ML20043B918

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Notifies of Nrc/Nea Workshop on Rules for Exemption from Regulatory Control on 881017-19 in Washington,Dc.Proposed Agenda Listed in Encl 1
ML20043B918
Person / Time
Issue date: 09/28/1988
From: Lahs W
NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To: Ader C, Joseph Austin, Beckjord E
NRC
Shared Package
ML20042C963 List: ... further results
References
FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006010039
Download: ML20043B918 (9)
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" MEMORANDUM FOR: 'Those on the Attached List

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William R. Lahs, Acting Chief Regulation Development-Branch Division of. Regulatory Applications, RES

SUBJECT:

NRC/NEA WORKSHOP ON RULES FOR EXEMPTION FROM REGULATORY CONTROL a

l A' workshop to focus international regulatory' attention on the deve"y,ent of a policy on exemption of radiation sources or practices from regulatory control.

will.be held at the Pan American Fealth Organization (PAHO) Conference Facilities, 525 23rd Street, NW, Washington, DC from the 17th through the 19th of October 1980.

The. preliminary agenda for the workshop.is attached at Enclosure 1. - The workshop-is not a public meeting and security.at the PAHO facility. requires that an attendance list be provided.

The purpose of this. memo,is to confirm the accuracy of the list of NRC attendees, Lattached as Enclosure 2, and-to determine, who among the ettendees, will attend the workshop luncheon on October 18, 1988. The cost for the no-host luncheon-

.is'$10.00 per person. If you wish to attend the luncheon or are not planning to attend the workshop, please contact me on ext. 23774 or Harvey L.Teott, of sqy staff, on ext. 23632.

  1. m Willipm R. Lahs Acting Chief RegulationDevelopmentBranch Division of Regulatory Applications, RES

Enclosure:

1. : Preliminary Agenda 2.

NRC Workshop Attendees cc: Chairman Zech 9006010039 891130 P

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NRC/NEA WORKSHOP ON RULES FOR EXEMPTION FROM, REGULATORY CONTROL Preliminary Agenda Monday, October 17

'19 M 8:30 Registration SESSION 1 - IEIRQDUOTION AND IDENTIFICATION OF ISSUES Chairman:

Themis'Speis U.S. Nuclear Regu)atory Commission 9:30 Welcoming Addresses Themis spels Office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission Victor Stallo Executive Director for Operations U.S. Nuclear Regulatory Commission Osvaldo Ilari Radiation Protection and Waste-Management Division Nuclear Energy Agency 10:00 overview of Major Regulatory Exemption Activities Underway at the U.S.

Nuclear Regulatory Comalesion Eric Beckjord Office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission 10:16 Definition of Exemption Rules, De Minials, and Below Regulatory Concern Donald Cool Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 10:40 Break 11:00 The Concept of Practice in Radiation Protection Osvaldo Ilari Radiation Protection and Waste Management Divi'sion Nuclear Energy Agency 11:30 The Concept of Negligible Risk Geoff Webb National Radiological Protection Board United Kingdom 12:00 Lunch l

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SESSION 2 - NATIONAL SITUATIONS AND APPROACHES TO THE ESTAB-i LISHMENT AND DEVELOPMENT - OF EXEMPTION RULES Chairman:

Yoshikazu Yoshida Atomic Energy Research Institute Japan

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1:30 EPA's Views on Reguistory Cutoffs for Radiation Exposure l'

Richard Guimond Office of Radiation Programs U.S. Environmental Protection Agency 2:00 Report on Facionsi Situation and Approaches in Canada George Jack Atomic Energy Control Board Canada 2:20 Exemption Rules Appiled in-Tiniend H.A.

Kahlos and Finnish Centre for Radiation'and i

E. Ruokola Nuclear Safety l

f Finlana 2:40 Report on Nations 1 Situation and Approaches in France i

Anne-Marie Chapuis Commissariat & ldEnergie Atomique Institut de Protection et de Surets Nucidaire France 3:00 Break 3:20 U.'S.

Department of Energy Guidelines for Residual Radioactive Materisi and ALARA l

Andrew Wallo Division of. Facility and Site Decommissioning Project U.S. Department of Energy 3:50 Report of Nscionsi Situation and Approaches in the Federal Republic of Germany R.-Neider Federal Institute for Materials Research and Testin?

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of Germany Note:

Where the paperc hr" authors, the individual presenting the papet i s

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4t10 Report of National Situation ~and Approaches in Icely G. Naschi-Directorate for Nuclear Safety and Radiation Protection Italy-4:30 Report of National Situation and Approaches in Japarv Masao Oshina Atomic Energy Research Institute Japan 9

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Tuesday. October 18, 1988

+s SESSION 2 (cont.)

NATIONAL SITUATIONS AND APPROACMES TO j

THE ESTABLISHMENT AND DEVELOPMENT OF EXEMPTION RULES 9:00 Rules'on Exemption from Regulatory Control A Proposed Broad Policy Scacement by the-U.S.

Nu c lear -' Regula tory Commission Willian Iahs'and Office of Nuclear Regulatory Research Bill Morris U.S. Nuclear Regulatory Commission-9:30 Report'on National Situation and Approaches in Spain Julia L6pez Consejo de Seguiridad Nuclear Espana de la Higuera spain 9:50 Report on National Situation and' Approaches in Sweden Curt Bergman National Institute of Radiation Protection Sweden l

- 10:10 Position of Switzerland Serge-Pretre Swiss Nuclear Safety Inspectorate Switzerland 10:30 Break 10:50 Report on National Situation and Approaches in the United Kingdom Alan Duncan Her Majesty's Inspectorate of Pollution England 11:10 Reguistory Aspects Within the European Connunity Felix Luykx Commission of the European Communities Luxembourg 11:30 Report on National Situation and Approaches in Australia J.E. Cook

  • Australian Nuclear Science and Technology Organization Australia To be presented by O.

Ilari

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-SESSION 3 - DISCUSSION OF EXISTING ISSUIS Chairman:

George Jack Atomic Energy Control Board Canada 1830 Revise of Existing Issues Geoff Webb National Radiological Protection Board United Kingdom

-1855 A Compromise Regarding ths Three Different' Cultural Responses to the 'De Minlais* Question Serge Pretro Swiss Nuclear Safety Inspectorate Switzerland ~

2:20 Principe De Decernination De Limites Derivees Pour L' Exemption D'Objets ou De Materlaux (Principles for Determining Derived Limits for Exemption of Objects or Materials)

Anne-Marie Chapuis Commissariat & l'Energie Atomique Institut de Protection et de Surets Nucidaire l,

1' France l-

.O 3:45 Current Status of Risk Estimates for Assessing Hesich Consequences of Lov Doses l:

W. Sinclair-National Council on Radiation Protection and Measurements United States g

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Tuesday, October 18, 1988 SESSION 4 - STATUS OF INTERNATIONAL GUIDELINES.QN lXEMPTION RULES Chairman:

Osvaldo Ilari 1

Huclear Energy Agency 3:30 ICRV Guidelines Taoff Webb National Radiological Protection Board

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-United Kingdom 4:00

'Research at the European Commis sion, Rela t ed to the Development and the Us.e of Exemption Rules.

Karl Schaller commission of the European Communities l

Belgium

- 4:30 Principles for Exemption of Radiation Sources and Practices from Radiation Protection Standards A.

Gonzales and Radiation Protection Section O.

Ilari International Atomic Energy Agency i

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.s Wednesday, October 19, 1988 r.

1 SESSION 5

PRESENTATION AND DISCUSSION OF THE-CONCLUSIONS OF THE WORKSHOP Chairman

Richard E. Cunningham, office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 9:00 Statement of Accom: 11shments.

Richard cunningham office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Identification of 9:15

_ Summary of-Areas of Consensus Outstanding Issues Robert Bernero office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 9:35 Additional Views from Session on National Approaches Yoshikaru Yoshida Atomic Energy Research Institute

-Japan 9:50

. Additional Vsevs from Session on Existing Issues-George Jack Atomic Energy Control Board Canada 10:05 A c t. i t ion s : Views from Session on International Guido11 '

osvaldo Ilari Radiation Protection and Waste Management Division Nucic,ar Energy Agency 10:20 Break 10:40 Floor Discussion 11:45 Workshop Closing Themit spels office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission

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TENTATIVE LIST OF NRC ATTENDEES FOR THE

~ INTERNATIONAL WORKSHOP ON RULES FOR EXEMPTION FROM REGULATORY CONTROL OCTOBER 17-19, 1998 1

-Charles Ader

' John Austin >

Eric Beckjord Robert Bernero Comissioner Carr; irank Congel--

Donald Cool i::

Richard Cunningham
Kitty,Dragorettel Janice Dunn-Lee Thomas'Elsasser

-Margaret.Federline Robert' Fonner :

William Lahs John Larkins Maria.Lopez-Otin.

Catherine Mattsen.

JGail Marcus Bill Morris Stanley Neuder Comissioner Roberts' Comissioner Rogers -

Jack Scarborough

.Themis Speis Victor Stello i

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te f7 UNITED STATES IN RESPONSE, PLEASE

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NUCLEAR REGULATORY COMMISSION REFER To:

M880916A' W ASHtNGToN. D.C. 30606 p

September 29, 1988 f,$,ckjord,RESl GPPICE oF THE Hoyle ssenttAny (Thnenean, NMSS ORMATCN ROUTING ONI.Y Murley. NRR Labs, RES THOMPSEEMORANDUM FOR:

Victor Stallo, Jr.

3ERNERO Executive Director for tion:9

' :UCiE'i 1

goMg Samuel J. Chilk, Secreta Qp

'[ SUBJdCT:

STAFF REQUIREMENTS - BRJFJ N 3 ON STATUS OF 3

' EFFORTS TO DEVEIDP A BEI.JpW { SEPTEMBER 16, i j EGULATORY CONCERN POLICY, 10:00 A.M.,

FRIDAY, 4

1988, COMMISSIONERS' CONFERENCE ROOM, ONE WHT.TE FLINT NORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE)

J The Commission was briefed by the staff and representatives of the Health PhyM es Society and NUMARC~on proposed options for a commission policy which establishes a generic radiation activity below regulatory concern.

Representing the Health Physics Society!=uere:

- Dr. Lauriston S. Taylor Past President, Health Physics Society A

- Robert Alexander President,'Haalth Physics Society Representing NUMARC was:

- Thomas Tipton e

Division Director, NUMARC The commission requested the staff to raise the following issues at the International Workshop on Rules for Exemption from Regulatory Control scheduled for October 17-19, 1038.

1, The need to include a collective dose criterion and possible alternatives for evaluating societal impact.

2.

The possibility of' limiting the activity of individual products as an alternative to usa of a collective done criterion.

3.

Allowing the use of radioactive materials under NRC surveillance as an alternative to exemption excitsions.

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,.- i The extent to which exposures resulting " rom any pnctice

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should be justified and the process for making such a determination:

(a) in considering proposals for exemptions, should the Commission evaluate the social acceptability of practices?

(b) should t*:a Commission determine a practice to be unjustified if non-radioactive alternatives exist?

The Commission emphasised the importance of presenting the proposed policy in terms the general public can relate to (i.e., number of additional cancer deaths expected vs. number of area).

The: staff should submit a paper to the Commission summarizing the activities and conclusions reached at the International Workshop, including a revised policy statement which considers the above issues.

4890)- (RES)

(SECY Suspense:

1/27/89)

The Chairman requested his fellow Commissioners to address in their vote sheets if the staff should publish the proposed policy, SECY-88-257, for public comment prier to the International Workshop.

cca Chairman Each Commissioner Roberts Commissioner Carr

. Commissioner Rogers OGC GPA PDR - Advance DCS - P1-124

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Action: Beckjord, ~RES NUCLEAR REGULATORY COMMISSION Cys: Stello Ta or wAsnw27on, o.c. sesos

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  • September'30, 1988

- OFFICE oF THE SECRETARY J

MEMORANDUM FOR:

Victor Stallo, Jr.

Executive Director for ons Samuel J. Chilk, Secretan FROM:

SUILTECT; STAFF REQUIREMENTS - SECY 8 257, ' PROPOSED COMMISSION POLICY STATEMENT N EXEMPTIONS FROM REGULATORY CONTROL FOR PRACTICES-WHOSE PUBLIC HEALTH AND SAFETY IMPACTS ARE BEIDW

. REGULATORY CONCERN (BRC)

L The Commission, with all Commissioners agreeing,-requested that the draft Advance Notice of the Development of a Commission

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Policy-on Below Regulatory Concern, as modified-in the attachment, be made available to the participants prior to the International Workshop on the subject and placed in the Public-Document Room.

At the International Workshop, the staff should clearly focus on those issues where differences of opinion may.

exist or specific. comments are sought (see commissioners' vote sheets and meeting SRM on-the subject matter dated 9/29/88 for additional details).

Following the International Workshop and other public workshops, the staff should forward for Commission ' review a revised Federal Register Notice for.public comment on tha proposed BRC policy.

(BOG)-(RES)-

(SECY suspense:

1/27/89)

Attachment:

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MP')MA N RO W *'.'.m As Stated THOMpe0. '

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Chairman Zach BERN : 0 Commissions: Roberts R)C..

Commissioner Carr Commissior.wr Pogers O

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t DRAFT Enc'.'sure 2 Advance Notice of the Development of a Preposed Commission Policy on

-Exemptions from Regulatory Control for Practices Whose Public Health-and Safety Impacts are Below Regulatory Concern I.

INTRODUCTION AND PURPOSE Over the last several years, the Commission has become increasingly aware of the need to provide a general policy on the appropriate criteria for release of radioactive materials from regulatory control. To address this need, the-Comission is expanding upon its existing policy.for protection of the public-from radiation, currently expressed in existing regulations (Title 10, Code of Federal RegulatYons) and policy statements (30 FR 3462, Use of fyproduct Me.terial and Source Material, dated March 16, 1965; 47 FR 57446, Licensing 27, 1982;-

Requirements for Land Disposal of Radioactive Waste, dated December and-51 FR;30839, General Statement of Policy and Procedures Concerning Petitions Pursuant to % 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29, 1986)..The expansion includes the

.prov4e4en develooment of an explicit policy on the exemption from regulatory control of practices whose public health and safety impacts'are below A practice is defined in this policy as an activity or a regulatory concern.

set or. combination of a number of similar sets of coordinated and continuing activities aimed at a given purpose which involve the potential for radiation Under this policy, the definition of

  • practice" is a critical exposure.

feature which will assure that the formtiation of exemptions from regulatory control will not allow deliberate dilution of noterial or fractionation of a practice for the purpose of circumventing controls that would otherwise be applicable.

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e The purpose of this policy statement is to establish the basis upon which the Comission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control persons who receive, possess, use, transfer, own, or acquire certain radioactive material. This policy is directed principally toward rulemaking activities, but may be applied to license amendments or license applications involving the release of licensed radioactive material either to the environment or to persons who would be exempt from Comission regulations.

It is imoortant to emohasire that this 20111Y.doesnotassertanabsenceorthresholdofriskbutratherestablishesa baseline where further government regulation to reduce risks is unwarranted..

The concept of regulatory exemptions is not new. For example, in 1960 and 1970, the Comission promulgated tables of exempt quantities and concentrations for radioactive material which a person, under certain circumstances, could receivo,. possess, use, transfer, own, or acquire without a requirement for a license (25 FR 7875 and 35 FR 6427). Other exemptions allowing distribution of consumer products v ether devices to the general public, or allowing releases of radioactive material to the environment, have beep embodied in the Comission's regulations for some time. More recently, the Low Level Radiosctive Waste Policy Amendments Act of 1985 cirected the Commission to develop st.andards and procedures for expeditious handling of petitions to exempt from regulation the disposal of slightly conteminated radioactive waste material that the Commission determined to be below regulatory concern. The Commission responded to this legislation by issuing a policy statement in August 1986 (51 FR 30839). That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow the Comission to act expeditiously in proposing appropriate regulatory relief on a " practice-specific" basis consistent with the merits of the petition.

The Comission believes that these " practice-specific" exemptions should be encompassed within a broader NRC policy which defines levels of radiation risk

.below which specified practices would not require NRC regulation based on public health and safety interests. For such exempted practices, the Comission's regulatory involvement could therefore be essentially limited to 2

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licensing, inspection, and compliance activities associated with the transfer of the radioactive material from a controlled to an extinpt status.

The Commission recognizes that, if a national policy on ex options from s-regulatory control is to be effective, Agreement States will play an important implementation role. In the past, States have been encouragin3 findings that certain wastes are below regulatory concern and the Commission believes that States will support an expansion of these views to all practices involving exempt distribution or release of radioactive material. The Commission intends that rulemakings codifying regulatory control exemptions will be made a matter of compatibility for Agreement States.

Consequently, any rulemakings that evolve from this policy will be coordinated with the States.

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Advisory and scientific bodies have offered diverse views to the Commission in anticipation of this Policy Statement. There is no clear consertus based on

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existing scientific evidence or research regarding the selection of numerical criteria for use in this Policy Statement. Further. the Commission is aware that there are differing views within the NRC staff on the selection of numerical criteria for BRC.

In the absence of a scientific consensus, it is the Commission's task to assess the diversity of views in establishing a responsible BRC poljcy. The authority and responsibility to make the final selection of criteria rests with the Commission. Criteria selected must:

1) provide reasonable assurance that public health and safety will be protected, and 2) consistent with such assurance, permit practices in the public domain which involve the use of i

radioisotopes for which society perceives a derand.

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It is recognized that there is a delicate balance here. Criteria can be set sufficiently restrictive such that there is absolute assurance that health and safety will always be protected, no matter what events might transpire.

Howevere in doing so, the regulator may then place undue and unnecessary restrictions on practices which should be permitted because of otherwise reasonable social, economic or industrial considerations. There is always the danger of over-regulation which results in effects that are felt in areas where the NRC does not have authority and responsibility. Moreover, 3

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c the Atomic Energy Act does not require absolute assurances of safety in the use of radioactive material and licensed facilities.

The numerical criteria ultimately selected will have significant impact on nuclear regulation here in the United States and potentfally in the international comunity. The values under consideration in this Policy Statement do not necessarily agree with those selected or under consideration by other countries. The Comission has carefully reviewed those alternate criteria, and does not find significant scientific evidence that would dictate oreferential selection of any of those views over what is prooosed in this Policy Statement.

II. RADIATION PROTECTION PRINCIPLES The Comission subser4bs-te recognizes that three fundamental principles of radiation protection 4n-formw4at4mg-4ts-pe44e4es-and-regulat4 ens have historically guided the formulation of a system of dose limitation to protect 1

l workers and the public from the potentially harmful effects of radiation. They are (1) justification 07 the practice, which requires that there be some net L

benefit resulting from the use of radiation or radioactive materials, (2) dose limits, which define the upper boundary of adequate protection for a member of the public which should not be exceeded in the conduct of nuclear activities, and (3) ALARA, which requires that radiation dose be as low as is reasonably achievable, economic and social factors being taken into account. The term, l

ALARA, is an acronym for As Low As is Reasonably Achievable. The Commission is

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interested in assessing how these principles should be applied in establishing i

appropriate criteria for release of radioactive materials from regulatory control.

l For-the-purpo s e -of-e st ab44 sh 4 ng-the-ateehast 4e 44 re v y-stat 4 st 4e a4 )-hea4th-P4 sk assee4ated-w4th-4ts-Pad 4ation-proteet4en-pe44e4est-the-Gem 4ss4en-alse-subser4bes L

te-a-44meer-quadrat 4e-relat4ensh4p-between-dase-and-effeet-whfeh-4s-44near-ever the-dese-range-for-wh4th-th4s-pe44ey-app 44es,--The-hypothes4s-upon-wh4eh-the l

l mede4-4s-based Because of the absence of observed health effects below i

5 rem / year, scientific experts including the International Comission on 4

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Radiation Protection (ICRP) and the National Comission on Radiation Protection (NCRP) make the assumption that the frequency of occurrence of health effects per unit dose at low dose levels is the same as'at high de; 3

( 10 Red) where health effects have been observed and studied in humans and animals. This linear non-threshold hypothesis assumes that the risk of radiation. induced effects (principally cancer) is linearly proportional to dose, no matter how small the dose might be. The coefficient used in the model as a basis'for estimatino statistical health risk is on the order of 2x10'k risk of fatal cancer per person rem of radiation dose Peee4ved by an-4Hd4v4dua4 in-subser4b4ng-to-th4a-models tThe Commission recognizes that it is a conservative model based upon data collected at relatively high doses and,

dose rates which is then extrapolated to the low dose and dose rate region where there are no statistically reliable epidemiological data available.

A4though aAlternative hypotheses have been proposed and reevaluations of the data base at higher doses continue 5-no-s4gn4f4eant-ehange-4s-ant 4e4 pated-4m the-genera 44y-seeepted-44near-mode 4-and-4ts numer4ea4-ooeff4e4 ente--it-4a therefere-the-Gem 4ss4enis-v4ew-that-the-use-of-the-44near-mode 4-prov4det-a Pea 9 enable-ba949-for-deWelop4mg-eMempt4en-pe44 eye The Comission believes that<

use of the linear non-threshold hypothesis allows the theoretical establishment of upper limits on the number of health effects that might occur at very low doses which are the subject of the exemption policy.

The risk of death to an individual, as calculated using the linear model, is shown in Table 1 for various defined levels of individual dose. A radiation exposure of 10 mrem per year for a lifetime corresponds theoretically to an increase of 0.1% of the individual's annual risk of cancer death. The lifetime risk is based upon the further assumption that the exposure level is the same for each year of a 70-year lifetime.

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Table 1*

Incremental Incremental 1.ifetime Risk from gnualDose Annual Risk Continuing Annual Dose-y 4

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= 1 x 10 2 x 10-6 w 1 x 10~4

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wem 0.1 wem 2 x 10-8

,j x jo-6 Risk coefficient of 2 x 10*4 per rem based upon publications of the ICRP.

For purposes of comparison, the risk to an individual of dying from cancer from all sources in the U.S. is 1 in 500. The additional-risk to an individual of dying from cancer when exposed to 10 mrom is 2 in oneimillion.

      • Unless otherwise indicated, the expression of dose in mrem refers to the Total ~ Effective Oose Equivalent. This term is the sum of the deep dose equivalent for sources external to the body and the comitted effective dose equivalent for sources internal to the body.

The Commission recognizes that it is impossible to measure risk to individuals or populations directly, and, that in most situations, it is impractical to measure annual doses to individuals at the low levels. imp"ed by exemption decisions, Typically, radioisotope concentrations or radiation levels from the material to be exempted are the actual measurements that can be made, and doses are then estimated by exposure pathway analysis combined with other types of Under assumptions related to the ways in which people might become exposed.

such conditions, conservative assumptions are frequently used in modeling so that tne actual dose is on the low side of the calculated do'se. The Comission believes that this is the appropriate approach to be taken when determining if an exemption from regulatory controls is warranted, in-the-opp 44 eat 4en-of-the-fundamenta4-pp4ne4p4es-of-Pad 4at4en-proteeteent ee44eet4ve-dest-prev 4 des-a-usefu4-way-to-express-the-4mpaet-44,ers-detP4ments) of-a-nuelear-aet4v4ty-en-the-hea4th-ef-the-population-subdeet-to-rad 4at4en Collective dose'is tiie sum of the individual doses resulting from a

empesure, practice or source of radiation exposure. By assigning collective dose a monetary value, it can be used in cost benefit and other quantitative analysis 1

. techniques.

It is therefere an-4mportant a, factor to consider in balancing benefits and societal detP4ments-for-praet4ee-fust4f4 eat 4en-and-AhARA determ4 mat 4ensimpacj.

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III. APPhiGAT19N-GF-RABIATi9W-PR9TEETiON PRINGIPEES-79 EXEMPT +0W6-FR9M REGWhATORV-69WTR9b CONSIDERATIONS IN GRANTING EXEMPTIONS FROM REGULATORY CONTROL The following sets-forth-guidelines-about-how-the-Ge m4ss4en-w444-apply-the fundamente4-pr4ne4p4es-of-red 4at4en-proteet4en-4n-sens4 derat 4en-of elements are beina considered by the Ccmission as a basis for evaluating practices which are proposed to be exempt from regulatory control. These practices, if approved, would result in products containing low levels of radioactive material being distributed to the general public and radioactive effluents and solid waste being released to areas of the publice41y accessible environment.

Justification

'(he Comission seeks comment on the extent to which o

Eexposures resulting from any practice should be justifiedt,

f thust-even-at-te4v4a4-4 eve 4s-of-doses-the-praat4ee-eens4dered-for exempt (en shou 4d-be-dust 4f4ede As lower levels of radiation exposure are projected, should lower levels of benefit w,44 be needed required for practice justification? Howevert 4In establuhing its po44e4es-the Gemm4ss4en-ws44-eent4 hue-to-preh4b44 exemption policy, should the Comission exclude certain practices for which there-4s appears to be no reasonable justification 1 In considering proposals for exemptions, should the Comission evaluate the social acceptability ipractices?

Should the Comission determine a practice to be unjustified if nonradioactive economical alternatives exist?

Dose Limits and Criterion - Individual doses from practices exempted o

under tnis policy should not be allowed to exceed 100 mrom per year.

This is the dose limit for members of the public specified in the final revision of 10 CFR Part 20. Standards for Protection Against Radiation.

The dose limits in the final revision of 10 CFR Part 20 apply to all sources of radiation exposure under a licensee's control (natural background and medical exposures are excluded). Because of the small risks it.volved, a 10 mrem individual dose criterion is proposed as the basis for exemption decisions based on simple analysis and judgements.

The Comission specifically seeks coment on the need for establishing a collective dose limit in addition to an individual dose criterion.

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n If such a collective dose criterion is needed, what is the basis for this need? If the Commission decides that a collective dose criterion is needed, what approaches allowing truncation of individual dose in calculation of collective dose or weighting factors for comoonents of collective dose would be appropriate? What alternatives should be considered for assessing societal impact?

o ALARA - The ALARA principle generally applies to determining dose'1evels below which exemptions may be granted on a cost-benefit basis. However, it is the purpose of this policy to establish ~ criteria for-4nd4v4dua4-end so44eet4ve-dese which would in effect, delineate achievement-of ALARA 2

without cost-benefit analysis.

Although it is possible to reasonably project what the dose will be from a practice, and then take this information into account in controlling regulated practices so that the dose limits are not exceeded, exemptions imply some degree of loss of control. The Commission believes that a key consideration in establishing a policy for exemptions, and subsequently in specific rulemaking or licensing decisions, is the poss4b(44ty-that que: tion of whether individuals may experience radiation _ exposure approaching the limiting values through the cumulative effects of more than one practice, even though the exposures from each practice are only small fractions of the limit. The Commission specifically seeks comment en the issue.

By appropriate choices of exemption criteria and through its evaluations of specific exemption proposals in implementing the policy, the Comission intends to assure that it is unlikely that any individual will experience exposures which exceed the 100 mrem limit.

IV. PRINCIPLES OF EXEMPTION Gnee-a-prae 64ee-4s-establ4shed-as-dust 4ffedr-4, erg-there-4s-a-pos4t4ve-net benef44-to-the-4ntrodset4en-er-use-of-rad 4eae64ve-materia 4,-the-dee4s4en-of whether-er-net-the-ent4re-praet4eer-or-name-def4ned-subset-of-the-praet4eer-4s

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a-eend4date-for-exempt 4en A major consideration in exempting any practice from regulatory control hinges on the general quection of whether or not 8

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f application or continuation of regulatory controls are necessary and cost

. effective in reducing dose. To determine if exemption is appropriate, the-l

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Comission must determine if one of the following conditions is met:-

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1.

The application or continuation of regulatory controls on the practice does not result in any significant reduction in the 4nd4v4dua4-er-ee44eet4ve dose received by individuals within the critical. group and by the exposed population or;

_t 2.

The costs of the regulatory controls that could be imposed g dose reduction to-reduee-the-4nd4v4 dual-agd-eo44eet4ve-dese are not balanced by the commensurate reduction in risk that could be realized.

For purposes of implementing its policy, the Comission recognizes that only under unusual circumstances would practices which cause radiation exposures approaching the 100 mrem limit be considered as candidates for exemption. The Comission will consider such circumstances on a case specific basis using the general principles outlined in this policy statement, However, as the doses and attendant risks to members of the exposed population decrease, the need for regulatory controls decreases and the analysis needed to support a proposal for exemption can reasonably be somewhat simplified. At-a-suff4e4ent4y-4ew-4 eve 4' ef-4nd4v4 dual-riskt-dee4s4 ens-regard 4ng-exempt 4 ens-f4teer-whether-AkARA-has been-aeh4eved)-een-be-redueed-te-en-evaivat4en-of-whether-the-evere44-pub 44e risk-4s-suff4e4ent4y-sma44r The Comission therefere-propeses-that it, evaluating the use of two numerical criteria shou 4d-be-estab44shed in defining the region where ALARA has been achieved. They are (a) a criterion for the maximum individual annual dose reasonably expected to be received as a result of the practice and (b) the ee44eet4ve-dese-te-the a measure of societal impact to the exposed population.

in-eemb4nat4ent tThese criteria are-ehesen are being considered to assure that, for a given exempted practice, no individual will be exposed to a significant risk and that the population as a whole does not suffer a significant impact.

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l If the individual doses from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared with other L

societal risks. The Comission believes that annual individual fatality risks-below approximately 100 (one in 100.000) are of little concern to most b

menbers of society. Providing for some margin below this level, the Comission proposes 10 mrem as the level of annual individual exposure below-wh4eh-AkARA-een-be-demonstrated on-the-bas 4s-that-ce44eet4ve-dese-4s else-suff4e4ent4y-sma44, The incremental annual individual cancer fatality risk associated with an exposure level of 10 mrom per year is about 2x10-6 l

(two in one-million) as indicated in Table 1 and of the order of 0.1 percent (one in one-thousand) of the overall risk of cancer death, i

In evaluating the need for a The collective dose criterion 2 proposed-4s-499 2

persen-rem-per-year-per-praet4eet--Adept 4en-of-this-ve4ue-prev 4 des-assuranee that-the-number-of-4md4v4dus4-empesures-et-er-near-49-meem-w444-be-no-mere then-a-few-thousand-people-and-that-for-the-exempt-praet4ees-to-wh4eh 44-4s app 44ed-a-fata44ty-among-the-empesed-popu4at4en-wou4d-be-very-un44ke4y, the Commission recognizes that this criterion could be the limiting consideration for practices involving very small individual doses t.o very large numbers of l

people.

It is also recognized that in such cases the collective dose criterion would, in effect. apply the ALARA concept to individual doses less than the below regulatory concern level of 10 mrem per year to the individual.

Conversely, where the collective dose criterion would not be limiting. it would The'Comission requests coments on this issue, including serve no purpose.

coments-on what the magnitude of the collective dose criterion, if any, should be.

If the ee44eet4ve dose end-4ndiv4dus4-dese-fe44-below-these-leve4ss is less than the below regulatory concern criteria. then the risk from a dust 4ffed The practice 4e would be considered to be ALARA without further analysis.

Comission stresses that adoption of the 4nd4v4 dual-end-ee44eet4ve-dese criteria should not be construed as a decision that smaller doses-be4ew these-er4ter4a are necessary before a practice can be exempted, while doses above the criteria would preclude exemptions. On the contrary, the criteria simply represent a range of risk which the Comission believes is sufficiently small compared to other individual and societal risks that a cost benefit analysis is not required in order to make a decision regarding the 10

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acceptability of an exemption. Practices not meeting these criteria may be l

granted exemptions on a case-by-case basis in accordance with the principles L

embodied within this policy. To further emphasize the Comission's rec'ognition that a rigid limitation on collective base-4s dose would be inappropriate, it notes that for some practices, such as use of smoke detectors, appreciable benefits can only be attained through extensive utilization and, hence, with a f

comensurate collective dose.

1 The Commission is aware that existing regulations of the Environmental l

Protection Agency establish criteria more restrictive than exemptions which could otherwise be granted under this proposed policy. With regard to its own regulations, the Comission will evaluate whether there are exemption criteria embodied therein for which modification, according to the principles of this policy, would be beneficial.

l V.

EXCLUSIONS FROM EXEMPTIONS The Commission's March 16, 1965, notice on the Use of Byproduct Material and Source Material-Products Intended for use by General.Public (Consumer Products),

(30 FR 3462) provides the basis for the Commission's approval of the use of these materials in consumer products without regulatory control on the This is accomplished by case-by-case exemption of the.

L consumer-user.

' possession and use of approved items from applicable licensing requirements.

p Approval of a proposed consumer product depends upon an assessment of.

exposures of persons to radiation as well as an evaluation of the usefulness of the product.

l There-are-some-types-of Certain practices involving radiation or radioactive materials wh4eh-arer-pr4ma-fee 4er have been judged by NRC to be socially L

unacceptable regardless of how trivial the resulting dose might be and, therefore, shou 4d-be have been excluded from exemption. Excluded practices wou4d include, but net-be are not limited to, the intentional introduction of radioactive material into toys and products intended for ingestion, inhalation or direct application to the skin (such as cosmetics).

Exe4usione-would-alse 4me4ude-the-purpesefu4-and-fr4ve4eus-d4stribut4en-er-release-of-rad 4eaet4ve 11

g,.www mater 4a4s-where-there-are-e4eart-eeenom4ea4-alternat4ves-to-eveh-use-and-the prae 64ee-4s-not-fust4f4ed-beesuse-there-are-no-un4que-benef4ts-from-using-the rad 4eaet4ve-meter 4aler In addition to socially unacceptable uses of radioactive materials, a question also arises regarding uses where there are clear economical alternatives, and no unique benefits exist from using radioactive material. Where risks are trivial, the regulatory prohibition of such uses could pose an unnecessary

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regulatory burden by interfering with the conduct of business.

The Comission seeks coments on whether practices should be categorically excluded based on the Commission's judgement regarding social acceptability or L

the existance of alternatives. An alternative to categorical exclusion could be case specific determination based on a safety analysis.

l I

VI. PROPOSALS FOR EXEMPTION A proposal for exemption must provide a basis upon which the Comission can determine if the basic conditions described above have been satisfied.

In general, this means that the proposal should address the individual dose-and i

ee44eet4ve-deses societal impact resulting from the expected activities under the exemption, including the uses of the radioactive materials. the pathways of exposure, the. levels of activity, and the methods and constraints for assuring that the assumptions used to define a' practice remain appropriate as the radioactive materials move from regulatory control to an exempt status.

I l

If a proposal for exemption results in a rule containing generic requirements, a person applying to utilize the exemption would not need to address justification or ALARA. The Comission decision en such proposals will be based on the licensee's meeting the conditions specified in the rule. The promulgation of th'e rule would, under these circumstances, constitute a finding that the exempted practice is justified, and that ALARA considerations have been dealt with. This approach is consistent with past practice, e.g.,

i consumer product rules in 10 CFR Part 30.

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l 4md4eates-that-the-44ke4y-eensequenees-of-enempt4en-are-4md4v4dua4-and-ee44ee U

44ve-deses-approx 4 mate 4y-equa4-te-or-4ess-than-the-er4ter4a-ve4Wes,-there-would j

be-h igh -44k e 44 heed-t h a t -t he -a pp 44 e a t 4en -wo u 4d-be-a ssep ted -by-the-Gemi s s 4 e n, j

L In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered with regard L

to the potential that some individuals may receive doses near the 100 mrem RE g limit when doses from other practices are also taken into consideration.

If exposures from multiple practices can occur which are significantly beyond the individual dose criterion (1,0 mrem), the exemption will not be granted without further analysis. As experience is gained, this policy and its

~1mplementation will be reevaluated with regard to this issue to assure that the exposures to the public remain well below 100 mrem.

L L

In addition to considerations of expected activities and pathways, the Comission recognizes that consideration must also be given to the potential for accidents and misuse of the radioactive materials involved in the practice.

l A proposal for exemption of a defined practice must therefore also address the L

potentials for accidents or misuse, and the consequences of these exceptional conditions in terms of individual and collective dose.

l Viir-GAhEWhATE9N-AND-WSE-9F-G9hhEGTIVE-996E-ASSESSMENT The-ee44ee64ve-dese-een-serve-as-both-a-measure-of-the-4mpaet-f4eerr-detr4 ment) of-a-praet4ee-en-the-exposed-pepu4ation-and-a-meehan4em-for-assess 4ng-the benef4ts-of-regu4atory-eenstra4nts-en-the-praet4ee-being-enempted-from regu4atery-eentreir--in-the-4atter-easer-a-monetary-value-een-be-assigned-te the-es44eet4ve-dese-se-that-eest-benef(t-assessmente-eanabe-made-with-respeet te-the-usefulness-of-eentreis-er-eenstra4nts-en-a-praet4ee-to-further-reduee ee44ee44ve-desev The-Gem 4ss4en-be44 eves-the-assessment-of-the-eempenents-ef-teta4-ee44eet4ve dese-must-be-made-te-sat 4sfy-Net 4ena4-Env4renmente4-Pe44ey-Aet-requirementse l

Hewevert-when-used-fer-eest-benef4t-analyses-er-for-eva4 mat 4en-aga4nst-the eel 4eet(ve-dese-er4ter4en-preposed-4n-th4s-pe44eyr-several-a4ternat4ve 13

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i apprenehes-een a44ew-truneet4 ens-or-we4ghting-feeters-to-be-app 44ed,--For example,-the-ee44ee44ve-dese-4s-often-used-to-d4ser4minate-between-alternet4ves j

er-optionse--The-ee44eet4ve-dese-4n-eveh-eases-shou 4d-be-ee4eulated-to-the j

pe4nt-where-a-ehe4ee-between-opt 4 ens-4s-e4 ear,--Gemp4y4ng-w4th-th4s-requ4pement l

w444-eften-s44ew-the-truneet4en-of-the-ee44eet4ve-dese-assessment-4n-44me end/or-spose,--A4ser-4arge-uneerte4ntfee-assee4sted-w4th-dese,-part4evier4y-et I

very-4ew-dese-or-dese-rates-may-render-eerte4n-eempenents-of-the-assessment non-usefv4-4n-the-eemper(sen-of-a4ternet4ves,--Furthermore,-an-4nd4v4dve4-dese e sto f f-eeu 4 d-e 4 se-b e-e e n s id e re e-e n-t h e-ba sis -t h a t -t he-s ussne t e en-of-sme 44 (nd4v4dua4-deses-ferger-4ess-than-9,4-meem-per-year}-represent-en-4ns4gniffeant seefete4-risk-or-thet-the-ee44eet4ve-dese-attr4buted-to-these-ema44-deses-4s l

very-sma44-4n-eemper(sen-to-the-rema4n4ng-ee44ee64ve-dese-from-the-enempted praet4eet--F4ne44ys-very4ng-menetary-values-eeu4d-be-assigned-to-components-of ee44eet4ve-dese,-evge,-64999-per-persen-rem-for-ee44eet4ve-dese-eemposed-of 4nd4v4due4-deses-4n-eneess-of-4-meem-per-year-and-$499-per-person-rem-for-4 ewer 4 nd 4 v 4d u a 4 -de s e s,--The-G em4 s s 4 e n-be 44 e ve s - t h a t -t he-u s e-of-ene -er-more-of-t he above-approaehes-eeu4d-be-appropr4ste-depend 4mg-en-the-preet4ee-under-eens4 der at4en-for-exempt 4en-from-regu4etery-eentrol, VIII.

VERIFICATION OF EXEMPTION CONDITIONS L

The Comission believes that the implementation of an exemption under this l

broad policy guidance must be accompanied by a suitable program to monitor and l

verify that the basic considerations under which an exemption was issued remain valid.

In most cases, the products or materials comprising an exempted practice will move from regulatory control to the exempt status under a defined set of conditions and criteria. The monitoring and verification program must therefore be capable of providing the Commission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being observed. The Comission will determine compliance with the specific conditions of an exemption through its established licensing and inspection program and will, from time to time, conduct studies as appropriate to assess the impact of an exempted practice or combinations of exempted practices.

14

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