ML20137T924
| ML20137T924 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/1999 |
| From: | Boger B NRC (Affiliation Not Assigned) |
| To: | Meyers D NRC OFFICE OF ADMINISTRATION (ADM) |
| References | |
| FRN-64FR9029, RULE-PR-50 TAC-M88651, NUDOCS 9906210170 | |
| Download: ML20137T924 (8) | |
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m i s 1:
c Juhe 16, -1999 MEMORANDUM TO: - David L Mey:rs, Chlaf Rules cnd Dir:ctives BrEnch
~ Office of Administration' Originali signed by: IBruce A. Boger
' FROM:
- Bruce A. Bogst, Director Division of 1ns pection Program Management :
Office of Nuclear Reactor Regulation
~
SUBJECT:
FEDERAL REGISTER NOTICE RESPONSE TO COMMENTS ON THE 10 CFR 50.54(a) DIRECT FINAL RULE (TAC NO. M88651)
A direct final and parallel proposed ruls for 10 CFR 50.54(a) concerning control of changes to quality assurance (QA) programs was published in the Federal Register (64 FR 90?9) on February 23,-1999 :The direct final rule amends the Commission's regulations to permit power reactor licensees to implement certain -QA program changes without obtaining prior NRC
< approval of these changes, its the Federa/ Register notice for the direct final rule, the
. Commission stated that the direct final rule would become effective on April 26,1999, unless a significant adverse comment was received by March 25,1999. Based on the nature of the public comments received, the staff has determined that no significant adverse comments were submitted.. The O'fice of the General Counsel (OGC) has reviewed the comments and has no legal objections to the determination that none of the submittals is considered a significant adverse comment.~ The Generic Issues, Er:vironmental, Financial and Rulemaking Branch is
' also in agreement with the determination thet no significant adverse comments were received.
Consistent with past practice, a Federa/ Register notice has been prepared that summarizes the public comments received, reports the NRC's determination that they are not considered to
.be "significant adverse" comments, and addresses questions raised in the comments. The comments are summarized and the NRC; responses to the comments are stated in the attached FederalRegister notice.
Attachment:
As stated -
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CONTACT: L Richard P. McIntyre h
(301) 415-3215 rpm 1@nrc. gov
~ DISTRIBUTION:
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Central File 3 IQMB R.F.
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- See previous concurrence :
DOCUMENT NAME: G:\\lOMBTDraft\\bugg\\ Comments on 54.54(a) Direct Final Rule for Federal Register Notice.wpd To receive a copy, Indicate in the box: "C* = Copy wit 1out attachment "E" = Copy with attachment "N" = No copy OFFICE lOMB OIPM NRR E
IQMR DIPM NRR E
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NAME MTBuno'
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DATE 0,5/($ /99 OFFICE OGC E
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NAME' STreby* ew me,s ee BABoger -
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0*V11/99 OFFICIAL RECORD COPY EN2086 9906210170 990616 CF SUBJ t
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[7590-01-P]
NUCLEAR REGULATORY COMMISSION 10 CFR Part 50 RIN: 3150-AG20 Changes to Quality Assurance Programs: Responses to Comments on Direct Final Rule AGENCY:
Nuclear Regulatory Commission.
ACTION:
Notice; responses to comments on the direct final rule.
SUMMARY
- The Nuclear Regulatory Commission issued a direct final rule that amends the Commission's regulations 'o permit power reactor licenses to implement certain quality assurance (QA) program changes without obtaining prior NRC approval of these changes. The direct final rule became effective on April 26,1999, because the NRC did not receive any significant adverse comments in response to an identical proposed rule which was concurrently published in the Federa/ 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 notice.
FOR FURTHER INFORMATION CONTACT: Harry S. Tovmasslan, 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, rpm 1@nrc. gov.
SUPPLEMENTARY INFORMATION: On February 23,1999 (64 FR 9029), the Nuclear Regulatory Commission published in the Federa/ Register a direct final rule amending 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 9025). The direct final rule became effective on April 26,1999, since 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 lette s are available for public inspection and copying for a fee at the NRC Public Document Room at 2120 L Street, NW, Washington, D.C.
Comments were received 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 pertaided 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 responses to the questions in the comment, and the NRC's determination that the comment is not a significant adverse comment, are discussed below:
1 1
- 1. Comment. We endorse this rulemaking effort and support promulgation 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 l
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 stendards, 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?
. _-__---_A
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. In response, it is the NRC's position 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 Q.A 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 3
commitment to reference a "non-programmatic" QA standard approved by the NRC, 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 CFR 50.54(a)(3)(i) of the direct final rule, the Commission allows later editions of QA standards currently referenced in a licensee's OA 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 CFR Part 50 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 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. In response, it is the NRC's position that under Section 50.54(a)(3)(i), a licensee may use later editions of QA standards pursuant to Section 50.54(a)(3)(i) only if the NRC explicitly approved th? later edition of the QA standard. NRC 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
-4 a
report (SER), in which case the limitations and conditions stated in the plant-specific or topical L_
report must be followed; 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 OA program to use a later standard under Section 50.54la)(3) on the basis that the change did not constitute a
" reduction in commitment." According!y, a second licensee could not use the later edition of a QA standaro pursuant to Section 50.54(a)(3)(i). Nor could that licensee use the later standard under Section 50.54(a)(3)(ii) since the first licensee's change did not involve an NRC safety
- evaluation and approval.
- 5. Comment. The first and only page of a seF-described two-page submittai 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 peneralin nature as some were written in the
- 1970s and 1980s, and 2) the o(her 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 11RC is unable to contact the commenter to inquire about the substance of the comments.
Based on the information' submitted, it is unclear whether the commenter was simply asking if v
the_ rule permits the use of older QA standards approved by the NRC Assuming, however, that the submittal was suggesting that the direct final rule should be medified to prohibit licensees
( o
b Efrom using an SER issued in the 1970s when a facility received its originallicense, the NRC i disagrees with the comment. Section 50.54(a)(3)(ii) allows licensees to adopt any QA
'altemative or exception approved by an NRC safety evaluation,'provided that the bases of the -
i NRC approval are applicable to the licensee's facility. Licensees may use alternatives or L exceptions, approved for a facility during issuance of the c' dng licenses, provided that the
- bases of the NRC approval are applicable.- Alternatives and exceptions approved in SERs were Japproved 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. Based on the above, the NRC is not treating this as a significant adverse
' comment.-
- 6. Comment; The NRC should cons,ider clarifying or correcting the direct final rule, 10 CFR 50.54(a)(4)(ii), with respect to the required content of submitted letters requesting NRC
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review of proposed reductions in QA program descriptions. Although tne comment may not be directly related to the specific changes that are proposed, it is directly related to the correct i functioning of the rule being changed.
f Response. The comment is not directly related to the specific changes that are proposed, as recognized by the commenter. Therefore, the NRC does not consider this to be a significant. -
$ II E:
adverse comment on the direct final rule, and will not take any action at this time to addr. ss this issue.' However, the NRC is attempting to develop a performance based option to 10 CFR
=
- 50.54(a). During th'e development of the performance-based option, the NRC will carefully consider this issue.-
- Dated at Rockville, Maryland, this day of June 1999.
For the Nuclear Regulatory Commission.,
Annette L. Vietti-Cook, Secretary of the Commission w
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