[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]



 ========================================================================
 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.

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

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 
AXD[email protected]. 

[[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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