Exemptions From Materials Licensing

NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20, 30, 40, and 70 [NRC-2025-1568] RIN 3150-AL61 Exemptions From Materials Licensing AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending several regulations for byproduct, source, and special nuclear material by expanding how certain nuclear material can be safely used without a license. This action is responsive to the NRC's mission to enable safe, efficient, and reliable licensing and consistent with several Executive orders. These changes are deregulatory in nature, eliminating the need to obtain licenses for certain materials uses and quantities. DATES: This direct final rule is effective December 21, 2026, unless significant adverse comments are received by November 4, 2026. If this direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register . Comments received on this direct final rule will also be considered to be comments on a companion proposed rule published in the Proposed Rules section of this issue of the Federal Register . ADDRESSES: Please refer to Docket ID NRC-2025-1568 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: Electronically at https://www.regulations.gov. Search for Docket ID NRC-2025-1568. Address questions about NRC dockets to Helen Chang; telephone: 301-415-3228; email: Helen.Chang@nrc.gov . For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin ADAMS Public Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section. • NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time, Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Denise Edwards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7204, email: Denise.Edwards@nrc.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Obtaining Information and Submitting Comments A. Obtaining Information B. Submitting Comments II. Executive Order 14300: Ordering the Reform of the Nuclear Regulatory Commission III. Rulemaking Procedure IV. Background V. Discussion A. Expanding Exemptions for Byproduct Material B. Expanding Exemptions for Department of Energy (DOE) Contractors VI. Regulatory Flexibility Certification VII. Regulatory Analysis A. Need for the Rule B. Analytical Framework C. Estimated Costs and Savings of the Direct Final Rule VIII. Backfitting and Issue Finality IX. Plain Writing X. National Environmental Policy Act XI. Paperwork Reduction Act XII. Executive Orders A. Executive Order 12866: Regulatory Planning and Review (as Amended by Executive Order 14215, Ensuring Accountability for All Agencies) B. Executive Order 14192: Unleashing Prosperity Through Deregulation C. Executive Order 14267: Reducing Anti-Competitive Regulatory Barriers XIII. Congressional Review Act XIV. Coordination With NRC Agreement States XV. Compatibility of Agreement State Regulations XVI. Voluntary Consensus Standards XVII. Availability of Guidance XVIII. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information Please refer to Docket ID NRC-2025-1568 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods: • Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-1568. • NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin ADAMS Public Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section. • NRC's PDR: The NRC Public Document Room (PDR), where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time, Monday through Friday, except Federal holidays. B. Submitting Comments Comments must be submitted electronically using https://www.regulations.gov no later than 11:59 p.m. eastern time on November 4, 2026. Please include Docket ID NRC-2025-1568 in your comment submission. The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information. If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS. II. Executive Order 14300: Ordering the Reform of the Nuclear Regulatory Commission On May 23, 2025, President Donald J. Trump signed Executive Order (E.O.) 14300, “Ordering the Reform of the Nuclear Regulatory Commission.” Section 5, “Reforming and Modernizing the NRC's Regulations,” directs the NRC to undertake a review and wholesale revision of its regulations and guidance documents as guided by the policies set forth in section 2 of the E.O. This rulemaking is part of the NRC's response to the direction in Section 5 of the E.O. because in conducing the wholesale review of its regulation, the NRC reexamined the regulations pertaining to the use of certain nuclear material without a license. III. Rulemaking Procedure Because the NRC considers this action to be noncontroversial, the NRC is using the “direct final rule procedure” for this rule. This amendment is effective on December 21, 2026. However, if the NRC receives significant adverse comments on this direct final rule by November 4, 2026, then the NRC will publish a document that withdraws this action and will address the comments received in a subsequent final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register . Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action. A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if: (1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when: (a) The comment causes the NRC to reevaluate (or reconsider) its position or conduct additional analysis; (b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or (c) The comment raises a relevant issue that was not previously addressed or considered by the NRC. (2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition. (3) The comment causes the NRC to make a change (other than editorial) to the rule. For detailed instructions on filing comments, please see the ADDRESSES section of this document. IV. Background This rulemaking (1) amends the regulations pertaining to quantities of byproduct material that are exempt from licensing in title 10 of the Code of Federal Regulations (10 CFR) part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material,” specifically § 30.71 (“Schedule B”); and (2) expands the exemptions from licensing for Department of Energy (DOE) contractors. Exemptions for DOE contractors are in part 30, and also in 10 CFR part 40, “Domestic Licensing of Source Material”; and 10 CFR part 70, “Domestic Licensing of Special Nuclear Material,” specifically §§ 30.12, 40.11, and 70.11. The NRC has authority to issue licenses to persons for the use of radioactive material under the Atomic Energy Act of 1954, as amended (AEA). With respect to the revision to Schedule B, the exempt quantities of byproduct material, under section 81 of the AEA, the NRC also has authority to exempt certain classes or quantities of byproduct material from the requirements for a license. In considering its exemptions from licensing, the NRC is directed by the AEA to make a finding that the exemption of such classes or quantities of such material or such kinds of uses or users will not constitute an unreasonable risk to the common defense and security and to the health and safety of the public. Consistent with this direction, the NRC has defined limits for such material by quantity (mass), radioactivity (activity), the material's use, the person using the material, or a combination thereof. The NRC has identified its regulations for exempt quantities in Schedule B as an area for regulatory improvement. Exempt quantity limits for exempt use in Schedule B were identical to other quantity limits in the NRC's radiation protection regulations in 10 CFR part 20 until it was revised in 1991 (56 FR 23360; May 21, 1991). The NRC published changes to 10 CFR part 20 to reflect the adoption of recommendations of the International Commission on Radiation Protection (ICRP) Publication Nos. 26 and 30. At the time, the values in Schedule B were not revised because conformity was not considered essential when 10 CFR part 20 was updated. In June 2001, the NRC conducted a technical evaluation of its exemptions, published in NUREG-1717, “Systematic Radiological Assessment of Exemptions for Source and Byproduct Materials.” This evaluation concluded that providing a cross-reference to appendix C to 10 CFR part 20 continues to ensure reasonable assurance of adequate protection of public health and safety. Further changes were made due to the Energy Policy Act of 2005, which added additional byproduct material to the NRC's jurisdiction. Schedule B was partially updated in a final rule, “Requirements for Expanded Definition of Byproduct Material; Final Rule” (72 FR 55864; October 1, 2007) to include radionuclides that were commonly used at that time. More recently, the NRC has received information that expanding the use of byproduct material under exemption should be pursued, following a comment letter from National Institutes of Health, dated December 15, 2020. Next, based on licensing experience, the NRC also has identified its regulations granting exemptions to DOE contractors as an area for regulatory improvement. These regulations for byproduct, source, and special nuclear material are addressed in §§ 30.12, 40.11, and 70.11, respectively. Almost identical versions of these regulations have been in place since the existence of the Atomic Energy Commission (AEC), when the AEC reviewed its contractor activities for exemption (see e.g., 16 FR 3251; April 13, 1951; 21 FR 213; January 11, 1956; 29 FR 14401; October 20, 1964). When the AEC was reorganized in 1975, the NRC retained the responsibility to perform the review of the exemption requests for DOE contractors working in areas subject to the jurisdiction of the NRC. V. Discussion The NRC is amending its regulations in this rule to expand how byproduct material can be safely used without a license and expand exemptions from licensing for certain activities of DOE contractors. As discussed in the “Background” section, these long-standing exemptions both for exempt quantities of byproduct material in Schedule B and the exemptions for DOE contractors have only been slightly changed in the past decades. Since their promulgation, from time to time the NRC has evaluated exempt material use to ensure that the limits are still protective of health and safety. On its own initiative, the NRC has also performed technical evaluations of Schedule B, examining if higher quantity or activity limits would still provide adequate protection of health and safety, common defense and security, and the environment. A comprehensive technical evaluation was published in “Systematic Radiological Assessment of Exemptions for Source and Byproduct Materials” (NUREG-1717, June 2001), which supports the quantity and activity limits established in revised Schedule B. That evaluation demonstrated that the quantity and activity limits in revised Schedule B present such low risk, even in conservative misuse scenarios, that regulation would not meaningfully improve safety. Further, the revised Schedule B more closely aligns the NRC's labeling and licensing requirements by matching the quantities of materials that are exempt from licensing under 10 CFR part 30 with those that are exempt from labelling under 10 CFR part 20 with limited exceptions. With respect to the exemptions for DOE contractors, the NRC has reviewed exemption requests it has received and approved from its licensees and from the DOE in order to assess what limits would ensure safe use of radioactive material exempt from the licensing process. Overall, these amendments will provide greater regulatory flexibility, thereby accomplishing the goals of E.O. 14300 while ensuring safety. The following discussion elaborates on these points, organized by subject area. A. Expanding Exemptions for Byproduct Material This rule amends the NRC's regulations in Schedule B to include all the radionuclides that are widely used by researchers and in academic, industrial, and medical settings. Without this update, individuals who use and possess radionuclides not included in the existing Schedule B list must continue to apply for a specific license where one is not needed to ensure reasonable assurance of adequate protection of public health and safety. Therefore, the NRC is replacing the current Schedule B with a reference to appendix C to 10 CFR part 20 and a clarifying footnote that the quantities listed are also used in 10 CFR part 30 to define quantities exempt from licensing. The limits in Schedule B are referred to elsewhere in regulations as “exempt quantities”; however, Schedule B limits are published in terms of activity, as are the values in appendix C to part 20. The majority of the exempt quantity thresholds specifically listed in the current Schedule B match values contained in appendix C to 10 CFR part 20. This will expand radionuclides that are currently not listed in Schedule B, will update the quantities of existing radionuclides on the table based on the latest safety data, and will ensure that persons currently exempt from requiring a license continue to be exempt. This change updates the activities of byproduct material for which possession is exempt from the requirement for a specific license. This rulemaking ensures exempt quantity thresholds are tied to risks associated with the radionuclide as appendix C to 10 CFR part 20 is developed based on NRC risk modules. The change saves resources for individuals who use low-risk quantities of certain radionuclides identified in appendix C to 10 CFR part 20 as it removes the need to get a specific license. It also saves resources for NRC and Agreement States to review specific license applications and conduct inspections. The quantities for three radionuclides specifically listed in § 30.71 (cadmium-109, iridium-192, and zirconium-93) have lower values (1 µCi, 37 kilobecquerel) in appendix C to 10 CFR part 20 than currently contained in 10 CFR 30.71 (10 µCi). If the values for these radionuclides are replaced by the values in appendix C to 10 CFR part 20, the exempt quantity threshold for these radionuclides will decrease. Additionally, the current exempt quantity of any byproduct materials other than alpha emitting byproduct material not listed in § 30.71 is 0.1 µCi, which is equal to the smallest exempt quantity listed. Since the smallest quantity in appendix C to 10 CFR part 20 is 0.001 µCi and the quantity for any radionuclide other than alpha emitting radionuclides not listed in appendix C to 10 CFR part 20 is 0.01 µCi, radionuclides not listed in § 30.71 could have their exempt quantity reduced if not listed in appendix C to 10 CFR part 20 or if they are listed in appendix C to 10 CFR part 20 with a quantity lower than 0.1 µCi. These situations could require individuals to obtain a specific license when they are currently exempt from that requirement. To avoid this the NRC is including in the rule language exceptions retaining the current exempt quantities for the three specified radionuclides and any byproduct material other than alpha emitting byproduct material for which the quantity in appendix C to 10 CFR part 20 is lower than 0.1 µCi. This rulemaking modernizes the exempt quantity thresholds by effectively adding values for widely used radionuclides in medical, academic, and industrial applications not previously exempted and updating certain thresholds based on updated scientific and safety information. This rulemaking also reduces the number of specific licenses that nuclear materials users must apply for due to the exempt quantities in the current Schedule B. B. Expanding Exemptions for Department of Energy (DOE) Contractors Since September 11, 2001, DOE contractors have routinely provided training involving radioactive materials to law enforcement personnel and first responders at the Federal, state, and local levels. Whenever these training activities take place outside a Federal government-owned or controlled site, the DOE contractor must obtain an exemption from the NRC (and Agreement State, if applicable) to perform the activity. This rule updates the NRC's regulations in §§ 30.12, 40.11, and 70.11 so that DOE contractors will no longer need to request specific exemptions individually. Instead, the rule would grant a standing exemption for temporary training activities involving law enforcement emergency response, and similar personnel, provided the radioactive materials used fall below specified quantity limits. Once Agreement States adopt the rule, these exemptions would apply within their jurisdictions as well. The rule establishes explicit quantity thresholds, confines the exemptions to temporary training activities, and ensures the continued use of appropriate safety procedures. This approach increases efficiency and reduces administrative workload for NRC, Agreement States, and DOE contractors by eliminating repeated reviews of training activities that have already demonstrated a consistent safety record under DOE oversight. These radioactive materials are used in accordance with DOE's occupational radiation protection program in 10 CFR part 835, which is similar to the NRC's radiation protection program in 10 CFR part 20 and provides protection of public health and safety and security controls. The DOE contractors typically conduct multiple training activities and exercises each year, submitting multiple, nearly identical, exemption requests. These training activities generally involve quantities of radioactive material which do not require additional security controls beyond 10 CFR part 20 requirements. In limited cases, the NRC has approved exemptions involving quantities that fall under security requirements under 10 CFR part 37, “Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.” In assessing how to structure the new exemptions, the NRC staff reviewed years of past case-by-case exemption approvals. Since 2001, the NRC has consistently evaluated these exemption requests without identifying any safety issues. The DOE already regulates similar radioactive materials under its jurisdiction and typically only seeks NRC and Agreement State exemptions when training occurs outside DOE controlled sites. The DOE also maintains emergency response procedures that address work performed in NRC or Agreement State jurisdictions and includes processes for notification in the event of abnormal conditions. Historically, the NRC has considered these procedures when reviewing exemption requests. Therefore, considering DOE's history of safe oversight of these activities and the continued involvement of the NRC or Agreement States in the event of an abnormal condition, the NRC staff believe there is a low safety risk associated with providing the exemptions for certain quantities of material that are typically used in these training exercises. Additionally, the NRC staff do not believe additional notification is required outside of existing notifications during abnormal conditions. When DOE training is conducted in Agreement States, the NRC has performed the review and provided the Agreement State opportunity to comment. The quantity limits now being codified reflect these past approvals and were validated with DOE during this rule's development. To ensure consistency across the National Materials Program, Agreement States need to adopt compatible regulations so that DOE contractors receive the same exemptions nationwide. In addition to the changes made to the regulations for byproduct, source, and special nuclear material exemptions, the NRC is making administrative clarifications to §§ 30.12, 40.11, and 70.11. These revisions enumerate the DOE contractor exemptions more clearly, replacing language that was previously ambiguous and could cause confusion once the expanded exemptions take effect. These administrative edits do not change any existing exemptions. They improve clarity so the expanded rule can be implemented without misinterpretation. VI. Regulatory Flexibility Analysis The Regulatory Flexibility Act, as amended at 5 U.S.C. 601 et seq., requires that agencies consider the impact of their rulemakings on small entities and, consistent with applicable statutes, consider alternatives to minimize these impacts on the businesses, organizations, and government jurisdictions to which they apply. The NRC has established standards for determining which of its licensees qualify as small entities pursuant to 10 CFR 2.810, “NRC size standards.” These standards are based on the Small Business Administration's most common receipt-based size standards and provide for business concerns that are manufacturing entities, with the use of a criteria of less than 500 employees. The Small Business Regulatory Enforcement Fairness Act requires that the NRC prepare a written compliance guide to assist small entities in complying with each rule for which a regulatory flexibility analysis is prepared. Because this direct final rule is deregulatory and does not impose new requirements on small entities, the NRC does not expect to prepare a compliance guide under this Act. This direct final rule reduces regulatory burden and results in cost savings compared to maintaining the current requirements. Aligning § 30.71 (Schedule B) with appendix C to 10 CFR part 20 will increase the number of radionuclides eligible for exemption and will raise quantity thresholds for certain radionuclides. These changes allow small entities, such as universities, research institutions, and small businesses, to use a broader range of radionuclides without a specific license, provided the quantities remain below the quantity limits. This rule also updates §§ 30.12, 40.11, and 70.11 to add exemptions for DOE contractors conducting temporary training activities with byproduct, source, and special nuclear material under specific, previously approved quantities. Under the current regulations, DOE must request case-by-case exemptions from the NRC and Agreement States for these activities when performed in NRC and Agreement State jurisdiction. These exemptions eliminate the need for repeated exemption requests on a case-by-case basis, provided DOE contractors meet the conditions specified in these sections. This change reduces administrative burden for DOE, NRC, and Agreement States while maintaining oversight and public protection. Overall, this rule benefits small entities and DOE contractors by streamlining licensing and exemption processes, saving time and costs, and improving efficiency without compromising health and safety. The Commission certifies that this deregulatory rule does not have a significant impact on a substantial number of small entities. VII. Regulatory Analysis This regulatory analysis is prepared in accordance with E.O. 12866, “Regulatory Planning and Review,” and E.O. 14215, “Ensuring Accountability for All Agencies.” E.O. 14215 requires all federal agencies, including the NRC, to comply with E.O. 12866 and submit significant actions for Office of Information and Regulatory Affairs (OIRA) review. The analysis assesses the costs and savings of the alternatives considered by the NRC and concludes that the deregulatory actions in this rule are expected to reduce regulatory burden and generate cost savings for licensees, the NRC, the Agreement States, and the DOE contractors when compared to the no-action baseline. The regulatory analysis is detailed in the following paragraphs of this document. Comments on the analysis may be submitted to the NRC as indicated under the ADDRESSES section of this document. A. Need for the Rule The NRC was created by Congress in 1974 to ensure the safe use of radioactive materials for beneficial civilian purposes while protecting people and the environment. The NRC protects public health and safety and advances the nation's common defense and security by enabling the safe and secure use and deployment of civilian nuclear energy technologies and radioactive materials through efficient and reliable licensing, oversight, and regulation for the benefit of society and the environment. From an economic perspective, common defense and national security are public goods for which the markets cannot maximize net benefits, and markets alone can sometimes create unintended impacts to public health and safety. Consistent with its statutory authority, NRC provides reasonable assurance of adequate protection of public health and safety. Section 5 of E.O. 14300 directs the NRC to undertake a review and wholesale revision of its regulations and guidance documents as guided by the policies set forth in section 2 of the E.O. This rulemaking is part of the NRC's response to the direction in Section 5 of the E.O. because in conducting the wholesale review of its regulation, the NRC reexamined the regulations pertaining to the use of certain nuclear material without a license and determined—based on past experience and practice—such uses can be expanded. Rulemaking is the most effective way to achieve this. Licensees may amend their current license for additional radionuclides; however, such amendments impose a cost on licensees and regulators without a proportionate benefit to public health and safety. Expanding the use of certain nuclear material without the need for a license also cannot be accomplished through guidance, as such guidance would conflict with the existing regulatory text. Therefore, amending the NRC's regulations is the most effective way to make this deregulatory change for all intended exempt uses. B. Analytical Framework This analysis uses the current regulations under 10 CFR parts 30, 40, and 70 as the no-action baseline (Alternative 1), evaluates the changes in this direct final rule as the regulatory alternative (Alternative 2), and estimates the costs and savings associated with implementing the rule. Alternative 2 will revise 10 CFR parts 30, 40, and 70 to modernize exempt quantity thresholds and add exemptions for DOE contractors conducting temporary training activities under specified quantities of radioactive material. Specifically, these amendments include aligning § 30.71 (Schedule B) with appendix C to 10 CFR part 20, adding radionuclides widely used in research, industry, and medicine, and updating quantity thresholds based on current scientific and safety information. These changes will allow a broader range of radionuclides to be used without a specific license, provided the quantities remain below the updated exempt limits. The rule also will add exemptions for DOE contractors under §§ 30.12, 40.11, and 70.11 to eliminate repeated case-by-case exemption requests for temporary training activities performed in NRC and Agreement State jurisdiction. These training activities have historically been completed safely under DOE oversight. Additionally, the DOE has routinely requested similar quantities of byproduct, source, and special nuclear material often resulting in nearly repetitive reviews and approvals by the NRC and Agreement States. This rule identifies maximum quantities of byproduct, source, and special nuclear material that qualify for exemptions based on the robust past history of approval and safe use. By removing unnecessary regulatory burden, these changes will improve efficiency, predictability, and flexibility while maintaining the NRC's mission of protecting public health and safety. The amendments include administrative updates, clarifications, and streamlined requirements that improve consistency and support regulatory efficiency. Overall, these changes address E.O. 14300, Section 5, by reducing administrative burdens for the NRC, Agreement States, licensees, and applicants while ensuring continued oversight and safety. To estimate the regulatory impact of this direct final rule, the NRC used input from NRC staff, internal data sources, and information provided by stakeholders. Where possible, the NRC provides quantitative estimates based on available data; where data are not available, the NRC relies on staff judgment to approximate the impact and level of effort involved. The analysis then monetizes the estimated time savings for NRC staff, Agreement State staff, licensees, and DOE contractors resulting from activities that will no longer be required under this rule. These savings include (1) avoided license applications and amendments for exempt quantities of radioactive material due to updates to § 30.71 (Schedule B) and (2) avoided case-by-case exemption requests for DOE contractors. Monetized savings are calculated by multiplying the estimated labor hours avoided by (1) licensees for preparing and submitting license applications and amendments, (2) DOE contractors for preparing exemption requests, and (3) NRC and Agreement State staff for reviewing these submissions, by the applicable wage rates. For NRC staff, the NRC uses its internal labor rate of $158 per hour. 1 Wage rates for licensees and Agreement State staff are derived from U.S. Bureau of Labor Statistics (BLS) 2 data and adjusted using the NRC's standard 2.4 multiplier to account for fringe benefits and overhead costs. Wage rates for DOE contractors are based on DOE-provided data and reflect costs specific to DOE operations rather than BLS blended averages. 1  This NRC labor rate differs from those developed under the agency's license fee recovery program (10 CFR part 170, “Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services under the Atomic Energy Act of 1954, as Amended”). NRC labor rates for fee recovery purposes are appropriately designed for full-cost recovery of the services rendered and thus include nonincremental costs ( e.g., overhead, administrative, and logistical support costs). https://www.nrc.gov/about-nrc/regulatory/rulemaking/regulatory-analysis. 2  U.S. Bureau of Labor Statistics, Occupational Employment and Wage Statistics, National Industry-Specific Occupational Employment and Wage Statistics, May 2024. Table 1—Wage Rates Used in the Analysis [2024 U.S. dollars] Standard occupational classification Position title Weighting (%) Hourly mean wage NRC loaded multipliers Fully loaded hourly mean wage Licensees/Applicants Labor Rates (National Cross-industry, Private Ownership) 17-2081 Environmental Engineers 33 $54.44 2.4 $43.55 19-5010 Occupational Health and Safety Specialists and Technicians 33 40.25 2.4 32.20 23-1011 Lawyers 33 93.72 2.4 74.98 Blended mean wage 150.73 Agreement States Wage Rates (State Government, including Schools and Hospitals) 17-2081 Environmental Engineers 33 48.66 2.4 38.93 19-5010 Occupational Health and Safety Specialists and Technicians 33 37.24 2.4 29.79 23-1011 Lawyers 33 57.44 2.4 45.95 Blended mean wage 114.67   NRC wage rate 158.00   Contractor Labor Rates   Radiological Engineering 69 273.70 188.17   Principal Researcher 13 331.30 41.41   Supervisor/Manager 9 273.70 25.66   Administrative 9 154.95 14.53 Blended mean wage 269.77 All costs and cost savings are expressed in 2024 dollars. The analysis covers a 5-year period, which provides a reasonable basis for projecting licensee activities. In accordance with Office of Management and Budget (OMB) Circular A-4 and the NRC's internal guidance document, NUREG/BR-0058, Revision 5, the staff used net present value (NPV) calculations to estimate the value of future cost savings in constant 2024 dollars, the most recent year for which complete annual data are available. NPV analysis allows for the comparison of costs and benefits that occur at different points in time by discounting them to a common base year. Consistent with OMB guidance, the analysis applies real discount rates of 3 percent and 7 percent. The 3-percent rate reflects the social rate of time preference and approximates the real return on long-term government debt. The 7-percent rate reflects the opportunity cost of capital and approximates the average pretax real rate of return on private-sector investments. The resulting estimates and underlying calculations are presented in the subsequent sections. C. Estimated Costs and Savings of the Direct Final Rule This section analyzes the estimated costs and savings associated with revisions to § 30.71 (Schedule B) to align with appendix C to 10 CFR part 20, as well as exemptions for DOE contractors under §§ 30.12, 40.11, and 70.11. The analysis concludes with a summary of implementation costs, anticipated cost savings, and net cost savings. 1. Expanding Exemptions for Byproduct Material As discussed in Section IV.A, “Expanding Exemptions for Byproduct Material” of this document, this direct final rule will replace the current § 30.71 (Schedule B) table with a reference to appendix C to 10 CFR part 20, which includes a broader range of radionuclides. It will also retain the current exempt quantities for cadmium-109, iridium-192, and zirconium-93 because their thresholds in § 30.71 (Schedule B) are already higher than those in appendix C to 10 CFR part 20. The rule will add a blanket provision stating that the exempt quantity limit for any byproduct material other than alpha emitting radionuclides is 0.1 microcuries. This change reduces the need for specific licenses for very small quantities of certain radionuclides, eliminating associated application, review, and compliance costs for both applicants and regulators. Agreement States will be required to adopt compatible regulations; however, the scope of changes is limited, and the associated revisions are expected to be minimal. The estimated savings apply only to reduced licensing requirements for possession of exempt quantities and do not include any changes for manufacturers or distributors, because distribution requirements under § 32.18 remain unchanged. By aligning § 30.71 (Schedule B) with appendix C to 10 CFR part 20, this rule will reduce the need for specific licenses for certain radionuclides without compromising public health and safety. Based on NRC experience, at least 10 specific license applications or amendment requests are submitted to the NRC each year, and approximately 70 similar applications are submitted to Agreement States. Each licensee/applicant spends about 40 hours per license on compliance activities. NRC staff spend an average of 50 hours reviewing each application. Agreement State staff spend 50 hours reviewing each application. As shown in table 2, eliminating the specific licenses requirement for certain radionuclides will reduce burden for licensees, the NRC, and Agreement States. These activities represent approximately 7,200 hours of effort and $962,682 in annual costs that will be eliminated under this rule. Table 2—Annual Cost Savings From Elimination of Exemption Requests [NRC, agreement states and licensees] Entity Reduction in number of exemption requests Burden hours per request Total burden hours reduced Fully loaded wage rate Annual cost savings Licensees/Applicants 80 40 3,200 $150.73 $482,330 NRC 10 50 500 158.00 79,000 Agreement States 70 50 3,500 114.67 401,352 Total 7,200 962,682 Over the 5-year analysis period (2027-2031), these changes are projected to generate cumulative undiscounted savings of $4.8 million. Using 2024 as the base year, the net present value of these savings is estimated at $4.4 million using a 3 percent discount rate or $3.9 million using a 7 percent discount rate. Table 3—Total 5-Year Cost Savings [NRC, agreement states and licensees] Year Cost of exemption requests with existing regulations Cost of exemption requests with this final rule Cost savings due to this rule ($) 3% NPV ($) 7% NPV ($)   Undiscounted 1 962,682 0 962,682 934,642 899,702 2 962,682 0 962,682 907,420 840,843 3 962,682 0 962,682 880,990 785,835 4 962,682 0 962,682 855,330 734,425 5 962,682 0 962,682 830,418 686,379 Total 4,813,408 0 4,813,408 4,408,800 3,947,185 The NRC and industry stakeholders may incur minimal implementation costs associated with updating internal procedures. These costs are expected to be minimal and have not been quantified. 2. Expanding Exemptions for DOE Contractors As discussed in Section IV.B “Expanding Exemptions for DOE Contractors” of this document, this direct final rule will revise the exemption provisions under §§ 30.12, 40.11, and 70.11 to add exemption approvals for DOE contractors conducting temporary training activities under specified quantities of radioactive material. Under the current regulations, DOE contractors must request case-by-case exemptions from the NRC when training occurs in NRC and Agreement State jurisdiction. The NRC first reviews these requests to confirm that the material poses a low risk to public health and safety. Agreement States conduct confirmatory reviews of the exemption requests that fall within their jurisdiction. Preparing and reviewing exemption requests imposes a recurring administrative burden. Each request requires DOE contractors to prepare documentation describing the material involved, outline applicable safety controls, and demonstrate that the training activity is authorized and consistent with applicable regulatory requirements. NRC staff then review the exemption request, verify compliance, and document their findings. The NRC then forwards its findings and the exemption decision to the Agreement States for confirmatory review. As shown in table 4, eliminating the exemption requirement will reduce burden for DOE contractors, NRC, and Agreement States. DOE contractors currently submit about 29 exemption requests annually, based on the 3-year average. The NRC reviews all exemption requests, while Agreement States review only those within their jurisdictions, which account for approximately 90 percent of the total requests. These activities represent approximately 1,390 hours of effort and $266,921 in annual costs that will be eliminated under this rule. Table 4—Annual Cost Savings From Elimination of Exemption Requests [DOE contractors, NRC, agreement states and licensees] Entity Reduction in number of exemption requests Burden hours per request Total burden hours reduced Fully loaded wage rate Annual cost savings DOE Contractors 29 16 464 $269.77 $125,172 NRC 29 28 822 158.00 129,823 Agreement States 26 4 104 114.67 11,926 Total 1,390 266,921 The rule will eliminate the need for these case-by-case exemption requests by adding exemptions for specified quantity limits, provided the activity is a temporary training of law enforcement, emergency response, or other similar personnel and appropriate procedures are in place. This change will reduce administrative burden for DOE contractors, NRC, and Agreement States while maintaining oversight and public protection. As shown in table 5, over the 5-year analysis period (2027-2031), these changes are projected to generate cumulative undiscounted savings of approximately $1.3 million. Using 2024 as the base year, the NPV of these savings is estimated at $1.2 million using a 3 percent discount rate or $1.1 million using a 7 percent discount rate. NRC and industry stakeholders may incur minimal implementation costs associated with eliminating the exemption process and updating internal procedures. These costs are expected to be minimal and have not been quantified. Table 5—Total 5-Year Cost Savings [DOE contractors, NRC, agreement states and licensees] Year Cost of exemption requests with existing regulations($) Cost of exemption requests with this final rule Cost savings due to this rule ($) 3% NPV ($) 7% NPV ($)   Undiscounted 2027 266,921 0 266,921 259,147 249,459 2028 266,921 0 266,921 251,599 233,139 2029 266,921 0 266,921 244,271 217,887 2030 266,921 0 266,921 237,156 203,633 2031 266,921 0 266,921 230,249 190,311 Total 1,334,606 0 1,334,606 1,222,421 1,094,430 3. Summary of Costs, Cost Savings, and Net Cost Savings Overall, this direct final rule is considered a deregulatory action and is expected to reduce administrative burden by streamlining exemption provisions, improving efficiency and predictability, and increasing flexibility for the NRC, Agreement States, licensees, and DOE contractors. These changes include aligning exempt quantity thresholds in § 30.71 (Schedule B) with appendix C to 10 CFR part 20 and adding exemption approvals for DOE contractors conducting temporary training activities under specified quantities of radioactive material under §§ 30.12, 40.11, and 70.11. Over the 5-year analysis period (2027-2031), the revisions are estimated to generate net savings of $6.1 million (savings minus costs), undiscounted. As shown in table 6, the NPV of these net savings will be $5.6 million, discounted at 3 percent, or $5.0 million, discounted at 7 percent. The projected annualized cost savings will be $1.2 million, discounted at 3 percent, or $1.1 million, discounted at 7 percent. Although the rule will generate savings, NRC and industry stakeholders may incur minimal implementation costs associated with eliminating the exemption process and updating internal procedures. These costs are expected to be minimal and have not been quantified. Licensees account for the largest share of net savings, with about 2.4 million over 5 years, undiscounted, and 2.2 million discounted at 3 percent, or 2.0 million discounted at 7 percent. Agreement States will realize about 2.1 million over 5 years, undiscounted, and 1.9 million discounted at 3 percent, or 1.7 million discounted at 7 percent. NRC savings are estimated at 1.0 million over 5 years, undiscounted, and 956,000 discounted at 3 percent, or 856,000 discounted at 7 percent. DOE contractor savings are estimated at 626,000 over 5 years, undiscounted, and 573,000 discounted at 3 percent, or 513,000 discounted at 7 percent. Table 6—Total 5-Year Costs, Savings, and Net Savings [NRC, agreement states, licensees, and DOE contractors]  3 Attribute Undiscounted 3% NPV 7% NPV Licensees' Savings from Rule $2,412,000 $2,209,000 $1,978,000 NRC Staff's Savings from Rule 1,044,000 956,000 856,000 Agreement States' Savings from Rule 2,066,000 1,893,000 1,695,000 DOE Contractors' Savings from Rule 626,000 573,000 513,000 Implementation Costs Minimal cost, not quantified Total Net Savings 6,148,000 5,631,000 5,042,000 Annualized Savings 1,159,000 1,074,000 In addition to the quantified analysis, this direct final rule provides qualitative benefits by improving regulatory clarity and predictability. Aligning exempt quantity thresholds in § 30.71 (Schedule B) with appendix C to 10 CFR part 20 and codifying exemptions for DOE contractors reduces ambiguity and minimizes the need for case-by-case reviews. These changes streamline processes, support broader use of radionuclides in research, industry, and medicine, and enhance efficiency while maintaining safety. The exemptions for DOE contractors further reduces administrative burden and improves coordination among NRC, Agreement States, and DOE contractors. 3  Values rounded to the nearest 1,000 dollars. In addition to this analysis, OIRA requires agencies to report results as a perpetual stream (perpetuity) once a rule is implemented. The perpetual stream has annualized savings of about 1.1 million. VIII. Backfitting and Issue Finality This final rule amends the NRC's byproduct, source, and special nuclear material regulations to expand how nuclear material can be safely used without a license. The final rule does not meet the definition of backfitting in § 50.109, 70.76, 72.62, or 76.76, or affect issue finality of an approval issued under 10 CFR part 52. Therefore, the NRC has determined that this final rule does not constitute a backfit or affect issue finality for any approvals issued under 10 CFR part 52. IX. Plain Writing The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885). X. National Environmental Policy Act A. Introduction The NRC has prepared this environmental assessment (EA) of the direct final rule amending byproduct, source, and special nuclear material regulations to determine the significance of the environmental effects of the agency action in accordance with the National Environmental Policy Act of 1969, as amended (NEPA) and NRC's NEPA implementing regulations in 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” As explained in this EA, the NRC has determined that the agency action to amend these regulations to expand which radionuclides are exempt from the requirement for a specific license, update the quantity thresholds for certain radionuclides exempt from a specific license, and expand exemptions for certain DOE contractor activities would have no significant effect on the quality of the human environment. The direct final rule amends regulations in 10 CFR parts 30.12, 30.71, 40.11, and 70.11. B. Rule Amendments Requiring Environmental Assessment The NRC evaluated the direct final rule amendments for the potential to affect the human environment and determined that the agency action (rulemaking) does not have a significant environmental effect. Environmental effects were determined to be the same for a given facility regardless of the amendment. However, these amendments also involve safety requirements that differ from those under the existing regulatory framework. Therefore, the environmental effects analysis focuses on whether changes in safety requirements would lead to significantly different environmental effects than those experienced under existing NRC regulations. As explained in Table B-1, these rule amendments update NRC regulations, continue to provide reasonable assurance of adequate protection of public health and safety, and therefore, result in no new or different environmental effects. Table B-1 presents the basis for why these rule amendments have no significant environmental effects. Table B-1—Basis for No Significant Environmental Effects Determination for Rule Amendments Not Covered by a Categorical Exclusion Rule amendments Basis for no significant environmental effects 30.71 The direct final rule amendment aligns exempt quantity thresholds in 10 CFR 30.71 (Schedule B) with appendix C to 10 CFR part 20 to reduce the need for specific licenses for certain radionuclides without compromising public health and safety. The direct final rule amendment replaces the 10 CFR 30.71 (Schedule B) table with a reference to ap