ML20043B931

From kanterella
Jump to navigation Jump to search
Notice of Proposed Policy Statement on Exemptions from Regulatory Control
ML20043B931
Person / Time
Issue date: 12/02/1988
From: Stello V
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
Shared Package
ML20042C963 List: ... further results
References
FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006010063
Download: ML20043B931 (16)


Text

%

L *.. ;;

s

[*. * $

[759001)

NUCLEAR REGULATORY COMMIS$10N 10 CFR Chapter !

Policy statement on Exemptions from Regulatory Control AGENCY: Nuclear Regulatory Comission.

ACTIONS: Advance notice of proposed policy statement and meeting.

1 i

l SUPMARY: The NRC is in the process of developing a broad policy on exemptions from regulatory control for practices whose health and safety impacts could be considered be' vow regulatory concern. Ybis policy statement would provide for scre efficien and consistent regulatory actions in conection with exemptions h

frm varicus specific Comissico requiremnts. The Caserission, in formulatihp j

this Advance Notit,a, is seeking p:slic input on some 6tecific questions which j

L are key t'onsidt. rations in developing such a polig. TN HRC staff will contact a resting to inform the public of its intentions, tretifically e.,o clarify ar.d J

l l

answer questions concerning the advance notice, and to hear preliminary views l

concerning a policy for exemptions with emphasis on the specific questions l

l raised by the Commission.

L DATES: Meeting to be held on January it.198g. Written comments should be submitted by January 30,198g. Coments received after this date will be considered if it is practical to do so, but assurance of consideration can only be liven as to comments received on or before this date.

ADDRE55ES: Meeting will be held at the Holiday Inn, 8120 Wisconsin' Avenue, Bethesda, MD 20814(4 blocks north of the Bethesda Metro Station). Telephone:

(301) 652 2000,1800-465-432g. Mail written comments to: Secretary,U.S.

Nuclear Regulatory Comission, Washington, DC,20555, Attention: Docketing and Service tranch.. Coseents may be. delivered to 11555 Rockville Pike, Rockville, MD between 7:30 a.m. and 4:15 p.m. weekdays. Copies of the connents received may be examined and copied for a fee at the NRC Public Document Room at 2120 L Street,NW, Washington,DC.

,- w FOR FURTHER INFORMATION CONTACT Catherine R. Mattsen, telephone (301)agt.3f 35, 9006010063 891130 1

11 FR49886 PDC

1

[7590-01) orWilliamR.Lahs, telephone (301)4323774, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Coasnission, Washington, DC, 20555.

SUPPLEMD.'TARY INFORMATION:

International Workshop In addition to conducting this public meeting, the Connission has sought input from the international regulatory connunity through an international workshop on exemptions from regulatory control which was held October 17-19,1988 in l

Washington,DC. The importance of such interaction stems from the fact that may existing and potential exemptions involve radioactive meterials purresefully used in consumer products or introduced into vertous products or materials through the recycling of contaminated scrap, eithat of which any L

enter international trade. Even effluents and weste disposa! can involve C:posures to people in countries other than those from which the affluent or waste originated. This asp ct is a significant issue in the European cosaunity, Thuc, some degree of consistency internations11y is desirable.

since exemption decistons can affect populations outsida each country's bneder.

l It is hoped. that exchanges of ideas and inforration such as occurred at the international workshop will, besides providing one avenue of input to the Cosmission's actions, lead toward a greater degree of consistancy in such exemptions world-wide. At the international workshop, the ' Advance Notice of the Development of a Connission Policy on Exemptions from Regulatory Control for Practices Whose Public Health and Safety lupacts are Below Regulatory" -

The Concern *, presented in this notice, was made available for discussion.

transcript of the international workshop which includes all the papers presented at the meeting may be examined and copied for a fee at thh NRC Public Document Room at 2120 L Streat, NW, Washington, DC.

Advance Notice of the Development of a Cosnission Policy Introduction and Purpose Over the last several years, the Connission has become increasingly aware of the need to provide a general policy on the appropriate criteria for release of

' 'm 2

,, 7

...................................-..........,,,,, _,,,,,,, o.,,, _,,.,

[7590-01) radioactive materials from regulatory control. To address this need, the Comission is expanding upon its existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10 Code of Federal Regulations) and policy statements (30 FR 3462, Use of Byproduct Material and Source Material, dated March 16, 1965: 47 FR 57446, Licensing Requirements for Land Disposal of Radioactive Weste, dated December 27,19826 and 51 FR 3083g, General Statement of policy and procedures Concerning i

Petitions Pursuant to i 2.802 for Disposal of Radioactive Weste Streams Below Regulatory Concern, dated August 29,1986). The expeision includes the development of an explicit policy on the exemption from regulatory control of practices whose public health and safety impets are below regulatory concern.

A practice is defined in this policy n an activity or a set or combination of a number of staiihr sets of coordinated and contfreing activities sinc 4 at a given purpose which involvt: the potential for radiation Exposure. Under th1ir policy, the definition of *pN ctice is a critical feature which will assure that the formulation of exemptions frou regulatory control will not allow l

delit,arate dilution of material or fractionation of c practice for the purpose of circumventing controls that would otherwitc be applicable.

(

The purpose of this policy statement is to establish the basis upon which the i

Cosmission maw initiate the development of appropriate regulations or make

l 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 important to emphasize that this policy does not assert an absence or threshold of risk but ratherestablishes a 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 Cosni'ssion promulgated tables of exempt quantities and concentrations for radioactive material which a person, under certain circumstances, could receive, possess, use, transfer, own, or acquire without a requirement for a license (25 FR 7875: August 17,1960and35FR6426; April 22,1970).

Other exemptions allowing distribution of consumer products or other devices t:

the general public, or allowing releases of radioactive material to the 3

w

.............. - -........... c.

.... ~ -..

\\

I'

[7590-01) e, environment, have been embodied in the Comission's regulations for some time.

More recently, the Low Level Radioactive Waste Policy Amendments Act of 1985 directed the Comission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the disposal of slightly contaminated radioactive waste material that the Comission determined to be below regulatory concern. The Comission responded to this legislation by issuing a policy statement on August 29,1986 (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.

I The Nainion believes that these " practice-specific

  • exemptiers should be ancompassed within a broader WRC policy which defir.es levels of radiction risk i

below whit.h specified practices woul:1 not require NRC regulation beted on public health and safety interet,ts. For such exempted practices, the Caecissien's regulatory involvement could therefore be essentially limited to l

licensing, inspection, and cosp1Dnce activities associata4 with the transfer l

of the radioactive material from a controlled to en e'xempt status.

The Commission recognizes that, if a national policy on exemptions from regulatory control is to be effective, Agreement States will play an isportant implementation role. In the past, States have been encouraging findings that I

certain wastes are below regulatory concern 'and the Cosnission believes that States will support an expansion of these views to all practices involving-exempt distribution or release of radioactive material. The Cosnission intends that rulemakings codifying regulatory control exemptions will be made a matter of compatibility for Agreement States.

onsequently, any rulemaktngs that

~

evolve from this policy will be coordinated with the States.

l l

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

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

4

.,, - 7

. m....,.......,...,.......

i

[759001)

)

In the absence of a scientific consensus, it is the Cosnission's task to assess the diversity of views in establishing a responsible BRC policy. The authority and responsibility to make the final selection of criteria rests with the Comission. Criteria selected must: 1) provide reasonable assurance that l

publichealthandsafetywillbeprotected,and2)consistentwithsuch assurance, permit practices in the public domain which involve the use of radioisotopes for which society perceives a demand.

It is recognized that there is a delicate balance here. Criteria can be set sufficiently restrictive such that there is absolute assurance that health L

and t.afety will aiways be prctet. ed, no matter what tvents might transpire.,

l Howaver, in doing so, the r6gulator say then place vndu and vnneassary respictiers an practices tehich should be persitted because of otherwise reasen4ble seeini, econor.ic, or industrial considerations. There is always the d6nger of over-regulation which results in effects that are felt in 6reas where the NRC does Mt have authority and respasibility. Moreover.

the Atomic Energy Act #es not requite absolute easurances of safety in the nse of radioactive s terial and licensed facilities.

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

1 Radiation protection Principles The Comission recognizes that three fundamental principles of radiation protection have. historically guided the formulation of a system of dose limitation to protect workers and the public from the potentially harmful effects of radiation. They are (1) justification of the practice, which requires that there be some net benefit resulting from the use of radiation or radioactive materials, (2) dose limits, which define the upper 5

~ _ -

i*.

[7590 01)

E*

boundary of adequate protection for a mes6er of the public which should not be exceededintheconductofnuclearactivities,and(3)ALARA,whichrequires that radiation dose be as low as is reasonably achievable, economic and social factors being taken into account.

The ters, ALARA, is an acronym for As Low As is Reasonably Achievable. The Comission is interested in assessing how these principles should be applied in establishing appropriate criteria for release of radioactive materials from regulatory control.

Becauseoftheabsenceofobserndhealtheffectsbelow5res/ year (50 m5v/ year), scientif te experts including the International Connission on Radiologicd Prc.uction (ICRP) and the National Council on Raciation ProtectionandMeasurements(NCRP)maketheassurptionthatthefrequencyof occurrence of health effectr. per unit dose at low dose levels is the same as l

at high doses (10 Red (0.1 iny)) where health effects have been ebserved eet l

studied in humans and animals. This linear non-thrcshc.1d typothesis asswnes that the rhk of radiation induced effects (principally cancer) is linearly l

The coefficient proportional to dose, no matter how small the dose might be.

used in the model as a basis for estimating statistical health risk is on the l

risk of fatal cancer per person-rem of radiation dose (2x10-2 4

order of 2x10 per Sv). The Comission recognizes that it is a conservative model based upon data collected at relatively high doses and dose rates which is then l

extrapolated to the low dose and dose rate region where there are no L

statistically reliable epidemiological data available. Alternative hypotheses have been proposed and reevaluations of the data base at higher doses continue.

The Commission believes that use of the linear non threshold hypothesis a,1 lows 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 ares per year (0.1 mSv per year) for a lifetime corresponds theoretically to an increase of 0.15 of the individual's annual risk of cancer The Itfetire risk is based upon the further assumption that the death.

exposure level is the same for each year of a 70 year lifetime.

p 6

[759001)

In estimating the dose rates to meders of the public that might arise through the use of various practices for which exemptions are being considered, the Comission has decided to apply the concept of the ' effective dose equivalent.'

This concept, which is based on a comparison of the delayed mortality effects of ionizing restation exposures, permits through use of weighting factors, the calculation of the whole body dose equivalent of partial body exposures. This

{

approach was originally developed by the International Cosmission on Radiological Protection and was first expnssed in its publication 26 issued in 1977.

Since that time, the concept has bsen reviewed end evaluated by radir. tion protectic,n crganizations throughout the world and has gained vide f

acceptance.

Table 1*

Incremental Incremental Liftlime Risk from Annual Dose Annual Risk Continuing Annual Dose l

100 mrer***

P x 10 5 1 x 10 10 mrem **

2 x 10-6 1 x 10*45 2 x 10*7 1 x 10 6 1

prem 2 x 10-8 1 x 10-0.1 prem Risk coefficient of P x 10 perrem(fx10-2 perSv)basedupon 4

publications of the ICRP.

For purposes of comparison, the annual risk to an individual of dying from cancer from all sources in the U.S. is 1 in 500. The additiona risk to an individual of dying from cancer when exposed to 10 arem (0.1mSv)is2inonemillion.

      • Unless otherwise indicated, the expression of dose in arem'refirs to the Total Effective Dose Equivalent. This term is the som of the deep dose equivalent for sources external to the body and the comitted effective dose equivalent for sources internal to the body.

The Comission recognizes that it is impossible to measure risk to individuals or populations directly, and, that in most situations, it is impractical to measure annual doses to individuals at the low levels implied by exemption l

decisions. Typically, radioisotope concentrations or radiation lev'els from the

~ " '

material to be exempted are the actual measurements that can be made, and doses I

[7590-01) are then estimated by exposure pathway analysis combined with other types of assumptions related to the ways in which people might become exposed.

Under such conditions, conservative assumptions are frequently used in sedeling so that the actual dose is on the low side of the calculated dose. The Cosaission believes that this is the appropriate approach to be taken when determining if an exemption from replatory controls is warranted.

L Cc11 erg.tve dose 1$ the sum of the individual doses resulting from a practice or i

sou we of radiatios e 90sure. By sesigning rollective dose a monttery value, it can be used in e.ost tenefit and other quantitative analysis techniques.

It is a factor to consider in balancieg benefits and societal impact.

Considerations in Granting Exemptions from Regulatory Control The following elements are being considered by the Comission as a basis for

\\

evaluating practices which are proposed to be exempt from regulatory control.

These practices, if approved, would result in products containing low levels of radioactive material being distributed to the general public and radioactive effluents and solid waste being released to areas of the publicly-accessible environment.

o Justification - The Comission seeks coment on the extent to which exposures resulting from any practice should be justified. As lower levels of radiation exposure are projected, should lower levels of benefit be requiredforpracticejustification? In establishing its exemption policy, should the Cosefssion exclude certain practices for which there appears to be no reasonable justification? In considering proposals for exemptions, should the Cosnission evaluate the social acceptability of practices? Should the Comission determine a practice to be unjustified if nonradioactive economical alternatives exist?

c.

Dose Limits and Criterion - Individual doses from practices exempted under this policy should not be allowed to exceed 100 mrem per year (1 s$v per year). This is the dose limit for mes6ers of the public specified in the i.

final revision of 10 CFR Part 20, Standards for Protection Against l

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

^ ^ - - ~ ^ ~ ~ - ~ ~~ ~

~ - ~ ~ - ~ ~ ~ ~ ~ - ~ ~ -

~ ~ ~ ~ ~

w - - _

l s

l.

[75g0-01) t 1

'l background and medical exposures are excluded). Because of the sm:11 risks involved, a 10 arem (0.1 m$v) individual dose criterion is proposed I

as the basis for exemption decisions based on simple analysis and judgements. The Commission specifically seeks comment on the need for establishing a collective dose limit in addition to an individual dose criterion.

If such a celtective dose criterion is needed, what is the basis for this need? If the Cosm.ission det. ides thn a collective dose critethn is needed, what approaches allowing trer,r,ation of individual dnte in calculation of collective dose or weighting i

Esctors for components of collective dost would be appropriate't b' hat alternatives should be considered for assessing societal impact?

o ALARA - The ALARA principle generally applies to determining dose levels L

below which exemptions may be Granted on a cost-benefit basis. However, it is the purpose of this policy to establish criteria which would, l

in effect, delineate achievement of ALARA without cost-benefit analysis.

Although it is possible to reasonably project what the, dose will be from a practice, and then take this information into account in controlling regulated practices so that the dose limits are not exceeded, exemptions imply some degree of loss of control. The Cosnission believes that a key consideration in i

establishing a policy for exemptions, and subsequently in specific rulemaking or licensing decisions, is the question 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 consnent on the issue. By appropriate choices of exemption criteria and through its evaluations of specific exemption proposals in implementing the policy, the Commission intends to assure that it is unlikely that ary individual will experience exposures which exceed the 100 orem per year (1 mSv per year) limit.

principles of Exemption A major consideration in exempting arty practice from regulatory control hinges l

on the general question of whether or not application or continuation of l

1.

R

' ~~

y.

s r*.*

l' '

D590-01) regulatory controls are necessary and cost effective in reducing dose. To detemine if exemption is appropriate, the Comission must determine if one of the following conditions is met:

1 1.

The application or continuation of regulatory controls on the l

practice does not result in any significant reduction in the dose

{

i received by individuals within the critical grce and by the exposed l

L population or; i

l 2.

The costi of the regulatory controls that could I,e ispsed for,

dose reduction are net balanced by the cossenwrate reduction in risk y

l that could be realized.

For purposes of implementing its policy, the Cosnission recognizes that only under unusual circumstances would practices which cause radiatier. exposures

- approaching the 100 mrem per year (1 mSv per year) limit be considered as j

candidates for exemption. The Comission will consider such circumstances on a

~

case specific basis using the general principles outlined in this policy L

statement. However, as the doses and attendant risks to members of the exposed L

population decrease, the need for regulatory controls ' decreases and the analysis needed to support a proposal for exemption can reasonably be somewhat simplified.

The Comission is evaluating the use of two numerical criteria in defining the region where ALARA has been achieved. Theyare(a)acriterionforthemaximum individual annual dose reasonably expected to be received as a result of the practiceand(b)ameasureofsocietalimpacttotheexposedpopulation. These criteria 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.

If the individual doses from a practice under consideration for exemption are sufficiently ses11, the attendant risks will be small compared with other societal risks. The Comission believes that annual individual fatality risks below approximately 10-5 (one in 100,000) are of little concern to most members of society. Providing for some margin below this level, the Cosmission proposes 10 mrem (0.1 m$v) as the level of annual individual exposure. The I

10

- - - wa. ::.:~

^ - ^ ~ ~ ~ ^ ~ ~ - ~ ^ ~ ~ - ~ ^

~ ^ ^ ^ ~ ~ ~

~-

c

[75g0-01) n incremental annual individual cancer fatality risk associated with an espesure level of 10 arem per year (0.1 mSv per year) is about fx10-6 (two it. 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 collective dose criterion, the Commission eccognizes that this criterion could be the limiting consideration for practices involving very small individual ct.es to very large ngthers of j

people.

It is also recognized that in such cases the em11ective dose i

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 individua1.

Conversely, where the collective dose critation would not be limitir.g. it would The Comission requests courtnis a this issue, including serve no purpose.

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

If the dose is less than the below regulatory concern criteria, then the risk The from a practice would be considered to be ALARA without further analysis.

Comission stresses that adoption of the criteria should not be construed as a decision that smaller doses 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,

acceptability of an exemption. practices not meeting these criteria may be granted exemptions on a case-by. case basis in accordance with the principles esbodied within this policy. To further emphasize the Comission's1 recognition that a rigid limitation on collective dose would be inappropriate, it notes that for some practices, such as use of smoke detectors, appreciable benefits l

can only be attained through extensive utilization and, hence, with a l

comensurate collective dose.

L The Comission is aware that existing regulations of the Environmental protection Agency establish criteria more restrictive than exemptions which could otherwise be granted under this proposed policy. With regard to its own regulations, the Cossission will evaluate whether there are exemption criteria

)

L 1

c __. a

~

- ~ - ~ - - - - -

[759001) es6edied therein for which modification, according to the principles of this policy, would be beneficial.

Exclusions from Exemptions i

i The Cossnission's March 16, 1965, notice on the Use of Ryproduct Material and Source Material-products Intended for use by General public (Consumer products)

(30 FR 3462) provides the basis for the Coesniation's approval of the use of these materials in conamer products without reguietory control on the consumer-user. This is acccmplished by case-by. case exemption of the possession and use of approved items from applicable licensing requirements.

Approval of a proposed consumer product depends upon an assessment of I-4 exposures of persons to radiation as well as an evaluation of the usefulness of the product.

Certain practices involving radiation or radioactive materials have been judged by NRC to be socially unacceptable regardless of how trivial the resulting dose might be and, therefore, have been excluded from exemption.

Excluded practices include, but 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).

f 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' regulatory burden by interfering with the conduct of business.

~

The Connission seeks cosnents on whether practices should be categorically excluded based on the Cosnission's judgement regarding social acceptability or the existance of alternatives. An alternative to categorical exclusion could be a case speci,fic determination based on a safety analysis.

12

[7590-01)

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

In general, this means that the proposal should address the individual dose and 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 radicactiver materials move from regulatory control to an exempt status, i

If a proposal for exemption results in a rule containing generic requiresents, a person applying to utilize the exemption would not need to addresa 1

justification or ALARA. The Comission decision on such proposals will be based on the Itcensee's meeting the conditions specified in the rule. The promulgation of the rule would, under these circumstances, constitute a finding that the exempted practice is justified, and that ALARA considerations have been dealt with. This approach is consistent with pas,t practice, e.g.,

consumer product rules in 10 CFR part 30.

l In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered with regard to the potential that some individuals may receive doses near the 100 mrem per year (1 mSv per year) limit when doses from other practices are also taken into consideration.

If exposures from multiple practices can occur which are significantly beyond the individual dose criterion (10 arem per year (0.1 mSv per year)), the exemption will not be granted without further analysis. As experience is gained, this policy and its implementation will be reevaluated with regard to this issue to assure that the exposures to the public remain well below 100 mrem per year (1 mSv per year).

In addition to considerations of expected activities and pathways, the

  • Comission recognirec that consideration must also be given to the potential for accidents and misuse of the radioactive materials involved in the practice.

1 A proposal for exemption of a defined practice must therefore also address the l-potentials for accidents or misuse, and the consequences of these exceptionel I

conditions in terms of individual and collective dose.

=

n.

.--. -. r

[759001)

Verification of Exemption Conditions The Comission believes that the implementation of an exemption under this broad policy guidance must be acconipanied by a suitable program to monitor and verify that the basic constrierations vnder 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, capabie of providing the Comission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being observed. The Comission will detennine compliance with the specific conditions of an exemption t!. rough 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.

Tentative Meeting Agenda l

1.

Introduction and Sumary NRC Staff

11. Discussion of $pecific Questions-Brief NRC Staff sumary and presentations or questions from scheduled participants.

A.

Application of principle of justification including the questions:

l-1.

As lower levels of radiation exposures are projected, should l

lower levels of benefit be required for justification of a practice which is a candidate for exemption?

2.

In establishing exemption policy, should the Cosnission exclude l

certain practices for which there appears to be no reasonable justification?

3.

In considering proposals for exemption, should the Commission evaluate social acceptability of the practice?

4.

Should the Commission determine a practice to be unjustified if non radiological economical alteratives exist?

8.

Individual dose criterion for determining achievement of the 'as low as reasonably achievable" (Al. ARA) principle in exemotion decision making:

1.

Is the 10 mrea/ year criterion proposed by the Comission appropriate?

9

- 14.

~ ~ ~ " '

~...

t t

  • [-

[?$9001) 2.

Is the appropriateness of this number affected by the decision regarding whether a collective dose criterion should be used with the individual dose criterion?

3.

Should the individual dose criterion be chosen on the basis of negligible risk as is done internationally (i.e. IAEA safety Series No. 89) or can a somewhat higher number be used based on a l

Comission policy decision regarding a level of individual risk for which expenditure of resources is not warranted?

4 How important is international consistency in choosing an individual dose criterion?

C.

Use of a collective dose criterion for detemining achievement of the l

ALARA principle in exemption decision-making:

1.

Is a collective doce criterion needed in addition to an individual dose criterion?

2.

If so, what is the basis of that need?

f 3.

If the Comission decides a collective dose criterion should be used, what should its magnitude be?

4.

What alternative to a collective dose criterion should be considered for assessing societal impac.t?

l 5.

In calev1 sting collective dose, what approaches allowing truncation of individual doses or the use of weighting factors for components of collective dose are appropriate?

D.

Approaches for assuring total exposures of individuals from multiple l

practices will not exceed the 100 mrom/ year limit.

1.

Is the approach of Generally limiting individual doses from each I

source or practice to a fraction of the overall limit appropriate?

l 2.

Although most exempted sources would be expected tolnvolve individual doses which are a small fraction of the overall limit, should flexibility be maintained by considering exemptions on a cost-benefit basis above 10 mren/ year?

l 3.

Is the evaluation of collective dose important-in considering l

the multiple ex;nure issue?

l 15

g s, m.:. mms y.

t

.s s

[7690-01) j 4.

Will the application of justification of practice help to maintain a smaller nus6er of sources making it easier to control I

overall exposures?

5.

How important is monitoring to maintaining assurance that individual exposures do not exceed the overall limit?

111. General Discussion / Question period Coments or questions by scheduled participants. Open to the floor as time permits.

Those members of the public who wish to participate by speaking at the meeting should notify one of the contacts listed above, so that they can be scheduled in the agenda.

Dated in Rockville, Maryland, th of A 83 988.

I l

For the Nucleat Regulatory Comission.

o n b.A.

MAN, VictorSte'150,Jr.(('

Executive Director ter Operations t

el8

\\

l L

.g