ML20128G939

Corrected Pages to Encl 10 Part III of SECY-85-147, Proposed Rev to 10CFR20, `Stds for Protection Against Radiation

ML20128G939
Person / Time
Issue date:	05/20/1985
From:	NRC OFFICE OF THE SECRETARY (SECY)
To:
References
SECY-85-147, SECY-85-147-ERR, NUDOCS 8505300353
Download: ML20128G939 (64)

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MAY 20, 1985 C

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E TO ALL HOLDERS OF SECY-85-147 - PROPOSED REVISION TO 10 CFR PART 20,

" STANDARDS FOR PROTECTION AGAINST RADIATION" (COMMISSION ACTION ITEM)

THE ATTACHED PAGES SHOULD BE INCLUDED IN ENCLOSURE 10 (PART-III) OF'SECY-85-147.

ATTACHMENTS:

AS STATED SECRETARIAT

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NUCLEAR REGULATORY COMMISSION WASHING TON, D. C. 20555

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JAN 31 1984 MEMORANDlH FOR:

Robert B. Minogue, Director Office of Nuclear Regulatory Research FROM:

John G. Davis. Director Office of Nuclear Material Safety and Safeguards

SUBJECT:

PROPOSED REVISION OF 10 CFR PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION This refers to your January 25, 1984 memorandum with the same subject.

The Office of Nuclear Material Safety and Safeguards concurs in submitting the revision of 10 CFR Part 20 to the Comission for publication as a proposed rule.

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o n G. Davis. Director i Office of Nuclear Material Safety and Safeguards cc: Mr. Denton Mr. DeYoung

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March 27, 1985 MEMORANDUM FOR: Robert B. Minogue, Director Office of Nuclear Regulatory Research FROM:

James P. Murray Acting Executive Legal Director

SUBJECT:

PROPOSED REVISION OF 10 CFR PART 20 The Office of the Executive Legal Director has no legal objection to the

- subject revision.

7 ames P. Murray

,p Acting Executive Legal Director

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!*El'CRANDUit FOR:

Parold R. Centon, Director Office of Nuclear Reactor Regulation FRCF:

William A. ftills, Chief Health Effects Branch Division of Radiation Programs and Earth Sciences, RES St;SJECT:

PRCPOSED REVISION OF 10'CFR PART 20 The purpcse of this memorandum is to provide ycu with my views.and those of the 2 ranch's drsf ting group related to your June 5,1984 memorancum to Victor.Stelle concerning CRGR's review of the proposed revision of 10 CFR Part G.

The drafting group has tried to be ooen and responsive to all ccmments received during cevelopnent and review of the revision, inclCding the concerns raised by certain incividual NRR staff members and new precented in the enclosures to your rnccorandum. hcwever, since many of the comments ucre rnly informally discussed and we dia not receive copies of some of the f:RR staff cenoranca until after the CRGR review, I believe a written re:ponse to cunr.ents of the inoividual i!RR staff members is warranted.

The initial draft revision of 10 CFD. Dart 20 as,orecarec in 1981 n 49 EPO (SECY-81-232) ano Commissien (July 24, 1981 letter to EPA) guidance, with input arc advice frca senior scientists frca all icpacted offices. Throughcut the craf-inr process, the crafting grcup had curerous' fornal and inforcal oiscussiors with i:RR staff regarding the varicus crovisicns, especially those icpacting cr. reactor Mcensing and cperation.

Following distribution of the draft revision for the initial Office level

-eview, the drafting group and NRR staff had a series cf meetings (Jure 9 and July 5, 7, 12, 14 and 19, 1983) to discuss the' proposed revisien pcge-by-page.

At each meeting, HRR staff members presented their questions and cocments, with nany NRR suggestions ccepted on the sont. However, some ccatents were centinucusly overtoned with an attitude of "if it ain't broke, con't fix it" and, therefore, were not comnensurate with the -hrust of the effort to provide

-he Ccmissinn with a viable alternative to the present Part 20 consistent with

'CRP rec:mtendations in Publicaticn 26.

At tre conclusion of this series uf neetings, the craftir.g group had no reason to believe that any NRR staff had not beer provice6 ar. opportunity to directly voice ar.y concerr.s abcut the revision'. ',

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'H. R. Denton-On September-13, 1963, a meeting of-senior managers from NRR, NHSS and RES was

' held tc resolve remaining isstes raisec by NRR and HMSS concerning the prepcsed revision. Prior to this meeting, NRR and NMSS had ideatified certain. issues they wanted resolved before the rulemaking proceeced. - A copy of a Memorandum For Files, dated October 3,1983, that summarizes these issues and the resolution of those issues reached during that meeting is enclosed (Enclosure l').

All of the changes agreed upon by the senior managers were incorporated' into the rulemaking " package." Scme of the required modifications were major, such as deletion of the de minimis prevision, deletion of the proposed dose limit.for the embryo / fetus of a declared woman, provision for further exposure following overexpo(voluntary) pregnant sure, changes in the application o'f the reference level, and expansion of Appendix B to include reference level concentrations in air and water and discharges into sanitary The view of the managers was that, if the requested changes were sewerage.

made, they felt that the rule was ready.for CRCR considerction.

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Questions of implementation cost and coeplexities and of the bor.efit of a~ revision were not issues requiring further consideration' prior to CRGR review.- I note that during CRGR meetirgs these Questions recuired censiderable attention.

In view of the history of development of this revisicn, we are somewhat dismayed by the continued opposition cf certain mer.bers of NRR to the preposed revision cf Part 20; cpposition based on suppositions and a priori views. We believe all staff members have been given every opportunity to present their comments to the Part 20 drafting group and during Office and CRGR reviews, and ue beite"e that the issues have been apprcpriately censidereo.

"evertheless, enclosed are cur responses to the ccaments contaired in the

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reemeranda frco Willis to Ccrgel, dated September 1,1983, (Enclosure Z) and from Cleveland to Denton, dated June 5, 1984, (Enclosure 3). Note that the

-mercrancum ar.c enclosures from Willis tc Congel datec September 1,1983 crecate the abcse mentioned senior management meeting held on September 13, 1983.

Fe have also acdresseo Mr. Willis' corments en the EPA guidance, which were similar tc his comments cn the Part 20 revision. Our response to his comments on the EPA guidance is included as Enclosure 4 It is important to recognize li

.that epa is developing revised guidance for Federal agencies on occupational I

radiation protection which will also be based on ICRP-26. Since the NRC and its predecessor, the AEC, have as a matter cf policy censidered such guidance as bir. ding and cen#orced our regulations accordingly, we have developed the Part 20 revisier. in close cocrdination with EPA.

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that the proposeo revision should be published fo needed and timely and this memo and enclosures to V. Stello we are making c comment. By copy of staff comments available to the CRGR.

our responses to the NRR comments, please let me know how we can be helpfulShould you have any ques origin.1 Sisnad Bn William A. Mills, Chief Health Effects Branch Division of Radiation Programs and. Earth Sciences, RES Er: closures:

1 10/3/83 Venoranaum For Files 2.

Part 20 Drafting Grcup's Response to 9/1/83 Mercrandum frcm Willis to Congel 3

Part 20 Draftirg Group's Response to 5/5/84 Mercrancum frca Cleveland tc Centen 4

Part 20 Drafting Group's Response to Comments in 4/20/84 Mercrandum frcm Wil14: tt C16veland RE:

Prctecticn Guidance Draft Rad:c-ion cc:

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OCT 3 1393 MEMORANDUM FOR:

Files

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W. A. Mills, Chief HEB/RES

SUBJECT:

PROPOSED REVISION OF 10 CFR PART 20 On September 13,1983 representatives of RES, NMSS, and NRR met with the RES group drafting the proposed revision of 10 CFR Part 20. The purpose of the meeting was to discuss and to obtain direction on issues raised by NRR and NMSS concerning the proposed revision (Enclosure 1).

Attendees at the meeting included:

R. E. Cunningham, NMSS~

R. B. Minogue, RES R. J. Mattson, NRR F.~J. Arsena'lt, RES u

D. R.- Muller NRR

.W. A. Mills, RES F. Congel, NRR R. E. Baker, RES W. S. Cool, RES D. S. Flack, RES After discussions, consensus was reached on the following directions among R.- B. Minogue, R. E. Cunningham, and R. J. Mattson as the principal repre-sentatives of their respective offices.

The issues raised and the guidance given to the drafting group on th'e issues are sumarized below:

Issue #1: Should the revised Part 20 include a de minimis provision and how should this be applied?

Direction for Issue 41: There was agreement that a de minimis provision that truncated consioeration of collective dose would definitely have merit as far as saving millions of dollars in costs related to calculating and controlling the' effects of licensed activities over all time, etc., and is to be retained.

On the other hand, concern was voiced over the possible abuse in applying the provision for "de minimis" individual exposure (1 mrem /yr) to activities such 4

as waste disposal and the use of radioactive material in consumer products.

The conclus, ion reached was that the provision should apply only to disposal of C0 raft copies of this memorandum were distributed to all attendees for review and '

coment.

Coments received from R. E. Cunningham were incorporated into this final copy.

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r waste from approved, licensed operations and involve prior NRC review and approval of this use of the prevision. The consensus was also that the provision i

should not~ apply to consumer products because of potential abuse.

In addition.

guidance was given that the provision should not apply ~ to LWR waste stream ef-fluents, since the value to regulate them had been set, and had been demonstrated to be cost-effective, during a previous ALARA rulemaking.

In sumary, direction tras given to the drafting group to keep the provision' pertaining to collective to main-

' dose and to set bounds on the application of the de minimis provision:

tain some control over its application to waste disposal; to consider increasing the ~de minimis value used in operations under NRC control; to deny its application to consumer products and LWR waste stream effluents; and to build constraints into the provision which would allow the'NRC, if desired, to look over the considerations used in determining that other actions, including waste disposal,

. could be perfonned under this provision.

Issue 42: Should the combined external and internal occupational exposure be limited to 5 rems / year?

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Direction for Issue #2: The 5 rems / year occupational limit is consistent with the limit accepted by the international comunity. The consensus was that application of this limit shall apply to the sum of the internal and external It is anticipated that suming internal and external exposures would exposures.

not result in undue administrative burdens because sumation would only be required for demonstrating compliance when an individual is occupationally exposed at levels exceeding both 10% of the (external) deep dose equivalent and 30t of the (internal) annual limit of intake (ALI) of radioactive material.

In sumary, the 5 rem occupational limit applicable to the sum of the internal and external exposures would remain as presented in the proposed revision.

c Issue #3: Should a provision for planned special exposures be included, and is the provision as presently worded either too stringent or subject to abuse?

-The consensus was that the provision for planned special Direction for Issue #3:

is consistent with ICRp 26; is not too stringent so as to-prevent its exposures:

.use in necessary situations; and, yet, is stringent enough to prevent its abuse.

Therefore, no changes in this provision were proposed at.the meeting, although Dr. dongel was to supply suggestions which might enhance flexibility in use.

Issue #4: Should the limit for members of the general public be 500 mrem /yr or 100 mrem /yr, end how should these limits apply to operations licensed by the NRC7 Direction for Issue #4:

The general consensus was that the limit.for members of the public from all sources should be 500 mrem /yr. However, several practical problems with application of this limit were noted:

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i, 3 (a) The ability _of licensees to account for all significant contributions of dose to individual members of the public under the 500 mram/ year limit.

(b)- The ability of most material licensees to undertake the modeling and do'se 1

calculations necessary to demonstrate compliance with the 500 mrem / year limit.

(c) With the present structure of the rule, the need to make a determination

'in issuing licenses that the applicant does in fact have the capability i

ofmakingassessmentsin(b)aboveandtheeconomicburdenthisimplies.

(d) The problem of the "second guessing" syndrome appearing between the licensee and~ inspectors regarding the accuracy of calculations and-assessments if the 100 mrem per year reference level is exceeded.

With these issues in mind, the drafting group was directed to reword this section of the proposed rule to more clearly reflect the following:

(a) The limit for members of the public from all sources is 500 mram/ year.

(b) A licensee shall be assumed to meet the 500 mrem / year limit if it controls exposure to members of the public to doses within a 100 mram/ year reference

-level from its own operations.

(c) A licensee may apply to the NRC for prior authorization of operations which may result in public exposures greater than the 100 mrem / year reference level. Such applications shall include the licensee's program which assesses and controls dose within the 500 mrem / year limit; shall demonstrate a clear need to operate

. in excess of the reference level; and shall be supported by an explanation to do so in tems of ALARA requirements.

Issue #5: Should any restriction be placed on the worker whose dose has exceeded the quarterly or annual limit?

Direction for Issue #5: The consensus of the office representatives was that the proposed provision to allow workers who have exceeded their quarterly limits to receive an additional 300 mrem /. quarter for the remainder of the calender year was not acceptable.

It was felt that the additional 300 mrem / quarter:

1)would penalize the worker by contributing to his potential unemployability; and 2) would not help at al] to assure employability of those workers who are most likely to 4

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4-receive the higher exposures because of the nature of their job.

than 300 mrem / quarter additional exposure was not felt to increase the health riskAllow of the worker significantly.

Consideration was given to discounting exposures from isolated incidents, but it was felt that defining isolated incidents would present a problem.

After further discussion of resetting the limits after over-exposures, the direction to the drafting group was to remove all constraints on limiting additional exposures to overexposed workers in order to protect their employability and to cou penalizes the licensee, ple this action with a strong enforcement policy which rather than the worker, in cases of occupational overexposures.

Issue #6: Should the dose to the embryo / fetus be restricted by specific dose limits for either the pregnant woman or.the embryo / fetus per se?

Direction for Issue #6:

The drafting group was directed to drop the dose limit for lof Federal Guides on this topic.the ceclared pregnant woman from its propose the Statement of Considerations.

Discussion of this point should be included in Issue #7:

Should the ICRp-26 methodology be adopted for inclusion in the revision of Part 207 Direction for Issue 47:

The consensus was that the proposed revision should include the ICRF-25 methocology.

licensees to apply the ALI and DAC occupational values listed in Appe demonstrate compliance with the limits for unrestricted areas.

Therefore, the drafting group was directed to ex appJicable to unrestricted areas.pand Appendix B to include concentration values l

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William A. Mills. Chief Health Effects Branch Office of Nuclear Regulatory Research e

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l PART 20 DRAFTING GROUP'S RESPONSE TO COMMENTS IN 9/1/83 MEMORANDUM FROM C. WILLIS TO F. CONGEL

. ENCLOSURE'10F INCOMING MEMORANDUM General Comments:

"The proposed new Part 20 raises a multitude of issues. Many of these appear to have the potential for major programmatic and economic impact without concommitant benefits. Generally,' regulations should not be changed unless a net benefit is foreseen.

Even where the reasons for a change appear compelling, an evaluation of the potential impacts should be provided as a basis for the Commission's' decision.

"The proposed evaluation is deficient in that it fails to address many important potential impacts, it contains many misleading or erroneous statements and it is not in sufficient depth.

The following list identifies key issues for which evaluation should be provided before the proposal goes to 4

the Commission. These issues are discussed briefly in Enclosure 2."

Response to General Comments:

-The overall revision of 10 CFR Part 20 is a major policy matter and we agree that a number of important issues are _ addressed.

For this reason, it is imoortant that the entire rulemaking package be transmitted to the EDO and Commission for their consideration.

Both the EDO (SECY-81-232)-and the Commission (July 24, T981 letter to EPA) have already recognized the merits of adopting the system of dose calculation in ICRP Publication 26.

The revision offers the potential for establishing a scientifically sound and explicit health protection basis for not only the Part 20 standards, but also other NRC regulatory. actions, including licensing decisions affecting nuclear power plants. The revision would permit control of licensed operations on the basis of the regulation itself, as opposed to technical specifications imposed

.i on the licensees in a non-uniform manner.

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The economic impact has been assessed, not only in two contract efforts, but by a pumber of licensees and industrial groups. The cost estimates presented in the staff paper and its enclosures have been reviewed by the Office of Resource Management's Cost Analysis Group (CAG) and, with only minor changes, have been accepted. The potential benefits have been discussed in the Commission paper, the draft Statement of Consideration, and the presentations to 'the CRGR. We

- believe that they well justify the potential cost of the revision.

Identification and suggested corrections of allegedly misleading and erroneous statements are welcomed.

ENCLOSURE 2 9

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y Specific Comment 1:

"In vfew of the lack of potential benefit and past overwhelmingly. negative responses, is it worthwhile to publish the. proposed rule for comment?"

Response to Specific Comment-1:

We disagree that the proposed revision lacks potential benefit.

An unusual amount of effort has been made to assess the potential benef interested p'eople and views by ACRS, CAG, and CRGR.

An independent assessment of the benefits and cost.of the draft revisicn was presented by Paul E. Ruhter

. Mr. Ruhter..is convinced that the benefits far outweigh the costs.

We,also disagree that past response has been overwhelmingly negative.On the contrary, the response of representatives of licensees and the very-large number of other interested people with whom we have discussed the revision has been very favorable.. The comment might be in reference to the respon~ses to the

" draft guidance to Federal agencies on occupational exposure published by EPA in

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January 1981.

The draft revision of Part 20 has been developed in light of those responses and the' hearings that were held jointly by EPA-OSHA-NRC and in parallel with EPA's revision.of the guidance.

is greatly different from the guidance proposed ~in 1981. and we do not believe that the generalizati_on is valid or that the proposed revision of Part 20 will receive comparable criticism.

We are convinced that the revision is needed as a viable alternative to the presen't Part 20, that its use by the NRC is cost beneficial, anc that early publication as a proposed rule is in the public interest.

'Soecific Comment 2:

"With so little to be gained, why accept the inevitable problems, confusion and cost of working with a completely new regulation?"

_Resoonse to Soecific Comment 2:

As noted in our response to Comment 1, we consider the benefits of the proposed revision to outweigh the costs.

The rulemaking package clearly identifies the principal benefits (Supplementary Information, pp. 71-74) of the proposed stevision (Addendum 2).

In addition, the three CRGR presentations of Part 20 included handouts and subsequent lengthy discussions of the benefits of the proposed revision, improvements in safety features and workers' protection, and areas of economic benefits of the proposed revision. At the May 30, 1984 CRGR meeting.we described our " guesstimates" of the ratio of the annual cost of the revision per unit of occupational dose reduction and it is.very reasonable.

We recognize that there are new terms and definitions, and that new text will raise concerns about complexity and questions of interpretation.

This is because adoption of a new system of protection that is based explicitly on health risks associated with the dose limits requires some changes in the "way

.of~doing things" by tnose who license, inspect or operate.

However, we would 2

ENCLOSURE 2 i

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-expect this-situation to be short term and subsequently mitigated by education through comments, hearings, and general training before the date of effective implementation. Our experience to date would indicate that once the terms are

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understood the.use of the system appears less complex and, therefore, less

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ominous.

Specific Comment 3:

"Is it respo.nsible regulatory practice to drastically change requirements to partially follow ICRP recommendations?"

Response to Specific Comment 3:

We are convinced that it.is responsible regulatory ~ practice to update the' requirements'in Part 20 to reflect updated recommendations by such authoritative organizations as ICRP and NCRP. That does not mean, however, that an effective regulation should embody every detailed aspect of -the -

recommendations of.those organizations. Some aspects are not amenable to

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regulatory structure and these organizations recognize that national authorities must tailor the recommendations to their specific circumstances.

Other aspects _ provide more flexibility in the management of individual worker's exposure than we deemed.necessary (such as the ICRP-recommendation that two times the basic annual dose limit be permitted during a single planned special exposure event) and are constrained in the proposed revision of Part 20. On the other hand, we believe that it would not be responsible action for NRC to maintain status quo and fail to implement, in general, the international system of dose limitation recommended by ICRP in Publications 26 and 30. Other

- countries' (Canada.UK, the Netherlands, etc.) have alreacy implemented these recommendations, or are moving in that direction.

In the U.S., as well, adoption of the system' appears certain sooner or later.

-Soecific Comment 4:

"Should limits be changed to make them a bit more nearly proportional to decade-old risk estimates, considering that biological risk estimates change so frequently?"

Response to Specific-Comment 4:

The system of dose limitation.that would be implemented permits change to reflect significant changes in risk estimates.

Such changes are not frequent, as indicated in the' comment. Further, according to a " Report of Foreign Travel-

- May 11-26, 1984", by Mr. R. E. Cunningham, ICRP Committee 1 has recently made an extensive review of scientific literature and has proposed to the main Commission the following statement:

The Commission continued its review of-epidemiological surveys' and related reports which claim either an excessive or a decreased risk of irradiation at low doses, in relation to current cancer risk estimates presently used by ICRP for the purpose of radiation protection. On the basis of these reviews and discussions, it was concluded that no changes in current cancer risk estimates are required at the present time.

3 ENCLOSURE 2

We believe that the risk coefficients presently provided by expert bodies a revision will not be a troublesome problem.suffici_ently consisten Specific Comment 5:

"Should the regulations show so little regard for a technically overexpose worker?

Should one be thrown out of work for exceeding an arbitrary limit?"

Response to : Specific Comment 5:

The provision (proposed following exposure in excess of the limits was changed follow level meeting on September subsequent to Mr. Willis' comments,13,1983 (see enclosed Memo 10/3/1983),

The Supplementary Information in the rulemaking package clearly states n to alleviate this perception.

"The Commission believes that for those individuals who do exce dose limits, the regulations should not present a cotential for adversely e annual affecting an individual's availacility for continued employment within the basic dose limits, provided that there is no medical advice.to the contrary a

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the incividual chooses to do so."

Specific Comment 6:

"Do we want to promote sexual discrimination in the name of " safety?"

Resconse to Soecific Comment 6:

This comment appears to ce accressea to a proposed limit on the dose to the embryo / fetus due to occupational exposure of a declared pregnant woman, a provision that was incorporated in earlier drafts of the revised Part 20 Tnis former provision could certainly not have promoted " sexual discrimination" because the provision depended on voluntary declaration of pregnancy by the employee.

In the absence of a declaration, the licensee would have been to any other employee. expected to provide to the employee all entitlements and prote As a result of discussion during the Office level meeting on September 13 1983, the provision was removed from the draft revision so this comment is no longer applicable.

However, there is discussion of the provision in the Statement of Consideration, and comment on the issue is specifically invited During the CRGR review on May 30, 1984, of the provision in the Statement of Consideration in order to permit morewe were meaning,ful review and comment on the issue.

ENCLOSURE 2' 0F INCOMING MEMORANDUM

_Resconse to Background Comment:

Three major points are raised in this section, namely that the proposed revision of part 20:

(1) differs from the ICRP recommendations in some provisions; (2) adopts the ICRp limits for internal emitters; and (3) limits 4

ENCLOSURE 2

the combined internal and external exposure.

. As clearly stated in the Commission paper, the proposed revisio ICRP, as set forth in ICRP Publications 26, 30 and 32.in on of the the revision differs differences are neces,sary to translate the recommendatio The into practical regulatory requirements.

publications of incoming Enclosure 1.)

(See response to preceding comment #3 We have considered the point regarding the ICRP of dose consideration of SECY-81-232 and the letter to EPA dated July 24 on's documents recommended that EPA adopt the ICRP system of dose limit

, 1981. Those directed the staff to consider the ICRP recommendations in t ation and the revision of Part 20.

evelopment of The use of the weighted sum of the internal and a regulatory Mem.orandum for Files dated 10/3/83).

The consensus of the Office ee merit and, therefore. the limit shall apply to.the sum of external doses. This summing should as and because summation would only be requ.not result in undue administrative burdens individual is occupationally exposed at levels exceeding both 10*; of t

.(external) deep dose equivalent and 30*; of the (internal) annual limit of e

intake (ALI)' of radioactive material.

expected to be relevant _only for workers in' uranium milling, conversionA fuel fabricatien, and, potential y

, and manufacturing or.in hospital prepar,ation of radioactive medicinals.some worne We recognize that there are inherent ine.ccuracies in estimating both int dose and' external dose.

for neglecting the assessment and recording of the best estima ernal components of the dose and' when applicable,.their sum.

difficulties in measurement of internal dose, the proposed S20 202(b)

Recognizing alternative ways of demonstrating compliance with the limits. specifies estimates of intake (already required under the existing Part 20) can be m Conversion from-readily to committed effective dose equivalent (using the instructions with. revised NRC Form 5) with no disruption of operations provided Wh.ile acknowledging the correctness of the commen e present estimates", the present Part 20 does not. require it,'and is not structured i way as to encourage summation.

Most often, compliance with limits on intake

.(current 520.103) is demonstrated by air sampling and records of MPC-hours of exposure.

However, these are seldom recorded in an individual's records Indeed, the dos'e record is likely to show only overexposures and the re

-routine bioassays, which are seldom translated to dose.

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5 ENCLOSURE 2

Response to " Publication for Comment Not Justified" Comments (Page 2)

At this stage of the Part 20 rulemaking we consider publication of the proposed regulation to be in the public interest. ~Public comments can be both

. instructive and constructive for the Commission in making its decision on the

' merits of this risk-based alternative and, ultimately, result in an improved final rule if so adopted.

The drafting group has already had the benefit of

-many comments and discussions which served as a valuable resource in preparing-the proposed revision.

particularly in regard to technical and administrative problems fores implementing. the revision, enhancing its viability and probable acceptance.

We have no reason to expect the overwhelmingly negative responses received b EPA following publication of the draft guidance to Federal agencies on occupa.tfonal exposure on January 23, 1981. The draft revision of Part 20 has been. developed in the light of those comments.and the hearings that were held jointly.by EPA-OSHA-NRC and in parallel with EPA's rev and generally consistent with the proposed revision of Part 20.

Additional comments on publication and expected responses are addressed in the Response to Specific Comment 1 in Enclosure 1 of the incoming memorandum.

Resconse to "The Value of Comoletely Re-Writino the Rule is Not Established" Comments (Paaes 3-5)

The present Part 20 is a combination of the original rule and approximately 100 amencments that have been added in a piecemeal fashion over nearly thirty As a result, we believe the entire regulation requires rewriting to years.

correct deficiencies, ambiguities, etc.

The proposed revision provides a uniform integrated approach to the radiation protection stancards, which can

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serve as a consistent and contemporary basis for regulatory actions.

Supplementary Information, Regulatory Analysis.and Environmental Assessment The draft address, in detail, the alternatives to rewriting.the regulation and the

' reasons for not adopting these alternative actions.

Our discussions with representatives of many licensees and other interested persons indicate that many ambiguities in the present regulations have been

-removed in many places, reducing the opportunity for misinterpretations in licensing and inspection.

unicn workers showed us that once people attempt to understand the new terminology and basic concepts in the proposed rule, they can understand the

.better than they understand the present Part 20 and its bases. propose We have attempted to correct ambiguous provisions and resolve existing problems, not to create new problems.

The draft revision of Part 20 is not intended to serve as a-training doc 6 ment, although we have attempted to incorporate the bases for the enanges to the extent.that it was feasible to do so.

This was one of the relatively few directives given the drafting group by the middle-management steering group at the. outset of the work.

extra effort to help the readers understand the regulations.Most reviewers have appreciat 6

ENCLOSURE 2

?T The proposed revision has received extensive, detailed review by many individuals and numerous review groups. Contrary to the comment offered by NRR staff, all of the Appendix B values have been checked. A number of the values were questioned by reviewers, but all were found to be matters of rounding from the data provided by ORNL, in Bq/m3 with two significant numbers, to the single digit. values in uti/ml'we chose for Appendix 8.

The reviewers were making the comparison against data in ICRP-30, which were presented in one significant figure and contained a number of printing errors (corrected in Part 3 of the publication).

-With respect to the need for implementing license amendments, we would hope that in time the NRC will find it reasonable to remove some of the license conditions or technical specifications that have been considered necessary beyond the coverage of the present Part 20. By proposing a relatively long period for comment following publication of'the proposed rule, we believe there will be little need for early amendment of the revised Part 20.

Resoonse to " Benefits From Changing the Reouirements of Part 20 Not Established" Comments (Paoes 5-7)

The issue of the benefits of the proposed revision has already been responded to (See Response to Specific Comments 1 & 2 in Enclosure 1 of the incoming memorandum). Therefore, this response is limited to those specific benefits addressed in this particular section of incoming Enclosure 2.

The ALARA issue is addressed in detail in the response to "The ALARA Requirement is Unjustified and, Without Criteria, is p.cor Regulatory Practice" comments.

We do not believe that the statement that "cenversion to the ICRP-recommended limits will allow comp'arison of theoretical risks to radiation workers with risks in other occupations" is misleading. While it might not meet all of the cesirable criteria of comparison between risks to workers, it does offer some perspective. The present 10 CFR Part120 and all of the Statement of-Consider.ations that have been published in association with the nearly 100 amendments that have been made never have stated a numerical value for the risk associated with exposure within the limits.

Prior to publication of ICRP 26 this was true of the recommendations put forth by ICRP and NCRP. NRC's regulatory limits have not been keyed into any level of risk. However, in the j

t nearly 51rty years since Part 20 was originally published there have been data

~

developed and greatly ~ expanded on the risk of developing various types of cancer and other radiation effects.

Particularly important has been the identification of many radiation-induced solid tumors, which are now recognized to be more important than leukemia, previously considered to be the controlling risk. The system of dose limitation that would be implemented in the revision is contemporary and employs weighting factors to relate dose to each of the organs and tissues'of the body to dose to the whole body, with the (stochastic) limit on this " effective" dose equivalent set at a level of. risk chosen as the average of so-called " safe" industries.

The (non-stochastic) " capping dose" linit to any organ or tissue, imposed after careful consideration (not arcitrarily), ensures that health effects other than cancer and genetic camage, such as cataract and reduced thyroid function, will not occur.

7 ENCLOSURE 2

(

6-We believe that workers and members of the public will be well able to understar.d the risk estimates associated with exposure at the limits, and will be able to get a much better perspective of those risks by being able to compare them to their own experiences in life, including risks of auto accidents, risks of food additives, and risks in their work place.

this a'very significant benefit in the instruction of the worker and a positive We consider step forward in building understanding and perspective in the public on radiation matters.

We believe that the comment on our claiming as a benefit that the revision would permi.t a consistant regulatory basis for all licensees is particularly addressed at the proposed extension of very high radiation area controls to all licensees rather than present application to irradiators only.

Our expectation of a benefit is much broader, but.does include benefit of added protection in such areas.

Our broader expectations of benefit relates to the many license conditions and technical specifications that have been used to deal with areas in which the present Part 20 is deficient in providing the basic standards of protection against radiation.

applied to all' types of licensees (or even to licensees within a given constitute much of the actual regulatory control of licensees and much of the administrative and economic burden because they can be more restrictive than Part 20 requires.

perhap's some relaxation in the'se Itcensing provisions.The revision of Par An example is the technical specification requiring operation of the liquid rad waste systems at very low doses for off+ site dose projections.

'The NRR comment appears to attribute only to the planned special exposure provision our view that the proposed revision provides increased flexibility in the use of workers.

A numoer of otner features acc to the aoility of a licensee ~to use a worker within the dose limits.

For example, in the present Part.20 there are certain precautionary procedures, such as the limitation to 40 MPC-hours in seven consecutive days when respiratory protective equipment is used, that greatly reduce sho.t term intakes and reduce utilization of workers unnecessarily.

That precautionary procedure has been_ removed because the wearing of respirators may not be in the best interest of the worker, if the expected intake _is not significant. As a second example, under the proposed revision the licensee may permit any individual (adult) to receive up to 3 rems per quarter (and 5 rems per year) without obtaining the complete occupational exposure history of the individual and maintaining the individual's status under-the present 5(N-18) dose-averaging formula.

As a third example, the licensee may control on the basis of real dose to individuals, rather than on the basis of the concentrations of radioactive material that may be present and standard man assumptions.

Licensees would not be required to assess real dose, but would have the cotton to control en that basis or on the basis of assessed intake, as in the present. regulation.

Thus, we believe the revision offers

-operational flexibility to the licensee without increasing any potential health risk to the' worker exposed.

Resconse to "The Cost Estimates Accear Unrealistically Low" Ccmments (Paces 7-9)

The earlier value/ impact report, which was the source of NRR staff comments, has been~replacec in the rulemaking package by an updated version of the report 8

ENCLOSURE 2

by Jack Faucett Associates and S. Cohen and Associat estimates were reviewed by.the Office of Reso es, entitled " Cost of Group (CAG) and suggested changes -incorporated Part 20."

Our cost gement's Cost Analysis

~ fixed discount rate. addition of an estimate of the total ~ cost of im ng the revision at a The e.conomic impact of the revision has also been licensees and industrial groups.

As expected, there is a wide range of. evalu program costs and costs theyanticipated costs among utilities, r current health physics which they,would incur anywaywould charge to the proposed revision, such as training programs.

Mr. Willis points out that "a contested licensing a Part_20 revision could force an extended outage co tiction associat a single plant."

the opinion that it is equally;1ikelyWe recognize the potential for licen s

and NMSS staff members have expressed conc g, but are of hearings in which they might be called upon to te tif s regulations. Some NRR ng into licensing and technical specifications that go beyond present Pa t 20y abou s

-As_noted earlier, the proposed revision of Part 20 could p r

requirements.

' economic benefits.

could be used to provide some relief from present requirA q meet dose levels well below levels required by health n limits is not possible to accurately estimate the savings whi h ements for licensees to considerations. While it through less restrictive technical specificationsmight be realized ~

c

_ commitments made during the' licensing process, tne savin millions of-dollars annually.

imposed on applicants and licensees 'are performe of a

requirements l proposed revision of the Part 20 rule and it e context of the on health risk decisions.

s system of dose limitation based Resconse to "The Documentation is Misleading in R B_ases for tne New Limits" Comments (paces 9-11)ecard to the We do not consider the statements in the Commissio Consideration that there is new knowledge and substa tin paper and St y

for the new limits and requirements to be misleadi n

ve_ scientific support

. thirty years of research on the' biological effects of radiation ng.

was first published and information was'by-in-large li i leukemia and bone tumors (radium induced) m ted to-recognition of art 20

'research program ~ conducted has resulted in much betterThe extensive and i behavior and the effects of radiation and radio understanding of the Mr. Willis acknowledges. studies have resulted in better dosimetric mod These

~

ved calculations, as We also believe that the statement by Mr biological risks based on the most recent stucilow level y succesed" is wrong.

The es of exposed populations are 9

ENCLOSURE 2~

made~ effective. The principal reason is that th when Part 20 was lifetime _ of the individualtumors (as opposed to leukemia) appears to evelopment of solid 4

population of Japanese expo)s.

The number of excess solid cancers in theonger (

ed to the atomic bombs continues to incre age.

The ICRP system of dose limitation and the weighting f earlier.

To repeat briefly, the weighting factors are based o actors were discussed data available and are based on the assessment of ri k you would not expect to "see" evidence of biologic n the biological s

normally encountered in occupational exposure because thage at the d ssue. We agree that achieve that goal.

rather that any increased incidence is sufficiently smallHow indistinguishable from cancers or other effects that oc

, but

, as to be exposure.

cur without radiation information and concluded that no changes in the c o ogical and related as used in its Publication 26, are warranted at this timerent cancer risk est Resconse to "The Commission Pape~r is Misleadino in I Limits on ICRP-26 is Imoortant to Risk Estimates" Com mplyino that Basino s (paces 11-12) 4 We agree that the present Part 20 in no way constrai estimating risk or even using risk to health as a considerati ns the NRC against making.

However, the present Part 20 coes not acdress risk on in decision-it requirt (or permit) summation of external and inte

, as sucn, nor does to organs othef than the organs of reference (criti rnal dose consider dose

-a number of other features that we consider benefits and thcal organs),, o related to health risk.

used under the present Part 20;We do not agree that the ICRP-26 methodolog Publication 26. differences in organ sensitivities makes Part 20 inco the lack of a risk basis that reflects effective dose equivalent or to use theFor example, licensees would not be mpatible with ICRP derive from that concept in some cases. less restrictive intake limits that e

As noted above, ICRP reviewed the most recent literat year (1984) and concluded that no changes are warrantedure on risk estimates non stochastic effects, a constraint which we conside void the It is highly unlikely that the risk estimates will change essary and desirable.

future to pose any problem with changing limits enough in the near We disagree

• that "no one has seriously suggested th dose commitment."

em odied in the recommendations in ICRP Publication 2 an have presented a rather. detailed discussion of the coof NCRP. We the Commission paper and in the craft Statement of C mmitted dose concept in certainly incorrect to iraply that risk f onsideration.

It is year and that the retained body burden does not continue trom internal emitters 1

o contribute to J

10 ENCLOSURE 2

.,,,y,,,.y,-

,-..-~,

,,.4_

-...ym..--,-3,.,-..---m.

,-.y m

q r-overall risk. This is particularly true for long lived alpha-emitting radionuclides and it is generally accepted by the expert scientific community that linearity is the likely true dose-response relationship for these radionuclides.

Operationally, it is conservative, in that it charges to the year of intake the whole dose that would be calculated to result if the individual lived for 50 years after an intake. However, this conservatism is balanced-agatast the inherent weakness of controlling on the basis of annual dose where the individual might not be aware of the commitment to dose in fut'ure years and where the licensee must maintain rather extensive and burdensome records to account each year for the dose delivered from radioactive material taken into the body in all previous years.

We believe the adoption.of the conservative committed dose concept is simpler, less burdensome, and morally correct since it fully accounts for the overall risk to the worker resulting from a significant intake.

We do not argue that risks do not change with age, or that the risk that would be assigned in the year of intake might be greater than that actually received later in life (or perhaps not at all). However, the statement that "the genetic risk is relatively small for people under age 20" is wrong. Genetic risk is proportional to the espected number of offspring and would be somewnat higher at age 16 than at age 20, or any subsequent age. The statement is most incorrect in regard to exposure of women because they are born with a fixed number of ova that begin to decrease.with onset of menstruation. The values in Appendix B, Table 2, which are applicable to the assessment and control of dose to the public, were adjusted by an additional factor of 2 from the occupational values, so that the'y are applicable to other age groups--including the young.

These values will be used until more definitive values related to age, sex and race are available and changes are warranted. While differences in metabolic parameters, etc. must be carefully assessec in cetermining regulatory values, descrimination on the basis of age, sex, or race must also be avoided in setting limits.

~

Res:ense to "The ALARA Recairement is Unjustified and. Without Criteria, is Poor Reculatory practice" Comments (Paces 12-13)

Mr. Willis has indicated his belief that the proposed requirement for inclusion of ALARA considerations in the licensee's radiation protection program is

" unjustified", "one major ratchet", and may lead to increased exposures (see pages 5,12, and 13 of Enclosure 2 to his 9/01/83 memorandum). We agree that ALARA can be, and often is, used by regulators as a means of ratcheting licensees; but, we disagree that our inclusion of the concept has this effect.

~

On the contrary, we believe that we have placed ALARA in the proper use as it relates to worker and public protection. Many licensees, such as power reactor

- licensees and medical licensees, are already committed for one reason or another -(including regulatory pressure), to more detailed and specific ALARA programs than would be called for under the revision.

We are convinced of the need to include those involved in management decisions in the establishment and review of procedures for maintaining exposures ALARA.

This involvement offers one of the greatest opportunities for dose recuction because cost savings can accompany such decisions in some instances. It is cifficult to assess the potential cose reduction that might result frcm the 11 ENCLOSURE 2

,,.--,-,-we,-

-.-,,,--..-,,,,e

--,,,-,,,v----.-v,a

~ -,,

e-w,.

t-requirement for ALARA.

However, if there is only a 5'.' reduction in man-rems in the licensed facilities not already required by technical specifications or license conditions to have ALARA programs, there could be over 1,000 man-rems saved per year.

We do not believe that the proposed At. ARA provision will lead to any shift from Itcensed to unlicensed materials, to diversion from real radiation control measures to paperwork, or to distributing doses more widely to avoid levels E

that might attract regulatory attention. The undesired results noted in the G

NRR comment.would, in our view, come about by use of the requirements in a way not intended by the regulation, which provides considerable leeway to the licensee and perhaps less to the ratcheting-oriented regulators.

We note that,

~

at the outset NRR advised the Part 20 drafting group that the only change NRR really wanted was to change the wording regarding ALARA from "should" to "shall."

{

We also do not agree with the comment that "if we cannot define what is

' reasonable,' we should not establish the requirements."

ALARA will vary on a case-by-case basis and should be implemented as a philosophy in making decisions on radiation protection, rather than as quantitative requirements imposed upon the broad range of licensed activities 1.o which Part 20 applies.

Response to "Overexoosures" Co'ements (Paces 13-15)

The response to Specific Comment #5 in Enclosure 1 of the inecming memorandum discusses changes in the overexposure provision that make additional discussion of this issue unnecessary.

Resconse to "Preenant Women" Comments (Paces 16-18)

The response to Specific Comment #6 in Enclosure 1 of the incoming memorandum discusses changes in the rulemaking package that make additional discussion of this issue unnecessary. However, it should be noted that even though the Commission does currently operate under a policy of informed consent, it stated in its July 24, 1981 letter to EPA that "the Commission believes that the lower ICRP exposure limit should apply." EPA is currently updating the guidance to Federal regulatory agencies regarding occupational radiation exposure that was established by Presidential memorandum and Federal Radiation Council Report No.

1 on May 13, 1960. The latest draft of the revised guidance includes a statement that the dose equivalent to an unborn child as a result of occupational exposure of a woman declared or known to be pregnant should not exceed 0.5 rem, and in addition, positive efforts to control dose equivalents to the unborn to less than 0.2 rem in any month are encouraged. We recognize the authority of EPA to develop recommendations in this area, and, following approval by the President of any recommendations as Federal guidance, NRC will implement tnat. guidance in a revision of 10 CFR Part 20.

- The biological realities" of the importance of protecting the emb yo/ fetus have been docunented, most recently in a May 1984 paper by Otake and Shull, which was published in the British Journal of Radiology.

The published data cemenstrate an increase in mental retardation from 3 utero radiation during the 8th to 15th week of gestation.

12 ENCLOSURE 2

\\

Response to Comments on "No Evident Justification for 'Very Hich

_ Radiation Area' Requirements" (paces 18-19)

The revised requirements for very high radiation areas have been sim the degree considered consistent with achieving positive a p

e to individuals will not be inadvertently exposed at very high dose ssurance that There should be additional control measures for all area rates which c

ty.

levels might exist such that an individual could receive a lethal d a ation very short period of time.

Only those licensees who use sealed radioactive ose in a sources to irradiate materials are required by the present Part 20 to use su additional controls.

However, very high radiation levels are not limited to irradiator facilities, but are present in areas of nuclear power plant c

industrial radiography operations (primarily fixed installations) s, some teletherapy installations workers in nuclear power p,lants, while overexposed, could have recei etc.

, medical doses under slightly different circumstances.

ved lethal (On two occasions, shift

' exposed; on another, workers failed to recognize a large p were provisions in the presenttransfer and were near the pipe when a " hot" element pa

~

sed for fuel While the 520.203(c) application to all types of licensees (6) have been modified somewhat to oermit accompanying overexposures.tive in preventing such instances and the, we bel revision will be more effec

_Resconse to "Should the Reculatory Limits be on the Weichted Sum of th Internal and Exte-nal Gose?" Comments (paces 20-21) to Mr. Willis' memorandum.This question-is raised in parag

, of It was also raisec as an issue at the Office level meeting on 9/13/B3 (see Memorancum fo The sum of the internal and external exposures.

in undue administrative burdens because summation w result demonstrating compliance when an individual is occupationally expo red for y

exceeding both 10*4 of the (external) deep dose equivalent and 30!! of the sed at levels

[

-(internal) annual limit of intake (ALI) of radioactive material.

re*guirement for summation is estimated, in the absence of good data on th The extent of exposure to radioactive materials, to impact the workers in uranium milling, conversion, and fuel fabrication, and, potentially radicpharmaceutical manufacturing or in hospital preparation of radioa

, some workers in medicinais., The total number of workers invoited is estimated to exceed ctive 10,000.

We recognize that there are inherent inaccuracies in estimation of int dose, as there are in the comoarable estimation of external dose. They do n ernal components of the dose, and when assessed, to sum them. constitu not possible to actually measure internal (or external) doseIt is true that it is This is 13 ENCLOSURE 2

recognized in the draft revision and the proposed alternative ways of demonstrating compliance with the limits.520.202(b) s estimates of intake (already required under the present Part 20) to Conversions from effective dose equivalent can be readily made (using the instruct e

on revised NRC Form 5 which is included in the notice of propos with no disruption of operations.

While "nothing in the present system prevents th n ernal and structured in such a way as to permit or encourage summation.

observation of licensed operations, compliance with the limits on inta In our (present 5

' exposure. 20.103) is demonstrated by air sampling and records of MPC-However, these are seldom recorded in an individual's record Indeed, the dose record is likely to show only overexposures and routine bicassays, which are seldom translated to dose.

u s of Resoonse to "Non-Radiolocical Risks Should be Reccan aces 21-23)

These comments raise a valid point on the desirability of balancing r radiation exposure with other risks that might be involved s from example of this is the use of respiratory protective equipment to reduce

• A very good intake of-radioactive material.

the use of some of these devices There is considerable stress associated with heat discomfort, clumsiness, movem(ent limitations, communica effort that must be expended in.the radiation area.in given. task.

The proposed revision includes changes, such as deletion of the recuirement in the present 520.103(b)(2) tnat limits incividual intake to 40 MPC-hours in any seven days when using respiratory protective devices 3

intended to.put internal dose into better perspective with external dose

, that are

-clear recognition of the non-radiation problems mentioned above.

and in done about all we can in this area at this time.that the proposed We believe

, and that we have examples or language.which would'further this intention.We would welcome any specific There is a powerful psychological differentiation by workers (and by m staff members) between external dose and dose received from material taken into their bodies.

. calculations and chooses respiratory protection, with its associatedThis difficulties, often resulting in higher external doses.

that can be done in three hours without respiratory protection might For example, a task four hours with such ~ protection.

require If the work conditions involved air ~

concentrations ten times MPC and an external dose rate of one use of respir. tory protection could cost an extra 0.925 man rem in addition t

-the stress of respirator use.

~ hours of intake at ten times MPC, without respiratory protection (One M Three equivalent to 75 mrems.

, would be Even if the respirator is 100% efficient, dose of I rem for the additional hour would outweigh the internal dose that the external might be saved.)

14 ENCLOSURE 2

~

Part of this comment addresses ~the basis (ICRP Publication 27, " Problems Involved In Developing an Index of Harm") used to select the level of risk to which the recommended limits would be targeted.

It is recognized that accidental deaths are not directly comparable to potential cancer fatalities or to genetic defects expressed in the first two generations of offspring.

We understand that ICRP is-considering other bases for selecting the level of risk.

However, changing the bases would not necessarily change the system of dose limitation, and is unlikely to result in significant change in the level of risk-selected because of the many non-technical elements that are inevitably part of a decision regarding acceptability.

Concerns about unjustified exclusion of people from. radiation work (such as overexposed workers and pregnant women) are addressed in other responses.

Response to "Other Important Issues for Which Evaluation is Needed" (Page 23)

Issue 1:

"Should detailed requirements,. such as ' reference levels' for radiation protection be established by regulation? Should the requirements be the same for a nuclear power plant, a hospital and a one-man instrument shop?"

Response to Issue 1:

The reference level provision was raised and resolved at the Office level meeting 9/13/83 (see Memorandum For Files dated October 3, 1983),

subsequent to Mr. Willis' memorandum of 9/1/83. The reference level of dose to the public was proposed as a tool to accomplish several purposes.

First,'the limit for members of the puolic from all sources is 0.5 rem / year.

However, it is impractical, if not impossible, to determine precisely an actu'ai dose because of possible multiple sources, complex problems involving dosimetry, incomplete information concerning water and food intake, habits, spatial and temporal considerations, and other confounding factors.

Therefore, a licensee shall be assumed to meet the 0.5 rem / year limit if the licensee controls exposure to members of the public to doses within 0.1 rem / year from the licensee's own operations.

Second, the preposed requirement for reporting wnen the reference level is exceeded (proposed $20.1205) will icentify those licensees who are making the more significant contributions to public dose and permit consideration of those operations for additional control.

Further, the reference level would implement the ICRP recommendation that life-long dose to the individual member of the public be limited.to 0.1 rem / year.

Issue 2:

"Why eliminate the 5(N-18) provision which tends to shift exoosure to

-older workers where theoretically it is less harmful?"

Resconse to ' Issue 2:

By memorandum of November 30, 1978 Chilk to Gossick, the staff was directed to develop for Commission-review and approval a revision of Part 20 to eliminate the use of the 5(N-18) formula. Commission paper SECY-78-415A responded to that directive.

The notice of preocsed rulemaking, puolished February 20, 1979 (44 FR 10388), incicated that the

.o 15 ENCLOSURE 2

action was based on assessment of.the need for the dose-averaging formula, which allows a worker to receive up to 12 rems per year, and the desire of the. Commission to reduce the risks of occupational radiation doses in Commission-licensed activities. The proposed rulemaking was not carried-forward to effective rulemaking, but rather combined with the overall revision of Part 20.

Other than the NRC, the drafting group is not aware of any domestic or international organization which still permits the use of the 5(N-18) dose-averaging formula. Both the NCRP and ICRP agree that the use of the formula should not be permitted.

J Issue 3:

"Should requirements for elaborate environmental dose calculations be included in Part 20?

It-would seem more appropriate to address such requirements to those specific facilities where there may be a need."

Response to Issue 3:

First, note that the revision of Part 20 would not require elaborate environmental. dose calculations.

Licensees may continue to operate on the basis of the' concentrations of radioactive material released in air and water effluents to unrestricted areas, as most licensees do at this time.

The values listed in Appendix B, Table 2, are calculated to meet the reference level, rather than the 0.5 rem / year limit, or equivalent organ or tissue dose, targeted in the current Appendix B, Table II.

The licensee would be provided the option to control releases on the basis of real dose, and, if so, might then have to make environmental assessments in order.to assure snat the dose to memoers of the puolic from.all sources and pathways does not exceed 0.5 rem / year. We believe that the few licensees who would choose this option are already operating in a comparable manner under procedures specifically approved in the license.

This is only one example of our efforts in the revision of Part 20 to make the limits, and the optional methods of demonstrating compliance, uniformly applicable and available to all licensees.

Issue 4: "What is the value and impact of dramatically changing the limits for certain nuclides? The changed thorium limit may be the most important aspect of the ICRP-based regulations; it might effectively preclude the consideration of thorium as a nuclear fuel in the USA."

R(sponse to Issue 4:

An important value in changing the limits for certain nuclides is that the NRC's regulatory values will reflect defensible, widely accepted, contemporary scientific knowledge.

It is recognized that a large portion of the cost impact of the revision derives from the more restrictive ALIs

-and DACs for uranium.

Little cost was assigned to the greater reduction 4

(about a' factor of 60) in the value for thorium, primarily because of the limited use of thorium at this time. No attempt has been mace to assess the cost or industrial impacts of potential future uses of a given.

nuclide.

The. values for thorium have been larger than calculations based on dose limits would have indicated for many years.

The listings for 16 ENCLOSURE 2

~.

r thorium in ICRP Publication 2 (1959) are footnoted as " Provisional values", arbitrarily listed a factor of ten higher than would be

_ suggested by calculations based upon evidence even then available.

The footnote further states that "the possibility that further evidence may require lower. values and to urge especially that exposure levels for

' these radionuclides be kept as low as is operationally possible."

The

-additional. factor of 5 or 6 (from the 10 of the provisional values to the 60 that'would relate to the' values in the revision) applies to uranium and other alpha emitters, as well as thorium.

Addenda:

1.

Ruhter, Paul E., "The Effect of Revised 10 CFR 20 on power Reactor Health Physics, June 5,1984.

2.

Supplementary Information, pp.71-74.

17 ENCLOSURE 2

w e

0

.-44 EGzG.

P.O. SOX 1625. IDAMO FALLS, IDAHO 33413' I

Dear Mr. Mills:

Enclosed is -a copy-of the paper presented' at the 29th Annual Health Physics Society meeting which you requested.

Thank you

-for your interest.

If you have any, questions, please.give me a call.

Sincerely,

/,.

/ '.'

' * * * * /.,.d it. : t '. <

r Paul E. Ruhter-

.it-cc: File

)

. / Addendum 1 4

p, g.

e THE EFFECT OF REVISED 10 CFR 20 ON POWER REACTOR HEALTH PHYSICS Paul E. Ruhter EG6G Idaho, Inc.

j'i Presented at 29th Annual Meeting HEALTH PHYSICS SOCIETY New Orleans, Louisiana June 5, 1984 l

• ./ Addendum 1 I

$4 v

THE EFFECT OF REVISED 10 CFR 20 ON POWER REACTOR HEALTH PHYSICS P. E. Ruhter EG6G Idaho, Inc.

~

A major. revision to 10 CFR 20 has been prepared by the Nuclear Regulatory Commission (NRC).- Although it has not yet been published for public comment, it has been released in-formally to industrial sources for review and comment.

Changes are being made on the draft, which was available in early-1982, and where those changes are significant, they will be-discussed.

A casual glance at the proposed revision immediately reveals that it is substantially longer than the current regulation.

The current regulation was written with-the philosophy of identi-fying_those minimum items which would be essential to preventing serious exposures to workers or significant loss of control of radioactive materials.

The details of a radiation protection

. program were left up to the experienced professionals to determine, and were covered as a part of the licensing process for each spe-cific plant.

The proposed revision to 10 CFR 20 provides con-siderably more detail.

In fact, it effectively is a reasonable guideline for the procedures which would constitute an acceptable radiological co'ntrols program.

From the standpoint of one~ who

. believes that our society should be moving toward fewer, more effi-cient laws and regulations which permit a person to exercise reasonable'and prudent judement,.this abundance of detail would seem objectionable.

However, the NRC has the same proolem in hiring personnel that the nuclear power industry has; every new hire does not have

-20 years experience.

The current regulations are clear if one knews what they mean.

Unfortunately not all power plant health

vr-4' physicists nor all NRC inspectors have the years of experience require l

to exercise reasonable and prudent judgment.

As a power plant health physicist, you do not operate in a vacuum, but must frehuent.ly interact with the NRC during preoperational approvals or during inspections and audits.

Although one may have the experience to understand what the current regulations were intended to mean, the NRC personnel with whom one interacts may have a differing opinion which leads to long discussions and inefficiencies.

Although the proposed revision to 10 CFR 20 is much more detailed, the detail is in those areas which are generally accepted as being routine requirements for a radiological controls program and should not be the subject of misunderstandings or long discussions.

Examples will be provided below.

This paper is intended to identify the effect this proposed revision will have on health' physics at nuclear-power plants and to provide background for reviewing the proposal when it is published for comment.

The most controversial aspect of the proposed revision deals with how the bookkeeping will be done on internal exposures from long-lived isotopes such as uranium and plutonium.

The proposed revision incorporates the methodology of ICRP 26 and 30, parti-cularly with respect to determining 50-year committed doses.

In those cases where the long-lived isotopes make this impractical, a 'further provision' has been included which permits, with certain limitation, assigning only the annual dose to a given year rather j

than the 50 year committed dose.

Since a nuclear power plant sel, dom is concerned about internal uptakes of plutonium or uranium, this controversial area has essentially no effect on power reactor health physics and will therefore not be discussed in any more l

detai1J Improvements Over Current 10 CFR 20 The definitions for the various radiologically controlled areas in the proposed revision are substantially improved over

... ~

the current definitions..

as a' good example.

The definition for Radiation Area serves Cufrent Definition-Radiation Area Any area, accessibi to personnel, in which there exista radia t'io n, origina:ing in uhole or in part within Licensed material, at such level that a major portion of the b d could receive in any one hour a dose in excess of S oy or in any E consecutive days a dose in e= cess of 100

mitirems, mittrems.

I Although we may all understand this definition are unclear and have been the subject of long discussio several areas personally with NRC inspectors.

ns held The phrase within-licensed material' looms as potentially significant'in whole what does 'in part' mean?

, but The phrase is reasonably. clear, but how is it applied in the fi ld b'a majo technician with a survey meter trying to determi e

ya hot spot?

ne how to post a Although 5 mrems per hour is clear, what dose rate is squal to 100 millirems in 5 consecutive days?

Most health physi-cists 'know' that this means 100 mrem in 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> or 2.5 mrem /h However there is an official interpretation by NRC that 100 mrem in 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> or 0.8 mrem /hr.

this means At TMI, radiation areas ware posted at 0.8 mrem /hr because of this interpretation.

The-proposed definition is much clearer.

_ Proposed Definition An area, accessible to individuals, in which radiation i

levels could result in an individual receiving a dose

~

lent in excess of 0.005 rem in one hour a:

ecuiva-30 cm from the radiation source or from any surface uhich :he radia: ion penetrates.

)

1

-,-mv-.

,--w.

,c

-,-.,,-,,r--.-,..

~-.-,-,--.-...m

--_,.,,m..-,, - -., -,, ~.,

a This definition omits the legalese 'in whole or in part'.

It states unambiguously that the dose rate for a radiation area is 5 mrem / hour and it provides a distance at which the dose rate shall be measured.

This definition as well as the other ' area' definitions are clearer and therefore more effective.

The definitions are equivalent to how most power plants have imple-mented them, but are stated in a much clearer fashion.

The effect will be more consistent implementation of the regulations.

The proposed revision uses the ICRP nomenclature of Derived Air Concentration (DAC) instead of Maximum Permissible Concentra-tion (MPC).

The definition for Airborne Radioactivity Area is the same except that the average air activity has'been raised from 25% MFC to 30% or 12 DAC-hours in 1 week.

A comparison of proposed DACs and current MPCs is presented in the table below.

A few isotopes have been selected that are typical of those encountered at a power reactor.

The DACs are equal to or greater

~

than current MPCs.

The increase for noble gases is about a factor of 10 as shown for Kr-85.

This is due to the correction of errors in the' calculation that derived MPCs.

COMPARISON OF AIR CONCENTRATIONS Current Proposed MPC DAC H-3 5 x 10 6 2 x 10 3 Co-60 9 x 10 9 1 x 10 e K -85 1 x 10 5 1 x 10 "

7 Sr-90 1 x 10 9 2 x 10 9 I-131 9 x 10 9 2 x 10 e Cs-137 1 x 10 e 6 x 10 8 (s) 6 x 10 8

The DACs are listed by solubility classes of D (days),

W (weeks), and Y (years) -instead of-'the more nebulous soluble '

- and insoluble.

The table of DACs in the proposed revision gives considerable information to aid in determining which class is appropriate.

There'is a new definition included in the proposed revision--

1Very High Radiation' Area.

Although the definition is new, this area designation and the access controls are included in the current 10 CFR 20 albeit buried in paragraph 20.203.(c)(6) and have probably escaped detection by all but those with a fine-toothed comb.. The access controls are applicable primarily to facilities-with large irradiation sources and have little ef'fect on power

' reactors.

However, by including the definitions for a Very High Radiation Area (500 rads in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 1 meter), it is less likely to be overlooked.

The access controls in the proposed revision are the same as those specified in the current 10 CFR 20.

The proposed revision correctly reminds us that dose in this range should be recorded as rads since the quality or modifying factors at these dose rates are not well understood.

This could be a recordkeeping nuisance but is not'a practical problem since exposures this' rate do not occur routinely!

at The proposed revision clears up some signficiant gray areas.

For example, the current 10 CFR-20 identifies acceptable dose rates in ' unrestricted areas' and identifies restricted areas as those areas access to which is controlled for radiological pur-poses.

Most power reactors have an area known as the ' owner-contro11ed, area' that is not actually a restricted area but is also not an unrestricted area.

The acceptable dose rates in this gray area (the owner-controlled area) are ambiguous.

The proposed revision clarifies this by defining restricted area and controlled area as follows:

l 1

^

Restricted Area An area, access ' to which is timited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive matericts; Controlled ' Area An arsa, access to uhich is limited by the Licensee for any reason.

The proposed revision provides reasonable guidance concerning.

the exposures permitted to occupational workers or the public who might be in these areas without limiting dose rates.

This is very sensible since it is exposure to people that should actually be controlled, not just dose rates in air.

In this. manner, the proposed' revision has eliminated a potentially gray area and by placing the limit on the proper parameter has given the licensee more flexibility in conducting his activities providing the exposure to people is properly controlled.

The proposed revision.provides clear guidance in several areas which have the possibility of being 'gotchas', i.e. circumstances beyond reasonabl~e control which create potential noncompliance situation.

A good example is the paragraph which specifies dose limits for the embryo / fetus.

The limits are the same as presently covered by Regulatory Guide 8.13, however the proposed revision provides more definitive direction about how to handle the pregnant person situation.

One potentia 11y' sticky situat, ion deals with how to calculate the dose to the embryo / fetus if the pregnant worker receives an uptake of internal emitters.

A literature search provides very little guidance on how to calculate the dose

• .o the fetus.

However the propostd revision states that the dose assigned to the embryo / fetus should be twice that assigned to the pregnant worker 7

unless a more appropriate value can b'e substantiated. This makes

n the health physicist's job much easier should h this situation.

e ever encounter The second 'gotcha' dea'is with how to handle the

,-situation where the pregnant worker finally identifies that is pregnant but has already received more tha she becoming pregnant.

n 0.5 rem since The current guidance would suggest this to be a noncompliance situation from a regulatory standpoint be essentially beyond the health physicist's control

, yet would is a likely scenario involving a pregnant worker who conti Yet this to work while trying to decide whether to tell h nues she is pregnant.

er employer that The proposed revision states that you would not be charged with an overexposure providing her exposure duri remainder of her pregnancy did not exceed 50 mrem.

ng the This is a reasonable and workable requirement.

Note:

the limits for the embryo / fetus will be eliminated comment version.

rom the public I personally believe that to be a mistake since handling it as a Regulatory Guide matter does not place the p emphasis on it.

roper Potential Problem Areas in Proposed Revision Although the proposed revision has eliminated many of the problems of the current 10 CFR 20, it is not without fault.

example is provided by the limits placed on exposure to membe An of the public.

rs Dose Limits for Members of the Public

he Li'censee shalt constrain e=posure of any individu l member of the public frcm sources under the a

licensee's control so tha: the to:ct dose from al; sources and operations, licensed and unlicensed, e=cep: fcr na: ural background and medical diagncsis and thereapy,does not acceed 0.5 rem per year.

The phrase ' licensed and unlicensed' makes the licensee r sible for the sins of his neighbors.

on-the health physicist must This phrase indicates that be aware of what radiological exposures the public is receiving from sources other than his ow adjust the releases from his plant accordingly if the expos n plant and

-were approaching 0.5 rem per year.

ures Experience has shown it is very prudent to.be aware of the 'other' sources of radioactivity in the' environment around a power plant, be they natural background, fallout, or a nearby radioisotope user.

But having to potentially shut down to accommodate the releases from facilities beyond one control is unreasonable.

However, this will not generally be a practical problem since exposures to the public from power reactors is typically less than 0.001 rem. The proposed revision also that if a power plant states is in compliance with the epa guidelines of 40 CFR 190, " Environmental Radiation Protection Standards fo power Operations", then the effluents would be considered ALARA r Nuclear Another area in the proposed revision which appears unreasonable is the specification of conversion factors for photons of differing energies.

The proposed revision specifies a factor of 1 for all energies except those from 35 key to 150 key for which the conversion factor is specified as 1.5.

This is a potential inspection / audit trap with no redeeming benefit A' properly calibrated dosimetry system accommodates the correct conversion faccor implicitly, although doing the background research to prove this to the inquiring inspector would be in-officiently time consuming.

With the current direction which NRC i

is taking in requiring NVLAp approved dosimetry processors, inclusion of the conversion factor appears unnecessary.

the NOTE:

Recent discussions with NRC personnel have indicated this will be corrected in the public comment version The proposed revision has incorporated the methodology and terminology of ICRp 26 and 30.

This will require an adjustment

/-

in the terminology health physicists use while discussing personnel dosimetry since there will be many more terms than

..' internal dose', ' external. dose',.' extremity dose' and ' skin dose'.

The new terms include absorbed dose,' dose equivalent,

. deep dose equivalent, committed dose equivalent, effective dose equivalent, committed effective dose equivalent, shattou dose equivalent, etc.

Although reasonably clear after a small amcunt of study, the use of these terms with lay people, such as operations and maintenance personnel and even the boss, will undoubtedly add some confusion for awhile.

While some may consider this. additional job security, others will view it as a nuisance.

It is fortunate that the proposed revision does not also'try to convert to SI units!

The proposed revision has an expanded'section of definitions.

The definitions for these dosimetry terms are generally clear with one exception.

Effective dose eouivalent' is defined as The sum of the products of the usighting factors applicable to each of the body organs or tissues which are irradia:ed and the annuci dose equivalent to the organ or tissue (T) from an inecke of radioactive materict.

The use of the term ' annual dose equivalent' with refer-once to the intake of radioactive material is confusing.

The other definitions associated with internal. dose refer to committed dose equivalent as a 50-year dose.

The usage throughout the proposed revision of the term ' effective dose equivalent' appears to mean 50-year committed dose.

As discussed at the beginning of this paper, there are provisions for assigning to the individuals' records only the dose actually received during that year from long-lived isotopes.

However, the use of the term ' annual' raises a question about whether the intent is to apply this procedure to other isotopes.

Omitting the word ' annual' in the definition for Effective Dose Equivalent or replacing it with ' committed' would

[

clear up the confusion.

Major Additions to the Regulations As discussed th'us far, much of the proposed revision looks

• very-much like the current 10 CFR 20 with minor changes which have been substantive improvements.

There have also been some major additions.

The proposed revision has added a section on De Minimus levels for doses to individual members of the public.

As stated, the levels are limited in scope but at least it is a start in

~

this sensitive area.

De~Minimus levels are defined as 0.001 rem in a year-to any individual, while 0.0001 rem or less in a year may be omitted in making collective dose estimates as long as the sum total of De Minimus is less than 0.001 rem in a year.

This should

. help simplify the dose calculations for annual environmental impact reports.

The requirement for and the elements of an ALARA program have been added to the proposed revision.

Briefly these elements are:

1.

A radiation protection program including ALARA is required.

2.

Management or designee must examine and verify the

. program features and records, and investigation levels below the -

limits must be established.

3.

Licensee shall review circumstances which cause doses in excess of investigation levels.

~

4.

Records must be maintained of ALARA actions.

This addition places in the regulations what previously was essentially a part of a Regulatory Guide.

This will effect a power reactor' health physics program only if these elements have not been included.

However, the requirements allow considerable flexibility in implementation.

.-s s

1-The' incorporation of ICRP 26 and 30 has caused the occupat dose limits to. appear different.

nal proposed. revision.

The following summari:es the.

- Occupational Dose Limits for' Adults 1.

Annual limit is the more limiting of:

The sum of the (external) deep dose equivalent o

to the whole body.and the (internal) committed effective dose being equal to 5 rems; or The' sum of the deep dose equivalent and the o

committed dose equivalent being. equal to 50 rems to an organ or tissue other than the eye.

2.

The annual dose equivalent limit oye is 15 rems.

to the lens of the 3.

'The annual dose equivalent limit to the skin and to each of the extremities is 50 rems (applies to DE averaged over 10 cm 2

in region of highest exposure).

4.

The deep dose equivalent component of the annual effec-

\\

tive dose equivalent... shall not exceed 3 rems in any calendar

. quarter..

The limits for effective whole body exposure, both internal innd external, is 5 rem in a year with

-limited [to.3reminaquarter.

the external component This is essentially a reduction from the current external exposure. limits, but should have little offect since few workers receive exposure greater than 5 rem in a yoar.

The proposed limits also include internal and external where-the current 10 CFR 20 has separate limits for each. Although this is a significant reduction, this should have no practical effect l

v".

e since internal exposures at power reactors are normally not detectable or seldom significant.

regulations more in line with international recommenda actual practice.

s and The proposed revision also states the area of skin which skin, exposures should be averaged.

over perpetual ~ debate for NRC licensees.

This will end that The current 10 CFR 20 has the 5(N-18) rule which pr some flexibility for unusual exposure requirements that ce ovided crop up at a power reactor.

casionally proposed revision but has been replaced with provisio

' Planned Special Exposures" which are explained as follow r

s:

_ Planned Special Exposure 1.

addition to normal occupational exposures. Permits re 2.

Lifetime limit for PSE's and overexposures of 5 times the annual limits.

The special exposure must be planned in advance with appr priate records.

is limited to the values in item 2.The total exposure from PSEs o-i j

This provision retains the flexibility to conduct an exposure intensive job with ex in excess of the annual limits.

posure Although current indicate, the option may not be frequently used experiences it is desirable end necessary, particularly in an emergency situation, to have this flexibility.

radiation indicates thatThe knowledge of the biological effects of be treated rigidly and thatthe proposed exposure limits should not increase the risk to workers this flexibility does not significantly O

--,.n.

w

.-,p.

y Another addition to the proposed revision is the requirement to. report to the NRC and the individual worker his occupational exposures on an annual basis.

This is.a significant change from

• the current practice of reporting-only when the employee terminates.

As a trade off, the annual statistical report and the termination report have been eliminated..The effect of this change will be to require.the reporting of more information to the NRC but on a i

regular basis'rather than on the non-regular basis of whenever.ter-i minations occur.

This latter was a significant continual work load at TMI and would be very significant at the end of outages at routinely operating plants.

The proposed revision should permit a more'organi:ed approach to reporting this.information to the NRC.

The addition of the report to the individual worker on an annual basis will be an increase in reporting.

However, the bene-fits of making the worker more aware of and k'.owledgeable about his own personal exposure should outweigh the impact of preparing the individual reports.

The degree to which records are computerized

.and ' termination reports' are prepared by the computer should permit an annual letter to be generated fairly easily.

The proposed revision addresses respiratory protection pro-grams-in a more direct manner than the' current 10 CFR 20.

Currently 10 CFR 20.103 states that the respiratory protection program must comply with Regulatory Guide 8.15 which directs one to be in compliance with NUREG-0041, " Manual of Respiratory protection Against Airborne Radioactive Materials".

The proposed revision incorporates the requirements of the NUREG-0041 in a broad sense

'directly into the regulations by identifying the elements that must exist to have a satisfactory program.

To avoid the bulk of NUREG-0041, th'e proposed revision requires, among other things,

[

that the licensee have " writ' ten procedures regarding selection, 2

fitting, issuance, maintenance, and testing of respirators; supervision and trainihg of personnel; and recordkeeping".

This

. requirement covers about everything.

Although specific requirements

r. -

+-

l as to what should be in'these written procedures is not included, one?could suspect that NUREG-0041 would be used as guidance'for the reviewer.

Because of the current emphasis on respiratory pro-

.tection, these procedures should be in general existence and this particular requirement should have very little effect.

Several'other changes should be noted in the area of respira-tory protection.- The current guidance.in NUREG-0041 states that th the respirator should be selected such that the anticipated peak concentration does not exceed MPC by the Protection Factor of the respirator.

Although this may sound great on paper, it is not a practical criteria because of the difficulty in anticipating the peak concentration and then being able to prove it afterwards.

The proposed revision relates the Protection Factor and' the DAC to the average concentration of airborne radioactive material.

This,is a more reasonable requirement.

The current time requirement for respiratory physical exam is one year, with no allowance for overrun of this period.

The proposed revision requires certification by a physician every 9-15 months.

This allows some leeway to accommodate training schedules, peak loads, and other interferring factors that always crise.

The proposed revision specifically requires testing of respira-tors.for operability immediately prior to each use.

Although this is a reasonable requirement considering worker protection, it is not universal practice to do so in the power reactor industry.

This will

~

require incorporating such a test into the routine use of respiratory equipment.

The financial effect of the revision to 10 CFR 20 has been estimated by L. F. Booth and F. L. Bronson in their paper " Dosimetry and Recordkeeping Implications of the Proposed Revisions to 10 CFR 20".. The estimates were about $500,000 initial costs and about

$250,000 additional operating costs annually.

Much of this cost

I is_in the recordkeeping portion of the program where many utilities are currently upgrading their systems.for improved operability Consequently some of these costs may not be incurred

• reasons.

. solely because of the proposed revision.

The costs will vary from one plant to the next depending on the degree of computerization and the flexibility of the software used to conduct the record-keeping.

For reference, a health physics program with 50 people will typica'lly have an annual budget in the range of $2-3 million dollars, where many utility. health physics programs have annual budgets approaching $10 million.

Although the estimated costs of the proposed revision are significant, they would not generally have a major impact on the budgets.

Summary Chi the balance, the proposed revision would appear to have a beneficial effect on power reactor health ph'ysics.

This occurs because of clearer requirements which permit more flexibility where years of experience has shown this to be desirable.

Many of the rigid requirements have been replaced by more reasonable options.

The revision will require more reporting and recordkeeping but in many cases the new reports and records are more sensible than the current ones which are being deleted.

As an example of the " flexibility-where-appropriate" philosophy which the NRC has appeared to use in developing the proposed revision, consider the way internal exposures should be reported.

The current 10 CFR 20 establishes the limits for internal uptake in terms of MpC-hou Consequently,.even though the internal exposure may be calculated in terms of rem, it gets converted to and reported in units of MpC-hours.

The proposed revision states that ecmpliance with the limits may be demonstrated by using the fraction of the Annual Limit of Intake, or the fraction of DACs inhaled during the year, or the committed effective dose equivalent (any of the above) in conjunction with the fraction of the deep dose equivalent limit.

Consequently the internal dose may be kept in the most convenient and appropriate terms--a much more reasonable approach.

o.-..a.

Although.a significant improvement over the current 10 CFR 20, the proposed. revision still has rough edges.

Proper attention by

' published for public commentpower reactor health physicists du will aid in eliminating those remaining rough edges.

Look for it later this year and give it the benefit of your experiences.

4 e

e O

e Y

S l

1

TABLE 5.

PRINCIPAL BENEFITS FROM PROPOSED REVISIDN OF 10 CFR PAR CONCERN WITH PRESENT PART 20 PdOPOSEDPART20 REVISION BENEFITS OF REVISION 1.

Many Values in Appendix B Do Not Reflect Current Revises and expands Appendix 8 Knowledge.

to reflect contemporary knowl-Derived values will reflect' edge of dosimetry and biology.

ICRP risk based system and make use of contemporary knowledge.

Present MPCs can cause underestimates of doses by Air concentrations are based a factor of 6 for most on a lung model which permits alpha emitters and 60 for adjustment for the particle thorium.

sizes of aerosols.

" Soluble" and " insoluble" i

i designations in Part 20 ar.d Values are presented for many other bases were various compounds.

abandoned by health physicists many years ago.

Coverage of radionuclides has been increased from

^

k Cl 260 to 757.

Of the radionuclides where comparisons can be made, i

about 65% of the new values are less restrictive, about i

8% are unchanged, and about 27% are more restrictive.

2.

5(N-18) Dose-Averaging Formula Permits Workers to Receive 12 Deletes 5(N-18) and adopts 1 g Rems per Year from External 5 rems per year and 3 rems Annual and Lifetime doses to n

g Sources.

per quarter dose limits.

individuals receiving highest 1

exposures will be reduced.

1 i;E 4

Several hundred workers each i

year receive doses of 5 rems Provides " planned special

. s, s

or more, exposures" for necessary Risks to radiation workers and unavoidable activities.

receiving highest exposures i

3 2E:

will be more comparable to i

i$

those in safe industries.

.{

. u

- An l

I 1

g

.g.

I TABLE 5, (Continued)

CONCERN WITH PPESENT PART 20 PROPOSED PART 20 REVIS10H BENEFITS OF REVI5!0N Potential risk could be sub-stantial (3-10%) from 50 years Provides substantial flexibil-external exposures at 5 rems ity for licensee to manage per year,and additional dose justifiable exposures beyond from Internal exposures.

selected annual dose limits, Provides for readily monitored l

records of use.

3.

Dose Limits for Internal and External Doses are Independent.

Establishes 5 rems annual limit for sum of external Effective dose equivalents Risks from dose Ilmits to various and internal doses, limits from combined external and internal exposures are Adopts ICRP " effective dose related to individual risk.

organs are unequal.

equivalent" which adjusts doses to*various organs to

• ' Limits for various organ doses whole body dose equivalent reflect comparable risks, based on risk.

U Dose weighting factors based on quantified risk of radiation-induced health effects are con-sistent with Commission policies on use of quantitative risk.

Workers and pubile can under-stand risk base which is more rational than present dose

.E limit selection.

n;g Doses to workers sisjected to jg both external and internal expo-33 sures will be reduced.

4.

No Requirements for Formal y

Requires written radiation Radiation Protection Program protection program with ALARA Ensures adequate radiation s

or for ALARA.

provisions.

protection program and ALARA

}"

efforts by all licensees.

m u

u

~~T

.2-n-

e i

TA8LE 5.

(Continued)

CONCERN WITH PRESENT PART 20 PROPOSEDPAR[20 REVISION BENEFITS OF REVISION Uneven requirements among

• -Requires management commit-types of licenst brought about mostly th.., ugh ifcens-ment and participation.

Would reduce doses to workers.

Ing actions other than l

Part 20.

Requires selection of invest-Provides basis for more effec -

j igation. levels for doses to tive ALARA efforts with reliance workers below dose limits.

on licensee's judgment.

Provides regulatory require-5.

_ Limits Treated As Sharp Line ments for enforcement actions.

of Demarcation Between Accept-Emphasizes ALARA and provides able and Unacceptable.

reference levels to permit.

Actions are taken to reduce graded scale of action as exposures before dose limits Ilmits are approached, are exceeded and to review expo-l De Facto limits are estabilshed sures when they are substantial.

i i

by licensing' actions, Would reduce doses to workers and pubile without: resorting u

6.

Staff Cannot Obtain Dose Data to other regulatory means, on Specific Workers until they Requires reporting of annual Terminate Employment.

doses to worker and to NRC by Would provide worker dose Social Security Number.

histories in real time.

Data on annual doses to workers are inadequate for regulatory Eliminates present " annual Improved data base would purposes.

statistical summary" report.

. permit NRC to better assess adequacy of radiation protec-No reports are made of internal Eliminates present "termina-Lion efforts and regulations.

doses.

tion" report.

Would permit evaluation of E

Workers are not required to be transient worker annual doses.

E' 2

informed of annual or accumu-lated doses without request.

(

7.

Presents No clear Dose Limits for Members of the Public.

Establishes 500 mrem /yr effec-tive dose equivalent (external Dose limits for public would 3

and internal sources).

include possible multiple S

sources and multiple exposure u

modes.

TABLE 5.

(Continued)

I EONCERN WITH PRESENT PART 20 PROPOSE 0 PART 20 REVISION BENEFITS OF REVISt0N NRC can require de facto limits withcut compromising Part 20.

Establishes reference levels for action below limits, Would provide clearly identi-j fled limits and graded actions.

would result in individual doses less than 100 arem per year.

Fact 11tates use of estimates of health risk as.a fundamental determinant in decision-making and in any reform of_ nuclear 8.

Present Part 20 Provides No regulation and licensing.

Constraint on Collective Provides constraint on collec-Dose Evaluations.

.tive dose evaluations to omit Would save considerable resources.

doses less than 0.1 arem per Can restit in unwarranted year to indtviduals.

Would prowfde perspective fa expendituras of resource for Judgments, incremental risks which are y*-

trifles.

Would eliminate consideration cf health risks which are trifles.

k n

=

Pl*

M N

E

~

~

g e

b

t THE PART 20 ORAFTIt:G GROUP'S RESPONSE TO THE 6/5/S4 MEl'CRAllDUM FRCil R. CLEVELATID TO H. DENTCtl Ccmment 1:

"...First, I:believe much of the difficulty in considering the merits of the proposal stems from a lack of clarity as to what is needed to be done (i.e.,

what is broken?).

Without a clear indication of the objectives to be accomplished..."

Response to Comment 1:

The rulemaking package clearly ider.tifies the tcjor conce of the proposed revision. paper, pp. 2-3) and principal benefits (Supplementary Infcr In addition, the three CRGR incluced handouts, with subsequent lengthy discussiuns,presentaticns on Part 20 deficicncies with'the'present Purt 20, benefits of the propose 6 revision of lists of benefits of the proposed revision.icprovements in safety features and ucrkers Cemeent 2:

"...decsn't or:ce*1 sinple."

y c:nsider a tasic prir.ciple fcr a - ;ulaticn: Kaen it Fcscense :o Cornert 2:

I Je roccgnize that the propotec major change in the Part 20 r'egulaticn is viewed by nany as being difficult to uncerstand.

c' protection that is basec explicitly on health risks asscciated with the doseThi linits is new and requires sore changes in the "way of doing things" by those whc license, inspect or operate.

short term and subsecuently mitigated by education through comments,

{

and gereral training before the date of effective implementation.

experier.ce to date would indicate that much of the perceived complexity of the Our prgposed revision is causeo by the introduction of some new terns which are needeo to ccmmunicate accurately and effectively the newer systen proposed.

Once the terns are understocd the use cf the systen aerears less ccmplex and, therofere, less emincus.

Ir accition, ciscussions with IE persennel have assuroc us that the regulation is not se complex as te bc difficult to either frolerent-on enforce.

The draft revisicn has beer mocifiec tc hele users ur.derstand nct cnly what is inplementation by allcwing greeter flexibility in checsing alterrative ccepliance methods.

hirdle cnly. smali quantities of radicactive materials.':e believe this will be.hcipful tc E:' CLOSURE 3

Comment 3:

...the contention that the ICFP 26 cethccologies are ' state-of-the-art' and scientifically supportable appears open to some challenge."

Respor.se to Coment 3:

The " state-of-the-art" reflected in ICRP puolicaticn 26 methodologies are not seriously challenged by knowledgeable scientists and eany practitieners of

.raciation protection..In its July 24, 1981 letter to EPA on its

~

" Federal Radiation Protection Guidance fcn Occupational Exposure, proposed Commission noted that recommendations in ICRP Publicaticn 26 were "legical and

" the self-consistent, and appear to be based on the best scientific informaticn available."

We believe that-the-ICRP-26 system remains defensible and know of no serious challenge to its bases.

Decently, Cenmittee 1 cf the ICRP ccmpleted reviewing e;fdenfological surveys and related reports and concluded that no changes in the cancer risk estin:ates used by ICRP in radiation protection were warranted at the present time.

Comment 4

...I find the new Appenoix B impressive in its detail.anc absurd in its recital of distinctions withcut differences.

For example, the two sets of entries of Antimony-116 have only one pair of values which are different (not ecuntin versus -:g the three unexplained omissiens of entries for Class W), 4X10(-7)

XIO(-7)."

esponse o Comnent 4:

Anticony-116 is only one example of a racionuclide that reouires several ontries in Appctdix 3 because there are cultiple lung clearance classes appropriate to the radienuclice.

chemical and physical forn of the radioactive material.These lung clearance classes are tate If values of DACs,

- Alls, and reference level air concentrations are not-giver. for each appropriate lung clearance class, questions woulc be raised about the pecper centrol levels fer the emitted clas'ses of radionuclices.

As noted, there may be scall differences in the DAC values whenever a radionuclide has a radioactive half life ~ which is shorter than its translocation tice. Tnese differences become even more obscure when the values are rcunded to cne significant figure, as in the Appencix 5 entries.

The "unexplainec omissiens" refer to the dashes in the cciurns for the ALIs for Loral intake, the reference level cercentration for water, arc the centhly t

average cor.centrations for releases to sewerage. These values are net related te lung clearance class, ard, therefore, there is only one set c' values for each radionuclido.

As a matter of format, and convenience, these oral intake values are pre:ented in the first line,' Shich also hacpens to c:rtain value:

for One'cf the innalation classes. Other eviewers have r.:t fcune either the f:rmat or the listaa values ccnfusing.

ENCLOSUPE :

'F

~

~

Comment 5:

"...this massive change in Part 20 ccr.veys a false cessage to the public that

~

our present radiation protection progran is not adeouate and that raoiation ha ards are in need of even nere stringent control."

7.esponse to Ccement 5:

The rulemaking package for Part 20 is written to convey to the public that the NRC intends.to base its standards on the best scientific knowledge, the latest in radiation protection philosophy and practices, and experience gained during the nearly thirty years since promulgation of the original Part 20. The proposed revision could lead to adjustments in both. directions -- more stringent control, where outdated data have led to routine underestimates of doses, or less stringent control and more flexibility, where present regulatory practices have gone beyond those justified by the current regulaticn. The comment appears to reflect personal perception rather than being misleading.

\\

I 3

EliC'.CSURE 3

r PART 20 DRAFTIDG GROUP'S RESPONSE-TO CCPMENTS IN 4/20/P4 HEPORANDUM FROM WILLIS TO CLEVEL.ifiD RE-EPA DRAFT FACIATION PROTECTION GUIDANCE General Comment:

" Glen Sjoblum's April

. guidance allows little time, so my comments must be brief.13,1984 -lette the NRC comment that this guidance should not be issued because:I recomend that 1.

' Existing guidance is resulting in an adequate level of protection.

2.

The raw guidance will not provide ary inproverent fr. health and safety.

1 L

3.

Icplementing t.ne new guidence will be ecstly; 100 cillion dollars present werth seems a minicun esticate."

Resterre te General Cerrent:

The three basic ccmments are similar to URR staff ceccents made cr~ the proposed revisior, of Part 20, and have been. addressed in the respcotes of the drafting grcup to comments on the Part 20 revisicn.

The Part 20 revision has been ceveloped. in parallel with the draft EPA

• guidance and woulc be ccepatible with

't.

Specific' Comment I:

. "Reccarerditicn 1, requiring 'everall benefit' before occupational exposure it

.; err.ittec.shcul-be decpped because the agencies generall: are_ neither cualified rer encouered to make such judgenents. Treating this reccmmendation with her.igr.. neglect nahes something'of a farce of the entire process."

Sercense to Scecific Coc ent 1:

~

I The reccmmendation being addressed, "There shculc r.ct be any occupational i.

e I

exposure of workers to ionizing raciation without the expectatfor. of an overall ter.efit...", is not.new.

It is a restater.ent.cf the basic principle expresseo in the Feceral Radiation Council Report No. I, signed by President Eisenhower In Pay 13. 196C.

Agencies, ircluding the NRC, jic ma<'e such value judgener.ts

• na they ere within their.. authorities to do so :n, protectir.g public health.

In stne inr ances, the judger.ents have teen nade by the Ccngress.

Specific Cormen't'2:

";tternencation 2, recuirirc th? igercies to suitcr :o IC??-2? ne:acccir.gy,

-heuld be~droppec bactise inplercrtaticc wculc ce cuite c stly, anc because it

f ers na health and sa# sty 5enef't.

!':. eever. re '.rce'

ter is rot 0"7pc*ted bf sClic, scientif#C kViG@r.C5."

g I

E.1CLCfcRE 4 l.

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R_e_spcase to Specific Coment 2:

Le disagree with this contention.

We have addressed the pctential costs, the benefits of impler:entation, and the scientific merits of the ICRP-26 syste

~

dose limitation in considerable detail ir response to ecmparable cerments en the overall revision of Part 2G.

_ Specific Coment 3:

j.

to avoid uptake, as far as is reasonably achievable, s it is technically absurd.

such regulations would be unenforceable as well as unbeneficial.Ze recomendation would also impose impracticable limits or the uptake.of certain This important long-lived nuclides."

~

Restanse to Seccific Comrent 3:

We agree with this comment and have expressed it to EPA with respect to s drafts of the updated guidance.

See para cated May 3,1984, frcm Mills to Sjoblem, graph four of the enclesed letter i

transmitting ccordinated f.RC staff corrents tc EPA (Addendum 1). A more recent draft of the EPA cuidarce, trans.-itted Jur.e 20, 1954, recognizes the need to balance ex ernal exposure with efforts to cent

' ntake.

It reads:

i 3.

As the pricary means for limiting internal exposure to radienuclic'es, ucrcies shcuid :ecuire thu radicact'to ca trfa'.s ba ecntrcllec so as to avoic intake, to the extent reasonably achievable, considering concomitant external exposure.

Stecic Ccrr.ent 4:

be drooped because it is not needed and because it impose s

~

descrimir.ation."

_ Response to Specific Comrent 4:

We disagree with drcppino this EPA reccertendation in toto.

However we are prnblems, such as interpreting known by whom..:cccerned that the wordi the following quotation free tre latest EPA craft transri-.ed JuneThe Iey words are un 20, 1984.

...The tctal ocse ecuivalent to an unborn child as a result of occupational exposure of a wor.an declarec cr known to be pregnant shculc be naintained as icw as reasonably achievaETe, arc in any case stculd net exceed an RPG of 0.5 ren.

ecuivalent to tha unborn o iets than C.:Ir addition, pcsitive e' forts to centrol dose rar in anv cutn are enccuraged.

Earder'draftr c' -he preposed revisien of 10 CFR Part N avoiced sue.'1 pr:

o.* [Stt.irir; lictrsecs to linit te cccupa.icnal exposure cf onlf 51cc~e erp.cyees -wPs Ecc vclun arily ceclared their pregnancy Ic the licensee.

~ these In the E.'iCLOSUF.E 4

v g

~.-

absence of. such a declaration, the licensee would be expected to maintair. doses to a pregnant woman as low as is reasonably achievable and within the limits.

as for any other employee.

Additional comments en the issue of protection for an embryo / fetus are in cur -

response to comments on the revision of Part 20. We note that during internal review of this issue one of the reasons for deleting the proposed ccse limit for.the enbryo/ fetus from the revision was the belief that EPA should address the issue because cf the broader application of Federal guidance.

Specific Comment 5:

" Recommendation 2, requiring ' state of the art monitoring methods,' should be dropped because bonest implementation would be extremely costly and would provide no significant benefit.

In that instruments serve their intended curpcse, the agencies shculd not require their replacement merely because something better is available."

Resconse to Scecific Ccer.ent 5:

The referenced sertence in Recommendcticn 8 of.he draft EPA guidarce transr.i-ted Acril 13, 1924 reads --

...The types, accuracy, anc state of the art of monitering rethods and precedures utilized shoulc be periodically reviewed to ensure that apprcpriate techniques are being competently applied.

Tha-..crci.; f.c 2 ;:secuen: j :een encrgec so -he.c:n.T.ent is r.v icnger an issue. The comparable sentence in the draft guidance transeitted June 20, '98a, reads --

...The ty;e; i.r.c accuracy cf mcnitorir.g metheus arc procedures utilizec sbcula be periccically reviewea tc assure that appropriate techniques are being cer:etently applied.

Acdencum:

1.

Letter fron itills (NRC) to Sjoblem (EPA), May 3, 1984 2

E.CLOSL'RE 4

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(( reg Iq, UNITED STATES h

NUCLEAR REGULATORY COMMISSION J

WASHING 70N. D. C. 20555 n

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MAY 3 ISM Mr. Glen L. Sjoblom, Director Office of Radiation Programs U.S. Environmental Protection Agency

Subject:

Radiation Protection Guidance to Federal Acencies for Occupatienal Exposure (4-09-84)

~

-Thanks for ycur letter of April 13, 1984 Protection Guides) for occupational exposures to ioniz

' review that goes beyond the recomendations themselves. p I was substantial rewrite before it is ready to go to the Federa femal review and comment.

how the guidance was developed (draft pgs.-3-5) attention be changes are being made in the.1960 RPG's for radiation workers.

done in a recommendation-by-recommendation comparison femat--but n This could be into details which'can better be explained in the backgrcund document (will there.be a revised one?) or in readily available referenced material

' The lengthy discussion of " net benefit", justification, " o t

point.. I suggest deletion because, as I have noted bef: e, I believe that' the wording of Recommendations 1 and 2 in the 1960 Federal Guides is mos and that no change in language is necessary.

'contipues to project an intent of unnecessary rigidity in im

~ these recomendations 'by Federal agencies.

(why uptake rather than intake), " continued... exposure at (the RPG) woul

' provide an' acceptable level-of protection and should be avoided," and " publ note or specify situations in which exceeding the RPG's has been authorized" are not reducible to reasonable regulatory requirements and can be easily interpreted in a inost restrictive way.

well as other concerns in earlier letters (12/9/83 to Guimond,1/5/83 andI ex to 4/583 Richardson).

in drafting the latest draft but remains unconvinced.I trust that ORP has consid possible reconsideration I am enclosing a copy of my December 9,1983 letterFor yo to R. Guimond.

i / Addendum '.

~.

Mr. Glen L. Sjoblem.

I assume from your letter that the guidance will not be reproposed for public comment and that Federal agencies will be sent a final draft for formal review and comment before the Administrator sends his recommendations to the President for approval. In view of this perceived procedure, I suggest that the interagency working group be provided an opportunity to meet with you as a group to receive EPA's response to our comments and to go over what ORP. views as the package likely to be sent to our respective agencies for review and concurrence.

Enclosed are some selected specific comments from an ad hoc review which we hepe will per.v.it an impreve craft.

j

'.,'. / >,..,.'

i..'

4 William A. Mills, Ph.D.

Chief, Health Effects Branch Division of Radiation Programs and and Earth Sciences Office of Nuclear Regulatory Research

Enclosures:

As stated Y

e e

i

Mr. Glen L. Sjoblem.

Mr. Robert E. Alexander, NRC cc:

Mr. Lewis Andrews, NASA Ms. Joanna M. Becker, NRC CDR Tom Bell, DOD Mr. Elmer H. Eisenhower, DOC Dr. Aurel Goodwin, MSHA Mr. Charles Gordon, OSHA Mr. Richard Rawl, DOT Dr. Marvin Rosenstein, HHS Dr. Warren K. Sinclair, NCRP Mr. Allan C. Tapert, CRCPD

~

Mr. Edward J. Va11ario, DOE Dr. Sheldon Weiner, OSHA J

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umTso starts af NUCLEAR REGULATORY COMMISSION s

m sm ucrow.o.c.aosss

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DEC S 1983 Mr. Richard J. Guimond Director, Criteria and Standards Division (ANR-460)

.U.S. Environmen.tal Protection Agency 401 M. Street, S.W.

Mashington, D.C.

20460 Dear M G

ond:

recomendations for Federal Radiation Protection Exposure'sent to me by memorandum, dated November personal coments and, thus, have not been coordinated with my collea 10, 1983.

These are my the NRC.

I assume this package'will include a copy of the F it.

and other related documents the working group should consider in pr recomendations.

I believe that the draft has come a long way as an expression of consens am looking forward to revidwing the preamble that explains how we arriv I

conclusions.

Rec. 1.

In the second sentence change "may" to "should" or delete the sentence.

"May" means

~ through Federal guides;giving permission for such activities activities when the Federal guides are conformsd with.whereas the latter is the working group's intent.

I believe Rec. 2.

Delete the wording "... establish the upper limits of..." and replace with "... apply as guides for limiting...".

i believe the word " limit" is suitable for guidance, and " upper" I don't implies that lower limits may be warranted.

!~

group has rejected the idea of lower limits and accepted lowerI believe t levels of administrative controls as aeditional requirements instead.

A, working group in NEA has opted for the ~ inclusion of partial bod external exposure in the definition of effective dose equivalent.

An example of when-this inclusion is important arises in the situation of the head and neck being exposed when a lead apron is used.

The definition of H suggest" footnote (1)"be$$[ngedaccordingly.is amenable to this situa Add a sentence after the period in the second sentence to make clearer the meaning of H to read:

"H is the dose equivalent received in a year from both residual add new intakes during the year." Since H has a different meaning than used by the ICRP it

--,-w r

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--m

e Mr. Richard J. Guimond 2

is desirable to use a symbol such as Ha q

to designate this annual dose ' equivalent for organ weighted intaRes.

I am still opposed to the general use of annual dose equivalent for internal depositions in the sumation of doses that is i.ntended to be a surrogate for the total health risk to the-

. exposed. worker.

I believe the use of comitted dose equivalent is more straight forward, technically and administratively.

Certainly, the worker is more likely to understand the meaning of risk ipvolved with his getention of long-lived materials.

Rec. 3.

Delete the lead sentence--it is redundant with the first sentence in the following paragraph that follows.

Reword the first sentence in the second paragraph to read:

"If an agency concludes that it is not practical to avoid intakes, it should require that the control of exposures to radioactive materials be designed, operated and maintained such that any expected comitted effective dose equivalent will not exceed 5 rems, and the comitted dose equivalent to any organ or tissue will not exceed 50 rems from any intakes in a given, year."

Question:

How does ORP see this requirement handled when the agency also expects some external exposure to occur? Are the two types of exposures to be treated separately?

. Reword the last sentence to read:

"When design, operating, and maintain controls are not effective in meeting the above numerical guides for comitted effective dose equivalent or comitted dose equivalent to any organ or tissue, annual dose equivalents..."

Rec. 4.:

Reword second sentence to read:

"However, it should be general practice to maintain expected and actual doses from radiation to levels below the RPGs... agencies should encourage the establishment of radiation protection programs that include ALARA considerations."

Federal guides should not advocate the establishment of goals for limiting exposures through agency requirements--it leads to "de facto" ALARA Ifmits (likely to be based on erroneous optimization apsumptions) wnicn de-emphasize the dose limits established.

Rec fi:

What is the meaning of "known", and by whom mEst it be known?

Ambiguous.

Rec. 7:

Make the following changes in the second sentence:

add "...the principles and recommendations set forth..."; and delete "and cperating procecures wnicn implement this guidance." The limited operating procedures given can hardly be considered adequate to implement the guidance plus implementation of the guidance is the responsibility of the responsible agencies.

(

!!C 9 lit; Mr. Richard J. Guimond 3

Rec. 8:

In the last sentence delete " lifetime".

This could be a very troublesome recommendation for NRC to implement.

It would require that every licensee be held accountable for recording lifetime doses--a requirement lof verification that would be an impossible imposition in the' transfer of records.

Without a centralized national registry for all-radiation workers this cannot be done.

Footnote 5.

Change " limits" to " requirements".

Rec. 10:

Reword to read:

" Agencies should not adopt procedures that would result in doses exceeding the RPGs except for emergencies or unusual ' circumstances that merit such action.

In making exceptions the responsible federal agency should carefully consider the above recommendation and, as necessary, procedures for public awareness."

Note 3:

Would not ICRP-32 be used for uranium mill workers?

Note 4:

What is " general guidance established herein"--the non-numerical recommendation?

Note 5:

Reword the second sentence to read:

"The handling of such cases is the responsibility of the Federal agency having the necessary legislative authority." Federal guides cannot assign responsibility to the private secter.

Note 6:

Reword to read:

... exposure to workers in underground uranium mines..."

Happy Holidays to ORP.

Sincerely, William A. Mills, Chief Health Effects Branch Office of Nuclear Regulatory Research cc: Members of Working Group A

~

ENCLOSURE 2 SPECIFIC COMMENTS ON EPA DRAFT GUIDAN p.

8.

optimization will be required. EPA should make it clear that neit Here (3rd last line) and in several other ldcations e.g., p. 10, 11, it is stated that the primary objec is to minimize the total harm.

This is incorrect.

The objective is to maximize benefit and/or minimize total cost (including dete i rment).

p.10. The term "may" throughout the paper should be reserved to ind permissive actions.

To minimize collective and cumulative doses are generally contra actions.

ory p.12. It is not clear that there is a legal base for agencies to protect t unborn without loss of job security or ecomcmic penaltv to women e

workers.

p.13. The term " uptake" ratherthan " intake" appe This resolution prior to proceeding with the guidance.

p.15. Recommendation 1 should make it clear that demonstration of net benefit is not required.

the committed dose. Recommendation 2 uses annual dose while Recom

. 16) uses of precedence, is unclear. _ This ambiguity should be elimin Further the definition of effective dose equivalent is inconsistent with the definition of that term by the ICRp.

If the guidance is to be previous comments to EPA dated December 9, 198 abbreviation should be used to void confusion.

• The definition of H states that it is from external irradiation.

couldalsobeinterHIt,e.g.,fromtritium.(Alsosee~p.17line2.)

This

.p.16. The judgement that " continued annual exposure of an individual at level for substantial portions of his or her lifetime would not provide an acceptable level of protection and should be avoided" does not appear to be warranted.

It is ambigious and does not recogni:e the possible need for some skilled individuals to perform in high-exposure environ-ments.

The acceptability should be left to the judgment of the individual so long as it is within the legal limits.

by EPA in Recommendation 2 (p. 16) invite litigacion. Such judgements s

t1

.a 2-p.16. Avoiding" all uptake" as in Recommendation 3, is obviously impossibl Avoiding exposures to the extent practicable is ALARA.

Recommendation 3, with respect to monitorin In substitution of "...on a continuing basis..g, we would suggest the

" with the words "with sufficient frequency",

p.17. The admonition for agencies to establish measures by which manag can assess ALARA efforts should be left to the agencies and deleted from Recommendation 4. Limiting individual and collective dose are usually contrary results.

Since there are no collective dose limit as requirements, we believe that the emphasis shculd be on limiting individual doses.

would permit the unborn to receive higher doses than bfworkers.

p. 18. The phrase..."or known to be pregnant"... in Recommendation 6 makes impossible to implement.this guidance least ambiguous, e.g., known by w What is a " positive effort" when used as an admonition?

Workers cannot be expected to " avoid and minimize exposure" except in the most general way. The administration is only a " motherhood" statement in Recommendation 7 Recommendation 8 would require that state of the art monitoring systems be used.

We do not believe that_it is appropriate for-Federal guidance to specify continuous upgrading of monitoring systems simply because a newer inst /ument is developed.

should therefore be deleted.

The phrase "and state of the art of" It is impossible for agencies to provide the lifetime dose records

,to workers as suggested in Recommendation 8.

'This statement should be revised into two sentences wh present the intent of the recommendation.

3-t.

The notes provided to clarify application of the recommendations use and metabolic models~ developed by the ICRp.the annual limi 3, the tenn " uptake" is used rather.than " intake".However, in Recommendation calculations currently based upon the intake.terminol'ogy is in We recommend that " intake" be used.

changes have been made to accomodate them. Previous sugge Few e

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