[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]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 64, No. 151 / Friday, August 6, 1999 / Rules
and Regulations
[[Page 42823]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, hst@nrc.gov 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, 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, 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]
BILLING CODE 7590-01-P
