[Federal Register Volume 65, Number 235 (Wednesday, December 6, 2000)]
[Proposed Rules]
[Pages 76178-76179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31100]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 /
Proposed Rules
[[Page 76178]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 50
[PRM-50-62]
Changes to Quality Assurance Programs; Withdrawal of Remaining
Issues Concerning a Petition for Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking: withdrawal.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is terminating its
plans to develop a voluntary option alternative to its regulations to
allow licensees to make unilateral changes to their quality assurance
(QA) program descriptions. This action is being taken because the
petitioner, the Nuclear Energy Institute (NEI), has withdrawn the
remaining issues raised in its petition for rulemaking submitted on
June 8, 1995 (Docket No. PRM-50-62). NEI's action is related in part to
a revision dated February 23, 1999, to the Commission's regulations
that was implemented in response to the petition and provided the
industry with a reduction of unnecessary regulatory burden. The effect
of this action is that further revisions to the Commission's quality
assurance regulations are not being developed.
ADDRESSES: Copies of the petition for rulemaking, the public comments
received on the notice of receipt of the petition (60 FR 47716;
September 14, 1995), NRC's response to the petitioner, public comments
received on the direct final rule (64 FR 9029; February 23, 1999),
NRC's response to comments received on the direct final rule partially
granting the petition (64 FR 42823; August 6, 1999), the Petitioner's
letter (Accession No. ML003755305), stating that it is not necessary to
pursue further changes, and NRC's confirmation letter (Accession No.
ML003747685), pertaining to the withdrawal of the petition are
available for public inspection or copying for a fee in the NRC Public
Document Room (PDR), One White Flint North, Room O-1F21, 11555
Rockville Pike, Rockville, Maryland 20852. These documents are also
available for perusal at the NRC's rulemaking website http://ruleforum.llnl.gov. Questions or comments regarding this website should
be directed to Carol A. Gallagher at 301-415-5905 or [email protected].
FOR FURTHER INFORMATION CONTACT: Michael T. Bugg, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001, telephone 301-415-3221, e-mail [email protected].
SUPPLEMENTARY INFORMATION:
Background
By letter dated June 8, 1995, NEI petitioned the NRC to amend its
regulations controlling changes to nuclear power plant licensee QA
programs. The petition was received by the Commission on June 19, 1995,
and assigned Docket No. PRM-50-62. The petitioner requested that the
NRC modify 10 CFR 50.54(a) to permit a nuclear power plant licensee to
make a broader range of changes to its QA programs without prior NRC
approval. At the time of the petition submittal, 10 CFR 50.54(a)(3)
allowed a licensee to ``* * * make a change to a previously accepted
quality assurance program description included or referenced in the
Safety Analysis Report, provided the change does not reduce the
commitments in the program description previously accepted by the
NRC.'' NEI requested that the Commission amend this requirement to
allow a licensee to ``* * * make a change to a previously accepted
quality assurance program description included or referenced in its
Safety Analysis Report without prior Commission approval unless the
proposed change involves a change in the technical specifications
incorporated in the license or involves an unreviewed safety
question,'' consistent with the criteria of 10 CFR 50.59. According to
NEI's proposal, changes involving unreviewed safety questions (USQs)
would require NRC approval before implementation.
The Petition
NEI stated that 10 CFR 50.54(a) is sometimes interpreted by the NRC
as requiring NRC approval for any changes in the QA program, regardless
of the safety significance associated with the change. As a
consequence, there are often prolonged and sometimes unnecessary
regulatory debates about the correct interpretation of the term
``reduction in commitment.'' NEI presented the following examples of
changes that it believed could be made without the need for prior NRC
approval but that have been viewed as ``reductions in commitment,''
requiring prior NRC approval:
1. Changes in the level of approval of administrative,
implementation, or policy procedures, regardless of the safety
significance;
2. Changes in the company organization as it is described in a
licensee's original quality plan;
3. Changes in frequency for audit, review, or surveillance
activities that have minimal, if any, safety significance;
4. Adoption of a more recent national standard that may, or may
not, have been endorsed by the NRC staff, that results in a different
implementation methodology, yet fulfills the same function and achieves
the same objective as the original standard described in the QA program
description through the use of enhanced technology or other
developments; and
5. Adoption of quality processes different or more effective and
efficient than those described in a licensee's original quality plan
based on the safety significance and past operating performance.
NEI estimated that NRC review and approval of these types of
changes cost the industry in excess of $1 million per year. In
addition, NEI asserted that licensees occasionally were hesitant to
pursue QA program improvements because of the resources required for
NRC approval, even though the ultimate result would be improvements in
efficiency, quality, or safety.
NEI also noted that the NRC's main purpose for the current
requirement in 10 CFR 50.54(a) (which was adopted in 1983) was to
preclude licensees from making certain changes to QA programs without
prior NRC approval because, in the past, some QA programs had been
changed and no longer conformed to NRC regulations. NEI claimed that
its proposed approach in PRM-50-62 would still address the NRC's
concerns
[[Page 76179]]
because QA program changes would continue to be reported periodically
to the NRC as required by 10 CFR 50.71(e) as program updates, and
changes that involve a USQ or cause a change to the technical
specifications would be submitted to the NRC for approval before they
are implemented. The petitioner reiterated that this is the same
process used for change control for many other aspects of the facility
design and operation, and should be used for QA programs as well. NEI
further stated that the proposed amendment would improve the
consistency of the regulatory process and would result in increased
safety of commercial nuclear power plants through more efficient use of
NRC and industry resources.
Comments Received on the Petition
On September 14, 1995 (60 FR 47716), the NRC published a notice of
receipt of the NEI petition for rulemaking and provided an opportunity
for public comment. The document requested that public comment on eight
specific questions on critical regulatory aspects of the NEI petition.
Seventeen comment letters were received, plus one comment letter that
supplemented one of the original letters.
Eleven of the public comment letters were sent by nuclear power
plant licensees and NEI; all supported the proposed change in the
regulations. The six non-NEI/non-licensee letters were sent by
individual concerned citizens (two are currently employed in the
nuclear field); all expressed opposition to the relaxation of current
requirements that address changes in QA programs. All of the comment
letters addressed issues raised in the petition, particularly the
appropriateness of using the 10 CFR 50.59 criteria for QA program
changes.
Commission Decision
The Commission agreed with NEI that the 10 CFR 50.54(a) criteria
under which a licensee was allowed to make unilateral QA program
changes was too stringent because it prevented a licensee from making
QA program changes of minor safety significance without first obtaining
NRC approval. The Commission decided that new criteria should be
adopted to broaden the scope of changes that could be made by a
licensee without prior NRC approval. Therefore, the Commission accepted
the petition in part and issued a direct final rule (64 FR 9029;
February 23, 1999) that revised 10 CFR 50.54(a) to allow a licensee to
make additional changes to selected elements of its QA program without
having to obtain prior NRC approval. As of April 26, 1999, a licensee
is permitted to make the following types of unilateral changes to its
QA programs:
1. The use of a quality assurance standard approved by the NRC that
is more recent than the QA standard in a licensee's current QA program
at the time of the change;
2. The use of a quality assurance alternative or exception
previously approved by an NRC safety evaluation, provided that the
bases of the NRC approval are applicable to a licensee's facility;
3. The use of generic organizational position titles that clearly
denote the position function, supplemented as necessary by descriptive
text, rather than specific titles;
4. The use of generic organizational charts to indicate functional
relationships, authorities, and responsibilities, or, alternately, the
use of descriptive text;
5. The elimination of quality assurance program information that
duplicates language in quality assurance regulatory guides and quality
assurance standards to which a licensee is committed; and
6. Organizational revisions that ensure that persons and
organizations performing QA functions continue to have the requisite
authority and organizational freedom, including sufficient independence
from cost and schedule considerations, when these concerns are in
conflict with safety considerations.
Licensees shall continue to conform to the requirements in Appendix
B to 10 CFR Part 50 and 10 CFR 50.34(b)(6)(ii) and to notify the NRC of
these changes as required by 10 CFR 50.71(e). The direct final rule
provided immediate relief to licensees by clearly defining six
categories of QA program changes that do not require NRC approval prior
to implementation. On June 7, 2000, the NRC staff conducted a public
workshop to solicit feedback on the implementation of the revision to
10 CFR 50.54(a) and to gather information to determine the need for and
feasibility of developing a voluntary alternative rule based on the NEI
petition. Workshop participants acknowledged the significant burden
reduction already achieved through the 1999 revision to 10 CFR
50.54(a). As a result of the discussions at the workshop, NEI
concluded, and the NRC agreed, that a separate rulemaking on 10 CFR
50.54(a) is not needed at this time. By letter dated August 15, 2000
(Accession No. ML003755305), NEI documented its belief that ``it is not
necessary to pursue'' further changes to 10 CFR 50.54(a) related to its
petition. By letter to NEI dated September 5, 2000, the NRC staff
confirmed NEI's intent to withdraw the remainder of the 1995 petition.
In the direct final rule published on February 23, 1999 (64 FR
9029), the NRC noted that completion of the NEI petition should be
accomplished in two stages. The first stage was the immediate burden
relief of partially granting the NEI petition through the direct final
rule. The second stage proposed was a follow-on rulemaking action in
which criteria would have been developed for determining other areas in
which unilateral changes could be made by licensees without prior NRC
approval that would not negatively impact on the effectiveness of the
licensee's QA program. However, given the petitioner's belief that it
is not necessary to pursue further changes and based upon feedback from
a public workshop on the implementation of the direct final rule, the
NRC has decided not to pursue the previously planned second rulemaking.
For these reasons, the NRC finds that all outstanding issues
relating to PRM-50-62 are resolved. This completes NRC action on PRM-
50-62.
Dated at Rockville, Maryland, this 30th day of November, 2000.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 00-31100 Filed 12-5-00; 8:45 am]
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