ML20043B909

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Forwards Discussion of Potential Inconsistencies Re Commission Policy Statement on Exemptions from Regulatory Control
ML20043B909
Person / Time
Issue date: 12/14/1989
From: Taylor J
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To: Carr, Roberts, Rogers
NRC COMMISSION (OCM)
Shared Package
ML20042C963 List: ... further results
References
FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006010016
Download: ML20043B909 (36)


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DEC 141989

.g-MEMORANDUM FOR: Chairman Carr Comissioner Roberts Comissioner Rogers Commissioner Curtiss Comissioner Remick James M. Taylor, Executive Director for Operations FROM:

COMMIS$10N POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY

SUBJECT:

CONTROL l

In SECY-89-360, the staff noted that in recent comunications with both the Comission and the ACR$ the issue of coherence in the regulatory process has been raised.

In light of the increased emphasis upon a consistent regulatory approach, the staff has prepared a discussion of several perceived l

inconsistencies between the policy statement on Exemptions from Regulatory Control and prior actions related to the regulation of nuclear power The discussion of these potential inconsistencies is enclosed, reactors.

The staff is prepared to work with the Commission to make changes or additions to the policy statement as may be appropriate following Comission review of-i i

the enclosed information.

Original Signed By:

James M. Taylor James M. Taylor Executive Director for Operations

Enclosure:

1 As stated cc: SECY 0GC GPA 11STRIBUTION:

RPHEB R/F - DCool Cire./Chron.

RECORD. NOTE: This paper was reviewed by the staff of NMSS JMTaylor E00 R/F JBlaha EBeckjord Dross TMurley NRR andOGC,andreflects theIrinput.

WHouston TSpeis FCongel BMorris ZRosztoczy Revised enclosure rev1wed DCool ACRS by F. Congel, NRR on 12/12/89 MThompson for factual content. No problems

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.4 POTENTIAL AREAS OF INCONSISTENCY During the preparation of the final policy statement on Exemptions from Regulatory Control, SECY-89-360, the staff noted that in recent connunications l

with both the Commission and the ACRS the issue of coherence in the regulatory In that regard, the staff has identified several process has been raised. areas of potential inconsistency between the final policy regulated activities, particularly with prior actions related to reactors.1)

These areas include:

for collective dose calculations; and 3) the potential lack of finality for decommissioning actions.

1.

The Collective Dese Criterion 13,1989, directed the staff The Staff Requirements Memorandum of October to include a collective dose criterion of 1,000 person rem per year for j

This criterion defines a level of collective dose below which further efforts to reduce the collective dose would not be necessary and, exemptions.

This could be interpreted as in essence, a lower bound for ALARA efforts.

level of collective dose is larger than the collective dose that has re-suited from some other situations where the NRC or licensees have expended resources to analyze and further reduce the dose, such as at reactors.

The use of a 1,000 person-rem value covid, for example, be construed as implying that the controls of effluents for nuclear power reactors ha been too stringent.

nuclear power reactors in the United States in 1986 was 110 person-rem It may be reasonable to conclude that the exemp.

(NUREG/CR-2850,Vol.8). tion policy collective dose criterion could influ In the effluent releases below the limits established in 10 CFR Part 20.

case of operating power reactors, this could lead to an increase in ef-fluents by h significant factor, if the release of effluents were to be l

defined as a practice separate from other activities causing public expo.

sure (e.g., waste disposal).

i The staff notes that if the annual effluent releases were at the 10 C l

Part 50, Appendix I, design objective values (5-10 mrem range) rather than the achieved (61 mrem) for a reactor site, the collective dose from all operating nuclear power reactors could, for example, be on the o few thousand person-rem per year.

the exemption policy collective dose criterion is with the design objec-tive values, rather than the actual ALARA operation experience, there would be no inconsistency in approach.

It should also be noted that there is a potential inconsistency-in approach between the policy statement on exemptions from regulatory control and The safety goal policy statement includes the safety goal policy statement.the risks of normal operations as well a a collective dose objective. In the case of the exemption policy, a In addition, the exemption collective dose criterion has been included.

The policy criteria do not specifically apply to accident situations.

potential risks and impacts resulting from potential mis a request for exemption, and demonstrated not be be significant.

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!!. The 0.1 aree. Collective Dese Cutoff In The collective dose has almost alway (e.been truncated in some manner.g.,1 s

various analyses, a cutoff in time Each of the approaches to collective or dose has been used.

50 miles)ffhasadvantagesanddisadvantages. However, the cutoff has dose cuto usually applied such that the truncated portion was considered to be i

insignificant in the decision process. Thus, the collective dose assessment has generally been carried out in time or space to the point necessary to distinguish among viable alternatives when applying the ALARA principle.

This poses a potential inconsistency with the selection of a generic cutoff In particular, there may be situations where some or all based upon dose.

of the collective dose infor1 nation that would be useful to distinguish because of the narrow between exemption alternatives will not be available,llective dose cutoff interval between the individual dose criterion and coThis inconsistency would (1 mrem and 0.1 mrom).

limit and cutoff, so long as the narrow interval was maintained.

111. Lack of Finality in Decomissioning. Actions L

During the August 3,1989, hearing before Congressman Synar, Chairman Carr i

One of discussed the problems of decomissioning nuclear facilities.

these problems related to the lack of definitive criteria upon which final decomissioning actions could be based. The exemption policy individual dose criterion of 10 mrem is contemplated as the basis for waste disposal and decomissioning decisions, and, in the latter case, the staff is preparing guidance on soils and structures to implement the dose criterion.

However, the 10 mrem dose level is potentially inconsistent with recomen-dations or regulations of EPA, and the NRC may be' faced with reexamination and reopening of decisions at some future date, at a significant expense unless EPA included some type of to both the government and licensees,f a lack of finality in the decom-

' grandfather clause. The problems o missioning area will be discussed in greater detni) in a staff paper on decomissioning.

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SUBJECT:

PROPOSED SUBMISSION TO COMMISSION - INCONSISTENCIES IN EXEMPTION POLICY As we have4 discussed, I have some serious concerns regarding RES actions to accommodate what are purported to be ED0's concern with the draft exemption policy. This action shows up in SECY 89-360 and the draft Commission memorandum currently in preparation.

My primary concern regards the issue of potential inconsistencies between the policy statement and prior actions related to the regulation of nuclear power reactors. The basis for this conclusion of inconsistency is stated as being the difference between the policy's 1000 person-rem per practice per year collection dose criterion and the total collective dose from effluents from all operating-nuclear reactors (e.g.

110 person-rem in 1986).

The collective doses from postulated accidents, discussed in NUREG-1150 are also referred to, although the exemption policy does not apply to practi,ces in which significant

-accident consequences are possible.

Ac shown on the figure, it should not be surprising thit the policy's dose criteria are not entirely consistent with past practices in which radioactive material has been released from regulatory control.

In fa:t, for reactor effluents, the policy's 10 mrem per year individual dose criterton is identical to 10 CFR 50, APPI's dose criteria for exposure to gaseous effluents in unrastricted areas.

From the staff discussions in Baltimore, it was pointed out that the cost / risk reduction ratio applied to any additional effluent greater than $pment at nuclear power plants was over an order of magnitu treatment equi o

1000 per person-rem. The inference would be that we would expect l

L actual emissions to cause collective dose impacts less than the policy's collective dose criteria. This is the case; thereT5R, no significant inconsistency exists.

one could argue that With regard to the other exemptions shown on the figure ALARA principles were applied in all cases in which collective dose is greater However, if one than 1000 person-rem,) consistent with the policy's concept.looks at NUREG-1785 But here again, if the actual impact of a practice is "well within the box,"

this outcome could be a result of the limited amount of radioactivity needed for the product in question.

On the collective dose from accidents, I believe the issue is a " red herring,"

but nevertheless, one should be aware that the collective dose free accidents l

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has also been truncated -- eliminating contributions outside a 50-mile radius.

The 100-500 person-rem values attributed to NUREG-1150 could be doubled.

A second, but more minor concern, relates to the " lack-of-finality" discussion.

i Again, I believe this discussion is another " red herring" stating the obvious.

The point raised was brought out in past Commission papers. Certainly, failure of EPA to issue a standard on total allowed radioactivity in consumer products has not disuade us from licensing their distribution. With regard to decommissioning, a number of research reactors have had licenses terminated, and at least one used a 10 mrem per year individual dose criterion. 'IE Circular No. 81-07 also goncludes that surfaces uniformly contaminated at levelr. of 5000 dpm/100 cm (Reg. Guide 1.86)wouldresultinpotentialdoseslessthan 5 mrem / year.

Thus, it would seem that all our past license terminations may be affected by this lack-of-finality issue.

I believe we are making a mistake by diluting our major disagreements with the Commission's policy by bringing up these more peripheral issues.

In fact, the arguments for inclusion of the " justification of practice" principle are to be discussed.

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dcool Document Comments:

. COMMISSION POLICY STATEMENT ON EXEMPTION FROM REG. CONTROL l-i I-1 I

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MEMORANDUM FOR:

Chairinan Carr Commissioner Roberts Commissioner Rogers

  • Conmissioner Curtiss Commissio,ner Remick FROM:

James M. Taylor, Executive Director for Operations

SUBJECT:

COMMISSION POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY-CONTROLS In SECY-89-360, the staff noted that in recent communications with both the Commission and the ACRS the issue of coherence in the regulatory process has been raised.

In light of the increased emphasis upon a consistent regulatory approach, the staff has prepared a discussion of several potential inconsistencies between the policy statement on Exemptions from Regulatory Control and prior actions related to the regulation of nuclear power reactors. The discussion of these potential inconsist'encies is enclosed.

James M. Taylor Executive Director for Operations

Enclosure:

As stated cc:

SECY OGC GP DISTRIBUTION:

[ COMMISSIONERS]

RPHEB R/F - DCool Circ./Chron.

RECORD NOTE: This paper was reviewed JMTaylor EDO R/F by the staff of NRSS, EBeckjord Dross NRR, and OGC, and reflects WHouston TSpeis their input.

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Potential areas of inconsistency i

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POTENTIAL AREAS OF INCONSISTENCY During the preparation of the finti policy statement on Exemptions from Regulatory Control, SECY-89-360, the staff noted that in recent communications with both the Commission and the ACRS the issue of coherence in the regulatory process has been raised.

In that regard, the staff has identified several areas of potential inconsistency between the final policy statement and other regulat&Id activities, particularly with prior actions related to reactors.

These areas include:

1) the magnitude of the collective dose criterion; 2) the i

use of the 0.1 rem cutoff for collective dose calculations; and 3) the potential lack of finality for decommissioning actions. Other areas of potential l

inconsistency, such as with national and international recommendations, have been discussed previously with the Commission, j

1.

Maonitude of the Collective Oose Criterion The Staff Requirements Memorandum of October 13, 1989, directed the staff to include a collective dose criterion of 1,000 person-rem per year for exemptions. Under the final policy statement (SECY-89-360), this criterion would define a level of collective dose below which further efforts to reduce the collective dose would not be necessary. Thus, in the policy i

statement the Commission would establish in essence, a lower bound for l

ALARA efforts at 1,000 person-rem. 4--tW.Wh n; ;;.'d pr;.x t:

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e( resources to analyze and further reduce the dose.

For example, the Commission has, as part of its regulatory oversight of nuclear power reactors, pursued ALARA efforts to considerably lower levels. The total collective dose from effluents from all operating nuclear power reactors in the United States in 1986 was 110 person-rem (NUREG/CR-2850, Vol. 8).

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Likewise, the collective doses from some postulated accidents e

44M64MG, are on the order of 100 to 500 person-rem.

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manner, taking into account the risk from a reactor accident (probability of the event times the probability of death resulting from the collective j

dose) and employing the $1,000 per person-rem criterion, the NRC has required backfitting to reduce risk, tr W.~ h eu Ar "w s n <e'*

1 The use of a larger collective dose criterion in circumstances where i

further regulatory control will not be exercised than when continued regulation is required would appear to be inconsistent both in terms of the relative magnitudes of concern, and the philosophy of control of sources. The use of a 1,000 person-rem value could, for example, be construed as implying that the controls of effluents and containment systems for nuclear power reactors have been too stringent. The dichotomy becomes even more apparent, however, when the number of decisions that may be made under the exemption policy is taken into account. Although l

some practices might be broadly defined, the combined total of all consumer l

products, decommissioning activities, etc will be considerably greater than the number of nuclear power reactors.

In each of these decisions, j

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the collective dose could, under the final policy statement, be considerably greater than that allowed for situations where we maintain i

regulatory control.

It=could therefore, be argued that the collective dose criterion for exemptions should be less than or equal to the level required when the NRC continues to exercise control.

II. Use of the 0.1 mrem Collective Dose Cutoff J

The concept of collective dose was established a number of years ago as a mechanism for quantifying the societal impact of radiation sources or practices.

In its pure, theoretical form, the collective dose is a representation of the societal impact only when all of the contributions to the dose are included.

However, as a practical matter, the collective 3

dose has almost always been truncated in some manner.

In various analyses, a cutof f in time (e.g.,10,000 years), distance (e.g., 50 miles), or dose has been used.

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Each of the approaches to collective dose cutoff has advantages and disadvantages. However, in each case the cutoff was applied so that the l

truncated portion was considered to be insignificant eogenetden to the total collective dose from the practice.

In general, the collective dose assessment has been carried out in time or space to the point necessary to distinguish among viable alternatives when applying the ALARA principle. A-estoff % : ;:= "yMtL....

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The distribution of doses from any practice is often characterized by a normal or log-normal distribution.

In many cases', the hverage dose is an order of magnitude lower than the limit. The staff believes that for most exemption decisions this will be the case. However, because of the individual dose criterion and collective dose cutoff of 1 mrem and 0.1 L

mrem respectively, there may be numerous circumstances where the majority of the collective dose will not be included in determining if a practice i

meets the collective dose criterion.

In an extreme case, a dose on the order of 10,000 person-rem would not be subject to consideration.

Application of the. policy statement criteria in cases such as this could be inconsistent with previous actions, and the use of a cutoff in a safety analysis determination would be inconsistent with an environmental assessment of the exemption under NEPA. This type of case would also be inconsistent with the expectation, given the collective dose criteria in the policy statement, that NRC is examining and taking into account the societal impact.

111. Lack of Finality in Decisions During the August 3, 1989, hearing before Congressman Synar Chairman Carr discussed the problems of deconnissioning nuclear facilities. One problem related to the lack of definitive criteria upon which final decommissioning actions could be based.

The exemption policy individual dose criterion of 10 mrem is contemplated as the basis for decommissioning decisions, and the staff is preparing guidance on soils and structures to implement the dose criterion. However, the 10 mrem dose level is potentially inconsistent with recommendations or regulations of EPA, and the NRC may 12/05/89 2

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be faced with. reexamination and reopening of decisions at some future

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unless cate, at a significant expense to both the government and licenseesThe problems o EPA included some type of " grandfather" clause.

i finality in this area will be discussed in greater detail in staff paper on decommissioning.

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1 AGENDA j

Interoffice Meeting to Develop Staff Consensus on i

Broad-Based BRC Policy Statement J

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OVELVIEW AND RATIONALE BEHIND "STRAWMAN" DRAFT POLICY 1

11.

SECTION BY SECTION CRITIQUE OF DRAFT POLICY IN LIGHT OF COMMISSION AND l

ACRS DIRECTIVES AND COMMENTS MAIN POLICY SECTIONS Basic Elements of a Broad-Based Exemption Policy,Section II, pgs. 3-5 l

Major Determinations Are the three stated basic elements of the radiation protection r

framework sufficient (i.e., (1) 10 CFR Part 20 Individual Dose i

Limits, (2) determination on multiple source exposures, and (3) identification of levels of risk including dose benchmarks)?

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Are the ALARA principle and the " secondary" effluent and environmental standards treated correctly?

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15 the " finding" approach suitable as a near-term proposed solution L'

to the issue of multiple exposures?

Is further defense of this

. finding needed?

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J Are the principles of (1) non-fractionalization of practice, (2) totality of exposure and (3) consideration of accidents or misuse I

sufficient? Are there others?

Criteria for Definition of Individual Dose Benchmarks Applicable to Specific BRC Determinations,Section III, pgs. 5-6 Hajor Determinations Is the need for development of a regulatory (monitoring?) program and the potential need for secondary standards appropriate,and justified?

Are there other approaches to address the multiple exposure issue (e.g., fraction of benchmark vis-a-vis IAEA)?

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Minor Determination Can the individual dose benchmark equal or approach a value in a existing or future " secondary" standard?

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AGENDA

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Definition of Individual Dose Benchmarks Appliegb,le to BRC Positions,Section IV, pgs. 6-10 What emphasis should be placed on justification rationale (risk vs backgrounddosecomparisons)? Can limits of detectability form a basis for Individual Dose Benchmark justification?

!s defense of numbers adequate?

Low range in graded approach 4 mrem /yr and 1,000 p-rem /yr collective dose Middle range in graded approach

< 20 mrem / year Upper range in graded approach 3 20 mrem / year l

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Is the 0.1 mrem dose cutoff for collective dose calculations justiftsd? Should it be applied to the low-range in the graded approach?

Is the rationale for the licensee requirements under the graded I

l approach defensible?

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AGENDA p

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Minor Determination i

Should defense of numbers be in body of Policy Statement? Or Appendix?

f Constraints in Defining BRC Positions Applicable to Specific Practices,

.SectionV,pgs.)4F-11 Major Determination 6

Aretheconstraintsnecessaryandsufficient(i.e.,(1)no significant environmental impact, (2) acceptable cost benefit, (3)nationalorregionalusefulness,(4)geographicpractice characterization, (5) practice characterization, and (6) practice inspectability)?

Minor Determinations Should potential need to " tie" BRC individual dose benchmark to

" upper bound" secondary standard be emphasized?

Should constraints apply to practices falling within the bottom level of the graded approach?

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'4 AGENDA

Preparation of BRC Positions and Administration of Exemption,Section VII, 1

.pgs. 12-14 i-Major Determination F'

Is the treatment of low probability of occurrence events proper? How can position be further justified?-

Minor Determination Other than the treatment of low probability events, is this section necessary?

Oth'er Issues Major Determination Should or how should contradictions with past policy statements and L

existing regulations be addressed?

1 Should restrictions on widespread use of radioactive material in common household items (i.e., toys and novelties, but excluding adornments)beapartofthispolicy.

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Should a dollar per man-rem be included in the statement? If so, whatvalue?

Should or how should compatibility issue (with Agreement States) be addressed?

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AGENDA

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i Introduction & Purpose, Section 1, pgs. 1-3 i

Najor Determination Has purpose of policy been stated correctly?

J Minor Determinations Is more detail on cost savings appropriate?

Is " individual-dose benchmark" the best tencinology for designating

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individual dose limits associated with an exempt practice?,

Question " source specific" vs " practice specific" terminology.

Verification that Public Health and Safety Continues to be Protected as Below Regulatory Concern Policies are Implemented,Section VI, pgs.11-12 Minor Determination Should this section be expanded? What specifics should be added?

III.

IDENTIFICATION OF SECTIONS RE0VIRING SIGNIFICANT MODIFICATION -

ASSIGNMENT OF REWRITE TASK GROUPS 06/03/88 6

AGENDA

p IV. GENERAL DISCUSSION ON FORMAT FOR COMMISSION PAPER Should Commission Paper include one or two draft policy statements (e.g.,singlenumbersvsgradedapproach)? To what extent should policy attempt to envelop existing practices (i.e., research reactor decommissionings;U-Thsitelicenseterminations).

If Commission is given choice on " numbers," how should alternative discussion be conveyed? Enclosure? What range of values should be offered for consideration?-

Do we need enclosure explaining the limitations of the linear non-threshold hypothesis? Other topics? Answer to Commission-identified issues in SRM7 O

V.

DISCUSSION OF PROPOSED REVISIONS VI. OTHER ISSUES

. Yll. ASSIGNMENT OF LONGER TERM TASKS 06/03/88 7

AGENDA

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a II. BASIC PRINCIPLES The purpose for regulating radioactive materials is to control the potential Control of radiation exposure is maintained risk from radiation exposure.

through a system of licensing and inspection. However, as the dose from a practice or source decreases, the controls necessary to limit radiation exposure can be reduced while maintaining an assurance that the resulting risk remains acceptable. Thus, as the dose decreases, the source may be a candidate for reduced regulation by the granting of exemptions from provisions such as specific-lienesees.

The Commission also recognizes that there exists a level of dose that is p,e sufficiently small that the risk associated with the dose would be con I as negligible to any individual. 'These levels of risk, which are on the order l /,/

of 1 x 10-6 is a lifetime, would not cause the individual to take any actions

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to further reduce the risk.

y For purposes of radiation protection planning, the Commission considers the I-In doing so, linear hypothesis of radiation dose effect to be appropriate.

the Commission-recognizes that this model is appropriate only when the effects of radiation to be considered are. stochastic effects (i.e..' cancer Further, it must be recognized that this model is based upon l

induction).

extrapolition from dose effect data collected at relatively high levels of dose to the low dose and low dose rate region where there is no experimental Despite these limitations, however, the Commission believes that it is data.

an appropriate model upon which to establish radiation protection regulations.

One of the direct outgrowths of the linear hypothesis is the concept of the If it can be assum-d that the total dose is directly collective dose.

proportional to the total risk, irrespective of whether the dose is

+

2 delivered to a few individuals or in small quantities to many individuals, then the collective dose can be taken as a measure of the collective risk to the exposed population.

The basic system of radiation protection is founded upon three interrelated The first of these is that exposures to radiation or radioactive components.

materials should be justified, i.e. there should be some type of benefit

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associated with the risk from the radiation exposure.

In some cases, the benefits to be derived are direct, such as in the medical use of radioactive material s.

In other cases, the benefits may be more indirect, such as in the benefits of electrical power derived from a nuc1' ear power plant. However..it is

/ ri,e7.a basic fact that there should be some benefit

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' The second component of the basic system of radiation protection is the dose p6 st 4...'

jf limits, which establish the boundary between allowable and unacceptable exposures &

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  • These limits are contained in 10 CfR Part 20 and are established to individuals.

i Within the rtgion II to provide adequate protection for public health and safety.

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of potential acceptable exposures, i.e. within the dose limits, exposures lL are further limited by application of the third principle, optimization

'(or ALARA). Using this principle, doses are reduced to As Low As Reasonably Achievable, taking into account economic and social factors.

At the lower end of the ALARA region of doses, well below the basic dose limits.

BRC connotes the concept of below regulatory concern (BRC) comes into play.

levels of risk or dose that may be considered trivial from a regulatory standpoint, i.e., individual and collective doses that warrant limited government attention taking into account the cost of further regulation and the A

likelihood that such regulation would significantly alter the resulting dose.

source of exposure could be considered as a candidate for reduced regulatory The conditions for BRC requirements if certain specific conditions are met.

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consideration might include requirements such as additional controls on the-source of exposure not resulting in additional reductions in the dose received; or the costs of additional regulatory controls not being balanced by the benefits of dose reduction that could be achieved.

t The establishment of a BRC level for a particular source or practice is viewed by the Commission as a step-wise process in which consideration is first given to whether or not the source or practica is justified, and then, if 4

justified, to the dose levels delivered to determine if a reduction in regulatory controls is warranted. The Commission believes that there is a direct correlation between the risks of radiation exposure that could be delivered by the' source or practice, and the necessity for regulatory controls on that source.

The selection of a BRC level for a particular practice or source would not 1

L however, imply that the dose would necessarily be considved as trivial by

' individual s.

k Determining if a justified practice should be exempted from regulatory control usually involves consideration of both the individual risk and the population risk (individual dose and collective dose).

Collective dose is a key element in. deciding if a practice should be exempted from regulatory control based on M, cost effectiveness.- This is accomplished by assigning l

A collective dose.

f y@lV)On the assumption, however, that increasing individual dose proportionally reduces acceptability to the individual, and a given collective dose to a small

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!je-population could have a greater societal impact on that population than would

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a similar collective dose on a significantly larger population, there is a basis for ass'gning weighting factors to the monetary values assigned to

~) v For example, $10,000/ person rem for individual doses in the individual doses.

100-20 mr range $1000/ person rem for individual doses in the 20%/mr range;

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$100/ person. rem, the 1 mr to 0.1lmr individual dose range and $1/ person rem for 'any individual dose below 0.1 mr provides 'a bases for addressing %th '

the acceptability of individual risk and the collective risk in cost-benefit r

balancing.

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The consideration of al source or practice for exemption from regulatory contoris-is J

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is' justified. ' After it is determined that the source or practice is justified, then j

J consideration should be given to the levels of dors created by the source, and the' o

measures which could' reasonably be taken to teduce this levle of dose. This is the optim-ization of the source.

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u ' v The purpose for regulating radioactive materials is to control the potential'. risk from 33 radiation exposure.

Control of radiation exposure is maintained through a system of licensing ~and inspection. However, as the dose feom a practice or source decreases, the controls nedessary to limit radiation exposoee can be reduced while maintaining-an assurance that the resulting risk memains acceptable. Thus, as the dose a fr?%KtW1-decreases, the source may be s:N::::d )> reduced regulation by the granting of exemptions from provisions such as specifih licensees.

NNNNNNNMMINNB533 As the dose becomes yet smaller, a point is reached where no further regulatory

    • f N controls use necessary to. assume limitation of risk.

In this low dose range, regulatory controls will either. not add any measure of safety by their implementation, or the added measures of safety are not sufficient to justify l

the costs of the regulation.

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For purposes.of radiation protection planning, the Commission consider', the J

linear hypothesis of radiation dose effect to be appropriate.

In doing.so, the Commission recog46ees that this model is appropffate only when the effects of radiation to be considered are stochastic effects (i.e, cancer induction)

Further, it must be recognized that this model is based upon extrapolition from dose effect data collected at relatively high levels of dose to the low dose and low dose rate region where there is no experimental data.

Despite-these limitations, however, the Commission believes that it is/dpp/d an appropfiate model upon which to establish radiation protection regulations.

One of -the direct outgrowths of the linear hypothesis is the concept of.

.the collective dose.

If it can be assumed that the total dose is directly proportional to the total risk, irrespective of whether the dose is delivered to a few individuals or in small quantities to many individuals, then the collective dose can be taken as a measure of the collective risk to the exposed population.

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The -establishment of a BRC level for a particular source or practice is viewed by'the Commission as a step-wise process in which consideration is first given to whether or not the soruce or practice is' justified, and 'then, if justified, i

to the' dose levnts delivered to determine if a reduction in regulatory controls is warranted. The commission believes that there is a direct correlation between-u

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the risks of radiation exposure that could be delivered by the source or practice, and the necessity for regulatory controls on that source. The

&o selection of a BRC level for a particular practice or source would notp-^'- -

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e The basic system of radiation protection is founded upon three interrelated components. The first of these is that exposures to radiation or radioactive i

materials should be justified, i.e. there should be some type of benefit associated with the risk from the radiation exposure.

In.some cases, the

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in benefits to be derived are direct, such as the medical use of. radioactive materials.

In other cases, the benefits may be more indirect, such as the benefits of electfical power derived from a nuclear power. plant. However, it is a basic tenet that there should be some benefit to be gained from the use, or that use-should not be allowed.

The second component of the basic system of radiation pootection is the dose limits, which establish the boundary between allowable and unacceptable exposure to individuals.

These-limits are contained in 10 CFR Part 20 and are L

established to hrovide adequate protection for public health and safety.

Within the region of potestial acceptable exposures, i.e. within the dose limits, I'

. exposures are further limited by application of the third princ p e, AEARA/

il optimization (or ALARA). Using this principle, doses are reduced to AS Los As Reasonably Achievable, taking into account economic and social factors.

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At the lower endal of the ALARA region of doses, well below the basic dose limits, the concept of below regulatory concern (BRC) comes into play. BRC connotes levels of risk or dose that may be considered trivial from a regulatory i

standpoint, i.e., individual and collective doses that warrant. limited government attention taking into account the cost of further regulation and the likelihood 1

that such regulation would significantly alter the resulting dose. A source of exposure could be considered as a candidate for reduced regulatory requirements if certain specific conditions are met. The conditions for BRC consideration might include requirements such as additional controls on the source of exposoee not resulting in additional reductions in the dose received; or the costs of additional regulatory controls not being balanced by the benefits of dose reductio.1 that could be achieved.

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