[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 804-805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00374]


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NUCLEAR REGULATORY COMMISSION

[NRC-2018-0056]


Digital Instrumentation and Controls--Interim Staff Guidance-06, 
Revision 2, ``Licensing Process''

AGENCY: Nuclear Regulatory Commission.

ACTION: Interim staff guidance; issuance.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing 
Interim Staff Guidance (ISG) Digital Instrumentation and Controls 
(DI&C)--ISG-06, Revision 2, ``Licensing Process.'' This ISG defines the 
licensing process used to support the review of license amendment 
requests (LARs) associated with safety-related D&IC equipment 
modifications in operating plants and in new plants once they become 
operational. This ISG provides guidance for activities performed before 
a LAR is submitted and for activities performed during LAR review. The 
NRC staff uses the process described in this ISG to evaluate compliance 
with NRC regulations.

DATES: This guidance is available on January 31, 2019.

ADDRESSES: Please refer to Docket ID NRC-2018-0056 when contacting the 
NRC about the availability of information regarding this document. You 
may obtain publicly-available information related to this document 
using any of the following methods:
    <bullet> Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0056. Address 
questions about Docket IDs in Regulations.gov to Krupskaya Castellon; 
telephone: 301-287-9221; email: <a href="/cdn-cgi/l/email-protection#18536a6d686b73796179365b796b6c7d7474777658766a7b367f776e"><span class="__cf_email__" data-cfemail="e0ab929590938b819981cea3819394858c8c8f8ea08e9283ce878f96">[email protected]</span></a>. For 
technical questions, contact the individual listed in the FOR FURTHER 
INFORMATION CONTACT section of this document.
    <bullet> NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS 
Search.'' For problems with ADAMS, please contact the NRC's Public 
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or 
by email to <a href="/cdn-cgi/l/email-protection#3d4d594f134f584e52484f5e587d534f5e135a524b"><span class="__cf_email__" data-cfemail="364652441844534559434455537658445518515940">[email protected]</span></a>. The Digital Instrumentation and 
Controls-Interim Staff Guidance-06, Rev. 2, is available in ADAMS under 
Accession No. ML18269A259.
    <bullet> NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Joseph Golla, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001; telephone: 301-415-1002, email: <a href="/cdn-cgi/l/email-protection#1e54717b30597172727f5e706c7d30797168"><span class="__cf_email__" data-cfemail="92d8fdf7bcd5fdfefef3d2fce0f1bcf5fde4">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    The NRC published a notice of the availability of ISG-06, Rev. 2, 
in the Federal Register (83 FR 38731) on August 7, 2018, for a 30-day 
public comment period. The public comment period closed on September 6, 
2018. Public comments on ISG-06, Rev. 2, and the staff responses to the 
public comments are available under ADAMS Accession No. ML18290A623.
    This ISG provides guidance for the NRC staff's review of LARs 
supporting installation of Digital I&C equipment in accordance with 
licensing processes defined in the NRC's office instruction LIC-101, 
``License Amendment Review Procedures.'' This ISG identifies 
information the NRC staff should review for Digital I&C equipment. This 
ISG provides guidance on when that information should be reviewed.
    This ISG is designed to be used with the NRC's topical report 
review and approval process defined in the NRC's Office of Nuclear 
Reactor Regulation office instruction LIC-500, ``Topical Report 
Process.'' Where a licensee references an NRC-approved topical report, 
the NRC staff should be able to, where appropriate, limit its review to 
assessing whether the application of the Digital I&C modification falls 
within the envelope of the topical report approval. This ISG was 
developed based upon, and is designed to work in concert with, 
established guidance. As a result, this ISG references other guidance 
documents for review criteria.

[[Page 805]]

    The NRC staff performs evaluations of proposed Digital I&C 
equipment to ensure equipment will perform required functions. These 
evaluations use the guidance in the Standard Review Plan, Chapter 7, 
and other associated guidance. When a licensee seeks to amend its 
license, the application for amendment must fully describe the changes 
desired. The application should describe the safety functions of 
identified in the Final Safety Analysis Report, as updated, and the 
Digital I&C equipment that performs each function. Additionally, 
licensees identify those parts of the licensing basis being updated as 
a result of the proposed change.
    The Standard Review Plan, Appendix 7.0-A, and Branch Technical 
Position 7-14, guide the NRC staff in performing reviews of digital 
systems in support of safety evaluations. For reviews using the 
Alternate Process as defined in the ISG, the ISG provides additional 
guidance for performing early stage reviews of digital safety-related 
systems in support of safety evaluations. The NRC staff may review the 
system design and development process to support a determination that 
the design meets regulatory requirements and that in safety-related 
applications in nuclear power plants, the process is of sufficiently 
high quality to produce systems and software suitable for use. The NRC 
staff review processes include activities for evaluating documentation 
of plans and processes that are used to support system development 
activities and their outcomes.

II. Backfitting and Issue Finality

    The NRC is issuing a revision to interim guidance for the NRC staff 
regarding its review of requests from nuclear power plant licensees for 
license amendments involving installation of Digital I&C equipment. 
Issuance of the revised ISG does not constitute backfitting as defined 
in title 10 of the Code of Federal Regulations (10 CFR) section 50.109 
(the Backfit Rule) and is not otherwise inconsistent with the issue 
finality provisions in 10 CFR part 52. The NRC's position is based upon 
the following considerations.
    1. The ISG positions do not constitute backfitting, inasmuch as the 
ISG is guidance directed to the NRC staff with respect to its 
regulatory responsibilities.
    The ISG provides interim guidance to the staff on how to review 
certain requests for license amendments. Changes in guidance intended 
for use by only the staff are not matters that constitute backfitting 
as that term is defined in 10 CFR 50.109 or involve the issue finality 
provisions of 10 CFR part 52.
    2. Backfitting and issue finality--with certain exceptions 
discussed in this section--do not apply to current or future 
applicants.
    Applicants and potential applicants are not, with certain 
exceptions, the subject of either the Backfit Rule or any issue 
finality provisions under 10 CFR part 52. This is because neither the 
Backfit Rule nor the issue finality provisions of 10 CFR part 52 were 
intended to apply to every NRC action that substantially changes the 
expectations of current and future applicants.
    The exceptions to the general principle are applicable whenever a 
10 CFR part 50 operating license applicant references a construction 
permit or a 10 CFR part 52 combined license applicant references a 
license (e.g., an early site permit) and/or an NRC regulatory approval 
(e.g., a design certification rule) for which specified issue finality 
provisions apply.
    The NRC staff does not currently intend to impose the positions 
represented in this final SRP section in a manner that constitutes 
backfitting or is inconsistent with any issue finality provision of 10 
CFR part 52. If in the future the NRC staff seeks to impose positions 
stated in this SRP section in a manner that would constitute 
backfitting or be inconsistent with these issue finality provisions, 
the NRC staff must make the showing as set forth in the Backfit Rule or 
address the regulatory criteria set forth in the applicable issue 
finality provision, as applicable, that would allow the staff to impose 
the position.
    3. The NRC staff has no intention to impose the ISG positions on 
existing nuclear power plant licensees either now or in the future 
(absent a voluntary request for a change from the licensee).
    The staff does not intend to impose or apply the positions 
described in the ISG to existing (already issued) licenses (e.g., 
operating licenses and combined licenses). Hence, the issuance of this 
ISG--even if considered guidance subject to the Backit Rule or the 
issue finality provisions in 10 CFR part 52--would not need to be 
evaluated as if it were a backfit or as being inconsistent with issue 
finality provisions. If, in the future, the NRC staff seeks to impose a 
position in the ISG on holders of already issued licenses in a manner 
that would constitute backfitting or does not provide issue finality as 
described in the applicable issue finality provision, then the staff 
must make a showing as set forth in the Backfit Rule or address the 
criteria set forth in the applicable issue finality provision, as 
applicable, that would allow the staff to impose the position.

III. Congressional Review Act

    This Interim Staff Guidance document is a rule as defined in the 
Congressional Review Act (5 U.S.C. 801-808). However, the Office of 
Management and Budget has not found it to be a major rule as defined in 
the Congressional Review Act.

    Dated at Rockville, Maryland, this 2nd day of January 2019.

    For the Nuclear Regulatory Commission.
Eric J. Benner,
Director, Division of Engineering, Office of Nuclear Reactor 
Regulation.
[FR Doc. 2019-00374 Filed 1-30-19; 8:45 am]
BILLING CODE 7590-01-P


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