ML23159A113

PR-050 - 64FR09035 - Changes to Quality Assurance Programs

ML23159A113
Person / Time
Issue date:	02/23/1999
From:	Annette Vietti-Cook NRC/SECY
To:
References
PR-050, 64FR09035
Download: ML23159A113 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 02/23/1999 TITLE: PR-050 - 64FR09035 - CHANGES TO QUALITY ASSURANCE PROGRAMS CASE

REFERENCE:

PR-050 64FR09035 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PR-050 (64FR09035)

In the Matter of CHANGES TO QUALITY ASSURANCE PROGRAMS DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

02/19/99 02/17 /99 FEDERAL REGISTER NOTICE - PROPOSED RULE 03/15/99 03/11/99 COMMENT OF NUCLEAR ENERGY INSTITUTE (ANTHONY R. PIETRANGELO, DIR. LIC.) ( 1) 03/24/99 03/23/99 COMMENT OF NORTHEAST NUCLEAR ENERGY CO. & NORTH ATLANTIC (TED C. FEIGENBAUM, EXEC. VP & CNO) ( 2) 03/25/99 03/23/99 COMMENT OF GARY BEATTY ( 3) 03/25/99 03/24/99 COMMENT OF VERMONT YANKEE (GAUTAM SEN) ( 4) 04/12/99 03/31/99 COMMENT OF PECO ENERGY COMPANY (GARRETT D. EDWARDS, DIRECTOR, LIC.) ( 5) 08/03/99 08/02/99 FEDERAL REGISTER NOTICE - DIRECT FINAL RULE:

RESPONSES TO COMMENTS

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10 CFR Part 50 RIN : 3150-AG20 Changes to Quality Assurance Programs: Responses to Comments AGENCY: Nuclear Regulatory Commission.

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ACTION: Direct final rule: Responses to comments.

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SUMMARY

The Nuclear Regulatory Commission (NRG) issued a direct final rule that amends the Commission's regulations to permit power reactor licensees to implement certain quality assurance (QA) program changes without obtaining prior NRC approval of these changes. The NRC did not receive any significant adverse comments in response to an identical proposed rule that was concurrently published in the Federal Register. The public comments received, the NRC's reasons for determining that the comments are not significant adverse comments,

• and responses to questions raised in the comments are discussed in this document.

EFFECTIVE DATE: The direct final rule became effective April 26, 1999.

FOR FURTHER INFORMATION CONTACT: Harry S. Tovmassian, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001; telephone, 301-415-3092; e-mail, hst@nrc.gov or Richard P. Mylntre, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001; telephone, 301-415-3215; e-mail, rpm1@nrc.gov.

SUPPLEMENTARY INFORMATION:

On February 23, 1999 (64 FR 9029), the NRC published a direct final rule in the Federal Register that amended its regulations to permit power reactor licensees to implement certain quality assurance (QA) program changes without obtaining prior NRC approval of these changes. The NRC also concurrently published an identical proposed rule on February 23, 1999 (64 FR 9035). The direct final rule became effective on April 26, 1999, because no significant adverse comments were received by March 25, 1999. This direct final rule modifies 10 CFR 50.54(a) to provide six QA programmatic areas within which changes to the QA program will not be considered reductions in commitments and subject to prior NRC approval.

Copies of the comment letters are available for public inspection and copying for a fee at the NRC Public Document Room at 2120 L Street, NW, Wa<::hington, D.C.

The NRC received comments from six respondents, comprising three power reactor licensees, one industry group, and two anonymous sources. Three of the commenters either supported or had no objections to the direct final rule. Two commenters asked for a clarification or interpretation of the direct final rule, and did not explicitly object to the direct final rule. One commenter's issue pertained to sections of 10 CFR 50.54(a) that were not being changed by the direct final rule. The NRC does not consider any of the comments to be a significant adverse comment. Each of the NRC's res9onses to the questions in the comment, and the NRC's determination that the comment is not a significant adverse comment, are discussed below:

1. Comment. We endorse this rulemaking effort and support promulgatior. of the final rule.

Response. No response necessary.

2. Comment. This rule change represents a small step, but certainly in the correct direction. We have reviewed the comments submitted separately by the Nuclear Energy Institute (NEI) on behalf of the nuclear industry and endorse those comments . Therefore , we have no adverse comments on the direct final rule.

Response. No response necessary.

3. Comment. It is clear from the section-by-section analysis that 10 CFR 50.54(a)(3)(i) of the direct final rule is intended to apply to programmatic quality assurance standards, such as the American National Standards Institute (ANSI) standard N45.2 and its daughter standards, endorsed by NRC regulatory guides. However, a licensee may have referred to other national codes or standards in its QA program , either as primary references or approved alternatives, that contain specific QA guidance although they are not endorsed by regulatory guides. Are non-programmatic QA standards intended to come under the purview of 10 CFR 50.54(a)(3)(i) of the direct final rule if earlier editions are presently included by reference in a licensee's approved QA program?

Response. The comment does not directly or indirectly oppose the direct'tinal rule (end therefore does not constitute a significant adverse comment), but rather asks a question. The NRG's position is that the direct final rule does not distinguish between "programmatic" and "non-programmatic" QA standards included by reference in the QA program described or referenced in the safety analysis report. Therefore, "non-programmatic" QA commitments contained in the approved QA program fall within the purview of 10 CFR 50.54(a)(3)(i) of the direct final rule. Under the direct final rule, revising an existing commitment to reference a "non-programmatic" QA standard approved by the NRG, which is more recent than the "non-programmatic" QA standard in the licensee's QA program at the time of the change, is not considered to be a reduction in commitment .

4. Comment. In 10 GFR 50.54(a)(3)(i) of the direct final rule, the Commission allows later editions of QA standards currently referenced in a licensee's QA program to be adopted by that licensee if they have been found to be acceptable by the NRC with respect to the requirements of 10 GFR Part 50, Appendix 8. Does inclusion of a later edition by reference in a licensee's approved licensing bases constitute acceptance by the NRC tor adoption by another licensee under the direct final rule 10 CFR 50.54(a)(3)(i)?

Response. The comment does not directly or indirectly oppose the direct final rule (and therefore does not constitute a significant adverse comment) , but rather asks a question. The NRC's position is that under §50.54(a)(3)(i), a licensee may use later editions of QA standards under §50.54(a)(3)(i) only if the NRG explicitly approved the later edition of the QA standard.

NRG approval consists of: (1) endorsement in a regulatory guide; (2) approval of a plant-specific or topical report by the issuance of a safety evaluation report (SER), in which case the

limitations and conditions stated in the plant-specific or topical report must be foltowed; and (3) approval by issuance of an SER for a license amendment changing the QA program, in which case the limitations and conditions stated in the SER must be followed.

By contrast, there is no NRC approval if a licensee unilaterally changes its QA program to use a later standard under §50.54(a)(3) on the basis that the change did not constitute a "reduction in commitment." Accordingly, a second licensee could not use the later edition of a QA standard under §50.54(a)(3)(i). Nor could that licensee use the later standard under

§50.54(a)(3)(ii) because the first licensee's change did not involve an NRC safety evaluation and approval.

5. Comment. The first and only page of a self-described two-page submittal was received from a commenter stating, "My main issues deal with not having the rule to address the use of old safety evaluations that may be general in nature as some were written in the 1970s and 1980s, and 2) the other public comments provided in early March at the information conference [Regulatory Information Conference in March 1999] addresses my other issues."

Response. The envelope containing the letter, which was addressed to the "Chief, Quality Assurance and Vendor Inspection," did not have a name or a return address.

Therefore, the NRC is unable to contact t~e commenter to inquire about the substance of the comments. Based on the information submitted, it is unclear whether the commenter was simply asking if the rule permits the use of older QA standards approved by the NRC.

However, assuming that the submittal was suggesting that the direct final rule should be modified to prohibit licensees from using an SER issued in the 1970s when a facility received its original license, the NHC disagrees with the comment. Section 50.54(a)(3)(ii) allows licensees to adopt any QA alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility. Licensees may use alternatives or exceptions approved for a facility during issuance of the operating licenses, provided that the bases of the NRC approval are applicable. Alternatives and exceptions approved in SERs were approved in the context of the entire QA program. In all cases, it is the licensee's responsibility to ensure that the QA program as revised contains all elements that formed the bases of the NRC approval of alternatives or exceptions so that compliance with Appendix B to 10 CFR Part 50 is maintained. Therefore, the NRC does not consider this a significant adverse comment.

6. Comment. The NRC should consider clarifying or correcting the direct final rule, 10 GFR 50.54(a)(4)(ii), with respect to the required content of submitted letters requesting NRG review of proposed reductions in QA program descriptions. Although the comment may not be directly related to the specific changes that are proposed, it is directly related to the correct functioning of the rule being changed .

• Response. The comment is not directly related to the specific changes that are proposed, as recognized by the commenter. Therefore, the NRG does not consider this to be a significant adverse comment on the direct final rule and will not take any action at this time to address this issue . . However, the NRC is attempting to develop a performance-based option to 10 CFR 50.54(a). During the development of the performance-based option , the NRC will carefully consider this issue .

Dated at Rockville, Maryland, this 2n° day of August, 1999.

For the Nuclear Regulatory Commission.

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(in;fte l.'fietti-Cook, Secretary of the Commission .

Station Support Department PECO NUCLEAR PECO Energy Company 965 Chesterbrook Boulevard A Unit of PECO Energy *co Ar~ Wayne, PA 19087-5691 I/

'" r r,iv.*43 March 31 , 1999 OCKET NUMBER PROPOSED RULE.PR 50

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Mr. John C. Hoyle Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

Comments Concerning Direct Final Rule and Proposed Rule 10 CFR 50, *changes to Quality Assurance Programs*

(64FR9030 and 64FR9035, dated February 23, 1999)

Dear Mr. Hoyle:

This letter is being submitted in response to the NRC's request for comments concerning the Direct Final Rule and Proposed Rule 10 CFR 50, *changes to Quality Assurance Programs, "

published in the Federal Register (i.e., 64FR9030 and 64FR9035, dated February 23, 1999).

This rulemaking will amend the regulations to allow power reactor licensees to make certain changes to their Quality Assurance (QA) programs without obtaining NRC approval of the changes in advance. Specifically, the rule will permit licensees to make routine or administrative changes that should not have an adverse impact on the effectiveness of the QA programs.

PECO Energy appreciates the opportunity to comment on this Direct Final Rule and Proposed Rule. We endorse this rulemaking effort and support promulgation of the final rule.

If you have any questions, please do not hesitate to contact us.

Very truly yours,

~~r Garrett 0. Edwards Director - Licensing

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NUCLEAR POWER CoRm .* ! °rION 185 Old Ferry Road, Brattleboro, VT 05301-7002 (ao2) 257-5271

• 99 MA 25 A11 :54 March 24, 1999 BVY99-41 Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Rulemaking and Adjudications Staff

References:

(a) Federal Register, Vol. 64, No. 35, pages 9030 through 9037, 10CFR Part 50, RlN 3150-AG-20, "Changes to Quality Assurance Programs," dated February 23, 1999.

Subject:

Vermont Yankee Nuclear Power Station License No. DPR-28 (Docket No. 50-271)

Comments Ree;ardine; Proposed Amendments to 10CFRS0.S4(a)(3}

• Pursuant to instructions in Reference (a), Vermont Yankee (VY) is submitting the following comments and questions regarding the subject rulemaking, which is scheduled to become effective on April 26, 1999.

1. It is clear from the Section-by-Section Analysis on page 9032 of Reference (a) that section 10CFR50.54(a)(3Xi) of the proposed rule is intended to apply to programmatic quality assurance standards, such as ANSI N45.2 and its daughter standards, endorsed by NRC Regulatory Guides.

However, a licensee may have referred to other national codes or standards in its Quality Assurance (QA) program, either as primary references or approved alternatives, that contain specific QA guidance although they are not endorsed by Regulatory Guides. An example in VY' s case would be ANS-22, "Nuclear Safety Criteria for the Design of Stationary Boiling Water Reactor Plants,"

which includes criteria for safety classification of plant systems and which has been superseded by ANS-52.1 , a later standard with the same title. ANS-22 was approved for this purpose by the NRC for use at VY as an acceptable alternative to adherence to Regulatory Guide 1.26.

Are such non-programmatic QA standards intended to come under the purview of section 10CFR50.54(aX3Xi) of the proposed rule if earlier editions are presently included by reference in a licensee's approved QA program?

2. Section 10CFR50.54(a)(3(i) of the proposed rule allows later editions of QA standards currently referenced in a licensee' s QA program to be adopted by that licensee if they have been found acceptable by the NRC with respect to the requirements of 10CFRS0 Appendix B.

Does inclusion of a later edition by reference in a licensee's approved licensing bases constitute acceptance by the NRC for adoption by other licensees under 10CFR50.54(a)(3Xi)? [Note that 10CFR50.54(a)(3)(ii) allows use of a QA alternative or exception approved by the NRC in a Safety Evaluation Report for another facility as long as applicability to the adopting licensee' s facility is demonstrated; however, this is not addressed in 10CFR50.54(aX3Xi)]

MAR 3 1 1999

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VERMONT YANKEE NUCLEAR POWER CORPORATION BVY 99-41\ Page 2 of2 Please direct any questions regarding this correspondence to Mr. Wayne M. Limberger at (802) 258-4237.

Sincerely, POWER CORPORATION Licensing Manager cc: USNRC Region I Administrator USNRC Resident Inspector - VYNPS USNRC Project Manager - VYNPS Vermont Department of Public Service

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~t./FR 9035 The following comment is provided in response to proposed rulemaking described in the Federal Register on February 23, 1999, Volume 64, Number 35, Pages 9035-9037. The rulemaking would revise 10 CFR 50.54(a) criteria for determining whether prior NRC approval is required when a licensee makes changes to an NRC accepted quality assurance program description. The rule would be revised to add a description of some specific types of changes that a licensee may make, which have already been considered by the NRC and determined not to be reductions in commitments. While the following comment may not be directly related to the specific changes which are proposed, it is directly related to the correct functioning of the rule being changed.

Comment:

The NRC should consider clarifying or correcting the 50.54(a)(4)(ii) with respect to the required content oflicensee's submittal letters requesting NRC review of proposed reductions in quality assurance program descriptions.

Background:

Among other things, 10 CFR 50.54(a)(4)(ii) requires that a licensee provide the basis for concluding that the revised program incorporating the change continues to satisfy (1) the criteria of Appendix B to 10 CFR 50 and (2) the SAR QA program description commitments previously accepted by the NRC.

Comment Basis:

The requirement to provide the basis for concluding that the revised program incorporating the change continues to the SAR QA program description commitments previously accepted by the NRC gives the appearance of being in conflict with the basic purpose of the rule. If the rule is being interpreted correctly, it would seem that a licensee is being asked to explain how a reduction in commitments would continue to satisfy the commitments. This would seem to exclude the possibility of justifying any reduction in commitments.

In addition, it may be inferred that the basis provided by the licensee would be used by the NRC in determining whether a proposed change is acceptable. However, the Standard Review Plan contains the complete procedure and all acceptance criteria for all areas of review pertinent to a quality assurance program description. The SRP cites Appendix B to 10 CFR 50 as the only underlying regulation pertaining to the content of a quality assurance program description. Therefore, it is unclear how any basis provided by a licensee (other than basis for satisfying Appendix B) could be applied in the NRC's review process.

Gary Beatty P.O. Box 164 ~

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DOCKETED March 24, 1999 US . F.C

• 99 HAR 25 A1 1 :54 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher 11 ,, l,t I J .ML r--'

ADM, DAS L,(µ-t-v ,,,-,,~7/ --

SUBJECT:

DOCKETING OF COMMENT ON DIRECT FINAL RULE - CHANGES TO QUALITY ASSURANCE PROGRAMS Attached for docketing is a comment letter related to the subject direct final rule. This comment was received via the rulemaking website on March 23, 1999. The submitter's name is Gary Beatty, P .O . Box 164, Shippingport, PA 15077. Please send a copy of the docketed comment to Harry Tovmassian (mail stop 01 l-F-1) for his records.

Attachment:

As stated cc w/o attachment:

H. T ovmassian

DOCKElEO North Atlantic Energy Service Corporation North - 1s* c.*c*

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P.O. Box 300 Seabrook, NH 03874 Atlantic (603) 474-9521

• 99 MAR 24 P3 :25 The Northeast Utilities System OF,-

R, .J~ March 23, 1999 ADJLI NYN-99040 AR#99002641 Ms. Annette Vietti-Cook Secretary of the Commission DOCKET NUMBER Attention: Rulemaking and Adjudications Staff PROPOSED RULE p 50 U.S. Nuclear Regulatory Commission IPLIFRqo35 11555 Rockville Pike Rockville, MD 20852 Northeast Nuclear Energy Company & North Atlantic Energy Service Company Millstone and Seabrook Nuclear Power Stations Comments on Changes to Quality Assurance Programs Direct Final Rule, Amendment to 10 CFR 50.54(a)

(64 Fed. Reg. P. 9035 - February 23, 1999)

This letter provides the Northeast Nuclear Energy Company (NNECO) and North Atlantic Energy Service Company (North Atlantic) comments on the Direct Final Rule, Changes to Quality Assurance Programs, Amendment to 10 CFR 50.54(a) (64 Fed. Reg. P. 9035 - February 23, 1999).

NNECO and North Atlantic have reviewed the comments submitted separately by the Nuclear Energy Institute (NEI) on behalf of the nuclear energy industry and endorses those comments. NNECO and North Atlantic are encouraged by the NRC action of the direct final rule which will provide greater flexibility to make selected improvements in our quality assurance programs, without prior NRC approval. Therefore, we have no adverse comments on the direct final rule.

If you have any questions regarding these comments, please contact Mr. James M. Peschel, Regulatory Compliance Manager, at (603) 773-7194.

Very truly yours, NORTH ATLANTIC ENERGY SERVICE CORP.

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and Chief Nuclear Officer il#Aft 78 199

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United States Nuclear Regulatory Commission NYN-99040 I Page 2 cc: H. J. Miller, Region I Administrator J. T. Harrison, NRC Project Manager, Project Directorate 1-2 R. K. Lorson, NRC Senior Resident Inspector, Seabrook L.L. Wheeler, NRC Project Manager, Millstone Unit No. I S. Dembek, NRC Project Manager, Millstone Unit No. 2 J. W. Andersen, NRC Project Manager, Millstone Unit No. 3 D. P. Beaulieu, NRC Senior Resident Inspector, Millstone Unit No. 2 A. C. Cerne, NRC Senior Resident Inspector, Millstone Unit No. 3

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~ ED 1C NUCLEAR ENERGY INSTITUTE

• 99 NAR 15 A9 :4 o Anthony R. Pietrangelo DIRECTOR, LICENSING NUCLEAR GENERATION orr:: ,_ n RU.

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• March 11, 1998 <.F F Secretary DOCKET NUMBER U.S. Nuclear Regulatory Commission PROPOSED RULE PR So Washington, D.C. 20555-0001 ({pt/fRCf035)

ATTENTION: Rulemaking and Adjudications Staff

SUBJECT:

Changes to Quality Assurance Programs (Amendment to 10 CFR 50.54(a)), Direct Final Rule. (64 Fed. Reg. P. 9035 February 23, 1999).

The following comments are provided by the Nuclear Energy Institute on behalf of the nuclear energy industry in response to the subject direct final rule. The industry appreciates the opportunity to provide input on this important revision to 10 CFR 50.54(a) on changes to quality assurance programs.

In the NEI petition, submitted in 1995, we indicated industry experience suggested that without being granted greater regulatory flexibility, utilities would be deterred from making improvements in their quality assurance programs. The petition spoke to the issue of accepting changes to a plant's quality assurance program predicated on the effect(s) of the changes on plant safety, and not solely on a perceived "reduction in commitment."

• The industry is encouraged that the NRC, through this direct final rule, will provide greater flexibility to make selected changes to quality assurance programs without prior NRC approval. This rule change represents a small step, but certainly in the correct direction. Therefore, we have no adverse comments on the direct final rule.

The industry looks forward to a more substantive rulemaking in the near future, going beyond the six areas addressed in this direct final rule. Specifically, the industry expects the NRC will move quality assurance requirements in a direction which will mirror the current thrust toward risk-informed, performance-based regulation. With a focus on a quality assurance program's effect (performance) relative to safety, the NRC can provide additional flexibility for the nuclear industry to maintain dynamic quality assurance programs.

Sincerely, ....

Anthony R. Pietrangelo l\cknowledged by caJ'd ._Jllaff ' 1 1999 ARP/RCE/ngs I 77 6 I STRcET. NW S UI T E 400 WAS H IN GTON DC 20006 - 3708 PHONE 2 02 739 . 8000 FAX 202 785 4 0 1 9

U.S. NUCLEAR REGULATORY COMMISSION RUlEMAKINGS &ADJUOICATD48 Slff EOFtH SECRETARY THE vvm"""°ION DccllnentStatiBllcs 3(,;l./qq ffl>

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'99 FEB 9 A9 :32 NUCLEAR REGULATORY COMMISSION 10 CFR Part 50 OF~

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RIN 3150-AG-20 CHANGES TO QUALITY ASSURANCE PROGRAMS AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRG) is proposing to amend its regulations to permit power reactor licensees to make certain quality assurance (QA) changes without obtaining NRG review and approval of these changes in advance. The proposed rule would allow licensees to make routine or administrative changes that should not have an adverse impact on effectiveness of their QA programs. This action is intended to reduce the financial and administrative burden on power reactor licensees without adversely impacting public health and safety.

/YYJ~  ;;s_, I qq 9 DATES: Comments must be received by [ifliert th0 date ao days att0r publicatioo io the ADDRESSES: Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff.

Hand-deliver comments to 11555 Rockville Pike, Maryland, between 7:30 am and 4:15 pm on Federal workdays.

2 Copies of the petition for rulemaking, the public comments received on the Federal Register Notice announcing the receipt of the petition, public comments received on this Federal Register Notice, and the NRC's response to the petitioner are available for public inspection or copying for a fee in the NRC Public Document Room (PDR), 2120 L Street, NW (Lower Level), Washington, DC.

The public may submit comments via the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc.gov). This site enables commenters to upload comments as files (any format), if their browser supports that function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, telephone (301) 415-5905, e-mail cag@nrc.gov.

Certain documents related to this proposed rulemaking, including comments received, may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower Level),

Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking.

FOR FURTHER INFORMATION CONTACT: Harry S. Tovmassian, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-3092, e-mail hst@nrc.gov.

3 SUPPLEMENTARY INFORMATION:

As a partial acceptance of a Nuclear Energy Institute (NEI) petition for rulemaking, the NRC is proposing to amend its regulations related to changes that power reactor licensees may make to their QA programs without obtaining advance NRC approval. This action is necessary because the NRC agrees with NEl's stated position that under the existing regulations many QA program changes that are administrative or routine in nature are burdensome to the industry and NRC because they constitute a "reduction in commitment" and thus require NRC staff approval prior to implementation. This proposed action will provide relief to facility licensees by specifying a number of QA program elements that may be changed unilaterally, without the need for prior NRC approval.

Because the NRC considers this action to be noncontroversial, it is publishing this Proposed Rule concurrently with a Direct Final Rule. The Direct Final Rule will become effective on [insert the date 60 days after publication in the Federal Register]. However, if the NRC receives significant adverse comment on the Direct Final Rule by [insert the date 30 days after publication in the Federal Register], then the NRC will publish a document that withdraws the Direct Final Rule. If the Direct Final Rule is withdrawn, the NRC will address the comments received in a subsequent final rule. The NRC will not initiate a second comment period on this action.

For additional information, see the Direct Final Rule published in the Rules and Regulation section of this Federal Register.

Finding of No Significant Environmental Impact

4 The Commission has determined, in accordance with the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the Proposed Rule, if adopted would not be a major action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required.

The Direct Final Rule amends NRC's regulations pertaining to changes to licensee QA programs which may be made without prior NRG approval. Under the current regulation in 10 CFR 50.54(a), licensees are permitted to make unilateral changes to their QA programs provided that the change does not reduce the commitments in the program description previously approved by the NRG. The Direct Final Rule amends CFR 50.54(a) to define six types of QA program changes, which the NRG considers to be administrative and routine, and would not be considered reductions in commitment. The effect that this rule change will have on NRG licensees is that the prior requirement for NRG approval will no longer apply to these six programmatic areas. These permitted QA programmatic changes, such as adopting NRG endorsed standards and adoption of generic organizational charts, were specifically selected because the NRG has determined that they would not adversely impact the effectiveness of the QA program. The changes that would be permitted by the rule are those which past NRG experience has shown do not result in any significant reduction in the effectiveness of the QA program as implemented by licensees. For example, correction of typographical errors, use of generic organizational charts as a substitute for more detailed charts, and elimination of duplicative language already contained in standards and guidance to which the licensee has committed cannot have any impact upon the effectiveness of the QA program. The use of a QA alternative previously approved by the staff in circumstances where the licensee has

5 reasonably determined that the basis of the NRC approval is applicable to the licensee's facility, should not significantly reduce the effectiveness of the licensee's QA program to the point where there is an unacceptable level of safety. Since proper implementation of the rule would assure that no significant reductions in the QA program will occur, the rule should have no effect on the probability of occurrence of accidents, result in the occurrence of a new accident, or change the consequences of accidents previously evaluated. For these reasons, the Commission concludes that this rule should have no significant adverse impact on the operation of any licensed facility or the environment surrounding these facilities.

The conclusion of this environmental assessment is that there will be no significant offsite impact to the public from this action. However, the general public should note that the NRC has also committed to complying with Executive Order (EO) 12898 "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations," dated February 11, 1994, in all its actions. Therefore, the NRC has also determined that there are no disproportionately high adverse impacts on minority and low-income populations. In the letter and spirit of EO 12898, the NRC is requesting public comment on any environmental justice considerations or questions that the public thinks may be related to this Proposed Rule. The NRC uses the following working definition of "environmental justice": the fair treatment and meaningful involvement of all people, regardless of race, ethnicity, culture, income, or education level with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies. Comments on any aspect of the environmental assessment, including environmental justice, may be submitted to the NRC as indicated under the ADDRESSES heading.

The NRC has sent a copy of this Proposed Rule, including the foregoing Environmental Assessment, to every State Liaison Officer and requested their comments on this assessment.

6 Paperwork Reduction Act Statement This Proposed Rule would amend information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements have been sent to the Office of Management and Budget for approval.

The burden reduction for public reporting of this information collection is estimated to average 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per response, including reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments on any aspect of this information collection, including suggestions for reducing the burden, to the Records Management Branch (T-6 F33), U.S.

Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet e-mail at bjs1@nrc.gov; and to the Desk Officer, Office of Information and Regulatory Affairs NEOB-10202, (3150-0011), Office of Management and Budget, Washington, DC 20503.

Public Protection Notification If a means used to impose an information collection does not display a currently valid 0MB control number, the NRG may not conduct or sponsor, and a person is not required to respond to, the information.

Regulatory Analysis The Commission has prepared a draft regulatory analysis on this proposed regulation.

The analysis examines the costs and benefits of the alternatives considered by the Commission. This draft regulatory analysis is available for inspection in the NRG Public

7 Document Room, 2120 L Street NW (Lower Level), Washington, DC. Single copies of the analysis may be obtained from Harry S. Tovmassian, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, telephone (301) 415-3092 or by e-mail at hst@nrc.gov.

Regulatory Flexibility Certification In accordance with the Regulatory Flexibility Act of 1980 [5 U.S.C. 605(b)], the Commission certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. This Proposed Rule affects only the licensing and operation of nuclear power plants. The companies that own these plants do not fall within the scope of the definition of "small entities" as stated in the Regulatory Flexibility Act, or the size standards adopted by the NRC (1 O CFR 2.810).

Backfit Analysis The provisions of the Proposed Rule would permit licensees to make unilateral QA program changes in several program areas but would not require them to do so. Licensees would be free to continue to seek NRC approval for QA program changes that are "reductions in commitment," as currently required in 10 CFR 50.54(a)(3), and the NRC would continue to review these requests as it has done in the past. Thus, the NRC has determined that the backfit rule does not apply to the Proposed Rule; therefore, a backfit analysis is not required because these amendments do not involve any provision that would impose backfits as defined in 10 CFR 50.109(a)(1 ).

8 List of Subjects in 10 CFR Part 50 Antitrust, Classified information, Criminal penalties, Fire protection, Intergovernmental relations, Nuclear power plant and reactors, Radiation protection, Reactor siting criteria, Reporting and record keeping requirements.

For the reasons stated in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Part 50.

PART 50- DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES

1. The authority citation for Part 50 continues to read as follows:

AUTHORITY: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 Stat. 936,937, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C.

2132, 2133, 2134, 2135, 2201, 2232, 2233, 2236, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246, (42 U.S.C. 5841, 5842, 5846).

Section 50.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951, as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851). Sections 50.10 also issued under secs. 101, 185, 68 Stat. 936, 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. L. 910190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 50.54(dd), and 50.103 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a, and Appendix Q also issued under sec. 102, Pub. L.91-190, 83 Stat. 853 (42 U.S.C.

4332). Sections 50.34 and 50.54 also issued under sec. 204, 88 Stat. 1245 (42 U.S.C. 5844).

Sections 50.58, 50.91, and 50.92 also issued under Pub. L.97-415, 96 Stat. 2073 (42 U.S.C.

9 2239). Sections 50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Sections 50.80, 50.81 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234).

Appendix Falso issued under sec. 187, 66 Stat. 955 (42 U.S.C. 2237).

2. In § 50.54 (a), paragraph (a)(3) is revised and a new paragraph (a)(4) is added to read as follows:

§50.54 Conditions of licenses.

(a) * * *

(3) Each licensee described in paragraph (a)(1) of this section may make a change to a previously accepted quality assurance program description included or referenced in the Safety Analysis Report without prior NRG approval, provided the change does not reduce the commitments in the program description as accepted by the NRG. Changes to the quality assurance program description that do not reduce the commitments must be submitted to the NRG in accordance with the requirements of §50.71 (e). In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, the following changes are not considered to be reductions in

• commitment:

(i) The use of a QA standard approved by the NRG which is more recent than the QA standard in the licensee's current QA program at the time of the change; (ii) The use of a quality assurance alternative or exception approved by an NRG safety evaluation, provided that the bases of the NRG approval are applicable to the licensee's facility; (iii) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles;

10 (iv) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text; (v) The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the licensee is committed; and (vi) Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

(4) Changes to the quality assurance program description that do reduce the commitments must be submitted to the NRC and receive NRC approval prior to implementation, as follows:

(i) Changes made to the quality assurance program description as presented in the Safety Analysis Report or in a topical report must be submitted as specified in

§50.4.

(ii) The submittal of a change to the Safety Analysis Report quality assurance program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B of this part and the Safety Analysis Report quality assurance program description commitments previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).

11 (iii) A copy of the forwarding letter identifying the change must be maintained as a facility record for three years.

(iv) Changes to the quality assurance program description included or referenced in the Safety Analysis Report shall be regarded as accepted by the Commission upon receipt of a letter to this effect from the appropriate reviewing office of the Commission or 60 days after submittal to the Commission, whichever occurs first Dated at Rockville, Maryland, this ~O~- day of February 1999.

For the Nuclear Regulatory Commission

~,c:.c:;. LUw'~-~

Annette L. Vietti-Cook Secretary of the Commission