ML20043B910

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Forwards Info Re Proposed Commission Policy on Rules for Exemption from Regulatory Control,Per M Taylor Request
ML20043B910
Person / Time
Issue date: 12/07/1989
From: Acharya S
NRC
To: Cool D
NRC
Shared Package
ML20042C963 List: ... further results
References
FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006010017
Download: ML20043B910 (29)
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DRAFT Proposed Comission Policy on Rules for Exemption from Regulatory Control - Criteria lfor approving exemption for practices whose public health and safety impacts are below regulatory concern. -

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1.

' INTRODUCTION AND PURPOSE

' :Over the last several-years, the Comission has become increasingly concerned with the apparent inconsistency between radioactivity release standards and the L

varying, but-often large, expenditure of resources to protect the public from' man-made sources of radiation that represent small or even negligible health L

To address this concern, the Commission is expanding upon its existing risks.

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. policy for protection of the public from radiation, currently expressed h'

existing regulations (Title 10, Code of Federal Regulations) and recent policy statements (47 FR 57446 dated, December E.J98.2 an..d.-.5_1 F_R 30839, dated August 29,1986). The revised policy.specifically incorporates a feature That feature is the

'l which, to date, has-been applied in a piecemeal fashion.

establishment of levels of radiation risk below which there is no compelling need for government regulation to further control or reduce the distribution or n

1 release of radioactive materials. A request for exemption for a specific class

[.y of activity or practice could receive favorable consideration if adequate protection of public health and safety is being maintained and either (1) the costs of regulatory controls are not balanced by the benefits achieved in the reduction of risk or (2) the use of additional controls on a source of ra L

The bases for such tion exposure does not result in a net risk reduction.

requests for exemption must include, and may be largely justified by, the

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magnitude of the maximum dose which could potentially be received by any

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  • y,- m The purpose of this policy statement is to clearly establish the regulatory basis upon which the Comission may initiate the development of appropriate regulations so as to act upon future license applications and other requests to This policy is directed exempt radioactive material from regulatory ccntrol.

specifically toward license applications, license amendments and petitions rulemaking involving the release or distribution of licensed radioactive material to either persons not subject to Comission regulation or the environment.

t The concept of regulatory exemptions is not new; in fact, in the Low Level Waste Policy Amendments Act of 1985, the Congress directed the Nuclear Regulatory Commission to develop standards and procedores for expeditious handling of petitions to exempt from NRC regulation disposal of slightly i

contaminated radioactive waste material that the Comission de The Comission responded to this legislation by below regulatory concern.

1986 (51 FR 30839). That statement issuing a policy statement in August contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow the Comission to act expeditiously in proposing appropriate regulatory relief on a " source-specific" basis consistent with Exemptions allowing distribution of consumer products merits of the petition.

or other devices have been embodied in Comission regulations for some j

occasionally have been included in license conditions.

2

-o; The Comission believes that these " source-specific" exemptions should be

,1 enveloped within a broader NRC policy which will define levels of radiation risk, including individual dose benchmarks for radiation exposure, below which there is no compelling need, in the interests of public health and safety, for Below these levelt, the public radiation protection benefits NRC regulation.

from further application of the "as-low-as reasonably achievable" (ALARA) principle to a specified class of activity or practice is not justified, and the extent of further regulatory involvement can be essentially limited to inspection and compliance activities. The inspection and compliance involve-ment would generally be directed at licensee activities associated with the transfer of the radioactive material from a controlled to an exempt status.

THE BASIC ELEMENTS OF A BROAD-BASED REGULATORY EXEMPTION POLICY 11.

., ef The proposed broad-based regulatory exemption policy 1s made up of three basic

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elements:

(1) the currently established dose limits for individuals in Y

unrestricted areas as set forth in 10 CFR Part 20 (2) a finding that, based on current and expected near-tem practices, individual exposures from multiple sources of radiation from licensed activities, including exempt practices, are not likely to cause the upper-bound individual dose limits in 10 CFR 20 to be exceeded, and (3) an identification of levels of radiation risk, including individual dose benchmarks, below which there is no compelling need for NRC regulation to further control or reduce release or distribution of radioactive materials.

The first element, the 10 CFR Part 20 unrestricted area dose limits,

establishes the boundary between allowable and unacceptable exposures to 3

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a individual _ members of the public. This. limit provides a perspective from which d..

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the individual dose and risk benchmarks for exemption can be compared.

frevision of.10 CFR Part 20, currently under preparation, establishes an annual-

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, exposure limit for members of the_ public of 100 millirems / year from any.

licensed activity.

b The finding provided by the second element ensures thai the 10 CFR Part 20 limits are unlikely to be exceeded as a result of an individual being exposed.

L' to multiple sources or practices involving use or release of radioactive In practice, this finding is supported by " source specific" L

substances.

regulatory limits imposed by both the Nuclear Regulatory Comission (NRC) and

'the Environmental Protection Agency (EPA). ~ These " source specific" limits restrict exposures to individual members of the public from specific activities

. such as the discharge of effluents from nuclear power plants, the disposal of

'high and low level waste at licensed sites, and the operation of nuclear fuel

cycle facilities (see e.g., 40 CFR Part 190-191). These effluent and environ-a mental standards have been established, at least in part, on the basis of_what dose reductions are achievable for particular practices given the current status of technology, i.e., what constitutes "as low as is reasonably achievable."

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[ The third element involves the establishment of levels of radiation risk,

. / 'l.f including individual-dose benchmarks, below which the Commission believes that l'

there is no compelling need for further NRC regulation. The intent of the

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individual dose benchmarks is to define a " graded approa'ch" from which the S-)/

Comission believes that specific exemption decisions (referred to as below I

regulatory concern or BRC positions) can be developed, fonnulated and

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e-implemented. These BRC. positions would include the definition of reasonable and prudent conditions under which radiation or radioactive material may be authorized for release or distribution.with no further NRC regulatory controls, i

The formulation of source or practice specific BRC positions must reflect the following principles:

(1) unacceptable amounts of radioactive material from licensed activities must not be pemitted to enter the environment due to unreasonable dilution or fractionalization practices, (2) all licensed practices or sources using radioactivity or r,adioactive material for which a BRC position is forinulated are considered potential sources of exposure and (3) potential misuse or accidents involving exempted radioactive material must be considered in setting the constraints associated with a specific BRC position.

CRITERIA FOR THE DEFINITION OF INDIVIDUAL DOSE BENCHMARKS APPLICA l

III.

SPECIFIC BRC DETERMINATIONS y

The basic standard which must be met by any annual individual dose benchmark, included within a BRC position or detemination, is that any value chosen should be of low radiological risk significance. That risk significance may be

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l low either in the absolute sense or relative to the societal benefit derived The Commission from the source or practice in which the exposure orginates.

believes that this standard can be satisfied if the following two criteria are i

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Individual doses from multiple exposures to similar classes of exempt 1.

practices must not be allowed to significantly exceed benchmark levels.

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The.Comission has found, for currently licensed activities and those activities which may be licensed in the near future, that the 10 CFR E

Part 20 individual dose limits for members of the public are not likely to t

be exceeded as a result of individual exposures to multiple sources or This finding practices involving use or release of. radioactive material.

is. supported by the existence of current EPA and NRC effluent and environ-mental regulations which impose " secondary" limits that are fractions of-However, the the 10 CFR 20 unrestricted area individual dose limit.

Comission recognizes that regulatory programs must be developed and, perhaps, additional " secondary" limits imposed to ensure that this finding remains valid.

L Since, after exemption, it may no longer be possible to precisely assess 2..

or limit the radiological impact of exempt sources or practices, the individual dose benchmarks associated with a specific exemption,should, with few exceptions, be a fraction of the 10 CFR Part 20 limits.

I DEFINITION OF INDIVIDUAL DOSE BENCHMARKS APPLICABLE IV.

Given the previously stated criteria, the Comission believes that a projection i

l of-an individual's maximum annual effective dose equivalent can be used, withi a graded approach, to detemine if a specific source or practice should be exempted i

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. from regulatory control. The Comission believes that the graded app q

be characterized by three ranges of annual. effective dose equivalent:-

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-(1) below 4 mrem per year, if associated with a specific collective dose.

constraint (2) less: than 20 mrem per year and (3) greater than 20 arem per

year but less than applicable upper-bound limits for a specific source or
practice.-

Below 4 mrem-oer year with a soecific collective dose constraint l

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' The Comission believes that from an individual risk standpoint, individual

doses which do not exceed a.few millirems per year can reasonably be rega Any number within the general range of a as trivial by regulatory authorities.

L few millirem per year could be selected as the: lowest of the specific b

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The Comission, benchmarks to beTconsidered within-the graded approach.

l however, is cognizant of other authorities and regulations which impact' oi

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exemption policies; specifically, the-individual dose limit of 4 arems per year included in the Environmental Protection Agency's S6fe Drinking Water Act a being considered as a below regulatory concern level (applicable to waste y

-stream disposal, at other than low level waste facilities) in proposed 40 CFR p

pt 193.- The Comission believes that a source or practice should be a strong L

candidate for exemption from regulatory control if individual exposures resulting from the source or practice are limited to an annual dose of less This individual dose benchmark is than'4 mrem effective dose equivalent.

f the public

.one-twenty fifth (1/25) of the dose limit recomended for members o t-in the proposed 10 CFR Part 20. This value also corresponds to an exposure 1evel which is (1) approximately equivalent to the estimated national average l

-individual exposure received through use of domestic drinking water supplies, i

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4 (2)- approximately equivalent t'o' exposures received by a large fraction of the L

population.from radioactive material in building materials. (3) about 4% of the

- annual effective dose equivalent from natural background radiation excluding

, (4),less than ore-fifth (1/5) of the variation in dose from natural

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exposure-to. cosmic radiation across the United States, and (5) less than

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one-seventh (1/7) of the variation'in dose from natural terrestrial gamma E

radiation.

1 If risk coefficients, derived for exposures-greater than I rem / year, have L

validity at this low level of-dose, the corresponding risk of inducing lethal cancer would be on the order of 10-6 per year - a risk considered trivial by many regulatory bodies and one'which is held to be of no concern to the

-individual; Within the context of the graded approach proposed in'this policy, the Commission believes a collective dose constraint must be applied to this lowest-

? individual dose benchmark. This constraint is necessary.for two reasons: '(1) to-emphasize that this proposed policy is not defining a level of de minimis or negligible individual risk but is directed toward BRC determinations (which implies.that the optimization of radiation protection (or ALARA) principle has L

been used in establishing benchmark values) and (2) to provide reasonable assurance, given current and expected near-term practices, that individual doses are very unlikely to approach any existing public protection dose limit as a result of multiple exposures to distributed radioactive material (e.g.,

consumer products). The selected collective dose value is 1,000 person-rem per year.and is applicable to each source or practice applying for exemption in this lowest range within the graded approach. The 1,000 person-rem value is I

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chosen to constrain the number of potential exposures-at the 4 mrom indiv

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dose value to a-small fraction (0.1%)~of the total U.S. population.

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' coefficients:are presumed to tie valid at low levels of dose, the collective fatalities to dose would constrain the stochastic prediction of latent cancer less than unity for any. specific source or practice.

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l.ess than 20 stem oer year Individual exposures less than 20 mrem effective dose equivalent per year, d if resulting from a defined source or practice, can be considered small an,

the practice or source, is subject to minimal constraints, a strong argumen The upper for a below regulatory concern determination could.still be made.

bound of this range represents a value which is 1/5 of the dose limit recom-The 20 meems/ year value mended for manbers of the public in 10 CFR Part 20.

corresponds to an exposure level which is (1) about 20% of the annual ef dose equivalent from natural background (excluding radon), (2) representa of the variation in dose from natural exposure to cosmic radiation across t United Stated (i.e., Washington, D.C. vs Denver, Colorado), (3) less than the the variation in dose from natural terrestrial gamma radiation between Atlantic / Gulf coastal plain and regions on the eastern slope of the Roc approximately equal' to the variation between the Atlantic / Gulf coasta and the remainder of the country excluding the eastern slope of the Rockie Based on risk coefficients estimated for annual dose rates 50 times greater (1 rem / year), the corresponding risk of inducing lethal cancer would be s Individual doses in this range, if they are what greater than 10-6 per year.

the result of exposures received through the direct or inhalation pathways, would not be inconsistent with existing regulations (e.g., 40 CFR 190, Clear 9

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~ AirAct). Exemption positions involving individual doses in this range should (1) the be supported by-assessments which provide reasonable assurance that:

individual dose goal.(20 mrem / year) will:not be exceeded and (2) the societal In

- benefit of the practice justifies the applicable national collective dose.

collective dose calculations, individual doses less than 0.1 arem per year may a

be' neglected.

The 0.1 mrem individual dose cutoff for collective dose assessments was selected on the basis that, if. risk coefficients derived for higher dose levels are conservatively extrapolated downward to this dose, an individual's lifetime risk would approach 10-6 This level of lifetime risk serves as a target level used by.other Federal agencies (i.e., the EPA and the Food and Drug Administration) in the control of chemical carcinogens. Typically no actions c

L are taken to reduce lifetime risks below this level.

I Greater than 20 mrem per year but less than applicable upper bound 3.

L limits Individual exposures greater than 20 mrem effective dose equivalent per year from a defined source or practice may still be justified within a-specific below regulatory concern position. For below regulatory concern determinations involving individual doses in this range, it must be demonstrated that l,

L optimization of protection has been achieved for the specific source or practice under evaluation.

In this range of individual dose, benefit / cost studies must be undertaken for the class of activity or ' practice being Collective dose must be evaluated and the cost of considered for exemption.

imposition of additional regulatory requirements prior to the transfer of the l

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' i l-radioactive material from regulatory control to exempt status must be considered.

As in range 2 individual doses less than 0.1 mram per year need not be included in collective dose calculations.

CONSTRAINTS IN DEFINING BRC POSITIONS APPLICABLE TO SPECIFIC PRA V.

l In defining levels of individual dose below which BRC positions can be justified, the Commission recognizes that any specific BRC positions which are l

i t i ts.

. developed are likely to, and in most cases should include certa n cons ra n D

These constraints would typically evolve from technical considerations which, l

t-c The in many cases, have been reflected in existing NRC and EPA regulations.

constraints may involve. but are not necessarily limited to, the following considerations:

(1) no significant impact on the quality of the environment must occur, (2) the collective dose to a critical population group and general i ~

populationmustbeacceptableinlightofthesocietaibenefitachievedthrough the establishment of a BRC position, (3) the specific BRC determination must be h

useful on a regional or national scale and its application must result in a significant reduction in societal costs. (4) the radiation properties or levels

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of radioactivity must be suitably characterized on an appropriate,or national basis, (5) the characterization of the source or practice must be based on real data, and (6) effective inspection programs to demonstrate compliance must be implementable.

The Commission expects that proposed BRC determinations will be compatible with existing regulations and policies since, for the most part, this policy has been developed with the above constraints in mind.

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.g VERIFICATION THAT PUBLIC HEALTH AND SAFETY CONTINUES TO B VI.

AS BEL,0W REGULATORY CONCERN POLICIES ARE IMPLEMENTED The Comission believes that the implementation of any BRC determination made under this broad policy guidance must be accompanied by a suitable monitoring This: program, through suitable recordkeeping and f

and verification program.

sampling, must be capable of providing appropriate assurance that no individual' C

member of the public is likely to exceed th.e individual dose benchmark justified for the specific source or practice being exempted and that compliance is achieved with the other constraints imposed within a specific L

I below ' regulatory concern detemination. The Comission intends to develop and I

propose for public coment a suitable monitoring and verification program prior to finalization of this policy statement.

l PREPARATION OF BRC POSITIONS AND ADMINISTRATION *0F EXEMPTIONS,,

VII.

In general, the methodologies to develop BRC positions will be based on assessments of individual and collective doses that may arise from the specific These assessments should be appropriate to the practice under practice.

consideration and must address the applicable constraints.

If a simple assessment indicates that the likely consequences of exemption are individual and collective doses within the lowest range in the graded approach, there would be high likelihood that the BRC detemination would be accepted by There may be cases, however, where simplified assessments will the Comission.

In these cases more indicate the potential for higher individual doses.

detailed cost / benefit assessments and the imposition of constraints on the l

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licensee will be required before transfer of ra'dioactive material frem a D'

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' controlled to an exempt. status.

/ doses greater than 20 mrem / year, a thorough evaluation of available options will, most 'likely, be required.

In-both situations,'the assessment must be carried out using calculational f

A models which take account of:

the characteristics of the practice to be exempted; the characteristics of the sources involved in the practice.

I Models to accomplish:the required assessments can be deterministic, covering in 4

etail a sufficient number of exposure scenarios, and/or probabilistic. designed d

to provide a measure of the uncertainty inherent in the modeling and the.

database use.-

The choice of scenarios should cover all the likely pathways and exposure situations that arise as a result of the decision to exempt the practice in question. Inclusion of low probability of occurrence events will, of necessity, f

require regulatory judgements; however, such events should not cause exposures i

exceeding annual 10 CFR Part 20 public dose limits and, if averaged over the life of the practice, the expected annual dose should not exceed the 4 mrem l

value associated with the lowest dose benchmark.

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Judgements on choice of scenarios and criteria for acceptability within a-BRC position may also apply to cases of misuse of sources involved in the practice proposed for exemption.

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!!* kne calculation of individual and collective doses, particular attention should be paid to type of materials involved, physical and chemical characteristics, isotopic composition, surface and sess activity concentrationst i

total mass (es) and activities involved.

Radiation sources involved in an exemption will pass from a regulated to an The exemption must be clearly defined to enhance a common exempt status.

understanding about what is exempted.

Restrictions on exemptions will rarely, l

if ever, be expressed in terms of individual or collective dose since these

Rather, parameters are not practical to measure at the operational level.

exemptions should be expressed in quantities that are measurable at the point of transfer so that compliance with the provisions of the exemption can be determined.

In addition to the basic parameters for the exemption, constraints on the exemption may ensure that the assumptions made in individual and collective dose assessments will not be invalidated and may minimize the likelihood or These additional provisions consequence of accidents or incidents of misuse.

may include constraints or.:

a) the trnal activity which raf be released in a year from a regulated activity; t

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.the chemical end physical fem of the exempted material or its l

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origint-c) the design of the exempted sourcel 3

d) quality assurance requirementsi

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e) the disposition of the exempted material.

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DRAFT Proposed Commission Policy on Rules for Exemption from Regulatory Control -

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Criteria for approving exemption for practices whose public health and safety l

impacts are below regulatory concern.

I.

INTRODUCTION AND PURPOSE Over the last several years, the Comission has become increasingly aware of the need to provide an explicit policy to deal with uncertainties on the f

subject of what are appropriate radioactivity control standards.

In particular, in considering the release of radioactive material, the Commission has noted the

't varying, but often large, expenditure of resources which are and could be spent to protect the public from man-made sources of radiation that represent small or even negligible health risks. To address this uncertainty, the Commission is expan' ding upon f ts existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10. Code of Federal Regulations) and recent policy statements (47 FR 57,446 dated December 27, 1982 and 51 FR 30839, dated August 29, 1980).

The purpose of this policy statement is to clearly establish the regulatory basis upon which the Commission may initiate the development of appropriate regulations This polic) is directed

,) to exempt radioactive material from regulatory control.

n# [' (' specifically toward petitions for rulemaking, and license amendments and license

.. # lY F applications involving the release or distribution of licensed radioactive r

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material to either persons not subject to Commission regulation or the

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environment.

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,e, i The concept of regulatory exemptions.is not new.

For example, in 1970, a tables of exempt quantities and concentrations for radioactive material were defined which a person could receive, possess, use, transfer, own, or acquire without a requirement for a license.

Exemptions allowing distribution of consumer

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products or other devices have also been embodied in Commission regulations i

Recently, for some time and occasionally have been included in license conditions.

in the Low Level Waste Policy Amendments Act of 1985, the Congress directed the Nucle Regulatory Commission to develop standards and procedures the expenditious handling of petitions to exempt from NRC regulation disposal af slightly contaminated radioactive waste material that the Commission otterwined to The Commission responded to this legislation by issuing below regulatory concern.

a policy statement in August 1986 (51 FR 30839). That statemerc contained criteria which, if satisfactorily addressed in a petition fu rulemaking, would -

allow the Commission to act expeditiously in proposing appropriate regulatory relief on a "pract. ice-specific" basis consistent with the merits of the petition.

The Comission believes that these " practice-specific" exemptions should be enveloped within a broader NRC policy which will define levels of radiation risk, including individual dose benchmarks for radiation exposure, below which, specified practices would not require NRC re'gulation based on public Below these risk levels, the public radiation health and safety interests.

protection benefits from further application of the "as-low-as reasonable achievable" (ALARA) principle to a specified class of activity or practice is not justified, and the extent of further regulatory involvement can be essentiall The inspection and compliance limited to inspection and compliance activities.

involvement would generally be directed at licensee activities associated with the transfer of the radioactive material from a controlled to an exempt i

status.

111. THE BASIC ELEMENTS OF A BROAD-BASED REGULATORY EXEMPTION POLIC The Commission in this policy statement is revising its existing policy to specifically incorporate a feature which, to date', has been 4pplied in a piecemeal That feature is the establishment of levels of radiation risk below fashion.

which there is no compelling need for government regulation to further control f

j or reduce the distribution or release of radioactive materials. A request for exemption for a specific class of activity or practice could receive favorable consideration if adequate protection of public health and safety is being mainteined and either (1) the costs of reg 116 tory controls are not balanced I

by the benefits achieved in the reduction of risk or (2) the use of additional controls on a source of radiation exposure does not result in a net risk The bases for such requests for exemption must include, and may be j

reduction.

largely justified by, the magnitude of the maximum dose which could potentially by received by any individual member of the public.

The broad-based regulatory exemption polipy is made'up of three basic elements:

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(1)the currently established dose limits for individuals in unrestricted areas and the limits associated with generally applicable environmental standards 4

as set forth in 10 CFR Part 20 (2) a finding that, based on current and expected near-term practices, individual exposures from multiple sources of radiation l

from licensed activities, including exempt practices, are not likely to cause the upper bound individual dose limits in 10 CFR 20 to be exceeded, and (3) 1 identification of levels of radiation risk, including individual dose benchmarks, below which the need for NRC regulation to further control or reduce release or distribution of radioactive materials is a function of the magnitude of exempted risk and benefit of the exempted practice as described in the previ section.

2 The first element, the 10 CFR Part 20 unrestricted area and environmental dose limits, establishes the boundard between allowable and unacceptable exposures to individual members of the public. This limit provides a perspective from which the individual dose and risk tenchmarks for exemption can be compared.

The revision of 10 CFR Part 20, currently under preparation, establishes an annual exposure limit for members of the hic of 100 millirems / year from any licensed activity.

The finding provided by the second element ensures that the 10 CFR Part 20 limits are unlikely to be exceeded as a result of an individual being exposed to multiple sources or practices involving use or release of radioactive In practice, this finding is supported by " source specific" substances.

regulatory limits inposed by both the Nuclear Regulatory Conrnission (NRC) an l

the Environmental Protection Agency (EPA). These " practice specific" limits restrict exposures to individual members of the public from specific activities such as the discharge of effluents from nuclear power plants, the disposal of l

high and low level waste at licensed sites, and the operation of nuclear fuel 190-191). These effluent and environ-cycle facilities (see e.g., 40 CFR Part mental standards have been established, at least in part, on the basis of what dose reductions are achievable for particular practices given the current status of technology.

The third el'ement involves the establishment of levels of radiation risk, including individual dose benchmarks, below which the Comission believes that The intent of the there is no compelling need for further NRC regulation.

individual dose benchmarks is to define a " graded approach" from which the Commission believes that specific exemption decisions (referred to as below regulatory concern or BRC positions) can be developed, formulated and l

3

. implemented These B/C positions world include the definition of reasonable

. and prudent conditions under which radiation or radioactive material may be authorized for release o'r distribution with no further NRC regulatory controls.

The formulation of source or practice specific BRC positions must reflect the following principles: (1) unacceptable amounts of radioactive material from licensed activities must not be permitted to enter the environment due to unreasonable dilution or fractionalization practices, (2) all licensed practices or sources using radioactivity or radioactive 1 material for which a BRC position is' formulated are considered potential sources of exposure and (3) potential misuse or accidents involving exempted radioactive material must be considered in setting the constraints associated with a specific bRC position.

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PRINCIPLES AND CRITERIA FOR THE DEFINITION OF INDIVIDUAL DOSE SENCHM l

IV.

APPLICABLE TO 5PECIFIC BRC DETERMINATIONS l

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l The underlying principles of radiation protection applicable to exemption policy include the recognition that all deliberate radiation exposures should be justified.

l Recognizing that an upper bound for exemption - related exposures may be set, it is evident that exposures which fall below th.is bound should be justified in proportion to their ir. tensity. The linear non-threshold hypothesis is accepted as a basis for proportional ~ justification for any exemption-related exposure.

But as lower levels of radiation exposure are projected, the lower levels or degrees of justification open the possibility of simpler, less rigorous evaluation, and even the possibility of summg:y jup=ements on simple bases at suit m

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This dhthh n rigor of justification, p due proportion i

of radiation exposure.

to the lower level of exposure envisioned, is entirely consonant with reliance on the linear hypothesis.

The concept of a risk or radiation exposure cutoff or threshold may also be The linear hypothesis consistent witgegulation based on the linear hypothesis.

simply equates risk of stochtic affects to radiation exposure in some proportion The use of risk to the level of that exposure even down to the smallest exposure.

off does not have to be based on an assertion'that there is no or exposure c It can be based biological damage or no risk at exposure levels below that cutoff.

'on the agrument that the admitted risk entailed at exposure' levels below the asonable cutoff is so low in comparison to everyday risk as to be beneath

. threshold of concern.

' Coupled with these underlying principles, the following two criteria must

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also be met:

Individual doses from multi.ple exposures to similar classes of exempt-1.

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practices must not be allowed to significantly exceed benchmark s

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The' Commission has found, for currently licensed activities and thos5 activities which may be licensed in the near future, that the 10 CFR Part 20 individual dose limits for members of the public are not likely to j

be exceeded as a result of individual exposures to multiple sources or practices involving use or release of radioactive material. This finding is supported by the existence of current EPA and NRC effluent, and environmental regulations which impose " secondary" limits that are fractions of the 10 CFR 20 unrestricted area individual dose limit. However, the Commission recognizes that regulatory programs must'be developed and, perhaps, additional

" secondary" limits imposed to ensure that tris finding remains valid.

i Since, after exemption, it may no longer be possible to precisely assess or 2.

i limit the radiological impact of exempt sources or practices, the individual dose benchmarks associated with a specific exemption should, with few exceptions, be a fraction of the 10 CFR Part 20 limits.

I DEFINITION OF INDIVIDUAL DOSE BENCHMARKS APPLICABLE TO BRC POSITIONS V.

t The Commistion believes that projections of individ0a1 and collective dose i

can be used, within a graded approach, to determine if a specific source The Commission or practice should be exempted from regulatory control.

believes that the graded approach can be characterized by three ranges of individual annual effective dose equivalent:g k1) The range from applicable upper-bound limits for the specific source or I

practice down to /0 mrem per year.]

(2) the range below k0 mrem per year, ang h - the range below about 1 mrem per year. Ich range of individual dos withfa specific collective dose consideration. The Comission considers it appropriate in this context to use a maximum or limiting basis for calculating individual In dose and a realistic average basis for calculating collective dose.

M both cases the lifetime dose cojmitment of annual exposure to the practice sho be used.

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The first two of these ranges of interest, namely:

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upper bound limits down to O mrem per year, and,

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below h mram per year, cover those practices where justification of I

projected exposure associated with practice must consider the proportion of The third cost and benefit for both individual dose and collective dose.

range, below 1 mrem per year, enters a regime where summary disposition or acceptance of the practice can be possible based on the simplest i

considerations of justification for both individual and collective dose.

Greater than 20 meerr per year but less than apolicable upper bound.

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14mits Individual exposures greater than 20 mrem effective dose equivalent per year from a defined source or practice may still be justified within a specific below regulatory concern position. For below regulatory concern deteminations involving individual doses in this range, it must be demonstrated i

optimization of protection has been achieved for the specific source or that practice under evaluation. In this range of individual dose, benefit / cost studies must be und(taken for the class of activity or practice being considered Collective dose must be evaluated and the cost of imposition for exemption.

of additional regulatory requirements prior to the transfer of the radioactive material from regulatory control to exempt status must be considered.

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In collective dose calculations, individual doses less than 0.1 arem per year The 0.1 mrem individual dose cutoff for collective dose i

may be neglected.

assessments was selected on the basis that. if risk coefficients derived fo l

higher dose levels are conservatively extrapolated downward to this dose, an individual's lifetime risk would approach 10-6 This level of lifetime risk

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e serves as a target level used by other Federal agencies (i.e., the EPA and the Food f

and Drug Administration) in the control of chemical carcinogens. Typically i

no actions are taken to reduce lifetime risks below this level.

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l.ess than 20 mrom per. year j

Individual exposures less than 20 mrem effective dose equivalent per year j

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resulting from a defined source or practice can be considered small and, if the practice or source is subject to minimal constraints, a strong argument for a below regulatory concern determination could still be made. The upper 1

bound of this range represents a value which is 1/5 of the dose limit recommended

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for members of the public in 10 CFR Part 20. The 20 mrams/ year value corresponds to an exposure level which is (1) about 20% of the annual effective dose equivalent from natural background (excluding radon), (2) representative of the variation in dose from natural exposure to cosmic radiation across the gk Uniteo States (i.e., Washington, DC vs Denver, Colorado), (3) less than 1/2 9

I the variation in dose from natural terrestrial gammi radiation between the

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Atlantic / Gulf coastal plain and regions on the eattern slope of _the Rockies and approximately equal to the variation between the Atlantic / Gulf coastal plain and the remainder of the country excluding the eastern slope of the Rockies.

Based on risk coefficients estimated for annual dose rates 50 times greater (1000 mrem / year), the corresponding risk of the inducing lethal cancer would Individual doses in this range, if they be somewhat greater than 10-6 per year.

are the result of exposures received through the direct or inhalation pathways.

would not be inconsistent with existing regulations (e.g., 40 CFR 190, Clean Air Act).

Exemption positions involving individual doses in this range should be supported (1) the individual by assessments which provide reasonable assurance that:

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dose goal (20 erem/ year) will not be exceeded and (2) the societal benefit i

As in of the practice justifies the applicable national collective dose.

the upper range, the 0.1 mrem individual dose cutoff for collective dose assessments can be utilized.

Below 1 mesm per year with__ a specific. collective dose constraint 3.

The Commission believes that from an individual rish standpoint, individual l

doses which do not xceed a few millirems per year can reasonably be candidates for exempting from regulatory control. Any number within the general range of a few millirem per year could be selected as the lowest of The the specific benchmarks to be considered within the graded approach.

Commission, however, is cognizant of other authorities and regulations which impact on exemption policies; specifically, the individual dose limit of 4 mrams per year included in the Environmental Protection Agency's Sa'fe Drinking Nte Act and being considered as a below regulatory concern level (applicable to waste stream disposal at other than low level waste' facilities) in proposed j

The Commission believes that a source or practice should be a 40 CFR 193.

strong candidate for exemption from regulatory control if individual exposures resulting from the source or practice are limited to an annual dose of less than 1 mrem effective dose equivalent. This individual dose benchmark is one-twenty-fifth (1/100) of the dose limit recommended for members of the public in the proposed 10 CFR Part 20. This value also corresponds to an exposure

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level which is (1) approximately one-fourth (1/4) the estimated national average individual exposure received through use of domestic drinking water supplies (2) approximately one-fourth (1/4) the exposure received by a large fraction of the population from radioactive material in building materials, 4

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(3) about 1% of the annual effective dose equivalent from natural background t

radiation excluding radon, (4) less than one. twentieth (1/20) of the variation in dose from natural exposure to cosmic radiation across the United States, and f

(5) less than one twenty-fifth (1/25) of the variation in dose from natural terrestrial gamma radiation.

If risk coefficients, derived for exposures greater than 1 rem / year, have validity at this. low level of dose, the corresponding risk of inducing lethal cancer would be less than 10'0 per year - a risk considered trivial by many regulatory bodies and one which is held to be of no concern to the individual.

Within the context of the graded approach in this policy as discussed in Section IV, the Commission belives a collective dose constraint can be applied to this lowest individual dose benchmark.

This constraint also serves two other (1) to emphasize that this policy is not defining a level of purposes:

de minimis or negligible individual risk but is directed toward BRC deteminations l~

(which implies that the optimization of radiation protection (ALARA) principle has been used in establishing benchmark values) and (2) to provide reasonable assurance, given current and expected near-tem practices, that individual doses are very unlikely to approach any existing pubite protection dose limit as a l

i result of multiple exposures to distributed radioactive material (e.g., constaner

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The selected collective dose value is 1,000 person-rem per year.

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and is applicable to each source or practice applying for exemption in this lowest range within the graded approach. The 1,000 person-rem value is chosen to constrain the number of potential exposures at the 1 mrom individual l

If risk dose value to a small fraction (0.4%) of the total U.S. population.

coefficients are presumed to be valid at low levels of dose, the collective dose would constrain the stochastic prediction of latent cancer fatalities to less than unity for any specific source or practice.

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6$ +o The Comission has found, for currently licensed activities and those activities which may be licensed in the near future, that the 10 CFR Part 20 individual dose limits for members of the public are not likely to be exceeded.

as a result of individual exposures to multiple sources or practices involving t

l f radioactive material. This finding is supported by the

.use or re ease o existence of current EPA and NRC effluent and environmental regulations which impose " secondary" limits that are fractions of the 10 CFR 20 unrestricte a

However, the Commission recognizes that regulatory area individual dose limit.

programs must be developed and, perhaps, additional " secondary" limits im to ensure that this finding remains valid.

Since, after exemption, it may no longer be possible to precisely assess or 2.

limit the radiological impact of exempt sources or practices, the individual dose benchmarks associated with a specific exemption should, with few excepti be a fraction of the 10 CFR Part 20 limits.

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