ML20044A557
| ML20044A557 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/1990 |
| From: | Rogers K NRC COMMISSION (OCM) |
| To: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| References | |
| NUDOCS 9006290206 | |
| Download: ML20044A557 (53) | |
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AFFIRMATION 96{kj'SETO PDR RESPONSE SHEET 6hM90
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i TO:
SAMUEL J. CHILK, SECRETARY _0F THE COMISSION FROM:-
COMISSIONER ROGERS
SUBJECT:
SECY-89-360 - COMISSION POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL APPROVED w/=
~e rs DISAPPROVED ABSTAIN 1%C L NOT PARTICIPATING REQUEST DISCUSSION COMENTS:
Approve with the following comments.
I endorse the' policy statement offered in Chairman Carr's vote, with the. changes noted in the initialed pages of the attached copy.
I.' also strongly support the Chairmen's suggestion regarding the esteblishment - of a working group to develop and implement a
. comprehensive strategy for releasing the BRC policy.
This effort
.should be initiated as soon as possible and take a high priority.
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N;u Med b pQa.cA. cb " PopAcut\\b Clov " (ScA W NUCLEAR REGULATORY COMMISSION Below Regulatory Concern; Policy Statement AGENCY:
Nuclear Regulatory Commission.
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ACTION:
Policy statement.
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i Thispolicystatembntestablishestheframeworkwithin'
SUMMARY
which the Commiss&Me&s ar uadendn ion willieake. decisions to 1xempt from some or prae nw all regulatory controls certain-pr: ducts c.nd activita=5 involving
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small quantities of radioactive material,that are Sche
-reg"l e ry ::ncern.
The exemptions may involve the release of licensee-controlled radioactive material either to the generally.
accessible environment or to persons who would be exempt from N4M i
commission regulations.
Actre: W.u.s-for which exemptions may be
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granted include-but are not limited to (1) the release for.
unrestricted public use of lands and structures containing residual radioactivity, (2) the distribution of consumer products containing small amounts of radioactive material, (3) the disposal of very low-level radioactive waste at other than licensed disposal sites, (4) the recycling of slightly contaminated equipment a'd materials, and (5) the release of n
effluents from licensed facilities.
As described in this policy a
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statement, NRC intends to exempt specific practices from regulatory control if the pr="* 4"e r-sults ir emell deree to h
individu:1: and the pepulation-at -larg: :nd if available ::n:r:12._
,einn+4-2 hieve're-dumLivo. In th::
doses that cre'en=~eneurate.
-with *ba r"kli: :nd private rc: urces n;;d:d to imple-en* the -
-::ntr:1.
The policy statement defines the dose criteria and s
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 l
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 commission's determination on whether exemptions
.from" regulatory controls will be granted. PThe policy statement
~
5 eeded t: establish a consistent risk framework for regulatory 1
s exemptiondecisions,HMrensure[anadequateandconsistent11evel of protection of the publiccin their use of radioactive ss
. rfocus the Nation's resources on reducing the j
materials,
..a s
most significant radiological risks from: practices under NRC's jurisdiction.
The average U.S. citizen should benefit from implementation of the BRC policy through (1) timely cleanup of contaminated sites; (2) increased assurance that adequate funds 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 weste management practices commensurate with
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potential risks; and (5) increased assurance that consumer s
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3
.is products containing radioactive material under the Commission's jurisdiction are safe.
EFFECTIVE.DATE:
(Insert Publication Date.)
FOR FURTHER;INFORMATION CONTACT:
Dr. Donald A.
Cool,-Office of l
Nuclear Regulatory Research, U.S.
Nuclear Regulatory Commission, Washington, D.C.
20555,. telephone: (301) 492-3785.
8 SUPPLEMENTARY INFORMATION:
Statement of Policy I..
Introduction.
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 sources, including the cosmos, earth, building materials, i
' industrial' facilities, clothing, medicine, food, air, and our own (hoSk Ccme W4AM S bodies.
All m;tter exhibitK some degree of radioactivity.
The g
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.
Recognition lof 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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+
a fh e w Natural and man-made radionuclides are used in today's society in many forms for a variety of purposes, such as medical r
i therapy and diagnosis, materials analysis, and power generation.
In general, the existing regulatory framework ensures that radioactive materials are controlled consistent with the. degree i
of risk posed to the public and the environment.
Some products I
swLw as WhHer smoke detectors and lamp mantles contain small quantities of radioactive materials that pose such-a low risk that they have been widely distributed without continuing regulatory controls, To require that 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 1
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 materials 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 l
Onh 4e that the threshold would need to be low enough to ensure adequate 3
l protection of the public.
The Commission also recognized that l
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the threshold should be compatible with technological and w$od measurement capabilities so it could be readily inpl--a"+-d 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 IA+
W Ss0 guide decisions on which r-a4-ioact-ivemai.wilots are "below n
regulatory concern" (BRC) because the low levels of risk they 4
pose do not warrant regulation to the same degree as other radioactive materials to ensure adequate protection of the public SL.
and environment.
This policy translates the Commission's p
9<veMco) judgement on acceptable risk into explicit and imple"entabit-criteria on which to base decisions to exempt ="claSr s A
r
- t e rials-P'o e.
from the full; scope of NRC's regulatory fram ucrk.
The BRC 1
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> add licensing decisions based on careful'and thorough 59<i4 6o pra.cALe4 analyses of the risks associated withgex vuuts to ensure that the e
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
d
. g the health and safety of both workers and members of the general public, and the environment.
For example, radioactive material l
is controlled by NRC-and Agreement State-licensees to ensure i
that dose limits are not exceeded.
In addition, sources of l
radiation are designed, used and disposed of in a manner that 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 Part 20).
However, NRC has not yet provided criteria that would establish the basis for defining the level of residual risk at which further regulatory control is no longer warranted.
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A major' provision of this policy involves /the definition of l
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criteria that delineate conditions under/
l expenditures of regulatory and licensee resources are not j
necessary to further reduce radia/
i tion exposures from a given
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practice.
Application of these criteria by NRC will promote
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consistent decisions on,A:he need to require further reductions in
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radiation exposure at dose levels that are comparable to i
i incremental radi on doses associated with routine activitics suchaserops/*countryairtravel.
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1 The policy statement in today's notice provides a unifying risk framework for making decisions about which radicactive P
- m 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 6
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, e materials fr:n regulatory controls would involve the transfer of very small quantities of the materials from a regulated to an es A t
unregulated status.
NRC will analyze such proposed transfern to 3
ensure that doses resulting from exposure to exempted practices will be sufficiently low that the public health and safety and
- ' licensed the environment vill remain adequately protected.
e ons activity producing 44w> 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 pte;o A ca n y g
p:riodic research to evaluate the ef fectiveness of th. Ex:rptic?
3 Policy and to confirm the safety bases that support the exemption decisions.
Through appropriate rulemaking actions or licensing decisions, the Commission will establish constraints, 5(x40 l
requirements, and conditions applicable to exemptions of g
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, the Commission may promulgate regulations that would require some type of labeling so that consumers could make informed darisions about purchasing a product containing exempted materials.
Such labeling is presently required by the j
commission for smoke detectors containing radi,, active 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 anc 9
Policy Amendments Act (LLRWPAA) of 1985 directed the Commission to develop standards and procedures and act upon petitions "to exempt specific radioactive vaste sttsams from regulation... due to the presence nf radionuclides... in sufficiently low concentrations or quantities to be below regulatory concern."
The Commission responded to this legislation by issuing a policy statement on August 29, 1986 (51 FR 30839).
That policy statement contained criteria that, if satisfactorily addressed in a petition for rulemaking, would allow the commission to act expediticusly in proposing appropriate relief in its regulations on a " practice-specific" basis consistent with the merits of the petition.
Federal and State agencieg have also developed and implemented similar e::emptions based on evaluations of their risks to the public and the environment.
The Food and Drug Administration (FDA), for example, has applied sensitivity-of-method, risk-based guidelines in connection with the regulation of animal drugs, food contaminants, and trace constituents in some food additives.
Similarly, the Environmental Protection Agency (EPA) established exemption or threshold levels based on individual risks in the regulation of pesticides and other toxic and carcinogenic chemicals.
For example, EPA employs such a concept in defining hazardous waste under the Resource Conservation and Recovery Act.through the EMtrcction Procedure 4 EP; Tewkity Characterict-io-end-the Tow 4 city C+a-r.seterietic --
4+ aching-Srece61re in 4 0 crn Peets-Mrl-end-46". -These testir.g-
.peeeedu rW eM--oonsentra tio n s4f-ca r cinog e nic-a nd-toxic _.-.
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' constituents in leachate, which are then compared with thr stfoId concentrations to determine whether solid was are hazardous' wastes and to evaluate the adequac treatment processes.
Wastes whose leachate ce trations fall below the threshold levels establish y EPA may be " exempted" from compliance with the comp ensive hazardous waste regulations or allowed to be d
osed of in permitted land disposal facilities, respectively.
M for certain practices involving minimal public health and
/
i safety concerns, the imposition of undue or unnecessary regulatory controls could prohibit a practice that s tfld otherwise be permitted because of reasonable so etal (including I
public health and safety) benefits.
In ad ition, with the necessary national focus on fiscal re onsibility, resources expended for regulatory control practices with minimal health and safety impacts could be sed to address more significant radiological and nonra dological health and safety concerns.
To f address this need the Commission, in this policy, is t
establishin framework for expanding on its existing regulat ns for protection of the public from radiation which cur ntly define a number of longstanding exemptions from egulatory contro g This policy will also be used by the
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1 Commission as a basis for reevaluating existing NRC exemptions to r
ensure that they are consistent with the criteria defined herein
- Decau== thi;; po14cy-pr4v4das a consistent risk-bast +-fw
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exempting the usa of--byproduc* and an"rce m:teri-al-1n-consumer--
product + Ihis policy supersedes the Atomic Energy Commission's t
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I ch 16, 1965, policy statement on this subject (30 FR 3462)7
_, gud The Commission believes that the Below Regulatory Concern policy is needed to establish a consistent, risk-based framework for making exemption decisions.
Specifically,thhk$fYY["Is l
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 -
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 t:ing adequately *nd ceneittently
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protected from consumer products that contain radioactive g
materials under the Commission's jurisdiction, (4) provide decision criteria for reviewing petitions to exempt very low level radioactive wastes in accordance with the Low-Level Radioactive Waste policy Amendments Act of 1985, (5) focus the cuid e e d6g
-resources of NRC, Agreement States, and licensees on more g
significant risks posed by nuclear materials, (6) establish a risk-based threshold to ensure that the potential benefits of additional reductions in risk are commensurate with the costs of attaining the Teductions aux! Of-- perfor ing th: analy::: t: -
-*eh-iaus -:nd confirm the - reducti% and (7) review NRC's regulatory framework to ensure that existing exemptions involving radioactive materials are consistent and adequate to protect the i
Q ru der M public.
The everage ".C. citizenrhouldbenefit[from inchad4:
implementation of the BRC policy throught increased assurance that consumer products containing radioactive material under the 11
.[.
N 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 medical treatment and other services that use radioactive materials resulting from the optimal use of the Federal, State, and licensee resources; and focus of Federal and State efforts and resources on reducing the most significant radiological risks from practices under their jurisdiction.
The Commission's BRC policy establishes an explicit and uniform risk framework for making regulatory exemption decisions, yW{y (pt In lieu of such a policy, the Commission could continue the I
6 current practice of exempting practices on a case-specific basis.
4 Such an approach, however, does not Mc:c::rilg ensure consistent evaluation and control of risks associated with exempted practices.
For this reason and the reasons discussed above, the Commission has established the BRC policy Statement.i Nd kW^
pap \\o The Commission recognizes that Agreement States will play an j
l 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 radioactive wastes 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 to regulate source, special nuclear, and byproduct materials to j
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l(wl ensure protection 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 regulatory responsibilities in lieu of rederal regulation for certain classes of nuclear materials, it required that State radiation protection standards be coordinated and compatible with the rederal standards for radiation protection.
NRC regulations exempting BRC wastes will not af fect 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 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 e
significant for articles containing radioactive materials which receive widespread distribution, such as consumer products, ~'---
4r.censistent regulatica.e ceuld unduly re:trict end burde" _
4rmmiote end intern:ticn:1 commereer 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 have expressed concerns that economic and j
t NOL institutional impacts of the Commission's BRC policy may i
undermine their ef forts to develop new disposal f acilities for low-level radioactive vaste in accordance with the Low-Level Radioactive Waste Policy Amendments Act of 1985.
These States would prefer to ectablish 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 I
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 that accompanied S.
1517, Senate Committee on Energy and Natural Resources, November 22, 1985, 99th Congress, 1st Ser.dion at page 9).
The Commission is confident that waste exemption decisions made in accordance with requirements that implement its BRC t
policy will be adequate to ensure protection of the public health '
and safety.
Th: C:rmierien ol e Lelieve: that in:Onci: tent-
-segui tien f SRC seste exempt 4cn: :;uld not only-resu-it in -
.4aereased ricks-to-the-pub 1ie and--t,he-env4ronment-but-could-10:
. imp:de state-et-f+ rte-to-devel+p-14w=leval-west; di3F0011 -
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1 The policy described in this document is intended to provide prou cNi m
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the public health and safety framework that would apply to a wide spectrum of Commission exemptio decisions.
As such, it provides j
14
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l individual and collective dose criteria, and discusses other important elements of the exemption decisionmaking process.
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 will 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 d M 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 support the exemption decisionmaking process.
M gs)
'M II. Definitions.
Y@ n y N
" Activity," when used to describe radioactive material in
' this policy statement, is the rate of disintegration (transformation) or decay of radioactive material.
The units of activity are the curie (1 Ci = 3.7 x lo" disintegrations per (second) and the becquerel (1 Bq = 1 disintegration per second).',
"ALARA" (acronym for "as low as is reasonably achievable")
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 health and safety, and other societal and so71oeconomic 15
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i containing small amounts of radioactive material; and the recycle Sprid t +3m s o b and reuse of residually contaminated materials and equipment are l
A examples of practices for which this policy will have potential applicability. ($ a ScAlan In ge p ew cuc.d mb c h [m e +s'u.).
" Rem" is the special unit of dose equivalent (1 rem = 0.01 sievert).
" Risk," for purposes of this policy, means the annual or l
lifetime probability of the development of fatal cancer from exposure to ionizing radiation and is taken as the product of the dote 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 be 5 x 10" fatal cancers per rem of radiation dose.
The fatal cancer risk is considered, in i
general, to be either more likely or have more severe outcome than the potential genetic and nonfatal cancer risks and the potential risks of developmental anomalies in fetuses.
While the
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Commission recognizes that the risks from exposure to radiation are greater for children than adults and that there are increased f
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risks from exposure to the embryo / fetus, the estimate of fatal cancer risk for all ages and both sexes is considered to be an j
appropriate measure of risk from practices being considered for exemption in accordance with this policy statement (see Appendix).
" Source material" means --
l 19
kb basis upon which the Commission will initiate the development of appropriate regulations or make licensing decisions to exempt certain practices from some or all regulatory controls.
This policy is directed principally toward rulemaking activities but may be applied to license amendments or license applications involving the release of licensed radioactive material either to the environment or to persons who would be exempt from Commission regulations. d.Aom4y p peGe c,e,nM M k prbM Q mm e, cc. wan.
It is the commission's intent to broadly define specific practices so that the effect of an exemption decision on any individual or population will ba 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 i
reasonable impact analyses and allow imposition of appropriate constraints, requirements, and conditions as the radioactive material passes from a regulated to an unregul'ated status (i.e.,
the material is no longer required to be under the control of a licensee).
Under this policy, the definition of a " practice" in any specific decision (rulemaking or licensing action) is a i
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 1
that would otherwise be applicable.
The definition of the practice in any specific exemption decision will also provide the framework for taking into account the possible consequences of accidents or misuse or the potential for othe'r nonstochastic 21
i f.
/rCK practices should not be considered candidates for exemption, such as the Antroduction of radioactive materials into products to be cor.sumed or used primarily by children.
Such practices should be specifically evaluated to determine if they could result in greater risk levels to exposed members of the public than the levels found acceptable by the Commission in formulating this policy.
Unlike justification decisions involving complex trade-offs between cultural and societal values, these decisions clearly f all within the commission's purview to protect the health and safety of the public.
A.
Principles of Exemption.
114. pr in e[ pal
-A-mefw.nconsideration in exempting any practice frem some or all regulatory controls hinges on the general question of whether the application or continuation of regulatory controls is necessary to protect the public health and safety and the environment.;nd i:-00 t effective in-further reducing e-:::11 1
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riek
(....,
e co;;;naurat; d::: reductien)~
To deternin if
- ki-e*=ndpeint, the commission exemption is appropriate f-a-must determine if one of the following conditions is met:
1.
The application or continuation of regulatory controls on the practice does not result in any significant
-i reduction in dose received by individuals within a critical group (i.e., the group expected to receive the highest exposure) and by the exposed population; or 23
/rau 2.
The costs of the controls that could be imposed for 4
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further dose reduction are not balanced by commensurate reduction in risk.th;t ;;;1d bc ::;11:::.
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 collective risks from each particular practice are sufficiently small.
The cont c49c Commission believes that individual and sc u..wivn dose crit.ria e
should be basic features of its overall policy to define the 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 criteria include (1) values for the individual annual dose reasonably expected 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 population as a whole does not suffer a significant radiological impact.
It is important to emphasize 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
C As described in the Appendix to this policy is unwarranted.
the technical rationale for the Commission's-BRC statement, criteria is explicitly based on the assumption that the risk from exposure to radiation is linearly proportional to the dose to an The presence of natural background radiation and individual.
variations in the levels c' this background have been used to provide a perspective from whic;i to judge the relative significance of the radiological risks involved in the exemption decisionmaking process.
grA p g a. p B.
The Individual Dose Criterion.
If the doses to individuals from a practice under consideration for exemption are suf ficiently s nall, the attendant risks will be small compared to other societal risks, and there would be little merit in expending resoureus to further reduce this dose or risk provided that sound radiation protection and principles have been applied in the design, development, The Commission believes proposed implementation of the practice.
4 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 on analysis of voluntary and involuntary risks commonly the accepted by the public without significant concern, Commission believes that most members of society will not expend i
resources to reduce an annual individual risk of fatality below approximately 1 chance in 100,000 (1 x 10 5; this is equivalent
br s>
i individual dose thresholds below which additional regulatory controls are unnecessary and unwarranted to require further reductions in individual doses.
The Commissien considers these criteria to be appropriate given the uncertainties involved in estimating doses and risks, and notes that these criteria should facilitate straightforward implementation of this policy in future rulemakings or licensing decisions.
The Commission believes that, notwithstanding exemption of practices from regulatory control under these criteria, it still has reasonable assurance that exposures 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 evaluate potential exposures over the lifetime of the practice, 4(/) to monitor and verify how exemptions are implemented under 3
this policy, (/) to impose
- bo4heempenica individual and collective dose criteria, (S) to verify dose calculations through licensing reviews and rulemakings with full benefit of public review and 1
comment, and (6) to inspect and enforce licensee adherence to specific constraints and conditions imposed by the Commission on exempted practice *s.
The Commission intends that only under unusual circumstances would exemptions be considered for practices that could cause continuing radiation exposure to individuals exceeding a small
..o_._
fraction of the 100 mrem per year (1 mSv per year)( ose limig. In rare cases, exemptions of such practices may be en toCJCLFkre'30 29
? b r granted if, after 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 doses. %\\uAe4 C. The."cpulati-on Dese Criterion. The Commission believes that the collective dose (i.e., the sum of individual total ef fective 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 per year), the resources of the Commission and its licensees i could be better spent by addressing more significant health and safety issues than by requiring further analysis, reduction, and confirmation of the magnitude of the collective dose. The Commission notes that, at this level of collective dose, the number of hypothetical health effects calculated for an exempted practice on an annual basis would be less than one. The National Council of Radiation Protection and Measurements recommends in its Report No. 91' that collective dose assessments for a particular practice should exclude consideration of those individuals whose annual effective dose ' Recommendations on Limits for Exposure to Ionizing Radiation, NCRP Report No. 91, National Council on Radiation Protection and Measurements, June 1, 1987. Availcble for purchase from NCRP i Publications, 7910 Woodmont Ave., Suite 1016, Bethesda, MD 20814. 30
CIL : c s. J l equivalent is less than or equal to 1 mrem per year (0.01 mSv per j year). Taking this reconmendation into account and considering the practicality of dose estimation techniques and uncertainties associated with such low dose and dose-rate estimates, the l Commiss ion,senelvdes-that--ited4vid;;l - deres--itss-then ^.1 - are; pe r yea r-- 00. 001 -Sv-per-year-)- n;;d not4e considered-4n-caanlet4ng ocl'ar*4va derer. ..c : practica4-mattrer, censideret4cn -ci dose ra+== in +ha-alsrer-em-per p r.r=nga and large--nu-tere of hypothetica-1-individuais potentisiit-exposed-tc en-ex+mpt+d practice-aay wuduly - pilvatw the dose calculations--that-*i44-be used--to-support 4emonstratimis-t-het--proposed-eNempt4cne comport-M th Ne Tri-teriS la Lhis-Poldey. The-CommlE& ion. believes that g 'o.Oos m sv yr 9 tw i inclusion of individual doses below 0.1 mrem per year introduces g unnecessary complexity into collective dose assessments and could impute an unrealistic sense of the significance and certainty of suchdoselevels.) In the sensitivity-of-measure, risk-based guidelines used by 4 EPA and FDA, a 10 lifetime risk of cancer has been used as a quantitative criterion of insignificance. Using an annual risk coef ficient of 5 x 10" health ef fects per rem (5 x 10 2 per 4 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 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 per year is an appropriate truncation value to be applied in the assessment of collective doses for the purposes of this policy. 31
{ p 4%; The Commission notes that adoption of the individual and collective dose criteria does not indicate a decision that doses Mlee the;; erit..s 1... ne;e;;;ry befcre - e preet4ee--can.-Jie-ex;mpted er that d;;;; above the criteria would necessarily } preclude exemptions. The criteria simply represent a range of i 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 regarding the acceptability of an exemption. Practices not meeting these criteria may nevertheless be granted exemptions I from regulatory control on a case-by-case basis in accordance with the principles embodied within this policy, if (1) the potential doses to individual members of the public rre sufficiently small or unlikely, (2) further reductions in the doses are neither readily achievable nor significant in terms of protecting the public health and safety and the environment, and (3) the collective dose from the exempted practice is sufficiently small. ~% IV. Implementation. i The Commission's BRC policy will be implemented principally through rulemakings; however, exemption decisions could also be implemented through specific licensing actions. In the first case, a proposal for exemption, whether initiated by the NRC or requested by outside parties in a petition for rulemaking, must provide a basis upon which the w
+ (Ki c , s. exemption, a person using the exemption would no longer be i 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 1 of the regulation and that ALARA considerations have been 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 fact, reduce actual doses significantly below the BRC criteria or the development of new technologies to enhance protection to ublic and the environment. 4.s.A a, o b E M M e t u h % p q S d w e lit 'm 3Thisispargiulr1{;c(ertine S no k0 Na he area of decontamination and decommissioning,fwhere the Commission anticipates that emerging technologies over the next several decades should enhance existing technical capabilities and further reduce doses to workers and the public. The second means of policy implementation could involve exemptions that would be granted through licensing actions, such as site-epecific determinations that h k has been sufficiently decontaminated to be released for unrestricted public use. The NRC intends to develop guidance regarding the implementation of the BRC criteria te ensure that such site-specific actions adhere to the criteria and principles of this policy statement. These licensing actions may be subject to a public hearing process and,- will dep udius vu%e-speeM4c-act4cr. takertr-may--beveguired tgbe noticed in the Federal Register. 34
h The description should address the quality assurance program ased in data collection and analysis and supporting information. If any surveys were conducted, they should be described. Market information may be useful in characterizing a practice on a national basis, 3. As low as is reasonably achievable (ALARA). An analysis should be provided that demonstrates that radiation exposure and radionuclide releases associated with the exempted practice overall will be AIARA. The AIARA principle referred to in 10 CTR Part 20 applies to efforts by licensees to maintain radiation exposures and releases of radioactive materials to unrestricted areas !l- 'ow as is reasonably achievable. Appendix I to 10 CTR Part describes AIARA for radioactive material releases from light water reactors (nuclear power plants). Exemption proposals should describe how AIARA considerations have been applied in the design, development, and implementation of controls for the proposed practice. Licenses compliance with the AIARA principle must remain in effect up to and including the point at which the materials are transferred to an unregulated status in accordance with an exemption gkanped under this po .I u A bg n Ay o ' In nn g udl W. pe Anen b }e.dne)m. i E O.4.. -,_m .m .c r a,-mq ..e n r u,,. w _ =, m.1,. - - - - ~- ' * ' TD. Impact AnalysSs. ' ~~~" To support and justify a request for exemption, each petitioner or licenses should assess the radiological and nonr'adiological impacts of the proposed exemption. The analyses should be based on the characterizations described previously and 'J 9
pi ? , s - I 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. d k 1. Radiological impacts. The evaluation of radiological impacts should clearly address the policy's individual and collective dose criteria or provide a sufficient ALARA evaluation supporting the exemption. In either case, the following impacts should be assessed: 4 Average doses to the critical population group; Collective doses to the critical population group and the total exposed population (under conditions defined in i Section III); The potentiaT for nonstochastic radiological impacts; and The potential for reconcentration of radionuclides, doSuk The collective pep"1 2'w rin= ara should be estimated and u summed in two parts: total dose to the critical population group l exfesed and total dose to the population. The critical group is the 4 relatively homogeneous group of individuals whose exposures are likely to be the greatest and for whom the assessment of doses is likely to be the most accurate. Average doses to this group are the controlling factors limiting individual doses and risk, and should be compared with the individual dose criteria, as l i l 6@
? . o 4 F. Constraints, Requirements, or Conditions on Exemptions. In most cases, the characterizations of the material and the assessment of impacts will be based on either explicit or implicit constraints, such as limitations on the amount of radioactive material in a consumer product. In order for an exemption decision to take credit for these constraints, the exemption proposal should specifically identify appropriate constraints, such as quantity limits, concentration limits, and physical form characteristics. The bases on which these constraints are to be ensured should also be discussed. In general, constraints should be inspectable and verifiable in order to provide the basis for an exemption decision. h%w Qsura~.w G. -R;;;rdk:; ping and Reporting. This portion of the exemption proposal should be tailored to either a generic petition for rulemaking or specific proposal for a license amendment. For generic petitions for rulemaking, the proposal should provide and justify ':::iblef generic requirements for ::cerd 6 eping end
- rting for Quality Assurance / Quality Control and Reporting.
Such proposals should include example requirements and show their effectiveness and feasibility. For site-specific license amendments, the exemption proposal should provide specific requirements for Quality Assurance / Quality Control and Reporting that have been tailored to the licensee's program. 62
N .. o, o B. Collective or Population Risk 1 In the application of the fundamental principles of radiation protection, collective dose provides a useful way to i express the radiological impact (i.e., potential detriments) of a e & rx muci;;; ewiliity 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 exposure. It is used in comparative cost-benefit and other quantitative analytical techniques and, therefore, 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 mrem 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 mrem per year imputes 4 a sense of significance and certainty of their magnitude that is l not justified considering the inherent uncertainties in dose and risk estimates associated with potentially exempted practices. l The Commission also notes that doses in the range of 0.01 to 0.1 mram 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 l 28}}