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NUCLEAR REGULATORY COMMISSION
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MAY 0J 1983 MEMORANDUM FOR: Eric S. Beckjord, Director Office of Nuclear Regulatory Research FROM:
Thomas E. Murley, Director Office of Nuclear Reactor Regulation 1
SUBJECT:
PROPOSED COMMISS10t FOLICY STATEMENT ON i
EXEMPT 10li FROM REGULATORY CONTROL i
Ue have revieutd the proposed policy statement and have two major comments which should be censidereo prior to fintlizing the policy statenent.
Other minor comments and suggestions are annotated in the enclosed copy of the proposeo pclicy statement.
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The first cor. ment re16tts to the designation of a criterion for the maximum incividual annual dose. This week the NRC staff is presenting couents to the L
Radiation Advisory Committec cf the Science Advisory F,oard for EPA concerning l
the proposed standards for the Clean Air Act.
Part of the NRC staff coments l
admonis1 EPA for pro?osing to apply the standard to the n.aximally exposed individuti in the pualic rather than use the
- critical group" concept as recommended by ICRP.
It appears advisat'le to have a consistent agency policy.
One option for this paper is to delete the word "maximun? since it is not used I
any place else in the paper.
The second coment relt.itt to the argument set forth as the sccond basis for establishing a collective dose criterion. The argument that a collective dose l
criterion will provide reasonable assurance that individual members of the public will not approach 100 mrem per year from noltiple practices is not Previous versions that developed such that the rationale is clearly evident.
eddressed limiting societal impacts seemed more appropriate.. Focussing socte-thi impacts on the 100 nrem per year limit is less ef f ectivt..
If there are questions concerning these coments, please contact frank.Congel L
or L. J. Cunningham.
MA L
Thomas E. Murley, D Of fice of huclear Reactor Regulation
Enclosure:
Proposed Policy Statenent CONTACTS:
LeMoine J. Cunningham, NPR 4M-1111-Frank J. Congel, NRR
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- a of PRELIMINARY RES DRAFT Proposed Comission Policy on Exemptions from Regulatory Control 4
1.
INTRODUCTION AND PURp0SE Over the last several years, the Comission has become increasingly aware of the need to provide a general policy on the appropriate criteria for release of certain radioactive materials from the full extent of existing regulatory controls. The need has been driven by two recurring realizations. The first is the recognition that, for certain practices involving minimal public health and safety concerns, the imposition of undue and unnecessary regulatory controls i
could prohibit a practice which should otherwise be permitted because of reasonable social, economic, or industrial benefits. The second results from the nation's focus on fiscal responsibility and the knowledge that resources expended for regulatory control of practices with minimal radiological impacts could be i
To better used to address more significant radiation protection concerns.
address this need, the Comission is expanding upon its existing policy for protection of the public from radiation, currently expressed in existing regulations l
(Title 10, Code of Federal Regulations) and policy statements (30 FR 3462, Use l
of Byproduct Material and Source Material (Consumer Productsi, dated March 16, l
1965; 47 FR 57446, Licensing Requirements for Land Disposal of Radioactive i
Waste, dated December 27,1982; and 51 FR 30839, General Statement of Policy l
and Procedures Concerning Petitions Pursuant to i 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion includes the development of an explicit exemption policy for those Comission-regulated practices which involve minimal public health and safety impacts.
t The Comission, however, recognizes the benefits of uniform regulation and therefore, supports the development of broader Federal Guidance regarding In doing so, the Comission realizes that, when signed by exemption policies.
the President, the Federal Guidance could supplant this policy.
In this policy, a practice is defined 6s an activity or a set or combination of l
a number of similar sets of _ coordinated and continuing activities aimed at a Disposal of given purpose which involve the potential for radiation exposure.
very low level radioactive waste; the releast for unrcstricted public use of lands and structures with residual-levels of radioactivity; the distribution, use, and consumer products containing small amounts of radioactive material; IELOSU?I
1 and the recycle and reuse of residua 11y contaminated materials and equipment are examples of classes of practices for which this policy is judged to have It is the Comission's intent to broadly define potential applicability.
specific practices in terms which will preclude any individual or population being significantly affected by similar practices within a given class while, at the same time, identifying and describing the practice in tems which will facilitate reasonable impact analyses and allow imposition of appropriate constraints as the radioactive material passes from controlled to exempt status.
Under this policy, the definition of a " practice" is a critical feature which will assure that the formulation of exemptions from regulatory control will not allow deliberate dilution of material or fractionation of a practice for the The purpose of circumventing controls that would otherwise be appitcable.
definition will also provide the framework for taking into account the possible i
consequences of accidents or misuse associated with exemption decisions.
The purpose of this policy statement is to establish the basis upon which the Comission may initiate the developr:ent of appropriate regu1ations or make licensingdecisionstoexemptfremregulatorycontro1[irso,nYw$ receive, This possess, use, transfer, own, or acquire certain radioactive material.
policy is directed principally toward rulemaking activities, but may be applied to license amendments or license applications involving the release of licensed l
radioactive material either to the environment or to persons who would be It is important to emphasize that this exempt from Comission regulations.
policy does not assert an absence or threshold of risk but rather establishes a baseline where further government reguiation to reduce risks is unwarranted.
The Atomic Energy Act of The concept of regulatory exemptions is not new.
1954, as amended, authorizes the Comission to exempt certain classes, quantities, or uses of radioactive material when it finds that such deregulation will(not constitute an unreasonable rishto comon defense and In 1960 and 1970, the security and to the health and safety of the public.
Comission used this authority to promulgate tables of exempt quantities and concentrations for radioactive material which a person, under certain i
circumstances, could receive, possess, use, transfer, own, or acquire without a Other exemptions reoutrement for a license (25 FR 7875 and 35 FR 64271 fdf M~ 4a,a M so oJ4J w & x r
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allowing distribution of consumer products or other devices to the general pubite, or allowing releases of radioactive material to the environment, have been embodied in the Comission's regulations for some time. For example,
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regulations currently specify conditions under which licensees are allowed to dispose of radioactive material into a sanitary sewer system (Title 10, Code of Federal Regulations Part 20, Section 303). That is, the regulations specify requirements which a licensee must meet if radioactive material is to be "
More recently, transferred" from a controlled to an uncontrolled status.
Section 10 of the Low-Level Radioactive Weste Policy Amendments Act (LLRWPAA) of 1985 directed the Comnssion to develop standards and procedures for expeditious handling of n titions "...to exempt specib c radioactive waste streams froin. regulation... due to the presence of radionuclides... in sufficiently low concentrations or quantities to be below regulatory co
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The Commission responded to this legislation by issuing a policy statement in August 1986 (51 FR 30839). That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow the Comissien to act expeditiously in proposing appropriate regulatory relief on a
" practice-specific" basis consistent with the merits of the petition.
l The Comission believes that these " practice-specific" exemptions should be encompassed within a broader NRC policy which defines levels of radiation risk below which specified practices would require only minimal, practice-specific For such NRC regulation based on public health and safety interests.
mission's regulatory involvement could be essentially limited practices, th g nspection.WJ,' Z...
activities associated with the i
to licensing transfer of the radioactive material]m a,c ntgled to an exempt status.
ission would define constraf/its e ff : = t D dhered to by
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That is, the Co f dioactive materia M be transferred from a controlled to NRC licensees an uncontrolled or exempt status.
The Comission recognizes that, if a national policy on exemptions from regulatory contrel is to be effective Agreement States will play an important Pursuant to the LLRKPAA, States are responsible for implementation role.
providing, either alone or in cooperation with other States, for disposal of certain low level redloactive wastes.
In the past. States have been encouraging findings that certain wastes are below regulatory concern and the l
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' Commission believes that States will support the application of a national policy on exemptions for specific' practices involving distribution o.r release.
intei.d; eles it.e;..;. _ U ni,e m
of radioactive thaterial. -L svi.insion r-- 8*u nn halteves that tut:: -ill.vppvr5 se pplisei, ion vi. n wiyoet -
M h" 05. ea....yllvne 7v. erwe U N p ewiIsra inVDiving distripusivn er tvIweee Tha Comission intends also that rulemakings
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ccdifying exemptions in all areas will be made a matter of strict compatibility Consequently, any rulemakings that evolve from this for Agreement States.
policy will be closely coordinated with the States, i
The Commission recognizes that its policy will potentially have a significant
-l The approach and impact on nuclear regu.ition in the international community.
i criteria in this policy differ in some respects from those selected or under It is the Comission's intent to continue consideration by other countries.
f ts dialogue with the international comunity in order to resolve, or foster l
mutual understandings of the rationales behind, differences in exemption i
r policies.
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RADI ATION PROTECTION PRINCIPLES The Three Fundamental Principles of Radiation Protection i
The Comission recognizes that three fundamental principles of radiation protection have his'torically guided the 'fomulation of a system of dose limitation to protect workers and the public from the potentially hamful I
Theyare(1)justificationofpractice,whichrequires effects of radiation.
that there be some net societal benefit resulting from the use and dispos of radiation or radioactive materia
)pe limits, which define the upper boundaryofadequateprotectionforgmembe3ofthepublicwhich.shouldno
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exceeded in the conduct of nuclear activities, and (3) ALARA, which requ that radiation dose be as low as is reasonably achievable, economic The tem. ALARA, is an acronym for As low As factors being'taken into account.
is Reasonably Achievable.
Dose Estimation In estimating tt.e dose rates to members of the public that might arise the use of various practices for which exemptions are being consider 4
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Commission has decided to apply the concept of the
- effective do effects This concept, which is based on a comparison of the delayed h
of ionizing radiation exposures, permits through use of weighting fac This dose equivalent of partial body exposures.
d calculation of the whole bo y approach was proposed by the International Comission on Radiol Protection in its Publication 26, issued in 1977.
. I has been reviewed and evaluated by radiation protection organtrations throughout the world and has gained wide acceptance.
Estimatino Health Effects From Radiation Exoosure l
Individual Risks l
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l Commission In the establishment of its radiation protection policies, th(
has considered the three major types of delayed health effects whi
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cancer, genette effects, and f
.be caused by exposures to radiation: Regulatory agencies, including the f
developmental anomalies in fetuses.
This is done
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NRC, focus on the risk of fatal cancer development. (1) the best data principally because, at relativelv high radiation doses:
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base exists for cancer mortality, (2) the mortality risk represents a severe outcome _than the non-fatal cancer risk and (3) the m than'theriskassociatedwithgeneticandhtaleffects)
However, even though radiation has been shown to be carcinog is f
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development of a risk factor applicable to continuing radiation ex at levels equal to or far below natural background requires a s I
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is a significant uncertainty reflected by the views of experts in t field. For example, the National Academy of Science's Comitte Natural background radiation can very with time and a person In Washington, DC natural backgrou1nd rad 1
the value is about 160 mrem per year including, The health effects clearly attributable to radiation have ocurred contained in the human body.
t ic bomb principally among early radiation workers, surv 2
dical purposes, and laboratory animals.
h one year period which is at least two orders of magnitude les dose ' received by populatforis from which the cancer risks a 5
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Biological Effects of Iontring Radiation. has cautioned that the risk values are "... based on incomplete data and involve a large degree of This Connittee also uncertainty, especially in the low dose region."
stated that it "...does not know whether dose rates of gesna or x-rays (Iow LET) [ low linear energy transfer radiation) of about 100 mrads/ yea
- are detrimental to man."
In the inte of this and similar cautions, the NRC, the Environmental Protection Agency, and other national and international radiation protection authorities have established radiation standards defining recommended dose limits for radiation workers and individual members K
As a matter of regulatory 5 *udence, all these bodies hay the public.
derived the value presumed to apply at lower dose and dose rates associated with the radiation protection standards by extrapolation from l
values derived at higher doses and dose rates. The extrapolation is frequently referred to as the no-threshold hypothesis.
The Commission, in the development of an exemption policy, is again faced with the issue of how to characterire the individual and population risks associated with low doses and dose rates. Although the uncertainties are large, useful perspective en the bounding risk associated with very l
low-levels cf radiation can be provided by continued use of the no threshold hypothesis. Consequently, such risk estimates will be a factor l
in establishing individual and collective dose criteria associated with The estimations of the low risk from potential exempted this policy.
practices can be compared to the relatively higher potential risks associated with other activities or decisions over which the NRC regulatory responsibility. Through such comparisons, the Connission can assure that its radiation protection resources and those of its licensees, l
are expended in an optimal manner to accomplish its public health and safety mission.
In this context, the risk to an individual, as calculated using the no threshold model, is shown in Table 1 for various defined levels of annual l
The values in the lifetime risk column are based on the individual dose.
further assumption that the annual dose is continuously received during 6
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f' each year of a 70-year lifetime. To provide further perspective, a radiation dose of 10 mrem per year (0.1 m5v per year) received
. continuously over a lifetime corresponds to an estimated hypothestred increase of about 0.25% in an individual's lifetime risk of cancer death, i
Table _1 Hypothestred Hypothestred incremental Incrementa1 Lifetime Risk from 2
2 Annual Dose Annual Risk Continuino Annual Dose I
5 x 10-5 3.5 x 10'3 5 x 10-6 3.5 x 10~4 100 mrem 5 x 10~7 3.5 x 10-5 10 mrem 5 x 10-8 3.5 x 10-6 1
mrem 0.1 mrem Unless otherwise indicated, the expression of dose in mrem refers to the I
This term is the sum of the deep dose 1-Total Effective Dose Equivalent.
equivalent for sources external to the body and the comitted effective dose equivalent for sources internal to the body.
Risk coefficient of 5 x 10 ~4 per rem for low linear energy transfer radiation based upon BEIR Y.
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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 the health of the l -
(f.e., potential detriments) of a nuclear activity c' Collective dose is the sum of population subject to radiation exposure.
the individual doses resulting from a practice or source of radiation l
By assigning collective dose a-monetary value, it can be used exposure.
in comparative cost-benefit and other quantitative analysis techniques.
It is therefore an important factor to comider in balancing benefits and societal detriments for practice justification and in the carrying out of The NRC has used collective dose in this manner in Al. ARA determinations.
a number of rulemaking decisions and decisions involving resolution of a variety of generic safety issues.
Derivation of Measurable Quantities from Dose / Risk Estimates The Comission recognizes that it is impossible to measure risk to individuals or populations directly, and, that in most situations, it is impractical to 7
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measure annual' doses to individuals at the low levels potentially asso j
Typically, radioisotope concentrations or with its exemption decisions.
radiation levels from the material to be exempted are the actual measu that can be made, and doses are then estimated by exposure-pathwa cetr.bined with other types of assumptions related to the ways in whic i
Under such conditions, conservative assumptions are Gight become exposed.
frequently used in modeling so that any actual dose would be expecte The Comission believes that this is the lower than the calculated dose.
l appropriate approach to be taken when detemining if an exemption froml regulatory controls is warranted.
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111. APPLICATION OF RADI AT!0N' PROTECTION PRIN PEGULATORY CONTROL ll apply the The following sets forth guidelines about how the Comission wi fundamental principles of radiation protection in consideration of practic l
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.which are proposed to be exempt from certain regulatory contro s.1) practices, if approved, would result in low levels of raglicact}vy ma T16Kand products being distributed to the general public and D L.o u s
.N solid waste being released to areas of the publically-accessible enviro f
Justification r Dect! ions regarding justification of practice usually s
derive from considerations which are much broade i
Therefore, these decisions may be made radiation protection alone.
in a broader context before the need for regulatory control is L
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addressed (or the need for exemptions from certain aspects of The Comission continues to
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control,asaddressedinthispolicy).
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should be justified; however, as lower levels of individual and i
population dose are projected, lower levels of benefit will b to achieve a positive balance although other societal impacts of The Comission will continue to l
practice must also be considered.
identify or characterize certain practices for which benefits are 0
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":~ix n-considered marginal and for which there appears to be no reasonable justification.
9 Dose Limits - Individual doses from practices exempted under this policy should generally not be allowed to exceed a small fraction of j
100 mrem per year (1msv per year). This is the non-occupational dose limit recommended by the International Coasnission on Radiological Protection and the National Council of Radiation Protection and.
Measurements for continous exposure from man-made sources of radiation other than medical.
It is also the value specified in the final revision of 10 CFR Part 20, Standards ~for Protection Against Radiation. The dose limits in the final revision of 10 CFR Part N apply to all sources of radiation exposure under a licensee's control (natural background and medic 61 exposures are specifically excluded).
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ALARA - Once a practice has been justified and controls are in place to assure that dose limits are not exceeded, it is necessary to
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design and plan the subsequent use and disposal of the sources of radiation in a manner which ensures that exposures am as low as reasonably achievable, economic and social factors being taken into l
i account. As a result, this principle' applies when considering a practice for possible exemptions from some or all regulatory controls. This requirement that doses be ALARA has been a part of NRC regulatory practice for a number of years and is now fomally embodied in the revist T g Code of Federal Regu gg f
Part 20. However, no _
- 'er criteria provided w ch K,yy g
would establish the bases for defining heric loor" to ALARA. A N
majorpurposeofthispolicyistoestEi riteria which would delineate when further regulatory and licensee resources need not be spent to further reduce radiation exposures from a practice for which an exemption decision is being considered.
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Although it is possible to project what the dose will be from a practice, and then take this infomation into account in controlling regulated practices so that the dose limits are not exceeded. exemptions involve a reduction or elimination of some or all controls.
In view of this, the Comission believes l
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w-that'a key objective in estabitshing a policy for exemptions. is to provide l
adequate assurance that individuals will not experience radiation exposure approaching 100' mrem per year (1mSv per year) through the cumulative effects o
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more than one exempted practice even though the exposures from any single By l
exempt practice would be expected to be a ssell fraction of this value.
appropriate choices of exemption criteria and constraints, and through its l
evaluations of specific exemption proposals, the Coenission intends to assure i
that it is unlikely that any individual will experience continuing exposures which approach er exceed 100 arem per year Umsv per year) from all exempted practices.
IV. PRINCIPLES Or EXEMPTION
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A major consideration in exempting any practice from some or all regulatory controls hinges on the genera 1' question of whether or_not application or continuation of reguletory controls are necessary and cost effective in To detemine if exemption is appropriate, the Comission m reducing dose.
determine if one of the following conditions is met:
The application or continuation of regulatory controls on the 3.
practice does not result in any significant reduction in dose received by individuals within critical groups and by the exposed population or; The costs of the regulatory controls that could be imposed for dose 2.
reduction are not balanced by the commensurate reduction in risk that could be realized.
For purposes of implementing its policy, the Comission recognizes that only under enusual circumstances would exemptions be considered for practices w L
could cause continuing radiation exposure to individuals exceeding a small fractionof100mremperyear(1m5vperyear). The Commission will consider such circumstances on a case specific basis using the general-principles Mcwever, as the doses and attendant risks l
outlined in this policy statement.
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to members of the exposed population decrease, the need for regulatory con decreases and the analysis needed to support e proposal for exemption can 10 I
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l reasonably be somewhat simplified. At a sufficiently low level of individual risk, decisions justifying the distribution to er use of radioactive material by individuals hot controlled by NRC licenses, or decisions granting specific exemptions from regulatory control for a justified practice may be reduced to an evaluation of whether the overall individual and public risk is sufficiently small.
1 The Comission therefore proposes that two numerical criteria should be established in defining the region where the risk reduction does not warrant the expenditure of Comission or licensee resources to bring about a further incremental _ compliance with the ALARA principle. Theyare(a)acriterionfor the maxim ndividual annual dose reasonably expected to be received as a a the practice and (b) a measure of societal impact to the exposed resu In combination, these criteria are chosen to assure that, for a popr ut a.
giv6:- v empted practice, no individual will be exposed to a significant i
radiological risk and that the population as a whole does not suffer a significant impact.
The individual Dose Criterion If the individual doses from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared to other societal risks and the merit of expending resources to further reduce the dose or risk from a justified practice can be seriously questioned. The Comission believes the definition of this risk or dose level can be developed from two The first is the risk perspective. The Comission believes that ptrspectives.
nest members of society will not expend resources to reduce an annual individuel fatality risk below approximately 10-5 (i.e., I chance in 100,000).
This risk level is comparable to that (i.e. 2x10~0) selected by the Comission in the development of its safety goal policy - (i.e., a risk level equal to O.1% (1/1000) of the sum of cancer fatality risk from all other causes).
Using the no threshold hypothesis, the incremental continuing annual individual exposure level associated with this " safety goal" risk level can be estimated I
The second perspective is based on those variations in as 4 mrem per year.
f dose tolerated by individuals because of factors such as their lifestyle or The Comission notes that resources are not expended to place of residence.
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l reduce dif ferential exposures associated with variations in natural background radiation (e.g.,the 70 mrem per year difference between annual doses received in Denver, Colo'rado vs Washington, DC). Nor are resources spent to reduce the 710 mrem dose which an individual would receive during a single round trip j
coast-to coast aircraft flight or the dose from other activities which involve doses representing a small fraction of background radiation.
In view of the uncertainties involved (such as, the appitcability of the no-threshold model itself and its input data) and taking into account the results of analysis from both the risk and dose perspectives, the Comission finds an individut,1 dose of 10 mrem per year to be appropriate for use as one of two boundary criteria which would define whether or not additional resources need be spent to comply further with the ALARA principle. The Comission j
l considers this value to be appropriate given the uncertainties involved and I
notes that, at this value, implementation of this policy in future rulemakings or licensing decisions should be a practical undertaking.
The Societal Impact Criterion in proposing criteria which would demonstrate practical achievement of ALARA, the Comission seriously considered whether the imposition of the individual dose criterion would also provide a sufficient measure to judge societal impact, and, thus, could stand alone as a basis for detemining when further The resources need not be expended to further comply with the ALARA principle.
Commission finds that the individual dose criterion should not stand alone and l
l believes the need for a companion collective dose criterion has two bases.
l First, these criteria are being put forward as a means of demonstrating practical compliance with the ALARA principle. The ALARA process involves.
among other considerations, the trade-offs between cost of dose or risk l
reduction and the magnitude of'the reduction in population dose achieved.
Furthermore, since the individual dose criterion is not claimed to represent a negligible or de minimis individual dose, the sum of the individual doses from a given practice cannot be considered negligible.
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7 d[kfi Second, the Comission believes a collective dcse criterion is necessary to s
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provide reasonable assurance that total doses to individuals from all exempted V
practices will hot approach 100 mrem per year (1mSV per year).
This consideration specifically applies to the potential exposure of some few g-individuals to multipie practices and, in particular to those practices or r
classes of practices involving potential widespread, direct distribution of radioactive material to members of the public (i.e., in the form of consumer products, or recycled equipment or materials containing residual levels of radioactivecontamination). The Comission notes that the uncertainties in establishing reasonable scenarios through which the public may interact with these products, equipments or materials, creates uncertainty in the calculation of individual doses, and as a result argues for a compensatory provision of Furthemore, for these collective dose as a matter of regulatory prudence.
I practices, effective dose reductions may be possible at relatively small costs.
As a result, a practice must also result in a collective dose of less than 500 person-rem per practice per year in order for the Comission, based on these criteria alone, to agree that further resources need not be expended to comply with the ALARA principle.
The Comission stresses that adoption of the individual and collective dose criteria should not be construed as a decision that doses below these are necessary before a practice can be exempted, while doses above the criteria On the contrary, the criteria simply represent a would preclude exemptions.
range of risk which the Comission believes is sufficiently small compared to other individual and societal risks that further cost-risk redaction analyses, or_more broadly, ALARA analyses) are not required in order to make a decision Practices not meeting these regarding the acceptability of an exemption.
criteria may be granted exemptions on a case-by-case basis in accordance with To further emphasize the the principles embodied within this policy.
Commission's recognition that a rigid limitation is inappropriate, it notes that for some practices, such as use of smoke detectors, collective doses have been estimated to exceed 500 person-rem per practice per year, yet appreciable benefits can only be attained through extensive utilization and, hence, with a comensurate collective dose.
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The Comisstori is aware that existing and future regulations of the Environmental'. Protection Agency for environmental protection (e.g., the Clean Air Act) may establish criteria for specific practices more restrictive than exemptions which may be granted under this proposed policy. Any affect 9d NRC regulations developed on-the foundations of this policy may need to se reviewed and, if necessary, revised, to ensure compatibility. With regard to its own regulations, the Comission will evaluate whether there are exemption criteria erbodied therein for which modification, according to the principles of this policy, would be beneficial.
V.
EXCLUSIONS FROM EXEMPTIONS Since it is not possible to foresee every possible use of radioactive material that may be proposed in the future, the Comission does not believe it is possible tc prejudge any class of practices as innately unjustifiable.
However, the Comission continues to believe that there are certain classes of practices involving radiation or radioactive materials which potentially have little or no benefit to society (e.g., consistent with the policy statement on 16, 1965, 30 FR 3462). These practices could include, j
consumer products, March but are not be limited to, the intentional introduction of radioactive material into toys, novelties, and non-medical products intended for ingestion, f
I inhalationerdirectapplicationtotheskin(suchascosmetics).
The Commission's determinations regarding the justification of these practices will L
also include consideration of any non-radioactive alternatives; that is, there 1
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should be a net benefit of the radioactive over the non radioactive i
alternative.
l Yl. PROPOSALS FOR EXEMPTION A proposal for exemption must provide a basis upon which the Comission can l
In detemine if the basic conditions described above h' ave been satisfied general, this means that the proposal should address the individual and societal impact (i.e., benefits and detriments) resulting from the expected l
activities under the exemption, including the uses of the radioactive materials, the pathways of exposure, the levels of activity, and the methods l
and constraints for assuring that the assumptions used to define a practice i
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remain appropriate as the radioactive materials move from regulatory control to
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If a proposal for exemption results in a rule containing specific requirements,
_a person applying to utilize the exemption would not need to address justificationorALARA. The Commission decision on such proposals will be bssed on the licensee's meeting the conditions specified in the rule. The promulgation of the rule would, under these_ circumstances, constitute a finding that t.he exempted practice is justified, and that ALARA considerations have been daalt with. This approach is consistent with past practice, e.g.,
consumer product rules in 10 CFR Part 30.
In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered with regard to the potential that some individuals may receive doses from other practicts.
If exposures from multiple practices can occur which are significantly beyond the individual dose criterion (10 mrem per year (0.1 mSv As per year)), the exemption will not be granted without further analysis.
experience is gained, this policy and its implementation will be reevaluated with regard to this issue to assure that the exposures to individual members of the public from exempted practices remain well below 100 mrem.
1 In addition to considerations of expected activities and pathways, the Commission recognizes that consideration must also be given to the potential for accidents and misuse of the radioactive materials involved in the practice.
A proposal.for exemption of a defined practice must therefore also address the potentials for accidents or misuse, and the consequences of these exceptional conditions ir. terms of individual and collective dose.
VII. VERIFICATION OF EXEMPTION CONDITIONS The Commission believes that the implementation of an exemption under this broad policy guidance must be accompanied by a suitable program to monitor and verify that the basic conditions under which an exemption was issued remain valid.
In most cases, the products or materials comprising an exempted practice will move from regulatory control to the exempt status under a defined 15 L
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n set of conditions and criteria. The monitoring and verification program
- established by licensees, who propose to release materials under the provisions l
of regulations or licensing conditions developed from this policy,' must therefore be capable of providing the Commission with the appropriate assurance l
' that the conditions for the exemption remain valid, and that they are being observed. The Comission will determine compliance with the specific 1
conditions-of an exemption through its established licensing and inspection-program and will, from time to time, conduct studies as appropriate to assess the impact of an exempted practice or combinations of exempted practices.
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'~ NUCLEAR REUMTTRY COMMIS$l0N
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April 28, 1989 A[
MEMORANDUM FOR: Eric $. Beckjord. Director office of Nuclear Regulatory Research FROM:
Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
PROPOSED COMMIS$10h POLICY STATEMENT ON EXEMPTION FROM REGULATORY CONTROL As requested in your menorandum.of April 19, 1989, we have reviewed the preliminary draft proposed statement on Exemptions f rom Regulatory Control.
Although there remain a number of drafting points and concerns, we believe that the draft is in general acceptabic. A suunary of our coments is enclosed. These coments, and other editorial notes have been discussed with Mr. Willitn. Lahs of your staff, b
2*ut Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc:
H. Thompson, DEDS T. Murley, HRR H. Denton, GFA W. Parler, OGC CI "Y y
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$UMMARY OF SIGNIFICANT CUNN j
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t MM0R C0fMENT$:
The new UNSCEAR report indicates that risk factors are ge 1
The discussion could also higher than previously thought.
1.
ik not provide a rationale for the change. include the possible t
i
- factor, The proposed policy indicates that individu41's should not e l tive radiation exposure approaching 100 mrem pyr' year through 1
2.
effects of more than 1 exempted practice.
include exposure from all exempted and regulated practices ce" -
from exempt practices should be limited to a small fraction 3
m rp twW overall limit.
Collective dose from an exempted practice w e
jy n
3.
The wording on page 13 should be reconsidered.
d approach practices.
The current draf t does not come to grips with the rationale anA iteria of the staff is using for multiple practices.
4.
on how and why multiple exemptions using an indivicual dose cr i
osure 10 mrem will not result in any individual receiving a cumulat s and greater than a small fraction of the dose limit for all source practices.
laid The distinctions between ALARA and justification are not cl a justified practice separate from the ratio i
is 5.
out.
determined to be justified.
l OTHER C0tEENTS:
The presence of natural background presents practical lim l is measurements. The thought could be added that all materia i
have 1.
radioactive and that although improvements in survey techn que his does resulted in the ability to detect extremely low I
to be L
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regulated.
If 50, Have we consulted with the States in formulating this policy?
2.
lets say it.
The policy statement and any supporting discussions nee rationale for differences with international recomm 3.
completely.
Add reference to 1987 Presidential guidance on occupa 4,
paragraph 1 of page S.
Enclosure
...a sbh g.
What is the basis fer the 40 arem per year from natural radioactivi This is unclear and potentially confusing.
5.
A tern We should not suggest assigning collective dose a monetary value.
like weighting f actor may be more acceptable.
i 6.
First sentence of paragraph 2, page 9 indicates that ALARA for aIf it ha justified practice is still required.The text should be clarified to avoid 7.
this may not be appropriate.
misconceptions.
(page We may not want to guarantee compatibility with EPA at this point.
8.
14 paragraph 1).
COMMENTS ON NRC RESPONSE TO EPA REMARKS:
We indicate that we are currently considering the individual do 3.
It is criterion to be applied.(sage 2, paragraph 4,andpage5, paragraph 2).
same numbers.
unclear that we lave responded to the comment, t
The circumstences under which truncation could be 2.
clarified.
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T. c i;o t M 'fL RATE RECCIVFD 04/20/89 ORIGI!JAL DUE DT 04/29/89 CatJTROL tJO: G*?OO200 i
DIVISIOtJ DATE: 04/06/09 JCC DT 04/19/G9 I
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TIME:
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Parhero. et.al.
FOR 51CstJATUL.E OF:
48 F'LC 4i EECY NO:
Marnero ASS 10!JF.D TO:
C OtJT ACT IlifJ 3 Cunninham/ Cool l
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DESC:
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FROF05ED COMMIS31CtJ POLICY R~41 EMFtJT f.itJ E 1MPT ICil Dernero FROM RECGULATORY CONTROL g perto D runt hr:B PECIAL ItJ9TEUCTIClJS C R hit!1ARI 5:
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