnitude.
'Penitoring of Exempt Practices All commenters who favored the development of the policy, and addressed the monitoring question, supported the need to monitor and enforce. licensee's compliance with any developed exemption regulations. Many, however, stated opposition to any requirement for Itcensee monitoring once the material was
' transferred from controlled to exempt status. These commenters believed such monitoring would be perceived to contradict the underlying basis for the-pclicy.
' International Consistency All who commented on the issue believed international consistency was desirable, but not necessary. A few agreed that consistency would be an element which would be helpful in gaining acceptance for a policy.
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-In early May, a meeting will be scheduled with the ED0 to discuss any RES disposition of Office comments on the major policy issues.
Your efforts, particularly in documenting the changes you propose and the reasons for them, would be appreciated.
ORIGIRAL SIGNED BT Eric S. Beckjord, Director Office of Nuclear Regulatory Research
Enclosure:
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1.
Prelim. Draft Prop. Pol. Statement 2.
Responses to EPA coments 3; Sumary of Major Comments Received in Response to the Advance Notice cc:
J. M. Taylor, OEDO H. L. Thompson,'Jr., OEDO Distribution: [0FFICEDIRECTORS2]
subj-circ-chron L'
Reading Files ESBeckjord DFRoss TPSpets BMMorris ZRRosztoczy Wlahs l
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RDA:RES DD P :RES D:DRA:REpsID:GIR:RES D:RES Name: Wlahs*:pt Ro oczy BMMorris' TSpeis*
ESBeckjord Date: 4/18/89-
-/ 9 4/81/89 4/18/89 4/if/89 0FFICIAL RECORD COPY
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APR 191999 r
MEMORANDUM FOR: Thomas E. Murley, Dimctor, Office of Nuclear Reactor Regulation C
Robert M. Bernero, Director, Office of Nuclear Materials
. Safety and Safeguards Harold R. Denton, Director, Office of Governmental and Public Affairs William C. Parler, General Counsel FROM:
Eric S. Beckjord, Dimetor, Office of Nuclear Regulatory y
Research l
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SUBJECT:
PROPOSED COMMISSION POLICY STATEMENT ON EXEMPTION FROM REGULATORY CONTROL The staff is expected to submit the subject proposed policy statement for Comission consideration by June 2,1989. This schedule necessitates submission of a Comission paper to the EDO by May 19, 1989.
In order to meet this schedule RES must receive comments from affected Offices and-resolve outstanding differences in an expedited manner.
In order to move forwa'rd to accomplish this task, the RES staff has prepared a
. preliminary draft proposed policy statement which is-attached as Enclosure 1.
This draft has included consideration of coments received (1) at the October January 12, 1989, and (3) y authorities (2) from the public meeting held on 1988 workshop of regulator through the 220 coment letters received in response to'the solicitation made in the December 12, 1988 Federal Register Advance Notice. We are also using this preliminary draft policy in discussions with the U.S. Environmental Protection Agency (EPA 1:to identify outstanding issues.
Our objective is to identify any outstanding issues, not only with EPA but among NRC Offices, so that the policy statement can be revised as appropriate.
In parallell with Office. review, RES intends to complete a package which will r
(11.sumarize coments received on the advance notice proposal and (2) provide proposed Comission responses. To assist you in your review, Enclosure 2 contains responses to EPA' coments while Enclosure 3 provides a sumary of the i
major coments received in response to the advance notice.
'I request that written 0 ce coments or con urrence on the enclosed policy statement be submitte April 28, 1989. R is, of course, mainly interested in coments on the jor olicy princt nd criteria, but we would welcome any~ suggestions f editor i deuses you may find appropriate. The contacts within the Offices who have, to date, assisted in the development of this policy are listed below:
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F. Congel L. J. Cunningham OGC R. Fonner GPA K. Schneider In early May, a meeting will be scheduled with the EDO to discuss any RES disposition o Office coments on the major policy issues. Your efforts, particularly in documenting the changes you propose and the reasons for them, would be appreci ted.
Eric S. Beckjord, Director Office of Nuclear Regulatory Research
Enclosure:
1.
Prelim. Draft Prop. Pol. St ment 2.
Responses to EPA comments 3.
Summary of Major Comments Rece ved s
in Response to the Advance Notice Distribution: [0FFICEDIRECTORS2]
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7 PRELIMINARY RES DRAFT Proposed Comission Policy on Exemptions from Regulatory Control I.
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 certain radioactive materials from the full extent of existing regulatory controls. The need has been driven by two recurring realizations. The first is the recognition that, for certain practices involving minimal public health and safety concerns, the imposition of undue and unnecessary regulatory controls could prohibit a practice which should otherwise be permitted because of reasonable social, economic, or industrial benefits. The second results from the nation's focus on fiscal responsibility and the knowledge that resources expended for regulatory control of practices with minimal radiological impacts could be better used to address more significant radiation protection concerns. To address this need, the Comission is expanding upon its existing policy for protection of the public 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 (Consumer Products), dated March 16, 1955; 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 i 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion includes the development of an explicit exemption policy for those Comission-regulated practices whir.h involve minimal public health and safety impacts.
The Comission, however, recognizec the benefits of uniform regulation and l-therefore, supports the development of broader Fsderal Guidance regarding exemption policies.
In doing so, the Comission realizes that, when signed by the President, the Federal Guidance could supplant this pe11cy.
l In this policy, a practice is defined as an activity or a set or c(ebination of a number of similar sets of coordinated and continuing etivities aimed at a given purpose which involve the potential for radiation uposure. Disposal of very low 1mi radioactive waste; thc release for unrestricted public use of layds and structu>ts with residual levels of radioactivity; the distribution, i
dnd ensume products containing small amounts of radioactive material;
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o and the recycle and reuse of residua 11y contaminated materf als and equipment
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- potential applicability.
It is the Comission's intent to broadly deffne speciffe practices in terms which will preclude any indfvfdual or population being significantly affected by similar $ffiRNes within a given Mhile, at the same time, identifying and describing the practice in terms which will facilitate reasonable impact analyses and allow imposition of appropriate constraints as the radioactive material passes from controlled to exempt status.
Under this policy, the definition of a ' practice" is a critical feature which will assure that the formulation.of exemptions from regulatory control will not allow deliberate dilution of material or fractionati,on of a practice for the purpose of circumventing controls that would otherwise be applicable. The definitior, will also provide the framework for taking into account the possible consequences of accidents or misuse associated with exemption decisions 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 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 government regulation to reduce risks is unwarranted.
The concept of regulatory exemptions is not new. The Atomic Energy Act of 1954, as amended, authorizes the Comission to exempt certain classes, quantities, or uses of radioactive material when it finds that such deregulation will not constitute an unreasonable risk to comon defense and l_
security and to the health and safety of the public.
In 1960 and 1970, the Comission used this authority to promulgate tables of exempt quantities and concentrations for radioactive material which a person, under certain L
circumstances, could receive, possess, use, transfer, own, or acquire without a l
reoufrement for a license (25 FR 7875 and 35 FR 6427).
Other exemptions 1
2
b allowing distribution of 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. For example, regulations currently specify conditions under which licensees are allowed to dispose of radioactive material-into a sanitary sewer system (Title 10. Code of Federal Regulations, Part 20, Section 303). That is, the regulations specify requirements which a licensee must meet if radioactive material is to be '
transferred" from a controlled to an uncontrolled status. Mort recently, Section 10 of the Low-Level Radioactive Waste Policy Amendments Act (LLRWPAA) of 1985 directed the Commission to develop standards and procedures for expeditious handling of petitions "...to exempt specific radioactive waste streams frou. regulation... due to the presence of radionuclides... in sufficiently low concentrations or quantities to be below regulatory concern.
The Comission responded to this legislation by issuing a policy statement in August 1986 (51 FR 30839). That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow the Comissien 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 enconassed within a broader NRC policy which defines levels of radiation risk below which specified practices would require only minimal, practice-specific NRC regulation based on public health and safety interests.
For such practices, the Comission's regulatory involvement could be essentially limited to-licensing, inspection, and compitance activities associated with the transfer of the racioactive material from a controlled to an exempt status.
That is, the Comission would define constraints which must be adhered to by NRC licensees if radioactive material is to be transferred from a controlled to an uncontrolled or exempt status.
The Comission recognizes that, if a national policy on en smptions from regulatory control is to be effective, Agreement States will play an important implementation role.
Pursuant to the LLRWPAA, States are responsible for providing, either alone or in cooperation with other States, for disposal of certain low-level radioactive wastes.
In the past, States have been encouraging findings that certain wastes are below regulatory concern and the 3
'4 JU d')L Commission believes that States will suppurt the application of a national policy on exemptions for specific practices involving distribution or release I 7 M.#
of radioactive anaterial. The Comission intends also that rulesekings I
Commission believes that States will support the application of a national policy on exemptions for specific practices involving distribution or release of radioactive material
_ The Coanission ir.tends also that rulemakings ccdifying exemptions in all areas will be msde a matter of strict compatibility for Agreement States. Consequently, any rulemakings that evolve from this policy will be closely coordinated with the States.
The Commission recognizes that its policy will potentially have a significant impact on nuclear reguation in the international community. The approach and criteria in this policy differ in some respects from those selected or under consideration by other countries.
It is the Comission's intent to continue its dialogue with tha international community in order to resolve, or foster mutual understandings of the rationales behind, differences in exemption policies.
II. RADIATION PROTECTION PRINCIPLES The Three Fundamental Principles of Radiation protection The Commission recognizes that three fundamental principles of radiation protection have historically guided the formulation of a system of cose
-limitation to protect workers and the public from the potentially hamful effects of radiation. They are (1) justification of practice, which requires that there be some net societal benefit resulting from the use and disposition of radiation or radioactive materials, (2) dose limits, which define the upper boundary of adequate protection for a member of the pubite 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.
Dose Estimation In estimating the dose rates to members of the public that might arise through the use of various practices for which exemptions are being considered, the 4
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Cosnission has decided to apply the concept of the
- effective dose equivalent.*
This concept, which is based on a comparison of the delayed mortality effects of ionizing radiation exposures, permits through use of weighting factors, the calculation of the whole body dose equivalent of partial body exposures. This approach was proposed by the International Commission on Radiological Protection in its Publication 26, issued in 1977. Since that time, the concept has been reviewed and evaluated by radiation protection' organizations throughout the world and has gained wide acceptance.
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Estimating Health Effects From Radiation Exposure N
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Individual Risks In the establishment of its radiation protection policies, the Commission has considered the three major types of delayed health effects which can be caused by exposures to radiation: cancer, genetic effects, and developmental anomalies in fetuses. Regulatory agencies, including the NRC, focus on the risk of fatal cancer development. This is done principally because, at relatively high radiation doses: (11 the best data base exists for cancer mortality (2) the mortality risk represents a more severe outcome then the non-fatal cancer risk and (3Lthe mortality risk ishigherthantheriskassociatedwithgenetic[fetaleffect j#
However, even though radiation has been shown to be carcinogenic the 4
-v development of a risk factor applicable to continuing radiation exposures %fcgAR at levels-equal to or far below natural background roquires a-significant #4 I
extrapolation from the observed effects at much higher doseskresult is a significant uncertainty reflected by the views of experts in the ~M6u field. For example, the National Academy of Scionee's Cosmittee on the 1
Natural background radiation can very with time and a person's location.
In Washington, DC natural background radiation (excludin; redon1 results in individual doses of about 90 mrem per year, while in Denver, Colorado the.value is about 160 mrem per year including, in both cases, a contribution of about 40 mrem per year from natural radioactivity contained in the human body.
2 The health effects clearly attributable to radiation have ocurred principally amorg early radiation workers, survivors of the atomic bomb explosions at Hiroshima and Nagasaki, individuals exposed for medical purposes, and laboratory animals. Natural background causes a dose over a one year period which is at least two orders of magnitude less than the l
dose received by populatioris from which the cancer risks are derived.
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Biological Effects of lonizing Radiation, has cautioned that the risk values are "... based on incomplete data and involve a large degree of uncertainty, especially in the low dose region." This Committee also stated that it "...does not know whether dose rates of gasma or x-rays (low LET). [ low linear energy transfer radiation] of about 100 erads/ year ?
are detrimental to man." {g g y pprcu Age, /.AEE.Mse _
In the face of this and sistler cautions, the NRC. the Environmental 4 W M#
Protection Agency, and other national and international radiation protection authorities have established radiation standards defining d, f.
recomended dose limits for radiation workers and individual asabers or the public. As a matter of regulatory mdence, all thek bodies have derived the value presumed to apply at lower dose and dose rates associated with the radiation protection standards by extrapolation from values derived at higher doses and dose rates. The extrapolation is frequently referred to as the ho-threshold hypothesi'.M s
4 w+.
The Comission, in the development of an exemption policy, is again faced with the issue of how to enaracterize the individual and population risks associated with low doses and dose rates. Although the uncertainties are large, useful perspective en the bounding risk asso:tated with very low-levels of radiation can be provided by continued use of the no threshold hypothesis. Consequently, such risk estimates will be a factor in estabitshing individual and collective dose criteria. associated with this policy. The estimations of the low risk from potential exempted practices can be compared to the relatively higher potential risks associated with other activities or decisions over which the NRC ha's regulatory responsibility. Through such comparisons, the Commission can assure that its radiation protection resources and those of its licensees, are expended in an optimal manner to accomplish its public health and safety mission.
In this context, the risk to an individual, as calculated using the no threshold model, is shown in Table 1 for various defined levels of annual
-individual dose. The values in the lifetime risk column are based on the further assumption that the annual dose is continuously received during 6
e
,w ug each year of a 70-year lifetine. To provide further perspective, a q
radiation dose of 10 mrem per year (0.1 mSv per year) received -
continuously over a lifetime corresponds to an estimated hypothesized increase of about 0.25f in an individual's lifetime risk of cancer death.
i I
Table _1 Hypothestred Hypothesized-
! Incremental Incrementa1 Lifetime Risk from 2
2
' Annual Dose ~
Annual Risk Continuino Annual Dose I
5 x 10-5 3.5 x-10'3 i
100 -
mrem 5 x 10-6 3.5 x 10'4 10 mrem
.5 x 10'7 3.5 x 10-5 1
mrem 5 x 10-8 3.5 x 10-6 0.1 mrem IUnless otherwise; indicated, the expression of dose in arem refers to the -
Total Effective Dose Equivalent. This tem 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.
l Risk coefficient of 5'x 10 ~4 per rem for low linear energy transfer -
2 b
radiation based upon BEIR V.
b.
_ Collective or Population Risk In the application of the fundamental principles of radiation protection, collective dose provides a useful way to express the radiological impact (i.e., potential detriments) of a nuclear activity on the health of the population subject to radiation exposure. Collective dose is the~ sum of.
the individual' doses. resulting from a practice or source of radiation e'xposure.
By assigning collective dose a monetary value, it can be used in comparative cost-benefit and other quantitative analysis techniques.
It is therefore an important factor _ to consider in balancing benefits and societal detriments for practice justification and in the carrying out of ALARA determinations. The NRC has used collective dose in this manner in a number of rulemaking decisions and decisions involving resolution of a variety of generic safety issues.
Derivation of Measurable Quantities from Dose / Risk Estimates The Comission recognizes that it is impossible to measure risk to individuals or populations directly, and, that in most situations. it is impractical to y
7 1.
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measure annual doses to individuals at the low levels potentially associated
'with its exemption decisions. Typically, radioisotope concentrations or radiation levels from the material to be er.empted are the actual measurements that can be made, and doses are then estimated by exposure pathway analysis -
combined with other types of assumptions related to the ways tri which people might become exposed. Under such conditions, conservative assumptions are frequently used in modeling so that any actual dose would be expected to be lower than the calculated dose. The Comission believes that this is the appropriate approach to be taken when detemining if an extmption from regulatory controls is warranted.
III. APPLICATION'0F RADIATION PROTECTION PRINCIPLES TO EXENPTIONS'FRfH REGULATORY CONTROL The following sets forth guidelines about how the Comission will apply the fundamental principles of radiation protection in consideration of practices l
which are proposed to be exempt from certain regulatory controls. These practices, if approved, would result in low levels of radioactive material in products being distributed to the general public and radioactive effluents and solid waste being released to areas of the publically-accessible environment.
l Justification - Decisions regarding justification of practice usually derive from considerations which are much broader than those based on i
radiation protection alone. Therefore, these decisions may be made in a broader context before the need for regulatory control is addressed (or the need for exemptions from certain aspects of control,asaddressedinthispolicy). The Comission continues to believe that any practice causing a potential radiation exposure should be justified; however, as lower levels of individual and population dose are projected, lower levels of benefit will be(needed) to achieve a positive balance although other societal impacts of a practice must also be considered.
The Comission will continue to identify or characterize certain practices for which benefits are l
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y considered marginal and for which there appears to be no reasonable m
. justification.
I -
L Dose Limits - Individual doses from practices exempted under this L
policy should generally not be allowed to exceed a small fraction of 100 mrom per year (ImSv per year). This is the non-occupational dose
-limit recomended by the International Comission on Radiological.
1 L
Protection and the National Council of Radiation Protection and Measurements for continous exposure from man-made sources of '
li#~s also'the value specified in the radiation other than medical 1
final revision of 10 CFR Part 20, Standards for Protection Against-0 Radiation. The dose limits in the final revision of 10 CFR Part N i
apply to all sources of radiation exposure under a licensee's control (natural' background and medical exposures are specifically excluded),
i ALARA - Once a practice has been justified and controls are in place L
to assure that dose limits are not exceeded, it is necessary to design and plan the subsequent use and disposal of the sources of radiation in a' manner which ensures that exposures are as low as reasonably achievable, economic and social factors'being taken into-l account. As a result, this principle applies when considering a practice for possible. exemptions from some or all regulatory L
controls.- This requirement that doses be ALARA has-been a part of NRC regulatory practice for a number of years and.is-now fomally i
L embodied in the revisions to Title 10 Code of Federal Regulations, Part 20. However, no policy or criteria have been provided wh,1ch would establish the bases for defining a generic " floor" to ALARA. A major purpose of this policy is to establish criteria which would delineate when further regulatory and licensee resources need not be spent to further reduce radiation exposures from a practice for which an exemption decision is being considered.
u!;
- Although it is possible to project what the dose will be from a practice, and then take this infomation into account in controlling regulated practices so that the dose limits are not exceeded, exemptions involve a reduction or elimination of some or all controls.
In view of this, the Comission believes t
9 l-L
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that a key objective in establishing a policy for exemptions, is to provide adequate assurance that individuals will not experience radiation exposure approaching 200' mrem per yeapamSvpr gthrough the cumulative effects of more than one exempted practice even though the exposures free any single g
exempt practice would be expected to be a sm611 fraction of this value. By apprcpriate choices of exemption criteria and constraints, and through its
[
evaluations of specific exemption proposals, the Cosnission intends to assure that it is unlikely that'any individual will experience continuing exposums which approach or exceed 100 arem per year (ImSv per year) from all exempted practices m M M W = &,
so, IV.
PRINCIPLES OF EXEMPTION L
A major consideration in exempting any practice from some or all regulatory i
controls hinges on the general question of whether or not application or continuation of regulatory controls are necessary and cost effective in reducing dose. To detemine if exemption is appropriate, the Commission must determine if one of the following conditions is met:
l 1.
The application or continuation of regulatory controls on the
. practice does not result in any significant reduction in dose received by individuals within critical groups and by the exposed population or; 2.
The costs of the regulatory controls that could be imposed for dose reduction are not balanced by the comensurate reduction in risk that could be realized.
For purposes of implementing its policy, the Commission recognizes that only under unusual circumstances would exemptions be considered for practices which could cause continuing radiation exposure to individuals exceeding a small-fraction of 100 mrem per year (ImSv per year). The Commission 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 10
11 h Sys!t" ab.
reasonably be somewhat simp 1tfied. At a sufficiently low level of individual
. risk, decisions justifying the distribution to er use of radioactive material by individuals hot controlled by NRC licenses, or decisions granting specNic exemptions from regulatory control for a justified practice may be reduced to an evaluation of whether the overall individual and public risk is sufficiently Ah small.
f s 4
+AM4 JA The.Comission therefore proposes that two numerical criteria should be l
established in defining the region where the risk reduction does not warrant l the expenditure of Comission or licensee resources to bring about a further incremental compliance with the Al. ARA principle., Thjy are (a) a criterion for-g, the maximum individual annual dose r"eaYr.a$y eitpecteItNNiv dYa hW result of the practice and (b) a seasure of societal impact to the exposed population.
In combination, these criteria are chosen to assure that, for a given exempted practice, no individual will be exposed to a significant L
radiological risk and that the population as a whole does not suffer a significant impact.
The Individual Dose Criterion l
l If the individual doses from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared to other L
societal risks and the merit of expending resources to further reduce the dose or risk from a justified practice can be seriously questioned. The Comission believes the ~ definition of this risk or dow level can be developed from two perspectives. The first is the risk perspective. The Comission believes that l'
most members of society will not expend resources to reduce an annual individual fatality risk below approximately 10-5 (i.e., I chance in 100.000).
This risk level is comparable to that (i.e. 2x10-6) selected by the Comission L
in the development of its safety goal policy - (i.e., a risk level equal to 0.1%(1/1000) of the sum of cancer fatality risk from all other causes). Using the no threshold hypothesis, the incremental continuing annual individual exposure level associated with this " safety goal" risk. level can be estimated as 4 mrem per year. The second perspective is based on those variations in dose tolerated by individuals because of factors such as their lifestyle or place of residence. The Comission notes that resources are not expended to 11 L
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reduce differential exposures associated with variations in natural backgroun j
radiation (e.g..the 70 mrom per year difference between annual doses received gg in Denver, Colo' ado vs Washington, DC).
Nor are resources spent to reduce the OM r
7-10 mrem dose which an individual would receive during a single round trip coast-to-coast aircraft flight or the dose from other activities which involve doses representing a small fraction of background radiation.
i In view of the uncertainties involved (such as, the applicability of the no-threshold model itself and its input data) and taking into account the results of analysis from both the risk and dose perspectives, the Commission f//M finds an individuc1' dose of 10 mrom per year to be appropriate for use as one of two boundary criteria which would define whether or not additional resourcesiMM need be spent to comply further with the ALARA principle. The Cossnission considers this value to be appropriate given the uncertainties involved and notes that, at this value, implementation of this policy in future rulemakings a g;.,,,,c, / l M
or licensing decisions should be a practical undertaking.
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-72.,A d C MF The Societal Impact Criterion DW A,d In proposing criteria which would demonstrate practical achievement of ALARA,p;g g the Consr.ission seriously considered whether the imposition of the individual dose criterion would also provide a sufficient measure to.iudge societal impact, and, thus, could stand alone-as a basis for detemining when further resources need not be expended to further comply with the ALARA principle. The Commission finds that the individual dose criterion should not stand alone and believes the need for a companion collective dose criterion has two bases.
First, these criteria are being put forward as a means of demonstrating practical compliance with the ALARA principle. The ALARA process involves, among other considerations, the trade-offs between cost of dose or risk reduction and the magnitude of the reduction in population dose achieved.
Furthermore, since the individual dose criterion is not claimed to represent a negligible or de minimis individual dose, the sum of the individual doses from a given practice cannoty e considered negligible.
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- w Second, the Comission believes a collective dcse criterion is necessary to - gy provide reasonable assurance that total doses to individuals from all exempted
~
practices will-hot approach 100 mrom per year (1mSv per year). This p
consideration specifically applies to the potential exposure of some few L
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L individuals to multiple practices and, in particular to those practices or L
classes of practices involving potential widespread, direct distribution of radioactive material to members of the public (i.e., in the fom of consumer b
' products, or recycled equipment or materials containing residual levels of L
radioactivecontamination). The Comission notes that the uncertainties in L
establishing reasonable scenarios through which the public may interact with
-these products, equipments or materials, creates uncertainty in the calculation of individual doses, and as a result argues for a compensatory provision of l
collective dose as a matter of regulatory prudence. Furthermore, for these practices, effective dose reductions may be possible at relatively small costs.
As a result, a practice must also result in a collective dose of less than 500 person-rem per practice per year in order for the Comission, based on these criteria alone, to agree that further resources need not be expended to comply with the ALARA principle.
l The Comission stresses that adop' tion of the individual and collective dose criteria should not be construed as a decision that doses belev Mir.se criteria 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 further cost-risk reduction analyses, or more broadly, ALARA analyses) are not required in order to make a decision regarding the acceptability of an exemption.
Practices not meeting these criteria may be granted exemptions on a case-by-case basis in accordance with the principles embodied within this policy. To further emphasize the Commission's recognition that a rigid limitation is inapprig? late, it notes that for some practices, such as use of smoke detectors, collective doses have been estimated to exceed 500 person-rem per practice per year, yet appreciable benefits can only be attained through extensive utilization and, hence, with a commensurate collective dose.
13
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e ngulations of the 1;~ Comisstori is aware.th'at extsting end fu urionmentalprotec t
ictive then.
Ij iironmental_ Protection Agency for env r iteria for specific practices more restrropose L
viewed l
.rAct)mayestablishcr lemptionswhichmaybeigrantedunderthis;ptions of this policy its own re compatibiitty. With regard to_are exemptio Jagulations' developed on the founda a
nd, if;necessary, revised, to ensumissier; will evaluate whether ther principles of this j
h stbodied therein for which modification, according to C
Mcgulations, the' om il Jpolicy..would be benefic a.
't
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. JXCLUS10NSFROMEXEMPTIONS ossible use of radioactive materia
^
l 0 V.
it is Since it is not possible to foresee every p the Commission does not believe actices as innately unjustifiable I
E : that may be proposed in the future, f
f possible to prejudge any class.c prHowever, th l have dioactive materials which pote Lpractices involving radiation or ralittle or no be These practices could include, f1 0 FR 3462).al introduction of radio
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16,1965,3 L
consumer products. March but are not be limited to, the intent onl products intended for in i
The kin (such as cosmetics). practices will I into' toys, novelties, and non-medica inhalation er direct application to the s h
regarding the justification of t esen r is, there
! Commission's determinations i
also include consideration of any no -adioactive over the non-radi h
should be:a net benefit of t e r b
alternative.
[
PROPOSALS FOR EXEMPTf0N basis upon which the Commission can VI.
In ibed above have been satisfied.
A proposal for exemption must provide a l should address the individual a determine if the basic conditions descr ected and detriments) resulting from the exp general. this means that the proposa i
l ding the uses of the radioactive
- s'ocietal impact (i.e., benefits h
ethods the levels of activity, and t e m activities under the exemption, inc u actice materials, the pathways of exposure,the assumptions used t
~and constraints for assuring that 1A i
g.-
k; m
remain appropriate as the radioactive materials move from regulatory control to an exempt status.
-If a proposal for exemption results in a rule containing specific requirements, a person applying to utilize the exemption would not need to address justification or ALARA. The Com !ssion 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 considerttions ha've been dealt with. This approach is consistent with past practice, e.g.,
consumer product rules in 10 CFR Part 30.
In evaluating proposals for exemption under this policy, the projected exposures to different component'; of the exposed population will be considered with regard to the potential that some individuals may receive doses from other practicts.
If exposures from multiple practices can occur which are significantly beyond the individual dose criterion (10 arem per year (0.1 mSv per year)), the exemption will not be granted without further analysis. As experience is-gained, this policy and its implementation will be reevaluated with regard to this issue to assure that the exposure's to individual members of thepublicfromexemptedpractices/remainwellbelow100arem.
4-mAqWp A
.In addition to considerations of expected activities and pathways, the Comission 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 conditions in terms of individual and collective dose.
VII. VERIFICATION OF EXEMPTION CONDITIONS The Commission believes that the implementation of an exemption under this broad policy guidance must be accompanied by a suitable program to monitor and verify that the basic conditions 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 15
4 4
. set of conditions and criteria. The monitoring and verification program established by licensees, who propose to release materials under the provisions L
- of' regulations or licensing conditions developed from this policy must therefore be capable of providing the Comaission with the appropriate assurance that the conditions for the exemption remain valfd and that they are befng observed. The Commission will detemine compliance with the specific conditions of an exemption through its estabitshed licensing and inspection program and will, from time to~ time, conduct studies as appropriate to assess j
the impact of an exempted practice er. combinations of exempted practices.
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CONCEPTS FOR ESTABLISHING BRC LEVELS EPA Comment There-are two essential elements of any decision to limit regulation of a practice that, while beneficial [ justified), can cause radiation exposure to the general.public.
The first is that the deleterious impact of the practice on health in the exposed population, taken as a whole, is small enough that the-effort and expense of regulation of the radioactive. hazard is not warranted.
The second is that the risk to any person is small enough that the majority of individuals would not consider it of concern.
Neither element 'is adequately addressed by the proposed policy [ advance notice of a proposed policy statement].
NRC Response On the contrary, we believe the discussion in the advance notice reflected our appreciation of these elements.
A major purpose of the proposed policy would be to establish criteria which would, in effect, delineate achievement of ALARAforajustifiedpracticei.e.[ cost-riskreduction) efforts. indicating when a licensee need further resources for cost-benefit The advance notice stated that the Commission is evaluating the use of two numerical criteria in defining.the region where ALARA has been achieved:
a) c criterion for the maximum individual annual dose reasonably expected to be received as a An individual dose criterion was proposed (i.e., 10 mrem per year) population.
result of the practice and (b) a measure of societal impact to the but comments were solicited on whether, or in what form, a societal impact criterion should be proposed.
The Commission recognized that a collective dose criterion could be used to address societal impact but questioned whether alternative approaches could be devised to define a minimal societal impact for a given practice (e.g.
setting different individual dose criterion on the basis of the number of.
people potentially exposed and the distribution of the expected individual doses). Therefore, although the Commission has questioned how to characterize the societal impset criterion (including consideration of the argument that the societal impact of the total of all trivial or negligible individual risks should be treated as being negligible), conceptually, the need for such a criterion has not been rejected. As a result, we believe both of the two essential elements have been addressed for the purposes you describe.
EPA Comment The proposed policy could be considered arbitrary since, without definition of a practice, an optimization assessment can not be performed.
Sufficient experience should be gained with individual case from which a trend may emerge permitting generalization to a single set of generic numerical criteria for BRC.
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'ff j&tb d a NRC Respons hMd The NRC elievis the approach described in IAEA Safety Series 89, can be followed. TMs'Tpproach wetM involvesthe definition of both an appropriate individual risk and a minimal societal-impact. The value of the societal impact would be such that most reasonable people would agree that the broad societal cost of any regulation would be greater than the value chosen, and that regulatory resources would be better spent on the control and regulation of more risk significant radiological activities.
As the discussion in the advance notice indicates, the individual criterion could be based on a fatality risk judged to be of little concern to most members of society (e.g., a risk which the individual would not spend resources to avoid). The importance
' attached to optimization assessments was also reflected in our recognition that there could be situations in which the optimization evaluation for a specific practice could indicate that an exemption should be granted, even though-calculated individual and collective doses may exceed the aforementioned criterion values. The discussion in the advance notice, however, does need to be improved since we have received many comments indicating that many readers believed that the Commission was proposing that practices causing potential individual exposures approaching public dose-limits would be routinely exempted from regulation. 'This is not the case,and in developing a proposed policy for.
Commission consideration, the NRC staff intends to rewrite and clarify this point.
9 THE EXEMPTION LEVEL FOR INDIVIDUAL DOSE EPA Comment At the international workshop in October 1988, there appeared to be virtual unanimity that a 10 mrem / year value was too high as a criterion for establishing l
when licensees need not expend further resources on ALARA or optimization efforts.
NRC Response On review, we believe your conclusion is somewhat overstated. Our view was t
that most participants considered individual effective dose equivalents in the L
range of 1-10 mrem per year to be " trivial." The discussion at the meeting revolved around the issue of how this number should be " fractionalized" to l
apply to a single practice.
Our approach was to establish the individual dose criterion on the basis
.t of a risk level which the Commission believes most individuals would not spend f [7 their resources to avoid. This represents a slightly different approach than the trivial risk basis used internationally.
However, the NRC is' still actively S/
L considering what individual dose criterion should'be proposed and what rationale b should be used to defend the selected value.
Your comments on this issue will receive serious consideration.
// #
pm EPA-Comment Consideration of exemptions involving the possibility of exposures as high as 100 mrem per year is totally inappropriate.
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NRC Response As stated in the advance notice, t e intent of-the policy is to assure that individual exposures to the ublic remain well below 100 mrem per year.
-The intent of the discussion in tie advance notice was to reflect flexibility in the regulatory decision-making process regarding exemptions.
For example, 1
there may be rare instances where; exemptions, on the basis of an optimization evaluation, could be granted for/ practices where a few individuals could receive doses above 10 mrem per year Our intent is to clarify this point in the proposed policy statement, p
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cert & d & L,q #-b "Ad epa Coment The individual risk levels associated with doses in the 10-100 mrem / year range are not consistent with many Congressional and regulatory actions being taken relative to other environmental contaminants.
l; NRC Response The NRC is aware of this issue and is concerned that all of the many factors important in establishing acceptable health risk levels.be considered for each environmental contaminant.
Populations impacted, distribution of individual impacts, uncertainties in health impacts, persistence of the purported hazard, the potential for multiple exposures, and other issues -- all must be addressed in establishing " risk-based" regulatory policy.
Our intent is to discuss this t
issue of consistency further in the development of the proposed policy.
EFA Comment The dose to risk conversion factor used in the advance notice is l
out-of-date.
I NRC Response The NRC was aware of _the impending recomenda ions regarding dose-to-risk conversion factors as the proposed policy was eing developed.
In lieu of speculating on the implication of_ unpublished dat_a, the_ discussion in the l
advance notice indicated that the Commission included a margin-of-safety in L
establishing an appropriate individual dose value.
However, with the iminent publication of the BEIR V report and the recent publication of the 1988 report by the United Nations Scientific Comittee on the Effects of Atomic Radiation, the NRC staff will include consideration of these developments in its recomended proposed policy.
COLLECTIVE DOSE epa Comment Any decision to exempt a practice from regulatory control needs to include an evaluation of the total impact of the exemption on public health, i
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_3 NRC Resoonse As mentioned previously, the discussion in the advance notice recognized that the total. impact of any exemption decision on public health and the environment needs to be considered. The NRC staff is currently evaluating the
- efficacy.of using collective dose, or some other alternative, to address total social impacts.
EPA Comment There is no valid scientific basis for truncktions in the assessment of collective dose in the exemption decision-making process.
NRC Response j
Although the Commission asked for comments on this subject, I uld emphasize that neither the advance notice nor the staff's original draf proposed policy included a decision regarding truncations. On this point, d further noted that an assessment of the total societal impact of an exenption decision does not necessarily preclude the usefulness of a truncation provision in the numerical process of evaluating collective dose. 7w
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IMPLEMENTATION epa Comment 3 b-Upper limits for doses to populations cannot be assured if exemptions were pemitted to cause. potential exposures approaching 100 mrem / year.
NRC Response This would be true if such exemptions involved widespread individual exposures at this elevated level or were routinely granted. However, as discussed previously, this is not the intent of the policy. While it may be possible to grant an exemption involving doses above 10 mrem in some cases, these would be rare and would involve special measures to assure that the individual doses for the-limited population involved would not exceed 100 mrem per year.
-epa Comment How would there be assurance that some source-specific limits are not exceeded as a result of exemption decisions?
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NRC Response The advancer, notice made reference, and we are aware, that certain existing
^PA or proposed regulations may impose additional restrictions on exemption decisions.s if this is the case, the effect of compliance with these more restrictive regulations would be to further assure that no individual member of the public is likely to approach an annual exposure of 100 mrem per year from all sources.
4
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CONS!$7ENCY WITH INTERNATIONAL AND NRC POLICY EPA Coment
+
Theproposedpolicy[advancenoticediscussion)isnotconsistentwith international recomendations.
I WRC Response The NRC staff is familiar with IAEA Safety Series 89, ' Principles for the Exemption of Radiation Sources and Practices from Regulatory Control" and its fore,*unner draf ts and, in fact, attempted, in many cases, to use this document as a model for certain sections of the draft proposed policy originally presented to the Comission. As you correctly point out, a major difference involves the selection of the individual dose criterion which, when coupled with other requirements, would delineate when a licensee need not expend further resources to minimize radiological im The international approach uses the concept s :.
1 of trivial (or negligible) pacts. individual risk while the Commissions' pro
>osal is 3 g7 w
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tied to a Comission policy judgement on the level of risk below whics an p __ m individual would not expend resources to avoid. Although the NRC staff believet g w kv b/'h this is a significant distinction, we are reevaluating all our alternatives for Qestablishingcriteriafordefininga" floor"forALARAevaluations.
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" EPA Comment The discussion in the advance notice is inconsistent with the Comission's own policy on BRC for low level waste issued in August 1986.
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The 1986 policy Nebir'-
the 2chhe:n::.t ef r:gdMWj m;At+eyt thM-h, the policy provided the criteria which must be met, if a petition for rulemaking on "BRC disposals" was to be treated by NRC in an expeditious manner.
The implication of expeditious l
treatment was that the NRC could publish a proposed rule within 6 or 7 months of receipt of the petition, but does not imply that exemptions would be granted only if the criteria of the policy were met. As stated in the advance notice, the Comission will evaluate whethcr there are exemption criteria embodied
[withinitsownregulations)forwhichmodificationsaccordingtotheprinciples of this policy, would be beneficial.
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COMM[NTS ON ADVANCE NOTICE General in response to the publication on December 12, 1989 of an advance notice regarding the sub.iect policy, 203 coment letters were received, most durin the month of February and many in March, after the official January 30,198h coment closing date. The issues raised in these letters have been categorized into 33 subject areas which include the subjects for which coment was explicitly solicited in the advance notice. The coment letters were almost evenly split, with slightly more than half supporting the need for a Comission exemption po1(cy. The coment letters included about 135 from individuals, of which about 1/5 in ntified themselves as health physicists. Two of these letters frcm individu61s were petitions expressing opposition to policy development. There were 21 letters from public interest groups,18 from utilities or their representatives,11 from industry, 7 from state or local government organizations, 3 from professional societies 2 from members o' the u
National Council on Radiation Protection and Measurements (NCRP), one from the U.S. Environmental Protection Agency, and two from members of Congress.
Cormat Sumery A sumary of the substance of the major coments is as follows:
l
' Support /Oppesition to Policy Development Thost opposed to policy development generally stated that any health risk should not be the subject of deregulation. Post of these comenters focused on LW dispcsal and believed that disposal of radioactive material in licensed I
facilities sheuld be considered a cost of doing business. The pessibility that implementation of the policy could lead to abuses or accidents was also sited in several latters. Many of these comenters were not aware that exemption regulations exist and that case-by-case licensing decisions involving '
exemptions have been made.
A large number of these comenters believed an exemption policy completely eliminated NRC regulatory involvement in the exempt practice.
Those favoring policy development focused on the issue of optimum use of licensee and rerulator resources, believing resources spent to control small or negitgible risks could be better directed at more significant problems.
' Criteria (Criterion 1 For Establishing " Floor" For ALARA Most comenters agreed that a criterion (criteria) should be included to establish a " floor" below which it should be unnecessary to expend resources to L
i further comply with ALARA principles. Several stated that, to be effective, numerical criteria were needed and not broadly defined ranges (e.g. a few i
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t mrom). Most reflected the Health Physics Society position, believing the
' floor" could be defined through use of an individual dose criterion alone without the need for a ecliect've dess or societ61 impact criterion. The argument used by many of these comenters was that protection of the individual assured protection of society. Others specifically related their opposition to
.the uselessness of a collective dose criterion when considering esemptions involving LLW disposal practices. A number of these comenters recognised that in addressing other practices, such as consumer products, the magnitude of the population exposure would have to be a consideration.
A few comenters, including the EPA and fomer Commissioner Kennedy, presented arguments for including a societal impact criterion which together with the individual dose criterton, would respectively, determine if an exemption could be granted or define the " floor" below which further ALARA cfforts would not be required.
Both these comenters, believed that some assessment of societal impact was mandatory to the decision process regarding an exemption for regulatory control.
'Value Selected for Individual Dose Criterion Almost all comenters in favor of an exemption policy believed that 10 mrem / year was a conservative but acceptable value for the individual dose criterior,. Other values, as high as several hundred millirem / year were suggested, with many propoting 20 mrem / year. Notable exceptions to these views included the EPA, the DOE, fomer Comissioner Kennedy, a pro nuclear interest group (California Padiation Vaterials Mar.agement Forum), the Conference of Radiation Control Program Directors and responders f rom the NCRP, who believed 10 mrem / year may be too high a value, and that a lower value, consistent with international views, would result in greater acceptance of the policy as a whole.
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- Applicability of the
- Justification of Practice
- Principle On the seplicability of the justification of practice principle to exemption decision-haking, opinions were split with many believing that this principle should not be applied to pr6ctices meeting the *ALARA floor
- criterion (which comenters frtquently referred to as, " meeting the *BRC" criterion *).
Many utility c amtr.ters believed that the discussion in the advance notice confused justification of practice with ALARA. These commenters stated that since practices such as nuclear power have already been justified, the issue of exempt vs controlled cisposal of LLW is simply an optimitation of protection or ALARA issue.
A few recognized that, because of the broad nature of the policy, justific& tion of practice can be an issue in the context of the distribution of new consumer products ccntaining small amounts cf radioactive material.
Although not completely logical, many comenters agreed that certain practices could be precluded from exemption but statto that NRC'should not become it.volved in judging social acceptability of specific practices.
' Maintaining Flexibility in the Exemption
- Decision-Making Process"
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Essentially all supporters of the need for a policy believed that flexibility should be maintained; that is if a proper ALARA analysis supports an enemption for a practice in which an individual dose could exceed the criterion value (e.g.10 mrom/ year 1. this practice should not be precluded fmm enemption consideration. EPA. however, believes that, as a condition for esemption, no individual should receive a dose which is a significant fraction of existing pubite dose limits.
'Compatab111ty with Agreement States A number of consenters stressed the need fer making any exemption regulation a matter of exact corpatibility with Agreema y States. Other cessenters.
including two representing local governments, stated their belief that the low level waste sites, being created as a result of state compacts mandated by the Low Level Radioactive Waste Policy Amendments Act of 1985. should be the m pository for all low level waste, and that there is no need for the Comission to define "BRC" waste. These latter comenters often stated that allowing radioactive material to be disposed at local landfills would significantly compitcate the already complex task of siting these facilities.
'Value Used For Risk Coefficient several comenters opposed to the development of an exemption policy. and one comenter favoring a policy. Stated their belief that, based on most recent data, the risl: coefficient cited in the advance notice was too low.
'Need for Perspective A number of comenters believed that far more perspective was needed to indicate the magnitude of the dose and risk levels being discussed in the policy. Several mentioned the differences in risk level used by NPC and other federal agencies (e.g., EPA). noting that the NRC values were less restrictive by almost two orders of magnitude.
'Ponitoring of Exempt Practices All commenters who favored the development of the policy, and addressed the monitoring question, supported the need to monitor and enforce licensee's compliance with any developed exemption regulations. Many, however, stated opposition to any requirement for licensee monitoring once the material was transferred from controlled to exempt status. These commenters believed such menitoring would be perceived to contradict the underlying basis for the pclicy.
' International Consistency All who commented on the issue believed international consistency was desirable, but not necessary. A few agreed that consistency would be an element which would be helpful in gaining acceptance for a policy.
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