[Federal Register Volume 91, Number 38 (Thursday, February 26, 2026)]
[Proposed Rules]
[Pages 9476-9498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-03865]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 91, No. 38 / Thursday, February 26, 2026 /
Proposed Rules
[[Page 9476]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20, 30, 37, 50, 51, 72, 110, 150, 170, and 171
[NRC-2023-0071]
RIN 3150-AL00
Regulatory Framework for Fusion Machines
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule; guidance; and request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations to augment the existing byproduct material
framework to be inclusive of fusion machines. The NRC is proposing
requirements that are technology-inclusive to accommodate the wide
variety of anticipated fusion machine designs across the National
Materials Program. The NRC is also issuing for comment draft guidance
for the implementation of this proposed rule, entitled NUREG-1556,
Volume 22, ``Consolidated Guidance About Materials Licenses: Program-
Specific Guidance About Fusion Machine Licenses.'' The NRC will conduct
at least one public meeting to promote full understanding of the
proposed rule and to facilitate public comments. We seek comment on all
aspects of this proposed rule.
DATES: Submit comments by May 27, 2026. Comments received after this
date will be considered if it is practical to do so, but the Commission
is able to ensure consideration of only comments received before this
date.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject). The NRC encourages electronic comment
submission through the Federal rulemaking website (please choose only
one of the ways listed):
Federal rulemaking website: Electronically at https://www.regulations.gov. Follow the ``Submit a comment'' instructions. If
you are reading this document on federalregister.gov, you may use the
green ``SUBMIT A PUBLIC COMMENT'' button beneath this rulemaking's
title to submit a comment to the regulations.gov docket. 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.
Email comments to: [email protected]. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff. Mailed comments must be received by the close of
the comment period.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. eastern time, Federal
workdays; telephone: 301-415-1677.
Do not include any personally identifiable information (such as
name, address, or other contact information) or confidential business
information that you do not want publicly disclosed. All comments are
public records; they are publicly displayed exactly as received, and
will not be deleted, modified, or redacted. Comments may be submitted
anonymously.
Follow the search instructions on https://www.regulations.gov to
view public comments.
You can read a plain language description of this proposed rule at
https://www.regulations.gov/docket/NRC-2023-0071. For additional
direction on obtaining information and submitting comments, see
``Obtaining Information and Submitting Comments'' in the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Dennis Andrukat, Office of Nuclear
Material Safety and Safeguards, telephone: 301-415-3561, email:
[email protected], and Ed Harvey, Office of Nuclear Material
Safety and Safeguards, telephone: 301-415-1897, email:
[email protected]. Both are staff of the U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
Executive Summary
The U.S. Nuclear Regulatory Commission (NRC) is proposing the
revision of its byproduct material framework at part 30 of title 10 the
Code of Federal Regulations (10 CFR), ``Rules of General Applicability
to Domestic Licensing of Byproduct Material,'' for the licensing and
oversight of the possession, use, and production of byproduct material
associated with fusion machines. The proposed amendments to 10 CFR part
30 are primarily focused on definitions and the content of an
application. Proposed amendments to 10 CFR part 20, ``Standards for
Protection Against Radiation,'' are focused on definitions and
establishing a waste disposal site intruder assessment requirement, and
proposed amendments to 10 CFR part 51, ``Environmental Protection
Regulations for Domestic Licensing and Related Regulatory Functions,''
are focused on a requirement to submit an environmental report. In
addition, the draft proposed rule includes changes to the definition of
byproduct material in several other parts of the regulations (10 CFR
parts 37, 50, 72, 110, 150, 170, and 171) as required by section 205 of
the ADVANCE Act.\1\
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\1\ The Accelerating Deployment of Versatile, Advanced Nuclear
for Clean Energy (ADVANCE) Act of 2024 was signed into law on July
9, 2024; Public Law 118-67 (https://www.congress.gov/118/plaws/publ67/PLAW-118publ67.pdf).
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This rulemaking is separate from NRC's comprehensive review and
reform of its regulations, including those governing transportation, in
accordance with Executive Order (E.O.) 14300, ``Ordering the Reform of
the Nuclear Regulatory Commission'' (90 FR 22587; May 29, 2025). The
rulemakings associated with that effort will comprehensively reexamine
NRC requirements, including those in 10 CFR part 30. While there could
be additional revisions to 10 CFR part 30 as a result of these future
rulemakings, the NRC is moving forward with publication of this
proposed rule at this time because it is a deregulatory action of high
interest for stakeholders that was in progress before the issuance of
E.O. 14300. In this rule,
[[Page 9477]]
the NRC is proposing to augment the existing byproduct material
framework in 10 CFR part 30 to be inclusive of fusion machines. The NRC
is proposing requirements that are technology-inclusive to accommodate
the wide variety of anticipated fusion machine designs across the
National Materials Program.
A. Description of the Regulatory Action
This proposed rule includes regulatory requirements for the
possession, use, and production of byproduct material associated with
near-term fusion machines that are consistent with existing
requirements, to the extent practicable. The technology-inclusive and
risk-informed focus of this rulemaking will ensure applicability for
the wide variety of anticipated fusion machine designs while also
accounting for the differing quantities of radioactive material that
may be used and produced by these machines. In the context of this
proposed rulemaking, the focus of licensing and oversight would be on
possession, use, and production of radioactive materials associated
with fusion machines, as well as activation products.
B. Major Provisions
The major provisions of this proposed rule include--
Development of a regulatory framework for licensing the
possession, use, and production of byproduct material associated with
fusion machines under the existing 10 CFR part 30 byproduct material
framework. This framework would provide a systematic, risk-informed,
performance-based approach to the licensing and oversight of byproduct
material associated with fusion machines and their associated
radiological hazards.
Establishment of new proposed definitions, adopted from
the Atomic Energy Act (AEA) of 1954, as amended by the ADVANCE Act of
2024, to establish the scope of regulatory requirements for the
possession, use, and production of byproduct material associated with
fusion machines and technology-inclusive content-of-application
requirements supportive of a performance-based approach to regulation.
Other targeted changes to current regulations that would
ensure the applicability of current domestic licensing practices, and
other updates necessary for the safe and secure use of radioactive
materials associated with fusion machines.
Concurrent with this proposed rule, the NRC is issuing draft NUREG-
1556, Volume 22, ``Consolidated Guidance About Materials Licenses:
Program-Specific Guidance About Fusion Machine Licenses.''
C. Costs and Benefits
The NRC has prepared a regulatory analysis to determine the
expected quantitative costs and benefits of this proposed rule, as well
as qualitative factors considered in the NRC's rulemaking decision. The
quantitative analyses evaluated four attributes: industry operation,
NRC implementation, NRC operation, and other government entities.
Qualitative analyses were necessary to assess the attributes of
regulatory efficiency and increased public confidence along with
augmenting the assessments of the attributes that were quantitatively
assessed because monetizing the full impact of each attribute is not
possible or practical. Fully monetizing the impact of each attribute
would require estimation of factors such as the frequency of security-
related events and the consequences of such events.
The analysis concluded that this proposed rule would result in net
averted costs to the industry that exceed the net costs to Agreement
States and the NRC. The proposed rule would result in total net benefit
of approximately $1.38 million, and greater than a 99-percent chance
that there would collectively be a positive net benefit. The total cost
of the proposed rule reflects the cost impact on fusion machine
applicants, the NRC, and Agreement States.
Fusion machine applicants' benefits stem from clarified regulations
resulting in lower costs. NRC costs to implement this proposed rule
include future rulemaking costs incurred at the final rule phase and
costs for the preparation and issuance of final guidance. The benefits
to the NRC are avoided cost associated with the application reviews and
the oversight of the possession, use, and production of byproduct
material associated with fusion machines. The costs to Agreement States
are the costs of revising their regulations to be compatible with the
proposed rule. The benefits for Agreement States would be reduced
efforts in licensing due to improvements in clarity. The regulatory
analysis concludes that this proposed rule would result in a total
estimated implementation cost of $858,000 at a 7-percent discount rate
and $1.26 million at a 3-percent discount rate.
The regulatory analysis results show that this rulemaking is
justified because the total estimated quantified benefits, estimated to
be $2.24 million at a 7 percent discount rate or $4.50 million at a 3
percent discount rate, exceed the estimated costs of the rule. The
regulatory analysis also considered the following qualitative
considerations and associated benefits: regulatory efficiency and
increased public confidence. Benefits not monetized include reduced
need for exemptions and license conditions, and more timely completion
of licensing and oversight. Based on the assessment of the costs and
benefits of this proposed rule, including those benefits that are
unquantified, the NRC has concluded that the proposed rule provisions
would be justified to protect public health and safety and security.
For more information, please see the regulatory analysis (ADAMS
Accession No. ML25168A339).
Table of Contents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
B. Submitting Comments
II. Background
A. Introduction
B. Rulemaking Activity
C. What is fusion? How is it different from fission as seen in
nuclear reactors?
D. What is byproduct material, and why are the regulations for
byproduct material a good fit for fusion machines?
E. Why is the NRC undergoing rulemaking to address fusion
machines?
III. Discussion
A. General Scope
B. Specific Technical Topics
C. Implementation Guidance
IV. Specific Requests for Comment
V. Section-by-Section Analysis
VI. Regulatory Flexibility Certification
VII. Regulatory Analysis
VIII. Cumulative Effects of Regulation
IX. Plain Writing
X. Environmental Assessment and Proposed Finding of No Significant
Environmental Impact
XI. Paperwork Reduction Act
XII. Executive Orders
XIII. Coordination With NRC Agreement States
XIV. Compatibility of Agreement State Regulations
XV. Availability of Guidance
XVI. Public Meeting
XVII. Availability of Documents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2023-0071 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-2023-0071.
NRC's Agencywide Documents Access and Management System
[[Page 9478]]
(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 ADAMS Public 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 public 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.
B. Submitting Comments
The NRC encourages electronic comment submission through the
Federal rulemaking website (https://www.regulations.gov). Please
include Docket ID NRC-2023-0071 in your comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at
https://www.regulations.gov as well as enter the comment submissions
into ADAMS. The NRC does not routinely edit comment submissions to
remove identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Background
A. Introduction
In anticipation of future applications for licenses authorizing the
possession, use, and production of byproduct material associated with
fusion machines,\2\ the Commission stated in 2009 that ``the NRC has
regulatory jurisdiction over commercial fusion energy devices whenever
such devices are of significance to the common defense and security, or
could affect the health and safety of the public.'' \3\ However, the
Commission directed the NRC staff to wait until the commercial
deployment of fusion technology became more predictable before
expending significant resources to develop a regulatory framework.
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\2\ With the passage of the ADVANCE Act of 2024, section 11 of
the Atomic Energy Act of 1954 (AEA) was amended to add ``fusion
machine'' to describe the fusion process and its resultant products.
The ADVANCE Act also amended the AEA definition of byproduct
material to expressly include radioactive material generated by a
fusion machine. With the amendment of the AEA, NRC staff will now
use the term fusion machine instead of previous terms used to
describe the fusion process and its resultant products such as
fusion reactor, fusion energy systems, or fusion systems. Those
previous terms will be used if quoted from other documents.
\3\ See Staff Requirements Memorandum (SRM)-SECY-09-0064,
``Staff Requirements--SECY-09-0064--Regulation of Fusion-Based Power
Generation Devices,'' dated July 16, 2009 (ADAMS Accession No.
ML092230198).
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Since 2009, commercial companies worldwide have continued
development of fusion technologies using a variety of designs and fuel
cycles.\4\ Design proof of concept, including exceeding scientific
break-even (i.e., Q > 1) \5\ and net power production, is now targeted
for some commercial fusion machine concepts as soon as the mid-to-late
2020s, with commercial deployment projected to follow in the late 2020s
and early 2030s.
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\4\ See the Fusion Industry Association's report ``The Global
Fusion Industry in 2023'' (https://www.fusionindustryassociation.org/fusion-industry-report-archive/).
\5\ Q denotes the ratio of the energy of the fusion products to
the energy used to heat the plasma. Q = 1 would denote the fusion
breakeven point where equal amounts of energy were used and produced
by the fusion machine. Q > 1 denotes the fusion machine generated
more energy than it used to heat the plasma, while Q < 1 denotes the
fusion machine generated less energy than it used to heat the
plasma.
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In 2019, the Nuclear Energy Innovation and Modernization Act
(NEIMA) required the NRC to develop the regulatory infrastructure to
support the development and commercialization of advanced nuclear
reactors, including both nuclear fission reactors and fusion
machines.\6\ Section 103 of NEIMA requires the NRC to complete a
rulemaking to establish a technology-inclusive regulatory framework for
optional use by commercial advanced nuclear reactor applicants by
December 31, 2027.
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\6\ The ADVANCE Act of 2024 amended NEIMA to replace ``fusion
reactor'' with ``fusion machine.''
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In response to NEIMA and due to the continued development of fusion
technologies, the Commission in 2020 directed the NRC staff to
``consider the appropriate treatment of fusion reactor designs in our
regulatory structure by developing options for Commission consideration
on licensing and regulating fusion energy systems.'' \7\ In its
November 2, 2020, response to this Commission direction, the NRC staff
stated that it would assess the potential risks posed by fusion
technologies and explore regulatory approaches separate from the
ongoing rulemaking for advanced nuclear fission reactors that would
create 10 CFR part 53, ``Risk-Informed, Technology-Inclusive Regulatory
Frameworks for Commercial Nuclear Plants.''
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\7\ SRM-SECY-20-0032, ``Staff Requirements--SECY-20-0032--
Rulemaking Plan on `Risk-Informed, Technology-Inclusive Regulatory
Framework for Advanced Reactors (RIN-3150-AK31; NRC-2019-0062),' ''
dated October 2, 2020 (ADAMS Accession No. ML20276A293).
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The NRC staff developed an options paper \8\ that included three
potential approaches for the regulation of fusion machines: (1) a
utilization facility approach, (2) a byproduct material approach, and
(3) a hybrid approach. The utilization facility approach would use the
part 53 framework and apply the requirements for fission facilities to
fusion machines. The byproduct material approach would use the existing
10 CFR part 30 framework, along with a limited-scope rulemaking
proposed by the NRC staff. The hybrid approach would have the NRC first
regulate fusion machines under the part 30 framework but later develop
decision criteria to identify whether a fusion machine design should be
regulated under a part 53 framework. The NRC would develop the criteria
during a future limited-scope rulemaking.
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\8\ SECY-23-0001, ``Options for Licensing and Regulating Fusion
Energy Systems,'' dated January 3, 2023 (ADAMS Accession No.
ML22273A178).
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B. Rulemaking Activity
The Commission directed the NRC staff to proceed with a rulemaking
on fusion machines in ``Staff Requirements--SECY-23-0001--Options for
Licensing and Regulating Fusion Energy Systems,'' dated April 13,
2023.\9\ The Commission chose the byproduct material approach (Option
2) using the existing 10 CFR part 30 framework. The Commission further
stated that this rulemaking should--
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\9\ SRM-SECY-23-0001, ``Staff Requirements--SECY-23-0001--
Options for Licensing and Regulating Fusion Energy Systems,'' dated
April 13, 2023 (ADAMS Accession No. ML23103A449).
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Take into account the existence of fusion machines that
already have been licensed and are being regulated by the Agreement
States, as well as those that may be licensed prior to the completion
of the rulemaking;
Develop a new volume of NUREG-1556, ``Consolidated
Guidance About Materials Licenses,'' dedicated to fusion
[[Page 9479]]
machines, so as to provide consistent guidance across the National
Materials Program;
Evaluate whether controls-by-design approaches, export
controls, or other controls are necessary for near-term fusion
machines; and
If in the future, the NRC staff, in consultation with the
Agreement States, determines that an anticipated fusion design presents
hazards sufficiently beyond those of near-term fusion technologies, the
NRC staff should notify the Commission and make recommendations for
taking appropriate action as needed.
On July 9, 2024, the ADVANCE Act of 2024 \10\ was signed into law.
Section 205 of the ADVANCE Act amended section 11 of the AEA to add the
definition of ``fusion machine'' and amended the definition of
``byproduct material'' to include fusion machine generated radioactive
material in section 11e.(3)(B). The ADVANCE Act thus establishes that,
for the purposes of the AEA's definition of byproduct material, fusion
machines are a subset of particle accelerators. In addition, the AEA's
amended definition creates two criteria for determining whether
radioactive material produced through use of a particle accelerator is
byproduct material under AEA section 11e.(3)(B): one set of criteria
for fusion machines, and another set for particle accelerators that are
not fusion machines.\11\ These changes are included in this rulemaking.
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\10\ The Accelerating Deployment of Versatile, Advanced Nuclear
for Clean Energy (ADVANCE) Act of 2024 was signed into law on July
9, 2024; Public Law No: 118-67 (https://www.congress.gov/118/plaws/publ67/PLAW-118publ67.pdf).
\11\ Under AEA section 11e.(3)(B)(i), byproduct material is any
material that has been made radioactive by use of a particle
accelerator, including by use of a fusion machine. Under AEA section
11e.(3)(B)(ii), byproduct material is any material that if made
radioactive by use of a particle accelerator that is not a fusion
machine, is produced, extracted, or converted after extraction,
before, on, or after August 8, 2005, for use for a commercial,
medical, or research activity (42 U.S.C. 2011 et seq.).
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The ADVANCE Act also amended section 103 of NEIMA to delete
``fusion reactor'' and replace it with ``fusion machine.'' Finally,
subsection 205(c) of the ADVANCE Act requires the NRC to submit a
report to Congress, by July 9, 2025, on design-specific licensing
frameworks for ``mass-manufactured fusion machines''; and provide an
estimated timeframe for the NRC to issue regulations or guidance for
licensing mass-manufactured fusion machines. This report is being
prepared separately from this rulemaking.
C. What is fusion? How is it different from fission as seen in nuclear
reactors?
Fusion machines are distinctly different from fission reactors.
Fusion is a process in which two or more atomic nuclei are combined to
form a heavier element, releasing energy along with charged particles
and neutrons. In addition to heat, particles, and electromagnetic
radiation, fusion machines can produce tritium, neutrons, and neutron
activation products that need to be properly contained to protect
public health and safety. The generation of net energy from fusion
requires creating conditions, such as in a plasma,\12\ that confines
the particles and energy for long enough time at high enough density
and temperature so that the energy produced by the fusion reactions
exceeds the energy used to create and maintain the conditions. Fusion
reactions require active control to sustain these specific conditions,
such as maintaining confinement of the plasma at fusion conditions,
otherwise fusion reactions will cease along with the production of
radiation and radioactive material. There can be long-term generation
of decay heat in the structures due to the decay of radionuclides made
radioactive by neutrons from the fusion reactions, but the level of
decay heat generated is not expected to require engineered emergency
heat removal systems.
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\12\ A plasma is a state of matter consisting of positive ions
and free electrons with a small overall electrical charge that is
dominated by electric and magnetic interactions.
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Fission, as seen in nuclear reactors, is the splitting of a heavy
atom (usually enriched uranium-235), which releases energy (usually in
the form of heat) that can be used to produce electricity. Fission may
be spontaneous but is usually caused by the nucleus of an atom becoming
unstable after capturing or absorbing a neutron. During fission, the
heavy nucleus splits into roughly equal parts, producing radionuclides
of at least two lighter elements that can be radioactive. There must be
enough neutrons being released from fissions to maintain a self-
sustaining fission reaction rate, namely criticality. Unlike fusion
reactions, self-sustaining fission reactions require active control to
maintain criticality and, when necessary, to cease the fission
reactions (i.e., reach a sub-critical condition). Fission reactors also
generate long-term decay heat at a high enough level that they need
engineered emergency heat removal systems to ensure that the decay heat
is removed from the system.
D. What is byproduct material, and why are the regulations for
byproduct material a good fit for fusion machines?
Byproduct material is regulated under the framework presented in 10
CFR part 30. Byproduct material is currently defined in 10 CFR part 30
as (1) any radioactive material (except special nuclear material)
produced or made radioactive by exposure to the radiation incident to
the process of producing or using special nuclear material (this
includes most of the available inventory of the radionuclide hydrogen-3
also known as tritium); (2) any discrete source of radium-226 that is
produced, extracted, or converted after extraction, before, on, or
after August 8, 2005, for use for a commercial, medical, or research
activity; or (3) any material that has been made radioactive by use of
a particle accelerator and is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity. In addition, the NRC, in
consultation with the Environmental Protection Agency (EPA), Department
of Energy (DOE), Department of Homeland Security (DHS), and others, can
designate as byproduct material any source of naturally occurring
radioactive material, other than source material, that the NRC
determines would pose a threat to public health and safety or the
common defense and security of the United States and has been extracted
or converted after extraction for use in a commercial, medical, or
research activity.
The NRC currently uses an approach to licensing byproduct material
that regulates the potential hazards from a wide spectrum of
technologies, from lower risk portable nuclear gauges to higher risk
panoramic irradiators and commercial manufacturers of radioactive
sources or devices. Byproduct material regulations provide a
comprehensive list of technical and regulatory areas that must be
addressed in the licensing processes. NUREG-1556, ``Consolidated
Guidance About Materials Licenses,'' provides guidance on meeting those
requirements. For larger quantities of byproduct material, such as
those that may be present at commercial fusion machine sites, NRC
regulations, such as 10 CFR parts 20 and 30, include specific
programmatic requirements, such as those related to financial
assurance, emergency planning, waste management, and decommissioning.
The types of radioactive materials and hazards associated with a
near-term fusion machine are more aligned with those of a byproduct
material license
[[Page 9480]]
holder than those of a nuclear power plant. For example, key areas of
focus for protecting public health and safety for byproduct material
license holders are confinement of radioactive materials, shielding to
protect people from radiation hazards, consideration of potential
supporting systems for breeding tritium, and the accountability of
tritium or other radionuclides at the site. Potential radiological
hazards posed by fusion machines include the following:
Significant quantities of tritium may be located on the
site, including within the vacuum vessel, in processing, in storage,
and permeated into structural materials.\13\
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\13\ The maximum inventory of tritium at the International
Thermonuclear Experimental Reactor (ITER) is expected to be 4,000
grams (about 40 million curies). Commercial companies pursuing
fusion machines for deployment in the United States have
communicated to the NRC that tritium inventories for their designs
are expected to be significantly less (about 5 to 10 million
curies).
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During operation, fusion machines represent a large
radiation source, including high-energy neutrons and gamma radiation,
that requires shielding and containment of activated components.
Neutron bombardment will activate components, with
quantities of activation products increasing over time.
Energetic plasma-surface interactions with the vacuum
vessel interior wall may generate dust containing tritium and
activation products.
Fusion also can directly generate radioactive materials;
for example, about 50 percent of the time, when two deuterium atoms are
fused together (D-D fusion), the fusion reaction generates a tritium
atom (the other direct products are not radioactive).
Fusion machines may use byproduct material as fuel or may produce
byproduct material, such as through exposure of nonradioactive material
to neutron radiation or from the fusion reactions. The byproduct
material framework provides a flexible approach to regulate the
anticipated diversity of fusion designs, fuels, and quantities of
radioactive materials produced by a fusion machine.
E. Why is the NRC undergoing rulemaking to address fusion machines?
Besides incorporating the statutory changes to the AEA and the
NEIMA requirement for the NRC to establish fusion machine (advanced
reactor) regulations by December 31, 2027, the NRC also endeavored to
provide centralized, predictable, dedicated fusion machine regulations
and guidance. Rulemaking would allow for the timely alignment of the
licensing and regulation of the possession, use, and production of
byproduct material associated with fusion machines across the NRC and
the Agreement States, as part of the National Materials Program, to
provide near-term regulatory predictability for fusion developers,
regulators, and the public. In addition, the participation of the
public in the Administrative Procedure Act rulemaking process enables
all stakeholders (e.g., regulators, industry, and the public) to
interact, provide feedback, and gain an understanding of the risks,
costs, cost savings, and benefits of this new technology.
In this proposed rule, the NRC proposes definitions to establish
the scope of regulatory requirements for the possession, use, and
production of byproduct material associated with fusion machines and
technology-inclusive content-of-application requirements supportive of
a performance-based approach to regulation. Other targeted changes to
current regulations and guidance would ensure the applicability of
current domestic licensing practices, and other updates necessary for
the safe and secure use of radioactive materials used in a fusion
machine.
III. Discussion
A. General Scope
The NRC is undertaking a limited-scope rulemaking to license and
regulate the possession, use, and production of byproduct material
associated with fusion machines. The proposed changes would amend 10
CFR parts 20, 30, 37, 50, 51, 72, 110, 150, 170, and 171, include
changes to definitions, content-of-application requirements,
recordkeeping and inspection requirements, intruder assessment
requirements for waste disposal sites, and environmental report
submission requirements. This proposed rule is focused on fusion
machines for both commercial and research and development purposes that
are currently contemplated for deployment in the near term. At the time
of this rule, there are 29 fusion companies \14\ based in the United
States, including several that are constructing proof-of-concept
facilities. The phrase ``near-term'' for fusion machines was described
in SECY-23-0001 and is not used to refer to a particular timeframe;
rather, it encompasses certain characteristics associated with all the
known approaches to fusion currently being researched or under
development. As described in SECY-23-0001, these include--
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\14\ See Fusion Industry Association's report on ``Global Fusion
Industry Report,'' dated July 22, 2025.
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No fissile material is present, and criticality (a self-
sustaining neutron chain reaction) is not possible.
Energy and radioactive material production from fusion
reactions cease without any intervention in off-normal events or
accident scenarios.
Active post shutdown cooling of the fusion machine's
structures containing radioactive material is not necessary to prevent
a loss of radiological confinement (i.e., vessel breach).\15\
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\15\ See EURFUBRU XII-217/95, Safety and Environmental
Assessment of Fusion Power (SEAFP): Report of the SEAFP Project,
European Commission DG XII, Fusion Programme, issued June 1995
(https://www.researchgate.net/publication/303252621_Safety_and_Environmental_Assessment_of_Fusion_Power_SEAFP_Final_Report_of_the_SEAFP_Project).
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Radionuclides present in the fusion machine, in processing
or storage, or in activated materials, in any significant mobilizable
amount are expected to result in low doses to workers and member of the
public during credible accident scenarios (e.g., less than 1 rem (10
millisievert (mSv)) effective dose equivalent to a person offsite).
Active engineered features (e.g., plasma confinement
mechanisms, vacuum maintaining systems, fuel injection, external
heating) are needed to achieve sustained fusion reaction.
The NRC considered these characteristics and the level of risk
associated with the scientific and technical approaches to fusion known
to the NRC at the time of this rulemaking.\16\ The proposed rule, while
technology inclusive, is not intended to address speculative fusion
technologies significantly different from those being researched,
developed, piloted, and deployed today (for example, today's design
types include tokamak, stellarator, z-pinch, field reverse, and
configurations with fuels that include deuterium-tritium, deuterium-
helium-3, and proton-boron-11). The NRC will continue to monitor the
development of fusion technology as it advances towards
commercialization.
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\16\ See e.g., the National Academies of Science report,
``Bringing Fusion to the US Grid,'' issued in 2021 (https://doi.org/10.17226/25991); UKAEA-RE(21)01, ``Technology Report--Safety and
Waste Aspects for Fusion Power Plants,'' issued September 2021
(https://scientific-publications.ukaea.uk/wp-content/uploads/UKAEA-RE2101-Fusion-Technology-Report-Issue-1.pdf); and the Fusion
Industry Association's report, ``The Global Fusion Industry in
2023,'' (https://www.fusionindustryassociation.org/fusion-industry-report-archive/).
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The proposed rule would add new requirements and modify some
existing
[[Page 9481]]
requirements to license and oversee the possession, use, and production
of byproduct material associated with fusion machines under the 10 CFR
part 30 byproduct material framework. Agreement States are currently
using requirements compatible with 10 CFR part 30 and have safely
regulated laboratory-scale fusion research and development systems for
over 25 years. The 10 CFR part 30 requirements include safety,
security, emergency preparedness, and radiation protection for workers
and the public. Each applicant would need to provide specific design
information and proposed radiological materials that will be used or
generated (quantity and form), which would further shape the NRC's
understanding of potential hazards that can impact safety, security,
and emergency preparedness. This information may result in the need for
specific license conditions. This proposed rulemaking does not amend 10
CFR parts 170 and 171 to add new initial application of annual fee
categories for fusion machines. New fees for the possession, use, and
production of byproduct material associated with fusion machines will
be proposed in the annual fee rule following publication of the final
rule for this rulemaking. The NRC uses annual fee rules to make changes
to the NRC's fees; therefore, the NRC is not proposing any fee-related
amendments for the possession, use, and production of byproduct
material associated with fusion machines in this proposed rule.
Informed by stakeholder interactions during the development of this
proposed rule, the NRC has concluded that the current requirements for
key topics such as emergency preparedness, physical security, radiation
protection, and waste disposal (except for a small adjustment to 10 CFR
part 20) are adequate for near-term designs. The fusion industry is
emerging rapidly, and designs are both diverse and evolving. The NRC,
in consultation with the Agreement States, will continue to evaluate
the hazards presented by near-term fusion designs as they are developed
for deployment. Additionally, the NRC has coordinated with DOE on
topics such as tritium handling, training, international cooperation,
and public outreach and the NRC will continue to collaborate with
Federal partners, as needed.
The NRC, and the Atomic Energy Commission before it, has experience
licensing new and rapidly evolving technologies. The NRC has authority
under Sec. 30.32(b) to require additional information as necessary to
evaluate an application, and under Sec. 30.34(e) to impose any license
conditions, orders, or other requirements needed to ensure that fusion
machines will be operated safely and securely. As stated in Sec.
30.33(b), the NRC will only grant a license upon a determination that
the application meets the requirements of the Atomic Energy Act of
1954, as amended, which includes protection of the public health and
safety and promotion of the common defense and security. In the
proposed rule, the NRC is specifying the basic regulatory requirements
that applicants must meet (e.g., dose limits) and providing licensing
guidance that asks for basic information to ensure a common
understanding of the machine such that it will provide adequate public
health and safety (such as meeting dose limits and training of
radiation safety staff and users). This performance-based approach
provides safety and security while providing the applicant or licensee
the necessary flexibility to design and innovate its fusion machine
design. This paragraph in this proposed rule is intended to explain how
the licensing and oversight provisions allow for the use of flexible,
technology appropriate safety measures even though these measures are
not prescribed in the regulations.
If the NRC receives an application for the possession, use, and
production of byproduct material associated with a near-term fusion
machine that includes safety and security elements that were not
anticipated, the proposed and existing regulations under 10 CFR part 30
afford the NRC adequate authority to impose requirements to carry out
that responsibility on a case-by-case basis. In addition, the NRC will
continue to work with the Agreement States to ensure that the States
have licensing and inspection programs for fusion machines that are
compatible and provide consistency across the National Materials
Program.
For waste disposal, new proposed rule language would allow fusion-
machine-produced byproduct material that was not considered during the
development of the existing 10 CFR part 61, ``Licensing Requirements
for Land Disposal of Radioactive Waste'' (47 FR 57463; December 27,
1982), to be disposed at low-level radioactive waste (LLW) disposal
facilities. This disposal path for materials used or generated in a
fusion machine provides safe disposal at existing LLW disposal
facilities.
For emergency preparedness, the NRC would continue to require
applicants to determine if the maximum dose to a person offsite could
exceed 1 rem (10 mSv), and if so, to provide an emergency plan for
offsite protection of the public. The basis for the offsite dose
evaluation and the subsequent emergency plan (if needed) would consider
the unique characteristics of the radionuclides generated or used by
the fusion machine, such as dispersion and radiochemistry. Separately,
an onsite emergency plan, or emergency procedures, would be needed
based on the potential events and radiological hazards within the site
boundary of each fusion machine.
For physical security, the quantities or forms of radioactive
material associated with the fusion machine possessed by a licensee may
warrant additional protection beyond that required by 10 CFR part 20,
and those radionuclides may not be listed in appendix A to 10 CFR part
37, ``Physical protection of category 1 and category 2 quantities of
radioactive material.'' In such cases, the NRC would determine on a
case-by-case basis if other additional security requirements are
warranted (e.g., based on the use of structural materials that create
new radionuclides of concern through activation).
For radiation protection, the existing 10 CFR part 20 radiation
safety requirements apply to all licensees currently regulated by the
NRC. Licensees that possess fusion machines would be required to meet
these 10 CFR part 20 radiation safety requirements, some of which may
or may not apply depending on a licensee's specific radioactive
materials and their quantities. Therefore, this proposed rule would
require applicants to describe what radionuclides and quantities will
be used and produced in their specific fusion designs, which would
allow regulators to evaluate how these requirements apply to a fusion
machine before a license can be issued.
B. Specific Technical Topics
This proposed rule would revise requirements in several technical
areas. The NRC also considered certain additional technical areas
(e.g., export controls, emergency preparedness) to determine if
revisions were needed but, as described above, ultimately concluded no
new or amended requirements were necessary beyond those described
below.
1. Defining Fusion Machines and Particle Accelerators
This proposed rule would add a new definition for ``fusion
machine'' in Sec. Sec. 20.1003 and 30.4 of this chapter; revise the
definition of ``particle accelerator'' in Sec. Sec. 20.1003, 30.4, and
110.2 of this chapter; and revise the definition of ``byproduct
material'' in Sec. Sec. 20.1003, 30.4, 37.5, 50.2, 72.3, 110.2,
[[Page 9482]]
150.3, 170.3, and 171.5 of this chapter. The NRC has been evaluating
the linkage between fusion devices and particle accelerators for
several years, and these definitions have been a topic of extensive
discussion with stakeholders. Congress clarified this issue with the
passage of the ADVANCE Act of 2024. The ADVANCE Act clarified this
linkage by clearly defining all fusion-machine-produced radioactive
material as falling within the AEA's existing definition for byproduct
material. Specifically, the term ``fusion machine'' was added to
section 11 of the AEA and ``byproduct material'' was amended in section
11e.(3)(B) to include any material that (i) has been made radioactive
by use of a particle accelerator, including by use of a fusion machine;
and (ii) if made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity.\17\ As explained above, the
AEA's amended definition creates two criteria for determining whether
radioactive material produced through use of a particle accelerator is
byproduct material under AEA section 11e.(3)(B): one set of criteria
for fusion machines, and another set for particle accelerators that are
not fusion machines.
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\17\ The term ``particle accelerator'' is not defined in the
AEA. The NRC's proposed regulatory definitions would define fusion
machines as a subset of particle accelerators. The new requirements
would apply to fusion machine applicants and licensees.
---------------------------------------------------------------------------
The ADVANCE Act also amended NEIMA to change ``fusion reactor'' to
``fusion machine'' and points to the fusion machine definition under
the ADVANCE Act. The definition of fusion machine in the ADVANCE Act
and proposed for this rulemaking does not define fusion but focuses on
what broadly is the role of the ``machine,'' i.e., transforming atomic
nuclei using fusion processes and capturing and using the resultant
products from those processes. Given the diversity of fusion processes
and designs currently under consideration, the new definition provides
the flexibility to be incorporated into NRC's part 30 framework in a
technology-inclusive manner. The proposed regulatory framework would
provide a risk-informed approach to protecting workers, the public, and
the environment from the possession, use, and production of byproduct
material associated with fusion machines.
The NRC's existing regulations and guidance (i.e., NUREG-1556,
Volume 21, ``Consolidated Guidance About Materials Licenses: Program-
Specific Guidance About Possession Licenses for Production of
Radioactive Material Using an Accelerator'') provide for the licensing
of particle accelerators. Consistent with the distinction in the AEA
between byproduct material produced by fusion machines and other
particle accelerators, the NRC's proposed definitions would consider
fusion machines as a subset of particle accelerators. This approach
would affirmatively establish that existing guidance for particle
accelerators would not apply to fusion machines.
In addition, the NRC would revise the part 110.2 definition for
``byproduct material'' to replace the reference to 10 CFR 20.1003 with
the language found in 10 CFR 20.1003. This change would be consistent
with the definition language found in the other byproduct material
definitions in this chapter.
2. Specific Requirements for Fusion Machines
This proposed rule would add new Sec. Sec. 30.32(k), 30.33(a)(6),
and 51.60(b)(1)(viii) of this chapter. This proposed rule would also
amend existing regulations in Sec. Sec. 20.2008, 30.51(a) introductory
text, 30.51(a)(1), and 30.52(a) of this chapter. The proposed new
sections Sec. Sec. 30.32(k) and 30.33(a)(6) are specific to the
license application requirements for the possession, use, and
production of byproduct material associated with fusion machines. The
proposed new paragraph Sec. 51.60(b)(1)(viii) is specific to the
submission of an environmental report for the possession, use, and
production of byproduct material associated with fusion machines. The
proposed new language in paragraph Sec. 20.2008(a) is specific to the
disposal requirements for waste from a fusion machine. The remaining
proposed changes amending the existing regulations in Sec. Sec.
30.51(a) introductory text, 30.51(a)(1), and 30.52(a) of this chapter
are conforming changes to existing byproduct material requirements to
address specific attributes of fusion machines.
This proposed rule would add technology-inclusive, content-of-
application requirements supportive of a performance-based approach to
regulating the possession, use, and production of byproduct material
associated with fusion machines. The content-of-application section
would provide the requirements for the licensing of byproduct material
associated with a fusion machine which would be supplemented by the
current general regulatory requirements and the terms and conditions of
licenses already contained in Sec. Sec. 30.32, 30.33, and 30.34. In
addition to the contents of application, other conforming changes would
be added specific to fusion machines.
The proposed contents of application section in Sec. 30.32(k)
would require that an applicant for a license to possess, use, and
produce byproduct material associated with a fusion machine provide
several items:
(1) a general description of the fusion machine;
(2) a summary of operating and emergency procedures related to
radiation safety;
(3) a description of the radiation safety organizational structure;
(4) a description of the training program for fusions machines and
radiation protection;
(5) a description of inspection and maintenance programs; and
(6) a description of the methodology for maintaining a radioactive
material inventory.
In the summary of the procedures important to radiation protection,
the applicant must provide descriptions of (1) the radiation protection
measures to be employed for byproduct material, including all
interlocks, access control systems, shielding, and radiation monitors;
(2) the byproduct material handling systems procedures and inventory
control procedures; and (3) description of any other components or
systems used to control radiation and radioactive material.
The proposed contents of application for the possession, use, and
production of byproduct material associated with fusion machines also
would give an applicant an alternative to providing a description of
the fusion machine and operational programs relative to radiation
safety as proposed in Sec. 30.32(k)(2)(i)-(iii). The alternative
pathway, proposed in Sec. 30.32(k)(2)(iv), would require the applicant
to provide a description of any aspects of the fusion machine relevant
to radiation safety that differ from the information listed in
paragraphs (k)(2)(i) through (iii), an explanation for how those
aspects of the application ensure the fusion machine can be operated
safely, and any other information requested by the NRC during
preapplication communications to enable the NRC to evaluate whether the
applicant can safely possess, use, and produce byproduct material
associated with a fusion machine. This technology-inclusive approach to
licensing recognizes the diversity of fusion machine designs currently
being considered and possible in the future while helping to provide
early
[[Page 9483]]
awareness of some information the applicant would need to provide to
allow the NRC to determine whether byproduct material associated with a
fusion machine can be possessed, used, and produced safely.
A new, proposed paragraph would be added to Sec. 30.33(a)(6) to
specifically provide the general requirement for approving an
application to license the possession, use, and production of byproduct
material associated with a fusion machine.
A new, proposed paragraph would be added to Sec. 51.60(b)(1)(viii)
to require that an environmental report be prepared for the
construction and operation of a fusion machine unless a categorical
exclusion applies.\18\ The NRC expects that scope of the environmental
report would be discussed during any voluntary preapplication
discussions described in Sec. 30.32(k)(2)(iv)(B).
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\18\ Based on case-specific circumstances, a categorical
exclusion may apply. Categorical exclusions are established by rule
in Sec. 51.22 for categories of actions that the Commission has
found do not individually or cumulatively have a significant effect
on the human environment. Even if a categorical exclusion would
otherwise apply, the NRC may determine that special circumstances
are present that warrant the preparation of an environmental
document.
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Radioactive material as defined in paragraphs (3) and (4) of the
definition of byproduct material in Sec. 20.1003 is not LLW.\19\ Given
that fusion machines produce radioactive material that meets paragraph
(3) of the definition of byproduct material, the NRC is proposing to
include new language in paragraph (a) to Sec. 20.2008 that would allow
certain licensed waste from fusion machines to be disposed in a LLW
disposal facility. The addition would not affect the ability of waste
to be disposed of under Sec. 20.2002 (e.g., in a hazardous waste
facility) if it met any other applicable State and Federal
requirements. The NRC is not proposing any changes to Sec. 20.2006 or
appendix G to 10 CFR part 20 because those requirements are
sufficiently general to apply to fusion machine generated waste without
modification. The NRC would add Sec. 20.2008 to the list of approved
information collections in Sec. 20.1009.\20\
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\19\ Some radioactive material, added to the AEA definition of
byproduct material by Section 651(e) of the Energy Policy Act of
2005 and ADVANCE Act of 2024, has special status relating to its
disposal at LLW disposal facilities. These 11e.(3) and (4) byproduct
materials include certain discrete sources of radium 226
(11e.(3)(A)), radioactive material resulting from operation of an
accelerator or a fusion machine (11e.(3)(B)), and certain other
discrete source[s] of naturally occurring radioactive material,
other than source material (11e.(4)). As described in AEA sections
81b. and c., 11e.(3) and (4) byproduct materials intended for
disposal are not considered LLW under the Low-Level Radioactive
Waste Policy Act but may nevertheless be disposed of at near surface
LLW disposal facilities. Under NRC regulations, licensed material
that contains LLW must be disposed of in accordance with the
requirements for LLW. Thus, licensed material that contains a mix of
LLW and 11e.(3) and (4) byproduct material must be disposed of as
LLW. In addition, AEA section 81c. provides that 11e.(3) and (4)
byproduct material may be disposed of at hazardous waste facilities.
\20\ Concurrent with the development of this rulemaking, the NRC
staff proposed to the Commission, a revision of 10 CFR part 61 in a
separate rulemaking activity. See SECY-24-0045, ``Proposed Rule:
Integrated Low Level Radioactive Waste Disposal,'' dated May 29,
2024 (ADAMS Accession No. ML23242A249). The draft proposed part 61
rule, if approved by the Commission, would not conflict with the
fusion machine rule's proposed changes to Sec. 20.2008. Similarly,
the draft proposed changes to 10 CFR part 61 would not change the
requirements for disposal of fusion machine waste.
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The NRC is proposing to amend Sec. Sec. 30.51(a) and 30.52(a) to
include requirements for recordkeeping and to allow inspection of the
production of byproduct material. Maintaining records of the total
quantity of byproduct material possessed by the licensee is important,
including that material produced and used by the fusion machine, for
purposes of material control and accountability, maintaining adequate
financial assurance, and evaluation of offsite doses from routine and
accidental releases. The NRC recognizes that calculating the total
quantity of byproduct material may be complex and the uncertainties in
those calculations for fusion machines have yet to be determined. The
draft NUREG-1556 acknowledges the complexity of accountability and
provides flexibility for licensees to use computational methods for
this purpose. Additionally, the NRC is supportive of receiving feedback
from industry and academia on proposals for byproduct material
accountability.
3. Decommissioning and Financial Assurance
It is expected that some licensees that possess, use, and produce
byproduct material associated with a fusion machine would need to meet
the existing requirements for financial assurance or a decommissioning
funding plan as described in Sec. 30.35. The NRC is not proposing
changes to these requirements for decommissioning and financial
assurance because the existing regulations already provide the needed
flexibility based on the quantity of radioactive material remaining at
the facility at the end of life. The current regulations already offer
fusion machine applicants a clear pathway to determine the appropriate
level of financial assurance for decommissioning their facility and to
fund that decommissioning using a financial instrument that aligns with
their business model and needs.. For the same reasons, the NRC is not
proposing revisions to NUREG-1757, Volumes 1-3, ``Consolidated
Decommissioning Guidance.''
4. Emergency Preparedness
For an application to possess, use, and produce byproduct material
associated with a fusion machine submitted to the NRC, the proposed
rule would require the applicant under Sec. 30.32(k)(2) to submit a
summary of the radiation safety aspects of the written operating and
emergency procedures. Onsite emergency procedures are needed to handle
events ranging from a minor spill to a larger incident that could
require intervention by outside emergency response personnel. The NRC
is issuing draft guidance, Volume 22 of NUREG-1556, ``Consolidated
Guidance About Materials Licenses: Program-Specific Guidance About
Possession Licenses for Fusion Machines,'' for public comment with this
proposed rule that includes guidance on developing emergency procedures
for fusion machines. This draft guidance is similar to the emergency
procedure guidance available in other volumes of NUREG-1556 for similar
types of 10 CFR part 30 licenses. This draft guidance describes what an
applicant should consider regarding response capabilities for
protecting onsite personnel, as well as coordination with fire,
medical, and local law enforcement agencies, as needed, for an incident
at a fusion machine facility.
Potential unsealed sources of radioactive material for fusion
machines include tritium for fuel and materials made radioactive by
exposure to neutrons from the fusion reactions (activated materials).
Activated materials may contribute to offsite doses during an
accidental offsite release of radioactive material.
In accordance with the requirements of Sec. 30.32(i), each
application to possess radioactive materials in unsealed form in excess
of quantities in Sec. 30.72, ``Schedule C--Quantities of radioactive
materials requiring consideration of the need for an emergency plan for
responding to a release,'' must contain either an evaluation showing
that the maximum dose to a person offsite due to a release of
radioactive materials would not exceed 1 rem (10 mSv) effective dose
equivalent or 5 rem (50 mSv) to the thyroid, or the application must
contain an emergency plan for responding to the release of radioactive
[[Page 9484]]
material. Draft Volume 22 of NUREG-1556 includes program-specific
guidance for how applicants to possess, use, and produce byproduct
material associated with a fusion machine can meet the requirements for
the dose evaluation to demonstrate that an offsite emergency plan is
not needed, and guidance for applicants for the contents of an
emergency plan when one may be needed.
5. Environmental Review
Under the proposed Sec. 51.60(b)(1)(viii) the applicant would be
required to include an environmental report unless a categorical
exclusion applies. Requiring an applicant to develop an environmental
report would enable the NRC to fully assess the environmental impacts
of these novel and evolving fusion machine designs.
The NRC would review the environmental report with each application
pursuant to the regulation in 10 CFR part 51. The NRC can prepare an
environmental assessment (EA) under Sec. 51.21 if the NRC expects the
findings to not be significant and could reach a finding of no
significant impact (FONSI). If an EA cannot reach a FONSI, an
environmental impact statement (EIS) under Sec. 51.20 would be
prepared. An EIS would not be prepared by default, as is done in other
portions of the NRC's regulatory process, but only if the circumstances
warrant or the Commission so directs.\21\
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\21\ The Commission could determine, under Sec. 51.20(b)(14),
that a particular licensing action is a major Commission action
significantly affecting the quality of the human environment and
instruct staff to prepare an EIS.
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Although 10 CFR part 51 is not required as a matter of
compatibility for Agreement States, several Agreement States have State
environmental requirements that are similar to the requirements in the
National Environmental Policy Act (NEPA). A fusion machine licensed in
an Agreement State would be required to comply with the State's
applicable environmental requirements.
An applicant for a license to possess, use, and produce byproduct
material associated with a fusion machine may apply the guidance in
NUREG-1748, ``Environmental Review Guidance for Licensing Actions
Associated with NMSS Programs,'' in preparing their environmental-
related submittals to the NRC whether to support an EIS, EA, or a
categorical exclusion. Under Sec. 51.40, a prospective applicant to
possess, use, and produce byproduct material associated with a fusion
machine is encouraged to confer with the NRC staff to discuss the
guidance in NUREG-1748 as early as possible in its planning process
before submitting environmental information or filing an environmental
report.
6. Export Controls
This rule does not propose any changes to export controls related
to fusion machines because a comprehensive export control framework for
fusion machines currently exists, and this framework is consistent with
international policy, obligations, and commitments, as well as U.S. law
and regulations. Different U.S. Government departments and agencies
have export control jurisdiction over nuclear-related technology,
equipment, and materials depending on the commodity to be exported.
Generally, the NRC controls the export of equipment, components, and
material that require the application of safeguards by the
International Atomic Energy Agency (IAEA). Nuclear-related items that
do not require IAEA safeguards are generally controlled by the
Department of Commerce (DOC). Since fusion machines do not use or
produce nuclear material, they do not require the application of IAEA
safeguards. Accordingly, the DOC, rather than the NRC, currently
controls the export of fusion machines. There is precedent for DOC
export control over fusion machines as well. As a participant in the
International Thermonuclear Experimental Reactor (ITER) fusion project
in France, the United States has already exported fusion equipment and
components to the ITER facility under DOC export authority.
This export control framework is also consistent with international
frameworks and commitments. As a member of the Nuclear Suppliers Group
(NSG), the United States has made a commitment to implement the NSG's
export control guidelines. Part 1 of the NSG Guidelines (INFCIRC/254/
Part 1) contains a list of items that should be controlled for export
because they would require IAEA safeguards, and it explicitly excludes
``fusion reactors'' from the scope of control. The United States also
has adopted the ``Model Protocol Additional to the Agreement(s) Between
State(s) and the International Atomic Energy Agency for the Application
of Safeguards'' (INFCIRC/540 (Corrected)), known as the Additional
Protocol (AP). Annex II of the AP contains a list of equipment and non-
nuclear material that must be reported when exported or imported. This
list likewise excludes fusion machines from its scope, since they would
not be subject to IAEA safeguards.
The NRC's export control authority is not limited by the NSG
Guidelines or the AP. If the NRC were to exert export control over
fusion machines, its authority would stem from section 109b of the AEA.
However, because section 109b requires that IAEA safeguards be applied
to the exported item, exerting NRC export control authority over fusion
machines under section 109b would not be consistent with the
established international export control and IAEA safeguards framework.
Consideration was also given to export control of non-nuclear
materials that could be used or produced by fusion machines. Tritium,
which could have end uses related to nuclear weaponization, could
reasonably be used and produced in significant quantities by a fusion
machine. While tritium is not subject to IAEA safeguards, the NRC
controls tritium and other byproduct material for export under its AEA
section 82 authority rather than its AEA section 109b authority.
Further, the DOC controls export of lithium-6 as well as lithium target
assemblies, which could be used to produce tritium. The DOC also
controls export of tritium production, recovery, extraction, and
handling equipment. Additionally, export of deuterium for nuclear end
use is controlled by the NRC, and deuterium for non-nuclear end use is
controlled by DOC. In the event that the neutrons produced from a
fusion machine are used to irradiate a subcritical assembly or blanket
of nuclear material, then such use or production of nuclear material
would automatically trigger IAEA safeguards, and the NRC would then
control such nuclear material for export.
In summary, the U.S. Government's existing, comprehensive export
control framework for fusion machines is consistent with, and based
upon, international export control frameworks. If the United States, in
conjunction with the international export control community, as well as
the IAEA, determine that fusion machines may warrant additional export
controls and safeguards, then the U.S. Government can evaluate and
adjust its national framework at that time, including whether the NRC
should exert export authority over fusion machines.
7. Physical Security and Accountability of Licensed Material
In accordance with Sec. 20.1801 and Sec. 20.1802, licensees must
ensure the security and accountability of licensed material. Therefore,
all byproduct material that is used, produced, and
[[Page 9485]]
stored as part of fusion machine activities must be protected. In
addition to the security requirements in 10 CFR part 20, 10 CFR part 37
requires additional security measures for specific types of byproduct
material considered to be risk significant and meet the category 1 and
category 2 quantity thresholds identified in appendix A to 10 CFR part
37.
Tritium used, produced, and stored as part of fusion machine
activities is not considered a risk-significant radionuclide. However,
there could be activation products not listed in appendix A to 10 CFR
part 37 that are produced from fusion machines that require
implementation of additional security measures, beyond those required
by 10 CFR part 20. Currently, not enough information is available to
determine the activation products that may be produced by near-term
fusion machines. For radionuclides not listed in table 1 of appendix A
to 10 CFR part 37, the NRC will determine on a case-by-case basis
whether additional security requirements are warranted (e.g., based on
the use of structural materials that create new radionuclides of
concern through activation). The NRC would address the issue through
license conditions or orders.
Guidance regarding security measures that can be used to protect
byproduct material that will be produced, used, and stored as part of
fusion machine activities is provided in draft Volume 22 of NUREG-1556.
8. Waste Management
The NRC's regulations governing waste management requirements under
10 CFR part 20 are proposed to be amended to apply specifically to
fusion machine facilities and their expected associated radioactive
waste. The scope of this discussion includes aspects of 10 CFR part 20
and 10 CFR part 61 related to the handling and disposal of radioactive
waste generated by fusion machines. The NRC determined that fusion
machine waste is adequately addressed by the existing regulations
related to land disposal of radioactive waste (i.e., 10 CFR part 61)
with a proposed change to 10 CFR part 20.
The Energy Policy Act of 2005 adopted on August 8, 2005, expanded
NRC jurisdiction to include certain materials made radioactive by a
particle accelerator. The NRC's 2007 final rule made conforming changes
to Sec. 20.2008(a), providing disposal requirements for byproduct
material as defined in sections 11e.(3) and (4) of the AEA. Further,
the definition of waste in Sec. 61.2, which excludes material produced
by an accelerator, does not prevent disposal of accelerator-produced
waste with LLW. The ADVANCE Act of 2024 amended section 11e.(3) of the
AEA to ensure all radioactive material generated by fusion machines is
defined as byproduct material. Therefore, the NRC determined that the
existing NRC regulations under 10 CFR part 61 for land disposal of
radioactive waste could apply to waste generated by fusion machines.
Similarly, Sec. 20.2008(b) states that accelerator waste can be
disposed of at a Federal or State solid or hazardous waste disposal
facility authorized to dispose of such material. In general, the NRC
evaluates whether NRC-licensed material can be sent to a solid or
hazardous waste disposal facility for disposal on a case-by-case basis
under Sec. 20.2002, ``Method for obtaining approval of proposed
disposal procedures.'' For either disposal with LLW or disposal under
Sec. 20.2002, existing NRC regulations allow NRC-licensed,
accelerator-produced material to be sent for disposal with other types
of waste if additional applicable requirements are met. Those
requirements may include approvals from State and other Federal
agencies.
Several stakeholders have expressed concern that the Sec. 61.55
waste classification tables may fail to address risk-significant
radionuclides in fusion machine waste because those tables were based
on expected waste streams in the early 1980s. The Advisory Committee on
Reactor Safety (ACRS) proposed, in its letter dated October 21, 2022,
that the NRC consider revising the Sec. 61.55 waste classification
tables to address radionuclides generated by fusion machines. Based on
stakeholder feedback, the NRC understands that fusion machines could
create significant inventories of activation products \22\ that are not
included in the waste classification tables (e.g., see SECY-23-0001).
However, this rule does not propose to revise those tables because
sufficient information is not yet available to determine which
radionuclides will drive the risk significance of fusion machine
generated waste. As described by the ACRS, the activation products
formed by fusion machines will depend on the structural materials used
in the systems and their impurities. Because many of those materials
have not yet been selected or developed, the identity, quantities, and
concentrations of the potential activation products in those materials
are not yet known. In a staff requirements memorandum (SRM) responding
to the NRC staff's plan to revise 10 CFR part 61 (SRM-SECY-08-0147),
the Commission directed the NRC staff to consider changing the waste
classification tables after the completion of the integrated low-level
radioactive waste disposal rulemaking for 10 CFR part 61. The NRC staff
plans to consider the radionuclides in fusion machine waste during that
process. In addition, the NRC is proposing a change to 10 CFR part 20
that would address issues related to the Sec. 61.55 waste
classification tables with a requirement for site-specific analyses in
some circumstances, as described below.
---------------------------------------------------------------------------
\22\ Many stakeholders, including the ACRS, expect fusion
machines to generate significant quantities of tritium-contaminated
waste in addition to activation products. Class A tritium is
addressed in the existing Sec. 61.55 waste classification tables.
The NRC addresses tritium disposed with Class B waste in guidance
accompanying the proposed rule. There is no concentration limit for
tritium in Class C waste because the calculated value exceeds the
specific activity of tritium.
---------------------------------------------------------------------------
A key safety concern associated with land disposal of waste from
fusion machines is the protection of individuals who might
inadvertently intrude into LLW. This protection is typically
demonstrated by compliance with technical requirements that are based
in part on LLW classification. Therefore, to ensure intruder protection
at this time, the NRC proposes to require that licensees with novel
wastes or radionuclide concentrations from fusion machines use disposal
sites that have completed a site-specific intrusion assessment for such
waste material. The NRC proposes to allow disposal of novel waste types
without a site-specific intrusion assessment for waste with physical,
chemical, and radiological characteristics that can be shown to be
consistent with an appropriate waste classification description in
Sec. 61.7, ``Concepts.''
Specifically, the NRC proposes to amend Sec. 20.2008 to add new
language to paragraph (a). The new text would require that fusion
machine waste that would be disposed of as low-level waste under 10 CFR
part 61 either be accompanied by an analysis showing the waste is
manifested and labeled for disposal consistent with the description of
the applicable waste class in Sec. 61.7 or be disposed of at a
disposal site that has completed a site-specific intrusion assessment.
Draft NUREG-1556, Volume 22, includes guidance on waste types and
radionuclide concentrations the NRC staff has previously analyzed under
the waste classification descriptions in Sec. 61.7. If a site-specific
intrusion assessment will be relied on, the assessment should
demonstrate the projected dose to an individual who inadvertently
intrudes into the waste at the facility will not exceed 0.5 rem (5
[[Page 9486]]
mSv) per year. That dose limit is consistent with the dose limit used
to develop the LLW classification tables in 10 CFR part 61, which the
NRC selected based on safety, costs, disposal efficiency, and the
potential for increased disposal of waste containing long-lived
radionuclides that could increase the hazard for long time periods (see
NUREG-0945).
9. Reporting and Recordkeeping
The NRC is proposing to amend its regulations governing the
reporting and recordkeeping requirements under Sec. 30.51 to cover
licensees authorized for the possession, use, and production of
byproduct material associated with fusion machines by adding
``production of'' tritium and activation products for the necessary
reports, analyses, submittals, inspection documentation, and other
required documentation for a fusion machine. The draft guidance in
NUREG-1556, Volume 22, provides additional discussion on
accountability, including inventory, production, use, decay, and
consumption of radioactive material. The draft guidance emphasizes the
importance of confirming the accuracy and reliability of the facility's
accounting records, particularly for the detection of any unmeasured
material losses or diversion or theft of radioactive materials.
Licensees are already required to have records for what they possess
including what they produce and therefore it is not expected to change
the record retention at other stakeholder facilities.
C. Implementation Guidance
The NRC has developed a new draft volume under the NUREG-1556
series to address possession, use, and production of byproduct material
in a fusion machine. NUREG-1556, Volume 22, ``Consolidated Guidance
About Materials Licenses: Program-Specific Guidance About Possession
Licenses for Fusion Machines,'' would provide guidance on preparing a
license application for the radioactive byproduct materials associated
with the use of a fusion machine. This draft guidance document also
includes criteria the NRC would use in evaluating license applications
for the possession, use, and production of byproduct material
associated with fusion machines.
NUREG-1556, Volume 22, would provide guidance related to each of
the topics an applicant should address in its materials license
application. These topics would include radioactive material that will
be used and produced and its purpose; information on individuals
responsible for the radiation safety program; training for individuals
that will handle radioactive material; description of the facilities
and equipment used; and the radiation safety program. This guidance
document would be applied to a wide variety of near-term fusion machine
design applications and would contain information about how licensees
may choose to implement their programs to meet NRC regulatory
requirements. The information in this guidance document would not be
intended to impose any conditions beyond those required by regulations
nor will all items discussed in this guidance document apply to every
applicant.
There are some unique aspects of handling radioactive materials
involved in or produced by a fusion machine that are discussed in this
draft guidance document. For example, there is draft guidance on
training and experience for individuals who will handle radioactive
material during the maintenance and repair of the fusion machine, draft
guidance on security and emergency procedures, and draft guidance on
facility design and type of equipment needed to store and handle large
quantities and activities of radioactive materials.
On March 7, 2024, the NRC staff issued a preliminary draft of this
guidance document and discussed it during a March 18, 2024, public
meeting. Information on how to access the meeting summary, preliminary
draft guidance document, and the draft guidance are available in the
NRC's Agencywide Documents Access and Management System (ADAMS), as
provided in the ``Availability of Documents'' section of this document.
IV. Specific Requests for Comment
The NRC is seeking advice and recommendations from the public on
this proposed rule. We seek comment on all aspects of this proposed
rule. NRC requests comment on the assumptions regarding the costs,
benefits, and cost savings of this rule. NRC acknowledges that other
ongoing rulemaking efforts may impact similar regulated entities and
solicits comments on the cumulative regulatory burden of rules
affecting these entities. We solicit comments on potential impacts, if
any, on U.S. manufacturing and supply chains including the production
of advanced nuclear fuel, the current commercial nuclear reactor fleet;
national security, critical infrastructure for national defense,
nuclear energy dominance, and American competitiveness abroad. We are
particularly interested in comments and supporting rationale from the
public on the following:
(1) Section 30.55(c) requires licensees who are authorized to
possess tritium to report to the NRC any incident in which an attempt
has been made or is believed to have been made to commit a theft or
unlawful diversion of more than 10 curies of such material at any one
time or more than 100 curies of such material in any one calendar year.
This requirement was originally promulgated by the Atomic Energy
Commission (AEC) in the early 1970s as part of a set of requirements
that in the interest of national security, provide the AEC information
within reasonable limits and on a current basis as to the flow of
tritium into, out of, and within the country, and inventory quantities
at various locations (36 FR 16593, August 24, 1971).
In addition to the reporting requirement in Sec. 30.55(c), Sec.
20.2201 requires reports when it becomes known to a licensee that
certain quantities of tritium (and other materials listed in appendix C
to 10 CFR part 20) have been lost or stolen or are otherwise missing.
Under Sec. 20.2201, licensees must immediately report an occurrence of
lost, stolen, or missing tritium in aggregate quantities equal to or
greater than 1 curie after it becomes known to the licensee and if it
appears to the licensee that an exposure to persons in unrestricted
areas could occur. Licensees are also required to report if more than
10 millicuries of tritium are still missing within 30 days after an
occurrence of lost, stolen, or missing quantities of tritium greater
than 10 millicuries becomes known to the licensee. These reporting
requirements apply only when a licensee believes or has knowledge that
a theft or attempted theft has occurred or that tritium is missing.
Based on information provided by fusion industry stakeholders,
including fusion machine developers and the DOE, the quantities of
tritium used and produced at near-term commercial fusion machines could
exceed 100 grams, which is approximately 1 million curies. Accurately
accounting for the location of all tritium in a fusion machine will be
difficult due to various factors including absorption of tritium into
components, tritium produced in the breeder blankets, losses of tritium
during the fusion reaction, and the difficulty in measuring tritium
inside the components of a fusion machine.
The NRC recognizes that due to the physical and chemical properties
of tritium, there can be difficulties in tracking its location within a
fusion machine, and licensees may not be able
[[Page 9487]]
to rely on tritium inventory monitoring to discover all losses. One
Agreement State has issued an exemption to its licensee regarding the
State's equivalent of Sec. 20.2201 to raise the tritium threshold due
to a licensee's inability to account for tritium at the millicurie and
low curie levels.
Specific request for comment: Should the NRC revise Sec. 30.55(c)
and Sec. 20.2201 to change the reporting threshold to a higher
activity for tritium? If so, what should be the new reporting threshold
for tritium? Please provide the basis for your response.
(2) The NRC staff proposes to amend paragraph (a) of 10 CFR
20.2008, ``Disposal of certain byproduct material,'' to require either
(1) an analysis showing that the waste is manifested and labeled for
disposal consistent with the description of the applicable waste
classification in Sec. 61.7, ``Concepts,'' based on the physical,
chemical, and radiological characteristics of the waste, or (2) that
the waste be disposed of in a facility that has completed a site-
specific intrusion assessment. The NRC's view is these revisions would
allow safe disposal of novel waste types from fusion machines.
Specific request for comment: The NRC is particularly interested in
feedback on this proposed approach to amend 10 CFR 20.2008 to provide
options for safe waste disposal. Does this approach comprehensively
address potential waste generated by fusion machines? Are there other
approaches the NRC should consider? If yes, please provide the basis
for your response.
(3) In addition, the NRC is interested in the need to develop more
specific guidance to address disposal of large volumes of low-activity
fusion waste.
Specific request for comment: What would the benefits be of
expanding existing guidance for alternative disposal under 10 CFR
20.2002, ``Method for obtaining approval of proposed disposal
procedures,'' to specifically address fusion machine waste? Should the
NRC develop guidance focused on reusing or recycling low-activity
fusion machine waste? Are there alternative approaches the NRC should
consider? Please provide the basis for your response.
(4) This rule does not propose any changes to export controls
related to fusion machines because a comprehensive export control
framework for fusion machines currently exists, and this framework is
consistent with international policy, obligations, and commitments, as
well as U.S. law and regulations. However, the NRC is interested in
ensuring that the proposed rule provides clarity on the export
controls.
Specific request for comment: Should the NRC propose export
controls related to fusion machines? Please provide the basis for your
response.
(5) The NRC is interested in ensuring that the proposed rule
provides clarity on the licensing process for both the applicants and
Agreement States.
Specific request for comment: Does the proposed rule provide
adequate clarity on the licensing process, including designated
Compatibility Categories, and if not, where is additional clarity
needed? Please provide the basis for your response.
(6) Lastly, the NRC is interested in the unintended consequences or
impacts of changes to the ``particle accelerator'' definition. Some
Agreement States have definitions for particle accelerators that are
different from the NRC definition. Agreement States that have licensed
existing fusion machines have done so under their particle accelerator
regulatory frameworks. The NRC is also interested in the unintended
consequences or impacts of the proposed compatibility designations for
``byproduct material'' and ``fusion machine'' definitions. The NRC is
proposing a compatibility designation of ``B'' for the ``fusion
machine'' definition and paragraph 3(ii)(A) of the ``byproduct
material'' definition. Currently, the definition for ``byproduct
material'' and ``particle accelerator'' are compatibility designation
health and safety (H&S).
Specific request for comment: Are there unintended consequences or
impacts not considered by the NRC by including fusion machines in the
definition of ``particle accelerator''? Are there unintended
consequences or impacts not considered by the NRC with respect to the
proposed compatibility designations of the ``fusion machine'' and
paragraph 3(ii)(A) of the ``byproduct material'' definitions? Please
provide a basis for your response.
V. Section-by-Section Analysis
The following paragraphs describe the specific changes proposed by
this rulemaking.
Section 20.1003 Definitions
This proposed rule adds a definition for Fusion machine. This
proposed rule also revises the definitions for Byproduct material and
Particle accelerator.
Section 20.1009 Information Collection Requirements: OMB Approval
In Sec. 20.1009, this proposed rule revises paragraph (b) to add
Sec. 20.2008 to the list of approved information collection
requirements contained in 10 CFR part 20.
Section 20.2008 Disposal of Certain Byproduct Material
This proposed rule adds new requirements to paragraph (a) for
disposal of certain fusion machine waste under the regulations of part
61 of this chapter.
Section 30.4 Definitions
This proposed rule adds a definition for Fusion machine. This
proposed rule also revises the definitions for Byproduct material and
Particle accelerator.
Section 30.32 Application for Specific Licenses
This proposed rule adds new paragraph (k), which describes required
content specific to a license application for a possession, use, and
production of byproduct material associated with a fusion machine. This
new section is not intended to address the licensing of a standard
fusion machine design or the approval of mass production of fusion
machines.
Section 30.33 General Requirements for Issuance of Specific Licenses
This proposed rule adds new paragraph (a)(6) for the issuance of a
license to possess, use, and produce byproduct material associated with
a fusion machine when all requirements for the license in 10 CFR part
30 are met.
Section 30.51 Records
This proposed rule amends paragraphs (a) and (a)(1) to include the
production of byproduct material.
Section 30.52 Inspections
This proposed rule amends paragraph (a) to include the production
of byproduct material.
Section 37.5 Definitions
This proposed rule revises the definition for Byproduct material.
Section 50.2 Definitions
This proposed rule revises the definition for Byproduct material.
Section 51.60 Environmental Report--Materials Licenses
This proposed rule adds new paragraph (b)(1)(viii) to require that
an environmental report be prepared for the construction and operation
of a fusion machine.
[[Page 9488]]
Section 72.3 Definitions
This proposed rule revises the definition for Byproduct material.
Section 110.2 Definitions
This proposed rule revises the definitions for Byproduct material
and Particle accelerator.
Section 150.3 Definitions
This proposed rule revises the definition for Byproduct material.
Section 170.3 Definitions
This proposed rule revises the definition for Byproduct material.
Section 171.5 Definitions
This proposed rule revises the definition for Byproduct material.
VI. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission certifies that this rule, if adopted, will not
have a significant economic impact on a substantial number of small
entities.
The structure of the industries that would form to use the emerging
fusions machine technologies is uncertain. The most significant
potential sector that could use fusion machines is the electric power
sector. Among electric utilities that might operate a fusion machine,
90 percent have revenues between $7.8 million and $1.2 billion (EIA,
2022). Thus, for 95 percent of electric utilities, the cost impact of
the proposed rule would be a benefit of less than 0.6 percent. Note
that larger utilities would be more likely to have an economy of scale
that could benefit from fusion machines in their power supply mix. An
electric utility that might be classified as a small entity would be
less likely to be able to afford to invest in fusion technology.
Therefore, the NRC estimates that the proposed rulemaking will not have
a significant economic impact on a substantial number of small
entities.
As for any entity building or operating fusion machines, the
proposed rule reduces the regulatory impact of obtaining the materials
licenses required for fusion machines, for small entities also, by
clarifying the application of existing requirements to fusion machines.
This clarity might be more useful to small entities to the extent that
the smaller organizations have fewer resources available for
interpreting less clear regulatory language.
NRC requests all comments from potentially impacted small entities.
Any small entity subject to this regulation that determines, because of
its size, it is likely to bear a disproportionate adverse economic
impact should notify the Commission of this opinion in a comment that
indicates--
(a) The licensee's size and how the proposed regulation would
impose a significant economic burden on the licensee as compared to the
economic burden on a larger licensee;
(b) How the proposed regulations could be modified to take into
account the licensee's differing needs or capabilities;
(c) The benefits that would accrue or the detriments that would be
avoided if the proposed regulations were modified as suggested by the
licensee;
(d) How the proposed regulation, as modified, would more closely
equalize the impact of NRC regulations or create more equal access to
the benefits of Federal programs as opposed to providing special
advantages to any individual or group; and
(e) How the proposed regulation, as modified, would still
adequately protect public health and safety.
Comments should be submitted as indicated under the ADDRESSES
caption of this document.
VII. Regulatory Analysis
The NRC has prepared a draft regulatory analysis on this proposed
regulation. The analysis examines the costs and benefits of the
alternatives considered by the NRC. The NRC requests public comment on
all aspects of the draft regulatory analysis. The regulatory analysis
is available as indicated in the ``Availability of Documents'' section
of this document. Comments on the draft analysis may be submitted to
the NRC as indicated under the ADDRESSES caption of this document.
VIII. Cumulative Effects of Regulation
The NRC seeks to minimize any potential negative consequences
resulting from the cumulative effects of regulation (CER). The CER
refers to the challenges that licensees, or other impacted entities
such as State partners, may face while implementing new regulatory
positions, programs, or requirements (e.g., rules, generic letters,
backfits, inspections). The CER is an organizational effectiveness
challenge that may result from a licensee or impacted entity
implementing a number of complex regulatory actions, programs, or
requirements with limited available resources.
The NRC is following its CER process by engaging with external
stakeholders throughout this proposed rule and related regulatory
activities. Opportunity for public comment is provided to the public at
this proposed rule stage.
To better understand the potential CER implications incurred due to
this proposed rule, the NRC is requesting comment on the following
questions. Responding to these questions is voluntary, and the NRC will
respond to any comments received in the final rule.
1. In light of any current or projected CER challenges, would the
proposed effective date of 30 days after the date of publication of a
final rule provide sufficient time to implement the new, proposed
requirements? Please provide a rationale for your response.
2. If CER challenges currently exist or are expected, what should
be done to address them? For example, if more time is required for
implementation of the new requirements, what period of time is
sufficient? Please provide a rationale for your response.
3. What other (NRC or other agency) regulatory actions (e.g.,
orders, generic communications, license amendment requests, inspection
findings of a generic nature) influence the implementation of this
proposed rule's requirements? Please provide a rationale for your
response.
4. What are the unintended consequences, and how should they be
addressed? Does this proposed rule create conditions that would be
contrary to this proposed rule's purpose and objectives? Please provide
a rationale for your response.
5. Please comment on the NRC's cost and benefit estimates in the
regulatory analysis that supports this proposed rule.
IX. 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). The NRC requests comment on this document with respect to the
clarity and effectiveness of the language used.
X. Environmental Assessment and Proposed 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 rule, if adopted, would not be a
major Federal action significantly affecting the quality of the human
environment, and an EIS is not required. The implementation of
[[Page 9489]]
the proposed rule requirements would not have a significant impact on
the environment. The proposed rule would either have requirements that
are administrative in application or matters of procedure. The proposed
rule would provide clarity on licensing and regulating the possession,
use, and production of byproduct material associated with fusion
machines but would not materially change any requirements and would not
result in any new or different environmental impacts.
The determination of this draft EA is that there would be no
significant effect on the quality of the human environment from this
action. Public stakeholders should note, however, that comments on any
aspect of this draft EA may be submitted to the NRC as indicated under
the ADDRESSES caption. The draft EA is available as indicated under the
``Availability of Documents'' section of this document.
XI. Paperwork Reduction Act
This proposed rule contains new or amended collections of
information subject to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.). This proposed rule has been submitted to the Office of
Management and Budget for review and approval of the information
collections.
Type of submission: Revision.
The title of the information collection: Regulatory Framework for
Fusion Machines.
The form number if applicable: NRC Form 313.
How often the collection is required or requested: Once per event,
on occasion, and annually.
Who will be required or asked to respond: Applicants for a license
to possess, use, and produce byproduct material associated with a
fusion machine, licensees that possess, use, and produce byproduct
material associated with a fusion machine, and low-level waste disposal
facility licensees.
An estimate of the number of annual responses: 3 (1 reporting
response + 2 recordkeepers).
The estimated number of annual respondents: 3.
An estimate of the total number of hours needed annually to comply
with the information collection requirement or request: 607 (600
reporting + 7 recordkeeping).
Abstract: The NRC is proposing to amend its regulations to
establish a regulatory framework for the possession, use, and
production of byproduct material associated with fusion machines. The
proposed rule includes definitions to establish the scope of regulatory
requirements for fusion machines and technology-inclusive, content-of-
application requirements supportive of a performance-based approach to
regulation. The proposed rule includes specific requirements for
submitting an application for a license to possess, use, and produce
byproduct material associated with a fusion machine. Such applicants
may file an application using NRC Form 313, ``Applications for
Materials License.'' The proposed rule would add a requirement for an
applicant to submit an environmental report for the construction and
operation of a fusion machine unless a categorical exclusion applies.
The proposed rule would require applicants or licensees to maintain
records of production of tritium and activation products associated
with fusion machines. The records and recordkeeping requirements would
allow the NRC to determine if the applicant has training, experience,
equipment, facilities, and procedures that provide reasonable assurance
of adequate protection of public health and safety and the environment.
The records and recordkeeping requirements associated with receipt,
transfer, production, and disposal of byproduct material would be
reviewed by the NRC to determine that licensees have confined their
possession and use of byproduct material to the locations, purposes,
receipt, and quantities authorized in their licenses.
The proposed rule would require that radioactive waste resulting
from fusion machines must either be accompanied by an analysis showing
the waste is manifested and labeled for disposal consistent with the
description of the applicable waste class in [10 CFR] 61.7 of this
chapter, based on the physical, chemical, and radiological
characteristics of the waste, or be disposed of in a disposal facility
that has completed a site-specific intrusion assessment that
demonstrates the projected dose to an individual who inadvertently
intrudes into the waste at the facility will not exceed 0.5 rem (5
(mSv)) per year. The information requested would allow the NRC to
determine whether the proposed activities can be conducted safely
without harming the common defense and security or constituting an
unreasonable risk to public health and safety and the environment. The
NRC is proposing to amend its regulations to establish a regulatory
framework for licensing the possession, use, and production of
byproduct material associated with fusion machines. The NRC is also
proposing new guidance for the implementation of this proposed rule,
entitled NUREG-1556, Volume 22, ``Consolidated Guidance About Materials
Licenses: Program-Specific Guidance About Fusion Machine Licenses.''
The NRC is seeking public comment on the potential impact of the
information collections contained in this proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility? Please explain your response.
2. Is the estimate of the burden of the proposed information
collection accurate? Please explain your response.
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected? Please explain your response.
4. How can the burden of the proposed information collection on
respondents be minimized, including the use of automated collection
techniques or other forms of information technology?
A copy of the Office of Management and Budget (OMB) clearance
package and proposed rule are available in the ``Availability of
Documents'' section of this document or may be viewed free of charge by
contacting the NRC's Public Document Room reference staff at 1-800-397-
4209, at 301-415-4737, or by email to [email protected]. You may
obtain information and comment on submissions related to the OMB
clearance package by searching on https://www.regulations.gov under
Docket ID NRC-2023-0071.
You may submit comments on any aspect of these proposed information
collection(s), including suggestions for reducing the burden and on the
above issues, by the following methods:
Federal rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2023-0071.
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
or to the OMB reviewer at OMB Office of Information and Regulatory
Affairs (3150-0014, 3150-0017, 3150-0021, and 3150-0120), Attention:
Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW,
Washington, DC 20503.
Submit comments by March 30, 2026. Comments received after this
date will be considered if it is practical to do so, but the NRC staff
is able to ensure
[[Page 9490]]
consideration only for comments received on or before this date.
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.
XII. Executive Orders
Executive Order (E.O.) 12866
The Office of Information and Regulatory Affairs (OIRA) has
determined that this proposed rule is a significant regulatory action
under E.O. 12866, ``Regulatory Planning and Review.'' Accordingly, NRC
submitted this proposed rule to OIRA for review. NRC is required to
conduct an economic analysis in accordance with section 6(a)(3)(B) of
E.O. 12866. More can be found in Section VII, of this document,
``Regulatory Analysis.''
Review Under E.O.s 14154, 14192, 14215, and 14300
NRC has examined this proposed rule and has determined that it is
consistent with the policies and directives outlined in E.O. 14154,
``Unleashing American Energy,'' E.O. 14192, ``Unleashing Prosperity
Through Deregulation,'' E.O. 14215 ``Ensuring Accountability for All
Agencies,'' and E.O. 14300, ``Ordering the Reform of the Nuclear
Regulatory Commission.'' This proposed rule is tentatively considered
an E.O. 14192 deregulatory action. Details on the estimated costs of
this proposed rule can be found in Section VII, of this document,
``Regulatory Analysis.''
Review Under E.O. 14270
Executive Order 14270, ``Zero-Based Regulatory Budgeting to Unleash
American Energy,'' requires the NRC to insert a conditional sunset date
into all new or amended NRC regulations provided the regulations are
(1) promulgated under the Atomic Energy Act of 1954, as amended (AEA),
the Energy Reorganization Act of 1974, as amended (ERA), and the
Nuclear Waste Policy Act of 1982, as amended (NWPA); (2) not
statutorily required; and (3) not part of the NRC's permitting regime.
The NRC determined that the regulatory changes proposed in this rule
are for augmenting the existing byproduct material framework to be
inclusive of fusion machines. Therefore, the NRC views this rulemaking
to be outside the scope of Executive Order 14270 and did not insert
conditional sunset dates for the regulatory changes in this proposed
rule.
XIII. Coordination With NRC Agreement States
Thirty eight of the 39 Agreement States \23\ have assumed authority
for 11e.(3) byproduct material. Consequently, these 38 Agreement States
would have oversight of byproduct material associated with fusion
machines licensed in their jurisdiction.
---------------------------------------------------------------------------
\23\ The State of Wyoming's Agreement with the NRC is limited to
the oversight of byproduct material from uranium milling and certain
source material. Accordingly, a fusion machine in the State of
Wyoming would be regulated by the NRC.
---------------------------------------------------------------------------
The NRC has coordinated with the Agreement States throughout the
development of this proposed rule. Agreement State representatives
served on the rulemaking working group that developed this proposed
rule and guidance and on the Standing Committee on Compatibility for
the review of the rulemaking and the compatibility determinations. In
addition, the NRC held a total of six government-to-government meetings
with Agreement States during the development of this proposed rule.
The NRC also provided a preliminary draft of this proposed rule and
guidance to the Agreement States for formal review. The NRC held one of
the government-to-government meetings with Agreement States during this
formal review. The NRC received comments on the preliminary draft of
the proposed rule from four Agreement States (New Jersey, New York,
Tennessee, and Wisconsin) and the Organization of Agreement States
Board. Regarding the draft guidance, the NRC received comments from
four Agreement States (New Jersey, New York, Tennessee, and Wisconsin)
and the Organization of Agreement States Board. The NRC considered
these comments in the development of the proposed rule, which covered
topics such as definitions, emergency plan, security, waste management,
and other more general topics.
XIV. Compatibility of Agreement State Regulations
Under the ``Agreement State Program Policy Statement'' approved by
the Commission on October 2, 2017, and published in the Federal
Register (82 FR 48535; October 18, 2017), NRC program elements
(including regulations) required for adequacy and having a particular
health and safety component are those that are designated as Categories
A, B, C, D, NRC, and H&S: and those required for compatibility include
those regulations and other legally binding requirements designated as
Compatibility Categories A, B, C, and D. Compatibility Category A are
those program elements that include basic radiation protection
standards and scientific terms and definitions that are necessary to
understand radiation protection concepts. An Agreement State should
adopt Category A program elements in an essentially identical manner in
order to provide uniformity in the regulation of agreement material on
a nationwide basis. Compatibility Category B are those program elements
that apply to activities that have direct and significant effects in
multiple jurisdictions. Compatibility Category B pertains to a limited
number of program elements that cross jurisdictional boundaries and
should be addressed to ensure uniformity of regulation on a nationwide
basis. The Agreement State program element should be essentially
identical to that of NRC. Compatibility Category C are those program
elements that do not meet the criteria of Category A or B, but the
essential objectives of which an Agreement State should adopt to avoid
conflict, duplication, gaps, or other conditions that would jeopardize
an orderly pattern in the regulation of agreement material on a
national basis. An Agreement State should adopt the essential
objectives of the Category C program elements. Compatibility Category D
are those program elements that do not meet any of the criteria of
Category A, B, or C, above, and, thus, do not need to be adopted by
Agreement States for purposes of compatibility. Compatibility Category
NRC are those program elements that address areas of regulation that
cannot be relinquished to the Agreement States under the AEA, or
provisions of 10 CFR. These program elements should not be adopted by
the Agreement States. Category H&S program elements are not required
for purposes of compatibility; however, they do have particular health
and safety significance. The Agreement State should adopt the essential
objectives of such program elements to maintain an adequate program.
This proposed rule is a matter of compatibility between the NRC and
the Agreement States. The proposed compatibility categories are
designated in the following table:
[[Page 9491]]
Compatibility Table
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
20.1003........................ Amend................ Definitions H&S.............. H&S
``Byproduct
material''.
20.1003........................ Amend................ Definitions H&S.............. B
``Byproduct
material''
paragraph
3(ii)(A).
20.1003........................ New.................. Definitions ................. B
``Fusion
machine''.
20.1003........................ Amend................ Definitions H&S.............. H&S
``Particle
accelerator''.
20.1009........................ Amend................ Add ``20.2008'' to D................ D
information
collections list.
20.2008........................ Amend................ Disposal of B................ B
certain byproduct
material.
30.4........................... Amend................ Definitions H&S.............. H&S
``Byproduct
material''.
30.4........................... Amend................ Definitions H&S.............. B
``Byproduct
material''
paragraph
3(ii)(A).
30.4........................... New.................. Definitions ................. B
``Fusion
machine''.
30.4........................... Amend................ Definitions H&S.............. H&S
``Particle
accelerator''.
30.32(k), except (k)(2)(iv).... New.................. Application for ................. C
specific licenses.
30.32(k)(2)(iv)................ New.................. Application for ................. D
specific licenses.
30.33(a)(6).................... New.................. General ................. D
requirements for
issuance of
specific licenses.
30.51(a) introductory text..... Amend................ Records........... C................ C
30.51(a)(1).................... Amend................ Records........... C................ C
30.52(a)....................... Amend................ Inspections....... D................ D
37.5........................... Amend................ Definitions H&S.............. H&S
``Byproduct
material''.
37.5........................... Amend................ Definitions H&S.............. B
``Byproduct
material''
paragraph
3(ii)(A).
150.3.......................... Amend................ Definitions H&S.............. H&S
``Byproduct
material''.
150.3.......................... Amend................ Definitions H&S.............. B
``Byproduct
material''
paragraph
3(ii)(A).
----------------------------------------------------------------------------------------------------------------
The Agreement States have licensed fusion research and development
facilities operated by academic institutions and commercial companies
using their existing authorities. Since the term ``fusion machine'' is
a new definition, staff is proposing that the definition of fusion
machine be Compatibility Category B to ensure consistency across the
National Materials Programs. Accordingly, the staff is proposing that
paragraph 3(ii)(A) of the definition of ``Byproduct material,'' which
refers to ``fusion machine,'' is also Compatibility Category B. The new
section on application for specific licenses is proposed to be
Compatibility Category C, based on the need for Agreement States to
have the flexibility to include other components that generate non-
ionizing radiation or other machine-produced radiation which the
Agreement States may already regulate and would be integral parts of a
fusion machine.
With the exception of paragraph 3(ii)(A) of the definition of
``Byproduct material,'' the amended definitions of byproduct material
and particle accelerator would continue to be Category H&S. The
definition of byproduct material was expanded by the Energy Policy Act
of 2005 to incorporate certain discrete sources of radium-226 and
certain accelerator-produced radioactive material. NRC amended its
regulations in 2007 (72 FR 55864, October 1, 2007) to revise the
definition of byproduct material and add the new definitions of
discrete source and particle accelerator. All three of these
definitions were designed as Category H&S. Particle accelerator was
designated as H&S to provide the Agreement States flexibility to meet
the essential objectives of the definition since several Agreement
States already had regulations in place for particle accelerators and
the naturally occurring and accelerator-produced radioactive material
(NARM) they produced. Byproduct material was also designated as H&S to
provide the Agreement States flexibility to meet the essential
objectives of the definition since several Agreement States already
incorporated NARM into the statutory definition or radioactive
material.
XV. Availability of Guidance
The NRC is issuing new draft guidance, NUREG-1556, Volume 22,
``Consolidated Guidance About Materials Licenses: Program-Specific
Guidance About Fusion Machine Licenses,'' for the implementation of the
proposed requirements in this rulemaking for comment. This draft
guidance is available in ADAMS under Accession No. ML24092A377. You may
obtain information and submit comments related to the draft guidance by
searching on https://www.regulations.gov under Docket ID NRC-2023-0071.
Draft NUREG-1556, Volume 22, provides guidance to applicants and
licensees for the possession, use, and production of byproduct material
associated with fusion machines concerning the contents of a licensing
application necessary to comply with the licensing requirements under
part 30 of this chapter. You may submit comments on this draft
regulatory guidance by the methods outlined in the ADDRESSES section of
this document.
XVI. Public Meeting
The NRC will conduct at least one public meeting on this proposed
rule for the purpose of describing this proposed rule to the public and
answering questions from the public on this proposed rule.
The NRC will publish a notice of the location, time, and agenda of
the meeting(s) in the Federal Register, on Regulations.gov, and on the
NRC's public meeting website within at least 10 calendar days before
the meeting. Stakeholders should monitor the NRC's public meeting
website for information about the public meeting at https://www.nrc.gov/public-involve/public-meetings/index.cfm.
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.
[[Page 9492]]
------------------------------------------------------------------------
ADAMS Accession No./web link/
Document Federal Register citation
------------------------------------------------------------------------
SECY-24-0085, Proposed Rule--Regulatory ML24019A064.
Framework for Fusion Machines, December
11, 2024.
Draft Environmental Assessment, February ML25168A335.
2026.
Draft Regulatory Analysis, February 2026 ML25168A339.
Draft NUREG-1556, Volume 22, ML24092A377.
``Consolidated Guidance About Materials
Licenses: Program-Specific Guidance
About Possession Licenses for Fusion
Machines,'' February 2026.
Office of Management and Budget (OMB) ML24183A213.
Supporting Statement, Proposed Rule--
Form 313, February 2026.
OMB Supporting Statement, Proposed Rule-- ML24019A080.
10 CFR part 20, February 2026.
OMB Supporting Statement, Proposed Rule-- ML24019A081.
10 CFR part 30, February 2026.
OMB Supporting Statement, Proposed Rule-- ML24019A082.
10 CFR part 51, February 2026.
SECY-24-0045, ``Proposed Rule: ML23242A249.
Integrated Low Level Radioactive Waste
Disposal,'' May 29, 2024.
SRM-SECY-23-0001, ``Staff Requirements-- ML23103A449.
SECY-23-0001--Options for Licensing and
Regulating Fusion Energy Systems,''
April 13, 2023.
SECY-23-0001, ``Options for Licensing ML22273A163 (paper).
and Regulating Fusion Energy Systems,'' ML22273A178 (package).
January 3, 2023 [Rulemaking Plan].
SRM-SECY-20-0032, ``Staff Requirements-- ML20276A293.
SECY-20-0032--Rulemaking Plan on `Risk-
Informed, Technology-Inclusive
Regulatory Framework for Advanced
Reactors (RIN-3150-AK31; NRC-2019-
0062),' '' October 2, 2020.
SRM-SECY-09-0064, ``Staff Requirements-- ML092230198.
SECY-09-0064--Regulation of Fusion-
Based Power Generation Devices,'' July
16, 2009.
SRM-SECY-08-0147, ``Staff Requirements-- ML090770988.
SECY-08-0147--Response to Commission
Order CLI-05-20 Regarding Depleted
Uranium,'' March 18, 2009.
Preliminary Proposed Rule Language, ML23258A145.
``Fusion Systems Proposed Rule,''
October 11, 2023.
Preliminary Draft NUREG-1556, Volume 22, ML24067A227.
``Consolidated Guidance About Materials
Licenses: Program-Specific Guidance
About Possession Licenses for Fusion
Systems,'' March 7, 2024.
NUREG-0945, ``Final Environmental Impact https://www.nrc.gov/reading-rm/
Statement on 10 CFR Part 61 Licensing doc-collections/nuregs/staff/
Requirements for Land Disposal of sr0945/index.html.
Radioactive Waste,'' November 1982.
NUREG-1556, Volumes 1-21, ``Consolidated https://www.nrc.gov/reading-rm/
Guidance About Materials Licenses''. doc-collections/nuregs/staff/
sr1556/index.html.
NUREG-1748, ``Environmental Review ML032450279.
Guidance for Licensing Actions
Associated with NMSS Programs,'' August
2003.
NUREG-1757, Volumes 1-3, ``Consolidated https://www.nrc.gov/reading-rm/
Decommissioning Guidance''. doc-collections/nuregs/staff/
sr1757/index.html.
July 12, 2023, Public Meeting Summary-- ML23191A156.
Fusion System Proposed Rule.
October 11, 2023, Public Meeting ML23258A146.
Summary--Fusion System Proposed Rule.
November 1, 2023, Public Meeting ML23258A169.
Summary--Fusion System Proposed Rule.
November 9, 2023, Public Meeting ML23258A182.
Summary--Fusion System Proposed Rule.
January 17, 2024, Public Meeting ML23355A142.
Summary--Fusion System Proposed Rule.
March 18, 2024, Public Meeting Summary-- ML24067A237.
Fusion System Proposed Rule.
August 14, 2024, Public Meeting Summary-- ML24207A028.
Fusion Machine Proposed Rule.
Memo to Commission from M. Doane, EDO, ML20288A251.
RE: Response to Staff requirements--
SECY-20-0032--``Rulemaking Plan on Risk-
Informed, Technology-Inclusive
Regulatory Framework for Advanced
Reactors,'' November 2, 2020.
ACRS Letter--Draft SECY White Paper on ML22290A177.
Licensing and Regulating Fusion Energy
Systems October 5-7, 2022, Full
Committee, October 21, 2022.
Executive Order 12866, ``Regulatory 58 FR 51735.
Planning and Review,'' October 4, 1993.
Executive Order 14154, ``Unleashing 90 FR 8353.
American Energy,'' January 29, 2025.
Executive Order 14192, ``Unleashing 90 FR 9065.
Prosperity Through Deregulation,''
February 6, 2025.
Executive Order 14215, ``Ensuring 90 FR 10447.
Accountability for All Agencies,''
February 24, 2025.
Executive Order 14270, ``Zero-Based 90 FR 15643.
Regulatory Budgeting to Unleash
American Energy,'' April 15, 2025.
Executive Order 14300, ``Ordering the 90 FR 22587.
Reform of the Nuclear Regulatory
Commission,'' May 29, 2025.
Final Rule, Requirements for Expanded 72 FR 55864.
Definition of Byproduct Material,
October 1, 2007.
Final Rule, Licensing Requirements for 47 FR 57466.
Land Disposal of Radioactive Waste,
December 27, 1982.
Proposed Rule, Reporting and Control 36 FR 16593.
Requirement for Tritium, August 24,
1971 [issued by the Atomic Energy
Commission].
Presidential Memorandum, ``Plain 63 FR 31885.
Language in Government Writing,'' June
10, 1998.
Agreement State Program Policy 82 FR 48535.
Statement, October 18, 2017.
Atomic Energy Act of 1954, as amended... https://www.nrc.gov/about-nrc/governing-laws.html.
Nuclear Energy Innovation and https://www.govinfo.gov/app/
Modernization Act (NEIMA; Pub. L. 115 details/PLAW-115publ439.
439).
Energy Policy Act of 2005, Public Law https://www.congress.gov/109/
109-58). plaws/publ58/PLAW-
109publ58.pdf.
Low-Level Radioactive Waste Policy Act.. https://www.nrc.gov/about-nrc/governing-laws.html.
Low-Level Radioactive Waste Policy https://www.nrc.gov/about-nrc/
Amendments Act of 1985. governing-laws.html.
[[Page 9493]]
Public Law (Pub. L.) 118-67, https://www.congress.gov/118/
Accelerating Deployment of Versatile, plaws/publ67/PLAW-
Advanced Nuclear for Clean Energy of 118publ67.pdf.
2024 (ADVANCE Act of 2024).
EURFUBRU XII-217/95, ``Safety and https://www.researchgate.net/
Environmental Assessment of Fusion publication/
Power (SEAFP): Report of the SEAFP 303252621_Safety_and_Environm
Project, European Commission DG XII, ental_Assessment_of_Fusion_Po
Fusion Programme,'' June 1995. wer_SEAFP_Final_Report_of_the
_SEAFP_Project.
INFCIRC/254, Part 1, ``Guidelines for https://
Nuclear Transfers,'' Nuclear Suppliers www.nuclearsuppliersgroup.org/
Group (NSG) Guidelines, October 18, index.php/en/guidelines/nsg-
2019. guidelines/guidelines-part-1.
IAEA INFCIRC/540 (Corrected), ``Model https://www.iaea.org/topics/
Protocol Additional to the Agreement(s) additional-protocol.
Between State(s) and the International
Atomic Energy Agency for the
Application of Safeguards,'' also known
as the Additional Protocol (AP),
September 1997.
Fusion Industry Association's Report, https://
``The Global Fusion Industry in 2023,'' www.fusionindustryassociation
July 2023. .org/fusion-industry-report-
archive/.
National Academies of Science report, https://doi.org/10.17226/
``Bringing Fusion to the US Grid,'' 25991.
2021.
UKAEA-RE(21)01, ``Technology Report-- https://scientific-
Safety and Waste Aspects for Fusion publications.ukaea.uk/wp-
Power Plants,'' September 2021. content/uploads/UKAEA-RE2101-
Fusion-Technology-Report-
Issue-1.pdf.
NRC Glossary............................ https://www.nrc.gov/reading-rm/basic-ref/glossary.
------------------------------------------------------------------------
The NRC may post materials related to this document, including
public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2023-0071. In addition, the
Federal rulemaking website allows members of the public to receive
alerts when changes or additions occur in a docket folder. To
subscribe: (1) navigate to the docket folder (NRC-2023-0071); (2) click
the ``Subscribe'' button; and (3) enter an email address and click on
the ``Subscribe'' button.
List of Subjects
10 CFR Part 20
Byproduct material, Criminal penalties, Fusion, 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 30
Byproduct material, Criminal penalties, Government contracts,
Fusion, Intergovernmental relations, Isotopes, Nuclear energy, Nuclear
materials, Penalties, Radiation protection, Reporting and recordkeeping
requirements, Whistleblowing.
10 CFR Part 37
Byproduct material, Criminal penalties, Exports, Hazardous
materials transportation, Imports, Licensed material, Nuclear
materials, Penalties, Radioactive materials, Reporting and
recordkeeping requirements, Security measures.
10 CFR Part 50
Administrative practice and procedure, Antitrust, Backfitting,
Classified information, Criminal penalties, Education, Emergency
planning, 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 energy, Nuclear materials, Nuclear
power plants and reactors, Reporting and recordkeeping requirements.
10 CFR Part 72
Administrative practice and procedure, Hazardous waste, Indians,
Intergovernmental relations, Nuclear energy, Penalties, Radiation
protection, Reporting and recordkeeping requirements, Security
measures, Spent fuel, Whistleblowing.
10 CFR Part 110
Administrative practice and procedure, Classified information,
Criminal penalties, Exports, Imports, Intergovernmental relations,
Nuclear energy, Nuclear materials, Nuclear power plants and reactors,
Penalties, Reporting and recordkeeping requirements, Scientific
equipment.
10 CFR Part 150
Criminal penalties, Hazardous materials transportation,
Intergovernmental relations, Nuclear energy, Nuclear materials,
Penalties, Reporting and recordkeeping requirements, Security measures,
Source material, Special nuclear material.
10 CFR Part 170
Byproduct material, Import and export licenses, Intergovernmental
relations, Nonpayment penalties, Nuclear energy, Nuclear materials,
Nuclear power plants and reactors, Source material, Special nuclear
material.
10 CFR Part 171
Annual charges, Approvals, Byproduct material, Holders of
certificates, Intergovernmental relations, Nonpayment penalties,
Nuclear materials, Nuclear power plants and reactors, Registrations,
Source material, Special nuclear material.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing
to amend 10 CFR parts 20, 30, 37, 50, 51, 72, 110, 150, 170, and 171.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
0
1. 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.
0
2. In Sec. 20.1003:
0
a. Revise the definition for Byproduct material;
0
b. Add in alphabetical order the definition for Fusion machine; and
[[Page 9494]]
0
c. Revise the definition for Particle accelerator.
The revisions and addition read as follows:
Sec. 20.1003 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2) The tailings or wastes produced by the extraction or
concentration of uranium or thorium from ore processed primarily for
its source material content, including discrete surface wastes
resulting from uranium solution extraction processes. Underground ore
bodies depleted by these solution extraction operations do not
constitute ``byproduct material'' within this definition;
(3)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(4) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
Fusion machine means a machine that is capable of--(1) transforming
atomic nuclei, through fusion processes, into different elements,
isotopes, or other particles; and (2) directly capturing and using the
resultant products, including particles, heat, or other electromagnetic
radiation.
* * * * *
Particle accelerator (or accelerator) means any machine capable of
accelerating electrons, protons, deuterons, or other charged particles
in a vacuum, and of discharging the resultant particulate or other
radiation into a medium at energies usually in excess of 1 megaelectron
volt, including fusion machines. For the purposes of this definition,
``accelerator'' is an equivalent term.
* * * * *
Sec. 20.1009 [Amended]
0
3. In Sec. 20.1009, in paragraph (b), add the citation ``20.2008,''
after the citation ``20.2006,''.
0
4. In Sec. 20.2008, revise paragraph (a) to read as follows:
Sec. 20.2008 Disposal of certain byproduct material.
(a) Licensed material as defined in paragraphs (3) and (4) of the
definition of Byproduct material set forth in Sec. 20.1003 may be
disposed of in accordance with part 61 of this chapter, even though it
is not defined as low-level radioactive waste. Therefore, any licensed
byproduct material being disposed of at a facility, or transferred for
ultimate disposal at a facility licensed under part 61 of this chapter,
must meet the requirements of Sec. 20.2006. In addition, waste
resulting from fusion machines must either be accompanied by an
analysis showing the waste is manifested and labeled for disposal
consistent with the description of the applicable waste class in Sec.
61.7 of this chapter, based on the physical, chemical, and radiological
characteristics of the waste, or be disposed of in a disposal facility
that has completed a site-specific intrusion assessment that
demonstrates the projected dose to an individual who inadvertently
intrudes into the waste at the facility will not exceed 0.5 rem (5 mSv)
per year.
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
0
5. The authority citation for part 30 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 81, 161, 181,
182, 183, 184, 186, 187, 223, 234, 274 (42 U.S.C. 2014, 2111, 2201,
2231, 2232, 2233, 2234, 2236, 2237, 2273, 2282, 2021); Energy
Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C.
5841, 5842, 5846, 5851); 44 U.S.C. 3504 note.
0
6. In Sec. 30.4:
0
a. Revise the definition for Byproduct material;
0
b. Add in alphabetical order the definition for Fusion machine; and
0
c. Revise the definition for Particle accelerator.
The revision and addition read as follows:
Sec. 30.4 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(3) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
Fusion machine means a machine that is capable of--(1) transforming
atomic nuclei, through fusion processes, into different elements,
isotopes, or other particles; and (2) directly capturing and using the
resultant products, including particles, heat, or other electromagnetic
radiation.
* * * * *
Particle accelerator (or accelerator) means any machine capable of
accelerating electrons, protons, deuterons, or other charged particles
in
[[Page 9495]]
a vacuum, and of discharging the resultant particulate or other
radiation into a medium at energies usually in excess of 1 megaelectron
volt, including fusion machines. For the purposes of this definition,
``accelerator'' is an equivalent term.
* * * * *
0
7. Amend Sec. 30.32 by adding new paragraph (k) to read as follows:
Sec. 30.32 Application for specific licenses.
* * * * *
(k) An application for a specific license filed under this part for
possession, use, and production of byproduct material associated with a
fusion machine must include the following information:
(1) A general description of the fusion machine.
(2) A summary of the radiation safety aspects of the written
operating and emergency procedures, including, as applicable--
(i) A description with diagram(s) of the radiation protection
measures to be employed for the possession, use, and production of
byproduct material associated with the fusion machine, including all
interlocks, access control systems, shielding, and radiation monitors;
(ii) A description of the radioactive material handling procedures
and inventory control procedures; and
(iii) A description of any other components or systems used to
control radiation and radioactive material.
(iv) As an alternative to paragraphs (k)(2)(i) through (iii) of
this section:
(A) A description of any aspects of the fusion machine relevant to
radiation safety that differ from the information listed in paragraphs
(k)(2)(i) through (iii) of this section, and an explanation for how
they ensure the possession, use, and production of byproduct material
associated with a fusion machine can be performed safely; and
(B) Any other information requested by the NRC staff in
preapplication communications to enable the NRC to evaluate whether the
possession, use, and production of byproduct material associated with a
fusion machine can be performed safely.
(3) A description of the applicant's organizational structure that
describes the radiation safety responsibilities, authorities, and
qualifications.
(4) A description of training related to the fusion machine and
radiation protection provided to personnel.
(5) A description of the plan for inspection and maintenance of the
fusion machine.
(6) A description of the methodology for radioactive material
inventory.
0
8. In Sec. 30.33, add new paragraph (a)(6) to read as follows:
Sec. 30.33 General requirements for issuance of specific licenses.
(a) * * *
* * * * *
(6) In the case of an application for possession, use, and
production of byproduct material associated with a fusion machine, the
application demonstrates adequate training and planning to operate and
decommission the fusion machine safely.
* * * * *
0
9. In Sec. 30.51, revise paragraph (a) introductory text and paragraph
(a)(1) to read as follows:
Sec. 30.51 Records.
(a) Each person who produces or receives byproduct material
pursuant to a license issued pursuant to the regulations in this part
and parts 31 through 36 of this chapter shall keep records showing the
production, receipt, transfer, and disposal of the byproduct material
as follows:
(1) The licensee shall retain each record of production or receipt
of byproduct material as long as the material is possessed and for
three years following transfer or disposal of the material.
* * * * *
Sec. 30.52 [Amended]
0
10. In Sec. 30.52, in paragraph (a), remove the phrase ``is used or
stored'' and add in its place the phrase ``is used, stored, or
produced''.
PART 37--PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2
QUANTITIES OF RADIOACTIVE MATERIAL
0
11. The authority citation for part 37 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 53, 81, 103,
104, 147, 148, 149, 161, 182, 183, 223, 234, 274 (42 U.S.C. 2014,
2073, 2111, 2133, 2134, 2167, 2168, 2169, 2201, 2232, 2233, 2273,
2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202 (42
U.S.C. 5841, 5842); 44 U.S.C. 3504 note.
0
12. In Sec. 37.5, revise the definition for Byproduct material to read
as follows:
Sec. 37.5 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2) The tailings or wastes produced by the extraction or
concentration of uranium or thorium from ore processed primarily for
its source material content, including discrete surface wastes
resulting from uranium solution extraction processes. Underground ore
bodies depleted by these solution extraction operations do not
constitute ``byproduct material'' within this definition;
(3)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(4) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION
FACILITIES
0
13. The authority citation for part 50 is revised 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.
0
14. In Sec. 50.2, revise the definition for Byproduct material to read
as follows:
[[Page 9496]]
Sec. 50.2 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(3) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
PART 51--ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC
LICENSING AND RELATED REGULATORY FUNCTIONS
0
15. The authority citation for part 51 is revised 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.
0
16. Amend Sec. 51.60 by adding new paragraph (b)(1)(viii) to read as
follows:
Sec. 51.60 Environmental report--materials licenses.
* * * * *
(b) * * *
(1) * * *
(viii) Construction and operation of a fusion machine pursuant to
part 30 of this chapter.
* * * * *
PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF
SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-
RELATED GREATER THAN CLASS C WASTE
0
17. The authority citation for part 72 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63,
65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42
U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e,
2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy
Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C.
5841, 5842, 5846, 5851); National Environmental Policy Act of 1969
(42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a),
132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C.
10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168,
10198(a)); 44 U.S.C. 3504 note.
0
18. In Sec. 72.3, revise the definition for Byproduct material to read
as follows:
Sec. 72.3 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(3) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
PART 110--EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL
0
19. The authority citation for part 110 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 51, 53, 54, 57,
62, 63, 64, 65, 81, 82, 103, 104, 109, 111, 121, 122, 123, 124, 126,
127, 128, 129, 133, 134, 161, 170H, 181, 182, 183, 184, 186, 187,
189, 223, 234 (42 U.S.C. 2014, 2071, 2073, 2074, 2077, 2092, 2093,
2094, 2095, 2111, 2112, 2133, 2134, 2139, 2141, 2151, 2152, 2153,
2154, 2155, 2156, 2157, 2158, 2160c, 2160d, 2201, 2210h, 2231, 2232,
2233, 2234, 2236, 2237, 2239, 2273, 2282); Energy Reorganization Act
of 1974, sec. 201 (42 U.S.C. 5841); Administrative Procedure Act (5
U.S.C. 552, 553); 42 U.S.C. 2139a, 2155a; 44 U.S.C. 3504 note.
Section 110.1(b) also issued under 22 U.S.C. 2403; 22 U.S.C.
2778a; 50 App. U.S.C. 2401 et seq.
0
20. In Sec. 110.2, revise the definitions for Byproduct material and
Particle accelerator to read as follows:
Sec. 110.2 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2) The tailings or wastes produced by the extraction or
concentration of uranium or thorium from ore processed primarily for
its source material content, including discrete surface wastes
resulting from uranium solution extraction processes. Underground ore
bodies depleted by these solution extraction operations do not
constitute ``byproduct material'' within this definition;
(3)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
[[Page 9497]]
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(4) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
Particle accelerator (or accelerator) means any machine capable of
accelerating electrons, protons, deuterons, or other charged particles
in a vacuum, and of discharging the resultant particulate or other
radiation into a medium at energies usually in excess of 1 megaelectron
volt, including fusion machines. For the purposes of this definition,
``accelerator'' is an equivalent term.
* * * * *
PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274
0
21. The authority citation for part 150 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 53, 81, 83, 84,
122, 161, 181, 223, 234, 274 (42 U.S.C. 2014, 2201, 2231, 2273,
2282, 2021); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C.
5841); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C.
10155, 10161); 44 U.S.C. 3504 note.
Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued
under Atomic Energy Act secs. 11e(2), 81, 83, 84 (42 U.S.C.
2014e(2), 2111, 2113, 2114).
Section 150.14 also issued under Atomic Energy Act sec. 53 (42
U.S.C. 2073).
Section 150.15 also issued under Nuclear Waste Policy Act sec.
135 (42 U.S.C. 10155, 10161).
Section 150.17a also issued under Atomic Energy Act sec. 122 (42
U.S.C. 2152).
Section 150.30 also issued under Atomic Energy Act sec. 234 (42
U.S.C. 2282).
0
22. In Sec. 150.3, revise the definition for Byproduct material to
read as follows:
Sec. 150.3 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2) The tailings or wastes produced by the extraction or
concentration of uranium or thorium from ore processed primarily for
its source material content, including discrete surface wastes
resulting from uranium solution extraction processes. Underground ore
bodies depleted by these solution extraction operations do not
constitute ``byproduct material'' within this definition;
(3)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(4) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT
LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT
OF 1954, AS AMENDED
0
23. 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
24. In Sec. 170.3, revise the definition for Byproduct material to
read as follows:
Sec. 170.3 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(3) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
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
25. 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.
[[Page 9498]]
0
26. In Sec. 171.5, revise the definition for Byproduct material to
read as follows:
Sec. 171.5 Definitions.
* * * * *
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2)
(i) Any discrete source of radium-226 that is produced, extracted,
or converted after extraction, before, on, or after August 8, 2005, for
use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator,
including by use of a fusion machine; and
(B) If made radioactive by use of a particle accelerator that is
not a fusion machine, is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a
commercial, medical, or research activity; and
(3) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
* * * * *
Dated: February 23, 2026.
For the Nuclear Regulatory Commission.
Carrie Safford,
Secretary of the Commission.
[FR Doc. 2026-03865 Filed 2-25-26; 8:45 am]
BILLING CODE 7590-01-P