Regulatory Framework for Fusion Machines
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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
ublic 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
pending significant resources to develop a regulatory framework.
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).
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.
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
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.
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.
6 The ADVANCE Act of 2024 amended NEIMA to replace “fusion reactor” with “fusion machine.”
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.”
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)
nd 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—
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).
• 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
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
ion 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.
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. ).
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
e 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
holder than those of a nuclear power plant
es, 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
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
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).
• 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
resent 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
cated 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
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—
14 See Fusion Industry Association's report on “Global Fusion Industry Report,” dated July 22, 2025.
• 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
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 )
needed.
The NRC, and the Atomic Energy Commission before it, has experience licensing new and rapidly evolving technologies. The NRC has authority under § 30.32(b) to require additional information as necessary to evaluate an application, and under § 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 § 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
he 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
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 §§ 20.1003 and 30.4 of this chapter; revise the definition of “particle accelerator” in §§ 20.1003, 30.4, and 110.2 of this chapter; and revise the definition of “byproduct material” in §§ 20.1003, 30.4, 37.5, 50.2, 72.3, 110.2,
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
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.
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
rocesses 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 §§ 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 §§ 20.2008, 30.51(a) introductory text, 30.51(a)(1), and 30.52(a) of this chapter. The proposed new sections §§ 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 § 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 sections §§ 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 § 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 § 20.2008(a) is specific to the disposal requirements for waste from a fusion machine. The remaining proposed changes amending the existing regulations in §§ 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 §§ 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 § 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
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 § 30.32(k)(2)(i)-(iii). The alternative pathway, proposed in § 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
er 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
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 § 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 § 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 § 30.32(k)(2)(iv)(B).
18 Based on case-specific circumstances, a categorical exclusion may apply. Categorical exclusions are established by rule in § 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.
Radioactive material as defined in paragraphs (3) and (4) of the definition of byproduct material in § 20.1003 is not LLW
ion 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.
Radioactive material as defined in paragraphs (3) and (4) of the definition of byproduct material in § 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 § 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 § 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 § 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 § 20.2008 to the list of approved information collections in § 20.1009. 20
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
r 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 § 20.2008. Similarly, the draft proposed changes to 10 CFR part 61 would not change the requirements for disposal of fusion machine waste.
The NRC is proposing to amend §§ 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
g 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 § 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
le 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 § 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 § 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
21 The Commission could determine, under § 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.
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 § 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
nder 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 § 20.1801 and § 20.1802, licensees must ensure the security and accountability of licensed material
y 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 § 20.1801 and § 20.1802, licensees must ensure the security and accountability of licensed material. Therefore, all byproduct material that is used, produced, and
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
Volume 22, includes guidance on waste types and radionuclide concentrations the NRC staff has previously analyzed under the waste classification descriptions in § 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
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 § 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
eet 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
licits 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 § 30.55(c), § 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 § 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
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
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 § 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 § 30.55(c) and § 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.
uivalent of § 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 § 30.55(c) and § 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 § 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.
port—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.
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
ies 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
ties;
(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
e 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
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
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 PDR.Resource@nrc.gov. 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
A, 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
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
, “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
greement 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
ry 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
l Review Guidance for Licensing Actions Associated with NMSS Programs,” August 2003 ML032450279. NUREG-1757, Volumes 1-3, “Consolidated Decommissioning Guidance” https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1757/index.html. July 12, 2023, Public Meeting Summary—Fusion System Proposed Rule ML23191A156. October 11, 2023, Public Meeting Summary—Fusion System Proposed Rule ML23258A146. November 1, 2023, Public Meeting Summary—Fusion System Proposed Rule ML23258A169. November 9, 2023, Public Meeting Summary—Fusion System Proposed Rule ML23258A182. January 17, 2024, Public Meeting Summary—Fusion System Proposed Rule ML23355A142. March 18, 2024, Public Meeting Summary—Fusion System Proposed Rule ML24067A237. August 14, 2024, Public Meeting Summary—Fusion Machine Proposed Rule ML24207A028. Memo to Commission from M. Doane, EDO, RE: Response to Staff requirements—SECY-20-0032—“Rulemaking Plan on Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors,” November 2, 2020 ML20288A251. ACRS Letter—Draft SECY White Paper on Licensing and Regulating Fusion Energy Systems October 5-7, 2022, Full Committee, October 21, 2022 ML22290A177. Executive Order 12866, “Regulatory Planning and Review,” October 4, 1993 58 FR 51735. Executive Order 14154, “Unleashing American Energy,” January 29, 2025 90 FR 8353. Executive Order 14192, “Unleashing Prosperity Through Deregulation,” February 6, 2025 90 FR 9065. Executive Order 14215, “Ensuring Accountability for All Agencies,” February 24, 2025 90 FR 10447. Executive Order 14270, “Zero-Based Regulatory Budgeting to Unleash American Energy,” April 15, 2025 90 FR 15643. Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission,” May 29, 2025 90 FR 22587. Final Rule, Requirements for Expanded Definition of Byproduct Material, October 1, 2007 72 FR 55864. Final Rule, Licensing Requirements for Land Disposal of Radioactive Waste, December 27, 1982 47 FR 57466
o-Based Regulatory Budgeting to Unleash American Energy,” April 15, 2025 90 FR 15643. Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission,” May 29, 2025 90 FR 22587. Final Rule, Requirements for Expanded Definition of Byproduct Material, October 1, 2007 72 FR 55864. Final Rule, Licensing Requirements for Land Disposal of Radioactive Waste, December 27, 1982 47 FR 57466. Proposed Rule, Reporting and Control Requirement for Tritium, August 24, 1971 [issued by the Atomic Energy Commission] 36 FR 16593. Presidential Memorandum, “Plain Language in Government Writing,” June 10, 1998 63 FR 31885. Agreement State Program Policy Statement, October 18, 2017 82 FR 48535. Atomic Energy Act of 1954, as amended https://www.nrc.gov/about-nrc/governing-laws.html. Nuclear Energy Innovation and Modernization Act (NEIMA; Pub. L. 115 439) https://www.govinfo.gov/app/details/PLAW-115publ439. Energy Policy Act of 2005, Public Law 109-58) https://www.congress.gov/109/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 Amendments Act of 1985 https://www.nrc.gov/about-nrc/governing-laws.html. Public Law (Pub. L.) 118-67, Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy of 2024 (ADVANCE Act of 2024) https://www.congress.gov/118/plaws/publ67/PLAW-118publ67.pdf. EURFUBRU XII-217/95, “Safety and Environmental Assessment of Fusion Power (SEAFP): Report of the SEAFP Project, European Commission DG XII, Fusion Programme,” June 1995 https://www.researchgate.net/publication/303252621_Safety_and_Environmental_Assessment_of_Fusion_Power_SEAFP_Final_Report_of_the_SEAFP_Project. INFCIRC/254, Part 1, “Guidelines for Nuclear Transfers,” Nuclear Suppliers Group (NSG) Guidelines, October 18, 2019 https://www.nuclearsuppliersgroup.org/index.php/en/guidelines/nsg-guidelines/guidelines-part-1
he 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
on, 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
1
, 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
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.
2. In § 20.1003:
a. Revise the definition for Byproduct material;
b. Add in alphabetical order the definition for Fusion machine; and
c. Revise the definition for Particle accelerator.
The revisions and addition read as follows:
§ 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)
l order the definition for Fusion machine; and
c. Revise the definition for Particle accelerator.
The revision and addition read as follows:
§ 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
ion 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.
ntal Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note.
14. In § 50.2, revise the definition for Byproduct material to read as follows:
§ 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
e 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
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.
16. Amend § 51.60 by adding new paragraph (b)(1)(viii) to read as follows:
§ 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
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
zation 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.
20. In § 110.2, revise the definitions for Byproduct material and Particle accelerator to read as follows:
§ 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
(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—
celerator, 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.
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
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)
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).
22. In § 150.3, revise the definition for Byproduct material to read as follows:
§ 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
U.S.C. 2215; 31 U.S.C. 901, 902, 9701; 44 U.S.C. 3504 note.
24. In § 170.3, revise the definition for Byproduct material to read as follows:
§ 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
r 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
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.