[Federal Register Volume 64, Number 35 (Tuesday, February 23, 1999)]
[Rules and Regulations]
[Pages 9030-9034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4395]



[[Page 9029]]

_______________________________________________________________________

Part IV





Nuclear Regulatory Commission





_______________________________________________________________________



10 CFR Part 50



Changes to Quality Assurance Programs; Final and Proposed Rules

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

[[Page 9030]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 50

RIN 3150-AG20


Changes to Quality Assurance Programs

AGENCY: Nuclear Regulatory Commission.

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations to permit power reactor licensees to make certain quality 
assurance (QA) program changes without obtaining NRC approval of these 
changes in advance. The final rule allows licensees to make routine or 
administrative changes that should not have an adverse impact on the 
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: The Direct Final Rule is effective on April 26, 1999, unless 
significant adverse comment is received by March 25, 1999. If the rule 
is withdrawn, timely notice will be published in the Federal Register.

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, Rockville, 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 web 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 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: The Nuclear Regulatory Commission (NRC) is 
amending its regulations to permit power reactor licensees to make 
certain changes to their QA programs without obtaining NRC approval in 
advance. This action is being taken in response to a Nuclear Energy 
Institute (NEI) petition for rulemaking. The changes that a licensee 
can make under this rulemaking are administrative or routine in nature 
and should not adversely impact the effectiveness of the licensee's QA 
program. There may be other QA program areas for which unilateral 
changes could be made by licensees without prior NRC approval that 
would not negatively impact the effectiveness of the licensee's QA 
program. However, the NRC is in the process of developing suitable 
criteria for such changes. When such criteria have been developed, an 
additional rulemaking will be undertaken. This action, the publication 
of the Direct Final Rule, constitutes the NRC's granting of the 
petition in part. When the Commission decides to undertake a second 
rulemaking, it would also be considered a partial granting of the 
petition.
    Because the NRC considers this action noncontroversial, the Direct 
Final Rule will be published in final form. This action will become 
effective on April 26, 1999. However, if the NRC receives significant 
adverse comments by March 25, 1999, the NRC will publish a document 
that withdraws this action. In this separate part of this issue of the 
Federal Register, the NRC is publishing a separate document that will 
serve as the proposal to approve the rule and to constitute the 
mechanism through which the NRC will consider its final action on this 
matter, should adverse comment be received. Any significant adverse 
comment will be addressed in a subsequent final rule. The NRC will not 
initiate a second comment period on this action.

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 nuclear power plant licensees to 
make a broader range of changes to their QA programs without prior NRC 
approval. Currently, 10 CFR 50.54(a)(3) allows licensees 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 prior to 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 the 
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, which 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

[[Page 9031]]

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 reluctant 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.
    In NEI's opinion, the acceptability of changes made to a licensee's 
QA program without NRC approval should be governed by the effect of the 
change on safety and not by whether the change represents a ``reduction 
in commitment.'' In this way, the attention and resources of the 
nuclear industry and the NRC would be more appropriately and 
effectively focused on issues that could have an impact on public 
health and safety, rather than on administrative details and issues 
having minimal or no safety impact. The NEI proposed that the threshold 
for submittal of QA program changes should be whether or not the change 
involves a USQ or results in a change to the technical specifications 
incorporated in the license. This approach is identical to the 
regulatory control in 10 CFR 50.59, with respect to changes in the 
facility as described in the SAR, changes in procedures as described in 
the SAR, and the conduct of tests or experiments not described in the 
SAR. All these changes may be made without prior NRC approval provided 
that the relevant thresholds in Sec. 50.59 are not exceeded. These 
thresholds restrict the licensee from making unilateral changes if the 
changes involve (i) a change in the technical specifications 
incorporated in the license, (ii) an increase in the probability of 
occurrence or the consequences of an accident or malfunction of 
equipment important to safety previously evaluated in the safety 
analysis report, (iii) the creation of the possibility for an accident 
or malfunction of a different type than evaluated previously in the 
safety analysis report, or (iv) a reduction of the margin of safety as 
defined in the basis for any technical specification.1 NEI 
stated that NRC acceptance of the proposed approach would bring QA 
program changes under the same umbrella as the regulatory change 
control in Section 50.59 that has been in effect since 1974.
---------------------------------------------------------------------------

    \1\ The NRC is currently considering changes to the thresholds 
in Sec. 50.59. See 63 FR 56098 (October 21, 1998).
---------------------------------------------------------------------------

    NEI noted that the NRC's main purpose for the current regulatory 
change control 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 the proposed approach would still address the NRC's 
concerns because QA program changes would continue to be reported 
periodically (under 10 CFR 50.71(e)) to the NRC as program updates, and 
changes that involve a USQ or cause a change to the technical 
specifications would be formally submitted to the NRC for approval 
prior to implementation. The petitioner reiterated that this is the 
same process used for change control for many other aspects of the 
facility design and operation, and it should be used for QA programs as 
well. The NEI further stated that the proposed amendment would thereby 
improve the consistency of the regulatory process and would result in 
increased safety of commercial nuclear power plants through more 
efficient use of agency and industry resources.

Commission Action on the Petition

    On September 14, 1995 (60 FR 47716), the NRC published a Federal 
Register Notice announcing the receipt of the NEI petition for 
rulemaking and providing an opportunity for public comment. The Federal 
Register Notice requested that the public comment on the petition and 
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 the 
current regulatory control of changes. All of the comment letters 
addressed themselves to issues raised in the petition, particularly to 
the appropriateness of using the 10 CFR 50.59 criterion for QA program 
changes.

Commission Decision

    The Commission has given careful consideration to the merits of 
this petition as well as the public comments received in response to 
the Federal Register Notice announcing the receipt of the petition. 
While the Commission agrees with the NEI proposal to broaden the scope 
of permitted QA program changes, it does not agree with NEI's central 
premise that 10 CFR 50.59 criteria, by themselves, can be used to 
determine the need for prior NRC approval of proposed QA program 
changes. Section 50.59 requires that a proposed change to a facility 
description be deemed a USQ if it (1) increases the probability of 
occurrence or consequences of a previously evaluated accident, (2) 
creates a possibility of a different type of accident, or (3) reduces 
the margin of safety. For hardware changes or hardware-related 
procedural changes, the effect of the change on the availability or 
unavailability of safety-related equipment can be determined in order 
to perform the required evaluation. However, for QA program changes, 
the determination of the effect of the change on plant safety is 
difficult to quantify. How changes such as organizational 
responsibilities or QA program training, as examples, will affect the 
availability of safety-related equipment cannot be determined with any 
degree of certainty. The NEI petition did not propose any guidance, NRC 
has not developed an analytical technique to make such a determination, 
and the NRC staff is not aware of any quantitative correlations between 
QA elements and equipment performance to provide such a determination. 
Thus, the NRC has concluded that use of 10 CFR 50.59 criteria for QA 
program changes is not appropriate.
    The NRC does not believe that NEI's draft guidance document, even 
in conjunction with the other NEI guidance documents cited, would 
ensure that acceptable QA programs would result. These documents rely 
heavily on NSAC-125, which is oriented toward hardware changes and does 
not contain acceptable guidance for determining whether a QA program 
change constitutes a USQ. In addition, the NRC is concerned with NEI's 
characterization in its guidance document of certain QA program changes 
as being administrative in nature and having no relationship to safety.
    However, the Commission agrees with NEI that the present 10 CFR 
50.54(a) criterion for permitting unilateral QA program changes by 
licensees is too

[[Page 9032]]

stringent because it prevents licensees from freely making changes to 
their QA programs of minor safety significance. The Commission believes 
that new criteria should be adopted that will broaden the scope of such 
changes that can be made by the licensee without prior NRC approval. 
Therefore, the Commission, is accepting the petition in part. The first 
stage of this partial acceptance is the promulgation of this Direct 
Final Rule to revise 10 CFR 50.54(a) to allow licensees to make 
additional changes to selected elements of their QA program without 
having to obtain prior NRC approval. As of the effective date of the 
Direct Final Rule, licensees would be permitted to make the following 
types of unilateral changes to their QA programs:
    1. The use of a quality assurance 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,
    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 the 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 the 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 when opposed to 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 
will provide some immediate relief to licensees by minimizing the need 
for debate with the NRC on changes that currently would constitute 
reductions in commitment which need prior NRC approval, but which are 
of minor safety significance. This action constitutes the first stage 
of NRC's partial granting of the NEI petition.
    The completion of NRC's action on the NEI petition will be 
accomplished through a second rulemaking action in which criteria will 
be 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.

Section-by-Section Analysis

    This Direct Final Rule amends 10 CFR 50.54(a) by specifying six QA 
programmatic areas in which licensees may make changes without prior 
NRC approval. Licensees are at liberty to continue the practice of 
seeking approval for ``reductions in commitments'' under the provisions 
of 10 CFR 50.54(a)(3); however, it is expected that most licensees will 
avail themselves of the relaxations provided by this Direct Final Rule.
    1. Paragraph (a)(3)(i) of Sec. 50.54 specifies that licensees may 
adopt a QA standard approved by the NRC but only if it is more recent 
than the QA standard in the licensee's current QA program at the time 
of the change. The majority of licensee QA programs have committed to 
implement QA standards endorsed by Regulatory Guide 1.28 (Rev. 2 or 
earlier) and Regulatory Guide 1.33 (Revision 2 or earlier) that were 
published in the late 1970s. This provision would allow licensees to 
adopt a more recent standard (with respect to their previous 
commitments), provided that the NRC has approved it for use. Under 
existing regulations, such a change might be considered a reduction in 
commitment, depending upon the differences between the licensee's QA 
program and the content of the standard, and could require prior NRC 
approval. However, if the NRC has evaluated the more recent standard 
and found it acceptable with respect to the requirements of 10 CFR part 
50, appendix B, the licensee would be free to implement the provisions 
of the standard in lieu of the provisions of their current QA program. 
Such use would have to account for any conditions of the NRC 
endorsement of the standard or site-specific situations.
    2. Paragraph (a)(3)(ii) of Sec. 50.54 specifies that licensees may 
use a QA alternative or exception previously approved by the NRC in a 
safety evaluation, provided that the bases of the NRC approval are 
applicable to the licensee's facility. The licensee must demonstrate, 
however, that the plant conditions under which the previously endorsed 
alternative or exception was granted apply to its plant as well. That 
is to say that the NRC safety evaluation performed to grant the 
previous alternative or exception is relevant to the licensee's plant 
and that any QA elements credited by the original licensee or the NRC 
staff are applied as part of the implementation of the position. 
Licensee QA programs typically contain an array of alternate positions 
and exceptions to NRC QA regulatory guides and QA standards. This 
provision would allow licensees to use other alternatives and 
exceptions that have an accompanying NRC safety evaluation. In the 
event that QA alternatives or exceptions have been approved without a 
safety evaluation (e.g., prior to 1997, the NRC approval letters for QA 
program changes did not elaborate on the rationale for accepting the 
change), the NRC is willing to perform the evaluations for the 
incorporation of these changes by other licensees, if licensees request 
such actions.
    3. Paragraph (a)(3)(iii) of Sec. 50.54 specifies that licensees may 
replace specific organizational and position titles with generic titles 
that clearly denote the position function, supplemented as necessary by 
descriptive text, without prior NRC approval. This provision permits 
licensees to revise organizational position titles without the need for 
prior NRC approval provided that the functional description and 
organizational relationship of the position remain unchanged, or 
satisfy the provisions of item 6 below.
    4. Paragraph (a)(3)(iv) of Sec. 50.54 specifies that licensees may 
make use of generic organization charts to indicate functional 
relationships, authorities, and responsibilities, or alternatively 
descriptive text, as opposed to specific ones. QA functional 
relationships and responsibilities, and lines of authority may be 
described generically by charts or descriptive text provided that the 
flow of quality assurance authority and responsibility is clearly 
presented.
    5. Paragraph (a)(3)(v) of Sec. 50.54 specifies that licensees may 
eliminate QA program information that duplicates language in QA 
regulatory guides and QA standards to which the licensee to committed. 
Typically, QA programs present information in descriptive text that 
discusses how each of the 18 criteria of Appendix B are met. In 
addition, the QA programs describe the level of commitment to QA 
regulatory guides and QA standards. This permitted change will allow 
the elimination of information that duplicates the commitments. 
Licensees should assure that identical provisions exist through their 
commitments to the

[[Page 9033]]

NRC regulatory guides or industry standards.
    6. Paragraph (a)(3)(vi) of Sec. 50.54 specifies that licensees may 
make changes in organization 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 when opposed to safety considerations. Changes in 
organization, however, must continue to assure the proper authority and 
organizational freedom of the QA functions (i.e., to identify quality 
problems, to promote solutions, and to verify implementation of 
activities) from cost and schedule pressures by maintaining 
independence and an adequate level of management reporting. Of 
particular importance to an effective QA program is the independence 
between the performing and verifying activities in the areas of 
auditing, inspection, and procurement.

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 this rulemaking is not 
a major action significantly affecting the quality of the human 
environment, and, therefore, an environmental impact statement is not 
required. This Direct Final Rule amends NRC's regulations pertaining to 
changes to licensee QA programs that 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 that, henceforth, 
will not be considered reductions in commitment. The effect that this 
rule change will have on NRC licensees is that the prior requests for 
NRC approval will no longer be necessary in these six program areas. 
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 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 general public from this 
action. However, the general public should note that the NRC has also 
committed to comply 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. 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 Direct Final 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 Direct Final Rule including the 
foregoing Environmental Assessment to every State Liaison Officer and 
requested their comments on this assessment.

Paperwork Reduction Act Statement

    The Direct Final Rule amends information collection requirements 
that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.). These requirements were approved by the Office of Management 
and Budget (OMB), approval number 3150-0011.
    The public reporting burden reduction for 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 electronic 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 
collection.

Regulatory Analysis

    The Commission has prepared a regulatory analysis on this 
regulation. The analysis examines the costs and benefits of the 
alternatives considered by the Commission. The 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 does not have a 
significant economic impact on a substantial number of small entities. 
The Direct Final Rule affects only the licensing and operation of 
nuclear power plants. The companies that operate 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 Direct Final Rule permits licensees to make unilateral QA 
program changes in several program

[[Page 9034]]

areas but does not require them to do so. Licensees are free to 
continue to seek NRC approval for changes that reduce the commitments 
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 Direct Final 
Rule; therefore, a backfit analysis is not required for this Direct 
Final Rule because these amendments do not involve any provision that 
imposes backfits as defined in 10 CFR 50.109(a)(1).

Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs of the OMB.

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. 552 and 553, the NRC is adopting 
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 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. 99-4395 Filed 2-22-99; 8:45 am]
BILLING CODE 7590-01-P