Draft Regulatory Guide for NPUF Proposed Rule

U.S. NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR REGULATORY RESEARCH

March 2017
Division 2

DRAFT REGULATORY GUIDE
Technical Lead
Duane Hardesty

DRAFT REGULATORY GUIDE DG-2006
(Proposed New Regulatory Guide)

PREPARATION OF UPDATED FINAL SAFETY ANALYSIS
REPORTS FOR NON-POWER PRODUCTION OR UTILIZATION
FACILITIES
A. INTRODUCTION
Purpose
This regulatory guide (RG) provides licensees of non-power production or utilization facilities
(NPUFs) with a method that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers
acceptable for use in updating facility final safety analysis reports (FSARs).
Applicability
This RG applies to NPUFs licensed under the authority of Section 103, Section 104a, or Section
104c of the Atomic Energy Act of 1954, as amended (AEA), and sections 50.22, 50.21(a), or 50.21(c) of
part 50, “Domestic Licensing of Production and Utilization Facilities,” of Title 10 of the Code of Federal
Regulations (10 CFR) (Ref. 1).
Applicable Regulations
•

10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities”
o

Section 50.71(e)(3)(iv) states, “For non-power production or utilization facility licenses
issued after [EFFECTIVE DATE OF FINAL RULE], a revision of the original FSAR
must be filed within 5 years of the date of issuance of the operating license. The revision
must bring the FSAR up to date as of a maximum of 6 months prior to the date of filing
the revision.”

o

Section 50.71(e)(4)(ii) states, “Non-power production or utilization facility licensees
shall file subsequent FSAR updates at intervals not to exceed 5 years. Each update must

This regulatory guide is being issued in draft form to involve the public in the development of regulatory guidance in this area. It has not
received final staff review or approval and does not represent an NRC final staff position. Public comments are being solicited on this draft
guide and its associated regulatory analysis. Comments should be accompanied by appropriate supporting data. Comments may be submitted
through the Federal rulemaking Web site, http://www.regulations.gov, by searching for Docket ID NRC-2011-0087. Alternatively, comments
may be submitted to the Rules, Announcements, and Directives Branch, Office of Administration, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001. Comments must be submitted by the date indicated in the Federal Register notice.
Electronic copies of this draft regulatory guide, previous versions of this guide, and other recently issued guides are available through the
NRC’s public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doccollections/reg-guides/. The draft regulatory guide is also available through the NRC’s Agencywide Documents Access and Management
System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML17068A041. The regulatory analysis may be
found in ADAMS under Accession No. ML17068A038.

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reflect all changes made to the FSAR up to a maximum of 6 months prior to the date of
filing the update.”
Related Guidance
•

NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the Licensing of
Non-Power Reactors: Format and Content” (Ref. 2), provides guidance for applicants preparing
license applications for NPUFs.

•

NUREG-1537, Part 2, “Guidelines for Preparing and Reviewing Applications for the Licensing of
Non-Power Reactors: Standard Review Plan and Acceptance Criteria” (Ref. 3), provides
guidance on the NRC’s review of license applications.

Purpose of Regulatory Guides
The NRC issues RGs to describe to the public methods that the staff considers acceptable for use
in implementing specific parts of the agency’s regulations, to explain techniques that the staff uses in
evaluating specific problems or postulated events, and to provide guidance to applicants. Regulatory
guides are not substitutes for regulations, and compliance with them is not required. Methods and
solutions that differ from those set forth in RGs will be deemed acceptable if they provide a basis for the
findings required for the issuance or continuance of a permit or license by the Commission.
Paperwork Reduction Act
This RG contains and references information collections covered by 10 CFR part 50 that are
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections
were approved by the Office of Management and Budget (OMB), control number 3150-0011.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to respond to, a request for
information or an information collection requirement unless the requesting document displays a currently
valid OMB control number.

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B. DISCUSSION
Reason for Issuance
This RG provides implementing guidance for a rulemaking that established a requirement for
NPUF licensees to submit an updated FSAR every five years. Periodic updates to FSARs provide a
mechanism for incorporating design and operational changes into the licensing basis as they occur. As a
result, NPUF licensees will routinely update their licensing bases, and NRC staff will be made aware of
changes to the licensing bases more frequently than prior to the rulemaking.
Background
This RG describes the information that should be included in submittals of FSAR revisions for
NPUFs to comply with the applicable parts of 10 CFR 50.71(e). Each submittal serves to reflect changes
and the effects of changes to the design basis and to assure that the information included in the FSAR
contains the latest information developed by the licensee. The FSAR (as updated) helps both the NPUF
licensee and the NRC ensure that the facility design and licensing bases are current. This also helps
provide reasonable assurance that a facility will continue to operate without undue risk to public health
and safety or the environment.
Role of the FSAR (as updated)
Once the NRC issues a license for a nuclear facility, the licensee must operate the facility in
compliance with its license. Because the facility’s design and operation are not static, certain changes
may be necessary over the course of facility life. Licensees are required to follow NRC regulations to
justify and implement any changes and the effects of changes to the design basis and licensing basis. The
FSAR (as updated) provides the NRC with current design and licensing bases for a facility that is needed
by the NRC in its regulatory oversight of NPUF licensees, including its use as a reference for evaluating
license amendment requests and in preparation for and conduct of inspection and operator examination
activities.
The NRC licensee has primary responsibility for operating its facility safely and in compliance
with its license. This responsibility includes maintaining an up to date facility design basis and facility
licensing basis. The FSAR (as updated) also serves to provide the general public a description of the
facility and its operation.
Harmonization with International Standards
The International Atomic Energy Agency (IAEA) has established a series of specific safety
guides (SSG) and Technical Documents (TECDOC) promoting a high level of safety for protecting
people and the environment. These documents present international good practices and increasingly
reflect best practices to help users striving to achieve high levels of safety. With respect to this RG, IAEA
Specific Safety Guide, No. SSG-10, “Aging Management for Research Reactors” (Ref. 4), addresses
aging considerations in different stages of the lifetime of a research reactor. The IAEA TECDOC-792,
“Management of Research Reactor Aging” (Ref. 5), provides to research reactor operators a guide to
understanding the behavior and influence of aging mechanisms on reactor structures, systems and
components; how to detect and assess the effects of aging; and preventive and corrective measures to
mitigate these effects. While the NRC has an interest in facilitating the harmonization of standards used
domestically and internationally, the agency does not specifically endorse SSG-10 or TECDOC-792 and
is only acknowledging that these documents may be a useful reference for general information. The NRC

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could consider the use of international standards in a licensing action following adequate justification by a
licensee or applicant and technical review by the NRC.

DG- 2006, Page 4

C. STAFF REGULATORY GUIDANCE
1. Content of the FSAR (as updated)
a. The scope of information provided through the update process should be guided by requirements
for establishing the original safety analysis report in 10 CFR 50.34 and submitting periodic
updates to the FSAR in 10 CFR 50.71, as augmented by the guidance of NUREG-1537, Part 1.
The updated information should include all the changes necessary to reflect information and
analyses prepared by the licensee since submittal of the original FSAR or, as appropriate, the last
update to the FSAR. This includes any information provided in the special reports and annual
reports to the NRC that requires changes to the FSAR and any information and analysis that
support a licensing action (e.g., a license amendment) during the 5-year period between FSARs
(as updated), such as:
i.

Changes to the facility or facility operations resulting from new or amended regulatory
requirements.

ii.

Changes and the effects of changes to the facility or procedures and new experiments to
assure the information included in the FSAR (as updated) contains the latest information
developed. NPUF licensees are required by Technical Specification to make operating reports
(annually) and special reports (as required). These reports should be reviewed by the licensee
to determine what information should be included in the FSAR revisions submitted to the
NRC to meet the requirements of 10 CFR 50.71(e). Examples include:
1. Licensee evaluations performed under 10 CFR 50.59, “Changes, tests, and experiments,”
which result in changes to the FSAR. For example:
a. Evaluation of major preventive or corrective maintenance operations to safety-related
items that may have required facility modifications (e.g., replacing a safety-related
analog meter with a digital readout; replacing a safety-related pump with one with
increased flow when the flow is an analyzed condition in the FSAR; or changes to
electrical and instrumentation and control drawings in the FSAR); or
b. Evaluation of changes in the facility and procedures, new tests or classes of
experiments not previously analyzed or described in the FSAR.
2. Licensee evaluations performed under 10 CFR 50.90, “Application for amendment of
license, construction permit, or early site permit.”
3. Licensee responses to NRC requests for additional information (RAI) which result in
changes to the FSAR (e.g., during license renewal, relicensing or the amendment
process).
4. Evaluations of significant changes in the nature and amount of radioactive effluents
released or discharged beyond the effective control of the licensee that effect the
conclusions in the NRC’s Environmental Impact Statement (EIS) or Environmental
Assessment (EA) for the facility.
5. Evaluations of environmental surveys performed outside the facility for significant trends
that affect the conclusions in the NRC’s EIS or EA for the facility.

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6. Evaluations of potential facility aging to safety-related items and any aging management
actions taken (e.g., repair of pool liner leakage, abandonment of underground piping).
7. Evaluations of changes in the facility site environs (e.g., new industrial, transportation or
residential facilities near the facility site or changes in the population potentially exposed
to facility releases).
8. Any licensee regulatory commitment made in licensee special reports that requires
changes to the FSAR.
b. Licensees are generally not expected to update historical information unless the licensee becomes
aware of significant changes in the facility site environs. Historical information includes such
material as data obtained to support or develop the original facility design basis related to natural
phenomena such as geography, meteorology, geology, and seismology.
c. As part of the FSAR update process, licensees should remove obsolete information from the
FSAR, such as structures, systems and components that are no longer installed in the facility and
evaluations or other descriptions that no longer apply to the facility as described in the FSAR.
The information removed from the FSAR as part of the update process should be identified and
reported to the NRC with a basis for the licensee’s determination that such information should be
removed.
d. Pending licensing actions (e.g., approval of a license amendment request) need not be included if
the licensing action requested has not been completed within 6 months of the date the FSAR (as
updated) is required to be filed.
e. The NRC staff will review the updates to the FSAR in accordance with the criteria contained in
NUREG-1537, Part 2.
2. Format of the FSAR (as updated)
a. The format of the FSAR (as updated) is at the discretion of the licensee and should generally
follow the format guidance in NUREG-1537, Part 1.
b. The FSAR (as updated) should highlight the changed portion on each page, including the contents
page. A summary of changes should accompany the FSAR (as updated).

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3. Submittal of the FSAR (as updated)
a. The FSAR (as updated) shall be submitted in accordance with 10 CFR 50.71(e)(2) which requires
that the submitted FSAR include: (1) a certification by a duly authorized officer of the licensee
that either the information accurately presents changes made since the previous submittal,
necessary to reflect information and analyses submitted to the Commission or prepared pursuant
to Commission requirement, or that no such changes were made; and (2) an identification of
changes made under the provisions of Section 50.59 but not previously submitted to the
Commission.
b. The FSAR (as updated) must be submitted in accordance with 10 CFR 50.4, “Written
communications.” Where practicable, licensees should electronically submit the entire document,
for example via Electronic Information Exchange, e-mail, or CD-ROM. As specified in paragraph
(a), “General requirements,” of 10 CFR 50.4, “Electronic submissions must be made in a manner
that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and
process and retrieve it a single page at a time. Detailed guidance on making electronic
submissions can be obtained by visiting the NRC’s Web site at http://www.nrc.gov/site-help/esubmittals.html; by e-mail to [email protected]; or by writing the Office of the Chief
Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001. The
guidance discusses, among other topics, the formats the NRC can accept, the use of electronic
signatures, and the treatment of nonpublic information.”
c. Information included in the FSAR (as updated) that is considered sensitive or proprietary, that the
licensee seeks to have withheld from the public, must be marked in accordance with 10 CFR
2.390, “Public inspections, exemptions, requests for withholding” (Ref. 6). Any information
related to security must be submitted in accordance with 10 CFR 73.21, “Protection of Safeguards
Information: Performance Requirements” (Ref. 7).

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D. IMPLEMENTATION
The purpose of this section is to provide information on how applicants and licensees may use
this guide and information regarding the NRC’s plans for using this RG.
Applicants and licensees may use the guidance in this document to demonstrate compliance with
the underlying NRC regulations. Methods or solutions that differ from those described in this RG may be
deemed acceptable if they provide sufficient basis and information for the NRC staff to verify that the
proposed alternative demonstrates compliance with the appropriate NRC regulations. Current licensees
may continue to use guidance that the NRC has found acceptable for complying with the identified
regulations as long as their current licensing basis remains unchanged.
Licensees may use the information in this RG for actions that do not require NRC review and
approval. Licensees may use the information in this RG or applicable parts to resolve regulatory or
inspection issues.
The NPUF licensees are not protected by the backfitting provisions in 10 CFR 50.109. The NRC
staff may discuss with licensees various actions consistent with staff positions in this RG, as one
acceptable means of meeting the underlying NRC regulatory requirement. However, unless this RG is
part of the licensing basis for a facility, the NRC staff may not represent to the licensee that the licensee’s
failure to comply with the positions in this RG constitutes a violation.

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GLOSSARY
Notwithstanding the definitions in 10 CFR Chapter I, for the purposes of this guide, the following
definitions (derived from the referenced documents) apply:
aging

Aging is the general process in which characteristics of structures, systems or
components (SSC) change with use or time which eventually leads to degradation of
materials subjected to normal service conditions, including normal operation and
transient conditions under which the SSC is required to operate (derived from Ref. 5).

aging management Aging management is engineering, operations, and maintenance actions to control,
within acceptable limits, aging degradation and wear of SSCs, including timely
detection and mitigation (derived from Ref. 4).
change

Change means a modification or addition to, or removal from the facility or
procedures, that affects a design function, method of performing or controlling the
function, or an evaluation that demonstrates that intended functions will be
accomplished (derived from Ref. 8).

design bases

Design bases means that information which identifies the specific functions to be
performed by a structure, system, or component of a facility, and the specific values
or ranges of values chosen for controlling parameters as reference bounds for design.
These values may be (1) restraints derived from generally accepted "state of the art"
practices for achieving functional goals, or (2) requirements derived from analysis
(based on calculation and/or experiments) of the effects of a postulated accident for
which a structure, system, or component must meet its functional goals (derived from
Ref. 9).

effects of changes

Effects of changes include appropriate revisions of descriptions in the final safety
analysis report (FSAR) such that the FSAR (as updated) is complete and accurate
(derived from Ref. 10).

facility

Facility as described in the FSAR (as updated) means:
(i) The SSCs that are described in the FSAR (as updated);
(ii) The design and performance requirements for such SSCs described in the FSAR
(as updated); and
(iii) The evaluations or methods of evaluation included in the FSAR (as updated) for
such SSCs which demonstrate that their intended function(s) will be accomplished
(derived from Ref. 11).

FSAR (as updated) FSAR (as updated) means the final safety analysis report (or Final Hazards Summary
Report) submitted in accordance with 10 CFR 50.34, as amended and supplemented,
and as updated per the requirements of Section 50.71(e) (derived from Ref. 12).
historical
information

Historical information is the information that was accurate at the time the licensee
facility was originally licensed that is not expected to be updated for the life of the
facility; information that is not affected by changes to the licensee facility or its
operation; or information that does not change with time (derived from Ref. 13).

licensing basis

The licensing basis for a facility is comprised of selected information exchanged
between a licensee and the NRC relating to design features, equipment descriptions,
operating practices, site characteristics, programs and procedures, and other factors
that describe a facility’s design, construction, maintenance and operation. Licensing
basis information is contained in a variety of document types (e.g., final safety

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analysis report, license amendments). Each licensing basis document has certain
characteristics in terms of change control mechanisms, reporting of changes to the
NRC, dealing with discrepancies, and possible involvement of the public (derived
from Ref. 14).
A non-power production or utilization facility (NPUF) means a non-power reactor,
non-power
testing facility, or other production or utilization facility, licensed under 10 CFR
production or
utilization facility 50.21(a), 50.21(c) or 50.22 that is not a nuclear power reactor.
obsolete
information

Obsolete information is information about safety-related items that has been removed
from the licensee facility; programs or procedures which are no longer in effect; or
design information, evaluations and FSAR descriptions that no longer apply to the
facility (derived from Ref. 12).

safety-related items Safety-related items are those physical SSCs whose intended functions are to prevent
accidents that could cause undue risk to health and safety of workers and the public;
and to control or mitigate the consequences of such accidents (derived from Ref. 15).

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REFERENCES1
1. U.S. Code of Federal Regulations (CFR), “Domestic Licensing of Production and Utilization
Facilities,” part 50, Chapter I, Title 10, “Energy.”
2. U.S. Nuclear Regulatory Commission (NRC), “Guidelines for Preparing and Reviewing
Applications for the Licensing of Non-Power Reactors: Format and Content,” NUREG-1537,
Part 1, February 1996, Agencywide Document Access and Management System (ADAMS)
accession number ML042430055.
3. NRC, “Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power
Reactors: Standard Review Plan and Acceptance Criteria,” NUREG-1537, Part 2, February 1996,
ADAMS accession number ML042430048.
4. International Atomic Energy Agency (IAEA), “Aging Management for Research Reactors,”
Specific Safety Guide No. SSG-10, Vienna, Austria, 2010.2
5. IAEA, “Management of Research Reactor Aging (TECDOC-792),” Vienna, Austria, 1995.
6. CFR, “Agency Rules of Practice,” part 2, Chapter 1, Title 10, “Energy,” Section 2.390, “Public
inspections, exemptions, requests for withholding.”
7. CFR, “Physical Protection of Plants and Materials,” part 73, Chapter 1, Title 10, “Energy,”
Section 73.21, “Protection of Safeguards Information: Performance Requirements.”
8. CFR, “Domestic Licensing of Production and Utilization Facilities,” part 50, Chapter 1, Title 10,
Energy, Section 50.59(a)(1).
9. CFR, “Domestic Licensing of Production and Utilization Facilities,” part 50, Chapter 1, Title 10,
“Energy,” Section 50.2, “Definitions.”
10. CFR, “Domestic Licensing of Production and Utilization Facilities,” part 50, Chapter 1, Title 10,
Energy, Section 50.71, “Maintenance of records, making of reports,” Footnote 1.
11. CFR, “Domestic Licensing of Production and Utilization Facilities,” part 50, Chapter 1, Title 10,
“Energy,” Section 50.59(a)(3).
12. CFR, “Domestic Licensing of Production and Utilization Facilities,” part 50, Chapter 1, Title 10,
“Energy,” Section 50.59(a)(4).
1

Publicly available NRC documents are available electronically through the NRC Library on the NRC’s public Web site
at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC’s Agencywide Documents Access and
Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html. The documents can also be viewed
online or printed for a fee in the NRC’s Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD. For
problems with ADAMS, contact the PDR staff at 301-415-4737 or (800) 397-4209; fax (301) 415-3548; or e-mail
[email protected].

2

Copies of International Atomic Energy Agency (IAEA) documents may be obtained through their Web site:
www.IAEA.org/ or by writing the International Atomic Energy Agency, P.O. Box 100 Wagramer Strasse 5, A-1400
Vienna, Austria.

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13. Electric Power Research Institute (EPRI) Nuclear Energy Institute (NEI) EPRI/NEI Report No.
98-03, Rev. 1, “Guidance for Updating Final Safety Analysis Reports,” Palo Alto, CA, June
1999.3
14. EPRI/NEI Report No. 07-06, “Nuclear Regulatory Process,” Palo Alto, CA, March 2007.
15. American Nuclear Society, “Quality Assurance Program Requirements for Research Reactors,”
ANSI/ANS 15.8–1995, LaGrange Park, IL.4

3

Copies of Electric Power Research Institute (EPRI) standards and reports may be purchased from EPRI, 3420 Hillview
Ave., Palo Alto, CA 94304; telephone (800) 313-3774; fax (925) 609-1310.

4

Copies of American National Standards (ANS) may be purchased from the American National Standards Institute
(ANSI), 1819 L Street, NW, 6th floor, Washington, DC 20036; telephone: (202) 293-8020). Purchase information is
available through the ASCE Web site at http://webstore.ansi.org/ansidocstore/.

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