ML20011D106

Staff Requirements Memo Informing That Commission Disapproved Recipients Recommendation on Proposed Commission Policy Statement on Exemption from Regulatory Control (SECY-89-184)

ML20011D106
Person / Time
Issue date:	10/13/1989
From:	Chilk S NRC OFFICE OF THE SECRETARY (SECY)
To:	Harold Denton, Parler W, Taylor J NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA), NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO), NRC OFFICE OF THE GENERAL COUNSEL (OGC)
Shared Package
ML20011D107	List: ML20011D106 ML20011D123 ML20011E967 ML20011E969
References
FOIA-89-542 NUDOCS 8911010158
Download: ML20011D106 (1)

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SECRETARY October 13, 1989 MEMORANDUM TOR:

James M. Taylor Acting Executive Director for Operations i

Willian c. Parler, General Counsel Harold R.

Denton, Director, CPA TROM:

el J. Chilk, Secretary

SUBJECT:

STAFF REQUIREMENTS - SECY-89-184 PROPOSED COMMISSION POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL This is to advise you the the commission, with all I

Commissioners agreeing, har disapproved your recommendation on l

a proposed Commission Policy Statement on Exemption from l

Regulatory Contrel.

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.....v AUG 8 3 MEMORANDUM FOR: Hugh L. Thompson, Jr., Director Office of Nuclear Material Safety and Safeguards FROM:

Malcolm R. Knapp, Director Division of Low-Level Waste Management and Deconmissioning

SUBJECT:

PROPOSED APPROACH FOR NRC LICENSING OF.SNM WASTE DISPOSAL AT AGREEMENT STATE LICENSED LLW DISPOSAL FACILITIES This memorandum, for your endorsement, outlines a proposed approach for NRC to licenseandregulatedisposalofspecialnuclearmaterial(SNM)atthe 1

Agreement State licensed low-level waste disposal facilities where $NM is disposed of under NRC license. We anticipate that implementation of this approach will more effectively utilize limited staff resources and minimize dual regulation.

The NRC can relinquish responsibility for regulating disposal of low-level waste containing small amounts of SNM to Agreement States.

However, disposal of amounts of SNM that are sufficient to form a critical mass must be regulated I

by the NRC (AEA 274(b) and 10 CFR Part 150.10 and 150.11).

NRC's regulatory program for SNM disposal must ensure that three objectives are met:

1.

Maintain criticality safety through control of SNM during receipt, storage, disposal, and post-disposal, 2.

Safeguard the SNM from diversion or sabotage; and, 3.

Protect the public health and safety from the hazards of. disposal of SNM through demonstration of compliance with the requirements of 10 l

CFR Parts 20, 51, and 61. (Per Section 61.1, the applicability of l

Part 61 requirements to existing disposal facilities is to be

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determined on a case-by-case basis and implemented through terms and conditions of licenses or orders issued by the Cosmission.)

Consistent with the intent of the law and to take advantage of the work of l

Agreement States, the NRC will directly regulate SNM disposal in objectives 1.

and 2. above, and will rely, to the extent practicable, on Agreement State programs to help regulate SNM disposal so as to meet objective 3.

In more L

detail, the above three areas are distributed among twelve individual subjects that LLW regulation addresses. These subjects, and the NRC activity in each, appear in Enclosure 1.

In both Washington and South Carolina, NRC will be relying on the State to effectively regulate overall disposal facility design, construction, and operations. Therefore, NRC must ensure through its Agreement State oversight program that the State's program for regulation of source and byproduct E$

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2 material is also adequate for the disposal of SNM, assuming all these classes of material are disposed of in the same disposal unit.

To effectively discharge this responsibility, LLWM staff will participate in the NRC reviews of the State's program to review activities and technical quality of licensing (incluaing SER or comparable documentation) involving regulation of the Hanford and Barnwell disposal facilities.

Problem areas wil be identified to the State and corrective actions requested of the State will receive NRC follow ups.

If a situation should develop where we believe the State is not effettively discharging its responsibilities to protect the public health and the NRC will safety in a manner that also ensures proper disposal of SNM independentlyconductareviewtojudgetheacceptabilityofthoseaspectsof 4

disposal facility operations and take appropriate action with respect to the SNM aspect, as well as any required follow-up with respect to the State Program.

In order to implement this approach, the staff will omit from the SNM license specific and detailed conditions relating to those areas where State regulation has been deferred to. The NRC special nuclear material license will be conditioned to require that, unless otherwise specifically authorized by the NRC license, special nuclear material LLW will only be received and disposed of in accordance with design, construction and operating procedurts approved by the State. The procedures will be incorporated by reference into the NRC license 50 as to allow for NRC enforcement, if necessary.

Given the shared responsibility of the NRC and State for disposal facility regulation, )eriodic inspections of disposal facility' activities can be jointly conducted.

Enforcement of requirements relating to overall disposal facility design, construction, and operations shall be taken by the State with coordination, as necessary, with NRC staff.

Enforcement of requirements relating specifically to SNM will be taken by the NRC.

In conjunction with the Office of Governmental and Public Affairs, the LLWM staff will explore the utility of an agreement, under Section 2741 of the Atomic Energy Act, to cover inspections of SNM disposal at State licensed disposal facilities.

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i Malcolm R. Knapp, Director Division of Low-level Waste Management and Decommissioning

Enclosure:

As stated l

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7.ppr;ved:

Date Hugh L. Thompson, Jr., Director

j ENCLOSURE 1 1

Sub.iect NRC Regulatory Activity Staff NRC must assure that licensee Qualification staff are trained and qualified to and Training comply with SNM criticality

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requirements and security provisions.

Waste Form NRC direct review will be ' limited to and ensuring that criticality criteria Classification of the waste form and package are met.

1 Site Operations The NRC must ensure that receipt, transportation, storage, and disposal of SNM does not result in criticality or reduce the level of physical security.

Physical The NRC must ensure that physical Security security is appropriate to prevent misuse of SNH through diversion or sabotage.

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Performance The NRC will review this subject 1

Assessment to assure that post-closure migration of SNM nuclides are covered and to determine whether any requriements specific to SNM are needed.

Environmental The NRC will evaluate incremental Impacts environmental impacts of SNM receipt and disposal per 10 CFR Part 51.

Radiation Protection The NRC must ensure that the i

licenses's radiation protection program is adequate to afford worker protection with regard to SNM insofar as incremental protection over and above that whi;h is required by the State for t

source and byproduct material is l

necessary.

In the following areas, the NRC will rely on the Agreement State's regulatory program:

Disposal Unit Design & Construction Environmental Monitoring Program Facility Closure Institutional & Financial Site Utilization Plan As periodic program reviews are conducted, the NRC staff will specifically review any license or Agreement State documentation supporting any licensing actions for disposal.

The staff will also assure that the program remains adequate for the dis posal of SNM, assuming that all three types of material are disposed of in tie same disposal unit.

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NOTE TO:

Mal Knapp FROM:

Hugh L. Thompson, Jr.

SUBJECT:

PROPOSED APPROACH FOR NRC LICENSING OF SHM WASTE DISPOSAL AT AGREEMENT STATE LICENSED LLW DISPOSAL FACILITIES im WA5TE DISPOSAL Approved.

Make sure the implications for

. FACILITIES expansion to all of the possible Low-Level Waste Sites that could be established under the Low-Level Waste Policy Amendments Act are considered.

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NRC's regula,ory s are met:

SM during receipt, nd, izards of dinnesal of i requirements of 10 1e applicability of ities is to be ted through terus and

osmission.)

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....Je of the work of Agreement States, the NRC will directly regulate S W disposal in objectives 1.

and 2. above, and will rely, to the extent practicable, on Agreement State programs to help regulate SW disposal so as to meet objective 3.

In more detail, the above three areas are distributed among twelve individual subjects that LLW regulation addresses. These subjects, and the NRC activity in each, appear in Enclosure 1.

In both Washington and South Carolina, NRC will be relying on the State to effectively regulate overall disposal f acility design, construction, and operations. Therefore NRC must ensure through its Agreement State oversight g

program that the State s program for regulation of source and byproduct

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June 16',--1989 SECY-89-184*'

(Reissued) l For:

The. Commissioners From:

Victor Stello, Jr.

Executive Director for Operations

Subject:

PROPOSED COMMISSION POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL

Purpose:

To provide, for Commission consideration, a revised proposed policy statement on exemptions from regulatory control.

1 Sunr.a ry:

h is paper discusses the development of the enclosed policy 1

.tatement (Enclosure 1). The purpose of the policy is to define the bases upon which Connission exemption decisions are made involving the release of certain radioactive materials from the full extent of regulatory controls. The principles underlying this policy are outlined and the criteria L

applicable to the decision-making process are presented. ~ The principles 4id criteria are essentiall those which were (1) originally sresented in SECY-88-257; (y) issued for public 2

comment in Federal Register advance notice (53 FR 49886),

published on December 12, 1988; and (3) considered and discussed by international regulatory authorities at an October 1988 workshop.

3 The three fundamenta1' principles of radiation protection have

i been used in formulating the proposed exemption policy; namely:- (1) justification of practice (2) compliance with applicable dose limits, and (3) optimization of protection

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(i.e., the application of the as-low-as reasonably. achievable-L

.(ALARA) principle). The policy, however, does specify maximum individual and collective dose criteria, which, if met by a L

practice under consideration-for exemption, would delineate conditions such that further incremental compliance with the ALARA principle is not warranted. The maximum individual dose criterion is 10 mrem (0.1 mSv) per year per practice and the L

Contact:

W.R. Lahs, RES

• SECY NOTE:

This copy of SECY-89-184 is x23774 being reissued to correct a number of pages in the enclosures.

Prior copies of the paper (those without this note) should be destroyed.

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collective dose criterion is 500 person-rem (5 person Sv) per year per practice.

Although fundamental principles of tadiation protection have been considered in recomending the individual and collective dose criteria, the specific values selected represent a policy judgement based on risk and resource allocation considerations. As a result, the criteria do not exactly-i agree with the bases for, or magnitudes of similar criteria selected or under consideration nationally by the U.S.

Environmental Protection Agency (EPA), by other countries, or by international agencies.

An explanation of the reasons t

behind these differences is provided below. Also provided is a discussion of the policy implications related to (1) EPA-proposed dose and risk standards and (2) recent increases in cancer risk estimates per unit dose developed at high doses and dose rates. includes the staff's current analysis of and proposed responses to the major coments received from the international workshop, the public meeting, and the solicita-

- tion made_in the-December-12 -1988,_ Adv.ance_Notic Following Comission approval the staff will prepare a Federal Register notice issuing the proposed policy, accompanied by this analysis and response to comments.

Discussion:

Sackground On September 8,1988, the staf f, in SECY 88-257, provided for Comission consideration a proposed Comission policy statement on exemptions from regulatory control for practices 4

whose public health-and safety impacts are below regulatory concern (BAC). In staff requirements' memoranda (SRM's) of September 29 and 30, 1988, the Comission requested the staff to (1) raise several specific issues with foreign regulatory s

authorities attending an NRC-sponsored workshop on Rules for Exemption from Regulatory Control and (2) make available for coment, to the workshop participants and to the public, a Connission-modified advance notice of a Commission Policy on Below Regulatory Concern [ Exemption Policy). The advance notice subsequently became a major topic for discussion at the international workshop (NUREG/CP-0101) and was published for coment in the Federal Register on December 12, 1988 (53 FR 49886). The Federal Register notice also announced a public meeting which took place on January 12, 1989.

In response to the Federal Register publication, over 225 comment letters have been received, most during the months of February and March, after the official January 30, 1989 closing date, but with responses continuing to be received to

s The Comissioners 3

the present time.

(in California, a movement is taking place L

among county boards of supervisors to oppose the exemption policy as it applies to low level waste disposal practices, and to restrict any disposal of radioactive material at local disposal sites.) The coment letters were almost evenly split with regard to support-or nonsupport for a Comission exemption policy.

The issues raised in these le~ ters and at t

the international workshop and public meeting.have been categorized into 18 subject areas which include the subjects for which coment was.specifically solicited by the Comission. The principles underlying the proposed policy, and the dose criteria used in the exemption decision-making _

process, have been revised and clarified based on the insights gained through these review and coment processes.

The Proposed Exemption Policy The proposed exemption policy statement recommended by the staff is attached as Enclosure 1.

This policy statement includes the following major features:

The Justification of Practice Principle Following consideration of the responses to questions raised in the advance notice, the staff believes this basic radiation protection principle must underlie any exemption decision. Decisions on " justification of a practice" may be based on a broad range of qualitative and quantitative factors. Basically, however, it involves a Comission determination that an activity resulting in exposure of individuals to radiation or a release of radioactivity to the environment must also result in a comensurate benefit to society, i.e. a net enhancement to human life and health. This is now emphasized in the proposed policy statement and the staff has attempted to provide clarifications to eliminate any confusion between the principle of " justification of practice" and-the principle of as low as reasonably 1

. The coment letters included about 149 from individuals, of which about a

= quarter identified themselves as health physicists.

Four of these letters from individuals were petitions expressing opposition to policy development. There were 21 letters from'public interest groups,19 from utilities or their representatives, 9 from industry, I from a university, 10 from state or local government organizations, 4 from professional societies. 2 from members of the National Council on Radiation Protection and Measurements (NCRP), one each from the U.S. Environmental Protection Agency and the Department of Energy, and two from members of Congress.

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achievable (ALARA) or its international equivalent,

" optimization of protection." Recognizing that factors.

important to the justification determination can be weighted differently by different individuals, the staff intends to seek Commission concurrence on any exemption denials based on staff findings that a practice is not

. justified.

Criteria for Establishing a " Floor" for ALARA The proposed policy defines individual and collective dose criteria which would delineate a region where further incremental compliance.with the ALARA principle is not warranted. The selected maximum individual dose criterion of 10 mrem per year per practice is based on absolute and comparative risk considerations. The collective dose criterion of 500 person-rem per year per practice serves two purposes. First, it represents a i

policy judgement regarding the level of population dose below which Commission resources are better applied to other radiation protection issues (provided the i

individual. dose criterion is met). Second, it provides additional assurance that the total dose to any.

individual from all practices should not exceed 100 mrem per year.

In practical applications, the collective dose criterion will assure that the ALARA principle is applied when considering potential exposure of individuals to wide-ranging practices (e.g., in the form of consumer products or recycled equipment or materials containing residual levels of radioactive contamination). -The magnitude of the value is such that, for any single exempt practice meeting this criterion, a hypothetical health effect would not be expected on an annual basis.

important Policy Considerations i

The magnitude of and bases for the individual and collective dose criteria in the proposed policy do not agree with those under' international consideration, as described in IAEA Safety Series No. 89, " Principles for the Exemption of Radiation.

Sources and Practices From Regulatory Control,"

(e.g.,the magnitude of the maximum individual dose criterion and the collective dose criterion are higher in the proposed policy by factors of about 3-and 5, respectively). With regard to the policy's individual dose criterion, the difference occurs as a result of the international definition and use of a quantified level of insignificant or trivial individual risk. The proposed policy defines and uses a level of dose based on (1) a risk level which the staff believes an individu61 will not spend resources to avoid and (2) a small fraction of J

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L background radiation and a level of variation in exposure-L which individuals tolerate in their daily. lives.

Regarding the collective dose criterion, the internationally proposed value is based on consideration of the minimal costs associeted with formal optimization procedures. The proposed policy includes a collective dose value (500 person-rem per year per practice) which, in the staff's judgement, not only

. demonstrates practical compliance with the ALARA principle,

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but also provides additional assurance that total dose to any individual from all practices should not exceed 100 mrem per year.

Nationally, EPA has expressed its view that the individual and-collective dose criteria are too high and are also inconsistent with many Congressional and regulatory actions being taken relative to other environmental contaminations.

EPA has also stated that exemption policy is an area in which x

the NRC and EPA.have overlapping authorities under the Atomic Energy Act. The EPA noted that it has sole responsibility for regulating environmental radiation under a number of other statutes ic.g., the EPA, is proposing 4 mrem per year.as a

'below reguletory concern" value for land disposal of low level waste at other than licensed sites).

In response to this EPA concern, the revised policy includes a statement which encourages the development of Federal Guidance on this subject, and points out that, when signed by the President.

- this Federal Guidance could supplant the Comission's policy statement.

The Comission should also be aware that the U.S.

Environmental Protection Agency has proposed National Emission Standards for Hazardous Air Pollutants; Regulation-of Radio-nuclides, with lower radiation protection standards (refer to SECY-89-150). This results in a situation.in which proposed or defined " acceptable standards" of public health risk (or dose) are essentially equivalent to risk and dose levels being proposed as or.emption criteria (1.e., levels below Which no further efforts need be taken to comply;incrementally with the ALARA principle in the exemption decision-making process).

Although the staff believes that the. bases for the Comission's exemption policy, in general, and the proposed e

numerical criteria, in particular, are sound, the promulgation of this exemption policy could enter the Comission into a much broader debate on acceptable risk levels.

g Also, published cancer risk estimates per unit dose, derived E

for higher doses and dose rates, have increased (UNSCEAR 1988, Sources Effects and Risks of Ionizing Radiation). When coupled with the application of the "no-threshold hypothesis "

this suggests that the risks at low dose levels (all of which include a " background" base) are higher than previously 2

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6 The Commissioners thought. The proposed policy incorporates a risk coefficient for low linear energy transfer radiation which has been extrapolated from results in UNSCEAR 1988 and anticipated to be included in the forthcoming BEIR V report (National-Academy of Sciences' Committee on the Biological Effects of Ionizing Radiation).

Coordination:

The Office of General Counsel has reviewed this Commission a

paper and has no legal objection.

The policy statement has been discussed with the Advisory Connittee on Nuclear Waste-(ACNW) over the course of several meetings, the latest on April 28, 1989. The ACNW has stated its views in a May 3, 1989 letter to Chairwan Zech. Two outstanding differences with ACNW recommendations remain.

These differences are discussed in Enclosure 3.

The revised policy has also been discussed with EPA representatives (Office of Radiation Programs) in meetings on January 25 and April 18, 1989.

EPA has been provided with a copy of the revised policy and the analysis of and response to

-comments.

Recommendation:

That the Commission:

Approve publication of the proposed policy statement in the Federal Register. The Federal Register notice would include a summary and response to public comments and would request public comment on the basic foundations and key elements of the proposed policy.

D m-s-

ctor St Jr Executive Director for Operations

Enclosures:

1.. Policy Statement 2.

Analysis of and Responses to Comments 3.

Response to ACNW Comments

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7 Commissioners' comments or consent should be provided=directly to the Office of-the-Secretary by COB Friday, July 7, 1989.

Commission Staff Office comments, if any, should be submitted to the Commissioners.NLT. Wednesday, June 28, 1989, with an information copy to the Office of the Secretary.

If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be-apprised of when comments may be expected.

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4 PROPOSED COMMISSION POLICY ON EXEMPTIONS FROM REGULATORY CONTROL 1.

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 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 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 respor.sibility and the knowledge that resources expended for regulatory control of practices with minimal radio-logical impacts could be better used to address more significant radiological and non-radiological health and safety concerns. To address this need, the Commission is expanding upon its existing regulations and policies for protec-tion of the public from radiation which currently define a nunber of long-standing exemptions from regulatory control.I The expansion includes the development of an explicit exemption policy for those Comission-regulated practices which involve minimal public health and safety impacts. The Commission, however, recognizes the benefits of uniform regulation and, i

therefore, supports the development of broader Federal Guidance regarding exemption policies.

In doing so, the Commission realizes that, when signed by the President, the Federal Guidance could supplant this policy.

1

.The existing radiation protection regulations (Title 10, Code of Federal Regulations, Part 20) contain provisions which allow certain disposals of radioactive material (e.g., into sanitary sewer systems). Other parts of the regulations (Parts 30 and 40) define specific quantities of radio-active material which may be possessed by-unlicensed individuals. Several policy statements also have addressed the transfer of radioactive material from a controlled to an uncontrolled status (47 FR 57446, Licensing Requirements for Land Disposal of Radioactive Waste, dated December 27, 1982; 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; and 30 FR 3462 Use of Byproduct Material and Source Material (Consumer Products), dated March 16, 1965).

In this policy, a practice is defined as an activity or a set or combination of a number of similar sets of coordinated and continuing' activities aimed at a given purpose which involve the potential for radiation exposure. Disposal of very low level radioactive waste; the release for unrestricted public use of lands and structures with residual levels of radioactivity; the distribution, use, and disposal of consumer products containing small amounts of radioactive material, and the recycle and reuse of residue 11y contaminated materials and equipment are examples of classes of practices for which this policy is judged to have potential applicability.

It is the Comission's intent to broadly define specific practices 50 that any individual or population will be precluded from being significantly affected by similar activities within a given practice. At the same time, the practice must be identified and described in terms which will facilitate reasonable impact analyses and allow imposition of appropriate constraints as the radioactive material passes from a i

controlled to an uncontrolled status (i.e., the material is no longer under the control of Commission or Agreement State licensees). 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 purpose of circumventing controls that would otherwise be applicable. The definition will also provide the framework for taking into account the possible consequences of accidents or misuse associated with exemption decisions, i

The purpose of this policy statement is to establish the basis upon which the Commission may initiate the development of appropriate regulations or make licensing decisions to exempt certain practices from some or all regulatory controls. This policy is directed principally toward rulemaking activities, but may be applied to license amendments or license applications involving the release of licensed radioactive material either to the environment or to persons who would be exempt from Commission regulations.

It is important to emphasize that, in this policy, the Comission does not assert an absence or threshold of risk at low radiation dose levels but rather establishes a baseline where further government regulation to reduce risks is unwarranted. The presence of natural background radiation and variations in

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the levels of this background are used to provide a perspective on which to judge the relative significance of the radiological risks involved in the exemption decision-making process.

The concept of regulatory exemptions is not new. The Atomic Energy Act of 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 risk to connon defense and security and to the health and safety of the public.

In 1960 and 1970, the Counission'used this authority to promulgate tables of exempt ovantities and concentrations for radioactive material which a person, under certain circumstances, could receive, possess, use, transfer, own, or acquire without a requirement for e license (25 FR 7875 and 35 FR 6427). 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 Cownission's regulations for some time.

For example, 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

" transferred" from a controlled to an uncontrolled status. More recently, Section 10 of the low-Level Radioactive Waste Policy Amendments Act (LLRWPAA) of 1985 directed the Connission to develop standards and procedures for expeditious handling of petitions "...to exempt specific radioactive waste streams from regulation... due to the presence of radionuclides... in sufficiently low concentrations or quantities to be below regulatory concern."

The Connission 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 Connission to act expeditiously in proposing appropriate regulatory relief on a

" practice-specific" basis consistent with the merits of the petition.

1 The Connission 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 NRC regulation based on public health and safety interests. For such 3

1 practices 'the Cownission's regulatory involvement could be essentially limited to licensing and' inspection activities associated with the transfer of the radioactive material'from a controlled to an uncontrolled status. That is, the Comission would define constraints and verify that these constraints are adhered to by NRC licensees when radioactive materials are to be transferred from a controlled to an uncontrolled or exempt status.

The Connission recognizes that, if a national policy on exemptions from regulatory control is to be effective, Agreement States will play an important j

role in its implementation. Pursuant to the LLRWPAA, States are responsible for providing, either alone or in cooperation with.other States, for disposal of certain low-level radioactive wastes, in the past, some States have been encouraging findings that certain wastes are below regulatory concern and the Commission believes that States will benefit from the application of a national policy on exemptions for specific practices involving distribution or release of radioactive material. The Comission therefore intends that rulemakings codifying exemptions for practices under this policy will be made a matter of strict compatibility for Agreement States to the extent that States, under the terms of the Agreements, are responsible for exemptions in their States.

Consequently, this policy development effort and those Yulemakings involving State Agreements that evolve from this policy will continue to be closely i

i coordinated with the States.

i The Comission recognizes that its policy will potentially have a significant impact on nuclear regulation in the international community. The approach and criteria in this policy differ in some respects from those selected or under consideration by other countries.

It is the Comission's intent to continue its dialogue with the international comunity in order to resolve, or foster mutual understandings of the rationales behind, differences in exemption policies.

!!.- RADIATION PROTECTION PRINCIPLES The Three Fundamental Principles of Radiation Protection l

The Commission recognizes that three fundamental prificiples of radiation l

protection have historically guided the formulation of a system of dose 4

n.

limitation to protect workers and the public from the potentially harmful effects of radiation. They are (1) justification of practice, which requires that there be some net societal benefit resulting from the use and disposition Lof radiation or radioactive materials, (2) dose. limits, which define the 1

permissible radiation' doses for workers and members of the public, and (3) ALARA,.which req'uires that radiation dose be as low as is reasonably l'

achievable, economic and societal factors being taken into account.

The term, ALARA, is an acronym for As low As is Reasonably. Achievable.

,o LDose Estimation-(=

in estimating the dose rates to members of the public that might arise through the use of various practices for which exemptions are being considered, the Commission has decided to apply the concept of the " effective dose equivalent."

o L

This concept, which is-based on a comparison of the delayed health effects of ionizing radiation exposures, permits, through use of weighting factors, the calculation of the whole body dose equivalent of partial body and organ exposures. This approach was proposed by the International Comission on Radiological Protection in its Publication 26, issued in 1977.

Since that time, the concept has been reviewed, evaluated, and adopted by radiation protection organizations throughout the world and has gained wide acceptance.

The " effective dose equivalent" concept is incorporated in " Radiation

. Protection Guidance to Federal Agencies for Occupational Exposure -

.Recomendations Approved.by the President," that was signed by the President and published in-the Federal Register on January 27, 1987 (52 FR 2822).

The Commission' recognizes that in considering specific exemption proposals, both the annual effective dose equivalent and the comitted effective dose -

equivalent must be taken into account.

i Estimating Health Effects From Radiation Exposure a.

Individual Risks In the establishment-of its radiation protection policies, the Commission has considered the three major types of health effects which can be caused by relatively low doses of radiation:

cancer, genetic effects, and developmental anomalies in fetuses. The NRC focuses on the risk of fatal cancer development principally because, at relatively high radiation 5

doses: (1) the strongest basis exists for quantifying the risk of cancer g

mortality in humans, (2) the mortality risk represents a 'more severe outcome than the non-fatal cancer risk, and (3) the mortality risk is t

thought to be higher than the' risk associated with genetic and developmental effects on fetuses.2 However, even though radiation has i

been shown to be carcinogenic, the development of a risk factor applicable 3

to continuing radiation exposures at levels equal to natural background requires a significant extrapolation from the observed effects at much higher doses and dose rates.4 The result is a significant uncertainty reflected by the views of experts in the field.

For example, the National Academy of Science's Comittee on the Biological Effects of lonizing

.i Radiation, has cautioned that the risk values are "... based on incomplete data and involve a large degree of uncertainty, especially in the low dose region." This Comittee also stated that it "...does not know whether dose rates of gamma or x-rays (low LET) [ low linear energy transfer radiation] of about 100 mrads/ year (1 mGy/ year) are detrimental to man."

The Comission-understands that the Comittee's statement is a reflection.

j of the uncertainties involved and does not imply either the absence or presence of detrimental effects at this-dose level.

In addition, the Comission is aware that the United Nations Scientific Comittee on the Effects of Atomic Radiation,(UNSCEAR), in their 1988 i

Report to the General Assembly, has stated that "...there was a need for a 2

Further discussion on these topics is provided in " Sources, Effects and

-i Risks of Ionizing Radiation," United Nations Scientific Comittee on the l

Effects of Atomic Radiation, 1988 Report to the General Assembly with Annexes.

3 Natural background radiation can vary with time and a person's location.

~

In Washington, DC natural background radiation (excluding radon) results in individual doses of about 90 mrem per year (0.9 mSv/

)

ile in

. Denver.. Colorado the value is about 160 mrem per year (year, wh 1.6 mSv/yr) i including, in both cases, a contribution of about 40 mrem per year (0.4 mSv/ year) from naturally occurring radioactive material contained in the human body (NCRP Report No. 93, Ionizing Radiation Exposure of the Population of the United States).

4 The health effects clearly attributable to radiation have occurred principally among early radiation workers, survivors of the atomic bomb explosions at Hiroshima and Nagasaki, individuals exposed for medical purposes, and laboratory animals.

Natural background causes a dose over a one year period which is at least two orders of magnitude less than the dose received by populations from which the cancer risks are derived.

6

- I

reduction factor to modify the risks [ derived at high doses and dose rates)... for. low, doses and dose rates... an appropriate range (for this factor) to be applied to total risk for low dose and dose rate should be 4

between 2 and 10."

[Thisfactorwouldleadtoariskcoefficientvalue

-between 7x10-5 and 3.5x10'4 per rad (7x10-3 and 3.5x10*2 per Gy) based on an UNSCEAR risk coefficient of 7.1x10'4 per rad (7.15 per gray) for T gray (100 rad)organabsorbeddosesathighdoserates). The report also stated, "The product of the risk coefficient appropriate for individual risk and the relevant collective dose will give the expected number of cancer deaths in the exposed population, provided that the collective dose is at least of the order of 100 man-Sv (10,000 person-rem).

If the collective dose is only a few man-Sv (a few hundred person-rem), the most likely outcome is zero deaths."

In view of this type of information, the NRC, the Environmental Protection Agency, and other national and international radiation protection authorities have established radiation protection standards defining recommended dose limits for radiation workers and individual members of the public. As a matter of regulatory prudence, all these bodies have derived the value presumed to apply at lower dose and dose rates associated with the radiation protection standards by extrapolation from values derived at higher doses and dose rates. The extrapolation is frequently referred to as the no-threshold hypothesis in which the risk factor at low doses reflects the slope of the dose-effect relationship.

The Commission, in the development of an exemption policy, is-again faced with the issue of how to characterize the individual and population risks' associated with low doses and dose rates. Although the uncertainties are

-large, useful perspective on the bounding risk associated with very low-levels of radiation can be provided by continued use of the no-threshold hypothesis. Consequently, such risk estimates will be a factor in establishing individual and collective dose criteria associated with this policy. The estimations of the low risk from potentially exempted practices can be compared to the relatively higher potential risks associated with other activities or decisions over which the NRC has regulatory responsibility. Through such comparisons, the Commission can assure that its radiation protection resources and those of its licensees 7

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 individual: dose. The values in the hypothesized lifetime risk column are based on the further assumption that the annual dose is ' continuously.

received during each year of a 70-year lifetime. To provide further perspective, a radiation dose of 10 mrem per year (0.1 mSv per year) received continuously over a lifetime corresponds to a hypothesized increase of about 0.25% in an individual's lifetime risk of cancer death.

Ten millirem per. year (0.1 mSv per year) is also a dose rate which is a small fraction of naturally occurring background radiation and not much larger than the temporal variations in natural background radiation due to fluctuations which occur at any specific location.

Table 1 Hypothesized Hypothesized incremental Incremental lifetime Risk from 2

2 Annual Dose Annual Risk Continuing Annual Dose I

100 mrem -

(1 mSv) 5 x 10 3.5 x 10-3 10 mrem (0.1 mSv)-

5 x 10-6 3.5 x 10~4 1

mrem (0.01 mSv) 5 x 10'7 3.5 x 10'6 0.1 meem (0.001 mSv) 5 x 10-8 3.5 x 10-6 I Unless otherwise indicated, the expression of dose in mrem refers to the Total Effet.tive Dose Equivalent. This-term is the sum of the deep dose

- equivalent for sources external to the body and the committed effective dose equivalent for sources internal to the body.

2 Risk coefficient.of 5 x 10'" per rem (5x10'2 per Sv) for low linear transfer radiation has been based on results reported in UNSCEAR energy (footnote 2). Also, refer to NUREG/CR-4214 (Rev.1),

1988-b.

Collective or Population Risk in the application of the fundamental principles of radiation protection, collective dose provides a useful way to express the radiological impact

-(i.e., potential-detriments) of a nuclear activity on the health of the population subject to radiation exposure. Collective dose is the sum of the individual doses resulting from a practice or source of radiation 8

1 exposure.- It has been used in comparative cost-benefit and other

. quantitative analysis techniques.

It is therefore an important factor to consider in balancing benefits and societal detriments for practice justification and in applying the ALARA principle. The NRC has used collective dose in this manner in a number of rulemaking decisions and dectsions involving resolution of 4 variety of generic safety issues.

Derivation of Measurable Quantities from Dose / Risk Estimates The Commission recognizes that it is frequently not possible 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 potentially associated with its exemption decisions.

Typically, radioinuclide concentrations or radiation levels from the material to be released from regulatory control are the actual measurements that can be made, and doses are l

then estimated by exposure pathway analysis using assumptions related to the ways in which people might become exposed. These assumptions incorporate sufficient conservatism in modeling to account for uncertainties so that any actual dose would be expected to be lower than the calculated dose. The Commission believes that this is the appropriate approach to be taken when p

determining if an exemption from some or all regulatory controls is warranted.

1 l

l 111. APPLICATION OF RADIATION PROTECTION PRINCIPLES TO EXEMPTIONS FROM l

REGULATORY CONTROL l

l

~

The fo11owing sets forth guidelines about how the' Commission will apply the fundamental principles of radiation protection in consideration of practices which are proposed to be exempt from certain regulatory controls.

These practices, if approved, would result in low levels of radioactive material l

being transferred from a. controlled to an uncontrolled state (1) in products being distributed to the general public and (2) on lands and structures and'in h.

effluents and solid waste being released to areas of the publicly-accessible environment.

Justification - Decisions regarding justification of practice usually derive from considerations which are much broader than those based on 9

m

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4

. jI radiation protection alone. Therefore, these decisions may be made in a broader context before the~need for regulatory control is addressed (or the need for exemptions'from certain aspects of control,- as addressed in this policy).

The Comission continues to believe that any practice causing a potential radiation exposure should be justified; however, as lower levels of individual and population dose are projected, lower levels of benefit may be sufficient to achieve a positive balance although other societal impacts of a practice must also be considered. The Commission will.

continue to' identify or characterize certain practices for which benefits are considered marginal and for which there appears to be no reasonable justification.

Dose limits Individual doses from individual practices exempted under this policy should not, with rare exception, exceed a small

' fraction of 100 mrem per year (1 mSv per year). This is the non-occupational dose limit reconnended by the International Commission on Radiological Protection and the National Council of Radiation Protection and Measurements for continous exposure from all practices using man-made sources of radiation other than medical, it i

is also the value specified in the recent major revision of 10 CFR Part 20, Standards for Protection Against Radiation. The dose limits in the major revision of 10 CFR Part 20 apply to all sources of radiation exposure under a licensee's control (natural background and i

medical exposures are specifically excluded).

ALARA - Once a practice has.been justified and controls are in place to assure that dose limits are not exceeded, it is necessary to

)

design and plan the subsequent use and disposal of the sources of radiation in a manner which ensures that exposures are as low as reasonably achievable, economic and social factors being taken into account.

As a result, this principle applies when considering a practice for possible exemptions f rom 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 formally embodied in the revisions to Title 10 Code of Federal Regulations, Part 20. However, no policy or criteria have been provided which 10 m

i would establish the bases for defining a generic

• floor' to ALARA, A

+

major purpose of this policy is to establish criteria which would delineate conditions such that additional expenditure or regulatory and licensee resources would not be necessary to further reduce c

radiation exposures from e practice for which an exemption has been granted.-

[

Although it is possible to 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 involve a reduction or elimination of some or all controls.

In view of this, the Connission believes that a key objective in establishing a policy for exemptions, is to provide adequate assurance that individuals will not experience radiation exposure exceeding 100 mrem per year (1 mSv per year) through the cumulative effects of all exempted and regulated practices even though the exposures from any single exempt practice would be expected to be a small fraction of this value.

By appropriate choices of exemption criteria and constraints, and through its evaluations of specific exemption proposals, the Connission intends-to assure that it is unlikely that any individual will experience continuing exposures which exceed 100 mrem per year (1 mSv per year).

IV.

PRINCIPLES OF EXEMPTION A major consideration in exempting any justified practice from some or all regulatory controls hinges on the general question of whether or not application or continuation of regulatory controls is necessary and cost effective in reducing dose. To determine if exemption is appropriate, the Cownission must determine if one of the following conditions is met:

1.

The application or continuation of regulatory controls on the practice does not result in any significant reduction in dose received by individuals within critical groups (i.e., the group expected to receive the highest exposure) and by the exposed population or; l

11

2.

.The costs of the regulatory controls that could be imposed for dose reduction are not balanced by the commensurate reduction in risk that

,could be realized.

For purposes of implementing its policy, the Commission recognizes that only L

under unusual circumstances would exemptions be considered for justified practices which could cause continuing radiation exposure to individuals exceeding a small fraction of 100 mrem per year (1 mSv per year). The Commission will consider such circumstances on a case specific 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 l

regulatory controls decreases.

At a sufficiently low level of individual risk, decisions granting specific exemptions from some or all regulatory controls, i

for a justified practice, may be reduced to an evaluation of whether the overall individual and public risk are sufficiently small.

The Commission therefore proposes that two numerical criteria should be established in defining the region where the risk reduction does not warrant j

the expenditure of Commission or licensee resources to, bring about a further

{

incremental compliance with the ALARA principle. They are (a) a criterion for i

the maximum individual annual dose reasonably expected to be received as a I

result of the practice (e.g., an average dose to individuals in a critical group) and (b) a measure of societal impact to the exposed population.

In combination, these criteria are chosen to assure that, for a'given exempted practice, no individual will be exposed to a significant radiological risk and that the population as a whole does not suffer'a significant impact.

The Individual Dose Criterion if the doses to individuals from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared to other societal risks and there would be little merit in expending resources to further reduce the dose or risk from a justified practice. The Commission believes the definition of this risk or & e level can be developed from two perspectives. The first of these is related to quantitative risk levels. The Commission believes that most

-members of society will not expend resources to reduce an annual 12

i individual fatality risk below approximately 10-5 (i.e., I chance in 100,000). This risk level is comparable to that (i.e. 2x10-6) selected by the Comission-in the development of its safety goal policy - (i.e., a risk level equal _to 0.11 (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 comparable to this ' safety' 1

goal" risk level can be estimated as 4 meem per year (0.04 mSv per year).

The second perspective is based on those. variations in dose, and hence risks, knowingly or unknowingly tolerated by individuals because of factors such as their lifestyle or place of residence. The Comission notes that resources are not expended to reduce differential exposures associated with variations in natural background radiation (e.g., the 60-70 mrem per year difference between annual doses received in Denver, Colorado vs Washington, DC). Nor are resources spent to reduce (1) the l

difference in doses between living in a brick vs a frame house, (2) the 5-l-

mrem dose which an individual would receive during a single round trip coast-to-coast aircraft flight, or (3) the dose from other activities which involve doses representing a small fraction of backgrourd radiation.

L

-In view of-the uncertainties involved (such as, the applicability of the no-threshold model itself and its input data) and taking into account the 1

L the aforementioned risk and dose perspectives,.the Commission finds an individual dose of 10 mrem per year (0.1 mSv 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 considers this value to be appropriate given L

the uncertainties involved and notes that, at this value, implementation of this policy in future rulemakings or licensing decisions should be a practical undertaking.

Given the Comission's intent (1) to define practices broadly (2) to evaluate potential exposures over the lifetime of the practice, (3) to monitor and verify how exemptions are implemented

)'

under this policy, and (4) to impose a companion collective dose criterion in defining when further compliance with the ALARA principle is unwarranted, the Cownission believes that reasonable assurance can be l

provided that individual exposures from all practices should not exceed 100 mrem per year (1 mSv per year).

13

q The Societal Impact Criterion In proposing criteria shit.h would demonstrate practical achievement of ALARA, the Commission seriously considered whether the imposition of the individual dose criterion would also provide a sufficient measure to judge societal impact,'and, thus, could stend alone as a basis for determining when further resources need not be expended to comply with the ALARA principle. The Commission finds that the individual dose criterion thould not stand alone and believes the need for a companion _ collective dose criterion has two bases.

First, these criteria are being put forward as a means of demonstrating -

practical compliance with the ALARA principle. The ALARA process involves, among other cdnsiderations, the trade-offs between cost of dose or risk reduction and the magnitude of the reduction in population dose L

achieved. ' The Comission believes that if a justified practice involves -

l an appropriately small potential for individual risk and societal detriment, efforts directed toward further reduction of this risk and detriment are not likely to represent an optimum use of either the Connission's or a licensee's resources from an overall public health and safety standpoint. The Comission is therefore proposing that a L

collective dose criterion be used, with the individual dose criterion, to define this minimal societal detriment. This criterion is considered l

necessary since the individual dose criterion is not claimed to represent L

a negligible or de minimis individual dose; and thus, the sun of the individual doses from a given practice cannot necessarily be' considered L

negligible.

l:

Second, the Comission believes a collective dose criterion, in conjunction with the individual dose criterion, is necessary to provide additional assurance that the curtailing of the ALARA process will not lead to total individual doses from all exempted and regulated practices j

l

. exceeding 100 mrem per year (1 mSv per year). The collective dose represents a sumation of all individual doses resulting from a practice, independent of any pattern of individual dose distribution. However, collective dose is most likely to be the overriding consideration for those practices or classes of practices involving potential widespread 14 L

11

.~

y distribution of radioactive material to members of the public (e.g., in the form of consumer products, or recycled equipment or materials containing residual levels of radioactive contamination). 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 collective dose as a matter of regulatory prudence.

Furthermore, for these practices.

-i effective dose reductions may be possible at relatively small costs.

As a result, a practice siust 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 no further resources need be expended to comply incrementally with the ALARA principle, i

The Commission stresses that adoption of the individual and collective dose l

criteria should not be construed as a decision that doses below these criteria i

are necessary before a practice can be exempted, while doses above the criteria I

would preclude exemptions. On the contrary, the criteria simply represent a

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range of risk which the Commission believes is sufficiently small compared to other individual and societal risks that further cost-risk reduction analyses, (or more broadly, ALARA analyses) are not required in order to make a decision regarding the acceptability of an exemption.

Practices not meeting these criteria may be granted exemptions on-a case-by-case basis in accordance with the principles embodied within this policy. To further emphasize that a rigid l

limitation is inappropriate, the Comission notes that for some practices, such l

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 commensurate collective dose.

The Comission is aware that existing and future regulations of the Environmental Protection Agency for environmental protection may establish criteria for specific practices more restrictive than exemptions which may be granted under this proposed policy. Any affected NRC regulations developed on the foundations of this policy may need to be reviewed and, if necessary, revised. With regard to its own regulations, the Comission will consider whether there are exemption criteria embodied therein for which modification, according to the principles of this policy, would be beneficial.

15

V.

UNJUSTIFIED PRACTICES t

Since it is not possible to foresee every use of radioactive material that may

{

be. proposed in the future, the Commission does not believe it should prejudge any class of practices as innately unjustifiable.

However, the Commission 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 consumer products, March 16,1965,30FR3462). These practices could include, but are not L

limited to, the intentional introduction of radioactive material into toys, novelties, and non-medical products intended for ingestion, inhalation, or direct application to the skin (such as cosmetics).

The Commission's determinations regarding the justification of practices will also include l

consideration of any non-radioactive alternatives; that is, there should be a net benefit of the radioactive over the non-radioactive alternative.

i VI.

PROPOSALS FOR EXEMPTION

[

A proposal for exemption must provide a basis upon which the Coonission can determine if the basic conditions described above have'been satisfied.

In general, this means that the proposal should address the individual and societal impact (i.e., benefits and detriments) resulting from the expected activities under the exemption, including the uses of the radioactive materials, the pathways of exposure, the levels of activity, and the methods i

and constraints for assuring that the assumptions used to define a practice remain appropriate as the radioactive materials move from regulatory control to an uncontrolled status.

If a proposal for exemption results in a rule containing specific requirements, a person applying to utilize the exemption would not need to address justification or ALARA. The Commission 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 Al. ARA considerations have been dealt with. This approach is consistent with past practice, e.g.,

{

consumer product rules in 10 CFR Part 30.

16 r

-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 practices.

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 annual exposures to individual menbers of the public from exempted and regulated practices remain below 100 mrem (1 mSv).

In addition to considerations of expected activities and pathways, the Comission recognizes that consideration must also be given to the potential b

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 f

conditions in terms of individual and collective dose.

Yll.

VERIFICATION OF EXEMPTION COND!TIONS The Comission 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 meterials 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 established by licensees, who propose to release materials under the provisions o,f regulations or licensing conditions developed from this policy, must therefore be capable of providing the Comission with the appropriate assurance 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 program and may, from time to time, conduct studies as appropriate to assess the impact of an exempted practice or combinations of exempted practices.

17

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ANALYSIS OF AND RESPONSE TO COMMENTS INDEX I

fin Background.............................................................

I 1

' Genera l Comment on Policy Need and Viability...........................

2

• =

Criteria for Establishing a " Floor" for ALARA..........................

5 Numerical Criteria Selected-for Determining Compliance With the ALARA-Principle......................................................

8 Justification of Practice..............................................

14 1

Maintaining Flexibility in the Exemption Decision-Making Process.......

18 Federal-State Authority-State Compacts for Disposal of Low-Level I

c Radioactive: Waste....................................................

20 Value Used for Risk Coefficient........................................

22 1

Public Perceptions and Need for Added Perspective on Risk Levels.......

27 Monitoring.............................................................

31

.]nternational Consistency..............................................

33 l

Concept and Terminology Clarification..................................

34 j

Truncation of Collective Dose Calculations.............................

38 Definition of What Constitutes a Practice..............................-

40 The No-Threshold Hypothesis Relating Dose to Health Effects - Hormesis.

42 l

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h, Accidents and Misuse...................................................

46

- National Consistency in Risk-Based Radiation Protection Standards......

48 Cumulative Effect of Exposures to Multiple Exempted Practices..........

50 Federal Responsibilities and Authorities...............................

53 o

j '.

l

ANALYSIS OF AND RESPONSE TO COMMENTS -. ADVANCE NOTICE, POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL in response to a December 12, 1988, advance notice (53 FR 49886) regarding the subject policy statement, over 225 coment letters were received. Most of these letters were received during the months of February and March, after the official January 30, 1989, coment closing date; however, receipt of additional coments has continued into late April. The comment letters included about 149 from individuals, of which about one quarter identified themselves as health 4

physicists. Four of these letters from individuals were petitions expressing opposition to policy development.

There were 21 letters from public interest groups, a union, and professional organizations; 19 letters from utilities or their representatives; 9 le'.ters from industry; one letter from a university; 10 letters from state or local government organizations; 4 letters from professional societies; 2 letters from members of the pational Council on Radiation Protection and Measurements (NCRP); one letter each from the U.S.

Environmental Protection Agency ;,nd the U.S. Department of Energy; and two letters from members of Congress.

The issues raised in these letters have been categorized into 18 subject areas which include those for which coment was explicitly solicited in the advance notice.

in the following paragraphs, the issues, coments, and questions in each category are sumarized and the Comission responses'are provided.

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1.

General Comment on Policy Need and Viability I

Comments i

The comment letters were approximately equally divided between those favoring and those opposing a Commission exemption policy.

i Those opposed to policy development generally stated that any health risk should not be the subject of deregulation.

Most of these commenters focused on

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low level radioactive waste disposal practices and believed that the disposal

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of radioactive material at licensed facilities should be considered a cost of doing business.

Many, however, also specifically opposed (1) the use of

'i radioactive material in consumer products and (2) the release for public use of any lands or structures or recycled equipment or materials with any level of radioactive contamination.

Several of these commenters claimed that continuing regulation was especially important when the effects of low level radiation are p

unknown and the trends in the dose to health effect relationships are in a

[

direction of increasing risk per unit dose.

I l

Those favoring policy development focused on the issue *of the optimus use of licensee and regulator resources, believing resources spent to control small or i

i negligible risks could be better directed at more significant problems.

These comment 9rs viewed cost and regulatory savings in both parochial and national terms, e.g., the focusing of regulatory and industrial resources on more important public health concerns, including, but not limited to, radiological impacts on public and occupational health and on the environment, c

Many of these commenters also pointed out that any potential exposure associated with a proposed exemption decision would be very low (e.g.,

frequently comparing the policy's 10 millf rem per year (0.1 mSv per year) per i

practice individual dose criterion to (1) variations in background radiation across the United States (Washington, D.C. vs Denver, Colorado (60-70 mrea/ year)), (2) exposures resulting from naturally occurring radioactive potassium-40 in the human body (30 arem/yr), or (3) exposure resulting from airplane flights across the continent (5 arem per 10 hrs, of flight).

2

l

Response

The Commission believes that its principal regulatory mission is to assure that proper protection of radiation workers, the public, and the environment is provided in the conduct of licensed activities involving the use of radioactive materials. The Commission considers that its existing 10 CFR Part 20 regula-tions, which provide dose limits and requirements that doses be as low as reasonably achievable (ALARA), form the basis for defining a proper level of occupational and pubite radiological protection.

However, under provisions of i

the Atomic Energy Act (AEA), as amended (e.g., Sections 57d, 62 and 81), the Commission has also been given authority to exempt certain classes or quantities of material or kinds of uses or users from requirements for a license, if the Commission finds that its actions would not constitute an unreasonable risk to the health and safety of the public.

This authority has been used in establishing exemptions for certain waste disposal practices which are codified in 10 CFR Part 20.

Other exemptions from the requirements for a person to have a license to receive, possess, use, transfer, own, or acquire products or materials containing byproduct material appear in 10 CFR Part 30.

More recently, the Low Level Radioactive Waste Policy Amendments Act (LLRWPAA) of 1985 reaffirmed both the need for exemption (below regulatory concern) decisions and the Commission's authority to develop implementing policies and regulations.

The Connission believes that these provisions in the AEA and the LLRWPAA are well-intentioned and reasonable.

Such provisions assure that licensing decisions can be made and regulations can be promulgated in a manner which allows the Commission to correctly direct both its own and its licensees' resources toward substantive radiation protection problems and issues.

In this regard, the Commission would point out that exemption provisions have been embodied in the Commission's regulations for some time and that this policy is intended to broadly define the bases for future regulations or Itcensing decisions involving exemptions from some or all regulatory controls.

In response to commenters who contend that the regulated community is the only 9.}

benefactor of this policy, the Commission is aware that, in many cases when the y",

e i extent of regulatory activity is reduced based on health and safety considera-tions, a monetary benefit accrues to the regulated community.

Thus, those i

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I commenters opposed to this policy who cite the existence of such benefits are l

Correct.

However, the NRC believes its proposed policy is consistent with its regulatory mission.

This mission is to assure proper protection of public i

health and safety.

Since resources expended for regulatory control of l

t practices with minimal radiological impacts could be better used to address i

more significant radiation protection concerns, the einfalzation of regulatory control at levels of radiation exposure well below acceptable limits can lead i

to an optimum use of regulator and licensee resources.

As a result, a specific exemption decision, although producing a savings to the regulated community, can ultimately best serve the public.

The subjects of the effects of low level radiation and the dose to health effect relationships are further discussed in response to issues 3, 7, and 14.

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i 2.

Criteria For Establishing a ' Floor" For ALARA Comments Most connenters supporting an exemption policy agreed that criteria should be defined to establish a " floor,' below which it should be unnecessary to expend j

resources to further comply incrementally with the ALARA principle.

Several stated that, to be effective, numerical criteria were needed rather than broadly defined ranges (e.g., a few arem). Most reflected the position expressed by the Health Physics Society, believing the " floc,r" could be defined through sole use of an individual dose criterion without the need for a collective dose or societal impact criterion.

The argument used by many of these connenters was that protection of the individual assures protection of society. Many of these commenters believed that any practical value in the use of a collective dose criterion is clearly outweighed by detriments associated with its use. Concern was expressed that the very act of calculating point values for collective dose and implied health effects misleads the public into thinking that precise quantitative results are possible when they are not.

Others specifically related their opposition to a collective dose criterion to the measure's uselessness when considering exemptions involving low level waste disposal practices. A number of these commenters recognized that in addressing other practices, such as consumer products, the magnitude of the number of people potentially receiving an exposure would have to be a consideration in the exemption decision making process. Several of these connenters correctly recognized that the societal impact criterion was also being considered as a constraint to reduce the effects of uncertainties in dose projections when large numbers of people could interact with the exempted radioactive material.

These commenters believed that this issue should be confronted directly and not through use of a collective dose constraint.

l A few connenters, including the EPA, presented arguments for including a l

societal impact criterion which together with the individual dose criterion.

i would either (1) detemine if an exemption could be granted, or (2) define the

" floor" below which further efforts to comply incrementally with the ALARA principle would not be warranted. These connenters believed that some 5

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assessment of societal impact was mandatory to the decision process regarding en esemption from regulatory control. The Department of Energy also stated its belief that collective dose should be a part of the consideration in order to assess the total impact of the operation proposed for exemption. The Department encouraged NRC to define a de minimis dose level, so that suumation of individual doses below this level could be ignored.

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Response

In proposing criteria which would demonstrate practical achievement of ALARA,

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the Commission seriously considered whether the imposition of the individual dose criterion would also provide a sufficient means to judge societal impact, and, thus, could stand alone as a basis for determining when resources need not i

be expended to further comply incrementally with the ALARA principle. The l

Comission finds that the individual dose criterion should not stand alone and believes the need for a companion collective dose criterion has two bases, i

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 reduction and the magnitude of the reduction in the individual and population doses achieved.

The Comission believes that if a justified practice involves an appropriately small potential for individual risk or societal detriment, efforts directed toward further reduction of the risk and detriment are not likely to represent an optimum use of either the Comitision's or a licensee's resources from an overall public health and safety standpoint. Since the individual dose criterion is not claimed to represent a negligible or de minimis individual dose,as the Department of Energy has pointed out, the sum of the individual doses from a given practice cannot necessarily be considered negligible. As a result, the Comission believes a collective dose critsrlon is necessary.

(Furtherdiscussionoftheissueofcollectivedcsetruncationsisprovidedin response to issue 12).

Second, the Comission believes a collective dose criterion is necessary and provides a simple and useful parameter through which added assurance can be 6

i provided that total doses to individuals from all exempted practices will not approach 100 arem per year (1 mSv per year).

This consideration specifically applies to the potential exposure of some few individuals to multiple practices and, in particular, to those activities or practices involving potential widespread distribution of radioactive material to members of the pubite (i.e.,

in the fom of consumer products, or recycled equipment or saterials containing residual levels of radioactive contamination).

The Commission notes that the i

uncertainties in establishing the extent of reasonable scenarios through which the public may interact with these products, equipments, or materials, in turn, create uncertainty in the calculation of individual doses. As a result, a compensatory provision could be considered a matter of regulatory prudence.

Collective dose has been selected as this compensatory provision.

The Commission acknowledges that the use of a collective dose measure could i

imply a degree of precision in predicting health effects which is unwarranted; l

however, it is the intent within the proposed policy to emphasize (1) the l

relationship between the resource allocation issue and the establishment of a quantitative value of collective dose, and (2) the use of collective dose as a r

surrogate means to reduce potential average individual, exposures resulting from practices involving widespread distribution of radioactive material to members of the public.

As a result, the Commission has decided that a practice must l

also meet a collective dose criterion in order for the Commission, based on both the individual and collective dose criteria, to agree that further l

resources need not be expended to further comply incrementally with the ALARA principle.

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4 3.

Numerical criteria Selected for Deteretnino Compliance With The ALARA Principle l

i comments--!ndividual Dose Criterion For Curtailina Incremental Compliance With The ALARA Principle f

Almost all of the commenters favoring a Commission exemption policy expressed a view regarding the numerical value assigned to the individual annual dose criterion used to detemine when incremental compliance with the ALARA principle is no longer warranted.

This criterion, together with the collective j

dose criterion proposed for the same purpose, delineates a region where the risks are sufficiently small that expenditure of Commission or licensee resources to further reduce those risks is not warranted.

Most of the above l

commenters stated that the 10 mrem per year per practice value for cutoff of ALARA evaluations was very conservative, with many suggesting a value in the 10-20 mrem per year (0.1-0.2 mSv per year) range.

A few commenters considered 10 mrem per year (0.1 mSv per year) a de minimis or negligible individual dose and referred to the Negligible Individual Risk Level (NIRL) defined by the National Council on Radiation Protection and Measurements in their NORP Report No. 91.

It was also pointed out by a commenter that others have stated that background radiation represents an unavoidable " noise level" in which human beings have evolved and prospered.

Thus, in this commenter's view, it can be considered to be a benchmark for detemining a level that should be "below regulatory concern." It was proposed that the temporal variation in the magnitude of background radiation levels (10-20 mres/ year (0.1-0.2 mSv per year)) at any specific location could also be used to establish such a "below regulatory concern" level.

A significant fraction of commenters suggested that a value as high as 100 arem per year (1 mSv per year) could be used, while a few commenters suggested values above 100 mrem per year (1 mSv per year), ranging to as high as 500 arem per year (5 mSv per year) (Note:

Some of these commenters may be incorrectly considering the maximum individual dose criterion for cutoff of ALARA evaluations as an individual dose limit on exemptions.

However, no such criterion has been included in the policy statement).

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Five connenters favored a value less than 10 mrem per year (0.1 mSv per year)

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including the EPA, the DOE, and Dr. Warren Sinclair, President of the National

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Council of Radiation Protection and Measurements. The EPA believed that "10 i

mrem [for the individual dose criterion) is too high" and "...would confound assessment of doses allowed for most controlled sources." Dr. Sinclair stated 1

that *...the NCRP [had] reconnended an annual negligible individual risk level of 10 ~7 per year (corresponding to 1 millirem per year)" and "[f]or these reasons, the NCRP does not believe a blanket exemption of sources contributing 10 millirem in a year to individuals is sound radiation protection policy." He added, however, that "...a source producing 10 millirem in a year could be exempted provided justification and ALARA are applied." Another connenter

"... agreed with the basic approach outlined in the NRC statement but

...[would]arguefordifferentspecificnumbersforstandardsmorealignedwith the 1AEA position." He noted that "...!AEA identifies a range of trivial individual risk as being from 10'0 to 10 per year, or in the range of 10-100 u $v (1-10 mrem) per year" and "...has acceptance by many other countries." The 00E believed "...the proposed lower limit of 10 mrem /y may be too high considering other existing standards (e.g., the current 4 mrem /y drinking water standard). A fifth connenter suggested that a 5 mrem per year (0.05 mSv per year) value should be considered in light of impending revisions to the risk factor being proposed by the International Connission on Radiological Protection (ICRP) and others (refer to discussion issue 7). One connenter noted that a lower dose value would not only account for the impact of radiation induced fatal cancers but also the impact of non-fatal cancers.

For the most part, connenters opcosed to the development of an exemption policy believed no individual dose criterion was appropriate for cutoff of ALARA evaluations, with one connenter pointing out that the 10 arem per year (0.1 mSv per year) value was the same level which EPA proposed in 1983 as the limit for public exposures from NRC licensed facilities. The EPA also stated that the 10 mrem per year (0.1 mSv per year) value is too high and would not be consistent

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with many Congressional and regulatory actions being taken relative to other environmentalcontaminants(Referto1ssue16).

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Response

The Commission has seriously considered the wide range of connents on the individual risk issue.

In considering this subject, it must be borne in mind that selection of the individual risk or dose criterion cannot be divorced from consideration of (1) other regulatory actions taken relative to public radia-i tion protection limits (i.e., acceptable upper-bound limits on exposure) and i

(2) the policy's companion collective dose criterion.

Currently, the recent major revision to Title 10 of the Code of Federal Regulattens, Part 20, requires licensees to conduct operations so that the total effective dose equivalent to an individual member of the public from those operations does not exceed 100 mrem per year (1 mSv per year). This is also the principal dose limit for members of the public as stated by the International Commission on Radiological Protection (ICRP) and National Council e

on Radiation Protection and Measurements (NCRP).

Using the no-threshold hypothesis and a risk coefficient derived from effects observed at higher exposure levels, these 100 mrem per year (1 mSv per year) dose limits can be equated to a bounding hypothetical annual cancer fatality risk of 5 x 10-5,

With this derived acceptable risk value in mind, the Commission believes that 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

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or risk from a justified practice can be seriously questioned. The Coonission believes the definition of this risk or dose level can be developed from two perspectives. First, in absolute terms, the Counission believes that most members of society would not expend resources to reduce an annual individual fatality risk below approximately 10-5 (i.e., I chance in 100.000). This risk level is comparable to that (i.e., 2x10-6) selected by the Cownission in the development of its safety goal policy and equal to 0.1%(1/1000) of the sum of I

cancer fatality risk from all other causes.

Using the no-threshold hypothesis, the incremental continuing annual. individual exposure level associated with this 2x10-6 risk level can be estimated as 4 mrem per year (0.04 mSv per year).

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The second perspective is relative and is based on those variations in dose and the associated risk tolerated by individuals because of factors such as their I

lifestyle or place of residence. The Commission notes that, although they may i

be unaware of the fact, individuals voluntarily accept certain variations in j

exposure to background radiation, and that resources are not expended to reduce i

differential exposures associated with variations in natural background radiation, e.g., the 60-70 mrem per year (0.6-0.7 mSv per year) difference between annual doses received in Denver, Colorado vs Washington, DC. Nor are resources spent to reduce the 5 crem (0.05 mSv) dose received by an individual from cosmic radiation during a single round trip coast-to-coast I

aircraft flight, or the doses from other similar variations in normal activities (e.g., occupancy in granite structures). These latter examples involve doses representing a small fraction of background radiation.

In view of the uncertainties involved (such as the applicability of the no-threshold model itself and its input data), and taking into account the absolute risk and dose / risk perspectives, the Comission has found that an individual dose of 10 mrem per year (0.1 mSv per year) is an appropriate level for use as one of two boundary criteria which would de. fine whether or not additional resources need be spent to bring about further incremental compliance with the ALARA principle. This value is an order of magnitude below the aforementioned NRC and ICRP public dose limits. The Commission considers this value to be appropriate given the uncertainties involved and notes that, at this value, implementation of this policy in future rulemakings or licensing decisions should be a practical undertaking.

Coments - Societal Impact Criterion for Curtailing Incremental Compliance With the ALARA Principle As stated in the sumary of Issue 2, most commenters agreeing with the need for a Comission exemption policy did not see the need for, or usefulness of, a definitive collective dose criterion which represents societal impact. Those comenters who supported the use of such a criteriot generally referred to International Atomic Energy Agency Safety Series No. 89, ' Principles for the Exemption of Radiation Sources and Practices from Regulatory Control,' and the 100 person-rem per year per practice value cited in that report as being a l

11 1

i total detriment low enough to permit exemption without more detailed examina-i tionofotheroptions(i.e.,Al.ARAevaluations).

It was suggested that consistency with this international position may improve the policy's acceptance among the regulatory connunity.

Response

In formulating its exemption policy, the Connission has decided that if a justified practice involves an appropriately small potential for individual risk and societal detriment, efforts directed toward further reductions of this risk and detriment are not likely to represent an optimum use of either the Cownission's or a licensee's resources from an overall public health and safety standpoint.

In clarifying practical compliance with the Al. ARA principle, the Connission, as a policy judgment, believes that for practices resulting in a calculated collective dose of less than 500 person-rem per year (5 person-Sv per year) of practice, and for which the maximum individual dose criterion is not exceeded, no further resources need be expended to further comply incrementally with the Al. ARA principle. At this level of societal impact, resources are better directed at more significant radiation protection or other health-preserving issues.

Yet, this level accommodates the possibility that for practices involving distribution of consumer products or recycled equipment and materials, effective dose reductions may, in fact, be possible at relatively small costs.

The Commission also notes that 500 person-rem (5 person-Sv) represents an annual level of societal impact per practice which, using the no-threshold hypothesis in relating collective dose to health effects, would provide assurance that, on an annual basis, no potential health effect would be predicted from an exempted practice meeting this criterion.

Furthermore, the 500 person-rem per year (5 person-Sv per year) per practice collective dose criterion provides additional assurance that total doses to an individual from all exempted practices will not approach 100 mrem per year (1 mSv per year). This additional assurance is gained by the impact of this j

criterion on practices involving widespread distribution of radioactive material to members of the public in the form of consumer products or recycled equipment or materials containing residual levels of contamination. As an example of this impact, the Connission considered the potential for nationwide 12

c distribution of a consumer product containing radioactive material for which a justification of practice determination is presumed to have been ende.

l Distribution of this product (e.g., to 100 million people) would require i

predicted average individual doses to be less than 5 microrem per year (0.05 l

microSy per year) (i.e., if the collective dose is to be less than 500 i

person-rem (5 person-$v)) before further resources would not need to be expended to incrementally comply with the ALARA principle.

If this average is a true representation of the actual distribution of individual doses, then an individual could be exposed to 2000 of such practices and still not receive a total individual exposure approaching 10 mrem per year (0.1 mSv per year). On the other hand, if the distribution of individual doses from such a practice was more limited (e.g., exposure of about 50,000 people to doses approaching 10 mrem per year (0.1 mSv per year)), the probability of any specific individual in the nation's population being exposed to two or more such practices would be expected to be extremely small.

As a result of either of these extreme examples, individual exposures from multiple exempted practices meeting the ALARA " cutoff" criteria would not be expected to approach 100 mrem per year (1 mSv per year) and added assurance would be provided that no individual would receive a dose exceeding this value from all exempted and regulated practices.

On these two bases, the Comission has determined that a practice must result in a collective dose of less than 500 person-rem per year (5 person-Sy per year) of practice in order for the Commission, based on both the individual and collective dose criteria, to agree that resources need not be expended to further incrementally comply with the ALARA principle.

In this use of the collective dose criterion, the Comission stresses that the adoption of individual and collective dose criteria to demonstrate compliance with the ALARA principle should not be construed as a decision that doses below these criteria are necessary before a practice can be exempted, while doses above the criteria would preclude exemptions. On the contrary, the citeria simply represent a range of risk which the Comission believes is sufficiently small compared to other individual and societal risks that further cost-risk reduction analyses (or more broadly, ALARA analyses) are not required in order to make a decision regarding the acceptability of an exemption. Practices not meeting these criteria may be granted exemptions on a case-by-case basis in accordance with the principles (including ALARA) embodied within this policy.

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Justification of Practice l

i Comments On the questions related to justification of practice, most commenters agreed

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that in considering various practices, lower levels of projected radiation i

exposures would require lower levels of benefit to justify a practice.

Some pointed out that this fact is inherent in the definition of justification

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(assuming radiation exposure is the primary adverse impact to be considered).

Quite a number of commenters expressed the opinion that if the exposures were low enough (usually interpreted as meeting the dose criteria used to determine i

when further compliance with the ALARA principle is unwarranted), a practice need not be justified. Others presented arguments that even if exposures are negligible, a determination on the justification of a practice must still be i

made.

(Note:

Some of those arguing for a " cutoff" to the use of the principle of justification apparently incorrectly interpreted the dose criteria used in the policy as a determination of trivial or negligible risk).

Response

The Commission believes that justification of practice involves a finding that i

an activity, source, or practice involving exposure to radiation or release of radioactivity into the environment results in a net enhancement or benefit to human life and health.

Many of the commenters did not appear to appreciate the fact that the justification principle may involve consideration of a broad range of qualitative and quantitative factors in establishing this benefit.

Adoption of this principle reflects the Commission's view that releases of, or exposures to, radioactivity should only be allowed when necessary in order to provide a benefit to society.

If " justification of practice" were curtailed on a basis similar to that proposed for the ALARA principle, a proliferation of uses of radioactive material from numerous allowed releases may occur.

Specifically, if such a proliferation of uses were to occur, it may complicate the Commission's task of assuring that multiple exposures of the public to many exempted practices will be unlikely to result in individual exposures approaching 100 arem/ year (1 mSv 14

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I per year) even if most of these uses are projected to involve extremely small

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doses to the public.

The Commission believes that it is not appropriate to use the smallness, or even the triviality of exposures alone, to detemine the justification of a practice.

However, the Commission does agree with a number of commenters who pointed out that many existing practices have already been

" justified " in some cases by Congress through the enactment of Public Law, and in other cases by previous determinations of the Commission.

The Commission does not intend, for example, to reconsider the justification of nuclear power or the use of radioactive material by its existing licensees, although a few commenters do not consider that these practices are justified.

Comment-Waste Disposal Some commenters also expressed the opinion that exemptions for waste disposal options need not involve consideration of practice justification because the need for waste disposal results from sources or more broadly defined practices which have been justified.

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Response

Although the impacts from waste disposal operations should rightly be considered in a determination of not benefit for a practice resulting in the waste needing disposal, the Commission does not agree that any option for waste disposal should automatically be considered a justified practice. Various options for waste disposal constitute separate practices and must be

" justified" independently of the practice that produced the waste. However, a waste disposal practice is unique in that "no action" is not a viable alternative; that is, waste must be disposed of in one way or another.

The number of factors affecting a justification decision tend to be reduced by this fact and may not be significantly different from those factors affecting an ALARA determination.

Comments-Unjustified Practices On the question of exclusions from consideration for exemption of practices for which there appeared to be no reasonable justification, there was a diversity 15

-h of opinions; those opposed to blanket exclusions pointed to the difficulty of prejudging any category of practice, or were of the opinion that the Commission I

should be careful not to interfere with the conduct of business or free enterprise.

Those who specifically commented on a prohibition against the intentional

' addition of radioactive material into toys or products intended for ingestion, inhalation, or direct application to the skin were in favor of such prohibitions, although many of the same commenters thought that the Commission should not be trying to judge social acceptability.

Most of those opposed to using social acceptability as a criterion were concerned about the difficulty of making such a judgement and a few alluded to the fact that relying on social acceptability could sometimes be contrary to the best interests of the public.

Response

Since it is not possible to foresee every use of radioactive material that may be proposed in the future, the Commission does not believe it should prejudge any class of practice as innately unjustifiable.

However, the Commission continues to consider the use of radioactive material in trys, novelties, and adornments to be of marginal benefit to society (consistent with the policy statement on consumer products, March 16, 1965, 30 FR 3462).

In the case of direct, purposeful addition of radioactive material to products intended for ingestion, inhalation, or direct application to the skin, it appears unlikely that a net benefit of such a use, other than a medical use, could be shown.

(Administrative 1y, the Commission has not exempted medical uses of radioactive material; however, this does not indicate that such exemptions would not be considered under appropriate circumstances).

In judging any particular practice, social acceptability cannot be eliminated as a consideration, in spite of the difficulties of making such judgments.

Input from the public on this and all aspects of a potential rulemaking is obtained through the rulemaking process. As noted by a few of the commenters, because of the broad range of factors which can affect a decision on justification, some subjective judgment will be necessary on the part of the Commission.

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Comments-Nonradioactive Alternatives On the question of excluding the use of radioactive material in products for which there is a clear economic alternative and no unique benefits from using radioactive material, again, comments were mixed.

The commenters opposed to such an exclusion felt that the marketplace is adequate to eliminate less preferable alternatives.

The primary specific point made by a number of these commenters, was that there could be non-radiological risks associated with the alternatives.

Others noted that " economical" is not clearly defined.

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Response

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Although it was not made clear in the advance notice, the Commission would not attempt to eliminate radiological risks without consideration of other risks.

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It is acknowledged that the unique benefit of using radicactive material, and hence a factor in justification, could be the reduction or elimination of a non-radiological risk associated with the alternative.

Because of the need to 1

consider a number of different factors such as relative economic costs of alternatives, potential impacts other than radiological, and relative benefits of alternatives, it does not appear practical to develop criteria to clearly define when radioactive material should not be used in a product because of the existence of a non-radiological alternative.

However, in determining whether a proposed practice is justified, consideration will be given to the existence of any alternatives.

Specifically, it would be expected that to be justified the use of radioactive material should present a net benefit over any non-radioactive alternative taking into account any factors otherwise affecting justification.

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5.

Maintainino Flexibilit.y in the Exemption Decision-Makina Process l

Comments I

Most comenters supporting a Comission exemption policy believed that flexibility should be maintained.

Specifically, if a practice is justified and an exemption decision is supported by a defensible ALARA analysis, the exemption could be allowed even if doses could exceed either or both the 10 I

I arem per year (0.1 mSv per year) individual dose criterion, and the 500

. person-rem (5 person-Sv) per year collective dose criterion.

The regulatory authorities at the international workshop agreed that the magnitude of the collective dose alone should not arbitrarily preclude a practice from being exempt from some regulatory controls.

These same authorities were split, with 1

regard to the application of flexibility, if individual exposures exceeded a fraction of a trivial individual risk criterion (i.e., a few millirem per year f

cr a few IO's of microSv/ year) proposed in the IAEA document, Safety Series No. 89, " principles for the Exemption of Radiation Sources and Practices from Regulatory Control." The Commission's Advisory Comittee on Nuclear Waste and the Environmental Protection Agency supported the view that no exemptions should be considered for practices involving potential individual exposures exceeding a defined limit, which in their opinion should be a small fraction of applicable dose limits.

Some commenters believed that the Commission's advance notice reflected this viewpoint.

On the other hand, the EPA expressed the belief that the advance notice indicated Commission willingness to routinely consider exemptions involving individual doses which could approach public dose limits.

Response

The Commission's intent in the advance notice was to provide for regulatory flexibility; however, as reflected by the comments received, the policy intent on this issue was not clear.

A large part of this confusion occurs as a result of differing views on the meaning and scope of the numerical criteria associated with exemption or "below regulatory concern" decisions, i

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i As stated in the advance notice and in the proposed policy statement, the overall Commission intent regarding its exemption decisions is to assure that exposures to individual members of the public from all such decisions do not approach 100 mres per year.

Within the spectrum of exemption decisions, however, the Commission believes there may be instances where exemptions, defended on the basis of justification of practice and a defensible ALARA analysis (i.e., a reasonable optimization evaluation), could be granted for l

practices where some individuals could receive doses above 10 arem per year i

(0.1 mSv/ year).

Such exemptions are expected to be rare and certainly would not be granted without a high level of confidence that the conditions of exemption would assure protection of the public against undue risk.

With regard to practices exceeding the collective dose criterion, the Commission is in agreement with other national regulatory authorities, and believes that, if supported by a defensible ALARA analysis, a justified practice can be exempted from some or all regulatory controls.

Further clarification in terminology is discussed in the response to comments under issue 11.

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Federal-State Authority-State Compacts for Disoosal of Low-Level Radioactive Waste.

l Comments i'

A number of commenters, mainly utilities, but including two responders from f

State departments of health, stated that it would be crucial that' Agreement States adopt verbatim any Comission exemption regulations.

These commenters,

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for the most part, believed that the goal of establishing appropriate national criteria would be undermined if individual States are able to abstain or to

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establish more restrictive exemption criteria.

Response

The Commission agrees with these coments and, as stated in the advance notice and the proposed policy statement, intends that rulemakings codifying exemptions from some or all regulatory controls will be made a matter of compatibility for

, Agreement States.

As reflected by many of the comenters, the degree of compatibility must be such that national consistency 1.s achieved--a requirement which the Commission agrees is necessary, 1

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Coenents i

l A few comenters, including two who are members of county boards of supervisors, argued that their State, working together with other States, is l_

making good progress toward the establistment of low level radioactive waste disposal facilities as required by the Low Level Radioactive Waste Policy i

Amendments Act (LLRWPAA) of 1985. These commenters thought that the NRC's exemption policy initiative is unnecessary since the State's low level radioactive waste disposal facilities, being sited under LLRWPAA, are designed

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to handle all radioactive waste identified under current rules as low-level."

These same comenters noted that using local facilities such as public landfills and incinerators to handle low-level radioactive materials, even though defined as "below regulatory concern," would make the siting of these waste disposal facilities extremely difficult and would put an extra burden on existing facilities.

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Response

In Section 10 of the LLRWPAA of 1985, the Commission was directed to establish j

standards and procedures, pursuant to existing authority, and to develop the technical capability for considering and acting upon petitions to exempt specific radioactive waste streams from regulation due to the presence of radionuclides in such waste streams in sufficiently low concentrations or quantities as to be "below regulatory concern." The Commission responded to the LLRWPAA by issuing a " General Statement of Policy and Procedures Concerning Petitions Pursuant to 52.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern." This general statement of policy was published for comment in the Federal Register on August 29, 1986. Thus, the same piece of legislation that defined the State's responsibilities for low level radioactive waste disposal directed the Comission to develop a "below regulatory concern" policy.

The Comission's response to this legislation was the August 1986 general statement of policy ($1 FR 30839) which provided criteria which, if met, would allow the Ccmission to expeditiously evaluate petitions for "below regulatory concern" waste disposals.

The purpose of this proposed policy is to establish the basis upon which the Comission may init, tate the development of appropriate regulations or make licensing decisions to exempt certain practices from some or all regulatory controls, including those related to low level radioactive waste disposal.

The Comission acknowledges that its exemption policy may increase difficulties in the siting of waste disposal facilities.

The Commission believes, however, that as enhanced public understanding of the underlying rationale, the technical basis and the resource utilization implications for its policy occurs, such difficulty will be reduced.

One objective of issuing the policy stat'ement is to so enhance the public understanding of these matters.

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Value Used for Risk Coefficient Comments The EPA and others, in their comments, stated that the dose-to-risk conversion

~4 factor used in the advance notice (i.e., 2x10 latent cancer fatalities (LCF) j

-2 per rem (2X10 LCF per Sv) of low linear energy transfer radiation) was out-of-date and did not reflect extensive new information gained in the last

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decade.

Two commenters questioned the adequacy of this value in accounting for a11' health and genetic ef fects in the first two generations.

[ Note: Other relevant comments are discussed under issue No.14, Applicability of the No-threshold Hypothesis - Horsesis).

Response

A In the establishment of its radiation protection policies, the Commission has considered the three major types of health effects which can be caused by relatively low doses of radiation:

cancer, genetic effects, and developmental anomalies in fetuses.

The NRC and EPA focus on the risk of fatal cancer development principally because (1) the strongest basis exists for quantifying the risk of cancer mortality in humans (2) the mortality risk from fatal cancer represents a more severe outcome than the risk from non-fatal cancers, and (3) the mortality risk is believed to be higher than the risk associated with genetic and fetal effects.

Therefore, the Commission believes this to be an appropriate basis for its decisions at this time.

The Commission notes that, even though radiation has been shown to be carcinogenic, the development of a risk factor applicable to continuing I

radiation exposures at levels equal to natural background requires a 1

Natural background radiation can vary with time and a person's location.

In Washington, DC natural background radiation (excluding radon) results in individual doses of about 90 arem per year (0.9mSv/ year), while in Denver, Colorado the value is about 160 mren per year (1.6mSv/ year) including, in both cases, a contribution of about 40 mrem per year (0.4mSv/ year) from natural radioactive material contained in the human body.

22

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significant extrapolation from the observed ef fects at much higher doses.2 The result is a significant uncertainty reflected by the views of experts in the field.

For example, the National Academy of $ctence's Committee on the giological Effects of Ionizing Radiation, has cautioned that the risk values are "... based on incomplete data and involve a large degree of uncertainty, especially in the low dose region." This Committee also stated that it

"..does not know whether dose rates of gamma or x-rays (10w LET) [ low linear energy transfer radiation] of about 100 mrads/ year (1 mSv/ year) are detrimental l

to man." The Commission recognizes that the Committee's statement is a reflection of the uncertainties involved, and does not imply either the absence or presence of detrimental effects at this dose level.

In the face of this and similar cautions, the advance notice contained an estimate of the lifetime risk of cancer mortality from low LET radiation which was based on the following table.

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2 The health effects clearly attributable to radiation have occurred principally among early radiation workers, survivors of the atomic bomb explosions at Hiroshima and Nagasaki, individuals exposed for medical therapy purposes, and laboratory animals.

Natural background causes a dose over a one year period which is at least two orders of magnitude less than the dose received by populations from which the cancer risks are derived.

l 23

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i Estimates of Lifetime Risk of Cancer Mortality a

from Low LET Radiation Received at Low Dose Rates Number of Cancer Deaths 0

(per 10 person-rad) or (per 10 person-gray)

(

Type of Cancer

---Range of Estimates---

lower Central Upper l

Leukemia 4.8 14 48 In Utero 1.2 1.2

3. 0 Bone Cancer 0.2 0.6 12.1 Breast Cancer 4.4 60 87

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Lung Cancer 5.3 20 245 l

GI Cancer 9.1 57 327 Thyroid Cancer 7.2

7. 2 7.2 Other Cancer 5.1 29 169 3

In Utero 1.2 1.2 3.0 e

Whole body (rounded) 40 200 900 m

1ess than 5 rad / day (50mGy/ day)

. These risk estimates were taken from NUREC/CR-4214. " Health Effects Models for Nuclear Power Plant Accident Consequence Analysis," Rev. 1, 1989.

The risk estimates were based primarily on the 1980 Report of the Committee on the Biological Effects of Ionizing Radiation of the National Academy of Sciences entitled, "The Effects on Populations of Exposure to Low Levels of Ionizing Radiation," (BEIR III). However, radioepidemiological data that became p

available since the publication of BEIR III were utilized in the development of NUREG/CR-4214 risk estimates.

In estimating the somatic health effects, the BEIR III report utilized epidemiological data obtained from studies of survivors of Hiroshima and f

Nagasaki and, to a lesser extent, other irradiated populations.

In BEIR III there are variations in risk estimates which are due to factors in addition to uncertainties in the Japanese and other epidemiological data bases.

Excess cancers have been observed mostly following relatively large doses delivered at 24

, ~.

I high dose rates.

Moreover, the observation time of the exposed populations does not yet extend through the lifetimes of the irradiated individuals.

Therefore, assumptions must be made about how observations at high doses and I

dose rates should be applied at low doses and low dose rates for radiation of a given type and how risks from radiation might vary long after the time of I

exposure, f

The SEIR III report examined three dose response functions in detail:

f (1) linear, in which effects are directly proportional to dose at all doses; l

(2) linear quadratic, in which effects are very nearly proportional to dose at very low doses and proportional to the square of tSe dose at high doses; and (3) quadratic, in which the risk varies as the square of the dose at all dose levels.

All mathematical functions in BEIR III assume that there is no dose below which there is no health risk.

For low LET radiations, BEIR III recommended the use of a linear quadratic dose response function.

To estimate the risk of radiation exposure beyond the years of observations, eithea a relative risk or an absolute risk projection model (or suitable variations) must be used.

The relative risk projection model projects the currently observed percentage increase in cancer risk per unit dose into future years.

An absolute risk model prcjects the average observed number of excess cancers per unit dose into the future years at risk.

Because the baseline rate of cancer incidence rises dramatically with age, the relative risk projection model predicts a larger number of radiation induced cancers in the ag'ng population for years beyond the periods of observation; consequently, the average lifetime risk calculated according to the relative risk model is higher than that which would be calculated using the absolute risk model.

The BEIR Committee did not specify which projection model is the appropriate choice for most radiogenic cancers.

NUREG/CR-4214 provided upper, central, and lower risk estimation models for l

leukemia and cancers of the bone, breast, lung, gastrointestinal tract.

1 thyroid, skin, and other organs.

Models for cancers due to prenatal 1rradiation were also given.

For the central estimates considered most realistic by the scientists who prepared NUREG/CR-4214, linear quadratic dose response models were used for all cancers except those of the breast and thyroid, and those due to prenatal' irradiation.

The linear dose response model 25

was used for these cancers.

The relative projection model was used to estimate the risk of breast, lung, gastrointestinal, and other cancers.

In estimating the potential radiological impact associated with the individual dose values used in this policy statement, the central estimate was used.

For alpha emitters, a Quality Factor (Q) of 20 would be applied.

The reevaluation of the doses received by the survivors of the atomic bombs in I

Hiroshima and Nagasaki is expected to affect the aforementioned estimates of risk of increased incidence of cancer in an irradiated population.

The cancer risk estimates in BEIR III and NUREG/CR-4214 are based on the tentative 1965 dosimetry system (T650).

Only recently, reports have been published comparing the risk coef ficients for cancer mortality based on the revised dosimetry system (DS86) (Preston and Pierce,1987, Shimizu et al.,1987).

Complete assessment of the data has not yet been published.

However, based on results given in the above mentioned reports, the risk coefficient for low LET radiation in the proposed policy has been tentatively changed to a value of 5x10'4 latent cancer fatalities per tem ($X10 LCF s per sievert),

-2 i

i The Commission also recognizes that irradiation of the, reproductive organs may cause increased incidence of disorders of genetic origin among the offspring of irradiated people.

Such disorders may manifest themselves in the first generation following parental irradiation and/or in future generations.

The NRC has derived estimates for genetic effects based on experimental animal data, since no suitable human data is available.

These estimates are provided in NUREG/CR-4214.

However, because these estimates are primarily based on animal data, and their magnitudes are somewhat less than for fatal cancers, they have not been used in developing this policy.

Thus, although the Commission has focused on the risk of fatal cancer in the development of its exemption policy statement, the C(mmission has evaluated the possibility of genetic disorders occurring as a result of low level exposcres to ionizing radiation.

26

i 8.

Public Perceptions and Need for Added Perspective on Risk Levels Comments A number of commenters raised concerns regarding public perceptions of the numerical values of individual and collective dose used in the proposed policy statement.

One commenter stated that the 10 mrom per year (0.1 mSv/ year) individual dose criterion for a practice was unnecessarily low and that the public would perceive this value as a threshold of harm.

This commenter believed that NRC must provide a better basis for public understanding of the significance of " low level" radiation exposure (<100 mrem per year or 1 mSv per year), and stated that a considerable fraction of the regulatory ef forts are concerned with radiation exposures much smaller than those received from variations in natural radiation due to altitude changes or other causes.

Another equated 10 mrem per year (0.1 mSv per year) with 1/3 the dose received in a chest X-ray.

Several other consenters also suggested comparisons to variations in background radiation and to doses received during high altitude aircraft flights due to increased levels of cosmic radiation.

One commenter suggested comparisons to radiation doses received in upe of coal or cement which contain low levels of naturally occurring radioactive material.

Another commenter provided the following tabulation of annual risk levels:

7 27

i Table some " Annual" Risks of Dyino l

Risk Nomalized to That from One Normal Year's Exposure to Cancer Condition Risk Natural Background incidence i

Being age 60 2 X 10 200 10 Seing age.50 7 X 10 70 4

Heart disease 5 X 10.3 50 3

Being age 40 3 X 10.3 30 2

Cancer or being age 30 2 X 10.3 20 1

Being 1 or 20 years of age 1 X 10.3 10 0.5 Accidents (total, all kinds) 6 X 10.4 6

0.3 4

Being age 10, flu, etc.

3 X 10 4 3

0.2 Natural background 1 X 10 1

0.05 i

-5 Fires, drowning, poisoning 3 X 10 0.3 0.02

-6 Electric current-5 X 10 0.05 0.003 10 arem/yr "BRC" dose 3 X 10.6 0.03 0.002 7

Lightning 6 X 10 0.006 0.0003 i

Commenter's note:

(The risks from radiation cited above were calculated using the EPA risk coefficient of 400 fetal cancers per million man-rem, yielding results about twice those calculated by NRC.)

4 Other commenters, on the other hand, objected to presentations which compare actuarial risks (e.g., risk of death by drowning or fire) with hypothetical risks from radiation exposure.

These commenters pointed out that the radio-l logical risk depends on extrapolation of risk coefficients derived at high exposure levels to the levels of dose received from background radiation or even lower levels reflected by the 10 arem (0.1 mSv) individual dose criterion included in the Commission's proposed exemption policy statement.

Another commentor took exception to any regolatory policy which, as a basis, measures human life against economic benefits.

This commenter believed that it is only acceptable for regulators to allow practices which add risk to human health and life if, and only if, the benefits of these practices actually enhance human health and life to a greater degree.

28

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Response

The Commission sees merit in many of the )c:spectives presented. However, the Commission believes that care must be taken to clearly distinguish those perspectives which support the basis for the Commission's exemption policy and those which are presented only to provide a perspective on the individual and societal risk levels under discussion.

The Commission believes that compari-sons, such as thc,se presented in the table, are proper in establishing a perspective on the magnitude of the hypothesized risks associated with potential exemption decisions.

However, these comparative values should not, by themselves, be used to justify the risk levels of any practice considered for exemption from some or all regulatory controls.

The Commission further realizes that comparisons of hypothesized and actuarial risks can be mis-b leading, if a fair characterization of the processes and assumptions leading to-

- the-hypothesized values are not provided.

The Commission, in the supplemental information discussion accompanying this proposed policy statement and in the P

policy statement itself, has attempted to reflect these distinctions in the perspectives it has provided.

In responding to the commenter who took exception to trade-offs equating human life and economic benefits, the Commission would point out that before considering a practice for exemption from some or all regulatory controls,= the Commission must decide that the practice is justified.

This determination, in its bradest sense, derives from many considerations beyond those based solely on radiation protection and economics, and must find that allowing the practice results in a net enhancement to human health and life.

In many cases,this

' justification of practice determination may involve a balancing of risk against obvious benefits to the person exposed to the radiation, as in the case of smoke detectors.

In other cases, the benefit may be more obscure, perhaps relating to the fact that the practice under consideration for exemption may (1) hava a societal benefit which exceeds the total societal risk to human health and safety or (2) be associated with an already justified " source" or physical entity whose use, manipulation, operation, decommissioning and/or disposal constitute the coordinated set of activities defined as a practice.

3 Thus, through application of the justification of practice principle, the Comission believes that a determination is made that the benefits to human gg

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- health and life of's specific practice or source exceed all associated real or hypothetical:' risks.

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-Monitorina Comments Many of the commenters were concerned about the issue of monitoring. A concern of many who were opposed to the policy was that there may not be

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adequate verification of compliance with any release limits or with the assumptions made to estimate the effects from releases. Some thought

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adequate verification was impossible or,more specifically,that prevention of dilution of waste to meet criteria would be impossible..-These concerns were mainly in connection with " deregulation" of waste. Among those in q

favor of an exemption policy, the primary concern was that the Commission might require additional environmental monitoring or,more specifically,-

monitoring of municipal landfills by licensees.

This was seen as unnecessary, counter productive, and contrary to the BRC concept.

Some felt that it was also inappropriate for NRC to monitor landfills.

Many of the commenters expressed agreement that there is a need for adequate controls at the point of radioactive material release from regulatory control to verify that applicable constraints and criteria are complied with. A few commenters indicated that some offsite verification may be appropriate when individual doses exceeding 10 mres/ year (0.1 mSv/ year)'are projected.

One pointed specifically to the need for NRC to monitor quality control in the production and distribution of consumer products and to check actual distribution vs that estimated.

One commenter suggested that only "in house" monitoring was appropriate and.that no' documentation should be required.

Re.sponse 1

None of the comments changed the Commission's position on monitoring and verification as presented in.the advance notice; however, some points may need to be clarified. The term "below regulatory concern" may have implied that the Commission would allow licensees to determine what materials or products could be released without any oversight by the 31

Commission._ Exemptions, however, do and will continue to involve survey.

and recordkeeping requirements to show compliance with applicable criteria governing _the exemption.- In some cases,' reporting to NRC is also required, while, in others, oversight is. exercised through inspection 6nd enforcement.

In granting an exemption, the Commission will evaluate the potential for intentional or inadvertent releases of radioactive material-in excess of the proposed exemption criteria to determine the' type and extent of regulatory controls and constraints which should be applied.

These _ evaluations will also determine the level of inspections and enforcement which will be established.

The Commission does not intend, as a result of this policy, to specifically introduce added environmental monitoring requirements.

However, the Commission does intend to occasionally reconsider assumptions made when granting exemptions and may conduct research or other confirmatory studies to verify that individual and population exposures are not exceeding expected levels.

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4 10.

International Consistency Comments 4

5 The comments on the importance of international consistency ranged from "not important" to "very important." The predominant opinion of those commenting specifically on this issue was that consistency is desirable but not necessary, and/or that the Commission should proceed with developing the policy while encouraging consistency through continued information exchange.

At least one commenter indicated that the U.S. NRC should be the leader for the development of rational standards. One pointed out that in attempting international consensus, the most restrictive position tends to rule the outcome.

Two commenters expressed the concern that an indefensible standard could be adopted on the basis of the childish rationale, "everyone else is doing it."

Two others expressed the opinion that the individual dose criterion should not be higher than the international position because they believed a negligible risk was the appropriate basis for this criterion.

A few were concerned about potential inhibition of international trade if there were inconsistencies on standards for consumer products or recycled materials..

Response

The Commission agrees that international consistency is desirable but not necessary. This policy covers a broad range of activities, some of which do not have international significance.

The specific differences between this policy-and the international position expressed in IAEA Publication 89 and the i

rationale behind each are discussed under other specific issues, primarily the issues on individual and collective dose criteria (issues 2 and 3). The Commission believes that the main concern related to international consistency would be standards directed at products or materials in international trade.

The effect on trade of international inconsistency is one factor that would be considered in the. development of specific standards affecting such products or j

saterials.

1 33

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~11.

Concept and Terminolony Clarification Comments L

Several.commenters believed that clear definition of the concepts and' terminologies used in the policy statement would be important.

These commenters stated that confusion exists between the terms "de minimis,"

" negligible individual. risk level," " trivial risk,". and "below regulatory j

^

concern" as well as between the principles of " justification of practice" and "as low as reasonably achievable." Furthermore, many commenters believed that the exemptions addressed in the advance notice would 1

typically result in the complete elimination or loss of all regulatory controls. This need for clarification of terminology was also discussed by international regulatory authorities at the NRC-sponsored workshop in October 1988 and at the public meeting held on January 12, 1989 in Bethesda, Maryland.

Several of the commenters suggested appropriate definitions for these concepts, terms, and principles.

On a separate topic, many commenters supporting ap exemption policy believed that the discussion in the advance notice confused the

" justification of practice" and "as-low-as-reasonably-achievable" principles.

Response

The Commission acknowledges the need for clear definitions and understandings of the concepts., terminologies, and principles used in the proposed policy statement.

Numerous national and international efforts have been undertaken to develop both broad-based and specific, practice-related. exemption policies or to define small levels of risk upon which regulatory decisions may be based.

In these efforts, a number of concepts and terms have been put forward; however, in many cases, different terms have been used to describe similar concepts, i

In the Commission's view, the terms de minimis risk, negligible individual risk level, and trivial risk are essentially synonymous.

These terms have 34

a been used in the literature to represent what is believed to be the level of annual risk of death which is held to be cf no concern to most individuals in society.

This level of risk is selected on' the basis of being' trivial compared to the. risk of fatality associated with ordinary, normal societal activities and is therefore proposed to be a risk level which can be dismissed from consideration.

This definition is similar to that proposed by the National Council on Radiation Protection and i

Measurements (NCRP) to describe the basis for their definition of a negligible individual risk level (NIRL).

1 The Commission, in this proposed policy, is not intending to establish a de minimis, negligible, or trivial risk level.

The Commission belleves that such a level of risk should be defined independently of considerations regarding the compensatory benefit to society from the activity causing the negligible risk.

This determination is a controversial and complex social evaluation which need not be the foundation of the Commission's proposed exemption policy.

Instead, the Commission-believes that its exemption policy can be developed from an extension of the existing system of dose limitation which includes the.

elements of:

(1) justification of practice,- (2) limitation of individual doses or risks below existing acceptable limits, and (3) the optimization of radiation protection 'or the application of the as-low-as reasonably achievable principle.

Following this approach, the Commission's exemption

. policy:

(1) requires a justification analysis which demonstrates a net positive benefit for the practice (i.e., the benefits exceed any detriment associated with the practice), (2) specifies that the individual risk level should be a suitably small fraction of applicable, acceptable public dose. limits, and (3) requires the use of ALARA analyses in the evaluation of exemption proposals but includes a Commission judgment on when Commission and licensee resources need not be spent to further incrementally comply with the ALARA principle.. The Commission believes this approach, in considering a broad spectrum of practices, is consistent with the intent of Section 10 of the Low-Level Radioactive Waste Policy Amendments Act of 1985, which specifically applies only to the practice of Iow level waste disposal.

This Act directed the Commission to

"... establish standards and procedures, pursuant to existing authority, 35

s and' develop the technical capability for considering and acting _upon petitions to exempt specific radioactive waste streams from regulation by the Commission due to the presence of radionuclides in such waste streams in sufficiently low concentrations or quantities as to be below regulatory concern." The Commission believes the terminology, "below regulatory concern," has a meaning which allows considerations, including costs, to be used in establishing practice-specific regulations for low-level radioactive waste disposal at other than licensed sites.

The Commission is broadening the application of this concept to address other practices such as the distribution of radioactive materials in consumer products and.

the reclamation of decommissioned land, facilities, equipment, and materials which'have been used in nuclear operations.

The Commission notes that the EPA, in developing its proposal for environmental radiation protection standards for management and disposal of low-level radioactive wastes, appears to be using a similar approach in defining:the ters, "below regulatory concern."

Initially, in its Advance Notice, the Commissfon used the terminology, "below regulatory concern," to describe the healt.h and safety impacts from practices which could be exempted from regulatory control under the

' developing policy.

Based on the comments received, the Commission has l'

noted that the use of-this terminology when coupled with the concept of justifying practices by balancing benefits of the practice against'its detriment, has caused considerable confusion.

Many commenters believed that the policy was singularly directed at low-level waste disposal practices or that the exemptions resulting from the policy provisions would eliminate all regulatory controls on any exempted practices.

Neither assumption is correct.

First, the policy is directed at a variety of practices (e.g., consumer products containing small amounts of radioactivity, the release for public use of lands and structures containing residual levels of radioactivity, etc.) including, but not limited to low level radioactive waste disposal.

Second, while it is true that the practices considered for exemption could result in radioactive l

material being used, possessed, or interacted with by indiv6 duals not licensed by the Commission, most practices will include conditions or constraints which must be adhered to by Commission or Agreement State 36 I

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licensees before radioactive material can pass from a controlled to an uncontrolled status..These conditions and constraints will be inspectable' and enforceable by the Commission.' As a result'of the significant

' comments on this issue, however, the Commission has attempted to refrain from using any of the above tems in describing its proposed exemption policy statement.

-The policy statement has also (1) added language clarifying the definition of what constitutes a practice and (2) emphasized the fact that most exemption decisions will include suitable conditions or constraints which must be complied with by Commission licensees and others.using the exemption.

In responding to those who believed that confusion was in evidence regarding differences between the " justification of practice" and "as-low-as-reasonably-achievable" principles, the Commission notes that a decision regarding " justification of practice" can be. based on a broad range of qualitative and quantitative factors beyond those related to radiation protection and economics.

Basically, 1,t is a finding that an activity, source, or practice results in a net enhancement to human life and health.

The ALARA principle, on the other hand, requires, given a-justified activity, source, or practice, that potential doses to occupational workers or members of the public be as low as reasonably achievable, economic and societal factors being taken into account (e.g.

state of technology, economics of improvements in relation to the benefits to the public health and safety, and socio-economic considerations). This policy statement provides the bases upon which further incremental compliance with the ALARA principle can be determined to be unwarranted. The policy requires that exemptions may only be granted for practices which have been 7,

or can be_ justified.

37

12. Truncation of Collective Dose Calculations Coments Most of those that comented specifically on the issue of truncation noted and agreed with the position of the NCRP that 1 mrem / year (0.01 mSv/ year) could be considered a " negligible individual risk level" and any individual doses below this level could be ignored in calculating collective doses. A few also supported 1 mrem / year as a cutoff to collective dose calculations but supplied their own rationale, e.g., that it was 10% of a negligible individual dose, that it was 10% of the below

' egulatory concern (BRC) individual dose level, or that the cost of calculating the small(r doses was greater than any benefit that can be achieved by including these doses.

One comenter suggested that a much higher individual dose, at least 10 mrem / year (0.1 mSv/ year), could be used for truncation of collective doses.

Only a few comenters specifically opposed any truncation.

Response

The Comission does not agree that the calculation of collective dose for

' purposes of this policy should be truncated at 1 meem/ year (0.01 mSv/ year) simply because of the smallness of the individual dose or risk. Although such a risk may not be significant to the individual, the sumation of such doses when large populations are exposed may result in a large collective dose and potentially significant number of hypothesized health effects to the population. A number of potential health effects should not be ignored simply because they occur in a large population. As far as the position of some that the uncertainty of the dose / risk relationship increases greatly as individual doses get smaller, at least one connenter correctly pointed out that these very small doses are incremental increases to the doses that people otherwise receive (background, medical); thus, the actual risks, if any, from, for example.

0.1 mrem / year,1 mrem / year, or 10 mrem / year are about equally uncertain.

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Calculation of such risks assumes only that the dose /rf sk relationship

-derived from observed effects at high doses and dose rates is applicable in the vicinity of 200 - 300 arem/ year (2-3 mSv/ year).

The Commission is not including any individual dose' criterion for the truncation of collective dose calculations in this policy, but notes that there are circumstances where some truncation is appropriate such as (1) when the " tail" of the collective dose calculation cannot be accurately calculated but can be projected to be a relatively small portion of the total collective dose or (2) when, in comparing alternative actions, the part of the collective dose being truncated is approximately the same for each alternative such that calculation of the additional doses would not be expected to affect overall conclusions concerning the comparison.

The acceptability of such truncations will be determined on a case-by-case basis.

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l 13, Definition Of What Constitutes A Practice 1

Comments.

The principles used in establishing the size, scope, and time duration of what is considered a practice can have a significant tapact on the J

potential for individuals to receive, from several practices, multiple exposures which in magnitude could approach or exceed public dose limits (refer to issue 17).

The importance attached to the definition of a practice was raised by several regulatory authorities attending the NRC-sponsored international workshop in October 1988.

The EPA commented that practice optimization involves minimizing the sum of societal risks from exposure to radiation and the costs of avoiding those risks, Exemption, in the EPA's thinking, will be the optimum choice when there is no regulation which' already achieves the minimum net effect on society.

In EPA's view, the proposed policy was considered arbitrary since it did r

not specifically define a practice, make estimates of the societal risk, or-define the minimum cost of regulation.

Response

The Commission agrees that in proposing rulemakings or in making licensing decisions under the proposed policy, the definition of what constitutes a practice is important to establish ", justification" as well as to conduct 1-ALARA or optimization evaluations.

The proposed policy statement has been clarified 'to not only support the use of these basic radiation protection principles in the exemption decision-making process but also to define i

individual and collective dose criterin which, if met by a practice,-would l

define when further incremental compliance with the ALARA principle is no L

longer warranted.

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The policy statement contains a definition of " practice" as an activity or l=

a set or combination of a number of similar sets of coordinated and continuing activities aimed at a given purpose which involves the potential for radiation exposure. This definition is essentially the same as that included in the IAEA's Safety Series No. 89, " Principles for the 40 l

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Exemption of Radiation Sources and Practices from Regulatory Control."

The policy indicates that the Commission's intent, in proposed rulemakings and licensing decisions, is to broadly define specific practices in terms which will preclude'any individual or population being significantly affected by similar activities within a niven practice.

The Commission's intent is also to prevent the possibility of deliberate dilution of material or fractionation ofLa practice for the purpose of circumventing controls that would otherwise be applicable.

By broadly ' defining what constitutes a practice, the Commission will limit the number of practices for which exemptions may be considered.

This limitation on the number of practices will provide added assurance that individual exposures from-i multiple, exempt practices are not likely to reach levels approaching public dose limits.

The Commiss ion recognizes that, in certain cases, practical considerations will prevent definition of a practice in the broadest possible sense.

For example, regulations applicable to public.

distribution of certain consumer products using small amounts of radioactive material have historically been considered on a product-by product basis and, in the future, will not likely be developed on a generic basis.

In addressing this type of 4xemption possibility, the Commission intends to be mindful of the potential for cumulative impacts from all similar practices (i.e.,-other consumer products).

It should be noted.that the definition of what constitutes _ a-practice will-provide the framework for taking into account other aspects of the i

exemption decision-making process, i.e., the possible consequence of accidents or misuse, occupational exposures, non-radiological impacts,.

etc.

I As a result of the above, the Commission does not believe specific f

definitions of practices are needed to outline, in the proposed policy statement, the principles and criteria which the Commission will use in making its exemption decisions.

41

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l

'14.. The No-Threshold H.ypothesis Relatina Dose to Health Effects - Hormesis

-i Comments Y

Many commenters opposed to the exemption policy argued that since the Commission'is' subscribing to the no-threshold hypothesis, it is admitting j

to the-potential for health effects at any level of radiation exposure.

As a ressit, these commenters believed that the' Commission is obligated to I

regulate the practices causing these exposures.

Other commenters opposed to the policy erroneously concluded that the Commission was denying the possibility of harmful effects from low levels of exposure to radiation, t

Several commenters supporting the exemption policy stated that there are no valid scientific findings supporting the existence of a linear relationship between dose and health effects at low dose levels.

Others referred to the conservative assumptions embodied in the linear, no-threshold hypothesis and stated that this hypothesis has overwhelmed the possibility of more reasonable regulatory approaches.

A few of these commenters referred to the phenomenon of horsesis,(i.e., a proposed benefit.to human life and health from exposures to low levels of 4

radiation) and suggested that, if valid, the NRC may be harming public health, as well as causing-the expenditure of needless effort by implementing overly restrictive regulations.

Reference was also made to the 1980 BEIR Committee (Committee on the Biological Effects of Ionizing Radiation) which concluded that the risk coefficients derived from the study of the atomic bomb survivors and other studies are statistically inadequate for use at doses less than 10 rad or dose rates less than I rad per year.

A commenter stated that the linear no-threshold hypothesis persists in regulatory matters largely because the effects data are not sufficiently robust to distinguish between linear and non-linear models and this insufficiency has resulted in a regulatory position misnamed as " conservatism." Furthermore, this commenter stated

-that the hypothesis persists partly because EPA and others jump from the fact that cancers are frequently monoclonal (derived from a single cell) to presume that cancer yield is ifnearly related to the number of cells 42 e

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affected by radiation, no matter how few.

The latter approach, this' i

commenter claimed, ignores' the existence of an immune system in animals

.which is not present in the in-vitro systems in which many studies en -

response curve shape have been done.

In this commenter's view, the immune system seems to be very efficient in preventing diseases from developing when only small numbers of attacking cells are present.

In addition to infectious diseases, this commenter suggested the consideration of the

. fact that in various animal experiments many tumor cells (typically hundreds to millions of cells) must be injected into test animals before cancer develops in the test animals.

Finally, this commenter cited the

-fact "...that billions of potentially initiating events occur in our bodies over our lives just from the [ body's natural) "K content, and the annoying but persistent observation that cancer rates are generally lower where background radiation levels are higher." Along this same line, a commenter stated that millions of people have lived for hundreds of years with background radiation levels 2-10 times above the U.S. average, with 4

no evidence of excess cancer deaths.

Another commenter, who also discussed his views af. the NRC's January 12, 1989 public meeting, presented arguments to indicate that reliance on in-vitro systems and repair processes alone leads to unwarranted unconservatism in estimating the carcinogenic potential-of low doses of radiation, or higher doses delivered at a low dose rate.

This commenter believed that experimental evidence indicates that, in order to explain a reduced frequency of expressed tumors as a function of reduced dose rates, a mechanism other than intra-cellular repair must exist.

To explain this phenomenon, this commenter postulated a mechanism, whose existence is'well established, that can seek out and kill malignant cells.

This commenter believed the factor of 2-3 currently used to account for the " dose rate l

effect" may in actuality, be much larger than 10.

Response

The Commission acknowledges that radiation has been shown to be carcino-genic at high doses and high dose rates (~50 rads absorbed dose at high dose rate for low linear energy transfer radiation).

However, the 43

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development of a. risk factor applicable to continuing radiation exposures at levels comparable to natural background requires a t'gnificant.extrapo--

lation from these effects observed at much higher doses. -(Here, the L

-Commission would point out that the natural background level represents a base on which'all other exposures to man-made sources of radiation must be.

added.) - The need for extrapolation results in expressions of uncertainty reflected by the views of experts in the field.

For example', as stated in the proposed policy statement, the National Academy of Science Committee

-on the Biological-Effects of Ionizing Radiation has cautioned that the risk values are "... based on incomplete data and involve a large degree of uncertainty, especially in the low dose region." This Committee also stated that it "...does not know whether dose rates of gamma or x-rays (Iow LET) [ low linear energy transfer radiation] of about 100 mrads/ year i

-[1mGy/ year) are detrimental to man."

The Commission recognizes that the

[

Committee's statement is a reflection of the uncertainties involved, and does not imply either the absence or presence of detrimental effects at this dose level.

In addition, the Commission is aware that the Uni.ted Nations Scientific Comittee on the Effects of Atomic Radiation (UNSCEAR)-in their 1988 Report to the General Assembly has stated that "...there was a need for a reduction factor to modify the risks [ derived at high doses-and dose rates]...for low doses and dose rates...an appropriate range (for this factor) to be applied to total risk for low dose and dose rate-should lie between 2 and 10."

[This factor would lead to a risk coefficient value-

-5

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-2 between 7x10 and 3.5x10 per rad (7X10 and 3.5X10 per gray)] based on an UNSCEAR risk coefficient of 7.1x10~4 per rad (7.1% per gray) for 1 gray (100 rad) organ absorbed dose at high dose rates.

Given this information, 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 of the public. As a matter of regulatory prudence, all these bodies have derived the risk value presumed to apply at lower dose and dose rates associated with these radiation protection standards by extrapolation from values derived at higher doses 44

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and dose rates. While some have suggested ~a reduction factor to modify I

the risks for low doses and dose rates, others have presumed a linear l

quadratic relationship between dose and cancer mortality risk.

In either case, the coefficients applied to estimate the risks from low doses and

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~ dose rates are similar.

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While the~ Commission has used.this hypothesis in establishing the risk

-basis for decisions regarding dose limits for workers and the public,-it is guarded in totally relying.on this hypothesis when establishing criteria for " cutting off" the need for further incremental compliance

.a.,

with the ALARA principle.

The Commission notes that the individual dose value proposed for this purpose is well below (i.e.,1/10) applicable dose limits and only a fraction (1/30 to 1/10) of background radiation. The Commission, therefore, has combined its consideration of the absolute risks predicted by the no-threshold hypothesis with a comparative risk perspective.

It has used both in establishing the individual dose

. criterion applicable to exemption decisions when considering if further incremental compliance with the ALARA principle is warranted.- These perspectives are discussed further in the response to Issue 3.

The Commission also notes that the annual risk of cancer in the United.

~3 States is 1.9x10 which leads to almost la million cancer deaths each year.

As a-result of this large number of cancer deaths from all causes, observations relative to potential thresholds, horsesis, or repair mechanisms for those potentially caused by radiation in the low dose regime are extremely difficult to statistically verify.

The Commission, therefore,.is supportive of continuing efforts to better quantify the

, relationship between risk and low radiation dose which are ongoing at both the international and national-level.

45

g 15.

Accidents and Misuse

- Coments s

Some commenters raised concerns that some licensees would misuse exemption regulations or specifications, either intentionally or' inadvertently,- in.a -

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way that would result in releases exceeding those allowed.

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Respr3.e.

The Commission notes that this-issue is common to all areas of regulation including those related to exemptions from some or all regulatory controls.

The Commission views these concerns as a compliance issue which

.t will be addressed through licensing, inspection, enforcement, and monitoring.

The subject of'_" Monitoring of Exempt Practices" is discussed.

under issue #9.-

L Comment l-L Other commenters were apparently concerned that once radioactive material is released from a licensee's control, there would be significant uncertainty about the possible exposures that could occur.

Accidents, i

misuse of products containing radioactive material, or the occurrence of unlikely scenarios involving interactions between individuals and exempted radioactive material were inferred.

The IAEA addressed this issue in

- Safety Series No. 89 by stating that "The (regulatory) authority will also need to take into account the severity of possible consequences of accidents or misuse.

Such considerations may contra-indicate the a

exemption of a practice, even if it gives rise to very small doses under normal conditions."

L

Response

The policy indicates that a proposal for exemption must address potential accidents and misuse.

The proposal must address the probabilities of such events and the resulting individual and collective doses.

The exemption 46 i

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decision-making process would consider both these factors,-including.any uncertainties' associated with their estimation, i

The Commission believes that-the impact of potential accidents and misuse events, in the context of the exemption decision-making process, can only be judged properly on a case-by-case basis.

However, the Commission'would expect that for a practice to be granted an exemption from some or all regulatory controls, both the risks (i.e., probability times consequences) and consequences from all potential accidents and misuse events should be small.

The Commission believes.these considerations'are in concert with the intent expressed in the IAEA Safety Series No. 89 document.

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National Consistency in Risk-Based Radiation Protection Standards a

Commentsi Several commenters, including the U.S. Environmental Protection Agency (EPA),noted that inconsistencies exist in the risk basis used for decision making.throughout the' Federal regulatory process.

Specifically, the EPA pointed out that exemptions based on individual risk. levels associated with doses in the range of 10-100 arem per year (0.1-1 mSv/ year) would not be consistent with the many Congressional and e

regulatory actions being taken relative to other environmental contaminants.

Response

i i

The Commission recognizes that different numerical risk bases.are used in'

_ decision-making processes involving a wide range of regulatory actions.

Logical differences in risk bases can occur when consideration is given_ to factors such as populations impacted, the distrib.ution of individual impacts, the relative uncertainties in health effect predictions, the j

persistenc6 of the purported hazard, the potential-for multiple exposures, and many_ other issues.

Furthermore, the rationale used in defining a safe or acceptable level of risk could differ from that used to establish a -

basis for considering exemptions from some or all regulatory controls.

The Commission believes that a11' these factors and considerations must be addressed in establishing any " risk-based" regulatory policy and that, if

{

properly addressed, a logical consistency between different risk-based f

standards should result.

i In proposing-its exemption policy, the Commission notes that under the Atomic Energy Act authorities, which have been in place for thirty-five i

years, the.NRC and its predecessor, the Atomic Energy Commission, have been regulating source, special nuclear, and by product material under a program that applies -internationally-accepted standards.

The NRC's radiation protection program is based on principles that will ensure that i

exposures are, first, justified, second, adequate to protect health and 48

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'i safety, and third. "as low as reasonably achievable," taking into account j

U costs'and the state of the art of. technology for reducing exposures.

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. risk basis'used to define the public dose limit is described in ICRP Publication 26, " Recommendations of the International Commission on Radiological Protection," as clarified by the ICRP's " Statement from the 1985 Paris Meeting of the'ICRP." With this risk basis in mind, the Commission has developed individual' and collective dose criteria within its proposed exemption policy which define a region where the risk reduction does not warrant the expenditure of resources to bring about further incremental compliance with the ALARA principle.

The Commission is aware of apparent differences between the risk basis j

used for its standards and policies and those used or proposed by other Federal Agencies (e.g., the U.S. Environmental Protection Agency).

The Commission is actively attempting to resolve these differences through interagency contacts and proposals for development of appropriate Federal Guidance.

The Commission believes a public airing of the respective risk-bases for all Federal public protection standards is the preferred method which must be used to institute rational-and cons.istent risk-based public protection policies.

The Commission therefore proposes that the U.S.

Environmental Protection Agency chair an interagency committee whose charter would be to develop a framework for public radiation protection.

This framework could be promulgated as Federal Guidance, which upon signature of the President, would be implemented by all Federal Agencies.

49

,-~.

k 17.

Cumulative Effect of Exposures to Multiple Exempted Practices Comments Mahy commenters opposed to the proposed exemption policy. and a few supporting the development of such a policy, expressed their concerns regarding.the potential exposure of individuals to several exempted practices.

These commenters believed that the summation of doses received from multiple ~ individual practices could result in a total which could s

approach or exceed existing public dose limits..This possibility led several comenters, who supported development of an exemption policy, to recomend that continued incremental compliance with the ALARA principle be maintained if individual ~ exposures could exceed 1 area (0.01 mSv) per l

year per practice.

Some of these commenters cited the internationally accepted, " Principles for the Exemption of Radiation Sources and Practices from Regulatory Control," described in IAEA Safety Series No. 89, as an acceptable. approach to resolve the multiple exposure issue.

A comment letter from the National Council on Radiation Protection and Measurements (NCRP) expressed the= view that a blanket exemption of sources contributing 10 millirem in a year is not negligible and exposure to a few such sources.

could bring an individual-close-to the annual limit of 100 millirem in a year.

Many responders opposed to the exemption policy believed that a significant buildup of radioactive materials with long half-lives could occur in the environment over time.

Those in opposition to policy

-development also stated that the " bottom line" result of the proposed policy would be to increase existing background levels.

Responses The Commission agrees that the issue of potential individual exposures to multiple exempted practices, and from any cumulative buildup of long-lived radioactive material is important and has attempted to address this issue in both the advance notice and the proposed exemption policy statement.

Contrary to the comments submitted by the NCRP, the policy is not intended to grant a blanket exemption of sources contributing 10 millirem per year to individuals.

Rather, as the NCRP suggests, "...a source producing 0.1 50

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3 mil 11 sievert (10 millires) in a year could be exempted provided justification,and ALARA are applied." This, in essence, is the approach the policy statement-is attempting to convey.

As a result of the many comments on this issue, the proposed policy has been revised to clarify this point. The Commission has also attempted to broadly define what constitutes a " practice" so as to assure that the granting of any exemptions from some or all regulatory controls will not allow deliberate dilution of material or fractionation of practice.

Under this broad definition, the radiological properties of the material associated with the practice must be characterized on a national basis which takes into account the potential for increased individual exposures resulting from multiple-sources encompassed within any defined practice. The NRC must,

.in its rulemaking and licensing processes, take account of potential exposures from multiple practices.

Furthermore, the potential annual individual and collective dose resulting from an exempted practice 'must be evaluated over the lifetime of the practice.

The evaluation must take into account the effects of any accumulation of radioactive material in the environment over time.

Based on the above discussion, the Commission has concluded that few, if any, individuals are likely to receive exposures approachina applicable public dose limits from exposure to multiple sources or practices because:

(1) multiple sources within a practice must be considered in an application for exemption (e.g., multiple waste paths from a nuclear power reactor and all nuclear reactors are included in one practice);

(2) exposures to the same individuals.from multiple practices will be considered in the process of developing specific exemption decisions, and the potential for overlapping impacts will be accommodated or controlled; (3) the requirement that each practice be justified will limit the number of practices exempted and (4) the exposures associated with any exempt practice will be limited because of the requirement to apply ALARA to each practice as appropriate.

Finally, for those practices meeting the dose criteria which define when further incremental compliance with ALARA is unwarranted, the satisfaction 51

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n of the criteria provides additional assurance that the distribution of individual ~ exposures is such that. only a small fraction of the national' population could receive exposures _ approaching 10 arem per year.

The l

likelihood of one or more individuals receiving doses at this level from more than a very few practices is expected to be very small.

In making I

its exemption decisions, whether through the rulemaking process or

' individual. licensing decisions, the Commission intends to be vigilant in_

assuring that individuals are not likely to approach public dose limits i

through multiple exposures to exempt prac' ices.

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18.

Federal Responsibilities and Authority Comments:

The Environmental Protection Agency (EPA), in its comment letter, pointed out that the EPA and NRC have some shared and many complementary responsibilities under the Atomic Energy Act (AEA). The letter stated that although NRC regulates onsite activities of its licensees, as defined in 1970 by Reorganization Plan No.3, the primary responsibility for regulating offsite levels of radiation, as well as for recommending the-general principles which govern all radiation protection activities of Federal Agencies, is assigned to EPA.

This division of responsibilities, it was pointed out, applies to the AEA; however, it was noted that EPA has sole responsibility for regulating environmental radiation under a number of other statutes.

The EPA recognized that the Low Level Radioactive Waste Policy Amendments Act of 1985 required the Commission to establish a-policy for exemption of specific radioactive waste streams from regulation by NRC, but believed the proposed policy, by virtue of its potential application to all aspects of regulation, goes far beyond the 1985 Act.

It would, it was claimed, define a general principle for radiation protection accompanied by a numerical, generally-applicable standarde Almost any conceivable application of the proposed policy, it was believed, would directly affect public exposures and the release of radioactive material to the general environment, an area of primary concern to the EPA.

Response

The Commission agrees with EPA's assessment of the NRC and EPA authorities; however, in the absence of Federal Guidance, the Commission believes that its authorities under the AEA allow for exemptions from its regulation to be granted (e.g., Sec. 81) "... when it makes a funding that the exemptions... will not constitute an unreasonable risk to common defense and security and to the health and safety of the public." In fact, such exemptions are currently included in the Commission's 53

b regulations.

The _ Commission, however, recognizes the benefits of uniform regulation and, therefore, in the _ proposed policy statement, supports the

.c development of broader Federal Guidance regarding exemption policies.

In doing so, the Commission realizes that, when signed by the President, the Federal Guicance could supplant the proposed policy.

LThe Commission would also highlight the fact that its actions under consideration here involve the development of a policy statement.

Any regulations formulated from the principles in this policy statement will be subject to the Commission's rulemaking procedures.

These procedures include a public process which assures that-the EPA and others can comment on the health, safety, and environmental impact of proposed Commission exemption regulations.

The Commission, however, would intend to work closely with EPA to develop a unified Federal Position on any such regulation, i

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RESPONSE TO ACNW COMENTS The policy statement' has been discussed with the Advisory Comittee on Nuclear i

Waste (ACNW) over the course of several meetings, the latest on April 28, 1989.

The;ACNW has stated its most recent views regarding the proposed policy statement in a May 3, 1989 letter to Chairman Zech. Although the staff has 1

reached agreement with the ACNW on most issues, two outstanding differences with ACNW recomendations remain.

• l first, the staff has not proposed, as the ACNW has suggested, any specific I

' limit" on an individual dose which may result from an exemption decision, other than the existing dose limits applicable to members of the public.

Instead, the proposed policy states that practices, which are candidates for exemption for some or all regulatory controls, should not result in individual doses greater than a small fraction of these existing annual dose limits. The q

policy also inc1"dct-a statement that ".....the Commission recognizes'that only under unusual

^ tances would exemptions be considered for justified practices whict, cause continuing radiation exposure to individuals exceeding a small fraction of 100 mrem per year (1 mSv per year)." The staff

-t believes that this approach provides flexibility which should be maintained.

.Second, the staff does not believe, as the ACNW has recommended, that "....the permissible annual collective dose " limit" [f'or a practice to be exemptable]

should be reduced as the allowable dose rate to members of the public from y

individual _ practice increases." The staff believes the annual collective dose associated with a specific exempted practice should be derived through an appropriate ALARA analysis. The collective dose crite-ion as used in the

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proposed policy is not a " limit", but instead provides one of two criteria which define a basis for curtailing or " cutting off" the need to further comply

-incrementally with the ALARA principle. Evaluations applying the ALARA principle would be used to determine whether a collective dose greater than this value should be accepted as a result of any particular exemption decision.

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