[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Rules and Regulations]
[Pages 42823-42824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20267]



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  Federal Register / Vol. 64, No. 151 / Friday, August 6, 1999 / Rules 
and Regulations  

[[Page 42823]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 50

RIN 3150-AG20


Changes to Quality Assurance Programs: Responses to Comments

AGENCY: Nuclear Regulatory Commission.

ACTION: Direct final rule: Responses to comments.

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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 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, [email protected] or 
Richard P. MyIntre, Office of Nuclear Reactor Regulation, U.S. Nuclear 
Regulatory Commission, Washington, D.C. 20555-0001; telephone, 301-415-
3215; e-mail, [email protected].

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, Washington, 
DC.
    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 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. 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 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 final 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 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 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 Sec. 50.54(a)(3)(i), a licensee may use later editions of QA 
standards under Sec. 50.54(a)(3)(i) only if the NRC explicitly approved 
the later edition of the QA

[[Page 42824]]

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 
limitations and conditions stated in the plant-specific or topical 
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 QA program to use a later standard under Sec. 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 Sec. 50.54(a)(3)(i). Nor could that 
licensee use the later standard under Sec. 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 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 prohibit licensees from using 
an SER issued in the 1970s when a facility received its original 
license, the NRC 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 CFR 50.54(a)(4)(ii), with respect to the required 
content of submitted letters requesting NRC 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 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 
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, MD, this 2nd day of August, 1999.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 99-20267 Filed 8-5-99; 8:45 am]
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