ML20210Q289
| ML20210Q289 | |
| Person / Time | |
|---|---|
| Issue date: | 08/02/1999 |
| From: | Vietticook A NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-64FR9030, FRN-64FR9035, RULE-PR-50 NUDOCS 9908160001 | |
| Download: ML20210Q289 (7) | |
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DOCKET NUMBER
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PROPOSED RULEN 9 (6VfRfoso) 00CHE7EC "
n' yr[7590-01-P]
(HFR9035)
NUCLEAR REGULATORY COMMISSIOg py, -3 o 4 52 l
10 CFR Part 50 RIN: 3150-AG20 p.
Changes to Quality Assurance Programs: Responses to Comments l
AGENCY: Nuclear Regulatory Commission. l ACTION: Direct final rule: Responses to comments.
SUMMARY
- The Nuclear Regulatory Commission (NRC) 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 i
NRC did not receive any significant adverse comments in response to an identical proposed rule that was concurrent!y published in the Federa/ Register. The public comments received, the NRC's reasons for determining that the comments P.fe 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. Tovmasslan, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001; telephone, 301-415-3092; e-mail, hstOnrc. gov or Richard P. Mylntre, Offico of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washbgton, D.C. 20555-0001; telephone, ,
301-415-3215; e-mail, rpm 1 Onrc. gov. -i g ig ^{ ulk .
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SUPPLEMENTARY INFORMATION: %
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On February 23,1999 (64 FR 9029), the NRC published a direct final ru.' in the Federal 4
Register that amended its regulations to permit power reactor licensees to impien ont 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 orior 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, Washington, D.C.
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The NRC received comments from six respondents, comprising three power reactor 1 licensees, one industry group, and two anonymous sources. Three of the commenters either i
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 explict?ly 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.1 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:
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' 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 l direction. We have reviewed the comments submitted separately by the Nuclear Energy j Institute (NEI) on behalf of the nuclear industry and endorse those comments. Therefore, we l;
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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 qua!ity assurance standards, such as the American National Standards institute (ANSI) standard N45.2 and its daughter standards, endorsed by NRC regulatory quia. However, a licensee may have referred to othe d'd codes or standards in its OA program, either as primary references or approved I
altamatives, 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?
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Resmitse. The comment does not directly or indirectly oppose the direct %nal rule (and therefore does not constitute a significant adverse comment), but rather asks a question. The NRC'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 NRC, which is .aore recent than the "non-1 programmatic" QA standard in the licensee's OA program at the tir.'e of the change, is not considered to be a reduction in commitment.
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- 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 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 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. The NRC's position is that under $50.54(a)(3)(i), a licensee may use later editions of QA standards urder $50.54(a)(3)(i) only if the NRC explicitly approved the 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 report (SER), in which case the 9
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limitations and conditions stated in the plant-specific or topical report must be follewed; 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 $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 OA 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 ,
1 1970s and 1980s, and 2) the other public comments provided in early March at the information I
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conference [ Regulatory information Conference in March 1999) addresses my other issues."
Response. The envelope containing the letter, which was addressed to the " Chief, j Quality Assurance and Vendor inspection," did not have a name or a retum address.
Therefore, the NRC 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 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 p,vtiibit licencess from using an SER issued in the 1970s when a facility received its n
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. original license, the NHC disagrees with the comment. Secta 50.54(a)(3)(ii) allows licensees to adopt any QA attemative 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 altematives or exceptions approved for a facility during issuance of the operating licenses, provided that the bases of the NRC approval are applicable. Altematives 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.
G. Comment. The NRC should consider 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 review of proposed reductions in OA 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 NRC 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 I
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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. j l
Dated at Rockville, Maryland, this 2* day of August,1999.
1 For the Nuclear Regulatory Commission. '
a6 tK '
nneIte'L. Vietti-Cook, Secretary of the Commission.
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