ML20207L033
| ML20207L033 | |
| Person / Time | |
|---|---|
| Issue date: | 10/07/1988 |
| From: | Lahs W NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | NRC |
| References | |
| NUDOCS 8810170147 | |
| Download: ML20207L033 (15) | |
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UNITED STATES
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OCT 7 WII MEMORANDUM FOR: Nuclear Documents System FROM:
William Lahs, Acting Chief, Regulation Development Branch Division of Regulatory Applications, Office of Nuclear Regulatory Research
SUBJECT:
ADVANCE NOTICE OF THE DEVELOPMENT OF A COMMISSION POLICY ON EXEMPTIONS FROM REGULATORY CONTROL FOR PRACTICES WHOSE PUBLIC HEALTH AND SAFETY IMPACTS ARE BELOW REGULATORY CONCERN Enclosed is a draft document, "Advance Notice of the Development of a Comission Policy On Exemptions From Regulatory Control For Practices Whose Public Health and Safety Impacts Are Below Regulatory Concern." Please send this document to the Public Document Room as requested by the Comission in a Staff Requirements Memo dated September 30, 1988 (response to SECY-88-257).
JA William Lahs Acting Chief, Regulation Development Branch, Division of Regulatory Applications, Office of Nuclear Regulatory Research
Enclosure:
As Stated I
e is(
8810170147 891007 PDR ORG NREA
R-2 6 63 R. >7 :1 POR Advance Notice of the Development of a Cornmission Policy On Exemptions From Regulatory Control for Practices Whose Public Health and Safety Irrpacts Are Below Regulatory Concern
DRAFT Advance Notice of the Development of a Comission Policy on Exemptions from Regulatory Control for Practices Whose Public Health and Safety Impacts are Below Regulatory Concern I.
INTRODUCTION AND PURPOSE Over the last several years, the Comission has become increasingly aware of the need to provide a general policy on the appropriate criteria for release of radioactive materials from regulatory control. To address this need, the Comission is expanding upon its existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10, Code of Federal Regulations) and policy statements (30 FR 3462, Use of Byproduct Material and Source Material, dated March 16, 1965; 47 FR 57446 Licensing Requirements for Land Disposal of Radioactive Waste, dated December 27, 1982; ano 51 FR 30839, General Statement of Policy and Procedures Concerning Petitions Pursuant to i 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion includss the development of an explicit policy on the exemption from regulatory control of practices whose public health and safety impacts are below regulatory concern. A practice is defined in this policy as an activity or a set or combination of a nurrber of similar sets of coordinated and continuing activities aimed at a given purpose which involve the potential for radiation exposure.
Under this policy, the definition of "practice" is a critical feature which will assure that the formulation of exerrptions from regulatory control will not allow deliberate dilution of material or fractionation of a practice for the purpose of circumventing controls that would otherwise be l
applicable.
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The purpose of this policy statement is to establish the basis upon which the Comission may initiate the development of appropriate regulations or make licensing decisions to except from regulatory control persons who receive, possess, use, transfer, own, or acquire certain radioactive material.
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 Comission regulations.
It is important to emphasize that this palicy does not assert an cbsence or threshold of risk but rather establishes a baseline where further government regulation to reduce risks is unwarranted.
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l The concept of regulatory exerptions is not new.
For example, in 1960 and 1970, the Commission prorulgated tables of exempt quantities and concentrations for radioactive material which a person, under certain circumstances, could receive, possess, use, transfer, own, or acquire without a requirement for a license (25 FR 7875 and 35 FR 6425).
Other exemptions allowing distribution of consumer products or other devices to the general public, or allowing releases of radioactive material to the environment, have been embodied in the Comission's regulations for some time. More recently, the low Level Radioactive Waste Policy Amendments Act of 1985 directed the Commission to develop stanJards and procedures for expeditious handling of petitions to exempt from regulation the disposal of slightly contaminated radioactive waste material that the Comission determined to be below regulatory concern.
The Commission responded to this legislation by issuing a policy statement in August 198f, (51 FR 30839).
That statement contained criteria which, if satisf actorily addressed in a petition for rulemaking, would allow the Comission to act expeditiously in proposing appropriate regulatory relief tm a "practice-specific" basis consistent with the merits of the petition.
The Comission believes that these "practice-50ecifir" exemptions should be encorpassed within a broader WC policy whict, d' ~1ner ',esels of radiation risk below which specified practices F ' ' r, req'iir' NRC egulation ba ed en public health and safety interests.
Fe.uch er 7ted p octices, the j
Comission's regulatory involvement c -
therets. ve essentially '"mited to
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i licensing, inspection, and compliance activities associated with the transfer l
of the radioactive material from a controlled to an exempt status.
I The Comission recognizes that, if a national policy on exemptions from i
regulatory control is to be effective, Agreement States will play an important f
implementation role, in the past, States have been encouraging findings that i
certain wastes are below regulatory concern and the Comission believes that f
States will support an expansion of these views to all practices involving exempt distribution or release of radioactive material.
The Comission intends
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that rulemakings codifying regulatory control exemptions will be made a matter of compatibility for Agreement States.
Consequently, any rulemakings that I
evolve from this policy will be coordinated with the States, j
t Advisory and scientific bodies have offered diverse views to the Comission in i
anticipation of this Policy Statement.
There is no clear consensus based on existing scientific evidence or research regarding the selection of numerica' criteria for use in this Policy Statement.
Further, the Comistion is aware that there are differing views within the NRC staff on the selection of
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numerical criteria for BRC.
In the absence of a scientific consensus, it is the Comission's task to assess the diversity of views in establishing a responsible BRC policy. The authority and responsibility to make the final selection of criteria rests with the l
Commission.
Criteria selected must:
- 1) provide reasonable assurance that f
public health and safety will be protected, and 2) consistent with such i
a s surancre, permit practices in the public 6 main which involve the use of f
radioisotopes for which society perceives a demand.
l It is recognized that there is a delicate balance here. Criteria can be set i
sufficiently restrictive such that there is absolute assurance that health j
and safety will always be protected, no matter what events might transpire.
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However, in doing so, the regulator may then place undue and unnecessary j
restrictions on practices which should be permitted because of otherwise reasonable social, economic, or industrial considerations. There is always the danger of over-regulation which results in effects that are felt in areas where the NRC does not have authority and responsibility. Moreover, 3
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the Atomic Energy Act does not require absolute asserances of safety in the use of radioactive material and licensed facilities.
l The numerical criteria ultimately selected will have significant impact on nuclear regulation here in the United States and potentially in the international comunity.
The values under consideration in this Policy Statement do not necessarily agree with those selected or under consideration by other countries.
The Comission bas carefully reviewed those alternate criteria, and does not find significant scientific evidence that would dictate preferential selection of any of those views over what is proposed in this Policy Statement, II.
RADIATION PROTECTION PRINCIPLES The Comission recognizes that three fundamental principles of radiation protection have historically guided the formulation of a system of dose limitation to protect workers and the public from the potentially 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 l
or radioactive materials, (2) dose limits, which define the upper boundary of l
adequate protection for a member of the public which should not be exceeded in i
the conduct of nuclear activities, and (3) ALARA, which requires that radiation I
dose be as low as is reasonably achievable, economic and social factors being taken into account.
The term, ALARA, is an acronym for As low As is Reasonably l
Achievable.
The Comission is interested in assessing how these principles should be applied in establishing appropriate criteria for release of radioactive materials from reDulatory control.
Because of the absence of observed health effects below S rem / year (50 mSv/ year), scientific experts including the International Comission on Radiological Protection (ICRP) and the National Council on Radiation Protection and Measurements (NCRP) make the assumption that the frequency of occurrence of health effects per unit dose at low dose levels is the same as I
at high doses (10 Rad (0.1 Gy)) where health effects have been observed and l
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studied in humans and animals.
This linear non-thresho'd hypothesis assumes that the risk of radiation induced effects (principally cancer) is linearly proportional to dose, no matter how small the dose might be. The coefficient used in the model as a basis for estimating statistical health risk is on the order of 2x10 risk of fatal cancer per person-rem of radiation dose (2x10-2 per Sv). The Comission recognizes that it is a conservative 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 epidemiological data available.
Alternative hypotheses have been proposed and reevaluations of the data base at higher doses continue. The Comission believes that use of the linear non-threshold hypothesis allows the theoretical establishment of upper limits on the number of health effects that might occur at very low doses which are the subject of the exemption policy.
l The risk of death to an individual, as calculated using the linear model, is shown in Table 1 for various defined levels of individual dese. A radiation exposure of 10 mrem per year (0.1 mSv per year) for a lifetime corresponds theoretically to an increase of 0.1% of the individual's annual risk of cancer death.
The lifetime risk is based upon the further assumption that the exposure level is the same for each year of a 70-year lifetime.
In estimating the dose rates to members of the public that night arise through the use of various prrctices for which exemptions are being considered, the Comission has decided to apply the concept of the "effective dose equivalent." This concept, which is based on a comparison of the delayed mortality effects of ionizing radiation exposures, permits through use of weighting factors, the calculation of the whole body dose equivalent of partial body exposures.
This approach was originally developed by the International Comission on Radiological Protection and was first expressed in its publication 26 issued in 1977. Since that time, the concept has been reviewed and evaluated by radiation protection organizations throughout the world and has gained wide acceptance.
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Table 1*
Incremental incremental Lifetime Risk from Annual Dose Annual Risk Continuing Annual Dose 100 mrem ***
2 x 10-5
~ 1 x 10'4 3
10 mrem **
2 x 10-6
~ 1 x 10' 7
2 x 10~8
~ 1 x 10-5 1
mrem 0.1 mrem 2 x 10-
~ 1 x 10-6 Risk coefficient of 2 x 10'4 per rem (2x10-2 perSv)basedupon publications of the ICRP.
For purposes of comparison, the annual risk to an individual of dying from cancer from all sources in the U.S. is 1 in 500.
The additional risk to an individual of dying from cancer when exposed to 10 mrem (0.1 mSv) is 2 in one million.
- Unless otherwise indicated, the expression of dose in mrem refers to the Total Effective Dose Equivalent.
This term is the sum of the deep dose equivalent for sources external to the body and the comitted effective dose equivalent for sources internal to the body.
The Commission recognizes that it is impossible to measure risk to individuals or populations directly, and, that in most situations, it is impractical to measure annual doses to individuals at the low levels implied by exemption decisions. Typically, radioisotope concentrations or radiation levels from the material to be exempted are the actual measurements that can be made, and doses are then estimated by exposure pathway analysis combined with other types of assumptions related to the ways in which people might become exposed.
Under such conditions, conservative assumptions are frequently used in modeling so that the actual dose is on the low side of the calculated dose.
The Comission believes that this is the appropriate approach to be taken when determining if an exemption from regulatory controls is warranted, i
l 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 and other quantitative analysis techniques.
It is a factor to consider in balancing benefits and societal impact.
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!!!. CONSIDERATIONS IN GRANTING EXEMPTIONS FROM REGULATORY CONTROL The following elements are being considered by the Commission as a basis for evaluating practices which are proposed to be exempt from regulatory control.
These practices, if approved, would result in products containing low levels of radioactive material being distributed to the general public and radioactive effluents and solid waste being released to areas of the publicly-accessible environment, o
Justification - The Comission seeks comment on the extent to which exposures resulting from any practice should be justified. As lower levels of radiation exposure are projected, should lower levels of benefit be required for practice justification?
In establishing its exemption policy, should the Comission exclude certain practicec for which there appears to be no reasonable justification?
In considering proposals for exemptions, should the Comission evaluate the social acceptability of practices? Should the Comission determine a practice to be unjustified if nonradioactive economical alternatives exist?
o Dose Limits and Criterion - Individual doses from practices exempted under this policy should not be allowed to exceed 100 mrem per year (1 mSv per year). This is the dose limit for members of the public 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 20 apply to all sources of radiation exposure under a licensee's control (natural background and medical exposures are excluded).
Because of the small risks involved, a 10 mrem (0.1 mSv) individual dose criterion is proposed as the basis for exemption decisions based on sirple Onalysis and judgerents.
The Commission specifically seeks comment on the need for establishing a collective dose limit in addition to an individus1 dose criterion.
If such a collective dose criterion is needed, what is the basis for this need?
If the Comission decides that a collecthe dose criterion is needed, what approaches allowing truncation of individual dose in calculation of collective dose or weighting factors for components of 7
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i collective dose would be appropriate? What alternatives should be j.
considered for assessing societal impact?
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o ALARA - The ALARA principle generally applies to determining dose levels l
below which exemptions may be granted on a cost-benefit basis. However, it is the purpose of this policy to establish criteria which would, in effect, delineate achievement of ALARA without cost-benefit analysis.
Although it is possible to reasonably project what the dose will be from a practice, and then take this information into account in controlling regulated practices so that the dose limits are not exceeded, exemptions imply some degree of loss of control. The Conrnission believes that a key consideration in
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establishing a policy for exemptions, and subsequently in specific rulemaking or licensing decisions, is the question of whether individuals may experience l
radiation exposure approaching the limiting values through the cumulative j
effects of nore than one practice, even though the exposures from each practice i
are only small fractions of the limit.
The Comission specifically seeks comment on the issue. By appropriate choices of exemption criteria and through j
its evaluations of specific exemption proposals in inplementing the policy, the Comission intends to assure that it is unlikely that any individual will experience exposures which exceed the 100 mrem per year (1 mSv per year) limit.
IV.
PRINCIPLES OF EXEMPTION
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l A major consideration in exempting any practice from regulatory control hinges j
on the general question of whether or not application or continuation of l
regulatory controls are necessary and cost effective in reducing dose.
To j
determine if exemption is appropriate, the Comission must determine if one of l
the following conditions is met:
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The application or continuation of regulatory controls on the l
practice does not result in any significant reduction in the dose received by individuals within the critical group and by l
the exposed population or; i
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The costs of the regulatory controls that could be imposed for i
dose reduction are not balanced by the comensurate reduction in risk that could be realized.
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For purposes of implementing its policy, the Comission recognizes that only i
under unusual circumstances would practices which cause radiation exposures approaching the 100 mrem per year (1 mSv per year) limit be considered as candidates for exemption. The Comission will consider such circumstances on a j
case specie'ic basis using the general principles outlined in this policy statement. However, as the doses and attendant risks to members of the exposed population decrease, the need for regulatory controls decreases and the analysis
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needed to support a proposal for exemption can reasonably be somewhat simplified.
4 The Comission is evaluating the use of two numerical criteria in defining the region where At. ARA has been achieved.
They are (a) a criterion for the maximum l
individual annual dose reasonably expected to be received as a result of the j
practice and (b) a measure of societal impact to the exposed population.
These l
criteria are being considered to assure that, for a given exempted practice, no j
individual will be exposed to a significant risk and that the population as e whole does not suffer a significant impact, i
If the individual doses from a practice under consideration for exemption are
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sufficiently small, the attendant risks will be small compared with other societal risks.
The Corsnission believes that annual individual fatality risks below approximately 100 (one in 100,000) are of little concern to most members of society.
Providing for some margin below this level, the Connisdon prtnows 10 inrem (0.1 inSv) as the level of annual individual exposure.
l The incremental annual individual cancer f atality risk associated with an 4
exposure level of 10 mrem per year (0.1 mSv per year) is about 2x10 1
(two in one million) as indicated in Table 1 and of the ordar of 0.1 percent I
(one in one thousand) of the overall risk of cancer death.
1 In evaluating the need for a collective dose criterion, the Comission recognizes j
that this criterion could be the limiting consideration far practices involving l
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very small individual doses to very large nunters of people.
It is also recognized that in such uses the collective dose criterion would, in effect, apply the ALARA concept to individual doses less than the below regulatory concern level
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of 10 mrem per year to the f ndividual.
Convers61y, where the collective dose criterion would not be limiting, it would serve no purpon.
The Comission requests connents on this issue, including coments on what the magnitude of the collective dose criterion, if any, should be.
I If the dose is less then the below regulatory concern criteria, then the risk from a practice would be considered to be ALARA without further analysis.
The
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Commission stresses that adoption of the criteria should not be constrt.ed as a h
decision that smaller doses are necessary before a practice can be exempted.
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while doses above the criteria would preclude exenptions. On the contrary, the criteria simply represent a range of risk which the Commission believes is
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sufficiently small compared to other individual and societal risks that a cost i
benefit analysis is not required in order to make a decision regarding the acceptability of an exemption.
Practices not meeting these criteria may be j
granted exemptions on a case-by-case basis in accordance with the principles
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embodied within this policy.
To further emphasize the Comission's recognition t
that a rigid limitation on collective dose would be inappropriate, it notes that for some practices, such as use of smoke detutors, appreciable benefits can only be attained through extensive utilization and, hence, with a comensurate collective dose, i
The Comission is aware that existing regulations of the Environental
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Protection Agency establish criteria more restrictive than exemptions which could otherwise be granted under this proposed policy.
With regard to its own regulatiom., the Comission will naluate whether there are exemption criteria i
enbodied therein for which modification, according to the principles of this policy, would be beneficial.
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T.
EXCLUSIONS FROM EXEMPTIONS 1
The Comission's March 16, 1965, notice on the Use of Byproduct Material and Source Material-Products Intended for use by General Public (Consumer Products) i 10
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(30 FR 3462) provides the basis for the Comission's approval of the use of
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these materials in consumer products without regulatory control on the f
consumer-user.
This is accomplished by case-by-case exemption of the i
possession and use of approved items from applicable licensing requirements, j
Approval of a proposed consumer product depends upon an assessment of exposures of persons to radiation as well as an evaluation of the usefulness
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of the product.
Certain practices involving radiation or radioactive materials have been f
judged by NRC to be socially unacceptable regardless of how trivial the f
resulting dose might be and, therefore, have been excluded from exemption.
Excluded practices include, but are not limited to, the latentional introduction of radioactive material into toys and products intended for ingestion,inhalationordirectapplicationtotheskin(suchascosmetics).
In addition to socially unacceptable uses of radioactive raterials, a question i
also arises regarding uses where there are clear economical alternatives, and I
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no unique benefits exist from using radioactive materia' Where risks are j
trivial, the regulatory prohibition of such uses could pose an unnt:cessary regulatory burden by interfering with the conduct of ;us. ness.
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The Comission seeks coments on whether practices should be categorically f
excluded based on the Comission's judgement regarding social acceptability or l
the existance of alternatives.
An alternative to categorical exclusion could I
be case specific determination based on a safety analysis.
l VI.
PROP 0sALS FOR EXUtPTION
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A proposal for exemption must provide a basis upon dich the Comission car, r
f determine if the basic conditions described above have been satisfied, in general, this means that the proposal should address the individual dose and
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societal trapact resulting from the expected activities under the exemption, j
including the uses of the radioactive materials, the pathways of exposure,
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f the levels of activity, and the methods and constraints for assuring that the f
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assumptions used to define a practice remain appropriate as the radioactive naterials move from regulatory control to an exempt status.
If a proposal for exerption results in a rule containing generic requirements, a person applying to utilize the exemption would not need to address justification or ALARA.
The Comission decision on such proposals will be based on the licensee's meeting the conditions specified in the rule.
The promulgation of the rule would, under these circumstances, 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.
In evaluating proposals for exerption under this policy, the projected exposures to different corponer.ts of the exposed population will be considered with regard to the potential that some individuals may receive doses near the 100 mrem per year (1 mSv per year) limit when doses from other practices are also taken into consideration.
If exposures from multiple practices can occur which are significantly beyond the individual dose criterion (10 mrem per year (0.1 mSv per year)), the exemption will not be granted without further analysis.
As experience is gained, this policy and its implementation will be reevaluated with regard to this issue to assure that the exposures to the public remain well below 100 mrem per year (1 mSv per year).
In addition to considerations of expected activities and pathways, the Comissinn recognizes that consideration must also te 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 nisuse, and the consequences of the;e exceptional conditions in terms of individual and collective dose.
VII.
VERIFICATION OF EXUtPTION CONDIT1,0NS l
The Comission believes that the implementation of an exemption under this broad policy guidance must be accorpanied by a suitable program to monitor and verify that the basic considerations under which an exenption was issued remain i
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f' valid.
In most cases, the products or materials comprising an exempted
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practice will move from regulatory control to the exempt status under a defined i
set of conditions and criteria.
The monitoring and verification program must therefore be capable of providing the Comission with the appropriate assurance i
that the conditions for the exemption remain valid, and that they are being observed.
The Comission will determine compliance with the specific conditions of an exemption through its established licensing and inspection
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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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