ML20211A914

Recommends Publication of Fr Notice Re Backfit Analysis for Proposed Rev to 10CFR20 Concerning Radiation Protection,For Public Comment.Notice Should State Only Tentative Conclusions Re Conformance of Rev to Backfit Rule

ML20211A914
Person / Time
Issue date:	05/19/1986
From:	Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
TASK-RINV, TASK-SE SECY-86-048A, SECY-86-48A, NUDOCS 8606110409
Download: ML20211A914 (35)

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May 19, 1986 SECY-86-48A For: The Commissioners From: Victor Stello, Jr.

Executive Director for Operations

Subject:

BACKFIT ANALYSIS FOR PROPOSED REVISION OF 10 CFR PART 20

Purpose:

To respond to Commissioners' comments and questions on SECY-86-48 and to provide a revised draft backfit analysis.

Category: This paper addresses a major policy issue.

Issue: Should the draft backfit analysis for the 10 CFR Part 20 revision be published for public comment?

Background:

On January 9, 1986, the NRC published a notice of proposed rulemaking containing a proposed complete revision of 10 CFR Part 20, the Commission's regulations for radiation protection.

This proposed revision was prepared by the staff prior to the adoption of the revised "backfit rule" 650.109 which was published on September 20, 1985. The Commission approved the publication for comment of the proposed 10 CFR Part 20 subject to the condition that a backfit analysis would be prepared for the Part 20 analysis. A draft backfit analysis for 10 CFR Part 20 was forwarded to the Commission on February 7,1986 (SECY-86-48). This paper is in response to the Commissioners' ccmments and suggested revisions to that draft backfit analysis.

Discussion: Enclosure 1 provides a summary of individual Commissioner comments on SECY-84 48 and the staff's proposed resolution or the location of the staff's response. Enclosure 2 is a revised Federal Register notice containing a revised draft backfit analysis. Enclosure 3 is an annotated version of this Federal Register Notice indicating where revisions or changes to the SECY-86-48 version have been made.

Contact:

K. R. Goller, RES 42-74350 0(($d IlGb4k YW

l 2 Several of the Commissioners' concerns can be addressed under the two questions posed by Commissioner Asselstine:

1. To what extent can qualitative factors be considered in doing cost-benefit analyses?

As stated in NRC Manual Chapter 0514,* "A qualitative assessment of benefits may be made in lieu of quantitative analysis where it would provide more meanirgful insights, or is the only analysis practicable." Section 50.109(a)(3), for example, re-quires that direct and indirect costs of implementation of the "backfit" be justified in view of the increased protection. It does not require a direct numerical cost-benefit analysis using the cost of implementation and a quantified measure of "in-creased protection." In areas involving dose reductions, a value such as $1,000 per person-rem could be used to establish criteria for allowing the backfit. The Part 20 Regulatory Analysis (Enclosure 2 to SECY-86-48) estimates initial imple-mentation costs of $33 million and annual costs of $7.8 million, roughly one-third of which is associated with power reactors.

Quantifying all of the costs and benefits that might be associated witn this proposed action or some other NRC actions is probably beyond the current state of the art and efforts to improve this quantization would require extensive staff resources.

Furthermore, qualitative factors may be extremely important, even the overriding considerations for or against an action.

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2. Does the staff's analysis support, with or without the qualitative factors, a determination that the proposed rule's benefits outweigh the costs and that the proposed rule will result in a substantial improvement in safety?

The staff does not believe that the Part 20 revision will provide a " substantial" change in the radiation dose received by workers and members of the public. While dose limits in the present and proposed Part 20 are, for the most part, similar, it should be noted that the regulatory effort is directed toward assessing and controlling dose well within the limits. To do this the NRC staff generally employs biological models, methods of assessment and protection concepts which are reflected in the proposed Part 20 revision rather than those that formed the bases of the current 25-year-old Part 20 .

• Manual Chapter 0514, "NRC Program for Management of Plan Specific Backfitting of Nuclear Power Plants," (February 1986), page 13.

3 There are, however, some changes in the Proposed Part 20 which affect the degree of radiation protection provided. Much of the value of the revision would lie in updating the NRC regu-lations to reflect advances in risk assessment methodology so that the regulations are compatable with current methodology, such as the " effective whole body dose" (summation of risk-weighted organ doses), and in updating the radionuclide intake limits in Appendix B to reflect advances in dosimetry and the understanding of radionuclide uptake and metabolism since the last complete revision of Part 20 was issued in 1960. Compared with the present Appendix B, 65% of the limits would be higher (less restrictive), 26% would be lower, and 8% would remain about the same. Of particular importance would be the large reductions in the intake limits for most of the alpha radiation emitters -- now considered to be more hazardous. For those limits which would increase, the staff does not foresee immediate licensee actions that would raise actual exposures, such as removing glove boxes; however, the limits might be reflected in later design decisions.

There would be a reduction in the upper dose limit for occu-pational exposure from the 12 rems per year (3 rem per quarter) in the present Part 20 to 5 rems per year in the proposed revision. Between 200-400 workers in NRC licensed activities are exposed oach year in excess of 5 rems. Thus only about 0.5% of all workers exceed the 5 rem / year limit, so that the potential population dose reduction would be small. Although some exposures above 5 rem / year will be permitted under the

" Planned Special Exposure Provisions" (Section 20.206 of the proposed rule), the overall doses are expected to be reduced because of the additional constraints in the proposed rule placed upon the use of the " Planned Special Exposures."

The dose limit for the embryo / fetus would be reduced from 9 rem (3 rem per quarter - external only) to 0.5 rem (external plus internal). For an individual embryo / fetus this dose reduction could be significant. However, only a fraction of the worker population is female and only a small fraction of that population is pregnant at any given time, so that the collective dose saving would be relatively small. Due to the effectiveness of ongoing licensee ALARA programs, which include recognition of the radiosensitivity of the embryo / fetus, the overall effect of reducing this limit might not be considered to be " substantial".

Extremity dose limits would be reduced from 75 rems per year to 50 rems per year. However, dose limits for skin and the lens of the eye would be increased (30 to 50 rems per year for the skin; 5 to 15 rems per year for the lens). These changes are not highly significant with regard to increased or decreased risks of radiation-induced health effects.

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4 The proposed reduction in the level of exposure of a member of the general oublic from a limit of 500 millirems per year to a reference level of 100 millf rem per year would be primarily for consistency with the ICRP recomendations. The levels for most radionuclide releases are already limited by EPA's 40 CFR Part 190 for gaseous and liquid effluents from nuclear power reactors and fuel cycle facilities and for airborne effluents from other licensed activities by the Clean Air Act (40 CFR Part 61) to 25 millirem per year whole body dose. Therefore, the apparent 500 to 100 millirem reduction would, in practice, only limit liquid effluents from non-fuel cycle facilities, and these do not currently come close to the 100 millirem level. Hence, it is not possible to say unequivocally that there would be a substantial improvement in health protection for offsite individuals.

As to whether the benefits outweigh the costs, the answer is not obvious. The non-quantifiable factors involve issues that the staff cannot evaluate in terms of dollars. For example, what is the value of relying upon up-to-date nuclide intake limits rather than the more than 25-year-old recommendations now believed to be inaccurate or out of date? What is the value of setting exposure limits that include consideration of the total of both internal and external dose? What is the public health importance of lower limits which specifically protect the embryo / fetus? What are the advantages of having scientifically up-to-date regulations in consonance with those in other countries and current risk assessment methodolcgy?

These are more than just " housekeeping" factors. For example, international assessment of dose, characterization of biological consequences and initiation of protective actions resulting from the Chernobyl reactor accident are based on scientific knowledge, models and dose parameters reflected in the proposed Part 20 rather than the out of date current rule.

International agreement regarding standards also affects inter-national shipments of radionuclides and other areas of inter-national commerce, but it would be extremely difficult, if possible at all, to quantify these benefits in monetary terms.

Finally, it should be noted that, for radiological events that have occurred in recent years, the staff employs up-to-date

information to assess consequences and impose corrective actions rather than continuing to use the methodology under-lying the Present Part 20. The value of having a rule which reflects what the staff is doing to provide adequate protec-

• tion and which could increase public understanding is difficult to quantify.

It is the staff's belief that the new Federal guidance on occupational radiation protection (developed under EPA leader-

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5 ship and to be issued by the President) will have to be imple-mented by the NRC in some way. The proposed Part 20 is not the only method by which this implementation could be accomplished.

However, at this stage of development, the proposed Part 20 rule would seem to be the most efficient and timely method for NRC to firplement the EPA guidance. Taking all factors, quanti-tative and qualitative, into consideration, it is the staff's judgement that the benefits of promulgating the proposed 10 CFR Part 20 would outweigh the costs.

Recommendation: The staff rect wends that the Comission approve publication of the FRN, which includes the draft backfit analysis, (Enclosure 2) for public coment and state only " tentative" decisions regarding the cost-benefit balancing and conformance of the proposed Part 20 to the "Backfit Rule" pending receipt of public comments on these issues.

Note:

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1. The attached Federal Register notice has been modified in accordance with Commissioners' specific coments, including requesting public input on the issues of whether the Part 20 revision provides a " substantial increase in the overall

. protection of the public health and safety" and whether the non-quantitative factors would outweigh the requirement for a

" substantial increase in the overall protection of the public health and safety."

2. Since the Proposed Revision to 10 CFR Part 20 already has been published for public comment, the Comission's decision on whether to publish this FRN for public comment will have a direct effect on continuing the rulemaking.

3. Because of requests from the public and the nonavailability of the backfit analysis, the staff recently submitted to the Comission a recommendation that the comment period for the proposed Part 20 be extended to September 12, 1986. The FRN for that extension commits to having at least 60rdays of con-current coment period on the proposed rule and the draft backfit analysis. If necessary, this will be provided by further extending the September 12, 1986, date for the proposed

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Victor Stello, Jr.

Executive Director for Operations

Enclosures:

1. Sumary of Commissioner Coments

2. Revised Draft Federal Register flotice

3. Annotated FRN Showing Changes

• Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Thursday, June 5, 1986.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Thursday, May 29, 1986, with an infor-mation copy to the Office of the Secretary. If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

DISTRIBUTION:

Commissioners OGC OPE OI OCA OIA OPA REGIONAL OFFICES EDO ELD ACRS ASLBP ASLAP SECY 4

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ENCLOSURE I 4

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SUMMARY

OF COMMISSIONERS' COMMENTS ON SECY-86-48 A. Chairman Palladino's Comments

1. FR Notice should make clear that the backfit analysis incorporates the regulatory analysis [Done - revised FRN page 4]

2. Questions in first paragraph, Part II, whether procedural changes do not also need to be prioritized. [ clarified, page 4 of revised FRN]

3. First and last sentence of Part III are vague ("may become"....

...would apparently...") [ Rewritten and condensed, pages 9-10].

How does this affect decision? [ Area on which public comment is solicited FRN, page 11-12].

4. Should not the FRN contain a finding of " substantial increase in overall protection" and does the backfit analysis provide a basis for such finding? [ Addressed on page 2 of Commission paper and revised FRN page 11 .

5. Are additional factors (1) - (4) on page 12 " relevant and material" to the implementation or suspension of Section 50.109(a)(3)? As requested, staff has modified the issues on which public comments are being solicited on whether other factors permit suspension of 550.109. [#(4) on page 12 of FRN].

6.

What factorspublic (3) andhealth and12 (4), page safety 3rd and[ objectives supportitems 4th unnumbered the "need" on of revised page 11], or are they simply housekeeping factors? [ Addressed in Commission paper, in answer to Question 2, page 4, 1 2]

7. Revise request for comment issues, page 12, as follows:

(a) Whether the Ccmmission has adequately implemented Section 50.109 for purposes of the proposed Part 20 amendments; [Done, item

1. (2) on page 12 of revised FRN.]

(b) Whether, because of other factors which support the proposed Part 20 revision, the application of Section 50.109(a)(3) should be suspended for this rulemaking so that the proposed amendment can be adopted without regard to whether or not the Commission makes the determination called for in that Section. [Done-item #(4) on page 12 of revised FRN]

8. Specific comments written onto the backfit analysis:

(a) Take out ". . .or orders. . ." in Summary, page 1. New or modified staff positions are also included, but it is rot necessary to include them in this notice. [ Dane]

(b) Page 2, 3rd and 4th line under B, same ccmment as page 1. Take out " order or rule..." and change " additional" to " amended."

Enclosure 1

Add "...for such backfits..." to last line of 1st paragraph under B. [Done]

B. Commissioner Roberts' Comments

1. Backfit rule requires showing substantial increase of safety and cost

! justification. [ Addressed on page 2 of Commission paper and page 11 of revised FRN]

2. It the Commission wants to preserve the option of issuing the rule despite a negative backfit analysis, the soundness and rationale of that option should be presented for public comment. [ Item #4 i on page 12 of revised FRN requests public comemnt on this issue]

) 3. Personally believes benefits of proposed rule are not sufficient to override backfit requirements.

4. Since level of protection is not being changed, would wait until EPA guidance is issued.

C. Commissioner Asselstine's Comments Raises issues on:

a. Extent to which qualitative cost-benefit factor can be considered.

[ Addressed in Commission paper, Question 1 p. 2]

b. Whether staff analysis supports rule by cost-benefit and safety considerations with, or without qualitative factors. [Addressedin Commissionpaper, Question 2,p.2-4]

D. Commissioner Bernthal's Comments

1. Agrees with Commissioner Roberts that backfit analysis does not justify issuance of 10 CFR Part 20. Although he did not support the backfit rule insofar as application to the NRC's own rulemakings, he feels NRC must follow it now and cannot impose regulations that do not meet the cost-benefit requirements.

2. Is concerned that the complexity of the rule as written may, in fact, be a source for even greater worker exposure in the long run.

3. If the Commission publishes the " proposed rule" as is, he will have additional views on the adequacy of compliance with the backfit rule, E. Commissioner Zech's Comments Factors other than the backfit analysis are most persuasive. FRN should l indicate that Part 20 may be revised on basis of these factors alone, and public comment should be solicited on this possibility. [ Cone-#(4)on page12ofrevisedFRN]

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Enclosure 1 l

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ENCLOSURE 2 .

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NUCLEAR REGULATORY COMMISSION PARTS 19, 20, 30, 31, 32, 34, 40, 50, 61, AND 70 STANDARDS FOR PROTECTION AGAINST RADIATION; AVAILABILITY OF SUPPLEMENTAL INFORMATION AGENCY: Nuclear Regulatory Comission.

ACTION: Proposed rule; availability of supplemental information.

StIMMARY: On January 9,1986, the Nuclear Regulatory Comission published for public comment a proposed revision of its radiation protection standards, 10 CFR Part 20. If implemented, that rule would require changes in the radiation protection procedures at nuclear power reactors and other NRC-licensed activities. Section 50.109 of the Comission's regulations requires that a backfit analysis be prepared for proposed NRC regulations that require changes to operating procedures for nuclear power reactor facilities licensed by the Comission under 10 CFR Part 50.

This notice provides such an analysis for the proposed revision of 10 CFR Part 20 and solicits public coment on it.

DATES: Coments on this backfit analysis must be submitted in writing on or before (enter September 12,1986 or 60-days after publication date, whichever is later). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments filed on or before this date. The coment period for the proposed Part 20 revision will end on this same date, thereby providing at least 60 days of concurrent coment period.

ADDRESSES: Submit written comments or any other information concerning this matter to the Secretary of the Ccamission, U.S. Nuclear Regulatory 1

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Comission, Washington, DC 20555, Attention: Docketing and Service Branch. Copies of the proposed revision of 10 CFR Part 20 and the accompanying Regulatory Analysis that supports this Backfit Analysis may be examined, and copied for a fee, at the Commission's Public Document Room at 1717 H Street, NW, Washington, DC. Single copies of these documents may be obtained from the person indicated under the "FOR FURTHER INFORMATION CONTACT" heading.

I FOR FURTHER INFORMATION CONTACT: Robert E. Alexander, Division of Radiation Programs and Earth Sciences, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Telephone (301) 427-4370.

SUPPLEMENTARY INFORMATION:

I. BACKGROUND A. Part 20 Revision The Commission's primary standards governing radiation protection requirements for its licensees are given in 10 CFR Part 20. -The original Part 20 was issued on January 29, 1957 (22 FR 548). Although about 100 amendments to 10 CFR Part 20 have been made since that time, this is the first complete revision of these regulations in over 25 years. This revision will bring the Commission's radiation protection standards into accord with current recommendations of the International Commission on Radiological Protection (ICRP). The revision is also consistent with

" Radiation Protection Guidance to Federal Agencies for Occupaticaal Exposure," which has been prepared for the signature of the President l

under the leadership of the Environmental Protection Agency.

On March 30, 1980, the Commission published an Ar'vance Notice of Proposed '

Rulemaking (45 FR 18023) announcing its . initiation of a rulemaking proceeding for the purpose of updating its radiaticn protection standards. The notice described in detail the' elements being-considered l for incorporation into the proposed rule and solicited public comrent 2

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thereon. About 70 responses were received in response to this notice.

In addition, numerous meetings were held between the cognizant NRC staff members preparing the revision and groups associated with States, unions, the nuclear industry, licensees, public interest groups, radiation protection organizations, and other Federal agencies. On December 20, 1985, the Commission published a proposed revision of Part 20 in the Federal Register (50 FR 51992). A corrected version was published in the Federal Register on January 9, 1986 (51 FR 1092). There is an ongoing public coment period on the proposed rule.

B. The Backfit Rule On September 20, 1985, the Commission published a final rule (50 FR

! 38097), commonly called the "backfit rule" (10 CFR 50.109), which sets forth requirements on imposing new or amended requirements on nuclear te power reactor facilities licensed by the Comission under 10 CFR Part 50.

This regulation sets forth the following requirements, among others:

1. (550.109(a)(2)) "The Comission shall require a systematic and documented analysis pursuant to paragraph (c) of this section for backfits which it seeks to impose..."

2. (550.109(a)(3)) "The Comission shall require the backfitting of a facility only when it determines, based upon the analysis described in paragraph (c) of this section, that there is a substantial increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit t and that the direct and indirect costs of implementation for that facility are Justified in view of the increased protection."

s In order'to reach this determination, 550.109(c) sets forth certain factors that are to be considered in the backfit analysis. These factors and the acccmpanying analyses are presented in Section II of this notice.'

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4 II. DRAFT BACKFIT ANALYSIS The proposed revision to 10 CFR Part 20 is not anticipated to require physical modification to nuclear power reactors (or other licensed facilities). However, the definition of a "backfit" in 950.109(a)(1) includes the modification of or addition to the procedures or organi-

! zation required to design, construct or operate a nuclear power reactor facility. Even though the Part 20 rule is applicable to all NRC licensees and therefore is broader in scope than the "Backfit Rule,"

it would result in the need for revisions in the operating procedures dealing with radiation protection at nuclear power reactor facilities licensed under 10 CFR Part 50 and, consequently, a backfit analysis is to be performed for power reactor facilities.

Paragraph 50.109(c) requires consideration of the priority and scheduling of the action under consideration in light of other regulatory activities.

Implementation of the proposed revision of 10 CFR Part 20 should not significantly affect any other backfits or safety-related activities.

In order to minimize the impact of the retraining and revisions of procedures, the proposed implementation period of the Part 20 revision extends over a five-year period. Therefore the changes required to implement the Part 20 revision would not conflict with and do not need to be further prioritized with respect to other activities at nuclear power plants.

Paragraph 50.109(c) of the backfit rule also sets forth certain factors which are to be considered in the backfit analysis. These factors ar.d l how the proposed Part 20 revision relates to each are summari ed below.

These summary statements are based on the Regulatory Analysis which describes the anticipated benefits and anticipated costs that would be associated with the implementation of the proposed revision, were it to be adopted. This Regulatory Analysis is the primary source of the estimates of the benefits and the impacts described in this draft backfit analysis and is incorporated as part of this draft backfit analysis. Copies of the Regulatory Analysis are available for inspection 4

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e in the Public Document rocm (see addresses) and single copies are available from the NRC staff contact.

1. Statement of Specific Objectives to be Achieved The proposed revision of 10 CFR Part 20 is intended to:

a. Update the quarter-century-old 10 CFR Part 20 to incorporate advances in science and new concepts of radiation protection methodology and philosophy;

b. Implement pending Federal Radiation Guidance on occupational radiation protection;

c. Implement the principal current dose-limiting recommendations of the ICRP;

d. Incorporate the ICRP " effective dose equivalent" concept;

e. Update the limits on airborne radionuclide intakes, effluent releases and doses from inhaled or ingested radionuclides using up-to-date metabolic models and dose factors; and

f. Require that licensees have prcgrams for keeping radiation exposures "as low as is reasonably achievable" (ALARA).

2. General Description of the Actions to be Reouired of the Licensee or Applicant The principal new or additional actions that would be required of licensees by the proposed 10 CFR Part 20 revisions are to:

a. Sum, under some circumstances, the estimated dose from radionuclides external to the body and frcm radionuclides deposited in the body; 5

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b. If not previously done, provide documentation of programs for l keeping exposures "as low as is reasonably achievable"; j l

c. Provide increased protection for the embryo / fetus when female workers declare themselves pregnant;

d. Employ the latest ICRP limits on airborne radionuclide intakes, effluent releases and doses from inhaled or ingested radionuclides; and

e. Modify training guides, operating procedures, and manuals to incorporate the new concepts and requirements and provide retraining of employees on these concepts and their implementation.

3. Change in the Risk to the Public from Accidental Off-Site Release of Radioactive Material 10 CFR Part 20 generally applies only to normal off-site releases of radioactive material, so there would be no direct impact on risks associated with accidental releases of radioactive materials.

4. Potential Imoact on Radiological Exposure of Facility Employees The principal impact of the revision would be to assure significantly better and more up-to-date worker protection. The added protection results from the following:

a. The limit for annual worker dcses would be 5 rems (effective whole-body dose) per year. Workers are permitted to receive 12 rems per year (3 rems per quarter) under the current Part 20 providing that the worker's average dose does not exceed 5 rems per year. Between 200 and 400 workers receive more than 5 rems per year under the existing rule. The Part 20 revision would provide for Planned Special Exposures which would alicw worker 6

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doses to exceed 5 rems per year, but only under very stringently controlled conditions.

b. The worker dose limit for extremities would be reduced from 75 to 50 rems per year.

c. A limit would be placed on the dose to the embryo / fetus. There is currently no specific limit in the NRC regulations to protect the embryo / fetus,

d. Allowable intakes of radionuclides would be based upon the latest radiobiological, metabolic, and dosimetric data. For a number of radionuclides the intake limits would be lowered.

e. Doses would be limited by considering both internal and external radiation doses added together rather than evaluating them separately as allowed by the present rule,

f. Dose limits would be expressed as the sum of organ doses weighted by the comparative biological risk of the organ.

These limits would therefore be based on a better characterization of the predicted biological effect on the body organs.

g. More effort would be required of some licensees to formulate and implement programs to keep worker exposures "as low as is reasonably achievable" (ALARA).

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5. Installation and Continuing Costs, Including the Cost of Facility l

Downtine or the Cost of Construction Delays There should be little or no costs associated with facility downtime or construction delays. The Part 20 changes apply primarily to operational procedures and should cause only minor revisicns, if any, in facility design or in shielding. The initial and annual costs associated with various previsions in the revisicn are 7

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discussed and analyzed in the Regulatory Analysis and are summarized in the notice of proposed rulemaking (51 FR 1121). The total estimated costs for all affected licensees are $33 million for initial implementation and $7.8 million additional costs per year thereafter. Of these amounts, a $13.1 million initial cost and

$2.5 million annual cost are estimated to apply to nuclear power reactors. These costs may be reduced as a result of the five-year implementation period mentioned in the proposed revision.

6. Potential Safety Impact of Changes in Plant or Operational Complexity, Including Relationships to Proposed and Existing Regulatory Requirements Any safety impacts and changes in plant ccmplexity would be negligible, since the proposed rule should not entail changes in

,_ plant design. Some of the proposed changes could increase operational complexity. However, once the new procedures are fully implemented they are expected to beccme routine.

The impact of modifying operating procedures, manuals, and records would be minimized by a five-year implementation period during which licensees may develop the necessary new procedures, manuals, and

- records and convert to the new system at any time most convenient to the licensee.

7. The Estimated Resource Burden on the NRC and the Availability of These Resources 3 Costs to the NRC would primarily be associated with the preparation

! of new regulatory guides for implementing the new procedures ana revising existing regulatory guides, branch technical positions, and inspection procedures to reflect the Part 20 revisions. It has been y

estimated that this effort would consist of 5 to 7 new regulatory

guides requirinf 0.2 staff-years per guide or 1 to 1.4 staff-years

totalandappro{imately$350Koftechnicalsupporteffort. At least seven existing regulatory guides would reouire revision, resulting 8

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in an additional staff-year of effort. It is estimated that approximately one staff-year would be required in both the Office of Nuclear Material Safety and Safeguards (NMSS) and the Office of Nuclear Reactor Regulation (NRR) to modify license conditions and technical specifications to comply with the proposed revision.

The largest impact in NRC would be in the Office of Inspection and Enforcement and the NRC Regional Offices to revise inspection procedures and to train inspectors on the new regulations and procedures. It is estimated that this would require about 5 staff-years total. Once the new procedures are in place, there should not be any significant resource expenditures above current levels.

These impacts would be spread over the 5-year implementation period.

For this reason and the fact that the impact would be distributed over several NRC offices, the Part 20 implementation should not have a major impact on NRC programs.

8. Potential Imoact of Differences in Facility Type, Design, or Age on the Relevancy and Practicality of the Proposed Action Since the proposed revisions principally affect operating procedures rather than facility physical design, there would be no significant impact from differences in facility type, design or age.

9. Are the Proposed Revisions Interim or Final and if Interim, What is the Justification for Imoosing Them on an Interim Basis The proposed rule, with modifications, is intended to be issued as a final rule.

Other Factors The Environmental Protection Agency, in cooperation with NRC and other Federal Agencies, has prepared revised Federal guidance on radiation 9

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protection for workers. This guidance, if approved by the President, would greatly influence the formulation of occupational radiation protection standards. The proposed Part 20 modifications would implement the new guidance. If the Part 20 revision are not adopted, NRC regu-lations would not be consistent with the new Federal guidance and the regulations of other Federal Agencies.

Conclusion The proposed revisions will provide improved public health protection by virtue of:

Limiting routine annual occupational doses to.5 rems and deleting the present 5(N-18) formula option which allows doses up to 12 rems per year; Imposing a limit on radiation doses to the embryo-fetus. (No specific limit exists in the present Part 20 for the embryo-fetus);

Updating the radionuclide intake limits based upon current scientific data, including substantially lower limits for several radionuclides such as uranium. (Part 20 now relies upon more than 25-year-old methodology and information);

Providing limits for the combined doses frem both internal and external radiation sources. (The current Part 20 permits the evaluations to be done separately);

Incorporating the " effective dose" concept whereoy organ doses are weighted by their relative health risk and summed to give a risk-equivalent dose. (The current Part 20 uses the " critical organ" concept and does not consider doses to organs other than the critical organ in setting allowable limits on radionuclide intake);

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Requiring licensees to develop and implement a program and procedures for keeping radiation exposures "as low as is reasonably achievable" or "ALARA." (Except for LWR effluent releases subject to Appendix I of 10 CFR Part 50, the present regulations exhort the licensee to keep radiation exposures "ALARA", but do not make this a requirement.)

In spite of these expected improvements, the Commission's analysis does not show unequivocally that the direct and indirect costs of imple-mentation are justified in view of the increased protection. However, the Commission believes that there are additional relevant and material factors not amenable to quantitative cost ccmparisons and having signifi-cant bearing on this issue, including:

Incorporation of updated Presidential guidance on radiation protection; Consistency with international standards, particularly with regard to international commerce.

Updating the technical basis for the Part 20 limits; and Consistency of the methods and technical approaches for radiation protection regulations and those for current risk assessment methodologies.

The Commission has tentatively concluded, pending consideration of public ccmments, that when all factors, qualitative as well as quantitative, are taken into consideration, the benefits to be derived from the proposed revision of Part 20 justify the direct and indirect costs of its implementation. Therefore, the rule should be promulgated even though it may not provide a substantial increase in the overall protection of the public health and safety or the common defense and security.

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III. REQUEST FOR C0fGENTS The Commission solicits public comment on:

t .

(1) The draft Backfit Analysis for the proposed revision of Part 20; (2) Whether the Commission has adequately implemented $50.109 as it applies to the proposed Part 20 revision; (3) Whether the proposed revision of 10 CFR Part 20 would provide a k substantial increase in the overall protection of public health and safety that will justify the direct and indirect costs of implementing this rule; and (4) Whether, because of other factors which support the proposed Part 20 revision, the application of Section 50.109(a)(3) should be '

\

suspended for this rulemaking if it is found that the proposed amendments do rot meet the criteria in that section.

Dated at Washington, DC this ___ day of , 1986.

For the Nuclear Regulatory Commission.

Samuel S. Chilk, Secretary of the Commission 12

9 ENCLOSURE 3 i

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M.H9WuP wiTH cth wes Meg sa=c y'- % - yg , g;ve wu,y, 4 NUCLEAR REGULATORY COMMISSION m/he p .

PARTS 19, 20, 30, 31, 32, 34, 40, 50, 61, AND 70 h"b 7he e sa-fr0fMe n e htx STANDARDS FOR PROTECTION AGAINST RADIATION; AVAILABILITY OF SUPPLEMENTAL INFORMATION AGENCY: Nuclear Regulatory Comission.

ACTION: Proposed rule; availability of supplemental information.

SUMMARY

On January 9,1986, the Nuclear Regulatory Comission published for public comment a proposed revision of its radiation protection standards, 10 CFR Part 20. If implemented, that rule would require changes in the radiation protection procedures at nuclear power reactors and other -gense gigit g . j e, ctg g 0 if9 g ge mission's yg regulation 3 gu q t a backfit nalysisbe rpagd, gpg regulationsfttat reqdTre changes to operaYdhroce$ures for nucTear_ ~

dg e jdl I

g power reactor facilities licensed by the Comission under 10 CFR Part 50.$

co# This notice provides such an analysis for the proposed revision of 10 / Nee CFR Part 20 and solicits public comment on it. ffheWed)

- DATES: Comments on this backfit analysis must be submitted in writing on or before (enter September 12,1986 or 60-days after publication date,whicheverislater). Coments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments filed on or before this date. The coment period for the proposed Part 20 revision will end on this same date. thereby providino at least 60 days of concurrent coment period t ADDRESSES: Submit written comments or any other information concerning this matter to the Secretary of the Commission, U.S. Nuclear Regulatory 1

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Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Copies of the proposed revision of 10 CFR Part 20 and the accompanying Regulatory Analysis that supports this Backfit Analysis may be examined, and copied for a fee, at the Commission's Public Docur.ent Room at 1717 H Street, NW, Washington, DC. Single copies of these documents may be obtained from the person indicated under the "FOR FURTHER INFORMATION CONTACT" heading.

FOR FURTHER INFORMATION CONTACT: Robert E. Alexander, Division of Radiation Programs and Earth Sciences, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Telephone (301) 427-4370.

fW p4/ SUPPLEMENTARY INFORMATION:

I. BACKGROUND A. Part 20 Revision The Commission's primary standards governing radiation protection requirements for its licensees are given in 10 CFR Part 20. The original Part 20 was issued on January 29, 1957 (22 FR 548). Although about 100 amendments to 10 CFR Part 20 have been made since that time, this is the first complete revision of these regulations in over 25 years. This revision will bring the Commission's radiation protection standards into accord with current recommendations of the International Commission on Radiological Protection (ICRP). The revision is also consistent with

" Radiation Protection Guidance to Federal Agencies for Occupational Exposure," which has been prepared for the signature of the President under the leadership of the Environmental Protection Agency.

On March 30, 1980, the Commission published an Advance Notice of Proposed Rulemaking (45 FR 18023) announcing its initiation of a rulemaking proceeding for the purpose of updating its radiation protection standards. The notice described in detail the elements being considered for incorporation into the proposed rule and solicited puolic ccmment 2

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thereon. About 70 responses were received in response to this notice.

In addition, numerous meetings were held between the cognizant NRC staff members preparing the revision and groups associated with States, unionsA the nuclear industry, licensees, public interest groups, radiation -

protection organizations, and other Federal agencies. On December 20, /,

1985, the Commission published a proposed revision of Part 20lin the g Federal Register (50 FR 51992). A corrected version was published in the Federal Register on January 9, 1986 (51 FR 1092). There is an

[ M 4 M4 q ongoing public coment period on the proposed rule, fe 7 h /7%]

/

> l~ BAN Cept y yg (p B. The Backfit Rule Y

ft"F pt(,OnSeptember 20, 1985, the Commission published a final rule (50 FR W p 38097), comonly called the "backfit rule" (10 CFR 50.109), wh chgp g

'forth requirements o igos/n ew og amegdg g u g gs jo nuc)_ ear g.j,,

ghe# power reactor fkcNities fi[ensed by the Comission under 0 Firt50. ~

g4 This regulation sets forth the following requirements, among others:

44M i [ 7 (650.109(a)(2)) "The Commission shall require a systematic and f,1.

pr1 documented analysis pursuant to paragraph (c) of this section for backfits which it seeks to impose..."

T 3

2. (650.109(a)(3)) "The Commission shall require the backfitting of a facility only when i etemin based upon the analysis described R,/df.gs, in paragraph (c) of s section, ) that there is a substantial I

increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit and that the direct and indirect costs of implementation for that l

facility are justified in view of the increased protection."

1 In order to reach this determination, 650.109(c) sets forth certain factors that are to be considered in the backfit analysis. These factors and the accompanying analyses are presented in Section II of l

this n_otice. [ mv Gr) i l

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(#k 't 3 0 ifEvsstcQ 3 II. DRAFT BACXFIT ANALYSIS -

l The proposed revision to 10 CFR Part 20 is not anticipated to require priysical modification to nuclear power reactors (or other licensed .-~ ' ,

j { facilities). However, the definition of a "backfit" in 650.109(a)(1) 4 includes the modification of or addition to the procedures or organi-g zation required to design, construct or operate a nuclear power reactor g facility. Even though the Part 20 rule is applicable to all NRC '

licensees and therefore is broader in scope than the "Backfit Rule,"

f it would result in the need for revisions in the operating procedures dealing with radiation protection at nuclear power reactor facilities licensed under 10 CFR Part 50 and, consequently, a backfit analysis is to be performed for power reactor facilities.

Le-w.yu /unuar ro f a.isMV[

Paragraph 50.109(c) requires consideration of the priority and scheduling ~

h of the action profconsiderat Impie[n'tN$n t5e koN r on ig 1pht vision obbFR of ot4rjgulatory PartN sNd ap[ities.

n significantly affect any other backfits or safety-related activities. j

[ g In order to minimize the impact of the retraining and revisions of ..]

procedures, the proposed implementation period of the Part 20 revision -

extends over a five-year period. Therefore the changes required to implement the Part 20 revision would not conflict with and do not need to be further prioritized with respect to other activities at nuclear power plants.

Paragraph 50.109(c) of the backfit rule also sets forth certain factors which a{e to be considered in the backfit analysis. These factors and hcw the proposed Part 20 revision relates to each are sumariped gloy. g /

These sumary statements are based on the Regulatory Analysi which describes the anticipated benefits and anticipated costs that would be associated with the inclementation of the crocosed revision. were it to be adooted. This Reculatorv Analysis is the crimary source of the b estimates of the benefits and the imoacts described in this draft j T

Q $ ;[ _backfit analysis and is incorocrated as cart of this draft backfit c>/dg7. analysis.}CooiesoftheReculatoryAnal_ysisareavailableforinspection

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in the Public Document room (see addresses) and single cooies are available from the NRC staff contact.

1. Statement of Soecific Objectives to be Achieved The proposed revisior 10 CFR Part 20 nterided to:

a. Update the quarter-century-old 10 CFR Part 20 to incorporate advances in science and new concepts of radiation protection methodology and philosophy;

b. Implement pending Federal Radiation Guidance on occupational radiation protection;

c. Implement the principal current dose-limiting recommendations ofthe(ICRl);

bhfa] ts w ad c. m.w w a 44 Apulinhes Q -

d. Incorporate the ICRP " effective dose equivalent" concept;

e. Update the limits on airborne radionuclide intakes, effluent releases d doses from inhaled or ingested radionuclides usingup' pan metabolic models and dose factors; and

-to-date

f. Require that licensees have programs for keeping radiation exposures "as low as is reasonably achievable" (ALARA).

2. General Description of the Actions to be Reouired of the Licensee or Applicant The principal new or additional actions that would be required of licensees by the proposed 10 CFR Part 20 revisions are to:

a. Sum, under some circumstances, the estimated dose from radionuclides external to the body and from radionuclides deposited in the body; 5

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.jef4 < b. If not previously done, provide documentation of programs for keeping exposures "as low as is reasonably achievable";

ed .

a[ c. Provide increased protection for the embryo / fetus when female workers declare themselves pregnant;

d. Employ the latest ICRP limits on airborne radionuclide intakes, 8g effluent releases and doses from inhaled or ingested radionuclidesy'

e. Modify traininq guides, operating p ocedures, and manuals to incorporate the new concepts and requirements and provide retraining of emplcyees on these concepts and their implementation.

3. Change in the Risk to the Public from Accidental Off-Site Release of Radioactive Material 10 CFR Part 20 generally applies only to normal off-site releases of radioactive material, so there would be no direct impact on risks teri is O f* d d Ped W/

of fa,e mg , + W ex,cocu a sociated et s*vd with accidental +/ &kof r Nadi /E~tiv relebses <* l/le N A kkr M e,r,4, reg po;gh & me ceasespe ut uct #uecrm s% X.T Mof A *,4+ Wy~sweF&644 gjgQ *. Potential Imoact on Radiological Exposure of Facility Employees Nc /.a, v 4

] The principal impact of the revision would be to assure

~

significantly better and more up-to-date worker protection. The added protection results from the following:

a. The limit for annual worker doses would be 5 rems (effective whole-body dose) per year. Workers are permitted to receive 12 rems per year (3 rems per quarter) under the current Part 20 providing that the worker's average dose does not exceed 5 rems per year. Between 200 and 400 workers receive more than 5 rems per year under the existing rule. The Part 20 revision would provide for Planned Special Exposures which would allcw worker I

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doses to exceed 5 rems per year, but only under very stringently

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b.

controlledfcnitions[/wh The worker dose limit f extremities would be reduced from 75 to 50 rems per year,

c. A limit would be placed on the dose to the embryo /fatus. There pg is currently no specific limitlin tne hRC regulationsQprotect the embryo / fetus.

d. Allowable intakes of radionuclides would be based upon the latest radiobiological, metabolic, and dosimetric data. For fred) a number of radionuclides the intake limits would be lowered.

e. Doses would be limited by considering both internal and external radiation doses added together rather than evaluating them separately as allowed by the present rule,

f. Dose limits would be expressed as the sum of organ doses weighted by the comparative biological risk of the organ.

These limits would therefore be based on a better characterization of the predicted biological effect on the body organs.

g. More effort would be required of some licensees to formulate and implement programs to keep worker exposures "as low as is reasonably achievable" (ALARA).

i

5. Installation and Continuing Costs, Including the Cost of Facility l

Downtime or the Cost of Construction Delays There should be little or no costs associated with facility dcwntime or construction delays. The Part 20 changes apply primarily to operational procedures and should cause only minor revisions, if any, in facility design or in shielding. The initial and annual costs associated with various provisions in the revision are l

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discussed and analyzed in the Regulatory Analysis and are summarized in the notice of proposed rulemaking (51 FR 1121). The total estimated costs for all affected licensees are $33 million for initial implementation and $7.8 million additional costs per year thereafter. Of these amounts, a $13.1 million initial cost and

${.5 million annual cost are estimated to apply to nuclear power reactnes, _These costs may be reduc.ed as a result of the five-year jmplementation period mentioned in the proposed revision.

6. Potential Safety Impact of Changes in Plant or Operational Comple,sity, Including Relationships to Proposed and Existing Regulatory Requirements Any safety impacts and cnanges in plant complexity would be negligible, since the proposed rule should not entail changes in plant design. Some of the proposed changes could increase operational complexity. However, once the new procedures are fully implemented they are expected to become routine.

The impact of modifying operating procedures, manuals, and records would be minimized by a five-year implementation period during which licensees may develop the necessary new procedures, manuals, and records and convert to the new system at any time most convenient to the licensee.

7. The Estimated Resource Burden on the NRC and the Availability of These Resources Costs to the NRC would primarily be associated with the preparation of new regulatory guides for implementi1g the new procedures and revising existing regulatory guides, branch technical positions, and inspection procedures to reflect the Part 20 revisions. It has been estimated that this effort would consist of 5 to 7 new regulatory l guides requiring 0.2 staff-years per guide or 1 to 1.4 staff-years total and approximately S350K of technical support effort. At least seven existing regulatory guides wculd require revision, resulting l

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in an additional staff-year of effort. It is estimated that approximately one staff-year would be required in both the Office of Nuclear Material Safety and Safeguards (NMSS) and the Office of Nuclear Reactor Regulation (NRR) to modify license conditions and technical specifications to comply with the proposed revision.

The largest impact in NRC would be in the Office of Inspection and Enforcement and the NRC Regional Offices to revise inspection procedures and to train inspectors on the new regulations and procedures. It is estimated that this would require about 5 staff-years total. Once the new procedures are in place, there should not be any significant resource expenditures above current levels.

These impacts would be spread over the 5-year implementation period.

For this reason and the fact that the impact would be distributed over several NRC offices, the Part 20 implementation should not have a major impact on NRC programs.

8. Potential Impact of Differences in Facility Type, Desian, or Age on the Relevancy and Practicality of the Proposed Action Since the proposed revisions principally affect operating procedures rather than facility physical design, there would be no significant impact from differences in facility type, design or age.

9. Are the Proposed Revisions Interim or Final and if Interim, What is the Justification for Imposing Them on an Interim Basis The proposed rule, with modifications, is intended to be issued as a final rule.

% . Other Factorsc. n . e c m , u n ., t u ~ s .e M f<w e e em e s .t? e yew r r+rh The Environment i Q ro cowsrst%ttcyIinc$pe}r!ti[n$tnN M on an $her #

Federal Agencies, has prepared revised Federal guidance on radiation A

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[",a , led ' mi,ntatea 12eN H M*pnw/3 h

• protection for workers. This guidance, if ap+ pro,v. e v the President, would greatly influence the formulation of occupational radiation protection standards. The proposed Part 20 modifications w impleme t J the guidance If the t 20 revision ,vd are t adopted, w ra.

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la ons would not consist nt wit t e new Fe eral ou;r tdan a requlations of other Federal Agencies. g c

Conclusion J The proposed revisions will provide improved public health protection by virtue of:

Limiting routine annual occupational doses to 5 rems and deleting the present 5(N-18) formula option which allows doses up to 12 rems per year; Imposing a limit on radiation doses to the embryo-fetus. (No specific limit eaists in the present Part 20 for the embryo-fetus);

Updating the radionuclide intake limits based upon current scientific data, including substantially lower limits for several radionuclides such as uranium. (Part 20 now relies upon more than 25-year-old methodology and information);

Providing limits for the ccmbined doses from both internal and external radiation sources. (The current Part 20 permits the evaluations to be done separately);

Incorporating the " effective dose" concept whereby organ doses are weighted by their relative health risk and summed to give a risk-eouivalent dose. (The current Part 20 uses the " critical organ" concept and does not consider doses to organs other than the critical organ in setting allcwable limits on radionuclide intake);

and 10

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Requiring licensees to develop and implement a program and procedures for keeping radiation exposures "as low as is reasonably achievable" or "ALARA." (Except for LWR effluent releases subject to Appendix I of 10 CFR Part 50, the present regulations exhort the ,

licensee to keep radiation exposures "ALARA", but do not make this a

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/>spite

.ss&of these Mhg y )j i~f extecieT)impro,ve,.,f, f *y f* ft,' 'P' 4,/%-

In ments. H [mdisQsi 's' analysis does not show unequivocally that the direct and indirect costs of imple-mentationgre justified in view of the increased protection. However, theCobiss n believes that there are additional relevant and material factors not amenable to quantitative cost comparisons and having signifi-cant bearir.g on this issue, including:

[fht att hbnfltMen/0 (d

• Incorocration of undatad Presidential guidance on radiation protection; (N* Consistency with international standards, particularly with regard to international comerce.

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S C Un<ed Sf'[77pe yg gg_sgi W ed o e.t ANow/W Updating the t chnical basis for the Part 20 limi s; and h Consistency of the methods and technical aporoaches for radiation protection regulations and those for current risk assessment methodologies. [ The e O/**ry M We M add ec.4 w)s s-( # p/2 4 t C h ld,t e kJ e v r- 8CJ.]

The Comihission has tentatively concluded, pendina consideration of oublic l

comments, that when all factors, cualitative as well as cuantitative, are l

taken into consideration, the benefits to be derived from the proposed r,evision of Part 20 justify the direct and indirect costs of its .

l imolementation. Therefore, the rule should be promulgated even though it may not orovide a substantial increase in the overall protection of the Dublic health and safetv or the common defense and security.

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9 III. REQUEST FOR COMMENTS The Commission solicits public comment on:

(1) The draft Backfit Analysis for the proposed revision of Part 20; YC4dMaml (y)(2) Whether the Commission has adequately implemented 650.109 as it applies to the proposed Part 20 revision; [a-/MG[.v.

Onnt (3) Whether the ornnosed revision of 10 CFR Part 20 wnold -avide a 7 [4) substantial increase in the overall protection of public health and safety that will justify the direct and indirect costs of implementing this rule; and g Whether, because of other factors which support the proposed Part 20 (pvision, the application of Section 50.109(a)(3) should be suspended fcr this rulemaking if it is found that the proposed amendments

}

do not neet the criteria in that section.

, 1986. '

Dated at Washington, DC this _ day of  ;

For the Nuclear Pegulatory Comission.

Samuel S. Chilk, Secretary of the Commission den Q d A//4,Y

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