[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.
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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is withdrawn, timely notice will be published in the Federal Register.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 cag@nrc.gov.
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 hst@nrc.gov.
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.
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\1\ The NRC is currently considering changes to the thresholds
in Sec. 50.59. See 63 FR 56098 (October 21, 1998).
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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 bjs1@nrc.gov; 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 hst@nrc.gov.
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
