ML20044A461
| ML20044A461 | |
| Person / Time | |
|---|---|
| Issue date: | 04/05/1990 |
| From: | Carr NRC COMMISSION (OCM) |
| To: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006290089 | |
| Download: ML20044A461 (56) | |
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$If T T"ASED TO THE POR AFFIRMATI0N
- " "on.......
r.uc RESPONSE SHEET l4 6 y/90 cp j
date /
="."...........Init),8.,,,,;
TO:
SAMUEL J. CHILK, SECRETA 3Y OF THE COMMISSION FROM:
CHAIRMAN CARR
SUBJECT:
SECY-89-360 - 00l44ISSION POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL APPROVED w/ comment DISAPPROVED ADSTAIN NOT PARTICIPATING REQUEST DISCUSSION C0l44ENTS:
see attached comment Q._
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CORRESPONDENCE PDC
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s Chairman Carr's comments on SECY.89-360:
I approve of the revised version of the Commission's BRC policy statement included as an attachment to this vote.
The policy statement _has been revised to (1) clarify my views and address staff concerns about justification of practice, (2) summarize the need for the BRC policy, (3) deceribe my concept of an exemption from regulatory control in accordance with the criteria in the policy, (4) clarify my position on the need for establishing a uniform and consistent framework for regulatory exemptions of-radioactive materials, (5) incorporate staff's recommended revisions to reflect consideration of BEIR V, (6) incorporate revisions suggested by Commission staff and Dr. Moeller of the l
ACNW, and (7) improve the general clarity and presentation of the policy, statement.
I agree with staff. tha': certain practices, _,
-such as the purposeful introduction of radioactive material into children's toys, should not be considered acceptable candidates for exemption because of the increased risks and uncertainties associated with the resulting doses.
I also believe that the Commission's BRC policy is consistent with the three fundamental tenets of radiation protection,as appropriate for the low doses and dose rates typically associated with exempted-practices.
Justification decisions involving' complex-social and cultural value judgments should rightfully be made by affected elements of society because they involve considerations ~that fall outside of the Commission's health and safety and environmental protection pu rview.
Once the Commission has completed its deliberations on the BRC policy statement, I urge staff to proceed expeditiously with its-program for disseminating information on the BRC policy to Congress, media representatives, other Federal agencies, State and local authorities, Indian Tribal organizations, and the-public.
The success of the BRC policy will be determined, at least in part, by NRC's ability to communicate the basis and need for the policy with these groups.
Accordingly, I-believe that a working group of NRC managers should be established to. develop and implement a comprehensive strategy for releasing the BRC policy.
The working group should include representatives of all involved Commission and staff cffices.
In addition to such activities as conducting pre-release briefings for Congressional' staff and other Federal and State agencies.(including EPA, DOEi FDA, CPSC, Agreement States, and affiliated organizations), the working group should arrange internal workshops to prepare-NRC Headquarters and Regional staffs for responding to inquiries about BRC.
The working group'should also coordinate.the development and release of information about BRC, such as the BRC pamphlet already developed by Public Affairs.
I look forward to staff's rapid progress in implementing the BRC policy, including establishment. of interim residual radioactivity criteria for decommissioning and *.ssessing existing exemptions for consistency with the BRC policy.
These efforts will not only enhance the coherence of NRC's regulatory framework, but may also
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encourage the use of a consistent risk basis in other areas of the Federal government's regulatory framework for protecting the-public and the environment from a variety of' risks.
Staff should also develop a program for. systematically assessing existing NRC exemptions (as directed-in the October 13,.1989 SRM) to evaluate-their consistency with the' criteria and provisions of the BRC policy and for developing a framework of new regulations and guidance to inplement the BRC policy (e.g., residual radioactivity limits for decommissioning, waste exemptions, regulations to establish a framework for exempting ~ consumer Products)
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(7590-01)
I NUCLEAR D?6c LATORY COMMISSION Below Regulatory Concern; Policy Statement l
AGENCY:
Nuclear Regulatory Commission, j
ACTION:
Policy statement.
SUMMARY
This policy statement establishes the framework.within:
-which the commission.will make-decisions to exempt from some or all regulatory controls certain products'and activities involving small quantities of radioactive material that are below regulatory concern.
The exemptions may involveLthe release of licensee-controlled radioactive material either to;the generally accessible environment or to persons who would be exempt from Commission regulations.
Activities for which exemptions may be aranted include'but are not limited to-(1) the release for onrestricted public use of. lands and structures containing residual radioactivity, _ (2) the-distributi'on of consumer products containing small' amounts of radioactive ~ material, (3) the disposal of very low-level radioactive waste at other than.
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licensed disposal sites, (4) the recycling of slightly contaminated equipment and materials, and (5) the release of-effluents from licensed' facilities.
As described in this policy 1
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s statement, NRC intends to exempt specific practices from regulatory control if the practice results in small doses to individuals and the population at large and if available controls cannot achieve reductions in these doses that are commensurate with the public and private resources needed to implement the controls.
The policy statement defines the dose criteria and other considerations that.will be used by NRC in making exemption decisions.
The policy establishes individual dose criteria (1 and 10 mrem per year (0.01 and 0.1 millisieverts per year)) and a collective dose criterion (1000 person-rem per year (10 person-Sieverts per year)).
These criteria, coupled with other considerations enumerated in_the policy statement, will be major factors in the Commicsion's determination on whether exemptions from regulatory controls will;beLgranted.
The policy statement is needed to establish a consistent risk framework for regulatory-exemption decisions, to ensure an adequate and: consistent level of protection of the publicLin their.use of radioactive-materials, and to focus the Nation's resources on reducing the 4
most significant radiological risks from practices under NRC's jurisdiction.
The average U.S. citizen should benefit from implementation of the BRC policy through-(l) timely cleanup-of contaminated sites;-(2) increased assurance that adequate funds
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are available to decommission operating nuclear facilities;.(3) potential improvements in medical treatment and other. services that use radioactive materials resulting from optimal use of Federal, State, and-licensee-resources; (4) enhanced low-level
' radioactive waste management practices commensurate with i
potential risks; and (5) increased assurance that consumer
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products containing radioactive material under theLcommission's I
jurisdiction are safe.
EFFECTIVE DATE:
(Insert Publication Date.)
FOR FURTHER INFORMATION CONTACT:
Dr. Donald A. Cool, office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, D.C.
20555, telephone: (301) 492-3785.
l SUPPLEMENTARY INFORMATION:
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Statement of policy I.
Introduction.
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Ionizing radiation is a fact of life.
From the day _we.are born until the day we die, our bodies are exposed to' low levels.
of radiation emitted from a variety of natural and man-made i
sources, including the cosmos, earth, building materials,
- j industrial facilities, clothing, medicine, food $1 air, and our own bodies.
All matter exhibits some degree of radioactivity.. The consensus belief among scientists is that even low: levels of radiation typical of the natural environment pose some correspondingly low risk of adverse health, effects to. humans.
1 Recognition of the risk due to radiation exposure from natural sources provides perspective on the risks associated with human uses of radioactive materials.
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Natural and man-made radionuclides are used in today's society in many forms for a variety of purposes, such as medical therapy-and diagnosis, materials analysis, and power generation.
In general, the existing regulatory framework ensures that radioactive materials are controlled consistent with the degree of risk posed to the public and the environment.
Some products like smoke detectors and lamp mantles contain small quantities of radioactive materials that pose such a low risk that they have'
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been widely distributed without continuing; regulatory controls.
To require thet all radioactive materials be controlled in the same strict manner regardless of the risks they pose would not be' a sound use of scarce National resources.
Such strict control could also deprive society of the' numerous benefits already derived from appropriate uses of radioactive materials and radiation.
In addition,:such control would not significantly reduce the risks associated with. radiation exposure from controlled sources compared with risks associated with natural background radiation.
Therefore, responsible decisions need to be made on how radioactive saterials are controlled based on a judgement about the levels of risk they pose..
over the last several years, the Commission has pursued development of a risk threshold to distinguish those radioactive materials that do not require the same stringent level of regulatory control as that imposed on potentially more hazardous materials.
The Commission recognized throughout this process that the threshold would need to be low enough to ensure adequate protection of the public.
The Commission also recognized that.
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e the threshold should be compatible with technological and measurement capabilities so it could be readily implemented in NRC's regulatory program for nuclear materials.
In' addition, the Commission identified the need to balance incremental reductions in risk below the safety threshold with the attendant expenditure of private and public resources.
In today's notice, the commission establishes a policy to guide decisions on which radioactive = materials are "below regulatory concern" (BRC) because the low -levels of risk-they-pose do not warrant regulation to the same, degree.as other radioactive materials to ensure adequate protection.of the public and environment.
This policy translates the-Commission's-judgement on acceptable risk into explicit and implementable criteria on which to base decisions'to exempt nuclear 1 materials from the full scope of NRC's regulatory framework.L The BRC criteria are necessary to ensure adequate and consistent decisions on acceptable risks posed by decontaminated and decommissioned nuclear facilities, consumer: products containing radioactive materials, and very: low activity. radioactive wastes.
These decisions will be implemented by the Commission through-rulemakings and licensing decisions based on careful end thorough analyses of the risks associated with exposure to ensure that~the public is adequately protected.
Under the regulatory approach used by the U.S. Nuclear Regulatory Commission (NRC), the use of radioactive materials is-subject to limits and conditions that ensure the protection of 5
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j the health and safety of both workers and members of the general =
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public, and the environment.
For example, radioactive material is controlled by NRC-and= Agreement State-licensees to ensure i
that dose-limits are not exceeded.- In addition, sources of l
L radiation are designed, used and~ disposed of in a manner that-I ensures that exposures to radiation or radioactive material are as low as is reasonably achievable (ALARA),. economic and social-factors being taken into account.
NRC has endorsed the ALARA provision in regulatory practice for a' number.of years (10 CFR
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Part 20).
However, NRC has not yet provided criteria that would establish the basis for defining the level of-residual risk.at l
which further regulatory control.is no longer warranted.
a A major provision of.this' policy involves the definition of criteria that delineate-conditions under which additional expenditures of regulatory and licensee resources are not-necessary to further reduce radiation exposures from a given practice.
Application of these criteria by NRC will promote l
. t, consistent decisions on the need to require further reductions in-radiation exposure at dose levels that are comparable to incremental radiation doses associated with routine activities-such as cross-country air travel.
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The policy statement'in'today's notice provides a unifying risk framework for making decisions about which radioactive i
materials can be exempted from the full scope of NRC's comprehensive regulatory controls.
Under the criteria and principles of this policy statement, exemptions of radioactive-L' 6
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materials from regulatory controls would' involve the transfer of a
very small quantities of the-materials from a regulated to an unregulated status.
NRC will analyze such proposed transfers to ensure that doses resulting from exposure to exempted practices' will be sufficiently low that_the public health and safety and the environment will remain adequataly-protected.
The' licensed activity producing the. exempt material would continue to be.
subject to the full range of regulatory oversight ~,. inspection, and enforcement actions up to and-including the point of_ transfer to an exempt status.
The Commission also intends to conduct
. periodic research to evaluate the effectiveness of the Exemption Policy and to confirm the safety bases that support-the exemption decisions.
Through appropriate rulemaking actions or~ licensing decisions, the Commission will establish constraints,.
requirements, and conditions applicable.to exemptions of radioactive materials from NRC's regulations.
The NRC will verify that licensees adhere to these' exemption constraints and conditions through NRC's licensing, inspection, and enforcement programs.
For example, the1Ccamission may promulgate regulations 1
that would require some type of-labeling-so that consumers could l
make informed' decisions about purchasing-a product containing exempted materials.
Such labelingtis presently required by the y
Commission for smoke detectors containing radioactive material (see 10 CFR 32.26).
The NRC' ensures.that manufacturers label the detectors in compliance with the' labeling requirement through:
licensing reviews.and inspections.- Specific source controls ~and 7
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exemption conditions are not discussed further in this policy because they will be more appropriately addressed in developing.
the exemption requirements for specific exemption proposals.
The concept of regulatory exemptions is not new.
The Atomic-Energy Act of 1954, as amended,- authorizes the - Commission-to -
exempt certain classes, quantities, or uses of radioactive material 'when it finds.thatL such exemptions-will not constitute an unreasonable risk to common defense and security and to-the health and. safety of the public. - In the 1960s and-1970s, the i
Atomic Energy commission used this' authority to promulgate -tables of exempt quantities and concentrations for radioactive material.
These-exemptions allow a person or a' licensee, under certain circumstances, to receive, possess, use, ' transfer, own, or acquire radioactive material without a requirement :for a license' (30 FR 8185; June 26,1965 and 35 FR 6425; April 22,' 1970).
Other exemptions allowing distribution of consumer products or devices to the general public or allowing releases 1of radioactive material to the environment have been incorporated in the Commission's regulations for some time.
For example, regulations currently specify the conditions-under which licensees are allowed to dispose' of small quantities of radioactive ma'terial into sanitary sewer systems (see 10 CFR-20.303).
These existing; regulations specify requirements, conditions, and constraints that a licensee must meet if radioactive material is to be
" transferred" from a regulated to an exempt status.
More recently, Section-10 of'the Low-Level Radioactive Waste l
Policy Amendments Act-(LLRNPAA) of 1985 directed the Commission to develop standards and pftcedures and act upon petitions."to L
l exempt specific radioactive waste streams from regulation... due-p l
to the presence of radionuclides... in sufficiently low concentrations or quantitles'to be below regulatory. concern."
q The commission responded t'o this legislation by issuing a policy i
statement on August 29,1 1986-(51 FR 30839).
That' policy statement contained. criteria-that, if satisfactorily addressed in a petition for rulemaking, would allow the Commission to'act
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expeditiously in proposing appropriate relief in its regulations.
on a " practice-specific" basis consistent with the merits of the-petition.
t Federal and State agencies have also developed and implemented similar exemptions based on evaluations of their risks to the public and the environment.
The Food and: Drug Administration (FDA), for example, has applied sensitivity-of-L method, risk-based guidelines in connection with the regulation of animal drugs, food contaminants, and trace constituents in some tood additives.
Similarly,nthe Environmental Protection.
Agency (EPA) established exemption or threshold levels based on.
individual risks in the regulation of pesticides and other toxic i
i and carcinogenic chemicals.
For' example, EPA employs such a concept in defining hazardous waste under the Resource-conservation and Recovery.Act through the Extraction Procedure (EP) Toxicity Characteristic and the Toxicity Characteristic Leaching Procedure in 40 CFR Parts 261 and 268.
These testing procedures yield _ concentrations of carcinogenic and toxic 4
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constituents in leachate, which are then compared with threshold concentrations to. determine whether solid wastes are hazardous wastes and to evaluate the adequacy of treatment processes.
Wastes whose leachate concentrations fall below the threshold levels established by EPA may be " exempted" from complCance with.
the comprehensive hazardous waste regulations or allowed to~be
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disposed of in permitted land disposal facilities, respectively, s
For certain practices involving minimal public health and safety concerns, the imposition of undue or unnecessary regulatory controls could prohibit a practice that should otherwise be permitted because of reasonable societal (including public health and safety) benefits.
In-addition,,with the necessary national focus on fiscal responsibility, resources-expended for regulatory control of practices withLminimal health and safety impacts could be.used to. address more significant radiological and nonradiological health and safety concerns.
To address this need, the Commission, in this policy, is establishing a framework for expanding,on'its existing regulations for protection of the public from. radiation which a
4 currently define a number of longst'anding exemptions'from regulatory control.
This policy'will also be used by the Commission as a basis for reevaluating existing NRC exemptions to ensure that they are consistent with<theLcriteria defined herein.
Because this policy provides a' consistent risk basis for exempting the use of byproduct and source material in consumer-products, this policy supersedes the Atomic Energy Commission's 1
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c March 16, 1965, policy statement on this subject (30 FR 3462).
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The Commission believes.that the Below-Regulatory Concern policy is needed to establish a consistent, risk-based framework for making' exemption decisions, specifically, the policy is needed to (1) establish residual radioactivity criteria and requirements for decommissioning and cleanup of. radioactive contamination at licensed and formerly-licensed nuclear facilities, (2) ensure that licensee decommissioning funding
-I plans provide adequate. funds to cover the costs of cleanup of these facilities to protect people and'the environment, (3)-
ensure that the public is being adequately and consistently.
protected from consumer products that contain radioactive.
materials under the Commission's jurisdiction, (4) provide-decision criteria for reviewing petitions to. exempt very low y
level radioactive wastes in accordance with the Low-Level-Radioactive Waste Policy Amendments Act:of 1985, (5) focus the resources of NRC, Agreement. States, and' licensees on more significant risks posed by nuclear materials, (6)festablish a-risk-based threshold to; ensure thatLthe potential benefits of additional reductions in risk are commensurate with the costs 1of attaining the reductions and of performing the analyses to
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achieve and confirm the reductions, and (7) review NRC's regulatory framework to ensure that existing exemptions involving
. radioactive materials are consistent andLadequate to protect the public..The averago U.S. citizen should benefit from implementation of the BRC policy through:
increased assurance r
that consumer products'containing radioactive material under the 11 l
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h Commission's jurisdiction are safe; timely cleanup of contaminated sites; -increased assurance that-adequate funds are.
available to decommission currently operating nuclear facilities; potential improvements in medicalitreatment and other services
-that use radioactive materials resulting from the optimal use o'f?
j the Federal, State, and licensee resources; and focus of~ Federal and State efforts and resources on. reducing the-most significant-i
. radiological risks from practices under their jurisdiction.
l The Commission's PRC policy establishes an explicit and l
uniform risk framework for making regulatory' exemption' decisions.
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In lieu of such a policy, the Commission could continue the current practice of exempting practices on aLcase-specificLbasis.
Such an approach, however, does not necessarilyLensure: consistent f
evaluation and control of risks associated with exempted' practices.
For this reason and the reasons discussed above,-the Commission han established the BRC Policy Statement.
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l The Commission recognizes that Agreement States:will play an f
important role in the implementation of the Below Regulatory concern policy, specifically in the areas of developing and.
enforcing compatible State regulations, regulating. cleanup'and' decommissioning of certain types of contaminated nuclear facilities, and exempting certain low-level radioactiveLwastes H
from requirements for disposal in licensed low-level waste.
disposal facilities.
The Atomic Energy Act'of 1954, as> amended,
'gives to the Federal government the exclusive authority toL regulate source, special nuclear, and byproduct materials to-12
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ensure protectton of the public health and safety.
While Congress subsequently provided for Federal-State agreements under Section 274b of.the. Atomic-Energy Act through which States could' assume:regul'atory responsibilities in lieu of Federall regulation for certain-classes of. nuclear materials, it required that' State radiation protection standards be coordinated and compatible with the Federal standards'for radiation protection.
NRC regulations exempting BRC wastes will not affect the authority of State or local agencies to regulate BRC wastes'for, purposes other than radiation protection in accordance with Section 274b of the Atomic Energy Act.
,The Commission intends that rulemakings which codify exemptions from the-regulatory requirements applicable to certain types of radioactive materials' N
will be matters of strict compatibility'for' Agreement States to the extent that States, under the terms of their Section 274b Agreements with NRC, have assumed regulatory responsibility for these classes of materials.
The Nation will benefit from:the; application of a uniform policy, thereby avoiding conflicting, overlapping, and inconsistent standards.
This is particularly significant for articles containing radioactive materials which receive widespread distribution,.such as consumer products, where inconsistent regulations could unduly restrict and' burden J
interstate and international-commerce.
In initiating proceedings to implement NRC's BRC policy, the Commission ~will continue to consult with and seek the advice of the States.
Some States nave expressed concerns;that economic and i
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institutional impacts of the Commission's BRC policy may undermine their ef forts to develop new disposal f acilities for low-level radioactive waste in accordance with the Low-Level Radioactive Waste Policy Amendments Act of 1985.
These States would prefer to establish their own standards for determining which wastes should be exempted from regulatory control rather than adopting standards that are compatible with uniform Federal standards.
The Commission has developed the BRC policy to provide a uniform and consistent health and safety framework for exemption decisions.
In so doing, the Commission recognized the concerns expressed by Congress when it enacted the Low-Level Radioactive Waste Policy Amendments Act of 1985 that health, safety, and environmental considerations should take precedence over economic or institutional concerns (see Senate Report 99-199
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that accompanied S. 1517, Senate Committee on Energy and Natural Resources, November 22, 1985, 99th Congress, 1st Session at page 9).
The Comminsion is confident that waste exemption decisions made in accordance with requirements that implement its BRC policy will be adequate to ensure protection of the public health and safety.
The Commission also believes that inconsistent regulation of BRC waste exemptions could not only result in increased risks to the public and the environment but could also impede State efforts to develop low-level waste disposal facilities.
The policy described in this document is intended to provide the public health and safety framework that would apply to a wide spectrum of Commission exemption decisions.
As such, it prct ides
individual and collective dose criteria,. and discusses other important elements of the exemption decisionmaking process.
3 Section II provides definitions of key. terms and concepts used in the policy statement.Section III presents the-basic elements of the policy, while Section IV discusses how the policy 1will be implemented,through rulemakings and licensing actions and-describes how the public will have an opportunity-to= comment on the commission's exemption decisions.
This section also discusses NRC plans to review past exemption decisions to ensure consistency with the provisions of the-BRC policy.
Section V describes, in general terms, the.information needed to su'pport the exemption decisionmaking process.-
II. Definitions, o
" Activity," when used to describe radioactive material in 1
this policy statement, is the rate of' disintegration (transformatied) or decay of radioactive material.
The units of I
activity are the curie (1 ci = 3.7'x 1010 disintegrations per second) and the becquerel (1 Bq = 1-disintegration per:second).
"ALARA" (acronym for "as low as is reasonably achievable")-
O means making every-reasonable effort to maintain' radiation exposures as far below applicable dose limits as is practical, consistent with the purpose for which the licensed activity is\\
undertaken taking into account the state of technology, the.
economics of improvements in relation to benefits to the public j
health and safety, and other societal and socioeconomic
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I coraiderations and in relation to utilization of; nuclear energy and licensed materials in the public interest.
" Agreement State" means-any State with which the Commission has entered into an ef fective agreement under ' subsection 274 (b) of the Atomic Energy Act ofs1954, as amended.
" Byproduct material" means --
(1)
Any radioactive material (except special' nuclear material) yielded in, or made' radioactive by, exposure'to the-radiation incident to the process of producing or utilizing special nuclear material; and (2)
The tailings or wastes produced by:the extraction or concentration of uranium or thorium from ore l processed.
primarily for its source material content, including discrete surface wastes resulting'from uranium solution extraction l
processes.
Underground; ore. bodies depleted by these solution extraction operations do not constitute " byproduct material" within this definition.
" Collective dose" is_the sum of the individual. doses (total effective dose equivalents) received in: a-given period of tima by a specified population from exposure to a specified source of radiation (or practice involving the use of radioactive material).
Note:
The calculated collective dose used to
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determine compliance with the criterion of this, policy need not l
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include individual dose contributions received at a rate of less than 0.1 mrem per year.
" Committed effective dose equivalent" is the sum of the i
t products of weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to those organs or tissues as defined in?10 CFR Part 20.
" Deep dose equivalent"'is the dose equivalent at.a tissue depth of a cm.
" Dose" or " radiation dose" in this policy:is the total effective dose equivalent.
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" Exemption from regulatory control" refers to a decision 3
process that may allow radioactive material to be transferred 4
from a regulated status to an unregulated status, in which the-material will no longer be subject. to NRC requirements.
5 Decisions to grant exemptions will be based upon findings that the radioactive material poses a small risk-to public health'and safety and the environment and that the small magnitude of the risk does not. warrant expenditure of additional resources of R
regulatory agencies and the regulated community in attempting to.
further reduce the risk.
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" Exposure" means being exposed to ionizing radiation or to radioactive material.
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" Licensed material" means source material, special nuclear material, or byproduct material that is received, possessed,.
used, transferred, or disposed of under a general or specific license. issued by the Commission or an Agreement State.-
" Licensee" means the holder.of an NRC or Agreement State license.
" Natural background dose" means the dose-received'from:
naturally occurring ccsmic and terrestrial radiation and-radioactive material but not from source, byproduct, or-special.
nuclear material.
"No-threshold hypothesis" refers to the theory'that, at the small done levels considered in this policy,-there continues to be a risk without threshold for exposure to radiationsand that there is a relationship between dose and=theLatatistical.
probability of the occurrence of a health leffect (such as latent cancers and genetic effects).-
" Practice" is a broadly defined activity or a set or combination of.a number of similar coordinated and continuing.
activities aimed at a given purpose that involves the potential for radiation exposure.
Disposal of very low level radioactive waste; the release for unrestricted public use of lands and structures with residual levels of radioactivity; the distribution, use, and disposal of specific consumer products 18 3
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I containing small_ amounts of ra'dioactive material; and the recycle and reuse of residually contaminated materials and__ equipment are examples of practices for'which this policy will have potential:
applicability.
" Rem" is the special unit of dose equivalent _(1 rem = 0.01 sievert).
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" Risk," for purposes of this' policy,_means'the annual or.
lifetime probability of the development.of fatal cancer from exposure to ionizing radiation and is'taken as_the product of the-dose received by an exposed-individual and a conversion factor
' based upon_the linear, no-threshold hypothesis.
The conversion factor for dose to risk is taken to be65 x.109 fatal' cancers lper rem of radiation dose.
The fatal cancer risk is' considered,.in
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general, to be either more likely or_have-more severe outcome-i than the potential genetic and nonfatal cancer risks and the o
potential risks of developmental anomaliesc.in fetuses.
While the Commission recognizes that the risks from. exposure to radiation-are greater for children than adults and that there are increased risks from exposure to the embryo / fetus, the. estimate of fatal cancer risk for all ages and both sexes-is considered'to be an appropriate measure of risk from practices being considered for exemption in'accordance with this policy statement (see Appendix).
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" Source material" meat.y --
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.9r (1). Uranium or thorium, or any' combination of uranium and thorium in any physical-or chemical form;'or (2)
Ores which contain, by weight, one-twentieth of one percent (0.05 percent), or more, of uranium, thorium,.or any I
combination of uranium and thorium. ' Source material does not i
include special nuclear material.
"Special nuclear material" means --
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(1)
Plutonium, uranium-233, uranium enriched.in the i
isotope 233 or in the isotope 235, and any other material which-I the commission, pursuant to the provisions of-section 51 of the Act, determines to be special nuclear material, but does=not=
include source material; or
-(2)
Any material artificially enriched by any of the foregoing but does not include source material..
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" Total effective dose equivalent" means the sum of the deep dose equivalent (for external exposures) and the committed-effectiva dose equivalent (for internal exposures) expressed in rems or sieverts.
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III. Policy Elements.
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The purpose of this policy statement is to establish the i
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basis upon which the Commission will initiate the development of
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appropriate regulations or make licensing deJisions to exempt certain practices from some or all regulatory controls.
This-policy is directe 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.
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It is the Commission's intent to broadly define specific 1
practices so that'the effect of an exemption decision.on any individual or population will-be evaluated in its entirety and not in a piecemeal fashion.
At the same time, the practice must be identified and-described in terms that will facilitate reasonable impact analyses and_ allow. imposition of appropriate' constraints, requirements, and conditions as the radioactive material. passes from a regulated to an unregulated status'(i.e.,
the material is no longer required to be under the control of a
!i licensee).
Under this policy, the definition of a " practice" in any specific decision (rulemaking or licensing' action) is a critical ~ feature.
The NRC will ensure that' formulation of exemptions from regulatory control will not allow deliberate dilution of material or fractionation of the radiation or radioactive material for the purpose of circumventing controls that would otherwise be applicable.
The definition of the practice in any specific exemption decision will also provide tho' q
framework for taking into account the possible consequences of l
accidents or misuse or the potential for other nonstochastic 21 1
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4 radiological impacts associated with the exemption.
In formulating this policy statement, the Commission deliberated at length on the need to consider whether practices must be rigorously justified in terms of societal' benefit-regardless of the-level of risk they pose.
Justification ~of practice is recognized by health physics professionals and national and international organizations as one of the three fundamental tenets of radiation protection = (justification,' dose limits, and ALARA).
The Commission has prepared this policy statement in conformance with these basic tenets as appropriate for exemption decisions.
Consistent with the position.of the
- International Atomic Energy Agency in its Safety Series Report No. 89, the Commission believes that' justification: decisions usually derive from considerations that are much broader than.
radiation protection alone and that -fall catside of the context of the Commission's regulatory authority'to ensure the protection of the public health and safety and the environment. -The Commission recognizes-that justification decisions ~ involving social and cultural value judgments should" rightfully be made lar affected elements of society.
Consequently, at the low levels of risk associated with practices eligible-for exemption in accordance with this policy, the Commission will not consider whether a practice is-justified in terms of' net. societal benefit.
Nevertheless, the-Commission may determine on the basis of J
risk estimates and associated uncertainties that certain l
22 i
j i
i practices should not be considered candidates.for exemption, such as the introduction of radioactive materials into products to be consumed or used primarily by children.
Such practices should be i
specifically evaluated to determine if they could result in I
greater risk levels to exposed members of the public than the-levels found acceptable by the Commission in formulating this i
policy.
Unlike justification decisions involving complex trade-offs between cultural and societal values, these decisions clearly fall within the commission's purview to protect the health'and safety-of the public.
i A '.
Principles of Exemption.
I A major consideration in exempting:any practice from some or j
all regulatory controls hinges on the general' question of whether j
the application or continuation of regulatory con'trols'is d
necessary-to protect the public health and safety:and the.
i environment'and is cost effective in further reducing a small i
risk-(i.e., a commensurate dose reduction)..To determine if exemption is appropriate from this-standpoint, the commission.
must determine-if one of the following conditions is met:
l l
- ?
1.
The application or continuation of regulatory controls
]
1 on the practice does not. result in any significant reduction in dose received by individuals within a
}
critical group (i.e., the group expected to receive-the j
highest exposure) and by the exposed population; or'
}a 1
l 23 1
4
l 2.
The costs of the controls that-could be imposed for.
further dose reduction are'not balanced by the commensurate reduction in risk-that could be realized.
At a sufficiently low level of risk, the commission believes-the decisionmaking process for granting specific exemptions from-some or all. regulatory controls can be~ essentially reduced to an evaluation of whether the overall individual and col _lentive risks from-each particular practice are sufficiently small.
The-Commission believes that individual and population done criteria should be basic features of its overall policy to define the-j region where the expenditure of Commission' resources'to enforce-requirements for further dose reductions or licensee resources to comply with such requirements-is no longer warranted.- These-specific criteriaLinclude (1) values /for the individual annual dose reason;Aly expectat=to be received as a result of the practice (e.g.,
an average dose to individuals in a critical' group) and (2) a measure of radiological:. impact to the exposed population.
In combination, these criteria are. chosen to ensure that, for a given exempted practice, no individual will be exposed to a significant radiological risk and that the h
1 population as a whole does not suffer a significant radiological' i
impact.
j It is important to emphacize that, in this policy, the commission does not assert an absence or, threshold of risk ~at low radiation dose levels but rather establishes a baseline level of risk beyond which further government regulation to reduce risks 24 I
I.
is unwarranted.
As described in the Appendix to this policy statement, the technical rationale for the Commission's BRC i
criteria is explicitly based on the. assumption that the risk from i*
exposure to radiation is linearly proportional to the dose to an individual.
The presence of natural background radiation and variations in the levels of this background have been used to provide a perspective from which to judge the relative significance of the radiclogical risks involved in the exemption decisionmaking process.
1 B.
The Individual Dose Criterion.
If the doses to individuals from a practice under consideration for exemption are sufficiently small, the attendant I
risks will be small compared to other societal risks, and'there
^
would be little merit in expending resources to further reduce this dose or risk provided that sound radiation protection principles have been applied in the design, develepr.ient, and proposed implementation of the practice.
The commission' believes the definition of this risk or dose level can be developed from two perspectives.
The first of these is related to quantitative risk levels.
Based cc analysis of voluntary and involuntary risks commonly accep;#d by the public without significant concern, t'
a commission believes that most members of society will not expend resources to reduce an annual individual risk of fatality below approximately 1 chance in 100,000 (1 x 104; this is equivalent 25
to a-lifetime risk of 7 chances in 10,000 or 7 x 10).
The 10 4 annual risk level is greater than that selected by the Commission 1
in the development of its safety goal policy'for nuclear power reactors, (i. e., 2 x 10*').
The safety goal risk level equals one l
one-thousandths (0.1%) of the-sum of cancer fatality. risk from all other causes.
The Commission compared this risk to the 4
lifetime risk-of developing fatal cancer of about 2 chances in 10 (2 x 10)=and the lifetime risk associated with natural background radiation generally ranging from 3 chances in 1,000 to.
1 chance in 100 (3.x 10'3 to 1 x 10 2),
The second perspective is based on variat4ons in dose, and 1
hence risks, knowingly or unknowingly tolerated by individuals because of factors such as their-lifestyle or place of residence.
The Commission notes that resources are not expended to reduce L
differential' exposures associated with variations in natural background radiation (e.g., the 60-70 mrem per year; difference between annual: doses received in Denver,-Colorado, vs.
- q Washington, DC.).
In addition, individuals are_ generally not concerned about the difference in doses between living in a brick versus a frame liouse, the 5 mrem dose received during-a typical l
roundtrip coast-to-coast flight, or incremental doses from other activities that involve a small fraction of background radiation.
D In developing the BRC policy, the Comm'ission is faced with the issue of how to characterize the individual and population risks associated with low doses and dose rates.
Although the uncertainties are large, useful perspective on the bounding risk
'l 26
}
associated with very low levels of radiation can be provided by l
continued use of the linear, no-threshold hypothesis.
Comparison I
of the low risk from very low doses with the potentially more 1
significant risks from higher doses associated with other activities which the NRC regulates provides additional I
perspective.
I i
In this context, the risk to an individual as calculated f
using the linear, no-threshold hypothesis is shown in Table i for i
various defined levels of annual individual dose.
The values in i
the hypothetical lifetime risk column are based on the further assumption that the annual dose is centinuously received during each year of a 70-year lifetime.
To provide further pauspective, a radiation dose of 10 mrem per year (0.1 mSv per year) received continuously over a lifetime corresponds to a risk of about 4 chances la 10,000 (3.5 x 10) or a hypothetical increase of about 0.25% in an individual's lifetime risk of fatal cancer. The Commission prefers to use factors of ten to describe such low i
individual doses because of the large uncertainties associated l
with the dose estimates.
The Appendix to the policy statement provides a more complete discussion of the risks and uncertainties associated with low doses and dose rates.
t m
4 27
-. ~.
. ~..
__~ _
o Table 1 Hypothetical Hypothetical Incremental Incremental Lifetime Risk From Annual Dose
- Annual Risk **
Continuina Annual Dese**
100 mram (1 mSv) 5 x '10 5 3.5 x 10*3 4
3.5 x 10*'*
10 mram (0.1 mSv) 5 x 10 1
mrem (0.01 mSv) 5 x 10*7 3.5 x 10*
0.1 mram (0.001 MSV) 5 x 10*8 3.b x 104 i
e
- The expression of dose refers to the Total Effective Dose Equivalent.
i This term is the sum of the deep (whole body) dose equivalent for sources external to the body and the committed effective (whole body) dose equivalent for sources internal to the body.
- Calcu, lated using a conservative risk coefficient of 5 x 10" per rem (5 x 10' per SV) for low linear energy transfer radiation based on the results reported in UNSCEAR 1988 (Footnote 2) and BEIR V (see also NUREG/CR-4214, Rev. 1).
3 i
In view of the uncertainties involved in risk assessment at low doses and taking into account the aforementioned risk and dose perspectives, the Commission finds that the average dose to individuals in the critical group should be less than 10 mram per year (0.1 mSv per year) for each exempted practice.
In addition, an interiu does criterion of 1 mrem per year (0.01 mSv per year) averava dose to indiviQtlais in the critical' group will be applied i
to those practices -Involving widespread distribution of radioactive material in such items as consumer products or-i L
recycled materjal and equipment, until the commission gains more experience with the potential for individual exposures from I
multiple licensed and exempted practices.
These. criteria provide i
I 28 i
n
--s
e individual dose thresholds below which additional regulatory l
controls are unnecessary and unwarranted to require further reductions in individual doses.
The Commission considers these l
criteria to be appropriate given the uncertainties involved in I
estimating doses and risks, and notes that these criteria should facilitate straightforward implementation of this policy in i
future rulemakings or licensing decisions.
l The Commission believes that, notwithstanding exemption of practices from regulatory control under these criteria, it still has reasonable assurance that cxposures to individual members of the public from all licensed activities and exempted practices will not exceed 100 mrem per year (1 mSv per year) given the Commission's intent (1) to define practices broadly, (2) to j
i evaluate potential exposures ever the. lifetime of the practice, (3) to monitor and verify how exemptions are implemented under this policy, (4) to impose a companion individual and collective dose criteria, (5) to verify dose' calculations through licensing l
i reviews and rulemakings with full' benefit of public review and:
-l comment, and (6) to inspect and enforce licensee adherence to l
specific constraints and conditions imposed by the Commission on i
exempted practices.
1 The Commission intends that only under unusual circumstances l
would exemptions be considered for practices that could cause
.j i
continuing radiation exposure to individuals exceeding a small L
i fraction of the 100 mrem per year (1 mSv per year) public dose limit.
In rare cases, exemptions of such practices _may be-i 29 1
l' granted if, a;ter conducting a thorough analysis of the proposed exemption, the Commission determines that doses to members of the public are ALARA and that additional regulatory control is not justified by further reductions in individual and collective l
doses.
{
I C.
The Population Dose criterion.
The Commission believes that the collective dose (i.e., the sum of individual total effective dose equivalents) resulting from exposure to an exempt practice should be ALARA.
However, if
{
the collective dose resulting from an exempted practice is less than an expected value of 1000 person-rem per year (10 person-Sv f
per year), the resources of the commission and its licensees could be better spent by addressing more significant health and safety issues than by requiring further analysis, reduction, and l
t confirmation of the magnitude of the collective dose.
The l
Commission notes that, at this level of collective dose, the
}
number of hypothetical health effects calculated for an exempted i
practice on an annual basis would be less than one.
l The National Council of Radiation Protection and 1
Measurements recommends in its Report No. 91 that collective l
dose assessments for a particular practice should exclude j
consideration of those individuals whose annual effective dose l
' Recommendations on Limits for Exposure to Ionizing Radiation, NCRP Report No. 91, National Council on Radiation Protection and Measurements, June 1,
1987.
Available for purchase from NCRP Publications, 7910 Woodmont Ave., Suite 1016, Bethesda, MD 20814.
i 30
l i
i equivalent is less than or equal to 1 mrom per year (0.01 mSv per i
1 year).
Taking this recommendation into account and considering i
t the practicality of dose estimation techniques and uncertainties
[
t associated with such low dose and dose-rate estimates, the commission concludes that individual doses less than 0.1 arem per year (0.001 mSv per year) need not be considered in calculating l
collective deses.
As a practical matter, consideration of dose l
l rates in the microrem per year range and large numbers of hypothetical individuals potentially. exposed to an exempted l
practice may unduly complicate the dose calculations that will be used to support demonstrations that proposed exemptions comport with the criteria in this policy.
The commission believes that inclusion of individual doses below 0.1 mrem per year introduces unnecessary complexity into collective dose assessments and could impute an unrealistic sense of the significance and certainty of such dose levels.
l l
In the sensitivity-of-measure, risk-based guidelines used by r
EPA and FDA, a 10 lifetime risk of cancer has been used as n'
[
quantitative criterion of insignificance.
Using an annual risk f
coef ficient of 5 x 10 health ef fects per rem (5 x 10 2 per l
sievert) as discussed in the Appendix, the 10 lifetime-risk
[
value would approximate the risk that an individual would hypothetically incur from a continuous lifetime dose rate in the f
1 l
range of 0.01 to 0.1 mrem (0.0001 to 0.001 mSV) per year.
For the all of these reasons, the Commission believes that 0.1 mrem l
per year is an appropriate truncation value to be applied in the f
assessment of collective doses for the purposes of-this policy.
31'
l f'
The Commission notes that adoption of the individual and collective dose criteria does not indicate a decision that doses below these criteria are necessary before a practice can be exempted or that doses above the criteria would necessarily 1
preclude exemptions.
The criteria simply represent a range of risk that the Commission believes is sufficiently small compared to other individual and societal risks that further cost-risk I
reduction analyses are not required in order to make a decision i
j regarding the acceptability of an exemption.
Practices not meeting these criteria may nevertheless be granted exemptions from regulatory control on a case-by-case basje in accordance j
with the principles embodied within this policy, if (1) the potential doses to individual members of the public are sufficiently small or unlikely, (2) further reductions in the i
doses are neither readily achievable nor significant in terms of protecting the public health and safety and the environment, and f
(3) the collective dose from the exempted practice is sufficiently small.
f I
IV. Implementation.
The Commission's BRC policy will be implemented principally
[
through rulemakings; however, exemption decisions could also be F
implemented through specific licensing actions.
f In the first case, a proposal for exemption, whether initiated by the NRC or requested by outside parties in.a f
petition for rulemaking, must provide a basis upon which the l
?
32
o I
I j
petition for rulemsking, must provide a basis upon which the Commission can determine if the basic policy criteria have been I
satisfied.
The Commission intends to initiate a number of l
rulemakings on its own (e.g., to establish a dose criterion for j
j decommissioning) and may initiate others as a result of HRC's l
review of existing codified exemptions (e.g., consumer product exemptions in 10 CFR Parts 30 and 40).
Rulemakings may also be
{
initiated in response to petitions for rulemaking submitted by outside parties, such as a BRC waste petition submitted in accordance with Section 10 of the Low-14 vel Radioactive Waste i
Policy Amendment Act of 1985.
In general, rulemaking exemption I
proposals should assess the potential individual and societal impacts that could result if the exemption were to be granted.
The proposal should consider the uses of the radioactive i
materials, the pathways of exposura, the levels of radioactivity, and the methods and constraints for ensuring that the assumptions used to define a practice remain appropriate as the radioactive i
materials move from a regulated to an unregulated status.
Any such rulemaking action would follow the Administrative Procedure Act, which requires publication of a proposed rule in order to solicit public comment on the rulemaking action under consideration.
The rulemaking action would include an l
appropriate level of environmental review in e.acordance with the Commission's regulations in 10 CFR Part 51, which implement the r
National Environmental Policy Act.
l l
If a proposal for' exemption results in a Commission regulation containing specific requirements for.a particular p
33 s
exemption, a person using the exemption would no longer be
]
. required to apply the ALARA principle to reduce doses further for the exempted practice provided that the licensee' meets the conditions specified in the regulation.
The promulgation of the regulation would, under these circumstances, constitute a finding that the practice is exempted in accordance with the provisions f
)
of the regulation and that ALARA considerations have been l
adequately addressed from a regulatory standpoint.
The Commission in no way wishes to discourage the voluntary application of additional health physics practices which may, in I
fact, reduce actual doses significantly below the BRC. criteria or the development of new technologies to enhance protection to i
public and the environment.
This is particularly pertinent in l
the area of decontamination and decommissioning, where the l
Commission anticipates that emerging technologies over the next several decades should enhance existing technical capabilities and further reduce doses to workers and the public.
F h
The second means of policy implementation could involve exemptions that would be granted through licensing actions, such.
f I
as site-specific determinations that a site has been sufficiently r
decontaminated to be released for unrestricted public use.
The NRC intends to develop guidance regarding the implementation of I
the BRC criteria to ensure that such site-specific actions adhere to the criteria and principles of this policy statement.
The'se licensing actions may be subject to a public hearing process and, depending on the specific action taken, may be required to be noticed in the Federal Register.
i t
34
- hi
.a m
-+-w-m w
v r
g
I
)
['
i one of the principal benefits of the policy is that it provides a framework to evaluate and ensure the consistency of
]
past exemption decisions by the Commission.
With the adoption of this BRC policy, the NRC will initiate a systematic assessment of exemptions currently existing in NRC's regulations to ensure that the public is adequately and consistently protected from the i
risks associated with exempted practices.
In addition, the NRC l
l will, on a periodic basis, review the exemptions granted under this policy to ensure that the public health and safety continue to be protected adequately.
V.
Information To Support Exemption Decisions.
A.
General.
The information required to support an exemptio'n decision in a rulemaking or licensing action should provide the basis for the proposed exemption in accordance with Section III of this policy.
5 In addressing the radiological health and safety impacts, l
t potential individual and collective. doses attributed to the i
i practice under consideration should either meet the policy's dose i
criteria or otherwise be demonstrated to be low enough to ensure protection of the public health and safety and ALARA.
In l
addition to the impacts of routine exposures, the impacts resulting from potential misuse or accident scenarios-should also be evaluated and demonstrated to be insignificant.
The NRC.may t
reject proposals for exemptions if theyLdo not provide a sufficient technical basis to support analysis of the benefits i
j
.and impacts associated with the potential exemption.
I l
35 i
o-l Practices should be defined with respect to the geographic and demographic areas to which the exemption will apply.
In some cases, an exemption will be limited to one particular locality or area.
However, many practices will have national applicability and should be characterized accordingly.
Information on these-issues will be necessary for determinations regarding which individual dose criterion should be applied.
The Commission believes that the implementation guidance provided with its " General Statement of Policy and Procedures l
Concerning Petitions Pursuant to 52.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern," published August 29, 1986, 51 FR 30839, generally defines the types of information needed to support an exemption decision.
- However, not all of the information may be applicable to the broader range of practices considered for exemption under this policy.
Applicants should examine potentially relevant guidance available at the time the exemption proposal is being prepared and provide the information which is relevant to the particular type of exemption decision being requested.
B.
Material Characterization.
1.
Radiological properties.
The radiological properties of the materials to be exempted should be described, including, as
)
appropriate, the concentration'or contamination levels and tho' half-lives, total quantities, and identities of the radionce13 des 36
associated with the exempted practice.
The chemical and physical form of the radionuclides should be specified.
All radionuclides present or potentially present should be specified.
The distribution of the radionuclides should be noted (e.g., surface or volume distribution).
Mass-and volume-averaged concentrations should also be presented.
The variability of radionuclide concentration, distribution, or type as a function of process variation or variations among licensees should be addressed and bounded, as appropriate.
2.
Nonradiological properties.
The nonradiological properties of the materials to be exempted should be described to ensure complete characterization of the properties of the material and consideration of any adverse impacts associated with these properties.
An NRC exemption, based on radiological I
impacts, would not relieve licensees from compliance with i
applicable rules of other agencies which cover nonradiological properties.
A description of the materials, including their origin, chemical composition, physical state, volume, and mass should be provided.
The variability and potential changes in the materials as a function of process variation should be addressed.
The variation among licensees should be described and bounded, as applicable.
C.
Practice Characterization 1.
Total it< pact.
A regulatory action taken under this policy is likely to be generic and may be nationwide in scale.
37 i
I 4
Therefore, to the extent possible, an estimate of the number of 1
NRC and Agreement State licensees that possess the radioactive material considered for exemption, the annual volumes and masses, 1
and the total quantities of each radionuclide that would be a 4
part of the exempted practice should be given.
The estimates l
should include the current situation and the likely variability I
over the reasonably foreseeable future.
A geographical distribution would be a helpful tool in characterizing the radioactive material 1.9volved in the exemption decision.
Such distribution, submitted as part of the practice characterization, should be used to assess realistic impacts of the practice in addition to conservative bounding estimates that tend to overestimate human exposures and doses.
In any case, the typical quantities produced per practice (e.g., number of units of a particular consamer product) and an estimate of the geographic 4
distribution of the practice should be described.
T;He potential for short-and long-term recycle or reuse of the product containing the exempted radioactive material should also be addressed.
Both the resource value (e.g., salvageable metals) and the functional usefulness (e.g., usable tools) should 'be examined.
k 2.
Basis for assessment.
A description of bases for the l
materials and practice characterizations should be provided.
l Monitoring and analytical data and calculations should be I
specified and provided in support of the characterization, j
Actual measurements or vt. lues that can be related to measurements to confirm calculations are iniportant and should be provided.
j l
l 38 q
)
i The description should address the quality assurance program used in data collection and analysis and supporting information.
If any surveys were conducted, they should be described.
Market i
information may be useful in characterizing a practice on a j
national basis.
i i
3.
As low as is reasonably achievable ( ALARA).
An analysis should be provided that demonstrates that radiation exposure and i
radionuclide releases associated with the exempted practice j
overall will be ALARA.
The ALARA principle referred to in 10 CFR f
Part 20 applies to efforts by licensees to maintain radiation exposures and releases of radioact;.ve materials to unrestricted areas as low as is reasonably achievable.
Appendix I to 10 CFR Part 50 describes ALARA for radioactive material releases from light water reactors (nuclear power plants).
Exemption proposals should describe how ALARA considerations have been applied in the design, development, and implementation of controls for the j
t proposed practice.
Licensee. compliance with the ALARA principle l
must remain in effect up to and including the point at which the I
materials are transferrod to an unregulated status in accordance f
with an exemption granced under this policy.
D.
Impact Analyses.
[
i l
To support and justify a request for exemption, each petitioner or licensee should assess the radiological and nonr'adiological impacts of the proposed exemption.
The analyses should be based on the characterizations described previously and l
i i
39
. ~..
l..
should cover all aspects of the proposed exempt practice, including possession, use, transfer, ownership, and disposal of the material.
NRC consideration of the exemption proposal and any environmental assessments and regulatory analyses required to implement the exemption will be based on the impact analyses and-supporting characterizations.
i i
1.
Radiological impacts.
The evaluation of radiological impacts should clearly address the policy's individual and l
collective dose criteria or provide a sufficient ALARA-evaluation f
supporting the exemption.
In either case, the following impacts j
should be assessed:
r Average doses to the critical population group; collective doses to the critical population group and the total exposed population (under. conditions defined in f
Section III);
j The potential for nonstochastic radiological impacts; and The potential for reconcentration of radionuclides.
The collective population exposure should be estimated and l
summed in two parts: total dose to the critical population group and total dose to the population.
The critical group is the
{
relatively homogeneous group of individuals whose exposures'are f
likely to be the greatest and for whom the assessment of doses is f
likely to be the most accurate.
Average doses-to this group are i
the controlling factors limiting individual doses ar.d. risk, and should be compared with the individual dose criteria, as f
i 40
i s
l 1
1 Y
appropriate.
The critical group should be the segment of the f
I r
population most highly exposed to radiation or radioactive materials associated with the use of ;;adioactive material under i
unregulated conditions.
The second pa rt of the population I
exposure is the general population exposure, exclusive of f
critical group exposure.
For this group, the individual t
exposures should be smaller, and the assessment will often be i
i less precise.
The impacts analysis should present an estimate of the distribution of doses within the general population.
In situations where truncation of.the collective dose calculation is j
done under the provisions of this policy, the basis fe,r applying l
the truncation provision and the uncertainty in dose estimates i
should be provided.
The evaluation of radiological impacts should distinguish
[
between expected and potential exposures and events.
The analysis of potential exposures in acejdent or misuse Nenarios
[
should include all of the assumptions, data, and results used its the analysis in order to facilitate review.
The evaluation I
should provide sufficient information to allow a reviewer to t
independently confirm the results.
The potential for reasonable interactions between the exempted radioactive material and the l.
public should be assessed.
I I
.l I
l 2.
Other impacts.
The analysis of other radiological impacts such as those from transportation, haradling, processing, and disposal of exempted materials should be avaluated.
l Nonradiological impacts on humans and the environment should also I
i 41 r
1 o
be evaluated in accordance with NRC requirements in 10 CFR part 51.
The analysis should also consider any adverse impact of the measures taken to provide nonradiological protection on radiation exposure and releases of radioactive material.
Any NRC action to exempt a practice from further regulatory control would not relieve persons using, handling, processing, owning, or disposing of the radioactive material from other requirements applicable to the nonradiological properties of the material.
E.
Cost-Benefit Considerations (as required).
A cost / benefit analysis is an essential part of both I
environmental and regulatory impact considerations.
The analysis should focus on expected exposures and realistic concentrations or quantities of radionuclides.
The cdst/ benefit analysis should compare the exposures and economic costs associated with the-
?
regulated and unregulated alternatives.
Benefits and costs should be considered in both quantitative and qualitative terms.
I Costs of surveys and compliance verification discussed under Iten V.G. should also be covered.
Any legal or regulatory constraints that might affect an exemption decision should be identified.
For example, one such constraint might stem from Department of Transportation (DOT) requirements for labeling, placarding, and I
manifesting radioactive materials in 49 CFR part 173.
d 42 u
l I
l
\\
F.
Constraints, Requirements, or Conditions on Exemptions.
f i
i In most cases, the characterizations of the material and the assessment of impacts will be based on either explicit or I
implicit constraints, such as limitations on the amount of f
radioactive material in a consussr product.
In order for an exemption decision to take credit for these constraints, the j
exemption proposal should specifically identify appropriate
]
constraints, such as quantity limits, concentration limits, and t
physical form characteristics.
The-bases on which these y
constraints are to be ensured should also be discussed.
In l
general, constraints should be inspectable and verifiable in order to provide the basis for an exemption decision.
G.
Recordkeeping and Reporting.
[.
I This portion of the exemption proposal should be tailored to 5
either a generic petition for rulemakingor specific proposai for a license amendment.
For generic petitions for rulemaking, the proposal should provide and justify' feasible, generic requirements for record keeping and reporting for Quality j
Assurance / Quality Control and Reporting.
Such proposals-should include example requirements and show their effectiveness and feasibility.
For site-specific license amendments, the e:temption j
proposal should provide specific requirements for Qualit)
.i e
Assurance / Quality control and Reporting that have bean tailored l
to the licensee's program.
l 1
.A
s 1.
Quality assurance / quality control.
The program to ensure compliance with specific exemption constraints, requirements, or conditions should be defined.
The records of inventory, tests, surveys, and calculations used to demonstrate compliance with the exemption constraints should be riaintained for inspection.
Such programs are necessary to prov:de the NRC and the public reasonable assurance of conformance with the constraints and of adequate protection of human health and the environuent.
2.
Reports.
Annual reports may be required from licensees who, by rule or license, are permitted' to release materials exempted from regulatory control.
Associated recordkeeping to generate the reports should be defined.
Minimum information in the annual reports could include volume and curie content.
More detailed recordkeeping and reporting requirements may be imposed to address uncertainties in projecting future volumes or amounts of exempted materials and to consider the cumulative inpacts of multiple exemptions.
l l
44 i
O 1
1 l
3 APPENDIX - DOSE AND HEALTH EFFECTS ESTIMATION I.
Dose Estimation In estimating the dose rates to members of the public that might arise through various practices for which exemptions are being considered, the Commission has decided to apply the concept of the " total effective dose equivalent."
This concept, which is based on a comparison of the delayed health effects of ionizing radiation exposures, permits the calculation'of the whole body dose equivalent of partial body and organ exposures through use of weighting factors.
The concept was proposed by the International Commission on Radiological Protection (ICRP) in its Publication 26 issued in 1977.
Since that time, the concept has been reviewed, evaluated, and adopted by radiation protection organizations throughout the world and has gained wide acceptance.
ICRP plans to update the. concept by publishing a new, revised report in 1990.
The " total effective dose equivalent" concept is incorporated in " Radiation Protection Guidance to Federal Agencies for Occupational Exposure -
I Recommendations Approved by the President," that was signed by the President and published in the Federal Register on i
January 27, 1987 (52 FR 2822).
The Commission recognizes that, in considering specific exemption proposals,.the total effective dose equivalent must be taken into account.
- j 45
l i
II. Estimating Health Effects From Radiation Exposure I
A.
Individual Risks.
l l
?
l l
In the establishment of its radiation protection policies, f
I the commission has considered the three major types of stochastic l
l health effects thau can be caused by relatively low doses of l
i radiation:
cancer, genetic effects, and developmental anomalies l
in fetuses.
The NRC principally focuses on the risk of fatal l
cancer development because, at relatively high radiation doses, i
(1) the mortality risk represents a more severe outcome than the nonfatal cancer risk, and (2) the mortality risk is thought to be higher than the risk associated with genetic and developmental effects on fetuses.2 However, even though radiation has been l
shown to be carcinogenic, the development of a risk factc.
I applicable to continuing radiation exposures at levels equal so t
3 natural background requires a significant extrapolation from the
(
i
)
i i
i 2Further discussion of these topics is provided in " Sources, Effects and Risks of Ionizing Radiation," United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR),1988 Report j
to the General Assembly with Annexes.
3Natural background radiation can vary with time and-location.
In Washington, D.C., natural background radiation (excluding radon) results in individual doses of about 90 arem per year (0.9 mSv/yr),
l while in' Denver, Colorado, the value is about 160 arem per year (1.6 mSv/yr).
In both cases, naturally occurring radioactive material in the human body contributes approximately 40 mram per year.
Radiation from inhalation of the daughter products-of radon contributes an average additional dose of 200 mrem per year (2 i
mSv/yr) to members of the U.S.
population (NCRP Report No. 93,
" Ionizing Radiation Exposure of the Population of the United States").
- 1 l
46 j
l 1
. _...... -, ~. - -i
observed effects at much higher doses and dose rates.'
This results in significant uncertainty in risk estimates as reflected by the views of experts in the field.
For example, the Committee on the Biological Effects of Ionizing Radiation (BEIR III) of the National Academy of Science 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 gamma or x-rays (low LET; low linear energy transfer radiation) of about 100 mrads/ year (1 mGy/ year) are detrimental to man."
More recently, the BEIR V Committee of the National Academy of I
Science / National Research Council stated that it " recognizes that i.
its risk estimates become more uncertain when applied to very low doses.
Departures from a linear model at low doses, however, could either increase or decrease the risk per unit dose."
The Commission understands that the Committees' statements reflect the uncertainties involved in estimating the risks of radiation exposure and do not imply either the absence or presence of i
detrimental effects at such low dose levels.
The United Nations Scicrtific Committee on the Effects of i
Atomic Radiation (UNSCEAR) stated in their 1988 Report to the
{
l
'The health ef fects clearly attributable to radiation have occurred principally among.early radiation workers, survivors of I
the atomic bomb explosions at Hiroshima and Nagasaki, individuals exposed for medical purposes, and laboratory animals.
Natural background radiation causes an annual dose that is at least two orders of magnitude less than. the dose received by human populations from which the cancer risks are derived.
Experiments at the collular level, however, provide similar indications of biological effects at low doses.
47 wo
s j.
O General Assembly that "...there was a need for a reduction factor to modify the risks (derived at high doses and dose. rates)...for low doses and dose rates...an appropriate range (for this' factor) to be applied to total risk for low dose and dose rate should be between 2 and 10."
This factor would lead to a risk coefficient 4
3 value between 7 x 10 and 3.5 x 10*' per rad (7 x 10I,and 3.5 x 10*I per Gy) based on an UNSCEAR risk coefficient of 7.1 x 10*'
per rad (7.14 per gray) for 100 rad (1 gray) organ absorbed doses l
at high dose rates.
The report also stated, "The product'of the risk coefficient appropriate for individual risk and the relevant l
collective dose will give the expected number of cancer deaths in
{
.the exposed population, provided that the collective dose is at least of the order of 100 man-Sv (10,000 person-rem).
If the s
collective dose is only a few person-Sv (a few hundred person-rem), the most likely outcome is zero deaths."
l In December 1989, the BEIR V committee published a' report-
{
entitled " Health Effacts of Exposure to Low Levels =of' Ionizing f
i Radiation," which contained risk estimates that are, in general, f
similar to the findings of the 1988 UNSCEAR report.
The.BEIR V report's estimate of lifetime excess risk of death from cancer l
4 following an acute dose of 10 rem (0.1 Sv) of low-LET radiation was 0.8%.
Taking into account a dose rate effectiveness factor of 2 for doses occurring over an extended period of time, the risk coefficient is on the order of 4 x 10*' per rem, consistent f
with the upper level of risk estimated by UNSCEAR.
I f
48
l In view of this type of information, the NRC, the Environmental Protection Agency, and other national and international radiation protection authorities have established radiation protection standards defining recommended dose limits for radiation workers and individual nembers of the public.
As a matter of regulatory prudence, all these bodies have derived the value presumed to apply at lower doses 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 linear no-threshold hypothesis, I
in which the risk factor at low doses reflects the straight-line
)
(linear) dose-ef fect relationship at much higher doses and dose rates.
In this respect, the BEIR V report notes that "in spite i
of evidence that the molecular lesions which give rise to somatic i
l and genetic damage can be repaired to a considerable degree, the new data do not contradict the hypothesis, at least with respect to cancer induction and hereditary genetic effects, that the
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frequency of such effects increases with low-level radiation as a' I
linear, nonthreshold function of the dose."
The commission, in the development of the BRC policy, is
.I faced with the issue of how to characterize the individual and population risks associatrid with low doses and dose rates.
Although the uncertainties are large, useful perspective on the bounding risk associated with very low levels of radiation can be provided by continued use of the linear no-threshold hypothesis.
l i
consequently, such risk estimates have been a primary factor in i
establishing individual.and collective dose criteria associated l
49 i
with this policy.
The estimations of the low risk from potentially exempted practices can be compared to the relatively higher potential risks associated with other activities or decisions over which the NRC has regulatory responsibility.
j Through such comparisons, the Commission can ensure that its i
radiation protection resources and those of its licensees are expended in an optimal manner to accomplish its public health and
[
safety mission.
In thic context, the risk to an individual as calculated 1
using the linear no-threshold hypothesis is:shown in Table 1 for f
various defined levels of annual individual dose.
The values in the hypothetical lifetime risk column are-based on the further assumption that the annual done is continuously received during each year of a 70-year lifetime.
To provide further perspective, a radiation dose of 10 mrom per year (0.1 mSV per year) received continuously over a lifetime corresponds to a hypothetical increase of about 0.25% in an individual's lifetime risk of cancer death.
Ten millirem per year (0.1 mSv per year) is also a dose rate that is a small fraction of naturally occurring background radiation and comparable to the temporal variations in natural background' radiation due to fluctuations that occur at any specific location.
i 50 t
+
~
1 Table 1 i
Hypothetical Hypothetical Incremental Incremental Lifetime Risk From Annual Dese*
Annual Risk **
Continuina Annual Dose **'
=
100 aren (1 mSV) 5 x 10 5 3.S X 10'3 10 mrea (0.1 RSV) 5 x 10
3.5 x 10*'
1 arem (0.01 mSV) 5 x 10'7 3.5 x 10
O.1 mrem (0.001 RSV) 5 x 10a 3.5 x 10
- The expression of dose refers to the Total Effective Dose Equivalent.. 4" This term is the sum of the deep (whole body) dose equivalent for sources external to the body and the committed effective (whole body) dose equivalent for sources internal to the body.
energy transfer radiation has been conservatively based on the results 1
reported in UNSCEAR 1988 (Footnote 2) and BEIR V (see also NUREG/CR-
'i 4214, Rev. 1).
The Commission prefers to use factors of ten to describe such low individual doses because of the large uncertainties associated with the dose estimates.
Use of values such as 0.7 or j
12 imputes a significance and sense of certainty that is not justified considering the levels of uncertainty in the dose and risk estimates at these low levels.
Thus, order of magnitude values such as 1 and 10 are preferable to avoid providing i
analysts and the public with a sense of certainty and significance that is not commensurate with.the actual precision and certainty-of the estimates.
.i 51 j
,.o 1
a 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 exposed population.
Because of the stochastic nature of risk, analysis of exposures of large groups of people to very small doses may result in calculated health effects in the population at large.
Collective dose is the sum of the individual total effective dose equivalents resulting from a practice or source of radiation i
exposure.
It is used in comparative cost-benefit and other l
quantitative analytical techniques and, tbsrefore, is an important factor to consider in balancing benefits and societal detriments in applying the ALARA principle.
For purposes of this policy, individual total effective dose equivalents less than 0.1 mram per year (0.001 mSv per year) do not need to be considered in the estimation of collective doses.
The Commission believes consideration of individual doses below 0.1 mram per year imputes a sense of significance and certainty of their magnitude that is not justified considering the inherent uncertainties in dose and 1
risk estimates associated with potentially exempted practices.
The Commission also notes that doses in the range of 0.01 to 0.1 mrom per year correspond approximately to lifetime risks on the order of one in a million.
The NRC has used collective dose,-
including rationales for its truncation, in a number of 52
- 1
o rulemaking decisions and in resolving a variety of generic safety issues.
III. Dose and Risk Estimation The commission recognizes that it is frequently not possible to measure risk to individuals or populations directly and, in most situations, it is impractical to measure annual doses-to individuals at the low levels associated with potential exemption decisions.
Typically, radionuclide concentrations or radiation dose rates can only be measured before the radioactive material is released from regulatory control.
Estimates of doses to members of the public from the types of practices that the commission would consider exempting from regulatory control must be based on input of these measurements into exposure pathway models, using assumptions related-to the-ways in which people might become exposed.
These assumptions incorporate sufficient conservatism to account for uncertainties so that any actual doses would be expected to be lower than the calculated doses.
The commission believes that this is an appropriate approach to be taken when determining if_an exemption from some or all regulatory controls is warranted.
Dated at Rockville, Maryland, this day of
, 1990.
9 For the Nuclear Regulatory Commission.
samuel J. Chilk Secretary of the Commission.
53