Documents › Agency rules › 2026-20336
Nuclear Regulatory Commission
Exemptions From Materials Licensing
Published October 5, 2026. Takes effect December 21, 2026, printed at 91 FR 63133, amending 10 CFR 20, 10 CFR 30, 10 CFR 40, 10 CFR 70. 11,963 words.
What the Rule Says It Does
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.
This is the rule's own summary, as the Federal Register prints it.
The Orders It Names
- Executive Order 14267: Reducing Anti-Competitive Regulatory Barriers
- Executive Order 14300: Ordering the Reform of the Nuclear Regulatory Commission
The rule names these orders itself. What it does about them is a reading, and none is recorded here.
On the Face of the Rule
- As filed
[Federal Register Volume 91, Number 191 (Monday, October 5, 2026)] [Rules and Regulations] [Pages 63133-63146] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2026-20336]
Rules and Regulations
Federal Register
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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.
- 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 If this direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register.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: [email protected]. 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 [email protected]. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.
NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to [email protected] or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time, Monday through Friday, except Federal holidays.
- FOR FURTHER INFORMATION CONTACT
Denise Edwards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415- 7204, email: [email protected].
The fields the Federal Register prints at the head of the rule, quoted as printed. Its summary is quoted above.
Why the Agency Says It Is Doing This
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
The passage that opens the rule's preamble, where the agency sets out what it is doing and on what authority. Every heading that follows it is listed below.
What the Rule Contains
Every heading the Federal Register prints in this rule, in the order it prints them. 46 headings, 11,963 words in all.
- AGENCYOn its face · 4 words
- ACTIONOn its face · 4 words
- SUMMARYOn its face · 70 words
- DATESOn its face · 77 words
- ADDRESSESOn its face · 207 words
- FOR FURTHER INFORMATION CONTACTOn its face · 19 words
- SUPPLEMENTARY INFORMATIONPreamble · 2 words
- Table of ContentsPreamble · 3 words
- I. Obtaining Information and Submitting CommentsPreamble · 154 words
- I. Obtaining Information and Submitting CommentsPreamble · 6 words
- A. Obtaining InformationPreamble · 183 words
- B. Submitting CommentsPreamble · 159 words
- II. Executive Order 14300: Ordering the Reform of the Nuclear Regulatory CommissionPreamble · 112 words
- III. Rulemaking ProcedurePreamble · 297 words
- IV. BackgroundPreamble · 619 words
- V. DiscussionPreamble · 310 words
- A. Expanding Exemptions for Byproduct MaterialPreamble · 625 words
- B. Expanding Exemptions for Department of Energy (DOE) ContractorsPreamble · 621 words
- VI. Regulatory Flexibility AnalysisPreamble · 394 words
- VII. Regulatory AnalysisPreamble · 133 words
- A. Need for the RulePreamble · 302 words
- B. Analytical FrameworkPreamble · 939 words
- C. Estimated Costs and Savings of the Direct Final RulePreamble · 1,155 words
- 3. Summary of Costs, Cost Savings, and Net Cost SavingsPreamble · 497 words
- VIII. Backfitting and Issue FinalityPreamble · 87 words
- IX. Plain WritingPreamble · 57 words
- X. National Environmental Policy ActPreamble · 5 words
- A. IntroductionPreamble · 145 words
- B. Rule Amendments Requiring Environmental AssessmentPreamble · 796 words
- C. Environmental Impacts of the Agency ActionPreamble · 117 words
- D. Environmental Impacts of the Alternative to the Agency ActionPreamble · 151 words
- E. Finding of No Significant ImpactPreamble · 158 words
- F. ReferencesPreamble · 112 words
- XI. Paperwork Reduction ActPreamble · 51 words
- Public Protection NotificationPreamble · 38 words
- XII. Executive OrdersPreamble · 17 words
- A. Executive Order 12866: Regulatory Planning and Review (as Amended by Executive Order 14215, Ensuring Accountability for All Agencies)Preamble · 93 words
- B. Executive Order 14192: Unleashing Prosperity Through DeregulationPreamble · 43 words
- C. Executive Order 14267: Reducing Anti-Competitive Regulatory BarriersPreamble · 62 words
- XIII. Congressional Review ActPreamble · 40 words
- XIV. Coordination With NRC Agreement StatesPreamble · 120 words
- XV. Compatibility of Agreement State RegulationsPreamble · 254 words
- XVI. Voluntary Consensus StandardsPreamble · 78 words
- XVII. Availability of GuidancePreamble · 48 words
- XVIII. Availability of DocumentsPreamble · 290 words
- List of SubjectsRegulatory text · 2,204 words
The Rest of the Text
The preamble and the amendments to the Code of Federal Regulations, under the headings the rule prints. 37 headings, 11,318 words.
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 [email protected]. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.
NRC's PDR: The 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 [email protected] or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time, Monday through Friday, except Federal holidays.
B. Submitting Comments
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 Sec. 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 Sec. Sec. 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 Sec. Sec. 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 Sec. 30.71 (cadmium-109, iridium-192, and zirconium-93) have lower values (1 [micro]Ci, 37 kilobecquerel) in appendix C to 10 CFR part 20 than currently contained in 10 CFR 30.71 (10 [micro]Ci). 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 Sec. 30.71 is 0.1 [micro]Ci, which is equal to the smallest exempt quantity listed. Since the smallest quantity in appendix C to 10 CFR part 20 is 0.001 [micro]Ci and the quantity for any radionuclide other than alpha emitting radionuclides not listed in appendix C to 10 CFR part 20 is 0.01 [micro]Ci, radionuclides not listed in Sec. 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 [micro]Ci. 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 [micro]Ci.
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 Sec. Sec. 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 Sec. Sec. 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 Sec. 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 Sec. Sec. 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 Sec. 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 Sec. Sec. 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 Sec. 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]
Fully
Hourly loaded
Standard occupational Position title Weighting mean NRC loaded hourly
classification (%) wage multipliers 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 33 40.25 2.4 32.20
Specialists and Technicians. 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 33 37.24 2.4 29.79
Specialists and Technicians. 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 Sec. 30.71 (Schedule B) to align with appendix C to 10 CFR part 20, as well as exemptions for DOE contractors under Sec. Sec. 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 Sec. 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 Sec. 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 Sec. 32.18 remain unchanged.
By aligning Sec. 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]
Reduction in
number of Burden hours Total burden Fully loaded Annual cost
Entity exemption per request hours reduced wage rate savings
requests
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 $3.9 million using a 7 percent discount rate.
Table 3--Total 5-Year Cost Savings
[NRC, agreement states and licensees]
Cost of
exemption Cost of Cost savings
Year requests with exemption due to this 3% NPV ($) 7% NPV ($)
existing requests with rule ($)
regulations this final rule
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 Sec. Sec. 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]
Reduction in
number of Burden hours Total burden Fully loaded Annual cost
Entity exemption per request hours reduced wage rate savings
requests
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 $1.1 million using a 7 percent discount rate. NRC and industry stakeholders may incur minimal implementation costs associated with eliminating the exemption process and updating internal procedures. These costs are expected to be minimal and have not been quantified.
Table 5--Total 5-Year Cost Savings
[DOE contractors, NRC, agreement states and licensees]
Cost of
exemption Cost of Cost savings
Year requests with exemption due to this 3% NPV ($) 7% NPV ($)
existing requests with rule ($)
regulations($) this final rule
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 Sec. 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 Sec. Sec. 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 Sec. 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 Sec. 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
Basis for no significant environmental
Rule amendments 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 appendix C to 10 CFR part
20, except for cadmium-109, iridium-192,
and zirconium-93, for which current
exempt quantities are retained.
Retention of current quantities for
these radionuclides avoids creating a
requirement for a specific license where
one is not currently required. The
amendment also adds a provision stating
that the exempt quantity limit for any
byproduct material other than alpha
emitting radionuclides is 0.1
microcuries. This eliminates the need
for specific licenses for very small
quantities of certain radionuclides that
would not be harmful. Licensing
requirements for possession of exempt
quantities do not include any changes
for manufacturers or distributors.
Distribution requirements under 10 CFR
32.18 remain unchanged. The NRC has
reviewed updated scientific and safety
information, as discussed in the rule
preamble, and determined that higher
exempt quantity and activity limits for
certain radionuclides continue to
provide reasonable assurance of adequate
protection of public health and safety
and would not result in any physical
changes in the environment. Therefore,
the NRC has determined that the
rulemaking action results in no
significant environmental effects. 30.12; 40.11; 70.11.......... Based on licensing experience, NRC staff
identified byproduct, source, and
special nuclear material regulations
granting exemptions to DOE contractors
as an area for regulatory improvement.
This direct final rule updates Sec. Sec.
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
current regulations, DOE contractors
must request on a case-by-case basis
exemptions for these activities when
performed in NRC and Agreement State
jurisdictions. The amendments 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 by eliminating
repeated reviews of training activities
that have already demonstrated a
consistent safety record, while
maintaining oversight and public
protection.
In addition, 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,
providing continued public health and
safety protection and security controls.
The NRC reviewed years of past
approvals, as discussed in the rule
preamble, and determined that a standing
exemption for temporary training
activities involving law enforcement
emergency response and similar
personnel, provided the radioactive
materials used fall below the specified
quantity limits, has a low safety risk
and continues to provide reasonable
assurance of adequate protection of
public health and safety and would not
result in any physical changes in the
environment. Therefore, the NRC has
determined that the rulemaking action
will result in no significant
environmental effects.
The rule amendments listed in Table B-1 would modernize existing NRC byproduct, source, and special nuclear material 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 temporary DOE contractor training activities while ensuring these regulations continue to be safe, effective, and efficient and continue to provide reasonable assurance of adequate protection of public health and safety and the environment. As noted in Table B-1, the amendments consist of administrative and procedural changes for license exemptions and do not authorize any site-specific action on the part of the NRC or licensee and would have no significantly different environmental effects than those from the current regulatory framework.
C. Environmental Impacts of the Agency Action
Implementation of the direct final rule would result in no physical changes to the environment, and, therefore, the NRC has determined that this agency action does not have a significant effect on the quality of the human environment. The rule amendments are administrative in application, maintain ample margins of safety for public exposure, and would provide an equivalent level of safety and security as current NRC regulations.
Since no physical changes would occur in the human environment, the agency action (direct final rule) would not affect any threatened or endangered species or historic properties. Accordingly, the NRC finds that implementing the direct final rule would have no significant environmental impact.
D. Environmental Impacts of the Alternative to the Agency Action
Under the no-action alternative (i.e., the status quo), NRC regulations would remain unchanged. As explained in section B, the direct final rule does not have a significant effect on the quality of the human environment. Therefore, the no action alternative and the agency action (direct final rule) would have the same environmental effect, although there would be costs attributable to reviewing the environmental effects of exemption requests under the no action alternative. Licensees would continue to comply with existing NRC regulations or request regulatory relief (exemption) from the regulations. The NRC would continue to evaluate the environmental effects of exemption requests. The averted costs (benefits) of the rulemaking would not occur. The Regulatory Analysis for the direct final rule in Section VII provides information about the costs and benefits of the no action alternative and the agency action (direct final rule).
E. Finding of No Significant Impact
The NRC has prepared this EA to determine the environmental effects of the agency action (direct final rule). As explained in the EA, the NRC has determined the direct final rule does not change radiation protection and emergency preparedness requirements or overall risk, continues to provide reasonable assurance of adequate protection of public health and safety, and results in no new or different environmental effects. Therefore, the
NRC concludes that these regulatory changes do not have a significant effect on the quality of the human environment. Based on this conclusion, the NRC has determined there is no need to prepare an environmental impact statement. Accordingly, the NRC finds the agency action to amend its regulations to expand which radionuclides are exempt from needing a specific license, update the quantity thresholds for certain radionuclides exempt from a specific license, and to expand exemptions for certain DOE contractor activities has no significant environmental impact.
F. References
10 CFR Part 30. Code of Federal Regulations, Chapter I, Title 10, Energy, Part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material.”
10 CFR Part 40. Code of Federal Regulations, Chapter I, Title 10, Energy, Part 40, “Domestic Licensing of Source Material.”
10 CFR Part 70. Code of Federal Regulations, Chapter I, Title 10, Energy, Part 70, “Domestic Licensing of Special Nuclear Material.”
Endangered Species Act of 1973, as amended. Pub. L. 93-205, 87 Stat. 884 (1973).
National Environmental Policy Act of 1969, as amended. Pub. L. 91-190, 83 Stat. 852 (1969).
National Historic Preservation Act of 1966, as amended. Pub. L. 89-665, 80 Stat. 915 (1966).
XI. Paperwork Reduction Act
This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing collections of information were approved by the Office of Management and Budget, approval numbers 3150- 0017, 3150-0020, and 3150-0009.
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
The following are Executive orders (E.O.) that are related to this direct final rule:
A. Executive Order 12866: Regulatory Planning and Review (as Amended by Executive Order 14215, Ensuring Accountability for All Agencies)
The Office of Information and Regulatory Affairs (OIRA) has determined that this direct final rule is a significant regulatory action under section 3(f) of E.O. 12866, though not economically significant under section 3(f)(1). Accordingly, the NRC submitted this direct final rule to OIRA for review. The 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.”
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
This action is determined to be a deregulatory action as defined by E.O. 14192. Details on the estimated costs of this direct final rule can be found in Section VII of this document, “Regulatory Analysis.”
C. Executive Order 14267: Reducing Anti-Competitive Regulatory Barriers
E.O. 14267 requires the NRC to identify anti-competitive regulations for rescission or modification. The NRC identified Sec. 30.71 because of section 3(a)(iv) of the Executive order. The modification of the regulation supports the objectives of E.O. 14267 by removing regulatory requirements that could create or facilitate licensure or accreditation requirements that unduly limit competition.
XIII. Congressional Review Act
This final rule is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has found that it does not meet the criteria at 5 U.S.C. 804(2).
XIV. Coordination With NRC Agreement States
On September 3, 2025, the NRC held a government-to-government meeting with the Agreement States regarding E.O. 14300, “Ordering the Reform of the Nuclear Regulatory Commission.” In this meeting, the NRC presented its goals and objectives for future rulemakings, including this rule, to be done in response to the E.O. At the time of the meeting, the rule text was not available. Additionally, throughout the development of the rule, the NRC interacted with Agreement State representatives to hear their perspectives on the rule where early rule language was shared. On February 5, 2026, the NRC met with certain Agreement State representatives to discuss the rule text and to resolve the compatibility of Agreement State regulations.
XV. Compatibility of Agreement State Regulations
On the basis of 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 can be placed into six categories (A, B, C, D, NRC, or health and safety (H&S)) to form the basis for evaluating and classifying the program elements. Under the Policy Statement, a program element means any component or function of a radiation control regulatory program, including regulations and other legally binding requirements imposed on regulated persons, which contributes to implementation of that program. This rule only modifies regulations that are of Compatibility Category B.
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. For Compatibility Category B, the Agreement State program element shall be essentially identical to that of NRC.
The rule is a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among Agreement State and NRC requirements. The compatibility (A, B, C, D, and NRC) and adequacy (H&S) categories are designated in the following table:
Adequacy and Compatibility Table
Adequacy or compatibility
Section Change Subject ---------------------------------
Existing New
30.12........................... Amend.............. Byproduct material B B
exempt persons under
DOE contract. 30.71........................... Amend.............. Byproduct material B B
exempt limits.
40.11........................... Amend.............. Source material exempt B B
persons under DOE
contract. 70.11........................... Amend.............. Special Nuclear B B
Material exempt
persons under DOE
contract.
XVI. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise regulations exempting users from regulatory requirements. This action does not constitute the establishment of a standard that contains generally applicable requirements.
XVII. Availability of Guidance
The NRC will not be issuing guidance for this rulemaking. The NRC and Agreement States do not license exempt users of byproduct, source, and special nuclear material. This rule only amends regulations for such exemptions; therefore there is no applicable guidance for this rulemaking.
XVIII. Availability of Documents
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
ADAMS accession No./web
Document link/Federal Register
citation
Related Documents
Requirements for Expanded Definition of 72 FR 55864.
Byproduct Material, Final Rule, October 1,
2007. Standards for Protection Against Radiation, 56 FR 23360.
Final Rule, May 21, 1991. NUREG-1717, “Systematic Radiological ML011980433 (package).
Assessment of Exemptions for Source and
Byproduct Materials,” June 2001. Letter from Catherine A. Ribaudo, National ML20353A268 (package).
Institutes of Health, December 15, 2020. Licensing Requirements, Exemptions for 29 FR 14401.
Certain AEC Contractors, Final Rule,
October 20, 1964. Licensing of Byproduct Material, Final 21 FR 213.
Rule; January 11, 1956. Radioisotope Distribution, Final Rule, 16 FR 3251.
April 13, 1951. Agreement State Program Policy Statement, 82 FR 48535.
October 18, 2017. Presidential Memorandum, “Plain Language 63 FR 31885.
in Government Writing,” June 10, 1998. NRC Regulatory Analysis, Public Website.... https://www.nrc.gov/about-nrc/regulatory/rulemaking/regulatory-analysis.
Executive Orders
Executive Order 12866, “Regulatory 58 FR 51735.
Planning and Review,” October 4, 1993. Executive Order 14192, “Unleashing 90 FR 9065.
Prosperity Through Deregulation,”
February 6, 2025. Executive Order 14215, “Ensuring 90 FR 10447.
Accountability for All Agencies,”
February 24, 2025. Executive Order 14300, “Ordering the 90 FR 22587.
Reform of the Nuclear Regulatory
Commission,” May 29, 2025.
The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2025-1568. 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-2025-1568); (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, Intergovernmental relations, Isotopes, Nuclear energy, Nuclear materials, Penalties, Radiation protection, Reporting and recordkeeping requirements, Whistleblowing.
10 CFR Part 40
Criminal penalties, Exports, Government contracts, Hazardous materials transportation, Hazardous waste, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Source material, Uranium, Whistleblowing.
10 CFR Part 70
Classified information, Criminal penalties, Emergency medical services, Hazardous materials transportation, Material control and accounting, Nuclear energy, Nuclear materials, Packaging and containers, Penalties, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment, Security measures, Special nuclear material, Whistleblowing.
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 adopts the following amendments to 10 CFR parts 20, 30, 40, and 70:
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
0
1. The authority citation for part 20 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 53, 63, 65, 81, 103, 104, 161, 170H, 182, 186, 223, 234, 274, 1701 (42 U.S.C. 2014, 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2210h, 2232, 2236, 2273, 2282, 2021, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); Low-Level Radioactive Waste Policy Amendments Act of 1985, sec. 2 (42 U.S.C. 2021b); 44 U.S.C. 3504 note.
0
2. Amend appendix C to part 20 by adding footnote 2 to the heading and the corresponding footnote entry at the end of the appendix to read as follows:
Appendix C to Part 20--Quantities\1\ \2\ of Licensed Material Requiring
Labeling
Radionuclide.............................. Quantity ([micro]Ci).
* * * * *
\1\ The quantities listed above were derived by taking 1/10th of the
most restrictive ALI listed in table 1, columns 1 and 2, of appendix B
to Sec. Sec. 20.1001-20.2401 of this part, rounding to the nearest
factor of 10, and arbitrarily constraining the values listed between
0.001 and 1,000 [micro]Ci. Values of 100 [micro]Ci have been assigned
for radionuclides having a radioactive half-life in excess of 10\9\
years (except rhenium, 1000 [micro]Ci) to take into account their low
specific activity. \2\ The quantities listed in this table are also used in 10 CFR part 30
to define quantities exempt from licensing.
* * * * *
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL
0
3. The authority citation for part 30 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 81, 161, 181, 182, 183, 184, 186, 187, 223, 234, 274 (42 U.S.C. 2014, 2111, 2201, 2231, 2232, 2233, 2234, 2236, 2237, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); 44 U.S.C. 3504 note.
0 4. Revise Sec. 30.12 to read as follows:
Sec. 30.12 Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts.
(a) Except to the extent that Department facilities or activities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974 are involved, any prime contractor of the Department is exempt from the requirements for a license set forth in sections 81 and 82 of the Act and from the regulations in this part to the extent that such contractor, under his prime contract with the Department manufactures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material for:
(1) The performance of work for the Department at a United States Government-owned or controlled site, including the transportation of byproduct material to or from such site and the performance of contract services during temporary interruptions of such transportation;
(2) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or
(3) The use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel.
(b)(1) In addition to the foregoing exemptions and subject to the requirement for licensing of Department facilities and activities pursuant to section 202 of the Energy Reorganization Act of 1974, any prime contractor or subcontractor of the Department or the Commission is exempt from the requirements for a license set forth in sections 81 and 82 of the Act and from the regulations in this part to the extent that such prime contractor or subcontractor manufacturers, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material under his prime contract or subcontract when:
(i) The Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and
(ii) Under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.
(2) A Department or Commission prime contractor or subcontractor does not need to obtain the Commission approval described in paragraph (b)(1) of this section where:
(i) The prime contractor or subcontractor is performing temporary activities involving the training of law enforcement, emergency response, or other similar personnel;
(ii) The contract specifies the applicable leak testing, operating, emergency, and security procedures consistent with any 10 CFR part 37 requirements that the contractor or subcontractor is to follow during the temporary activities; and
(iii) The byproduct material is less than the following quantities:
(A) Category 2 sealed sources listed in table 1 of appendix A to 10 CFR part 37, excluding Ir-192.
(B) Sealed sources containing Ir-192: 150 Ci.
(C) Sealed sources not listed in table 1 of appendix A to 10 CFR part 37: 20 millicuries per source and 100 millicuries aggregate.
(D) Unsealed sources: with a half-life less than or equal to 8 hours: 50 millicuries.
(E) Unsealed sources with a half-life less than or equal to 2 weeks: 5 millicuries.
0 5. Revise Sec. 30.71 to read as follows:
Sec. 30.71 Schedule B.
(a) Except as provided in paragraph (b) of this section, appendix C to part 20 of this chapter will be used as Schedule B for byproduct materials.
(b) The following specified quantities of byproduct material will be used in place of those in appendix C to part 20 of this chapter:
(1) Cadmium-109: 10 microcuries;
(2) Iridium-192: 10 microcuries;
(3) Zirconium-93: 10 microcuries; and
(4) Any byproduct material other than alpha emitting byproduct material for which the quantity in appendix C to part 20 of this chapter is less than this amount: 0.1 microcuries.
PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL
0 6. The authority citation for part 40 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 62, 63, 64, 65, 69, 81, 83, 84, 122, 161, 181, 182, 183, 184, 186, 187, 193, 223, 234, 274, 275 (42 U.S.C. 2092, 2093, 2094, 2095, 2099, 2111, 2113, 2114, 2152, 2201, 2231, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2022); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Uranium Mill Tailings Radiation Control Act of 1978, sec. 104 (42 U.S.C. 7914); 44 U.S.C. 3504 note.
0 7. Revise Sec. 40.11 to read as follows:
Sec. 40.11 Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts.
(a) Except to the extent that Department facilities or activities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974 or the Uranium Mill Tailings Radiation Control Act of 1978 are involved, any prime contractor of the Department is exempt from the requirements for a license set forth in sections 62, 63, and 64 of the Act and from the regulations in this part to the extent that such
contractor, under his prime contract with the Department, receives, possesses, uses, transfers or delivers source material for:
(1) The performance of work for the Department at a United States Government-owned or controlled site, including the transportation of source material to or from such site and the performance of contract services during temporary interruptions of such transportation;
(2) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or
(3) The use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel.
(b)(1) In addition to the foregoing exemptions, and subject to the requirement for licensing of Department facilities and activities pursuant to section 202 of the Energy Reorganization Act of 1974 or the Uranium Mill Tailings Radiation Control Act of 1978, any prime contractor or subcontractor of the Department or the Commission is exempt from the requirements for a license set forth in sections 62, 63, and 64 of the Act and from the regulations in this part to the extent that such prime contractor or subcontractor receives, possesses, uses, transfers or delivers source material under his prime contract or subcontract when:
(i) The Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and
(ii) Under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.
(2) A Department or Commission prime contractor or subcontractor does not need to obtain the Commission approval described in paragraph (b)(1) of this section where:
(i) The prime contractor or subcontractor is performing temporary activities involving the training of law enforcement, emergency response, or other similar personnel;
(ii) The contract specifies the applicable leak testing, operating, emergency, and security procedures that the contractor or subcontractor is to follow during the temporary activities; and
(iii) The source material does not exceed the following aggregate quantities:
(A) Sealed sources: 100 millicuries.
(B) Unsealed sources: 10 millicuries.
PART 70--DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL
0 8. The authority citation for part 70 is revised to read as follows:
Authority: Atomic Energy Act of 1954, secs. 51, 53, 57(d), 108, 122, 161, 182, 183, 184, 186, 187, 193, 223, 234, 274, 1701 (42 U.S.C. 2071, 2073, 2077(d), 2138, 2152, 2201, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2297f); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.
0 9. Revise Sec. 70.11 to read as follows:
Sec. 70.11 Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts.
(a) Except to the extent that Department facilities or activities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974 are involved, any prime contractor of the Department is exempt from the requirements for a license set forth in section 53 of the Act and from the regulations in this part to the extent that such contractor, under his prime contract with the Department receives title to, owns, acquires, delivers, receives, possesses, uses, or transfers special nuclear material for:
(1) The performance of work for the Department at a United States Government-owned or controlled site, including the transportation of special nuclear material to or from such site and the performance of contract services during temporary interruptions of such transportation;
(2) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or
(3) The use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel.
(b)(1) In addition to the foregoing exemptions, and subject to the requirement for licensing of Department facilities and activities pursuant to section 202 of the Energy Reorganization Act of 1974, any prime contractor or subcontractor of the Department or the Commission is exempt from the requirements for a license set forth in section 53 of the Act and from the regulations in this part to the extent that such prime contractor or subcontractor receives title to, owns, acquires, delivers, receives, possesses, uses, or transfers special nuclear material under his prime contract or subcontract when:
(i) The Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and
(ii) Under the terms of the contract or subcontract there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.
(2) A Department or Commission prime contractor or subcontractor does not need to obtain the Commission approval described in paragraph (b)(1) of this section where:
(i) The prime contractor or subcontractor is performing temporary activities involving the training of law enforcement, emergency response, or other similar personnel;
(ii) The contract specifies the applicable leak testing, operating, emergency, and security procedures that the contractor or subcontractor is to follow during the temporary activities; and
(iii) The special nuclear material consists exclusively of sealed sources in an aggregate quantity that does not exceed one one-millionth of special nuclear material of low strategic significance.
Dated: October 1, 2026.
For the Nuclear Regulatory Commission. Jody Martin, Secretary of the Commission. [FR Doc. 2026-20336 Filed 10-2-26; 8:45 am] BILLING CODE 7590-01-P
- The rule itself
Nuclear Regulatory Commission, “Exemptions From Materials Licensing,” 91 FR 63133 (October 5, 2026). Effective December 21, 2026.
https://www.federalregister.gov/documents/2026/10/05/2026-20336/exemptions-from-materials-licensing - This page
“Exemptions From Materials Licensing,” a final rule naming an order indexed here. Read the Mandate, https://readthemandate.org/rules/rule-2026-20336/ (retrieved October 3, 2026).
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