[Federal Register Volume 90, Number 65 (Monday, April 7, 2025)]
[Proposed Rules]
[Pages 14917-14920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05899]
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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. 90, No. 65 / Monday, April 7, 2025 / Proposed
Rules
[[Page 14917]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 72
[NRC-2025-0064]
Interim Enforcement Policy for Enforcement Discretion for General
Licensee Adoption of Certificate of Compliance Holder-Generated Changes
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed policy revision; request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing for
public comments a proposed Interim Enforcement Policy (IEP) titled,
``Enforcement Discretion for General Licensee Adoption of CoC Holder-
Generated Changes.'' This proposed IEP would allow enforcement
discretion for certain general licensee violations related to their
adoption of a change generated by the Certificate of Compliance holder.
DATES: Submit comments by April 28, 2025. Comments received after this
date will be considered if it is practical to do so, but the NRC is
able to assure consideration only for comments received on or before
this date.
ADDRESSES: You may submit comments by any of the following methods;
however, the NRC encourages electronic comment submission through the
Federal Rulemaking website:
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-0064. Address
questions about NRC dockets to Helen Chang; telephone: 301-415-3228;
email: Helen.Chang@nrc.gov. For technical questions contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Email comments to: Rulemaking.Comments@nrc.gov. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. eastern time (ET),
Federal workdays; telephone: 301-415-1677.
You can read a plain language description of this proposed rule at
https://www.regulations.gov/docket/NRC-2025-0064. For additional
direction on obtaining information and submitting comments, see
``Obtaining Information and Submitting Comments'' in the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Gerond A. George, Office of Nuclear
Material Safety and Safeguards, telephone: 301-415-3882, email:
Gerond.George@nrc.gov, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2025-0064 when contacting the NRC
about the availability of information for this action. You may obtain
publicly available information related to this action by any of the
following methods:
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-0064.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Documents collection at https://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 PDR.Resource@nrc.gov. For the convenience of the reader,
instructions about obtaining materials referenced in this document are
provided in the ``Availability of Documents'' section.
NRC's PDR: The PDR, where you may examine and order copies
of publicly available documents, is open by appointment. To make an
appointment to visit the PDR, please send an email to
PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8
a.m. and 4 p.m. ET, Monday through Friday, except Federal holidays.
B. Submitting Comments
The NRC encourages electronic comment submission through the
Federal Rulemaking website (https://www.regulations.gov). Please
include Docket ID NRC-2025-0064 in your comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at
https://www.regulations.gov as well as enter the comment submissions
into ADAMS. The NRC does not routinely edit comment submissions to
remove identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Background
The Certificate of Compliance (CoC or certificate) is the NRC
approved design for each dry cask storage system. Section 72.48 of
title 10 of the Code of Federal Regulations (10 CFR), ``Changes, tests,
and experiments,'' establishes the conditions under which an
Independent Spent Fuel Storage Installation (ISFSI) licensee, a
monitored retrievable storage installation (MRS) licensee, a general or
specific licensee, or a spent fuel storage cask certificate holder may
make changes to the ISFSI facility, MRS, spent fuel storage cask
design, or procedures, and under which they may conduct tests or
experiments, without prior NRC approval. In addition to the 10 CFR
72.48 change review process, paragraph (b)(7) of 10 CFR 72.212,
``Conditions of general license issued under Sec. 72.210,'' also
requires the general licensee to evaluate any changes to written
[[Page 14918]]
evaluations required by paragraphs (b)(5) and (6) of 10 CFR 72.212,
using the requirements of 10 CFR 72.48(c). Moreover, there are various
provisions in 10 CFR 72.212, such as paragraphs (a)(2), (b)(3),
(b)(5)(i), and (b)(11), that require general licensees to ensure they
use casks that conform to the terms, conditions and specifications of a
CoC listed in 10 CFR 72.214.
Therefore, if a general licensee wishes to adopt a change initiated
by the CoC holder under the CoC holder's 10 CFR 72.48 change authority,
then a general licensee must perform a separate 10 CFR 72.48 review as
required by the regulations. Additionally, if a general licensee adopts
a CoC holder's change made under 10 CFR 72.48 and that change is later
determined to be non-compliant, the general licensee would also be in
noncompliance with provisions of 10 CFR 72.48 and 72.212.
The NRC seeks to implement a more efficient process in which the
staff addresses CoC holders' apparent violations of the 10 CFR 72.48
change control process without pursuing an enforcement action against
the general licensee for an apparent violation that is strictly due to
the general licensee's adoption of a non-compliant change made under
Sec. 72.48 by the CoC holder. The NRC also seeks to implement a more
efficient process for general licensees to review and adopt changes
made by a CoC holder, pursuant to the CoC holder's Sec. 72.48 change
authority, as long as the general licensee does not need to make any
site-specific technical changes. Accordingly, the staff is considering
rulemaking, including potential interpretation of the applicable
regulations, and revision of the implementation guidance.
III. Discussion
A. Rulemaking
The NRC published a final rule on October 4, 1999 (64 FR 53582),
that revised 10 CFR 72.48 to clarify the specific types of changes,
tests, and experiments conducted at a licensed facility or by a
certificate holder that require evaluation, and revised the criteria
that licensees and certificate holders must use to determine when NRC
approval is needed before such changes, tests, or experiments can be
implemented. The Commission approved the publication of the final rule
in SECY-99-130, ``Final Rule--Revisions to Requirements of 10 CFR parts
50 and 72 Concerning Changes, Tests, and Experiments.''
The preamble to the final rule for 10 CFR 50.59 and 72.48 stated
the following in Section O.1, ``Part 72 Changes,'' provided on page
53601: ``The Commission envisioned that a general licensee who wants to
adopt a change to the design of a spent fuel storage cask it
possesses--which change was previously made to the generic design by
the certificate holder under the provisions of Sec. 72.48--would be
required to perform a separate evaluation under the provisions of Sec.
72.48 to determine the suitability of the change for itself.'' As
indicated by the rule and supported by the preamble, both the CoC
holder and general licensee are required to perform an evaluation when
implementing a change made by a CoC holder pursuant to Sec. 72.48.
The NRC staff may request that the Commission revise its
regulations or interpretation of existing regulations to establish that
CoC holders and general licensees have different obligations. The NRC
staff may seek this change because both entities have separate quality
assurance programs, and the NRC staff performs inspections of each
change control process on a regular basis, which would provide
reasonable assurance of safety and increase regulatory efficiency.
Specifically, the efficiency will be realized by streamlining the
inspections associated with the evaluation of the changes to occur for
(1) CoC holders and (2) general licensees only if additional changes
are made.
B. Summary
This IEP would allow staff to exercise enforcement discretion for
certain general licensee violations of 10 CFR 72.48 and 72.212 related
to the general licensee's adoption of a CoC holder generated
modification. This proposed IEP would allow for better efficiency and
reliability of spent fuel storage cask inspection oversight, while
still providing adequate protection of public health and safety. The
staff is proposing this IEP due to the NRC's operational experience
with its inspection and oversight of general licensees' adoption of CoC
holders' Sec. 72.48 changes. Certificate holders are NRC-regulated
entities that are required to (1) ensure their storage casks meet NRC
requirements and the Certificate of Compliance and (2) perform design
changes in accordance with Sec. 72.48; the NRC inspects their
processes. In addition, the staff recognizes that a general licensee
who wants to adopt a change to the design of a spent fuel storage cask
it possesses--where the change was previously made by the certificate
holder under the provisions of Sec. 72.48--must perform a review of
that change for their site under a variety of other processes in
addition to Sec. 72.48, including those set forth in paragraphs (b)(5)
and (6) of Sec. 72.212, and in the general licensee quality assurance
program. The combination of these review and oversight processes,
together with other existing inspection and oversight processes,
provide confidence that the general licensee has appropriately
considered changes made by CoC holders and appropriately evaluated the
potential safety implications of implementing those changes at its
site. For these reasons, the staff determined that this proposed IEP
continues to provide adequate protection of public health and safety
while enabling the safe and secure use of civilian nuclear energy
technologies. The staff believes this approach also aligns with the
NRC's new mission statement and the Principles of Good Regulation.
The NRC staff plans to review the regulations in 10 CFR part 72 and
guidance documents to determine if the NRC staff needs to consider
rulemaking, including potential interpretation of the applicable
regulations, and/or revising guidance to clarify the requirements in 10
CFR part 72.
IV. Paperwork Reduction Act
This proposed policy statement does not contain any new or amended
collections of information subject to the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.). Existing collections of information were
approved by the Office of Management and Budget (OMB), approval numbers
3150-0132 and 3150-0136.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless the document requesting
or requiring the collection displays a currently valid OMB control
number.
V. Availability of Documents
The documents identified in the following table are available to
interested persons as indicated.
[[Page 14919]]
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ADAMS accession No./ Federal Register
Document citation
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Final Rule: ``Changes, 64 FR 53582
Tests, and Experiments,''
October 4, 1999.
SECY-99-130, ``Revisions to ML992810140
Requirements of 10 CFR
Parts 50 and 72 Concerning
Changes, Tests, and
Experiments,'' May 12, 1999.
Staff Requirements ML003751724
Affirmation Session, June
22, 1999.
NEI 12-04, ``Guidelines for ML18250A255
10 CFR 72.48
Implementation,'' Revision
2, September 2018.
Regulatory Guide 3.72, ML20220A185
``Guidance for
Implementation of 10 CFR
72.48, Changes, Tests, and
Experiments,'' Revision 1,
September 2020.
NRC Enforcement Policy, ML24205A249
August 23, 2024.
Principles of Good ML15083A026
Regulation, April 6, 1990.
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The text of the Interim Enforcement Policy is attached.
Dated at Rockville, Maryland, this 1st day of April 2025.
For the Nuclear Regulatory Commission.
David Pelton,
Director, Office of Enforcement.
Attachment--Proposed Interim Enforcement Policy--Section 9.X,
Enforcement Discretion for General Licensee Adoption of CoC Holder-
Generated Changes Under 10 CFR 72.48
Proposed Interim Enforcement Policy--Section 9.X, Enforcement
Discretion for General Licensee Adoption of CoC Holder-Generated
Changes Under 10 CFR 72.48
9.X Enforcement Discretion for General Licensee Adoption of
Certificate of Compliance Holder-Generated Changes Under 10 CFR
72.48
This section sets forth the Interim Enforcement Policy (IEP)
that the NRC will use to exercise discretion for the disposition of
violations involving a General Licensee's (GL's) adoption of a
Certificate of Compliance (CoC) holder-generated change made under
the CoC holder's change authority of Section 72.48 of title 10 of
the Code of Federal Regulations (10 CFR), ``Changes, tests, and
experiments.'' The current NRC regulations state:
10 CFR 72.212, in a number of regulatory provisions,
such as 72.212(a)(2), 72.212(b)(3), 72.212(b)(5)(i), and
72.212(b)(11), requires a GL to ensure it uses casks that conform to
the terms, conditions and specifications of a CoC listed in 10 CFR
72.214.
10 CFR 72.212(b)(5) requires that the GL, before use
and before applying changes authorized by an amended CoC to a cask
loaded under the initial CoC or an earlier amended CoC, perform
written evaluations to establish that the storage cask, once loaded,
will conform to terms and conditions of the CoC.
10 CFR 72.212(b)(6) requires that the GL review, and
document the review of, the Safety Analysis Report referenced in the
CoC or amended CoC and the related NRC Safety Evaluation Report, to
determine whether or not the reactor site parameters are enveloped
by the cask design bases considered in these reports.
10 CFR 72.212(b)(7) requires the GL to evaluate any
changes to written evaluations required by paragraphs (b)(5) and (6)
of 10 CFR 72.212, using the requirements of 10 CFR 72.48(c).
10 CFR 72.48, as published on October 4, 1999 (64 FR
53582) and amended on February 26, 2001 (66 FR 11527), has
provisions under which general and specific licensees and CoC
holders may make changes to the facility or spent fuel storage cask
design as described in the Final Safety Analysis Report without
obtaining NRC review and approval. Change means a modification or
addition to, or removal from, the facility or spent fuel storage
cask design 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.
Under the current NRC regulations, if a GL chooses to adopt a
change the CoC holder made pursuant to a CoC holder's change
authority under 10 CFR 72.48 (referred to herein as a ``CoC holder-
generated change''), a GL must perform a separate review using the
requirements of 10 CFR 72.48(c). This is in addition to the
requirement that the GL evaluate any additional resulting site-
specific, technical changes the GL makes to written evaluations
required by paragraphs (b)(5) and (6) of 10 CFR 72.212 using the
requirements of 10 CFR 72.48(c), when adopting the CoC holder's
change. Further, the GL is required, by various provisions of 10 CFR
72.212, to only use casks that conform to the terms, conditions and
specifications of a CoC listed in 10 CFR 72.214.
Accordingly, when a GL chooses to adopt a CoC holder-generated
change, and that change results in a non-conforming cask, there is a
violation of 10 CFR 72.48 and certain provisions of 10 CFR 72.212 by
the GL, in addition to a CoC holder violation of 10 CFR 72.48. And,
when a GL chooses to adopt a CoC holder-generated change without
performing a separate 10 CFR 72.48 analysis, the GL is in violation
of 10 CFR 72.48.
These requirements have led to enforcement actions issued
against both the GL's 10 CFR 72.48 program (as well as certain 10
CFR 72.212 violations) and CoC holder's 10 CFR 72.48 program for
changes that originated with the CoC holder. The NRC has concluded
that this enforcement approach is inconsistent with efficiency,
which is one of the NRC's Principles of Good Regulation, and NRC's
mission of efficient and reliable oversight.
The NRC staff will review the regulations in 10 CFR part 72 and
guidance documents to determine what changes are needed to focus
requirements on the entity that initiated the change. Until such
time as regulatory changes are developed, the Interim Enforcement
Policy will be:
(1) The NRC will exercise enforcement discretion and not issue
an enforcement action to a GL, for a noncompliance with the
requirements of paragraphs (c)(1) and (2) and (d)(1) of 10 CFR 72.48
and with provisions of 10 CFR 72.212 that require GLs to ensure use
of casks that conform to the terms, conditions and specifications of
a CoC listed in 10 CFR 72.214, when the noncompliance results from a
CoC holder's failure to comply with 10 CFR 72.48 for a CoC holder-
generated change. In granting this discretion, the GL will be
expected to come into compliance with the 72.212 provisions that
require each cask to conform to the terms, conditions, and
specifications of a CoC or an amended CoC listed in Sec. 72.214
using established processes. The NRC staff will monitor the GL's
actions to determine if additional regulatory actions will be
necessary.
(2) The NRC will exercise enforcement discretion and not issue
an enforcement action to the GL for failure to perform a 10 CFR
72.48 screening and/or evaluation when the GL adopts a CoC holder-
generated change that does not result in the GL making a change to
the site-specific, technical aspects of the GL's 10 CFR 72.212
report.
(3) When the GL adopts a CoC holder-generated change and the
accompanying 10 CFR 72.48 screening and/or evaluation that was
performed by the CoC holder, the GL does not have to perform a
separate 10 CFR 72.48 evaluation of CoC holder-generated changes.
The GL only needs to review the CoC holder's change for
applicability to their spent fuel storage cask and for impact on the
site-specific, technical evaluations and analyses described in the
10 CFR 72.212 report, and site programs and procedures. The NRC's
inspections of the GL and enforcement actions against the GL will
focus on the GL's assessment for the site-specific applicability of
the CoC holder-generated change to its spent fuel storage cask.
(4) The GL is responsible for performing written evaluations to
establish that the storage cask conforms to terms and conditions of
the CoC, in accordance with paragraphs (b)(5) and (6) of 10 CFR
72.212. If the GL chooses to adopt a CoC holder-generated change,
the GL does not need to follow the requirements of 10 CFR
72.212(b)(7) unless the GL determines that GL-initiated site-
specific, technical changes are needed to the GL's written
evaluations required by paragraphs (b)(5) and (b)(6) of 10 CFR
72.212. Additionally, the GL is responsible for ensuring compliance
with
[[Page 14920]]
applicable requirements of Appendix B to 10 CFR part 50, ``Quality
Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing
Plants,'' and Subpart G to 10 CFR part 72, ``Quality Assurance.''
(5) NRC enforcement actions will focus on the entity that
initiated the change. The CoC holder will be accountable for a
noncompliance identified within CoC holder-generated 10 CFR 72.48
screenings and/or evaluations of a change made pursuant to the CoC
holder's 10 CFR 72.48 change authority. The GL will be accountable
for any noncompliance identified within GL-initiated changes.
An enforcement panel is not required to disposition a
noncompliance using this discretion; however, each time discretion
is granted, an enforcement action number will be assigned to
document the use of discretion under this IEP.
This IEP will remain in place until the underlying regulatory
issue is dispositioned through rulemaking or other regulatory
action.
[FR Doc. 2025-05899 Filed 4-4-25; 8:45 am]
BILLING CODE 7590-01-P