ML20055E144

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Advises That NRC Issuing Policy Statement on Below Regulatory Concern.Policy Will Benefit Public by Providing Commission-approved Framework for Development of Regulations & Guidance for Cleanup of Contaminated Sites
ML20055E144
Person / Time
Issue date: 06/27/1990
From: Carr K
NRC COMMISSION (OCM)
To: Cheney R
DEFENSE, DEPT. OF
References
FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9007110056
Download: ML20055E144 (50)


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d UNITED STATES

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NUCLEAR REGULATORY COMMISSION e

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June 27,1990 CHAIRMAN '

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h The Honorable Richard B.' Cheney Secretary of Defense

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Washington, D. C.

20301

Dear Mr. Secretary:

.The Nuclear Regulatory Commission (NRC) is issuing a policy statement on Below RegulatoryConcern-(BRC). This policy establishes the. basis for future agency-regulations and licensing decisions which would exempt very low level radio-i active material. from regulatory controls where the Comission determines that such controls are.nct necessary to protect public health and safety.

q This policy will provide a consistent and logical framework for review.of:

4 exemptions and~ cleanup decisions that have in the past been made on a case-by-case basis. Copies of the policy statement, along with a press release and

.infomation booklet, are enclosed.

The intent of the policy statement is to:

o Ensure that there continues to be adequate protection p

-of the health and safety cf all members of the public; i

Establish a broadly' applicable risk-based framework.to ensureiconsistency in future rulemaking and licensing.

i decisions and in the review of' existing exemptions; and Allow the NRC, Agreement States, and licensees to focus their resources on reducing the most'significant raciological risks.

There have been several common misconceptions about the Ccmmission's

~BRC policy which we believe need to be clarified, p

  • ' The BRC policy is not self-executing. Rulemakings or I

L licensing actions will be required to implement the BRC policy..

  • Public. participation will be afforded in rulemakings and licensing actions if they differ from previous generic y

exemption provisions.

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.9007110056 900627 E'l PDR -COMMS NRCC i

CORRESPONDENCE PDC

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.-T Prior to granting an exemption for a given practice, the HRC will conduct a thorough technical review.

If an exemp-tion is granted, a itcensed activity producing an exempt material will continue to be subject to the fullt range of regulatory oversight, inspection, and enforcement actions 1

up to and including the point of transfer to exempt status, r1

. We believe that the BRC policy will benefit the public,by providing a Comission-approved framework for the development of regulations and guidance-for cleanup of.' contaminated sites, a consistent level.of safety for consumer products,' and better use of resources for waste management.

1 The Comission considers this an important-regulatory undertaking and will hold publicly-noticed workshops in each NRC Region.

Sincerely, m_1W.

Kenneth M. Carr i

Enclosures:

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As stated i

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identical letter sent to:

l The Honorable Richard B. Cheney Secretary of Defense The Pentagon Washington, D.C.

20301 The Honorable Louis W. Sullivan Secretary of Health and Human Services 200 Independence Avenue, S.W.

Washington, D.C.

20201 The Honorable Manuel Lujan, Jr.

Secretary of the Interior C Street Bet. 18th & 19th St., N.W.

Washington, D.C.

20240 The Honorable James D. Watkins Secretary of Energy r

- Forrestal Building

- 1000 Independence Avenue S.W.

Washington, D.C. 20220 The Honorable William K. Reilly Administrator Environmental Protection Agency 401 M Street, S.W.

Washington, D.C.

20451 Dr. Allan Bromley, Science Advisor to the President Office of Science and Technology Policy Old Executive Office Building 17th. Street and Pennsylvania Avenue, N.W.

Washington, D.C.

20506 The Honorable James S. Benson Acting Commissioner food and Drug Administration Parklawn Building 5600 Fishers Lane

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Rockv1110. MD 20857 The Honorable Elizabeth H. Dole Secretary of Labor i

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200 Constitution Avenue, N.W.

Washington, D.C. 20210 L

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The Honorable Michael R. Deland Chairman

  • ouncil on Environmental Quality

's/2 Jackson Place, N.W.

i Washington, D.C.

20503 j

The Honorable Jacqueline Jones-Smith Consumer Product Safety Commission i

Westwood. Towers, Room 440 5401 Westbard Avenue Washington, D.C. 20207 The Honorable W1111cm F. Raub Acting Director National Institutes of Health 9000 Rockville Pike, NIH-1 i

Bethesda, MD 20892 i

Admiral James B. Busey, IV, USN (Ret.)

Administrator l

Federal Aviation Administration 800 Independence Avenue, S.W.

. Washington, D.C.

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UNITED STATES

/ y /j NUCLEAR REGULATORY COMMISSION

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f Office of Govemmental and Putdio Affairs

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Washington, D.C. 20555

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No.

90-93 FOR IMMEDIATE RELEASE' Tel.

301/492-0240 (Wednesday, June 27,1990)

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NRC APPROVES POLICY STATEMENT ON RADIATION LEVELS l

TO BE C0h!!DERr0 FOR EXEMPTIONS j

Chairman Kenrieth M. Carr of the U. S. Nuclear Regulatory Commission announcto today the Cornission has approved a pulicy statement to guide its future decisions on which radioactive materials are "below regulatory concern."

4 This would involve materials with levels of radioactivity so Icw that they do not warrant the same regulatcry controls to ensure proper protection of the public and the environmnt as do higher levels of radioactive materials.

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The Below Regulatory Concern levels are about 37 of the 300 millirem dose j

people receive annually from naturally occurring sources such as cosmic l

radiation and radinactive matcrial in the earth, inclucing radon.

In announcing the policy, Chairman Carr said:

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" Currently, the hRC is enfercing the cleanup of. more than 40 contaminated nuclear sitts across the country and there will be many more in the coming decades.

Last year, when I appearea before Congressman Mike Synar, he ouestioneo me as te why it has taken the Federal government so long to estab-lish safe and consistent cleanLp levels for these facilities.

I told him, as I am telling you today, I have no excuse for the past, but onr. of-nty highest priorities is to establish safe levels of cleanup. This will help ensure every operating facility will complete cleanup in a timely raanner and will have 1

adequete levels of funding tc complete that cleanup.

"The policy I am announcing today provides the fraftwork for determining these scie levels. The country needs a safe Below Regulatory Concern policy

today, l

"I want to stress that the NRC will enalyze and scrutinize each proposed j.

exemption to ensure that any radiation doses will be extremely low.

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safety of the public and the environment will remain properly protected."

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in the past, the Corsnission has exempted, on a case-by-case basis, some types, uses, and small quantities of radioactive material from regulatory l

i control.

Examples of exemptions that have already been granted by the Corrois-l sion include consumer products such as smoke detectors, as well as certain very low-level radioective waste from hospitals and research institutions.

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2 The Comission emphasized that the policy statement is not the same as a regulation and coes not constitute a decision to exempt any specific consumer 1

product, waste, or other materials frem regulatory control.

It is instead a j

general suiceline for the develcpment of such exemptions 6nd provides a uniform and consistent health and safety framework for considering whether to grant such exemptions.

It would cover such activities or products as (1) cleanup of decommissioned and decontaminated facilities, (2) consumer products containing smal) amounts of raoicactive traterial, (3) very low-level radioactive waste, ano (4) recycled equipment enc materials with slight amounts of radiation.

The Comission has always recognized that the use of radiation or radio-active materials, like all of the activities society engages in, involves some risk.

The levels of risk associated with exemptions are small, especially in comparison to risk from our e eryday activities.

For example, individuals are exposed te radiation coses.J about E millirem when they take a single round trip cross-country airplcra flight.

The NRC traditiorelly has sought to erture that any radiation cose received by workers or members of the public is reduced to a level that is as low es 15 reasonably achievable.

However, as the level of this risk or cost becomes very small, spending resources to reduce the risk reaches a point where the costs of such efforts far outweigh any small benefits that might rescit. The Ccarrission believes its regulatory eff orts should be directed toward more important health and safety issues, in its policy statorent, the Comnission gives the criteria for making exemption decisions that will troperly protect the public and the environment.

For indiviouals, the Comissien hos cec 1oed the radiation exposure from a single activity cr product c6) be consicered for exemption if it will result in an average dose of less than 10 raillirem per year. Incividuals are exposed to similar levels when they chocse to live in a brick rather than a freme house (e difference that can excetc 10 millirem per year).

The Commission also recognizes that some situations coulo develop where an incividual could receive a raciation dose from several different activities or products.

Therefore, as en added assurance of safety, the Comission has cecideo to apply an-interim incivicual dose criterion of 1 millirem per year for materials or products involving widespread distribution of radioective materials in items such as certurier produc.ts or recycito material and

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in aedition to these criteric for individuals, the Commission clso has establisheo a criterion that will opply to collective dose--the sum of all the individual doses.

The Comiss'on believes if the collective dose resulting from an exempted practice is less than 1000 person-rem per year, the resources of the Commission and its licentees would be better spent to address raore significant health and safety istues.

This criterion is equivalent to 100,000 individuals receiving 10 millirem oer year or a million individuals receiving 1 rrillirem per year.

Any licensee who produces materials containing very low levels of radioactivity that 6ro exemptec from NRC controls would continue to be subject to the full range of NRC regulatory oversight, inspection and enforcement

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actiens to ensure compliance with any constraints, requirements, and conditions estabitsheo by the Commission. For example, the Commission may require some type of labeling so consumers can make informed decisions about purchasing a procuct containirig exempt 6d materials.

The NRC plans to hold sublic meetings in each of the five regions around the country to explain the 3elow Rtgulatory Concern policy and answer questions.

l The dates and locations of these meetings will be announced later.

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NUCLEAR REGULATORY COMMISSION Below Regulatory Concern; Policy Statetnent AGENCW Nuc! car Regulatory Commission.

waste in a manner commensurate with their low radiologi-i cal risk; and (5) increased assurance of a consistent level

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ACTION:

Poh.ey statement.

of safety for consumer products containing radioactive

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SUMMARW nis policy statement establishes the frame, material under the Commission's jurisdiction, work within which the Commission will fortnulate rules or Jul 3'1990 ErrECTIVE DATF*

Y make licensing decisions to exempt from some or all regu-

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latory controls certain practices involving small quantities ADDRESSES: Documents referenced in this policy state-of radioactive material. Opportunity for pubhc comment ment are available for inspection in the NRC Public will be provided with each rulemaking and each licensing Document Room,2120 L Street, N. W. (lower level)'

action where generic exemption provisions have not al-Washgton, DC.

ready been established.nc exemptions may involve the release of licensee-controlled radioactive material either FOR FURTHER INFORMATION CONTACT:

to the generally accessible erwitonment or to persons who would be exempt from Commission regulations. Practices ne appropriate NRC Regional Office:

for which exemptions may be granted include, but are not limited to, (1) the release for unrestricted public use of Region 1 - Dr. Malcom Knapp, King of Prussia, lands and structures containing residual radioactivity;(2)

Pennsylvania; telephone (215) 337-5000 the distribution of consumer products containing small Region 11 - Mr. J. Philip Stohr, Atlanta, Georgia; amounts of radioactive material; (3) the disposal of very telephone (404) 331-4503 low-level radioactive waste at other than licensed disposal sites; and (4) the recycling of f. lightly contaminated equip-Region !!! - Mr. Charles E. Norelius, Glen Ellyn, ment and materials. As described in this policy statement, Illinois; telephone (708)790-5500 NRC intends to continue exempting specific practices from regulatory controlif the application or continuation Region IV - Mr. Arthur B. Beach, Arlington, Texas; of regulatory controls is not necessary to protect the pub.

telephone (817) 860-8100 lic health and safety and the em*ironment, and is not cost Region V - Mr. Ross A. Scarano, Walnut Creek, effective in further reducing risk. The pohey statement California; telephone (415) 943-3700 defines the dose criteria and other considerations that will be used by NRC in making exemption decisions. The Federal and State Government Officials may contact:

policy establishes individual dose criteria (1 and 10 mrem Mr. Frederick Combs, U.S. Nuclear Regulatory Commis-per year [0.01 and 0.1 millisievert per year]) and a collec-sion, Washington, DC 20555, Office of Governmental tive dose criterion (1000 pen,on rem per year [10 person-and Public Affairs, telephone (301) 492-0325.

sievert per year]). These criteria, coupled with other con-siderations enumerated in the policy statement, will be Questions may also be directed to the following l

major factors in the Commission's determination on individuals at the U.S. Nuclear Regulatory Commission, whether exemptions from regulatory controls will be Washington, DC 2055L granted.

Dr. Donald A. Coct, Office of Nuclear Regulatory 1

The policy statement establishes a consistent risk frame, Researth; telephone (301) 492-3785 work for regulatory exemption decisions, ensures an ade-Mr. John W. N. Hickey, Office of Nuclear Material quate and consistent level of protection of the pubhc in Safety and SafeEuards; telephone (301) 492-3332 their use of radioactive materials, and focuses the Na.

tion's resources on reducing the most significant radio-Mr. L J. Cunningham, Office of Nuclear Reactor logical risks from practices under NRC's jurisdiction.The Regulation; telephone (301) 492-1086 average U.S. citizen should benefit from implementation of the BRC policy through (1) enhanced ability of NRC, SUPPLEMENTARY INFORMATION:

Agreement States, and licensees to focus resources on more significant risks posed by nuclear materials; (2)

Statement of Polic}'

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timely and consistent decisions on the need for cleanup oi contaminated sites; (3) increased assurance that funds I.

Introduet, ion.

available to decommission operating nuclear facilities will be adequate; (4) reduced costs and overall risks to the Ionizing radiation is a fact of life. From the day we public from managing certain types of slightly radioactive are born until the day we die, our Imdies are exposed to 1

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ERC Policy Statement low levels of radiation emitted from a variety of natural policy translates the Commission's judgement on accept-and man made sources, including the cosmos, carth, able risk into explicit and pmetical criteria on which to building materials, industrial facilities, clothing, medi-base decisions to exempt practices from the full scope of cine, food, air, and our own bodies. All materials exhibit NRC's regulatory program. "Ihc IIRC criteria are neces-some degree of radioactivity.The consensus among scien-sary to ensure adequate and consistent decisions on ac-tists is that even low levels of radiation typical of the ceptable risks posed by decontaminated and decommis-natural emironment pose some correspondingly low risk sioned nuclear facilities, consumer products containing of adverse health effects to humans. Recognition of the radioactive materials, and very low activity radioactive risk due to radiation exposure from natural r,ources pro-wastes.'lhese decisions will be implemented by the Com-vides perspective on the risks associated with human uses mission through rulcrnakings and licensing decisions of radioactive materials, based on carciut and thorough analyses of the risks associ-ated with specific practices to ensure that the public is Natural and man made radionuclides are used in adequately protected.

today's society in many forms for a variety of purposes, such as medical therapy and diagnosis, materials analysis, Under the reputatory approach used by the U.S.

and powcr generation. in general, the existing regulatory Nuclear Regulatory Commission (NRC), the use of radio-framework casures that radioactive materials are con-active materials is subject to limits and conditions that trolled consistent with the degree of risk posed to the ensure the protection of the health and safety of teth public and the environment. Some products such as workers and members of the general public, and the envi-smoke detectors contain small quantitics of radioactive ronment. For example, radioactive material is controlled materials that pose such a low risk that they have been by NRC and Agreement State licensees to ensure that widely distributed without continuing regulatory controls.

dose limits are not exceeded in addition, sources of radia-To require that all radioactive materials be controlled in tion are designed, used and disposed of in a manner that the same strict manner regardless of the risks they pose ensures that exposures to radiation or radioactive mate-would not be a sound use of limited National resources.

rial are as low as is reasonably achievabic (ALARA),

Such strict control could also deprive society of the bene-cconomic and social factors being taken into account.

fits already derived from appropriate uses of radioactive NRC has endorsed the ALARA provision in regulatory materials and radiation. In addition, such control would practice for a number of years (10 CFR Part 20). Ilow-not significantly reduce the risks associated with radiation ever, NRC has not yet provided criteria that would estab-exposure from controlled sources compared with risks lish the basis for delining the level of residual risk at which associated with ratural background radiation. Therefore, further regulatory control is no longer warranted, responsible decisions need to be made on how radioactive The policy statement in today's notice provides a materials are controlled based on a judgement about the levels of risk they pose and the effectiveness of regulatory unifying risk framework for making decisions about which control to reduce those risks.

practices can be exempted from the full scope of NRC's comprehensive regulatory controls. Under the criteria Over the last several years, the Commission has and principles of this poli:y statement, exemptions of pursued development of a risk threshold to distinguish radioactive materials from regulatory controls would in-those radioactive materials that do not require the same volve the transfer of very smati quantitics of the materials stringent level of regulatory control as that imposed on from a regulated to an unregulated status. NRC will ana-potentially more hazardous materials. The Commission lyze cach proposed exemption to ensure that doses result-recognized throughout this process that the threshold ing irom the proposed transfer will be sufficiently low that would need to be low enough to continue to ensure ade.

the public health and safety and the environment will quate protection of the public. The Commission also rec-remain adequately protected. A licensed activity produc-ognized that the_ threshold should be compatible with ing an exempt material would continue to be subject to technological and measurement capabilities so it could bc the full range of regulatory oversight, inspection, and readily used in NRC's regulatory program for nuclear enforcement actions up to r.nd including the point of materials. In addition, the Commission identified the transfer to an exempt status. The Commission also in-need to balance incremental reductions in risk below the tends to conduct research periodically to evalunte the safety threshold with the attendant expenditure of private effectiveness of this policy and to confirm the safety bases and public resources.

that support the exemption decisions.

In today's notice, the Commission establishes a pol-Through appropriate rulemaking actions or licens-icy to guide its decisions on which radioactive materials ing decisions, the Commission will establish constraints, are "below regulatory concern" (llRC) because the low requirements, and conditions applicabic to specific ex-levels o_ risk they pose do not warrant regulation to the emptions of radioactive materials from NRC's regula-f same degree as other radioactive materials to ensure ade-tions. The NRC will verify that licensees adhere to these quate protection of the public and the environment.This exemption constraints and conditions through NRC's li-

IIRC Policy Stat 3 ment censing, inspection, and enforectnent programs. For ex-their risks to the public and the environment. ne Food ample, the Commission may promulgate regulations that and Drug Administration (FDA), for exampic, has ap-would require some type of labeling so that consumers plied sensitivity-of method, risk-based guidelines in con-could make informed decisions about purchasing a prod-nection with the regulation of animal drugs, food con-uct containing exempted materials. Such labeling is pres-taminants, and trace constituents in some food additives, ently required by the Commission for smoke detectors Similarly, the Erwironmental Protection Agency (EPA) containing radioactive material (see 10 CFR 32.26).nc established exemption or threshold levels based on indi-NRC ensures that manufacturers label the detectors in vidual risks in the regulation of pesticides and other toxic compliance with the labeling requirement through licens-and carcinoEenic chemicals. For example, EFA employs ing reviews and inspections. Specific source controls and such a concept in defining hazardous waste through the exemption conditions are not discussed further in this new Toxicity Characteristic rule in 40 CFR part 261 ($$

policy because they will be more appropriately addressed FR 11798; March 29,1990).

in developing the exemption requirements for specific exemption proposals.

%c Comrnission belicycs that the Ilclow Regula-tory Concern policy is needed to establish a consistent, ne concept of regulatory exemptions is not new.

risk-based framework for making exemption decisions.

%c Atomic Energy Act of 1954, as amended, authorizes Specifically, this framework is needed to (1) focus the the Commission to exempt certain classes, quantities, or resources of NRC, Agreement States, and licensecs on uses of radioactive material when it finds that such ex-addressing more significant risks posed by nuclear materi-emptions will not constitute an untcasonable risk to com-als; (2) ensure that beyond the adequate protection mon defense and security and to the health and safety of threshold potential benefits from additional regulation the public. In the 1960s and 1970s, the Atomic Energy outweigh the associated burdens; (3) r;tabh residual Commission used this authority to promulgate tables of radioactivity criteria and requirements fw d: commission-exempt quantitics and concentrations for radioactive ma-ing and cleanup of radioactive contamination at licensed terial. %csc exemptions allow a person or a licensee, and formerly licensed facilities; (4) ensure that licensee under certain circumstances, to receive, possess, use, decommissioning funding plans provide adequate funds transfer, own, or acquire radioactive material without a to cover the costs of c!canup of these facilitics to protect requirement for a license (30 FR 8185; June 26,1965 and people and the environment; (5) ensure that the public is 35 FR 6425; April 22,1970).The Commission currently consistently protected against undue risk from consumer allows distribution of consumer products or devices to the products that contain radioactive materials under the general public and allows releases of radioactive material Commission's jurisdiction; (6) provide decision criteria to the environment consistent with established regula-for reviewing petitions to exempt very low level radioac-tions. For exampic, regulations currently specify the con-tive wastes in accordance with the Ixiw Level Radioactive ditions under which licensees are allowed to dispose of Waste Policy Amendments Act of 1985; and (7) ensure small quantitics of radioactive material into sanitary that existing exemptions involving radioactive materials sewer systems (see 10 CFR 20.303).Rese existing regu-are consistent and adequate to protect the public, lations specify requirements, conditions, and constraints that a licensec must meet if radioactive materialis to be ne Commission's IIRC policy establishes an ex-

" transferred" from a regulated to an exempt or unregu.

plicit and uniform risk framework for making regulatory lated status, exemption decisions. nis policy will also be used by the Commission as a basis for reevaluating existing NRC cx-More recently, Section 10.of the low level Radio-emptions to ensure that they are consistent with the crite-active Waste Policy Amendments Act (11RWPAA) of ria defined herein. In lieu of such a policy, the Commis-1985 ditected the Commission to develop standards and sion could continue the current practice of evaluating procedures and act upon petitions "to exempt specific exemptions on a case specific basis. Such an approach, radioactive waste streams from regulation... due to the however, does not ensure consistent evaluation and con-presence of radionuclides... in sufficiently low concentra-trol of risks associated with exempted practices. For this tions or quantities as to be below regulatory concern."

reason and the reasons discussed above, the Commission ne Commission responded to this legislation by issuing a has established the llRC Policy Statement. his policy policy statement on August 29,1986 (51 FR 30839).That supersedes the Atomic Energy Commission's policy policy statement contained criteria that, if satisfactorily statement on this subject [30 FR 3462; March 16,1965).

addressed in a petition for rulemaking, would allow the Commission to act expeditiously in proposing appropriate The Commission recognizes that Agreement States relief in its regulations on a " practice-specific" basis con-will play an important role in the implementation of the sistent with the merits of the petition.

Below Regulatory Concern policy, specifically in the ar-cas of developing and enforcing compatible State regula-Federal and State agencies have also developed and tions, regulating cleanup and decommissioning of certain implemented similar exemptions based on evaluations of types of contaminated nuclear facilities, and exempting 3

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BRC Policy StatGment certain low level radioactive wastes from requirements sites.nc Commission is also concerned that inconsistent for disposal in licensed low level waste disposal facilitics.

regulation of BRC waste could in fact undermine State ne Atomic Energy Act of 1954, as amended, gives to the and Federal efforts to manage low-level waste safely. A Federal government the exclusive authority to regulate uniform framework for exemption decisions is needed source, special nuclear, and byproduct materials to en-now to avoid disrupting State and compact development sure protection of the public health and safety. While of new disposal facilities close to Congressional mile-Congress subsequently provided for Federal-State agree-stones in 1993 and 1996. Such a framework may also ments under Section 274b of the Atomic Energy Act facilitate the resolution of the mixed waste issues for through which States could assume regulatory responsi-these BRC wastes.

bilities in lieu of Federal regulation for certain classes of nuclear materials, it required that State radiation protec-

%c policy described in this document is intended to tion standards be coordinated and compatible with the provide the public health and safety protection frame.

Federal standards for radiation protection.

work that would apply to a wide spectrum of Commission exemption decisions. As such, it provides individual and NRC regulations exempting BRC wastes will not collective dose criteria, and discusses other important affect the authority of State or local agencies to regulate elements of the exemption decision-making process. Sec.

IIRC wastes for purposes other than radiation protection tion 11 provides definitions of key terms and concepts used in accordance with Section 274b of the Atomic Energy in the policy statement.Section III presents the basic Act. Under the Atomic Energy Act, Congress intended elements of the policy, while Section IV diset;sses how the that there be uniformity between the NRC and Agree-policy will be implemer.ted through rulemakings and li-ment States on basic radiation protection standards. Fu-censing actions and describes how the public will have an ture BRC Rulemakings will establish basic radiation pro-opportunity to comment on the Commission's exemption tection standards below which regulatory oversight is not decisions. His section also notes NRC plans to review needed. he Commission will address compatibility is-past exemption decisions to ensure consistency with the sues in future rulemakings. In initiating proceedings to risk framework described in the BRC policy.Section V implement NRC's BRC policy, the Commission will con-describes, in general terms, the information needed to tinue to consult with and seek the advice of the States, support the exemption decision making process.

Some States have expressed concerns that economic II. Definillons, and institutional impacts of actions resulting from the Commission's BRC policy may undermine their efforts to "ALARA" (acronym for "as low as is reasonably develop new disposal facilities for low-level radioactive achievable") means makmg every reasonable effort to waste in accordance with the Low-Level Radioactive maintain radiation exposure 4 as far below applicable dose Waste Policy Amendments Act of 1985. Dese States limits as is practical, constst ;nt with the purpose for which the licensed activity is und.rtaken taking mto accoont tl state of technology, the economics of improvements m}c would prefer to establish their own standards for deter, mining which wastes should be exempted from regulatory control rather than adopting standards that are compat-relation to benefits to tNe public health and safety, and other societal and soco, cconomic considerations and in ible with uniform Federal standards.ne Commission has developed the BRC policy to provide a uniform and con, relatior: to utilization of nuclear energy and licensed ma-sistent health and safety framework for exernption deci, terials in the public interest.

sions, in so doing, the Commission recognized the Commiss.eement State" means anY State with wh "A8r concerns expressed by Congress when it enacted the low-ion has entered into an effective agreement un-Level Radioactive Waste Policy Amendments Act of 1985 der subsection 274(b)of the Atomic Energy Act of 1954, that health, safety, and emironmental considerations as amended, should take precedence over economic or institutional concerns (see Senate Report 99-199 that accompanied "B) product material" means-S.1517, Senate Committee on Energy and Natural Re-sources, November 22,1985,99th Congress,1st Session (1) Any radioactive material (except special nu-at page 9),

clear material) yielded in, or made radioactive by, exposure to the radiation incident to the ne Commission is confident that waste exemption process of producing or utilizing special nu-decisions made in accordance with requirements that im-clear material; and plement its BRC policy will be adequate to ensure protec-tion of the public health and safety.ne Commission is (2) ne tailings or wastes produced by the extrac-concerned that inconsistent regulation of BRC wastes tion or concentration of uranium or thorium could result in differing levels of risks to the public and from ore processed primarily for its source ma-the emironment through the application of different re-terial content, including discrete surface wastes sidual radioactive criteria in the cicanup of contaminated resulting from uranium solution extraction 4

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t ilRC Policy Stat: ment processes. Underground ore txxiics depleted

" Natural background dose" means the dose received by these solution extmetion operations do not from naturally occurring cosmic and terrestrial radiation constitute " byproduct material" within this and radioactive material but not from source, byproduct, definition.

or special nuc! car material.

  • Collective dose" is the sum of the individual doses
  • Practice" is a defined acthity or a set or combina-tion of a number of similar coordinated and continuing (total effective dose equh'alents) received in a given pc.

acth*itics aimed at a given purpose that involves the po-riod of time by a specified population from exposure to a tential for radiation exposure. Disposal of specified types specified source of radiation (or practice involving the use of very low level radioae:ive waste; the release for unrc-of radioactive material). Note:'Ihc calculated collective dose used to determine compliance with the criterion of stricted public use of lands and structures with residual this policy need not include individual dose contributions levels of radioactivityt the distribution, use, and disposal received at a rate of less than 0.1 mrem per year (0.001 of specific consumer products containing small amounts of radioactive materialt and the recycle and reuse of spc-mSv/ year).

cific types of residually contaminated materials and

" Committed cifcctive dose equivalent"is the sum of equipment at c examples of practices for which this policy the products of weighting factors applicabic to cach of the will have potential applicability. (See Section III for fur.

body organs or tissues that are irradiated and the commit.

ther discussion of practice).

ted dose equivalent to those organs or tissues.

" Item" is the special unit of dose equivalent (1 rem

- 0.01 sicvert).

" Deep dose equhalent" is the dose equivalent at a tissue depth of I cm.

"ldsk " for purposes of this policy, means the annual or lifetime probability o,f the development of fatal cancer

" Dose" or " radiation dose" in this policy is the total fr m exposure to lomzmg radiation and is taken as the effective dose equivalent.

product of the dose received by an exposed individual and a e nycrsion factor based u m the linear, no-threshold

  • Exemption irom regulatory control" refers to a de.

hypothesis.'lhe conversion actor for dose to risk is taken cision process that may allow radioactive material to be to be 5 x 10 fatal cancers per rem of radiation dose.The transicrred from a regulated status to an unregulated fatal cancer risk,s considered, m general, to be more i

status, in which the material will no longer be subject to likely than other radiation induced health effects and to NRC rcquirements. Decisions to grant exemptions will be be the most severe outcome to an individual. While the based upon findings by reason of quantity or concentra-Commission recognizes that the risks from exposure to tion that the radioactive material poses a small risk to mdiation are greater for children than adults and that public health and safety and the environment and that the there are increased risks from exposure to the embryo /

small magnitude of the risk does not warrant expenditure ietus, the estimate of fatal cancer nsk for all ages and both of additional resource 6 of regulatory agencies and the sexes is considered to be an appropriate measure of risk regulated community in attempting to further reduce the from practices being considered for exemption in accor.

risk' dance with this policy statement (see Appendix).

" Exposure" means being exposed to ionizing radia-

" Source material" means -

tion or to radioactive material, (1) Uranium or thorium, or any combination of "llcensed material" means source material, special uranium and thorium in any physical or chemi-nuclear material, or byproduct material that is received, cal form; or possessed, used, transferred, or disposed of under a gen-eral or specific license issued by the Commission or an (2) Orcs which contain, by weight, one twentieth Agreement State.

of one percent (0.0$ percent), or more, of ura-nium, thorium, or any combination of uranium "Ilcensee" means the holder of an NRC or Agree-and thorium. Source material does not include ment State license.

special nuclear material.

" Linear, no-threshold hypothesis" refers to the the-

"Special nuclear material" means -

ory that there is a proportional relationship between a given dose of radiation and the statistical probability of (1) Plutonium, uranium-233, uranium enriched in the occurrence of a health effect (such as latent cancers the isotope 233 or in the isotope 235, and any and genetic effects), and that there is no dose level below other material which the Commission, pursu-which there is no risk from exposure to radiation.

ant to the provisions of Section $1 of the Act, 4

5 1

_m

.g

.I

HRC Policy Statement determines to be special nuclear material, but Such practices should be specifically evaluated to deter.

does not include source material; or mine if they could result in greater risk levels to exposed members of the public than the levels found acceptable (2) Any material artificially enriched by any of the by the Condsion in formulating this policy. These deci-foregoing butdoes not iactude source material, sions clearly fad within the Conmission's purview to pro-tect the health and safety of thc ptiblic

" Total effective dose equivalent" means the sum of in formul.. ting this policy statement, the Commis-the deep dose cquivalent (for external exposures) and the sion deliberated at length on the need to consider committed effective dose equivalent (for internal expo.

whether practices must be ngorously justified in terms of surcs) expressed in tem or sievert, societal benefit regardless of the level of risk they pose.

Justification of practice is recognized by health physics professionals and national and international organiza-111. Polley Elements.

tions as one of the three fundamental tenets of radiation

%c purpose of this policy statement is to establish protection (justification, dose limits, and ALARA). The the risk iramework within which the Commission will Commission has prepared this policy statement in confor-initiate the development of appropriate regulations or mance with these basic tenets as appropriate for exemp-make licensing decisions to exempt certain practices from tion decisions. Consistent with the position of the Inter-some or all regulatory controls. This policy is directed national Atomic Energy Agency in its Safety Series principally toward rulemaking activities but may be ap-Report No. 89, the Commission believes that justification plied to license amendments or license applications in-decisions usua!ly derive from considerations that are volving the release of licensed radioactive material either much broader thaa radiation protection alone. The Com-to the cwironment or to persons who would be exempt mission believes that justification decisions involving so-from Commission regulations. In either case, opportunity cial and cultural value judgments should be made by af-for public comment will be provided with each rulemak.

fccted elements of society and not the regulatory agency, ing and cach licensing action where pencric exemptions Consequently, the Commission will not consider whether provisions have not already been established, a practice is justified in terms of net societal benefit.

It is the Commission's intent to broadly define spe-A.

Principles of Exemption.

cific practices so that the effect of an exemption decision ne principal consideration in exempting any prac-on any mdividual or population will be evaluated in its tice from some or all regulatory controls hinges on the entirety and not in a picccmeal fashion. At the same time, gencral question of whether the application or continu-the practice must be identified and described in terms ation of regulatory controls is necessary to protect the that will facilitate reasonable impact analyses and allow public health and safety and the environment. To decide imposition of appropriate constramts, requirements, and if exemption is appropriate, the Commission must deter-conditions as the radioactive material passes from a regu-mine if adequate protection is provided and one of the lated to an unregulated status (i.e., the material is no following conditions is met:

longer required to be under the control of a lleensee).

Under this policy, the definition of a " practice" in any 1.

The application or continuation of regulatory specific decision (rulemaking or licensing action)is a criti-controls on the practice does not result in any cal feature, ne NRC will ensure that formulation of significant reduction in dose received by indi.

exemptions from regulatory control will not allow delib-viduals within a critical group (i.c., the group crate dilution of materialor fractionation of the radiation expected to receive the highest exposure) and or radioactive material for the purpose of circumventing by the exposed population; or controls that would otherwisc be applicable. The defini-tion of the practice in any specific exemption decision will 2.

The costs of the controls that could be imposed also provide the framework for taking into account the for further dose reduction are not balanced by potential effects of aggregated exposure from that prac-the potential commensurate reduction in risk.

tice together with other exempted practices, as well as the possible consquences of accidents or misuse or the po-At a sufficiently low level of risk, the Commission tential for other nonstochastic radiological irnpacts asso-believes the decision makirig process for granting specific ciated with the exemption.

exemptions from some or all regulatory controls can be essentially reduced to an evaluation of whether the over-The Commission may determine on the basis of risk all individual and collective risks from each particular I

estimates and associated uncertaint;es that certain prac-practice are sufficiently small.He Commission believes tices should not be considered candidates for exemption, th'at individual and collective dose criteria should be basic such as the introduction of radioactive materials into features of its overall policy to define the region where products to be consumed or used primarily by children.

the expenditure of Commission resources to enforce re-6 i

IIRC Policy Statement quirements for further dose reductions or licensee re-accepted as a fact of life and are identical to the kinds of sources to comply with such requirements is no longer risks posed by radiation from nuclear materials under warranted. These specific criteria include (1) values for NRC jurisdiction. These facts provide a context in which the individual annual dose reasonably expected to be to compare quantitatively the radiation risks from various received as a result of the practice (e.g., an average dose practices and make radiation risk especially amenable to to indhiduals in a critical group) and (2) a measure of the use of the approach described below to define an radiological impact to the exposed population. In combi-acceptable IIRC level.

nation, these criteria are chosen to ensure that, for the average dose to members of the critical population group

. The Comrnission believes that if the risk from doses from a given exempted practice, individuals wdl not bc to mdividuals from a practice under consideration for exposed to a significant radiological risk and that the exemption is comparable to other voluntary and involun.

population as a whole does not suffer a significant radio-tary risks which are commonly accepted by those same logicalimpact.

indhiduals without significant efforts to reduce them, then the level of protection from that practice should bc It is important to emphasize that, in this policy, the adequate. Furthermore, for risks at or below these levels Commission does not assert an absence or threshold of there would be little merit in expending resources to risk at low radiation dose levels but rather establishes a reduce this risk further. 'the Commission believes the baseline level of risk beyond which further government definition of a llRC dose level can be developed from this regulation to reduce risks is unwarranted. As described in perspective, the Appendix to this policy ' statement, the technical ra-tionale for the Commission s flRC criteria is explicitly Variations in natural background radiation appar-based on,the hypothesis that the risk from exposure to ently play no role in individuals' decisions on comm'm radiation is linearly proportional to the dose to an individ-matters such as places to live or work (e.g., the 60-70 ual. Ilowever, the presence of natural background radia-mrem differences between average annual doses received tion and vanations in the levels of this background have in Denver, Colorado versus Washington, DC). In addi-been used to provide a persp(.hc from which to judge tion, individuals generally do not seem to tre concerned the relative sigmficance of the radiological risks myolved about the difference in doses between living in a brick m the exemption decision-making process, versus a frame house, the 5 mrem dose received during a typical roundtrip coast to-coast flight, or incremental The Commission notes that adoption of the individ-doses from other activities that fall well within common ual and collective dose criteria does not indicate a deci.

variations in natural background radiation. *lhese factors sion that doses above the criteria would necessarily pre-lead to the conclusion that differential risks correspond.

clude exemptions.The critcria simply represent a range ing to doses on the order of 5-10 mrem (0.05-0.1 mSv)are of risk that the Commission believes is sufficiently small well within the range of doses that are commonly ac-compared to other individual and societal risks that fur-cepted by members of the public, and that this is an thercost risk reduction analyses are not required in order appropriate order,of magnitude for the Commission's to make a decision regarding the acceptability of an ex-IIRC individual dose criterion.

emption. Practices not meeting these criteria may never-theless be granted exemptions from regulatory control on Although the uncertainties in risk estimates at such a case-by-case basis in accordance with the prmeiples low doses are large, the risk to an individual as calculated embodied within this policy, if (1) the potential doses to using the linear, no threshold hypothesis is shown in mdividual members of the public are sufficiently small or Table 1 for various defined levels of annual individual unlikely; (2) further reductions in the doses are neither dose. 'the values in the hypotheticallifetime risk column readily achievable nor significant in terms of protecting are based on the further assumption that the annual dose the public health and safety and the cnvironment; and (3) s continuously received during each year of a 70-year th ective dose from the exempted practice is I fetime.To provide further perspective, a radiation dose of 10 mrem per year (0.1 mSv per year) received continu-ously over a lifetime corresponds to a risk of about 4 chances in 10,000 (3.5 x 10"J or a hypotheticat increase of

11. The Individual Dose Criterion, about 0.25% in an individual's lifetime risk of fatal cancer.

The Commission has noted that, although there is The Commission prefers to use factors of ten to describe significant uncertainty in calculations of risks from low-such low individual doses because of the large uncertain-level radiation, in general these risks are better under-ties associated with the dose estimates.The Appendix to stood than the risks from other hazards such as toxic the policy statement provides a more complete discussion chemicals. Moreover, radiation from natural background of the risks and uncertainties associated with low doses poses involuntary risks (primarily cancers), which must be and dose rates, 7

BRC Policy Statement Table 1 Ilypothetical Incremental liypothetical Lifetime Risk incremental Annual Dose

  • Annual Risk" l' rom Continuing Annual Dose" i

100 mrem (1.0 mSv) 5 x 10-8 3.5 x 10-8 10 mrem (0.1 mSv) 5 x 10-6 3.5 x 10-4 1 mrem (0.01 mSv) 5 x 10 3.5 x 10-8 d

0.1 mrem (0.001 mSv) 5 x 10 '

3.5 x 10-5 L

The expression of dose refers to the Total Effective Dose Equivalent. This term is the sum of the deep [whole body) dose equivalent for sources external to the body and the committed effective [whole body] dose equivalent for sources internal to the body.

" Calculated using a conservative risk coefficient of 5 x 10-* per rem ($ x 10-8 radiation based on per Sv for low linear energy transfer entific Committee on the Effects of Atomic Radiation (UNSCHAR),1988 Report to the General Assembly with Radiation, llEIR V," 1990, Committee on A'mexes and llealth Effects of Exposures to Imw Levels of lonizing(see also NUREG/CR--4214, Rey,1).

Biological Effects of ionizing Radiation, National Research Council In view of the uncertaintics involved in risk assess-straints and conditions imposed by the Commission on E

ment at low doses and taking into account the aforemen-exempted practices, tioned risk and dose perspectives, the Commission finds i

that the average dose to individuals in the critical group

'ihe Commission intends that only under unusual should be less than 10 mrem per year (0.1 mSv per year) circumstances would exemptions be considered for prac-for each exempted practice, in addition, an interim dose tices that could cause continuing radiation exposure to criterion of 1 mrem per ycar (0.01 mSv per year) average individuals exceeding a small fraction of 100 mrem per dose to individuals in the critical group will b( applied to year (1 mSv per year). In rare cases, exemptions of such those practices involving widespread c lstribution of radio.

practices may be granted if, hiter conducting a thorough active material in such items as consumer products or analysis of the proposed exemption, the Commission de-recycled material and equipment, umil the Commission terminu that doses to members of the public are ALARA gains more experience with the potential for individual and that additional regulatory control is not warranted by further reductions in individual and collective doses.

exposures from multiple licensed anj exempted prac.

tices. These criteria provide individual dose thresholds C. The Collective !)ose Criterion, below which continued regulatory comrols are unneces.

sary and unwarranted to require further reductions in The Commission believes that the collective dose individual doses.The Commission considers the nc eriteria (i.e., the sum of individual total effective dose equiva-to be appropriate given the uncertaintica involved in esti-lents) resulting from exposure to an exempt practice I

mating doses and risks, and notes that these criteria should be ALARA. However, if the collective dose re-should facilitate straightforward implerr.cntation of this sulting irom an exempted practice is less than an expected policy in future rulemakings or licensing decisi)ns, value of 1000 person rem per year (10 person Sv per year), the resources of the Commission and its licensees could be better spent by addressing more significant

'1he Commission believes that, notwithstanding ex-health and safety issues than by requiring further analysis, emption of practices from regulatory control under these reduction, and confirmation of the magnitude of the col-criteria. it still has reasonable assurance that exposures to lective dose. The Commission notes that, at this level of individual members of the public from alllicemed activt-collective dose, the number of hypothetical health effects ties and exempted practices will not exceed 100 mrem per calculated for an exempted practice on an annual basis year (1 mSv per year) piven the Commisston's intent (1) to would be less than one, define practices broadly; (2) to evaluate potential expo-sures over the lifetime of the practice;(3) to evaluate the The National Council on Radi;ttion Protection and potential for aggregated exposures from multiple ex-Measurements recommends in its Report No. 912 that empted practices; (4) to impose both individual and col-collective dose assessments for a particular practice l

lective dose criteria;(5) to monitor and verify how exemp-j tions are implemented under this policy; (6) to verify dose

' Recommendations on timits for Exposure to lonizing Radiation, calculations through licensing reviews and rulemakings NCRP Report No. 91, National Council on Radiat on Protection with full benefit of public review and comment; and (7)to

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inspect and enforce licensee adherence to specific con-Bethesda, htD 20814.

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1 8

BRC Policy Stat 3 ment i

should exclude consideration of those individuals whose ing that the assumptions used to define a practice remain anr.ual effective dose equhalent is less than or equal to appropriate as the radioactive materials move from a 1 mrem peryear (0.01 mSv per year). In the sensitivity of-regulated to an unregulated status. Any such rulemaking measure, risk based guidelines used by EPA and FDA, a action would follow the Administrative Procedure Act, 10 ' lifetime risk of cancer has been used as a quantitative which requires publication of a proposed rule in order to criterion of insignificance. Using an annual risk coeffi-solicit public comment on the rulemaking action under cient of 5 x 10" health effects per tem (5 x 10-8 per consideration. The rulemaking action would include an sievert), as discussed in the Appendix, the 10 lifetime appropriate level of emironmental review in accordance risk value would approximate the calculated risk that an with the Commission's regulations in 10 CFR Pan $1, individual would incur from a continuous lifetime dose which implement the National Environmental Policy Act.

rate in the range of 0.01 to 0.1 mrem (0.0001 to 0.001 mSv) per year, if a proposal for exemption results in a Commission regulation containing specific requirements for a particu.

As a practical matter, consideration of dose rates in lar exemption, a licensee using the exemption would no the microtem peryear range and large numbers of hypo-longer be required to apply.the ALARA principle to thetical indh'iduals potentially exposed to an exempted reduce doses further for the exempted practice provided practice may unduly complicate tl.e dose calculations that that it meets the conditions specified in the regulation, will be used to support demonstrations that proposed The promulgatica of the regulation would, under these exemptions comport with the criteria in this policy. The circumstances, t >nstitute a finding that the practice is Commission believes that inclusion of indhidual doses exempted in accordance with the provisions of the regula-below 0.1 mrem per year (0.001 mSv per year) introduces tion and that ALARA considerations have been ade-unnecessary complexity into collective dose assessments quately addressed from a regulatory standpoint. The and could impute an unrealistic sense of the significance Commission in no way wishes to discourage the voluntary and certainty of such dose levels. For all of these reasons, application of additional health physics practices which the Commission concludes that 0.1 mrem (0.001 mSv)per may, in fact, reduce actual doses significantly below the year is an appropriate truncation value to be applied in BRC criteria or the development of new technologies to the assessment of collective doses for the purposes of this enhance protection to the public and the emironment.

policy.

This is particularly pertinent in the area of decontamina-tion and decommissioning, where the Commission antici-pates that emerging technologies over the next several IV. Implementation, decades should enhance existing technical capabilities The Commission's BRC policy will be implemented and further reduce doses to workers and the public principally through rulemakings; however, exemption and where other Federal agencies are in the process of decisions could also be implemented through specific li-developing standards which may affect those receiving censing actions, exemptions, in the first case, a proposal for exemption, whether The second means of policy implementation could initiated by the NRC or requested by outside parties in a involve exemptions that would be granted through licens-petition for rulemaking, must proside a basis upon which ing actions, such as determinations that a specific site has the Commission can determine if the basic pohey criteria been sufficiently decontaminated to be released for unre-have been satisfied.The Commission intends to initiate a stricted public use. The NRC intends to develop guidance number of rulemakings on its own (e.g., to establish a dose regarding the implementation of the llRC criteria to en-criterion for decommissioning) and may initiate others as sure that such site specific actions adhere to the criteria a result of NRC's review of existing codified exemptions and principles of this policy statement. New licensing (e.g., consumer product exemptions in 10 CFR Parts 30 actions that transfer radioactive material to an unregu-and 40). Rulemakings may also be initiated in response to lated status will be noticed in the Federal Register if they petitions for rulemaking submitted by outside parties, differ from previous generic exemption decisions.

such as a BRC waste petition submitted in accordance with Section 10 of the low level Radioactive Waste Pol-One of the principal benefits of the policy is that it icy Amendment Act of 1985. In general, rulemaking ex-provides a framework to evaluate and ensure the consis-emption proposals should assess the potential health and tency of past exemption decisions by the Commission, safety impacts that could result if the exemption were to With the adoption of this llRC policy, th: NRC will be granted, initiate a systematic assessment of exemptiens currently existing in NRC's regulations to ensure that.he public is The proposal should consider the uses of the radio-adequately and consistently protected f rom tl.e risks asso.

active materials, the pathways of exposure, the levels of ciated with exempted practices. In addition, t ic NRC will, radioactivity, and the methods and constraints for ensur-on a periodic basis, review the exemptions F ranted under 9

1 HRC Policy Statement this policy to ensure that the public health and safety volume distribution). Mass and volume averaged con.

continue to be protected adequately, centrations should also be presented. '!he variability of radionuclide concentration, distribution, or type as a V. Information To. Support Exemption function of process variation or variations among licen.

Decisions.

sees should be addressed and bounded, as appropnate.

A.

General, 1 Nonradiological properties.1he nonradiological pr perties of the materials to be exempted thould be 1he information required to support an exemption described to ensure complete charactenzat,on of the i

decision in a rulemaking or licensing action should pro.

properties of the material and consideration of any ad-vide the basis for the proposed exemption in accordance verse impacts associated with these properties. An NRC with Section 111 of this policy,in addressing the radiologi-exemption, based on radiological impacts, would not re-cal health and safety impacts, potential individual and lieve licensees from comphance with applicable rules of collective doses attributed to the practice under consid-cration should either meet the policy's dose criteria or other agencies which cover nonradiological properties. A description of the materials,includir.gtheirongm.chemi-otherwise be demonstrated to be low enough to ensure protection of the public health and safety and ALARA. In cal comysition, physical state, volume, and mass should pmW vanabiht and potential changes in the addition to the impacts of routine exposures, realistic materials as a function o(process variation should be impacts resulting from potential misuse or accident sce-addressed. The variation among licensees should be de-narios should also be evaluated and demonstrated to be scribed and bounded, as applicable.

insignificant.1hc NRC may reject proposals for exemp-tions if they do not provide a sufficicnt technical basis to C.

Practice Characterization support analysis of the potential exemption.

1. Totalimpact. A regulatory action taken under this Practices should be defined with respect to the geo.

policy is likely to be generic and may be nationwide in graphic and demographic areas to which the exemption scale.1herefore, to the extent possible,an estimate of the will apply, in some cases, an exemption will be limited to number of NRC and Agreement State licensees that pos-one particular locality or area. Ilowever, many practices sess the radioactive material considered for exemption, will have national applicability and should be character, the annual volumes and masses, and the total quantities ized accordingly. Information on these issues will be nec-of each radionuclide that would be a part of the exempted essary for determinations regarding which individual dose practice should be given. The estimates should include criterion should be applied, the current situation and the likely variability over thc reasonably foreseeable future. A geographical descrip-The Commission believes that the implementation tion would be a helpful tool in characterizing the distribu-guidance provided with its " General Statement of Policy tion of radioactive material involved in the exemption and Procedures Conceming Petitions Pursuant to 92.802 decision. Such distribution, submitted as part of the prac-for Disposal of Radioactive Waste Streams llelow Regu.

tice characterization, should be used to assess realistic latory Concern," published August 29,1986, 51 FR impacts of the practice,in addition to conservative bound.

30839, generally defines the types of information needed ing estimates that tend to overestimate human exposures to support an exemption decision. Iloweven not all of the and doses, in any case, the typical quantities produced per information may be applicable to the luader range of practice (e.g., number of units of a particular consumer practices considered for exemption under this policy. Ap.

product) and an estimate of the geographic description of plicants'should examine potentially relevant guidance the practice should be described.The potential for short-available at the tirne the exemption proposal is being and long-term recycle or reuse of the product containing prepared and provide the information which is relevan t to the exempted radioactive material should also be ad-the particular type of exemption decision being re.

dressed. Both the resource value (e.g., sah*ageable met-quested.

als) and the functional usefulness (e.g., usable tools) should be examined.

B.

Material Characterization.

1 his At asussment, A description of bases for the

1. Radiologicalpropertirs. The radiological properties materials and practice characterizations should be pro-of the ma'terials to be exempted should be described, vided. Monitoring and analytical data and calculations including, as appropriate, the concentration or contami-should be specified and provided in support of the charac.

nation levels and the half lives, total quantities, and iden-ttion. Actual measurements or values that can be tities of the radionuclides associated with the exempted i to measurements to confirm calculations are im-

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practice. The chemical and physical form of the radionu-im and should be provided. The description should clides should be specified. All radionuclides present or he quality assurance program used in data collec-potentially present should be specified. The distribution tion and analysis and supporting information. lf any sur-of the radionuclides should be noted (e.g., surface or veys were conducted, they should be described. Market 10

11RC Policy Stat: ment information may be useful in characterizing a practice on accurate. Average doses to this group are the controlling a national basis.

factors limiting individual doses and risk, and should be compared with the individual dose criteria, as appropri-J. As low as is reasonably achirrable (AL4RA). An ate. The critical group should be the segment of the analysis should be provided that demonstrates that radia-population most highly exposed to radiation or radioac-tion exposure and radionuclide releases associated with tive materials associated with the use of radioactive mate-the exempted practice overall will be ALARA consistent rial under unregulated conditions.1hc second part of the with the criteria in this policy. The ALARA principle population exposure is the general population exposure, referred to in 10 CFR Part 20 applies to efforts by licen-exclusive of critical group cxposure. For this group, the secs to maintain radiation exposures and releases of ra-individual exposures should be smaller, and the assess-dioactive materials to unrestricted areas hs low as is rea-ment will often be less precise. 'Ihc impacts analysis sonably achievable. Appendix I to 10 C1711 Part 50 de-should present an estimate of the distribution of doses scribes ALARA for radioactive material releases from within the general population. In situations where trunca.

light water reactors (nuclear power plants). Exemption tion of the collective dosc calculation is donc under the proposals should describe how ALARA considerations provisions of this polig, the basis for applying the trunca.

have been applied in the design, development, and imp-tion provision should be provided.

Icmentation of controls for the proposed practice. Licen-see compliance with the ALARA principle must remain

'lhe evaluation of radiological impacts should distin-in effect up to and including the point at which the materi-guish between expected and potential exposures and als are transferred to an unregulated status in accordance events.The analysis of potential exposures in accident or with an exemption granted under this polig.

misuse scenarios should include all of the assumptions, data, and results used in the analysis in order to facilitate D,

impact Analyses.

review,The evaluation should provide sufficient informa-tion to allow a reviewer to independently confirm the To support and justify a request for exemption, cach resu ts. The potential for reasonable interactions be-pctitioner or licensee should assess the radiological and tween the exempted radioactive material and the pubhc nonradiologicalimpacts of the proposed exemption.The should be assessed.

analyses should be based on the characterizations de-scribed previously and should cover all aspects of the

2. Other impacts. The analysis of other radiological proposed exempt practice, including possession, use, mpacts such as those from transportation, handling transfer, o,wnerslu,p, and disposal of the material. NRC processing, and disposal of exempted materials should be consideration of the exemption proposal and any envtron-atuated. Nonradiological impacts on humans and the mental assessments and regulatory analyses required to environment should also be evaluated in accordance with implement the exemption will be based on the impact NRC requirements in 10 CPR Part $1. 'The analysis analyses and supporting charactenzations.

6 ih de W h um taken to provi6 nonradiological protection on radiation L Radiologicalimpacts. The evaluation of radiologi-exposure and reipases of radioactive material. Any NRC cal impacts should clearly address the policy's individual action to exempt a practice from further regulatory con-and collective dose criteria or provide a ' sufficient trol would not relieve persons using, handling, process-ALARA evaluation supporting the exemption. In either ing, owning. or disposmg of the radioactive material from case, the following impacts should be assessed:

other requirements applicable to the nonradiological pr perties of the material.

Average doses to the critical population group; E.

Cost llenefit Considerations (as required),

Collective doses to the critical population group and the total exposed population (under A cost / benefit analysis is an essential part of both conditions defined in Section 111); and environmental and regulatoiy impact considerations.The analysis should focus on expected exposures and realistic The potential for and magnitude of doses asso-concentrations or quantities of radionuclides. The cost /

ciated with accidents, misuses, and recon-benefit analysis should compare the exposures and eco-centration of radionuclides.

nomic costs associated with the regulated practice and alternatives not subject to regulation. Benefits and costs The collective doses should be estimated and should be considered in both quantitative and qualitative summed in two parts: total dose to the critical population terms. Costs of surveys and compliance verification dis-group and total dose to the exposed population. The cussed under item V.G. should also be covered. AnyIcgal critical group is the rclatively homoge neous group of indi-or regulatory constraints that might affect an exemption viduals whose exposures are likely to be the greatest and decision should be identified. For example, one such con-for whom the assessment of doses is likely to be the most straint might stem from Department of Transportation 11

,.m

I BRC Policy Statement (DOT) requirements for labeling, placarding, and mani-example requirements and show their effectiveness and festing radioactive materials in 49 Cril Part 173.

feasibility, l'or site specific license amendments, the ex-emption propont should provide specific requirements Fa Constralats, Requirements, or Conditions on for Quality Assuranec/Ouality control and Iteporting themptions, that have been tallored to the licensec's program.

/

In rnost cases, the characterizations of the material

1. Quality assurancriquality ccmtrol. 'lhe program to and the assessment of impacts will be based on either ensure compliance with specific exemption constraints, explici or implicit constraints, such as limitations on the requiremc'its, or conditions should be defined. The re.

t amount of radioactive material in a consumer product, in cords of inventory, tests, surveys, and calculations used to order for an exemption decision to take credit for these dernonstrate compliance with the exemption constraints constraints, the exemption proposal should specifically should be maintained for inspection. Such programs arc identify appropriate constraints, such as quantity limits, necessary to provide the NitC and the public reasonable concentration limits, and physical form characteristics.

assurance of conformance with the constraints and The bases on which these constraints are to be ensured of adequate protection of human health and the should also be discussed. In general, constraints should be environment, verifiable in order to provide the basis for an exemption decision.

2. Reports. Reports may be required from licensees who, by rule or license, are permitted to release materials G. Quality Assurance and Reporting, cwmpted fr m regulatory control. Associated record-kr eping to generate the reports should be defined, hiini-This portion of the exemption proposal should be mum information in the reports could include volume, tailored to either a generic petition for ru!cmaking or isotope and curic content hiore detailed recordkceping specific proposal for a license amendment. For generic and reporting requirements may be imposed to address petitions for rulemaking, the proposal should provide and uncertaintics in projecting future volumes or amounts of justify generic requirements for Quality Assurance / Qual.

cxempted materials and to consider the cumulative im.

ity Control and lleporting. Such proposals thould include pacts of multiple exemptions.

i i

i 1

12

IIRC Poli:y St:tement 1

APPENDIX-DOSE AND HEALTil EFFECTS ESTIMATION 1.

Dose Estimation from the observed effects at much higher doses and dose ratesmds rmhs b dgnpant uncenaWy in M csu-In estimating the dose rates to members of the pub-mates as renecte@y thews of experts in the field.1 or lic that mi ht arise throu8 various Eractices for which cxampic, the Committee on the Iliological Ilffects of 8

h exemptions are being considered, the Commission has lonizingRadiation(11EIR111 of theNational Academyof decided to apply the concept of the " total effective dose Science cautioned that the ' risk values are "... based on equivalent. *lhis concept, which is baf.ed on a comparison incomplete data and involve a large degree of uncertainty, of the delayed health effects of ionizing radiation expo-especially in the low dose region." *lhis Committec also sures, permits the calculation of the whole body dose stated that it "...does not know whether dose rates of equivalent of partial t>ody and organ exposures through amma or x. rays (low LET; low linear energy transfer use of weighting factors.The concept was proposed by the radiation) of about 100 mrads/ year (1 mGy/ycar) are det-International Commission on Radiological Protection rimental to man." Mol e recently, the llEIR V Committee (ICRP) in its Publication 26 issued in 1977. Since that of the National Academy of Science / National Research time, the concept has been reviewed, evaluated, and Council stated that it "recognires that its risk estimates adopted by radiation protection organizations throughout become more uncertain when applied to very low doses, the world and has gained wide acceptance. The ' total Departures from a linear model at low doses, however, cfIcctivedoseequivalent conceptisincorporatedin Ra-could either increase or dccicase the [ estimation of] risk diation Protection Guidance to Federal Agencies for Oc-per unit dose" The Commission understands that the cupational 11xposure-Recommendations Approved by Comm'ttecs' statements reflect the uncertaintics in-the President,, that was signed by the President and pub-volved in estimating the r;sks of radiation exposure and do lished in the Federal Register on January 27,1987 (5.171 not imply either the abwnce or presence of detrimental 2822). the Commission recogni7cs that, in considering cifects at such low dose levels.

specific exemption proposals, the total effective dose equivalent must be taken into account.

  • Ihc United NaGons Scientific Committee on the Effects af Atomic Radiation (UNSCEAR) stated in their
11. EstimatingIlcalth Effects From Radiation 1988 Report to the General Assembly that "...there was a Expostire need for a reduction factor to modify the risks (derived at high doses and dose rates)...for low doses and dose A. Individual Risks.

rates....[ A]n appropriate ranpc (for this factor) to be ap-In the establishment of its radiation protection poli

  • plied to total risk for low dose and dose rate should be cies, the Commission has considered the three major between 2 and 10." This factor would lead to a risk coeffi.4 types of stochastic (i.e., random)hcalth effects that can be cient value between ? x 10'8and 3.5 x 10"per rad (7 x 10 caused by relatively low dotes of radiation: cancer, genetic and 3.5 x 10 per Oy) based on an UNSCEAR risk toeffi-4 4

effects, and developmental anomatics in ietuses. The cient of 7.1 x 10" per rad (7.1 x 10 per gny)for 100 rad NRC principally focuses on the risk of fatal cancer devel-(1 gray) organ nosorbed doses at high dase rates. *lhe opment because (1) the mortality risk represents a more report also stated,"The product of the risk coefficient severe outcome than the nonfatal cancer risk, and (2) the appropriate for individual risk and the rcles ant collective mortality risk is thought to be higher than the risk associ*

dose will give the expected number of cancer deaths in the ated with genetic effects and developmental effects on exposed population, provided that the collective dose is at fetuses.:llowever, even though radiation has beca shown least of the order of 100 person.Sv (10,000 person rem).

to be carcinogenic, the development of a risk factor appli-If the collective dose is only a few person.Sv (a few hun-cable to con 6.nuing radiation exposures at levels equal to dred person. rem), the most likely outcome is 7ero natural backgt nund3 requires a significant extrapolation deaths."

'N*i[ksYt1YntIRNtN'NiYrl'NtuYsIe'n'tN ""

In December 1989, the Ill!!R V Committee pub.

Committee on the Ifflects of Atomic Radiation (UNSCliAR).

lished a report entitled "llcalth Effects of 11xposure to a

1988 Report to the General Assembly with Annexec.

I ow lxvels of lonizing Radiation," which contained risk at n (excl n ra'-

estimates that arc, in general, similar to the findings of kEhing

, a7u al ackg oun don) results in individual doses of about 90 mrem per year (0.9 mSv/yr).while in Denver. Colorado, the value is about 160 mrem

  • De heaht cafects clearly attributable to radiation have occurred pcr year (1.6 mSyryr). In both cages. naturally occurring radioac.

principally amon earfy radiation workers, survivors of the tive material in the human body contributes approximately 40 atomic bomb en osions at llirmhima and Nagasaki, individuals miem per year. Radiation from inhalation of the daughter prod.

expmed for met ical purpmes, and leoratory ammals, Natural 2

pcts of radon contributes an average adAtioaal dose of 2u0 background radiation causes an annual thwe that iut least two mrem per year 12 mSv/yr) to mend,ers of the U.S. population orders of magnitude less than the dme receWed by human popu-latiom from which the cancer risks are dettved. laperiments at (NCRp Report No. 93. *1onizing).Radiahon F.xpmure of the the cellular level, however, prmide similar indications of biologi.

population of the United States' cal effects at km dmes.

q 13

liitC Pohn Statement the 1%8 UNSCl.All report. The Ill;lR V report's esti-based on the further assumption that the annual dose is mate of lifetune excess nsk of death from cancer follow-continuously received dunng each year of a 70 year life-ing an acute dose of 10 rem (0.1 Sv)of low 1.1"I radiation time. To provide further perspective, a radiation dose of was S x 10. lakmg into account a dose rate effectiveness 10 mrem per year (0.1 mSv per year) received continu-4 factor for doses occurring over an extended period of ously over a hfetime corresponds to a hypothetical in-time, the nsk coefficient is on the order of $ x 10" per crease of about 0.25% in an individual's lifetime nsk of sem, consistent with the upper level of risk estimated by cancer death. Ten milhrem per year (0.1 mSv per year)is UNSCl!All.

also a dose rate that is a small fraction of naturally occur-ring background radiation and comparable to the temp &

In view of this type of mformation, the NitC, the ral vanations in natural background radiation duc to fluc-linvironmental Protection Agency, and other national tuntions that occur at any specific location, and mteniational radiation protection authonties have estabhshed radiation protection standards defming rec-

'lhe Commission prefers to use factors of ten to ommended dose hmits for radiation workers and mdivid-describe such low mdividual doses because of the large ual members of the pubhc. As a matter of regulatory uncertamties associated with the dose estimates. Use of prudence, all these todies have denved the value pre-values such as 0.7 or 12 imputes a sigmficance and sense sumed to apply at lower doses and dose rates ass iemted of certainty that is not justified considenng the levels of with the radiation protection standards by a linear ex*

uncertainty in the dose and risk estimates at these low trapolation f rom values denved at higher doses and dose levels. lhus, order of magnitude values such as 1 and 10 rates. this rnodel is ficquendy refeited to as the hncar, are preferable to avoid providmg analysts and the pubhc no-thteshold hypothesis, m which the nsk f actor at lo*

with a sense of certainty and significance that is not com-doses reflects the straight line (hnear) dose effect rela-mensurate with the actual precision and certainly of the tionship at ruuch higher doses and dose rates, in this estimates.

respect. the lilillt V report notes that "m spite of evi-dence that the molecular lesions which give rise to so-

11. Collective or Population Risk matic and penetic damage can be repaired to a consider-able degree, the new data do not contradict the hypo he-In the apphcation of the fundamental principles of sis, at least with respect to cancer induction and heredi.

radiation protection, collective dose provides a useful way tary genetic effects, that the frequency of ruch cifects to express the radiological impact (i.e., potential detn-mereases with low-level nidiauon as a Imcar, non thresh.

ments)of a practice on the health of the exposed popula-old function of the dose.*

tion. Ilecause of the stochastic nature of risk, analysis of evposures of large groups of people to very small doses The Commission, m the development of the llRC may r esult in calculated health effects in the population at pohn, is f aced with the issue of how to characterize the large. Collective dose is the sum of the individual total individual and population risks associatt 3 with low doses effective dose equivalents resulting from a pnictice or and dose rates. Although the. uncertainties are large, use-source of radmtion exposure,11 is used in comparative ful perspective on the boundmg risk assocmted with very cost benefit and other quantitative analytical techniques low levels of radiation can be provided by the Imcar, and, therefore, is an important factc,r to consider in bal-no threshold hypothesis. Consequently, such risk esti-ancing benefits and societal detnments m applying the mates have been a pnmary factor in estabhshmg individ.

Al.AR A pnnciple. For purposes of this policy, individual ual and collective dose criteria associated with this policy.

total effective dose equivalents less than 0.1 mrem per The estimations of the low nsk from potentially exempted year (0.001 mSv per yearl do not need to be considered in practices can be compared to the relatively higher poten-the cstimation of collective doses. The Commission be-tial risks associated with other activities or decisions os er lieves consideration of individual doses below 0.l mrem which the NRC has regulatory responsibility. Through per year imputes a sense of significance anu certainty of such compansons, the Commission can ensure that its their magnitude that is not justified considenng the inher-radiation protecuan resources an i those of its beensees ent uncertainties in dose and nsk estimates associated are expended in an optimal manner to accomplish its with potentially exempted practices. The Commission public health and safety mission.

also notes that doses in the range of 0.01 to 0.1 mrem per year correspond approximately to lifetime nsks on the in this context, the nsk to an mdividual as calculated order of one in a million. The NRC has used collective using the knear, no-threshold hypothesis is shown m 'Ia-dose, including rationales for its truncation, in a number ble 1 for var ous defmed levels of annual individual dose.

of rulemakmg decisions and m resolving a variety of ge-The values in the hypothetical lifetime nsk column are nene safety issues.

14

i URC Policy Statement I

t Table 1

}lypothetical incremental Hypothetical Lifetime Risk Incrementh! Annual Dose

  • Annual Risk" I' rom Continuing Annual Dose" 100 mrem (1.0 mSv) 5 x 10-s 3.5 x 10-8 10 mrem (0.1 mSv) 5 x 10-'

3.5 x 10-*

1 mrem (0.01 rnSv) 5 x 10 3.5 x 10-8 4

0.1 mrem (0.001 mSv) 5 x 10-8 3.5 x 10 5 The expression of dose refers to the Total Effective Dose Equhalent.This term is the sum of the deep (whole body) dose equivalent for sources external to the body and the committed effective [whole body} dose equivalent for sources internal to the body.

Risk coefficient of 5 x 10-' per tem (5 x 10-8 per Sv) for low linear energy transfer radiation has been conserva-tively based on the results reponed in UNSCEAR 198S (Pootnote 2) and BEIR V (see also NUREO/CR-4214, Rev.1).

III. Dose and Risk Estimation Commission would consider exempting from regulato.y control must be based on input of these measurements

'Ihc Commission recognizes that it is frequently not into exposure pathway models, using assumptions related possible to measure risk to individuals or populations to the ways in which peopic might become exposed.'lhese directly and, in rnost situations, it is impractical to meas.

assumptions incorporate sufficient conservatism to ac-ute annual doses to individuals at the low levels associ.

ated with potential exemption decisions. Typically, count for uncertainties so that any actual doses would be radionuclide concentrations or radiation dose rates can expected to be lower than the calculated doses.The Com-only be measured before the radioactive material is re-mission believes that this is an appropriate approach to be leased from regulatory control. Estimates of doses to taken when determiningif an exemption from some or all merr.bers of the public from the types of practices that the regulatory controls is warranted.

  • lhe additional views of Commissioner Curtiss and Chairman Carrr's comments are attached.

Dated at Rockville, Maryland, this day of _

_,1990.

F r the Nuclear Regulatory Commission.

I mh Owe

~damm a. Ct K

b ecretaryof e Commission.

S 1

15

ERC Polley St:ttment Additional Views of Commissioner Curtiss I strongly endorse going forward with a comprehensive high, when viewed in the context of other risks that we policy that will estabhsh a disciplined and consistent regulate and in view of the fact that the purpose of this Iramework within which the Commission can define those Policy Statement is to esthblish a framework for identify-practices that,irom the standpoint of radiological risk, we ing those practices that the Commission considers to be consider to be below regulatory concern (llRC). The prin-below regulatory concern.

cipal advantage of such a policy, in my view, is that it will bring much needed discipline and technical coherence y lleyond this, if the coilective dose criterion is to be de-the patchwork of IIRC regulatory decisions that have fined as the floor to ALARA (as I would propose bciow),

been rendered to date, providing a clearly articulated, a more conservative approach to establishing a collective risk based approach for reaching decisions on matters dose criterion is warranted in view of the fact that doses such as-(l) the release for unrestricted public use of may be truncated in the calculation of collective dose and lands and structures containing residual radioactivity,(2) the collective dose criterion may be applied to single the distribution of consumer products containing small licensing actions.

amounts of radioactive material,(3) the disposal of very For these reasons, I do not support a collective dose low-level radioactive waste, and (4) the recycling of criterion of 1000 person rem. Instead, in view of what slightly contaminated equipment and materials. A coher.

appears to be the prevailing technical view on this matter, ent, risk based policy is urgently needed to provide the I would endorse a collective dose criteriou of 100 person-foundation for future regulatory actions in cach of these

'C" areas. Accordingly,I strongly support this initiative.

A1 ARA There are certain aspects of this policy, however, with I would define the individual and collective dose criteria which I must reluctantly disagree. My views on these matters follow:

as floors to ALARA.8 Unfortunately, the policy State-ment is equivocal on this issue, suggesting at one point that the individual and collective dose criteria should be Individual Dose Criteria construed as floors to AIARA -

I support the individual dose criteria of 10 millirem per year for practices involving potential exposures to limited

[ A) licensec,,, would no longer be required numbers of the public and 1 millirem per year for wide-to apply the ALARA principle to reduce spread practices that involve potential exposures to large do.cs further for the exempted practice numbers of the public,in view of the potential for multi.

provided that it meets the conditions speci-ple exposures from widespread practices, however, and in fied in the regulation.

the interest of administrative finality, I believe that the Commission should establish the 1 millirem criterion as a but then going on to send what I consider to be a conflict-final criterion, rather than an interim value, ing and confusing message about what the Commission expects -

Collective Dose Criterion The Commission in no way wishes to dis-I do not support the establishment of a collective dose courage the voluntary application of addi-criterion at a level of 1000 person rem. This level is an tional health physics practices which may, in order of magnitude higher than the level recommended fact, reduce actual doses below the BRC cri-in I AEA Series No. 89, as well as the level recommended teria or the development of new technolo-by most other international groups. Furthermore, it is an gics to enhance protection to the public and order of magnitude higher than the 1986 collective dose the environment (emphasis added),

to members of the public duc to effluents from alloperat-ing reactors, the most recent year for which figures are if the Commission intends to say, as I believe it does in availabic, this Policy Statement, that those practices that fall within

'h A collective dose criterion of 1000 person-rem would

' !iveid Ug"Ns*,'h l[haWh

.e lect e i

i agven practiceberefore, adoption of the lower tAliA va mean, for example, that if, pursuant to this Policy State-ment, the Commission were to exempf on the order of j,,,[d AtNa*nat$":III[N!!*m'idieEOnN fifteen separate practices with collective doses at or near approve practices such as smoke detectors that invob large

[

e cgdgmgrs flhe puhh

, gumgo,f ppe;tg'r,,egulatory ob (ation to perform fu the exemption level of 1000 person-rem-not an unrea-ui,,

g sonable expectation, given previous practiCc-We would are relieved from the project somewhere between 5 and 10 excess health ef-AtARA analyses below these levels ti individual doses are 1 iects annually. I consider this level to be unacceptably milhrem/10 milhrem vid the collective dose is 100 person-tem, 16 j

liitC Policy Stateraent the indnidual and collective dose criteria can be desig-from all other practices, will inevitably lead to confusion.

nated below regulatory concern, it is unclear why the Morcover, this approach poses the very real potential i

Commi.<sion would then go on to say that it expects addi-that the Commission could, on the one hand, reject a tional sttps to be taken to keep exposures ALARA. As a practice involving children (e.g., baby food, pacifiers, and j

general matter, I do not object to the ALARA concept.

the like) on the ground that the risk posed by such a Ind:cd, I support the notion that collective dose and practice is too high, yet authorize a practice directed at ALARA analyses should be performed in a manner that the general public that could, coinciventally, expose an is consistent with basic national and international radia-even greater number of children, even though the prac-tion protection principles. Ilut in the context of a Policy tice itself is not specifically directed at children.

Statement on Below llegulatory Concern, for tbc Com-mission to say on the one hand that the individual and in my view, this ambiguity should be resolved in favor of a collective dose criteria reflect levels below which no regu.

clear and unequivocal statement endorsing the principle latory resources should be expended, while at the same of justification of practice. While I acknowledge that the time encouraging voluntary ALAllA cfforts to achieve principle of justification of practice calls upon the Com-lower doses, sends a confusing regulatory message.3 For mission to make decisions involving so called questions of the sake of regulatory clarity, I would explicitly identify

" societal value," that is an insufficient reason,in my view, the individual and collective dose criteria as floors to to step back from this widely accepted health physics principic. Indeed, the Commission already takes such ALARA.

considerations into account, cithe r explicitly or implicitly, justification of Practice in many of the decisions that it renders.

On the issue of justification of practice, the Policy State-Accordingly, in view of the central role that the justifica-ment is unclear as to when and under what circumstances tion of practice principle has played in health physics the justification of practice prmetple would be applied. At practice, as well as the compl::xity and coniusion that will one point, the Policy Statement provides that:

Invariably result from the approach set forth in the Policy Statement, I wwld s, tate explicitly in this Policy State-The Commission believes that justification ment that the Commission rettuns the prerogative to de-decisions involving social and cultural value termine that specific ractices may be unsuitable for ex-judgments should be made by affected cle-emption,regardlesso risk,documentingsuchdetermina-ments of society and not the regulatory tions on a case by case basis, agency, Consequently, the Commission will not consider whether a practice is justified Agreement State Compatibility in terms of net societal benefit.

With one exception,I concur in the general approach that At another point, the Policy Statement indicates that:

this Policy Statement takes on the issue of Agreement State compatibility. The onc area where I disagree in-The Commission may determine on the ba-volves the treatment of matters involving low level thdio-sis of risk estimates and associated uncer-active waste disposal.

taintics that certain practices should not be As I understand the position of the majority, the approach considered candidates for exemption. ::uch established in this Policy Statement, and to be imple-as the introduction oi radioactive materials mented in the context of subsequent rulemaking initir-into products to be consumed or used pri.

tives, will be considered a matter of strict compatibility for marily by children.

Agreement State programs. As a consequence, the ap-This bifurcated approach to justification of practice, proach taken by individual Agreement States on IlllC which appears to distinguish practices involving children issues must be identical to the approach taken by the Commission. I disagree with this approach for the follow-greas m

' I am also concerned that the approach to AtARA set forth in the Pohey Statement appears to be motwated, in part. by a concern that the linvironmental Protection A k may at some When Congress enacted the low 1.evel Radioacthc i pa ticular Waste Policy Amendments Act of 1985 (Lt.itWPAA),it f,u1,7gngorgiringent criteria for 11 vested in the States the responsibility for developing new 9

'this [ approach 'o At ARAl is particularly pertinen t low. level radioactive waste disposal capacity, indeed, the in the area of decont'imination and decommission-Congress recognized at the time that the States were

'"g g,7,[',',[n t$n $

[c a[aficNh[

uniquely equipped to handle this important responsibil-8 P

ity. Accordingly, the States were given a great deal of o

reiving exemptions, latitude in deciding how best to proceed with the develop-h"e'e#tiveYi rnhut aSu*nIaId dYle:Mh>Nr'atN[r ment, construction, and operation of new low-level waste than with an eye twards trying to anticipate what icy 1:PA disposal facilitics. To take one example, Congress might estabbsh in the future.

17

I BRC Policy Statement recognized that some States may decide to construct fa-rather than requiring such waste to be transported acro'ss cilitics that, from a technical standpoint, go beyond the the country to a licensed low level waste disposal facility, requirements established in 10 CFR Part 61 for shallow if examples such as this constitute the basis for declaring land burial facilitics; for this reason, Congress directed that a health and safety concern exists such that the Com.

the NRC to develop guidance on alternatives to the shal-mission should, in turn, prohibit a State irom requiring Iow land burial approach reflected in Part 61 (see Sec-such waste to be disposed of in a licensed low level waste tion 8 of PL,99-240). Similarly, should a State decide to disposal facility, then a more disciplined and persuasive.

require radioactive wastes beyond those defined by the presentation of the argument is needed. To date, I have NRC as Class A, B, and C wastes to be disposed of in a yet to see such a case.6 In the absence of a health and regional disposal facility, the Act permits the States that safety concern, it is incongruous, in my judgment, to say option as well (see Section 3(a)(2) of P.L 99-240).* In that the risk from a particular waste stream cim bc I,o short, the 11RWPAA grants States a great deal of lati-insignificant as to be "below [NRC's] tegulatory con-4 tude in deciding what kind of facility to build and what cern." but at the same time insist that we nevertheless types of waste will be disposed of in that facility, so long have a sufficient interest to dictate how a State might as-(1) the facility complies with the requirements of otherwise wish to handle that waste stream.e 10 CFR Part 61 and (2) the State provides disposal capac-ity for Class A, B, and C wastes.

For the foregoing reasons, I would not treat the Federal policy on below regulatory concern, as set forth in this if one interprets the 11RWPAA in this manner, as I do, Policy Statement and subsequent rulemakings, as a mat.

then in my judgment it is consistent with this general ter of compatibility for Agreement States when it comes approach to conclude that this Policy Statement (and the to issues involving commercial low level radioactive waste subsequent rulemaking initiatives implementing the Pol-

disposal, Icy Statement) should not be considered matters of com-patibility.The result of such an approach would be that a nis kind of intornation may well be a part of the waste stream -

individual States would be allowed the option of deciding petition that the nuclear utshhes are relottedly p eparin for whether low level wastes designated HRC by the Com-

' "'*Nn'dNeN "No7'in hlIdTSt thf 'p'dn"8 quc 1 ve mission under this Policy Statement should nevertheless p"i to see s healih and saEigiustification that would supp

$pg",7ffh C nininjonc uSder this Policy" statement lqtjhauta i

be disposed of in a licensed low level radioactive waste 8,

,e designated disposal facility, low-level radioactive waste despinal facilities.

The argument, as I understand it, that is advanced in

  • ne at!ument has been made that $ispned"of in licens 8 tion of rmittm states the tow.

support of the approach taken in the Policy Statement-giri g ime waste streana to be da**) f*'kiI7tseNd "$'o"n"Ee*M$ d i

and E d indeed, this appears to have been one of the princip that the Commission's position on HRC should be a mat-n p

ter of compatibility - is that States should be foreclosed cerns from departing in any way from the approach established advanced in the Commission's 1986 Policy Statement on BRC, by the Commission.To take the most visible and contro-y,*,$,'j'M;"j",,'t l "fP'y'[,'y "((nN [n*ble nation-

  • i '.tY i'

it g

versial example that has arisen to date, this would lead to dug ] sites and the lilR concept should be applica g;,,g,d',ryolg['l,d in the 1986 Po' j,'g8Jjl,',m works gng

- the result that a State could not require that low level h

m waste streams designated HRC by the Commission never-that the commision dec a e Statement that theless be disposed of in a licensed low level radioactive tliaemakin inntins petitions ton 11R ill be made a future *lf comh839 natier e tib for Agreement States " O hey Statement, waste disposal facility,

$1 fedReg 3 840 August 29,1986D. Whatever merit -

that approarh might have h(ad at the time, I disagree with it for I am not awarc of any public health and safety rationale two reasons- (1) congress has vested states with the reig*nsibihty

  1. "M"of $is,"UsN""iN"iM") #hiEed NcN*

involving low level wastc disposal that has been advanced

[,*d 8 d i

as a basis for the NRC to insist that the Commission's ins decisions about whether states prefer to require uRC waste streann to be di med of in heensed low-level waste sites rather

. position on BRC should be a matter of compatibility for I'gf

- Agreement States. One hears the anecdotalinformation N,"fg"7,3t und[nh*[>f dI$1 U0 ""iy uk" der $'e$'"'m' (c2: at about reducing exposures to truck drivers by allowing the { resent time and, for this reason,Th concern about usband-BRC waste streams to be disposed of in local landfills, jaMd.he Mn'b"*$iMe khanigt lt d d i

e nt.

dispue of radium waste in its regional dissmal facility seems to a

of

  • Indeed, the Commission did not object when the Rocky Moun-

$s; ge

,3 g(mj d g Qe

\\

n tain compact pronmed to dogme of radium waste in iie Rocky consideration-Mountam compact site.

18 l

llRC polin Statement Chairman Carr's Response to Commissioner Curtiss' Views on the HRC Policy Statement I am proud of the Commission's accomplishment in interim Individual Dose Criterion completing a comprehensive Below Regulatory Concern On the first itsue, Commissioner Curtiss would pre-palicy statement. I appreciate Commissioner Curtiss' cn-fer to establish the 1. millirem per year criterion as a final thusiasm and strong support for t>c policy. Commission criterion, rather than an interim value, deliberation of such views has helped to forge a compre.

hensive risk frarnework for ensuring that the public is As stated in the IIRC policy, the Commission is protected at a consistent level of safety from existing and establishing the 1 millirem per year criterion as an in.

Iuture exemptions and releases of radioactive materials to the general environment.'Ihc framework should also be terim value until after it develops more experience with helpful in allowing NRC, States, and the public to focus the potential for individual exposures from multiple li-resources on reducing the more significant risks under ccnsed and exempted practices.The widespread practices NRC's jurisdiction. I offer the following response to to which this criterion applies are primarily consumer Commissioner Curtiss' thoughtful views in the spirit of products, which could involve very small doses to large the constructive prwess that has culminated in the IIRC numbers of peopic.The 1 millfrem criterion was selected

polig, specifically to address the possibility that members of the public may be exposed to several exempted practices.

As with many of the issues that the Commission Simply put, exposure of an individual to a handful of deals with, there were very few right and wrong solutions exempted practices could result in annual dor.cs close to to the issues associated with the llRC policy. The Com.

100 millirem if each practice were allotted individual mission reached its decisbos on the policy by selecting doses up to 10 millitem per year. This is highly improb-preferred solutions from among a spectrum of possible able given the Commission's plans to closely monitor any policy options. These decisions were made based on the overlap of exposed populations from exempted practices Commission's technical analysis of the issues associated as well as the aggregate dose to the public from exemp-with regulamry exemptions, legal interpretation of gov-tions. Nevertheless, NRC does not presently know how crning legislation, and regulatory experience in approving many exemption requests will be submitted by the public, exemptions since the birth of civilian uses of nuclear how many will be approved, and what types of doses will materials in the 1950's. I believe Commissi6ncr Curtiss' be associated with the exemptions. IIfew exemptions are views on selected issues constitute part of the continuous requested and granted, the probability of multiple expo-spectrum of policy options. Ilowever, for the reasons sures from exempted and licensed practices exceeding n articulated below, I affirm the Commission's decision to sobstantial fraction of 100 mi!!irem per year is consider-approve the policy statement in its present form and ably reduced. Therefore, the 1 millirem per year crite-reject the differing views put forth by Commissioner Cur.

rion may be too restrictive and the regulatory resources L

tiss.

associated with its implementation may be better spent to control more significant risks. Consequently, the 1 mil.

lirem per year criterion was selected as an interim indi-Commissioner Curtiss clearly endorses the policy vidual dose criterion to ensure that the sum of all expo-and the concept of establishing a comprehensive frame.

sures to an individual from exempted practices does not work for making decisions on regulatory exemptions.

exceed a substantial fraction of 100 millirem per year.

Ilowever, he takesissue with five elements of the policy:

This criterion will remain an interim value until after the (1)the interim nature of the 1 millirem per year criterion Commission gains experience with the potential for mul-for practices with widespread distribution,(2) selection of tiple exposures to exempted and hcensed activitics.

l' the 1000-person-rem per year criterion for collective dose,(3) the manner in which the Commission views the The initial rulemakings to implement the policy, llRC criteria as a " floor" to ALAR A, (4) omission of the particularly in the area of consumer product exemptions, principle of justification of practice, and (5) making IIRC should provide valuable insights into the validity and ap-rules an item of compatibility for Agreement State pro.

propriateness of the 1 millirem criterion in terms of its 3

grams.These issues were fully considered by the Commis-need to protect the public against multiple exposures to sion and the NRC staff in the course of developing the nuclear materials. Although I agree with Commissioner llRC policy. Indeed, Commissioner Curtiss voted in Sep-Curtiss that a final criterion would be desirable from the l

tember 1989 to approve the IIRC policy, the essence of standpoint of" administrative finality," it would be prema-which is preserved in the final llRC policy in today's tu : to establish the 1 millirem criterion as a final crite-notice.

non until after the Commission gains more experience 19

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BRC Policy Statem:nt iL I

(with exemptions of prectices with widespread distribu-constrain decisions on exemptions without an adequate

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, tion..

health and safety or environmental basis, r

~ Collective Dose Criterion llased on these provisions, the Commission selected the value of 1000 person-rem / year as a level of collective

, Commissioner Curtiss would have preferred to dose that ensures less than one health effect rpractice.

adopt a collective dose criterion of 100 person-rem /ycar in selecting this value, the Commission rel' on contem.

because of his view that this value is more conststent with porary recommendations of expert national and interna.

. the prevalent technical view on this matter.

tionalixxlies.These included the 1988 conclusions of the -

United Nations Scientific Committee on the Effects of

. For the reasons discussed below, I believe that a Atomic Radiation (UNSCEAR) that collective dose cali collective dose critcrion of 1000 person-temlycar is more egi,ggon, o,,1y provide reasonable estimates of health consistent with the prevalent technical view on this mat' risks if the collective dose is at least of the order of 10,000

- ter and provides,a sounder regulatory basis for making peren-rem This value is an order of magnitude greater exemption decisions. The Commission considered two than the value of the collective dose criterion selected by.

fundamental questions associated with the collective dose the Commission. UNSCEAR also stated that the most criterion: (1)is there a need for a collective dose criterion likely outcome of collective doses on the order of a few and,if so,(2) what should the value of that criterion bc?

hundred person-tem is zero deaths.

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The Commission initially questioned the very need Mc Commission also considered the magnitudes of j

' for a collective dose criterion for the types of practices collective doses associated with practices, primarily con-L that would be considered as potential candidates for ex-sumer products, that have already been exempted by the -

emption. This questioning was based on a number of Commission. This was done to provide a benchmark for

= factors that indicated that the Commission may not need the value of the collective dose criterion based on histori-

)

to consider collective dose in making exemption deci-cal decisions that the public found acceptabic. The Com.

~t sions. Dese factors included:

mission found that the magnitudes of the collective doses for these exempted practices fell in the range of the 1000 i

L Thereisconsiderableuncertaintyassociatedwith person-remlycar dose. Specific examples inctude 1200 I

~ the validity of risk estimates based on projections of col-person-remlycar from watches whose dials are adorned.

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lective doses composed of small to very small doses to w th paint containing intium,800 person-rem / year from

. large numbers of pcopic, smoke detectors containing radioactive materials, and 8600 person-rem / year from gas mantles for lanterns that

2. The individual dose criteria of 1 and 10 millirem

.contain thorium (NCRP Report No. 95). '

i 1

per year, coupled with the other provisions of the pohey (e.g., broad definition of practice), should ensure a consis-

. In addition, the Commission considered the magni.

-f tent and adequate level of protection of members of the tude of collective doses associated with licensed activitics, public from all exempted and licensed practices.

such as discharge of effluents from nuclear power plants, j

The Commission established ALARA design objectives n

3. Although collective dose has been considered in for effluent treatment systems for power plants in Ap-j cvaluating environmental impacts and in assessing the pendix I to 10 CFR Part 50. The Commission noted that effectiveness of licensec ALAR A progmms, NRC's regu*

the dose values established in the design objectives are la!ory program has not traditionally placed specific con-generally consistent with a collective dose criterion with a l

straints on collective doses associated with regulated ac-magnitude of 1000 person-remlycar. However, the Com-1

' tivities.

mission also recognized that licensecs have performed better than required in accordance with Appendix ! by.

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4.i Based on comments submitted to the Commis-reducing estimated collective doses from reactor plant i sion' on its proposed BRC policy, inctuding comments efft ucats to 110 person-rem per year in 1986, which is the

, presented by the Health Physics Society, the prevailing most recent year for which the data have been completely technical view opposed adoption of a collective dose crite*

assessed (see NUREO/CR-2850, Vol. 8)J rion in the BRC policy.

Finally, the Commission and its staff are only begin-

. Despite these considerations, the Commission also ning to evaluate specific details of how the BRC policy recognized the benefit of a collective dose criterion in will be implemented through subsequent rulemakings limiting the. total population dose associated with ex-and licensing decisions, Even at this preliminary stage, empted practices and in evaluating environmental im-the Commission has identified substantive implementat.

pacts and the effectiveness of ALARA programs. Conse-ion issues pertaining to the application of the collective :

.)

' qucntly, the Commission decided to establish a colicctive dose criterion. For example, an issue has been identified

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- dose criterion as a part of the BRC policy, provided that it regardir:g how the collective dose critcrion would be ap-was based on valid scientific analysis and that it did not plied in making decisions about appropriate levels of

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BRC Policy Statement t

cleanup for contaminated sites. Specifically, does the col-practice, in this regard, I agree with Commissioner Cur-lective dose criterion apply generically to the practice of tiss because tbc truncation of further efforts to reduce I

decommissioning or would it be applied on a site-specific doses is one of the principal regulatory motivations for basis? Similarly, how should the collective dose criterion establishing the llRC policy.

be applied in cases where nuclear operations have con-taminated groundwater resources that could potentially However,I disagree with the rest of Commissioner supply municipal drinking water systems? Resolution of Curtiss' view on this issue. It would be inappropriate to these and other issues could cause the Commission to tell the regulated community that they cannot reduce revisc its selection of the magnitude of the collective dose doses below the llRC criteria in short, although we vill i

criterion through future rulemakings and dt veloptnent of not require licensees to reduce doses further, we do not generic guidance, llowever, based on the technical infor.

want to discourage their efforts to do so either.'Ihis would mation and recommendations currently before the Com.

be tantamount to telling a licensee how to operate his or l

mission,1000 person-rem / year appears to be an appro-her business regardless of whether any health or safety priate magnitude for the collective dose criterion, issues are involved. Such a direction would be inappropri-ate because it clearly falls outside of the health and safety For all of these reasons, the Commission established focus of the NRC, a collective dose criterion of 1000 person-rem / year for i

In formulating the IIRC policy, the Comm..ission rec-cach practice.

ognized that new technologies being developed today pr mise to reduce doses, and therefore risks, at lower m RA costs than present technologies. Indeed, technological Commissioner Curtiss would prefer to define the and cost considerations are explicitly recognized in the individual and collective dose criteria as " floors" to definition and application of the term "AIAR A." "Ihus,I ALARA, that is, that the regulated community and NRC believe it would be inappropriate to tell licensees that are relieved from the regulatory obligation to perform they cannot implement new technologies and health further ALARA analyses below these levels if individual physics practices to further reduce doses if they want to.

doses are 1 millirem /10 millitem and the collective dose is 100 person-rem. Specifically, Commissioner Curtiss be-Justification of Practice lieves that the llRC policy sends a confusing message by Commissioner Curtiss would prefer to endorse the encouragmg voluntary efforts to achieve doses below the nrinciple of justification of practice (i.e., whether the 11RC criteria.

potentialimpacts of a practice are justified in terms of net societal benefits) and retain the prerogative to teject ap-In responding to Commissioner Curtiss' view on this pl cations for exemptions regardless of the risk they pose.

issue, it is important to begin from the definition of the term A1 ARA. AIARA is the regulatory concept that I disagree with Commissioner Curtis' view on this radiation exposures and cifluents should be reduced as matter because it puts the Commission in a position of low as is reasonably achievable taking into account the making decisions in areas outside the normal arena of its state of technology, and the economics of improvements expertise, where the agency would be especially vulner.

In relation to the benefits to public health and safety and abic, perhaps justifiably so, to criticism. Consistent with other societal and socioeconomic considerations, and in the mission of the NRC, the Commission should base its relation to the utilization of atomic energy in the public judgments on an explicit, objective, and rational consid-interest (10 CFR 20.1(c)). The ALARA concep4 is one of cration of the health.. safety, and environmental risks the fundamental tenets of radiation protection and has associated with practices, rather than on what many been a keystone in NRC's regulatory framework. Public would perceive as personal preferences of the Commis-comments on the proposed IIRC pohey statement and on sioners. Such an approach fosters long-term stability in proposed revisions to 10 CIR Part 20 urged the Commis-regulatory decisionmaking on potential exemptions.

sion to definc " floors" to ALARA or thresholds below which NRC would not require further reductions in doses Decisions on justification of practice involve social or effluents.

and cultural considerations that fall outside the Commis-sion's primary focus and expertise for emuring adequate The Commission responded to these comments in protection of the public health and safety from the use of the policy by stating that "... a licensee using the exemp-nuclear materials. Such decisions should be made by af-tion would no longer be required to apply the ALARA fccted elements of society, such as residents near a con-principle to reduce doses further for the exempted prac-taminated site, potentla! customers, suppliers, and other

/

tice provided that it meets the conditions specified in the members of the general public, rather than NRC. I be-regulation" established for a particular exemption. In lieve that this position is consistent with regulatory prac-other words, the llRC criteria and implementing regula-tices of other Government agencies that generally do not tions will provide " floors" to ALARA for the exempted regulate on the basis of whether a particular practice is 1

21

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" dRC Policy Statement t

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_ justified ' n terms of net societal benefit. For example, to The low level Radioactive Waste Policy Amend.

i the best of my knowledge, the Environmental Protection ments Act did not change the regulatory framework ap.

-l Agency does not question whether the generation of haz-

_ plicable to Atomic Energy Act materials, On the contrary, ardous wastes is justified in terms of net societal benefit, the Act specifically recognized the importance of that even though the agency promotes the minimization and framework by including provisions such as the following:

i elimination of such wastes to reduce risks.

Sec. 4(b)... (3) EFFECT OF COMPACTS ON 1 believe that Commissioner Curtiss misinterprets FEDERAL LAW.-Nothing contained in this Act the BRC policy when he claims that it embodies a bifur.

or any compact may be construed to confer any new cated approach on the principle of justification of prac, authority on any compact commission or State-tice. As clearly indicated in the policy, the Commission

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may determine that certain practices should no,t be con' Qs treat t sto l

.sidered candidates for exemption on the basis of risk tion of low-level radioactive waste in a man-p estimates or associated uncertainties. Rejection of such ner incompatible with the regulations of the -

! n application should be based on the n,sks posed by the

- Nuclear Regulatory Commission...t A

practice, rather than whether the practice is justified in c<

terms of net societal benefit. The types of concerns he

"(H) to regulate health, safety, or environ-l raises about risks to children and the general public would mental hazards from source material, be entically evaluated by the Commission in rulemakings byproduct material, or special nuclear ma-to determine whether particular practices should be ex-terial

empted. Therefore, I believe that the Commission has established an appropriate BRC policy that does not con-

' sider whether a proposed practice is justified in terms of i

societal benefit.

  • (4) FEDERAL AUTHORTIhExcept as ex-pressly provided in this Act nothing contained in this

' Agreement State Compatibility Act or any compact may be construed to limit the -

applicabilitfmof any Federal law or to diminish Commissioner Curtiss aiso disagrees with the Com-otherwise mission majority view on the need for uniformity between agency' "* '

' basic radiation protection standards estaonshed by NRC and Agreement States. He indicates that he would not Unlike the Urardum MillTallings Radiation Control treat the Commission's policy on below regulatory con-

. Act of 1978, as amended, the low-Level Radioactive cern as a matter of compatibility for Agreement States Waste Policy Act, as amended, does not au_thorize States with respect to disposal of commercial low-level radioac*

to establish more stringent standards;%e Act also spe-tive waste. He reaches this conclusion in part because he cifically directed the Commission to estallish standards

- reads the low-level Radioactive Waste Policy Amend-for exempting specific radioactive waste streams from

- ments Act of 1985 as giving States a' great deal of latitude regulation due to the presence of radion iclides in such in deciding how to proceed with the development, con

  • waste streams in sufficiently lo'v concentr itions or quan.

struction, and operation of new low-level waste disposal titles as to be below regulatory concern. If, in response to facilities. Drawing upon this interpretation, he concludes a request to exempt u specific waste stream, the Commis-that individual States should be allowed the option of sion determines that regulation of a radioactive waste -

deciding whether low-level waste designated BRC should stream is not necessary to protect the public health and :

be disposed of in a licensed low-level radioactive waste safety, the Commission is directed to take the necessary disposal facility, steps to exempt the disposal of such radioactive material l from regulation by the Commission. Thus, the Act did c

This policy statement in and of itself does not make not, in my view, grant any particular latitude to the States any compatibility determinations; as indicated in the to determine which waste streams were of regulatory statement, compatibility issues -vill be addressed in the concetn. Rather, it reaffirmed the existing roles of the

- context of individual rulemaki' gs as they occur. But I-NRC and the States in determining regulatory standards

' believe it is important to respond to Commissioner Cur-for low-level waste and specifically defined the Commis-tiss on this issue in two respects. Fint, I do not read the sion's authority in this regard as including designating;

- Low level Radioactive Waste Policy Amendments Act as waste streams which are below regulatory concern.

'giving the States particular latitude let alone specific authority in the area of waste to establish radiation stan.

De respective roles of the Commission and the dards different from those of the Commission. Second, I States with respect to the licensing and regulation of do not believe that the issue of BRC for waste disposal

' Atomic Energy-Act materials, including the disposal of can casily be divorced from BRC in other areas such as low-level radioactive waste received from other persons, decommissioning.

are governed by the provisions of Section 274 of the 22

llRC Policy Statement Atomic Energy Act of 1954, as amended. Absent the "Ihe potential probbms from conflicting standards execution of a Section 274b Agreement with the NRC, a identified by the JCAE in 1959 are fully apparent in the State is preempted by Federal law from exercising regula-context of BRC and demonstrate why the scope of com-tory authority over the radiological hazards of these matc*

patibility findings to be made by the NRC camnot be rials. The Commission is authorized to enter into an drawn to exclude low-level radioactive waste disposal.

agreement with a State only upon a finding that the State For instance, the Commission intends to use the risk rogram is com atible with the Commtssion's program criteria identified in the policy statement to establish or regulation o radioactive materials and adequate to decommissioning criteria, that is, the level at which a j

protect the public health and sdety. Section 274d.(2).

formerly b,eensed site may be released for unrestricted j~

The legislative history of Sectbn 274 stresses throughout use. lf the States are permitted to require that low-Icycl the importance of and the need for continuing compati, waste streams designated HRC by the Commission be bility between Federal and State regulatory programs, in disposed of in a low-level waste facility, it could result in a comments on the legislation, the Joint Committee on Atomic Energy (JCAE) stated that site in one state being released for unrestricted use, while s 1 or materials in an adjacent State at that level would be 5.The ! 4nt Comn/.ttec belicycs it important to required to be confined in a low-level waste facility. If a emphasize that the radiation standards adopted Eatchwork of disposal critcria were to develop, it would be by States under the agreements of this bill should virtually impossible to establish decommissioning funding either be identical or compatible with those of requirements that would be adequate to assure that all the Federal Government. For this reason the licensed facilitics will set aside sufficient funds over the committee removed the language 'to the extent feasible'insubsectiong.of theoriginal AECbill life of a facility to pay for decommissioning.The resulting ccmsidered at hearings from May 19 to 22,1959.

confusion from these conflicting standards could well re-The committec recognizes the importance of the sult in delays in adequate decommissioning of contami-testimony before it by numerous witnesses of the nated sites and certainly in unnecessary concern on the dangers of conflicting, overlapping and inconsis-part of the public. I continue to believe that reserving to tent standards in different jurisdictions, to the the NRC the authority to establish basic radiation protec-hindrance of industry and jeopardy of public tion standards, including designating which waste streams 8"IC8Y' are below regulatory concern, is fully justified to ensure Sen. Rept. No. 870, September 1,1959,86th Cong.,1st.

an adequate, uniform and consistent level of protection of

Sess, the public health, safety and the environment, a

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The Nuclear Regulatory Commission has published a -

new policy for detennining when radiation levels are so low.

that they do not warrant further regulatory control.The Beloor

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Regulatory Cancem, or "BRC" policy is needed to ensure con -

sistent NRC decisions on exemptions and to focus resources on the more significant risks posed by nuclear materials.

- The policy establishes a feiimwak for making future exemption decisions and for reviewing previous exemptions.

Ilowever, the BRC policy does not in itself exempt any radia-tion levels from regulatory control. Instead, the Commission will use the policy in developing new rules or amending -

existing ones, evaluating petitions for exemptons that may be received from members of the public and taking W.c licensing actions involving exemptions of nuclear materials.

Possible applications of the BRC policy include:

-Cleanup af contaminated sites.

Distribution of consumer products containing small amounts of nuclear materials,

- Disposal of very low-level radioactive waste and

-Recycle or reuse of slightly. contaminated equipment and materials.

This pamphlet summarizes the BRC policy and describes why the policy is needed now, how it will benefit the public, what criteria the NRC will use in makmg BRC decisions and how the policy will be implemented.The aim of this booidet is to pmvide information about the BRC policy. NRC believes that the policy will adequately protect the public health and safety and the envimnment Indeed, NRC does not expect any measurable adverse impact on the public health and safety as a result of the policy. In the long run, the BRC policy '

should enhance protection of the public and the envi:enment by allowing society to focus its limited resources on those l

. activities that pose the most significant &

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Available From:

Superintendent of Documents U.S. Government' Printing office l

Post. Office Box 37082 Washington,- DC'20013-7082 m

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WHOIS NRC The Nuclear Reguhtory Commission regulates the civil-ian uses of nuclear materials in the United States to protect the public health and safety, the environment and the com-Comparison of below regulatory mon defense and security. This mission is accomplished Concern doses to doses from through:licensingofnuclearfacilitiesandthepossession use nd disposal of nuclear materials; the development and imple-selected other radiation sources mentation of requirements governing 1mensed activities; and inspection and enforcement activities to ensure compliance

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with these requirements.

IIM WII M EM99444955 70

./,,//,/,/,e Denver, CO vs. Washington, DC :

WHATIS BELOW REGULATORY i ' " ' { " " 'j " " " " ' ' ' " ' ' '

CONCERN (BRC) y]

10 Brick vs. Wood Home The "Below Regulatory Concern"or BRC, policy defines radiation levels with such a small health risk that further Round-Trip 5

regulatory efforts to reduce those levels are unwarranted and Cross-Country Flight may detract from our ability to address greater risks.

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The BRC policy statement does not represent a decision

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BRC Practice Affecting to exempt any specific consumer products, wastes or other

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10 Limited Number of People materials or practices from regulatory control. Instead, it l

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establishes the framework within which the Commission will BRC Practice Affecting make decisions to exempt from some or all regulatory con-Large Number of People trols certain products and activities involving radioactive 1

m terials that are Mow regulatory concern.

0 10 20 30 40 50 60 70 80 i

Radiation Dose (mrem)

WHY A BRC POLICYIS NEEDED NOW liere is how the dose criteria in the below regulatory concern In the past, NRC has exempted certain types, uses and policy compare with doses from selected other radiation sources.

quantities of nuclear materials from regulatory control. As a All doses shown oce;* the airline flight are in average millirems.

regulatory agency serving the public NRC always seeks to per year per indivdml. The dose shown for flying is from one ensure adequate protection of the public health and safety mund-trip flight.

and the environment. Beyond this adequate pmtection thresh-i old, NRC also continually seeks to improve the balance between the risks associated with the use of nuclear materials and the burden of regulations intended to ensure that those risks are adequately controlled. NRC has developed and implemented a comprehensive regulatory framework, the u

lower end of which is bounded by exemptions and other Another issue involved in the BRC policy is the manage-decisions that allow release of nuclear matenals to the ment of wastes that contain very low levels of radioactivity environment. The NRC believes there is a need to ensure and that may not need to be disposed of in licensed disposal that ex, sting and future exemption decisions are consistent i

facilities. In the Low-Level Radioactive Waste Policy Amend-and continue to protect the public health and safety and ments Act of 1985, Congress directed the NRC to consider the the environment-merits of"...(exempting) specific radioactive waste streams Implementation of the BRC poh.ey should benefit the fmm regulation...due to the presence of radionuclides...in.

public by allowmg State and Federal agencies and others to sufficiently low concentration or quantities as to be below focus on the activities that pose greater risks to the public.

regulatory concern." N RC responded to this direction in 1986 Specifically, the public should benefit through:

with a specific policy statement on procedures for exempting

- More timely and consistent cleanup of contaminated sites, BRC waste streams. The 1985 law and the 1986 policy state-Increased assurance that funds set aside to clean up ment laid the foundation for developing the framework and decommission nuclear facilities are adequate, reflected in today's comprehensive BRC policy, which applies Reduced costs and overall risks to the public from man.

the same yardstick in all cases. Together with the 1986 policy, aging certain types of slightly radioactive wastes in a the new BRC policy is needed now to help resolve issues manner commensurate with their low radiological risk, associated with low-level waste management in order to mini-

-Increased assurance of a consistent level of safety for mize impacts on low-level waste disposal facilities in the consumer products containing nuclear materials.

States, which Congress required to be operational by the nuo s.

A foremost need for the BRC policy is related to NRC's responsibility for regulating the cleanup of contaminated com.

In all of these areas, the N RC's prm, cipal goal is to ensure I

mercial nuclear facilities around the country. This can be that the public health and safety and the environment are 4

broadly categorized as the " decommissioning issue." It arises adequately protected. The NRC has selected criteria for the rom NRC's need to ensure that the funds set aside by licens.

BRC pohcy, based on the latest scientific research and recom-5

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f e s today will be adequate to clean up and close the facilities mendations, to establish the level at which nuclear materials 2

at 'he end of their operating lifetimes. It also arises from the may be safely exempted from regulatory control.

netd to ensure that cleanup is performed in a consistent and adecuate manner. To accomplish these objectives, NRC needs to de termme acceptable levels of residual radioactivity-how RADIATION: SOME BACKGROUND clear is clean enough.The BRC policy establishes the frame-AND PERSPECTIVE i

work for developing these levels. It is important to develop i

these levels now so that the companies responsible for Everyone is continually exposed to low levels of natu-decommissioning the facilities can plan, pmvide the neces-rally occurring radiation. The earth is continually bathed in sary resources and perform the cleanup needed to satisfy radiation from the sun and space.

regulatory standards.

The earth itself is also a source of radiation; radioactive l

The exemption of certain consumer products that materials exist naturally in its soil, mck and water. There are contain nuclear materials is another area encompassed by a great many of these radioactive materials, the most com-i the Commission's BRC policy. We must ensure that current mon being uranium, thorium, radium and the radioactive and future exemptions of these products are consistent and fonns of carbon and potassium. Also common in nature is continue to provide an adequate level of safety to the people radon gas, a radioactive byproduct of the small amounts of I

who use them. Implementation of the BRC policy will help uranium found in the soil and rock of many parts of the country.

achieve this goal.

Radiation consists of x rays, alpha and beta particles, gamma rays and other components. When they pass through i

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the human body, they may damage some cells in the body. If The remaining 20 percent or so comes funn man-made damaged, some cells may not survive or reproduce normally.

sources of radiation,, including medical x-rays and nuclear Other damaged cells may survive, but m a modified form, medicine technokgies, which together account for bbout 15 which may later result _ in a cancer. Other health effects from percent, and consumer products, occupational exposures and radiation include birth defects and inherited diseases. Very -

various other sources, which account for the remaining large doses of radiation over short periods may'cause organ percentage.-

damage and, if high enough, death. Doses associated with natural backgmund radiation and the BRC criteria are thou-sands of times lower than the high doses that are so destruc.

Examples of natural tive. At low doses, the principal concern is the possible radiation exposure appearance of cancer years after the exposure to radiation.

Other effects such as birth defects and inherited diseases are f.

l lesslikely.

FROM Tile SKY-About l

A unit of radiation dose is called a " rem." A " millirem" 30 millirem per year fmm Q d-1 (abbreviated mrem) is one-thousandth of a rem. Evidence cosmic radiation.

from high doses (from tens of rem) delivered quickly (in.

seconds to hours) indicates that the probability of caus,ng i

cancer from radiation increases with the dose received. For g'FROM Tile AIR THAT doses in the range produced by natural backgmund radiation, however, the probability of producing cancer has not been directly established, because it is impossible to distinguish WE BREATHE-About I

200 millirem peryear, 6

cancers produced by such low levels of radiation from cancers 7

pmduced by other phenomena. Therefore, in estimating the a

including radon.

l consequences of any exposure to rJiation, it is assumed that L

the chance of developing cancer is linearly proportional to m

i dose and that there is no threshold below which there is no FROM OUR FOOD AND 1

chance of cancer. This chance, or risk, is expressed in terms -

DRINK-About 40 milli-of of probability because a given dose of radiation does not rem per year from natural L"*_-

,t produce a cancer in all cases. The International Commission radioactive materials such on Radiological Protection (ICRP) and the U.S. National Coun-as potassium-40.

t cil on Radiation Protection and Measurements (NCRP) have s-r both endorsed the " linear, no-threshold" appmach and the -

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$M$A DI U-mission used these pn,nciples m developmg its BRC pohey.

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. About 30 millirem per We all receive doses of naturally occurring radiation p

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year from natural radio-every day. It comes from space, the air we breath, the water 252= d_

$ nuchdessuchasuranium.

we drink, the food we eat, the buildings we live and work in.

and even our own bodies and the people we live and work Naturally occurring sources of radiation are all around us.This with. Such sources contribute about 80 percent of the aver-chart shows the average annual radiation dose from natural back-age annual radiation dose received by the U.S. population.

gmund sources.

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bricks are made. In addition, should your home be in a certain Our lifestyles and daily activities vary these amounts to area of the country where there is more uranium or radium in some extent. For example, if you live in Denver,"the Mile the soil you may have a high concentration of radon in your Iligh City," rather than a sea-level city such as Washington, house. The dose from radon in the home averages 200 milli-D.C., you receive an additional average annual exposure of rem per year in the United States, but can range up to several some 70 millirem, because the dose from cosmic radiation thousand millirem per ye'.r.

essentially doubles with each 6,600 feet of altitude and the The iGC 1.e created the framework for its new policy at soil of the Rocky Mountains contains higher concentrations of a level of individual radiation dosage well below these varia-natural radioactive materials. By the same token, a flight on a tions resulting from natural sources. It is at these very low commercial airliner increases your exposure to cosmic rays at levels, involving correspondingly low risks, that the NRC the rate of about 5 millirem for the time spent in a single would consider exemptions from regulation and deem certain mund-trip crossrountry flight.

practices "below regulatory concern."

Also, if you choose to live in a brick home instead of one With this as background, let's turn to the specific princi-made of wood you may add up to 10 millirem per year to your pies and criteria that the NRC used in establishing a BRC annual radiation exposure due to the naturally occurring thorium, uranium and radium found in the clays of which policy and how it plans to implement that policy.

Contribution of various radiation BRC CRITERIA sources to the average radiation What levels of radiation and risk place pmducts and dosein the U.S. population activities in the category considered below regulatory con-yy cem? And how did the NRC arrive at its new criteria, along j

q' with its principles of exemption, for a formal BRC policy?

i Terrestrial 11 %

Medica, X Rays First the principles: A major consideration in exempting i

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any practice from regulatory control hinges on the question of Nuclear Costnic Medicine whether the control is necessary for protecting the public j

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health and safety and the environment. The need for

- ProdE regulatory control decreases as (Ise dose and its risks to the exposed population decrease. The NRC believes that the D

granting of specific exemptions from regulatory controls 3%

should depend essentially on an evaluation of whether the Other <1%

risks are sufficiently small and whether further reductions in occupationat 0.3%

dose justify the effort to achieve them. Therefore, the NRC Fanout

<0.3%

believes that radiation dose criteria for both individuals and Nuclear the exposed population should be basic features ofits overall

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policy.That policy should define the region where efforts to j.

Radon 9,

55 %

further reduce exposures are no longer warranted.

The question then is: How low is low enough when it About 82% of the average radiation dose in the U.S. population comes to nsks and dose? At whct pomt is it clearly unneces-comes from natural sources. Of the remaining 18%, representing sary to further reduce the risk or dose?

man-made radiation sources, the largest percentage is attributable In selecting the BRC dose criteria, the Commission noted to medical x-rays. (Used with permission of the National Council on that, even though there is significant uncertainty in calcula-j Radiation Protection and Measurements.)

d l

ia i,

in.

.=I How do these dose levels translate into risks? The 10 tions of risks from low-level radiation, in general these risks millirem per year corresponds to an annual risk of death from.

are better understood than the risks from other hazards, such -

".r di tion-mduced cancer of about 5 m,1 milhon. The,I as toxic chemicals. In addition, radiation from natural back:

ground is a fact oflife and poses involuntary risks that are the elli}m per year dose corresponds to a nsk of about 5 m -

same as the kinds of risks posed by nuclear materials under In addit. ion to the individual dose criteria, NRC will also the NRC'sjurisdiction.

ensure,that the total impact of an exemption is appmpriately The Commission believes that if the risk to individuals

""""***d through a collective dose cn, tenon. The "collec-from a product or activity under consideration for exempti'en tive" dose is a measure of the impact of the practice on societ,y is comparable to other risks, knowingly or unknowingly taler-

".s a whole. It is the sum of the mdividual doses.The Commis-ated by individuals because of factors such as their lifestyle sion believes that if the collective dose resulting fmm a given or where they live, then the level of protection from that practice is less than 1,000 person-rem per year (equivalent to activity should be adequate. Related to this, variations in 1,000,000 mdividuals receivmg 1 milhrem per year),

natural background mdiation, such as the 70 millirem per year difference between average annual doses received in Comparison of below regulatory Denver versus Washington, D.C., apparently play no role in Concern doses to doses from natural individuals' decisions on where to live or work. Nor do people seem to be concerned about the difference i,n doses between background and medical exposures hymg m a brick or frame house, the 5 nu,lhrem dose from a round-trip coast-to-coast air flight, or the dose from other 300 activities involving a small fraction of background radiation.

,////

/////gM(Natura(@round.

Consideration of the magnitude and variation in natural l

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13 12 background doses suggests that individual doses in the range of 10 millirem and below would be appropriate for use as an f

50 All Medical Exams I

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individual dose criterion. However, the dose criteria must Natural Radioactive also be selected so that they are consistent with technological g

Materialsin the Body capabilities to monitor and assess doses. In addition, dose i

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criteria below those selected by the N RC could unnecessarily BRC Practice Affecting divert attention and resources from more significant health 10 Limited Number of People and safety programs.

i i

Taking all this into consideration, NRC decided that an a

individual dose oflo millirem peryear would be appropriate

$6 Chest X-Ray for use as the Commission's BRC individual dose criterion.

l l

BRC Practice Affecting However, until more experience is gained with the potential 3

for individual exposure from multiple sources, the Commis-Large Number of People sion decided that an interim individual dose criterion of I 0

50 100 150 200 250 300 350 millirem peryear would be applied to those practices involv-ing widespread distribution of material containing radioac-Radiation Dose (mrem) tive substances, such as consumer products or recycled This chart compares levels of radiation exposure established material and equipment.The interim criterion provides addi-by the Commission as below regulatory concem WRC) to levels of tional assurance that public doses will remain a small fraction radiation exposure in natural backgmund and to medical exp+

of background radiation and of generally recognized dose sures. All doses shown except the chest x-ray are in average milli-limits formembers of thepublic.

rem per year per individual. The 6-millirem chest x-ray dose is for one single x-ray for an individual.

l

..s In addition, NRC would continue its comprehensive program resources would be better spent addressing more significant f licensing, inspection and enforcement for that pmcess.

health and safety issues. At this collective dose level, the Issuance of the BRC policy statement does not repre-annual number of health effects for an exempted practice is sent a decision to exempt any specific consumer products,

. calculated at less than one and could be zero.

w stes or other materials or practices fmm regulatory contml.

These values will pmvide a consistent risk basis for Rather the policy statement is a framework for makmg future rulemaking or licensing decisions, makmg such imple.

exemption decisions.

mentation a practical undertaking. NRC believes that The policy will be implemented principally through the regulatory exemptions using the individual and collective NRC's rulemaking process. Exemption decisions could also dose criteria will provide reasonable assurance that individ.

be made through specific licensing actions.

ual exposures to the public from all licensed activities and In the case of rulemaking, a proposal for exemption, exempted practices will not exceed the generally recognized whether initiated by the NRC or requested by outside parties dose criterion for members of the public of 100 mrem per in a petition for rulemaking, would have to be supported by an year, given the Commission's intent to:

adequate tecimical basis.The Commission would review this Impose both individual and collective dose criteria, basis in determining whether the basic policy conditions have Consider the total impact of a proposed activity (not been satisfied in its decision. Such a proposal would generally justaportionof apractice),

have to address the m, dividual and societal impact that could

- Evaluate the potential that people may be exposed to result if the exemption were granted. To do this the proposal more than one exempted practice, would have to consider the uses of the radioactive materials.

Evaluate potential exposures over the lifetime of the their pathways of exposure and their levels of mdioactivity. It would also have to consider appropriate methods and con-15

practice, straints for ensuring that the doses fmm the exempt practice Monitor,and verify how exemptions are implemented remain sufficiently low.

14 under this pohcy, Proposed mles will be published in the Fede al Register

- Verify dose calculations through licensing reviews and to solicit public comments.The rulemaking action would also rulemakings with full benefit of public review and include an appropriate level of environmental review under -

comment and the National Environmental Policy Act to ensure that envi-

-Inspect and enforce licensee adherence to specific con.

ronmental impacts are adequately considered.

ditions and constraints imposed by NRC on exempted The second means of implementing the BRC policy practices.

would involve exemptions granted through licensing actions.

The public will be invited to comment on new licensing BRC POLICYIMPLEMENTATION actions on exemptions under the BRC policy if they differ fr m previous generic exemption decisions.

With these criteria for both individual and collective If product or practice goes through all the necessary exposures, the NRC will have a framework for reviewing procedures and receives an exemption, is it then free of requested exemptions from regulatory control for certain further surveillance? No. The NRC wd, l verify that licensees products or activities. Ilowever, other specified conditions dhere to exemption constramts and conditions thmugh the will also have to be met, such as determining that the risk gency'slicensmg.inspectu>n and enforcement programs. As from an accident or from misuse would be very low. The n ex mple of condition that may be imposed on a consumer Commission also may place certain conditions or constraints product, the Cmnmission may regmre some type of labehng on the activity that generates or manufactures the exempt so that consumers can make mformed decunons about the material, such as limits on the total quantity of radioactivity purchase of a pnxiuct contammg exempted materials. Such and restrictions on the transfer of materials to exempt status.

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labeling is presently required by the Commission for smoke y"'

detectors containing radioactive material.

The NRC may detennine on the basis of risk estiinates

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and associated uncertainties that specific practices should:

not be considered candidates for exemption. A prime exam-I pie would be the introduction of radioactive materials into:

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products to be used primarily by children. Such practices E

would be specifically evaluated to detennine if they could -

result in greater risk levels to exposed members of the public than those found acceptable by the Commission in formulat-

~~

ingits BRC policy.

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f[

BRC-A FINAL THOUGHT' l

i NRC believes that implementation of this policy will; adequately protect public health and safety and the environ,

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ment. Also, its implementation will allow the NRC, States I

and licensees to devote more of their limited time, trained -

d personnel and funds to nuclear related matters that are

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associated with potentially higher public health risks;it may 16 also allow other organizations, in such fields as health care, scientific research and the development of new and useful.

9 products and services, to devote more of their resources to a

k activities that contribute to greater health and safety protec -

[

tion in addition to better serving the public.

I But the success of any public policy depends largely on i

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its understanding and acceptance by the public.

We hope that this booklet and its explanation of our new d

below regulatory concern policy contribute toward these ends.

(Radiation dose data in the charts in this pamphlet are taken l

L directly or derived from reports of the National Council on Radia-L i

tion Protection and Measurements (NCRP), Bethesda,- MD. The o

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figure of 10 millirem additional dose from living in a brick rather

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than a frame home is derived from NCRP Report No. 94," Exposure F

of the Population in the United States and Canada from Natural Background Radiation,"1987. All other data are from NCRP Report t

[4 No. 93, "lonizing ' Radiation Exposure of the Population of the, United States,"1987.)

For more information contact:

^

h U.S. Nuclear Regulatory Commission,.

f Public Affairs, Washington, DC 20555.

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l(i l-This booklet was printed using recycled paper.

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