[Federal Register Volume 64, Number 35 (Tuesday, February 23, 1999)]
[Proposed Rules]
[Pages 9035-9037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4396]



  Federal Register / Vol. 64, No. 35 / Tuesday, February 23, 1999 / 
Proposed Rules  

[[Page 9035]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 50

RIN 3150-AG-20


Changes to Quality Assurance Programs

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 
its regulations to permit power reactor licensees to make certain 
quality assurance (QA) changes without obtaining NRC review and 
approval of these changes in advance. The proposed rule would allow 
licensees to make routine or administrative changes that should not 
have an adverse impact on effectiveness of their QA programs. This 
action is intended to reduce the financial and administrative burden on 
power reactor licensees without adversely impacting public health and 
safety.

DATES: Comments must be received by March 25, 1999.

ADDRESSES: Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, Attention: Rulemaking and 
Adjudications Staff.
    Hand-deliver comments to 11555 Rockville Pike, Maryland, between 
7:30 am and 4:15 pm on Federal workdays.
    Copies of the petition for rulemaking, the public comments received 
on the Federal Register Notice announcing the receipt of the petition, 
public comments received on this Federal Register Notice, and the NRC's 
response to the petitioner are available for public inspection or 
copying for a fee in the NRC Public Document Room (PDR), 2120 L Street, 
NW (Lower Level), Washington, DC.
    The public may submit comments via the NRC's interactive rulemaking 
web site through the NRC home page 
(http://www.nrc.gov). This site enables commenters to upload comments 
as files (any format), if their browser supports that function. For 
information about the interactive rulemaking site, contact Ms. Carol 
Gallagher, telephone (301) 415-5905, e-mail [email protected].
    Certain documents related to this proposed rulemaking, including 
comments received, may be examined at the NRC Public Document Room, 
2120 L Street NW. (Lower Level), Washington, DC. These same documents 
also may be viewed and downloaded electronically via the interactive 
rulemaking website established by NRC for this rulemaking.

FOR FURTHER INFORMATION CONTACT: Harry S. Tovmassian, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001, telephone (301) 415-3092, e-mail [email protected].

SUPPLEMENTARY INFORMATION: As a partial acceptance of a Nuclear Energy 
Institute (NEI) petition for rulemaking, the NRC is proposing to amend 
its regulations related to changes that power reactor licensees may 
make to their QA programs without obtaining advance NRC approval. This 
action is necessary because the NRC agrees with NEI's stated position 
that under the existing regulations many QA program changes that are 
administrative or routine in nature are burdensome to the industry and 
NRC because they constitute a ``reduction in commitment'' and thus 
require NRC staff approval prior to implementation. This proposed 
action will provide relief to facility licensees by specifying a number 
of QA program elements that may be changed unilaterally, without the 
need for prior NRC approval.
    Because the NRC considers this action to be noncontroversial, it is 
publishing this Proposed Rule concurrently with a Direct Final Rule. 
The Direct Final Rule will become effective on April 26, 1999. However, 
if the NRC receives significant adverse comment on the Direct Final 
Rule by March 25, 1999, then the NRC will publish a document that 
withdraws the Direct Final Rule. If the Direct Final Rule is withdrawn, 
the NRC will address the comments received in a subsequent final rule. 
The NRC will not initiate a second comment period on this action.
    For additional information, see the Direct Final Rule published in 
this separate part of this Federal Register.

Finding of No Significant Environmental Impact

    The Commission has determined, in accordance with the National 
Environmental Policy Act of 1969, as amended, and the Commission's 
regulations in subpart A of 10 CFR part 51, that the Proposed Rule, if 
adopted would not be a major action significantly affecting the quality 
of the human environment and, therefore, an environmental impact 
statement is not required. The Direct Final Rule amends NRC's 
regulations pertaining to changes to licensee QA programs which may be 
made without prior NRC approval. Under the current regulation in 10 CFR 
50.54(a), licensees are permitted to make unilateral changes to their 
QA programs provided that the change does not reduce the commitments in 
the program description previously approved by the NRC. The Direct 
Final Rule amends 10 CFR 50.54(a) to define six types of QA program 
changes, which the NRC considers to be administrative and routine, and 
would not be considered reductions in commitment. The effect that this 
rule change will have on NRC licensees is that the prior requirement 
for NRC approval will no longer apply to these six programmatic areas. 
These permitted QA programmatic changes, such as adopting NRC endorsed 
standards and adoption of generic organizational charts, were 
specifically selected because the NRC has determined that they would 
not adversely impact the effectiveness of the QA program. The changes 
that would be permitted by the rule are those which past NRC experience 
has shown do not result in any significant reduction in the 
effectiveness of the QA program as implemented by licensees. For 
example, correction of typographical errors, use of generic 
organizational charts as a substitute for more detailed charts, and 
elimination of duplicative language already contained in standards and 
guidance to which the licensee has committed cannot have any impact 
upon the effectiveness of the QA program. The use of a QA alternative 
previously approved by the staff in circumstances where the licensee 
has reasonably determined that the basis of the NRC approval is 
applicable to the licensee's facility, should not significantly reduce 
the effectiveness of the licensee's QA program to the point where there 
is an unacceptable level of safety. Since proper implementation of the 
rule would assure that no significant reductions in the QA program will 
occur, the rule should have no effect on the probability of occurrence 
of accidents, result in the occurrence of a new accident, or change the 
consequences of accidents previously evaluated. For these reasons, the 
Commission concludes that this rule should have no significant adverse 
impact on the operation of any licensed facility or the environment 
surrounding these facilities.
    The conclusion of this environmental assessment is that there will 
be no significant offsite impact to the public from this action. 
However, the general public should note that the NRC has also committed 
to complying with Executive Order (EO) 12898 ``Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations,'' dated February 11, 1994, in all its actions.

[[Page 9036]]

Therefore, the NRC has also determined that there are no 
disproportionately high adverse impacts on minority and low-income 
populations. In the letter and spirit of EO 12898, the NRC is 
requesting public comment on any environmental justice considerations 
or questions that the public thinks may be related to this Proposed 
Rule. The NRC uses the following working definition of ``environmental 
justice'': The fair treatment and meaningful involvement of all people, 
regardless of race, ethnicity, culture, income, or education level with 
respect to the development, implementation, and enforcement of 
environmental laws, regulations, and policies. Comments on any aspect 
of the environmental assessment, including environmental justice, may 
be submitted to the NRC as indicated under the ADDRESSES heading.
    The NRC has sent a copy of this Proposed Rule, including the 
foregoing Environmental Assessment, to every State Liaison Officer and 
requested their comments on this assessment.

Paperwork Reduction Act Statement

    This Proposed Rule would amend information collection requirements 
that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.). These requirements have been sent to the Office of Management 
and Budget for approval.
    The burden reduction for public reporting of this information 
collection is estimated to average 40 hours per response, including 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
information collection. Send comments on any aspect of this information 
collection, including suggestions for reducing the burden, to the 
Records Management Branch (T-6 F33), U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by Internet e-mail at 
[email protected]; and to the Desk Officer, Office of Information and 
Regulatory Affairs NEOB-10202, (3150-0011), Office of Management and 
Budget, Washington, DC 20503.

Public Protection Notification

    If a means used to impose an information collection does not 
display a currently valid OMB control number, the NRC may not conduct 
or sponsor, and a person is not required to respond to, the 
information.

Regulatory Analysis

    The Commission has prepared a draft regulatory analysis on this 
proposed regulation. The analysis examines the costs and benefits of 
the alternatives considered by the Commission. This draft regulatory 
analysis is available for inspection in the NRC Public Document Room, 
2120 L Street NW (Lower Level), Washington, DC. Single copies of the 
analysis may be obtained from Harry S. Tovmassian, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, telephone (301) 
415-3092 or by e-mail at [email protected].

Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
605(b)), the Commission certifies that this rule will not, if 
promulgated, have a significant economic impact on a substantial number 
of small entities. This Proposed Rule affects only the licensing and 
operation of nuclear power plants. The companies that own these plants 
do not fall within the scope of the definition of ``small entities'' as 
stated in the Regulatory Flexibility Act, or the size standards adopted 
by the NRC (10 CFR 2.810).

Backfit Analysis

    The provisions of the Proposed Rule would permit licensees to make 
unilateral QA program changes in several program areas but would not 
require them to do so. Licensees would be free to continue to seek NRC 
approval for QA program changes that are ``reductions in commitment,'' 
as currently required in 10 CFR 50.54(a)(3), and the NRC would continue 
to review these requests as it has done in the past. Thus, the NRC has 
determined that the backfit rule does not apply to the Proposed Rule; 
therefore, a backfit analysis is not required because these amendments 
do not involve any provision that would impose backfits as defined in 
10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Part 50

    Antitrust, Classified information, Criminal penalties, Fire 
protection, Intergovernmental relations, Nuclear power plant and 
reactors, Radiation protection, Reactor siting criteria, Reporting and 
record keeping requirements.

    For the reasons stated in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 553, the NRC is proposing to 
adopt the following amendments to 10 CFR part 50.

PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION 
FACILITIES

    1. The authority citation for Part 50 continues to read as follows:

    Authority: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 
Stat. 936, 937, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 
83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 
2232, 2233, 2236, 2239, 2282); secs. 201, as amended, 202, 206, 88 
Stat. 1242, as amended, 1244, 1246, (42 U.S.C. 5841, 5842, 5846).
    Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951, as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42 
U.S.C. 5851). Sections 50.10 also issued under secs. 101, 185, 68 
Stat. 936, 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. L. 
910190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 50.54(dd), 
and 50.103 also issued under sec. 108, 68 Stat. 939, as amended (42 
U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued 
under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 
50.55a, and Appendix Q also issued under sec. 102, Pub. L. 91-190, 
83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also issued 
under sec. 204, 88 Stat. 1245 (42 U.S.C. 5844). Sections 50.58, 
50.91, and 50.92 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 
U.S.C. 2239). Sections 50.78 also issued under sec. 122, 68 Stat. 
939 (42 U.S.C. 2152). Sections 50.80, 50.81 also issued under sec. 
184, 68 Stat. 954, as amended (42 U.S.C. 2234). Appendix F also 
issued under sec. 187, 66 Stat. 955 (42 U.S.C. 2237).

    2. In Sec. 50.54 (a), paragraph (a)(3) is revised and a new 
paragraph (a)(4) is added to read as follows:


Sec. 50.54  Conditions of licenses.

    (a) * * *
    (3) Each licensee described in paragraph (a)(1) of this section may 
make a change to a previously accepted quality assurance program 
description included or referenced in the Safety Analysis Report 
without prior NRC approval, provided the change does not reduce the 
commitments in the program description as accepted by the NRC. Changes 
to the quality assurance program description that do not reduce the 
commitments must be submitted to the NRC in accordance with the 
requirements of Sec. 50.71(e). In addition to quality assurance program 
changes involving administrative improvements and clarifications, 
spelling corrections, punctuation, or editorial items, the following 
changes are not considered to be reductions in commitment:
    (i) The use of a QA standard approved by the NRC which is more 
recent than the QA standard in the licensee's current QA program at the 
time of the change;
    (ii) The use of a quality assurance alternative or exception 
approved by an

[[Page 9037]]

NRC safety evaluation, provided that the bases of the NRC approval are 
applicable to the licensee's facility;
    (iii) The use of generic organizational position titles that 
clearly denote the position function, supplemented as necessary by 
descriptive text, rather than specific titles;
    (iv) The use of generic organizational charts to indicate 
functional relationships, authorities, and responsibilities, or, 
alternately, the use of descriptive text;
    (v) The elimination of quality assurance program information that 
duplicates language in quality assurance regulatory guides and quality 
assurance standards to which the licensee is committed; and
    (vi) Organizational revisions that ensure that persons and 
organizations performing quality assurance functions continue to have 
the requisite authority and organizational freedom, including 
sufficient independence from cost and schedule when opposed to safety 
considerations.
    (4) Changes to the quality assurance program description that do 
reduce the commitments must be submitted to the NRC and receive NRC 
approval prior to implementation, as follows:
    (i) Changes made to the quality assurance program description as 
presented in the Safety Analysis Report or in a topical report must be 
submitted as specified in Sec. 50.4.
    (ii) The submittal of a change to the Safety Analysis Report 
quality assurance program description must include all pages affected 
by that change and must be accompanied by a forwarding letter 
identifying the change, the reason for the change, and the basis for 
concluding that the revised program incorporating the change continues 
to satisfy the criteria of appendix B of this part and the Safety 
Analysis Report quality assurance program description commitments 
previously accepted by the NRC (the letter need not provide the basis 
for changes that correct spelling, punctuation, or editorial items).
    (iii) A copy of the forwarding letter identifying the change must 
be maintained as a facility record for three years.
    (iv) Changes to the quality assurance program description included 
or referenced in the Safety Analysis Report shall be regarded as 
accepted by the Commission upon receipt of a letter to this effect from 
the appropriate reviewing office of the Commission or 60 days after 
submittal to the Commission, whichever occurs first
* * * * *
    Dated at Rockville, Maryland, this 17th day of February 1999.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 99-4396 Filed 2-22-99; 8:45 am]
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