[Federal Register Volume 60, Number 178 (Thursday, September 14, 1995)]
[Proposed Rules]
[Pages 47716-47719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22705]
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Proposed Rules
Federal Register
________________________________________________________________________
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. 60, No. 178 / Thursday, September 14, 1995 /
Proposed Rules
[[Page 47716]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 50
[Docket No. PRM-50-62]
Nuclear Energy Institute; Receipt of a Petition for Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; Notice of receipt.
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SUMMARY: The Nuclear Regulatory Commission (NRC) has received and
requests public comment on a petition for rulemaking filed by the
Nuclear Energy Institute (NEI) on behalf of the nuclear power industry.
The petition has been docketed by the Commission and assigned Docket
No. PRM-50-62. The petitioner requests that the NRC amend its
regulations regarding quality assurance programs to permit nuclear
power plant licensees to change their quality program described or
referenced in a licensee's Safety Analysis Report (SAR) without prior
NRC approval under specified conditions. The petitioner believes that
this amendment would improve the regulatory process and increase the
safety of commercial nuclear power plants through a more efficient use
of agency and industry resources.
DATES: Submit comments by November 28, 1995. Comments received after
this date will be considered if it is practical to do so, but assurance
of consideration cannot be given except to those comments received on
or before this date.
ADDRESSES: For a copy of the petition, write: Rules Review Section,
Rules Review and Directives Branch, Division of Freedom of Information
and Publications Services, Office of Administration, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001.
Submit comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001. Attention: Docketing and Services Branch.
Deliver comments to 11555 Rockville Pike, Rockville, Maryland,
between 7:45 am and 4:15 pm on Federal workdays.
Electronic Access, see SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Office of
Administration, U.S. Nuclear Regulatory Commission, Washingtion, DC
20555-0001. Telephone: 301-415-7163 or Toll Free: 800-368-5642.
SUPPLEMENTARY INFORMATION:
Electronic Access
Comments may be submitted through the Internet by addressing
electronic mail to INTERNET:[email protected] Comments may also be
submitted electronically, in either ASCII text or WordPerfect format
(version 5.1 or later), by calling the NRC Electronic Rulemaking
Bulletin Board (BBS) on FEDWORLD.
The BBS is an electronic information system operated by the
National Technical Information Service of the Department of Commerce.
The purpose of this bulletin board BBS is to facilitate public
participation in the NRC regulatory process, particularly rulemakings.
With publication of this notice, proposed rulemakings and appropriate
supporting documents will be available for review and comment on the
BBS. These same documents are also available for review and comment at
the NRC's Public Document Room, 2120 L Street, N.W. (Lower Level),
Washington, DC. The BBS may be accessed using a personal computer, a
modem, and one of the commonly available communications software
packages, or directly via Internet.
The NRC rulemaking bulletin board (rulemaking subsystem) on
FEDWORLD can be accessed directly by using a personal computer and
modem, dialing the toll free number at 1-800-303-9672. Communication
software parameters should be set as follows: parity to none, data bits
to 8, and stop bits to 1 (N,8,1). Using ANSI or VT-100 terminal
emulation, the NRC rulemaking subsystem can then be accessed by
selecting the ``Rules Menu'' option from the ``NRC Main Menu.'' For
further information about options available for NRC at FEDWORLD consult
the ``Help/Information Center'' from the ``NRC Main Menu.'' Users will
find the ``FEDWORLD Online User's Guides'' particularly helpful. Many
NRC subsystems and databases also have a ``Help/Information Center''
option that is tailored to the particular subsystem.
The NRC subsystem on FEDWORLD also can be accessed by a direct dial
phone number for the main FEDWORLD BBS at 703-321-3339; or by using
Telnet via Internet: fedworld.gov. Using the 703 number to contact
FEDWORLD, the NRC subsystem will be accessed from the main FEDWORLD
menu by selecting the ``Regulatory, Government Administration and State
Systems,'' then selecting ``Regulatory Information Mall.'' At that
point, a menu will be displayed that has the option ``U.S. Nuclear
Regulatory Commission'' that will take you to the NRC Online main menu.
The NRC Online area also can be accessed directly by typing ``/go nrc''
at a FEDWORLD command line. If you access NRC from FEDWORLD's main
menu, then you may return to FEDWORLD by selecting the ``Return to
FEDWORLD'' option from the NRC Online Main Menu. However, if you access
NRC at FEDWORLD by using NRC's toll-free number, then you will have
full access to all NRC systems, but you will not have access to the
main FEDWORLD system.
If you contact FEDWORLD using Telnet, you will see the NRC area and
menus, including the ``Rules Menu.'' Although you will be able to
download documents and leave messages, you will not be able to write
comments or upload files. If you contact FEDWORLD using File Transfer
Program (FTP), all files can be accessed and downloaded, but uploads
are not allowed, and all you will see is a list of files without
descriptions (normal Gopher look). An index file listing all files
within a subdirectory, with descriptions, is available. There is a 15-
minute time limit for FTP access.
Although FEDWORLD also can be accessed through the World Wide Web
as well, like FTP, that mode only provides access for downloading
files, and does not display the NRC ``Rules Menu.''
For more information on NRC bulletin boards call Mr. Arthur Davis,
Office of Information Resources Management, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, telephone (301) 415-5780; e-mail
AXD3@nrc.gov.
[[Page 47717]]
The Petitioner
The petitioner is the Nuclear Energy Institute (NEI). NEI
represents that it is responsible for establishing unified nuclear
industry positions on matters affecting the nuclear energy industry,
including the regulatory aspects of generic operational and technical
issues. NEI's members include all utilities licensed to operate
commercial nuclear power plants in the United States, nuclear power
plant designers, major architect/engineering firms, fuel fabrication
facilities, nuclear materials licensees, and other organizations and
individuals involved in the nuclear energy industry.
Background
The NRC received an NEI petition for rulemaking on June 12, 1995.
The petition is dated June 8, 1995, and was docketed as PRM-50-62 on
June 19, 1995. The petitioner requests that the NRC amend its
regulations in 10 CFR 50.54(a) to permit licensees to make certain
changes to their quality assurance programs without prior approval from
the NRC. The petitioner believes that this will change the quality
assurance process consistent with the change process for other matters
described in the SAR.
Discussion of the Petition
The petition states that the current Sec. 50.54(a) allows NRC
licensees to change their quality assurance programs as long as any
prior commitment in that program is not reduced. The petitioner
believes that if a commitment is to be reduced, a licensee needs NRC
approval prior to implementation. The petitioner believes that this
requirement is sometimes interpreted by the NRC as requiring NRC prior
approval for any changes in the quality program, no matter the degree
of safety significance. The petitioner believes that prolonged and
sometimes unnecessary regulatory interactions often occur centered on
the correct interpretation of the term ``reduction in commitment.'' The
petitioner cites the following examples of topics that have been the
subject of concern in the past:
Changes in the level of approval of administrative,
implementation or policy procedures, regardless of the safety
significance.
Changes in the company organization as it is described in
the licensee's original quality plan.
Changes to audit, review or surveillance frequencies that
have minimal, if any, safety significance.
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 quality program description through the use of enhanced technology
or other developments.
Adoption of different, more effective and efficient
quality processes than those described in a licensee's original quality
plant based on the safety significance and past operating performance.
The petitioner believes that the current provisions of
Sec. 50.54(a) related to the quality assurance program change process
are inconsistent with the requirements associated with other changes to
the SAR (see Sec. 50.59).
The petitioner believes that a licensee's inability to adjust its
quality assurance program descriptions and commitments without prior
NRC approval is a significant administrative burden on a licensee and
can distract a licensee and the NRC from more significant safety
matters. The petitioner also believes that the proposed amendment would
improve regulatory consistency by instituting the same type of change
process for the quality assurance program described or referenced in
the SAR (i.e., a change process similar to the process delineated in
Sec. 50.59). The petitioner believes that the proposed amendment
ensures that the attention and resources of NRC and industry would be
more appropriately and effectively focused on issues that could have an
adverse effect on public health and safety.
The petitioner further believes that the proposed amendment is
consistent with the overall objectives of the 1993 Report of the
National Performance Review, conducted by the Vice President of the
United States, and the 1995 congressional initiatives on improving
Federal regulations. In conjunction with phase two of the NRC's
national performance review study, a review of current NRC regulations
has been performed to identify regulations that are obsolete,
unnecessarily burdensome, too prescriptive, or that overlap or
duplicate other regulations.
The petitioner states that the NRC's Regulatory Review Group (RRG),
in its review of power reactor regulations and related processes,
programs, and practices, identified specific examples of inconsistency
and incoherence in the current regulations and their associated
administrative requirements. The RRG also provided recommendations for
improvement. The petitioner states that, in some of the areas reviewed
by the RRG, licensees are responsible for controlling specific
activities that are very similar in nature to the quality assurance
process; however, these other activities are subject to different
regulatory constraints, reporting, and record retention requirements.
The petitioner cites the following examples that the regulatory
review group provided in its report of August 1993:
Changes that can be made by a licensee to a facility or
procedures without prior NRC approval if the change does not require a
change to the Technical Specifications or involve an unreviewed safety
question * * *.
Changes that can only be made to a licensee's quality
assurance program described or referenced in the SAR without prior NRC
approval if they do not reduce commitments in the program description
previously accepted by the NRC, even if the changes do not affect the
Technical Specifications, involve unreviewed safety questions, or have
any adverse safety significance * * *.
Varying record retention and reporting frequencies for
activities of a similar nature, such as those associated with quality
assurance and changes to the SAR.
The petitioner agrees with the NRC's RRG finding that there is no
reason for these inconsistencies in the NRC's regulations. The
petitioner believes that regulatory effectiveness would be improved,
the burden on licensees and the NRC reduced, and regulatory coherence
enhanced if there were a consistent change process for changes to the
facility, its procedures, tests and experiments, or other matters as
described in the SAR.
The petitioner states that in the development of a more efficient
and effective quality regime, it is important that licensees not be
discouraged by an unnecessary administrative burden of seeking prior
NRC approval when a change is of no regulatory significance (i.e., does
not result in non-compliance with the NRC's regulations, a change to
the technical specifications, or an unreviewed safety question). The
petitioner also states that in an evolving technological environment,
each licensee should be allowed the opportunity to respond to
improvements in technology, industry operating experiences, and new
operational or technical information by making changes to its quality
assurance program that do not degrade protection of the public health
and safety without the need for administrative and managerial
regulatory interactions.
The petitioner states that the proposed amendment does not
[[Page 47718]]
introduce a new type of change process. The petitioner believes that
the proposed amendment is based on a well-tried and proven process for
making changes to a facility, its procedures, tests, or activities that
are described or referenced in the SAR. Compliance with the regulations
to ensure proper control of a facility and the quality program
associated with the protection of public health and safety is still
provided by the adoption of a change process that is similar to the
established Sec. 50.59 process.
Section 50.59, Changes, tests and experiments, allows the holder of
a license authorizing operation of a production or utilization facility
to (i) make changes in the facility as described in the SAR, (ii) make
changes in the procedures as described in the SAR, and (iii) conduct
tests or experiments not described in the SAR, without prior Commission
approval, unless the proposed changes, tests, or experiments, involve a
change in the technical specifications incorporated into the license or
an unreviewed safety question.
The petitioner believes that its proposed amendment would allow the
licensee to have the authority to change its quality program if
analysis, as described in Sec. 50.59, demonstrates that a proposed
change does not involve an unreviewed safety question or change the
technical specifications. The petitioner states that the analysis to
support this determination would be consistent with that required to
support other types of changes to an SAR; therefore, it would be based
on the well-proven and established industry guidance.
The petitioner believes that if the analysis of a proposed change
to the quality assurance program indicates that any unreviewed safety
questions may be involved, a licensee would either decide not to
institute the change or submit the change for NRC approval before
implementation. For changes involving an unreviewed safety question,
the complete change, including the safety evaluation, would be
submitted in accordance with the requirements of Sec. 50.90.
The petitioner states that the proposed amendment would maintain
the requirements of Sec. 50.4, requiring licensees to submit a report
containing a summary description of the changes to the quality
assurance program described or referenced in the SAR. The petitioner
states that the report would be submitted annually, or along with the
FSAR updates as required by Sec. 50.71(e), or at shorter intervals as
determined by each licensee. The petitioner states that licensees would
maintain records of the changes as facility records for 5 years, a
period that is consistent with other similar NRC regulations (e.g.
Sec. 50.59).
The NEI did not address the impact of removing Sec. 50.4(b)(7)(i)
from the Commission's regulations or why NEI believes the deletion is
necessary.
The petitioner's suggested amendment would require that only a
summary, not a detailed safety evaluation, be submitted to the NRC for
changes that do not involve a Technical Specification change or an
unreviewed safety question. The petitioner believes that this is
consistent with the requirements of similar regulations (Sec. 50.59).
The petitioner also believes that the proposed amendment would require
that licensees maintain records of these evaluations until the
termination of the license.
The petitioner has provided supplemental analyses to facilitate the
NRC's consideration of the effect of the proposed action on the
environment and small business entities, as well as the paperwork
burden on all entities that would be affected by the change. NEI also
included analyses to assist NRC in its consideration of the need for a
regulatory analysis or application of the backfit rule to this
rulemaking.
The NRC is soliciting public comment on NEI's petition requesting
the changes to regulations in 10 CFR Part 50 as discussed below.
The Petitioner's Proposed Amendment
The petitioner recommends the following amendments to 10 CFR Part
50.
Sec. 50.4 [Amended]
1. In Sec. 50.4, paragraph (b)(7)(i) and the designation for
paragraph (b)(7)(ii) are removed.
* * * * *
2. In Sec. 50.54, paragraph (a) is revised to read as follows:
Sec. 50.54 Conditions of licenses.
(a)(1) Each nuclear power plant or fuel reprocessing plant licensee
shall implement a quality assurance program pursuant to
Sec. 50.34(b)(6)(ii) of this part, as described or referenced in its
Safety Analysis Report.
(2) 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 its Safety Analysis Report
without prior Commission approval unless the proposed change involves a
change to the technical specifications incorporated in the license or
involves an unreviewed safety question.
(i) A change shall be deemed to involve an unreviewed safety
question (A) if the probability of occurrence or the consequences of an
accident or malfunction of equipment important to safety previously
evaluated in a licensee's Safety Analysis Report may be increased; or
(B) if a possibility for an accident or malfunction of a different type
than any previously evaluated in a licensee's Safety Analysis Report
may be created; or (C) if the margin of safety as defined in the basis
for any technical specification is reduced.
(ii) When changes are made to a previously accepted quality
assurance program description, a licensee shall submit, as specified in
Sec. 50.4, a report containing a brief description of the change,
including a summary of the safety evaluation of each change. The report
may be submitted annually, or along with FSAR updates as required by
Sec. 50.71(e), or at shorter intervals as determined by each licensee.
(iii) Records of changes to the quality assurance program shall be
maintained as facility records for five years.
(3) For changes to the quality assurance program description that
involve an unreviewed safety question, licensees shall submit the
proposed change to the NRC for approval before implementation. The
licensee shall submit the application to amend the quality assurance
program pursuant to the requirements of Sec. 50.90.
(4) For changes that involve a change to the technical
specifications, a licensee shall submit an application for a license
amendment pursuant to Sec. 50.90.
* * * * *
Specific Areas for Public Comment
In addition to commenting on the petition for rulemaking (petition)
presented above, the NRC staff is soliciting specific comments on the
issues presented below. Because the NRC staff has not yet developed its
positions on the petition, it is soliciting these comments to obtain
information that it may consider in developing future rulemakings that
provide procedures for licensees to make changes to its quality
assurance program.
1. 10 CFR 50.54(a) was issued on January 10, 1983, to correct
instances where licensees had changed their programs that resulted in
some unacceptable programs without informing the NRC. What assurances
exist to prevent a similar situation from recurring if the petition and
the revised threshold for reporting QA program changes is adopted? Is
it necessary that such situations be prevented from
[[Page 47719]]
occurring by adoption of a regulatory approval system?
2. Traditionally, the NRC staff has used a variety of documents
such as the NRC Standard Review Plan, NRC Regulatory Guides, and
associated industry consensus standards to delineate what QA program
elements are necessary to meet Appendix B. Should these standards
continue to be used to define acceptable QA programs? Should a licensee
QA program change that constitutes a departure from a commitment to
comply with a specific regulatory position be considered of sufficient
importance that the NRC should be notified in advance of
implementation? How would such changes be evaluated under the
petitioner's proposed criterion?
3. The NRC has allowed licensees to relocate administrative
controls for review and audit functions from the technical
specifications. Examples include details on safety review committees,
audits, and technical review functions. These have been relocated to
the QA program based on the existing change control provisions in
Sec. 50.54(a). Would it be appropriate for activities such as safety
review committees, independent technical review groups, and audits to
be controlled so that only licensee changes exceeding the threshold of
an unreviewed safety question (USQ) be reported to the NRC for pre-
review before implementation? What kind of changes to a licensee's QA
program would constitute a USQ? Assuming that the USQ should/could be
applied, does not the use of Sec. 50.59 effectively negate the
administrative and regulatory advantage of removing this information
from technical specifications (because both technical specification
changes and USQs are subject to an opportunity for hearing)? If the
revised QA change control mechanism is adopted should aspects of the
review and audit functions remain in the QA program or be relocated
elsewhere to ensure appropriate NRC review of changes prior to
implementation?
4. Are there alternative thresholds for determining whether a
licensee must submit their QA program changes for advance review in
lieu of the USQ threshold? Provide a technical and/or policy
explanation as to why this or any other threshold would be more
appropriate.
5. The NRC Regulatory Review Group (RRG) examined change control
mechanisms in Sec. 50.54 for control of licensee plans and programs
(quality assurance, security, and emergency preparedness). The RRG
recommended that licensees should have greater flexibility to make
changes in their programs without having to receive prior NRC approval.
Currently, QA program changes that ``reduce the commitments in the
program'' are submitted for NRC staff review before implementation.
Similarly, security plan changes that ``decrease the effectiveness''
are submitted for staff review before implementation. Should the staff
consider a revision to Sec. 50.54(a) to set the threshold for reporting
QA program changes for NRC pre-review that constitute a decrease in
effectiveness? Would a ``decrease in effectiveness'' standard in
Sec. 50.54(a) provide a sufficiently flexible and technically
reasonable criteria for licensees to report QA program changes to the
staff before implementation?
6. Should the NRC staff consider retaining the current language of
Sec. 50.54(a) and to define explicit guidance or identify examples on
what types of QA program changes would be considered to ``reduce the
commitments in the program''? By developing this guidance could
sufficient flexibility be afforded to licensees to make changes in
their QA program without having to undergo a pre-review by the staff?
7. The petition proposes to apply a Sec. 50.59 process to evaluate
QA program changes to determine the necessity for pre-review by the
staff. Industry guidance for Sec. 50.59 exists within NSAC-125
``Guidelines for Sec. 50.59 Safety Evaluations.'' NSAC-125 appears to
contain little relevant guidance that would be helpful for determining
whether QA programmatic changes would constitute a USQ that requires
NRC pre-review of the change. In particular, Section 4.2 of NSAC-125
deals principally with evaluating changes associated with nuclear plant
equipment and not programmatic controls. Is existing guidance for
processing 10 CFR 50.59 evaluations sufficient for evaluating QA
program changes? What factors or aspects of the existing industry
guidance would need to be supplemented? What types of QA program
changes would be necessary to report to the NRC if the current
Sec. 50.59 criteria were applied to QA program changes? What are
examples of QA program changes that should be considered as meeting the
USQ threshold?
8. Would protection of the public health and safety be enhanced if
the petition were granted, and if so, in what way? What licensee and
NRC costs would be reduced, or increased, if the petition were granted?
Dated at Rockville, Maryland, this 7th day of September, 1995.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 95-22705 Filed 9-13-95; 8:45 am]
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