[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Rules and Regulations]
[Pages 106234-106253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30721]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 2, 20, 26, 50, 51, 55, 73, 140, 170, and 171
[NRC-2011-0087]
RIN 3150-AI96
Non-Power Production or Utilization Facility License Renewal
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule and guidance; issuance.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its
regulations that govern the license renewal process for certain
production or utilization facilities. In this final rule, the NRC
collectively refers to these facilities as non-power production or
utilization facilities (NPUFs). This final
[[Page 106235]]
rule revises the definitions of ``non-power reactor,'' ``research
reactor,'' and ``testing facility.'' This final rule also eliminates
license terms for licenses for facilities used for medical therapy or
research and development, other than testing facilities; these licenses
are issued under the authority of Sections 104a or 104c of the Atomic
Energy Act of 1954, as amended (AEA). This final rule defines the
license renewal process for licenses issued to testing facilities under
the authority of Section 104c of the AEA or commercial or industrial
NPUFs (including testing facilities) under the authority of Section 103
of the AEA. This final rule requires all NPUF licensees to submit to
the NRC final safety analysis report (FSAR) updates at intervals not to
exceed 5 years. In addition, this final rule provides an accident dose
criterion of 1 Roentgen equivalent man (rem) (0.01 sievert [Sv]) total
effective dose equivalent (TEDE) for NPUFs other than testing
facilities. The NRC is also issuing final implementation guidance for
this final rule.
DATES: This final rule is effective on January 29, 2025.
ADDRESSES: Please refer to Docket ID NRC-2011-0087 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-2011-0087. Address
questions about NRC dockets to Helen Chang; telephone: 301-415-3228;
email: [email protected]. For technical questions, contact the
individuals listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
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, at 301-415-4737,
or by email to [email protected]. 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
[email protected] or call 1-800-397-4209 or 301-415-4737, between 8
a.m. and 4 p.m. eastern time, Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: Robert Beall, Office of Nuclear
Material Safety and Safeguards, telephone: 301-415-3874, email:
[email protected] and Duane Hardesty, Office of Nuclear Reactor
Regulation, telephone: 301-415-3724, email: [email protected].
Both are staff of the U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
SUPPLEMENTARY INFORMATION:
Executive Summary
A. Need for the Regulatory Action
In April 2008, the Commission issued staff requirements memorandum
(SRM) M080317B, ``Briefing on State of NRC Technical Programs,'' which
directed the staff to ``examine the license renewal process for non-
power reactors and identify and implement efficiencies to streamline
this process while ensuring that adequate protection of public health
and safety are maintained.'' The need for improvement in the
reliability and efficiency of the license renewal process was primarily
driven by four issues: (1) historic NRC priorities and emergent issues;
(2) limited licensee resources; (3) inconsistent existing license
infrastructure; and (4) regulatory requirements and the broad scope of
the renewal process.
B. Major Provisions
The major provisions of this final rule include changes that:
Revise the definitions for Non-power reactor, Testing
facility, and Research reactor;
Eliminate license terms for medical therapy or research
and development facilities, other than testing facilities, licensed
under paragraphs (a) or (c) of Sec. 50.21 of title 10 of the Code of
Federal Regulations (10 CFR);
Define the license renewal process for all commercial or
industrial NPUFs (including testing facilities) licensed under Sec.
50.22 and testing facilities licensed under Sec. 50.21(c);
Require all NPUF licensees to submit an updated FSAR and
subsequent FSAR updates to the NRC at intervals not to exceed 5 years;
Amend the current timely renewal provision under Sec.
2.109, allowing NPUFs subject to license renewal to continue operating
under an existing license past its expiration date if the licensee
submits a license renewal application at least 2 years (rather than 30
days) before the current license expiration date;
Provide an accident dose criterion of 1 rem (0.01 Sv) TEDE
for NPUFs other than testing facilities;
Extend the applicability of Sec. 50.59 to NPUF licensees
regardless of their decommissioning status;
Clarify an NPUF applicant's requirements for meeting the
existing provisions of Sec. 51.45 for submitting an environmental
report; and
Eliminate the requirement for NPUF licensees to submit
financial qualification information with license renewal applications
under Sec. 50.33(f)(2).
Concurrent with this final rule, the NRC is issuing Regulatory
Guide (RG) 2.7, Revision 0, ``Preparation of Updated Final Safety
Analysis Reports for Non-Power Production or Utilization Facilities.''
C. Costs and Benefits
The NRC prepared a regulatory analysis to determine the expected
quantitative costs and benefits of this final rule and the final
implementing guidance, as well as qualitative factors to be considered
in the NRC's rulemaking decision. Based on the analysis, the NRC
concluded that this final rule will result in net savings to licensees
and the NRC. The analysis examined the benefits and costs of the final
rule requirements and the final implementing guidance compared to the
baseline for the current license renewal process (i.e., the no-action
alternative). Compared to the no-action baseline, the NRC estimates
that total net benefits to NPUFs (i.e., cost savings minus costs) will
be $5.5 million ($3.9 million using a 3-percent discount rate or $2.6
million using a 7-percent discount rate) over a 20-year period. The
average NPUF will receive net benefits ranging from approximately
$78,000 to $166,000 over a 20-year period. The NRC will receive total
net benefits of $12 million ($8.6 million using a 3-percent discount
rate or $5.9 million using a 7-percent discount rate) over a 20-year
period.
The regulatory analysis also considered, in a qualitative fashion,
additional benefits of this final rule and the final implementing
guidance associated with regulatory efficiency, protection of public
health and safety, promotion of the common defense and security, and
protection of the environment.
The regulatory analysis concluded that this final rule and the
final implementing guidance are justified because of the cost savings
received by both licensees and the NRC while public health and safety
are maintained. A detailed discussion of the
[[Page 106236]]
methodology and complete results is presented in the ``Regulatory
Analysis'' section of this document.
Table of Contents
I. Background
II. Discussion
III. Opportunity for Public Participation
IV. Public Comment Analysis
V. Section-by-Section Analysis
VI. Regulatory Flexibility Certification
VII. Regulatory Analysis
VIII. Backfitting
IX. Cumulative Effects of Regulation
X. Plain Writing
XI. Voluntary Consensus Standards
XII. Environmental Assessment and Final Finding of No Significant
Environmental Impact
XIII. Paperwork Reduction Act
XIV. Congressional Review Act
XV. Criminal Penalties
XVI. Availability of Guidance
XVII. Availability of Documents
I. Background
The NRC licenses NPUFs under the authority granted in Sections 103
and 104 of the AEA. Section 103 of the AEA applies to commercial and
industrial facilities, and Sections 104a and 104c of the AEA apply to
facilities used for medical therapy or research and development
activities, respectively. The section of the AEA that provides
licensing authority for the NRC corresponds directly to the class of
license issued to a facility (e.g., Section 104a of the AEA authorizes
the issuance of a ``class 104a'' license). Furthermore, Sections 104a
and 104c of the AEA require that the Commission impose the minimum
amount of regulation needed to promote the common defense and security;
protect the health and safety of the public; and permit, under Section
104a, the widest amount of effective medical therapy possible and,
under Section 104c, the conduct of widespread and diverse research and
development.
The NRC regulates 34 NPUFs, of which 29 are research reactors or
testing facilities currently licensed to operate. The NRC has issued
construction permits for two of the five remaining NPUFs (SHINE Medical
Technologies, Inc. (SHINE) and the Hermes-Kairos Testing facility),\1\
and the other three licensees are in the process of decommissioning
their facilities (i.e., removing a facility or site safely from service
and reducing residual radioactivity to a level that permits release of
the site for unrestricted use or use under restricted conditions). Most
NPUFs are located at universities or colleges throughout the United
States. The NRC regulates one operating testing facility at the
National Institute of Standards and Technology.
---------------------------------------------------------------------------
\1\ On May 18, 2018, the NRC issued a construction permit for
Northwest Medical Isotopes, LLC. That construction permit was
terminated on July 11, 2022.
---------------------------------------------------------------------------
A. License Terms
The AEA dictates an initial license term of no more than 40 years
for class 103 facilities, which the NRC licenses under Sec. 50.22, but
the AEA does not specify license terms for class 104a or 104c
facilities, which are licensed under Sec. 50.21(a) or (c). The
regulation that implements this statutory authority, Sec. 50.51(a),
currently specifies that the NRC may grant an initial license for NPUFs
for no longer than a 40-year license term. If the NRC initially issues
a license for a shorter period, then it may renew the license by
amendment for a maximum aggregate period not to exceed 40 years. An
NPUF license is usually renewed for a term of 20 years. If the
requested renewal would extend the license beyond 40 years from the
date of issuance, the original license may not be renewed by amendment.
Rather, the NRC must issue a renewed license that supersedes the
initial license.
Any application for license renewal must include an FSAR
describing: (1) changes to the facility or facility operations
resulting from new or amended regulatory requirements, and (2) changes
and effects of changes to the facility or procedures and new
experiments. The FSAR must include the elements specified in Sec.
50.34. The NRC has guidance for preparing the FSAR in NUREG-1537, Part
1, ``Guidelines for Preparing and Reviewing Applications for the
Licensing of Non-Power Reactors: Format and Content.'' The NRC reviews
NPUF initial and renewal license applications using NUREG-1537, Part 2,
``Guidelines for Preparing and Reviewing Applications for the Licensing
of Non-Power Reactors: Standard Review Plan and Acceptance Criteria.''
As a license term nears its end, a licensee must submit a license
renewal application to continue operations. A ``timely renewal''
provision exists in Sec. 2.109(a) to enable operations to continue
beyond the license term during the NRC's review of a license renewal
application. If the licensee files an application for a renewal or for
a new license for the authorized activity at least 30 days before the
expiration of an existing license, the existing license will not be
deemed to have expired until the application has been finally
determined.
B. Need for Improvement in the License Renewal Process
In 2008, the NRC recognized a need to identify and implement
efficiencies in the NPUF license renewal process while ensuring that
adequate protection of public health and safety is maintained. Four
issues primarily drove this effort to improve the reliability and
efficiency of the process.
1. Historic NRC Priorities and Emergent Issues
Under the Atomic Energy Commission (AEC), the NRC's predecessor
agency, NPUFs were some of the first reactors licensed and the first
reactors to undergo license renewal. Most of these reactors were
initially licensed in the late 1950s and 1960s for terms that varied
from 10 to 40 years. The AEC started renewing these licenses in the
1960s. License renewal was primarily an administrative activity until
1976, when the NRC decided to also conduct a technical review
equivalent to the initial licensing of the facility. The licenses that
had been issued with initial 20-year terms were due for renewal during
this timeframe. As the NRC started developing methods for conducting
these technical reviews, an accident occurred at Unit 2 of the Three
Mile Island (TMI) nuclear power plant.
The NRC's focus on post-TMI activities resulted in a suspension of
NPUF license renewal activities for several years. After license
renewal activities were reinitiated, the NRC issued numerous renewals
in a short period of time, primarily by relying on generic evaluations.
These 20-year renewals expired starting in the late 1990s. The original
licenses issued with 40-year terms also started expiring in the late
1990s, creating a new surge of license renewal applications.
As a result of the NRC's response to the events of September 11,
2001, the NRC deferred work on a number of NPUF license renewal
applications. In addition, the NRC's NPUF licensing activities focused
on implementing Sec. 50.64, ``Limitations on the use of highly
enriched uranium (HEU) in domestic non-power reactors,'' to convert
non-power reactors to the use of low-enriched uranium. Therefore,
reviews of these license renewal applications extended for many years.
In all cases, the timely renewal provision enabled these NPUFs to
continue operating during the NRC's review period.
2. Limited Licensee Resources
Many NPUF licensees have limited staff resources available for
licensing
[[Page 106237]]
support. The number of NPUF staff can range from one part-time employee
for some low-power facilities to four or five full-time employees for
higher-power facilities. The NPUF staff that perform the licensing
function typically do so in addition to their normal organizational
responsibilities, which often results in delays in the license renewal
process, particularly in responding to the NRC's requests for
additional information.
3. Inconsistent Existing License Infrastructure
The NPUFs licensed under Sec. 50.21(a) or (c) are primarily at
college and university sites. Staff turnover and limited staffing
resources at an NPUF often contribute to a lack of historical knowledge
of the development of the licensee's FSAR and changes to the FSAR.
During the most recent round of license renewals, the NRC found that
some of the submitted FSARs did not adequately reflect the current
licensing bases for the respective licensees. Because the only required
FSAR submission comes at license renewal, which can be at 20-year or
greater intervals, submitted FSARs often contain varying levels of
completeness and accuracy. Consequently, the NRC has issued requests
for additional information to obtain missing information, seek
clarifications and corrections, and document the current licensing
basis.
4. Regulatory Requirements and Broad Scope of the Renewal Process
For power reactors, license renewal reviews have a defined scope,
primarily focused on aging management, as described in 10 CFR part 54.
For NPUFs, there are no explicit requirements on the scope of issues to
be addressed during license renewal. Therefore, the scope of review for
license renewal was initially treated the same as that for an original
license.
In response to Commission direction in SRM-SECY-91-061,
``Separation of Non-Reactor and Non-Power Reactor Licensing Activities
from Power Reactor Licensing Activities in 10 CFR part 50,'' the NRC
developed licensing guidance for the first time since many NPUF
applicants were originally licensed. In that guidance (NUREG-1537,
Parts 1 and 2), the NRC provides detailed descriptions of the scope,
content, and format of FSARs and the NRC's process for reviewing
initial license applications and license renewal applications. However,
the first license renewals using NUREG-1537 had varying levels of
consistency and did not propose an acceptable alternative to the
guidance. This resulted in the NRC sending requests for additional
information and some of the issues already described in Section I.B. of
this document.
C. NRC Response to These Issues
As a result of these issues, a backlog of NPUF license renewal
applications developed and persisted. The Commission and other
stakeholders voiced concerns not only about the backlog, but also about
the burdensome nature of the license renewal process itself. The
Commission issued SRM-M080317B, ``Briefing on State of NRC Technical
Programs,'' in April 2008, directing the staff to ``examine the license
renewal process for non-power reactors to identify and implement
efficiencies to streamline this process while ensuring that adequate
protection of public health and safety are maintained.''
In October 2008, the staff provided the Commission with plans to
improve the review process for NPUF license renewal applications in
SECY-08-0161, ``Review of Research and Test Reactor License Renewal
Applications.'' In SECY-08-0161, the staff summarized a public meeting
held with stakeholders to gather feedback on the current process, ways
the process could be improved, and options for improving the review
process. The staff provided a detailed description of five options for
streamlining the NPUF license renewal process:
An ``alternate safety review approach'' that would limit
the review of license renewal applications to changes to the facility
since the previous license review occurred. Safe operation of the
facility would be assured by the review of changes to the facility,
compliance with the current regulations, the previous NRC analysis, and
the NRC's inspection process.
A ``graded approach'' that would base the areas of review
on the relative risk associated with the facility applying for a
renewed license. The graded approach would ensure safe operation by
properly identifying the inherent risk associated with the facility and
ensuring those risks are minimized.
A ``generic analysis approach'' that would require the NRC
to review and approve a generic reactor design similar to the NRC
topical report process. The NRC would rely on the previously approved
generic analysis and would not reanalyze those items.
A ``generic siting analysis approach'' that would require
the NRC to develop a generic communication that contains information
related to each of the licensee sites. The licensees could then
reference this generic communication in their license renewal
submittals.
An ``extended license term approach'' would permit
extended or indefinite terms for NPUF licenses. The staff described
this approach in SECY-08-0161:
In order to permit an extended term (including possibly an
indefinite term), the staff would have to explain why it is
appropriate and, more importantly, demonstrate that there are no
aging concerns.
Environmental conditions such as temperature, pressure and
radiation levels in most [research and test reactors] are not
significant. With surveillance, maintenance and repair, [research
and test reactors] can have indefinite lives.
For a facility to be eligible for an extended license term, the
staff would complete a detailed renewal with a licensing basis
reviewed against NUREG-1537. To maintain the licensing basis over
time, the staff would propose a license condition or regulation that
requires licensees to revise their [safety analysis reports] on a
periodic basis such as every 2 years. The inspection program would
be enhanced to place additional focus on surveillance, maintenance
and repair, and changes to the facility made under 10 CFR 50.59. The
licensee would still be required to adhere to changes in the
regulations.
The Commission issued SRM-SECY-08-0161, ``Review of Research and
Test Reactor License Renewal Applications,'' in March 2009. The
Commission directed the staff to: (1) immediately implement short-term
program initiatives to address the backlog of license renewal
applications; (2) work with the regulated community and other
stakeholders to develop an interim streamlining process to focus the
review on the most safety-significant aspects of the license renewal
application; and (3) streamline the review process to ensure that it
becomes more efficient and consistent, thereby reducing uncertainties
in the process while ensuring compliance with regulatory requirements.
As part of its direction to develop the program initiatives, the
Commission instructed the staff to implement a graded approach
commensurate with the risk posed by each facility, incorporate elements
of the alternate safety review approach, and use risk insights from
security assessments to inform the dose threshold. In addition, the
Commission told the staff to develop an interim staff guidance (ISG)
document that employs the graded approach to streamline the license
renewal application process.
Lastly, the Commission instructed the staff to submit a long-term
plan for an enhanced NPUF license renewal process. The Commission
directed that the plan include development of a basis
[[Page 106238]]
for redefining the scope of the process as well as a recommendation
regarding the need for rulemaking and guidance development.
The staff responded to the Commission's direction by implementing
short-term actions to address the license renewal application backlog
and developing ISG-2009-001, ``Interim Staff Guidance on the
Streamlined Review Process for License Renewal for Research Reactors,''
hereafter referred to as the ISG. The ISG called for employing a graded
approach to streamline the license renewal application process. Since
October 2009, the NRC has reviewed license renewal applications
according to the streamlined review process presented in the ISG. The
ISG identified the three most safety-significant sections of an FSAR:
reactor design and operation, accident analysis, and technical
specifications. The NRC also has reviewed licensees' radiation
protection and waste management programs and compliance with financial
requirements. The ISG divided facilities into two groups: (1) those
facilities with licensed power of less than 2 megawatts thermal
(MW(t)), which would undergo a limited review focusing on the safety-
significant aspects, considering the decisions and precedents set by
past NRC reviews; and (2) those facilities with licensed power of 2
MW(t) and greater, which would undergo a full review using NUREG-1537,
Part 2. The process outlined in the ISG facilitated the NRC's review of
license renewal applications and enabled the NRC to review applications
in a timelier manner.
In addition, the staff issued SECY-09-0095, ``Long-Term Plan for
Enhancing the Research and Test Reactor License Renewal Process and
Status of the Development and Use of the Interim Staff Guidance,'' in
June 2009, to provide the Commission with a long-term plan for
enhancing the NPUF license renewal process. In the long-term plan, the
staff proposed to develop a regulatory basis to support rulemaking to
streamline and enhance the NPUF license renewal process. The Commission
issued SRM-M090811, ``Briefing on Research and Test Reactor (RTR)
Challenges,'' in August 2009, which directed the staff to accelerate
the rulemaking to establish a more efficient, effective, and focused
regulatory framework.
D. 2012 Regulatory Basis
In August 2012, the staff completed the ``Non-Power Reactor (NPR)
License Renewal Rulemaking: Regulatory Basis Document,'' hereafter
referred to as the regulatory basis.\2\
---------------------------------------------------------------------------
\2\ At the time of publication of the regulatory basis, the
rulemaking title was ``Non-Power Reactor (NPR) License Renewal
Rulemaking.'' During the development of the proposed rule, the scope
of the rulemaking expanded to include licenses for certain
facilities that are not reactors, based upon recent license
applicants (e.g., for medical radioisotope irradiation and
processing facilities). In order to encompass all affected entities,
the NRC has changed the title of the rulemaking to ``Non-power
Production or Utilization Facility License Renewal.''
---------------------------------------------------------------------------
The NRC, in the regulatory basis, analyzed the NPUF license renewal
process's technical, legal, and policy issues; effects on public
health, safety, and security; effects on licensees; effects on the NRC;
and stakeholder feedback. The NRC also considered lessons learned from
implementation of the streamlined review process outlined in the ISG.
The NRC concluded that a rulemaking was warranted. A public meeting was
held on August 7, 2014, to discuss the regulatory basis and rulemaking
options. The NRC held another public meeting on October 7, 2015, to
afford stakeholders the opportunity to provide feedback and comment on
preliminary proposed rule concepts. Participant comments and questions
focused on the potential effects of eliminating license terms, the
scope of review under the new process, and how the amended regulation
would work compared to the existing license renewal process. The NRC
considered the comments when developing the proposed rule.
E. 2017 Proposed Rule
On March 30, 2017, the NRC published the proposed rule, ``Non-Power
Production or Utilization Facility License Renewal'' in the Federal
Register (82 FR 15643). The NRC proposed to eliminate license terms for
facilities used for medical therapy or research and development
licensed under the authority of Sections 104a or 104c of the AEA, other
than for testing facilities. Other proposed amendments addressed the
license renewal process for licenses issued to testing facilities under
the authority of Section 104c of the AEA and licenses issued to non-
power commercial facilities under the authority of Section 103 of the
AEA (including testing facilities). The proposed rule also included a
provision to require all NPUF licensees to submit FSAR updates to the
NRC every 5 years. The NRC also proposed an accident dose criterion of
1 rem (0.01 Sv) TEDE for NPUFs other than testing facilities. The NRC
requested public feedback on specific questions, including the
criteria, other than power level, to use when determining the
applicability of requirements for low-risk commercial production or
utilization facilities and low-risk testing facilities. The proposed
rule provided a public comment period of 75 days. The NRC received 16
comment submissions on the proposed rule and draft implementation
guidance, as discussed further in Section IV of this document. The NRC
considered those comments in developing this final rule.
II. Discussion
This final rule: (1) revises the definitions for Non-power reactor,
Research reactor, and Testing facility; (2) eliminates license terms
for NPUFs licensed under Sec. 50.21(a) or (c), other than testing
facilities; (3) defines the license renewal process for NPUFs
(including testing facilities) licensed under Sec. 50.22 and testing
facilities licensed under Sec. 50.21(c); (4) requires all NPUF
licensees to submit to the NRC an updated FSAR and subsequent FSAR
updates at intervals not to exceed 5 years; (5) amends the current
timely renewal provision under Sec. 2.109, allowing an NPUF subject to
license renewal to continue operating under an existing license past
its expiration date if the licensee submits a license renewal
application at least 2 years before the current license expiration
date; (6) provides an accident dose criterion of 1 rem (0.01 Sv) TEDE
for NPUFs other than testing facilities; (7) extends the applicability
of Sec. 50.59 to NPUFs regardless of their decommissioning status; (8)
clarifies the requirements for NPUF license applicants to meet the
existing provisions of Sec. 51.45; and (9) eliminates the requirement
to submit financial qualification information with license renewal
applications under Sec. 50.33(f)(2).
This final rule enhances the effectiveness and efficiency of the
NPUF license renewal process, consistent with the AEA's criterion for
imposing minimum regulation on facilities of these types that is needed
to promote the common defense and security and protect the health and
safety of the public. Each of the nine main objectives of this final
rule are discussed in detail in this section.
1. Revises the definitions for Non-power reactor, Research reactor,
and Testing facility.
This final rule addresses inconsistencies in definitions and
terminology throughout 10 CFR chapter I to improve clarity in
determining the applicability of the regulations associated with NPUFs
as defined in Sec. 50.2.
The NRC received public comments on the proposed definition of Non-
[[Page 106239]]
power production or utilization facility. In reviewing the comments,
the NRC identified that the proposed definition for Non-power
production or utilization facility was too broad for defining
production facilities that are NPUFs. Previously, the definition
excluded fuel reprocessing plants, but did not exclude production
facilities designed or used primarily for the formation of plutonium or
uranium-233 or designed or used for the separation of the isotopes of
plutonium. Ultimately, the NRC did not revise the definition for Non-
power production or utilization facility because an appropriate
definition to exclude all production facilities as defined under
paragraphs (1) and (2) of the definition of Production facility in
Sec. 50.2 was added by the rule on Emergency Preparedness for Small
Modular Reactors and Other New Technologies (88 FR 80050; November 16,
2023). Production facilities of the type defined under paragraph (1) of
the definition of Production facility in Sec. 50.2 have been owned by
the U.S. Department of Energy to produce plutonium or uranium-233 and
have not been NRC licensees. If such a facility were to be licensed by
the NRC, the facility's particular use of special nuclear material
would require the Commission to determine the licensing path for the
facility. Production facilities, as defined under paragraph (2) of the
definition of Production facility in Sec. 50.2, are not NPUFs because
these facilities have a higher potential of radiological risk to the
environment and the public than NPUFs (e.g., an inventory of high-level
liquid radioactive wastes). This higher risk is evidenced by the
applicability to these facilities of NRC regulations in appendix B to
10 CFR part 50, ``Quality Assurance Criteria for Nuclear Power Plants
and Fuel Reprocessing Plants'' and appendix F to 10 CFR part 50,
``Policy Relating to the Siting of Fuel Reprocessing Plants and Related
Waste Management Facilities.'' The definition of Non-power production
or utilization facility in Sec. 50.2 excludes production facilities
designed or used primarily for the formation of plutonium or uranium-
233 or the separation of the isotopes of plutonium.
The NRC also received a comment from the National Institute of
Standards and Technology on the definition of Testing facility in Sec.
50.2 and Research reactor in Sec. 171.11(b)(2). The commenter
recommended that the NRC revise the definitions of Testing facility and
Research reactor to ``remove the arbitrary 10 MW(t) threshold, and
apply instead a risk-based approach to its regulation of a testing
facility.'' Further, the commenter stated that the risk ``is best
quantified by accident analyses performed under a licensing safety
analysis'' and linked the recommended definition to the NRC's accident
dose criterion of 1 rem (0.01 Sv) in the proposed rule.
The technical basis associated with the 10 MW(t) threshold under
the current definition for Testing facility, while generally based on
safety significance, is not explicitly documented. Similarly, the
technical basis for the 1 MW(t) threshold (coupled with specific design
features) under the current definition for Testing facility is not
explicitly documented. These prescriptive power thresholds do not
account for the safety features that are engineered into the facility
design and those barriers that must be breached during an accident
before a release of radioactive material to the environment can occur.
Therefore, these thresholds do not accurately represent the risk
associated with a particular facility. For these reasons, the use of a
postulated accident dose is a more risk-informed, performance-based
approach, compared to using the power level of the reactor for
distinguishing between types of NPUFs, such as research reactors and
testing facilities. As a result of this public comment, the NRC revised
the definitions of Testing facility and Research reactor to reflect
this risk-informed approach by incorporating an accident dose criterion
of 1 rem (0.01 Sv) TEDE, the basis for which is discussed in section
II.6 of this document.
Additionally, the NRC is making conforming changes to the
definitions of Testing facility, Research reactor, and Non-power
reactor wherever these definitions appear throughout 10 CFR chapter I.
The regulations currently refer to many types of facilities that are
categorized as NPUFs, such as non-power reactors, research reactors,
training reactors, testing reactors, testing facilities, and critical
assemblies. The NRC reviewed each instance of these various terms in 10
CFR chapter I. Where appropriate in this final rule, the NRC added,
corrected, or standardized the terminology and definitions.
While this final rule revises the definition of Research reactor in
Sec. Sec. 170.3 and 171.5 to conform to other definitions in 10 CFR
chapter I, the NRC did not change the definition of Research reactor in
the specific exemption for Federally owned and State-owned research
reactors in Sec. 170.11(a)(9) or Sec. 171.11(b)(2). The current
definition in Sec. 171.11(b)(2) is based on the language of the
Omnibus Budget Reconciliation Act of 1990, as amended (Pub. L. 101-508)
(OBRA-90), a statutory requirement imposed by Congress. Further, a
substantively similar definition of Research reactor was included in
the provisions of the Nuclear Energy Innovation and Modernization Act
(Pub. L. 115-439) (NEIMA) that relate to the NRC's fee recovery
structure. Changing the definition of Research reactor in Sec.
171.11(b)(2) would therefore be inconsistent with OBRA-90 and NEIMA.
The definition of Research reactor in Sec. 170.11(a)(9) is not based
on OBRA-90, but the basis for that exemption from fees parallels the
basis for the exemption from annual fees in Sec. 171.11(b)(2).
Changing the definition of Research reactor in Sec. 170.11(a)(9) would
be a substantive change beyond the scope of this final rule.
Where appropriate, this final rule standardizes the terminology in
other parts of the regulations to modify the intended scope of
regulations citing Research and test reactors to be either Non-power
reactors or Non-power production or utilization facilities. For
example, this final rule changes Research and test reactors to Non-
power production or utilization facilities in appendix E to 10 CFR part
50, ``Emergency Planning and Preparedness for Production and
Utilization Facilities,'' while in Sec. 55.40, this final rule changes
Test and research reactors to Non-power reactors. Also, where
appropriate, the final rule changes the uses in other parts of the
regulations for Testing facility, Research reactor, and Non-power
reactor to reference only one definition in the part where that
definition is used most, unless the specific meaning is needed and
different for a given part. In addition, the final rule adds the
definition of Non-power reactor, as it is defined in Sec. 50.2, to the
definitions section in 10 CFR part 73 because the term is used many
times throughout that part. These changes increase clarity by defining
all NPUF-related terms consistently where they are most used in the
regulations.
This final rule also revises the definition of Non-power reactor to
distinguish between non-power reactors used for research and
development activities and non-power reactors used for commercial or
industrial purposes. Before this final rule, all non-power reactors
were defined in Sec. 50.2 as ``a research or test reactor licensed
under Sec. Sec. 50.21(c) or 50.22 of this part for research and
development.'' This final rule defines non-power reactors more
precisely as one of three mutually exclusive categories of facilities:
(1) testing facilities, (2) research reactors
[[Page 106240]]
that are NPUFs licensed under Sec. 50.21(c), or (3) commercial or
industrial reactors that are NPUFs licensed under Sec. 50.22. The
second and third categories exclude testing facilities, and the
facilities in those categories must meet the accident dose criterion in
Sec. 50.34(a)(1)(i). If they do not meet this criterion, then they
will be considered testing facilities.
2. Eliminates license terms for NPUFs, other than testing
facilities, licensed under Sec. 50.21(a) or (c).
The final rule language in Sec. 50.51(c) eliminates license terms
for NPUFs, other than testing facilities, licensed under Sec. 50.21(a)
or (c). Before this final rule, Sec. 50.51(a) stated, ``Each license
will be issued for a fixed period of time to be specified in the
license but in no case to exceed 40 years from date of issuance.'' This
included all facility licenses issued under 10 CFR part 50, including
licenses for facilities issued under Sec. 50.21(a) or (c). However,
the AEA does not establish specific license terms nor the need for
license terms for class 104 facilities.
Historically, license renewal afforded both the NRC and the public
the opportunity to re-evaluate the licensing basis of the NPUF. The
purpose of license renewal was to assess the likelihood of continued
safe operation of the facility, such that radioactive materials can be
used for beneficial civilian purposes in a safe and secure manner. For
several reasons that are unique to NPUFs, this objective can be
achieved through existing oversight activities and review of FSAR
updates submitted pursuant to the new requirements in Sec. 50.71(e) of
the final rule (see Section II.4. of this document). This approach is
consistent with the NRC's goal of efficient and effective licensing and
will implement and reflect lessons learned from decades of processing
license renewal applications. The NRC reached this conclusion based on
three considerations: (1) low overall radiological risk, (2) limited
aging-related issues, and (3) slow evolution of the design basis.
First, compared to power reactors, the NPUFs licensed under Sec.
50.21(a) or (c), other than testing facilities, operate at low power
levels, temperatures, and pressures, and have a small inventory of
fission products in the fuel. Therefore, these NPUFs present a lower
potential radiological risk to the environment and the public.
Additionally, the consequences of the maximum hypothetical accidents
(MHAs) for these facilities fall below the standards in 10 CFR part 20
for protecting the health and safety of the public.
Of the 30 NPUFs that are currently licensed to operate and are
eligible for non-expiring licenses (excluding the one testing
facility), 26 have cores that are submerged in tanks or pools of water
that provide sufficient passive decay heat removal to prevent
overheating of the fuel.\3\ Of these 26 licensed facilities, 24 are not
required to have emergency core cooling systems (ECCSs) because
conservative accident analyses have shown that these NPUFs do not
generate enough decay heat, even after extended operation at maximum
licensed power, to be at risk of overheating, failure of a fission
product barrier, or posing a threat to public health and safety.
Additionally, many of the licensees monitor for leaks by routinely
inspecting the facility, tracking and trending water inventory, and
performing surveillance on installed pool-level instrumentation and
sensors. Licensees sample the water periodically and analyze the
radioisotopes in the primary and, if applicable, secondary coolant.
Many licensees sample weekly for gross radioactive material content.
This data also is used to establish trends to quickly identify fuel or
heat exchanger failure. Most of these licensees analyze, in their
FSARs, pool and heat exchanger failures and the potential consequences
for the safety of the reactor, workers, and public. In general, the
radioisotope concentrations in pool or tank water at NPUFs are within
the effluent concentration limits specified in appendix B to 10 CFR
part 20, and therefore are not radiologically significant.
---------------------------------------------------------------------------
\3\ The three Aerojet-General Nucleonics reactors (University of
New Mexico (Docket No. 50-252), Idaho State University (Docket No.
50-284), and Texas A&M University (Docket No. 50-59)), each rated at
5 watts, and the University of Florida Argonaut reactor (Docket No.
50-83), rated at 100 kilowatts, are not considered tank or pool
reactors but have similarly low risk profiles.
---------------------------------------------------------------------------
Only two of the NPUFs eligible for non-expiring licenses are
required by their safety analyses to have an ECCS to maintain core
cooling in the highly unlikely case that a loss-of-coolant accident
uncovers the core.\4\ For these NPUFs, the ECCS is needed only to
direct flow into the top of the tank or pool to provide cooling for a
limited time after reactor shutdown. This period of time depends on the
recent operational history of the reactor, which determines the decay
heat present at reactor shutdown. After this relatively brief time, air
cooling is adequate to remove decay heat without the ECCS.
Additionally, required surveillance and testing of the ECCS at these
facilities help ensure the performance of the system. Operation of the
facility is not permitted if the ECCS has not been verified to be
operable before reactor startup or if the system is deemed inoperable
during reactor operation.
---------------------------------------------------------------------------
\4\ The two facilities are Massachusetts Institute of Technology
(MIT) (Docket No. 50-20) and the University of California/Davis
(Docket No. 50-607).
---------------------------------------------------------------------------
Second, the NRC has found that the simple design and operation of
these facilities yield a limited scope of aging-related concerns. There
have been no significant aging issues identified at the time of license
renewal because the NRC currently imposes aging-related surveillance
requirements on NPUFs via technical specifications, as needed. Aging of
components is specifically addressed in the standard review plan and
acceptance criteria used for evaluating license renewal applications
(i.e., NUREG-1537, Part 2). Parts 1 and 2 of NUREG-1537 document
lessons learned and known aging issues from prior reviews. Since NUREG-
1537 was published in 1996, NRC reviews and assessments have not
revealed any additional issues or need to update the NUREG.
Specifically, based on operating experience over the past 60 years and
review of license renewal applications over the past 40 years, and as
documented in NUREG-1537, Parts 1 and 2, the NRC has determined that
for NPUFs, the two main areas related to aging that could need
surveillance because of potential safety concerns are 1) fuel cladding
and 2) instrumentation and control features.
Regarding fuel cladding, the NRC currently requires NPUFs to
perform periodic fuel inspections. Through years of experience, the NRC
has found that aging-related fuel failures either do not occur, or
failures that do occur do not release significant amounts of fission
products and are quickly detected by existing monitoring systems and
surveillances. If fuel failures are detected, licensees are able to
take the facility out of service and remove any failed assemblies from
service.
With regard to instrumentation and control, the NRC has found that
failures in this area result in automatic facility shutdown. Failures
reveal themselves to the licensee and do not prevent safe shutdown.
Over the past 60 years of operation of these facilities, the potential
occurrence of age-related degradation has been successfully mitigated
through inspection, surveillance, monitoring, trending, recordkeeping,
replacement, and refurbishment. In addition, licensees are required to
report preventive and corrective maintenance activities in their annual
reports, which are reviewed by the NRC. This allows the NRC to identify
new aging issues if they occur. Therefore, the NRC has
[[Page 106241]]
concluded that existing requirements and facility design and
operational features will address concerns over aging-related issues
during a non-expiring license term.
Third, the design bases of these facilities evolve slowly over
time, with approximately five license amendment requests from all NPUF
licensees combined each year and, on average, only five Sec. 50.59
evaluations per facility per year for changes that do not require prior
NRC approval.
Given these considerations, the elimination of license terms for
medical therapy or research and development facilities, other than
testing facilities, licensed under Sec. 50.21(a) or (c), combined with
the addition of requirements for periodic FSAR submittals, will provide
a new framework for enabling licensees to continue to operate safely
while reducing burden on licensees and the NRC. The final rule at Sec.
50.71(e) requires licensees to submit updated FSARs and subsequent FSAR
updates to ensure that a facility's licensing basis is kept up-to-date,
a major function previously provided by the license renewal process,
while imposing significantly less burden on licensees. Eliminating
license terms for these licensees will allow the NRC to focus its
resources on oversight of these facilities, such as conducting routine
inspection activities and reviewing annual reports and FSAR updates.
Recurring FSAR updates by licensees and reviews by the NRC will
increase licensees' focus on maintaining their facilities' licensing
bases. Should the NRC identify potential issues with the facility's
continued safe operation in its reviews of FSAR updates, the Commission
can undertake regulatory actions specified in Sec. 2.202 to modify,
suspend, or revoke a license. In addition, the public will remain
informed about facility operations through the publicly available FSAR
submittals and will continue to have opportunities to participate in
the regulatory process through licensing actions and the Sec. 2.206
petition process. By eliminating license terms and requiring periodic
FSAR update submittals, coupled with existing oversight processes, the
NRC will reduce the burden on the affected licensees and the NRC, which
is consistent with the AEA and supports the NRC's goal of efficient and
effective licensing.
Most licenses of existing NPUFs licensed under Sec. 50.21(a) or
(c), other than testing facilities, will be modified by order to remove
the license terms after the effective date of this final rule (see
Section II.4. of this document). Facilities licensed under Sec.
50.21(a) or (c), other than testing facilities, that have undergone
relicensing using the guidance in NUREG-1537, Part 2 will be eligible
to receive a non-expiring license without again renewing the current
license. The current NPUF licensees that have not undergone the license
renewal process using the guidance in NUREG-1537, Part 2, will each
need to submit an application for license renewal if they wish to
continue facility operation beyond the current license term. The NRC
will review the application using NUREG-1537, Part 2, and the ISG. If
the NRC concludes that a licensee's application meets the standard for
issuing a renewed license, then the NRC would issue a non-expiring
renewed license. If, in the future, the NRC issues an operating license
to a new facility, other than a testing facility, under Sec. 50.21(a)
or (c), the license would be non-expiring and would be subject to
periodic FSAR submittal requirements applicable to all NPUF licensees.
This final rule makes conforming changes to requirements for
facilities that are decommissioning by revising Sec. 50.82(b) and (c).
These provisions currently use the expiration of the operating license
as a reference point to address license termination applications and
collection periods for shortfalls in decommissioning funding for NPUFs.
This final rule clarifies that NPUFs (including testing facilities)
licensed under Sec. 50.22 and testing facilities licensed under Sec.
50.21(c) are the only NPUFs with license expiration dates. The
reference point for NPUFs licensed under Sec. 50.21(a) or (c), other
than testing facilities, is the NPUF's permanent cessation of
operations.
3. Defines the license renewal process for NPUFs (including testing
facilities) licensed under Sec. 50.22 and testing facilities licensed
under Sec. 50.21(c).
For NPUFs (including testing facilities) licensed under Sec. 50.22
and testing facilities licensed under Sec. 50.21(c), this final rule
defines the license renewal process in Sec. 50.135. This one section
consolidates existing regulatory requirements (e.g., requirements
regarding written communications, application filing, application
contents, and the issuance of renewed licenses) for current and future
licensees. This final rule does not impose new regulations on these
facilities. The NRC also is making a conforming change to Sec. 50.8 to
reflect the approved information collection requirement of Sec.
50.135.
Section 103 of the AEA establishes a license term of no more than
40 years for commercial or industrial facilities licensed under Sec.
50.22. Although the AEA does not establish a fixed license term for
testing facilities, licensees for these facilities are currently
subject to additional license renewal requirements (e.g., siting
subject to 10 CFR part 100, Advisory Committee on Reactor Safeguards
review, and environmental impact statements) because of the potential
for higher radiological risks associated with their facilities' design,
operation, or use as compared to other class 104a or 104c licensees.
Therefore, all commercial or industrial NPUFs (including testing
facilities) licensed under Sec. 50.22 and testing facilities licensed
under Sec. 50.21(c) will continue to have fixed license terms and
undergo license renewal. As described in Sec. 50.135(c)(2), these
NPUFs will be able to submit a license renewal application to the
Commission no more than 10 years in advance of the expiration of the
operating license currently in effect. The requirement in Sec.
50.135(c)(2) is not intended to affect the term of operating licenses
granted to NPUFs.
The NRC is making renewed operating licenses for these facilities
effective, and thereby replacing the previous operating license,
immediately upon the date of issuance. The applicant for the renewed
license can propose a schedule for implementation of the renewed
licensee. This implementation schedule would ensure that the licensee
can make any necessary and conforming changes to the facility processes
and procedures required by the applicable conditions of the renewed
license. The NRC will review and make the schedule, if approved, a
condition of the renewed license. The immediate effectiveness of the
renewed license is a change from the proposed rule, which would have
made the renewed license effective 30 days after issuance. This final
rule provides a substantively similar result as the proposed rule and
provides licensees additional flexibility in the timing of their
implementation of the renewed license.
If administrative or judicial appeal affects the renewed license,
then the previous operating license will be reinstated unless its term
has expired and the facility has failed to submit a license renewal
application in a timely manner.
During the development of this final rule, the NRC recognized that
Sec. 50.135(e)(2) in the proposed rule could have unnecessarily
restricted the license term for a renewed NPUF license to less than 40
years. Section 103 of the AEA allows for license terms of up to 40
years. To address this issue, this final rule clarifies that renewed
licenses are
[[Page 106242]]
issued for a fixed period of time, not to exceed 40 years.
4. Requires all NPUF licensees to submit to the NRC updated FSARs
and subsequent FSAR updates at intervals not to exceed 5 years.
Maintaining up-to-date FSARs facilitates safe management of a
facility, including current understanding of the licensing bases and
effective training of personnel, and enables the NRC to fulfill its
statutory obligations and regulatory responsibilities effectively.
Section 50.71(e) of the final rule requires all NPUF licensees to
submit to the NRC updated FSARs and subsequent FSAR updates at
intervals not to exceed 5 years. The updated FSAR will incorporate the
various supplements and amendments that may have been submitted, either
in response to NRC questions or on the licensee's own initiative,
following the original submittal to create a single and complete
updated document that can then serve as the baseline for future
changes. Given the requirement to submit subsequent FSAR updates, the
NRC anticipates that licensees will document changes to the licensing
bases as they occur, which will aid in maintaining continuity of
knowledge and the understanding of changes and effects of changes on
the facility both for the licensee and the NRC. The NRC anticipates
that these changes will result in minimal additional burden on
licensees and the NRC because only a small number of changes have
occurred per facility each year. In addition, licensees should have
already documented these changes under Sec. 50.59 or through a license
amendment request under Sec. 50.90.
This final rule requires licensees to submit, in accordance with
Sec. 50.4, a complete updated FSAR within 5 years of receipt of a
facility operating license (Sec. 50.71(e)(3)(iv)) and subsequent FSAR
updates at successive intervals not to exceed 5 years (Sec.
50.71(e)(4)(ii)). The NRC will issue orders to existing facilities
licensed under Sec. 50.21(c) that have undergone the license renewal
process using the guidance in NUREG-1537, Part 2. These licensee-
specific orders will direct these licensees to submit their updated
FSARs, after which they will be subject to the new requirement in Sec.
50.71(e)(4)(ii) to submit subsequent FSAR updates.
To issue the licensee-specific orders, the NRC will group the
facilities based upon when they have undergone license renewal using
NUREG-1537. The orders will dictate when a licensee's initial updated
FSAR will be due to the NRC. The NRC plans to stagger the dates over a
5-year period following the effective date of this final rule. The NRC
will place existing operating and decommissioning NPUF licensees in
three groups as follows:
(1) Group 1 consists of licensees that completed the license
renewal process most recently using NUREG-1537. The NRC will establish
a due date for the updated FSAR that will be at least 1 year and no
later than 3 years from the effective date of this final rule. The NRC
will require these licensees to submit an updated FSAR first because,
with a recent license renewal, the FSARs should require minimal
updates.
(2) Group 2 generally consists of licensees for which the NRC
reviewed the license renewal application before Group 1 using NUREG-
1537, and includes the three facilities currently in decommissioning.
The NRC will establish a due date for the updated FSAR that will be at
least 2 years and no later than 5 years from the effective date of this
final rule. The NRC will allow these licensees more time to submit an
updated FSAR than Group 1 licensees because more time has passed since
license renewal, so additional time may be needed to update their
FSARs.
(3) Group 3 consists of the remaining NPUF licensees that have not
undergone license renewal using NUREG-1537. The licenses for these
facilities are all due to expire in less than 5 years from the
effective date of this final rule. If these licensees choose to renew
their facility operating licenses, they will be subject to the
requirements in Sec. 50.71(e) after issuance of the renewed license.
The general approach will be to stagger the submittal dates within
Groups 1 and 2 such that licensees that most recently completed license
renewal will be the first to submit their updated FSAR. However, the
licensee-specific orders will also consider facility-specific
circumstances and NRC discretion.
This final rule also corrects a grammatical error in footnote 1 to
Sec. 50.71(e). The footnote previously stated, ``Effects of changes
includes appropriate revisions of descriptions in the FSAR such that
the FSAR (as updated) is complete and accurate.'' This final rule
changes ``includes'' to ``include'' so that the plural subject is
followed by a plural verb.
5. Amends the current timely renewal provision under Sec. 2.109,
allowing an NPUF subject to license renewal to continue operating under
an existing license past its expiration date if the licensee submits a
license renewal application at least 2 years before the current license
expiration date.
The requirements in Sec. 2.101(a) allow the NRC to determine the
acceptability of an application for review by the NRC. However, before
this final rule, Sec. 2.109 allowed an NPUF licensee to submit its
license renewal application as late as 30 days before the expiration of
the existing license. Historical precedent indicates that 30 days is
not a sufficient period of time for the NRC to adequately assess the
sufficiency of a license renewal application for review. As a result,
the NRC accepted license renewal applications and addressed their
deficiencies in the license renewal process by issuing requests for
additional information. This approach increased the duration of the
license renewal process and resulted in multiple facilities operating
many years into a ``timely renewal'' period without renewed licenses.
To address this issue, the NRC is revising the timely renewal
provision for NPUFs (including testing facilities) licensed under Sec.
50.22 and testing facilities licensed under Sec. 50.21(c) to establish
a length of time adequate for the NRC to review the sufficiency of a
license renewal application. Specifically, this final rule amends Sec.
2.109, allowing a facility to continue operating under an existing
license past its expiration date if the licensee submits a sufficient
license renewal application at least 2 years before the current license
expiration date. In such cases, the existing license will not be deemed
to have expired until the application has been finally determined by
the NRC. This final rule ensures that the NRC has adequate time prior
to the expiration of the current license to review the sufficiency of
license renewal applications while the facility continues to operate
under the terms of its current license.
The proposed rule would have eliminated this provision for medical
therapy or research and development facilities, other than testing
facilities, licensed under Sec. 50.21(a) or (c), because these
facilities would no longer have license expiration dates.
The NRC reinstates the provision in this final rule to enable its
use for the remaining license renewal applications that may be
submitted after this final rule is published. The NRC anticipates that
there is one research reactor licensee that would use this provision.
6. Provides an accident dose criterion of 1 rem (0.01 Sv) TEDE for
NPUFs other than testing facilities.
The standards in 10 CFR part 20 for protection against ionizing
radiation provide a limit on the maximum yearly radiation dose a member
of the public can receive from the operation of any
[[Page 106243]]
NRC-licensed facility. Licensees are required to maintain programs and
facility design features to ensure that these limits are met. In
addition to the dose limits in 10 CFR part 20, accident dose criteria
are also applied during licensing to determine the acceptability of the
licensed facility. The accident dose criteria are not dose limits; they
inform a licensee's accident analyses and the development of successive
safety measures (i.e., defense in depth) so that in the unlikely event
of an accident, the NRC has reasonable assurance that no acute
radiation-related harm will result to any member of the public. Before
this final rule, the accident dose criterion for NPUFs, other than
testing facilities, was the 10 CFR part 20 dose limit to a member of
the public. For testing facilities, accident dose criteria are found in
10 CFR part 100: 25 rem (0.25 Sv) to the whole body and 300 rem (3 Sv)
to the thyroid.
Before January 1, 1994, the NRC had generally found acceptable
accident doses for applicants applying for an initial or renewed NPUF
license, other than for testing facilities, that were less than 0.5 rem
(0.005 Sv) to the whole body and 3 rem (0.03 Sv) to the thyroid for
members of the public. On May 21, 1991,\5\ the NRC amended 10 CFR part
20 to reduce the dose limit to a member of the public to 0.1 rem (0.001
Sv) TEDE (56 FR 23360) with an implementation date of January 1, 1994.
Since January 1, 1994, for applicants applying for an initial or
renewed NPUF license, other than for testing facilities, the NRC has
compared the results from the accident analyses submitted in initial or
renewed license applications with the standards in 10 CFR part 20.
---------------------------------------------------------------------------
\5\ In the proposed rule, the NRC misidentified the part 20
rulemaking date as January 1, 1994.
---------------------------------------------------------------------------
The NRC has determined that the public dose limit of 0.1 rem (0.001
Sv) TEDE in 10 CFR part 20 is unduly restrictive to be applied as
accident dose criteria for NPUFs except for testing facilities, which
are subject to 10 CFR part 100. The NRC bases this determination on the
NRC Atomic Safety and Licensing Appeal Board's decision that the
standards in 10 CFR part 20 are unduly restrictive as accident dose
criteria for research reactors (Trustees of Columbia University in the
City of New York, ALAB-50, 4 AEC 849, 854-855 (May 18, 1972)). At the
time of this decision, the 10 CFR part 20 public dose limit was 0.5 rem
(0.005 Sv) whole body.
However, the NRC considers the accident dose criteria in 10 CFR
part 100 to be too high for NPUFs other than testing facilities,
because those NPUFs have lower risk profiles than testing facilities.
For these reasons, this final rule modifies Sec. 50.34 to add an
accident dose criterion of 1 rem (0.01 Sv) TEDE for NPUFs not subject
to 10 CFR part 100. The accident dose criterion of 1 rem (0.01 Sv) TEDE
is based on the Environmental Protection Agency's (EPA) Protection
Action Guides (PAGs). The EPA PAGs are dose guidelines that support
decisions during a radiological incident to take protective actions
such as staying indoors or evacuating. The proposed rule stated that
the 1 rem (0.01 Sv) TEDE accident dose criterion was based on the EPA
PAGs published in EPA 400-R-92-001, ``Manual of Protective Action
Guides and Protective Actions for Nuclear Incidents.'' In January 2017,
the EPA published an update to its PAGs in EPA-400/R-17/001, ``PAG
Manual: Protective Action Guides and Planning Guidance for Radiological
Incidents.'' This update to the EPA PAGs does not change the basis for
the 1 rem (0.01 Sv) TEDE accident dose criterion.
The PAG is defined as the projected dose to an individual from a
release of radioactive material at which a specific protective action
to reduce or avoid that dose is recommended. Three principles
considered in the development of the EPA PAGs include: (1) prevent
acute effects; (2) balance protection with other important factors and
ensure that actions result in more benefit than harm; and (3) reduce
risk of chronic effects. In the early phase (i.e., the beginning of the
radiological incident, which may last hours to days), if the sum of the
projected dose from external radiation exposure and the inhalation of
radioactive material is 1 rem (0.01 Sv) to 5 rem (0.05 Sv), the EPA PAG
recommends the protective action of sheltering-in-place or evacuation
of the public to avoid inhalation of gases or particulates in an
atmospheric plume and to minimize external radiation exposures. The EPA
PAG Manual does not provide a protective action recommendation for the
public when the projected dose to an individual from an incident is
less than 1 rem (0.01 Sv). In light of this understanding of the early
phase EPA PAG, the NRC's accident dose criterion of 1 rem (0.01 Sv)
TEDE for NPUFs, other than testing facilities, provides reasonable
assurance of adequate protection of the public from unnecessary
exposure to radiation.
The NRC revised Sec. 50.34(a)(1)(ii)(D)(2) of the proposed rule to
replace ``postulated accidental release of licensed material'' with
``postulated accident.'' This final rule requires applicants and
licensees to evaluate the potential dose from postulated accidents to
include the potential exposure from all radiological sources, such as
direct or scattered radiation from an unshielded source inside the
facility, in addition to potential exposure from a release of
radioactive materials. This requirement is consistent with the
evaluation methodology described in NUREG-1537, Part 1. Under this
final rule, these evaluations need to demonstrate that the dose to any
individual located in the unrestricted area will not be in excess of 1
rem (0.01 Sv) TEDE for the duration of the accident. Although the EPA
PAGs were developed for radiological incidents that lead to the release
or potential release of radioactive materials into the environment, the
three principles considered in their development are not dependent on
whether the dose received is due to exposure from a release of
radioactive materials or from direct or scattered radiation.
To provide further clarification on the NRC's intent of the 1 rem
(0.01 Sv) TEDE accident dose criterion for NPUFs, other than testing
facilities, a footnote has been incorporated into the final rule text.
The footnote clarifies that this 1 rem (0.01 Sv) TEDE accident dose
criterion is not a dose limit, as explained in the preceding
paragraphs.
In this final rule, the NRC moves proposed Sec.
50.34(a)(1)(ii)(D)(2) to Sec. 50.34(a)(1)(i) and leaves the rule
language in Sec. 50.34(a)(1)(ii)(D) unchanged. During the development
of this final rule, the NRC recognized that the accident dose criterion
more appropriately belongs in Sec. 50.34(a)(1)(i) because the
requirements in Sec. 50.34(a)(1)(ii) apply to power reactor
construction permit applicants, while the requirements in Sec.
50.34(a)(1)(i) apply to all other construction permit applicants, such
as NPUF applicants. Similarly, proposed Sec. 50.34(a)(1)(ii)(D)(2)
would have imposed a requirement on applications for renewed NPUF
operating licenses, which more appropriately belongs in Sec. 50.34(b).
Therefore, the NRC moved the requirement to new Sec. 50.34(b)(13) in
this final rule to clarify that an application for an operating license
or a renewed operating license for an NPUF must include in the FSAR a
final evaluation of the applicable radiological consequences consistent
with Sec. 50.34(a)(1)(i).
7. Extends the applicability of Sec. 50.59 to NPUFs regardless of
their decommissioning status.
Before this final rule, Sec. 50.59(b) of the Commission's
regulations did not apply Sec. 50.59 to NPUFs whose licenses were
amended to reflect permanent cessation of operations and that no longer
had
[[Page 106244]]
fuel on site (e.g., they returned all of their fuel to the U.S.
Department of Energy). The former language stated that Sec. 50.59
applied to licensees ``whose license has been amended to allow
possession of nuclear fuel, but not operation of the facility.''
Therefore, Sec. 50.59 did not apply to NPUF licensees that no longer
possessed nuclear fuel. For these licensees, the NRC has typically
added license conditions identical to the provisions of Sec. 50.59 to
allow the licensee to make changes to its facility or changes in its
procedures that would not otherwise require obtaining a license
amendment pursuant to Sec. 50.90. Because most NPUFs promptly return
their fuel to the U.S. Department of Energy after permanent shutdown,
in contrast to decommissioning power reactors, these licensees had to
request the addition of the license conditions, which imposed an
administrative burden on the licensees and the NRC. This final rule
eliminates this burden by revising Sec. 50.59(b) to extend the
applicability of Sec. 50.59 to NPUFs regardless of their
decommissioning status.
8. Clarifies an applicant's requirements for meeting the existing
provisions of Sec. 51.45.
The NRC is required to prepare either an environmental impact
statement or environmental assessment, as appropriate, for all
licensing actions pursuant to 10 CFR part 51, unless a categorical
exclusion applies as provided in Sec. 51.22. For most types of
licenses, 10 CFR part 51 specifies that an applicant must submit
environmental documentation in the form of an environmental report, or
a supplement to a previously submitted environmental report, to assist
the NRC's review and its compliance with the National Environmental
Policy Act of 1969, as amended. However, before this final rule, the
NRC did not have explicit requirements under 10 CFR part 51 with
respect to the nature of the environmental documentation that must
accompany applications for construction permits, initial licenses, and
renewed licenses for NPUFs.
This final rule adds a new section to 10 CFR part 51 to clarify
NPUF environmental reporting requirements. Section 51.56 clarifies an
applicant's existing requirements for meeting the provisions of Sec.
51.45. This change improves consistency throughout 10 CFR part 51 with
respect to environmental report submissions required from applicants.
The NRC also is making a conforming change to Sec. 51.17 to reflect
the approved information collection requirement of Sec. 51.56.
9. Eliminates the requirement for NPUF licensees to submit
financial qualification information with license renewal applications
under Sec. 50.33(f)(2).
This final rule eliminates license renewal financial qualification
requirements for NPUFs. Before this final rule, Sec. 50.33(f) required
NPUF license applicants to provide information sufficient to
demonstrate their financial qualifications to carry out the activities
for which the license is sought. Because the regulatory requirements
for the content of an application for a renewed NPUF license were the
same as those for an original license, NPUF licensees that requested
license renewal were required to submit an update to the same financial
information that was required in an application for an initial license.
In addition, the NRC found that the financial qualification information
did not meaningfully contribute to the NRC's safety determination on
the license renewal application. The elimination of NPUF license
renewal financial qualification requirements reduces the burden
associated with license renewal applications while still enabling the
NRC to conduct its review of these applications.
This change is consistent with the current license renewal process
for power reactors. On January 30, 2004, the NRC published in the
Federal Register the final rule, ``Financial Information Requirements
for Applications to Renew or Extend the Term of an Operating License
for a Power Reactor'' (69 FR 4439). This final rule discontinued
financial qualification reviews for power reactors at the license
renewal stage except in very limited circumstances. The Commission
stated that ``[t]he NRC believes that its primary tool for evaluating
and ensuring safe operations at nuclear power reactors is through its
inspection and enforcement programs . . . .'' Further, the Commission
stated that ``[t]he NRC has not found a consistent correlation between
licensees' poor financial health and poor safety performance. If a
licensee postpones inspections and repairs that are subject to NRC
oversight, the NRC has the authority to shut down the reactor or take
other appropriate action if there is a safety issue.''
At NPUF sites, the NRC's inspection and enforcement programs serve
as important tools for evaluating licensee performance and ensuring
safe operations. The NRC periodically inspects each operating NPUF
using a graded approach that prioritizes higher-power facilities. The
NRC completes an annual inspection of NPUFs licensed to operate at
power levels of 2 MW(t) or greater. For NPUFs operating under 2 MW(t),
the inspection program is designed to be completed every two years,
although inspector availability and licensee availability sometimes
dictate that an inspection cycle is carried out in multiple inspections
over the 2-year cycle. Inspections can include reviews of
organizational structure, operator training and qualification, design
and design control, radiation and environmental protection, maintenance
and surveillance activities, transportation, material control and
accounting, operational activities, review and audit functions,
experiments, fuel handling, procedural controls, emergency
preparedness, and security. The NRC also performs special and reactive
inspections. In addition, the NRC manages the NPUF operator license
examination program. The NRC also manages the review of NPUF emergency
and security plans and develops and implements policy and guidance
concerning the NPUF licensing program.
The same basis for the NRC's elimination of financial qualification
requirements for power reactor licensees at the time of license renewal
supports the NRC's elimination of NPUF financial qualification
requirements at the time of license renewal. The NRC is not aware of
any connection between an NPUF's financial qualifications at license
renewal and safe operation of the facility. The NRC retains broad
authority under the AEA and Sec. 50.54(cc), Sec. 50.54(f), and Sec.
2.102 to request additional financial information from its licensees
and applicants, as necessary, to protect public health and safety.
III. Opportunity for Public Participation
The NRC hosted two public meetings to engage with external
stakeholders on the proposed rule and associated draft guidance
document during the public comment period. A public meeting was held on
May 24, 2017, to discuss the proposed rule. A public meeting on the
implementation schedule of the final requirements was held on April 25,
2019. Summaries of both public meetings are available in ADAMS, as
provided in the ``Availability of Documents'' section. The feedback
from these public meetings informed the development of this final rule.
IV. Public Comment Analysis
The NRC prepared a summary and analysis of public comments received
on the 2017 proposed rule and draft regulatory guide, as referenced in
the
[[Page 106245]]
``Availability of Documents'' section. In response to the proposed rule
and draft regulatory guide, the NRC received 16 comment submissions.
The public comment submittals are available from the Federal e-
Rulemaking website at http://www.regulations.gov under Docket ID NRC-
2011-0087. Responses to the public comments, including a summary of how
the final rule text or guidance changed as a result of the public
comments, can be found in the public comment analysis document.
For more information about the associated guidance document, see
the ``Availability of Guidance'' section of this document.
V. Section-by-Section Analysis
The following paragraphs describe the specific changes within this
final rule.
Section 2.109 Effect of timely renewal application.
In Sec. 2.109, this final rule revises paragraph (a) to exclude
NPUFs (including testing facilities) licensed under Sec. 50.22 and
testing facilities licensed under Sec. 50.21(c) from the 30-day timely
renewal provision by adding paragraph (f) to require these same
licensees to submit a license renewal application at least 2 years
before license expiration to be considered timely.
Section 20.1905 Exemptions to labeling requirements.
In Sec. 20.1905, this final rule revises paragraph (g) to
standardize terminology by replacing the term ``reactors'' with the
phrase ``production or utilization facilities.''
Section 26.3 Scope.
In Sec. 26.3, this final rule revises paragraph (e) to standardize
terminology by replacing the term ``reactor'' with the phrase
``production or utilization facility.''
Section 50.2 Definitions.
In Sec. 50.2, this final rule revises the definitions for Non-
power reactor and Testing facility.
Section 50.8 Information collection requirements: OMB approval.
In Sec. 50.8, this final rule revises paragraph (b) to include new
Sec. 50.135 as an approved information collection requirement in 10
CFR part 50.
Section 50.33 Contents of applications; general information.
In Sec. 50.33, this final rule revises paragraph (f)(2) to remove
the phrase ``for a power reactor'' from the fourth sentence and to
remove the fifth sentence, which required a non-power reactor applicant
to submit with license renewal applications the same financial
information that is required for initial license applications. It also
redesignates the footnote to conform to the Office of the Federal
Register's requirements.
Section 50.34 Contents of applications; technical information.
In Sec. 50.34, this final rule revises paragraph (a)(1)(i) to
include an accident dose criterion for applicants for construction
permits for NPUFs not subject to 10 CFR part 100 and a new footnote 2.
It also redesignates the footnotes to conform to the Office of the
Federal Register's requirements. This final rule also adds paragraph
(b)(13) to require an applicant for an operating or a renewed operating
license for an NPUF to include in the FSAR a final evaluation of the
applicable radiological consequences in Sec. 50.34(a)(1)(i).
Section 50.36 Technical specifications.
In Sec. 50.36, this final rule revises paragraph (c)(6) to
standardize terminology by replacing the term ``non-power reactor''
with the phrase ``non-power production or utilization.''
Section 50.51 Continuation of license.
In Sec. 50.51, this final rule revises paragraph (a) to add the
conditional phrase ``except as noted under Sec. 50.51(c).'' This final
rule also adds new paragraph (c) to clarify that NPUFs licensed under
Sec. 50.21(a) or (c), other than testing facilities, after the
effective date of this final rule, will have non-expiring license
terms.
Section 50.59 Changes, tests, and experiments.
In Sec. 50.59, this final rule revises paragraph (b) to extend
applicability to NPUFs that have permanently ceased operations and that
no longer have fuel on site.
Section 50.71 Maintenance of records, making of reports.
In Sec. 50.71, this final rule revises paragraph (e) to include
NPUFs in the requirement and makes a tense correction to footnote 1.
This final rule also revises paragraph (e)(3)(i) and redesignates
paragraph (4) as paragraph (4)(i) to clarify that these paragraphs only
apply to nuclear power reactors. New paragraphs (e)(3)(iv) and
(e)(4)(ii) are added to include the requirements for NPUFs. This final
rule also revises paragraph (g) to standardize terminology by replacing
the phrase ``non-power reactor'' with the phrase ``non-power production
or utilization facility.''
Section 50.75 Reporting and recordkeeping for decommissioning planning.
In Sec. 50.75, this final rule also revises paragraphs (d)(1),
(e)(1)(iv), and (f)(4) to standardize terminology by replacing the
phrase ``non-power reactor'' with the phrase ``non-power production or
utilization facility.'' This final rule also revises paragraph (f)(5)
by replacing the phrase ``non-power reactors'' with the phrase ``non-
power production or utilization facilities.''
Section 50.82 Termination of license.
In Sec. 50.82, this final rule revises paragraph (b) to
standardize terminology by replacing the term ``reactor'' with the
phrase ``production or utilization facility'' and revises paragraph
(b)(1) to include testing facilities licensed under Sec. 50.21(c) and
holders of a license issued under Sec. 50.22. Paragraph (c) is revised
by moving the phrase ``that has permanently ceased operation before the
expiration of its license'' to new paragraph (c)(2) to clarify when the
collection period for shortfalls in funding will be determined for
NPUFs and holders of licenses issued under Sec. 50.21(b) or Sec.
50.22, or testing facilities.
Section 50.135 Renewal of non-power production or utilization facility
licenses issued under Sec. 50.22 and testing facility licenses.
This final rule adds new Sec. 50.135 to clearly define the license
renewal process for NPUFs (including testing facilities) licensed under
Sec. 50.22 and testing facilities licensed under Sec. 50.21(c).
Appendix C to Part 50--A Guide for the Financial Data and Related
Information Required To Establish Financial Qualifications for
Construction Permits and Combined Licenses
In appendix C to part 50, this final rule revises paragraph III by
replacing the reference to ``medical and research reactors'' with a
reference to ``non-power production or utilization facilities of a type
described in Sec. 50.21(a) or (c), other than testing facilities.''
Appendix E to Part 50--Emergency Planning and Preparedness for
Production and Utilization Facilities
In appendix E to part 50, this final rule revises footnote 2 in
paragraph I.3 to include the title of Regulatory Guide 2.6 and to
replace the phrase ``research and test reactor'' with the phrase ``non-
power production or utilization facility.''
[[Page 106246]]
Section 51.17 Information collection requirements; OMB approval.
In Sec. 51.17, this final rule revises paragraph (b) to add new
Sec. 51.56 as an approved information collection requirement in 10 CFR
part 51.
Section 51.45 Environmental report.
In Sec. 51.45, this final rule revises paragraph (a) to add a
cross reference to new Sec. 51.56.
Section 51.56 Environmental report--non-power production or utilization
facility.
This final rule adds new Sec. 51.56 to clarify existing
requirements for the submittal and content of environmental reports by
applicants seeking a permit to construct, a license to operate, or a
renewal of a license to operate a non-power production or utilization
facility.
Section 55.5 Communications.
In Sec. 55.5, this final rule revises paragraph (b)(1) to remove
the conditional phrase ``except for test and research reactor
facilities.'' It also revises paragraph (b)(3) to clarify the
applicability of this paragraph to utilization facilities licensed
under 10 CFR part 50 that are not power reactors.
Section 55.40 Implementation.
In Sec. 55.40, this final rule revises paragraph (d) to replace
the phrase ``test and research reactors'' with the phrase ``non-power
reactors.''
Section 55.53 Conditions of licenses.
In Sec. 55.53, this final rule revises paragraphs (e) and (f)(2)
to replace the phrase ``test and research reactors'' with the phrase
``non-power reactors.'' It also revises paragraphs (j) and (k) to
clarify that these paragraphs apply to utilization facilities licensed
under 10 CFR part 50 that are not power reactors.
Section 55.59 Requalification.
In Sec. 55.59, this final rule revises paragraph (c)(7) to clarify
that this paragraph applies to utilization facilities licensed under 10
CFR part 50 that are not power reactors.
Section 55.61 Modification and revocation of licenses.
In Sec. 55.61, this final rule revises paragraph (b)(5) to clarify
that this paragraph applies to utilization facilities licensed under 10
CFR part 50 that are not power reactors.
Section 73.2 Definitions.
In Sec. 73.2, this final rule adds the definition of Non-power
reactor as it is defined in Sec. 50.2.
Section 73.21 Protection of safeguards information: performance
requirements.
In Sec. 73.21, this final rule revises paragraph (a)(1)(ii) to
replace the phrase ``research and test reactors'' with the phrase
``non-power reactors.''
Section 73.23 Protection of safeguards information--modified handling:
specific requirements.
In Sec. 73.23, this final rule replaces the phrase ``research and
test reactors'' with the phrase ``non-power reactors.''
Section 73.60 Additional requirements for physical protection at non-
power reactors.
In Sec. 73.60, this final rule revises all instances of
``nonpower'' to read ``non-power.''
Section 140.3 Definitions.
In Sec. 140.3, this final rule removes the definition of Testing
reactor and adds the definition of Testing facility as it is defined in
Sec. 50.2.
Section 140.11 Amounts of financial protection for certain reactors.
In Sec. 140.11, this final rule revises paragraph (a)(3) to
standardize terminology by replacing the term ``reactor'' with the term
``facility.''
Section 170.3 Definitions.
In Sec. 170.3, this final rule revises the definition of Research
reactor and revises the definition of Testing facility to align with
the definition in Sec. 50.2.
Section 171.5 Definitions.
In Sec. 171.5, this final rule revises the definitions of Research
reactor and Testing facility to align with the definitions in Sec.
170.3 and Sec. 50.2, respectively.
VI. Regulatory Flexibility Certification
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC
certifies that this rule does not have a significant economic impact on
a substantial number of small entities. This final rule affects only
the licensing and operation of NPUFs. In general, the companies,
universities, and government agencies that own and operate these
facilities do not fall within the scope of the definition of ``small
entities'' set forth in the Regulatory Flexibility Act or the size
standards established by the NRC (10 CFR 2.810). Additional information
is provided in Section 4 of the regulatory analysis, which is available
as indicated in the ``Availability of Documents'' section of this
document.
VII. Regulatory Analysis
The NRC has prepared a final regulatory analysis on this regulation
and the implementation guidance. The analysis examines the costs and
benefits of the alternatives considered by the NRC. The regulatory
analysis is available as indicated in the ``Availability of Documents''
section of this document.
VIII. Backfitting
The NRC's backfitting regulations for entities that are licensed
under 10 CFR part 50 and within the scope of the NRC's backfitting
policy appear in Sec. 50.109, ``Backfitting.'' ``Backfitting'' is
defined in Sec. 50.109(a)(1), in relevant part, as a modification of
or addition to the systems, structures, components, or design of a
facility, or the procedures or organization required to design,
construct, or operate a facility, which results from a new or amended
provision in the Commission's regulations.
The amendments in this final rule include the following:
revising the definitions for Non-power reactor, Testing
facility, and Research reactor; eliminating license terms for medical
therapy or research and development facilities, other than testing
facilities, licensed under 10 CFR 50.21(a) or (c);
defining the license renewal process for all commercial or
industrial NPUFs (including testing facilities) licensed under Sec.
50.22 and testing facilities licensed under Sec. 50.21(c) by
consolidating existing regulatory requirements in one section of the
NRC's regulations; requiring all NPUF licensees to submit an updated
FSAR and subsequent FSAR updates to ensure that a facility's licensing
basis is kept up-to-date;
amending the current timely renewal provision under Sec.
2.109, allowing NPUFs subject to license renewal to continue operating
under an existing license past its expiration date if the licensee
submits a license renewal application at least 2 years (rather than 30
days) before the current license expiration date; providing an accident
dose criterion of 1 rem (0.01 Sv) TEDE for NPUFs other than testing
facilities, for use in applicants' accident analyses; extending the
applicability of Sec. 50.59 to NPUF licensees regardless of their
decommissioning status;
clarifying an NPUF applicant's environmental report
requirements in Sec. 51.45; and eliminating the requirement for NPUF
licensees to submit financial qualification information with license
renewal applications under Sec. 50.33(f)(2).
[[Page 106247]]
These amendments do not result in a modification of or addition to
the systems, structures, components, or design of a facility, or the
procedures or organization required to design, construct, or operate a
facility. The final rule changes do not meet the Sec. 50.109(a)(1)
definition of ``backfitting'' and, thus, do not constitute backfitting
for any NPUF that may be within the scope of backfitting.
The NRC will clarify whether commercial NPUFs (i.e., NPUFs licensed
under Section 103 of the AEA) are within the scope of the NRC's
backfitting policy as a general matter through an interpretive rule
process. An interpretive rule is an agency's interpretation of a
statute or its regulations that does not revise the agency's
regulations. Examples of NRC interpretive rules include regulatory
guides and notices of interpretation.
As described in the ``Availability of Guidance'' section of this
document, the NRC is issuing Regulatory Guide (RG) 2.7, ``Preparation
of Updated Final Safety Analysis Reports for Non-Power Production or
Utilization Facilities,'' which provides guidance on methods acceptable
to the NRC for complying with the requirements in Sec. 50.71(e) of
this final rule. Issuance of this RG does not constitute backfitting
under Sec. 50.109. As discussed in the ``Implementation'' section of
RG 2.7, licensees generally are not required to comply with the
guidance in that RG. If, in the future, the NRC seeks to impose
positions stated in the RG in a manner that would constitute
backfitting or forward fitting, the NRC would need to make the showing
as required in Sec. 50.109 for backfitting or Management Directive
8.4, ``Management of Backfitting, Forward Fitting, Issue Finality, and
Information Requests,'' for forward fitting, that would allow the NRC
to impose the positions.
IX. Cumulative Effects of Regulation
Cumulative Effects of Regulation (CER) consists of the challenges
licensees may face in addressing the implementation of new regulatory
positions, programs, and requirements (e.g., rulemaking, guidance,
generic letters, backfits, inspections). The CER may manifest in
several ways, including the total burden imposed on licensees by the
NRC from simultaneous or consecutive regulatory actions that can
adversely affect the licensee's capability to implement those
requirements, while continuing to operate or construct its facility in
a safe and secure manner.
The goals of the NRC's CER effort were met throughout the
development of this final rule. The NRC engaged external stakeholders
at public meetings and by soliciting public comments on the proposed
rule and associated draft guidance document. A public meeting was held
on May 24, 2017, to discuss the proposed rule. A public meeting on
implementation was held on April 25, 2019. Summaries of both public
meetings are available in ADAMS, as provided in the ``Availability of
Documents'' section of this document. The feedback from the April 25,
2019, public meeting informed the NRC's final rule implementation
schedule.
Based upon input from the public and affected licensees, the NRC
has specified that this final rule will take effect 30 days from the
date of publication of this document. For the purposes of implementing
the requirements of Sec. 50.71(e), the NRC will be issuing orders to
certain holders of operating licenses, as described in Section II.4 of
this document.
X. Plain Writing
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, and well-organized
manner. The NRC has written this document to be consistent with the
Plain Writing Act as well as the Presidential Memorandum, ``Plain
Language in Government Writing,'' published June 10, 1998 (63 FR
31885).
XI. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995,
Public Law 104-113, requires agencies to use technical standards
developed or adopted by voluntary consensus standards bodies unless the
use of such standards is inconsistent with applicable law or is
otherwise impractical. The NRC is amending its requirements for the
license renewal process for certain production or utilization
facilities. This action does not constitute the establishment of a
standard that contains generally applicable requirements.
XII. Environmental Assessment and Final Finding of No Significant
Environmental Impact
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A of 10 CFR part 51, that this final rule will not be a major
Federal action significantly affecting the quality of the human
environment and, therefore, an environmental impact statement is not
required. The provision to eliminate license terms for NPUFs, other
than testing facilities, licensed under Sec. 50.21(a) or (c) will
result in no additional radiological or non-radiological impacts
because of the minimal accident consequences of these facilities,
existing surveillance and reporting by licensees, and NRC oversight. In
addition, the implementation of this final rule will not affect the
environmental review requirements for new facilities and facilities
applying for license renewal. The NRC concludes that this final rule
will not cause any additional radiological or non-radiological impacts
on the human environment.
The NRC requested the views of the States on the environmental
assessment for this rule. No States filed comments regarding the
environmental assessment for this rule.
The determination of this environmental assessment is that there
will be no significant offsite impact to the public from this action.
The environmental assessment is available as indicated under the
``Availability of Documents'' section.
XIII. Paperwork Reduction Act
This final rule contains new or amended collections of information
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et
seq.). The collections of information were approved by the Office of
Management and Budget (OMB), approval number 3150-0268.
The burden to the public for the information collections is
estimated to average 51 hours per response for information collection
requirements contained in 10 CFR part 50 and 0 hours per response for
information collection requirements contained in 10 CFR part 51,
including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing the information collections.
The information collections are being conducted to create a more
efficient licensing process that continues to protect public health,
safety, and the environment. Information will be used by the NRC to
ensure that licensing bases remain up-to-date and that adequate
protection of public health and safety is maintained. Responses to
these collections of information are mandatory under Sec. 50.71(e) and
Sec. 51.56. Confidential and proprietary information submitted to the
NRC is protected in accordance with NRC regulations at Sec. 9.17(a)
and Sec. 2.390(b).
You may submit comments on any aspect of the information
collections, including suggestions for reducing the burden, by the
following methods:
[[Page 106248]]
Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2011-0087.
Mail comments to: FOIA, Library, and Information
Collections Branch, Office of the Chief Information Officer, Mail Stop:
T-6 A10M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001; [email protected]; or to the OMB reviewer at: OMB Office of
Information and Regulatory Affairs (3150-0268), Attn: Desk Officer for
the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC
20503.
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.
XIV. Congressional Review Act
This final rule 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.
XV. Criminal Penalties
For the purposes of Section 223 of the AEA, the NRC is issuing this
final rule that amends 10 CFR 50.34, 50.36, 50.59, 50.71, 50.75, 50.82,
55.40, 55.53, 55.59, 73.21, 73.23, 73.60, and 140.11 and creates Sec.
50.135 under one or more of Sections 161b, 161i, or 161o of the AEA.
Willful violations of these provisions would be subject to criminal
enforcement.
XVI. Availability of Guidance
The NRC is issuing RG 2.7, Revision 0, ``Preparation of Updated
Final Safety Analysis Reports for Non-Power Production or Utilization
Facilities,'' for the implementation of the requirements in Sec.
50.71(e) of this final rule. The guidance is available in ADAMS under
Accession No. ML18031A007. You can access information and public
comment submissions related to the guidance at the federal rulemaking
website, www.regulations.gov, by searching on Docket ID NRC-2011-0087.
XVII. Availability of Documents
The documents identified in the following table are available to
interested persons through one or more of the following methods, as
indicated.
------------------------------------------------------------------------
ADAMS accession No./web
Document link/Federal Register
citation
------------------------------------------------------------------------
NUREG-1537, Part 1, ``Guidelines for ML042430055.
Preparing and Reviewing Applications for
the Licensing of Non-Power Reactors,
Format and Content''.
NUREG-1537, Part 2, ``Guidelines for ML042430048.
Preparing and Reviewing Applications for
the Licensing of Non-Power Reactors,
Standard Review Plan and Acceptance
Criteria''.
Interim Staff Guidance-2009-001, ``Interim ML092240244.
Staff Guidance on the Streamlined Review
Process for License Renewal for Research
Reactors''.
Non-Power Reactor License Renewal: 77 FR 38742; June 29, 2012.
Preliminary Draft Regulatory Basis;
Request for Comment.
Non-Power Reactor (NPR) License Renewal ML12240A677.
Rulemaking: Regulatory Basis Document.
Federal Register Notice: Final Regulatory ML12250A658.
Basis for Rulemaking to Streamline Non-
Power Reactor License Renewal; Notice of
Availability of Documents.
SECY-08-0161, ``Review of Research and Test ML082550140.
Reactor License Renewal Applications''.
SRM-SECY-08-0161, ``Review of Research and ML090850159.
Test Reactor License Renewal
Applications''.
SRM-M080317B, ``Briefing on State of NRC ML080940439.
Technical Programs''.
SECY-09-0095, ``Long-Term Plan for ML092150717.
Enhancing the Research and Test Reactor
License Renewal Process and Status of the
Development and Use of the Interim Staff
Guidance''.
SRM-SECY-91-061, ``Separation of Non- ML010050021.
Reactor and Non-Power Reactor Licensing
Activities from Power Reactor Licensing
Activities in 10 CFR Part 50''.
SRM-M090811, ``Briefing on Research and ML092380046.
Test Reactor (RTR) Challenges''.
Draft Regulatory Guide DG-2006, ML17068A041.
``Preparation of Updated Final Safety
Analysis Reports for Non-Power Production
or Utilization Facilities''.
Proposed Rule: Draft Regulatory and Backfit ML17068A038.
Analysis.
Proposed Rule: Draft OMB Supporting ML17068A077.
Statement.
Proposed Rule: Draft Environmental ML17068A035.
Assessment.
SECY-16-0048, ``Proposed Rulemaking: Non- ML16019A048.
Power Production or Utilization Facility
License Renewal (RIN 3150-AI96)''.
EPA 400-R-92-001, ``Manual of Protective https://www.epa.gov/sites/
Action Guides and Protective Actions for production/files/2016-03/
Nuclear Incidents''. documents/pags.pdf.
EPA-400/R-17/001, ``PAG Manual: Protective https://www.epa.gov/sites/
Action Guides and Planning Guidance for production/files/2017-01/
Radiological Incidents''. documents/
epa_pag_manual_final_revis
ions_01-11-
2017_cover_disclaimer_8.pd
f.
Summary of August 7, 2014, Public Meeting ML15322A400.
to Discuss the Rulemaking for Streamlining
Non[dash]power Reactor License Renewal.
Summary of October 7, 2015, Public Meeting ML15307A002.
to Discuss the Rulemaking for Streamlining
Non-Power Reactor License Renewal.
Federal Register Notice: Final Rule; 56 FR 23360; May 21, 1991.
Standards for Protection Against Radiation.
Federal Register Notice: Proposed Rule; 82 FR 15643; March 30,
Non[dash]Power Production or Utilization 2017.
Facility License Renewal.
SRM-SECY-16-0048, ``Staff Requirements-- ML17045A543.
Proposed Rulemaking: Non-Power Production
or Utilization Facility License Renewal
(RIN 3150-AI96)''.
``Supporting Statement For Information ML18031A006.
Collections Contained In 10 CFR Part 50
Non-Power Production Or Utilization
Facility License Renewal Final Rule,''
dated December 2024.
``Supporting Statement For Information ML19113A007.
Collections Contained In 10 CFR Part 51
Non-Power Production Or Utilization
Facility License Renewal Final Rule,''
dated December 2024.
[[Page 106249]]
``Environmental Assessment and Finding of ML24241A112.
No Significant Impact Supporting Final
Rule: Non-Power Production or Utilization
Facility License Renewal,'' dated December
2024.
Final Rule: ``Regulatory Analysis-- ML24241A114.
Non[dash]power Production or Utilization
Facility License Renewal,'' dated December
2024.
``NRC Response to Public Comments; Non- ML18031A005.
Power Production or Utilization Facility
License Renewal,'' dated December 2024.
Regulatory Guide 2.7, ``Preparation of ML18031A007.
Updated Final Safety Analysis Reports for
Non-Power Production or Utilization
Facilities,'' dated December 2024.
Federal Register Notice: Final Rule; 69 FR 4439; January 30,
Financial Information Requirements for 2004.
Applications to Renew or Extend the Term
of an Operating License for a Power
Reactor.
Summary of May 24, 2017, Public Meeting to ML17170A066.
Discuss the Proposed Non-Power Production
or Utilization Facility License Renewal
Rule.
Nuclear Energy Innovation and Modernization https://www.congress.gov/
Act (Pub. L. 115-439), enacted January 14, 115/bills/s512/BILLS-
2019. 115s512enr.pdf.
Summary of April 25, 2019, Public Meeting ML19133A080.
to Discuss the Implementation Schedule for
the Non-Power Production or Utilization
Facility License Renewal Final Rule.
NRC Response to Public Comment ML18031A005.
Non[dash]Power Production or Utilization
Facility License Renewal.
SECY-19-0062, ``Final Rule: Non-Power ML18031A000 (package).
Production or Utilization Facility License
Renewal (RIN 3150-AI96, NRC-2011-0087)''.
SRM-M240904: Affirmation Session--SECY-19- ML24248A208 (package).
0062, ``Final Rule: Non-Power Production
or Utilization Facility License Renewal
(RIN 3150-AI96, NRC-2011-0087)'', dated
September 4, 2024.
Federal Register Notice: Final Rule; 10 CFR 33 FR 9704; July 4, 1968.
Part 50--Licensing of Production and
Utilization Facilities.
Federal Register Notice: Final Rule; 47 FR 13750; March 31,
Elimination of Review of Financial 1982.
Qualifications of Electric Utilities in
Licensing Hearings for Nuclear Power
Plants.
Federal Register Notice: Final Rule; 49 FR 35747; September 12,
Elimination of Review of Financial 1984.
Qualifications of Electric Utilities in
Operating License Reviews and Hearings for
Nuclear Power Plants.
Federal Register Notice: Final Rule; 43 FR 55978; November 29,
National Environmental Policy Act-- 1978.
Regulations.
Advanced Notice of Proposed Rulemaking; 48 FR 44217; September 28,
Revision of Backfitting Process for Power 1983.
Reactors.
Policy Statement; Revision of Backfitting 48 FR 44173; September 28,
Process for Power Reactors. 1983.
Federal Register Notice: Proposed Rule; 49 FR 47034; November 30,
Revision of Backfitting Process for Power 1984.
Reactors.
Federal Register Notice: Final Rule; 50 FR 38097; September 20,
Revision of Backfitting Process for Power 1985.
Reactors.
Federal Register Notice: Final Rule; 69 FR 4439; January 30,
Financial Information Requirements for 2004.
Applications to Renew or Extend the Term
of an Operating License for a Power
Reactor.
Federal Register Notice: Proposed Rule; 52 FR 34223; September 10,
Revision of Backfitting Process for Power 1987.
Reactors.
Federal Register Notice: Final Rule; 53 FR 20603; June 6, 1988.
Revision of Backfitting Process for Power
Reactors.
Federal Register Notice: Final Rule; 51 FR 6514; February 25,
Limiting the Use of Highly Enriched 1986.
Uranium in Domestically Licensed Research
and Test Reactors.
Federal Register Notice: Final Rule; 58 FR 13699; March 15,
Clarification of Physical Protection 1993.
Requirements at Fixed Sites.
Federal Register Notice: Final Rule; 77 FR 27561, 27572; May 11,
Requirements for Fingerprint-Based 2012.
Criminal History Record Checks for
Individuals Seeking Unescorted Access to
Non-Power Reactors.
Plain Language in Government Writing....... 63 FR 31885; June 10, 1998.
------------------------------------------------------------------------
List of Subjects
10 CFR Part 2
Administrative practice and procedure, Antitrust, Byproduct
material, Classified information, Confidential business information;
Freedom of information, Environmental protection, Hazardous waste,
Nuclear energy, Nuclear materials, Nuclear power plants and reactors,
Penalties, Reporting and recordkeeping requirements, Sex
discrimination, Source material, Special nuclear material, Waste
treatment and disposal.
10 CFR Part 20
Byproduct material, Criminal penalties, Hazardous waste, Licensed
material, Nuclear energy, Nuclear materials, Nuclear power plants and
reactors, Occupational safety and health, Packaging and containers,
Penalties, Radiation protection, Reporting and recordkeeping
requirements, Source material, Special nuclear material, Waste
treatment and disposal.
10 CFR Part 26
Administrative practice and procedure, Alcohol abuse, Alcohol
testing, Appeals, Chemical testing, Drug abuse, Drug testing, Employee
assistance programs, Fitness for duty, Management actions, Nuclear
power plants and reactors, Privacy, Protection of information,
Radiation protection, Reporting and recordkeeping requirements.
10 CFR Part 50
Administrative practice and procedure, Antitrust, Classified
information, Criminal penalties, Education, Fire prevention, Fire
protection, Intergovernmental relations, Nuclear power plants and
reactors, Penalties, Radiation protection, Reactor siting criteria,
Reporting and recordkeeping requirements, Whistleblowing.
10 CFR Part 51
Administrative practice and procedure, Environmental impact
statements, Hazardous waste, Nuclear
[[Page 106250]]
energy, Nuclear materials, Nuclear power plants and reactors, Reporting
and recordkeeping requirements.
10 CFR Part 55
Criminal penalties, Manpower training programs, Nuclear power
plants and reactors, Penalties, Reporting and recordkeeping
requirements.
10 CFR Part 73
Criminal penalties, Exports, Hazardous materials transportation,
Imports, Nuclear energy, Nuclear materials, Nuclear power plants and
reactors, Penalties, Reporting and recordkeeping requirements, Security
measures.
10 CFR Part 140
Criminal penalties, Extraordinary nuclear occurrence, Insurance,
Intergovernmental relations, Nuclear materials, Nuclear power plants
and reactors, Penalties, Reporting and recordkeeping requirements.
10 CFR Part 170
Byproduct material, Import and export licenses, Intergovernmental
relations, Non-payment penalties, Nuclear energy, Nuclear materials,
Nuclear power plants and reactors, Source material, Special nuclear
material.
10 CFR Part 171
Annual charges, Byproduct material, Holders of certificates,
registrations, approvals, Intergovernmental relations, Nonpayment
penalties, Nuclear materials, Nuclear power plants and reactors, Source
material, Special nuclear material.
For the reasons set out in the preamble and under the authority of
the AEA, as amended; the Energy Reorganization Act of 1974, as amended;
and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments
to 10 CFR parts 2, 20, 26, 50, 51, 55, 73, 140, 170, and 171:
PART 2--AGENCY RULES OF PRACTICE AND PROCEDURE
0
1. The authority citation for part 2 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 29, 53, 62, 63, 81,
102, 103, 104, 105, 161, 181, 182, 183, 184, 186, 189, 191, 234 (42
U.S.C. 2039, 2073, 2092, 2093, 2111, 2132, 2133, 2134, 2135, 2201,
2231, 2232, 2233, 2234, 2236, 2239, 2241, 2282); Energy
Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846);
Nuclear Waste Policy Act of 1982, secs. 114(f), 134, 135, 141 (42
U.S.C. 10134(f), 10154, 10155, 10161); Administrative Procedure Act
(5 U.S.C. 552, 553, 554, 557, 558); National Environmental Policy
Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note.
Section 2.205(j) also issued under Sec. 31001(s), Pub. L. 104-
134. 110 Stat. 1321-373 (28 U.S.C. 2461 note).
0
2. In Sec. 2.109, revise paragraph (a) and add paragraph (f) to read
as follows:
Sec. 2.109 Effect of timely renewal application.
(a) Except for the renewal of licenses identified in paragraphs (b)
through (f) of this section, if at least 30 days before the expiration
of an existing license authorizing any activity of a continuing nature,
the licensee files an application for a renewal or for a new license
for the activity so authorized, the existing license will not be deemed
to have expired until the application has been finally determined.
* * * * *
(f) If the licensee of a non-power production or utilization
facility licensed under 10 CFR 50.22, or a testing facility, files a
sufficient application for renewal at least 2 years before the
expiration of the existing license, the existing license will not be
deemed to have expired until the application has been finally
determined.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
0
3. The authority citation for part 20 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 53, 63, 65, 81,
103, 104, 161, 170H, 182, 186, 223, 234, 274, 1701 (42 U.S.C. 2014,
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2210h, 2232, 2236, 2273,
2282, 2021, 2297f); Energy Reorganization Act of 1974, secs. 201,
202 (42 U.S.C. 5841, 5842); Low-Level Radioactive Waste Policy
Amendments Act of 1985, sec. 2 (42 U.S.C. 2021b); 44 U.S.C. 3504
note.
Sec. 20.1905 [Amended]
0
4. In Sec. 20.1905, amend paragraph (g) by removing the word
``reactors'' and adding in its place the phrase ``production or
utilization facilities''.
PART 26--FITNESS FOR DUTY PROGRAMS
0
5. The authority citation for part 26 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 53, 103, 104, 107,
161, 223, 234, 1701 (42 U.S.C. 2073, 2133, 2134, 2137, 2201, 2273,
2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42
U.S.C. 5841, 5842); 44 U.S.C. 3504 note.
Sec. 26.3 [Amended]
0
6. In Sec. 26.3, amend paragraph (e) by removing the word ``reactor''
and adding in its place the phrase ``production or utilization
facility''.
PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION
FACILITIES
0
7. The authority citation for part 50 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 101, 102, 103,
104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186,
187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135,
2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236,
2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs.
201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste
Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National
Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504
note; Sec. 109, Pub. L. 96-295, 94 Stat. 783.
0
8. In Sec. 50.2, revise the definitions for ``Non-power reactor'' and
``Testing facility'' to read as follows:
Sec. 50.2 Definitions.
* * * * *
Non-power reactor means:
(1) A testing facility; or
(2) A research reactor, which is a non-power production or
utilization facility that is a nuclear reactor licensed under Sec.
50.21(c):
(i) For which a safety assessment demonstrates accident radiation
doses consistent with Sec. 50.34(a)(1)(i); and
(ii) That is not a testing facility; or
(3) A commercial or industrial reactor, which is a non-power
production or utilization facility that is a nuclear reactor licensed
under Sec. 50.22:
(i) For which a safety assessment demonstrates accident radiation
doses consistent with Sec. 50.34(a)(1)(i); and
(ii) That is not a testing facility.
* * * * *
Testing facility means a non-power production or utilization
facility that is a nuclear reactor licensed under Sec. 50.21(c) or
Sec. 50.22 for which:
(1) Analyzed accident radiation doses are in excess of the dose
criterion for facilities not subject to 10 CFR part 100 set forth in
Sec. 50.34(a)(1)(i); or
(2) The Commission determines that the design, operation, or use
and the associated risk warrant classification as a testing facility.
* * * * *
Sec. 50.8 [Amended]
0
9. In Sec. 50.8, amend paragraph (b) by adding the number ``50.135,''
in numerical order.
Sec. 50.33 [Amended]
0
10. Amend Sec. 50.33 by:
0
a. Removing the phrase ``for a power reactor'' from the fourth sentence
and removing the last sentence in paragraph (f)(2); and
[[Page 106251]]
0
b. Redesignating footnotes 4 and 5 as footnotes 1 and 2.
0
11. In Sec. 50.34:
0
a. Revise paragraph (a)(1)(i);
0
b. Add paragraph (b)(13);
0
c. Redesignate footnote 5 as footnote 1;
0
d. Add footnote 2;
0
e. Redesignate footnotes 6 and 7 as footnotes 3 and 4;
0
f. Remove footnotes 8 and 9; and
0
g. Redesignate footnotes 10 and 11 as footnotes 5 and 6.
The revision and addition read as follows:
Sec. 50.34 Contents of applications; technical information.
(a) * * *
(1) * * *
(i) A description and safety assessment of the site on which the
facility is to be located, with appropriate attention to features
affecting facility design. Special attention should be directed to the
site evaluation factors identified in part 100 of this chapter. The
assessment must contain an analysis and evaluation of the major
structures, systems and components of the facility which bear
significantly on the acceptability of the site under the site
evaluation factors identified in part 100 of this chapter, assuming
that the facility will be operated at the ultimate power level which is
contemplated by the applicant. For non-power production or utilization
facilities not subject to 10 CFR part 100, the assessment must provide
an evaluation of the applicable radiological consequences that
demonstrates with reasonable assurance that any individual located in
the unrestricted area following the onset of a postulated accident,
including consideration of experiments, would not receive a radiation
dose in excess of 1 rem (0.01 Sv)\2\ TEDE for the duration of the
accident. With respect to operation at the projected initial power
level, the applicant is required to submit information prescribed in
paragraphs (a)(2) through (a)(8) of this section, as well as the
information required by this paragraph, in support of the application
for a construction permit, or a design approval.
* * * * *
(b) * * *
(13) Non-power production or utilization facility applicants who
apply for an initial or renewed operating license shall provide a final
evaluation of the applicable radiological consequences in Sec.
50.34(a)(1)(i).
* * * * *
\2\ The 1 rem accident dose criterion for non-power production
or utilization facilities is not a dose limit; it informs the
analysis of postulated accidents and the development of safety
measures so that in the unlikely event of an accident, the NRC has
reasonable assurance that no acute radiation-related harm will
result to any member of the public.
Sec. 50.36 [Amended]
0
12. In Sec. 50.36, amend paragraph (c)(6) by removing the phrase
``non-power reactor'' and adding in its place the phrase ``non-power
production or utilization''.
0
13. In Sec. 50.51, in the first sentence of paragraph (a) remove the
word ``Each'' and add in its place the phrase ``Except as noted in
Sec. 50.51(c), each'' and add paragraph (c) to read as follows:
Sec. 50.51 Continuation of license.
* * * * *
(c) Each non-power production or utilization facility license
issued under Sec. 50.21(a) or (c), other than a testing facility
license, after January 29, 2025, will be issued with no fixed license
term.
0
14. In Sec. 50.59, revise paragraph (b) to read as follows:
Sec. 50.59 Changes, tests, and experiments.
* * * * *
(b) This section applies to each holder of an operating license
issued under this part or a combined license issued under part 52 of
this chapter, including the holder of a license authorizing the
operation of a nuclear power reactor that has submitted the
certification of permanent cessation of operations required under Sec.
50.82(a)(1) or Sec. 50.110, a reactor licensee whose license has been
amended to allow possession of nuclear fuel but not operation of the
facility, or a non-power production or utilization facility that has
permanently ceased operations.
* * * * *
0
15. In Sec. 50.71:
0
a. In the first sentence of paragraph (e), add the phrase ``, or non-
power production or utilization facility,'' after the word ``reactor'';
0
b. In paragraph (e)(3)(i), remove the letter ``A'' at the beginning and
add in its place the phrase ``For nuclear power reactor licensees, a'';
0
c. Add paragraph (e)(3)(iv);
0
d. Redesignate paragraph (e)(4) as paragraph (e)(4)(i);
0
e. In newly redesignated paragraph (e)(4)(i), remove the word
``Subsequent'' and add in its place the phrase ``For nuclear power
licensees, subsequent'';
0
f. Add paragraph (e)(4)(ii);
0
g. In paragraph (g), remove the phrase ``non-power reactor'' and add in
its place the phrase ``non-power production or utilization facility'';
and
0
h. In footnote 1, remove the word ``includes'' and add in its place the
word ``include''.
The revisions and additions read as follows:
Sec. 50.71 Maintenance of records, making of reports.
* * * * *
(e) * * *
(3) * * *
(iv) Holders of non-power production or utilization facility
licenses issued after January 29, 2025, shall file a revision of the
original FSAR containing those original pages that are still applicable
plus new replacement pages 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.
* * * * *
(4) * * *
(ii) Non-power production or utilization facility licensees shall
file an FSAR update no more than 5 years from the date of the submittal
of the updated FSAR required by Sec. 50.71(e)(3)(iv) or by order and
shall file subsequent updates no more than 5 years from the date of the
previous submittal. Each submittal must reflect all changes made to the
FSAR up to a maximum of 6 months prior to the date of filing the
submittal.
* * * * *
0
16. In Sec. 50.75:
0
a. Revise paragraph (d)(1);
0
b. In paragraphs (e)(1)(iv) and (f)(4), remove the phrase ``non-power
reactor'' and add in its place the phrase ``non-power production or
utilization facility''; and
0
c. In paragraph (f)(5), remove the phrase ``power and non-power
reactors'' and add in its place the phrase ``power reactors and non-
power production or utilization facilities''.
The revision reads as follows:
Sec. 50.75 Reporting and recordkeeping for decommissioning planning.
* * * * *
(d)(1) Each applicant for or holder of an operating license for a
non-power production or utilization facility shall submit a
decommissioning report as required by Sec. 50.33(k) of this part.
* * * * *
0
17. In Sec. 50.82, revise paragraphs (b) introductory text, (b)(1),
and (c) to read as follows:
Sec. 50.82 Termination of license.
* * * * *
(b) For non-power production or utilization facility licensees--
(1) A licensee that permanently ceases operations must make
application for
[[Page 106252]]
license termination within 2 years following permanent cessation of
operations, and for testing facilities licensed under Sec. 50.21(c) or
facilities licensed under Sec. 50.22, in no case later than 1 year
prior to expiration of the operating license. Each application for
termination of a license must be accompanied or preceded by a proposed
decommissioning plan. The contents of the decommissioning plan are
specified in paragraph (b)(4) of this section.
* * * * *
(c) The collection period for any shortfall of funds will be
determined, upon application by the licensee, on a case-by-case basis
taking into account the specific financial situation of each holder of
the following licenses:
(1) A non-power production or utilization facility licensed under
Sec. 50.21(a) or (c), other than a testing facility, that has
permanently ceased operations.
(2) A facility licensed under Sec. 50.21(b) or Sec. 50.22, or a
testing facility, that has permanently ceased operation before the
expiration of its license.
0
18. Add Sec. 50.135 to read as follows:
Sec. 50.135 Renewal of non-power production or utilization facility
licenses issued under Sec. 50.22 and testing facility licenses.
(a) Applicability. The requirements in this section apply to
applicants for renewed non-power production or utilization facility
operating licenses issued under Sec. 50.22 and to applicants for
renewed testing facility operating licenses issued under Sec.
50.21(c).
(b) Written communications. All applications, correspondence,
reports, and other written communications must be filed in accordance
with applicable portions of Sec. 50.4.
(c) Filing of application. (1) The filing of an application for a
renewed license must be in accordance with subpart A of 10 CFR part 2
and all applicable sections of this part.
(2) An application for a renewed license may not be submitted to
the Commission earlier than 10 years before the expiration of the
operating license currently in effect.
(d) Contents of application. (1) Each application must include the
information specified in Sec. Sec. 50.33, 50.34, and 50.36, as
applicable.
(2) Each application must include conforming changes to the
standard indemnity agreement, under 10 CFR part 140 to account for the
expiration term of the proposed renewed license.
(3) Each application must include a supplement to the environmental
report that complies with the requirements of 10 CFR 51.56.
(e) Issuance of a renewed license. (1) A renewed license will be of
the class for which the operating license currently in effect was
issued.
(2) A renewed license will be issued for a fixed period of time.
The term of any renewed license may not exceed 40 years.
(3) A renewed license will become effective immediately upon its
issuance, thereby superseding the operating license previously in
effect. If a renewed license is subsequently set aside upon further
administrative or judicial appeal, the operating license previously in
effect will be reinstated unless its term has expired and the renewal
application was not filed in a timely manner in accordance with 10 CFR
2.109.
(4) A renewed license may be subsequently renewed in accordance
with all applicable requirements.
Appendix C to Part 50 [Amended]
0
19. In appendix C to part 50, amend paragraph III by removing the
phrase ``for medical and research reactors'' and adding in its place
the phrase ``for non-power production or utilization facilities of a
type described in Sec. 50.21(a) or (c), other than testing
facilities''.
0
20. In appendix E to part 50, revise footnote 2 to read as follows:
Appendix E to Part 50--Emergency Planning and Preparedness for
Production and Utilization Facilities
* * * * *
\2\ Regulatory Guide 2.6, ``Emergency Planning for Research and Test
Reactors and Other Non-Power Production and Utilization
Facilities,'' may be used as guidance for the acceptability of non-
power production or utilization facility emergency response plans.
* * * * *
PART 51--ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC
LICENSING AND RELATED REGULATORY FUNCTIONS
0
21. The authority citation for part 51 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 161, 193 (42 U.S.C.
2201, 2243); Energy Reorganization Act of 1974, secs. 201, 202 (42
U.S.C. 5841, 5842); National Environmental Policy Act of 1969 (42
U.S.C. 4332, 4334, 4335); Nuclear Waste Policy Act of 1982, secs.
144(f), 121, 135, 141, 148 (42 U.S.C. 10134(f), 10141, 10155, 10161,
10168); 44 U.S.C. 3504 note.
Sec. 51.17 [Amended]
0
22. In Sec. 51.17, amend paragraph (b) by adding the number ``51.56,''
in numerical order.
Sec. 51.45 [Amended]
0
23. In Sec. 51.45, amend paragraph (a) by adding the number ``51.56,''
in numerical order.
0
24. Add Sec. 51.56 to read as follows:
Sec. 51.56 Environmental report--non-power production or utilization
facility.
Each applicant for a non-power production or utilization
construction permit or facility license, or renewal of a non-power
production or utilization facility license issued pursuant to Sec.
50.21(a) or (c) or Sec. 50.22 of this chapter shall submit a separate
document, entitled ``Applicant's Environmental Report'' or ``Supplement
to Applicant's Environmental Report,'' as appropriate, with its
application to: ATTN: Document Control Desk, Director, Office of
Nuclear Reactor Regulation. The environmental report or supplement
shall contain the information specified in Sec. 51.45. If the
application is for a renewal of a license for which the applicant has
previously submitted an environmental report, the supplement, to the
extent applicable, shall include an analysis of any environmental
impacts resulting from operational experience or a change in
operations, and an analysis of any environmental impacts that may
result from proposed decommissioning activities.
PART 55--OPERATORS' LICENSES
0
25. The authority citation for part 55 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 107, 161, 181, 182,
183, 186, 187, 223, 234 (42 U.S.C. 2137, 2201, 2231, 2232, 2233,
2236, 2237, 2273, 2282); Energy Reorganization Act of 1974, secs.
201, 202 (42 U.S.C. 5841, 5842); Nuclear Waste Policy Act of 1982,
sec. 306 (42 U.S.C. 10226); 44 U.S.C. 3504 note.
Sec. 55.5 [Amended]
0
26. Amend Sec. 55.5 by:
0
a. In paragraph (b)(1), removing the phrase ``Except for test and
research reactor facilities, the'' and adding in its place the word
``The''; and
0
b. In paragraph (b)(3), removing the phrase ``a test and research
reactor or non-power reactor facility licensed under 10 CFR part 50''
and adding in its place ``a utilization facility licensed under part 50
of this chapter that is not a power reactor''.
Sec. 55.40 [Amended]
0
27. In Sec. 55.40, amend paragraph (d) by removing the phrase ``all
test and research reactors'' and adding in its place the phrase ``all
non-power reactors''.
[[Page 106253]]
Sec. 55.53 [Amended]
0
28. Amend Sec. 55.53 by:
0
a. In paragraphs (e) and (f)(2), removing the phrase ``test and
research reactors'' and adding in its place the phrase ``non-power
reactors''; and
0
b. In paragraph (j), removing the phrase ``non-power reactors'' and
adding in its place the phrase ``utilization facilities licensed under
10 CFR part 50 that are not power reactors''; and
0
c. In paragraph (k):
0
i. Removing the phrase ``non-power reactors'' and adding in its place
the phrase ``utilization facilities licensed under 10 CFR part 50 that
are not power reactors''; and
0
ii. Removing the term ``non-power'' at the end of the paragraph.
Sec. 55.59 [Amended]
0
29. In Sec. 55.59, amend paragraph (c)(7) by:
0
a. Removing in the paragraph heading, the phrase ``research and test
reactor facilities'' and adding in its place the phrase ``utilization
facilities licensed under 10 CFR part 50 that are not power reactors'';
and
0
b. Removing the phrase ``research reactor or test reactor facility''
and adding in its place ``utilization facility licensed under 10 CFR
part 50 that is not a power reactor''.
Sec. 55.61 [Amended]
0
30. In Sec. 55.61, amend paragraph (b)(5) by removing the phrase
``non-power reactors'' and adding in its place the phrase ``utilization
facilities licensed under 10 CFR part 50 that are not power reactors''.
PART 73--PHYSICAL PROTECTION OF PLANTS AND MATERIALS
0
31. The authority citation for part 73 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 53, 147, 149, 161,
161A, 170D, 170E, 170H, 170I, 223, 229, 234, 1701 (42 U.S.C. 2073,
2167, 2169, 2201, 2201a, 2210d, 2210e, 2210h, 2210i, 2273, 2278a,
2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42
U.S.C. 5841, 5842); Nuclear Waste Policy Act of 1982, secs. 135, 141
(42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.
Section 73.37(b)(2) also issued under Sec. 301, Public Law 96-
295, 94 Stat. 789 (42 U.S.C. 5841 note).
0
32. In Sec. 73.2, add in alphabetical order the definition for Non-
power reactor.
Sec. 73.2 Definitions.
* * * * *
Non-power reactor is defined at 10 CFR 50.2.
* * * * *
Sec. 73.21 [Amended]
0
33. In Sec. 73.21, amend paragraph (a)(1)(ii) by removing the phrase
``Research and test reactors'' and adding in its place the phrase
``non-power reactors''.
Sec. 73.23 [Amended]
0
34. Amend Sec. 73.23 by removing the phrase ``research and test
reactors'' and adding in its place the phrase ``non-power reactors''.
Sec. 73.60 [Amended]
0
35. Amend Sec. 73.60 by removing wherever it may appear, the word
``nonpower'' and adding in its place the word ``non-power''.
PART 140--FINANCIAL PROTECTION REQUIREMENTS AND INDEMNITY
AGREEMENTS
0
36. The authority citation for part 140 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 161, 170, 223, 234
(42 U.S.C. 2201, 2210, 2273, 2282); Energy Reorganization Act of
1974, secs. 201, 202 (42 U.S.C. 5841, 5842); 44 U.S.C. 3504 note.
0
37. Amend Sec. 140.3 by removing the definition for ``Testing
reactor'' and adding the definition for ``Testing facility'' to read as
follows:
Sec. 140.3 Definitions.
* * * * *
Testing facility is defined at 10 CFR 50.2.
* * * * *
Sec. 140.11 [Amended]
0
38. In Sec. 140.11, amend paragraph (a)(3) by removing the phrase
``testing reactor'' and adding in its place the phrase ``testing
facility''.
PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT
LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT
OF 1954, AS AMENDED
0
39. The authority citation for part 170 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 161(w) (42
U.S.C. 2014, 2201(w)); Energy Reorganization Act of 1974, sec. 201
(42 U.S.C. 5841); 42 U.S.C. 2215; 31 U.S.C. 901, 902, 9701; 44
U.S.C. 3504 note.
0
40. Amend Sec. 170.3 by revising the definitions for ``Research
reactor'' and ``Testing facility'' to read as follows:
Sec. 170.3 Definitions.
* * * * *
Research reactor means a non-power production or utilization
facility, as defined in 10 CFR 50.2, that is a nuclear reactor licensed
under 10 CFR 50.21(c):
(i) For which a safety assessment demonstrates accident radiation
doses consistent with 10 CFR 50.34(a)(1)(i); and
(ii) That is not a testing facility.
* * * * *
Testing facility is defined at 10 CFR 50.2.
* * * * *
PART 171--ANNUAL FEES FOR REACTOR LICENSES AND FUEL CYCLE LICENSES
AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF
COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS
AND GOVERNMENT AGENCIES LICENSED BY THE NRC
0
41. The authority citation for part 171 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 161(w), 223,
234 (42 U.S.C. 2014, 2201(w), 2273, 2282); Energy Reorganization Act
of 1974, sec. 201 (42 U.S.C. 5841); 42 U.S.C. 2215; 44 U.S.C. 3504
note.
0
42. Amend Sec. 171.5 by revising the definitions for ``Research
reactor'' and ``Testing facility'' to read as follows:
Sec. 171.5 Definitions.
* * * * *
Research reactor is defined at 10 CFR 170.3.
* * * * *
Testing facility is defined at 10 CFR 50.2.
* * * * *
Dated: December 19, 2024.
For the Nuclear Regulatory Commission.
Carrie Safford,
Secretary of the Commission.
[FR Doc. 2024-30721 Filed 12-27-24; 8:45 am]
BILLING CODE 7590-01-P