ML20043B912
| ML20043B912 | |
| Person / Time | |
|---|---|
| Issue date: | 07/05/1988 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20042C963 | List:
|
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006010022 | |
| Download: ML20043B912 (11) | |
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Policy Statement Exemption of Radioactive Materials from Regulatory Control 1,
INTRC Q g AND PURPOSE l
Over the past several years, the Comission has become increasingly aware of L
the need to provide a general policy on the appropriate criteria for rebase of radioactive materials from regulatory control. To address this need, the
-4 Comission is expanding upon its existing policy for protection of the public fromradiation,currentlyexpressedinexistingregulations(Title 10,Codeof Federal Regulations) and policy statements (30 FR 3462, dated March 16, 1965; 47 FR 57446, dated December 27, 1982; and 51 FR 30839, dated August 29,1986)by providing an explicit policy on the exemption from regulatory control of practices.
whose public health and safety impacts are below regulatory concern.
The purpose of this policy statement is to clearly establish the regulatory basis upon which the Comission may initiate the development of appropriate regulations to exempt from regulatory control certain radioactive sterial and persons who receive, possess, use, transfer, own, or acquire this material.
L This policy is directed specifically toward petitions for rulemaking, license amendments. and license applications involving the release or distribution of licensed radioactive material either to persons not subject to Commission regulation as currently defined in 10 CFR Parts 30, 40,; 50 and 70, or to the environment.
The concept of exemption from regulatory requirements is not new. For example, tables of exempt quantities and concentrations for radioactive material were defined in 1965 and 1970 (30 FR 8185 and 35 FR 6427) in which a person could receive, possess, use, transfer, own, or acquire without a requirement for a license. Other exemptions allowing distribution of consumer products or other devices, or releases of radioactive material, have been embodied in the Comission's regulations for some time. More recently, the Low Level Waste policy Amendments Act of 1985 directed the Comission to develop standards and 60 022 891130
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procedures for expeditious handling of petitions to exempt from regulation the disposal of slightly contaminated radioactive waste material that the Commission determined to be below regulatory concern. The Comission responded to this legislation by issuing a policy stetement in August 1986(51FR30839). That statement contained criteria which, if satisfactorily addressed in a petition-for rulemaking, would allow the Commission to act expeditiously in proposing appropriate regulatory relief on a " practice-specific" basis consistent with the merits of the petition.
The Comission believes that these " practice-specific" exemptions should be encompassed within a broader NRC policy which defines levels of radiation risk, including individual dose benchmarks of radiation exposure, below which specified practices would not require NRC regulation based on public health and safety interests.
For such exempted practices, the Commission's regulatory involvement could therefore be essentially limited to the inspection and compliance activities associated with the. transfer of the radioactive material from a regulated to an exempt status.
.II.
RADIATION PROTECTION PRINCIPLES The Comission subscribes to three fundamental principles of radiation protection in formulating its policies and regulations to protect workers and the public from the harmful effects of radiation. They are 1) justification of the practice, which requires that there be some net benefit resulting from the use of radiation or radioactive materials, 2) dose limits, which define the upper boundary of dose which must not be exceeded in the conduct of nuclear activities, and 3)
ALARA, which requires that radiation dose below the limits be as low as reason-ably achievable, economic and social factors being taken into account. The term.
' ALARA, is an acronym for As Low As Reasonably Achievable.
For the purpose of establishing the health risk associated with its regulatory policies, the Comission also subscribes to the linear model for dose and effect.
The hypothesis upon which the linear model is based assumes that th,e risk of radiation induced effects (principally cancer) is linearly proportional to dose.
l regardless of the size of the dose.
In subscribing to this hypothesis, the l
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L 4 Commission recognizes that it is a functional model based upon data collected at relatively high doses and dose rates which is then extrapolated to the low dose and ' dose rate region where there are no statistically reliable data availi able.
It is generally believed that the use of the linear model provides a conservative basis for planning purposes.
Although not a principle of radiation protection, collective dose provides a useful way to express the impact of a nuclear activity on health of the population subject to radiation exposure. Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure. By assigning collective dose a monetary value, it can be used in cost benefit analysis and other quantitative analysis techniques.
It is also an important factor to consider in balancing benefits and consequences for justification of a practice end determining if radiation doses are ALARA.
III. APPLICATION OF RADIATION PRINCIPLES TO EXEMPTION FROM REGULATORY CONTROL The following sets forth guidelines about how the staff will apply the fundamental principles of radiation protection in consideration of exemptions from regulatory control, o
Justification - Consistent with the linear model for dose and effect, the extent to which a candidate for exemption must be demonstrated as justified is roughly proportional to the dose involved. At triviallevelsofdose(seebelow),anyefforttopetitionorapply to the Conunission for an exemption implies that there is at least some margins 1 benefit to the practice, Dose limits - The dose limit for members of the public specified in o
10 CFR Part 20 is 100 mrem per year from all sources of radiation exclusive of natural background radiation and medical exposure.
Although it is possible to reasonably project what the dose will be from a practice and to take this into account in controlling regulated practices so that dose limits are not exceeded, exemptions imply some degree of loss of control. The Commission believes that individual I
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i doses from multiple excemptions must not be allowed to exceed the dose.
limits. Therefore, in order to provide reasonable asserance that regulatory decisions regarding exemptions, combined with other sources.
of radiation.will not cause members of the public to exceed the dose limits, candidates for exemptions should ordinarily not result in an-average dose to members of the critical group-(the group defined as the individuals expected to receive the greatest exposure from the practice) exceeding' 25 mrem per year. Further, it is the Connission's expectation that as the number if individuals affected increases, the maximum doses allowed by an exemption would decrease, o
ALARA-- The ALARA principle applies to exemptions in the same manner at it is applied to other practices which are subject to regulation.
However, as in the case with justification, the level of effort to achieve, or-to' demonstrate achieving ALARA, will be proportional to the individual and collective dose.
For trivial doses (see below),
any effort to achieve or analyze the benefit of further dose reduction is assumed not to be cost-effective.
IV. CATEGORIES OF EXEMPTIONS Once a practice is established as justified, i.e., there is a positive net benefit to the introduction or use of radioactive material, the decision of whether or not the practice is a candidate for exemption from regulatory controls hinges on the general question of whether or not such regulatory controls are necessary and cost effective in reducing dose. To determine if exemption'is appropriate, the Commission must determine if the following conditions are met.
1.
The imposition of regulatory controls on the practice does not result in any reduction in the individual or collective dose received by the critical group and exposed population or; 2.
The costs of the regulatory controls that could be imposed to reduce the individual and collective dose are not balanced by the benefits
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The Commission believes that a graded approach to exemptions is appropriate in which two specific categories can be identified, based upon the individual and collective doses that result from the practice. The first category encompasses the range of maximuni individual dose below 25 mrem per year. The second category encompasses the range of maximum individual dose below I mrem per year, with the collective. dose limited to 1,000 person-rem.
In addition to the above categories, the Commission recognizes that there may be unusual circumstances in which practices or certain discrete sources of radiation exposure could produce doses in excess of 25 mrem per year and yet be a candidate for exemption from regulatory control. The Commission will consider such circumstances on a case specific basis using the general principles outlined in this policy statement. However, when the maximum individual dose is in excess of 25 mrem per year, the analysis supporting an application for exemption must address additional factors, such as alternatives to the proposal and environmental impacts of the exemption, which would be in excess of the requirements for exemption under one of the categories discussed above.
Establishment of an exemption for a particular practice would not necessarily imply that the individual and _ collective doses would be considered as trivial by individuals and population involved. However, if the conditions given above are met, then promulgation of an exemption is appropriate from a regulatory standpoint because either the degree of risk is too small to justify the burden of additional regulatory controls, or because there would be little gain in risk reduction by the additional controls.
The Commission believes that an exemption should imply that the practice being exempted will not contribute significantly to the overall risk to the exposed individual, population, or to the environment.' In this regard, the collective dose is one of the principle factors in determining if Condition 2 above has been achieved.
In many instances, the collective' dose will be proportional to both the extent to which an exempt practice is utilized'and the resulting benefits.
For example, the use of smoke detectors containing radioactive sources in houses is known to save lives. Both the number of lives saved and the collective dose will increase proportionally to the number of smoke DRAFT 07/05/88 BRC POLICY STATEMENT
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.. detectors used. However, it is the Commission's expectation that an exemption would not be approved if both the individual and collective dose were large, i.e., a significant impact to the population.
. The second category of exemption has been established on the basis of levels of risk at which individuals are unlikely to take any actions to further reduce their risk. This range of risk has been taken as being on the order of l'0-6 to 10~7 per year. The 1 mrem per year dose represents a risk at the lower end of this range. The lower end of the range is chosen to compensate for the possibility that an individual might receive dose from multiple practices exempted on the basis that each represents a trivial dose.
A collective dose limitation has been added to the second category to ensure that a practice exempted under this category will not contribute significantly to the overall risk to the exposed population. Applications in which the individual dose in less than 1 mrem per year, but with a collective dose in excess of 1000 person-rem, could still be considered for exemption under the first category described above.
V.
APPLICATIONS FOR EXEMPTION An application for exemption, either as a petition for rulemaking or as a license application or amendment, must provide a basis upon which the Commission can determine if the basic conditions described above have been satisfied.
In general, this means that the application should address the individual and collective doses resulting from the expected activities under the exemption, including the uses of the radioactive materials, the pathways of exposures, the levels of activity, and the methods and constraints for assuring that the assumptions used remain appropriate as the radioactive materials move from regulatory control to an exempt status.
If a petition for exemption results in a rulemaking that contains generic requirements, a person applying for a license to utilize the exemption would not need to address justification or ALARA, and the Comission decision on such applications will be based on the licensee's meeting the conditions specified in the rule. The promulgation of the rule would, under these circumstances.
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constitute a finding that the exempted practice is justified, and that ALARA considerations have been dealt with. This approach is consistent with past
- practice, e.g., consumer product rules in 10 CFR Part 30.
-If a simple assessment indicates that the likely consequences of an exemption are individual and collective doses within 1 mrem per year and 1000 person-rem, respectively, there would be a high-likelihood that the application would be accepted by the Comission without detailed analysis related to justification or ALARA. There may be cases, however, where simplified assessments, which typically use conservative assumptions for bounding conditions, wi11' indicate the potential for higher individual or collective doses.
In these cases, a more detailed analysis will be required to make a determination on whether the basic ccnditions for an exemption have been met.
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.
An application for exemption must therefore also address the potentials for accidents or misuse, and the consequences of these exceptional conditions in terms of individual and collective dose.
VI. EXCLUSIONS FROM EXEMPTION As the individual and collective dose from a practice becomes trivial, the Commission expects the justification for the practice will be increasingly based
-upon an economic benefit to some individuals. However, these individuals are not necessarily the individuals receiving the radiation exposure. The Commission believes that this is reasonable and acceptable in view of the very small levels of dose and risk involved. However, there are some types of practices involving radiation or radioactive materials which are, prima facie, socially unacceptable regardless of how trivial the resulting dose might be.
These practices would not be candidates for exemption, and would, for example, include radioactive material introduction into children's toys, products DRAFT 07/05/88 BRC POLICY STATEMENT
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.I intended for ingestion, inhalation or direct application to the skin, and consumer products for certain identification purposes, e.g., the use of radio-active labels to prevent theft or shoplifting.
In addition, the purposeful and f rivolous introduction of radioactive material when there are clear, economical alternatives to the use of radionuclides is generally not justified because there is no unique benefit from using the radioactive materials.
VII. APPLICATION OF COLLECTIVE DOSE ASSESSMENT As noted above, the collective dose can serve as both a measure of the impact of a practice on the exposed population and a mechanism for assessing the benefits of regulatory controls.
In the later case, a monetary value can be assigned to the collective dose so that quantitative assessments can be made of the benefits of regulatory controls for comparison.with the costs of those controls.
In assigning values to collective dose, a value of $1 000 per person-rem has g
been used previously by the Commission.
It was first used in 10 CFR Part 50 Appendix I for determination of ALARA below 5 mrem per year. The Commission recognizes, however, that the more universal application of the $1000 per person-rem, when applied to summation of doses consisting of trivial individual risk for purposes of determining ALARA, can in some instances result in undue expenditure of resources which might better be applied to other uses.
Recently, the International Atomic Energy Agency has published guidelines on the valuation of collective dose on an international level. These guidelines contain a value of $35 per person-rem. The Commission believes that an appropriate valuation of collective dose for cost-benefit purposes can be obtained through the application of different valuations for different levels of dose or individual risk, consistent with the linear dose-effect model. This is also consistent with the " economic and social factors being taken into account" portion of the ALARA principle. Therefore, collective dose assessments for exemption may be assigned a monetary cost as follows:
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n,000 per person-rem for collective dose composed of individual
. doses in excess of 1 mrem, o
$35 per person-rem for collective dose composed of individual doses below 1 mrem.
-o Zero dollars per person-rem for collective dose composed of individual doses below 0.1 mrem per year, except for situations in which the collective dose is composed entirely of individual doses below I mrem per. year.
The valuation of $0 per person-rem for individual doses below 0.1 mrem per year reflects'the Commissions belief that the individual risk associated with these very small levels of dose do not warrent their inclusion in cost-benefit analyses. This is not meant to imply, however, that these doses can be dismisseo entirely.
In keeping with the linear hypothesis for dose and effect, these'small levels of dose should be considered when examining the overall
- impact of the practice. At.this level, an individual's overall risk.would
! approach.10-6 jf the exposuse continued throughout an entire lifetime, a level at which no actions are typically taken by federal agencies to further reduce
~or control the lifetime risk. - The 0.1 mrem'per year dose is'also well within the variation of background radiation that persons living in any given community would receive due to personal routines or living conditions.
VIII.
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 set of conditions and criteria. The monitoring and verification program must therefore be capable of providing the Comission with the appropriate assurance that the conditions for the exemption remain valid, and i
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4 that' they are being complied with during routine activities. The Commission will determine compliance with the specific 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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Document Name:-
BRC; POLICY STATEMENT w
Requestor's ID::
COOL-0"
= Author's'Name:
Cool, Donald A-.
' Document Comments:
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Policy' Statement on BRC and'De minimis - NMSS draft' 1
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