[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]


 ========================================================================
 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petitioner, the Nuclear Energy Institute (NEI), has withdrawn the 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]
BILLING CODE 7590-01-P