Natural Resources Conservation Service
International Trade Administration
National Oceanic and Atmospheric Administration
Engineers Corps
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Transportation Security Administration
U.S. Customs and Border Protection
Land Management Bureau
Drug Enforcement Administration
Occupational Safety and Health Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Nuclear Regulatory Commission.
Final amended state agreement.
This notification is announcing that on April 20, 2026, Ho K. Nieh, Chairman of the U.S. Nuclear Regulatory Commission (NRC or Commission), and on April 21, 2026, Governor Mark Gordon of the State of Wyoming, signed an amended Agreement as authorized by Section 274b. of the Atomic Energy Act of 1954, as amended (AEA). Under the amended Agreement, the Commission discontinues its regulatory authority, and the State of Wyoming assumes regulatory authority over source material recovered from any mineral resources processed primarily for purposes other than its uranium or thorium content. Wyoming's initial Agreement allowed the State to assume regulatory authority over byproduct material as defined in section 11e.(2) of the AEA, and source material involved in the extraction or concentration of uranium or thorium in source material and ores at milling facilities.
The effective date of the amended Agreement is April 30, 2026.
Please refer to Docket ID NRC-2025-2062 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
•
•
•
Allyce Bolger, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-0855; email:
The NRC published the proposed amended Agreement in the
After considering the request for an amended Agreement by the Governor of Wyoming, the supporting documentation submitted with the request for an amended Agreement, and its interactions with the staff of the Wyoming Department of Environmental Quality, the NRC staff completed an assessment of Wyoming's proposed program. The agency made a copy of the staff assessment available in the NRC's PDR and electronically on the NRC's website. Based on the staff's assessment, the Commission determined on April 15, 2026, that the Wyoming program for control of radiation hazards is adequate to protect the public health and safety and compatible with the Commission's program. As of the effective date of the amended Agreement, a person in Wyoming possessing these materials is exempt from certain Commission regulations. The exemptions have been previously published in the FR and are codified in the Commission's regulations. The Agreement is published here as required by Section 274e. of the Act.
This Agreement is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). The Office of Management and Budget has found that this action does not meet the criteria at 5 U.S.C. 804(2). The Office of Information and Regulatory Affairs has determined that this amended Agreement is not a significant regulatory action under Executive Order 12866.
The ADAMS Accession numbers for the request for an amended Agreement by the Governor of Wyoming, including all information and documentation submitted in support of the request, and the NRC staff assessment are identified in the following table.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies the Class E airspace extending upward from 700 feet above the surface at Nenana Municipal Airport, Nenana, AK, to accommodate revisions to the airport's instrument approach procedures (IAP). This action supports the safety and management of instrument flight rules (IFR) operations at the airport.
Effective date 0901 UTC, July 9, 2026. The Director of the
A copy of the notice of proposed rulemaking (NPRM), all comments received, this final rule, and all background material may be viewed online at
FAA Order JO 7400.11K, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Nathan A. Chaffman, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3460.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies Class E airspace to support IFR operations at Nenana Municipal Airport, Nenana, AK.
The FAA published an NPRM for Docket No. FAA-2026-1131 in the
Class E5 airspace designations are published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11K, dated August 4, 2025, and effective September 15, 2025. These amendments will be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11K, which lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points, is publicly available as listed in the
The FAA is amending 14 CFR part 71 by modifying the Class E airspace extending upward from 700 feet above the surface at Nenana Municipal Airport, Nenana, AK.
The Area Navigation (RNAV) (Global Positioning System [GPS]) Runway (RWY) 4 Left (L) and Non-directional Beacon (NDB) RWY 4L IAPs were revised, rendering the airport's Class E airspace excessive. The airspace footprint is reduced to more appropriately contain the procedures.
The centralized radius of the airspace is reduced to 4.2 miles and the northern portion is removed, as circling is not authorized northwest of the airport and airspace containment is not necessary beyond 4.2 miles south of the airport. The eastern portion of Nenana's Class E airspace is reduced to be a rectangular extension that will more appropriately contain arriving IFR aircraft conducting the missed approach portions of the
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Order 2100.6B, “Rulemaking and Guidance Procedure” (March 10, 2025); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1G, “FAA National Environmental Policy Act Implementing Procedures,” Appendix B, paragraph B-2.5. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p.389.
That airspace extending upward from 700 feet above the surface within 2.5 miles north and 2.3 miles south of the airport's 069° bearing extending to 5.8 miles east, within a 4.2-mile radius of the airport between its 100° bearing clockwise to its 240° bearing, and within 2.5 miles north and 2.9 miles south of the airport's 249° bearing extending to 7.2 miles west.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the phototherapy device for reducing the appearance of acute post-surgical incisions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the phototherapy device for reducing the appearance of acute post-surgical incisions. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
This order is effective May 1, 2026. The classification was applicable on December 3, 2021.
Yan Fu, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-6278,
Upon request, FDA (the Agency or we) has classified the phototherapy device for reducing the appearance of acute post-surgical incisions into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug
Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.
On February 4, 2020, FDA received Klox Technologies Inc.'s request for De Novo classification of the Klox Biophotonic LumiHeal System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on December 3, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 878.4880.
FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for phototherapy devices for reducing the appearance of acute post-surgical incisions. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include the following:
(i) Verification and validation testing of the spectrum and power intensity of the light source;
(ii) Heat dissipation from the area following device application; and
(iii) Biophotonic properties of the photoconverter gel, including radiant fluence (transmitted light and fluorescence) delivered through the photoconverter gel by the device.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must evaluate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the photoconverter gel by demonstrating continued sterility and functional performance over the identified shelf life.
(5) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device in the intended use environment.
(6) Software verification, validation, and hazard analysis must be performed for any software components.
(7) Labeling must include the following:
(i) A summary of the device technical specifications, including light wavelength, irradiance, and application area;
(ii) Warnings for ensuring eye safety, including use of protective eyeglasses used for both the operator and the patient; and
(iii) A shelf life for the photoconverter gel.
Drug Enforcement Administration, Department of Justice.
Final rule.
With the issuance of this final rule, the Drug Enforcement Administration places methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA),
Dr. Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.
In this final rule, the Drug Enforcement Administration (DEA) permanently places the following four substances in schedule I of the Controlled Substances Act (CSA), including their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
• methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA),
•
• ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate (other names: 5F-EDMB-PICA; 5F-EDMB-2201), and,
• methyl 2-(1-(4-fluorobenzyl)-1
Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as delegated to the Administrator of the DEA pursuant to 28 CFR 0.100) may, by rule, and upon the recommendation of the Secretary of Health and Human Services, add to such a schedule or transfer between such schedules any drug or other substance, if she finds that such drug or other substance has a potential for abuse, and makes with respect to such drug or other substance the findings prescribed by 21 U.S.C.
The neurochemical effects of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA occur primarily through cannabinoid receptor systems in the brain. 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA bind to cannabinoid subtype 1 (CB1) receptors, function as full agonists, and have a binding affinity and functional activity profile that is similar to that of other schedule I cannabinoids, including Δ9-THC, JWH-018, XLR11, and AKB-48.
DEA published an order in the
In a letter dated December 3, 2025, in accordance with 21 U.S.C. 811(b), and in response to DEA's April 15, 2025 request, the Department of Health and Human Services (HHS) provided to DEA a scientific and medical evaluation and scheduling recommendation for 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. DEA reviewed the scientific and medical evaluation and scheduling recommendation for schedule I placement provided by HHS, and all other relevant data, pursuant to 21 U.S.C. 811(b) and (c), and conducted its own analysis under the eight factors stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C. 811(b)(1), that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA warrant control in schedule I. Both DEA and HHS's Eight-Factor Analyses are available in their entirety under the tab Supporting Documents of the public docket for this action at
On December 10, 2025, the DEA Administrator signed a notice of proposed rulemaking (NPRM) to permanently control 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA in schedule I.
DEA received one comment in response to the NPRM that was not related to the rulemaking for the placement of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA into schedule I of the CSA.
After consideration of the public comment, scientific and medical evaluation and accompanying scheduling recommendation from HHS, and after its own eight-factor evaluation, DEA finds that these facts and all relevant data constitute substantial evidence of potential for abuse of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. As such, DEA is permanently scheduling 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA as controlled substances under schedule I of the CSA.
The CSA establishes five schedules of controlled substances known as schedules I, II, II, IV, and V. The CSA also specifies the findings requires to place a drug or other substance in any particular schedule, 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the then Assistant Secretary for Health of HHS and review of all other available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b)(1), finds that:
(1) 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA have a high potential for abuse that is comparable to other scheduled synthetic cannabinoids, such as JWH-018, XLR11, and AKB-48. In vitro studies demonstrate that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA bind to CB1 receptors and function as full agonists. In drug discrimination studies conducted in animals to evaluate its discriminative stimulus effects, 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA were shown to fully substitute for the discriminative stimulus effects produced by delta 9-THC. The ingestion of 4F-MDMB-BUTICA, ADB-4en-PINACA, or 5F-EDMB-PICA has been documented to result in serious adverse effects, including poisonings and deaths. Based upon results from in vitro and in vivo studies, and its similarity to other schedule I synthetic cannabinoids, MMB-FUBICA in particular would be expected to cause similar serious adverse effects following its ingestion.
(2) 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA have no currently accepted medical use in treatment in the United States. In HHS's 2025 recommendation to control 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA, it was noted there are no approved New Drug Applications and no known therapeutic applications for these substances in the United States. DEA is not aware of any other evidence suggesting that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA have a currently accepted medical use in treatment in the United States.
(3) There is a lack of accepted safety for use of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA under medical supervision. Because 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA have no approved medical use and have not been investigated as new drugs, their safety for use under medical supervision has not been determined.
Based on these findings, the DEA Administrator concludes that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA, as well as their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, warrant control in schedule I of the CSA.
4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA are subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, import, export, engagement in research, conduct instructional activities or chemical analysis with, and possession of schedule I controlled substances, including the following:
Any person who currently handles 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA and is not registered with DEA to conduct research with a schedule I controlled substance must submit an application for registration and may not continue to handle 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA as of May 1, 2026, unless DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.
Notwithstanding the foregoing, pursuant to 21 U.S.C. 822(h), if, on May 1, 2026, a person is conducting research on 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA and is already registered to conduct research with another controlled substance in schedule I, the person may continue to conduct research on 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA if they submit a completed application for registration or modification of existing registration, as applicable, to conduct research with 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA not later than 90 calendar days after May 1, 2026. The person may continue to conduct such research until the person withdraws the application or the Administrator serves on the person an order to show cause proposing denial of the application pursuant to 21 U.S.C. 824(c) and in accordance with 21 CFR 1301.37. If the Administrator serves an order to show cause proposing denial of the application or modification, the person may not continue to conduct research with 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA and may not receive or otherwise obtain additional 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA. If an order to show cause is served and the person requests a hearing in accordance with 21 CFR 1301.37(d), the hearing shall be held in accordance with 21 CFR 1301.41-1301.46 on an expedited basis and not later than 45 calendar days after the request is made, except that the hearing may be held at a later time if so requested by the person. If the person sends a copy of the application to a manufacturer or distributor of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA, receipt of the copy by the manufacturer or distributor constitutes sufficient evidence that the person is authorized to receive 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA pursuant to 21 U.S.C. 822(h)(4). Continuation of research under 21 U.S.C. 822(h) does not authorize any other handling (
Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity in a manner not authorized by the CSA is unlawful and those in possession of any quantity may be subject to prosecution pursuant to the CSA.
Any person who registers with DEA must take an initial inventory of all stocks of controlled substances (including 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA) on hand every two years, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
In accordance with 21 U.S.C. 811(a), this final scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563. DEA scheduling actions are not subject to either E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Overcriminalization in Federal Regulations.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the states, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
This action does not impose a new collection or modify an existing collection of information under the Paperwork Reduction Act of 1995.
The Administrator of DEA, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-612, has reviewed this final rule, and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.
DEA is placing methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA),
Based on the review of HHS's scientific and medical evaluation and all other relevant data, DEA determined that 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. There appear to be no legitimate sources for 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA as marketed drugs in the United States, but DEA notes that this substance is available for purchase from legitimate suppliers for scientific research. There is no evidence of significant diversion of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA from legitimate suppliers. Therefore, this final rule will
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1532, DEA has determined that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year. . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.
This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this rule to both Houses of Congress and to the Comptroller General.
The Administrative Procedure Act (APA) generally requires that rules enacted in accordance with the procedures of 5 U.S.C. 553 to be effective not less than 30 days after publication of the proposed rule.
DEA finds that there is good cause for this scheduling action to be immediately effective upon publication because a delay in the effective date is unnecessary and contrary to the public interest. First, it is unnecessary because 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA are currently listed in schedule I of the CSA under 21 U.S.C. 811(h).
Administrative practice and procedure, Drug traffic control, Reporting and record keeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
The additions read as follows:
(d) * * *
This document of the Drug Enforcement Administration was signed on March 23, 2026, by DEA Administrator Terrance C. Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
Internal Revenue Service (IRS), Treasury.
Temporary regulations.
This document contains temporary regulations regarding the statutory provision providing for payments to taxpayers with respect to certain previously taxed dyed fuel. Specifically, these temporary
Concerning these temporary regulations, Danielle Mayfield or Andrew Clark of the Office of Associate Chief Counsel (Energy, Credits, and Excise Tax) at (202) 317-6855 (not a toll-free number).
This document contains amendments to the Manufacturers and Retailers Excise Tax Regulations (26 CFR part 48) under section 6435 of the Internal Revenue Code (Code) relating to the determination of payments regarding dyed diesel fuel or dyed kerosene with respect to which excise tax under section 4081 of the Code was paid (regulations). The regulations are issued under the authority granted by sections 6435(a), 6001, and 7805(a) of the Code.
Section 6435(a) requires that a person claiming a payment under section 6435 establish to the satisfaction of the Secretary of the Treasury or the Secretary's delegate (Secretary) that such person meets the requirements under section 6435(b).
Section 6001 authorizes the Secretary to prescribe regulations related to recordkeeping, statements, and returns.
Section 7805(a) authorizes the Secretary to prescribe all needful rules and regulations for the enforcement of the Code, including all rules and regulations as may be necessary by reason of any alteration of law in relation to internal revenue.
This document amends the Manufacturers and Retailers Excise Tax Regulations (26 CFR part 48) to add temporary regulations providing rules relating to claims for payment under section 6435 regarding previously taxed dyed fuel. For the reasons discussed in Part IV of this Background, the temporary regulations limit the claimants under section 6435 to taxpayers that paid to the IRS the prior fuel excise tax under section 4081 with respect to the dyed fuel.
In accordance with section 7805(e)(1), concurrent with the publication of this Treasury Decision, the Department of the Treasury (Treasury Department) and the IRS are publishing in the Proposed Rules section of this issue of the
Interested persons are directed to the
Section 4081(a) imposes an excise tax (section 4081 tax) on certain removals, entries, and sales of taxable fuel, including diesel fuel and kerosene. Section 4081(a)(2) prescribes the tax rate for the section 4081 tax. Section 4081(a)(2)(A)(iii) prescribes a general tax rate of 24.3 cents per gallon for diesel fuel or kerosene. In addition to that tax rate, section 4081(a)(2)(B) prescribes a tax rate of 0.1 cent per gallon, referred to as the Leaking Underground Storage Tank Trust Fund financing rate (LUST tax).
Under section 4082(a), diesel fuel and kerosene are exempt from the section 4081 tax if the fuel: (i) is destined for a nontaxable use (as defined in section 4082(b)); (ii) is indelibly dyed by mechanical injection in accordance with Treasury regulations; and (iii) meets any marking requirements prescribed in Treasury regulations. Section 4082(f)(1) provides that the exemption in section 4082(a) generally does not apply to the LUST tax.
Section 48.4082-1 and Notice 2005-80, 2005-2 C.B. 953, provide rules and conditions for the exemption provided by section 4082(a) to apply to the removal, entry, or sale of any diesel fuel or kerosene.
Section 70525(a) of Public Law 119-21, 139 Stat. 282 (July 4, 2025), commonly known as the One, Big, Beautiful Bill Act (OBBBA), added section 6435 to allow recovery of the amount of the section 4081 tax paid with respect to diesel fuel or kerosene that later qualifies as exempt from section 4081 tax under section 4082(a).
Section 6435 allows a person that establishes to the satisfaction of the Secretary that the person removed eligible indelibly dyed diesel fuel or kerosene (eligible dyed fuel) from a terminal to claim a payment (without interest) equal to the amount of the section 4081 tax previously paid with respect to such dyed fuel. Eligible dyed fuel is diesel fuel or kerosene: (i) with respect to which tax under section 4081 was previously paid (and not credited or refunded); and (ii) that is exempt from the section 4081 tax under section 4082(a).
Section 6430 provides that no refunds, credits, or payments shall be made under subchapter B of chapter 65 for any LUST tax imposed except with respect to fuels as otherwise provided by section 6430. Section 70525(b)(2) of the OBBBA amended section 6430 to except from the general rule fuels which are removed as eligible dyed fuel under section 6435. Therefore, payments under section 6435 may include the LUST tax.
Announcement 2026-1, 2026-4 I.R.B 402 (released December 22, 2025), requested that taxpayers hold any section 6435 claims until the Treasury Department and the IRS issue guidance related to section 6435 and the process for requesting a refund. The announcement explained that, although section 6435 is functionally similar to other rules providing for payments to taxpayers with respect to previously paid excise tax, section 6435 lacks a directive to treat the payments as if they constitute refunds of overpayments of the underlying tax.
These temporary regulations, and the cross-referenced proposed regulations, are the forthcoming guidance referenced in Announcement 2026-1.
These temporary regulations, § 48.6435-1T, provide rules to determine eligibility for a refund under section 6435 with respect to eligible dyed fuel (section 6435 refund) and rules for filing a claim for a section 6435 refund (section 6435 claim).
Section 48.6435-1T(b) provides definitions of terms used for purposes of section 6435 and § 48.6435-1T. Section 48.6435-1T(c) provides that a person that satisfies the requirements of paragraphs (d) through (g) of that section with respect to eligible dyed fuel may receive a payment under section 6435 that is a refund of an overpayment of the section 4081 tax previously paid. Section 48.6435-1T(d) provides conditions that must be satisfied for a section 6435 refund to be allowed to the person that paid the section 4081 tax and incorporates and clarifies the rules in section 6435(b). Section 48.6435-1T(e) provides reporting requirements taxpayers must satisfy to make a section 6435 claim. Section 48.6435-1T(f) provides rules regarding the form and content of a section 6435 claim. Section 48.6435-1T(g) provides the claim period for section 6435 refunds.
The terms defined in § 48.6435-1T(b) include “approved terminal,” “eligible dyed fuel,” and “section 6435 refund.” To maintain consistency with existing fuel excise tax regulations, the term “approved terminal” has the same meaning as in § 48.4081-1(b).
Section 48.6435-1T(c) provides that the payment under section 6435 of the amount equal to the section 4081 tax paid to the IRS is the refund (without interest) of an overpayment to the taxpayer that paid the section 4081 tax with respect to the eligible dyed fuel. Section 48.6435-1T(c) incorporates and clarifies the rules in section 6435(a). Section 48.6435-1T(d) makes clear that only a taxpayer that removes the eligible dyed fuel from a terminal and also previously paid the section 4081 tax with respect to that fuel can receive a refund described in § 48.6435-1T(c).
As explained below, to the extent the claimant previously paid the section 4081 tax, the payment described in section 6435 represents a refund of an overpayment. Under section 6402(a), “[i]n the case of any overpayment,” the IRS “may credit the amount of such overpayment . . . against any liability in respect of an Internal Revenue tax on the part of the person who made the overpayment and shall . . . refund any balance to such person.” For a taxpayer to receive a credit or refund, there must first be an overpayment. An overpayment is “any payment in excess of that which is properly due.”
Section 4081(a)(1)(A) generally imposes an excise tax on the removal of taxable fuel (defined in section 4083(a) to include diesel fuel and kerosene) from any refinery or terminal; the entry of taxable fuel into the United States for consumption, use, or warehousing; and the sale of taxable fuel to an unregistered person. In certain circumstances, diesel fuel or kerosene with respect to which tax has previously been imposed may be transported outside the bulk transfer/terminal system and later entered into a terminal that is part of the system. That fuel would also generally be subject to a second instance of the section 4081 tax upon removal from such terminal. In other words, the section 4081 tax may be imposed with respect to fuel more than once. Section 4081(e) and § 48.4081-7 provide a refund mechanism that allows the person that pays the second instance of section 4081 tax to claim a refund in the amount of the second tax paid (without interest). However, if the fuel removed from the terminal is destined for a nontaxable use and dyed pursuant to the provisions of section 4082(a), then the second removal is exempt from section 4081 tax. Section 4081(e) does not apply to such a removal because there is no second instance of section 4081 tax.
Prior to the enactment of section 6435, there was no mechanism allowing a taxpayer to claim a refund when dyed fuel removed from a terminal was previously taxed under section 4081. Section 6435(a) creates such a mechanism by providing for a payment in the amount of the section 4081 tax previously paid (and not credited or refunded) with respect to eligible dyed fuel. However, as explained in Part IV of the Background section, section 6435 does not include language deeming such a payment as a refund of an overpayment of tax and lacks a specific appropriation for section 6435 payments.
The Treasury Department and the IRS view the general appropriation for refunds of Internal Revenue collections in 31 U.S.C. 1324(b) as appropriating funding for section 6435 payments to the extent that the taxpayer claiming the section 6435 payment is the same taxpayer that paid the section 4081 tax with respect to the diesel fuel or kerosene. Accordingly, these regulations provide that if the same taxpayer that paid the section 4081 tax with respect to the diesel fuel or kerosene subsequently removes that fuel from an approved terminal as eligible dyed fuel, such taxpayer can seek a refund under section 6435 of the section 4081 tax it paid. Construing the payment described in section 6435(a) as a refund of an overpayment on the part of the same taxpayer that paid the section 4081 tax to the IRS with respect to the diesel fuel or kerosene is consistent with the Supreme Court's explanation of how to determine an overpayment in
These regulations are also consistent with section 6402(a)'s requirement that only “the person who made the overpayment” is entitled to receive a credit or refund of that overpayment. Reading section 6435 in conjunction with section 6402(a), section 6435(a) requires that the payment be made to the same taxpayer that paid the section 4081 tax with respect to diesel fuel or kerosene and later removes the fuel as dyed for nontaxable use. Thus, under these regulations, the taxpayer entitled to payment under section 6435 is “the person who made the overpayment.”
The rules in § 48.6435-1T(e) closely follow existing reporting requirements under § 48.4081-7(c) applicable to section 4081(e) claims with which taxpayers are already familiar. Under § 48.6435-1T(e)(1), a taxpayer must file a section 6435 taxpayer's report with its section 6435 refund claim. Section 48.6435-1T(e)(2) provides a model report. This model report differs in a few respects from the first taxpayer's report used for section 4081(e) claims as provided in § 48.4081-7(c)(2). The model report requires a taxpayer to declare that, except for the section 6435 claim to which the report relates, the taxpayer has not received, and will not claim, a credit with respect to, or a refund of, the tax with respect to the diesel fuel or kerosene to which the report relates. The model report also differs by identifying and revoking any prior first taxpayer report filed pursuant to § 48.4081-7(c) by the taxpayer with respect to the fuel that is the subject of the section 6435 taxpayer's report.
This approach is expected to reduce the burden on taxpayers. It also avoids duplicate reporting for many taxpayers that also file a first taxpayer's report with their Form 720,
Section 48.6435-1T(f)(1) provides that a taxpayer must submit a section 6435 claim on Form 8849,
Section 48.6435-1T(g) provides that the time for filing a section 6435 claim begins after the removal of the eligible dyed fuel and lasts until the end of the period prescribed by section 6511 of the Code for filing a refund claim for the section 4081 tax paid with respect to the fuel.
The temporary regulations under § 48.6435-1T apply to removals of eligible dyed fuel occurring on or after December 31, 2025.
Section 553(b)(B) of the Administrative Procedure Act (5 U.S.C. Subchapter II) provides that advance notice and the opportunity for public comment are not required with respect to a rulemaking when an “agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.”
The Treasury Department and the IRS find that good cause exists for making these temporary regulations immediately effective without notice and comment because failure to do so would be impracticable and contrary to the public interest.
Section 6435 became effective on December 31, 2025, less than six months after it was enacted as part of the OBBBA on July 4, 2025. In addition to the implementation of this new dyed fuel payment provision, the OBBBA contained sweeping changes to the tax code, with extensive modifications and additions to provisions administered by the IRS, necessitating guidance-drafting and administrative responsibilities across the organization. Given the legal complexity and administration challenges presented by section 6435, discussed below, it is critical to provide taxpayers and the IRS with certainty as soon as possible regarding the rules governing eligibility for, and the procedures for claiming, a payment under section 6435.
Section 6435 is a complex provision that presented interpretation challenges. Specifically, the OBBBA does not direct that these payments be treated as refunds of overpayments of tax, nor does it provide a specific appropriation for payments. Accordingly, the Treasury Department and the IRS were required to determine if and how section 6435 could be implemented consistent with both Congressional intent and the lack of a specific appropriation to make the payments contemplated by section 6435 and then develop appropriate procedures that taxpayers can easily follow to claim section 6435 payments.
As noted, section 6435 became effective on December 31, 2025, and taxpayers are seeking certainty as to whether and how to file claims. It is important to provide that certainty by the issuance of these temporary regulations so that taxpayers understand the procedures they need to follow in order for the IRS to be able to process claims under section 6435 and the limitations on the IRS's ability to pay those claims. In addition, given that these regulations limit the scope of eligible claimants under section 6435 to taxpayers that paid the underlying section 4081 tax, taxpayers also need certainty as soon as possible to enable them to structure their business arrangements in a manner that results in eligibility for the section 6435 payment.
The guidance in these regulations also preserves government resources by discouraging taxpayers from filing claims that the IRS lacks the legal authority to pay. Issuing this guidance quickly also protects the Federal fisc as a delay in guidance would increase the likelihood of unappropriated funds being disbursed.
Following notice-and-comment procedures would delay when taxpayers receive the certainty provided by the rules and procedures in these temporary
Because of the limited time to provide the requisite certainty to taxpayers and the IRS without unduly delaying the ability of eligible taxpayers to file claims that the IRS is authorized to pay, it was impracticable to conduct notice-and-comment procedures. The limited time available to prepare these regulations is an important factor in finding good cause.
Comments are being solicited in the cross-referenced notice of proposed rulemaking that is in the proposed rules section in this issue of the
These temporary regulations are not subject to review under section 6(b) of Executive Order 12866 pursuant to the Memorandum of Agreement (July 4, 2025) between the Treasury Department and the Office of Management and Budget (OMB) regarding review of tax regulations.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA) generally requires that a Federal agency obtain the approval of the Office of Management and Budget (OMB) before collecting information from the public, whether such collection of information is mandatory, voluntary, or required to obtain or retain a benefit. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the OMB.
These temporary regulations set forth intended collections of information to be provided to the IRS with Form 8849 and Schedule 5 (Form 8849).
The collections of information associated with these temporary regulations include reporting and recordkeeping requirements that are necessary to ensure that a taxpayer qualifies for a section 6435 refund. The collections will be used by the IRS for tax compliance purposes and by taxpayers to establish eligibility for a section 6435 refund.
The reporting requirements include reporting related to claiming a section 6435 refund, including the execution and filing of reports as detailed in § 48.6435-1T(e). The recordkeeping requirements include that a taxpayer keep records to establish its eligibility for and the amount of a section 6435 claim. The burden for these requirements is included with Form 8849 and its instructions and with Schedule 5 (Form 8849) and its instructions. These forms and form instructions are already approved under OMB control number 1545-1420.
Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any Internal Revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
For applicability of the Regulatory Flexibility Act, please refer to the cross-referenced notice of proposed rulemaking (REG-119294-25) published elsewhere in this issue of the
Pursuant to section 7805(f), these temporary regulations will be submitted to the Chief Counsel of Advocacy of the Small Business Administration for comment on their impact on small business.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Tribal government, in the aggregate, or by the private sector, of $100 million (updated annually for inflation). These temporary regulations do not include any Federal mandate that may result in expenditures by State, local, or Tribal governments, or by the private sector, in excess of that threshold.
Executive Order 13132 (Federalism) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. These temporary regulations do not have federalism implications and do not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.
Pursuant to the Congressional Review Act (5 U.S.C. 801
Guidance cited in this preamble is published in the Internal Revenue Bulletin and is available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at
The principal authors of these temporary regulations are Danielle Mayfield and Andrew Clark of the Office of Associate Chief Counsel (Energy, Credits, and Excise Tax). However, other personnel from the Treasury Department and the IRS participated in their development.
Excise taxes, Reporting and recordkeeping requirements.
Accordingly, the Treasury Department and the IRS amend 26 CFR part 48 as follows:
26 U.S.C. 7805 * * *
Section 48.6435-1T also issued under 26 U.S.C. 6435(a) and 6001.
(a)
(b)
(1)
(2)
(3)
(c)
(d)
(1) Section 4081 tax was imposed with respect to diesel fuel or kerosene;
(2) The taxpayer was liable for and paid such tax to the IRS and the tax has not been credited or refunded;
(3) The taxpayer removes from an approved terminal the diesel fuel or kerosene, which has been dyed as provided in section 4082(a); and
(4) The taxpayer meets the reporting requirements of paragraph (e) of this section.
(e)
(2)
Taxpayer hereby revokes such report with respect to the fuel described in this statement.
Except for the section 6435 claim to which this report relates, the undersigned taxpayer (the “Taxpayer”) has not received, and will not claim, a credit with respect to, or a refund of, the tax to which this form relates.
Under penalties of perjury, Taxpayer declares that Taxpayer has examined this statement, including any accompanying schedules and statements, and to the best of Taxpayer's knowledge and belief, such statements are true, correct, and complete.
(f)
(2)
(i) Volume and type of fuel removed.
(ii) Date of removal of fuel.
(iii) Amount of section 4081 tax previously paid with respect to such fuel.
(iv) The section 6435 taxpayer's report that relates to such fuel.
(g)
(h)
(i)
(j)
Postal Service.
Final rule.
The Postal Service is amending
Catherine Knox at (202) 268-5636, William Craig at (540) 416-8057, or Garry Rodriguez at (202) 268-7281.
On March 25, 2026, the Postal Service published a notice of proposed rulemaking (91 FR 14490) to revise the application of the overweight and oversize fee. The Postal Service did not receive any formal comments. However, the Postal Service is making clarification to provide that in addition to overweight and oversize items found in the postal network, the fee would also apply to overweight or oversize items reported in a manifest.
The Postal Service is revising the application of the overweight and oversize fee. Except for overweight or oversize items that are discovered during a retail transaction and returned to the mailer, all other retail and commercial paid overweight or oversize items reported in a manifest or found in the postal network will be assessed the $200 overweight or oversize fee. When applicable, the fee must be paid before release of the item back to the mailer or addressee.
The Postal Service adopts the described changes to
Administrative practice and procedure, Postal Service.
Accordingly, the Postal Service amends
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401-404, 414, 416, 3001-3018, 3201-3220, 3401-3406, 3621, 3622, 3626, 3629, 3631-3633, 3641, 3681-3685, and 5001.
* * * Any item exceeding the 70-pound weight or 130-inch dimensional maximum limits is nonmailable and if reported in a manifest or found in the postal network assessed a fee as provided under 1.2.3, and when applicable must be secured for pick-up by the mailer or addressee.
Except for an overweight or oversize item discovered during a retail transaction and returned to the mailer, all other retail and commercial paid overweight or oversize items reported in a manifest or found in the postal network will be assessed the overweight or oversize item fee of $200. When applicable, the fee must be paid before release of the item to the mailer or addressee. The $200 overweight or oversize item fee may be paid by any authorized retail payment method or through USPS Ship.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This final rule approves changes to the Pacific Halibut Catch Sharing Plan (CSP) for the International Pacific Halibut Commission's (IPHC) Regulatory Area 2A off Washington, Oregon, and California. In addition, the rule implements management measures for the 2026 recreational fisheries in Regulatory Area 2A, including the recreational fishery season open dates and subarea allocations for Regulatory Area 2A. These actions are intended to conserve Pacific halibut, while providing additional angler opportunity to achieve the Regulatory Area 2A allocation set by the IPHC.
This rule is effective April 30, 2026.
This rule is accessible via the Office of the Federal Register website at
Melissa Mandrup, phone: 562-980-3231 or email:
The Northern Pacific Halibut Act of 1982 (Halibut Act), 16 U.S.C. 773-773k, gives the Secretary of Commerce responsibility for implementing the provisions of the Halibut Convention between Canada and the United States for the Preservation of the Halibut Fishery of the North Pacific Ocean and Bering Sea (Halibut Convention, signed at Ottawa, ON, on March 2, 1953), as amended by a Protocol Amending the Halibut Convention (signed at Washington, DC, on March 29, 1979), including the responsibility to adopt regulations to carry out the Act (16 U.S.C. 773c).
The Halibut Act provides that the regional fishery management council with authority for the geographic area concerned may develop regulations governing Pacific halibut fishing in U.S. waters that are in addition to, and not in conflict with, approved IPHC regulations (
Under the Halibut Act, the Secretary of State, with the concurrence of the Secretary of Commerce, may accept or reject, on behalf of the United States, regulations recommended by the IPHC in accordance with the Halibut Convention (16 U.S.C. 773b). Following acceptance by the Secretary of State, the annual management measures promulgated by the IPHC are published in the
At its annual meeting held January 19-22, 2026, the IPHC adopted new regulations that open the recreational fisheries in the Washington Puget Sound and U.S. Convention waters in the Strait of Juan de Fuca subarea on the first Thursday of April (
This final rule implements the opening dates and management measures (
Since 1988, the Council's CSP has included an allocation framework for apportioning the IPHC Regulatory Area 2A Pacific halibut FCEY between treaty Tribal and non-Tribal harvesters and among non-Tribal commercial and recreational (sport) fisheries. At 50 CFR 300.63
This rule finalizes changes to the 2026 Regulatory Area 2A CSP, which were developed through the Council's public process over multiple meetings. The changes to the CSP were detailed in the proposed rule and are not repeated here (91 FR 14511, March 25, 2026). This rule also implements recreational Pacific halibut fishery management measures for 2026, including certain season opening and closing dates for the Area 2A subareas that are not implemented through the annual IPHC regulations. These management measures are consistent with the recommendations made by the Council for the 2026 CSP and the season dates recommended by the Oregon Department of Fish and Wildlife (ODFW) during the proposed rule's public comment period.
This rule finalizes recreational fishery management measures consistent with the revisions to the 2026 CSP. If there is any discrepancy between the CSP and regulations, the regulations take precedence. These provisions may be modified through inseason action consistent with 50 CFR 300.63(c). All recreational fishing in Regulatory Area 2A is managed on a “port of landing” basis, whereby any halibut landed into a port counts toward the allocation, in net weight, for the subarea in which that port is located, and the regulations governing the subarea of landing apply regardless of the specific area of catch.
The 2026 recreational fishing subareas, allocations (in net weight), fishing dates, and daily bag limits are described below. The provisions contained in this rule may be modified through inseason action consistent with 50 CFR 300.63(c). For example, subarea allocations may be transferred between subareas within a State inseason in accordance with Federal regulations at 50 CFR 300.63—specifically, paragraphs (c)(6)(i)(C), (c)(6)(i)(D), and (c)(6)(i)(E)—and from one State to another inseason in accordance with Federal regulations
The Pacific halibut recreational fishing allocation for landings into ports in Puget Sound and the U.S. waters in the Strait of Juan de Fuca subarea is 80,512 lb (36.5 mt).
Consistent with IPHC regulations, the Puget Sound subarea is open 7 days per week from April 2 through June 30. If the subarea allocation remains for at least another full day of fishing after June 30, NMFS may take inseason action to reopen the fishery in August through September, up to 7 days per week. The area will be closed when there is not sufficient subarea allocation for another full day of fishing. If the subarea season is closed prior to September 30 and there is insufficient allocation for an additional fishing day, NMFS may take inseason action to transfer any remaining subarea allocation to another Washington coastal subarea.
Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
Consistent with the 2026 IPHC regulations, the daily bag limit is one Pacific halibut of any size per person.
The allocation for landings into ports in the Washington North Coast subarea is 131,149 lb (59.5 mt).
The Washington North Coast subarea is open:
• April 30 (Thursday);
• May 1, 2, 7, 8, 9, 14, 15, 16, (Thursday, Friday, Saturday);
• May 22, 23, 24, (Friday, Saturday, Sunday of Memorial Day weekend);
• May 28, 29, 30 (Thursday, Friday, Saturday); and
• June 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21, 25, 26, 27, 28 (Thursday, Friday, Saturday, Sunday).
If the subarea allocation remains for at least another full day of fishing after June 30, NMFS may take inseason action to reopen the fishery up to 7 days per week while sufficient subarea allocation remains in August through September. The specific day or days of the week that the fishery may reopen would be determined through inseason action. The subarea will be closed when there is not sufficient subarea allocation for another full day of fishing. If the fishery is closed prior to September 30 and there is insufficient allocation remaining to reopen for another fishing day, NMFS may take inseason action to transfer any remaining allocation to another Washington subarea.
Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
The daily bag limit is one Pacific halibut of any size per person.
The Pacific halibut recreational fishing allocation for landings into ports in the Washington South Coast subarea is 65,857 lb (29.9 mt).
The Washington South Coast primary fishery is open:
• April 30 (Thursday);
• May 1, 3, 5, 7, 8, 10, 12, 14, 15, 17, 19, 21, 22, 24, 26, 28, 29, 31 (Thursday, Friday, Sunday, Tuesday); and
• June 2, 4, 7, 9, 11, 14, 16, 18, 21, 23, 25, 28, 30 (Thursday, Sunday, Tuesday).
The fishery will close when there is not sufficient subarea allocation for another full day of fishing. However, if the subarea allocation remains for at least another full day of fishing after June 30, NMFS may take inseason action to reopen the fishery up to 7 days per week while sufficient subarea allocation remains in August through September. The specific day or days of the week that the fishery may reopen would be determined through inseason action. The subarea will be closed when there is not sufficient subarea allocation for another full day of fishing.
When the primary fishery does not have sufficient allocation to open for at least another full day of fishing, any remaining primary fishery allocation will be used to open a nearshore fishery. The nearshore fishery will open the first Saturday after the closure of the primary fishery and will be open 7 days per week until there is not sufficient nearshore fishery allocation remaining for another full day of fishing, at which point the subarea will be closed.
If the primary fishery is closed prior to September 30 and there is not sufficient allocation remaining for at least a full day of fishing in the nearshore fishery, NMFS may take inseason action to transfer any remaining subarea allocation to another Washington subarea.
Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
The daily bag limit is one Pacific halibut of any size per person.
The Pacific halibut recreational fishing allocation for landings into ports in the Columbia River subarea is 19,299 lb (8.8 mt).
The Columbia River subarea is open:
• April 30 (Thursday);
• May 1, 3, 7, 8, 10, 14, 15, 17, 21, 22, 24, 28, 29, 31 (Thursday, Friday, Sunday); and
• June 4, 5, 7, 11, 12, 14, 18, 19, 21, 25, 26, 28 (Thursday, Friday, Sunday).
Additionally, if NMFS determines that sufficient allocation is available to add fishing dates for this subarea in June, NMFS may take inseason action to allow the fishery to open the following additional days in June:
• June 8, 9, 15, 16, 22, 23 (Monday, Tuesday).
The determination of whether allocation is sufficient to open these
If the subarea allocation remains for at least another full day of fishing after June 30, NMFS may also take inseason action to reopen the fishery up to 7 days per week in August through September. The area will be closed when there is not sufficient subarea allocation for another full day of fishing. Any remaining subarea allocation may be transferred inseason to other Washington or Oregon subareas by NMFS, in proportion to the allocation formula in the CSP, in accordance with Federal regulations at 50 CFR 300.63(c). Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
The daily bag limit is one Pacific halibut of any size per person.
The Pacific halibut recreational fishing allocation for landings into ports in the Oregon Central Coast subarea is 278,835 lb (126.5 mt). The nearshore fishery allocation is 10,000 lb (4.5 mt), the spring all-depth fishery allocation is 209,126 lb (94.9 mt), and the summer all-depth fishery allocation is 59,709 lb (27.1 mt).
The nearshore fishery is open 7 days per week from May 1 through October 31. The area will close when there is not sufficient subarea allocation for another full day of fishing. Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
The spring all-depth fishery is open 7 days per week from May 1 through July 31. The area will be closed when there is not sufficient subarea allocation for another full day of fishing. Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
The summer all-depth fishery is open 7 days per week from August 1 through October 31; however, the weeks the fishery is open depends on the remaining amount of allocation from the nearshore and spring all-depth fisheries by July 31, the close of the spring all-depth fishery. If there is 50,000 lb (22.7 mt) or more allocation remaining, the summer all-depth fishery will open 7 days per week, every week, from August 1 through October 31. If there is less than 50,000 lb (22.7 mt) allocation remaining the summer all-depth fishery will open 7 days per week, every
Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
The daily bag limit is two Pacific halibut of any size per person.
The allocation for landings into ports in the Southern Oregon subarea is 8,000 lb (3.6 mt).
The fishery is open 7 days per week from May 1 through October 31. The area will close when there is not sufficient subarea allocation for another full day of fishing. If the Southern Oregon subarea is not projected to utilize its allocation by the season ending date, NMFS may take inseason action to transfer any projected unused allocation to another Oregon subarea.
Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
The daily bag limit is two Pacific halibut of any size per person.
The Pacific halibut recreational fishing allocation for landings into ports in the Northern California Coast subarea is 39,540 lb (17.9 mt).
Consistent with the 2026 IPHC regulations, the fishery is open 7 days per week from April 1 through November 15. If the Northern California Coast subarea is not projected to utilize its respective allocation, prior to or by the season ending date, NMFS may take inseason action to transfer any projected unused allocation to the South of Point Arena subarea. The area will close when there is not sufficient subarea allocation for another full day of fishing.
Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
Consistent with the 2026 IPHC regulations, the daily bag limit is one Pacific halibut of any size per person.
The Pacific halibut recreational fishing allocation for landings into ports in the South of Point Arena subarea is 500 lb (0.2 mt).
Consistent with the 2026 IPHC regulations, the fishery is open 7 days per week from April 1 through December 31. The area will close when there is not sufficient subarea allocation for another full day of fishing.
Any inseason action, including closures and reallocation, will be announced in accordance with Federal regulations at 50 CFR 300.63(c) and on the NMFS hotline at (206) 526-6667 or (800) 662-9825.
Consistent with the 2026 IPHC regulations, the daily bag limit is one Pacific halibut of any size per person.
NMFS published a proposed rule on March 25, 2026 (91 FR 14511) and requested public comment on the 2026 Regulatory Area 2A CSP and the proposed 2026 annual management measures. NMFS received four distinct public comments on the proposed rule only; one of which was responsive to this action from the ODFW.
This final rule is consistent with section 773 of the Halibut Act, which gives relevant regional fishery management councils the authority to develop regulations governing Pacific halibut fishing in U.S. waters that are in addition to, and not in conflict with, approved IPHC regulations, and that “shall only be implemented with the approval of the Secretary.” (
This action is exempt from review under Executive Order (E.O.) 12866. This final rule is exempt from the requirements of E.O. 14192 because it is a routine fishing action. A Treaty Tribal summary impact statement under section (5)(b)(2)(B) and section (5)(c)(2) of E.O. 13175 was not required for this final rule because this action does not impose substantial direct compliance costs on Treaty Tribal Governments and this action does not preempt Treaty Tribal law. A Treaty Tribal summary impact statement is not required and has not been prepared.
NMFS finds good cause to waive the 30-day delay in the date of effectiveness of this rule pursuant to 5 U.S.C. 553(d)(1) and (3) and make the 2026 Regulatory Area 2A recreational fishery management measures (
Moreover, a delayed effective date is not necessary to provide sufficient notice to the fishing community. The purpose of the 30-day delay in effectiveness provision of the Administrative Procedure Act (APA) is generally to give the regulated community time to adjust to new regulations. This rule does not make changes that would require fishery participants to purchase new gear or make other time-consuming adjustments. By contrast, this rule contains season structures and open dates for the Area 2A recreational Pacific halibut fishery that were recommended by the Council following a public process consisting of multiple meetings, which included the opportunity for public comment. The regulated community has made business plans based on these anticipated annual management measures. The final rule is also virtually unchanged from the proposed rule except for two minor changes. NMFS found a minor error in the proposed rule in the Columbia River subarea section regarding how inseason action may be taken to add additional dates in June, if appropriate. This section of the final rule has therefore been corrected to reflect the language in the 2026 CSP. Additionally, NMFS received a comment from ODFW, which expressed overall support for the proposed management measures; however, included a recommendation to revise the Central Oregon Coast and Southern Oregon subarea daily bag limits to two Pacific halibut of any size per person. NMFS made this revision to the final rule. No other changes were necessary to accommodate public comment.
Finally, waiver of the APA's 30-day delay in effectiveness is appropriate because this rule implements the 2026 Regulatory Area 2A subarea allocations for the recreational Pacific halibut fishery, as published in the proposed rule (91 FR 14511, March 25, 2026), based on the formulas set in the 2026 CSP and using the 2026 Area 2A FCEY for Pacific halibut set by the IPHC and accepted by the Secretary of State, with concurrence from the Secretary of Commerce, on March 12, 2026. Said differently, the compressed timeline necessitated by the processes outlined in the Halibut Act makes it impossible for NMFS to delay the effective date of this final rule and still allow for a timely start to the Area 2A recreational fishing season.
In conclusion, NMFS finds good cause to waive the 30-day delay in effective date pursuant to 5 U.S.C. 553(d)(1) and (3).
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities for purposes of the Regulatory Flexibility Act. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required for this action and none was prepared.
This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; inseason adjustments to biennial groundfish management measures.
This final rule announces routine inseason adjustments to management measures in commercial and recreational groundfish fisheries. This action is intended to allow commercial and recreational fishing vessels to access more abundant groundfish stocks while protecting overfished and depleted stocks. Additionally, this inseason action is expected to help achieve the full attainment of the groundfish annual catch limit (ACL), thereby supporting $164 million in ex-vessel revenue for commercial non-whiting groundfish landings and approximately 100,000 annual angler trips off Oregon.
This final rule is effective May 1, 2026.
This rule is accessible via the Office of the Federal Register website at
Christopher Biegel, 503-231-6291,
The Pacific Coast Groundfish Fishery Management Plan (PCGFMP) and its implementing regulations at title 50 in the Code of Federal Regulations (CFR), part 660, subparts C through G, regulate fishing for groundfish off the coasts of Washington, Oregon, and California. The Council develops groundfish harvest specifications and management measures for 2-year periods (
In September 2025, the Council recommended, and NMFS implemented, an emergency rule revising the 2026 harvest specifications for shortspine thornyhead, canary rockfish, and petrale sole; the temporary rule became effective January 21, 2026 (91 FR 2714). The 2026 commercial non-trawl harvest guidelines (HG) for canary rockfish increased from 50.8 to 55.7 metric tons (mt), adding 4.9 mt to the fishery. This increase, combined with low attainment and discard concerns, supports reconsideration of trip limits to improve utilization. The current trip limits north of latitude 40°10′ N for limited entry fixed gear (LEFG) are 3,000 lbs. (1,361 kilogram (kg)) per 2 months and for open access (OA) are 1,000 lbs. (454 kg) per 2 months. The current trip limits south of latitude 40°10′ N for LEFG are 3,500 lbs. (1,588 kg) per two months and for OA are 1,500 lbs. (680 kg) per 2 months. As detailed in Agenda Item D.5.a Supplemental Groundfish Management Team (GMT) Report 1, March 2026, the GMT evaluated two inseason trip limit change options.
Option 1 would increase the trip limit north of latitude 40°10′ N to match the limit south of latitude 40°10′ N for each sector, setting LEFG at 3,500 lbs. (1,588 kg) per 2 months and OA at 1,500 lbs. (680 kg) per 2 months. Option 2 would increase coastwide trip limits north and south of latitude 40°10′ N to 4,000 lbs. (1,814 kg) per 2 months for LEFG and 2,000 lbs. (907 kg) per 2 months for OA.
Table 1 of the Supplemental GMT Report provided the projected canary rockfish mortality associated with each option as compared to the 2026 commercial non-trawl HG (55.7 mt). Under option 1, attainment of the commercial non-trawl HG is projected to increase to 70 percent. Under option 2, attainment is projected to increase to 87 percent. Option 2 provides a substantial buffer between projected mortality and the fishery HG, while increasing access to shelf species, reducing discards, improving HG attainment, and simplifying management. Additionally, option 2 was requested by LEFG and OA fishery participants and has industry support. Therefore, at the March 2026 meeting, the GMT recommended Option 2 to set coastwide canary rockfish trip limits at 4,000 lbs. (1,814 kg) per 2 months for LEFG and 2,000 lbs. (907 kg) per 2 months for OA, north and south of latitude 40°10′ N.
For these reasons, the Council recommended, and NMFS is implementing, an inseason increase in the commercial non-trawl canary rockfish trip limits coastwide. The new limits for 2026, north and south of latitude 40°10′ N will be 4,000 lbs. (1,814 kg) per 2 months for LEFG, and 2,000 lbs. (907 kg) per 2 months for OA.
At the March 2026 meeting, the Council also recommended, and NMFS is implementing, inseason adjustments to the Oregon recreational long-leader fishery overall bag limit and the canary rockfish sub-bag limit. Currently, the long-leader fishery's overall bag limit for fishing in federal waters off Oregon is 12 fish and the canary rockfish sub-bag limit for federal waters is 1 fish.
During the 2025-26 harvest specifications process, a 5-fish sub-bag limit for canary rockfish was evaluated to provide a range for state regulations to work within, as the Oregon Fish and Wildlife Commission (OFWC) adopts state regulations each December for the following calendar year. For 2026, the OFWC adopted a 2-fish sub-bag for canary rockfish in the long-leader fishery to reduce regulatory discards and respond to the recent emergency action to increase the coastwide ACL for canary rockfish. As recommended by the Council in September 2025, NMFS took emergency action to increase the Oregon recreational HG for canary rockfish from 26.1 to 28.6 mt for 2026, adding 2.5 mt to the fishery.
The Oregon recreational HG of 26 mt was fully attained in 2025. For 2026, in order to attain but not exceed other species' catch limits, OFWC adopted a 10-fish bag limit for the long-leader fishery instead of the 12-fish bag limit for federal waters. In order to allow additional opportunity for full utilization of the Oregon recreational HG for canary rockfish for 2026, the Council recommended, and NMFS is implementing, inseason action to increase the canary rockfish sub-bag
In summary, the Council recommended, and NMFS is implementing, an increase of the canary rockfish sub-bag limit from 1 to 2-fish for the Oregon recreational long-leader fishery in federal waters and a reduction in the fishery's bag limit from 12 to 10-fish.
This final rule makes routine inseason adjustments to groundfish fishery management measures, based on the best scientific information available, consistent with the PCGFMP and its implementing regulations.
This action is taken under the authority of 50 CFR 660.60(c) and is exempt from review under Executive Order 12866.
The aggregate data upon which these actions are based are available for public inspection by contacting Christopher Biegel in NMFS West Coast Region (see
Pursuant to 5 U.S.C. 553(b), NMFS finds good cause to waive prior public notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. The routine inseason adjustments to management measures in this rule modify trip limits for fisheries in federal waters off the coasts of Washington, Oregon, and California by implementing trip limits designed to increase utilization while keeping catch within allocations established by the 2025-2026 harvest specifications. No aspect of this action is controversial, and changes of this nature were anticipated in the final rule for the 2025-2026 harvest specifications and management measures, which published on December 16, 2024 (89 FR 101514).
The Council recommended, and NMFS is implementing, an increase to the commercial non-trawl canary rockfish trip limits north and south of latitude 40°10′ N to 4,000 lbs. (1,814 kg) per 2 months for LEFG and 2,000 lbs. (907 kg) per 2 months for OA. Non-trawl rockfish allocations are generally underutilized and providing the LEFG and OA fishery with increased access to these stocks will have economic benefits without jeopardizing the stocks' ACLs. Additionally, the Council recommended, and NMFS is implementing, an increase of the canary rockfish sub-bag limit for the Oregon recreational long-leader fishery in federal waters from 1 to 2-fish and a reduction of the fishery's overall bag limit from 12 to 10-fish. Both measures are already in effect in state regulations. This action will therefore create consistency between Federal and State regulations.
This inseason action was developed through the Council process, which includes the opportunity for public comment. There was no opposition to any aspect of the rule in that venue. Delaying implementation of this rule to allow for additional public comment would reduce the economic and other benefits to commercial and recreational fishermen and fishing communities, including to businesses that rely on the fishing industry. To realize the full projected benefits of this inseason action to fishermen and fishing communities the new trip limits should be effective as soon as possible. A delay in implementation could also contribute to unnecessarily discarded and largely wasted fish, which could otherwise be landed to provide food and revenue. Thus, waiver of the requirement for prior notice and an opportunity for public comment under 5 U.S.C. 553(b) supports responsible use of the resource.
In addition, for the reasons described above, NMFS finds good cause to waive the 30-day delay in effectiveness pursuant to 5 U.S.C. 553(d)(1) so that this final rule may become effective upon filing with the Office of Federal Register. The adjustments to management measures in this rule affect commercial and recreational fisheries by increasing opportunity and allowing greater economic and other benefits to fishermen and fishing communities, while keeping catch within allocations established by the 2025-2026 harvest specifications. These adjustments were requested by the Council's advisory bodies, as well as members of industry during the Council's March 2026 meeting, and recommended unanimously by the Council following a public process. No aspect of this action is controversial, and changes of this nature were anticipated in the biennial harvest specifications and management measures established through notice and comment rulemaking (89 FR 101514).
Fisheries, Fishing, and Indian fisheries.
For the reasons set out in the preamble, NMFS amends 50 CFR part 660 as follows:
16 U.S.C. 1801
(c) * * *
(2) * * *
(iii) * * *
(A)
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain General Electric Company (GE) Model CF34-1A, CF34-3A, CF34-3A1, CF34-3A2, and CF34-3B engines. This proposed AD was prompted by a dual engine power loss event and consequent manufacturer investigation, which revealed corrosion in the high-pressure compressor (HPC) case affecting the variable geometry (VG) system. This proposed AD would require performing certain restart tests and, depending on the results of the tests, additional actions. This proposed AD would also require performing a borescope inspection (BSI) of the HPC case for corrosion and, depending on the results, a VG system functional check for pressure evaluation. This proposed AD would also require, depending on inspection results, performing a force gage test on the feedback cable for tightness and a visual inspection of the VG system for obstruction and, if necessary, removal of the engine from service. This proposed AD would also require revising the airworthiness limitations section (ALS) of the existing engine maintenance manual to incorporate the VG system functional check. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by June 15, 2026.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For GE material identified in this AD, contact GE, 1 Neumann Way, Cincinnati, OH 45215; phone: (513) 552-3272; email:
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call (817) 222-5110.
Alexei Marqueen, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198; phone: (781) 238-7178; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under the
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Alexei Marqueen, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
The FAA received a report that an airplane powered by GE Model CF34-3B engines experienced an uncommanded simultaneous dual engine in-flight shutdown. The engine manufacturer investigation revealed evidence of corrosion in the HPC module. Further analysis indicated corrosion in the HPC case vane boreholes traditionally associated with hardware that has been exposed to a saline environment, and pitting along the HPC case, with the worst corrosion in later stages from additional oxidation due to higher operating temperatures. While the investigation has yet to identify a definitive root cause, GE considers corrosion to be a contributing factor. Corrosion in the HPC case
The affected population of engines includes the entire GE Model CF34-3 fleet. GE Model CF34-1A engines have all been converted to CF34-3A or they are no longer in production or service, but they are included in the applicability of this proposed AD in case there are any remaining GE Model CF34-1A engines that are unaccounted for.
The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
The FAA reviewed GE CF34BJ Service Bulletin 72-0347, Revision 02, dated October 30, 2025. This material specifies procedures for performing repetitive engine heat soak restart tests for a hung start and, depending on the results of the tests, engine troubleshooting and corrective actions. This material also specifies procedures for performing a borescope inspection (BSI) of the HPC case for corrosion and, depending on the results of the BSI, a VG system functional check for pressure evaluation. This material also specifies procedures for performing a force gage test on the feedback cable for tightness and a visual inspection of the VG system for obstruction.
The FAA also reviewed MM 05-21-00, ENGINE MAINTENANCE PROGRAM from GE CF34-3 Maintenance Manual SEI-580, Rev. 49, dated August 1, 2024 (GE Model CF34-1A, CF34-3A, and CF34-3A2 engines); SM 05-21-00, MAINTENANCE PROGRAMS from GE CF34-3 Service Manual SEI-780, Rev. 65, dated February 1, 2025 (GE Model CF34-3A1 and CF34-3B engines); and EM 05-21-00 ENGINE—MAINTENANCE PROGRAM from GE CF34RJ Engine Manual SEI-756, Rev. 69, dated February 1, 2025 (GE Model CF34-3A1 and CF34-3B1 engines). This material specifies procedures for performing VG system inspections on certain GE Model engines, as applicable.
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This proposed AD would require performing repetitive engine heat soak restart tests for a hung start and, depending on the results of the tests, engine troubleshooting and corrective actions. This proposed AD would also require performing a borescope inspection (BSI) of the HPC case for corrosion and, depending on the results of the BSI, a VG system functional check for pressure evaluation. This proposed AD would also require, depending on inspection results, performing a force gage test on the feedback cable for tightness and a visual inspection of the VG system for obstruction and, if necessary, removal of the engine from service. This proposed AD would also require revising the ALS of the existing engine maintenance manual to incorporate the VG system functional check.
The FAA estimates that this AD, if adopted as proposed, would affect 1,152 engines installed on airplanes of U.S. registry.
The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the following costs to do any necessary repairs or checks that would be required based on the results of the proposed inspection. The agency has no way of determining the number of engines that might need these repairs or checks:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by June 15, 2026.
None.
This AD applies to the following General Electric Company (GE) Model engines:
(1) CF34-1A, CF34-3A, and CF34-3A2 engines with engine serial numbers (ESN) 350103 through 350525.
(2) CF34-3A1 engines with ESN 807001 through 807661.
(3) CF34-3B engines with ESN 872001 through 873999, 950000 through 950999, and 801001 through 801714.
Joint Aircraft System Component (JASC) Code 7230, Turbine Engine Compressor Section.
This AD was prompted by a dual engine power loss event and consequent manufacturer investigation, which revealed corrosion in the high-pressure compressor (HPC) case affecting the variable geometry (VG) system. The FAA is issuing this AD to detect corrosion in the HPC case that can restrict VG system movement, which can lead to compressor instability at or below idle speeds. The unsafe condition, if not addressed, could result in loss of engine thrust control and reduced control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For the purpose of this AD:
(1) Group 1 engines are engines with 12 months rolling average utilization of less than 250 hours per year.
(2) Group 2 engines are engines with 12 months rolling average utilization of more than 250 hours per year.
(3) Group 3 engines are spare engines or engines that are switched between two different aircraft tail numbers.
(1) Within 3 months after the effective date of this AD and every 3 months thereafter, perform an engine heat soak restart test on each engine in accordance with the Accomplishment Instructions, paragraph 3.B.(1), of GE Service Bulletin (SB) CF34-BJ 72-0347 Revision 02, dated October 30, 2025 (GE SB CF34-BJ 72-0347 R02). If a hung start is experienced, before further flight, troubleshoot the engine in accordance with the Accomplishment Instructions, paragraph 3.B.(2), of GE SB CF34-BJ 72-0347 R02.
(2) Within the applicable time specified in paragraphs (h)(2)(i) through (iii) of this AD, perform a borescope inspection (BSI) of the high-pressure compressor (HPC) case in accordance with the Accomplishment Instructions, paragraph 3.C, of GE SB CF34-BJ 72-0347 R02. If the applicable engine group cannot be determined due to lack of available data, use Group 1 engines as the applicable condition for the engine.
(i) For Group 1 engines, within 12 months after the effective date of this AD.
(ii) For Group 2 engines, within 24 months after the effective date of this AD.
(iii) For Group 3 engines, before further flight after the effective date of this AD.
(3) If, during the heat soak restart test or the engine troubleshooting required by paragraph (h)(1) of this AD, or during the BSI required by paragraph (h)(2) of this AD, corrosion is found, before further flight, perform a variable geometry (VG) system functional check in accordance with the Accomplishment Instructions, paragraph 3.D, of GE SB CF34-BJ 72-0347 R02.
(4) If, during the VG system functional check required by paragraph (h)(3) of this AD, the pressure necessary to fully extend or fully retract the actuator is more than 65 psi (448 kPa), before further flight, perform a force gage test on the feedback cable and a visual inspection of the VG system in accordance with the Accomplishment Instructions, paragraph 3.E.(1)(a) and 3.E.(1)(a)(1), of GE SB CF34-BJ 72-0347 R02. If a tight feedback cable or an obstruction in the VG system is found, before further flight, repair the part in accordance with the Accomplishment Instructions, paragraph 3.E.(1)(a)(1), of GE SB CF34-BJ 72-0347 R02.
(5) If, after performing the actions required by paragraph (h)(4) of this AD, the pressure necessary to fully extend or fully retract the actuator is more than 65 psi (448 kPa), remove the engine from service.
(6) Within 12 months after the effective date of this AD, revise the Airworthiness Limitations Section (ALS) of the existing CF34-3 Business Jet Engine Manual and the operator's existing approved maintenance program or inspection program, as applicable, by incorporating the information specified in Section 9. of MM 05-21-00, ENGINE MAINTENANCE PROGRAM from GE CF34-3 Maintenance Manual SEI-580, Rev. 49, dated August 1, 2024, and Section 8. of SM 05-21-00, MAINTENANCE PROGRAMS from GE CF34-3 Service Manual SEI-780, Rev. 65, dated February 1, 2025.
(7) Within 12 months after the effective date of this AD, revise the ALS of the existing CF34-3 Regional Jet (RJ) EM and the operator's existing approved maintenance program or inspection program, as applicable, by incorporating the information specified in Section 11. of EM 05-21-00 ENGINE—MAINTENANCE PROGRAM from GE CF34RJ Engine Manual SEI-756, Rev. 69, dated February 1, 2025.
Performing a BSI of the HPC case in accordance with paragraph (h)(2) of this AD constitutes terminating action for the repetitive heat soak test restart required by paragraph (h)(1) of this AD for Group 1 or Group 2 engines, as applicable. Group 3 engines are not subject to repetitive heat soak restart tests.
You may take credit for the actions required by paragraphs (h)(1) through (5) of this AD if you removed and repaired the following part numbers (P/N) within 48 months prior to the effective date of this AD using GE SEI-582, 72-31-00, REPAIR, dated September 15, 2001; or GE SEI-782, HMM 72-32-16, REPAIR 07, Rev 65, dated February 1, 2025; or GE SEI-782, HMM 72-32-17, REPAIR 07, Rev 65, dated February 1, 2025, at an approved Maintenance Repair and Overhaul (MRO) shop:
(1) HPC lower case P/N 6040T84P01 and 6052T48P01.
(2) HPC upper case P/N 6040T84P02 and 6052T48P02.
(3) Compressor case assemblies P/N 4922T71G01, 5088T55G01, 5088T55G02, 5088T55G03, 6078T70G01, 6078T70G02, and 6078T70G03.
The Manager, AIR-520 Continued Operational Safety Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the AIR-520 Continued Operational Safety Branch, send it to the attention of the person identified in paragraph (l)(2) of this AD and email to:
(1) For more information about this AD, Alexei Marqueen, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198; phone: (781) 238-7178; email:
(2) Material identified in this AD that is not incorporated by reference is available at the address specified in paragraph (m)(3) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) GE CF34-BJ Service Bulletin 72-0347, Revision 02, dated October 30, 2025.
(ii) MM 05-21-00, ENGINE MAINTENANCE PROGRAM from GE CF34-3 Maintenance Manual SEI-580, Rev. 49, dated August 1, 2024.
(iii) SM 05-21-00, MAINTENANCE PROGRAMS from GE CF34-3 Service Manual SEI-780, Rev. 65, dated February 1, 2025.
(iv) EM 05-21-00 ENGINE—MAINTENANCE PROGRAM from GE CF34RJ Engine Manual SEI-756, Rev. 69, dated February 1, 2025.
(3) For GE material identified in this AD, contact General Electric Company, 1 Neumann Way, Cincinnati, OH 45215; phone: (513) 552-3272; email:
(4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
In the Rules and Regulations section of this issue of the
Written or electronic comments and requests for a public hearing must be received by June 30, 2026.
Commenters are strongly encouraged to submit public comments electronically via the Federal eRulemaking Portal at
Concerning the proposed regulations, Danielle Mayfield or Andrew Clark of the Office of Associate Chief Counsel (Energy, Credits, and Excise Tax) at (202) 317-6855 (not a toll-free number); concerning submissions of comments or requests for a public hearing, Publications and Regulations Section at (202) 317-6901 (not a toll-free number) or by email at
This document contains proposed amendments to the Manufacturers and Retailers Excise Tax Regulations (26 CFR part 48) under section 6435 of the Internal Revenue Code (Code) relating to the determination of payments regarding dyed diesel fuel or dyed kerosene with respect to which excise tax under section 4081 of the Code was paid (proposed regulations). The proposed regulations would be issued under the authority granted by sections 6435(a), 6001, and 7805(a) of the Code.
Section 6435(a) requires that a person claiming a payment under section 6435 establish to the satisfaction of the Secretary of the Treasury or the Secretary's delegate (Secretary) that such person meets the requirements under section 6435(b).
Section 6001 authorizes the Secretary to prescribe regulations related to recordkeeping, statements, and returns.
Section 7805(a) authorizes the Secretary to prescribe all needful rules and regulations for the enforcement of the Code, including all rules and regulations as may be necessary by reason of any alteration of law in relation to internal revenue.
Temporary regulations in the Rules and Regulations section of this issue of the
Proposed § 48.6435-1 would apply to removals of eligible dyed fuel occurring on or after December 31, 2025.
These proposed regulations are not subject to review under section 6(b) of Executive Order 12866 pursuant to the Memorandum of Agreement (July 4, 2025) between the Treasury Department and the Office of Management and Budget (OMB) regarding review of tax regulations.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA) generally requires that a Federal agency obtain the approval of the OMB before collecting information from the public, whether such collection of information is mandatory, voluntary, or required to obtain or retain a benefit. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the OMB.
These proposed regulations set forth intended collections of information to be provided to the IRS with Form 8849,
The collections of information in these proposed regulations would include reporting and recordkeeping requirements that are necessary to ensure that a taxpayer qualifies for a section 6435 refund. The collections would be used by the IRS for tax compliance purposes and by taxpayers to establish eligibility for a section 6435 refund.
The reporting requirements would include reporting related to claiming a section 6435 refund, including the execution and filing of reports as detailed in proposed § 48.6435-1(e). The recordkeeping requirements would include that a taxpayer keep records to establish its eligibility for and the amount of a section 6435 claim. The burden for these requirements is included with Form 8849 and its instructions and with Schedule 5 (Form 8849) and its instructions. These forms and form instructions are already approved under OMB control number 1545-1420.
Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any Internal Revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
These proposed regulations would not change or create new collection requirements beyond the requirements that are being reviewed and approved by OMB under the temporary regulations.
Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that these proposed regulations will not have a significant economic impact on a substantial number of small entities within the meaning of section 601(6) of the Regulatory Flexibility Act.
As discussed in Announcement 2026-1, 2026-4 I.R.B 402 (released December 22, 2025), absent a statutory change, the Treasury Department and the IRS lack the authority to pay section 6435 claims to anyone other than the person that paid the section 4081 tax to the IRS with respect to the eligible dyed fuel to which the claim relates. Section 6435 allows a person that establishes to the satisfaction of the Secretary that the person removed eligible indelibly dyed diesel fuel or kerosene (eligible dyed fuel) from a terminal to claim a payment (without interest) equal to the amount of the section 4081 tax previously paid with respect to such dyed fuel. The proposed regulations would provide needed guidance for such taxpayers on eligibility and filing procedures for making a section 6435 claim. These proposed regulations would establish reporting procedures, including a model report, that allow the IRS to verify a taxpayer's entitlement to a payment under section 6435 as contemplated by the statute. Accordingly, the Treasury Department and the IRS intend that the proposed rules provide clarity for taxpayers on the availability and claim procedures for a payment under section 6435.
These proposed regulations would affect a narrow subset of businesses within the fuel industry: taxpayers removing dyed fuel from an approved terminal with respect to which they previously paid tax. Because section 6435 first went into effect on December 31, 2025, no historical data is available on the number or size of section 6435 claimants. While there is uncertainty as to the exact number of small businesses within this group, such taxpayers are necessarily a subset of taxpayers filing Form 720 with respect to certain taxes paid on diesel fuel and kerosene. From 2021 to 2024, more than 85 percent of such identifiable Form 720 filers were businesses with total positive incomes of at least $25 million, and more than two-thirds were businesses with total assets of at least $25 million. Moreover, under section 4081(e), the most analogous existing provision, the vast majority of taxpayers the IRS can identify have total positive incomes and assets of at least $100 million. This data is constrained by issues matching between databases, but the IRS has no reason to believe it is skewed. As such, of the relatively few taxpayers affected by section 6435, nearly all can be expected to be predominantly large, sophisticated businesses in the fuel industry.
Even if a substantial number of small entities are affected, the economic impact of these proposed regulations on small entities is not likely to be significant. The proposed regulations would provide taxpayers with guidance regarding the eligibility and filing requirements for section 6435, including the reporting requirements. As explained in the PRA section, the reporting and recordkeeping obligations imposed by these proposed regulations would include filing a report to make a claim. It is estimated that fewer than 60 taxpayers will prepare one or more of such reports annually and that each report will take no more than one hour to complete.
Accordingly, the Secretary of the Treasury certifies that these proposed regulations will not have a significant economic impact on a substantial number of small entities. The Treasury Department and the IRS specifically invite comments from any party, particularly affected small entities, on the accuracy of this certification.
Pursuant to section 7805(f), this notice of proposed rulemaking has been submitted to the Chief Counsel for the Office of Advocacy of the Small Business Administration for comment on its impact on small business.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Tribal government, in the aggregate, or by the private sector, of $100 million (updated annually for inflation). These proposed regulations do not include any Federal mandate that may result in expenditures by State, local, or Tribal governments, or by the private sector, in excess of that threshold.
Executive Order 13132 (Federalism) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. These proposed rules do not have federalism implications and do not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.
Before these proposed regulations are adopted as final regulations, consideration will be given to comments that are submitted timely to the IRS as prescribed in the preamble under the
A public hearing will be scheduled if requested in writing by any person that timely submits electronic or written comments. If a public hearing is scheduled, a notice of the date, time, and place for the public hearing will be published in the
Guidance cited in this preamble is published in the Internal Revenue Bulletin and is available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at
The principal authors of these proposed regulations are Danielle Mayfield and Andrew Clark of the Office of Associate Chief Counsel (Energy, Credits, and Excise Tax). However, other personnel from the Treasury Department and the IRS participated in their development.
Excise taxes, Reporting and recordkeeping requirements.
Accordingly, the Treasury Department and the IRS propose to amend 26 CFR part 48 as follows:
26 U.S.C. 7805 * * *
Section 48.6435-1 also issued under 26 U.S.C. 6435(a) and 6001.
[The text of proposed § 48.6435-1 is the same as the text of § 48.6435-1T in the temporary rule published elsewhere in this issue of the
Environmental Protection Agency (EPA).
Proposed rule; extension of public comment period.
On March 17, 2026, the U.S. Environmental Protection Agency (EPA) proposed a rule titled “National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration.” The EPA is extending the comment period on this proposed rule, which is scheduled to close on May 1, 2026. The comment period will now end on May 15, 2026, to allow additional time for stakeholders to review and comment on the proposal.
The EPA is extending the comment period for the proposed rule that published in the
You may send comments, identified by Docket ID No. EPA-HQ-OAR-2019-0178, by any of the following methods:
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For information about this comment period extension, contact U.S. EPA, Attn: Brian Langloss, Mail Drop: D243-04, 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-0675; and email address:
The EPA may publish any comment received to its public docket. A written comment must accompany multimedia submissions (audio, video,
The
Our preferred method to receive CBI is electronic transmittal, using email attachments, File Transfer Protocol (FTP), or other online file sharing services (
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM); extension of comment period.
FMCSA is extending the comment period for its April 7, 2026, NPRM, titled “Fees for the Unified Carrier Registration Plan and Agreement,” from May 7, 2026, to May 26, 2026. The purpose of the comment extension is to provide an opportunity for the public to access the supporting documentation regarding fee calculations for the 2027 registration year. The comment period is being extended at the request of the Small Business in Transportation Coalition (SBTC).
The comment period for the NPRM published April 7, 2026, at 91 FR 17618 is extended. Comments must be received on or before May 26, 2026.
You may submit comments identified by Docket Number FMCSA-2025-0655 using any of the following methods:
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Mr. Kenneth Riddle, Director, Office of Registration and Safety Information, FMCSA, 1200 New Jersey Avenue SE, West Building, 6th Floor, Washington, DC 20590;
If you submit a comment, please include the docket number for this NPRM (FMCSA-2025-0655), indicate the specific section of this document to which your comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period.
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to the NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission that constitutes CBI as “PROPIN” to indicate it contains proprietary information. FMCSA will treat such marked submissions as confidential under the Freedom of Information Act, and they will not be placed in the public docket of the NPRM.
Submissions containing CBI should be sent to Mr. Brian Dahlin, Chief, Regulatory Evaluation Division, Office of Policy, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 or via email at
To view any documents mentioned as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its regulatory process. DOT posts these comments, including any personal information the commenter provides, to
The April 7, 2026, NPRM (91 FR 17618) requested public comment on FMCSA's proposal to amend its regulations governing the annual Unified Carrier Registration (UCR) Plan and Agreement registration fees that participation States collect from motor carriers, motor private carriers of property, brokers, freight forwarders, and leasing companies. The UCR Board of Directors (Board) did not recommend any change in fees in the 2026 registration year, therefore the fees remained the same as the 2025 registration year. However, on September 18, 2025, the Board recommended a fee increase for the 2027 registration year and subsequent registration years. This increase averages 18 percent, with varying increases between $9 and $9,329 per entity, depending on the applicable fee bracket. FMCSA is proposing to adopt the fee increase.
The comment period for the NPRM expires on May 7, 2026. The SBTC requested an extension of the comment period on April 24, 2026, because certain supporting documentation referenced in the NPRM was not uploaded to the docket.
Issued under the authority of delegation in 49 CFR 1.87.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes regulatory and administrative changes to implement improvements to the Greater Atlantic Region's Catch Share Cost Recovery Programs. These updates are intended to simplify regulations and reduce costs for the Scallop Individual Fishing Quota, Tilefish Individual Fishing Quota, and Surfclam and Ocean Quahog Individual Transferable Quota fisheries. This action would result in improved administration and management of the scallop, tilefish, and surfclam and ocean quahog fisheries.
Comments must be received on June 1, 2026.
A plain language summary of this proposed rule is available at:
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Douglas Potts, Fishery Policy Analyst,
The Greater Atlantic Regional Fisheries Office (GARFO) manages three Limited Access Privilege Programs (LAPPs): Limited Access General Category (LAGC) Scallop Individual Fishing Quota (IFQ); Tilefish IFQ; and Surfclam and Ocean Quahog Individual Transferable Quota (ITQ). The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires the collection of fees to recover the “actual costs directly related to the management, data collection, and enforcement” of a LAPP at 16 U.S.C. 1854(d)(2). Permit holders in the three cost recovery programs must pay an annual cost recovery fee, based on the ex-vessel value of fish landed under the program. The fee may be up to, but cannot exceed, 3 percent of the ex-vessel value of the fish harvested under the LAPP. Vessel permits cannot be renewed until the previous year's fee is paid.
Centralized Receivables Service (CRS) is an initiative of the U.S. Department of Treasury (Treasury) to manage non-tax debts on behalf of Federal agencies. GARFO works with CRS to issue cost recovery bills for fees owed and to process payments. CRS attempts to collect debts owed through the cost recovery programs when fee payments become past due. If initial collection efforts fail and a debt is over 120 days past due, CRS sends the debt to Cross-Servicing, another program within the Treasury, for debt collection. Pursuant to 31 CFR 285.12(c)(2), Cross-Servicing's default minimum debt amount that can be collected is $25.
GARFO's current minimum cost recovery bill threshold is $10 (that is, if the fee that would be charged to a permit holder is less than $10, GARFO waives the fee for that permit holder). The difference between GARFO's fee threshold and Cross-Servicing's minimum debt collection amount creates a substantial administrative burden that results in higher costs for running LAPP programs, which, ultimately, drives up the total fees charges to the industry in future years. If CRS forwards a bill under $25 to Cross-Servicing for collection due to non-payment, GARFO staff must work with Cross-Servicing to ensure that the bill is not automatically canceled and that it remains open for payment. If Cross-Servicing cancels a bill because it is less than the $25 minimum, the permit holder remains in arrears but cannot make a payment and would be prohibited from renewing their permit (a LAPP permit holder is required to pay their cost recovery bill in full before receiving a permit for the next fishing year). There are typically five or fewer bills under $25 from all of GARFO's LAPP cost recovery programs annually.
This proposed action would waive fees under $25 to avoid the disproportionate costs associated with administering these bills. The cost of staff time spent working on billing for fees less than the Treasury's $25 minimum threshold for debt collection significantly exceeds the value of the bills themselves, ultimately costing the industry more in the subsequent billing cycle. The unbilled amounts would be rolled over into the following year's cost recovery accounting, so GARFO would still collect the total “actual costs” of the LAPPs as required by the Magnuson-Stevens Act. Waiving these fee amounts would also mitigate permit holders being unable to renew their permits, including permits for other non-LAPP fisheries, because of cost recovery bills that are overdue but have been canceled by Cross-Servicing. Should the Treasury revise its procedures in a manner that allows for collection of bills below $25, NMFS could consider, through a future rule, whether to resume billing of such amounts in LAPP fisheries.
The proposed action would also standardize the billing timeline for GARFO, and payment periods for permit holders, across the regulations implementing the three LAPPs administered by GARFO. These programs were developed at different times and by different regional fishery management councils, and include different billing and payment cycles as a result. Setting a standard timeline for billing and payment periods would reduce uncertainty for members of the fishing industry and reduce the administrative burden on the agency. The proposed action would require the agency to send out bills within 6 months of the end of the cost recovery period and set payments due within 30 days from the date bills are sent for all three LAPPs. Currently, Surfclam and Ocean Quahog ITQ bills are due within 30 days, Tilefish IFQ bills are due within 45 days, and LAGC Scallop IFQ bills are due within 60 days. Requiring payment within 30 days of the bill date, also known as “Net 30,” is standard practice across many industries. Providing 6 months from the end of the cost recovery period to send fee notices would allow time for GARFO staff to
NMFS is issuing this rule pursuant to section 305(d) of the Magnuson-Stevens Act. The reason for using this regulatory authority is that this action addresses the agency's administration of the cost recovery provisions of the Scallop, Tilefish, and Atlantic Surfclam and Ocean Quahog Fishery Management Plans (FMP) in order to minimize agency inefficiencies and unnecessary costs for the industry. NMFS notified the New England and Mid-Atlantic Fishery Management Councils of its intention to implement these changes using this authority. Neither Council objected, nor did they express interest in addressing these issues through the Council process. The NMFS Assistant Administrator has determined that this proposed rule is consistent with the Scallop, Tilefish, and Atlantic Surfclam and Ocean Quahog FMPs, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities.
The measures proposed by this action apply to quota shareholders in the LAGC Scallop IFQ, Tilefish IFQ, and Surfclam and Ocean Quahog ITQ fisheries. For Regulatory Flexibility Act (RFA) purposes, NMFS defines a small commercial fishing business as a firm that is independently owned and operated with receipts of less than $11 million annually (see 50 CFR 200.2). Under the North American Industry Classification System (NAICS), most firms with surfclam or ocean quahog ITQ quota share are commercial fishing firms (NAICS 11411). However, some quota share is held by firms that are more properly classified as fish and seafood wholesalers (NAICS 42446), commercial banks (NAICS 52211), credit unions (NAICS 52213), trusts (NAICS 525920), or the public administration sector (NAICS 92). For those entities, the appropriate SBA size standard to categorize small versus large businesses was used. Those thresholds are 100 employees for fish and seafood wholesalers, $850 million in assets for commercial banks and credit unions, and $40 million in annual receipts for trusts (13 CFR 121.201). Small business size standards are not established for the public administration sector.
In 2023, there were 545 total regulated entities across the LAGC Scallop IFQ, Tilefish IFQ, and Surfclam and Ocean Quahog ITQ fisheries. Of these, 515 are considered small entities, 25 are large entities, and 5 are public administration sector entities. Holdings by the public administration sector reflect quota share formally held by the NOAA Fisheries Finance Program as collateral on loans to different members of the fishing industry. The proposed measures are administrative in nature and are not expected to have impacts on the nature or operation of the scallop, tilefish, or surfclam and ocean quahog fisheries; including landings levels, ex-vessel revenues, fishery distribution, or fishing methods and practices. The proposed action would improve the efficiency of NMFS's internal process for calculating, issuing, and collecting cost recovery bills. Improving efficiency is expected to lead to a minor decrease in management costs, which would result in minor savings for the fishing industry because NMFS is required to recover the management costs of these programs. Waiving cost recovery fees under $25 is expected to result in annual decreases in cost recovery costs of $86 for 12 large entities and $52 for 29 small entities in the surfclam fishery, and of $13 for 2 large entities and $120 for 100 small entities in the scallop fishery. No economic impacts are projected for firms in the tilefish or ocean quahog fisheries.
Based on the analysis provided above, the proposed measures are not expected to have a significant economic impact on a substantial number of small entities. As a result, an initial regulatory flexibility analysis is not required and none has been prepared.
This proposed rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
Fisheries, Fishing, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, NMFS proposes to amend 50 CFR part 648 as follows:
16 U.S.C. 1801
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(h) * * *
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National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes a framework to determine catch limits for all U.S. fisheries and retention limits by U.S. longline fisheries under a Hawaii longline limited entry permit for Western and Central North Pacific Ocean (WCNPO) striped marlin (
NMFS must receive comments by June 1, 2026.
A plain language summary of this proposed rule is available at:
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The Western Pacific Fishery Management Council (Council) and NMFS prepared a draft environmental assessment (EA) that describes the potential impacts on the human environment that could result from the proposed action. The draft EA is available at:
David O'Brien, NMFS PIRO Sustainable Fisheries, 808-725-5038.
NMFS and the Council manage U.S. commercial fishing for Pelagic Management Unit Species (PMUS) under the Fishery Ecosystem Plan for Pelagic Fisheries of the Western Pacific Region (FEP) and implementing Federal regulations. Although the FEP indicates that PMUS have statutory exemptions from annual catch limits (ACL), the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) authorizes the Council to recommend catch limits for PMUS if such actions are deemed appropriate and consistent with the Magnuson-Stevens Act and other statutory mandates.
The WCFPC is the regional fisheries management organization that manages WCNPO striped marlin internationally. A 2023 stock assessment for WCNPO striped marlin indicates that while the stock was experiencing overfishing, it was not overfished. Subsequent negotiations at the WCPFC have resulted in adoption of a rebuilding plan for this stock that requires rebuilding to 20 percent of unfished biomass with at least 60 percent probability by 2034. In December 2024, the WCPFC adopted a new CMM for WCNPO striped marlin (CMM 2024-06; available at
The base U.S. catch limit specified in CMM 2024-06 is 228.4 mt (503,500 lb), or 9.5 percent of the TAC for the stock. The U.S. catch limit would apply to retained striped marlin caught by all vessels of the United States in the Pacific Ocean north of the Equator (0° latitude) and west of 150° W longitude. CMM 2024-06 allows an increase in the U.S. catch limit if there is unused TAC 2 years prior, up to a maximum of 165 mt. CMM 2024-06 also states that the United States may presume the availability of 165 mt of unused TAC from 2025-2027. The availability of unused TAC after 2027 is unknown at this time. The proposed catch limit framework will also account for any overage of the catch limit by subtracting it from the catch limit two years after the overage occurred, consistent with CMM 2024-06. The U.S. catch limit under the proposed framework thus depends on three factors: (1) a base catch limit for the United States set at 228.4 mt (503,500 lb); (2) the availability of unused quota relative to the overall international catch limit for the stock 2 years prior (set in advance by CMM
Hawaii-based longline fisheries catch approximately 97 percent or more of the total U.S. striped marlin landings and are monitored in-season. Other U.S. fisheries that catch striped marlin, especially the Hawaii-based troll and handline fisheries, lack real-time monitoring during the fishing season and their annual catch is only finalized post-season. Over the last 10 years (2015-2024), the total catch of troll and handline fisheries has averaged 2.6 percent of the total annual U.S. catch of WCNPO striped marlin and has never significantly exceeded 3 percent.
To ensure that the proposed catch limit is not exceeded, NMFS proposes, in alignment with the Council's recommendations, that the framework include a retention limit of 97 percent of the catch limit for any U.S. fishing vessel with a Hawaii longline limited entry permit issued under 50 CFR 665.801(b). This longline retention limit ensures that when troll and handline catches are finalized after the season ends, the total U.S. catch of WCNPO striped marlin will not exceed the catch limit.
Pursuant to this framework, NMFS would annually specify the WCNPO striped marlin limit and longline retention limit through the
If NMFS projects, based on vessel logbook, landing and other available information, that the retention limit will be reached, we will prohibit retention of striped marlin caught by U.S. longline vessels holding a Hawaii limited entry longline permit issued under 50 CFR 665.801(b) in the Pacific Ocean north of the Equator (0° latitude) and west of 150° W longitude for the remainder of the year. This retention prohibition would apply to striped marlin alive or dead when fishing gear is recovered. A retention prohibition would go into effect no earlier than 7 days after NMFS publishes a non-retention date notice in the
As the notification of a retention prohibition could occur while vessels are at sea fishing, NMFS proposes to include an exception for WCNPO striped marlin caught and retained on board longline vessels prior to the non-retention date. This exception would allow such fish to be landed within the 14 days following the non-retention date to allow time for vessels to return to port. Landing of this catch would have no impact on the projection of when the longline retention limit would be reached.
In addition to the proposed framework, NMFS proposes to specify a 2026 U.S. WCNPO striped marlin catch limit of 393.4 mt (867,300 lb) and a U.S. longline retention limit of 381.6 mt (841,300 lb). The 2026 catch limit is the U.S. base limit plus the unused TAC 2 years prior minus the catch overage 2 years prior (228.4 mt + 165 mt−0 mt = 393.4 mt) and the retention limit is 97 percent of the catch limit (393.4 mt * 0.97 = 381.6 mt), pursuant to the framework.
NMFS will not propose to specify a U.S. WCNPO striped marlin catch or U.S. longline retention limit for fishing year 2025 because that fishing year has already ended. The NMFS Pacific Islands Regional Administrator, in consultation with the Council, will update the U.S. catch and retention limits for 2027 and subsequent years by publishing an annual specification of the limits pursuant to the framework and consistent with limits set by the WCPFC in the
The proposed framework is consistent with international management requirements of CMM 2024-06 which expire at the end of 2027. We anticipate a new CMM will be adopted by the WCPFC that is consistent with this proposed framework and we would continue to apply it after 2027. If an updated CMM modifies the methodological basis for determination of U.S. catch limits, we would propose a new framework via rulemaking in the
NMFS will consider public comments on this proposed rule, including both the proposed framework and the proposed 2026 catch and retention limit specifications, and will announce the final rule in the
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the FEP, Magnuson-Stevens Act Section 303(c) and other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866.
This proposed rule is not an E.O. 14192 regulatory action because this rule is not significant under E.O. 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities.
The WCNPO striped marlin stock is experiencing overfishing due to excessive international fishing pressure. NMFS proposes this framework to determine catch limits for all U.S. fisheries and retention limits by U.S. longline fisheries under a Hawaii longline limited entry permit for WCNPO striped marlin (
The proposed action would apply to the hundreds of vessels that participate in the Hawaii troll and handline fisheries as well as up to 164 vessels with Hawaii limited entry permits (149 active as of December 2025). However, handline and troll fisheries would not be directly affected by the proposed action, as neither the retention limit nor the retention prohibition would apply to them. The Hawaii longline fleet, which would be subject to the retention limit, consists of deep-set longline participants who target tuna and shallow-set longline participants who target swordfish. Both components of the longline fishery incidentally catch WCNPO striped marlin and can opt to sell those catch. In 2024, the Hawaii longline fishery earned a fleetwide revenue of $102.9 million; the 147 longline vessels that fished in 2024 each earned $700,000 on average that year. Landings of WCNPO striped marlin by Hawaii longline vessels ranged from 182 to 565 mt during the 2020-2024 time frame with an average of 305 mt. The landing price of striped marlin has shown high variability in recent years, ranging from an average price of $2.78 per pound in 2023 to $0.99 per pound in 2024. The average price for striped marlin through December 9, 2025 (average 2025 price) was $1.49 per pound, and 2025 annual catch was projected to be 550 mt.
Under the proposed action, if U.S. longline fisheries are projected to reach the 2026 retention limit (381.6 mt), NMFS would prohibit retention of WCNPO striped marlin by the Hawaii deep-set and shallow-set longline fleet through the end of the year. This would result in a loss of potential revenue for the longline fishery participants, as well as a reduction of striped marlin supply to consumers. Given recent 5-year average longline catches are 305 mt (672,400 lb), we do not anticipate needing a retention prohibition in 2026, even though catches in 2024 and projected for 2025 exceed the proposed 2026 longline retention limit. If 2026 catch is similar to that in 2024 (565 mt (1,246,100 lb)) and the 2026 retention limit is 381.6 mt, the fleet could potentially discard 183.4 mt (404,327 lb) of WCNPO striped marlin catch. This would represent a loss in revenue of $400,284, based on the 2024 price of $0.99 per pound or $1,124,030 based on the 2023 price of $2.78 per pound. Using 149 active longline vessels (in December 2025), this revenue loss would be an estimated $2,686 to $7,544 per vessel. By comparison, in 2024, the Hawaii longline fleet earned $102.9 million from all catch, or $700,000 per vessel on average for the 147 vessels actively fishing (two fewer than in 2025). If 149 longline vessels were to earn similar per-vessel revenues in 2026, the expected loss in revenue would be 0.4 percent to 1.1 percent of total revenue per vessel.
As for 2027 and later years, the WCPFC catch and longline retention limits have not been set yet, but they could be lower than the 2026 limits, ranging 228.4 to 393.4 mt (catch limit) and 221.5 to 381.6 mt (retention limit). The likelihood of reaching the retention limit would be higher and the associated retention prohibition date would occur earlier in the year with lower retention limits, leading to potentially higher revenue losses compared to higher retention limits. Based on the past 5 full fishing years, catch from longline fisheries could range from 182 to 565 mt with an expected catch of 305 mt. In the extreme case, with a retention limit of 221.5 t, the lowest foreseeable limit under the proposed action, the fishery would have to discard 343.5 mt of striped marlin catch if catch were to be as high as 565 mt, which would represent a loss in fleetwide revenue of $2,105,258 and per vessel revenue loss of $14,129 at 2023 prices or fleetwide revenue losses of $749,714 and $5,032 per vessel at 2024 prices. If longline vessels earned revenues at levels similar to 2024 ($700,000 per vessel on average), the expected percentage of per vessel revenue loss due to a retention limit of 221.5 mt could range between 0.7 percent (2024 prices) and 2.0 percent (2023 prices) of total revenue per vessel. Striped marlin prices peak in February and March, and again in July-September, which could be prior to any potential prohibition in retention. Any overage from 2025 may apply to 2027 catch and retention limits which could further reduce those limits for 2027 and lead to higher revenue losses in 2027 for the Hawaii longline fishery. If, as a combined result of WCPFC decision on catch and retention limits and 2025 overage, the 2027 retention limit were set so that WCNPO striped marlin retention was prohibited throughout the year, the percentage of revenue loss to the Hawaii longline fishery in 2027 could be as high as 3.3 percent using the higher 2023 price and the highest annual catch during 2020-2024. Using average 5 year catch and 2024 prices, NMFS expects per vessel revenue loss to be 0.6 percent. The prohibition on striped marlin retention would not apply to troll or handline fisheries and these fishery participants would be able to sell striped marlin catch throughout the year.
NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (North American Industry Classification System (NAICS) code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. Based on available information, NMFS has determined that all affected entities are small entities under the NMFS standard, as they are engaged in the business of fish harvesting, independently owned or operated, are not dominant in their field of operation, and have annual gross receipts not in excess of $11 million. Even though this proposed action may apply to a substantial number of entities, based on our analysis the implementation of this action would not result in significant adverse economic impacts to individual entities.
NMFS anticipates no change in fishing activity from the proposed action, independent of the retention limit being reached (
For the reasons above, NMFS does not expect the proposed action to have a significant economic impact on a substantial number of small entities.
This proposed rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
Fisheries, Fishing, Hawaii, Longline, Limited access permit, Pacific Islands, Western Pacific.
For the reasons set out in the preamble, NMFS proposes to amend 50 CFR part 665 as follows:
16 U.S.C. 1801
(uu) Fail to immediately release any striped marlin captured on or after the non-retention date in the Pacific Ocean north of the Equator (0° latitude) and west of 150° W longitude by a vessel registered for use under a longline permit issued under § 665.801(b), in violation of § 665.813(l).
(l) Specification of striped marlin catch and longline retention limits.
(1) The Regional Administrator shall by notice in the
(2) The U.S. catch limit will be consistent with the international limit for the United States set by the Western and Central Pacific Fisheries Commission.
(i) The international limit is based on a base limit for the United States, plus available underage across all nations' catch of the stock 2 years prior minus any overage of the U.S. catch limit 2 years prior.
(ii) [Reserved]
(3) The longline retention limit will be 97 percent of the U.S. catch limit.
(i) Catches in troll and handline fisheries, for which there are no in-season catch estimates, are less than 3 percent of the total U.S. catch of striped marlin on average each year. Setting the longline retention limit at 97 percent ensures that when the catches from these other fisheries are added post-season, the total U.S. catch limit is not exceeded.
(ii) [Reserved]
(4) NMFS will monitor striped marlin landings with respect to the limits established under paragraphs (l)(2) and (l)(3) of this section using longline landings, data submitted in logbooks, and other available information.
(5) When the longline retention limit is projected to be reached based on analyses of available information in paragraph (l)(4) of this section, the Regional Administrator shall provide notice in the
(6) Once the non-retention date is noticed in the
(i) Exception for striped marlin retained prior to the non-retention date. Any striped marlin captured by longline gear in the Pacific Ocean north of 0° latitude and west of 150° W longitude already on board a fishing vessel registered for use with a Hawaii longline limited access permit issued under § 665.801(b) before the non-retention date noticed pursuant to paragraph (l)(5) of this section may be retained on board, transshipped, and/or landed, to the extent authorized by applicable laws and regulations, provided that the striped marlin is landed within 14 days after the effective non-retention date.
(ii) [Reserved]
(7) All striped marlin captured by longline gear in the Pacific Ocean north of 0° latitude and west of 150° W longitude on or after the non-retention date noticed in the
Natural Resources Conservation Service (NRCS), United States Department of Agriculture (USDA).
Notice of availability; record of decision.
NRCS announces the availability of the Record of Decision (ROD) for the Rattlesnake Creek Watershed Plan and Final Environmental Impact Statement (Final Plan-EIS) in Stafford County, Kansas. NRCS has selected the “Augmentation Wellfield and Groundwater Use Reduction Alternative” as the preferred alternative. This alternative includes constructing an augmentation wellfield, retiring 2,500 acre-feet of water rights, and implementing an adaptive management strategy to improve water availability for the Quivira National Wildlife Refuge while supporting long-term agricultural water management in the watershed.
The ROD and Final Plan-EIS are available on the NRCS project website at:
Dean Krehbiel, (785) 832-4500,
The ROD identifies NRCS's selected alternative for the Rattlesnake Creek Watershed project, as described in the December 2025 Final Plan-EIS for Stafford County, Kansas. NRCS reached its decision after reviewing the Final Plan-EIS, which is available on the NRCS project website listed in the Addresses section of this notice and was announced on January 23, 2026, through a notice of availability (91 FR 2930). The Final Plan-EIS evaluated the proposed action, the no-action alternative, and other alternatives. NRCS has selected the proposed action alternative, titled “Augmentation Wellfield and Groundwater Use Reduction Alternative.” This alternative includes constructing an augmentation wellfield, retiring 2,500 acre-feet of water rights, and implementing an adaptive management strategy to improve water availability for the Quivira National Wildlife Refuge while supporting long-term agricultural water management in the watershed.
The ROD documents the basis for NRCS's decision on the selected alternative, including the mitigation measures that will be implemented and the environmental, social, and economic factors considered under the National Environmental Policy Act (NEPA). NRCS concludes that the selected alternative provides the most balanced approach to meeting project objectives while minimizing adverse effects.
NRCS reviewed and considered all substantive comments received on the Final Plan-EIS following publication of the notice of availability on January 23, 2026 (91 FR 2930). While the comments did not require changes to the Final Plan-EIS, a summary of the comments and NRCS's responses, along with supporting materials, is available on the NRCS project website listed in the
This notice is issued in accordance with the polices set forth under NEPA (42 U.S.C. 4332).
U.S. Commission on Civil Rights.
Notice of virtual business meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Michigan Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public meeting via Zoom. The purpose of the meeting is to continue discussing their proposal for the Committee's study on civil rights implications of the Michigan government's use of AI.
Thursday, May 14, 2026, from 12:00 p.m. to approximately 1:30 p.m. Eastern Time.
This meeting will be held via Zoom.
Mallory Trachtenberg, Designated Federal Officer, at
This Committee meeting is available to the public through the registration link above. Any interested members of the public may attend this meeting. An open comment period will be provided to allow members of the public to make oral comments as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the scheduled meeting. Written comments may be submitted via:
Records generated from these meetings may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after each meeting. Records of the meetings will be available via the file sharing website,
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Comments must be submitted by June 30, 2026.
The U.S. Department of Commerce (Commerce) encourages any person having information on foreign government subsidy programs which benefit articles of cheese subject to an in-quota rate of duty to submit such information in writing. All comments must be submitted through the Federal eRulemaking Portal at
Samuel Brummitt, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-7851.
On January 30, 2026, pursuant to section 702(h) of the Trade Agreements Act of 1979, as amended (the Act), Commerce published the quarterly update to the annual listing of foreign government subsidies on articles of cheese subject to an in-quota rate of duty covering the period July 1, 2025, through September 30, 2025.
Pursuant to section 702(h) of the Act, we hereby provide Commerce's update of subsidies on articles of cheese that were imported during the period October 1, 2025, through December 31, 2025. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available. Commerce will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed.
This determination and notice are in accordance with section 702(a) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Every five years, pursuant to the Tariff Act of 1930, as amended (the Act), the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission automatically initiate and conduct reviews to determine whether revocation of an antidumping duty or countervailing duty order or termination of an investigation suspended under section 704 or 734 of the Act would be likely to lead to continuation or recurrence of dumping or a countervailable subsidy (as the case may be) and of material injury.
Pursuant to section 751(c) of the Act, the following Sunset Reviews are scheduled for initiation in June 2026 and will appear in that month's
No Sunset Reviews of suspended investigations are scheduled for initiation in June 2026.
Commerce's procedures for the conduct of Sunset Reviews are set forth in 19 CFR 351.218. The
Pursuant to 19 CFR 351.103(c), Commerce will maintain and make available a service list for these proceedings. To facilitate the timely preparation of the service lists, it is requested that those seeking recognition as interested parties to a proceeding contact Commerce in writing within 10 days of the publication of the Notice of Initiation.
Note that if Commerce receives a Notice of Intent to Participate from a member of the domestic industry within 15 days of the date of initiation, the review will continue.
Thereafter, any interested party wishing to participate in the Sunset Review must provide substantive comments in response to the notice of initiation no later than 30 days after the date of initiation. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f).
In prior proceedings we have encouraged interested parties to provide an executive summary of their comments, including footnotes. In these sunset reviews, we request that interested parties provide, at the beginning of their comments, an executive summary for each issue raised in their comments. Further, we request that interested parties limit their public executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the decision memorandum that will accompany the notice to be published in the
This notice is not required by statute but is published as a service to the international trading community.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that the sole producer/exporter subject to this administrative review, Pipe & Piling Supplies Ltd. (Pipe & Piling), made sales of the subject merchandise at less than normal value during the period of review (POR) May 1, 2023, through April 30, 2024. Further, we determine that Evraz Inc. NA (Evraz) had no reviewable shipments of subject merchandise during the POR.
Applicable May 1, 2026.
Bushra Bani-Salman, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-9170.
On September 12, 2025, Commerce published the
Due to the lapse in appropriations and Federal Government shutdown, on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days.
For a complete description of the events that occurred since the
Commerce conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).
The product subject to the
All issues raised in the case and rebuttal briefs are listed in the appendix to this notice and addressed in the Issues and Decision Memorandum.
As discussed in the Issues and Decision Memorandum, we continue to assign to the mandatory respondent in this administrative review, Pipe & Piling,
In the
Commerce determines that the following weighted-average dumping margin exists for the period May 1, 2022, through April 30, 2023:
Normally, Commerce will disclose to the parties in a proceeding the calculations performed in connection with a final results of review within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of final results in the
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S.
For Pipe & Piling, we will instruct CBP to assess antidumping duties on all appropriate entries based on the dumping margin listed in the “Final Results of Review” section, above. For Evraz, we will instruct CBP to assess antidumping duties on all appropriate entries at the rate equal to the cash deposit rate of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the POR, in accordance with 19 CFR 351.212(c)(1)(i).
Commerce intends to issue assessment instructions to CBP regarding Pipe & Piling and Evraz no earlier than 41 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date in the
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to an APO of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
In accordance with the Tariff Act of 1930, as amended (the Act), the U.S. Department of Commerce (Commerce) is automatically initiating the five-year reviews (Sunset Reviews) of the antidumping duty (AD) and countervailing duty (CVD) orders and suspended investigations listed below. The U.S. International Trade Commission (ITC) is publishing concurrently with this notice its notice of
Applicable May 1, 2026.
Commerce official identified in the
Commerce's procedures for the conduct of Sunset Reviews are set forth in its
In accordance with section 751(c) of the Act and 19 CFR 351.218(c), we are initiating the Sunset Reviews of the following AD and CVD orders and suspended investigations:
As a courtesy, we are making information related to sunset proceedings, including copies of the pertinent statute and Commerce's regulations, Commerce's schedule for Sunset Reviews, a listing of past revocations and continuations, and current service lists, available to the public on Commerce's website at the following address:
In accordance with section 782(b) of the Act, any party submitting factual information in an AD/CVD proceeding must certify to the accuracy and completeness of that information. Parties must use the certification formats provided in 19 CFR 351.303(g). Commerce intends to reject factual submissions if the submitting party does not comply with applicable revised certification requirements.
Pursuant to 19 CFR 351.103(d), Commerce will maintain and make available a public service list for these proceedings. Parties wishing to participate in any of these five-year reviews must file letters of appearance as discussed at 19 CFR 351.103(d). To facilitate the timely preparation of the public service list, it is requested that those seeking recognition as interested parties to a proceeding submit an entry of appearance within 10 days of the publication of the Notice of Initiation. Because deadlines in Sunset Reviews can be very short, we urge interested parties who want access to proprietary information under administrative protective order (APO) to file an APO application immediately following publication in the
Domestic interested parties, as defined in sections 771(9)(C), (D), (E), (F), and (G) of the Act and 19 CFR 351.102(b), wishing to participate in a Sunset Review must respond not later than 15 days after the date of publication in the
If we receive an order-specific notice of intent to participate from a domestic interested party, Commerce's regulations provide that
In prior proceedings we have encouraged interested parties to provide an executive summary of their comments, including footnotes. In these sunset reviews, we request that interested parties provide at the beginning of their comments, an executive summary for each issue raised in their comments. Further, we request that interested parties limit their public
This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable April 27, 2026.
Joshua Nixon, Office VIII, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-8361.
On April 6, 2026, the U.S. Department of Commerce (Commerce) received a countervailing duty (CVD) petition concerning imports of carbon and alloy steel wire rod (wire rod) from Algeria, filed in proper form on behalf of Charter Steel, Commercial Metals Company, Liberty Steel USA, Nucor Corporation, and Optimus Steel, LLC (collectively, the petitioners), domestic producers of wire rod.
Between April 10 and 20, 2026, Commerce requested supplemental information pertaining to certain aspects of the Petition in supplemental questionnaires.
In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioners allege that the Government of Algeria (GOA) is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to producers of wire rod in Algeria. Consistent with section 702(b)(1) of the Act and 19 CFR 351.202(b), for those alleged programs on which we are initiating a CVD investigation, the Petition was accompanied by information reasonably available to the petitioners supporting their allegations.
Commerce finds that the petitioners filed the Petition on behalf of the domestic industry, because the petitioners are interested parties, as defined in section 771(9)(C) of the Act. Commerce also finds that the petitioners demonstrated sufficient industry support with respect to the initiation of the requested CVD investigation.
Because the Petition was filed on April 6, 2026, the POI is January 1, 2025, through December 31, 2025.
The product covered by this investigation is wire rod from Algeria. For a full description of the scope of this investigation,
As discussed in the
Commerce requests that any factual information that parties consider relevant to the scope of this investigation be submitted during that period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party must contact Commerce and request permission to submit the additional information.
All submissions to Commerce must be filed electronically via Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS), unless an exception applies.
Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified the GOA of the receipt of the Petition and provided an opportunity for consultations with respect to the Petition.
Additionally, given the nature of certain subsidy programs alleged in the Petitions, on April 8, 2026, Commerce issued a letter to the Government of the People's Republic of China (GOC), providing the GOC with the opportunity to meet with Commerce officials.
Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) at least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The U.S. International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioners do not offer a definition of the domestic like product distinct from the scope of the investigation.
In determining whether the petitioners have standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the appendix to this notice. To establish industry support, the petitioners provided the 2025 production for the U.S. producers that support the Petition and compared this to the total 2025 production of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petition, the First General Issues and CVD Supplement, the Second General Issues Supplement, and other information readily available to Commerce indicates that the petitioners have established industry support for the Petition.
Based upon the examination of the Petition and supplemental responses, we find that they meet the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of wire rod from Algeria benefit from countervailable subsidies conferred by the GOA. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.
Based on our review of the Petition, we find that there is sufficient information to initiate a CVD
In the Petition, the petitioners identified three companies in Algeria.
On April 24, 2026, Commerce released CBP data on imports of wire rod from Algeria under administrative protective order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment on CBP data and/or respondent selection must do so within three days of the publication date of the notice of initiation of this investigation.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on Commerce's website at
In accordance with section 702(b)(4)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the GOA via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).
We note that Algeria is not a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act,
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors of production under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Section 351.301(b) of Commerce's regulations requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by Commerce. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301, or as otherwise specified by Commerce.
Any party submitting factual information in an antidumping duty or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. Parties wishing to participate in this investigation should ensure that they meet the requirements of 19 CFR 351.103(d) (
This notice is issued and published pursuant to sections 702 and 777(i) of the Act, and 19 CFR 351.203(c).
The merchandise subject to this investigation covers certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately circular cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (
The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.90.0090 and 7227.90.6090 of HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that SeAH Steel Corporation (SeAH), sold large diameter welded pipe (welded pipe) from the Republic of Korea (Korea) in the United States at prices below normal value (NV) during the period of review (POR) May 1, 2023, through April 30, 2024. Commerce also determines that Hyundai Steel Pipe Co., Ltd. (HSP) did not sell welded pipe from Korea at prices below NV during the POR.
Applicable May 1, 2026.
Katerina Katsiadas or Brian Smith, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4929 or (202) 482-1766, respectively.
On August 29, 2025, Commerce published the
Due to the lapse in appropriations and Federal Government shutdown, on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days.
A summary of the events that occurred since Commerce published the
Commerce conducted this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act).
The merchandise covered by the
We addressed all issues raised in the case and rebuttal briefs filed in this administrative review in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is in the Appendix I to this notice.
Based on our evaluation of the comments received from interested parties regarding our
Section 735(c)(5)(A) of the Act provides that the estimated weighted-average dumping margin for all other producers and exporters not individually examined shall be an
We determine that the following estimated weighted-average dumping margins exist for the period May 1, 2023 through April 30, 2024:
Commerce intends to disclose its calculations and analysis performed for these final results of review to interested parties within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in the
Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b). Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
Because the final weighted-average dumping margin for SeAH is not zero or
Consistent with Commerce's clarification of its assessment practice, for entries of subject merchandise during the POR produced by HSP or SeAH where it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original less-than-fair-value (LTFV) investigation of 7.08 percent
The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review in the
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that unwrought palladium (palladium) from the Russian Federation (Russia) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation is January 1, 2025, through June 30, 2025.
Applicable May 1, 2026.
Benjamin Nathan or Rebecca Janz, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3834 or (202) 482-2972, respectively.
On February 19, 2026, Commerce published in the
The product covered by this investigation is palladium from Russia. For a complete description of the scope of this investigation,
We received no comments from interested parties on the scope of the investigation as it appeared in the
Because Commerce had no participating respondents in this investigation, no verification was conducted.
As discussed in the
Because no Russian exporters qualified for a separate rate, we did not calculate producer/exporter combination rates for this final determination.
Commerce determines that the following estimated weighted-average dumping margin exists:
Normally, Commerce will disclose to interested parties the calculations performed in connection with a final determination within five days of any public announcement of the final determination or, if there is no public announcement, within five days of the date of publication of the notice of the final determination in the
In accordance with section 735(c)(1)(B) of the Act, Commerce will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of subject merchandise, as described in the appendix to this notice, entered, or withdrawn from warehouse, for consumption on or after February 19, 2026, which is the date of publication of the affirmative
Pursuant to section 735(c)(1)(B)(ii) of the Act and 19 CFR 351.210(d), we will instruct CBP to require a cash deposit for such entries of merchandise equal to the amount by which the normal value exceeds the U.S. price as follows: (1) for all Russian producers or exporters of subject merchandise, the cash deposit rate will be equal to the estimated dumping margin established for the Russia-wide entity; and (2) for all third country exporters of subject merchandise, the cash deposit rate is also the cash deposit rate applicable to the Russia-wide entity. These suspension of liquidation instructions will remain in effect until further notice.
To determine the antidumping duty (AD) cash deposit rate, Commerce normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion CVD proceeding. Accordingly, where Commerce has made a final affirmative determination of countervailable export subsidies, Commerce offsets the estimated weighted-average dumping margin by the appropriate CVD rate. However, Commerce has not yet made a final CVD determination. Accordingly, Commerce has not offset the estimated weighted-average dumping margin in this final determination.
In accordance with section 735(d) of the Act, Commerce will notify the ITC of its final affirmative determination of sales at LTFV. Because Commerce's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports, or sales (or the likelihood of sales) for importation, of palladium from Russia no later than 45 days after this final determination. If the ITC determines that material injury or threat of material injury does not exist, this proceeding will be terminated, all cash deposits will be refunded or canceled, and suspension of liquidation will be lifted. If the ITC determines that such injury does exist, Commerce will issue an AD order directing CBP to assess, upon further instructions by Commerce, antidumping duties on all imports of the subject merchandise that are entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation and Cash Deposit Requirements” section above.
This notice serves as the only reminder to parties subject to an APO of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This final determination is issued and published in accordance with sections 735(d) and 777(i) of the Act, and 19 CFR 351.210(c).
The scope of this investigation is unwrought palladium. Unwrought palladium includes palladium, whether or not refined, in the form of ingots, blocks, lumps, billets, cakes, slabs, pigs, cathodes, anodes, briquettes, cubes, sticks, grains, sponge, pellets, shot, powder, and similar primary forms.
Unwrought palladium is covered by the scope regardless of production method. The scope includes unwrought palladium produced through ore extraction, unwrought palladium produced by recycling palladium-containing scrap, unwrought palladium produced by any other method, and blends of unwrought palladium produced by different methods.
The scope includes unwrought palladium that is commingled with unwrought palladium from sources not subject to this investigation or commingled with other metals. Only the subject unwrought palladium component of such commingled
Subject merchandise includes merchandise matching the above description that has been finished, packaged, or otherwise processed in a third country, including by refining, grinding, commingling, adding or removing additives (such as other metals), or performing any other finishing, packaging, or processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the subject country.
The covered merchandise is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheading 7110.21.0000. Unwrought palladium meeting the scope description may also enter under HTSUS subheading 7110.29.0000. Although the HTSUS subheadings are provided for convenience and for customs purposes, the written description of the subject merchandise is dispositive.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability; request for comments.
NMFS announces the availability of the draft Supplemental Programmatic Environmental Assessment (SPEA) for Fisheries Research Conducted and Funded by the Southwest Fisheries Science Center. Publication of this notice begins the official public comment period for this SPEA. The purpose of this draft SPEA is to evaluate potential changes in the direct and indirect effects of research previously analyzed in the 2015 Southwest Fisheries Science Center (SWFSC) Programmatic Environmental Assessment (PEA) and the 2020 SWFSC SPEA, and new or modified research activities along the U.S. west coast and in the Scotia Sea area off Antarctica. Where necessary, updates to certain information on species, stock status, or other components of the affected environment that may result in different conclusions from the 2015 PEA and 2020 SPEA are presented in this analysis.
Comments must be received no later than June 1, 2026.
Electronic comments on the draft SPEA may be submitted to Elise Kohli, Environmental Compliance Specialist, at
A copy of the draft SPEA may be obtained by writing to the address specified above, telephoning the contact listed below (see
Elise Kohli,
The SWFSC is the research arm of NMFS in the Southwest Region. The purpose of SWFSC fisheries research is to produce scientific information necessary for the management and conservation of living marine resources along the U.S. west coast in the California Current Ecosystem (CCE), throughout the Eastern Tropical Pacific Ocean, and in the Scotia Sea area off Antarctica. SWFSC's research is needed to promote both the long-term sustainability of marine resources and the recovery of certain species, while generating social and economic opportunities and benefits from their use. Primary research activities include: trawl and seine surveys to support assessments of coastal pelagic species and groundfish in the CCE; fish cages to support groundfish biological studies; ecosystem surveys using active acoustic systems and other oceanographic equipment in the CCE; and surveys using unmanned systems in the Antarctic Research Area and CCE.
NMFS has prepared the draft SPEA (EAXX-006-48-1WC-1737064752) under NEPA to evaluate alternatives for conducting and funding fisheries and ecosystem research activities as the primary Federal action. In the draft SPEA, NMFS also evaluates the proposed promulgation of regulations and authorization of marine mammal take incidental to the fisheries research under the Marine Mammal Protection Act (MMPA). Additionally, the draft SPEA evaluates activities that could result in the incidental take of species listed under the Endangered Species Act (ESA) within the proposed research action area.
The following two alternatives are currently evaluated in the draft SPEA
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The alternatives include a program of fisheries and ecosystem research projects conducted or funded by the SWFSC as the primary Federal action. Because this primary action is connected to a secondary Federal action (also called a connected action under NEPA), to consider authorizing incidental take of marine mammals under the MMPA, NMFS must identify as part of this evaluation “(t)he means of effecting the least practicable adverse impact on the species or stock and its habitat” (section 101(a)(5)(A) of the MMPA [16 U.S.C. 1361
Potential direct and indirect effects on the environment are evaluated under each alternative in the draft SPEA. The environmental effects on the following resources are considered: physical environment, special resource areas, fish, marine mammals, birds, sea turtles, invertebrates, and the social and economic environment.
NMFS requests comments on the draft SPEA for fisheries research conducted and funded by the NMFS SWFSC. Please include, with your comments, any supporting data or literature citations that may be informative in substantiating your comment.
National Oceanic & Atmospheric Administration (NOAA), Commerce.
Notice of information collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before June 30, 2026.
Interested persons are invited to submit written comments to Adrienne Thomas, NOAA PRA Officer, at
Requests for additional information or specific questions related to collection activities should be directed to Luther Young III, Office of Marine and Aviation Operations, 1315 East West Hwy, 10th Floor, Silver Spring, MD 20910, telephone number (202) 710-3285, email address:
This is a request for extension of an existing information collection.
The Wage Mariner Hiring Portal (WMHP) is an internet-based system (website) that is designed to allow an applicant to apply for a “wage mariner” position within the National Oceanic and Atmospheric Administration (NOAA) fleet of maritime vessels. The WMHP system collects basic user information, wage mariner licensing, certifications, and relevant current and or past work history. The Department of Commerce (DOC), through NOAA, Office of Marine and Aviation Operations (OMAO) has special hiring authority under Code of Federal Regulations (CFR), Title 5, Chapter 1, Subchapter A, Part 3, § 3.2 and under the DOC Department Administrative Order (DAO) 202-302 Section 2, Subsection .02a. specific to the hiring of federal wage mariner employees. The regulations allow OMAO to hire wage mariners into excepted service positions within the NOAA fleet of ocean-going vessels in order to maintain adequate operations, maintenance, and safe staffing of the maritime ships.
No physical forms are used in this collection, it is all online. Applicants fill out basic personal, licensure, and work history information into a profile resume. Once their basic profile is complete, applicants can submit this resume to available wage mariner positions as shown on the WMHP website. The application information received is used to determine if the applicant meets the basic job qualification. The applicant's information is then passed on to the hiring official or it is placed in a pool of prospective candidates for future openings. Application information includes: first and last name, contact number and email address, wage mariner licenses and certifications, relevant work history.
Information will be collected electronically (internet) through an online web-based interactive system.
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The Department of Commerce will submit the following information
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
Commodity Futures Trading Commission.
Notice.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Information and Regulatory Affairs (OIRA), of the Office of Management and Budget (OMB), for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Comments must be submitted on or before June 1, 2026.
Written comments and recommendations for the proposed information collection should be submitted within 30 days of this notice's publication to OIRA, at
In addition to the submission of comments to
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1. Under Refine Documents Results—check the box to “Only show documents open for comment”;
2. Under Agency—select “See More” and check the box for “Commodity Futures Trading Commission,” then press the Apply button;
3. Identify this notice in the list of CFTC documents open for comment, press the “Comment” button to open the submission form, and follow the instructions on the form.
Alternatively, if you are viewing this notice on
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Please submit your comments using only one of these methods. To avoid possible delays with mail or in-person deliveries, submissions through
All comments must be submitted in English or, if not, accompanied by an English translation. Do not include in your comment text or attachments any personal identifying information or business information that you do not want published online. Comments (regardless of submission method) will be published without review for, and without removal of, any personal identifying information or information your business may consider confidential.
If you wish to submit confidential information for the Commission's consideration, please contact the CFTC personnel listed in this Notice under
The CFTC reserves the right, but shall have no obligation, to review, pre-screen, filter, or redact all or any part of your comment submission. The CFTC also reserves the right, without further notification, to refuse to publish or to remove from public view all or any part of your submission to the extent it contains content inappropriate for publication in a comment file, such as—without limitation—obscene language, threats of violence, solicitations for commercial sales or illegal activity, or obvious spam. If a submission that is refused for or withdrawn from publication because of inappropriate content also contains comments on the merits of this notice, such submission will be retained in the record for the matter and will be considered as required under the Administrative Procedure Act, the Paperwork Reduction Act, and other applicable laws, and may be accessible under the FOIA.
Lee McFarland, Attorney Advisor, Market Participants Division, Commodity Futures Trading Commission, (202) 418-5368; email:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
There are no capital costs or operating and maintenance costs associated with this collection.
Commodity Futures Trading Commission.
Notice.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Information and Regulatory Affairs (OIRA), of the Office of Management and Budget (OMB), for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Comments must be submitted on or before June 1, 2026.
Written comments and recommendations for the proposed information collection should be submitted within 30 days of this notice's publication to OIRA, at
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1. Under Refine Documents Results—check the box to “Only show documents open for comment”;
2. Under Agency—select “See More” and check the box for “Commodity Futures Trading Commission,” then press the Apply button;
3. Identify this notice in the list of CFTC documents open for comment, press the “Comment” button to open the submission form, and follow the instructions on the form.
Alternatively, if you are viewing this notice on
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Please submit your comments using only one of these methods. To avoid possible delays with mail or in-person deliveries, submissions through
All comments must be submitted in English or, if not, accompanied by an English translation. Do not include in your comment text or attachments any personal identifying information or business information that you do not want published online. Comments (regardless of submission method) will be published without review for, and without removal of, any personal identifying information or information your business may consider confidential.
If you wish to submit confidential information for the Commission's consideration, please contact the CFTC personnel listed in this Notice under
The CFTC reserves the right, but shall have no obligation, to review, pre-screen, filter, or redact all or any part of your comment submission. The CFTC also reserves the right, without further notification, to refuse to publish or to remove from public view all or any part of your submission to the extent it contains content inappropriate for publication in a comment file, such as—without limitation—obscene language, threats of violence, solicitations for commercial sales or illegal activity, or obvious spam. If a submission that is refused for or withdrawn from publication because of inappropriate content also contains comments on the merits of this notice, such submission will be retained in the record for the matter and will be considered as required under the Administrative Procedure Act, the Paperwork Reduction Act, and other applicable laws, and may be accessible under the FOIA.
Roger Smith, Division of Market Oversight, 202-418-5344, email:
In 2021, the Commission issued a final rule on position limits that implemented CEA section 4a and established the Commission's new position limits regime found in part 150 of the Commission's Regulations (“Final Rule”).
Separately, in 2016 the Commission issued a final rule amending Commission Regulation 150.4, which sets forth requirements regarding the aggregation of positions subject to federal position limits (the “Aggregation Rule”).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
There are no capital costs or operating and maintenance costs associated with this collection.
U.S. Army Corps of Engineers (USACE), Department of the Army, Department of Defense.
Notice of Intent; withdrawal.
USACE is issuing this notice to advise Federal, State, and local governmental agencies and the public that USACE is terminating the Collier County Coastal Storm Risk Management (CSRM) Feasibility Study and withdrawing its Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS) for said study, which was published in the
The NOI to prepare an EIS published in the
U.S. Army Corps of Engineers, Norfolk District, 803 Front Street, Norfolk, Virginia 23510.
Questions concerning this notice should be directed to Ms. Michelle Hamor at
The Collier County CSRM Study was initiated to investigate the feasibility of addressing storm and flood risks to vulnerable populations, property, infrastructure, and ecosystems along coastlines in Collier County, and develop and evaluate various alternatives aimed at managing those risks and increasing coastal resiliency against storm surge. Alternatives were formulated to address the full study scope in 2023. The time and cost to collect data and perform complex modeling required to properly identify a cost effective, viable solution led USACE to determine that current federal funding was insufficient to complete the analysis. USACE is therefore terminating this study and the preparation of the associated EIS, which was initiated by a NOI to Prepare an EIS in the
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Department of Education (ED) announces the opportunity to apply for competitive grants for the Fiscal Year (FY) 2026 Educational Technology, Media, and Materials for Individuals with Disabilities Program—Accessible Education Video Projects, Assistance Listing Number 84.327C.
Complete proposals must be submitted electronically through the
Eric Caruso. Telephone: (202) 987-0151. Email:
The purpose of the Educational Technology, Media, and Materials for Individuals with Disabilities Program is designed to improve results for children with disabilities by: (1) promoting the development, demonstration, and use of technology; (2) supporting educational activities designed to be of educational value in the classroom for children with disabilities; (3) providing support for captioning and video description that is appropriate for use in the classroom; and (4) providing accessible educational materials to children with disabilities in a timely manner. The FY 2026 competition includes an absolute priority, a competitive preference priority, selection criteria, and requirements. The absolute priority is: Accessible Education Video Projects. The competitive preference priority is Advancing Artificial Intelligence in Education.
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Department of Education (ED) announces the opportunity to apply for a competitive grant for the Fiscal Year (FY) 2026 Educational Technology, Media, and Materials for Individuals with Disabilities Program—National Center for Accessible Education Videos, Assistance Listing Number 84.327N.
Complete proposals must be submitted electronically through the
Eric Caruso. Telephone: (202) 987-0146. Email:
The purpose of the Educational Technology, Media, and Materials for Individuals with Disabilities Program is designed to improve results for children with disabilities by (1) promoting the development, demonstration, and use of technology; (2) supporting educational activities designed to be of educational value in the classroom for students with disabilities; (3) providing support for captioning and video description that is appropriate for use in the classroom; and (4) providing accessible educational materials to students with disabilities in a timely manner. The FY 2026
U.S. Department of Energy.
Notice of request for comments.
The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request with the Office of Management and Budget (OMB). The information collection requests a three-year extension of its collection, titled Application for Loans under the Advanced Technology Vehicles Manufacturing Incentive Program, OMB Control Number 1910-5137.
Comments regarding this proposed information collection must be received on or before June 1, 2026. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, please advise the DOE Desk Officer at OMB of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at (202) 881-9493.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Uchechukwu “Emeka” Eze, 1000 Independence Avenue SW, Ste. 4B-122, Washington, DC 20585-0121, telephone: (202) 586-1092, or by email at:
This information collection request contains:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
This document of the Department of Energy was signed on April 23, 2026, by Gregory A. Beard, Director, Office of Energy Dominance Financing, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
U.S. Department of Energy.
Notice of request for comments.
The Department of Energy (DOE) invites public comments on a proposed collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. The proposed collection allows BPA to solicit peer organizations for construction and design standards to identify advances that would benefit BPA and its customers if implemented.
Comments regarding this proposed information collection must be received on or before June 30, 2026. If you anticipate any difficulty in submitting comments within that period, contact the person listed in the
Written comments may be sent to Bonneville Power Administration, Attn: Stephanie Noell, Privacy Program, CGI-7, P.O. Box 3621, Portland, OR 97208-3621, or by email at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Attn: Stephanie Noell, Privacy Program, by email at
This information collection request contains:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
This document of the Department of Energy was signed on April 24, 2026, by Candice D. Palen, Information Collection Clearance Manager, Bonneville Power Administration, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any the above proceedings must file in
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following Complaints and Compliance filings in EL Dockets:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments received are subject to public disclosure. In general, comments received will be made available without change and will not be modified to remove personal or business information including confidential, contact, or other identifying information. Comments should not include any information such as confidential information that would not be appropriate for public disclosure.
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Benjamin W. McDonough, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551-0001, not later than May 18, 2026.
1.
Board of Governors of the Federal Reserve System.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments received are subject to public disclosure. In general, comments received will be made available without change and will not be modified to remove personal or business information including confidential, contact, or other identifying information. Comments should not include any information such as confidential information that would not be appropriate for public disclosure.
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Benjamin W. McDonough, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551-0001, not later than June 1, 2026.
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Board of Governors of the Federal Reserve System.
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by June 1, 2026.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:
William Parham at (410) 786-4669.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces the rechartering of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel), appointment of five new members to the Panel, and the next public meeting dates for the Panel on Tuesday, July 14, 2026, and Wednesday, July 15, 2026. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.
The Panel meeting will be held
The CLFS Policy Team via email,
The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs) (the Panel) is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m-1), as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), enacted on April 1, 2014. The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels.
Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (the Secretary) to consult with an expert outside advisory panel established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests, which may include the development, validation, performance, and application of such tests. Such individuals may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics.
The Panel will provide input and recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS), on the following:
• The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use “crosswalking” or “gapfilling” processes to determine payment for a specific new test.
• The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests.
• Other aspects of the payment system under section 1834A of the Act.
A notice announcing the establishment of the Panel and soliciting nominations for members appeared in the October 27, 2014
The new Panel member appointments are for 3-year terms.
Other Panel members include:
Unless extended, their terms will expire in August 30, 2027.
The Agenda for the July 14 and July 15, 2026, hybrid Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's charter:
• Calendar Year (CY) 2027 Clinical Laboratory Fee Schedule (CLFS) new and reconsidered test codes, which will be posted on the CMS website at
• Other CY 2027 CLFS issues designated in the Panel's charter and further described on our Agenda.
A detailed Agenda will be posted approximately 2 weeks before the meeting, on the CMS website at
This meeting is open to the public. Stand-by speakers may participate in the meeting in-person, via teleconference, and webinar. A stand-by speaker is an individual who will speak on behalf of a company or organization if the Panel has any questions during the meeting about technical information described in the public comments or presentation previously submitted or presented by the organization or company at the recent CLFS Annual Public Meeting for CY 2027 on June 10, 2026. The public may also attend the hybrid meeting in-person or view and/or listen-only to the meeting via teleconference and webinar. Please note that CMS reserves the right to shift the meeting format from hybrid to virtual-only, if for some reason, a hybrid format is not possible. If there is a need to shift to a virtual-only format, we will alert the public as soon as possible and post updated information on the CMS website at
Beginning May 1, 2026 and ending May 29, 2026 at 5:00 p.m. E.D.T., registration may be completed by stand-by speakers and in-person attendees. Individuals who intend to view and/or listen to the meeting virtually do not need to register. Stand-by speakers and individuals who intend to attend the meeting at the CMS campus must register online at
• Name.
• Indicate if individual is registering as a “Stand-by speaker” or “In-Person Attendee.”
• Organization or company name.
• Email addresses that will be used by the speaker to connect to the virtual meeting.
• Indicate if individual is a “Foreign National” visitor. Note: An additional review process is required for all foreign national visitors.
• Indicate any new or reconsidered code(s) for which a presentation or comment was submitted, if applicable.
Registration details may not be revised once they are submitted. If registration details require changes, a new registration entry must be submitted by the date specified in the
After registering, a confirmation email will be sent upon receipt of the registration. The email will provide information to the attendee in preparation for the meeting. Registration is only required for stand-by speakers and members of the public attending the meeting at the CMS campus (address specified in the
The Panel's recommendations regarding new and reconsidered test codes for CY 2027 will be posted approximately 2 weeks after the meeting on the CMS website at
The hybrid meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. We suggest that you arrive at the CMS campus and parking facilities between 9:00 a.m. and 10:00 a.m. E.D.T., so that you will be able to arrive promptly at the meeting by 10:00 a.m. E.D.T. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. We note that the public may not enter the CMS building earlier than 9:15 a.m. E.D.T. (45 minutes before the convening of the meeting).
Security measures include the following:
• Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. Persons without proper identification may be denied access to the building.
• Interior and exterior inspection of vehicles (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.
• Passing through a metal detector and inspection of items brought into the building. We note that all items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration.
Individuals attending, viewing, or listening to the meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, must send an email to the resource box (
The Secretary's Charter for the Medicare Advisory Panel on CDLTs is available on the CMS website at
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Mehmet Oz having reviewed and approved this document, authorizes Vanessa Garcia, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces meeting dates for a Clinical Laboratory Fee Schedule (CLFS) public meeting that includes the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Tuesday, September 15, 2026 and Wednesday, September 16, 2026. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests (CDLTs). During the meeting, the public will have an opportunity to present recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for CDLTs (crosswalking or gapfilling) for which CMS received no applicable information during the data reporting period from May 1, 2026 through July 31, 2026 to calculate Medicare payment rates. After the public provides this input, the Panel will provide its recommendations to the Secretary and the Administrator on payment recommendations for these CDLTs.
This meeting for the public and the Panel will be held
The CLFS Policy Team via email,
The CMS Press Office, for press inquiry, (202) 690-6145.
The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m-1), as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), enacted on April 1, 2014. The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels.
Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (the Secretary) to consult with an expert outside advisory panel established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests (CDLTs), which may include the development, validation, performance, and application of such tests. Such individuals may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics.
The Panel will provide input and recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS), on the following:
• The establishment of payment rates under section 1834A of the Act for new CDLTs, including whether to use “crosswalking” or “gapfilling” processes to determine payment for a specific new test.
• The factors used in determining coverage and payment processes for new CDLTs.
• Other aspects of the payment system under section 1834A of the Act.
A notice announcing the establishment of the Panel and soliciting nominations for members was published in the October 27, 2014
The Panel charter provides that Panel meetings will be held up to 4 times annually and the Panel Chair will serve for a period of 3 years, which may be extended at the discretion of the Administrator or his or her duly appointed designee. Additionally, the Panel Chair facilitates the meeting and the Designated Federal Official (DFO) or DFO's designee must be present at all meetings.
Section 1834A of the Act requires revisions to the payment methodology for CDLTs paid under the Clinical Laboratory Fee Schedule (CLFS). We implemented the requirements of section 1834A of the Act in the CLFS final rule that appeared in the June 23, 2016
The first data collection period occurred from January 1, 2016, through June 30, 2016 and the first data reporting period occurred from January 1, 2017, through March 31, 2017.
Under our existing regulations at 42 CFR 414.507(f), payment for a CDLT for which CMS receives no applicable information is based on the crosswalking or gapfilling methods described in § 414.508(b)(1) and (2). Consistent with this process and to support transparency in payment determinations, in early August 2026, CMS will post on the CMS website at
• What method of payment should be used to set rates for these test codes (crosswalking or gapfilling), as required by 42 CFR 414.507(f))?
• If crosswalking, specify the crosswalk code(s).
This virtual meeting will be conducted in two parts. During Part I, registered public participants may discuss and make recommendations regarding the basis of payment (that is, crosswalking or gapfilling) for CDLTs for which CMS received no applicable information to calculate Medicare payment rates. During Part II, the Panel will ask questions of the registered public participants and discuss the information presented in Part I and make recommendations for the establishment of payment rates for the test.
In Part I, due to time constraints, presentations must be brief, lasting no longer than 5 minutes. Written presentations must be electronically submitted to CMS on or before August 21, 2026. Presentation slots will generally be assigned based upon chronological order of receipt of presentation materials. In the event there is not enough time for presentations by everyone who is interested in presenting, we will only accept written presentations from those who submitted written presentations within the submission window and were unable to present due to time constraints. Presentations must be sent via email to our CLFS dedicated email box,
Presenters should submit all presentations using a standard PowerPoint template. In addition to the standard PowerPoint template available, presenters may also provide the same information from the PowerPoint presentation in a provided Excel worksheet template. Submitting the same information that is requested for the PowerPoint presentation in the Excel worksheet template will aid with triaging and reviewing recommendation information during the meeting and after the meeting, during the code review process. The standard PowerPoint presentation and Excel worksheet templates are available on the CMS website at
Presenters should address all of the following items (where applicable):
• Code(s) with the most current code descriptor.
• A recommendation with rationale for one of the two bases (crosswalking or gapfilling) for determining payment for the test code.
• Test costs.
• Charges.
Additionally, presenters should provide the data on which their recommendations are based. Presentations that do not address the previous four items (where applicable) may be considered incomplete and may not be considered by CMS when making a determination. However, we may request missing information following the meeting to prevent a recommendation from being considered incomplete.
In Part II of the meeting, the Panel will make recommendations to the Secretary and the Administrator of CMS regarding crosswalking and gapfilling for the codes discussed during Part I, the CDLTs for which CMS received no applicable information during the data reporting period to calculate Medicare payment rates.
Taking into account the comments and recommendations (and accompanying data) received at this meeting from the public and the Panel, we intend to post our proposed determinations with respect to the appropriate basis for establishing a payment amount for each test code along with an explanation of the reasons for each determination, the data on which the determinations are based, and a request for public written comments on these determinations on our website in late September 2026. This website can be accessed at
The Agenda for the September 15 and 16, 2026, virtual-only meeting with the public and the Panel will provide for discussion and comment on the following topics:
• CY 2027 CDLT codes for which CMS received no applicable information to calculate a Medicare payment rate, which will be posted on the CMS website at
• Other CY 2027 CLFS issues designated in the Panel's charter and further described on our Agenda.
A detailed Agenda will be posted approximately 2 weeks before the meeting, on the CMS website at
This meeting is open to the public. Speakers may participate in the meeting via teleconference and webinar. A speaker is an individual who submitted a presentation or who will speak on behalf of a company or organization if the Panel has any questions during the meeting about technical information described in the public comments or presentation previously submitted or presented by the organization or company.
Beginning August 3, 2026 and ending August 21, 2026 at 5:00 p.m. E.D.T., registration may be completed by presenters. Individuals who intend to view and/or listen to the meeting virtually do not need to register. Speakers must register online at
• Name.
• Confirm Presentation.
• Organization or company name.
• Email addresses that will be used by the speaker to connect to the virtual meeting.
• Code(s) for which the company or organization the individual is representing submitted a comment or presentation, if applicable.
Registration details may not be revised once they are submitted. If registration details require changes, a new registration entry must be submitted by the date specified in the “DATES” section of this notice. Additionally, registration information must reflect individual level content and not reflect an organization name. Also, we request organizations register all individuals at the same time. That is, one individual may register multiple individuals at the same time. Individuals who are not registered in advance will not be able to speak during the meeting.
After registering, a confirmation email will be sent upon receipt of the registration. The email will provide information to the speaker in preparation for the meeting. Registration is only required for speakers. All registration must be submitted by the deadline specified in the “DATES” section of this notice. Note: No registration is required for participants who plan to view this meeting via webinar or listen via teleconference.
The Panel's recommendations will be posted approximately 2 weeks after the meeting on the CMS website at
Individuals viewing or listening to the meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, must send an email to the resource box (
The Secretary's Charter for the Medicare Advisory Panel on CDLTs is available on the CMS website at
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Mehmet Oz having reviewed and approved this document, authorizes Vanessa Garcia, who is the
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule for calendar year 2027. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
The CLFS Annual Public Meeting will be held virtually and in-person at the Centers for Medicare & Medicaid Services (CMS), Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
The CLFS Policy Team and submit all inquiries to the CLFS dedicated email
Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) required the Secretary of the Department of Health and Human Services (the Secretary) to establish procedures for coding and payment determinations for new clinical diagnostic laboratory tests (CDLTs) under Part B of title XVIII of the Social Security Act (the Act) that permit public consultation in a manner consistent with the procedures established for implementing coding modifications for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). The procedures and Clinical Laboratory Fee Schedule (CLFS) public meeting announced in this notice for new tests are in accordance with the procedures published on November 23, 2001 in the
Section 942(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 1833(h)(8) of the Act. Section 1833(h)(8)(A) of the Act requires the Secretary to establish by regulation procedures for determining the basis for, and amount of, payment for any CDLT for which a new or substantially revised Healthcare Common Procedure Coding System (HCPCS) code is assigned on or after January 1, 2005. A code is considered to be substantially revised if there is a substantive change to the definition of the test or procedure to which the code applies (for example, a new analyte or a new methodology for measuring an existing analyte-specific test). (See section 1833(h)(8)(E)(ii) of the Act and 42 CFR 414.502.)
Section 1833(h)(8)(B) of the Act sets forth the process for determining the basis for, and the amount of, payment for new tests. Pertinent to this notice, sections 1833(h)(8)(B)(i) and (ii) of the Act require the Secretary to make available to the public a list that includes any such test for which establishment of a payment amount is being considered for a year and, on the same day that the list is made available, cause to have published in the
Two bases of payment are used to establish payment amounts for new CDLTs. The first basis, called “crosswalking,” is used when a new CDLT is determined to be comparable to an existing test, multiple existing test codes, or a portion of an existing test code. New CDLTs that were assigned new or substantially revised codes prior to January 1, 2018, are subject to provisions set forth under § 414.508(a). For a new CDLT that is assigned a new or significantly revised code on or after January 1, 2018, CMS assigns the new CDLT code the payment amount established under § 414.507 of the comparable existing CDLT. Payment for the new CDLT code is made at the payment amount established under § 414.507. (See § 414.508(b)(1)).
The second basis, called “gapfilling,” is used when no comparable existing CDLT is available. When using this method, instructions are provided to each Medicare Administrative Contractor (MAC) to determine a payment amount for its Part B geographic area for use in the first year. In the first year, for a new CDLT that is assigned a new or substantially revised code on or after January 1, 2018, the MAC-specific amounts are established using the following sources of information, if available: (1) charges for the test and routine discounts to charges; (2) resources required to perform the test; (3) payment amounts determined by other payers; (4) charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant; and (5) other criteria CMS determines appropriate. In the second year, the test code is paid at the median of the MAC-specific amounts. (See § 414.508(b)(2)).
Under section 1833(h)(8)(B)(iv) of the Act and § 414.506(d)(1) CMS, taking into account the comments and recommendations (and accompanying data) received at the CLFS Annual Public Meeting, develops and makes available to the public a list of proposed determinations with respect to the appropriate basis for establishing a payment amount for each code, an explanation of the reasons for each determination, the data on which the determinations are based, and a request for public written comments on the proposed determinations. Under section 1833(h)(8)(B)(v) of the Act and § 414.506(d)(2), taking into account the comments received on the proposed determinations during the public comment period, CMS then develops and makes available to the public a list of final determinations of payment amounts for tests along with the rationale for each determination, the data on which the determinations are based, and responses to comments and suggestions received from the public.
Section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) added section 1834A to the Act. The statute requires extensive revisions to the Medicare payment, coding, and coverage requirements for CDLTs. Pertinent to this notice, section 1834A(c)(3) of the Act requires the Secretary to consider recommendations from the expert outside advisory panel established under section 1834A(f)(1) of the Act when determining payment using crosswalking or gapfilling processes. In addition, section 1834A(c)(4) of the Act requires the Secretary to make available to the public an explanation of the payment rates for the new test codes, including an explanation of how the gapfilling criteria and panel recommendations are applied. These requirements are codified in § 414.506(d) and (e).
After the final determinations have been posted on the CMS website, the public may request reconsideration of the basis and amount of payment for a new CDLT as set forth in § 414.509. Pertinent to this notice, those requesting that we reconsider the basis for payment or the payment amount as set forth in § 414.509(a) and (b), may present their reconsideration requests at the following year's CLFS Annual Public Meeting provided the requestor made the request to present at the CLFS Annual Public Meeting in the written reconsideration request. For purposes of this notice, we refer to these codes as
We are following our usual process, including an annual public meeting to determine the appropriate basis and payment amount for new and reconsidered codes under the CLFS for CY 2027, with an additional meeting in September that we discuss later in this notice. The public hybrid meeting will be conducted virtually and will occur on-site at the CMS Central Building. Please note that CMS reserves the right to shift the meeting format from hybrid to virtual-only, if for some reason, a hybrid format is not possible. If there is a need to switch to a virtual-only format, we will alert the public as soon as possible and post updated information on the CMS website at
This meeting is open to the public. Registration is only required for those interested in presenting public comments during the meeting or attending the meeting in-person at the CMS campus at the address specified in the
During this hybrid meeting, registered persons from the public may discuss and make recommendations for specific new and reconsidered codes for the CY 2027 CLFS. The Medicare Advisory Panel on CDLTs (Advisory Panel on CDLTs) may participate in this CLFS Annual Public Meeting by gathering information and asking questions to presenters, and will hold its next public meeting, virtually and in-person, on July 14 and 15, 2026. The July public meeting for the Advisory Panel on CDLTs will focus on the discussion of and recommendations for new and reconsidered test codes presented during the June 10, 2026, CLFS Annual Public Meeting. In addition, the Advisory Panel on CDLTs will participate in another public meeting on September 15 and 16, 2026, which will focus on discussing and making recommendations on CDLTs for which CMS received no applicable information to calculate Medicare payment rates. During the September meeting, the public will have an opportunity to present recommendations (crosswalking or gapfilling) on those tests, after which the Advisory Panel on CDLTs will provide its recommendations to CMS. Both Panel meetings also will address any other CY 2027 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda. The announcements for the next meetings of the Advisory Panel on CDLTs are included in separate notices that appear elsewhere in this issue of the
Due to time constraints, presentations at the CLFS Annual Public Meeting must be brief, lasting no longer than 10 minutes. Written presentations must be electronically submitted to CMS on or before May 29, 2026. In addition, if presenting in-person, presenters should make copies available for approximately 50 meeting participants, since CMS will not be providing additional copies to the public. Presentation slots will generally be assigned based upon chronological order of receipt of presentation materials. In the event there is not enough time for presentations by everyone who is interested in presenting, we will only accept written presentations from those who submitted written presentations within the submission window and were unable to present due to time constraints. Presentations must be sent via email to our CLFS dedicated email box,
Presenters should submit all presentations using a standard PowerPoint template. In addition to the standard PowerPoint template available, presenters may also provide the same information from the PowerPoint presentation into a provided Excel worksheet template. Submitting the same information that is requested for the PowerPoint presentation into the Excel worksheet template will aid with triaging and reviewing recommendation information during the meeting and after the meeting, during the code review process. The standard PowerPoint presentation and Excel worksheet templates are available on the CMS website at
For reconsidered and new codes, presenters should address all of the following five items:
• Reconsidered or new code(s) with the most current code descriptor.
• Test purpose and method with a brief comment on how the new test is different from other similar analyte or methodologies found in tests already on the CLFS.
• Test costs.
• Charges.
• Recommendation with rationale for one of the two bases (crosswalking or gapfilling) for determining payment for reconsidered and new tests.
Additionally, presenters should provide the data on which their recommendations are based. Presentations regarding reconsidered and new test codes that do not address the previous five items for presenters may be considered incomplete and may not be considered by CMS when making a determination. However, we may request missing information following the meeting to prevent a recommendation from being considered incomplete.
Taking into account the comments and recommendations (and accompanying data) received at the CLFS Annual Public Meeting, we intend to post our proposed determinations with respect to the appropriate basis for establishing a payment amount for each new test code and our proposed determinations with respect to the reconsidered codes along with an explanation of the reasons for each determination, the data on which the determinations are based, and a request for public written comments on these determinations on our website by early September 2026. This website can be accessed at
The Division of Ambulatory Services in the CMS Center for Medicare is coordinating the CLFS Annual Public Meeting registration. Beginning May 1, 2026 and ending May 29, 2026, registration may be completed by presenters and in-person attendees. Individuals who intend to view and/or listen to the meeting virtually do not need to register. Presenter registration and individuals who intend to attend the meeting at the CMS campus must register online at
• Name.
• Organization/Company name.
• Email addresses.
• Indicate if individual is a presenter.
• Indicate how individual is participating in the meeting (that is, in-person or virtual).
• Indicate if individual is a “Foreign National” visitor. Note: An additional review process is required for all foreign national visitors.
When registering, individuals who want to make a presentation must also specify the test codes on which they will be presenting comments. Confirmation will be sent upon receipt of the registration. Individuals must register by the date specified in the
Registration details may not be revised once they are submitted. If registration details require changes, a new registration entry must be submitted by the date specified in the
After registering, a confirmation email will be sent upon receipt of the registration. The email will provide information to the presenter or in-person attendee in preparation for the meeting. Registration is only required for individuals giving a presentation during the meeting or attending the meeting at the CMS campus. Presenters or in-person attendees must register by the deadline specified in the
If you are not presenting during the CLFS Annual Public Meeting or cannot attend in person, you may view the meeting via webinar or listen-only by teleconference. If you would like to listen to or view the meeting, teleconference dial-in and webinar information will appear on the final CLFS Annual Public Meeting agenda, which will be posted on the CMS website when available at
Individuals viewing or listening to the meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, should send an email to the resource box (
This hybrid meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. We suggest that you arrive at the CMS campus and parking facilities between 9:00 a.m. and 9:45 a.m. E.D.T., so that you will be able to arrive promptly at the meeting by 10:00 a.m. E.D.T. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. We note that the public may not enter the CMS building earlier than 9:15 a.m. E.D.T. (45 minutes before the convening of the meeting).
Security measures include the following:
• Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. Persons without proper identification may be denied access to the building.
• Interior and exterior inspection of vehicles (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.
• Passing through a metal detector and inspection of items brought into the building. We note that all items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration.
This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Mehmet Oz, having reviewed and approved this document, authorizes Vanessa Garcia, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) is establishing a public docket entitled “Obesity and Drug Dosing: Clinical Pharmacology Considerations.” The Agency is soliciting input from interested persons on assessing the effect of obesity on drug pharmacokinetics and
Submit either electronic or written comments by June 30, 2026.
FDA is establishing a docket for public comment on this notice. The docket number is FDA-2026-N-3499. The docket will close on June 30, 2026. Submit either electronic or written comments by June 30, 2026. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 30, 2026. The
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Martina Sahre, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9659.
Obesity is a critical and increasingly prevalent public health concern in the United States affecting approximately 20% of children
Obesity is reported to affect the pharmacokinetics and pharmacodynamics of drugs in several ways: (1) lipophilic drugs can show increased distribution into fat tissues; (2) absorption can be altered due to changes in gastric transit times and gastrointestinal pH values; (3) metabolism and excretion could be altered due to an impact on drug-metabolizing enzymes, transporters, or changes in renal clearance; and (4) the sensitivity of drug targets could be altered. The impact of body size (usually total body weight) is typically considered as part of population pharmacokinetic analysis. If identified as a significant covariate in population pharmacokinetic analysis, the need for dosing based on body weight, body mass index, or body surface area is routinely assessed. However, limited enrollment of obese patients in clinical trials—particularly patients with morbid obesity—limits pharmacokinetic and pharmacodynamic assessments across a full range of body sizes.
FDA invites interested persons to provide detailed information and comments on relevant considerations for evaluating the impact of obesity on drug pharmacokinetics and pharmacodynamics and the need for specific dosage recommendations. Please provide the rationale for your suggestions and include supporting data if available.
FDA is particularly interested in responses to the following overarching questions:
1. Body mass index is often used to identify and classify the degree of obesity. Is the categorization of body mass index sufficient for evaluating the impact of obesity on drug pharmacokinetics or pharmacodynamics and to inform recommendations for use in the obese population? If not, what other pragmatic measures (
2. What drug-specific characteristics or therapeutic-area/disease-related considerations are important when assessing the impact of obesity on pharmacokinetics or pharmacodynamics?
3. How should the impact of obesity on pharmacokinetics or pharmacodynamics, and potentially safety and effectiveness, be assessed throughout drug development (
Persons with access to the internet may obtain relevant clinical pharmacology guidances at
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for information and comments.
The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect examples about how previous patient-focused drug development (PFDD) meetings have impacted stakeholders' drug development efforts. This includes impacts on community engagement, research priorities, advocacy strategies, medical product development programs, clinical practice, and other areas of interest.
Either electronic or written comments on the notice must be submitted by June 30, 2026
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
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• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Ethan Gabbour, Center for Drug Evaluation and Research, Food and Drug Administration, 301-796-8112,
As directed by Section 569C of the Federal Food, Drug, and Cosmetic Act, as amended by Section 3001 of the 21st Century Cures Act (Pub. L. 114-255), FDA has developed and implemented strategies to obtain patient input to inform drug development and regulatory decision-making. FDA-led PFDD and externally led-PFDD (EL-PFDD) meetings provide a structured opportunity to hear directly from patients, caregivers, family members, and patient advocates. These meetings center on the aspects of a disease or condition and its treatment that are most meaningful to patients, including symptoms, effects on daily life, and experiences with available therapies.
Patient input from these meetings can inform medical product development, research priorities, and regulatory oversight. In response to stakeholder requests to better understand the outcomes of these meetings, FDA is seeking to collect information about their subsequent impacts. The Agency recognizes that many significant outcomes such as interactions within patient communities, between patient groups and medical product developers, or among clinicians occur in forums to which FDA is not typically a party. Similarly, changes made by medical product developers in response to patient input may not be communicated to FDA outside of a formal regulatory submission.
FDA is issuing this request for information to gain a better understanding of how patient input from FDA-led PFDD and EL-PFDD meetings has informed stakeholder activities including research, product development, and patient care, outside of specific regulatory decisions. FDA invites input from all interested parties, including patient organizations, medical product developers, healthcare providers, and academic researchers.
FDA is seeking information that addresses the following:
1. How have PFDD meetings informed patient communities and stakeholder engagement activities?
2. What scientific questions, research initiatives, or identified gaps in the understanding of a disease or condition have resulted from PFDD meetings?
3. In what ways has patient input from PFDD meetings informed medical product development programs or strategies (
4. How has patient input gathered during PFDD meetings been integrated into or otherwise affected clinical practice?
5. Please describe any other outcomes or effects resulting from PFDD meetings, with examples, that were not addressed in the questions above.
FDA encourages respondents to provide specific examples in their answers where possible.
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA) is announcing its intent to exempt from premarket notification requirements certain class II clinical toxicology test system devices. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will further consider whether the exemption described in this notice should be modified prior to publication of its final determination in the
Either electronic or written comments on the notice must be submitted by June 30, 2026.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Joseph Kotarek, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3528, Silver Spring, MD 20993, 301-796-2718,
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness of the device; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act).
Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the issuance of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions FDA (the Agency) deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act).
Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act).
Under section 510(k) of the FD&C Act and FDA's implementing regulations in part 807 of Title 21 of the Code of Federal Regulations (CFR), subpart E (21 CFR part 807, subpart E), persons who are required to register and who propose to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use are required to submit a premarket notification (510(k)) to FDA. The device may not be marketed until FDA finds it “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval. A premarket notification is not required for devices in certain situations, such as when they have been exempted from that requirement under section 510(m) of the FD&C Act.
The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law on December 13, 2016. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act requires that within 90 days of the date of enactment of the Cures Act, and at least once every 5 years thereafter (as FDA determines appropriate), FDA publish in the
Exemptions from premarket notification for certain clinical toxicology test systems falling within the regulations identified in the instant notice,
FDA is now publishing this notice to announce its intent to expand the 510(k) exemptions in the classification regulations included in this notice to additional devices within the device types, and to request public comment, in accordance with section 510(m)(2) of the FD&C Act. If finalized, the expansion of these exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. Specifically, regulated industry will no longer have to invest time and resources in 510(k) submissions for devices exempt from such requirements.
There are a number of factors FDA generally considers to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998,
FDA's exemptions from premarket notification requirements for the class II device types listed in table 1 apply only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostics, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality (see § 862.9 (21 CFR 862.9) (titled “Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)”). Thus, a manufacturer of a device listed in this document will still be required to submit a premarket notification to FDA before introducing a device or delivering it for introduction into interstate commerce for commercial distribution when the device exceeds any of the limitations of exemptions described in § 862.9.
In addition to the general limitations described in section III.A of this notice, partial limitations may limit an exemption from premarket notification requirements to specific devices within a device type.
Currently, the classification regulations included in this notice already include an exemption from 510(k) requirements (subject to the general limitations in § 862.9 as discussed in section III.A of this notice) “provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing,” and as long as the device is not intended for use in Federal drug testing programs.
When FDA finalized the partial exemptions from 510(k) requirements that are currently included in the classification regulations listed in table 1, FDA assigned new product codes to ensure that exempt and non-exempt devices within a device type would have separate product codes (82 FR 31976 at 31977). If the proposed expansion of the 510(k) exemptions described in this notice is finalized, FDA will continue to use the previously established product codes; however, the definitions of the product codes for exempt devices will be modified to accurately reflect the scope of the exemption,
FDA has made an initial determination that premarket notification is no longer necessary to provide a reasonable assurance of safety and effectiveness for these devices when they are intended for Federal drug testing programs (see “Proposed Partial Limitations” listed in table 1 of this notice). If the proposed expansion of the 510(k) exemptions described in this
While this notice contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120.
The following reference is on display at the Dockets Management Staff (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.
Either electronic or written comments on the notice must be submitted by June 30, 2026.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 30, 2026. The
Submit electronic comments in the following way:
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Tracy Rupp, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0260,
Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b) describes the conditions that must be satisfied for drug products compounded by an outsourcing facility to be exempt from section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)), section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use), and section 582 of the FD&C Act (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements).
Compounded drug products that meet the conditions in section 503B are not exempt from current good manufacturing practice (CGMP) requirements in section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).
One of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility does not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of Health and Human Services identifying bulk drug substances for which there is a clinical need (the 503B Bulks List) or (2) the drug compounded from the bulk drug substance appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing.
Section 503B of the FD&C Act directs FDA to establish the 503B Bulks List by: (1) publishing a notice in the
FDA has published a series of
For purposes of section 503B of the FD&C Act,
In the
As FDA evaluates bulk drug substances, we intend to publish notices for public comment in the
FDA maintains a list of all bulk drug substances we have evaluated on our website and separately identify bulk drug substances we have placed on the 503B Bulks List and those we have decided not to place on the 503B Bulks List. This list is available at
FDA is evaluating bulk drug substances nominated for the 503B Bulks List on a rolling basis. FDA intends to evaluate and publish the proposed and final determinations in the
As noted above, the 503B Bulks List includes bulk drug substances for which the Agency has determined there is a clinical need. The Agency is evaluating bulk drug substances that were nominated for inclusion on the 503B Bulks List, proceeding case by case, under the clinical need standard provided by the statute.
For purposes of this analysis, FDA assumes without deciding that semaglutide, tirzepatide, and liraglutide are components of FDA-approved drug
1. Is there a basis to conclude, for each FDA-approved product that includes the nominated bulk drug substance, that: (a) an attribute of the FDA-approved drug product makes it medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation, and (b) the drug product proposed to be compounded is intended to address that attribute?
2. Is there a basis to conclude that the drug product proposed to be compounded must be produced from a bulk drug substance rather than from an FDA-approved drug product?
The reason for question 1 is that unless an attribute of the FDA-approved drug makes it medically unsuitable for certain patients, and a drug product to be compounded using a bulk drug substance that is a component of the FDA-approved drug is intended to address that attribute, there is no clinical need to compound a drug product using that bulk drug substance. Rather, such compounding would unnecessarily expose patients to the risks associated with drug products that do not meet the standards applicable to FDA-approved drug products for safety, effectiveness, quality, and labeling and would undermine the drug approval process. The reason for question 2 is that to place a bulk drug substance on the 503B Bulks List, FDA must determine that there is a clinical need for outsourcing facilities to compound a drug product
If the answer to both of these questions is “yes,” there may be a clinical need for outsourcing facilities to compound using the bulk drug substance, and we would evaluate the substance further, applying the factors described below. Each of the following factors is considered in the context of the others, balancing them to determine whether the statutory “clinical need” standard has been met:
• the physical and chemical characterization of the substance;
• any safety issues raised by the use of the substance in compounding;
• the available evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and
• current and historical use of the substance in compounded drug products, including information about the medical condition(s) that the substance has been used to treat and any references in peer-reviewed medical literature.
If the answer to either of these questions is “no,” we generally would not include the bulk drug substance on the 503B Bulks List, because there would not be a basis to conclude that there may be a clinical need to compound drug products using the bulk drug substance instead of administering or starting with an FDA-approved drug product.
FDA did not answer “yes” to both of the threshold questions for the bulk drug substances we are addressing in this notice. Accordingly, as explained below, we did not proceed further in our evaluation of these substances and are proposing not to include these bulk drug substances on the 503B Bulks List.
In this notice, FDA evaluated certain nominated bulk drug substances for potential inclusion on the 503B Bulks List either alone or in combination with other bulk drug substances. FDA does not intend to consider comments raising different bulk drug substances or combinations of bulk drug substances other than those evaluated by FDA in this notice to be within the scope of this notice. New bulk drug substance nominations may be submitted to Docket No. FDA-2015-N-3469. The docket is available on
To assess whether there is a clinical need for outsourcing facilities to use a bulk drug substance in compounding, FDA must consider the drug products that have been proposed to be made from the nominated bulk drug substances. Therefore, FDA's evaluation of a bulk drug substance includes detailed consideration of the drug products that are proposed to be compounded, including the conditions justifying clinical need under the applicable statutory standard. Comments on FDA's preliminary evaluation of a bulk drug substance should include adequate support for the commenter's position. For example, a commenter writing to support inclusion of a nominated bulk drug substance on the 503B Bulks List should include sufficient information to permit a meaningful clinical need evaluation by FDA of the proposed product. Commenters writing in favor of or in opposition to a proposal to include or not to include an entry on the 503B Bulks List should address, for each proposed compounded drug product, the factors FDA evaluated in making our proposal.
This notice identifies three bulk drug substances that FDA has evaluated and is proposing not to include on the 503B Bulks List: semaglutide, tirzepatide, and
Semaglutide has been nominated
Semaglutide is an active ingredient in FDA-approved drug products: 2 mg/3 mL, 4 mg/3 mL, and 8 mg/3 mL solutions for subcutaneous (SC) injection which contain propylene glycol (Ozempic, NDA 209637); 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, 2.4 mg/0.75 mL, and 7.2 mg/0.75 mL solutions for SC injection which do not contain propylene glycol (Wegovy and Wegovy HD, NDA 215256); 1.5 mg, 4 mg, 9 mg, and 25 mg oral tablets (Wegovy, NDA 218316); and 1.5 mg, 3 mg, 4 mg, 7 mg, 9 mg, and 14 mg oral tablets (Rybelsus and Ozempic, NDA 213051).
Semaglutide was nominated and evaluated for the SC injection, sublingual, buccal, and oral routes of administration in various strengths. The nominations provide examples of such strengths and state that different strengths may be compounded “depending on medical provider requests.”
The nominations propose to compound a “subcutaneous injection, oral sublingual, buccal, and oral tablet or capsule” in various strengths.
For “oral sublingual” products, the nominators identify concentrations of 1.5 mg/mL, 2 mg/mL, 2.5 mg/mL, and 3 mg/mL as examples; the nominators do not provide a proposed concentration for buccal administration. One nominator states that “the challenge of swallowing this tablet . . . can be daunting and can discourage [patients] from using the tablet” and that “difficulty swallowing is a well-documented issue . . . with dysphagia affecting up to 33% of older adults.”
For the reasons below, FDA has not identified a basis to conclude that the oral and injectable routes of administration of the FDA-approved semaglutide products cause those products to be medically unsuitable for certain patients and that a compounded buccal or sublingual product would address such an attribute. While we have no reason to disagree with the proposition that difficulty swallowing is a “well-documented issue” and that compounded drugs can serve an important need for patients who cannot swallow tablets, the nominators refer to concerns about oral routes of administration generally; they do not identify any unsuitability with approved semaglutide products. Nor do they explain why the injectable drug products would be medically unsuitable for patients who cannot swallow a tablet.
One nominator refers to an article, Pratap-Singh et al. (2023), that the authors characterize as “a guideline for future investigators in creating buccal or sublingual tablets for the delivery of [peptide] drugs used to treat diabetes.” The article explains that “clinical use [of peptides for diabetes mellitus] is limited by the challenges of subcutaneous injection,” referencing “patient discomfort as well as being subjected to refrigerated storage and the requirement for efficient supply chain logistics.” The article states that “[t]he oral route is possibly the most common and the most acceptable for patients” but that “oral delivery faces challenges such as low permeation, proteolysis enzymes in the upper gastrointestinal tract, low gastric pH, and bioavailability.” The article further states that “the gastrointestinal route is unpredictable and usually involves high losses of the delivered drug.” The paper
The authors did not design their study to assess, and, accordingly, do not identify, any medical unsuitability of FDA-approved GLP-1 receptor agonists for treatment of diabetes mellitus. Further, the article refers only to general concerns associated with injectable routes of administration (
The nominators refer to “[r]anges depending on medical provider requests” and list examples of such strengths. For products proposed for the SC route of administration, the nominators provide example concentrations of 0.00067 g/mL (0.67 mg/mL), 2 mg/3 mL (0.68 mg/mL), 4 mg/3 mL (1.34 mg/mL), 0.00167 g/mL (1.67 mg/mL), 0.0025 g/mL (2.5 mg/mL), 8 mg/3 mL (2.68 mg/mL), 8 mg/2 mL (4 mg/mL), 5 mg/mL, 8 mg/mL, and 16 mg/mL injections. As these are identified as examples, the nominations do not identify each of the concentrations—and therefore the drug products—proposed to be compounded for the SC route of administration.
Several of the concentrations identified differ from the approved products. At the time the nominations were submitted, the proposed concentrations of 8 mg/2 mL (4 mg/mL), 5 mg/mL, and 8 mg/mL exceeded the concentrations of the approved semaglutide products. In addition, the nominators proposed to compound a 16 mg/mL solution for SC injection. However, semaglutide is also now approved as a 7.2 mg/0.75 mL (9.6 mg/mL) solution for SC injection. Therefore, the proposed concentrations of 8 mg/2 mL (4 mg/mL), 5 mg/mL, and 8 mg/mL no longer exceed the concentrations of the approved semaglutide products. The nominations did not provide supporting data or information for the use of products with a higher concentration.
The nominators state that some patients are “hyper-responders” and that they may “need a lower dose than what is commercially available.” One nominator states that “[i]t has been estimated that 5-15% of the population are hyper-responders to this medication (and 15% have been estimated to be non-responders).” The nominator provides no reference that supports its statement about what “has been estimated.” The nominator cites Wilding et al. (2021), which does not mention “hyper-responders” or the 5-15% statistic (Ref. 3). As the nominator notes, the study showed that more patients in the semaglutide group than the placebo group discontinued treatment after gastrointestinal events, and that nausea occurred “primarily during the dose-escalation period” (Wilding et al. 2021). However, the article also states that “[m]ost gastrointestinal events were mild-to-moderate in severity, were transient, and resolved without permanent discontinuation of the regimen.” One nominator states that “[i]t is believed with alternative maintenance doses and/or a slower titration schedule, more patients will remain on the treatment and have clinically meaningful outcomes as a result.” The nominator again provides no support for its statement that this is “believed” to be the case, and the results of a study describing mild-to-moderate, transient gastrointestinal events primarily during a dose escalation period do not support the proposition that there are “hyper-responders” for whom the strength of the approved product makes it medically unsuitable.
One nominator states that “hyper-responders” are those who are “sensitive” to the drug and thus may need either a slower titration or a lower maintenance dose, noting that only the 1.7 mg and 2.4 mg weekly doses are approved for maintenance.
In its nomination, BPI Labs, LLC refers to “[i]njectable dosing, or microdosing,” for use in controlling side effects. In its nomination, the Outsourcing Facilities Association (OFA) states that a different dose may be “more suitable for their patient in order to manage side effects and increase adherence”—but does not identify alternative doses to be delivered from the proposed compounded drug product. Further, the general statement that a different dose may be “more suitable” does not mean that the concentration of the approved product is
The nominators also propose to compound semaglutide as oral tablets and capsules.
One nominator states that the current FDA-approved oral tablets “are inadequate to treat all cases of obesity in patients with inadequately controlled type 2 diabetes.” The other nominator states that “[o]ral dosages, other than commercially avaialble [
The nominations do not identify, and FDA is not otherwise aware of, data or information that identifies patients for whom the strengths of the FDA-approved oral tablets are medically unsuitable. In addition, semaglutide was approved as a 25 mg tablet after the nominators submitted their nomination. The nominators did not supplement their nominations after the approval to provide any data or information bearing on medical suitability. The nominators have not provided a basis to conclude that the FDA-approved 25 mg oral tablet is medically unsuitable for any patients who would need the 25 mg strength. Thus, we address here the proposal for 50 mg oral tablets.
One nominator submitted two articles, Aroda et al. (2023) and Knop et al. (2023), in which patients received oral semaglutide at doses of 25 mg and 50 mg. Aroda et al. 2023 (PIONEER PLUS) was a multi-center, randomized, double-blind, phase 3b trial that studied the use of 25 mg and 50 mg once-daily oral doses of semaglutide in adults with type 2 diabetes compared to the approved once-daily 14 mg dose. The 25 mg and 50 mg tablets “were a new formulation developed to enhance bioavailability compared with the 14 mg dose” (Ref. 5). Knop et al. (2023) (OASIS 1) was a randomized, double-blind, placebo-controlled, phase 3 superiority trial that studied the use of semaglutide 50 mg once daily compared to placebo in adults with overweight or obesity without type 2 diabetes (Ref. 6). The formulation used for the 25 mg and 50 mg doses was developed to enhance bioavailability. First, while Aroda et al. (2023) found that the 25 mg and 50 mg doses “were superior to 14 mg in reducing HbA
The Knop et al. study was a placebo-controlled trial that determined that oral semaglutide 50 mg is superior to placebo in decreasing bodyweight. Similar to the Aroda et al. (2023) study, this study utilized a new formulation of semaglutide to enhance the bioavailability.
The nominators' statements that the strengths of the approved tablets “are inadequate” or “do not fit all patient populations” do not explain why the approved products are inadequate or identify patients for whom they are inadequate. To the extent the nominators are referring to the arguments discussed above about obtaining a better response with a higher dose, as discussed, that does not mean that the approved product is medically unsuitable for patients.
One nominator states that “[a]n individual patient may have intolerances or sensitivities to inactive ingredients in the commercially available drug product,” but does not identify which inactive ingredients they are referring to. Therefore, the nominator does not identify an attribute of the approved drugs that makes them medically unsuitable or a compounded drug intended to address that attribute.
Some of the proposed concentrations are the same as the FDA-approved product (
Semaglutide for SC injection is approved by FDA under the brand names Ozempic, Wegovy, and Wegovy HD. Ozempic is approved in three concentrations as a multidose pen injector, each of which contains propylene glycol 14 mg/mL; Wegovy is approved in five concentrations as a single-dose pen injector, none of which contain propylene glycol; and Wegovy HD is approved in one concentration as a single-dose pen injector, which does not contain propylene glycol. One nominator observes that “type 2 diabetic patients that require doses not offered in the non-propylene glycol formulations can benefit [from] compounded semaglutide.”
A search of the FDA Adverse Event Reporting System (FAERS) database identified numerous reports associated with semaglutide and injection site reactions and, despite the presence or absence of propylene glycol in the FDA-approved formulation, injection site reactions occurred in both Ozempic and Wegovy users. Of the reports identified, one case referenced propylene glycol. The report described a patient with a history of severe allergy to propylene glycol who, after treatment with Ozempic for 2 months for type 2 diabetes mellitus, developed a “red, swollen bubble at the injection site the size of a quarter” that resolved after discontinuing Ozempic. It is unclear whether the reaction experienced can be attributed to propylene glycol.
FDA has not identified any data or information to suggest that propylene glycol would cause a drug product containing semaglutide to be medically unsuitable. Injection site reaction is an adverse event reported in trials with various injectable therapeutic products, including other anti-hyperglycemic products not formulated with propylene glycol (
The nominators also propose to compound semaglutide as “combination injectables including those doses above combined with [p]yridoxine or an antiemetic medication.” However, the nominations provide no other information about the proposed compounded products, or why they think patients would use these combinations. For example, the nominations do not identify the drug products containing semaglutide and pyridoxine, or semaglutide and “an antiemetic,” proposed to be compounded.
Whether for convenience or for some other purpose, as noted, the nominators provide no information (
One nomination also states that “a medical professional may determine that a different dose than is commercially available is more suitable for their patient in order to manage side effects and increase adherence,” and that “[a]n administration device, such as an auto-injector, that only provides a fixed dose does not allow for these more tailored doses”; it is, according to the nomination, “impossible to achieve lower or higher doses with an auto-injector pen.” The nomination further states that “an administration device, such as an auto-injector, may not be suitable for a specific patient” and that “an alternative container/closure [system] or administration device may improve patient compliance and safety.” We have addressed above the arguments about a need for different strengths than the approved products; we explained that FDA has not identified a basis to conclude that the strengths of such products cause them to be medically unsuitable for certain patients. To the extent the nominator is arguing that a different container-closure device would necessitate compounding from a bulk drug substance rather than an approved drug, that question is inapplicable to this Part 1(a) analysis. Thus, we need not reach the argument about use of a different container-closure to achieve different strengths.
The nominators also state that semaglutide should be added to the 503B Bulks List because FDA-approved products containing semaglutide are in or could be subject to shortage, drugs produced by outsourcing facilities are produced in accordance with CGMP, and there are also potential concerns related to growth demand and access to these products. However, FDA does not interpret such issues, such as shortages and backorders, to be within the meaning of “clinical need” for compounding with a bulk drug substance. As noted above, section 503B contains a separate provision for compounding from bulk drug substances if the drug product compounded from such bulk drug substance is on the FDA drug shortage list at the time of compounding, distribution, and dispensing.
For these reasons, FDA tentatively finds no basis to conclude that there is an attribute of the FDA-approved drug products containing semaglutide that makes them medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation and that the proposed compounded products are intended to address.
Because there is no basis to conclude that there is an attribute of the FDA-approved drug products containing semaglutide which makes them medically unsuitable to treat certain patients, FDA does not need to evaluate whether the proposed drug products containing semaglutide must be compounded from a bulk drug substance rather than using an FDA-approved drug product.
To the extent relevant to the clinical need analysis, FDA has considered the following submissions to the docket regarding the nomination of semaglutide for the 503B Bulks List (FDA-2015-N-3469):
Covington & Burling LLP on behalf of Novo Nordisk, Inc. (NNI) submitted a comment dated October 21, 2024 (FDA-2015-N-3469-0402),
Tirzepatide has been nominated
Tirzepatide is an active ingredient,
Tirzepatide was nominated and evaluated for the SC injection, sublingual, buccal, and oral routes of administration in various strengths. The nominations provide examples of such strengths and state that different strengths may be compounded “depending on medical provider requests.”
The nominators propose to compound a “subcutaneous injection, oral sublingual, buccal, and oral tablet or capsule” in various strengths. The nominators propose to compound drug products in various routes of administration and provide examples of strengths associated with some of those routes. The nominators suggest that tirzepatide might also be used to compound other drug products, but the nominators do not identify those products. To assess clinical need, we consider whether the nomination identifies an attribute of the approved drug that makes it medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation. With respect to the nominator's statement that the compounded products will be used for “related health conditions as determined appropriate by medical provider,” we cannot find that there is a clinical need for an outsourcing facility to compound tirzepatide for unidentified health conditions. With respect to the proposed use of “to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight,” the nominator did not provide any supporting data or information for this use. Additionally, the nominator does not identify an attribute of the FDA-approved drug containing tirzepatide that would make it medically unsuitable to treat this condition.
We address here the proposals for oral, “oral sublingual,” and buccal products because no tirzepatide drug product is approved in these routes of administration.
The nominators refer to “[r]anges depending on medical provider requests” and list examples of such strengths. For products proposed for the sublingual route of administration, the nominators provide example concentrations of 5 mg/mL and 7.5 mg/mL; the nominators do not provide any concentrations of products proposed to be compounded for oral and buccal administration. As the proposed concentrations for the sublingual route of administration are listed as examples, the nominations do not identify each of the strengths—and therefore the drug products—proposed to be compounded for the oral, sublingual, and buccal routes of administration.
One nominator states that the injection route of administration is “linked to patient discomfort and is subject to refrigerated storage.” The nominator further states that “[a]n injectable only formulation causes unnecessary fears in these patients and may lead to adherence failure,” and that “an oral tablet, capsule, sublingual or buccal tablet in varying strengths would satisfy this clinical need.” Regarding sublingual and buccal forms, the nominators state that “there are certain patients who cannot swallow and an injectable may not be preferable . . . therefore there is a clinical need for sublingual dosage forms.” One nominator claims that the buccal and sublingual routes “are recognized as valid alternatives” and that these routes “in varying strengths would satisfy this clinical need.” One nominator refers to an article, Pratap-Singh et al. (2023), that the authors characterize as “a guideline for future investigators in creating buccal or sublingual tablets for the delivery of [peptide] drugs used to treat diabetes.” For the reasons noted in our discussion of this article in the semaglutide section, addressing similar arguments from the nominators, we tentatively find that it provides no basis to conclude that the routes of administration of FDA-approved tirzepatide products make them medically unsuitable for certain patients.
FDA has not identified a basis to conclude that the injectable routes of administration of the FDA-approved tirzepatide products cause those products to be medically unsuitable for certain patients and that a compounded oral, buccal, or sublingual product would address such attribute. For example, with respect to the argument that “an injectable may not be preferable” for some patients, the
The nominators refer to “[r]anges depending on medical provider requests” and list examples of such strengths. For products proposed for the SC route of administration, the nominators provide example concentrations of 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL, 15 mg/0.5 mL, 20 mg/0.5 mL, and 30 mg/0.5 mL injection. As these concentrations are listed as examples, the nominations do not identify each of the concentrations—and therefore the drug products—proposed to be compounded for the SC route of administration.
One nominator states that a different dose may be “more suitable for their patient in order to manage side effects and increase adherence.” However, the nominator does not identify alternative doses to be delivered from the proposed compounded drug. Further, the general statement that a different dose may be “more suitable” does not mean that the available strengths of the approved product are
Regarding the proposals to compound tirzepatide for use as an SC injection in concentrations that exceed the concentrations of the approved tirzepatide products (proposed concentrations of 20 mg/0.5 mL and 30 mg/0.5 mL), the nominations do not provide supporting data or information for the use of compounded products with a higher concentration than the approved product. The nominations state that patients may benefit from higher doses but do not identify higher doses to be delivered from the proposed compounded drug product; nor do the nominations identify patients for whom the concentrations of the FDA-approved SC injections are medically unsuitable because a higher concentration is needed. With respect to the assertion that “[c]ertain patients benefit from higher doses than are commercially available,” even if accurate, obtaining a better response with a higher dose does not mean that the approved product does not achieve the intended clinical benefit or that it is otherwise medically unsuitable for patients. The nominators have not provided a basis to conclude that patients need the specific concentrations proposed. FDA is also not aware of data or information that identifies patients for whom the concentrations of the FDA-approved SC injections are medically unsuitable.
The nominators state that some patients are “hyper-responders” and that they may “need a lower dose than what is commercially available.” One nominator states that “hyper-responders” are those who are “very sensitive” to the drug and thus may need either a slower titration or a lower maintenance dose, noting that only the 5 mg, 10 mg, and 15 mg weekly doses are approved for maintenance. One nominator states that “an auto-injector that only provides a fixed dose does not allow for these more tailored doses.”
The nominators also propose to compound tirzepatide as “combination injectables including those doses above combined with [p]yridoxine or an antiemetic medication.” However, the nominations provide no other information about the proposed compounded products, or why they think patients would need these combinations. For example, the nominations do not identify the drug products containing tirzepatide and pyridoxine, or tirzepatide and “an antiemetic,” proposed to be compounded.
Regarding excipients, one nominator states that patients may have intolerances or sensitivities to inactive ingredients in the commercially available drug product. However, the nomination does not identify which inactive ingredients they are referring to. Therefore, the nominator does not identify an attribute of the approved drugs that makes them medically unsuitable, or a compounded drug intended to address that attribute.
One nomination also states that “a medical professional may determine that a different dose than is commercially available is more suitable for their patient in order to manage side effects and increase adherence,” and that “[a]n administration device, such as an auto-injector, that only provides a fixed dose does not allow for these more tailored doses.” The nomination further states that “an administration device, such as an auto-injector, may not be suitable for a specific patient” and that “an alternative container/closure system or administration device may improve patient compliance and safety.” We
The nominators also state that tirzepatide should be added to the 503B Bulks List because FDA-approved products containing tirzepatide are in shortage and drugs produced by outsourcing facilities are produced in accordance with CGMP. FDA does not interpret such issues, such as shortages and backorders, to be within the meaning of “clinical need” for compounding with a bulk drug substance. As noted above, section 503B contains a separate provision for compounding from bulk drug substances if the drug product compounded from such bulk drug substance is on the FDA drug shortage list. We also note that as of the date of this notice, FDA-approved tirzepatide drug products are not on the FDA drug shortage list.
For these reasons, FDA tentatively finds no basis to conclude that there is an attribute of the FDA-approved drug products containing tirzepatide that makes them medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation and that the proposed compounded products are intended to address.
Because there is no basis to conclude that there is an attribute of the FDA-approved drug products containing tirzepatide which makes them medically unsuitable to treat certain patients, FDA need not evaluate whether the proposed drug products containing tirzepatide must be compounded from a bulk drug substance rather than using an FDA-approved drug product.
To the extent relevant to the clinical need analysis, FDA has considered the following submission to the docket regarding the nomination of tirzepatide for the 503B Bulks List (FDA-2015-N-3469):
Eli Lilly and Company submitted a comment to the docket dated November 4, 2024 (FDA-2015-N-3469-0404),
Liraglutide has been nominated
Liraglutide is an active ingredient in FDA-approved drug products: 18 mg/3 mL (6 mg/mL) solution for SC injection (Saxenda, NDA 206321); 18 mg/3 mL (6 mg/mL) solution for SC injection (Victoza, NDA 022341); and 18 mg/3 mL (6 mg/mL) solution for SC injection (liraglutide 18 mg/3 mL,
Liraglutide was nominated and evaluated for the SC injection route of administration in strengths in “[r]anges depending on medical provider requests” (Ref. 9).
The nominator proposes to compound an SC injection containing liraglutide. The nominator suggests that liraglutide might also be used to compound other drug products, but the nominator does not identify those products. With respect to strengths to be compounded using the bulk drug substance, the nomination refers to “[r]anges depending on medical provider requests.” The nomination provides just one example concentration of “18 mg/3mL or 6 mg/mL that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg, 2.4 mg or 3 mg.” This proposed concentration is the same as that of the FDA-approved products (
After reviewing the nominations and comments to the docket, we tentatively find no basis to conclude that the strength of FDA-approved liraglutide products makes them medically unsuitable for certain patients. The nomination has not provided a basis to conclude that strength of the approved products is an attribute that makes them medically unsuitable to treat certain patients; the only proposed strength the nominator provides is the same as the FDA-approved drugs. Nor has the nominator identified the drug products proposed to be compounded; the nominator has provided only one example of a strength. Vague statements that a healthcare provider may determine that a different dose is needed for side effects and improved patient adherence, without identifying the dose, patients, or any attribute that makes the approved drugs unsuitable for such patients, do not establish clinical need.
The nominator also proposes to compound liraglutide products without certain excipients. The nominator states that “[a]n individual patient may have intolerances or sensitivities to inactive ingredients in the commercially available drug product,” but does not identify which inactive ingredients they are referring to. Therefore, the nominator does not identify an attribute of the approved drugs that makes them medically unsuitable, or a compounded drug intended to address that attribute.
The nominator notes that “FDA-approved liraglutide injections indicated for type 2 diabetes contain propylene glycol, which has caused an increase in irritation at the injection site.” The nomination further states that “[s]ince there are no commercially available forms of liraglutide that do not contain propylene glycol, patients with sensitivities to propylene glycol will benefit from compounds formulated without it.” Even if this were accurate, the notion that a patient “will benefit” from a compounded formulation does not mean that the approved formulation is medically unsuitable. The nominator submitted one article, Snitker et al. (2022), that evaluated the injection-site experience of two formulations of semaglutide, semaglutide C and semaglutide D, compared to semaglutide MPI
A search of the FAERS database identified numerous reports associated with liraglutide and injection site reactions occurring in both Victoza and Saxenda users. The search did not retrieve any reports of liraglutide and injection site reactions with a case narrative containing “propylene.”
The nomination also states that liraglutide might be used to compound drug products in different container-closure devices. The nomination states that use of an alternative container-closure system or administration device “may improve patient compliance and safety.” To the extent the nominator is arguing that a different container-closure device would necessitate compounding from a bulk drug substance rather than an approved drug, that question is inapplicable to this Part 1(a) analysis. With respect to the nominator's statement about “improve[d] patient compliance and safety,” the nominator does not identify an attribute of the approved products that makes them medically unsuitable.
For these reasons, FDA tentatively finds no basis to conclude that there is an attribute of the FDA-approved drug products containing liraglutide that makes them medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation and that the proposed compounded products are intended to address.
Because there is no basis to conclude that there is an attribute of the FDA-approved drug products containing liraglutide which makes them medically unsuitable to treat certain patients, FDA need not decide whether the proposed drug products containing liraglutide must be compounded from a bulk drug substance rather than using an FDA-approved drug product.
To the extent relevant to the clinical need analysis, FDA has considered the following submissions to the docket regarding the nomination of liraglutide for the 503B Bulks List (FDA-2015-N-3469):
Covington & Burling LLP on behalf of NNI submitted a comment dated December 20, 2024 (FDA-2015-N-3469-0407),
OFA submitted a comment on March 17, 2025 (FDA-2024-P-5966-0003),
For the reasons stated above, FDA tentatively finds no basis to conclude that there is a clinical need for an outsourcing facility to compound using the following bulk drug substances: semaglutide, tirzepatide, and liraglutide. Therefore, we propose not to include these bulk drug substances on the 503B Bulks List.
The following references marked with an asterisk (*) are on display at the Dockets Management Staff
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Office of AIDS Research Advisory Council.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast at the following link:
Registration is not required to attend this meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has procedures at
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the
The meeting will be videocast and can be accessed from the NIH Videocast website at the following links:
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
Substance Abuse and Mental Health Services Administration, HHS.
Notice.
The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.
Anastasia Flanagan, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N06B, Rockville, Maryland 20857; 240-276-2600 (voice);
The Department of Health and Human Services (HHS) publishes a notice listing all HHS-certified laboratories and Instrumented Initial Testing Facilities (IITFs) in the
If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter.
This notice is also available on the internet at
The Mandatory Guidelines using Urine were first published in the
The Mandatory Guidelines using Oral Fluid were first published in the
The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71 and allowed urine drug testing only. The Mandatory Guidelines using Urine have since been revised, and new Mandatory Guidelines allowing for oral fluid drug testing have been published. The Mandatory Guidelines require strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on specimens for Federal agencies. HHS does not allow IITFs to conduct oral fluid testing.
To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.
Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines using Urine and/or Oral Fluid. An HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that the test facility has met minimum standards.
In accordance with the Mandatory Guidelines using Oral Fluid effective October 10, 2023 (88 FR 70814), the following HHS-certified laboratories meet the minimum standards to conduct drug and specimen validity tests on oral fluid specimens:
At this time, there are no laboratories certified to conduct drug and specimen validity tests on oral fluid specimens.
In accordance with the Mandatory Guidelines using Urine effective February 1, 2024 (88 FR 70768), the following HHS-certified IITFs meet the minimum standards to conduct drug
In accordance with the Mandatory Guidelines using Urine effective February 1, 2024 (88 FR 70768), the following HHS-certified laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens:
The following laboratory is voluntarily suspending certification from the National Laboratory Certification Program effective March 19, 2026:
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer at (240) 276-0548.
SAMHSA awards PATH grants each fiscal year to states, the District of Columbia, the Commonwealth of Puerto Rico, the U. S. Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands (hereafter referred to as “states”), from allotments authorized under the PATH program established by Public Law 101-645, 42 U.S.C. 290cc-21
This submission is for the revision to the approved PATH Annual Report Manual. Section 528 of the Act specifies, not later than January 31 of each fiscal year, a funded entity will “prepare and submit to the Secretary a report in such form and containing such information as the Secretary determines to be necessary for: (1) securing a record and a description of the purposes for which amounts received under Section 521 were expended during the preceding fiscal year and of the recipients of such amounts; and (2) determining whether such amounts
The proposed revisions to the PATH 2026 Annual Report Manual are as follows:
In September 2025, HUD released the FY2026 Data Standards. HMIS Leads and System Administrators were notified of the changes and HMIS software vendors were given access to the necessary programming documentation and were instructed to be ready to deploy by October 1, 2025. The FY2026 updates included HMIS PATH Programming Specifications (Version 1.0), which removed the demographic question for gender, added the demographic question for sex, and updated the label for a question on Hispanic ethnicity. Field response options and questions have been updated to align with the most recent version of the HMIS Data Standards.
The requested revisions will not increase the overall burden.
The estimated annual burden for these reporting requirements is summarized in the table below.
Send comments to SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-A, Rockville, Maryland 20857,
Written comments should be received by June 30, 2026.
U.S. Customs and Border Protection (CBP), Department of Homeland Security.
30-Day notice and request for comments.
The Department of Homeland Security, U.S. Customs and Border Protection (CBP) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the
Comments are encouraged and must be submitted (no later than
Written comments and/or suggestions regarding the item(s) contained in this notice should be sent within 30 days of publication of this notice to
Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229-1177, Telephone number 202-325-0056 or via email
CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
This form is being utilized as part of the Vessel Entrance and Clearance System Public Test which has been very successful. CBP is considering regulatory change to move the test into a requirement.
U.S. Customs and Border Protection (CBP), Department of Homeland Security.
30-Day notice and request for comments.
The Department of Homeland Security, U.S. Customs and Border Protection (CBP) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the
Comments are encouraged and must be submitted (no later than June 1, 2026) to be assured of consideration.
Written comments and/or suggestions regarding the item(s) contained in this notice should be sent within 30 days of publication of this notice to
Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229-1177, Telephone number 202-325-0056 or via email
CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The respondents to this information collection are members of the trade community who are familiar with CBP regulations.
Transportation Security Administration, DHS.
30-Day notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0073, abstracted below, to OMB for review and approval for an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves public and private entities requesting participation in TSA's Reimbursable Screening Services Program (RSSP), to obtain TSA security screening services outside of an existing primary passenger airport terminal screening area.
Send your comments by June 1, 2026. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Christina A. Walsh, TSA PRA Officer, Information Technology, TSA-11, Transportation Security Administration, 6595 Springfield Center Drive, Springfield, VA 20598-6011; telephone (571) 227-2062; email
TSA published a
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Department of Housing and Urban Development (HUD) and Department of Agriculture (USDA).
Notice of rescission.
This document announces the immediate rescission of the “Final Determination: Adoption of Energy Efficiency for New Construction of HUD- and USDA Financed Housing” (Final Determination), published on April 26, 2024, as well as subsequent notices by HUD and USDA (the Agencies) related to extensions of effective dates for the standards rescinded by this notice.
This rescission is effective May 1, 2026.
Section 481 of the Energy Independence and Security Act of 2007 (“EISA,” Pub. L. 110-140) amended section 109 of the Cranston-Gonzalez National Affordable Housing Act of 1990 (Cranston-Gonzalez) (42 U.S.C. 12709), which establishes procedures for setting minimum energy standards for certain categories of newly constructed housing financed by HUD and USDA.
EISA references two standards: the International Energy Conservation Code (IECC) and American National Standards Institute/American Society of Heating, Refrigerating, and Air-Conditioning Engineers/Illuminating Electrical Society Standard 90.1 (ASHRAE 90.1). The IECC standard applies to single family homes and multifamily low-rise buildings (up to 3 stories), while the ASHRAE 90.1 standard applies to multifamily residential buildings with 4 or more stories.
The IECC and ASHRAE 90.1 are industry-based consensus codes that are typically updated on three-year cycles. Following each update, HUD and USDA are required to adopt the new versions of the IECC and ASHRAE 90.1 within one year. If the one-year deadline is not met, the agencies may adopt updated versions only if they make a determination “that the revised codes do not negatively affect the availability or affordability” of the covered housing and the Secretary of Energy has determined “that the revised code or standard would improve energy efficiency.”
On May 18, 2023, HUD and USDA published a Preliminary Determination (88 FR 31773) that the 2021 IECC and ASHRAE 90.1-2019 would not negatively affect the affordability or availability of EISA-covered housing. After receiving feedback during the public comment period, the agencies published the Final Determination on April 26, 2024, (89 FR 33112) with an updated economic analysis and found that adoption of the standards would not negatively impact the affordability or availability of EISA-covered housing.
The Final Determination made changes to the Preliminary Determination based on public comments.
On January 2, 2025, a coalition of fifteen States and the National Association of Home Builders filed a lawsuit in federal court against HUD and USDA alleging, among other things, that the 2024 Final Determination violates the Administrative Procedure Act, 5 U.S.C. 706, and should therefore be set aside.
On the first day of the new administration, the President highlighted the need to control the cost of living for ordinary Americans. See
Myriad factors beyond code-based energy requirements, including labor costs and material costs, combine to exert upward pressure on the cost of both single-and multifamily housing construction. For instance, according to the Bureau of Labor Statistics Producer Price Index for Single Family Residential Construction, a spike in the cost of building materials occurred between January 2020 and January 2022. While cost growth has slowed, it has not fallen with the result that building material costs have seen a 43% increase between January 2020 and November 2025.
As a threshold matter, the agencies consider it noteworthy that the econometrics relied upon in the Preliminary Determination are from 2020 and 2021, making them up to six years old. Even given the fact that the Final Determination included updated measures (see fn.2), the most recent of those numbers are from 2023.
Another factor at play in the complex mix of variables that affect potential homebuyers is mortgage rates, which have begun to show signs of improving in late 2025. Nonetheless, they currently stand at an average of 6.2% for conventional 30-year financing—nearly a full point above the 5.3% assumption of the Final Determination.
While not tied directly to the issue of code-based energy standards, another
This additional factor placing upward pressure on construction costs is yet another reason not to impose expensive new regulations—in the form of building code-based energy standards—at a time when ordinary Americans are struggling to achieve the dream of homeownership.
Finally, the agencies note that the Final Determination overstated the availability of the § 45L New Energy Tax Credit as a vehicle for builders to offset some of the costs of complying with the new energy standards, stating “there are now significant new resources available through the Inflation Reduction Act (IRA) which provide unprecedented financial support for building energy efficient housing.”
In light of the foregoing realities, the Final Determination flies in the face of the Administration's express policy of increasing the supply of housing and making housing more affordable. The net effect of these realities is that affordability of housing in the Departments' respective covered housing programs would be negatively affected by implementation of the Final Determination (42 U.S.C. 12709(d)(1)). In addition, as noted above, the Final Determination has been judicially vacated and thus is no longer in force. As such, effective immediately, the Department of Housing and Urban Development and the Department of Agriculture rescind the Final Determination of April 26, 2024, in its entirety. The Departments also rescind the subsequent notices of March 10, 2025, April 4, 2025, and November 10, 2025, related to extensions of effective dates for the standards rescinded by this notice. Each of the Departments' respective covered programs shall comply with the energy efficiency standards that were in effect immediately prior to the publication of the Final Determination.
Bureau of Land Management.
Notice of realty action.
The Bureau of Land Management (BLM) proposes a direct sale of a 157.31-acre parcel of public land in Emery County, Utah, to Ferron City (City). This parcel is currently leased to the City under the Recreation and Public Purposes Act (RPPA), and it contains a municipal golf course constructed and operated by the City pursuant to an authorized Plan of Development. The purpose of the sale would be to enable future golf course management that is not limited by the requirements of the RPPA. The parcel would be offered for sale pursuant to the John D. Dingell Jr., Conservation, Management, and Recreation Act. The sale would be subject to the applicable provisions of the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, and the BLM land sale regulations. The surface estate would be sold for no less than the appraised fair market value of $173,000, and it would not contain a reversionary clause.
Interested parties must submit written comments, postmarked, or delivered no later than June 15, 2026. The land will not be offered for sale until after June 30, 2026.
Mail written comments to the BLM Price Field Office, Field Manager, 125 South 600 West, Price, UT 84501. Comments may also be emailed to
Kyle Beagley, Assistant Field Manager, BLM Price Field Office, phone: 435-636-3608, or email:
On June 4, 2009, a
The BLM Price Field Office originally issued the City an RPPA lease for the 9-hole Millsite Golf Course in 1985. In 2009, the BLM amended the lease for an additional 9-hole expansion. The golf course has since been developed in accordance with the approved Plan of Development and currently operates as an 18-hole municipal course. In January 2020, the City requested to purchase the land associated with their golf course lease without a reversionary clause so it is not limited in future golf course management by the requirements of the RPPA. For example, the City has shown potential interest in co-managing the
The following described public land in Emery County, Utah, located approximately three miles west of Ferron City has been examined and found suitable for sale in accordance with section 203 of FLPMA (43 U.S.C. 1713):
The area described contains 157.31 acres, according to the official plats of surveys of the said land, on file with the BLM.
The parcel proposed for direct sale would include the conveyance of the surface interest of the United States in accordance with section 203 of FLPMA. All mineral interest will be reserved to the United States in accordance with FLPMA section 209 (43 U.S.C. 1719).
No warranty of any kind, express or implied, is given by the United States as to the title, whether or to what extent the land may be developed, its physical condition, future uses, or any other circumstance or condition. The conveyance of any parcel would not be on a contingency basis. However, to the extent required by law, the parcel is subject to the requirements of section 120(h) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) (42 U.S.C. 9620(h)).
The proposed sale conforms with the BLM Price Field Office Resource Management Plan (RMP), approved in October 2008. The land is identified for disposal in the Price Field Office RMP (RMP Appendix R-11), and sale of the parcel does not conflict with other decisions in the RMP. A parcel-specific environmental assessment (EA), document number DOI-BLM-UT-G020-2025-0035-EA, was prepared in connection with this realty action and may be viewed at
The parcel proposed for sale has been found appropriate for conveyance under section 203 of FLPMA, and sale is consistent with the following criteria: 43 CFR 2710.0-3(a)(2), “disposal of such tract shall serve important public objectives . . .”; and 43 CFR 2710.0-3(a)(3), “such tract, because of its location or other characteristics is difficult and uneconomic to manage as part of the public lands and is not suitable for management by another Federal department or agency.” The parcel has been developed by Ferron City as a municipal golf course, which serves an important public objective by providing a unique recreation opportunity in the local community. The parcel is expected to continue to be used as a golf course for the immediate future. The existing use of the land does, however, make the parcel difficult to manage by the BLM, and it is not appropriate for management by another Federal department or agency.
The land is suitable specifically for direct sale under FLPMA, without competition, consistent with 43 CFR 2711.3-3(a)(3), as direct sales may be used “when in the opinion of the authorized officer, a competitive sale is not appropriate and the public interest would best be served by a direct sale[,]” including when “there is a need to recognize an authorized use . . . which could suffer a substantial economic loss if the tract were purchased by other than the authorized user[.]” The parcel has been developed for decades as a municipal golf course. Development of the parcel has been completed by Ferron City at considerable cost, and sale of the land to another party could result in substantial economic loss to the City.
Upon publication of this notice the portion of the RPPA classification identified above and any associated segregations will be terminated, and the land described above shall be open to direct sale to the City in accordance with the RMP.
Pursuant to the requirements of 43 CFR 2711.1-2(d), publication of this notice in the
In addition to publication in the
The patent, if issued, will be subject to the following terms, covenants, conditions, and reservations:
1. A mineral reservation to the United States for all minerals;
2. A reservation to the United States for ditches and canals constructed by authority of the United States under the Act of August 30, 1890;
3. Valid existing rights issued prior to conveyance;
4. An appropriate indemnification clause protecting the United States from claims arising out of the patentee's use, occupancy, or operations on the patented lands;
5. Additional terms and conditions that the authorized officer deems appropriate.
The EA, maps, appraisal report, and other associated documents are available for review at the location listed in the
Interested parties and the public may submit in writing any comments concerning the land being considered for sale, including notification of any encumbrances or other claims relating to the identified land, to Millsite Land Sale, BLM Price Field Office, at the address listed in the
Before including your address, phone number, email address, or other personal identifying information in your comment, be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. The BLM will not consider comments received via telephone calls.
The BLM Utah State Director will review adverse comments regarding the parcel and may sustain, vacate, or modify this realty action, in whole or in part. In the absence of timely adverse comments, this realty action will become the final determination of the Department of the Interior.
United States International Trade Commission.
Notice.
The Commission hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930, as amended, to determine whether revocation of the countervailing duty order on steel nails from Vietnam and revocation of the antidumping duty orders on steel nails from Malaysia, Oman, South Korea, Taiwan, and Vietnam would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.
Instituted May 1, 2026. To be assured of consideration, the deadline for responses is June 1, 2026. Comments on the adequacy of responses may be filed with the Commission by July 13, 2026.
Gregory Gutierrez (202-205-1999), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
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Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.
Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 26-5-690, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.
Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at
(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.
(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the
(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.
(4) A statement of the likely effects of the revocation of the antidumping and countervailing duty orders on the
(5) A list of all known and currently operating U.S. producers of the
(6) A list of all known and currently operating U.S. importers of the
(7) A list of 3-5 leading purchasers in the U.S. market for the
(8) A list of known sources of information on national or regional prices for the
(9) If you are a U.S. producer of the
(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the
(b) Capacity (quantity) of your firm to produce the
(c) the quantity and value of U.S. commercial shipments of the
(d) the quantity and value of U.S. internal consumption/company transfers of the
(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the
(10) If you are a U.S. importer or a trade/business association of U.S. importers of the
(a) The quantity and value (landed, duty-paid but not including antidumping and/or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of
(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of
(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of
(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the
(a) Production (quantity) and, if known, an estimate of the percentage of total production of
(b) Capacity (quantity) of your firm(s) to produce the
(c) the quantity and value of your firm's(s') exports to the United States of
(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the
(13) (OPTIONAL) A statement of whether you agree with the above definitions of the
This proceeding is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930, as amended, to determine whether revocation of the countervailing and antidumping duty orders on steel grating from China would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.
Instituted May 1, 2026. To be assured of consideration, the deadline for responses is June 1, 2026. Comments on the adequacy of responses may be filed with the Commission by July 13, 2026.
Rachel Devenney (202-205-3172), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
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Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.
Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 26-5-688, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.
Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at
(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.
(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the
(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.
(4) A statement of the likely effects of the revocation of the countervailing and antidumping duty orders on the
(5) A list of all known and currently operating U.S. producers of the
(6) A list of all known and currently operating U.S. importers of the
(7) A list of 3-5 leading purchasers in the U.S. market for the
(8) A list of known sources of information on national or regional prices for the
(9) If you are a U.S. producer of the
(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the
(b) Capacity (quantity) of your firm to produce the
(c) the quantity and value of U.S. commercial shipments of the
(d) the quantity and value of U.S. internal consumption/company transfers of the
(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the
(10) If you are a U.S. importer or a trade/business association of U.S. importers of the
(a) The quantity and value (landed, duty-paid but not including antidumping or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of
(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of
(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of
(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the
(a) Production (quantity) and, if known, an estimate of the percentage of total production of
(b) Capacity (quantity) of your firm(s) to produce the
(c) the quantity and value of your firm's(s') exports to the United States of
(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the
(13) (OPTIONAL) A statement of whether you agree with the above definitions of the
Authority: This proceeding is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930, as amended, to determine whether revocation of the countervailing duty order on welded line pipe from Turkey and the antidumping duty orders on welded line pipe from South Korea and Turkey would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.
Instituted May 1, 2026. To be assured of consideration, the deadline for responses is June 1, 2026. Comments on the adequacy of responses may be filed with the Commission by July 13, 2026.
Lawrence Jones (202-205-3358), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
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Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.
Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 26-5-687, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission,
Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at
(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.
(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the
(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.
(4) A statement of the likely effects of the revocation of the countervailing duty order and revocation of the antidumping duty orders on the
(5) A list of all known and currently operating U.S. producers of the
(6) A list of all known and currently operating U.S. importers of the
(7) A list of 3-5 leading purchasers in the U.S. market for the
(8) A list of known sources of information on national or regional prices for the
(9) If you are a U.S. producer of the
(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the
(b) Capacity (quantity) of your firm to produce the
(c) the quantity and value of U.S. commercial shipments of the
(d) the quantity and value of U.S. internal consumption/company transfers of the
(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the
(10) If you are a U.S. importer or a trade/business association of U.S. importers of the
(a) The quantity and value (landed, duty-paid but not including antidumping and/or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of
(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of
(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of
(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the
(a) Production (quantity) and, if known, an estimate of the percentage of total production of
(b) Capacity (quantity) of your firm(s) to produce the
(c) the quantity and value of your firm's(s') exports to the United States of
(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the
(13) (OPTIONAL) A statement of whether you agree with the above definitions of the
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930, as amended, to determine whether revocation of the countervailing duty order on carbazole violet pigment 23 from India and the antidumping duty orders on carbazole violet pigment 23 from China and India would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.
Instituted May 1, 2026. To be assured of consideration, the deadline for responses is June 1, 2026. Comments on the adequacy of responses may be filed with the Commission by July 13, 2026.
Jesse Sanchez (202-205-2402), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
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Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.
Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 26-5-689, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.
Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at
(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.
(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the
(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.
(4) A statement of the likely effects of the antidumping and countervailing duty orders on the
(5) A list of all known and currently operating U.S. producers of the
(6) A list of all known and currently operating U.S. importers of the
(7) A list of 3-5 leading purchasers in the U.S. market for the
(8) A list of known sources of information on national or regional prices for the
(9) If you are a U.S. producer of the
(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the
(b) Capacity (quantity) of your firm to produce the
(c) the quantity and value of U.S. commercial shipments of the
(d) the quantity and value of U.S. internal consumption/company transfers of the
(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the
(10) If you are a U.S. importer or a trade/business association of U.S. importers of the
(a) The quantity and value (landed, duty-paid but not including antidumping and/or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of
(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of
(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of
(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the
(a) Production (quantity) and, if known, an estimate of the percentage of total production of
(b) Capacity (quantity) of your firm(s) to produce the
(c) the quantity and value of your firm's(s') exports to the United States of
(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the
(13) (OPTIONAL) A statement of whether you agree with the above definitions of the
By order of the Commission.
Occupational Safety and Health Administration (OSHA), Labor.
Notice of ACCSH Committee Meeting.
OSHA announces that ACCSH will meet virtually May 19th and 20th 2026.
The Contract Work Hours and Safety Standards Act (Construction Safety Act (CSA)) (40 U.S.C. 3701
ACCSH operates in accordance with the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. 1001,
ACCSH will meet virtually from 9:30 a.m. to 5:30 p.m. ET on Tuesday, May 19th and 9:30 a.m. to 5:30 p.m. ET, on Wednesday, May 20th, 2026. The meetings are open to the public.
• Opening remarks from OSHA;
• Supplementary briefing on and continued ACCSH discussion of several rulemakings discussed previously at the March 31st and April 1st, 2026, ACCSH meeting, including 1,3-Butadiene, 13 Carcinogens, Asbestos, Benzene, Cadmium, Ethylene Oxide, Formaldehyde, Inorganic Arsenic, Lead, Methylene Chloride, and Methylenedianiline (MDA) rulemakings;
• Briefing on a Notice of Proposed Rulemaking regarding Tree Care; and
• Committee recommendations to the Secretary.
Additional information and updates related to this agenda, including briefing materials regarding a tree care rulemaking, will be posted to the ACCSH website,
The ACCSH meeting will be virtual only, so both Committee members and the public will attend virtually. OSHA is not requiring registration to attend this meeting. Meeting information will be posted in the docket (Docket No. OSHA-2025-0001) and on the ACCSH website,
Amanda Laihow, Principal Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice pursuant to 29 U.S.C. 651,
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Fire Brigades Standard.
Comments must be submitted (postmarked, sent, or received) by June 30, 2026.
For further information on submitting comments, see the “Public Participation” heading in the section of this notice titled
Belinda Cannon, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor; telephone (202) 693-2222.
The Department of Labor, as part of the continuing effort to reduce paperwork and respondent (
OSHA does not mandate that employers establish fire brigades; however, if they do so, they must comply with the provisions of the Fire Brigades Standard. The provisions of the standard, including the paperwork requirements, apply to fire brigades, industrial fire departments, and private or contract fire departments, but not to airport crash rescue units or forest firefighting operations. Paragraphs (b)(1), (b)(2), and (c)(4) contain the paperwork requirements of the standard.
Under paragraph (b)(1) of the standard, employers must develop and maintain an organizational statement that establishes the: existence of a fire brigade; the basic organizational structure of the brigade; type, amount, and frequency of training provided to brigade members; expected number of members in the brigade; and functions that the brigade is to perform. This paragraph also specifies that the organizational statement must be available for review by workers, their designated representatives, and OSHA compliance officers. The organizational statement describes the functions performed by the brigade members and, thereby, determines the level of training and type of personal protective equipment (PPE) necessary for these members to perform their assigned functions safely. Making the statement available to workers, their designated representatives, and OSHA compliance officers ensures that the elements of the statement are consistent with the functions performed by the brigade members and the occupational hazards they experience, and that employers are providing training and PPE appropriate to these functions and hazards.
To permit a worker with known heart disease, epilepsy, or emphysema to participate in fire brigade emergency activities, paragraph (b)(2) of the standard requires employers to obtain a physician's certificate of the worker's fitness. This provision provides employers with a direct and efficient
Paragraph (c)(4) of the standard requires employers to inform fire brigade members of special hazards, such as the storage and use of flammable liquids and gases, toxic chemicals, radioactive sources, water-reactive substances that may be present during fires and other emergencies, and any changes in these special hazards. It also requires that employers develop written procedures describing the actions that brigade members are to take when special hazards are present, and to make these procedures available in the education and training program and for review by brigade members.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions to protect workers, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection, and transmission techniques.
OSHA is requesting that OMB extend the approval of the information collection requirements contained in the Fire Brigades Standard. The agency is seeking an adjustment increase in burden going from 2,695 to 2,819 hours, a total increase of 124 hours. The adjustment is due to an increase in the number of manufacturing facilities with 100 or more workers from 24,885 to 26,027. Also, the number of responses increased from 3,733 to 3,904.
OSHA will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirements.
You may submit comments in response to this document as follows: (1) electronically at
Comments and submissions are posted without change at
Contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627) for information about materials not available from the website, and for assistance in using the internet to locate docket submissions.
Amanda Laihow, Principal Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
Millennium Challenge Corporation.
Notice.
In accordance with the Millennium Challenge Act of 2003, as amended, the Millennium Challenge Corporation is publishing a summary, justification, and full text of the proposed First Amendment to Millennium Challenge Compact between the United States of America, acting through the Millennium Challenge Corporation, and the Republic of Senegal. Representatives of the United States Government and the Government of Senegal plan to conclude the Amendment in late May or early June of 2026.
Brian Finkelstein,
The Board of Directors of the Millennium Challenge Corporation (“
The Compact was signed on December 10, 2018 and entered into force on September 9, 2021. The Compact is designed to modernize Senegal's electricity sector through the delivery of reliable and stable electricity to allow for expansion of the grid, diversification of electricity generation sources, and leverage of Senegal's burgeoning oil and gas sector, which includes several American firms. The Compact aims to lower electricity costs and improve reliability, addressing key
MCC proposes to extend the term of the Compact for an additional six months to March 9, 2027 and to provide additional funding up to US$15.9 million. The term extension is necessary to mitigate implementation delays and to complete infrastructure projects as originally contemplated. The proposed increase in assistance will be provided entirely from funds already appropriated to MCC. The additional funds will be used to cover additional program administration and related oversight costs associated with extending the Compact's term.
Absent a time extension, the Compact's critical investments face completion, health and safety, and sustainability risks, jeopardizing the full realization of MCC's intended development and economic outcomes in the energy sector. The six-month extension will preserve implementation quality, support post-Compact sustainability of investments, and enable Senegal's gas-to-power energy strategy to advance with significant investments and opportunities for American firms. The amendment will reinforce MCC's model of delivering measurable development impact while supporting U.S. economic interests and fostering a more stable and market-oriented business environment in Senegal.
The unplanned halt to Compact implementation activities in early 2025 occurred during a critical implementation phase and led to the desynchronization of schedules, loss of personnel, costly demobilization/remobilization, and slow contractor restarts across multiple Compact activities. Without a six-month extension, several key Compact projects would be at risk of non-completion. Transferring these incomplete works and associated costs to the Government of Senegal could result in the potential waste of U.S. taxpayer funds if the works were improperly finished or incomplete, creating significant reputational risk to the United States.
The six-month extension addresses schedule delays and safeguards MCC's energy investments. On the Transmission Project, the extension will secure functional integration of large-scale infrastructure onto the national electricity network, allow sufficient testing and commissioning, and enable an orderly transfer of infrastructure assets to the grid. The additional time on the Access Project will help ensure the completion of critical works to extend the electricity distribution network and connect all planned communities, households, and socio-economic facilities to the grid. Additionally, a six-month extension will ensure sufficient time for an orderly and sustainable closure of administrative operations in line with MCC standards and procedural requirements.
This First Amendment to Millennium Challenge Compact (this “
1. Amendment to Section 2.1.
Section 2.1 (
“Section 2.1
2. Amendment to Section 2.2.
Section 2.2(a) (
“(a) Upon the signing of this Compact, MCC shall grant to the Government, under the terms of this Compact and in addition to the Program Funding described in Section 2.1, an amount not to exceed Twenty-Two Million Six Hundred Thirty-Two Thousand Two Hundred and Ninety-One United States Dollars (US$22,632,291) ( “
(i) financial management and procurement activities;
(ii) administrative activities (including start-up costs such as staff salaries) and administrative support expenses such as rent, computers and other information technology or capital equipment;
(iii) monitoring and evaluation activities;
(iv) feasibility, design and other project preparatory studies; and
(v) other activities to facilitate Compact implementation as approved by MCC.
The allocation of Compact CDF is generally described in Annex II.”
3. Amendment to Section 6.7(b).
Section 6.7(b) (
“(b) Each reference in this Compact, the PIA or any other agreement entered into in connection with this Compact, to the Compact's “expiration” refers to the date on which the Compact Term ends
4. Amendment to Section 7.4.
Section 7.4 (
“Section 7.4
5. Amendment to Annex II (Multi-Year Financial Plan Summary).
Exhibit A to Annex II (Multi-Year Financial Plan Summary) to the Compact is deleted in its entirety and replaced by revised Exhibit A set forth in
1. Entry Into Force of this Amendment.
This Amendment shall enter into force on the date of the last signature of the Parties.
2. Further Assurances.
Each Party hereby covenants and agrees, without necessity of any further consideration, to execute and deliver any and all such further documents and take any and all such other action as may be reasonably necessary or appropriate to carry out the intent and purpose of this Amendment.
3. Effect of this Amendment.
From and after the Amendment enters into force, the Compact and this Amendment shall be read together and construed as one document, and each reference in the Compact to the “Compact,” “hereunder,” “hereof” or words of like import referring to the Compact, and each reference to the “Compact,” “thereunder,” “thereof” or words of like import in any Supplemental Agreement or in any other document or instrument delivered pursuant to the Compact or any Supplemental Agreement, shall mean and be construed as a reference to the Compact, as amended by this Amendment.
4. Limitations.
Except as expressly amended by this Amendment, all of the provisions of the Compact remain unchanged and in full force and effect.
5. Governing Law.
The Parties acknowledge and agree that this Amendment is an international agreement entered into for the purpose of amending the Compact and as such will be interpreted in a manner consistent with the Compact and is governed by international law.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
This is a virtual meeting. Members and the public may attend this meeting virtually via Zoom. Attendance information for the meeting will be forthcoming on the AAAC website:
Registration for the virtual meeting can be accessed via the following link:
Weeks of May 4, 11, 18, 25, and June 1, 8, 2026. The schedule for Commission meetings is subject to change on short notice. The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (
Public.
Members of the public may request to receive the information in these notices electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301-415-1969, or by email at
There are no meetings scheduled for the week of May 11, 2026.
There are no meetings scheduled for the week of May 18, 2026.
There are no meetings scheduled for the week of May 25, 2026.
For more information or to verify the status of meetings, contact Wesley Held at 301-287-3591 or via email at
The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued Subsequent Renewed Facility Operating License Nos. DPR-67 and NPF-16 to Florida Power and Light Company (FPL) for St. Lucie Plant (St. Lucie), Units 1
Subsequent Renewed Facility Operating License Nos. DPR-67 and NFP-16 were issued on April 28, 2026.
Please refer to Docket ID NRC-2021-0197 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
•
•
•
Vaughn Thomas, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5897; email:
Notice is hereby given that the NRC has issued Subsequent Renewed Facility Operating License Nos. DPR-67 and NFP-16 to FPL for St. Lucie, Units 1 and 2, respectively. FPL is the operator of the facility. Subsequent Renewed Facility Operating License Nos. DPR-67 and NFP-16 authorize FPL to operate St. Lucie, Units 1 and 2, respectively, at reactor core power levels not in excess of 3,020 megawatts thermal, in accordance with the provisions of the St. Lucie licenses and technical specifications. Notice is also given that the ROD that supports the NRC's decision to issue Subsequent Renewed Facility Operating License Nos. DPR-67 and NFP-16 is available, and its location is listed in the “Availability of Documents” section of this document.
As discussed in the ROD and the final supplemental environmental impact statement (SEIS), published as “Generic Environmental Impact Statement for License Renewal of Nuclear Plants, Supplement 11, Second Renewal, Regarding Subsequent License Renewal for St. Lucie Plant, Units 1 and 2, Final Report,” dated March 2026, the final SEIS documents the NRC staff's environmental review, including the recommendation that the adverse environmental impacts of subsequent license renewal (SLR) for St. Lucie are not so great that preserving the option of SLR for energy-planning decisionmakers would be unreasonable. This recommendation is based on (1) the analysis and findings in the NRC's Generic Environmental Impact Statement for License Renewal of Nuclear Plants, (2) information provided in the environmental report submitted by FPL, as supplemented, (3) the NRC staff's consultation with Federal, State, and local agencies and Indian Tribes, (4) the NRC staff's independent environmental review, and (5) the NRC staff's consideration of public comments received during the scoping process and on the draft SEIS.
St. Lucie consists of two Combustion Engineering designed pressurized-water reactors located in St. Lucie County, Florida. FPL submitted its SLR application for St. Lucie on August 3, 2021, which it supplemented by letters through November 20, 2025 (see “Availability of Documents” section of this document). The NRC staff has detemined that FPL's SLR application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the NRC's regulations. As required by the Act and NRC regulations in title 10 of the
A public notice of the NRC's acceptance for docketing of the SLR application and an opportunity to request a hearing was published in the
For further details with respect to this action, see: (1) FPL's SLR application for St. Lucie, dated August 3, 2021, as supplemented by letters through November 20, 2025; (2) the NRC's safety evaluation, dated July 2023, as revised in September 2023; (3) the NRC's final SEIS, dated March 2026; and (4) the NRC's ROD, dated April 28, 2026.
The documents identified in the following table are available to interested persons through ADAMS, as indicated.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Request for resumes.
The U.S. Nuclear Regulatory Commission (NRC) seeks qualified candidates for appointment to the Advisory Committee on Reactor Safeguards (ACRS or Committee).
Resumes will be accepted until July 30, 2026.
Submit resumes to Sandra Walker, ACRS, Mail Stop: T2B50, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or email
The ACRS is a part-time advisory group, which is statutorily mandated by the Atomic Energy Act of 1954, as amended. The ACRS provides independent expert advice on matters related to the safety of existing and proposed nuclear reactor facilities and on the adequacy of proposed reactor safety standards. Of primary importance is the focus on unique, novel and noteworthy safety issues associated with new licensing applications for light-water and non-light water reactors, and the operation of commercial nuclear power plants in the United States and related regulatory initiatives, including risk-informed and performance-based regulation, and increased enrichment and enhanced burnup in fuels for the operating reactor fleet in support of first of a kind power uprate applications.
An increased emphasis is being given to safety issues associated with new light water and non-light water reactor designs and technologies, and the Committee is looking for a new member with multi-disciplinary background and experience related to: integrated reactor core and systems performance with an emphasis on new and novel reactor coolants, such as gas, liquid metals and molten salts; passive and inherently safe design features; nuclear fuels (TRi-structural ISOtropic (TRISO), metallic and traditional light-water) and fuel management; thermal-hydraulic phenomena; chemical engineering and high temperature material behavior (advanced alloys); and, international codes and industrial standards used in multinational and domestic nuclear design certifications and reviews. The ACRS may also have involvement in security matters related to the integration of safety and security of commercial reactors and facilities. For additional information about the ACRS, see the NRC website at:
Criteria used to evaluate candidates include education and experience, demonstrated skills in nuclear reactor safety matters listed previously, the ability to solve complex technical problems, and the ability to work collegially on a board, panel, or committee. The Commission, in selecting its ACRS members, also considers the need for specific expertise to accomplish the work anticipated for the Committee. The ACRS members are generally appointed for four-year terms and may be reauthorized by the Commission to serve subsequent terms. The Commission looks to fill one vacancy as a result of this request.
Consistent with the requirements of the Federal Advisory Committee Act, the Commission seeks candidates with varied backgrounds, so that the Committee membership is balanced in terms of the points of view represented and functions performed by the Committee. Candidates will undergo a thorough security background check to obtain the security clearance that is mandatory for all ACRS members. The security background check will involve the completion and submission of paperwork to the NRC. Candidates for ACRS appointments may be involved in or have financial interests related to NRC-regulated aspects of the nuclear industry. However, because conflict-of-interest considerations may restrict the participation of a candidate in ACRS activities, the degree and nature of any such restriction on an individual's activities as a member will be considered in the selection process. Each qualified candidate's financial interests must be reconciled with applicable Federal and NRC rules and regulations prior to final appointment. This might require divestiture of securities or discontinuance of certain contracts or grants. Information regarding these restrictions will be provided upon request. As a part of the Stop Trading on Congressional Knowledge Act of 2012, which bans insider trading by members of Congress, their staff, and other high-level federal employees, candidates for appointments will be required to disclose additional financial transactions.
A Curriculum Vitae or resume describing the educational and professional background of each candidate, including any special accomplishments, publications, and professional references should be provided. Candidates should provide their current address, telephone number, and email address. All candidates will receive careful consideration. The NRC does not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Candidates must be citizens of the United States and be able to devote approximately 100 days per year to Committee business but may not be compensated for more than 130 calendar days. Appointees may be able to attend some Committee meetings virtually. Resumes will be accepted until July 30, 2026.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). The Public Representative does not represent any individual person, entity or particular point of view, and, when Commission attorneys are appointed, no attorney-client relationship is established. Section II also establishes comment deadline(s) pertaining to each such request.
The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.
Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review.
None.
1.
This Notice will be published in the
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rules 353 and 931NY to eliminate certain of the Exchange's publication obligations as outdated and unnecessary. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rules 353 (American Trading Permit Requirements), and 931NY (Registration of Floor Brokers) to eliminate certain of the Exchange's publication obligations as outdated and unnecessary. The Exchange also proposes related conforming changes to Rules 452 (Equities. Giving Proxies by Member Organizations) and 459 (Equities. Other Persons to File Information When Associate with Member).
Rule 353 describes the procedure for applying for status as an American Trading Permit (“ATP”) Holder on the Exchange. Subparagraph (2) under the “Admissions Procedure” section of Rule 353 provides that, in connection with an application for an ATP, there is a minimum posting period of seven days, which period may be extended by the Exchange when necessary, and that notice of the proposed issuance of an ATP must be posted in the Exchange's Weekly Bulletin. This subparagraph further provides that the minimum posting period will be waived for prior active members. The Exchange proposes to delete the posting requirement set forth in this subparagraph (and to renumber the remaining subparagraphs accordingly) because the Exchange no longer accepts comments from ATP Holders in connection with the ATP application process; instead, the Exchange's decisions regarding such applications are based on objective criteria set forth in its rules.
Rule 931NY(a) requires that an applicant for registration as a Floor Broker must file an application in writing with the Exchange on such form or forms as the Exchange may prescribe and must pass a Floor Broker examination prescribed by the Exchange. The rule further provides that, before a registration becomes effective, the Exchange will post the name of the applicant on the bulletin board on the Floor of the Exchange for three business days. The Exchange proposes to delete the posting requirement as set forth in Rule 931NY(a) because the Exchange no longer accepts comments in connection with Floor Broker applications; instead, the Exchange's decisions regarding such applications are based solely upon objective criteria set forth in its rules.
Finally, with the proposed elimination of the publication and posting requirements in Rules 353 and 931NY as described above and given that the Exchange posts information relevant to market participants on its publicly available website, the Exchange also proposes to discontinue publication of the Weekly Bulletin and use of a physical bulletin board on the Trading Floor.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes the proposed rule change would remove impediments to, and perfect the mechanism of, a free and open market and a national market system because it eliminates publication and posting requirements that are outdated, unduly burdensome, and redundant of information publicly available on the Exchange's website. With respect to the posting requirements for ATP and Floor Broker applicants, as set forth in Rules 353 and 931NY(a), respectively, the Exchange believes that the original rationale for posting such information—to put market participants on notice of certain applications and provide them an opportunity to submit comments to the Exchange regarding such applications—is no longer relevant, given that the Exchange no longer accepts such comments. Instead, as noted above, the Exchange evaluates ATP Holder and Floor Broker applications based on objective criteria set forth in Exchange rules. The Exchange thus believes that eliminating these requirements would streamline Exchange rules, while promoting clarity and transparency as to the Exchange's practices with respect to evaluating such applications. The Exchange also believes that the elimination of the requirement, as set forth in Rule 353, to publish new ATP Holders in the Exchange's Weekly Bulletin is similarly unnecessary given that the Exchange maintains an up-to-date Membership Directory on its website, which makes publicly available to market participants the names of approved ATP Holders. Thus, the Exchange believes the proposed change would likewise streamline Exchange rules by removing unnecessary and outdated requirements. Finally, the Exchange believes that the proposed change to discontinue publication of the Weekly Bulletin and use of a physical bulletin board on the Trading Floor would similarly remove impediments to, and perfect the mechanism of, a free and open market and a national market system because it would reduce an administrative burden on the Exchange without impacting the continued availability of relevant information to market participants via the Exchange's website.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change will not impose an undue burden on intramarket competition because the changes will impact all similarly situated market participants equally. The Exchange believes that the proposed rule change will not impose an undue burden on intermarket competition because it is intended to streamline Exchange rules by removing unnecessary and outdated requirements that other exchanges have similarly eliminated or otherwise do not have in their rules.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to file number SR-NYSEAMER-2026-29 and should be submitted on or before May 22, 2026.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Exchange Rule 531(d), the Purge Liquidity Taker Report (the “Report”), to update the timeframe used by the Exchange for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member (described below) to cancel that resting quote was received by the Exchange.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Exchange Rule 531(d) for the Report to update the timeframe used by the Exchange for the time difference between the time the first response that executes against the resting quote
The Exchange recently filed a proposed rule change with the Securities and Exchange Commission (“Commission”) to establish the Report.
Report Content, Current Timeframes, and Scope
The Report is a daily report that provides a Market Maker (referred to as the “Recipient Member”) with the liquidity response/taker time details for executions against quotes entered by the Recipient Member that are resting on the Simple Order Book
Exchange Rule 531(d)(2)(i) provides that for the purge message sent by the Recipient Member to cancel the resting quote after the response that executes against that resting quote is received by the Exchange pursuant to paragraph (d)(1)(iii)(C) above, the Report includes the data listed in paragraph (d)(1) of Exchange Rule 531 within 100 microseconds from the time the resting quote was executed against to the Exchange's receipt of the purge message. Exchange Rule 531(d)(2)(ii) provides that for the purge message sent by the Recipient Member to cancel the resting quote before the next response that executes against that resting quote was received by the Exchange pursuant to paragraph (d)(1)(iii)(D) above, the Report includes the data listed in paragraph (d)(1) of Exchange Rule 531 within 200 microseconds from the time the Exchange received the purge message to when the Exchange receives the next execution.
Exchange Rule 531(d)(3) provides that the Report only includes trading data related to the Recipient Member and will not include any other Member's trading data other than that listed in paragraphs (1)(i) and (ii) of Exchange Rule 531(d), as described above.
Exchange Rule 531(d)(4) specifies that the Report contains historical data from the previous trading day and will be available after the end of the trading day, generally on a T+1 basis.
The Exchange proposes to amend Exchange Rule 531(d)(2)(i) to increase the timeframe for the time difference between the time the first response that executes against the resting quote was
The purpose of this change is for subscribers to the Report to see additional data points regarding their interactions with the Exchange to purge resting quotes when those quotes were executed prior to the Exchange receiving the purge message. The proposed increased timeframe should provide Recipient Members with a greater understanding of how much time their purge message(s) missed canceling a resting quote after that quote was executed. As currently provided under Exchange Rule 531(d)(2)(i), the Recipient Member would only see the information provided in the Report if their purge message missed canceling a quote in 100 microseconds or less from when that quote was executed. By increasing the timeframe, Recipient Members will be able to receive the information provided for in the Report within 500 microseconds or less from when that quote was executed. The Exchange believes this longer timeframe better serves the purpose of the Report by providing Market Makers with greater opportunities to improve quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly.
The Exchange does not propose to amend the content, any other timeframes or scope of the Report and will continue to make the Report available after the end of the trading day, generally on a T+1 basis.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed change to amend the Report to increase the timeframe for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member to cancel that resting quote was received by the Exchange removes impediments to and perfects the mechanism of a free and open market. This is because the proposed increased timeframe should further enhance the usefulness of the Report, which is designed to aid Market Makers by improving quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly.
The Exchange believes that with the proposed change, the Report continues to promote just and equitable principles of trade because it would provide latency information in a systematized way and standardized format to any Member that chooses to subscribe to the Report, as proposed to be amended by the increased timeframe. The Report will continue to not be a real-time market data product and will provide only historical data for the previous trading day, generally on a T+1 basis. Further, the data included in the Report, including additional data that may be provided with the increased timeframe, would continue to be specific to the Recipient Member regarding incoming purge messages that failed to cancel resting quotes ahead of an execution against those quotes.
The Report was designed for Market Makers that are interested in gaining insight into latency in connection with their purge messages that failed to cancel resting quotes. The Exchange believes that increasing the timeframe is consistent with facilitating transactions in securities, removing impediments to and perfecting the mechanism of a free and open market and a national market system, and, in general, protecting investors and the public interest because it provides additional information and insight to subscribing market participants regarding their interactions with the Exchange. More specifically, the Report, as proposed to be modified herein, will continue to provide greater visibility by showing how much time a purge message missed canceling a quote, particularly as market conditions change throughout the day and Market Makers attempt to cancel and replace quotes in certain symbols.
Additionally, the proposal would not permit unfair discrimination because the Report will continue to be available to all Exchange Market Makers and all Market Makers that subscribe will receive the same data points for the same timeframe, with the information specific to the Recipient Member.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Rather, the Exchange believes that the proposal may promote or enhance intra-market competition because subscribers to the Report will see additional data points regarding their interactions with the Exchange to purge resting quotes when those quotes were executed prior to the Exchange receiving the purge message. The proposed increased timeframe should provide Recipient Members with a greater understanding of how much time their purge message(s) missed canceling a resting quote after that quote was executed. The Exchange believes this longer timeframe may promote intra-market competition by providing Market Makers with greater opportunities to improve quote cancel success, particularly as market conditions change throughout the day
The Exchange also believes this proposal does not place any burden on inter-market competition that is not necessary or appropriate in furtherance of the purposes of the Act because other exchanges may offer similar reports and products that contain similar data points as the Report that are applicable to resting quotes and cancel messages of market participants of those exchanges. Accordingly, the Exchange believes this proposed rule change permits fair competition among national securities exchanges.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email
• Send paper comments in triplicate to Vanessa Countryman, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to file number SR-SAPPHIRE-2026-18 and should be submitted on or before May 22, 2026.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Exchange Rule 531(d), the Purge Liquidity Taker Report (the “Report”), to update the timeframe used by the Exchange for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member (described below) to cancel that resting quote was received by the Exchange.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Exchange Rule 531(d) for the Report to update the timeframe used by the Exchange for the time difference between the time the first response that executes against the resting quote
The Exchange recently filed a proposed rule change with the Securities and Exchange Commission (“Commission”) to establish the Report.
The Report is a daily report that provides a Market Maker (referred to as the “Recipient Member”) with the liquidity response/taker time details for executions against quotes entered by the Recipient Member that are resting on the Simple Order Book
Exchange Rule 531(d)(2)(i) provides that for the purge message sent by the Recipient Member to cancel the resting quote after the response that executes against that resting quote is received by the Exchange pursuant to paragraph
Exchange Rule 531(d)(3) provides that the Report only includes trading data related to the Recipient Member and will not include any other Member's trading data other than that listed in paragraphs (1)(i) and (ii) of Exchange Rule 531(d), as described above.
Exchange Rule 531(d)(4) specifies that the Report contains historical data from the previous trading day and will be available after the end of the trading day, generally on a T+1 basis.
The Exchange proposes to amend Exchange Rule 531(d)(2)(i) to increase the timeframe for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member to cancel that resting quote was received by the Exchange. In particular, the Exchange proposes to amend Exchange Rule 531(d)(2)(i) to provide that for the purge message sent by the Recipient Member to cancel the resting quote after the response that executes against that resting quote is received by the Exchange pursuant to paragraph (d)(1)(iii)(C) above, the Purge Liquidity Taker Report will include the data listed in paragraph (d)(1) of Exchange Rule 531 within 500 microseconds (instead of 100 microseconds) from the time the resting quote was executed against to the Exchange's receipt of the purge message.
The purpose of this change is for subscribers to the Report to see additional data points regarding their interactions with the Exchange to purge resting quotes when those quotes were executed prior to the Exchange receiving the purge message. The proposed increased timeframe should provide Recipient Members with a greater understanding of how much time their purge message(s) missed canceling a resting quote after that quote was executed. As currently provided under Exchange Rule 531(d)(2)(i), the Recipient Member would only see the information provided in the Report if their purge message missed canceling a quote in 100 microseconds or less from when that quote was executed. By increasing the timeframe, Recipient Members will be able to receive the information provided for in the Report within 500 microseconds or less from when that quote was executed. The Exchange believes this longer timeframe better serves the purpose of the Report by providing Market Makers with greater opportunities to improve quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly.
The Exchange does not propose to amend the content, any other timeframes or scope of the Report and will continue to make the Report available after the end of the trading day, generally on a T+1 basis.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed change to amend the Report to increase the timeframe for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member to cancel that resting quote was received by the Exchange removes impediments to and perfects the mechanism of a free and open market. This is because the proposed increased timeframe should further enhance the usefulness of the Report, which is designed to aid Market Makers by improving quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly.
The Exchange believes that with the proposed change, the Report continues to promote just and equitable principles of trade because it would provide latency information in a systematized way and standardized format to any Member that chooses to subscribe to the Report, as proposed to be amended by the increased timeframe. The Report will continue to not be a real-time market data product and will provide only historical data for the previous trading day, generally on a T+1 basis. Further, the data included in the Report, including additional data that may be provided with the increased timeframe, would continue to be specific to the Recipient Member regarding incoming purge messages that failed to cancel resting quotes ahead of an execution against those quotes.
The Report was designed for Market Makers that are interested in gaining insight into latency in connection with their purge messages that failed to cancel resting quotes. The Exchange believes that increasing the timeframe is consistent with facilitating transactions in securities, removing impediments to and perfecting the mechanism of a free and open market and a national market system, and, in general, protecting investors and the public interest because it provides additional information and insight to subscribing market participants regarding their interactions with the Exchange. More specifically, the Report, as proposed to
Additionally, the proposal would not permit unfair discrimination because the Report will continue to be available to all Exchange Market Makers and all Market Makers that subscribe will receive the same data points for the same timeframe, with the information specific to the Recipient Member.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Rather, the Exchange believes that the proposal may promote or enhance intra-market competition because subscribers to the Report will see additional data points regarding their interactions with the Exchange to purge resting quotes when those quotes were executed prior to the Exchange receiving the purge message. The proposed increased timeframe should provide Recipient Members with a greater understanding of how much time their purge message(s) missed canceling a resting quote after that quote was executed. The Exchange believes this longer timeframe may promote intra-market competition by providing Market Makers with greater opportunities to improve quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly. Furthermore, this product offering is entirely optional and is available to any Market Maker that believes this data will be helpful for their business purposes. As such, the Exchange does not believe this proposed rule change places any burden on intra-market competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange also believes this proposal does not place any burden on inter-market competition that is not necessary or appropriate in furtherance of the purposes of the Act because other exchanges may offer similar reports and products that contain similar data points as the Report that are applicable to resting quotes and cancel messages of market participants of those exchanges. Accordingly, the Exchange believes this proposed rule change permits fair competition among national securities exchanges.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email
• Send paper comments in triplicate to Vanessa Countryman, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to file number SR-MIAX-2026-15 and should be submitted on or before May 22, 2026.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Exchange Rule 531(c), the Purge Liquidity Taker Report (the “Report”), to update the timeframe used by the Exchange for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member (described below) to cancel that resting quote was received by the Exchange.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Exchange Rule 531(c) for the Report to update the timeframe used by the Exchange for the time difference between the time the first response that executes against the resting quote
The Exchange recently filed a proposed rule change with the Securities and Exchange Commission (“Commission”) to establish the Report.
The Report is a daily report that provides a Market Maker (referred to as the “Recipient Member”) with the liquidity response/taker time details for executions against quotes entered by the Recipient Member that are resting on the Book
Exchange Rule 531(c)(2)(i) provides that for the purge message sent by the Recipient Member to cancel the resting quote after the response that executes against that resting quote is received by the Exchange pursuant to paragraph (c)(1)(iii)(C) above, the Report includes the data listed in paragraph (c)(1) of Exchange Rule 531 within 100 microseconds from the time the resting quote was executed against to the Exchange's receipt of the purge message. Exchange Rule 531(c)(2)(ii) provides that for the purge message sent by the Recipient Member to cancel the resting quote before the next response that executes against that resting quote was received by the Exchange pursuant to paragraph (c)(1)(iii)(D) above, the Report includes the data listed in paragraph (c)(1) of Exchange Rule 531 within 200 microseconds from the time the Exchange received the purge message to when the Exchange receives the next execution.
Exchange Rule 531(c)(3) provides that the Report only includes trading data related to the Recipient Member and will not include any other Member's trading data other than that listed in paragraphs (1)(i) and (ii) of Exchange Rule 531(c), as described above.
Exchange Rule 531(c)(4) specifies that the Report contains historical data from the previous trading day and will be available after the end of the trading day, generally on a T+1 basis.
The Exchange proposes to amend Exchange Rule 531(c)(2)(i) to increase the timeframe for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member to cancel that resting quote was received by the Exchange. In particular, the Exchange proposes to amend Exchange Rule 531(c)(2)(i) to provide that for the purge message sent by the Recipient Member to cancel the resting quote after the response that executes against that resting quote is received by the Exchange pursuant to paragraph (c)(1)(iii)(C) above, the Purge Liquidity Taker Report will include the data listed in paragraph (c)(1) of Exchange Rule 531 within 500 microseconds (instead of 100 microseconds) from the time the resting quote was executed against to the Exchange's receipt of the purge message.
The purpose of this change is for subscribers to the Report to see additional data points regarding their interactions with the Exchange to purge resting quotes when those quotes were executed prior to the Exchange receiving the purge message. The proposed increased timeframe should provide Recipient Members with a greater understanding of how much time their purge message(s) missed canceling a resting quote after that quote was executed. As currently provided under Exchange Rule 531(c)(2)(i), the Recipient Member would only see the information provided in the Report if their purge message missed canceling a quote in 100 microseconds or less from when that quote was executed. By increasing the timeframe, Recipient Members will be able to receive the information provided for in the Report within 500 microseconds or less from when that quote was executed. The Exchange believes this longer timeframe better serves the purpose of the Report by providing Market Makers with greater opportunities to improve quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly.
The Exchange does not propose to amend the content, any other timeframes or scope of the Report and will continue to make the Report available after the end of the trading day, generally on a T+1 basis.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed change to amend the Report to increase the timeframe for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by
The Exchange believes that with the proposed change, the Report continues to promote just and equitable principles of trade because it would provide latency information in a systematized way and standardized format to any Member that chooses to subscribe to the Report, as proposed to be amended by the increased timeframe. The Report will continue to not be a real-time market data product and will provide only historical data for the previous trading day, generally on a T+1 basis. Further, the data included in the Report, including additional data that may be provided with the increased timeframe, would continue to be specific to the Recipient Member regarding incoming purge messages that failed to cancel resting quotes ahead of an execution against those quotes.
The Report was designed for Market Makers that are interested in gaining insight into latency in connection with their purge messages that failed to cancel resting quotes. The Exchange believes that increasing the timeframe is consistent with facilitating transactions in securities, removing impediments to and perfecting the mechanism of a free and open market and a national market system, and, in general, protecting investors and the public interest because it provides additional information and insight to subscribing market participants regarding their interactions with the Exchange. More specifically, the Report, as proposed to be modified herein, will continue to provide greater visibility by showing how much time a purge message missed canceling a quote, particularly as market conditions change throughout the day and Market Makers attempt to cancel and replace quotes in certain symbols.
Additionally, the proposal would not permit unfair discrimination because the Report will continue to be available to all Exchange Market Makers and all Market Makers that subscribe will receive the same data points for the same timeframe, with the information specific to the Recipient Member.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Rather, the Exchange believes that the proposal may promote or enhance intra-market competition because subscribers to the Report will see additional data points regarding their interactions with the Exchange to purge resting quotes when those quotes were executed prior to the Exchange receiving the purge message. The proposed increased timeframe should provide Recipient Members with a greater understanding of how much time their purge message(s) missed canceling a resting quote after that quote was executed. The Exchange believes this longer timeframe may promote intra-market competition by providing Market Makers with greater opportunities to improve quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly. Furthermore, this product offering is entirely optional and is available to any Market Maker that believes this data will be helpful for their business purposes. As such, the Exchange does not believe this proposed rule change places any burden on intra-market competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange also believes this proposal does not place any burden on inter-market competition that is not necessary or appropriate in furtherance of the purposes of the Act because other exchanges may offer similar reports and products that contain similar data points as the Report that are applicable to resting quotes and cancel messages of market participants of those exchanges. Accordingly, the Exchange believes this proposed rule change permits fair competition among national securities exchanges.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Cboe EDGX Exchange, Inc. (the “Exchange” or “EDGX”) proposes to amend its Fee Schedule by introducing new fee code ZP and amending the fee associated with fee code DX. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Commission's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its Fee Schedule applicable to its equities trading platform (“EDGX Equities”) by introducing new fee code ZP and amending the fee associated with fee code DX. The Exchange proposes to implement these changes effective April 1, 2026.
The Exchange first notes that it operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. More specifically, the Exchange is only one of 17 registered equities exchanges, as well as a number of alternative trading systems and other off-exchange venues that do not have similar self-regulatory responsibilities under the Securities Exchange Act of 1934 (the “Act”), to which market participants may direct their order flow. Based on publicly available information,
The Exchange's Fee Schedule sets forth the standard rebates and rates applied per share for orders that provide and remove liquidity, respectively. Currently, for orders in securities priced at or above $1.00, the Exchange provides a standard rebate of $0.00160 per share for orders that add liquidity and assesses a fee of $0.0030 per share for orders that remove liquidity.
On March 19, 2026, the Commission approved the Exchange's proposed adoption of the EDGX RPI Program.
The Exchange notes that its affiliate exchange, Cboe BYX Exchange, Inc. (“BYX”), similarly assesses a fee for RPI Orders that add liquidity to BYX as part of its retail liquidity program offering.
Additionally, the Exchange proposes to amend the fee associated with fee code DX. Specifically, the proposed rule change amends the fee assessed to orders that yield fee code DX under the Fee Codes and Associated Fees table of the Fee Schedule. Fee code DX is appended to MDOs using the QDP order instruction that remove liquidity from the Exchange. QDP is designed to provide enhanced protections to MDOs by tracking significant executions that constitute the best bid or offer on the EDGX Book
Currently, orders appended with fee code DX are assessed a fee of $0.00150 per share in securities at or above $1.00 and 0.30% of dollar value for securities priced below $1.00. The Exchange proposes to increase the fee to $0.00250 per share in securities at or above $1.00. There is no proposed change in the fee assessed to securities priced below $1.00. The purpose of increasing the fee associated with fee code DX in securities priced at or above $1.00 is for business and competitive reasons, as the Exchange believes that increasing such fee as proposed would decrease the Exchange's expenditures with respect to transaction pricing in a manner that is still consistent with the Exchange's overall pricing philosophy of encouraging added liquidity.
The Exchange believes the proposed rule changes are consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes that proposed fee code ZP is reasonable, equitable, and not unfairly discriminatory. As discussed, proposed fee code ZP would introduce pricing specific to RPI Orders executed in securities priced at or above $1.00 that add liquidity to EDGX. The proposed fee code reflects a competitive pricing structure designed to encourage Members to submit RPI Orders to EDGX for execution against contra-side Retail Orders, which are generally seen as more desirable than non-Retail Orders.
Additionally, the Exchange notes that the proposed fee code is not dissimilar from other fee codes associated with retail liquidity programs offered by other exchanges, such as those offered by BYX and NYSE National Exchange, Inc. (“NYSE National”).
Further, the Exchange's proposed fee code ZP is equitable and not unfairly discriminatory because it would apply to all RPI Orders that add liquidity to EDGX in securities priced at or above $1.00. Additionally, the RPI Order type is open to all Users on an equal basis and is completely voluntary. Users are not required to utilize the RPI Order type and may choose whether to utilize the RPI Order type to potentially benefit by executing against a contra-side Retail Order while incurring a fee to utilize the RPI Order. Should a User desire not to incur a fee to add liquidity to EDGX by using the RPI Order type, the User is free to utilize other order types that are eligible to execute against Retail Orders and would not incur a fee to add liquidity to EDGX.
Finally, the Exchange believes that its proposal to modify the fee associated with fee code DX is reasonable, equitable, and consistent with the Act because such change is designed to decrease the Exchange's expenditures with respect to transaction pricing in order to offset some of the costs associated with the Exchange's current pricing structure, which provides various rebates for liquidity-adding orders, and the Exchange's operations generally, in a manner that is consistent with the Exchange's overall pricing philosophy of encouraging added liquidity. The Exchange further believes that the proposed change is reasonable because the proposed fee remains consistent with pricing offered by the other exchanges and does not represent a significant departure from the Exchange's general pricing structure. Indeed, the proposed fee applicable to fee code DX ($0.0025) is lower than that of the Exchange's affiliate, Cboe EDGA Exchange, Inc. (“EDGA”), which currently assesses a fee of $0.00300 for MDOs removed from EDGA with a QDP order instruction. The Exchange further believes that the proposed increase to the fee associated with fee code DX is equitable and not unfairly discriminatory because it applies to all Members equally, in that all Members will be assessed the higher fee upon submitting orders appended with fee code DX. The Exchange notes that the QDP instruction is optional and market participants who do not wish to incur the increased flat fee can continue to enter MDOs without the QDP instruction.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Rather, as discussed above, the Exchange believes that the proposed changes will encourage the submission of additional order flow to a public exchange, thereby promoting market depth, execution incentives and enhanced execution opportunities, as well as price discovery and transparency for all Members. As a result, the Exchange believes that the proposed changes further the Commission's goal in adopting Regulation NMS of fostering competition among orders, which promotes “more efficient pricing of individual stocks for all types of orders, large and small.”
The Exchange believes the proposed rule changes do not impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. Particularly, the proposed fee associated with fee code ZP does not impose an unnecessary burden as all RPI Orders that add liquidity to EDGX in securities priced at or above $1.00 will be appended with fee code ZP. Further, use of the RPI Order type is completely voluntary and is not required by the Exchange. Similarly, the Exchange believes the proposed amendment to the fee associated with fee code DX does not impose any burden on intramarket competition as all Members will be subject to the higher fee assessed to orders appended with fee code DX. The Exchange does not believe the proposed changes burden competition, but rather, enhance competition as they are intended to increase the competitiveness of EDGX by amending existing pricing incentives in order to attract order flow and incentivize participants to increase their participation on the Exchange. Greater overall order flow, trading opportunities, and pricing transparency benefits all market participants on the Exchange by enhancing market quality and continuing to encourage Members to send orders, thereby contributing towards a robust and well-balanced market ecosystem.
Next, the Exchange believes the proposed rule changes do not impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. As previously discussed, the Exchange operates in a highly competitive market. Members have numerous alternative venues that they may participate on and direct their order flow, including other equities exchanges, off-exchange venues, and alternative trading systems. Additionally, the Exchange represents a small percentage of the overall market. Based on publicly available information, no single equities exchange has more than 15% of the market share.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
Pursuant to the provisions of Section 19(b)(1) under the Act,
The text of the proposed rule change is available at the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text
The Exchange proposes to modify its fee schedule applicable to Members (“Fee Schedule”
The Exchange periodically assesses its fee structure. Based upon a recent assessment, the Exchange believes that the introduction of the proposed Tape B Displayed Liquidity Adding Rebate Tiers would further incentivize Members to submit displayed orders in Tape B securities priced at or above $1.00 per share. IEX designed this new rebate offering to promote price discovery and market quality on the Exchange, which the Exchange believes benefits all Members and market participants.
IEX currently offers Members eight Displayed Liquidity Rebate Tiers based on the Member's trading activity in the immediately preceding month.
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IEX applies Fee Code Modifier “B” to executions of Tape B securities, although it currently offers the same fees and rebates to executions irrespective of if the security prints to Tape A, Tape B, or Tape C.
IEX now proposes to modify Fee Code Combinations MLB and MLYB with a new footnote, footnote 7, which will set forth the new Tape B Displayed Liquidity Adding Rebate Tiers, which are based on a Member's trading activity in the immediately preceding month.
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As proposed, if a Member added 600,000 ADV of displayed liquidity in Tape B securities in the prior month, the Member would qualify for Tier 3 of the Tape B Displayed Liquidity Adding Rebate Tiers and would receive a rebate of $0.0016 per share for all displayed liquidity adding executions of Tape B securities in the current month. This rebate is clearly higher than the rebate paid if the same Member added 600,000 ADV of displayed liquidity in either Tape A or Tape C securities, which would qualify the Member for Tier 1 of the Displayed Liquidity Adding Rebate Tiers, and result in free executions of all displayed liquidity adding executions of Tape A or Tape C securities in the current month (but no rebate).
However, there are circumstances in which the above Member would receive a higher rebate under the Displayed Liquidity Adding Rebate Tiers than it would receive under the Tape B Displayed Liquidity Adding Rebate Tiers. For example, if the above Member that qualified for Tape B Displayed Liquidity Adding Rebate Tier 3 (earning a $0.0016 per share rebate for all Tape B Added Displayed Liquidity in the current month) also (i) added at least 15,000,000 (but less than 20,000,000) ADV of Added Displayed Liquidity in Tape A, B, or C securities,
Thus, the proposed new Tape B Displayed Liquidity Adding Rebate Tiers, which are designed to incentivize the adding of displayed liquidity in Tape B securities, will not preclude a Member from receiving the highest possible rebate if it qualifies for the higher rebate through a different means.
IEX also proposes to revise the title of footnote 4 of the Fee Schedule by adding the words “for Tape A, B, or C Securities” to the end of the header. This change reflects that these rebates continue to apply to all displayed liquidity adding executions and matches the proposed title of the new footnote 7, which specifies that those rebate tiers only are applicable to displayed liquidity adding executions at or above $1 of Tape B securities.
IEX believes that the proposed rule change is consistent with the provisions of Section 6(b)
The Exchange operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive. As discussed in the Purpose section, the Exchange believes that the proposed addition of a new set of volume-based rebates that pays a higher rebate to Members who add progressively more displayed liquidity in Tape B securities (on a monthly average basis) is reasonable and consistent with the Act because it is designed to attract and incentivize Members to send displayed orders, as well as order flow seeking to trade with such displayed orders, to IEX.
Based on informal discussions with market participants, IEX believes that Members and other market participants may be more willing to send displayed orders in Tape B securities to IEX if the proposed fee structure was adopted. Accordingly, IEX has designed the proposed Tape B Displayed Liquidity Adding Rebate Tiers to attract and incentivize displayed orders in Tape B securities as well as order flow seeking to trade with such displayed orders. Moreover, increases in displayed liquidity of Tape B securities would contribute to the public price discovery process which would benefit all market participants and protect investors and the public interest.
The Exchange believes that the proposed new rebate tiers for providing displayed liquidity in Tape B securities are reasonable and consistent with the Act. Specifically, the Exchange believes that for securities that trade at or above $1.00 per share, it is reasonable to provide an increased rebate of $0.0014 per share for Members that in the prior month added at least 250,000 ADV but less than 500,000 ADV of displayed liquidity in Tape B securities, and to provide an increased rebate of $0.0016 per share for Members that in the prior month added at least 500,000 ADV of displayed liquidity in Tape B securities.
The Exchange notes that the proposed new Tape B Displayed Liquidity Adding Rebate Tiers are not designed to permit unfair discrimination because they will be applied uniformly to all Members who satisfy the specified criteria.
The Exchange also believes that it is reasonable and consistent with the Act not to modify its displayed fees for sub-dollar executions to synchronize those fees with the proposed fees for executions at or above $1.00 per share. The Exchange believes that the existing fee structure for such executions continues to be reasonably designed to incentivize displayed order flow (and orders seeking to trade with displayed order flow) in such securities.
And the Exchange believes it is consistent with the Act to specify that the criteria to qualify for the Tape B Displayed Liquidity Adding Rebate Tiers are based on the trading activity on IEX in the prior month in order to comply with Rule 610(d) of Regulation NMS.
As discussed above, the Exchange operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive. Within that context, the proposed new Tape B Displayed Liquidity Adding Rebate Tiers are designed to keep the Exchange's displayed trading prices competitive with those of other exchanges. The proposed new rebates are within the range or lower than fees [sic] offered by competing exchanges, and thus the Exchange does not believe that the proposal raises any new or novel issues not already considered by the Commission in the context of other exchanges' fees.
IEX believes that the proposed rule change will not result in any burden on competition that is not necessary or
The Exchange believes that the proposed rule change will not impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because, while different rebates are assessed on Members, these rebates are not based on the type of Member entering the orders that match, but rather on the Member's own trading activity on the Exchange. Further, the proposed fee change continues to be intended to encourage market participants to bring increased order flow to the Exchange and contribute to the public price discovery process, which benefits all market participants.
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) under the Securities Exchange Act of 1934 (the “Act”)
The Exchange is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to amend the Fee Schedule on the BOX Options Market LLC (“BOX”) options facility. Specifically, the Exchange proposes to amend Section IV. (Electronic Transaction Fees) to modify certain rebate tiers for Qualified Contingent Cross (“QCC”) transactions. The text of the proposed rule change is available from the principal office of the Exchange, and also on the Exchange's internet website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these
The Exchange proposes to update the Fee Schedule for trading on BOX to amend certain rebate tiers for Qualified Contingent Cross (“QCC”) transactions.
Currently, BOX assesses $0.20 per contract to Broker Dealers and Market Makers for both the Agency Order and contra order of a QCC transaction. Public Customers and Professional Customers are not assessed a QCC Transaction Fee. Further, rebates are applied to the Agency Order on all qualifying orders pursuant to Section IV.D.1. of the BOX Fee Schedule. Specifically, a QCC Rebate is paid to the Participant that entered the order into the BOX System when at least one party to the QCC transaction is a Broker Dealer or Market Maker. The Participant receives a per contract rebate applied to the Agency Order of a QCC Transaction according to the tier achieved, as provided in the table below. Volume thresholds are calculated on a monthly basis by totaling the Participant's QCC Agency Order volume on BOX. When only one side of the QCC transaction is a Broker Dealer or Market Maker, Rebate 1 applies. When both parties to the QCC transaction are a Broker Dealer or Market Maker, Rebate 2 applies. The Exchange notes that the QCC Rebate is intended to incentivize Participants to send QCC Orders to BOX.
The current QCC Rebate tier structure is as follows:
The Exchange now proposes to amend the QCC Rebate tier structure in Section IV.D.1. of the BOX Fee Schedule. Specifically, the Exchange proposes to amend the volume thresholds in Tiers 1 and 2. For Tier 1, the Exchange proposes to amend the volume threshold from 0 to 749,999 contracts to 0 to 499,999 contracts. For Tier 2, the Exchange proposes to amend the volume threshold from 750,000 to 1,499,999 contracts to 500,000 to 1,499,999 contracts.
The proposed QCC Rebate tier structure will be as follows:
As a result of the proposed change, Tier 2 will be easier to achieve thus affording Participants with additional rebate opportunities. The Exchange notes that achieving Tier 2 of the QCC Rebate is one of the qualifying criteria for the QCC Growth Rebate in Section IV.D.1.b., thus the QCC Growth Rebate will also be easier to achieve, assuming all criteria are met. The Exchange believes that the proposed changes will encourage Participants to send increased QCC order flow to BOX in order to achieve a higher rebate, which will result in increased liquidity on BOX to the benefit of all market participants.
The Exchange is also proposing to add language to Section IV.D.1.a. to make it clear that the QCC Rebate is applied to the Agency Order on qualifying QCC Transactions. Specifically, a Participant will receive a per contract rebate that is applied to the Agency Order on QCC Transactions according to the tier achieved, as provided in Section IV.D.1.a. With this new language, the Exchange is not proposing to make any changes to the way the QCC Rebate is currently applied, but merely seeks to provide greater clarity within the Fee Schedule relating to the application of the existing rebate.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act, in general, and Section 6(b)(4) and 6(b)(5) of the Act,
The Exchange believes the proposed changes to the QCC Rebate structure are reasonable because the proposed changes provide opportunities for Participants to receive higher rebates for their QCC Order volume on BOX. Further, the Exchange believes the proposed changes to the QCC rebate structure are equitable and not unfairly discriminatory as the proposed rebates will apply uniformly to the Participants that reach the applicable tiers.
The Exchange continues to believe that the proposed rebate structure and rebate amounts are reasonable as it provides an incremental incentive for Participants to strive for the higher tier levels, which provide increasingly higher rebates for incrementally more QCC volume achieved, which the
The Exchange believes adding language to make it clear that the QCC Rebate is applied to the Agency Order on qualifying QCC Transactions is reasonable and not unfairly discriminatory because it is not proposing to make any changes to the way the QCC Rebate is currently applied, but merely seeks to provide greater clarity within the Fee Schedule relating to the existing rebate.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange believes the proposal does not impose an undue burden on inter-market competition because the proposed changes to the QCC Rebate tier volume thresholds will promote competition for QCC transactions. Specifically, the volume threshold required to qualify for the Tier 2 rebates will be reduced, which may allow Participants access to higher rebates. The Exchange believes further its proposal remains competitive with other options markets and will offer market participants with another choice of where to transact its business. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees and rebates to remain competitive with other exchanges. Because competitors are free to modify their own fees and rebates in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The proposed changes do not impose an undue burden on intra-market competition. The Exchange does not believe that its proposal will place any category of market participant at a competitive disadvantage. The Exchange believes that the proposed changes will encourage market participants to send their QCC orders to BOX for execution in order to obtain greater rebates and lower their costs. The Exchange believes further that it is equitable and not unfairly discriminatory to continue to only offer the QCC Rebate to the Participant that entered the order into the BOX System when at least one party to the QCC transaction is a Broker Dealer or Market Maker and not when both Parties are Public Customers or Professional Customers because only Broker Dealers and Market Makers are assessed a fee for QCC transactions. Public Customers and Professional Customers are not assessed a fee for QCC transactions.
Lastly, the proposed change to add language to make it clear that the QCC Rebate is applied to the Agency Order on qualifying QCC Transactions is not intended to address competitive issues and instead is being proposed in an effort to reduce the potential for any investor confusion relating to the existing QCC Rebate and add transparency to the Fee Schedule.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Exchange Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend the rule change if it appears to the Commission that the action is necessary or appropriate in the public interest, for the protection of investors, or would otherwise further the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
SR-BOX-2026-09 on the subject line.
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 13, 2026, the Nasdaq Stock Market LLC (“Exchange” or “Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Nasdaq Rules require companies listed on the Nasdaq Global Market (“NGM”) and Nasdaq Capital Market (“NCM”) to maintain certain minimum continued listing requirements.
The Exchange states that the compliance periods provided to a company that has failed to maintain compliance with continued listing requirements are designed to allow time for a company facing temporary business issues, a temporary decrease in the value of its securities, or temporary market conditions to take action to come back into compliance.
Accordingly, the Exchange proposes to adopt Nasdaq Rules 5450(a)(3) and 5550(a)(6) to require that companies listed on the NGM and NCM, respectively, maintain a minimum Market Value of Listed Securities (“MVLS”)
The Exchange also proposes to add to the list of circumstances in which a request for Hearings Panel review will not stay the suspension of a company's securities from trading. Specifically, the Exchange proposes to amend Nasdaq Rule 5815(a)(1)(B) to provide that a timely request for a hearing will not stay the suspension of the securities from trading pending the issuance of a written Hearings Panel decision where the company received a Staff Delisting Determination notice due to a failure to comply with the MVLS Requirement.
Finally, the Exchange proposes to amend Nasdaq Rule 5815(c)(1)(H) to provide that in the case of a company that received a Staff Delisting Determination notice due to a failure to comply with the MVLS Requirement, the Hearings Panel may only reverse a delisting decision where the Hearings Panel determines that the Staff Delisting Determination letter was in error and that the company never failed to satisfy the applicable requirement. In such cases, the Hearings Panel may not consider facts indicating that the company had regained compliance under Nasdaq Rule 5815(c)(1)(E), nor may the Hearings Panel grant an exception under Nasdaq Rule 5815(c)(1)(A) allowing the company additional time to regain compliance.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
The development and enforcement of meaningful listing standards
As discussed above, the Exchange is proposing to adopt Nasdaq Rules 5450(a)(3) and 5550(a)(6) to require companies listed on the NGM and NCM, respectively, to maintain a minimum MVLS of at least $5 million. The Exchange is also proposing to amend Nasdaq Rule 5810(c)(1) to suspend trading and immediately delist from Nasdaq securities of companies that do not comply with the MVLS Requirement; and Nasdaq Rule 5810(c)(3)(C), to provide that such companies would not be entitled to a specified cure or compliance period. Furthermore, the Exchange is proposing to add Nasdaq Rule 5815(a)(1)(B)(ii)f., and to amend Nasdaq Rule 5815(c)(1)(H), to set forth the procedures for requesting a hearing before a Hearings Panel and the scope of the Hearings Panel's discretion for companies that do not comply with the MVLS Requirement.
Two commenters express general support for the proposal.
Other commenters raise concerns regarding the proposed rule change.
Several commenters state that the proposal would impair issuers' ability to raise capital or obtain debt financing due to heightened delisting risk.
Several commenters state that the rigid $5 million MVLS threshold, coupled with automatic suspension after 30 consecutive business days, could increase the potential for manipulative trading and market abuse in an effort to drive down the value of a company's stock, causing a company to be delisted.
Finally, several commenters raise concerns regarding the removal of the automatic stay of suspension pending Hearings Panel review and the limitations on Hearings Panel discretion to review the delisting determination under the proposal.
The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, which are set forth in the Notice, in addition to any other comments they may wish to submit about the proposed rule change. In particular, the Commission seeks comment on whether the proposal includes sufficient analysis to support a conclusion that the proposal to immediately suspend and delist companies that fail to comply with the MVLS Requirement, to maintain the suspension of such companies' securities from trading during the pendency of an appeal to the Hearings Panel, and to limit the Hearings Panel's discretion to reverse a delisting decision to circumstances involving a factual error is designed to be consistent with the requirements of Section 6(b)(5) and Section 6(b)(7) of the Act
The Commission requests that interested persons provide written submissions of their data, views, and arguments with respect to the issues identified above, including the issues raised by commenters and the Exchange's response, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposed rule change is consistent with Sections 6(b)(5), 6(b)(7) or any other provision of the Act, or the rules and regulations thereunder. Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of data, views, and arguments, the Commission will consider, pursuant to Rule 19b-4 under the Act,
Interested persons are invited to submit written data, views, and arguments regarding whether the proposed rule change should be approved or disapproved by May 22, 2026. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by June 5, 2026. The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, in addition to any other comments they may wish to submit about the proposed rule change.
Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
SR-NASDAQ-2026-004 on the subject line.
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to file number SR-NASDAQ-2026-004 and should be submitted by May 22, 2026. Rebuttal comments should be submitted by June 5, 2026.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend its rules to permit the listing of A.M.-settled options on the S&P 500 Index (“SPX” or “SPX options”) that expire (1) on any Monday, Tuesday, Wednesday, Thursday, or Friday (other than the third Friday-of-the-month or days that coincide with an end-of-month expiration) and (2) the last trading day of the month. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Commission's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its rules to permit the listing of A.M.-settled SPX options that expire (1) on any Monday, Tuesday, Wednesday, Thursday, or Friday (other than the third Friday-of-the-month or days that coincide with an end-of-month expiration) (“A.M.-Settled Weekly Expirations”) and (2) on the last trading day of the month (“EOMs” or “EOM Expirations”).
By way of background, when cash-settled
In 1993, the Commission approved a rule allowing Cboe Options to list P.M.-settled options on certain broad-based indices, including the S&P 500, expiring at the end of each calendar quarter (“Quarterly Index Expirations”) (since adopted as permanent).
Currently, under the Nonstandard Expirations Program set forth in Rule 4.13(e), the Exchange may open for trading (1) Weekly Expirations on any broad-based index eligible for standard options trading and on CBTX, MBTX, and the Cboe Magnificent 10 Index to expire on any Monday, Tuesday, Wednesday, Thursday, or Friday (other than the third Friday-of-the-month or days that coincide with an EOM expiration) and (2) EOMs on any broad-based index eligible for standard options trading and on CBTX, MBTX, and the Cboe Magnificent 10 Index to expire on last trading day of the month.
Further, under its rules, with respect to SPX options, the Exchange may open for trading standard monthly expirations with A.M.-settlement on the third Friday-of the-month,
The Exchange now proposes to amend its rules to permit the listing of A.M.-Settled Weekly and EOM Expirations on SPX options.
The Exchange proposes to amend Rule 4.13(e), which governs its Nonstandard Expirations Program (“Program”), to permit A.M.-settled SPX options that expire (1) on any Monday, Tuesday, Wednesday, Thursday, or Friday (other than the third Friday-of-the-month (“Expiration Friday”) or days that coincide with an EOM expiration) (“A.M.-Settled Weekly Expirations”) and (2) EOMs.
A.M.-Settled Weekly Expirations and EOM Expirations on SPX are subject to all provisions of Rule 4.13 and treated the same as A.M.-settled options on SPX that expire on the third Friday of the expiration month, as well as P.M.-settled Weekly and EOM SPX options. The maximum number of expirations that may be listed for each A.M.-Settled Weekly Expiration on SPX options (
If the Exchange is not open for business on a respective Monday, the normally Monday expiring Weekly Expirations will expire on the following business day. If the Exchange is not open for business on a respective Tuesday, Wednesday, Thursday, or Friday, the normally Tuesday, Wednesday, Thursday, or Friday expiring Weekly Expirations will expire on the previous business day. If two different Weekly Expirations on an index would expire on the same day because the Exchange is not open for business on a certain weekday, the Exchange will list only one of such Weekly Expirations.
In connection with proposed change, the Exchange proposes to amend Rule 5.1(b)(2)(C), which currently states in relevant part that on their last trading day, Regular Trading Hours for Nonstandard Expirations are from 9:30 a.m. to 4:00 p.m. Specifically, the Exchange proposes to replace the reference to “Nonstandard Expirations” with “P.M.-Settled Nonstandard Expirations.”
The Exchange believes that the introduction of A.M.-Settled Weekly Expirations and EOMs on SPX options will provide market participants with
The Exchange believes that expanding the SPX options offering to include A.M.-Settled Weekly and EOM Expirations would allow market participants to purchase an option based on their needed timing and allow them to tailor their investment or hedging needs more effectively. Further, the Exchange believes there is sufficient investor interest and demand in A.M-Settled Weekly and EOM Expirations on SPX options to warrant inclusion in the Program and in the Rules, and that the Program and the Rules, as amended, will continue to provide investors with additional means of managing their risk exposures and carrying out their investment objectives.
With regard to the impact of this proposal on system capacity, the Exchange has analyzed its capacity and represents that it believes that the Exchange has the necessary systems capacity to handle any potential additional traffic associated with trading of A.M-Settled Weekly Expirations and EOM Expirations for SPX options. The Options Price Reporting Authority (“OPRA”) also informed the Exchange it believes it has the necessary systems capacity to handle the additional traffic associated with the listing of A.M-Settled Weekly Expirations and EOM Expirations for SPX options that would result from this proposed rule change.
The Exchange does not believe that its Trading Permit Holders (“TPHs”) will experience any capacity issues as a result of this proposal and represents that it will monitor the trading volume associated with any possible additional SPX options series listed as a result of this proposal and the effect (if any) of these additional series on market fragmentation and on the capacity of the Exchange's automated systems.
In addition to this, the Exchange believes that its existing surveillance and reporting safeguards in place are adequate to deter and detect possible manipulative behavior which might arise from listing and trading A.M-Settled Weekly and EOM Expirations for SPX options (as the Exchange currently applies these to SPX options that are A.M.-settled with standard expirations, as well as P.M.-settled with weekly, monthly and quarterly expirations) and will support the protection of investors and the public interest. Furthermore, the trading of A.M-Settled Weekly and EOM Expirations for SPX options will be subject to the same rules that currently govern the trading of these options with other expirations, including governing customer accounts, position and exercise limits,
In response to any potential concerns that disruptive trading conduct could occur as a result of the concurrent listing and trading of two index option products based on the same index but for which different settlement methodologies exist (
The adoption of trading of A.M-Settled Weekly and EOM Expirations on the S&P 500 Index on the same exchange as A.M.-settled (with standard expirations) and P.M-settled options on the S&P 500 Index would provide greater spread opportunities. This manner of trading allows a market participant to take advantage of the different expiration times, which provides expanded trading opportunities. In the options market currently, market participants regularly trade similar or related products in conjunction with each other, which contributes to overall market liquidity.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes that the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. The Exchange believes that the introduction of A.M-Settled Weekly and EOM Expirations for SPX options will provide investors with expanded hedging tools and greater trading opportunities. As a result, investors will have additional means to manage their risk exposures and carry out their investment objectives. By offering expanded expirations along with the current standard A.M.-settled expirations (as well as P.M.-settled weekly, monthly and quarterly expirations), the proposed rule change will allow market participants to purchase options on SPX available for trading on the Exchange in a manner more aligned with specific timing needs (such as to hedge special events) and more effectively tailor their investment and hedging strategies and manage their portfolios. For example, the proposed rule change will allow market participants to spread risk across more trading days and incorporate daily changes in the markets, which may reduce the premium cost of buying protection. The Exchange represents that it believes that it has the necessary systems capacity to support any additional traffic associated with trading of A.M-Settled Weekly and EOM Expirations for SPX options and does not believe that its TPHs will experience any capacity issues as a result of this proposal.
The Exchange does not believe that the addition of A.M-Settled Weekly and EOM Expirations for SPX options to the Nonstandard Expirations Program will raise any prohibitive regulatory concerns, nor adversely impact fair and
The Commission previously recognized the benefits of A.M-settlement for broad-based index options when it approved Cboe Options' proposal to transition most of its cash-settled index options, including on the S&P 500 Index, to A.M.-settlement.
The Exchange believes the benefits set forth by the Commission are not unique to standard monthly expirations. Specifically, as daily and end-of-month P.M.-settled SPX expirations have grown in prominence, the same concerns regarding order imbalance and price discovery could arise at any expiration (not just the third Friday of each month). Accordingly, the Exchange believes that extending A.M.-settlement to daily and end-of-month expirations is consistent with the Commission's own rationale, and would provide market participants with those same protections across the full expiration calendar.
Finally, the Exchange believes its proposal to introduce changes to specify between A.M.-Settled Weekly Expirations and P.M.-Settled Weekly Expirations are reasonable, as they provide clarity within the Exchange rules, thereby mitigating potential investor confusion.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because A.M.-settled SPX options with Weekly and EOM Expirations will be available to all market participants. By listing SPX options with these expirations (in addition to the standard Expiration Friday expirations (A.M.-settled) and weekly and EOM expirations (P.M.-settled) that are currently listed), the proposed rule change will provide all investors that participate in the markets for these index options available for trading on the Exchange with greater trading and hedging opportunities and flexibility to meet their investment and hedging needs.
The Exchange does not believe that the proposal to list A.M.-settled SPX options with Weekly and EOM Expirations will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because these options are proprietary Exchange products. To the extent that the addition of these expirations for SPX options makes the Exchange a more attractive marketplace to market participants at other exchanges, such market participants are free to elect to become market participants on the Exchange. Further, to other exchanges offer “nonstandard” expirations
The Exchange neither solicited nor received written comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
A. by order approve or disapprove such proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Exchange Rule 531(d), the Purge Liquidity Taker Report (the “Report”), to update the timeframe used by the Exchange for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member (described below) to cancel that resting quote was received by the Exchange.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Exchange Rule 531(d) for the Report to update the timeframe used by the Exchange for the time difference between the time the first response that executes against the resting quote
The Exchange recently filed a proposed rule change with the Securities and Exchange Commission (“Commission”) to establish the Report.
The Report is a daily report that provides a Market Maker (referred to as the “Recipient Member”) with the liquidity response/taker time details for executions against quotes entered by the Recipient Member that are resting on the Simple Order Book
Exchange Rule 531(d)(2)(i) provides that for the purge message sent by the Recipient Member to cancel the resting quote after the response that executes against that resting quote is received by the Exchange pursuant to paragraph (d)(1)(iii)(C) above, the Report includes the data listed in paragraph (d)(1) of Exchange Rule 531 within 100 microseconds from the time the resting quote was executed against to the Exchange's receipt of the purge message. Exchange Rule 531(d)(2)(ii) provides that for the purge message sent by the Recipient Member to cancel the resting quote before the next response that executes against that resting quote was received by the Exchange pursuant to paragraph (d)(1)(iii)(D) above, the Report includes the data listed in paragraph (d)(1) of Exchange Rule 531 within 200 microseconds from the time the Exchange received the purge message to when the Exchange receives the next execution.
Exchange Rule 531(d)(3) provides that the Report only includes trading data related to the Recipient Member and will not include any other Member's trading data other than that listed in paragraphs (1)(i) and (ii) of Exchange Rule 531(d), as described above.
Exchange Rule 531(d)(4) specifies that the Report contains historical data from the previous trading day and will be available after the end of the trading day, generally on a T+1 basis.
The Exchange proposes to amend Exchange Rule 531(d)(2)(i) to increase the timeframe for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member to cancel that resting quote was received by the Exchange. In particular, the Exchange proposes to amend Exchange Rule 531(d)(2)(i) to provide that for the purge message sent by the Recipient Member to cancel the resting quote after the response that executes against that resting quote is received by the Exchange pursuant to paragraph (d)(1)(iii)(C) above, the Purge Liquidity Taker Report will include the data listed in paragraph (d)(1) of Exchange Rule 531 within 500 microseconds (instead of 100 microseconds) from the time the resting quote was executed against to the Exchange's receipt of the purge message.
The purpose of this change is for subscribers to the Report to see additional data points regarding their interactions with the Exchange to purge resting quotes when those quotes were executed prior to the Exchange receiving the purge message. The proposed increased timeframe should provide Recipient Members with a greater understanding of how much time their purge message(s) missed canceling a resting quote after that quote was executed. As currently provided under Exchange Rule 531(d)(2)(i), the Recipient Member would only see the information provided in the Report if their purge message missed canceling a quote in 100 microseconds or less from when that quote was executed. By increasing the timeframe, Recipient Members will be able to receive the information provided for in the Report within 500 microseconds or less from when that quote was executed. The Exchange believes this longer timeframe better serves the purpose of the Report by providing Market Makers with greater opportunities to improve quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly.
The Exchange does not propose to amend the content, any other timeframes or scope of the Report and will continue to make the Report available after the end of the trading day, generally on a T+1 basis.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed change to amend the Report to increase the timeframe for the time difference between the time the first response that executes against the resting quote was received by the Exchange and the time that the purge message that was sent by the Recipient Member to cancel that resting quote was received by the Exchange removes impediments to and perfects the mechanism of a free and open market. This is because the proposed increased timeframe should further enhance the usefulness of the Report, which is designed to aid Market Makers by improving quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly.
The Exchange believes that with the proposed change, the Report continues to promote just and equitable principles of trade because it would provide latency information in a systematized way and standardized format to any Member that chooses to subscribe to the Report, as proposed to be amended by the increased timeframe. The Report will continue to not be a real-time market data product and will provide only historical data for the previous trading day, generally on a T+1 basis. Further, the data included in the Report, including additional data that may be provided with the increased timeframe, would continue to be specific to the Recipient Member regarding incoming purge messages that failed to cancel resting quotes ahead of an execution against those quotes.
The Report was designed for Market Makers that are interested in gaining insight into latency in connection with their purge messages that failed to cancel resting quotes. The Exchange believes that increasing the timeframe is consistent with facilitating transactions in securities, removing impediments to and perfecting the mechanism of a free and open market and a national market system, and, in general, protecting investors and the public interest because it provides additional information and insight to subscribing market participants regarding their interactions with the Exchange. More specifically, the Report, as proposed to be modified herein, will continue to provide greater visibility by showing how much time a purge message missed canceling a quote, particularly as market conditions change throughout the day and Market Makers attempt to cancel and replace quotes in certain symbols.
Additionally, the proposal would not permit unfair discrimination because the Report will continue to be available to all Exchange Market Makers and all Market Makers that subscribe will receive the same data points for the same timeframe, with the information specific to the Recipient Member.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Rather, the Exchange believes that the proposal may promote or enhance intra-market competition because subscribers to the Report will see additional data points regarding their interactions with the Exchange to purge resting quotes when those quotes were executed prior to the Exchange receiving the purge message. The proposed increased timeframe should provide Recipient Members with a greater understanding of how much time their purge message(s) missed canceling a resting quote after that quote was executed. The Exchange believes this longer timeframe may promote intra-market competition by providing Market Makers with greater opportunities to improve quote cancel success, particularly as market conditions change throughout the day and Market Makers seek to update their quotes accordingly. Furthermore, this product offering is entirely optional and is available to any Market Maker that believes this data will be helpful for their business purposes. As such, the Exchange does not believe this proposed rule change places any burden on intra-market competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange also believes this proposal does not place any burden on inter-market competition that is not necessary or appropriate in furtherance of the purposes of the Act because other exchanges may offer similar reports and products that contain similar data points as the Report that are applicable to resting quotes and cancel messages of market participants of those exchanges. Accordingly, the Exchange believes this proposed rule change permits fair competition among national securities exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that the Securities and Exchange Commission (“Commission”) has issued an Order, pursuant to Section 17(d) of the Securities Exchange Act of 1934 (“Act”),
Section 19(g)(1) of the Act,
Section 17(d)(1) of the Act
To implement Section 17(d)(1), the Commission adopted two rules: Rule 17d-1 and Rule 17d-2 under the Act.
To address regulatory duplication in these and other areas, the Commission adopted Rule 17d-2 under the Act.
On July 28, 2016, the Commission declared effective the Plan entered into between FINRA and IEX for allocating regulatory responsibility pursuant to Rule 17d-2.
On April 15, 2026, the parties submitted a proposed amendment to the Plan (“Amended Plan”). The primary purpose of the Amended Plan is to add Securities Exchange Act Rule 14e-4(a)(1)(ii)(D) to the Certification to accommodate the upcoming launch of IEX's new options facility, to amend the procedures regarding statutory disqualifications, and to reflect updated rule citations. The text of the proposed Amended Plan is as follows (additions are italicized; deletions are [bracketed]):
This Agreement, by and between the Financial Industry Regulatory Authority, Inc. (“FINRA”) and Investors' Exchange LLC (“IEX”), is made this
This Agreement amends and restates the agreement entered into between FINRA and IEX on
Whereas, FINRA and IEX desire to reduce duplication in the examination and surveillance of their Dual Members (as defined herein) and in the filing and processing of certain registration and membership records; and
Whereas, FINRA and IEX desire to execute an agreement covering such subjects pursuant to the provisions of Rule 17d-2 under the Exchange Act and to file such agreement with the Securities and Exchange Commission (the “SEC” or “Commission”) for its approval.
Now, Therefore, in consideration of the mutual covenants contained hereinafter, FINRA and IEX hereby agree as follows:
1. Definitions. Unless otherwise defined in this Agreement or the context otherwise requires, the terms used in this Agreement shall have the same meaning as they have under the Exchange Act and the rules and regulations thereunder. As used in this Agreement, the following terms shall have the following meanings:
(a) “IEX Rules” or “FINRA Rules” shall mean: (i) the rules of IEX, or (ii) the rules of FINRA, respectively, as the rules of an exchange or association are defined in Exchange Act Section 3(a)(27).
(b) “Common Rules” shall mean IEX Rules that are substantially similar to the applicable FINRA Rules and certain provisions of the Exchange Act and SEC rules set forth on Exhibit 1 in that examination or surveillance for compliance with such provisions and rules would not require FINRA to develop one or more new examination or surveillance standards, modules, procedures, or criteria in order to analyze the application of the provision or rule, or a Dual Member's activity, conduct, or output in relation to such provision or rule; provided, however, Common Rules shall not include the application of the SEC, IEX or FINRA rules as they pertain to violations of insider trading activities, which is covered by a separate 17d-2 Agreement by and among, Cboe BZX Exchange, Inc., Cboe BYX Exchange, Inc., NYSE
(c) “Dual Members” shall mean those IEX members that are also members of FINRA and the associated persons therewith.
(d) “Effective Date” shall be the date this Agreement is approved by the Commission.
(e) “Enforcement Responsibilities” shall mean the conduct of appropriate proceedings, in accordance with FINRA's Code of Procedure (the Rule 9000 Series) and other applicable FINRA procedural rules, to determine whether violations of Common Rules have occurred, and if such violations are deemed to have occurred, the imposition of appropriate sanctions as specified under FINRA's Code of Procedure and sanctions guidelines.
(f) “Regulatory Responsibilities” shall mean the examination responsibilities, surveillance responsibilities and Enforcement Responsibilities relating to compliance by the Dual Members with the Common Rules and the provisions
2. Regulatory and Enforcement Responsibilities. FINRA shall assume Regulatory Responsibilities and Enforcement Responsibilities for Dual Members. Attached as Exhibit 1 to this Agreement and made part hereof, IEX furnished FINRA with a current list of Common Rules and certified to FINRA that such rules that are IEX Rules are substantially similar to the corresponding FINRA Rules (the “Certification”). FINRA hereby agrees that the rules listed in the Certification are Common Rules as defined in this Agreement. Each year following the Effective Date of this Agreement, or more frequently if required by changes in either the rules of IEX or FINRA, IEX shall submit an updated list of Common Rules to FINRA for review which shall add IEX Rules not included in the current list of Common Rules that qualify as Common Rules as defined in this Agreement; delete IEX Rules included in the current list of Common Rules that no longer qualify as Common Rules as defined in this Agreement; and confirm that the remaining rules on the current list of Common Rules continue to be IEX Rules that qualify as Common Rules as defined in this Agreement. Within 30 days of receipt of such updated list, FINRA shall confirm in writing whether the rules listed in any updated list are Common Rules as defined in this Agreement. Notwithstanding anything herein to the contrary, it is explicitly understood that the term “Regulatory Responsibilities” does not include, and IEX shall retain full responsibility for (unless otherwise addressed by separate agreement or rule) (collectively, the “Retained Responsibilities”) the following:
(a) surveillance, examination, investigation and enforcement with respect to trading activities or practices involving IEX's own marketplace for rules that are not Common Rules;
(b) registration pursuant to its applicable rules of associated persons (
(c) discharge of its duties and obligations as a Designated Examining Authority pursuant to Rule 17d-1 under the Exchange Act; and
(d) any IEX Rules that are not Common Rules, except for IEX Rules for IEX Services LLC as provided in paragraph 5.
3. No Charge. There shall be no charge to IEX by FINRA for performing the Regulatory Responsibilities and Enforcement Responsibilities under this Agreement except as otherwise agreed by the parties, either herein or in a separate agreement.
4. Applicability of Certain Laws, Rules, Regulations or Orders. Notwithstanding any provision hereof, this Agreement shall be subject to any statute, or any rule or order of the Commission. To the extent such statute, rule or order is inconsistent with this Agreement, the statute, rule or order shall supersede the provision(s) hereof to the extent necessary for them to be properly effectuated and the provision(s) hereof in that respect shall be null and void.
5. Notification of Violations.
(a) In the event that FINRA becomes aware of apparent violations of any IEX Rules, which are not listed as Common Rules, discovered pursuant to the performance of the Regulatory Responsibilities assumed hereunder, FINRA shall notify IEX of those apparent violations for such response as IEX deems appropriate.
(b) In the event that IEX becomes aware of apparent violations of any Common Rules, discovered pursuant to the performance of the Retained Responsibilities, IEX shall notify FINRA of those apparent violations and such matters shall be handled by FINRA as provided in this Agreement. With respect to apparent violations of IEX Services LLC FINRA shall not make referrals to IEX pursuant to this paragraph 5. Such apparent violations shall be processed by, and enforcement proceedings in respect thereto will be conducted by, FINRA as provided in this Agreement.
(c) Apparent violations of Common Rules shall be processed by, and enforcement proceedings in respect thereto shall be conducted by FINRA as provided hereinbefore; provided, however, that in the event a Dual Member is the subject of an investigation relating to a transaction on IEX, IEX may in its discretion assume concurrent jurisdiction and responsibility.
(d) Each party agrees to make available promptly all files, records and witnesses necessary to assist the other in its investigation or proceedings.
6. Continued Assistance.
(a) FINRA shall make available to IEX all information obtained by FINRA in the performance by it of the Regulatory Responsibilities hereunder with respect to the Dual Members subject to this Agreement. In particular, and not in limitation of the foregoing, FINRA shall furnish IEX any information it obtains about Dual Members which reflects adversely on their financial condition. IEX shall make available to FINRA any information coming to its attention that reflects adversely on the financial condition of Dual Members or indicates possible violations of applicable laws, rules or regulations by such firms.
(b) The parties agree that documents or information shared shall be held in confidence, and used only for the purposes of carrying out their respective regulatory obligations. Neither party shall assert regulatory or other privileges as against the other with respect to documents or information that is required to be shared pursuant to this Agreement.
(c) The sharing of documents or information between the parties pursuant to this Agreement shall not be deemed a waiver as against third parties of regulatory or other privileges relating to the discovery of documents or information.
7. Statutory Disqualifications. When FINRA becomes aware of a statutory disqualification as defined in the Exchange Act with respect to a Dual Member, FINRA
8. Customer Complaints. IEX shall forward to FINRA copies of all customer
9. Advertising. FINRA shall assume responsibility to review the advertising of Dual Members subject to the Agreement, provided that such material is filed with FINRA in accordance with FINRA's filing procedures and is accompanied with any applicable filing fees set forth in FINRA Rules.
10. No Restrictions on Regulatory Action. Nothing contained in this Agreement shall restrict or in any way encumber the right of either party to conduct its own independent or concurrent investigation, examination or enforcement proceeding of or against Dual Members, as either party, in its sole discretion, shall deem appropriate or necessary.
11. Termination. This Agreement may be terminated by IEX or FINRA at any time upon the approval of the Commission after one (1) year's written notice to the other party.
12. Arbitration. In the event of a dispute between the parties as to the operation of this Agreement, IEX and FINRA hereby agree that any such dispute shall be settled by arbitration in Washington, DC in accordance with the rules of the American Arbitration Association then in effect, or such other procedures as the parties may mutually agree upon. Judgment on the award rendered by the arbitrator(s) may be entered in any court having jurisdiction. Each party acknowledges that the timely and complete performance of its obligations pursuant to this Agreement is critical to the business and operations of the other party. In the event of a dispute between the parties, the parties shall continue to perform their respective obligations under this Agreement in good faith during the resolution of such dispute unless and until this Agreement is terminated in accordance with its provisions. Nothing in this Section 12 shall interfere with a party's right to terminate this Agreement as set forth herein.
13.
IEX hereby certifies that the requirements contained in the rules listed below for IEX are identical to, or substantially similar to, the comparable FINRA Rules, Exchange Act provision or SEC rule identified (“Common Rules”).
[# Common Rules shall not include provisions regarding (i) notice, reporting or any other filings made directly to or from IEX, (ii) incorporations by reference of other IEX Rules that are not Common Rules (iii) exercise of discretion in a manner that differs from FINRA's exercise of discretion including, but not limited to exercise of exemptive authority, by IEX, (iv) prior written approval of IEX, and (v) payment of fees or fines to IEX.]
Interested persons are invited to submit written data, views, and arguments concerning the foregoing. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
The Commission finds that the proposed Amended Plan is consistent with the factors set forth in Section 17(d) of the Act
The Commission notes that, under the Amended Plan, IEX and FINRA have allocated regulatory responsibility for those IEX rules, set forth in the Certification, that are substantially similar to the applicable FINRA rules in that examination for compliance with such provisions and rules would not require FINRA to develop one or more new examination standards, modules, procedures, or criteria in order to analyze the application of the rule, or a Dual Member's activity, conduct, or output in relation to such rule. In addition, under the Amended Plan, FINRA would assume regulatory responsibility for certain provisions of the federal securities laws and the rules and regulations thereunder that are set forth in the Certification. The Common Rules covered by the Amended Plan are specifically listed in the Certification, as may be amended by the Parties from time to time.
According to the Amended Plan, IEX will review the Certification at least annually, or more frequently if required by changes in either the rules of IEX or FINRA, and, if necessary, submit to FINRA an updated list of Common Rules to add IEX rules not included on the then-current list of Common Rules that are substantially similar to FINRA rules; delete IEX rules included in the then-current list of Common Rules that no longer qualify as common rules; and confirm that the remaining rules on the list of Common Rules continue to be IEX rules that qualify as common rules.
The Commission is hereby declaring effective an Amended Plan that, among other things, allocates regulatory responsibility to FINRA for the oversight and enforcement of all IEX rules that are substantially similar to the rules of FINRA for Dual Members of IEX and FINRA. Therefore, modifications to the Certification need not be filed with the Commission as an amendment to the Amended Plan, provided that the Parties are only adding to, deleting from, or confirming changes to IEX rules in the Certification in conformance with the definition of Common Rules provided in the Amended Plan. However, should the Parties decide to add an IEX rule to the Certification that is not substantially similar to a FINRA rule; delete an IEX rule from the Certification that is substantially similar to a FINRA rule; or leave on the Certification an IEX rule that is no longer substantially similar to a FINRA rule, then such a change would constitute an amendment to the Amended Plan, which must be filed with the Commission pursuant to Rule 17d-2 under the Act.
Under paragraph (c) of Rule 17d-2, the Commission may, after appropriate notice and comment, declare a plan, or any part of a plan, effective. In this instance, the Commission believes that appropriate notice and comment can take place after the proposed amendment is effective. The primary purpose of the Amended Plan is to add Securities Exchange Act Rule 14e-4(a)(1)(ii)(D) to the Certification to accommodate the upcoming launch of IEX's new options facility, to amend the procedures regarding statutory disqualifications, and to make other technical changes. The Commission notes that the prior version of this plan immediately prior to this proposed amendment was published for comment and the Commission did not receive any comments thereon.
This order gives effect to the Amended Plan filed with the Commission in File No. 4-700. The Parties shall notify all members affected by the Amended Plan of their rights and obligations under the Amended Plan.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (“Cboe” or the “Exchange”) is filing with the Securities and Exchange Commission (“Commission” or “SEC”) a proposed rule change to replace the existing flat monthly fee for the Silexx application programming interface (“API”) with a usage-based tiered pricing structure. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Commission's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the Silexx fee schedule, effective March 2, 2026, to replace the existing flat monthly fee for the Silexx application programming interface (“API”) with a usage-based tiered pricing structure.
By way of background, the Exchange adopted fees for the use of Silexx, a front-end order entry and management platform, on November 2, 2017,
The existing API fee is $200 per month per login identifier (“ID”) and has not been updated since its adoption in 2017. Upon reviewing API usage patterns, the Exchange has observed that users vary significantly in their call volume during any given month. Some users submit a relatively modest number of calls while others submit substantially higher volumes. The current flat fee structure does not account for these differences in usage, resulting in a pricing model that does not reflect the varying levels of resources consumed by different users. Accordingly, the Exchange is proposing to replace the flat fee with a tiered pricing structure that aligns fees with actual API usage. The proposed fee increase also reflects the fact that the existing fee has remained unchanged for nearly nine years since its adoption.
The Exchange proposes to establish three pricing tiers, each with corresponding rate limits, ranging from $299 to $999 per login ID per month. The proposed tiers are as follows:
•
•
•
By default, all login IDs will be assigned to Tier 1 unless a user elects otherwise. A user may elect to move to a higher tier at any time during the billing month; however, if a user switches tiers mid-month, the higher-tier fee will apply for the entirety of that month.
For firms on Tier 1 or Tier 2, the Exchange proposes to assess an overage fee of $0.01 per call for each call that exceeds the applicable daily call cap. No overage fee applies to Tier 3 firms, as Tier 3 carries no daily call cap. For all tiers, if a login ID reaches the applicable per-minute call cap, the login ID will be rate-limited and will be unable to make additional calls until the next minute window begins.
To illustrate how the proposed structure would operate, consider a firm with nine total login IDs allocated across all three tiers: four login IDs at Tier 1, three login IDs at Tier 2, and two login IDs at Tier 3.
• The four Tier 1 login IDs would each be subject to a 200 calls per minute rate limit, and the firm's Tier 1 login IDs would collectively be subject to a daily cap of 20,000 calls.
• The three Tier 2 login IDs would each be subject to a 2,000 calls per minute rate limit, and the firm's Tier 2 login IDs would collectively be subject to a daily cap of 200,000 calls.
• The two Tier 3 login IDs would each be subject to a 2,000 calls per minute rate and have no daily call cap, individually or in the aggregate.
The firm with these login IDs would pay a total of $5,291 ((4 Tier 1 IDs × $299)+ (3 Tier 2 IDs × $699) +(2 Tier 3 IDs × $999))
Any calls exceeding the applicable per-minute or daily cap for Tier 1 or Tier 2 login IDs would be subject to the $0.01 per call overage fee.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed tiered pricing structure is reasonable for several reasons. First, the existing flat API fee of $200 per month per login ID has not been updated since its adoption in 2017. The proposed fee increase reflects nearly nine years of unchanged pricing and is designed to better align the fee with the current cost of providing and maintaining API access. Second, the Exchange has observed that users of the Silexx API vary significantly in their call volume during any given month. The current flat fee structure does not account for these differences in usage, resulting in a pricing model that does not reflect the varying levels of resources consumed by different users. The proposed tiered structure, with monthly fees of $299, $699, and $999 per login ID, corresponding to increasing levels of API call volume, is designed to align fees with actual usage, such that users who consume greater API resources pay a higher fee commensurate with that usage.
In determining these tiers, the Exchange looked at general usage patterns to create appropriate thresholds that best reflect the different needs of firms who use the API. Specifically, Tier 1 is intended to be for those who use the API for getting position or portfolio information, while Tier 2 and 3 users typically send high order volume. Tier 2 is intended to cover users that submit several orders at once but only need to do that periodically throughout the day, while Tier 3 users want the ability to submit a high volume of orders throughout the day.
The Exchange believes this usage-based approach is a reasonable and rational method of pricing API access. Third, the proposed overage fee of $0.01 per call for Tier 1 and Tier 2 firms exceeding the applicable daily cap is reasonable because it ensures that users who exceed their tier's rate limits contribute appropriately to the cost of the additional resources consumed, while still providing users with flexibility in their API usage. Finally, the Exchange notes that all login IDs will default to Tier 1, the lowest-cost tier, and users retain the ability to select the tier that best fits their usage needs, providing users with meaningful choice in managing their costs.
The Exchange believes the proposed tiered pricing structure is equitable and not unfairly discriminatory because the tiers are available to all users of the Silexx API on an equal basis. Any user may elect any tier, and the tier assignments are based solely on the level of API usage a user requires, not on the identity of the user or any other characteristic. users[sic] with lower call volume needs may remain at Tier 1, while users with higher call volume needs may elect Tier 2 or Tier 3. Because the proposed fee structure applies uniformly to all users and reflects differences in usage rather than differences among users, the Exchange believes the proposed changes are equitable and not unfairly discriminatory.
Additionally, the Exchange notes that the ability to switch tiers during a billing month is available to all users equally. While a user who switches to a higher tier mid-month will be charged the higher tier fee for the entirety of that month, this billing treatment applies uniformly to all users and is designed to provide administrative simplicity and predictability in billing.
Finally, the Exchange notes that use of the Silexx API is discretionary and not compulsory. users[sic] are not required to use the API functionality, and the Silexx platform remains accessible without use of the API. Specifically, users may still send (and manage) orders to a trading venue without the use of the API and they may receive position information without the API. Using the API only offers the user a more automated way to manage its orders and position. If market participants believe that other products, vendors, or connectivity solutions available in the marketplace are more beneficial or cost-effective than the Silexx API, they may simply use those alternatives instead. The Exchange makes the Silexx API available as a convenience to market participants, and the proposed fee changes are designed to ensure that the fee structure reflects the actual usage and value of that functionality.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed tiered pricing structure applies uniformly to all Users of the Silexx API. Any User may elect any tier based on their individual usage needs, and no User is treated differently from any other User with respect to tier availability or eligibility. To the extent that different Users pay different monthly fees, those differences reflect differences in the level of API usage elected by each User, not differences among Users themselves. The Exchange therefore does not believe the proposed changes place any category of market participant at a competitive disadvantage relative to another.
The Exchange does not believe the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Silexx platform and its API functionality are proprietary tools offered by the Exchange as a convenience to market participants. Users are not required to use the Silexx API and may elect to use other front-end platforms, order management systems, or connectivity solutions offered by the Exchange or available in the broader marketplace. The existence of these alternatives constrains the Exchange's ability to set fees at unreasonable levels, as market participants may simply choose a competing product or service if they determine that the Silexx API fees are not commensurate with the value provided. Accordingly, the Exchange does not believe the proposed changes will have any meaningful impact on intermarket competition.
Finally, the Exchange notes that the proposed fee changes are designed to align the Silexx API fee structure with actual usage patterns and to reflect the fact that the existing flat fee has remained unchanged since its adoption in 2017. To the extent the proposed changes impose any burden on competition, the Exchange believes any such burden is necessary and appropriate in furtherance of the purposes of the Act, as the proposed changes serve the Exchange's legitimate interest in maintaining a fee structure that is commensurate with the resources consumed by API users and that reflects current market conditions.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
SR-CBOE-2026-039 on the subject line.
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to introduce a new data product to be known as the One Minute Intraday Open-Close Data Report (referred to herein as the “1-Minute Report”), to adopt fees for such product, to establish fees for the One Minute Intraday Ad-hoc Request (“1-Minute Report historical data”), to establish an academic discount for ad-hoc purchases of 1-Minute Report historical data, and to make clarifying changes to Section III.C.1. (Open-Close Data Reports) of the Fee Schedule. The text of the proposed rule change is available from the principal office of the Exchange, and also on the Exchange's internet website at
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to introduce a new data product on BOX to be known as the One Minute Intraday Open-Close Data Report, which will be available for purchase to Participants and non-Participants.
The Exchange currently offers the Open-Close Data Report End-of-Day
The Exchange also currently offers the Ten Minute Intraday Open-Close Data Report (“10-Minute Report”) and 10-Minute Report Ad-hoc Request, which provides intra-day Open-Close data and similar information to that of the End-of-Day Report, except that it is produced and updated every 10 minutes during the trading day. Data is captured in “snapshots” taken every 10 minutes throughout the trading day and is available to subscribers within five minutes of the conclusion of each 10-minute period.
The Exchange now proposes a new open-close data product, the 1-Minute Report, which is the same as the existing 10-Minute Report, except that it is produced and updated every 1 minute during the trading day. The 1-Minute Report data is captured in “snapshots” taken every 1 minute throughout the trading day and would be available to subscribers within five minutes of the conclusion of each one-minute period.
The Exchange proposes to amend the Fee Schedule to provide that market participants may purchase the 1-Minute Report on a subscription basis or by ad-hoc request for a specified month or series of months (historical file). The Exchange proposes to assess a monthly fee of $6,000 for subscribing to the 1-Minute Report. The Exchange also proposes to assess a fee of $2,500 per request per month for an ad-hoc request of historical data for the 1-Minute Report. An ad-hoc request for 1-Minute Report historical data can be for any number of months beginning with January 2020.
The Exchange also proposes to implement an academic discount for academic purchases of 1-Minute Report historical data that is similar to the academic discount currently in place for the existing End-of-Day Report Ad-hoc Requests.
The proposed academic discount for ad-hoc requests for the 1-Minute Report historical data shall permit academic purchasers, that are purchasing such data for academic purposes only and not for actual securities trading, to purchase 1-Minute Report historical data for $1,000 per request per year.
The Exchange believes that academic institutions and researchers provide a valuable service for the Exchange in studying and promoting the options market. Though academic institutions and researchers have need for granular options data sets, they do not trade upon the data for which they subscribe. The Exchange believes the proposed reduced fee for academic purchasers of 1-Minute Report historical data will encourage and promote academic studies of its market data by academic institutions. In order to qualify for the academic discount, an academic purchaser must be (1) an accredited college, university, or similar educational institution, (2) a member of the faculty or staff of such an institution, and (3) the data is to be used by students or professors to perform academic research or classroom-related activities.
The Exchange notes that while the 1-Minute Report is priced higher than the existing pricing for the 10-Minute Report, this is to be expected as a market participant subscribing to the 1-Minute Report receives 10x the data points than a subscriber of 10-Minute Report. The proposed higher pricing for the 1-Minute Report is also in line with other exchanges that offer substantively similar open-close report data products based on the trading activity on those exchanges and the pricing they charge for similar ten-minute and one-minute open-close data products.
The Exchange's proposed fee of $1,000 per request per year for academic purchasers of historical 1-Minute Report data is in line with the fee charged by other exchanges that offer academic discounts for their versions of the one-minute open-close data product.
Finally, the Exchange proposes to make clarifying changes to Section III.C.1. (Open-Close Data Reports) of the Fee Schedule to differentiate between the 1-Minute Report and the existing 10-Minute Report. Specifically, the Exchange proposes to add the qualifier “Ten Minute” to the Intraday Subscription and the Intraday Ad-hoc Request (historical data) in the Open-Close Data Reports table within Section III.C.1.
The Exchange notes that the 1-Minute Report and its related fees are effective upon filing. Additionally, the Exchange will announce by Notice when it will begin offering the 1-Minute Report historical data for purchase.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,
In adopting Regulation NMS, the Commission granted self-regulatory organizations (“SROs”) and broker-dealers increased authority and flexibility to offer new and unique market data to the public. It was believed that this authority would expand the amount of data available to consumers, and also spur innovation and competition for the provision of market data. Particularly, the Exchange believes that making the 1-Minute Report and 1-Minute Report historical data available for purchase would further broaden the availability of U.S. option market data to investors consistent with the principles of Regulation NMS. The proposed rule change would benefit investors by providing access to the 1-Minute Report and 1-Minute Report historical data, which may promote better informed trading throughout the trading day. Particularly, information regarding opening and closing activity across different option series during the trading day may indicate investor sentiment, which may allow market participants to make better informed trading decisions throughout the day. Subscribers to the data may also be able to enhance their ability to analyze option trade and volume data and create and test trading models and analytical strategies.
The proposal also promotes increased transparency through the dissemination of the 1-Minute Report. The proposed rule change would benefit investors by making the 1-Minute Report available for purchase, which as noted above, may promote better informed trading. The Exchange believes the 1-Minute Report and 1-Minute Report historical data provide valuable tools that subscribers can use to gain comprehensive insight into the trading activity in a particular series, but also emphasizes that such data is not necessary for trading. The Exchange believes that market participants may find it beneficial to receive additional data based on these shorter intervals as opposed to the existing intervals provided in the 10-Minute Report. While use cases are the same as the existing 10-Minute Report, the increased frequency of data intervals in the 1-Minute Report provides more current information and more data reporting intervals throughout the trading day to gain knowledge of the trading activity by origin for subscribers.
The Exchange notes that it operates in a highly competitive environment where there are currently 18 registered options exchanges that trade options. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. Particularly, in Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
The Exchange believes the proposed fees are reasonable as the proposed fees are both modest and similar to the fees assessed by other exchanges that provide similar data products.
The Exchange believes the proposed fees for the 1-Minute Report are reasonable because the proposed higher pricing is in line with other exchanges that offer substantively similar open-close report data products based on the trading activity on those exchanges and the pricing they charge for similar ten-minute and one-minute open-close data products.
Proposing fees that are excessively higher than established fees for similar data products would simply serve to reduce demand for the Exchange's data product, which as noted, is entirely optional. Like the Exchange's proposed 1-Minute Report and 1-Minute Report historical data products, other exchanges offer similar data products that each provide insight into trading on those markets and may likewise aid in assessing investor sentiment. Although each of these similar open-close data products provide only proprietary trade data and not trade data from other exchanges, it's possible investors are still able to gauge overall investor sentiment across different option series based on open and closing interest on any one exchange.
The Exchange also believes the proposed fees are reasonable as they would support the introduction of new market data products that are designed to aid investors by providing insight into trading on BOX. The proposed 1-Minute Report and 1-Minute Report historical data would provide options market participants with valuable information about opening and closing transactions executed on the Exchange, similar to other historical trade data products offered by competing options exchanges. In turn, this data would assist market participants in gauging investor sentiment and trading activity, resulting in potentially better-informed trading decisions. As noted above, users may also use such data to create and test trading models and analytical strategies.
The Exchange believes the proposed fees are equitable and not unfairly discriminatory as the fees would apply equally to all users who choose to purchase such data. The Exchange's proposed fees would not differentiate between subscribers that purchase One Minute Intraday Open-Close Data and are set at a modest level that would allow any interested Participant or non-Participant to purchase such data based on their business needs.
Selling historical market data, such as One Minute Intraday Open-Close Data, is also a means by which exchanges compete to attract business. To the extent that the Exchange is successful in attracting subscribers for the 1-Minute Report, it may earn trading revenues and further enhance the value of its data products. If the market deems the proposed fees to be unfair or inequitable, firms can diminish or discontinue their use of the data and/or avail themselves of similar products offered by other exchanges. The Exchange therefore believes that the proposed fees for the 1-Minute Report and 1-Minute Report historical data reflect the competitive environment and would be properly assessed on Participant or non-Participant subscribers.
The Exchange believes further that the academic discount for the 1-Minute Report historical data is reasonable because academic users are not able to monetize access to the data as they do not trade on the data set. The Exchange believes the proposed discount will allow for more academic institutions and faculty members to purchase 1-Minute Report historical data, and, as a result, promote research and studies of the options industry to the benefit of all market participants. The Exchange believes that the proposed discount is equitable and not unfairly discriminatory because it will apply equally to all academic institutions for academic purposes only and not for actual securities trading. As a result, the Exchange believes the proposed discount is equitable and not unfairly discriminatory because academic purchasers do not use the data for vocational, commercial or other for-profit purposes. The Exchange notes that other exchanges offer similar academic discounts.
The Exchange anticipates a wide variety of market participants may subscribe to the 1-Minute Report, including but not limited to individual customers, buy-side investors and investment banks. The Exchange reiterates that the decision as to whether or not to purchase the 1-Minute Report is entirely optional for all potential subscribers. Indeed, no market participant is required to purchase the 1-Minute Report, and the Exchange is not required to make the 1-Minute Report available to market participants. Rather, the Exchange is voluntarily making 1-Minute Report data available, and market participants may choose to receive (and pay for) this data based on their own business needs. Potential purchasers may request the data at any time if they believe it to be valuable or may cancel and decline to purchase such data at any time.
Lastly, the Exchange believes that the clarifying changes to Section III.C.1. (Open-Close Data Reports) of the Fee Schedule are designed to protect
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In this regard and as indicated above, the Exchange notes that similar products and fees are offered at other exchanges.
Furthermore, the Exchange operates in a highly competitive environment, and its ability to price the proposed data product is constrained by competition among exchanges that offer similar data products to their customers. As discussed, there are currently a number of similar products available to market participants and investors. Other U.S. options exchanges offer market data products that are substantially similar to the 1-Minute Report and 1-Minute Report historical data discussed herein, which the Exchange must consider in its pricing discipline in order to compete for historical market data purchasers. For example, proposing fees that are excessively higher than established fees for similar data products would simply serve to reduce demand for the Exchange's data product, which as discussed, market participants are under no obligation to utilize. In this competitive environment, potential purchasers are free to choose which, if any, similar product to purchase to satisfy their need for market information. As a result, the Exchange believes this proposed rule change permits fair competition among national securities exchanges.
The Exchange also does not believe the proposed fees would cause any unnecessary or inappropriate burden on intermarket competition as other exchanges are free to introduce their own comparable data product and lower their prices to better compete with the Exchange's offering. The Exchange does not believe the proposed rule change would cause any unnecessary or inappropriate burden on intramarket competition. Particularly, the proposed product and fee applies uniformly to any purchaser, in that it does not differentiate between subscribers that purchase the One Minute Intraday Open-Close data. The proposed fees are set at a modest level that would allow any interested Participants or non-Participants to purchase such data based on their business needs.
The Exchange also does not believe that the proposed academic discount will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the exchanges are not competing for academic purchasers. Rather, the Exchange believes that academic purchasers' research and publications as a result of access to historical market data benefits all market participants. The Exchange notes that other exchanges currently offer similar historical data to academic purchasers at a discounted price.
Further, the Exchange does not believe that the proposed academic discount will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because academic purchasers do not use the data for vocational, commercial or other for-profit purposes. The Exchange notes that all academic purchasers are treated equally and all Participants and non-Participants are treated equally.
Lastly, the Exchange does not believe that the clarifying changes to Section III.C.1. (Open-Close Data Reports) of the Fee Schedule will impose any burden on competition as they are not designed to address any competitive issue but rather are designed to clearly distinguish between the two reports and add clarity to the Fee Schedule.
As such, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. As other exchanges offer similar products to their members, the proposal does not raise new or novel issues.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street, NE, Washington, DC 20549-1090.
All submissions should refer to file number SR-BOX-2026-10 and should be submitted on or before May 22, 2026.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Section 205(a)(1) of the Investment Advisers Act of 1940 (“Advisers Act”) generally prohibits an investment adviser from entering into, extending, renewing, or performing any investment advisory contract that provides for compensation to the adviser based on a share of capital gains on, or capital appreciation of, the funds of a client (also known as performance compensation or performance fees).
The Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”)
On March 27, 2026, the Commission published a notice of intent to issue an order that would adjust for inflation the dollar amount thresholds of the assets-under-management test and the net worth test.
The Commission's notice established a deadline of April 27, 2026, for submission of requests for a hearing. No requests for a hearing have been received by the Commission.
This Order is effective as of June 29, 2026. To the extent that contractual relationships are entered into prior to the Order's effective date, the dollar amount test adjustments in the Order would not generally apply retroactively to such contractual relationships, subject to the transition rules incorporated in rule 205-3.
Accordingly, pursuant to section 205(e) of the Advisers Act and section 418 of the Dodd-Frank Act,
By the Commission.
U.S. Small Business Administration.
Notice.
This is notice of the Presidential declaration of a major disaster for Public Assistance Only for the state of South Carolina (FEMA-4908-DR), dated April 7, 2026.
Issued on April 7, 2026.
Jennifer Talarico, Office of Disaster Recovery and Resilience, U.S. Small Business Administration, 409 3rd Street, SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given as a result of the President's major disaster declaration on April 7, 2026, Private Non-Profit organizations providing essential services of a governmental nature may file disaster loan applications online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 21559B and for economic injury is 215600.
U.S. Small Business Administration.
Request for information.
The U.S. Small Business Administration (SBA) seeks public comment on questions related to supply chain gaps in critical industries and how entrepreneur technical assistance could be aligned to increase business growth and technology development in needed industries. Information received in response to this request will inform SBA's efforts to build innovation networks in critical industries.
Submit comments on or before May 18, 2026.
• Individual or Organization Name.
• (If applicable) Organization/Individual Point of Contact.
• (If applicable) Organization UEI.
Alison Evans, Program Analyst, Office of Investment and Innovation, U.S. Small Business Administration,
Since its inception in 1953, the U.S. Small Business Administration (SBA) has served to aid, counsel, assist and protect the interests of small businesses. While SBA is best known for its financial support of small businesses through its many lending programs, the Agency also plays a critical role in building and strengthening support and resource networks critical to small businesses and nascent entrepreneurs.
The role of innovation and deep tech entrepreneurs in spurring economic growth, strengthening industry supply chains, and maintaining U.S competitiveness and security is well-documented. The U.S is facing growing competition internationally and these entrepreneurs and small businesses are critical to continued U.S. success—but they face unique, and often, expensive challenges.
The Office of Investment and Innovation (OII) oversees SBA's Innovation Network Programs which are dedicated to building local and regional support and resource networks needed by small businesses and technology entrepreneurs developing critical and emerging technologies. In FY26, SBA anticipates funding new awards across the country through its Innovation Network Programs:
•
•
•
SBA's Innovation Network Programs are focused on building coordination across industries and geographies to catalyze critical technology development. SBA encourages organizations interested in applying to future solicitations for any of the Innovation Network Programs to consider:
• The current and/or historic industries driving the economic activity of your community and specific actions needed to strengthen those industries.
• The strengths and weaknesses of your innovation network with relevant qualitative and quantitative data.
• The small business programs or assistance needed to support technology entrepreneurs.
• The coordination, assets, or knowledge that is needed in your innovation network to enhance technology development and small business success.
• Partnerships, formal or informal, that are needed within your innovation network.
• The anticipated outcomes of strengthened innovation networks and impacts to small business success, including obtaining capital and job creation.
1. What existing or projected supply chain gaps may limit economic growth and be detrimental to national competitiveness and security?
a. Describe what technology(ies) are needed and the challenges to integrating into the supply chain.
b. Describe the anticipated timeframe of identifying and implementing the needed solution. The solution could be developing a new technology, adapting an existing technology, scaling production capacity, better industry coordination, etc.
c. Describe specific gaps small businesses are uniquely positioned to fill.
d. Describe workforce challenges, and/or models that may work to address those challenges in these supply chain gaps.
2. What businesses exist currently to fill supply chain gaps? Could certain types of businesses readily pivot to fill those gaps?
3. What challenges do highly specialized suppliers face and if solved what supply chain gaps could they fill? Do any highly specialized suppliers support multiple industry or technology areas?
4. Challenges entrepreneurs and small businesses experience in commercializing technologies relevant to national security and international competitiveness, and proven curricula or other resource models to overcome challenges.
5. Quantitative and qualitative data sources and tools to track supply chains most relevant to national and economic security.
U.S. Small Business Administration.
Notice.
This is notice of an Administrative declaration of a disaster for the state of Michigan dated April 28, 2026.
Issued on April 28, 2026.
Jennifer Talarico, Office of Disaster Recovery and Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given as a result of the Administrator's disaster declaration, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 21557C and for economic injury is 215580.
The states which received an SBA Administrative declaration are Indiana, Michigan.
U.S. Small Business Administration.
Request for information.
The U.S. Small Business Administration (SBA) requests public input to inform the design of near-term initiatives intended to strengthen domestic manufacturing capacity for critical components, subcomponents, materials, tooling, and specialized capabilities essential to economic resilience and national security. This request focuses on identifying opportunities to rapidly scale existing domestic supplier capacity in areas characterized by supply chain constraints or choke points. SBA is particularly interested in gaps where qualifying domestic small businesses have a demonstrated operating history but are unable to reach a specific near-term milestone due to a capital shortfall. Information received in response to this Request for information (RFI) will inform the development of SBA innovation programs and initiatives, including potential prize competitions designed to deliver measurable increases in production capacity, supplier participation, and supply chain resilience within a compressed execution window.
Submit comments on or before May 18, 2026.
You may send comments, identified by subject line “RFI Response: Strengthening Domestic Supply Chains and Critical Supplier Competition” to
• Individual or Organization Name
• (If applicable) Organization/Individual Point of Contact
• (If applicable) Organization UEI
Comments are strictly voluntary.
Rikki Jones, Program Analyst, Office of Investment and Innovation, U.S. Small Business Administration,
SBA administers programs to support small business development, access to capital, and innovation pursuant to the Small Business Act, as amended (15 U.S.C. 631,
SBA's investment and innovation programs are implemented in part through regulations at 13 CFR parts 107 and 121, as well as through sub-regulatory guidance, including Standard Operating Procedures and program notices. The Office of Investment and Innovation (OII) administers SBA's Innovation Network Programs, including the Growth Accelerator Fund Competition, the Regional Innovation Cluster Program, and the Federal and State Technology Partnership Program. These programs support the development of regional and sector-
Consistent with SBA's statutory authorities, SBA is seeking input to inform the design of future initiatives, including potential prize competitions authorized under the America COMPETES Act, 15. U.S.C. 3719.
SBA seeks input on how to most effectively accelerate the immediate scaling of existing domestic small business suppliers and proven solution providers that support expanded production capacity, and address supply chain choke points through the achievement of measurable near-term milestones.
SBA is also interested in understanding how targeted actions described in this RFI can improve supplier coordination and participation across industries and through vertical integration, particularly where such improvements would enable rapid expansion of domestic production by small business participants in the U.S. industrial base.
This RFI focuses on the following key areas:
• Supply chain gaps where an infusion of capital could measurably scale production capacity or rapidly implement a new technology solution that supports this scaled production;
• Identification of suppliers and solution providers that are ready to execute a near-term milestone (approximately 1-3 months);
• The required incremental capital investment to achieve the stated near-term milestone, including description of the full capital stack required that could include a combination of federal funding and expected non-federal cost share (equity, debt and cashflow from operations, etc.); and
• Non-capital related support and actions that could mitigate execution risk and deliver measurable, near-term improvements in output, cost, lead time, and domestic small business supplier participation.
SBA invites responses from entrepreneurs, small and large businesses, suppliers, manufacturers, entrepreneur support organizations, investors, and other industry stakeholders. Respondents are encouraged to provide concise, operational, and time-bound responses, include quantitative estimates and near-term projections, and identify assumptions and execution risks.
1.
a. Respondents may address:
i. Industry, sector, or application (including defense, commercial or dual-use relevance);
ii. The subject component, material, or solution and its position and/or impact in the supply chain or;
iii. An assessment or quantification of the impact of such supply chain gap or lacking solution on cost, lead time, or dependency;
iv. Whether the constraint is driven by insufficient production capacity, outdated production processes or increased cost or lack of supply of upstream components;
v. Any single points of failure or highly concentrated supply segments that could be effectively addressed by U.S. small businesses; and
vi. Whether such domestic firms could achieve a near-term milestone (1-3 months) with targeted support (financial and non-financial).
2.
a. Respondents may address:
i. Evidence of existing production capability and/or tested or proven solutions;
ii. Current utilization and surge capacity, as applicable;
iii. Customer demand, contracts, or near-term pipeline; and
iv. Ability to address supply chain chokepoint or implement solution(s) within a compressed timeframe (1-3 months).
3.
a. Respondents may address:
i. Capital requirements (equipment, materials, working capital);
ii. Workforce availability and training;
iii. Certification or qualification requirements for both commercial and government contracts;
iv. Demand uncertainty;
v. Infrastructure or equipment limitations;
vi. Price fluctuations and availability of upstream inputs; and
vii. Other risks that could adversely affect near-term execution.
4.
a. Respondents may address:
i. Financial support mechanisms that can be deployed quickly;
ii. Demand commitments or procurement alignment;
iii. Technical assistance or validation support;
iv. Innovations and solutions that facilitate near-term growth and/or efficiencies;
v. Partnerships or coordinated actions; and
vi. Role of service providers or intermediaries in removing bottleneck.
5.
a. Respondents may address:
i. Estimated level of funding required;
ii. Expected non-federal cost share or private investment;
iii. Specific milestones achievable within 1-3 months;
iv. Anticipated increases in output and throughput; and
v. Expected improvements in cost, lead time, or supplier participation.
6.
a. Respondents may address:
i. Methods for estimating current and near-term production capacity growth;
ii. Metrics for tracking short-term output increases;
iii. Indicators of reduced lead times, or cost performance;
iv. Metrics for measuring a specific supply chain's resilience or vulnerability; and
v. Metrics or indicators relating to improving national or economic security through the implementation of the applicable solution or scaled production.
SBA is considering approaches that may include:
• Direct support to small businesses to scale production capacity and/or implement solutions that serve supply chain resiliency;
• Support to entities that enable supplier scaling by addressing bottlenecks;
• Milestone-based funding structures tied to measurable, near-term outcomes;
• Requirements for demonstrated production capability and/or solution implementation and readiness to execute; and
• Consideration of creditworthiness, sources of capital (other than the
This section is provided to inform responses and does not represent final program design.
Responses to this RFI will inform the development of SBA initiatives, including SBA's Innovation Network Programs and potential prize competitions designed to deliver rapid, measurable increases in domestic production capacity through solutions that improve efficiencies and through scale and strengthened resiliency with respect to critical supply chains.
No reimbursement will be made for any costs associated with providing information in response to this RFI or any follow-up information requests. Moreover, any and all information shared in response to this RFI is protected by SBA's deliberative process and will not be associated with any single entity, person, and/or organization.
This request is issued pursuant to:
• 15 U.S.C. 631
• 15 U.S.C. 634(b) (General Powers of the Administrator);
• 15 U.S.C. 662-697g (Small Business Investment Company (SBIC) program);
• 15 U.S.C. 638 (Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs);
• 15 U.S.C. 3719 (Prize Competitions); and
• Implementing regulations at 13 CFR parts 107 and 121 and related authorities.
Mesabi Railroad LLC (Mesabi Railroad), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to operate a rail line in Itasca County, Minn. (the Line) and associated sidetracks. The Line is owned by the Itasca County Regional Railroad Authority (ICRRA) and runs approximately 6 miles from a connection with an existing rail line co-owned by BNSF Railway Company (BNSF) and Canadian National Railway Company (CN) at Taconite, Minn. The Line has no mileposts.
The verified notice states that ICRRA and Mesabi Railroad plan to enter into a rail use and operations agreement (the Agreement) requiring Mesabi Railroad to provide common carrier rail service over the Line. The Agreement will also allow Mesabi Railroad to use the associated sidetracks. Mesabi Railroad anticipates commencing common carrier service over the Line on or after May 17, 2026.
Mesabi Railroad certifies that the transaction will not involve an interchange commitment. Mesabi Railroad also certifies that its projected annual revenues resulting from the transaction will not result in the creation of a Class II or Class I rail carrier and will not exceed $5 million.
The earliest this transaction may be consummated is May 17, 2026, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than May 8, 2026 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36920, must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Mesabi Railroad's representative, Jason Tutrone, Thompson Hine LLP, 1919 M St. NW, Ste. 700, Washington, DC 20036.
According to Mesabi Railroad, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available at
By the Board, Anika S. Cooper, Chief Counsel, Office of Chief Counsel.
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval of a new information collection. The
Written comments should be submitted by June 1, 2026.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Matthew Stearns by email at:
Currently, 14 CFR 139.319 does not require an individual to be trained as an emergency medical technician (EMT). Instead, section 139.319(i)(4) requires one individual, who has been trained and is current in basic emergency medical services, to be available during air carrier operations. Section 769(a) of the FAA Reauthorization Act of 2024 (the “Act”) instructs the FAA to update section 139.319 to ensure that at least one individual maintains certification at the EMT basic level, or higher, at a small, medium, or large hub airport. Section 769(b) of the Act also requires the FAA to conduct a review of airport environments and related regulations to evaluate sufficient staffing levels necessary for firefighting, rescue, and emergency medical services and responses at airports certified under part 139.
To carry out the requirements of section 769 of the Act, the FAA will develop a questionnaire to:
• Establish an initial baseline of airport rescue staffing levels/resources;
• Assist the FAA in conducting a staffing review of airports to evaluate sufficient staffing levels necessary for emergency medical services at Part 139 airports; and
• Support its upcoming Notice of Proposed Rulemaking addressing the EMT certification requirement.
Office of the Secretary (OST), Department of Transportation (DOT).
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before June 1, 2026.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW, Washington, DC 20503.
Barbara Snoden, (202) 366-4834 (Voice) or
49 U.S.C. 41112 provides that an air carrier may not be issued or continue to hold air carrier authority unless it has filed with DOT evidence that it possesses insurance in accordance with DOT regulations. 14 CFR part 205 establishes procedures for filing evidence of liability insurance for air carriers and contains the minimum requirements for air carrier accident liability insurance to protect the public from losses and directs that certificates evidencing appropriate coverage must be filed with the Department. This insurance information is submitted to DOT using OST Form 6410 (U.S. air carriers) or OST Form 6411 (foreign air carriers). DOT expects to receive approximately 1,284 filed insurance certificates from U.S. air carriers and approximately 429 filed certificates from foreign air carriers. DOT expects to receive approximately 1,708 amended certificates each year from U.S. air carriers and approximately 571 amended filings from foreign air carriers. Total respondents expected is approximately 2,279. Further, DOT expects filers of certificates to take 15-30 minutes to complete the form with about 5 percent (114 responses) of all responses to continue to be handwritten requiring 30 minutes for completion and the remaining 95 percent (2,165 responses) using the fillable forms. The total annual burden is expected to be 599 hours.
Issued in Washington, DC.
Departmental Offices, U.S. Department of the Treasury.
Notice of information collection; request for comment.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before June 1, 2026 to be assured of consideration.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Copies of the submissions may be obtained from Spencer W. Clark by emailing
Consumer Financial Protection Bureau.
Final rule.
The Consumer Financial Protection Bureau (Bureau or CFPB) is revising certain provisions of Regulation B, subpart B, which implements changes to the Equal Credit Opportunity Act made by section 1071 of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The Bureau is amending coverage of certain credit transactions and financial institutions; the small business definition; inclusion of certain data points and how others are collected; and the compliance date. The Bureau believes these changes will streamline the rule, reduce complexity for lenders, improve data quality, and advance the purposes of section 1071.
This final rule is effective on June 30, 2026. The compliance date for the rule is January 1, 2028.
Dave Gettler, Paralegal Specialist, Office of Regulations, at 202-435-7700 or
In 2010, Congress passed the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Section 1071 of that Act
The Bureau worked toward a section 1071 rulemaking for a number of years and has sought public comment from stakeholders numerous times. The Bureau held a field hearing on May 10, 2017, and published a request for information regarding the small business lending market.
On September 15, 2020, the Bureau released an Outline of Proposals Under Consideration and Alternatives Considered pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA). On October 15, 2020, the Bureau convened a Small Business Review Panel for the section 1071 rulemaking, and the Panel met with small entity representatives (SERs). The Panel Report, publicly released on December 15, 2020, was the culmination of the SBREFA process for the section 1071 rulemaking and included feedback from SERs and written feedback from other stakeholders as well.
On October 8, 2021, the Bureau published in the
The Bureau received approximately 2,100 comments on the 2021 proposed rule during the comment period. Approximately 650 of these comments were unique, detailed comment letters representing diverse interests. These commenters included lenders such as banks and credit unions, community development financial institutions (CDFIs), community development companies, Farm Credit System (FCS) lenders, online lenders, and others; national and regional industry trade associations; software vendors; business advocacy groups; community groups; research, academic, and other advocacy organizations; Members of Congress; Federal and State government offices/agencies; small businesses; and individuals.
On May 31, 2023, the Bureau published a final rule in the
On July 3, 2024, the Bureau published in the
Challenges to the 2023 final rule filed by various plaintiffs remain ongoing in three jurisdictions; each of those courts stayed the rule's compliance deadlines for some market participants.
On June 18, 2025, the Bureau published in the
On October 2, 2025, the Bureau published in the
On November 13, 2025, the Bureau published in the
Based on reactions to the 2023 final rule, including continued feedback from stakeholders and the ongoing litigation, on comments received on the 2025 proposed rule, and on further consideration, the Bureau now believes that at the onset of a potentially long-term data collection regime, it should start with more modest requirements, focusing on core lending products, lenders, and data. The Bureau believes that that reaction to the 2023 final rule was in part based on its expansive approach, appearing to seek broad coverage of lenders, products, and information collected.
The Bureau now believes that the 2023 final rule should have given more weight to qualitative differences among certain types of lenders and the likelihood that smaller lenders would face difficulties—which they had expressed in comments on the 2021 proposed rule, after the 2023 final rule, and on the 2025 proposed rules—addressing the complexity of a rule of broad scope, both of which could potentially diminish the quality of the data they collect.
The Bureau believes, based on this experience, that a longer-term approach to advance the statutory purposes of section 1071 is to commence the collection of data with a narrower scope to ensure its quality and to limit, as much as possible, any disturbance of the provision and availability of credit to small businesses. The statutory purposes of the rule are not well served by an expansive rule that could create disruptions in small business lending markets.
Rather, the Bureau now believes that an incremental approach will better serve the statutory purposes of section 1071 in the long term. Such an approach will start with core lending products, core providers, and core data points. This approach complies with section 1071 and furthers its statutory purposes while reducing the rule's initial impact on small businesses and lenders. Over time, as the Bureau and financial institutions learn from early iterations of data collections, the Bureau could consider amending the rule.
The gradual development of data collection under the Home Mortgage Disclosure Act (HMDA)
The Bureau believes that it should approach the section 1071 data collection regime as a longer-term project akin to HMDA. The Bureau believes that it is a proper use of its authority under 15 U.S.C. 1691c-2 to make changes to several portions of the 2023 final rule to commence data collection with a focus on core lending products, core lenders, and mostly statutory data points. The Bureau believes that this incrementalist approach—starting with a more modest rule with a limited set of products, lenders, or data points—will serve the long-term interests of section 1071.
In addition, on January 20, 2025, the President issued Executive Order (E.O.) 14168, “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government” (Defending Women E.O.).
The Bureau has consulted with the appropriate prudential regulators and other Federal agencies regarding consistency with any prudential, market, or systemic objectives administered by these agencies as required by section 1022(b)(2)(B) of the Dodd-Frank Act.
The Bureau is issuing this final rule pursuant to its authority under section 1071. As discussed above, in the Dodd-Frank Act, Congress amended ECOA by adding section 1071, which directs the Bureau to adopt regulations governing the collection and reporting of small business lending data. Specifically, section 1071 requires financial institutions to collect and report to the Bureau certain data on applications for
To advance these statutory purposes, section 1071 grants the Bureau general rulemaking authority for section 1071, providing that the Bureau shall prescribe such rules and issue such guidance as may be necessary to carry out, enforce, and compile data pursuant to section 1071.
See the 2023 final rule for a more detailed discussion of the Bureau's legal authorities.
As set out above, the Bureau has reconsidered certain provisions of the 2023 final rule. The Bureau has determined that a potentially long-term data collection regime should start with a focus on core lending products, lenders, small businesses, and data points. The Bureau believes in retrospect that the approach it took in the 2023 final rule—a broad initial coverage of lenders, products, small businesses and data points—was not conducive to the long-term success of the data collection regime under section 1071. The Bureau now finds that a better, longer-term approach to advance the statutory purposes of section 1071 is to commence the collection of data with a narrower scope to ensure its quality, and to limit, as much as possible, any disturbance of the provision of credit to small businesses. The Bureau believes that such an incremental approach will also comply with section 1071 and minimize any negative initial impact on small business lending markets and on data quality. In the future, based on Bureau and industry experience during the early years of data collection, the Bureau may consider amending the rule as appropriate in furtherance of the purposes of section 1071.
The Bureau also finds that the 2023 final rule has not created significant reliance interests that dissuade the Bureau from reconsidering its position as to certain portions of the rule. Due to litigation challenging provisions of the 2023 final rule and delays in the compliance dates for this rule, the changes made by this final rule will not meaningfully change compliance obligations as they exist now.
This final rule therefore focuses data collection on data points specifically identified in section 1071 and a limited number of other data points needed to facilitate the collection of these statutory data points. This final rule removes the discretionary data points for application method, application recipient, denial reasons, pricing information, and number of workers. This final rule also contains changes to better conform with an executive branch mandate, resulting in modifications to the collection of data concerning business ownership status of small business applicants and to the format of demographic data collected concerning the principal owners of a small business.
The Bureau also addresses in this summary two other issues.
As part of eventual data publication, as with HMDA data, the Bureau intends to note to data users that data alone are generally not used to determine whether a lender is complying with fair lending laws. The data do not include all the legitimate credit risk considerations for loan approval and loan pricing decisions. Therefore, when regulators conduct fair lending examinations, they analyze additional information before reaching a determination about an institution's compliance with fair lending laws.
Many commenters, including banks, credit unions, non-depository and online lenders, trade associations for lenders and small businesses, advocacy groups, individuals, and others supported the Bureau's proposed rule.
A number of commenters, including lenders, community groups, and trade associations affirmed the importance of section 1071 and its statutory purposes. A coalition of lenders and community groups stated that section 1071 was a market-based, pro-competition solution to improving access to capital. Several industry commenters supported the aims of section 1071 and the proposed rule. An advocacy group supported section 1071 as important to strengthening credit markets and access to credit, and encouraged the Bureau to promulgate a final rule that would support a robust and inclusive credit ecosystem. An independent office of a Federal agency stated that the proposed rule was squarely in line with the Regulatory Flexibility Act and implemented statutory goals without excessive small-entity compliance costs.
One advocacy group stated that the proposed rule aligned with the Constitution, section 1071, the Defending Women E.O., and biological reality.
Several banks and a trade association stated that while they preferred a statutory repeal of section 1071, they welcomed the Bureau's proposed revisions to the rule.
A number of lenders and trade associations, as well as an advocacy group supported the proposed rule's rationale that a long-term data collection regime should start with core products, providers, and data points to avoid disruption to the markets. Two trade associations stated that the effectiveness of the rule depends on maintaining, rather than disrupting, access to credit while collecting reliable data. Several commenters, including trade associations, banks, and an advocacy organization, supported the proposal's calibrated approach to data collection, reflecting the operational and legal concerns raised by commenters earlier in response to the 2021 proposed rule and the 2023 final rule, and balancing the statutory purposes of section 1071 and the capacity of community banks to serve small businesses. An advocacy group stated that a long-term program that begins with modest, core requirements will ultimately provide more accurate and useful data while avoiding disruptions in credit availability. The commenter suggested that the Bureau commit to ongoing reassessment of this rule's requirements and that the Bureau should use the initial data collection to determine whether products, lenders, or data points should be added.
Several credit unions and their trade associations stated that the proposed rule would help credit unions and would reduce regulatory burden on credit unions. Some of these commenters stated that the 2023 final rule may have stopped small business lending by credit unions, but that the revisions in the 2025 proposed rule encourage them to continue it. A trade association stated that the proposal recognized the importance of credit unions in small business lending. One credit union cautioned the Bureau to consider carefully any expansion of the rule beyond core lenders and products.
Several community banks and trade associations supported the proposed rule, stating that it would provide substantial relief to community banks from regulatory burden. Several of these commenters called the proposed rule a meaningful recalibration. Another trade association warned that if rule was not well-tailored, it could harm community banks, their small business borrowers, and the nation's economy. Several community banks said they did not have the resources to comply with the 2023 final rule. One bank stated that a rigid rule would disrupt the tailored lending relationships and flexibility of small banks.
Some banks, trade associations, and an advocacy group supported the proposed revisions but expressed concern that the remaining requirements of the rule would still impose unintended negative consequences on lenders and small businesses. One trade association, while generally supporting the rule, suggested that the rule be brought into greater alignment with the Community Reinvestment Act regulations. One of the trade associations suggested that the 2023 final rule be rescinded entirely to remove any uncertainty caused by the judicial stays in the litigation challenging the 2023 final rule. A bank expressed concern that section 1071 did not comply with recent Supreme Court decisions concerning race-conscious university admissions and disparate impact.
One bank supported the proposed revisions but opposed incremental expansion of the rule in the future, arguing that this approach would result in a lack of regulatory uncertainty. An individual commenter supported the proposed rule and stated that a rule without bright-line tests, particularly for data points and institutional coverage, would result in the collection of insufficient or inconsistent data.
A trade association stated that the rule should evolve thoughtfully to generate reliable insights to support oversight over small business lending.
One advocacy group urged the Bureau to provide early and comprehensive technical compliance resources, including filing instructions, standardized demographic-data definitions, and system specifications, well before the January 1, 2028 effective date, noting that large last-minute revisions would undermine preparation efforts. Two trade associations requested that lenders have sufficient compliance lead time to develop data-collection platforms that accurately capture and report section 1071 data.
Many other commenters opposed the proposed rule generally. These commenters included community
Many commenters asserted that lending discrimination is still widespread, and that data collected under this rule is vital to addressing it. Two advocacy groups identified ongoing disparities in approvals or amounts approved for minority-owned and women-owned businesses. A trade association for small businesses cited studies by Federal agencies identifying gaps in credit access for minority-owned and women-owned businesses. A trade association for minority-owned CDFIs asserted that any revisions to the 2023 final rule must be evaluated against longstanding credit inequities section 1071 was enacted to address. An individual commenter stated women-owned and minority-owned businesses have faced systemic barriers in accessing fair credit, and that a rule that does not result in robust transparency in lending would be contrary to section 1071.
Several commenters, including community groups, Members of Congress, and an advocacy group, argued that the collection of less data would undermine fair lending laws. A community group supported the reduction in burdens related to this rule but argued that the proposed revisions would unintentionally reduce the usefulness of the section 1071 data, and that the Bureau must maintain elements necessary to maintain clear and consistent data on small business lending. The commenter encouraged the Bureau to reduce burden by focusing on implementation planning, clear definitions, and sequencing rather than removing data fields. Another community group stated that the Bureau should implement the 2023 final rule and collect a critical mass of data before revising the rule. Another stated that the Bureau should withdraw the 2025 proposed rule and restore the 2023 final rule to ensure the rule is sufficiently comprehensive.
One community group argued that it was inconsistent for the Bureau to propose a rule with more modest requirements that it could expand over time while seeking in the short term to shed staff and shut down its own operations. Members of Congress stated that the proposed rule would preserve the appearance that data was going to be collected but that the actual result would be too thin and partial to be useful.
Several commenters noted the benefits of collecting more data than less. A community group and a bank argued that a broader data collection would benefit both borrowers and lenders; lenders would be able to identify unmet credit needs, generate more revenue, and avoid fair lending violations, and small businesses would receive loans and expand. Several commenters stated that their experience with HMDA reinforced the importance of broad data collection and reporting in the context of section 1071. A community group argued that the Bureau should collect data on non-core lenders because data analysis can account for differences that may be attributable to different types of reporting lenders, such as MCAs.
A number of community groups, advocacy groups, service providers, and individuals, as well as a trade association for minority-owned CDFIs, argued that the proposed rule undermines the statutory purposes of section 1071. A community group asserted that, to comply with section 1071, the rule must require collection of sufficiently detailed data, and claimed that the proposed rule did not meet this standard. A coalition of community groups argued that the proposed rule would undermine section 1071's promise of bringing transparency to small business lending. One community group noted that data from the Paycheck Protection Program (PPP) demonstrated the value of section 1071 data in identifying issues faced by women-owned and minority-owned businesses in obtaining PPP funding. Another commenter noted that minority-owned community lenders have seen firsthand how incomplete data can obscure disparities and impede effective intervention.
An individual commenter asserted that the Bureau failed to adequately explain how its proposed changes would improve consumer outcomes or market stability, that a rational connection had not been made between the stated objectives and the foreseeable consequences for consumers, and that the Bureau had not considered alternatives that would maintain strong consumer protections while addressing administrative or operational concerns.
A number of commenters opposed the Bureau's rationale focusing on an initial data collection involving core products, lenders, and data points. Several community groups argued that section 1071 does not direct the CFPB to pursue a modest, pilot data collection but rather to develop a broad, comprehensive data collection immediately, sufficient to reveal patterns in credit access and support fair lending enforcement; they concluded that the proposal failed to do this and therefore would frustrate the statutory purposes of section 1071. Commenters also argued that the incremental expansion of section 1071 data would not be the best way to preserve data quality, and that lenders had years to prepare to comply with the 2023 final rule.
One advocacy group asserted that the Bureau offered no evidence of a plan to re-assess the rule at a later date to potentially expand the collection of data. A community group argued that the Bureau had taken other actions demonstrating that it was not committed to fair lending.
A bank disputed an assertion in the proposed rule that smaller institutions would produce worse data. A community group stated that the proposed revisions would shrink the scope of the rule despite evidence of an increase in high-cost and opaque small business lending products. Another community group stated that additional data is needed to explain these changes in the market. A coalition of lenders and community groups urged the Bureau to consider the risk of narrowing the rule, and argued that a less comprehensive rule could have gaps which would not permit a reliable assessment of credit flows and would limit the utility of the rule. A community group claimed that the proposed rule acknowledged, but did not justify, the loss of benefits associated with the proposed rule including a loss of fair lending benefits, reduction in community development benefits, as well as benefits associated with the coverage of certain financing markets and lenders.
One community group stated that the proposed rule's discussion of the history of HMDA was a misguided basis for the Bureau's longer-term, incremental approach to data collection. The commenter stated that HMDA implementation demonstrated that even small lenders can comply with data collection requirements, and that the market is stronger for data transparency. The commenter also asserted that while HMDA expanded over time, section 1071 does not require iteration because Congress learned from its decades of experience with HMDA. Another community group stated that the proposed revisions were not supported by evidence; by contrast, the commenter stated that HMDA's evolution provided 50 years of lessons to be learned that were embedded in the 2023 final rule.
A community group claimed that the Bureau repeatedly cited unsubstantiated comments justifying the proposed rule, arguing that where the Bureau referred to stakeholder feedback, it had met with groups with special access. The
The commenter further argued that frequent changes to regulations would depress economic output; regulatory uncertainty leads lenders to be overly cautious, leading them to restrict credit access. An advocacy group argued that smaller lenders tend to pull back when regulatory standards are unclear or overly expansive.
With regard to concerns expressed regarding the remaining requirements of the rule, the Bureau has attempted to reduce unnecessary costs or complexity as much as possible while still complying with the statutory mandate provided by section 1071. The Bureau also notes, in response to a commenter, that rescinding the 2023 final rule entirely would be impracticable.
The Bureau does not believe that incremental expansion of the rule in the future would lead to regulatory uncertainty. The Bureau intends to consider any future expansion carefully, with sufficient advance notice to avoid regulatory uncertainty.
In response to comments stating that lending discrimination is ongoing, the Bureau notes that the data cited by commenters are consistent with data cited in the 2023 final rule. The Bureau disagrees that this information requires the Bureau to pursue an immediate and maximalist approach to data collection to comply with section 1071. As the Bureau has noted before, such a position may have the effect of discouraging lending, including to those populations described by commenters, or the collection of accurate data generally, to the extent that lenders face cost and complexity that could have been avoided under a more gradual, longer-term approach to a new data collection.
The Bureau also disagrees that that the collection of less data in the short term necessarily undermines fair lending laws. The Bureau notes that the revisions in this final rule are intended to result in a fuller, higher-quality collection of data in the longer term with a minimum of disruption to the small business lending markets. Nothing in the text or history of section 1071 requires the Bureau to pursue a maximalist collection of data in the short term, regardless of the consequences of such a program on smaller lenders. The Bureau believes based on comments received and its experience with small business lending that caution at the start of this data collection is both warranted and appropriate.
With regard to the comment that the Bureau should focus on non-rule policies to reduce burden on lenders, rather than revising the rule, the Bureau believes that this is a false dichotomy. The Bureau intends to assist covered financial institutions with implementation planning outside of the rule. The Bureau believes that its definitions are sufficiently clear for operational purposes. The Bureau notes that its long-term approach to section 1071 is a type of sequencing, as characterized by the commenter. The Bureau disagrees that it should first collect data under the 2023 final rule and then revise the rule based on that data. The Bureau is concerned that the initial cost and complexity imposed on smaller lenders and those not experienced with similar data collection regimes may cause avoidable and irreversible harm.
The Bureau agrees in principle with comments that under section 1071, all else equal, there are benefits to collecting more data rather than less. The Bureau disagrees that this general principle means that the immediate collection of the most data possible is beneficial, for the reasons stated above; the Bureau believes that there is a risk that such an approach would disrupt credit access, and may cause lenders to reconsider participation in the small business lending markets, as comments from industry have stated. The Bureau disagrees that it should collect data from non-core lenders in the short term at the start of this data collection. While data analysis may help account for differences between such lenders and core lenders, the Bureau reiterates its concerns that the rule may impact such non-core lenders if required to comply in the short term. The Bureau believes that data collected from core lenders, on core products, may help guide and ease compliance for non-core lenders and products in the longer term.
The Bureau disagrees with commenters that the proposal undermines the statutory purposes of section 1071. The Bureau again believes that this position, taken by various commenters, assumes that section 1071 on its face requires an immediate collection of the most data possible without regard to the practical consequences of doing so. Further, these commenters characterize data collection under the proposed revisions as if they would result in the collection of no data, rather than the Bureau's estimates that the revised rule would result in the collection of 92 to 93 percent of small business loans by depository institutions. By contrast, the Bureau estimated that the 2023 final rule would result in the collection of approximately 94 to 95 percent of small business credit transactions.
Regarding one commenter's assertion that there was no evidence of a plan to reassess the rule in the future, the Bureau stated in the proposed rule that it would review data received and continue to observe the small business lending markets to determine whether and how to expand coverage of the rule in the future. There are also several other mechanisms that represent natural points for the Bureau to reassess the rule, including the inflation adjustment to the small business definition under § 1002.106(b)(2) occurring every five years, as well as the statutory requirement under Dodd-Frank Act section 1022(d) that requires a retrospective assessment of a significant rule five years after the effective date.
Regarding comments asserting that the proposal acknowledged, but did not justify, the loss of benefits associated with the proposed revisions, the Bureau disagrees. The preamble to the proposed rule is forthright in acknowledging the potential value of certain data that the Bureau has determined not to collect initially, but balances this against the cost and complexity of including such requirements at the start of this long-term data collection regime.
The Bureau disagrees that its discussion of the history of HMDA is a misguided basis for the proposal's incremental, longer-term approach to data collection. The Bureau is not persuaded by comments that the market's specific experience with HMDA has prepared small lenders to comply with section 1071 immediately; commenters stated the contrary, that either they have little or no experience with HMDA. As many commenters have noted, mortgage lending is different from the varied market in small business credit; many lenders that submitted comments stated that they are not HMDA-filers and have no previous experience in complying with any data collection rules.
The broader understanding the Bureau takes from its HMDA experience is that there is a learning curve to any new data collection requirement. In this sense, the experience that lenders, borrowers, and regulators have had with HMDA suggests that it is more prudent to start modestly and later expand a data collection rule than to start immediately
The Bureau disagrees that it cited unsubstantiated comments justifying the proposed rule. Since the release of the 2023 final rule, much of the commentary on the requirements of that rule have been entirely public in the form of submissions to the Bureau and publications on stakeholder websites, as well as formal submissions in litigation challenging the 2023 final rule.
The Bureau disagrees with the assertion that it is using Executive Orders to override a statutory mandate. The Bureau's revisions do not override statutory requirements but, rather, comply with the requirements of section 1071. In any case the revisions to the rule that reference their consistency with Executive Orders are justified on other independent grounds, as explained below in passages discussing different Executive Orders.
The Bureau agrees in principle with the commenter that frequent changes to regulations may depress economic output. The Bureau notes, however, that final rule revises regulatory provisions that lenders have not yet had to comply with; one of the purpose of these revisions is to minimize burdens at the start of this longer-term data collection and to avoid depressing economic output. The Bureau intends to consider any future revisions to the rule carefully and to implement them in a manner intended to reduce regulatory uncertainty and maintain credit access. The Bureau agrees with the same commenter that it should provide early and comprehensive technical compliance resources, including filing instructions, and other materials, well before the compliance date.
In the NPRM, the Bureau provided a 30-day comment period for the public to review and submit feedback on the proposed revisions to the section 1071 regulatory framework.
The Bureau received a number of comments requesting an extension of the 30-day comment period from a variety of stakeholders, including banks, community groups, and individuals.
Most of the commenters requesting an extension asked for an additional 60 days. One bank requested an additional 90 days, and two individual commenters requested an extension without specifying a timeframe.
Many of these commenters argued that 30 days was an insufficient amount of time to determine the proposal's impacts and provide meaningful feedback. Commenters pointed to the complexity and significance of the proposal, asserting that it was lengthy, differed significantly from the existing regulation, and contained issues that, they said, the Bureau had never before proposed or sought comment on. One bank specifically requested a 90-day extension to update the financial impact analysis it had conducted for the initial 2023 final rule, stating it needed more time for data collection and analysis to better inform the final rule.
Several commenters contrasted the 30-day period with the Bureau's past practices regarding the process leading up to the 2023 final rule, which included a robust SBREFA consultation process and public comment on the Bureau's Outline of Proposals Under Consideration, along with a 90-day comment period on the 2021 proposed rule (with some commenters noting stakeholders actually had 120 days to review the 2021 proposed rule because it was posted on the Bureau's website 30 days prior to publication in the
Commenters also cited logistical challenges making the 30-day deadline difficult to meet. Many commenters highlighted that the Bureau simultaneously issued a separate Regulation B proposal subject to the same 30-day deadline, stressing that it was difficult to delve into both complex proposals since they required review by many of the same organizational stakeholders and experts. Additionally, many commenters pointed out that the Thanksgiving and winter holidays fell within or immediately followed the comment period.
Commenters raised special concerns regarding the comment period's impact on certain types of stakeholders. Specifically, commenters suggested the short deadline was particularly challenging for community-based organizations that needed time to develop community-informed comments; trade associations that required time to meaningfully consult with their member banks to provide robust and granular feedback; and small or public-interest organizations that lack the resources to turn around complex analyses quickly.
Finally, one commenter asserted that the short comment period—combined with the simultaneous Regulation B proposal and the holiday timing—demonstrated the Bureau's disinterest in receiving and fully considering public comments. The commenter also suggested that the timeline indicated the Bureau was ready to ignore the full weight of the public record and its own detailed analysis leading up to the 2023 final rule.
For the reasons set forth below, the Bureau concludes the 30-day period provided in the proposed rule was sufficient.
The Bureau disagrees with commenters who argued that the 30-day timeframe was too short to allow for meaningful feedback or a thorough analysis of impacts, including the specific request for a 90-day extension to update a financial impact analysis. The issues raised in this rulemaking build upon a well-established foundation, familiar to the stakeholders who commented on this rule. The public has had a substantial amount of time to consider the core concepts of the section 1071 data collection regime across a multi-year, iterative process. This process has included the 2017 Request for Information, the 2020 SBREFA process, the 2021 proposed rule, and the 2023 final rule itself. Many commenters, including those opposed to the proposed revisions, reiterated many of the things they had said in prior comment letters, precisely because they had familiarity with many, if not most, of the issues raised by the 2025 proposed rule. The comment letters that the Bureau received, both in support of and in opposition to the proposed revisions to the rule, were detailed and appeared to have considered the proposal carefully and comprehensively.
For this same reason, and because this rulemaking largely proposes burden-reducing exemptions and clarifications rather than a new regulatory framework from the ground up, the Bureau determines that a new SBREFA process is neither required nor necessary. In addition, the SBA Office of Advocacy has given the Bureau a waiver from the requirement to conduct a SBREFA Panel for purposes of this rulemaking because the Bureau had already conducted a panel in advance of the 2023 final rule, as described below in part VII.
While the occurrence of the Thanksgiving and winter holidays may have placed competing demands on commenters' time, the Bureau reiterates
The Bureau disagrees that this timing, the concurrent publication of a separate Regulation B proposal, or the 30-day period itself, signaled a lack of interest in receiving and fully considering public feedback or an intent to ignore the full weight of the public record and its own detailed analysis leading up to the 2023 final rule. The Bureau does not agree that the concurrent Regulation B proposal limited commenters' ability to respond, because the topics of the two rulemakings were very different; while this rulemaking focuses on small business lending data collection under section 1071, the other proposal addressed aspects of ECOA related to its discrimination prohibition, specifically disparate impact, discriminatory discouragement of applications, and special purpose credit programs. To the contrary, the APA requires agencies to provide the public with a meaningful opportunity to participate in the regulatory process, but it does not mandate a minimum 60-day or 90-day comment period. The Bureau determines that 30 days provided a meaningful opportunity to comment under both the APA and all relevant E.O.s, including E.O. 13563, particularly given the targeted nature of the proposal and the extensive historical context surrounding the rule.
Furthermore, the Bureau's review of the rulemaking docket confirms that the 30-day period was sufficient for robust public participation. In total, the Bureau received approximately 410 comments on the proposal. The Bureau notes that many of the entities that submitted requests for an extension successfully submitted substantive, detailed comments on the proposal within the 30-day window. The Bureau has carefully reviewed all of these comments and utilized them to inform this final rule, demonstrating that the comment period provided an adequate and meaningful opportunity for public participation.
The Bureau finds that at the onset of data collection under section 1071, the rule should focus on core, generally applicable lending products that are most likely to be foundational to small businesses' formation and operation—loans, lines of credit, and credit cards—before determining whether to expand the scope of the rule to include more niche or specialty lending products. This final rule therefore excludes MCAs, agricultural lending, and small dollar loans from the definition of covered credit transaction to better ensure the smooth operation of the initial period of data collection, while minimizing disruptions and regulatory complexity in the credit markets subject to section 1071.
A trade association representing community banks opposed the Bureau's proposed exclusions, characterizing the exclusion of non-core lending products as “loopholes” that the Bureau should close. The commenter argued that small businesses—particularly those with limited access to traditional financing—frequently rely on non-traditional forms of credit, and that their exclusion would permit abuse and borrower dissatisfaction to go undetected in these less-regulated markets. Furthermore, the commenter asserted that such exclusions would give lightly regulated lenders a competitive advantage over community banks, which it described as unquestionably trusted small business lenders, potentially pushing borrowers toward what it characterized as more dangerous creditors. The commenter suggested that if the Bureau retains the exclusions, it should commit to monitoring the market with the intention of removing them at a later date.
The Bureau disagrees that these exclusions constitute “loopholes” that will harm small business borrowers. As discussed in the 2025 proposed rule and as confirmed in this final rule, the Bureau is adopting an incremental approach to coverage that focuses on core lending products that are most foundational to small business operations. The Bureau believes that this approach, at the inception of this data collection regime, appropriately balances the benefits of data collection with the need to minimize market disruption and regulatory complexity. The Bureau may revisit the scope of its coverage of credit products in future rulemakings.
Existing § 1002.104(a) defines a “covered credit transaction” as “an extension of business credit that is not an excluded transaction under paragraph (b) of this section.” Section 1002.104(b)(1)-(6) enumerates six types of transactions that are excluded from covered credit extensions. The Bureau proposed to add MCAs to the list of excluded transactions in § 1002.104(b). Proposed § 1002.104(b)(7) would exclude MCAs, which it would define as an agreement under which a small business receives a lump-sum payment in exchange for the right to receive a percentage of the small business's future sales or income up to a ceiling amount. Consistent with this proposed new exclusion, the Bureau also proposed deleting several references to MCAs, and the related term sales-based financing, in commentary.
The Bureau received many comments on several aspects of the proposal concerning MCAs from a wide range of lenders, trade associations, business advocacy groups, community groups, and individuals. The Bureau previously observed that, throughout the development of the rule to implement section 1071, MCAs had been the focus of significant attention and a unique source of near-consensus among a diverse array of stakeholders—almost all of whom advocated for covering MCAs except for MCA providers themselves and some trade associations representing MCA providers. Comments received in response to the recent NPRM were slightly different in that commenters supporting the exclusion from the rule also consisted of a few community banks and a research advocacy organization in addition to MCA providers and nonprofit trade associations. These commenters argued that MCAs do not meet the definition of credit under ECOA or State law. Conversely, many other commenters, including community groups, trade associations, and lenders urged the inclusion of MCAs in order to effectively monitor the small business credit market and facilitate fair lending enforcement. Below is a more detailed summary of comments grouped by topic.
Several commenters disagreed with the Bureau's focus on core lenders as justification for excluding MCAs. Community groups argued that MCAs should be covered because their originations have grown exponentially, they are no longer marginal products, and small businesses are commonly exposed to them via advertising. One commenter estimated that volume of MCAs would grow from $18 billion in 2024 to $25 billion by 2029; a small business trade association estimated that MCA volume would grow from $19.7 billion in 2024 to $32.7 billion by 2032. Both commenters, as a result, argued that covering MCAs is necessary to be consistent with the statutory purposes of section 1071.
One community group noted that while MCAs function differently from traditional loans, such differences would not preclude data comparability. For instance, the commenter noted that a standard MCA contract contains enough information to calculate an estimated annual percentage rate.
A small business trade association asserted that the proposed exclusion of MCAs would harm the financial health of small businesses and obscure from policymakers and industry stakeholders the predatory and high-cost nature of these products. This commenter argued that MCAs operate with little Federal oversight and harm small businesses, as evidenced by opaque pricing terms used by many financing companies that conceal the full cost of MCA products instead of displaying the annual percentage rate (APR). Further, the commenter stated the MCA industry has faced backlash from government entities, stating that, for instance, SBA 7(a) loans may not be used directly to refinance MCA debt because of the damaging nature of high-cost MCA products that often leave small firms with no choice but to restructure or refinance to retain or improve their credit history. The commenter further stated that, because of the absence of any regulation requiring data on the MCA industry and the unwillingness of certain government guaranteed lenders to refinance small businesses with MCAs, small businesses will feel the impact by facing the difficult decision to close their doors or declare bankruptcy.
A community group cited the 2024 Federal Reserve Small Business Credit Survey indicating that 9 percent of reporting small businesses applied for an MCA and that medium- and high-risk applicants were much more likely than low-risk applicants to apply for financing at online lenders. This commenter also stated that applicants that seek financing from online lenders were more likely than applicants to other sources to experience challenges with their lenders. The commenter argued that confirming the prevalence of MCA lending in certain markets will further the statutory purposes of section 1071 and provide valuable data to policymakers and lenders about small business community development needs, including concerns about potentially detrimental and discriminatory lending.
A trade association for MCA providers asserted that subjecting MCAs to the rule would be especially costly and impractical because of how MCAs are structured. This commenter predicted that implementing tracking systems under the rule would require costly programming upgrades and adjustments to MCA systems that might force smaller MCA providers to exit the industry, resulting in a less competitive markets dominated by larger funders and higher costs for MCA users.
An advocacy group supported excluding MCAs from coverage to avoid unnecessary complexity and disruptions in lending markets. This commenter asserted that including novel or specialized financing structures in the earliest round of data collection risks undermining both data quality and market stability. For example, the commenter said that MCAs differ fundamentally from conventional extensions of credit in structure, risk allocation, and repayment mechanics since pricing mechanisms are often tied to receivables rather than interest rates, underwriting focuses on future cash-flow volatility, and legal treatment varies significantly under State law.
By contrast, other community groups, trade associations, and a business advocacy group maintained that exclusion will create a blind spot in the data, obscure risks to small business borrowers, and reduce market transparency. A trade association asserted that excluding these transactions undermines the statutory purposes of section 1071 and risks perpetuating inequities in credit access since alternate lenders, such as MCA providers, frequently serve more vulnerable businesses that cannot qualify for conventional loans. A trade association representing CDFIs urged the Bureau to retain broad product coverage to support effective enforcement and sound policy analysis, especially given that the MCA market plays a substantial role in the financing outcomes of minority-owned firms. It also noted that a failure to cover them would constrain the Bureau's ability to assess pricing structures, repayment burdens, and other features relevant to fair lending analysis.
A trade association representing small businesses suggested excluding MCAs contradicts the proposed rule's own data quality rationale. Specifically, this commenter explained that the Bureau justifies many of its proposed changes by citing concerns that complex requirements might yield poor-quality data from smaller, less-resourced lenders. The commenter argues that this logic does not support excluding MCAs because MCA providers typically have advanced underwriting algorithms that already collect demographic-like data, use automated systems that could easily be adapted for data reporting, and are generally larger and better-resourced than many small lenders. This commenter claimed that excluding MCAs would eliminate oversight of a growing alternative finance sector with no regulatory oversight, without reducing compliance burden on traditional lenders requesting relief.
Two bank trade associations stated that MCAs should be covered because they do constitute credit under ECOA, even if they are structured differently than traditional loans. These commenters argued that unlike with factoring, the small business must repay the MCA provider for the advance out of future revenue. The commenters also stated that if there were some MCAs that would not meet the definition of credit, the Bureau should limit the exclusion to those specific MCAs as this would create a more level playing field across institutions that provide financing to small businesses, and create a data set that better reflects demand for small business financing.
A community group stated that the proposal's discussion of State regulation of MCAs reflected the Bureau's misunderstanding of the purpose of State laws regulating MCAs and their impact on the 1071 rule, arguing that instead such laws reflect concern about the pervasiveness of MCA lending and the impact on small businesses, and that they justify inclusion of MCAs in the final rule. The commenter further asserted that Congress did not require collection of 1071 data contingent on whether States regulate the product or not, and that in the period since the 2023 final rule was issued, few States substantively regulate MCAs and these State laws cannot reasonably be cited as a changed circumstance that justifies a substantial rewrite to the rule. Lastly, this commenter disagreed with the Bureau's contention that high costs and predatory practices in the MCA market could be addressed by Federal and State law enforcement agencies.
The Bureau is finalizing its proposal to add MCAs to the list of excluded transactions under § 1002.104(b). Final § 1002.104(a) defines a “covered credit transaction” as an extension of business credit that is not an excluded transaction under § 1002.104(b). Section 1002.104(b) enumerates types of transactions that are excluded from the definition of a covered credit transaction. The Bureau is adding MCAs to the list of excluded transactions in § 1002.104(b). Final § 1002.104(b)(7) excludes MCAs, which are defined as agreements under which a small business receives a lump-sum payment in exchange for the right to receive a percentage of the small business's future sales or income up to a ceiling amount.
In the 2023 final rule, the Bureau declined to exclude MCAs from its definition of a “covered credit transaction.” It explained its belief that the statutory term “credit” in ECOA is intentionally broad so as to include a wide variety of products without specifically identifying any particular product by name, such that all credit products should be included in the rule unless the Bureau specifically excluded them and concluded that “credit” encompasses MCAs. It further explained that MCAs should not be understood to constitute factoring within the meaning of the existing commentary to Regulation B subpart A or the definition it was including as comment 104(b)-1, because factoring involves entities selling an existing legal right to payment from a third party, while no such contemporaneous right exists in an MCA. The Bureau also noted its understanding that, as a practical matter, MCAs are underwritten and function like a typical loan (
Upon further consideration and in light of the comments received, the Bureau believes it would be consistent with the purposes of section 1071 to exclude MCAs from the definition of “covered credit transaction” under § 1002.104(a). The Bureau agrees with commenters who stated that monitoring the growth and development of MCAs will generate a stronger policy record to determine whether and how MCA products should be integrated into Federal data collection requirements in the future. For the reasons outlined below, the Bureau believes it advances the purposes of section 1071 at this time to exclude MCAs from the definition of covered credit transaction, and to focus on ensuring the smooth operation of data collection as to core lending products and providers most likely to be foundational to small businesses' formation and operation.
The Bureau believes that at the onset of the data collection under section 1071 the focus should be on core lenders and products before the Bureau considers expanding the scope of the rule. The CFPB believes it would advance the purposes of section 1071 at this time to exclude MCAs from the definition of covered credit transaction, and to focus on ensuring the smooth operation of data collection as to core lending products and providers most likely to be foundational to small businesses' formation and operation.
The Bureau believes it erred in the 2023 final rule by prematurely determining that collection of data on MCA transactions would serve section 1071's statutory purposes by concluding that all MCAs constitute credit. The 2023 final rule's one-size-fits-all approach did not take into account the varied terms and features of MCAs across the market that may be relevant to whether the products meet the definition of “credit” under ECOA, nor did it account for the fact that MCAs are relatively new products whose features and practices may be evolving, including in response to State regulation. Moreover, while some State courts have analyzed whether some MCAs meet State law definitions of “debt” or “credit,” there is a dearth of case law analyzing whether MCAs meet ECOA's definition of “credit.”
Excluding MCAs from the definition of “covered credit transaction” is consistent with the way the Bureau has already treated leases, which also present close questions as to whether they meet the definition of “credit” under ECOA. In the 2023 final rule's
The Bureau also concludes that the 2023 final rule's coverage of MCAs did not take into account State law developments addressing sales-based financing. Several States have legislation and/or regulations in place addressing the MCA market and requiring providers to disclose terms such as the total cost of capital and the financing rate. The Bureau understands that such laws provide key protections for users of MCAs and may shape MCA terms and practices in ways that bear on the question of whether they meet ECOA's definition of “credit.”
The Bureau acknowledges comments noting the rapid growth of MCAs and the wide exposure small businesses have to such products, but disagrees that this gives rise to an immediate necessity of covering MCAs. The Bureau recognizes that MCA data may be comparable with traditional loan data in that an estimated annual percentage rate can be calculated, but the Bureau does not agree that the calculation of an estimated APR resolves the question of whether all MCAs can or should be covered under section 1071.
The Bureau acknowledges commenter concerns that MCAs may harm the financial health of small businesses, including that government lenders will not refinance small businesses that have taken out MCAs, and that more data might help policymakers and industry stakeholders identify predatory and high-cost products. The Bureau also acknowledges the Federal Reserve survey data noting that many small businesses are familiar with and have applied for MCAs, and more often that it was medium- and high-risk applicants that did so. The Bureau further does not dispute that additional data on the prevalence of MCA financing may help policymakers and lenders understand small business community development needs, including concerns about potentially detrimental and discriminatory financings.
However, the Bureau does not necessarily agree with the conclusions of commenters that either MCAs must all be excluded from the rule on the grounds that none of them are credit or that they must all be covered by the rule on the grounds that all of them are credit. The Bureau further disagrees with the conclusion commenters draw from their observations regarding current MCA market dynamics, including that because of their growth and impact amongst small business lenders, the Bureau must collect data on all MCAs.
These observations do suggest, however, that it would be useful for the Bureau to continue monitoring the MCA market going forward. In any case, the Bureau reaffirms its determination that, while data cited by commenters suggests that nine percent of small businesses apply for MCAs, they are not yet a core product that should be covered at the onset of this long-term data collection program.
The Bureau agrees that MCAs should be excluded from the definition of a “covered credit transaction,” at least at the onset of this long-term data collection regime, to avoid unnecessary complexity and disruption in lending markets. The Bureau agrees fully that including novel or specialized financing structures in the earliest round of data collection risks undermining both data quality and market stability as to these products.
The Bureau acknowledges the concern by some commenters that excluding MCAs may obscure risks to small business that use MCAs and reduce market transparency. The Bureau further acknowledges comments that MCA providers frequently serve more vulnerable businesses that cannot obtain conventional loans. The Bureau agrees that MCAs may play a substantial role for many minority-owned firms. However, the Bureau returns to the predicate issue of whether it was appropriate in the 2023 rule for the Bureau to broadly conclude that all MCAs, regardless of their particular terms and features, meet ECOA's definition of “credit.” Given the difficulty of this determination, and the lack of clear resolution on this issue based on comments received, the Bureau believes it is prudent not to require the collection of data on MCAs at the onset of this data collection regime.
The Bureau disagrees that excluding MCAs necessarily contradicts the proposed rule's data quality rationale. Based on comments received, while some MCA providers may be well-positioned to provide data because they already comply with State laws or regulation requiring data collection and reporting. The same comments also suggest, however, that some MCA providers, more often but not necessarily smaller ones, have no such compliance infrastructure in place. These questions, however, appear to address the manner of implementing any data collection regime, assuming
The Bureau determines, however, that it has not found information in the comments it has received that would help in developing a clear, bright-line definition separating MCAs that constitute credit from those that do not. The Bureau believes, as a result, that further analysis is required to determine what subset of MCAs constitute credit for purposes of ECOA.
The Bureau believes the discussion on whether MCAs are credit and the connection to State laws developments is misplaced. The Bureau solicited comment on State laws and regulations to understand whether their categorization of MCAs generally, or of certain MCAs, meet the criteria of ECOA credit and coverage under this rule. Many States regulate MCAs, describing them as financings without addressing directly whether such products are credit or not.
The Bureau believes that, taking into account the factors listed above, the relative novelty and evolving landscape of the MCA industry and the ongoing changes at the State level concerning the regulation of MCAs, excluding MCA transactions from coverage under the rule at this time is necessary and appropriate to carry out the purposes of section 1071. As explained above, MCAs differ in kind from traditional lending products, such that collecting data on MCA transactions under section 1071 may not produce information that is comparable to data collected on other types of transactions. And because MCAs have not been widely regulated, many smaller MCA providers may lack the infrastructure needed to manage compliance with regulatory requirements. Taken together, requiring MCAs to be reported could lead to data quality issues, which would not advance the purposes of section 1071.
While the 2023 final rule and commenters cited concerns about high costs and predatory practices in the MCA market,
The CFPB will continue to monitor developments in the markets for MCAs and other sales-based financing to determine whether, over time, sufficient evidence might become available to allow a subset to be appropriately included in the definition of “covered credit transaction” for purposes of data collection.
The Bureau proposed to add agricultural lending to the list of excluded transactions under § 1002.104(b). The Bureau proposed new § 1002.104(b)(8), which would define agricultural lending as a transaction to fund the production of crops, fruits, vegetables, and livestock, or to fund the purchase or refinance of capital assets such as farmland, machinery and equipment, breeder livestock, and farm real estate improvements. Consistent with this proposed amendment, the Bureau proposed to delete references to agricultural credit in the current commentary. The Bureau explained in its proposal that this would simplify the rule by narrowing its scope to core, generally applicable, small business lending products and avoid covering a distinct and specialized lending sector that is already subject to a different regulatory reporting scheme.
Agricultural lenders, banks, trade associations, and community groups commented on this proposed exclusion. A number of banks and trade associations supported the exclusion. An advocacy group supported a phased approach to section 1071 requirements, noting that excluding coverage of certain products in the short term does not foreclose future coverage once lenders gain experience with data reporting and compliance burdens are better understood.
Some banks and trade associations stated that the utility of agricultural loan data is limited because such loans are subject to different underwriting criteria, are secured by unique assets (such as crops or livestock), and are subject to unique repayment cycles tied to seasons and commodity price cycles, making them difficult to compare with non-agricultural loans.
A trade association for banks argued that agricultural loan data is not likely useful in fulfilling section 1071's statutory purposes, explaining that agricultural lenders provide product offerings based on individual needs, financial strength, access to other funding, and other relationships with the creditor or collateral, and that the credit requests of agricultural borrowers pose unique underwriting challenges.
Other community bank commenters highlighted the relationship between community banks and agricultural borrowers, arguing that the exclusion would allow community banks to continue to serve such borrowers without increasing the costs of credit or reducing credit availability. One commenter emphasized the disproportionate importance of community banks in agricultural lending, stating that community banks extend over 75 percent of agricultural loans while representing less than 15 percent of banking assets nationwide. Two trade associations representing credit unions, and a community bank asserted that covering agricultural lending would increase compliance costs and reduce credit available to farmers.
Several commenters stated that the proposed exemption would avoid duplicate oversight and reduce unnecessary reporting. A trade association for banks, a community bank, and a small business trade association asserted that agricultural lending is already subject to Federal data collection requirements by the Farm Credit Administration (FCA) and by prudential regulators under the Community Reinvestment Act (CRA). A trade association for FCS lenders noted that if the rule covered agricultural lending, it would overlap with existing reporting requirements for small agricultural lending and would burden FCS lenders.
Commenters opposing the exclusion emphasized that agricultural lenders have a significant impact on small business lending markets and should be covered by the rule. One community group noted that farms are small businesses that apply for agricultural loans and are therefore a subset of small business loans intended to be covered by section 1071. A small business advocacy group expressed concern that the proposed exclusion would prevent lenders and policymakers from addressing gaps in lending that threaten the livelihood of small, family-owned farms, and urged coverage of agricultural lending to generate data necessary to address lending disparities, especially because minority-owned farms constitute less than 5 percent of all small farms.
One community group representing farmers asserted that no nationwide, publicly available data set exists for farm loan applications. This commenter stated that the FCA does not publish applicant-level data, that the data they have is available only through Freedom of Information Act (FOIA) requests, that the data do not contain demographic information, and that because the CRA only applies to banks, there is no comparable data on small farm loans made by credit unions, FCS lenders, or nondepository institutions. Another community group also objected to the proposed rule's statement that agricultural lending data is already reported to other agencies, noting that the same argument could be made to exclude small business loans reported under the CRA. This commenter stated that Congress, in establishing section 1071, did not distinguish between lending data that was or was not otherwise collected by different agencies. An advocacy group for small farms expressed concerns that the exclusion will negatively impact the farmers who have long struggled to access credit that works for them.
A community-based organization and group representing farms stated that the proposed exclusion would obscure lending to small farms, which would frustrate the community development and fair lending purposes of section 1071. These commenters disagreed with the rationale proposing to exclude agricultural lending, arguing that data on farm loans could still be collected and identified as such, permitting an analysis of farm and non-farm credit trends. Several commenters cited past litigation concerning discrimination against Black farmers as evidence of a significant risk of discrimination and unequal credit access in the agricultural context as a reason justifying the collection of agricultural loans, including whether the loans were issued by a public sector lender or had a Federal guarantee. A community group and advocacy group stated that this history of discrimination, including in public sector lending, necessitates the collection of agricultural lending data.
Several advocacy groups representing farms characterized the proposed exclusion as an unlawful, arbitrary, and capricious action that abdicates the Bureau's statutory responsibility through a policy of non-enforcement. These commenters argued that Congress mandated that the collection and publication of all application-level small business loan data, and that the proposed exclusion of farm loans would violate the plain text and purpose of section 1071. Another commenter stated that the proposed exclusion ignores the evidentiary record, the Bureau's own prior findings, and overwhelming public comments on the need for transparency in agricultural lending. This commenter asserted that the Bureau's rationale for the proposed exclusion—
In response to the request for comments on the proposed definition of agricultural lending, a trade association for banks requested several clarifications in the regulation text and commentary. First, the commenter suggested adding the word “principally” to the beginning of the regulatory text in proposed § 1002.104(b)(8) so that the revised text would be “transaction
An FCS lender and a trade association for banks asked the Bureau to use the definition of “agricultural purpose” in comment 8 of section 1026.3(a) in Regulation Z instead of the text of proposed § 1002.104(b)(8). One of these commenters further suggested a slight edit to the pre-existing Regulation Z definition of “agricultural purpose” by replacing “a natural person” with “any person.”
The Bureau is finalizing its proposal to add agricultural lending to the list of excluded transactions under § 1002.104(b). Final § 1002.104(b)(8) defines agricultural lending as a transaction to fund the production of crops, fruits, vegetables, and livestock, or to fund the purchase or refinance of capital assets such as farmland, machinery and equipment, breeder livestock, and farm real estate improvements. Consistent with this addition, the Bureau is deleting references to agricultural credit in commentary. This will simplify the rule by narrowing its scope to core, generally applicable, small business lending products and avoid covering a distinct and specialized lending sector that is already subject to a different regulatory reporting scheme.
In the 2023 final rule, the Bureau declined to exclude agricultural credit from its definition of a “covered credit transaction.” It noted that ECOA itself has no exceptions for agricultural credit, that agricultural businesses are included in section 1071's statutory definition of small business (defined by cross-reference to the Small Business Act),
The Bureau has considered the comments on the proposal and believes that excluding agricultural lending from the definition of “covered credit transaction” advances the statutory purposes of section 1071 at this early phase as the Bureau begins the collection of small business lending data. While the 2023 final rule declined to create such an exclusion, the Bureau now believes, on reconsideration and in light of comments received, that it did not adequately consider the marked distinctions—and resulting data disparities—between agricultural lending and other types of commercial lending.
Some commenters argued agricultural lending must not be excluded from the definition of “covered credit transaction” to monitor the farm economy sector and identify access to credit issues. However, as the Bureau and commenters have noted, agricultural lending is subject to several existing Federal data collection frameworks, meaning that existing data regimes serve to monitor agricultural lending and access to credit. The Farm Credit System, as discussed in further detail in part III.E conducts a substantial amount of agricultural lending through a nationwide network of congressionally chartered, borrower-owned cooperatives. This system is subject to extensive oversight by the FCA and other Federal agencies with oversight over agricultural lending. Among other things, many agricultural borrowers report data to the Farm Service Agency, which collects demographic data including race, ethnicity, and gender from applicants as part of its program oversight.
Further, the Bureau believes that excluding agricultural lending is necessary or appropriate to carry out the purposes of section 1071 to avoid imposing new, overlapping reporting requirements on agricultural lenders at this point when the Bureau is commencing the collection of data under this rule. The Bureau disagrees with commenters that characterize the proposed exclusion of agricultural lending as unlawful, arbitrary, and capricious. The Bureau has stated its change in position from the 2023 final rule, and justified it based on its own reconsideration of existing evidence and additional feedback from an array of stakeholders. The Bureau also believes that these comments did not take into consideration the approach Bureau articulated in the 2025 proposed rule. The Bureau believes that excluding agricultural lending at this time furthers the purposes of section 1071 because such an exclusion limits potential issues with data quality. Compliance may pose greater difficulties for small agricultural lenders, which are often rural entities with less compliance infrastructure than other lenders, potentially impacting the quality of their data. The Bureau is also concerned that these entities may need to divert their limited resources away from lending activities to comply with this rule. Further, for lenders that provide both agricultural and non-agricultural loans that will still be subject to coverage, the agricultural exclusion better situates such lenders to focus their section 1071 reporting efforts on data for core lending products.
Regarding the comment requesting modifications to the proposed definition of “covered credit transaction,” the Bureau does not believe it is necessary to modify or clarify the regulation text and commentary at this time. The Bureau is concerned that the modifications or clarifications requested might have the effect of reaching lending that may be related to agricultural lending but actually is not differentiated at all from non-agricultural small business lending. After this final rule is issued, lenders will have ample opportunity to contact the Bureau for informal staff guidance on specific questions about the agricultural lending exclusion.
The Bureau also declines to adopt the definition of “agricultural purpose” in Regulation Z instead of the definition of “agricultural lending” in § 1002.104(b)(8). Commenters failed to identify practical or material differences between the Regulation Z definition and § 1002.104(b)(8). The Bureau believes that cross-referencing Regulation Z may give rise to potential unintended consequences of adopting an acontextual definition from a legal and regulatory regime with somewhat different purposes and scopes. In particular, Regulation Z generally governs only consumer-purpose credit, in contrast to this rulemaking's explicit limitation to business-purpose credit.
Given these factors, the Bureau believes it is appropriate to focus on conventional, generally applicable small business lending at this time by excluding agricultural lending from coverage under the rule. In doing so, the Bureau is using its authority under ECOA section 704B(g)(2) to adopt exceptions to any requirement of section 1071 and, conditionally or unconditionally, exempt any financial institution or class of financial institutions from the requirements of section 1071, as the Bureau deems necessary or appropriate to carry out the purposes of section 1071.
Under the 2023 final rule, a “covered credit transaction” is defined as an extension of business credit that is not an excluded transaction under § 1002.104(b). In adopting the 2023 final rule, the Bureau considered but declined to adopt a de minimis loan size threshold, citing the significant volume of lending involving credit amounts below the thresholds suggested by commenters at that time.
The Bureau proposed to add small dollar business credit to the list of excluded transactions under § 1002.104(b). Proposed § 1002.104(b)(9) would exclude from the definition of covered credit transaction a transaction in an amount of $1,000 or less, to be adjusted for inflation over time.
The Bureau received comments regarding the proposed exclusion of small dollar business credit in § 1002.104(b)(9) from a wide range of industry stakeholders, including banks, credit unions, and trade associations representing financial institutions. The Bureau also received comments on the proposal from consumer and civil rights advocacy organizations, as well as community development financial institutions.
Industry commenters generally supported the Bureau's proposal to exclude small-dollar loans at any threshold, with banks, credit unions, and their trade associations arguing that the costs of data collection could make the provision of small loans infeasible, increase their cost, or reduce credit availability. One commenter explained the potential harm from such effects, emphasizing that small-dollar commercial loans are critical for vulnerable businesses, with another commenter highlighting their importance in rural and underserved communities. Several commenters stated that the exclusion would allow the Bureau to focus on market segments where transparency is most valuable and prevent the distortion of data by small transactions. A few commenters noted that small-dollar loans are typically incidental in nature and often function more like consumer credit than traditional small-business loans, and a trade association for fintechs similarly observed that these products do not align with traditional small business lending structures. Finally, one commenter noted that the Bureau could always increase the threshold at a later date.
Some industry commenters, including several banks, several trade associations for banks, a trade association for small businesses, and a trade association for fintechs supported the proposed $1,000 threshold, with one trade association noting that very few small business operations can be funded with $1,000 or less.
However, other industry commenters urged the Bureau to adopt a higher threshold. A coalition of trade associations for banks argued that a $1,000 exemption is of limited benefit because businesses are more likely to use consumer credit for loans of that size. This commenter also noted that merchant cash advance providers (which the Bureau proposed to exclude from the rule) offer advances as low as $5,000, suggesting that a higher threshold is needed to allow covered lenders to compete.
Regarding specific thresholds, one trade association representing fintechs suggested a $2,500 threshold to match the CDFI Small Dollar Loan Program and better fit the commercial lending context. Several commenters recommended a $5,000 threshold. These commenters argued that $5,000 would better capture operational realities, particularly in rural or high-cost markets, and avoid capturing loans that are likely exceptions to typical lending practices, while still excluding loans that are administratively burdensome to report.
One commenter suggested a $25,000 threshold to balance operational burden with the frequent business need for fast turn-around for loans needed to, for example, fund equipment repairs or purchase inventory. Several other commenters, including credit unions and related trade associations, advocated for a $50,000 threshold. They noted that this amount tracks the National Credit Union Administration's (NCUA) definition of a “commercial loan” and that consumer credit is available below this amount. One trade association argued that loans above $50,000 are more likely to involve individualized underwriting decisions and negotiated terms that are probative for fair lending analysis. It also asserted that this threshold provides a good balance between preserving the integrity and usefulness of the data set, while protecting borrower privacy and access to small-dollar business credit. Finally, the commenter suggested that if the Bureau does not adopt a $50,000 threshold, it should adopt a more streamlined reporting regime for such loans.
Some industry commenters requested specific modifications to the proposal other than the threshold amount. One trade association requested that the exclusion be optional, noting that some lenders may have difficulty tracking and excluding small loans, particularly for credit limit increases. Another trade association stated that there should be no distinction between types of loans or lenders, nor any limit on the number of small dollar loans to a single borrower. Finally, one trade association for small businesses suggested that the Bureau monitor whether this exemption inadvertently excludes meaningful data from the microlending sector.
Two community groups opposed the proposed exclusion, arguing that it would create significant gaps in understanding how small businesses access capital. They noted that the exclusion would limit the view of credit extended to businesses with limited access to traditional credit, as well as to businesses in rural and smaller communities, and would leave out a significant portion of financing used at the earliest stages of business formation. One community group also argued that the exclusion is unnecessary because technological improvements have reduced the burden of data submission. Additionally, an individual commenter challenged the Bureau's assumption that credit under $1,000 is not relevant to small business formation or operation, particularly for minority-owned businesses. This commenter opposed the proposal, citing statistics indicating that 17 percent of new businesses took a loan of less than $5,000 in their first year, and that minority groups are more likely to borrow smaller amounts. Finally, this commenter noted that the exclusion would reduce benefits associated with the community development purposes of the rule.
For the reasons set forth below, the Bureau is finalizing § 1002.104(b)(9) as proposed to exclude from the definition of a covered credit transaction any transaction in an amount of $1,000 or less, to be adjusted for inflation over time.
In finalizing these revisions, the Bureau agrees with industry commenters that requiring data collection on very small transactions would create a compliance burden disproportionate to the utility of the data collected. The Bureau acknowledges that establishing a specific threshold for such an exclusion involves a degree of judgment in balancing data utility against industry burden. Based on the comments received and its understanding of small business lending markets, gained
The Bureau declines to adopt any of the higher thresholds recommended by commenters because it is concerned about losing data necessary to fulfill the statutory purposes of section 1071. Regarding $2,500 or $5,000 alternative thresholds, the Bureau concludes that a $1,000 threshold better distinguishes between credit that is circumstantial or ancillary to a deposit account and more purposeful commercial credit that section 1071 intends to monitor. The Bureau disagrees that loans in this range generally represent exceptions to typical lending practices or that operational realities justify their exclusion. The Bureau believes, based on the comments received and its understanding of small business lending markets, that a $2,500 or $5,000 threshold would exclude valuable data on smaller dollar loans, which, as noted by commenters, is often a source of capital for the smallest minority-owned businesses. The $2,500 limit of the CDFI Small Dollar Loan Program is inapposite to this rule, as the program's goals—ultimately to assist consumers by funding CDFIs—differ from the statutory purposes of section 1071 focused on small businesses.
The Bureau also declines to adopt a threshold of $25,000 or $50,000. If loans in the $1,000 to $5,000 range include credit transactions that are not ancillary and advance the statutory purposes of section 1071, this is even more true of transactions between $5,000 and $50,000. While the Bureau acknowledges industry comments regarding the operational burden of reporting these loans, and the availability of consumer credit below these amounts, the Bureau concludes that thresholds at these levels would leave substantial gaps in the dataset. Available data indicates that financing in amounts of $25,000 or less is particularly important for the smallest firms, including those with low annual revenues, startup firms, and non-employer firms.
With respect to comments from community groups opposing the exclusion entirely, the Bureau concludes that the $1,000 threshold minimizes the loss of meaningful data while preventing distortions that result from reporting ancillary credit transactions. The Bureau acknowledges the importance of capturing data on credit for the smallest businesses, including minority-owned businesses, businesses in rural and underserved communities, and startups, and concludes that the $1,000 threshold will effectively capture such data. To the extent that the threshold excludes some non-ancillary credit, the Bureau determines that this reflects the necessary balance between data utility and burden reduction described above. Regarding the statistics cited by an individual commenter, that 17 percent of new businesses utilize loans of less than $5,000 in their first year, the Bureau notes that the exemption retains coverage for transactions between $1,001 and $5,000. Consequently, the threshold preserves significant visibility into the microlending activity cited by this commenter. The Bureau disagrees with the assertion that technological improvements render the exclusion unnecessary. The Bureau determines that, even with automated systems, the fixed costs and other burdens of data collection relative to the potential return on a transaction of $1,000 or less remain disproportionately high, creating a risk that lenders might cease offering very low dollar loans to avoid the compliance burden.
Finally, the Bureau declines to adopt the industry request to make the exclusion optional. The Bureau determines that lenders are capable of filtering these transactions out themselves before submission. Because lenders generally track the amount of the credit application, the Bureau does not believe it will be difficult for lenders to identify and exclude transactions of $1,000 or less. Regarding the comment that there should be no distinction between types of loans or lenders, the Bureau confirms that the exclusion in § 1002.104(b)(9) provides for none; nor is there a limit on the number of such small dollar loans to a single borrower that may be excluded. Finally, the Bureau intends to monitor the small business lending markets to determine if the threshold amount (as adjusted every five years for inflation) remains appropriate over time.
The 2023 final rule broadly defined a “covered credit transaction” as an extension of business credit that is not specifically excluded. While the rule enumerated certain exclusions—such as trade credit, HMDA-reportable transactions, insurance premium financing, public utilities credit, securities credit, and incidental credit—
In the 2025 proposed rule, the Bureau proposed narrowing the definition of “covered credit transaction” to focus on “core” lending products—loans, lines of credit, and credit cards—that are most likely to be foundational to small business formation and operation. Consistent with this focus, the Bureau proposed adding specific exclusions for merchant cash advances, agricultural lending, and small-dollar credit transactions. While the Bureau solicited comment on these specific proposals (discussed further elsewhere), the Bureau did not seek comment on other potential product or transactional exclusions.
A wide range of industry participants, including banks, credit unions, fintechs, and national and specialized trade associations urged the Bureau to adopt additional exclusions or clarify existing exclusions for specific types of products, transaction structures, and borrowers. Specific requests addressed indirect lending, trade credit, individual products (such as Purchase Money Obligations and Buy Now, Pay Later transactions), commercial real estate, and transactions involving entities with non-standard ownership structures such as trusts and government agencies.
A broad group of industry trade associations requested that the Bureau exclude all indirect lending transactions from coverage. These commenters argued that indirect lenders lack a direct relationship with the small business applicant, which would make data collection by the financial institution impractical and burdensome. They further asserted that indirect lenders would be forced to contact applicants solely to collect data, describing this as an unprecedented requirement unlikely to yield meaningful data and likely to harm the customer experience. Commenters also noted that intermediaries, such as vendors or dealers, often seek financing terms from multiple indirect lenders simultaneously, and that without an exclusion, the Bureau would receive duplicative data submissions from numerous financial institutions regarding the same potential transaction. One trade association suggested that if a full exemption were not feasible, the Bureau could instead allow demographic information collection after the credit decision, allow data collection to occur at the first contact between customer and financial institution, or create unique customer identifiers within loan applications and provide clear guidance on how vendors, dealers, and finance companies should collectively handle reporting using these identifiers.
Some commenters made specific requests for clarification or exclusion regarding indirect automobile lending. A group of banking trade associations urged the Bureau to clarify, through examples in commentary, that the compliance obligation for these transactions lies with the dealer, not the indirect lender, because dealers are typically the entities that interact with the applicant and have final authority to set credit terms. The commenters further noted that this was warranted because auto lending contracts are sometimes purchased by lenders after completion, when the customer already has their vehicle. Meanwhile, two trade associations for auto dealers requested that the Bureau work with the Federal Reserve Board (which has authority over auto dealers) to exempt auto dealers from any future rulemaking on this topic. The coalition argued that auto dealers do not have the appropriate staff or resources to carry out compliance functions designed for financial institutions. It also stated that auto dealers are often the type of small, women-owned, and minority-owned businesses that section 1071 is designed to protect, not the entities it should burden.
A few commenters requested exclusions for other forms of indirect credit. A group of trade associations, including one representing the equipment finance industry, requested an exclusion for indirect equipment finance transactions facilitated by dealers. The commenters argued that dealers have the final authority to set terms of equipment financing transactions, and that discrimination risk is low because credit decisions primarily focus on the value of the equipment being purchased rather than borrower characteristics. Another group of commenters requested an exclusion for private label, store-brand credit. These commenters pointed to Federal regulators' historical recognition of the unique nature of these point-of-sale transactions, citing specific exclusions in the Financial Crimes Enforcement Network's (FinCEN) beneficial ownership rule and the Bureau's Regulation P, and noted that data collection in this context would disincentivize retailers from offering this form of credit, as they are particularly interested in swift, frictionless transactions. The commenters recommended that the Bureau exempt in-store applications or at least permit demographic data requests to be sent to applicant's post-application.
A trade association representing the equipment finance industry requested that the Bureau exclude purchase money obligations (PMOs) as defined under UCC Article 9. The commenter argued that PMOs are distinct because they finance specific equipment rather than general business operations, and lenders rely on a priority security interest in that equipment for underwriting rather than borrower characteristics. Furthermore, the commenter noted that PMOs are often arranged through dealers or vendors, creating an indirect relationship between lender and borrower. Finally, the commenter asserted that PMOs should be exempt consistent with the rationale for excluding true leases, merchant cash advances, factoring, and trade credit, arguing that regulatory parity is necessary to ensure consistent treatment across similar financing structures.
Several trade associations requested that the Bureau expand the existing trade credit exclusion, which applies to “financing arrangement[s] where a business acquires goods or services from another business without immediate payment.” Two trade associations requested that the Bureau expand the exclusion to include similar credit provided by a financial institution. One of the commenters argued that such credit facilitates the same transactions between the same businesses and therefore deserves the same regulatory treatment; it also argued that any data collected by financial institutions would be of limited use without equivalent data from business-to-business trade credit. The commenter additionally asserted that, absent this exclusion, businesses would be forced to provide their own credit, but they sometimes lack the expertise or cash flow, potentially reducing the availability of credit.
A trade association requested that the Bureau exclude “floor plan financing,” which it argued is similar to trade credit in that the merchant receives the inventory without advance payment. The commenter also explained that floor plan financing has flexible timing and pricing terms that do not align well with other data to be collected under section 1071. Finally, two trade associations representing auto dealers recommended expanding the exclusion to include trade credit in situations where the business lender intends to sell or
A trade association representing the factoring industry supported the existing exclusion for factoring arrangements, noting that the 2025 proposed rule did not propose to change it.
With respect to leases, although the Bureau did not propose altering the existing exclusion for true leases, several industry participants requested an exclusion of such transactions from coverage, arguing that leases differ substantially from traditional small business credit because they involve the transfer of possession or use rather than an extension of credit. One commenter asserted that leases do not constitute credit under ECOA, and that including them would impose operational costs without advancing the rule's objectives. The commenter emphasized that the exclusion is necessary to ensure consistency with regulatory definitions and preserve data integrity.
A coalition of trade associations representing the commercial real estate finance industry requested an exclusion for all loans secured by non-owner-occupied commercial real estate. The coalition argued that such loans are not foundational to small business formation or operations. It further argued that commercial real estate loans differ from traditional small business loans because real estate loans are based on a property's expected cash flow and value, rather than the business's cash flow, and that Federal law acknowledges the distinction, citing SBA regulations, FFIEC Call Report instructions, and the OCC Commercial Real Estate Lending Handbook.
A trade association representing mid-size banks requested that the Bureau provide greater clarity regarding the existing exemption for HMDA-reportable transactions. The coalition noted that Regulation C, which implements HMDA, excludes mortgages and open-end lines of credit that are primarily for business purposes unless the loan is for home purchase, home improvement, or refinancing. They explained that although the existing rule exempts loans reportable under HMDA, the determination is burdensome and unclear because HMDA coverage depends on the purpose of the loan. To resolve this, the commenter recommended that the Bureau either provide more illustrative examples in commentary or base applicability of the section 1071 reporting framework on the purpose of the loan as expressed in FFIEC Call Report codes. One bank expressed support for the existing HMDA exemption, and an individual commenter urged the Bureau to end HMDA reporting for all commercial loans in favor of section 1071 reporting.
A trade association representing fintechs requested that the Bureau exclude Buy Now, Pay Later (BNPL) transactions, which it characterized as credit “not subject to a finance charge and not payable in more than four installments.” The commenter argued that BNPL loans differ from traditional small business loans because they facilitate discrete commercial purchases and do not involve pricing, risk-based terms, or extended underwriting considerations that give rise to potential discriminatory outcomes. The commenter further noted that BNPL loans lack the pricing variables required to even detect discriminatory credit practices. As a result, the commenter argued that the coverage under this rule of BNPL would introduce substantial volumes of low-risk data thus diluting the interpretive value of the reporting framework, could discourage BNPL lending, and would be inconsistent with Regulation Z, which the commenter characterized as excluding such arrangements from the definition of credit.
A bank requested that the Bureau exclude partner lines of credit, also known as “capital call lines of credit,” which are single-purpose loans extended to partners in venture capital or private equity firms to cover capital calls. Characterizing these loans as niche transactions, the commenter argued that an exemption would advance the purposes of the statute by allowing the Bureau to focus its data collection on core lending products that are foundational to small business formation and operation.
Two trade associations requested that the Bureau exclude transactions involving certain entities for which ownership is ambiguous or not determinable. Specifically, the commenters requested the exclusion of commercial loans made to trusts, arguing that these could raise difficult issues, including identifying the appropriate individuals for data collection (
The Bureau declines to adopt the additional categorical product exclusions suggested by commenters, though this final rule includes a correction to § 1002.109(a)(3) that will clarify reporting obligations, and provides clarifications regarding coverage and permissible data collection procedures for certain transactions as discussed below.
The Bureau declines to exclude indirect lending transactions from coverage. This decision encompasses the specific requests to exclude indirect automobile lending, indirect equipment finance, PMOs, and private label or store-brand credit. The Bureau believes, consistent with the 2023 final rule, that data concerning indirect lending furthers section 1071's statutory purposes. For instance, data on indirect auto and equipment finance helps data users identify business and community development needs because vehicles and equipment are often essential for small businesses to operate. Similarly, private label and co-branded credit cards can be an important source of working capital for small businesses.
In response to the request to clarify, through examples in commentary, that the compliance obligation for indirect auto transactions lies with the auto dealer, not the indirect lender, the Bureau notes that comment 105(a)-1 already clarifies the exclusion of auto dealers from coverage under this rule. Regarding the request that the Bureau work with the Federal Reserve Board (Board) to exempt auto dealers from future rulemaking, the Bureau notes that application of section 1071 requirements to entities excluded from the Bureau's jurisdiction by section 1029 of the Consumer Financial Protection Act is a matter for the Board to determine, and requests regarding the
Moreover, the Bureau finds the remaining arguments for excluding other indirect lending products unpersuasive. The Bureau does not believe that sufficient evidence has been presented that asset-based underwriting in equipment finance or PMOs eliminates discrimination risk; fair lending concerns remain relevant regardless of collateral. Similarly, the Bureau rejects the contention that these products are not foundational; for many small businesses, securing a vehicle or equipment is as critical to operations as a working line of credit. Regarding regulatory parity, PMOs differ from true leases (which are not “credit” under ECOA) and trade credit (which is strictly between business buyers and sellers without a financial or other intermediary). Finally, with respect to comments concerning the role of dealers in other indirect lending contexts, the Bureau emphasizes that § 1002.109(a)(3) and related commentary make clear that the compliance obligation rests with the last financial institution with authority to set material terms.
The Bureau acknowledges, however, the concerns raised by commenters regarding the practical difficulties of collecting data in indirect lending and point-of-sale environments. The Bureau recognizes that in these transactions, the financial institution typically does not have any direct interaction with the applicant at the time of application. The Bureau agrees that requiring third-party intermediaries—such as auto dealers, equipment vendors, or retailers—to collect demographic data could be operationally complex and possibly disruptive to the customer experience. The Bureau also shares the concern that requiring data collection before a credit decision is made for indirect loans could—depending on which entity is the last with authority to set material terms—result in an applicant receiving duplicative data requests from multiple lenders competing for the same contract.
To address these concerns, and consistent with its request for comment regarding the 2023 final rule's provisions dictating the time and manner of information collection, the Bureau is adopting revisions to the “time and manner” provisions in § 1002.107(c), as discussed in detail below. Specifically, this final rule amends the provision concerning the timing and manner of the collection of demographic data, clarifying that such collection may take place in certain situations even after a credit decision is made on an application. This flexibility allows indirect lenders to avoid adding complexity to point-of-sale interactions and eliminates the need for dealers or vendors to collect the data on the lender's behalf. Furthermore, because the rule permits this post-decision collection, financial institutions can gather the required information directly from the applicant at a later time, ensuring that the process does not delay or interrupt the underlying commercial sale. Consequently, the Bureau believes that these modifications to the data collection procedures largely resolve the operational challenges cited by commenters, rendering a categorical exclusion for these products unnecessary.
The Bureau declines to expand the trade credit exclusion to include credit similar to trade credit provided by financial institutions. As the Bureau explained in the 2023 final rule, trade credit is excluded because it is not a general-use business loan; rather, trade creditors generally extend credit as a means to facilitate the sale of their own goods or services. These entities are not primarily financial services providers, nor do they generally have the infrastructure needed to manage compliance with regulatory requirements associated with making extensions of credit. The Bureau understands that, unlike trade creditors themselves, financial institutions requesting this exclusion offer stand-alone credit products in the same way as other lenders and are not retailers or merchants with limited regulatory compliance experience. As such, the Bureau does not have the same concerns about data quality or reduced small business lending regarding these entities that it does about trade creditors themselves. The Bureau also disagrees that limiting the trade credit exclusion to non-financial institutions will negatively impact small business cash flow; small businesses retain access to diverse credit products, including trade credit from vendors and standard credit products from financial institutions.
Consistent with this distinction, the Bureau declines to remove the commentary provision regarding the transfer of creditor rights and declines to broadly exclude floor plan financing. Regarding the transfer of rights, the Bureau reiterates that credit extended by a business is not trade credit where the supplying business intends to sell or transfer its rights as a creditor to a third party. The Bureau stands by its determination that the trade credit exclusion should be limited to arrangements where the business providing the goods or services retains the credit obligation, rather than extending to transactions that involve financial institutions or third-party purchasers. The Bureau further disagrees that the inclusion of this commentary in the 2023 final rule violated the APA; rather, it was a logical outgrowth of the Bureau's proposal and directly responsive to comments on the 2021 proposed rule requesting that the exclusion be expanded to include third-party financial institutions. The commentary affirmed the Bureau's position that the trade credit exclusion is designed for merchants, not financial institutions or those acting on their behalf. Similarly, regarding the request to exclude floor plan financing, the Bureau notes that under § 1002.104(b)(1), the trade credit exclusion applies where the manufacturer or distributor is financing its own inventory, but not where a financial institution is providing the financing.
The Bureau reaffirms the existing exclusions for true leases and factoring arrangements. The Bureau agrees with commenters that true leases differ from small business loans because they involve the transfer of possession and use rather than the extension of credit.
The Bureau declines to exclude all loans secured by non-owner-occupied commercial real estate. While some commenters argued that these loans are underwritten based on property value rather than business cash flow, or that they often involve special-purpose vehicles (SPVs) formed by larger entities, the Bureau believes a categorical exclusion is unnecessary. The new definition of small business in revised § 1002.106(b), setting the gross annual revenue threshold at $1 million rather than $5 million, will likely exclude many of the transactions cited by commenters. Further, because comment 106(b)-3 allows financial institutions to include the revenue of an applicant's affiliates when determining whether an applicant is a small business, single-purpose entities—such as those common in commercial real estate—are permitted to have their revenue aggregated with that of their parent or affiliates for purposes of determining whether they are a small business under this rule. For instance, if a large developer with well over $1 million in revenue forms a new SPV with no gross annual revenue in the past fiscal year to purchase a property, the comment on affiliate revenue permits the SPV applicant for credit to be considered not a small business under this rule. The Bureau believes that this approach effectively filters out the large real estate developers that commenters sought to exclude, while preserving the collection of data on small businesses that purchase small rental properties without the help of large affiliates, as their access to credit is a core concern of the statute.
The Bureau also declines to modify the existing exclusion for HMDA-reportable transactions or to adopt an alternative standard based on FFIEC Call Report codes. The Bureau believes that existing § 1002.104(b)(2) is sufficiently clear: a transaction is excluded if it is a “covered loan” under Regulation C. The Bureau declines to adopt a different standard based on Call Report codes, as doing so could create inconsistencies where the definitions do not align, leading to coverage gaps or duplicative reporting. The Bureau also declines to provide additional illustrative examples in commentary, as the cross-reference to Regulation C already provides a precise and legally distinct boundary.
The Bureau declines to specifically exclude BNPL transactions from coverage, since the rule already excludes them as a type of “incidental credit.” The commenter requesting this exclusion defined BNPL credit in part as “not subject to a finance charge and not payable in more than four installments.” Existing § 1002.104(b)(6) excludes “incidental credit,” defined by reference to § 1002.3(c)(1) in Regulation B, subpart A (but without regard to whether the credit is consumer credit). Under that definition, extensions of credit are considered incidental credit if they are not made pursuant to the terms of a credit card account, are not subject to a finance charge, and are not payable by agreement in more than four installments. Accordingly, the BNPL transactions identified by the commenter requesting an exclusion already appear to meet these criteria for incidental credit, and are thus already excluded from the definition of a covered credit transaction.
The Bureau declines to adopt a specific exclusion for partner lines of credit, also known as “capital call lines of credit.” Specific exemptions for particular sub-types of lines of credit would complicate the rule and undermine the goal of a streamlined, consistent definition of coverage. Moreover, the concerns raised are largely mitigated by the existing regulatory framework. The commenter did not provide evidence regarding the scope of entities affected by this issue, but the Bureau believes that the volume of reportable transactions involving small businesses, as defined by revised § 1002.104(b)(2), in this context is likely minimal. Furthermore, as noted above regarding commercial real estate, the adjusted revenue threshold and existing affiliate revenue commentary will likely exclude the vast majority of investment funds and sophisticated vehicles that utilize these products.
Regarding comments on specific entity types, the Bureau confirms that nonprofit organizations and public agencies are generally excluded from coverage. The term “business” is defined in existing § 1002.106(a) by reference to the term “business or business concern” in 13 CFR 121.105 of SBA regulations. This definition, in turn, defines a business as an entity “organized for profit.” Nonprofit organizations and public agencies do not meet this definition of “business” and are not small businesses for purposes of this rule.
The Bureau declines to categorically exclude trusts or non-operating entities. Regarding trusts, the Bureau notes that many businesses are organized as trusts for commercial purposes and, provided they are organized for profit, meet the definition of “business” subject to coverage. While commenters raised concerns about identifying principal owners for trusts, the Bureau believes that existing comment 102(o)-2 provides sufficient clarity. That comment states that if the applicant is a trust, a trustee is considered the principal owner. Finally, regarding non-operating entities and wealth management vehicles, concerns regarding the reporting of investment vehicles are largely addressed by the changes to the small business definition discussed above. Specifically, the adjusted revenue threshold and existing affiliate revenue commentary will likely exclude the vast majority of the high-value investment vehicles and passive holding companies cited by commenters.
The Bureau finds that at the onset of data collection under section 1071 the focus should be on larger core lenders before the Bureau considers whether it would be appropriate to expand the scope of the rule to specialty lenders and smaller lenders. The Bureau therefore is excluding FCS lenders from the definition of covered financial institution and is raising the origination threshold from 100 to 1,000 covered credit transactions to better ensure the smooth operation of the initial period of data collection.
The Bureau proposed to exclude FCS lenders from the “covered financial institution” definition in § 1002.105(b). Consistent with this exemption, the Bureau proposed to delete several references to FCS lenders in commentary.
The CFPB sought comment on this proposed revision to the rule.
The Bureau received comments on this proposed exemption from various financial institutions, trade associations, research and business advocacy groups as well as community groups. Supporters of the exclusion included FCS lenders, an advocacy group, and trade associations representing small businesses and credit unions. An advocacy group characterized the exclusion of FCS lenders as acknowledging the specialized statutory oversight of agricultural credit and recognizing that reporting obligations under section 1071 would duplicate or conflict with existing supervisory
A trade association for FCS lenders argued that FCS lenders are different from other types of lenders and offered several rationales for why FCS lenders should not be covered. First, the commenter argued that FCS lenders are overseen solely by the FCA, and that Congress explicitly decreed that the Bureau should not supervise or enforce laws against FCS lenders, including requiring the reporting of data. Second, the commenter argued that Federal law limits FCS lenders to providing credit to “eligible” customers, and that therefore FCS lenders should not be subject to a broad reporting regime like section 1071. Third, the commenter asserted that FCS lenders are distinguishable from other lenders because their cooperative structure limits how their net income can be utilized, meaning that compliance costs would be passed onto to its Farm Credit customers since many FCS lenders also lack the compliance infrastructure of large commercial lenders. Fourth, FCS lenders are already subject to an existing regulatory reporting framework through the FCA. Lastly, the commenter asserted that FCS lenders should be exempt from a generally applicable reporting regime because their loan data would prove misleading. Specifically, the actual cost to the Farm Credit borrowers is usually less than the loan's contract pricing would indicate because FCS lenders provide their borrower-owners with patronage dividends from the FCS lenders' profits, unlike commercial banks and other lenders.
Community banks, trade associations, community groups, and an independent office of a Federal agency opposed the proposed FCS lender exemption. A number of banks and trade associations urged the Bureau to cover FCS lenders to ensure coverage of functionally identical lending and provide a level playing field. These commenters argued that such an exemption would add to the tax, funding, and regulatory advantages that FCS lenders, regardless of asset size, hold over banks. These commenters noted community banks make over 75 percent of bank-originated agricultural loans, and that imposing extensive reporting obligations on community banks while exempting FCS lenders would create a regulatory imbalance.
A trade association for community banks and a number of banks argued that exempting FCS lenders would disadvantage community banks, CDFIs, and other non-FCS agricultural lenders, and advocated for banks and FCS lenders to receive the same treatment for offering farm credit. These commenters stated that FCS lenders are able to provide more favorable loan terms and flexible payment options than community banks, and that FCS lenders are undermining their statutory mission and harming rural banks by increasingly competing in non-agricultural lending by operating as general-purpose lenders. A trade association for banks asserted that FCS lenders should not be categorically exempt and that both the agricultural lending exclusion and the 1,000-loan origination threshold should apply equally to all lenders. A trade association implied that an FCS lender originating more than 1,000 non-agricultural loans has deviated from a focus on agricultural lending and should be subject to reporting data related to those loans. This commenter further argued that an FCS lender that originates more than 1,000 loans in the rural area it is serving is a primary contributor of credit services, and that failing to collect data from that lender would provide an inaccurate portrayal of the small business lending market.
An employee from a community bank stated that all entities providing credit should be included in the definition of a “covered financial institution,” regardless of the credit's purposes or form, or whether the transaction is subject to a finance charge. Commenters argued that exempting FCS lenders is contrary to the congressional intent of section 1071, would distort the lending landscape, inhibit analysis of unmet credit needs, and lead to reputational risk for FCS lenders.
In reference to the statement in the 2025 proposed rule that FCS lenders already report certain data, including race, ethnicity, and gender from applicants, a bank trade association, community group, and trade association for farms stated that FCA does not publish applicant-level data, any such data can only be accessed by a FOIA request, that FCA does not collect demographic information, and that FCS lenders are not required to collect and report the data points required by the section 1071 rule. One of these commenters argued that section 1071 data will provide an incomplete picture of credit availability where FCS lenders operate if FCS lenders are excluded from the rule. Another commenter disagreed with the Bureau's statement that FCS lenders are already subject to regulatory compliance under the FCA as reasoning for exempting from section 1071 data collection and reporting requirements. This commenter stated that the goal of FCA oversight is to ensure compliance by FCS lenders with the unique rules governing the Farm Credit System, whereas it described the goals of section 1071 as disclosure and providing a complete view of the small business financing landscape for the benefit of the public, small businesses, and regulators. A community group suggested that since FCS lenders have years of experience submitting required data to FCA, the Bureau and the FCA could coordinate to eliminate duplicative data requirements.
Some community banks focused on the favorable and unique regulatory framework under which FCS lenders operate. One commenter noted a crucial difference between FCS lenders and other financial institutions—that community banks, which must compete for higher cost deposits in the private sector to fund their operations, must compete directly with FCS lenders, which are funded at a significantly lower cost by a government guarantee. The commenter also stated that the FCS lenders operate outside of safety and soundness supervision and examination by Federal prudential regulators and are subject to oversight by agricultural, rather than financial, committees in Congress. Lastly, the commenter asserted that the FCS is not accountable for compliance with the same rules and regulations as community banks, including the Community Reinvestment Act (CRA), and that FCS lenders would not be accountable for section 1071 small business data collection and reporting if exempted.
A trade association for community banks suggested covering FCS lenders in the final rule with phased compliance or tailored guidance as an alternative to exclusion if implementation challenges exist for FCS lenders. An independent office of a Federal agency recommended monitoring of the FCS lending market to assess whether coverage would be suitable in the future as regulatory frameworks and products develop.
For the reasons set forth herein, the Bureau is excluding FCS lenders from the “covered financial institution” definition in § 1002.105(b).
The Bureau disagrees with the argument by commenters that FCS lenders engage in functionally identical lending as other types of lenders and should be covered under section 1071 to provide a level playing field. The comments further reinforced the several significant differences between FCS lenders and traditional financial institutions. The FCS comprises a nationwide network of borrower-owned, cooperative institutions with a statutory mandate to provide the agricultural sector with reliable credit. FCS borrowers include agricultural and related businesses as well as rural homeowners. As owners of the FCS lending associations, these borrowers can receive patronage dividends that reduce borrowing costs and make FCS loans difficult to compare to loans issued by non-FCS lenders. The FCS cooperatives, as comments pointed out, face limitations on which borrowers they are permitted to lend to. Commercial banks, by contrast, are owned by shareholders; credit unions, while member-owned, serve a wide range of customers, provide a wide range of products and services, and lack a specific charter that is exclusively focused on agriculture. These differences between FCS lenders and other types of lenders, which the Bureau did not meaningfully address in the 2023 final rule, make it difficult to easily compare loans made by FCS lenders with those of other non-cooperative lenders.
In issuing the 2023 final rule, the Bureau explained the decision not to categorically exempt any specific type of financial institution from the rule's coverage, stating that such exemptions “would create significant gaps in the data and would create an uneven playing field between different types of institutions.”
However, after having reviewed the comments on the 2025 proposed rule and with a renewed focus on ensuring the consistent and smooth initial collection of data from core lenders and products, the Bureau believes it will further the purposes of section 1071 to commence the data collection without including FCS lenders.
The existing reporting requirements of FCS lenders further supports excluding FCS lenders.
In response to comments that an exemption would permit FCS lenders to compete unfairly—
The Bureau is finalizing the revisions to § 1002.105(b) to exclude FCS lenders pursuant to its authority under ECOA section 704B(g)(2) to adopt exceptions to any requirement of section 1071 and, conditionally or unconditionally, exempt any financial institution or class of financial institutions from the requirements of section 1071, as the Bureau deems necessary or appropriate to carry out the purposes of section 1071.
The 2023 final rule defined a covered financial institution as one that has made at least 100 covered credit transactions to small businesses in each of the two preceding calendar years.
The Bureau proposed to change this definition by increasing the threshold from 100 covered credit transactions to 1,000 covered credit transactions, explaining that it believed it would advance the statutory purposes of section 1071 to commence the data collection without including lower volume lenders under a 1,000-origination threshold. The Bureau explained that the initial iterations of data collection under the rule should focus on larger core lenders to better ensure the smooth operation of the initial period of data collection.
The Bureau received many comments from banks and credit unions, as well as
Many commenters stated that at a 100-loan threshold, increased operational and compliance costs would likely be passed on to borrowers or would result in less credit availability for small businesses. One trade association argued that the 100-loan threshold risks discouraging small business lending by the institutions best placed to offer relationship-based credit. Other commenters predicted that some institutions may reduce lending to stay under the threshold and to avoid spending on compliance systems.
An advocacy group commented that the higher proposed threshold promotes what it called regulatory equity, explaining that lenders just above or below the threshold would have materially different compliance burdens despite a small difference in loan volume. Two commenters argued that a low threshold would limit the growth of smaller lenders, while a higher one would foster competition, as community banks and nonbanks typically are willing to extend credit to applicants that do not meet conventional underwriting criteria, and might not do so if faced with the cost and complexity of complying with this rule. The advocacy group also stated that a higher threshold lowers compliance costs for local lenders and allows them to provide more credit to small businesses, including minority-owned, startup, and rural businesses.
Many commenters—including individuals, banks, credit unions, trade associations, and advocacy groups—argued that a higher loan threshold would still allow for the collection of accurate and robust data. An independent office of a Federal agency, citing data in the proposed rule, stated that the 1,000-loan threshold would still permit the collection of data on 92 to 93 percent of the number of small business loans and 60.3 to 62.0 percent of the dollar volume of such lending. According to the independent office of a Federal agency, only smaller institutions accounting for approximately 5.0 to 5.7 percent of originations, and 24.1 to 26.1 percent of the dollar volume of small business lending, would be excluded.
A trade association for nondepository lenders agreed with the proposal's initial focus on core lenders, which it said would allow for reporting infrastructure to develop in a stable and orderly manner that promotes data integrity and consistency. Another commenter stated that more accurate data collection would result from a focus on larger lenders, which have more standardized data collection and reporting systems, allowing the Bureau to draw meaningful insights before collecting data from smaller lenders. Another commenter noted that collecting data initially from core lenders would generate statistically meaningful data from which to draw analyses about fair lending patterns.
A number of commenters—including individuals, lenders, trade associations for banks, fintechs, and other nondepository lenders—suggested thresholds even higher than the proposal, ranging from 2,000 to 10,000 loans. One trade association stated that raising the threshold further would reduce unnecessary regulatory burden while still achieving the statute's purpose of monitoring small businesses lending.
A few commenters noted that even many smaller lenders that do not reach the new origination threshold will still be subject to fair lending requirements by other regulatory agencies, including fair lending oversight by Federal prudential regulators, through regulatory programs such as the Community Reinvestment Act, and by State regulatory bodies.
Finally, a few commenters supported the proposed origination threshold, but sought further clarification from the Bureau on several issues. One commenter sought clarification on how the effective date applied to lenders under the 1,000 covered transactions as of January 1, 2028, whether lenders that later exceed the 1,000-transaction threshold will receive a ramp-up period before having to comply fully with the rule, whether the Bureau intended to maintain the two-year look-back in the 2023 rule; how the Bureau expects lenders to monitor their activity and prepare for potential future coverage; and tailored expectations for institutions close to the 1,000-originations threshold.
A number of other commenters, including many community groups, advocacy groups, trade associations for small businesses, and two trade associations for larger lenders opposed the proposal to raise the origination threshold. Many of these commenters argued that raising the threshold would encourage regulatory evasion, distort data sets, and obscure risks to small business borrowers. A number of other commenters argued that the increased origination thresholds, in conjunction with the lowered small business revenue threshold, would create a strong regulatory disincentive to serve the smallest businesses. By rendering these loans unprofitable for banks to pursue, this dynamic would drive small businesses to turn to more predatory loans, increasing discriminatory behavior at local levels. Other commenters suggested that raising the threshold and collecting less comprehensive data would hinder fair lending enforcement and the identification of community development needs, contrary to Congress's intent in enacting section 1071.
Several community groups and two trade associations for larger lenders urged the Bureau to adopt a threshold below 1,000 loan originations. Some recommended a 25-loan threshold, while others recommended up to 500 loans as an appropriate threshold. One community group argued that the loan threshold for this rule should be lower than the threshold for loans under HMDA because mortgages are more common than small business loans, and a lower threshold would more accurately capture necessary data.
A community group and two trade associations for small farms opposed the proposed 1,000-loan threshold disagreed with concerns about the costs of data collection for smaller lenders. They argued that some smaller lenders, such as CDFIs and farm lenders, are calling for robust section 1071 data collection, noting that many of these lenders report much of this data already. One trade association for small farms argued that a higher threshold would result in a far less accurate picture of the farm sector's credit needs, and that many lenders collect the data required by the rule already. One community group stated that many smaller lenders have already invested significant resources to comply with the 2023 final rule. It also argued that lowering the threshold would disproportionately hurt lenders that have already made efforts to comply with the rule, and would also frustrate oversight and enforcement of the CRA. Finally, an advocacy group and a coalition of lenders and community groups argued that raising the origination threshold was arbitrary and capricious. The coalition argued
For the reasons set forth below, the Bureau is finalizing the proposed revisions to § 1002.105(b) with respect to the requisite loan origination threshold for being a covered lender. In the 2023 final rule, the Bureau explained its belief that a 100-loan origination threshold would best address widespread industry concerns regarding compliance burdens for the smallest financial institutions while also capturing the overwhelming majority of the small business lending market. It noted that while its original proposal in 2021 of a 25-loan threshold would have yielded more data than a 100-loan threshold, the 100-loan origination threshold “massively expands data availability relative to the status quo.”
The revised 1,000-loan origination threshold is justified for several independent reasons. First, the Bureau believes that at the onset of the data collection under section 1071 the focus should be on core lenders and products before the Bureau considers whether it would be appropriate to expand the scope of the rule. The Bureau believes that larger volume lenders are core to small business lending. Indeed, § 1002.114(b) under the 2023 final rule prioritized the collection of data from the largest volume lenders first because they have more resources, and because they account for the bulk of small business lending volume.
Second, the Bureau believes that the revised provision is responsive to feedback received from stakeholders following publication of the 2023 final rule and better aligns with E.O. 14192,
The Bureau is not persuaded that a higher threshold will promote regulatory equity for financial institutions. The Bureau does not believe that it is possible to resolve this question of regulatory equity at any threshold; whether the threshold is set at 100 loans or 1,000, there will always be lenders just above or just below the threshold, resulting in differing compliance obligations.
The Bureau disagrees that the loan threshold should be raised even higher, such as at thresholds of 2,000 to 10,000 loans. The Bureau believes, based on experience with small business lending markets, that thresholds much higher than 1,000 may lead to a decline in the collection of data from mostly larger financial institutions that are better able to comply with the cost and complexity of this rule. The Bureau believes a threshold of 1,000 originations, instead of 100, is more congruent with the statutory purposes of section 1071. The Bureau does not believe that commenters have provided evidence to the contrary.
The Bureau disagrees with commenters who posit that the threshold should be lower, such as 25 or 500. The change to a 1,000-loan origination threshold will result in a reduction in the number of smaller institutions covered by the rule without a proportionately large reduction in the volume of loan application-level data collected by the rule.
The Bureau is not convinced by the argument that the loan threshold for this rule should be lower than the threshold for loans under HMDA. Even assuming that mortgages are more common than small business loans, and there may be reason to believe that they are not, a lower threshold would not more accurately capture “necessary” data under this rule. Necessity, in this context, is driven by the specific statutory requirements of section 1071, not those of HMDA. Further, the argument concerning the HMDA threshold does not address the core proposition of this rulemaking—that at the onset of a data collection regime that the focus should be on core lenders.
The Bureau believes that the commenters disagreeing with concerns about the costs of data collection may be correct to observe that certain lenders are calling for robust section 1071 data collection and already collect such data. However, the Bureau has received statements to the contrary in comment letters from a great number of other smaller lenders and trade associations representing them. In short, while some smaller lenders, including CDFIs and farm lenders, are eager for section 1071 data collection and already collect and report much of this data already, many other lenders have taken the contrary position and have stated clearly that they are not ready to collect section 1071 data. The Bureau is not persuaded by the comment that raising the origination threshold will disproportionately hurt lenders that have already made efforts to comply with the rule. The Bureau acknowledges
The Bureau disagrees with the assertion by several commenters that increasing the origination threshold is arbitrary and capricious. The 2025 proposed rule, as well as this final rule, clearly identified reasoning and evidence in support of the change in loan origination threshold. This reasoning and evidence is further supported by a range of other comments received, and the analysis in this final rule. The move to a 1,000-loan threshold, according to undisputed Bureau data, will result in the collection of 92 to 93 percent of loan volume while significantly reducing the cost to smaller volume lenders of complying with the rule. Further, the comments received do not grapple with the core proposition set out in the 2025 proposed rule—that as a practical matter, it is more prudent at the onset of this data collection regime to collect data from larger lenders that are better resourced and better able to sustain the complexities and cost of compliance with the rule, and that the Bureau can work with larger volume lenders to better understand potential difficulties associated with collecting data before considering whether to expand the rule to require that lower volume lenders comply with the rule. Given this, the Bureau believes increasing the threshold will remove regulatory burden from small entities, and therefore the change is responsive to E.O. 14192.
The Bureau believes that increasing the threshold is necessary or appropriate to carry out the purposes of section 1071 because the complexity of compliance poses difficulties for lower volume lenders, many of which have no previous experience at all with data collection rules such as HMDA or CRA. The Bureau also recognizes commenters' arguments that notwithstanding, these smaller entities will still be subject to other fair lending requirements and examinations under State law. The compliance complexity of the rule may result in decreased data quality for those institutions, which would not advance the statutory purposes of section 1071.
The Bureau also recognizes that, commenters' arguments notwithstanding, these smaller entities that may no longer be subject to this rule will still be subject to other fair lending requirements and examinations under State law.
The revision in § 1002.105(b) requires other changes. Section 1002.112(b) provides that a bona fide error is not a violation of ECOA or Regulation B, subpart B. The provision cross-references numerical error thresholds in appendix F. Under appendix F, a financial institution is presumed to maintain procedures reasonably adapted to avoid errors with respect to a given data field if the number of errors found in a random sample of a financial institution's data submission for a given data field do not equal or exceed the threshold in column C of table 1 of appendix F.
The Bureau is finalizing the changes to appendix F as proposed to conform to the changes to § 1002.105(b), defining “covered financial institution,” based on a revised origination threshold of 1,000 covered credit transactions. Specifically, column A of existing appendix F lists ranges of small business lending application register counts. The Bureau is eliminating the rows in table 1 associated with application counts under 1,000, and revising the count in what was the 4th row to be “1,000-100,000” rather than “500-100,000.”
Section 1002.105(b) in the 2023 final rule did not provide exemption to any specific categories or types of financial institutions from the definition of covered financial institution. The Bureau in the 2025 proposed rule also did not propose any revisions that would add exemptions for specific categories or types of financial institutions to the definition of covered financial institutions. The 2025 proposed rule did not solicit comment on any such exemptions.
Some commenters argued that an asset-size threshold would be better tailored to the level of resources available to smaller lenders. Several banks stated that smaller lenders do not have the operational capacity to comply with the section 1071 rule and would need to adopt costly new technology, staff, and resources. One trade association suggested that the limited amount of data generated by smaller lenders does not justify imposing these compliance costs.
Many commenters requested an exemption for financial institutions with less than $10 billion in assets. One bank requested such an exemption because, it said, such banks are relationship-based lenders with limited market share, lower risk profiles, and business models that differ fundamentally from larger core lending institutions. The commenter added that this exemption would preserve competitiveness and stability for community lenders, and preserve access to credit for small businesses, while still allowing for the meaningful collection of data to fulfill statutory objectives.
A community group rejected an asset-based approach to defining “covered financial institutions,” preferring a loan origination threshold to an asset-based threshold because many small business loans are made by smaller lenders, and also because asset size is not a meaningful metric for nondepository institutions. The commenter added that small businesses in smaller, rural communities are more likely to seek credit from smaller banks and nonbanks because of a lack of larger lenders, and that excluding banks based on asset-size would result in an incomplete picture of small business lending in the United States.
The group of GSE lenders argued that FHLBs already are subject to comprehensive regulations and oversight, and that the requirements of the 1071 rule would be unnecessary and duplicative. They stated that FHLBs already must provide monthly loan-level data to the FHFA, and are subject to the anti-discrimination provisions of the Federal Home Loan Bank Act. These commenters also asserted that an exemption for FHLBs would reduce undue regulatory burden consistent with E.O. 14192 and eliminate inefficiency and waste. They argued that, while FHLBs are likely to originate far fewer than 1,000 loans to small businesses annually, requiring each FHLB to perform an analysis of whether it exceeded the threshold, when the result is predictable, would be inefficient and wasteful.
These commenters also noted that the proposal would already exempt other GSEs, such as the FCS lenders, from coverage, and therefore the FHLBs also should be excluded. Commenters asserted that FCS lenders were similar to FHLBs in that they do not lend directly to retail customers, that FHLBs are already subject to other data reporting regimes managed by other Federal agencies, and that the rationale for exempting FCS lenders also applies to FHLBs.
Finally, commenters argued that subjecting the FHLBs to the section 1071 rule would harm their members, requiring them to divert time and resources away from funding affordable housing and credit options to their members.
The Bureau acknowledges the comment that an asset-based exemption may align with other regulatory thresholds, but this reasoning only applies to banks and credit unions, and would not apply to nondepository institutions. The Bureau also acknowledges that an asset-based threshold may provide more predictability from year to year for smaller lenders. However, the two-year lookback period in existing § 1002.106(b)(1) is intended precisely to minimize this uncertainty surrounding data collection responsibilities; no commenters appeared to address this. For the same reason, the Bureau disagrees that under a loan origination threshold, smaller lenders could never be certain of their coverage under the rule; a two-year lookback gives smaller lenders at least a year's notice that they may need to come into compliance with this rule. With regard to the argument that small businesses may avoid lending to stay under a loan origination threshold to avoid costly compliance systems, the Bureau acknowledges that this may happen. However, the Bureau also notes, in its experience, that such behavior has been observed as financial institutions grow and approach certain asset-sized thresholds in other contexts.
The Bureau disagrees that an asset-size threshold would be necessarily better tailored to the level of resources available to smaller lenders. The Bureau believes based on its experience that larger and smaller lenders allocate compliance resources proportionate to the revenue derived from a specific business unit.
The Bureau is thus not persuaded that it should adopt an exemption for lenders with less than $10 billion in assets, instead of or alongside its 1,000-loan origination threshold. As noted above, an asset-based exemption would only apply to banks and credit unions, leaving open the question of whether any parallel asset-based metric could apply to nondepository institutions. The Bureau also believes that an asset-based exemption would not necessarily preserve competitiveness and stability for community lenders. It is unclear how competitiveness or stability are preserved by exempting such smaller-asset lenders above the 1,000-origination threshold, while requiring larger-asset lenders with comparable or even smaller volumes in small business lending to have to report data to the Bureau. The Bureau notes that the commenters provided no data or evidence that an exemption for banks and credit unions with less than $10 billion in assets would be better than a 1,000-loan origination threshold at preserving access to credit for small businesses and ensuring a meaningful collection of data. Finally, the Bureau agrees with the community group commenter that an asset-based threshold excluding only banks would result in an incomplete picture of small business lending in the United States.
Further, the Bureau disagrees that the type of “wholesale” funding FHLB provides to its members would be excluded from the small business lending data collected under this rule. It is possible for a loan to a financial institution (
The Bureau notes that the comparison of FHLBs with FCS lenders is inapposite, other than that both types of lenders share a cooperative structure. As set out in the FCS exemption, FCS loans are backed by collateral, including crops and livestock, that are materially different from the types of collateral supporting credit for non-agricultural small businesses. Further, another difference is that while the bulk of credit FHLBs furnishes is to its members, the Bureau understands that, contrary to the trade association commenter's assertions, FHLBs provide a limited number of loans to small businesses that are not FHLB members. The Bureau believes it unlikely that FHLBs would need to divert time and resources from lending to members because of the 1071 rule because of the unlikeliness that FHLBs would be covered by this rule.
Section 1002.106(b)(1) in the 2023 final rule defines “small business” and provides, among other criteria, that a business is small if its gross annual revenue for its preceding fiscal year is $5 million or less. Section 1002.106(b)(2) provides procedures for inflation adjustments to that threshold. The Bureau proposed to reduce the gross annual revenue threshold from $5 million or less to $1 million or less. It also proposed conforming changes to the inflation adjustment to require adjustment in $100,000 increments (rather than $500,000) every five years after 2030 (rather than 2025).
The Bureau received comments from banks, credit unions, trade associations, and community groups regarding the Bureau's proposal to revise the rule's small business definition. Many industry commenters supported the proposal to reduce the gross annual revenue threshold to $1 million or less. Many of these commenters asserted that a $1 million threshold would reduce compliance burdens for lenders while keeping data collection aligned with the statutory purposes of section 1071. They also asserted that a $5 million threshold is too high and covers many well-capitalized businesses that do not face undue barriers to credit. Industry commenters further asserted that a $1 million threshold is better aligned with industry lending practices as well as existing Federal regulations, reporting requirements, and programs, including ECOA adverse action notices, CRA regulations, and SBA loan programs.
Several community groups, Members of Congress, and trade associations opposed the proposal, asserting that a $1 million threshold would exclude many businesses that section 1071 is intended to help. A few community groups emphasized that firms with $1 to $5 million in revenue are often in transitional stages where access to credit remains critical for future expansion. One community group and a bank service provider calculated that lowering the threshold could reduce the number of reported loans by approximately 50 percent. One coalition of lenders and community groups commented that lowering the threshold would disproportionately exclude minority-owned and women-owned businesses. The coalition also emphasized that other Federal programs for small businesses do not exclude firms with annual revenues exceeding $1 million. Finally, one community group challenged the notion that the $1 million threshold is better aligned with CRA reporting requirements given that the CRA requires banks to report data on all business lending.
A few commenters requested further changes to the calculation of an applicant's annual revenue. One trade association recommended requiring the revenue of affiliates be included in an applicant's annual revenue rather than giving lenders the option. The association asserted that this would improve data uniformity. A coalition of trade associations requested that the assets on a schedule of real estate for a real estate loan applicant be considered affiliates of the applicant for calculating the applicant's annual revenue. A bank requested that the revenue of co-applicants be aggregated when the applicants have formed a transaction-specific entity.
A few commenters requested specific exceptions for certain types of businesses that they assert do not, or should not, fall within the rule's definition of small business. Two trade associations recommended that large commercial entities and asset management companies with more than $1 million in what they characterized as “nontraditional revenue” be excluded from the definition of small business. Similarly, a coalition of trade associations recommended that the definition exclude single-purpose real estate investment entities if the entity is projected to gross more than $1 million annually. Finally, a trade association requested that commercial real estate loans to a special purpose entity or other large project financing investment for amounts of tens of millions of dollars or more be excluded from coverage.
Several commenters preferred different approaches from the 2023 final rule or 2025 proposed rule. One credit union suggested a definition to include businesses with under 500 employees and under $8 million in annual revenue. The credit union asserted that an expansive definition of small business is important because the rule as proposed does not collect data from all women-owned or minority-owned businesses. A bank also expressed concern with a definition based purely on revenue on the grounds that revenue is not always indicative of a business' access to credit and ability scale. A trade association advocated for a threshold of $3 million as a reasonable middle ground that balances administrative burden with comprehensive coverage. A bank service provider suggested a threshold of $2.5 million based on adjusting for inflation an analogous revenue threshold in the 1995 regulatory changes to the CRA. A community group and a coalition of trade associations and community groups commented that the SBA size standards for defining small businesses is more accurate than the Bureau's approach. By contrast, several trade
Finally, a community bank argued that coverage should be based purely on attributes of the loan rather than attributes of the applicant. Specifically, the commenter suggested the rule cover only business loans of $1 million or less that are not secured by residential real estate, regardless of the applicant's revenue. The commenter argued that this approach would be more practical than relying on revenue because the loan amount is known at the time of application, whereas revenue is often unknown or inaccurately reported by applicants. It further asserted that because the vast majority of small businesses have revenues below $1 million and rarely borrow amounts exceeding that threshold, this definition would capture most relevant loans while reducing the risk of inadvertently collecting demographic data on ineligible transactions in violation of ECOA. Finally, the commenter emphasized that because this approach is consistent with covered transactions under the CRA, it would allow financial institutions—particularly community banks that often lack siloed product specialties—to leverage existing systems and institutional knowledge, thereby enhancing compliance and data accuracy.
Several trade associations and an advocacy organization supported the proposed changes to the inflation adjustment provision in § 1002.106(b)(2).
The Bureau is finalizing its changes to § 1002.106(b) as proposed. The Bureau believes that defining a small business as one with $1 million or less in gross annual revenue strikes the right balance between maintaining broad coverage of small businesses and reducing regulatory burden on financial institutions by better aligning this rule with other existing financial regulatory requirements and standard financial industry practices related to small businesses. The Bureau has obtained SBA approval for this alternate small business size standard pursuant to the Small Business Act.
The Bureau continues to believe, based on its assessments of the small business lending markets, that a $1 million threshold will cover most of small businesses as defined by the SBA size standards. Businesses above that threshold are likely to be well-capitalized and less likely to face undue barriers to credit, even if they may still be transitioning between early stages of growth, as some commenters assert. The assertion that lowering the threshold will reduce the reported loans by approximately 50 percent likely overstates the decline in loans and applications likely to be covered, for the reasons provided in part VI.D. The Bureau disagrees with the comment suggesting that a $1 million threshold disproportionately excludes minority-owned and women-owned businesses; data show that the share of minority-owned and women-owned businesses among all businesses under the $1 million threshold is likely higher than their equivalent share among all businesses between $1 million and $5 million.
As in the 2023 final rule, the Bureau disagrees that additional exceptions to the annual revenue threshold for certain types of businesses or large credit amounts are necessary or appropriate. Any such exemptions would add complexity to, and defeat the purpose of, a provision intended to promote simplicity in determining whether data must be collected and reported under this rule. In any case, several modifications requested by commenters are already addressed by existing regulatory provisions. For instance, covered financial institutions reporting on a special purpose entity or other large project financing investment entity are already permitted to rely on information provided by the applicant regarding its, and its affiliates, gross annual revenue as set forth in § 1002.107(a)(14) and (b) and comment 107(a)(14)-1. Single-purpose entities involved in large real estate investment projects are likely to be affiliated with one or more established entities whose combined gross annual revenue exceeds $1 million, and thus can be excluded from coverage under the rule regardless of the applicant's individual revenue or loan size. Moreover, the Bureau believes it would be inappropriate to define small business based on loan size because section 1071 borrows the SBA's definition of small business, and the SBA does not define small businesses based on loan size.
The Bureau considered the comments regarding affiliate revenue and aggregating revenue from unaffiliated co-applicants. For the reasons stated in the 2023 final rule, the Bureau is not permitting a financial institution to automatically categorize all owners of any real property listed on an applicant's schedule of real estate as affiliates of the applicant. Additionally, the Bureau continues to believe that permitting, but not requiring, a financial institution to include the revenue of affiliates, as provided for in comment 107(a)(14)-3, will carry out the purposes of section 1071 while reducing undue burden on financial institutions in collecting revenue data. Finally, for the reasons provided in the preamble of the 2023 final rule,
The Bureau also considered comments supporting alternative methods for defining a small business. As set out in the preamble to 2023 final rule,
The Bureau also is making conforming changes to the inflation adjustment provision in § 1002.106(b)(2), to require adjustment in $100,000 increments (rather than $500,000) every five years after 2030 (rather than 2025). The Bureau believes that, given the change to a $1 million
Section 1071 provides for two types of data points, those statutorily required under 15 U.S.C. 1691c-2(e) and those promulgated based on Bureau discretion provided for in 15 U.S.C. 1691c-2(e)(2)(H), which are sometimes referred to as discretionary data points, and which the Bureau has authority to add if the “Bureau determines [they] would aid in fulfilling the purposes of this section.” In the 2023 final rule, the Bureau finalized several discretionary data points, determining the additional data would aid in fulfilling the purposes of section 1071 of the Dodd-Frank Act, as required by 15 U.S.C. 1691c-2(e)(2)(H). The discretionary data points were for pricing information, time in business, North American Industry Classification System (NAICS) code, number of workers, application method, application recipient, denial reasons, and number of principal owners. The Bureau considered the additional operational complexity and potential reputational harm described by commenters that collecting and reporting these data points could impose on financial institutions, but determined that the costs were only incremental and that the data points were designed to minimize additional compliance burden.
Notably, in the 2023 final rule the Bureau declined to add other discretionary data points sought by commenters, because the decision whether to include a discretionary data point necessarily also involves considering the relative utility of a data point and the operational complexity of adding it. For that reason, in 2023 the Bureau stated that it was adopting a “limited number of data points . . . that it believes will offer the highest value in light of section 1071's statutory purposes,” and it rejected additional data points on the grounds that they would pose “operational complexities.”
In other words, to be included as a discretionary data point, the Bureau determined that a data point implicitly must satisfy two independent tests: (1) the data point would aid in fulfilling the purposes of section 1071,
After the publication of the 2023 final rule, two factors prompted reconsideration of the discretionary data points by the Bureau. First, as discussed above, pursuant to E.O.s 14192 and 14219 (“Ensuring Lawful Regulation and Implementing the President's `Department of Government Efficiency' Deregulatory Agenda”), the Bureau has reviewed the 2023 final rule as part of its effort to streamline and simplify regulations.
Given this new information, described in greater detail below, the Bureau is removing the discretionary data points for application method, application recipient, denial reasons, pricing, and number of workers in § 1002.107(a)(3), (4), (11), (12), (16), as well as the relevant commentary, and is making conforming changes throughout.
The data points identified for removal are not statutorily required and are not otherwise relied upon by or intertwined with the statutorily required data points.
The Bureau believes it prudent to focus on the collection of a more limited number of core data points (the statutory data points and a limited number of other data points needed to facilitate the collection of these statutory data points) to avoid complexity in the initial implementation of a rule to implement section 1071. This in turn will make it more likely that covered financial institutions face a smoother transition in the initial years of the rule in ramping up to the accurate, recurring collection of data.
In § 1002.107(a)(3), the 2023 final rule required financial institutions to collect data on whether applications were submitted in person, by phone, online, or by mail. The Bureau explained its belief that these data will improve the market's understanding of how different types of applicants apply for credit and provide additional context for the business and community development needs of particular geographic regions. In its 2025 proposed rule, the Bureau proposed removing this data point.
The Bureau received comments from banks, credit unions, trade associations,
By contrast, community groups, an advocacy organization, and a trade association for small businesses opposed the removal of the application method data point. A community group asserted that eliminating the data point would undermine the statutory purposes of section 1071. A trade association commented that application method is an important data point for identifying both predatory loan application tactics as well as successful methods for reaching historically underserved businesses. Similarly, a coalition of community groups commented that removing the data point would make it impossible to determine whether differences in application method facilitate or inhibit access to credit.
The Bureau is finalizing the removal of § 1002.107(a)(3) as proposed. The Bureau continues to believe that, in the 2023 final rule, it overestimated the relative value of data on application method and underestimated the potential cost and complexity of collecting the data. Many lenders do not already collect this data point, and many small business applicants have multiple interactions with lenders across different methods during the application process, yet the 2023 final rule reduces those interactions to only a single point in time—when the “application” is considered submitted. While the Bureau acknowledges that, as discussed in the 2023 final rule, the data point may have value in furthering the purposes of section 1071, it now believes that its value is currently outweighed by its cost. The Bureau now believes that the 2023 final rule erred in not sufficiently considering the value of the data point in light of its cost.
The Bureau disagrees with commenters' assertions that the removal of the data point for application method would undermine the statutory purposes of section 1071 at the inception of this data collection. The Bureau agrees that some manner of capturing application method could potentially be useful for identifying predatory loan application tactics, and may help identify historically underserved businesses. However, the Bureau notes that the commenter did not address whether the remaining data points are sufficient to address these inquiries, and did not address whether the application method data point set forth in the 2023 final rule was sufficient to capture the full complexity of relationships between lenders and applicants. The Bureau agrees that differences in application method may facilitate or inhibit access to credit but believes the effects are unlikely to be significant and will not justify the costs of the data collection. Moreover, the Bureau believes that the collection of the section 1071 data points, as amended by this final rule, will facilitate attempts to analyze access to credit more generally. Going forward, the Bureau may reconsider adding this data point.
In the 2023 final rule, the Bureau required financial institutions to collect data on application method—whether the applicant submitted the covered application directly to the financial institution or its affiliate, or whether the applicant submitted the covered application indirectly to the financial institution via a third party.
In 2025, the Bureau proposed removing § 1002.107(a)(4).
The Bureau received comments from banks, credit unions, trade associations, and community groups regarding the application recipient data point. Many industry commenters supported the proposal to remove this discretionary data point. A coalition of trade associations questioned the value of the data point and whether it advances 1071 statutory purposes.
Some commenters opposed the proposal to remove the application recipient data point. A community group asserted that eliminating the data point would undermine the 1071 statutory purposes. A trade association commented that application recipient is an important data point for identifying both predatory loan application tactics as well as successful methods for reaching historically underserved businesses. Similarly, a coalition of community groups commented that removing the data point would make it impossible to determine whether differences in application recipient facilitate or inhibit access to credit.
The Bureau is finalizing the removal of § 1002.107(a)(4) as proposed. As with application method, the Bureau continues to believe that in the 2023 final rule, it overestimated the relative value of data on application recipient and underestimated the potential cost and complexity of collecting the data. Many lenders do not already collect this data point, and in some instances, it may be difficult for lenders to determine whether they received an application through a third party. While the Bureau acknowledges that, as discussed in the 2023 final rule, the data point may have value in furthering the purposes of section 1071, it now believes that its value is currently outweighed by its cost. The Bureau now believes that the 2023 final rule erred in not sufficiently considering the value of the data point in light of its cost.
The Bureau disagrees with commenters' assertions that the removal of the application recipient data point would undermine the statutory purposes of section 1071 at the inception of this data collection. The Bureau agrees that application recipient could potentially be useful for identifying predatory loan application tactics, and may help identify historically underserved businesses. However, the Bureau notes that the commenter did not address whether the remaining data points are sufficient for those inquiries. The Bureau agrees that differences in application recipient may facilitate or inhibit access to credit but believes the effects are unlikely to be significant and will not justify the costs of the data collection. Moreover, the Bureau believes that the collection of the section 1071 data points, as amended by this final rule, will facilitate attempts to analyze access to credit more generally. Going forward, the Bureau may reconsider adding this data point after properly weighing costs and benefits.
The Bureau explained in the 2023 final rule that data on denial reasons will allow data users to better understand the rationale behind denial decisions, help identify potential fair lending concerns, and provide financial institutions with data to evaluate their
In 2025, the Bureau proposed removing § 1002.107(a)(11).
The Bureau received comments from banks, credit unions, trade associations, and community groups regarding the denial reasons data point. Many commenters supported the proposal to remove this discretionary data point. Some industry commenters asserted that doing so would better protect borrowers' privacy. These commenters further asserted that the data could be misinterpreted given the large variability in underwriting for small business lending. A small business trade association commented that the action taken data point is sufficient to further the fair lending objective of section 1071 and that applicants can already obtain denial reasons under existing ECOA requirements. A couple of industry trade associations noted that in indirect vehicle financing transactions, dealerships are not often provided and do not have access to reasons why a third-party finance source denied a credit application. Other trade associations commented that differences between the requirement to provide denial reasons under section 1071 and in ECOA adverse action notices may cause confusion among lenders.
A number of other commenters opposed the proposal. Several community groups stressed the importance of denial reasons in furthering the community development objective of section 1071. Specifically, they said that denial reasons would enable policymakers, lenders, and community groups to identify gaps and barriers to credit access and devise tailored solutions. A trade association and a number of community groups expressed concern that removing the data point would undermine the fair lending objective of section 1071 by weakening the dataset's capacity to identify discriminatory patterns. Several community groups asserted that the Bureau's concerns for borrower privacy are overstated. The groups emphasized that the collection of sensitive borrower information under HMDA has not resulted in the types of privacy breaches contemplated by the Bureau. A community group asserted that the Bureau's concerns about the complexity of collecting this data are also overstated because lenders already collect and store this information.
The Bureau is finalizing the removal of § 1002.107(a)(11) as proposed. While the Bureau acknowledges that, as discussed in the 2023 final rule, the data point for denial reasons may have value in furthering the purposes of section 1071, it now believes that its value is outweighed by its cost at the inception of this long-term data collection regime. The Bureau now believes that the 2023 final rule erred in not sufficiently considering the value of the data point in light of its cost.
The Bureau acknowledges that denial reasons could be helpful for furthering either of the statutory purposes of section 1071 but disagrees with commenters about the extent to which the data point, as written, would facilitate this. Relative to the action taken and other data points that the rule continues to require, the Bureau believes that data on denial reasons may provide only marginal value. Commenters who stressed the importance of this data point did not explain in detail why the action taken and other remaining data points are insufficient to identify discriminatory patterns and gaps and barriers to credit access. Additionally, applicants are already able to obtain a statement of denial reasons in adverse action notices required under Regulation B.
Requiring collection and reporting of this data point would, as acknowledged in the 2023 final rule, pose a privacy risk if re-identification of the applicant were to occur. The Bureau disagrees that it has overvalued borrower privacy concerns with respect to this data point. The Bureau also disagrees that it has overestimated the complexity of collecting this data point.
Lenders already collect and store the information on denial reasons consistent with the Regulation B subpart A requirements for providing adverse action notices. Those categories are similar to, but do not entirely align with, the denial reason categories required by the 2023 final rule.
In the 2023 final rule, the Bureau required reporting of an array of different pricing data: interest rate; total origination charges; broker fees; the total amount of all non-interest charges that are scheduled to be imposed over the first annual period; for a merchant cash advance or other sales-based financing transaction, the difference between the amount advanced and the amount to be repaid; and information about any applicable prepayment penalties. It explained its belief that because price-setting is integral to the functioning of any market, any analysis of the small business lending market—including to enforce fair lending laws or identify community and business development opportunities—would be less meaningful without this information. The 2023 final rule acknowledged the potential complexity of collecting these data, and commenters noted the risk that it could reveal confidential business information or lead to incorrect inferences about discrimination.
The Bureau proposed the removal of § 1002.107(a)(12).
The Bureau received comments from banks, credit unions, trade associations, and community groups regarding the pricing data point. Industry commenters generally supported the proposal to remove this data point. Several commenters asserted that the numerous data fields for pricing information required by the 2023 final rule are too complicated and burdensome for lenders to isolate, store, and report. As with denial reasons, commenters also asserted that the data would be prone to misinterpretation given the large variability in underwriting for small business lending. They claimed this could cause unwarranted damage to lenders' reputations even if a disclaimer accompanied published section 1071 data explaining that the data alone does not establish discriminatory conduct. Some commenters argued that fear of discrimination allegations would cause lenders to adopt stricter underwriting guidelines, thus reducing credit access and undermining the statutory purposes of section 1071. Finally, some industry commenters worried that the data would expose proprietary business information to competitors.
A number of commenters opposed the proposal. Many community groups emphasized that the loans in the dataset will not be comparable without pricing information, and that the dataset will be less effective for detecting discriminatory practices and understanding the market. Several community groups asserted that the lack of loan-to-loan comparability would incentivize lenders to increase their approval rates by raising prices instead of innovating to deliver accessible and affordable credit. One community group commented that the recent proliferation of high-cost loan products makes price transparency particularly important now. As with denial reasons, several commenters contested the Bureau's concerns of third parties misusing the data. These commenters asserted that the Bureau did not offer any evidence that the potential misuse of the data outweighs the benefits of reporting the
The Bureau is finalizing the removal of § 1002.107(a)(12) as proposed. While the Bureau acknowledges that, as discussed in the 2023 final rule, the data point for pricing information may have value in furthering the purposes of section 1071, it now believes that its value is outweighed by the substantial complexity of the data collection at the inception of this long-term data collection regime. The Bureau now believes that the 2023 final rule erred in not sufficiently considering the value of the data point in light of its cost.
The Bureau believes that the additional burden of collecting this data point exceeds its potential value at this time. The Bureau understands concerns that removing the pricing data point would potentially make it difficult to compare loans, and make it less effective in detecting discriminatory practices and understanding the market. As commenters have noted, pricing information has been important to the analysis of HMDA data.
However, as in their analysis of other discretionary data points, many commenters on this pricing data point seem to conflate the usefulness of a data point in the context of a long-standing data collection regime, and including such a data point at the inception of a new data collection regime. In essence, many comments on pricing treat the 2023 final rule as an existing data collection regime, from which the proposed revision would detract.
The manner in which Regulation C was implemented over time—even if the way the rule progressed over time was not necessarily by design—points to the value of incrementalism in data collection. The first pricing data point was introduced only two decades after HMDA data collection commenced, and only included at first a simplified “rate spread” field (the difference between the APR of certain loans and the Federal funds rate).
Whether intended or not, the Bureau believes that the effect of this incrementalism in HMDA/Regulation C was to make the pricing data point easier for lenders to adapt to over time with less disruption to mortgage markets. The contrafactual that no commenter has apparently contemplated is how much more disruptive HMDA might have been if lenders had to comply with the full complement of data points that exist now at the inception of that data collection. As a result, the Bureau continues to believe that, at the inception of this long-term data collection regime, the potential complexity and cost of the pricing data point would outweigh its value.
The Bureau, therefore, agrees that, in general, loans in the dataset would be more comparable with pricing information; however, the Bureau believes that, at the inception of the data collection regime, users of the data should analyze other data points as potentially clearer indicators of lending discrimination. In the future, it may be possible to introduce collection and reporting of pricing data and obtain greater comparability when lenders are more settled in collecting section 1071 data.
Regarding the argument that removing pricing data would incentivize lenders to increase approval rates by increasing prices, the Bureau believes that such a concern is speculative at this point; the commenter does not suggest any past instance of such practices occurring in response to changes in regulations for the purpose of evading fair lending analysis. The Bureau disagrees that it has overestimated the potential harm from third parties misinterpreting or misusing the data; the Bureau acknowledged in its preliminary privacy analysis in the 2023 final rule the possibility of such misuse. In any case, such harms are not the primary reason for the removal of the pricing data point.
The Bureau did not propose, or solicit comments on, the removal of the data point capturing a small business's 3-digit NAICS code to identify the industry in which the credit applicant operates.
The Bureau received comments from banks, trade associations, and community groups regarding the data point for the 3-digit NAICS code. Some industry commenters requested that the Bureau eliminate this data point. Several trade associations commented that the data point does not facilitate fair lending enforcement. Several banks and trade associations asserted that the data would be unreliable and inaccurate because applicants and lenders often do not know which NAICS code to apply. Commenters also asserted that the data point poses re-identification risk for applicants, especially in rural areas with few small businesses. One bank noted that re-identification risk could chill businesses' willingness to apply for credit. Several banks and trade associations commented that the cost for this data point will be significant because some lenders, including automobile dealerships and community banks, do not already collect this information. Some trade associations requested additional flexibility for reporting the data, such as permitting use of 2-digit NAICS codes and providing a safe harbor if an applicant does not provide the code.
By contrast, a community group and a bank supported retaining the data point, arguing that it helps identify whether certain sectors or industries are associated with unique barriers to lending.
The Bureau is retaining § 1002.107(a)(15) as is. The Bureau addressed similar comments opposing the data point for NAICS code in the 2023 final rule. The Bureau continues to believe that the 3-digit NAICS code achieves the right balance between minimizing compliance burdens and re-identification risk, while also providing valuable data to analyze fair lending patterns and identify industry subsectors with unmet credit needs. The Bureau does not believe that there is evidence for the assertion that the collection of the 3-digit NAICS code would discourage small businesses from applying for credit. The Bureau also disagrees with the comment that the cost for this data point will be significant because some lenders do not already collect this information. Furthermore, the Bureau notes that lenders already have significant flexibility in their collection of 3-digit NAICS codes. Their ability to rely on NAICS codes obtained from applicants or third-party sources, combined with the existing NAICS code safe harbor provision in § 1002.112(c)(3), significantly eases potential difficulties for financial institutions in collecting and reporting the data. Additionally, the Bureau believes that a 2-digit NAICS code would not provide sufficiently detailed information to aid regulators and the public in monitoring particular industries' access to small business credit, nor would it meaningfully diminish the cost of collecting and reporting the data point as compared to a 3-digit code. Finally, re-identification risk can be addressed by pre-publication modifications and deletions as needed.
The 2023 final rule required financial institutions to report the number of workers in ranges, and stated that data on the number of persons working for a small business applicant will provide data users and relevant stakeholders with a better understanding of the job maintenance and creation that small business credit provides.
The Bureau proposed removing § 1002.107(a)(16).
The Bureau received comments from banks, industry trade associations, and community groups regarding the number of workers data point. Many commenters supported the proposal to remove this discretionary data point. A couple of trade associations asserted that the data point offers limited value for fair lending enforcement, and that the data would be inaccurate because small businesses lack precise or stable employment figures. A coalition of trade associations suggested that the Bureau could obtain this data point through existing or new surveys of small businesses instead of imposing a costly data collection mandate.
Some commenters opposed the Bureau's proposal to remove this data point. Two community groups disagreed with the Bureau's assessment that it is difficult for small businesses to calculate their number of workers. One of those groups emphasized that most small businesses do not have any employees. The group further suggested that the Bureau could reduce ambiguity about how to report the number of workers by issuing additional instructions or guidance, including allowances for relying on the judgment of the loan applicant.
A trade association for small businesses and several community groups emphasized the importance of the data point in furthering the community development purpose of section 1071. A bank and a community group disagreed with the Bureau's explanation that the data point is not justified on fair lending grounds. The community group asserted that the capacity to hire and retain workers is an important control variable in assessing lending disparities. The group also questioned why the data point's benefits for community development are not sufficient justification for collecting the data even if the Bureau is correct to conclude that the data point cannot be justified on fair lending grounds.
The Bureau is finalizing the removal of § 1002.107(a)(16) as proposed. The smaller number of businesses with employees that remain covered under this rule, coupled with data inconsistences that are likely to result from the complexity of providing the information, diminish the value of this data point. While the Bureau acknowledges that the data point may have value in furthering the purposes of section 1071, its value is currently diminished by its likely imprecision and outweighed by the cost and complexity of collecting the data at the inception of this long-term data collection regime.
One commenter's assertion, that most small businesses have no employees, suggests removal of this data point as much as it suggests its retention. If most applicants have no employees, the cost and complexity of collecting this data point may be relatively low but the value of the data will also be low. Changing the gross annual revenue threshold from $5 million to $1 million means fewer covered businesses are likely to have any employees to report. The Bureau continues to believe that it could be difficult for small businesses—especially those that use contractors, temporary or gig workers, or seasonal workers, or those that cycle through employees frequently—to determine their number of workers in accordance with the 2023 final rule. Commenters who asserted otherwise did not explain how these types of businesses could determine the data point easily or suggest specific guidance that the Bureau could issue to simplify the data collection.
The Bureau disagrees with some commenters about the relative importance of this data point in furthering either of the purposes of section 1071. The Bureau has acknowledged the potential value of this data point but believes that the additional burden of collecting this data point exceeds its potential value at this time. It is simply not practicable to collect every possible control variable for assessing lending disparities.
The Bureau did not propose, or solicit comments on, the removal of the discretionary data point capturing a small business's time in business.
The Bureau received comments from banks, trade associations, and a community group regarding the discretionary data point for time in business. Some industry commenters requested that the Bureau eliminate this data point. Several banks asserted that the data point poses re-identification risk for applicants, especially in rural areas with few small businesses. A bank and a trade association commented that ambiguities in how to report this data (
A community group supported retaining the data point, arguing that it helps identify whether the age of a business is associated with barriers to lending.
The Bureau is retaining § 1002.107(a)(17) as is. The Bureau addressed similar comments opposing the data point for time in business in the 2023 final rule. As the Bureau acknowledged in the 2023 final rule, “allowing different methods for measuring time in business will have an effect on the comparability of the data, but information about the time in business actually collected by the financial institution for its own purposes will be useful for fair lending analysis and will impose less operational difficulty than requiring reporting based on a single definition.”
The Bureau did not propose, or solicit comment on, § 1002.107(a)(20), which requires financial institutions to collect and report the number of an applicant's principal owners.
The Bureau received comments from several banks and trade associations regarding the discretionary data point for number of principal owners. Several industry commenters requested that the Bureau eliminate this data point. Two banks questioned whether the data point advances either of the statutory
The Bureau is retaining § 1002.107(a)(20) as is. The Bureau addressed similar comments opposing the data point for number of principal owners in the 2023 final rule. As the Bureau explained in the 2023 final rule, “[a]lthough some small business applicants, such as family farmers, may have ownership structures where there are many owners and/or where ownership is through various business entities, the rule's definition for principal owner means that applicants would be required to identify only individuals, and not entities or trusts, with direct ownership in the business and would not need to trace ownership through multiple business entities or provide information about individuals with small equity shares in the business.”
The 2023 final rule required financial institutions to inquire whether a small business applicant for credit is a minority-owned, women-owned, and/or LGBTQI+-owned business. The Bureau proposed removing this data point. This discretionary data point is addressed in more detail below in the discussion of § 1002.107(a) on the collection of sex, gender, and related data.
The Bureau did not propose or solicit comment on revisions to certain other statutory data points, including unique identifier, (§ 1002.107(a)(1)), application date (§ 1002.107(a)(2)), credit type (§ 1002.107(a)(5)), credit purpose (§ 1002.107(a)(6)), amount applied for (§ 1002.107(a)(7)), amount approved or originated (§ 1002.107(a)(8)), action taken (§ 1002.107(a)(9)), action taken date (§ 1002.107(a)(10)), census tract (§ 1002.107(a)(13)), gross annual revenue (§ 1002.107(a)(14)). Minority-owned and women-owned status (§ 1002.107(a)(18)), and ethnicity, race and sex of principal owners (§ 1002.107(a)(19)) are also statutory data points, and the Bureau did propose certain revisions to those, as set out further below.
The Bureau received comments from several banks and a trade association regarding a few of the statutory data points, which the Bureau did not propose to amend. One bank from a rural area commented that reporting the census tract and gross annual revenue data points poses a re-identification risk, especially in conjunction with other data points like NAICS code and time in business. A trade association asserted that the “waterfall” approach in the 2023 final rule for reporting the applicant's census tract is confusing and burdensome, and requested that the Bureau instead use the definition of census tract in section 1071. Finally, a bank commented that loan term data should only be reported for originated loans. The bank asserted that loan term data is incomplete without pricing information and would not meaningfully advance the objectives of section 1071. The bank further asserted that the value of the data is outweighed by the operational burden.
The Bureau declines to adopt the changes to the statutory data points suggested by commenters. The Bureau addressed similar comments opposing the data point for census tract in the 2023 final rule. The Bureau appreciates concerns regarding the potential re-identification risk posed by the publication of unmodified census tract data and understands that modification of the data may be appropriate to mitigate that risk in some instances. Regarding the waterfall approach in the 2023 final rule, the Bureau continues to believe that this reporting method strikes the appropriate balance between collecting useful information to further section 1071's purposes while avoiding imposing additional burden on financial institutions. This approach was specifically intended to provide flexibility to financial institutions in collecting this data point based on information they already have.
Regarding the comments about the complexity and difficulty of reporting the remaining data points the Bureau emphasizes that nearly all the remaining data points are specifically enumerated in section 1071, and, as stated above, the limited number of other data points are needed to facilitate the collection of the statutory data points. Furthermore, the Bureau continues to believe that the commentary in the 2023 final rule for the remaining data points is sufficiently clear and does not need to be revised or augmented. In any case, the commenters did not suggest specific additional guidance or bright line rules that the Bureau could issue to simplify the data collection.
Section 1002.107(a)(19) requires the collection of both aggregate and disaggregated race and ethnicity information on principal owners of small business applicants. However, 15 U.S.C. 1691c-2(e)(2)(G) only specifies “race” and “ethnicity,” without referencing disaggregation of those categories. Given the Bureau's concern about commencing a long-term data collection regime by asking for potentially complex and costly data points, the Bureau's proposal sought comment on whether it should further revise the rule's data collection requirements to require collection only of aggregate ethnicity and race categories. It also sought specific comment on: (1) what utility there might be for carrying out the purposes of section 1071 in requiring the collection of disaggregated categories of ethnicity and race, in addition to the aggregate categories, and (2) the costs and burdens for financial institutions in requiring the collection of these disaggregated categories of ethnicity and race.
The Bureau solicited comment regarding the utility, in furthering the purposes of section 1071, of requiring the collection of the disaggregated categories of ethnicity and race in addition to the aggregated categories. Several trade associations and lenders provided comments supporting the elimination of the use of disaggregated race and ethnicity categories, for a
Several trade associations and advocacy groups supported retaining the disaggregated race and ethnicity categories. A trade association for lenders, two trade associations for small businesses, and community groups commented that disaggregated race and ethnicity categories advance the fair lending statutory purpose of section 1071, noting that fair lending statistical analyses using the aggregate categories alone often mask disparities within certain categories or across certain geographies. One trade association noted the existence of Federal statistical standards that emphasize structuring and organizing demographic data to support accurate and comparable analysis, and said that aggregation makes misclassification and error more likely, reduces comparability, limits interpretability, and weakens the reliability of any analysis. Finally, an advocacy group suggested that rather than eliminating the disaggregated categories, the Bureau should offer technical assistance to promote consistent reporting so as to strengthen the quality and the utility of the data over time.
Based on the requirements detailed in ECOA and the responses to its solicitation for comments on this issue, the Bureau has determined to eliminate the use of disaggregated categories in collecting principal owners' race and ethnicity in the commentary to § 1002.107(a)(19), including comments 107(a)(19)-13, -14 and 16, and has made conforming changes elsewhere in the regulatory text and commentary.
The Bureau is eliminating the use of disaggregate race and ethnicity categories for a number of reasons. First, as noted by several commenters, the best reading of the statute is that the collection and use of disaggregated race and ethnicity categories is not required explicitly by statute; only aggregated race and ethnicity are required. As such, eliminating the use of disaggregated categories will more closely align the regulation to the statute. Second, in the Bureau's view, eliminating the disaggregated race and ethnicity categories will reduce regulatory burden and operational costs and complexities while likely improving data quality, especially at the onset of a long-term data collection program. The Bureau agrees with commenters' concerns that the use of free-form text fields in collecting disaggregated race and ethnicity, could increase inconsistencies in, and unreliability of, the data reported. Additionally, eliminating the disaggregated categories will reduce small business applicants' confusion about what information to provide and decrease friction between financial institutions and customers. Finally, based on observations on data provided under the HMDA, the Bureau agrees that the disaggregated categories would not necessarily improve fair lending analysis if not enough small business applicants provide this data.
The Bureau is not persuaded by commenters supporting the retention of the disaggregated race and ethnicity categories. The Bureau finds that the regulatory burden and potential for unreliable, inconsistent data outweighs any potential benefits derived from analysis of disaggregated race and ethnicity categories, at least at the onset of this long-term data collection program. Analysis at the aggregate level should be sufficient to address the statutory requirement that race and ethnicity data be collected and shed light on areas of difference between groups of small business applicants and to conduct fair lending analysis. Further, any Federal standards regarding the specificity of the contents of large datasets do not relate directly to the particular complexities and burdens posed by this data collection statute, which, as commenters have explained, are significant.
The Bureau notes that commenters arguing that disaggregated race and ethnicity categories would advance the fair lending statutory purpose of section 1071 have not taken into account countervailing factors, such as the risk of application drop-offs and the fact that HMDA has historically had low response rates to requests for disaggregated race and ethnicity data. The Bureau notes that disaggregated data cannot unmask disparities within certain categories if meaningful numbers of small business applicants decline to provide such data. The Bureau observes that the commenters citing Federal statistical standards—which cast doubt on the reliability of aggregate race and ethnicity data—do not state if such standards take into account the specific context of small business lending, a market in which prior to section 1071 lenders were generally prohibited by ECOA from asking from such demographic data. The Bureau also observes that the Federal statistical standards cited by commenters may not take into account the most relevant basis for comparison—the historically low response rates to disaggregated race and ethnicity questions in the HMDA context.
The Bureau does not dismiss the possibility of incorporating disaggregated data in the future and acknowledges the comment that the Bureau should offer technical assistance to promote consistent reporting so as to strengthen the quality and the utility of the data over time, but has determined that it should do so first concerning aggregate data, if only to better assure the reception by applicants in the future, should the Bureau determine it appropriate to add disaggregated race and ethnicity data requests to the rule.
Section 1002.107(a)(18) in the 2023 final rule requires financial institutions to inquire whether a small business applicant for credit is a minority-owned, women-owned, and/or LGBTQI+-owned business. The Bureau explained that, based on limited information available, it believed that LGBTQI+-owned businesses may experience particular challenges accessing small business credit, and used its discretionary authority under 15 U.S.C. 1691c-2(e)(2)(H) to require financial institutions to request information about whether an applicant is a LGBTQI+-owned business.
The Bureau proposed several changes related to LGBTQI+ ownership.
In addition, on January 30, 2025, the President issued the Defending Women E.O. (E.O. 14168), which directs Federal agencies not to discuss gender identity and to refer to sex using a binary of male/female. Consistent with this E.O. and the feedback the Bureau received from stakeholders, the general public described above, and section 1071 itself, the Bureau is revising the rule. These changes generally include (1) removing references to and questions about “LGBTQI+”-owned business status, (2) requiring financial institutions to inquire about a principal owner's sex, rather than sex/gender, and (3) providing that the sex of the principal owners be selected from a static binary response option of male/female, rather than a free-form text field.
Several trade associations, lenders, advocacy groups, and at least one individual noted their support for the proposal to remove all references, definitions, and inquiries related to the LGBTQI+ status of small business applicants from the rule. One trade association and several advocacy groups argued that ECOA did not specifically cover gender and LGBTQI+ status, and that eliminating the data point would better align with ECOA and further its purposes. Several trade associations and a lender observed that the LGBTQI+ data point was discretionary and, they said, would add complexity to data collection, increase the likelihood of data errors and comparability, and require extensive staff training and system updates. Several trade associations and a bank asserted that collecting LGBTQI+ information was regulatory overreach and that removing the data point would be consistent with a more incremental approach to implementing the rule. Finally, several trade associations and lenders commented that collecting LGBTQI+ data presented privacy concerns. Two trade associations and a lender also stated that collecting this information risked damaging relationships between lenders and their customers, especially in smaller markets.
Several advocacy organizations and individuals opposed the removal of the LGBTQI+-owned status data point. Several commenters observed that LGBTQI+ applicants have faced historical, systemic barriers to accessing credit, making robust safeguards important. These commenters further noted the importance of data on LGBTQI+-owned businesses to identify unequal treatment and patterns of discrimination, and to enforce fair lending laws, including evaluating the effectiveness of special purpose credit programs intended to serve such businesses. Several commenters observed that the voluntary nature of the reporting, in that it is subject to the right to refuse, would protect applicant privacy. Finally, one advocacy group commented that LGBTQI+ persons were the best source of information on their privacy concerns, and that the Bureau should conduct outreach with them on this issue.
The Bureau is finalizing removal of the LGBTQI+-owned status data point as proposed. In the time since the 2023 final rule, the Bureau has heard repeated concerns from stakeholders, as well as Members of Congress and the general public, that this question in particular is an invasion of privacy and risks damaging the relationship between small businesses and their lenders, particularly in smaller lending markets. The Bureau now believes that the sensitivities involved in this inquiry, which the 2023 final rule failed to address, exceed any utility this data point might provide, and that it adds to the overall complexity of a lengthy data collection.
The Bureau agrees with commenters' observations that ECOA does not explicitly refer to gender identity or LGBTQI+ status. The Bureau also agrees with comments that collection of this discretionary data point could add cost and complexity to the data collection process. The Bureau also believes that removing this discretionary data point will alleviate the privacy concerns raised by commenters regarding the collection of LGBTQI+ data from small business applicants. Lastly, the Bureau agrees with the commenters' observations that the ECOA does not explicitly refer to gender or LGBTQI+ status.
The Bureau is not persuaded by commenters that wrote to express support for the collection of LGBTQI+-owned status of applicants. Even if, as the Bureau noted in the 2023 rule, LGBTQI+-owned businesses may experience challenges accessing small business credit, the Bureau believes that it should not require collection of such data at the onset of a long-term data collection program. None of the commenters requesting that the Bureau retain this data point suggested that the collection of this data would not add to the cost or complexity of the rule. Furthermore, the determination to collect this data using the Bureau's discretionary authority under 15 U.S.C. 1691c-2(e)(2)(H), as the 2023 final rule states, was “[b]ased on limited information.”
Finally, while the Bureau agrees with the commenter that the voluntary nature of the data collection would help protect applicant privacy on this data point, applicants would have far greater privacy protections from removing the data point entirely. The Bureau agrees with commenters stating that the very existence of such a query could strain customer relationships with financial institutions.
Section 1002.107(a)(19) in the 2023 final rule requires financial institutions to ask a small business applicant to provide its principal owners' ethnicity, race and sex. Commentary to § 1002.107(a)(19) required financial institutions, when requesting principal owners' sex, to use the term “sex/gender” and to give applicants a free-form text field to provide a response. In the 2023 final rule, the Bureau explained its belief that this approach would allow applicants to self-identify as they see fit. The Bureau proposed to
The Bureau received several comments on the proposed changes to revise the collection of principal owners' sex/gender to a binary choice between male and female, and to eliminate the use of a free-form text field to provide a response. Several trade associations, and two advocacy groups supported the proposal, stating that data collected via free-form text fields tend to result in lower data quality, inconsistency in the data that are collected, and leaves room for interpretation of the data collected. Several trade associations, an advocacy group, and a bank stated that free-form text fields increase costs for lenders and result in unnecessary regulatory complexity. Finally, referencing ECOA as well as the Defending Women E.O., several advocacy groups asserted that there are only two sexes, and that gender is not synonymous with sex.
Other commenters supported retaining the free-form text field. Several community groups disputed that the Defending Women E.O. governed in this instance, stating that section 1071 as a congressional mandate had legal priority over an executive order. One community group argued that the presence of a free-form text field does not amount to “discussing” gender as prohibited by the E.O. Another community group noted that forcing non-binary persons to select a binary response would violate their rights and would render data provided to the Bureau inaccurate. One community group noted that limiting collection to male and female sex renders LGBTQI+ individuals invisible in the data. The group also asserted that this data is important because of the history of discrimination against LGBTQI+ persons, many of whom, they said, turn to starting their own businesses. This commenter further stated that some experts in LGBTQI+ issues have developed standardized, two-step measures that separately capture sex assigned at birth and current gender identity, with structured responses and coding to support high-quality data analysis without erasing gender minorities.
The Bureau is finalizing the revisions as proposed regarding how principal owners' sex is to be collected in commentary accompanying § 1002.107(a)(19). Specifically, financial institutions are required to inquire about a principal owner's sex, rather than sex and gender, and sex of the principal owner is to be selected from only the choices of male or female, rather than allowing any response via a free-form text box. Additionally, this change comports with the plain text of the statute, which explicitly requires financial institutions to collect of data on the sex of principal owners, but does not mention gender identity, much less require collection of data on it. Further, the revisions are in accord with the Defending Women E.O. described above. The Bureau is also making conforming changes elsewhere throughout the regulatory text and associated commentary, as well as the sample form in appendix E.
The Bureau determines that, particularly in the context of a data collection rule, use of only a free-form text field would inhibit robust data analysis, contrary to the purposes of the rule. The Bureau also now believes, based on feedback from stakeholders of all kinds, that a free-form text field would likely result in poor data quality, given the variety of possible responses to the sex question. The Bureau believes that the most appropriate way to collect data on the sex of a principal owner is to ask the straightforward question of whether the owner is male or female. These changes are consistent with the statute, the Defending Women E.O., and feedback from many stakeholders and the public.
As noted by several commenters, providing a straightforward choice of male or female and eliminating the existing, free-form text field ensures data consistency, quality, and comparability, and eliminates any need for further interpretation of the data collected. The Bureau agrees that replacing the free-form field with a binary male or female choice is more cost-effective for financial institutions and reduces the operational complexity surrounding the collection of this data, especially at the onset of a long-term data collection program such as this.
The Bureau is not persuaded by commenters who advocated for retaining the free-form text field. The Bureau believes that a simple male or female choice for sex is adequate and appropriate for the data collection under section 1071. The Bureau disagrees with the comment that a requirement that applicants choose either male or female for the sex of a principal owner would violate their rights. The Bureau believes this argument is based on the premise that the reference to “sex” in the statute must be read to include gender identity. The Bureau observes that the 2023 final rule took this position based on the interpretation of a separate statute in
Further, whether an E.O. could be sufficient to repeal a statutory mandate to collect a data point is, here, is also irrelevant; section 1071 contains no reference to, much less a mandate to collect, gender, and the changes made in this rule have been made for reasons independent of the E.O., as described herein. In any case, it is appropriate for the Bureau to follow current guidance from other parts of the Federal government, including the current practice of the White House and other Federal agencies on the reporting of demographic data as a means of ensuring standardized and comparable data.
The Bureau's primary statutory duty is the collection of data required under the statute—here, the sex of principal owners—without unnecessary complexity and burden, and data collected solely via free-form text boxes cannot serve those ends as well as a binary choice between male and female. In addition, while some commenters suggest that there are standardized methods of collecting information beyond male/female, other than using a free-form data field, the Bureau believes that the collection of any such data would require the use of is discretionary authority under 15 U.S.C. 1691c-2(e)(2)(H) to accommodate choice beyond male and female. The Bureau does not believe that the collection of such data would advance the statutory purposes of the rule at the onset of a long-term data collection program like this.
Section 1002.107(a)(18) in the 2023 final rule requires covered financial institutions to seek information from applicants about their women-owned, minority-owned, and LGBTQI+-owned business status and § 1002.107(a)(19) requires covered financial institutions to seek information from applicants about the ethnicity, race, and sex of the principal owners of the applicant business. Those provisions and associated commentary also include discussions of the statutorily provided right of an applicant to refuse to provide this information.
The Bureau received several comments regarding its proposal to emphasize the statutory right to refuse to provide demographic information in § 1002.107(a)(18) and (19) as illustrated on the sample form in appendix E. Several trade associations offered comment in support of emphasizing the right to refuse. One trade association recommended that the language proposed in appendix E be moved from the commentary to the regulation itself in order to make applicants' right to refuse clearer. This trade association also commented that the revised language on the sample form in appendix E should be made more prominent to better inform applicants of both the financial institutions' compliance obligation and the applicants' right to refuse. Another trade association stated that the right to opt out of providing demographic data and the reporting respects statutory intent and would strengthen borrower trust. One trade association commented that small business applicants' right to privacy would be well supported with an emphasis on the right to refuse. Another trade association expressed concern that emphasizing the right to refuse creates a pathway to reduced data collection, due to increased refusal rates, which will ultimately reduce both the quantity and usefulness of the demographic data collection.
Several trade associations and a bank commented on the length and content of the sample demographic data collection form contained in appendix E. One trade association noted that longer applications increase application drop offs, and that each additional question adds to the loan application drop off rate. This commenter noted that page 2 of the sample form in appendix E included three questions but 34 possible answers for each small business applicant. The commenter suggested that allowing lenders to, at a minimum, collapse the disaggregated subcategories unless the category is selected, would mitigate applicant drop off rates. Another trade association commented that the sample form should make it clear to small business applicants that they may refuse to provide demographic data. Finally, at least one lender commented that the sample data collection form should include the ability to note or otherwise record that the small business applicant declined to provide race, ethnicity, and other demographic data.
The Bureau is revising the applicant right to refuse provisions in § 1002.107(a)(18) and (19), as well as the related commentary, as discussed in further detail below. In addition, the Bureau is making corresponding changes to the sample demographic data collection form in appendix E. The regulatory text of § 1002.107(a)(18) and (19) provides that covered financial institutions must inform applicants that the financial institution cannot discriminate against the applicant based on the demographic information provided pursuant to the rule or on whether the applicant invokes the right to refuse to provide the information. Existing comments 107(a)(18)-1 and 107(a)(19)-1 state that a financial institution must permit an applicant to refuse (
In addition, in this final rule, the Bureau has made several other revisions to commentary to further clarify the financial institutions' obligations to permit applicants to decline to answer inquiries regarding business status, and principal owners' ethnicity, race, and sex.
Comments 107(a)(18)-8 and 107(a)(19)-8 previously required financial institutions to report an applicant's substantive response to an inquiry requesting business status or principal owners' ethnicity, race, and sex in the event of a conflict in which the applicant selected also an option such as “none apply” or “I do not wish to respond.” The Bureau now believes that these comments did not give sufficient weight to the applicant's explicit choice of an option to decline to provide such demographic information. As a result, the Bureau now revises comments 107(a)(18)-8 and 107(a)(19)-8 to require a financial institution to report that an applicant declined to provide this information in the event of a conflict in which the applicant provides demographic information but also selects the option indicating that it declines to provide such information. The Bureau believes that this change will ease burden and decrease confusion.
Existing comments 107(a)(19)-13, 14, and 15 are amended to emphasize an applicant's right to decline to provide the ethnicity, race, and sex, respectively, of a principal owner when information about the ethnicity, race, and sex categories is provided.
Similarly, to emphasize the right to decline to provide demographic information, comment 107(a)(19)-16, concerning the financial institution's oral request for the ethnicity, race, and sex information of the principal owner(s), is amended. Previously, comment 107(a)(19)-16 required financial institutions collecting information on principal owners' ethnicity, race, and sex orally, such as by telephone, to present aggregate race and ethnicity categories before presenting the application the option to decline to provide this information. The Bureau now revises comment 107(a)(19)-16 to state that that the financial institution must present the applicant's right to decline to provide such information before listing the aggregate ethnicity, race, and sex categories that may be selected. The Bureau believes this revision is more consistent with an applicant's the statutory right to decline to provide such information because if ethnicity, race, or sex information is presented first, an applicant might answer such inquiries before becoming aware of the right to decline to provide such information.
Collectively, these changes clarify the financial institution's communication and reporting obligations related to the applicant's statutory right to refuse in response to inquiries concerning certain demographic information. The Bureau is also making changes to the sample form in appendix E to further emphasize the
The Bureau notes in response to comments concerned with the length of the proposed sample form in appendix E that the final sample form now reflects revisions adopted in this final rule that would eliminate disaggregated data. As a result, the revised form is much shorter, which should reduce application drop offs, and no longer includes 34 possible answers for each principal owner of a small business applicant. Regarding the comment that the sample form should make clear to applicants that they may refuse to provide demographic data, the Bureau notes that its revisions further emphasize the right to refuse. Finally, in the response to the comment that the sample data collection form should record that an applicant declined to answer questions requesting demographic data, the Bureau notes that it does.
In the 2023 final rule, the Bureau explained that it was adopting the provisions in § 1002.107(c) in an attempt to provide a balance between allowing institutions flexibility in how they collect data and ensuring that institutions do not discourage or otherwise interfere with applicants' providing their data. Existing § 1002.107(c) requires a covered financial institution to (1) not discourage an applicant from responding to requests for applicant-provided data under final § 1002.107(a) and to otherwise maintain procedures to collect such data at a time and in a manner that are reasonably designed to obtain a response; (2) identify certain minimum components when collecting data directly from the applicant that must be included within a financial institution's procedures to ensure they are reasonably designed to obtain a response; and (3) maintain procedures to identify and respond to indicia that it may be discouraging applicants from responding to requests for applicant-provided data, including low response rates for applicant-provided data. It also provides that low response rates for applicant-provided data may indicate that a financial institution is discouraging applicants from responding to requests for applicant-provided data or otherwise failing to maintain procedures to collect applicant-provided data that are reasonably designed to obtain a response.
The Bureau proposed to remove references to discouragement in § 1002.107(c)(1) and (c)(2)(iii), as well as related commentary. It also proposed to remove § 1002.107(c)(3) and (4) and related commentary; these provisions detail requirements to monitor for indicia of discouragement, such as low response rates from applicants, and explicitly provide that low response rates may be indicia of discouragement. Further, the Bureau proposed to revise commentary to § 1002.107(c)(2) which under the 2023 final rule established specific restrictions on the time and manner of data collection that are similar to the anti-discouragement provisions.
The Bureau received comments regarding the proposed changes to the time and manner of collection provisions in § 1002.107(c) from a range of industry participants—including banks, credit unions, fintech lenders, and national and State trade associations—as well as from community groups.
Several industry trade associations and banks supported the proposal to remove the anti-discouragement provisions. Many of these commenters argued that these provisions are unnecessary and redundant, noting that Regulation B already imposes an affirmative obligation to collect data and maintain procedures reasonably designed to obtain responses. Two trade associations stated that the Bureau had assumed without evidence that lenders would not comply.
Regarding the specific monitoring requirements, several trade associations conveyed their belief that low response rates are not necessarily an indicator of discouragement. One commenter stated that removal of the low response rate provisions is necessary to ensure borrowers a meaningful right to opt out of providing data. Additionally, two commenters stated that the Bureau's supervision and enforcement functions, rather than prescriptive rules, are the appropriate mechanisms to handle non-compliance.
A number of trade associations and banks stated that the monitoring requirements in the 2023 final rule were burdensome and subjective, with several of these noting that section 1071 does not contain such specific requirements. One bank explained that peer response rate comparisons are potentially misleading because lenders operate in diverse markets and with varied operational practices. That commenter further noted that the burden of compliance with the existing provisions generally outweighs any benefit.
Industry commenters generally supported the proposal to convert specific time and manner requirements into non-binding guidance, with one trade association arguing that this shift offers a more flexible, less burdensome framework while preserving the statute's core purposes. Another trade association noted that small business lending is not “one size fits all,” and asserted that increased flexibility allows lenders to collect information in a manner best suited to their specific procedures and most likely to yield a borrower response.
Some industry commenters requested additional clarity and modifications. Two trade associations requested standardized scripts, confirmation that a lender is only required to ask for data once per application, and confirmation that non-responses are not evidence of discouragement. Additionally, as discussed further in the section-by-section analysis of § 1002.104(b) regarding other requests for exclusions, several commenters highlighted the practical difficulties of collecting data in indirect lending scenarios where the financial institution lacks a direct relationship with the applicant. To address this, these commenters requested product exemptions or greater flexibility in the timing of data collection. One fintech lender requested explicit permission to seek data after a declination, noting that automated underwriting, where credit is referred by a broker, may result in an instant decline before the borrower has interacted with the lender to provide demographic data. The commenter also requested explicit permission for third-party brokers to collect data.
Conversely, several community groups opposed the removal of the anti-discouragement provisions. One coalition of community groups argued that allowing discouragement of data collection frustrates congressional
Regarding the specific monitoring provisions, one community group noted that while low response rates may not definitively indicate discouragement, they could still helpfully reflect a need for improved collection processes or language. This commenter also disputed the Bureau's claim that the provisions were redundant, arguing that the anti-discouragement provisions are distinct from the enforcement provisions of § 1002.112, which it stated address data errors rather than response rates. Additionally, a coalition of community groups urged the Bureau to require lenders to use visual observation and surname review to identify race and ethnicity when applicants decline to provide it, arguing this is necessary to ensure data integrity has not been compromised by improper lender discouragement.
For the reasons set forth below, the Bureau is finalizing the revisions to § 1002.107(c) and its associated commentary largely as proposed, with a modification to the text of § 1002.107(c)(2)(i) and the commentary accompanying § 1002.107(c)(2). The Bureau is removing references to discouragement in § 1002.107(c)(1) and (c)(2)(iii) and associated commentary, deleting the monitoring requirements in § 1002.107(c)(3) and (4) and associated commentary, and revising the text of § 1002.107(c)(2)(i) to adopt a flexible standard while revising the commentary to § 1002.107(c)(2) to provide additional flexibility for certain “time and manner” requirements.
With respect to comments from community groups arguing that removing these provisions will frustrate congressional intent or signal that discouragement is permissible, the Bureau emphasizes that removing these provisions is an effort to enforce the statutory obligation to permit applicants to opt out of the collection of sensitive demographic information, and that the statutory requirement to collect data remains in full effect. Section 1071, as implemented in Regulation B, already creates a binding obligation for covered financial institutions to request applicant-provided data. Further, § 1002.107(c) continues to require covered entities to maintain procedures to collect this data and to do so at a time and in a manner reasonably designed to obtain a response. The Bureau believes that this affirmative obligation is sufficient to ensure compliance. Contrary to comments suggesting that administrative and civil enforcement under § 1002.112 is limited to data errors, the plain text of the provision, on its face, covers the entirety of subpart B and section 1071 itself; as such, it could be used to address violations such as a failure to maintain proper procedures or to train employees in those procedures.
In finalizing these amendments, however, the Bureau agrees with industry commenters that the specific anti-discouragement and monitoring provisions in the 2023 final rule are redundant and add unnecessary regulatory complexity. The Bureau concludes that the prescriptive monitoring requirements and rigid time and manner restrictions in the 2023 final rule created redundant layers of compliance. Rather than simply relying on the indisputable obligation to request applicant-provided data, these specific provisions required financial institutions to perform subjective peer comparisons and adhere to inflexible timing requirements, adding significant operational complexity without a commensurate benefit to data integrity. The Bureau concludes that the prescriptive monitoring provisions in the 2023 final rule were based on anticipatory concerns of evasion not supported by evidence, including evidence from the implementation of HMDA or other similar data collection regimes. Furthermore, the Bureau determines that relying on general supervision and enforcement authority under § 1002.112 is a more efficient mechanism for addressing potential non-compliance than the rigid rule-based regime originally adopted. The Bureau also declines to adopt the industry requests for standardized safe-harbor scripts. Standardized scripts could reimpose the regulatory rigidity this final rule seeks to eliminate.
The Bureau disagrees with comments that it failed to scrutinize industry claims of burden or that the rationale and evidence set out in the 2025 proposed rule was insufficient. The Bureau's decision to reconsider these provisions was prompted by E.O.s 14192 and 14219, which mandate the identification of regulatory efficiencies. In the context of these E.O.s, the Bureau further relied on its own analysis of the assertions at issue,
While the 2025 proposed rule referenced feedback from stakeholders regarding implementation difficulties, that feedback served only to provide further impetus for reconsidering the provisions in the 2023 final rule. Furthermore, as with any proposed rule, through issuing the 2025 proposed rule the Bureau solicited public input to further develop the record, and it has now comprehensively considered and analyzed these public comments.
Further, the Bureau disagrees that the successful implementation of HMDA demonstrates that the requirements in the 2023 final rule would have no adverse market effects or that applicants are invariably willing to provide the requested data. Data collection under Regulation C is now well-established after several decades, and successful compliance in the mortgage context today may not be indicative of whether the prescriptive provisions here strike the right balance of burden versus benefit for small business lending at the onset of a data collection regime.
The Bureau also disagrees that the monitoring requirements should be retained because response rate data may help improve lender data collection processes. While the Bureau acknowledges that response rates may be informative for lenders' own internal analysis, lenders could voluntarily choose to track response rate data on their own. Mandating the monitoring of response rates, however, creates a regulatory burden and a presumption of non-compliance that the Bureau believes is not justified. Low response rates may not necessarily be a sign of discouragement, as applicants might overlook the request or otherwise ignore the data collection form for various reasons, including privacy preferences. The Bureau concludes, therefore, that penalizing lenders or mandating strict peer comparisons based on response rates could lead to misleading conclusions and unjustified burden. Consistent with this conclusion, the Bureau confirms that the bare fact that
The Bureau declines to adopt the suggestion by community groups to require the use of visual observation and surname review when applicants decline to provide demographic data, including for the reasons set out in the 2023 final rule.
Regarding commenters' request for explicit permission to collect data after notifying the applicant of a credit decision, the Bureau is modifying the text of § 1002.107(c)(2)(i) and the commentary accompanying § 1002.107(c)(2). The Bureau agrees with commenters that in certain instances, where an application is forwarded by an intermediary, the reporting financial institution may have no direct contact with the applicant until after notifying the applicant of the credit decision. Requiring data collection from an applicant by the reporting financial institution prior to notification in these specific instances may be impractical. To address this, the Bureau is finalizing § 1002.107(c)(2)(i) to provide that data be collected at a time “reasonably designed to obtain a response,” rather than deleting the provision as proposed. This revision creates a flexible regulatory standard that permits financial institutions to collect data in a manner consistent with their operations. Accordingly, revised comment 107(c)(2)-2.i. clarifies that while the general expectation remains that financial institutions should attempt to collect data prior to notification of the credit decision, a procedure can still be reasonably designed to obtain a response if the reporting institution requests the data after notification in instances where it had no prior direct interaction with the applicant. With this modification, the “time and manner” provisions of the 2023 final rule have been revised to provide the flexibility many commenters are seeking. The Bureau concludes that financial institutions are best positioned to determine the optimal phrasing and timing to maximize responses within their specific operational flows.
Finally, regarding the request for explicit permission for third-party brokers to collect data, the Bureau notes that existing § 1002.107(b) already explicitly permits financial institutions to rely on information from the applicant or appropriate third-party sources when compiling data. Additionally, existing § 1002.5, comment 1002.5(a)(2)-3, contemplates that third parties such as loan brokers may collect required sensitive data on behalf of creditors. The Bureau believes that this existing provision, combined with the revisions finalized in this final rule—specifically the removal of prescriptive monitoring requirements—provides sufficient flexibility for financial institutions to establish third-party collection procedures, without the need for additional regulatory text.
The compliance dates for covered financial institutions, as most recently amended by the 2025 compliance dates final rule, are set forth in existing § 1002.114(b). That section looks to a financial institution's volume of covered credit transactions for small businesses to determine which of three compliance dates (July 1, 2026, January 1, 2027, and October 1, 2027) are applicable to a financial institution.
The Bureau proposed to amend § 1002.114(b) to eliminate the system of tiered compliance dates in favor of creating a single compliance date. Mirroring the change to the rule's origination threshold set forth in proposed § 1002.105(b), proposed § 1002.114(b) would have required that all covered financial institutions that originated at least 1,000 covered credit transactions for small businesses in each of calendar years 2026 and 2027 begin to comply with the rule starting on January 1, 2028. The Bureau proposed to make corresponding updates throughout the commentary accompanying § 1002.114(b) and (c) to provide additional guidance and examples regarding the compliance date.
The Bureau received numerous comments on the proposed single compliance date, primarily from banks, lenders, trade associations, and an independent office of a Federal agency. Commenters generally supported a single compliance date, with some recommending that the Bureau make additional adjustments. In support, some commenters stated that the proposal would provide clarity and certainty, and would thus promote efficiency. Other commenters stated that it would minimize disruption and ensure that credit markets remain stable and accessible. A coalition of trade associations noted that the proposed single compliance date would avoid mid-year implementation, averring that that mid-year implementation is disruptive and that partial year data is generally not useful. A small business trade association stated that a single compliance date created more fairness among institutions and would avoid patchwork compliance.
Many supporters commented that the single compliance date as proposed would provide the time needed for lenders to come into compliance, especially given the need to adjust systems for compliance with any other additional changes to the 2023 final rule. Several of these stated that loan processors and third-party vendors need significant time to prepare for compliance. A trade association stated that the proposed inclusion of an option for voluntary early data collection would provide flexibility for institutions seeking to validate systems and refine workflows ahead of the mandatory deadline.
Several lenders and a trade association supported the single compliance date but stated that the proposed timeline would be sufficient so long as the rule is finalized in the first quarter of 2026. Several other commenters supported a single compliance date but urged the Bureau to set the date later than proposed. These commenters stated that a later date is needed because, among other things, collection of such data in this sector is novel and complex and will require significant effort on the part of lenders, working with third-party vendors, to develop and implement new procedures. Two bank trade associations also expressed concern that lenders would not have clarity about the rule's coverage and requirements until the rule is finalized, and possibly not until further clarifications are provided the Bureau. Compliance dates suggested by commenters include 24 months after
In a similar vein, several supporters of a single compliance date stated that there was not enough time between the end of the proposed period for determining coverage and the proposed compliance date. A few of these commenters expressed concerns that some lenders may have to prepare for compliance before they know whether they are covered and thus may have to estimate data, which could introduce uncertainty and inaccuracies.
Several of these commenters, including a coalition of trade associations, recommended that the Bureau finalize a two-year look-back period of 2025 and 2026 (rather than 2026 and 2027) to address their concerns. Two bank trade associations recommended that lenders be permitted to choose between using originations from 2025 and 2026, or from 2026 and 2027, to determine whether compliance by January 1, 2028 is required. Three bank trade associations suggested that compliance be required 12 months after meeting the coverage thresholds; one bank suggested 36 months after meeting the thresholds.
Several commenters recommended that, to provide compliance certainty as soon as possible, the Bureau should finalize the proposed compliance date before finalizing any other amendments to the 2023 final rule. A small number of commenters urged the Bureau to provide clear compliance guidance (
A bank trade association suggested that the Bureau adopt the proposed 2028 compliance date for large and midsize institutions, who have staff and expertise to implement rules more quickly, and a 2029 compliance date for smaller financial institutions and those that have proven to be successful and trusted small business lenders. A community bank suggested that if covered entities are not provided at least 30 months for implementation, then the Bureau should provide staggered deadlines for smaller institutions.
The Bureau received two comments opposing any further delay of the compliance date. A community group expressed concern that a delay to January 1, 2028, would create gaps in valuable data that would otherwise be recorded and available to the public. Another community group asserted that the proposed compliance date would constitute an unlawful withholding and unreasonable delay, and that compliance with the rule should have started in mid-2025.
The Bureau is finalizing § 1002.114(b) substantially as proposed. Accordingly, § 1002.114(b) is amended to eliminate the system of tiered compliance dates established in the 2023 final rule and to require instead that all covered financial institutions that originate at least 1,000 covered credit transactions for small businesses in each of calendar years 2026 and 2027 begin to comply with the rule starting on January 1, 2028. In response to certain commenters' concerns, the Bureau also is adopting a new special transitional rule, in § 1002.114(c)(3), that permits, but does not require, financial institutions to use the calendar years 2025 and 2026, instead of 2026 and 2027, for purposes of determining whether they must comply with the rule beginning January 1, 2028. The Bureau also is finalizing corresponding updates to the commentary for § 1002.114(b) and (c), providing additional guidance and examples regarding the compliance date and application of the two look-back periods.
The Bureau determines that the extension of the single compliance date to January 1, 2028, is appropriate for several independent reasons. As discussed in the 2025 proposed rule, covered financial institutions that would reasonably expect to be above the new 1,000-loan origination threshold will need additional time to adjust their compliance systems to the changes to Regulation B, subpart B made by this final rule. The revisions not only reduce certain reporting requirements, such as the elimination of many of the discretionary data points, but also change existing requirements concerning statutorily required demographic data points, consistent with the Defending Women E.O. Such revisions to the rule will require financial institutions that have already prepared to comply with the 2023 final rule to change forms, customer interfaces, or other compliance software or regulatory processes.
Further time will also be necessary for some institutions to determine whether they are covered at all under the rule, given the modification of the threshold for covered financial institutions from 100 to 1,000 originations, as well as other changes that will result in fewer transactions being counted toward the 1,000 origination threshold, such as the additional exclusions from the definition of covered credit transaction in revised § 1002.104(b), and the change to the definition of small business in revised § 1002.106.
In making this determination, the Bureau notes that many industry commenters expressed support for extending the single compliance date as proposed and stated that the January 1, 2028 deadline would give them the time they need to comply. The Bureau acknowledges that some commenters recommended that the Bureau finalize a date later than proposed, citing the novelty and complexity of collecting the data and the need to work with third parties as reasons for the Bureau to provide them more time. As discussed above, other commenters expressed concern that there was insufficient time between the end of the proposed period for determining coverage and the proposed compliance date, and suggested that the Bureau finalize a date later than proposed, finalize a 2025 and 2026 look-back period instead, or provide the option of using a 2025 and 2026 look-back period.
The Bureau declines to adopt a compliance date later than January 1, 2028. The Bureau believes that the marginal benefits of adopting a later compliance date do not warrant further delaying the rule's reporting requirements. However, the Bureau is adopting an additional special transitional rule, in § 1002.104(c)(3) that, as discussed below, will permit, but not require, financial institutions to use 2025 and 2026, instead of 2026 and 2027, as the look-back period for purposes of determining whether they are initially covered by the rule. As such, it will afford financial institutions, especially smaller ones, greater flexibility and certainty in determining whether they are covered in advance of the January 1, 2028 compliance date.
The Bureau also determines it appropriate to adopt a single compliance date, to begin on January 1, 2028, for all covered financial institutions. The need for a tiered compliance structure is diminished by the length of time that has passed since the adoption of the 2023 final rule as well as the coverage of fewer lenders as a result of amendments to §§ 1002.104(b), 1002.105(b), and 1002.106(b). Moreover, as noted in the 2025 proposed rule, the Bureau acknowledges feedback from lenders regarding difficulties commencing compliance with the rule mid-year, which is resolved by setting a single compliance date on January 1.
Finally, the Bureau determines that its new single compliance date resolves lingering concerns arising from previous compliance date extensions. As the Bureau explained in its 2025 compliance date interim final rule and 2025 compliance date final rule, those rules were necessary to avoid a situation in which only a subset of covered financial institutions were obligated to come into compliance with the 2023 final rule. Many of these institutions will, under revised § 1002.105(b), have had too low a volume of loan originations to be covered financial institutions under this final rule. If covered financial institutions were not given additional time to comply with the changes contained in this final rule, the Bureau is concerned that credit access and data quality might be affected in a manner that would not have advanced the purposes of the statute.
The Bureau declines to finalize the new single compliance date before any other revisions to the 2023 final rule, as some commenters suggested. The Bureau concludes that finalizing all revisions at once provides greater compliance certainty and efficiency to covered financial institutions than would adopting yet another compliance date in the interim. The Bureau also declines to adopt different or staggered compliance dates for larger and smaller institutions, as some commenters suggested. The Bureau believes that between the revisions to § 1002.105(b) that focus on core lenders at the onset of data collection, and the substantial steps the Bureau understands many larger-volume lenders have taken already to comply with the rule, the reasoning underlying a system of tiered compliance dates is moot. The Bureau concludes that adopting a staggered or tiered framework would risk re-creating many of the problems that the single compliance date is designed to resolve. Additionally, for the reasons set forth above, the Bureau declines to adopt an earlier compliance date than January 1, 2028, as two commenters suggested; covered financial institutions need, at a minimum, additional time to comply with the new requirements in this final rule.
Finally, as recommended by some commenters, the Bureau expects to issue compliance materials, updated to reflect the changes made by this final rule, in advance of the compliance date.
In the 2023 final rule, financial institutions were instructed to determine their compliance tier based on their originations in 2022 and 2023. Subsequent changes to the rule added the alternative look-back periods of 2023 and 2024, or 2024 and 2025, that financial institutions could choose to use instead of 2022 and 2023. These alternatives were set out in § 1002.114(c)(3) and related commentary.
The Bureau proposed revising § 1002.114(c)(3) and related commentary to require a financial institution to count its originations of covered credit transactions in each of calendar years 2026 and 2027 to determine whether it must comply with the rule by the proposed compliance date of January 1, 2028. The Bureau believed that this proposed change would simplify § 1002.114(c) and better align it with the proposed revisions to § 1002.114(b).
As discussed above, in response to the proposed single compliance date of January 1, 2028, several industry commenters expressed concern that some financial institutions would need more time between the proposed look-back period of 2026 and 2027 and the proposed compliance date to determine whether they are covered by the rule. Some of these commenters suggested that the Bureau adopt a later compliance date. Others suggested the Bureau use 2025 and 2026 as the look-back period instead of 2026 and 2027. Yet others suggested that the Bureau provide financial institutions the option of using 2025 and 2026 as the look-back period, as well as 2026 and 2027.
The Bureau is adopting revised § 1002.114(c) as proposed with the addition of a new special transitional rule, in § 1002.114(c)(3), to address the concerns of some industry commenters. Under this provision, for purposes of determining whether a financial institution is a covered financial institution under revised § 1002.105(b) as of January 1, 2028, a financial institution is permitted, but not required, to use its originations of covered credit transactions for small businesses in the calendar years 2025 and 2026 (rather than its originations in calendar years 2026 and 2027).
Accordingly, financial institutions have the option of using the period of 2025 and 2026 instead of 2026 and 2027 for purposes of determining whether they must comply with the rule beginning January 1, 2028. The Bureau determines that this provision will provide greater clarity and certainty to financial institutions as to whether they would be covered financial institutions as of the initial compliance date. This may be particularly important for those financial institutions that originate a volume of covered credit transactions close to the 1,000-loan threshold under revised § 1002.105(b). The Bureau also determines that this provision is necessary to carry out, enforce, and compile data pursuant to section 1071.
In addition, the Bureau concludes that the range of options provided by the last iteration of § 1002.114(c), as set out in the 2025 compliance date final rule, intended to provide flexibility to potentially covered lenders, is no longer appropriate for a single compliance date with a single origination threshold. Further, revised § 1002.114(c) uses calendar years closer to the new compliance date and is a fairer time period to count originations. The January 1, 2028 compliance date in revised § 1002.114(b) is nearly five years removed from some of the two-year look-back periods used to determine when a covered financial institution must begin to collect data that had been set forth in § 1002.114(c). If a financial institution using the 2026 and 2027 look-back period would exceed 1,000 loan originations in each of 2022 and 2023, but fell below the 1,000 origination threshold in either 2026 or 2027, it would not be a covered financial institution for 2028. The Bureau thus finds that referring to the number of originations during calendar years 2026 and 2027 (or 2025 and 2026, if lenders prefer to use their originations in those years) is more appropriate and relevant to determining whether a financial institution must comply with the rule starting in January 2028.
The Bureau received comments on other aspects of the 2023 final rule that it had not proposed revising in the 2025 proposed rule.
Existing section 1002.102(o) defines principal owner as an individual who directly owns 25 percent or more of the equity interests of a business. The 2023 final rule stated that the definition is, in part, consistent with the beneficial ownership requirements in FinCEN's customer due diligence rule.
One lender called for the Bureau to adopt FinCEN's definition of beneficial owner in lieu of the definition of principal owner listed in the NPRM, as financial institutions already collect beneficial owner information and are familiar with the requirements under the Know Your Customer regulations.
The Bureau declines to revise the definition of principal owner. The definition of principal owner already borrows substantially from FinCEN's customer due diligence rule, which has been in place since 2016.
The 2023 final rule implemented the statutory “firewall” provision of 15 U.S.C. 1691c-2(d) in § 1002.108. This provision generally prohibits underwriters and other employees involved in making a determination concerning a covered credit application from accessing an applicant's demographic information collected under section 1071. However, the rule includes an exception permitting access if a financial institution determines that limiting access is not feasible. Under the rule, it is not feasible to limit access if the institution determines that an employee or officer “should have access” to the information to perform their assigned job duties, provided the institution issues a specific notice to the applicant.
The 2025 proposed rule did not contain any proposed substantive amendments to the firewall provision in § 1002.108, nor did it solicit comment on this requirement.
Although the Bureau did not propose altering the existing firewall provision in § 1002.108, a number of industry commenters, including several banks and a trade association representing community banks, expressed general opposition to the requirement. These commenters argued that the firewall imposes an unnecessary regulatory burden, does not reflect the realities of small business lending, and does not further the statute's fair lending enforcement objectives. Two banks asserted that the firewall risks disrupting established workflows, slowing communication and decision-making, introducing inefficiencies, and increasing compliance costs, which could ultimately reduce access to credit.
Many of these commenters emphasized that compliance with the firewall provision is highly difficult or impossible for small institutions and community banks. Several banks noted that employees at small banks often perform multiple functions, with commercial lending staff frequently taking applications, serving as underwriters, making credit decisions, and acting as the applicant's primary point of contact. Consequently, these commenters argued that fully segregating demographic information is not feasible without substantial staffing increases, costly system changes, and significant role restructuring.
Furthermore, a trade association and two other commenters argued that the provision interferes with the relationship-based banking model. They noted that, unlike high-volume lending, small business transactions demand individualized credit analysis, close collaboration between origination and underwriting teams, and high-contact engagement. One commenter pointed out that segregation could be counterproductive because most business loan applications are processed by commercial loan officers who personally know the applicant and participate in credit committees. Another trade association asserted that while large institutions with automated systems and a broad division of labor might be able to implement firewalls, the requirement is impossible to reconcile with the community bank model.
Commenters also raised significant concerns regarding the existing feasibility exemption and its accompanying notice requirement. Several banks argued that providing notice to the applicant that underwriters may have access to demographic data places smaller lenders at a competitive disadvantage compared to larger institutions and fintechs that can comply with the firewall and avoid providing the notice. Multiple commenters expressed concern that the required notice will raise unnecessary questions, doubts, or mistrust in the applicant's mind regarding the impartiality of the credit decision. A trade association characterized the disclosure as having no practical value, serving only to “paper the file,” and damaging the close and beneficial relationships between community banks and their borrowers.
Commenters requested various modifications to the existing rule to address these concerns. Several banks urged the Bureau to eliminate the firewall provision entirely, with one bank arguing that elimination would preserve the integrity of the data collection process without creating competitive disparities, operational burdens, or undermining borrower confidence. Other banks requested that the Bureau rely entirely on an applicant disclosure or notice provision instead of requiring a firewall. One commenter noted that the HMDA does not impose a firewall requirement and alternatively relies on applicant disclosures to adequately protect borrowers. A different commenter added that reverting to a single applicant disclosure requirement would maintain transparency while reducing the significant operational burdens of costly system redesigns, complex access controls, and additional compliance monitoring.
Finally, some commenters requested specific exemptions or thresholds to alleviate the burden. One bank suggested limiting the application of the firewall requirement to only the largest institutions. A trade association requested that community banks be exempted entirely from what it characterized as an unworkable disclosure and notice requirement. Another trade association suggested addressing the firewall burden by either increasing the activity-based loan threshold exemption or adopting a general rule exemption for banks under $10 billion in assets.
The Bureau declines to adopt the commenters' suggested modifications to the firewall provision. Because the Bureau did not propose changes to this provision in the NPRM, and because the existing framework appropriately implements the statutory mandates of section 1071 while providing significant operational flexibility, the Bureau is retaining the firewall requirements in § 1002.108 without modification.
The Bureau declines requests to eliminate the firewall provision entirely or to replace it with a HMDA-style applicant disclosure. The firewall is an explicit statutory requirement under 15 U.S.C. 1691c-2(d). Congress, which would have been aware of the HMDA data collection regime and its lack of a firewall at the time section 1071 was enacted, specifically mandated that financial institutions limit certain employees' and officers' access to the demographic information collected under this statute. Therefore, eliminating the firewall requirement entirely, or relying solely on a single disclosure requirement for all institutions regardless of feasibility,
The Bureau disagrees with commenters' assertions that the firewall provision fails to reflect the realities of small business lending, requires costly system redesigns and staffing increases, or fundamentally interferes with the relationship-based banking model of community banks. The Bureau believes these concerns are largely resolved by the substantial flexibility already built into the rule's feasibility exception. Under § 1002.108(c) and its associated commentary, a financial institution is not required to maintain a firewall for an employee or officer if it determines that the individual “should have access” to the information to perform their assigned job duties.
The Bureau also declines to exempt community banks from the notice requirement when utilizing the feasibility exception, as providing this notice is a statutory condition of the exception under 15 U.S.C. 1691c-2(d)(2). The Bureau disagrees with the characterization that the disclosure has no practical value or merely serves to “paper the file.” Congress explicitly provided applicants with the right to refuse to provide the requested demographic information. The required notice serves the practical purpose of informing applicants that individuals involved in making their credit decision may see their demographic data, allowing the applicant to make an informed choice about whether to exercise their statutory right to refuse.
Regarding concerns that the notice will place smaller lenders at a competitive disadvantage or raise mistrust and doubts regarding the impartiality of the credit decision, the Bureau notes that the rule provides flexibility to mitigate these issues. The rule does not mandate the use of specific language. While the Bureau provides sample language in the sample data collection form at appendix E, financial institutions are free to use different language that better suits their customer relationships, provided the notice informs the applicant of the statutorily required information. The Bureau believes this flexibility will allow community banks to maintain borrower confidence while fulfilling their compliance obligations.
Finally, the Bureau declines to adopt specific exemptions from the firewall provision for institutions under $10 billion in assets, or to limit the firewall's application only to the largest institutions. Creating a separate compliance regime specifically for the firewall would add unnecessary regulatory complexity. Furthermore, the Bureau believes that the burden on smaller institutions is already appropriately addressed by the broader threshold changes adopted in this final rule. Specifically, the revised definition of a small business in § 1002.106(b), which sets the gross annual revenue threshold at $1 million rather than $5 million, combined with the increased institutional coverage threshold in § 1002.105(b) and additional product exclusions in § 1002.104(b), will naturally exclude many of the smallest institutions from the rule entirely and reduce the overall volume of reportable transactions for others. The Bureau concludes that these revisions sufficiently balance the benefits of data collection with the need to minimize industry burden, making additional, firewall-specific exemptions unwarranted.
One trade association suggested that the Bureau include a severability clause in the rule to safeguard any revisions to the existing rule to the extent possible in the event that discrete aspects of this final rule are challenged and set aside in Federal court.
The Bureau notes that the existing rule already includes a severability clause in § 1002.113, which provides that “[i]f any provision of this subpart, or any application of a provision, is stayed or determined to be invalid, the remaining provisions or applications are severable and shall continue in effect.”
The Bureau intends that the provisions of this final rule are separate and severable from one another. If any provision of this final rule or the 2023 final rule as modified by this rule, or any application of a provision, is stayed or determined to be invalid, the remaining provisions or applications are severable and shall continue to be in effect. The Bureau has designed each provision—including but not limited to the covered credit transaction exclusions articulated in § 1002.104(b), the covered financial institution exclusions in § 1002.105(b), and the small business definition in § 1002.106(b)—to operate independently so that the effect of each provision will continue regardless of whether one or another provision is not effectuated. Therefore, any of the revisions in this final rule concerning the coverage of certain products, financial institutions, applicants, or data points, or other provisions including those concerning how financial institutions should report data, compliance dates for covered financial institutions, and any other provisions are intended to be separate and severable. Moreover, aspects of these provisions are also intended to be severable, if any portion is not effectuated.
In the 2023 final rule, the Bureau offered a preliminary assessment, based on comments received on the 2021 proposed rule, of how it might appropriately balance and advance privacy interests through the selective deletion or modification of data. It did not make final, binding decisions regarding specific modifications or deletions, nor did it reach conclusions regarding the procedural vehicle it would use to convey those decisions.
The 2025 proposed rule did not include any proposed revisions and solicited no comments on its preliminary assessment, set out in the 2023 final rule, of how it might appropriately assess and advance privacy interests by means of selective deletion or modification.
Nevertheless, the Bureau received comments regarding the public release and transparency of collected data. Industry participants raised a number of privacy and re-identification concerns,
A wide range of industry commenters, including banks, credit unions, and trade associations, warned that publishing granular loan data creates a meaningful risk of reverse-engineering and re-identifying small businesses. Commenters emphasized that these re-identification risks are particularly severe in rural communities and niche markets where anonymity is difficult to maintain. Industry commenters argued that this loss of privacy could damage borrower trust, chill credit application rates, and expose proprietary underwriting and pricing models. Furthermore, they cautioned that publishing data without the full context of a lender's underwriting considerations could result in unfair reputational harm to financial institutions.
To mitigate these risks, industry commenters urged the Bureau to implement robust aggregation and suppression standards. Several lenders and trade associations requested that the Bureau finalize a formal privacy-balancing framework through a separate notice-and-comment rulemaking process prior to requiring institutions to submit data or publishing any data. They opposed relying on post-hoc balancing tests or undefined future judgment calls, arguing that sensitive information must be protected through formal, upfront standards. Other high-level suggestions from industry included eliminating data points not explicitly required by statute, restricting the use of the data to specific enforcement or academic purposes, and ensuring clear caveats are provided alongside any published data to prevent misinterpretation.
Conversely, community groups urged the Bureau not to delay the publication of data, describing public availability as the linchpin of section 1071 and a foundational mechanism to combat redlining and ensure a fair marketplace. Pointing to the history of HMDA, one commenter requested that data be published on the Bureau's website in a searchable, downloadable format. Other commenters emphasized that the data must be sufficiently detailed to allow the public and researchers to assess local and national trends, hold lenders accountable, and build trust within communities.
The Bureau is not making any specific modification or deletion decisions with respect to the publication of application-level data in this final rule. The Bureau acknowledges the feedback it has received from stakeholders regarding the privacy of small business applicants, the risk of re-identification, and the importance of public data availability to fulfill the statutory purposes of section 1071.
The Bureau acknowledges commenters' concerns regarding re-identification—particularly in rural and niche markets—as well as requests for a formal notice-and-comment rulemaking to establish a privacy-balancing framework. The Bureau reiterates that it needs a full year's worth of reported data to conduct the re-identification analysis necessary to determine the appropriate modifications or deletions to make to application-level data. Under the compliance date finalized in this rule, the first full year of data will be collected in 2028 and submitted to the Bureau by June 1, 2029.
The Bureau, after further consideration and in response to comments received, has determined that the appropriate vehicle to memorialize its modification and deletion decisions is a notice-and-comment rulemaking under 5 U.S.C. 553. The Bureau believes that its previous, preliminary determination that an APA rulemaking was not necessary is erroneous. In support of its previous determination, the Bureau cited 15 U.S.C. 1691c-2(e)(4), which provides that the Bureau “may, at its discretion, delete or modify data collected under this section which is or will be available to the public, if the Bureau determines that the deletion or modification of the data would advance a privacy interest.”
The Bureau believes that in the 2023 final rule it read section 1691c-2(e)(4) in isolation, ignoring the fuller statutory context of the provision. In the 2023 final rule, the Bureau appeared not to consider either 15 U.S.C. 1691c-2(f)(2)(C), under which section 1071 data shall “annually [be] made available to the public generally by the Bureau, in such form and in such manner as is determined by the Bureau,
The Bureau now believes that the better reading of section 1691c-2(e)(4) is in conjunction with section 1691c-2(f)(2)(C) and the whole of section 1691c-2(e). In full context, section 1071 enables the Bureau to use its discretion to make modification or deletion decisions prior to the publication of application-level data, but because those modifications expressly implicate the “form and manner of information” under 1691c-2(e), the Bureau believes such modification or deletion decisions must be announced and made by way of regulation.
Further, in light of the statutory purpose in section 1691c-2(a) to enable communities, governmental entities, and creditors to identify business and community development needs and opportunities,” the Bureau believes it requires public input on how data will be modified or deleted to ensure that that purpose is met. In light of this provision, the Bureau believes that it would be imprudent to decide what data to make publicly available without public input. As a result, even if the statute did not require the Bureau to make these determinations via a notice-and-comment rulemaking, considering and responding to public input would clearly be appropriate.
As a result, the Bureau now commits to releasing a notice of proposed rulemaking, with proposed modifications and deletion decisions for specific data points, in a timely fashion after it has received and analyzed a full year's worth of section 1071 data.
The Bureau is adopting an effective date of 60 days after the publication of this final rule in the
In the 2023 final rule, the Bureau adopted a 12-month grace period during which the Bureau—for covered financial institutions under its supervisory and enforcement jurisdiction—would not intend to assess penalties for errors in data reporting, and would intend to conduct examinations only to diagnose compliance weaknesses, to the extent that these institutions engaged in good faith compliance efforts. The Grace Period Policy Statement set forth in the 2023 final rule explained the Bureau's reasons for adopting such a grace period along with how the Bureau intended to implement such a grace period.
Although the Bureau did not address the grace period policy statement in the proposal, it did announce its intention to maintain the grace period for the same reasons articulated in the 2023 final rule, as amended in the 2025 interim final rule, and to coincide with the proposed compliance date, if finalized. Several industry commenters responded to this announcement. All of these commenters expressed support for a grace period, though some suggested that the Bureau provide a longer grace period or issue a more robust statement than in the past, among other things.
The Bureau is again updating its Grace Period Policy Statement to reflect the new single compliance date set forth in this final rule.
With respect to covered financial institutions subject to the Bureau's supervisory or enforcement jurisdiction that make good faith efforts to comply with this final rule, the Bureau intends to provide a grace period to reflect the new single compliance date. The Grace Period Policy Statement will apply to those covered financial institutions that must comply with the new single compliance date specified in revised § 1002.114(b)(1), as well as any financial institutions that make a voluntary submission for the first time for data collected in 2028, for data collected in 2028,
As discussed in the 2023 final rule, the 2024 and 2025 interim final rules, and the 2025 compliance date final rule, the Bureau believes that a 12-month grace period will give institutions time to diagnose and address unintentional errors without the prospect of penalties for inadvertent compliance issues, and may ultimately assist other covered financial institutions, especially those in later compliance tiers, in identifying best practices. The Bureau views this grace period as enabling deliberate and thoughtful compliance with the rule, while still providing important data regarding small business lending as soon as is practical.
During the grace period, if the Bureau identifies errors in a financial institution's initial data submissions, it does not intend to require data resubmission unless data errors are material. Further, the Bureau does not intend to assess penalties with respect to unintentional and good faith errors in the initial data submissions. Any examinations of these initial data submissions will be diagnostic and will help to identify compliance weaknesses. However, errors that are not the result of good faith compliance efforts by financial institutions, especially attempts to discourage applicants from providing data, will remain subject to the Bureau's supervisory and enforcement authority.
The Bureau believes that the grace period covering the initial data submissions will provide financial institutions an opportunity to identify any gaps in their implementation of this final rule and make improvements in their compliance management systems for future data submissions. In addition, a grace period will permit the Bureau to help financial institutions identify errors and, thereby, self-correct to avoid such errors in the future. The Bureau can also use data collected during the grace period to alert financial institutions of common errors and potential best practices in data collection and submissions under the rule.
In developing this final rule, the Bureau has considered the potential benefits, costs, and impacts as required by section 1022(b)(2) of the Consumer Financial Protection Act of 2010 (CFPA). Section 1022(b)(2) calls for the Bureau to consider the potential benefits and costs of a regulation to consumers and covered persons, including the potential reduction of consumer access to consumer financial products or services, the impact on depository institutions and credit unions with $10 billion or less in total assets as described in section 1026 of the CFPA, and the impact on consumers in rural areas.
In the Dodd-Frank Act, which was enacted “[t]o promote the financial stability of the United States by improving accountability and transparency in the financial system,” Congress directed the Bureau to adopt regulations governing the collection of small business lending data. Under section 1071 of that Act, covered financial institutions must compile, maintain, and submit certain specified data points regarding applications for credit for small businesses, with particular attention to women-owned and minority-owned small businesses, along with “any additional data that the Bureau determines would aid in fulfilling the purposes of this section.” Under the 2023 final rule, covered financial institutions are required to collect and report the following data points: (1) a unique identifier, (2) application date, (3) application method, (4) application recipient, (5) credit type, (6) credit purpose, (7) amount applied for, (8) amount approved or originated, (9) action taken, (10) action taken date, (11) denial reasons, (12) pricing information, (13) census tract, (14) gross annual revenue, (15) NAICS code, (16) number of workers, (17) time in business, (18) minority-owned, women-owned, and LGBTQI+-owned business status, (19) ethnicity, race, and sex of principal owners, and (20) the number of principal owners.
Under the 2023 final rule, financial institutions are required to report data on small business credit applications if they originated at least 100 covered credit transactions in each of the two preceding calendar years. Loans, lines of credit, credit cards, and merchant cash advances (including such credit transactions for agricultural purposes) all fall within the transactional scope of the 2023 final rule, with no limitations on loan amount. The Bureau excluded trade credit, transactions that are reportable under HMDA, insurance premium financing, public utilities credit, securities credit, and incidental credit. Factoring, leases, and consumer-designated credit used for business or agricultural purposes are also not covered credit transactions. For purposes of the 2023 final rule, a business is a small business if its gross annual revenue for its preceding fiscal year is $5 million or less. Finally, the 2023 final rule, as subsequently amended, establishes several compliance dates for financial institutions based on three origination size thresholds.
This final rule amends or removes certain provisions of the 2023 final rule. Under this final rule, covered financial institutions will no longer be required to collect and report the following data points: application method, application recipient, denial reasons, pricing
In addition, under this final rule, a financial institution is required to report data if the financial institution originated at least 1,000 covered credit transactions in each of the two preceding calendar years, and one category of financial institutions (FCS lenders) is excluded from coverage. The Bureau is also excluding merchant cash advances, credit transactions for agricultural purposes, and small dollar loans of $1,000 or less from the transactional scope of the rule. For the purposes of this final rule, a business is a small business if its gross annual revenue for its preceding fiscal year is $1 million or less. Finally, this final rule changes the compliance date provision to require a single compliance date for covered financial institutions.
Congress directed the Bureau to adopt regulations governing the collection of small business lending data. Specifically, section 1071 of the Dodd-Frank Act amended ECOA to require financial institutions to compile, maintain, and submit to the Bureau certain data on applications for credit for small businesses, particularly women-owned and minority-owned small businesses. Congress enacted section 1071 for the purpose of facilitating enforcement of fair lending laws and enabling communities, governmental entities, and creditors to identify business and community development needs and opportunities of women-owned, minority-owned, and small businesses. The Bureau is issuing this final rule to amend portions of the 2023 final rule in order to more effectively fulfill section 1071's statutory purposes.
As discussed in parts I and III, the Bureau believes, in retrospect, that its approach in the 2023 final rule was not conducive to fulfilling the long-term statutory purposes of section 1071 of the Dodd-Frank Act. The Bureau now believes that a more incremental approach will limit, as much as possible, any disturbance to the provision of credit to small entities. The Bureau expects that a more gradual approach to adding data points or expanding coverage, if needed, will more effectively serve both the fair lending and community development purposes of the rule in the long run.
In particular, the Bureau believes it should focus on core lending products, core lending providers, and core data points, rather than take the more expansive approach of its 2023 final rule. To accomplish this, the Bureau is making multiple changes to the 2023 final rule. Among the most consequential changes, the Bureau is exempting several categories of credit from the definition of covered transactions, including merchant cash advances, loans for agricultural purposes, and small dollar loans. The Bureau now believes that application data collected on these types of transactions would be of lower quality while imposing collection requirements on institutions that issue them. The Bureau also is raising the number of loans that trigger reporting requirement to 1,000 and exempting FCS lenders from coverage of the rule to focus on core providers in the small business lending space. The Bureau is changing the definition of “small business” in § 1002.106(b) from $5 million or less to $1 million or less in annual gross revenue to ensure that data is collected on truly small businesses, rather than also collect data on businesses that could be considered large in some contexts. Lastly this final rule removes several data points from the collection, relative to the 2023 final rule, including application method, application recipient, denial reasons, pricing and number of workers to limit the initial compliance costs for collecting and reporting data in compliance with section 1071.
The Bureau believes these changes help further the statutory purposes, for facilitating fair lending enforcement and community development, in several ways. By reducing the initial burden of the data collection on some institutions and removing the collection requirement from others, the Bureau believes that it will reduce disruption in the small business lending market compared to the more expansive 2023 final rule requirements. Disruption in the small business lending market could run counter to the community development purposes of this final rule. By focusing the data collection on core providers, transactions, and data points the Bureau expects the data collected under this final rule will be of higher quality and will be more useful for fair lending enforcement and community development.
In evaluating the potential benefits, costs, and impacts of this final rule, the Bureau takes as a baseline that all financial institutions covered under the 2023 final rule are in appropriate compliance with that rule, as codified in subpart B of Regulation B and amended by the 2024 interim final rule, the 2025 interim final rule, and the 2025 compliance date final rule.
Pursuant to section 1022(b)(2)(A) of the Dodd-Frank Act,
The Dodd-Frank Act defines the term “consumer” as an individual or someone acting on behalf of an individual. It defines a “covered person” as one who engages in offering or providing a “consumer financial product or service,” which means a
Below, the Bureau conducts the statutorily required analysis with respect to this final rule's effects on consumers and covered persons. Additionally, consistent with the approach in the 2023 final rule, the Bureau is electing to conduct this same analysis with respect to small businesses and the financial institutions that will be required to compile, maintain, and submit data under this final rule. This analysis relies on data that the Bureau has obtained from industry, other regulatory agencies, and publicly available sources. However, as discussed further below, the available data limit the Bureau's ability to quantify the potential costs, benefits, and impacts of this final rule.
The 2023 final rule implemented a data collection regime in which certain covered financial institutions must compile, maintain, and submit data with respect to applications for credit for small businesses. This final rule amends that implementation. This final rule will not directly impact consumers, including consumers in rural areas, as those terms are defined by the Dodd-Frank Act. However, some consumers may be impacted in their separate capacity as sole owners of small businesses covered by this final rule. Some covered persons, including some depository institutions or credit unions with $10 billion or less in total assets, will be affected under this final rule not in their capacity as covered persons (
This final rule modifies the 2023 final rule with respect to which financial institutions and transactions are covered, and which data points are required to be collected and reported. Many financial institutions that are not covered by this final rule will still be impacted by it because they would have been covered under the 2023 final rule (as amended). The Bureau analyzes the impacts of this final rule relative to the baseline (1) on covered institutions and (2) on institutions that are no longer covered and calls the combined group of institutions “impacted financial institutions.” The main expected benefit of this final rule to impacted financial institutions comes in the form of cost savings. The Bureau calculates these cost savings by estimating the change in compliance costs between this final rule and the baseline.
In order to precisely quantify the cost savings for impacted financial institutions, the Bureau would need representative data and information on the operational costs that financial institutions would incur to gather and report section 1071 data, on one-time costs for financial institutions to update or create reporting infrastructure to implement requirements of this final rule, and on the level of complexity of financial institutions' business models and compliance systems. Furthermore, the Bureau would need this information under both the baseline and this final rule. Currently, the Bureau does not believe that data on section 1071 reporting costs with this level of granularity are systematically available from any source. The Bureau has made reasonable efforts to gather data on section 1071 reporting costs and primarily uses the same methodology that it used to analyze the 2023 final rule, unless otherwise noted. The Bureau continues to believe that its analysis here and in the 2023 final rule constitutes the most comprehensive assessment to date of the compliance costs associated with implementing section 1071 reporting by financial institutions and provides the most accurate estimates of costs given available information. However, the Bureau recognizes that these estimates may not fully quantify the costs to each covered financial institution, especially given the wide variation of section 1071 reporting costs among financial institutions.
The Bureau categorizes costs required to comply with the baseline and this final rule into “one-time” and “ongoing” costs. Similarly, the Bureau reports cost savings in these terms. “One-time” costs refer to expenses that the financial institution incur initially and only once to implement changes required in order to comply with the requirements of a rule. “Ongoing” costs are expenses incurred as a result of the ongoing reporting requirements of a rule, which the Bureau considers on an annualized basis. In considering the costs and impacts of the 2023 final rule, the Bureau engaged in a series of efforts to estimate the cost of compliance by covered entities. The Bureau conducted a One-Time Cost Survey, discussed in more detail in part IX.E.1 of the 2023 final rule,
The Bureau understands that some financial institutions that are covered under the baseline have started implementing the 2023 final rule. Institutions that are no longer covered as a result of this final rule may have already incurred some one-time costs to implement the baseline that are not necessary under this final rule. The Bureau does not count these expenditures as costs of this final rule because those costs have already been incurred and are discussed in more detail in part VI.E.1. Instead, the Bureau accounts for these expenditures through reductions in cost savings. If an institution is no longer covered as a result of this final rule, it will no longer be able to recoup all one-time implementation costs, as discussed in part VI.E.1.
Consistent with the 2023 final rule, the Bureau elects to estimate the benefits and cost savings to small businesses in addition to cost and benefit savings to impacted financial institutions. As with financial institutions, the Bureau expects that the main benefits of this final rule to small businesses will arise as a result of cost savings. The Bureau expects the direct cost savings of this final to small businesses will be negligible. However, the Bureau expects that there would be indirect cost savings from this final rule to small businesses if financial institutions pass on their cost savings. Therefore, the Bureau focuses its analysis on whether and how the Bureau expects impacted financial institutions to pass on the cost savings from this final rule to small businesses and any possible effects on the availability or terms of small business credit. The Bureau relies on economic theory to understand the potential for cost savings of financial institutions to be passed on to small businesses.
The costs to small businesses and to impacted financial institutions associated with this final rule will primarily come from a decrease in the benefits associated with the 2023 final rule. As discussed above, Congress enacted section 1071 for the purpose of facilitating enforcement of fair lending laws and enabling communities, governmental entities, and creditors to identify business and community development needs and opportunities of women-owned, minority-owned, and small businesses. Quantifying these benefits to small businesses presents substantial challenges because the Bureau does not have the data to do so and because the Bureau is not able to assess how effective the 2023 final rule would be in achieving those benefits. The same difficultly holds for the change in benefits associated with this final rule. As discussed further below, as a data reporting rule, most provisions of the baseline and this final rule will benefit small businesses in indirect ways, rather than directly.
Similar issues arise in attempting to quantify the decrease in benefits to impacted financial institutions. Certain benefits to impacted financial institutions are difficult to quantify. For example, the Bureau believes that the data collected under both the baseline and this final rule will reduce the compliance burden of fair lending reviews for lower risk financial institutions that are likely to be in compliance with ECOA by reducing the “false positive” rates during fair lending prioritization by regulators. However, the Bureau does not have the information to quantify such benefits.
In light of these data limitations, the discussion below generally provides a qualitative consideration of the reduction of benefits under this final rule relative to the baseline. General economic principles, together with the limited data available, provide insight into the loss of benefits. Where possible, the Bureau makes quantitative estimates based on these principles and the data that are available. Quantifying these benefits is difficult because the size of each effect cannot be known in advance. Given the number of small business credit transactions and the size of the small business credit market, however, small changes in behavior can have substantial aggregate effects.
In addition, financial institutions that remain covered under this final rule may incur adjustment costs. This occurs when institutions have already made efforts to implement the provisions of the 2023 final rule and incur additional costs to modify their existing implementation to comply with this final rule. If a financial institution has not begun to implement the 2023 final rule, then it will not incur adjustment costs.
This final rule provides that financial institutions (both depository and nondepository) that meet all the other criteria for a “financial institution” in § 1002.105(a) will only be required to collect and report section 1071 data if they originated at least 1,000 covered credit transactions in each of the two preceding calendar years. In addition, under this final rule, FCS lenders will not be required to collect and report section 1071 data, even if they meet this new threshold.
As discussed above, market-wide data on small business lending are currently limited. The Bureau is unaware of any comprehensive data available on small business originations for all financial institutions, which are needed to precisely identify all institutions to be covered by this final rule or the 2023 final rule. To estimate the change in coverage as a result of this final rule, the Bureau uses publicly available data for financial institutions divided into two groups: depository (
With respect to depository institutions, the Bureau relies on National Credit Union Administration (NCUA) Call Reports to estimate coverage for credit unions, including for those that are not federally insured, and Federal Financial Institutions Examination Council (FFIEC) Call Reports and the CRA data to estimate coverage for banks and savings associations. For the purposes of the analysis in this part VI.D, the Bureau estimates the number of depository institutions that would have been required to report small business lending data for 2023, based on the estimated number of originations of covered products for each institution in 2022 and 2023.
The NCUA Call Report captures the number and dollar value of originations on all loans over $50,000 to members for commercial purposes, regardless of any indicator about the borrowing business's size. For the purposes of estimating the impacts of this final rule, the Bureau uses the annual number of originated commercial loans to members reported by credit unions as a proxy for the annual number of originated covered credit transactions under the rule.
The FFIEC Call Report captures banks' and savings associations' outstanding number and dollar amount of small loans to businesses (
Although banks and savings associations reporting under the CRA are required to report the number of originations of small loans to businesses and farms, the Bureau is not aware of any comprehensive dataset that contains originations made by banks and savings associations with assets below the CRA reporting threshold. To fill this gap, the Bureau simulated plausible values for the annual number and dollar value of originations for each bank and savings association that falls below the CRA reporting threshold for 2022 and 2023.
Based on 2023 data from FFIEC and NCUA Call Reports and the CRA data, using the methodology described above, the Bureau estimates that the number of depository institutions that will be required to report under this final rule is between approximately 172 to 181, as shown in Table 1 below. This comprises between 167 and 176 banks and savings associations and five credit unions that will be required to report under this final rule. These ranges represent 95 percent confidence intervals over the number of credit unions, banks and savings associations that will be covered under this final rule. The Bureau presents this range to reflect the uncertainty associated with the estimates and notes that the uncertainty is driven by the lack of data on originations by banks and savings associations below the CRA reporting threshold.
The Bureau also estimates the number of institutions that would have been covered under the baseline but are no longer covered under this final rule, using the same methodology discussed above. A depository institution would have been covered at the end of 2023 by the 2023 final rule if that institution had over 100 small business and small farm loan originations in 2022 and 2023, accounting for mergers. The Bureau estimates that the number of depository institutions required to report under the 2023 final rule but that will not be required to report under this final rule is between approximately 1,421 to 1,570 institutions, as shown in Table 2 below.
The Bureau does not have sufficient information to meaningfully estimate the change in the number of nondepositories relative to the analysis conducted for the 2023 final rule. For consistency with the method the Bureau uses to estimate covered depository institutions, the Bureau estimates the number of nondepository institutions impacted by the final rule as of the end of 2023. For the purposes of the analysis of the impacts of this final rule, the Bureau assumes that the number of nondepository institutions that are active in the small business lending market has not changed since the 2023 final rule, except for FCS members, for which the Bureau relies on data from the FCA, and merchant cash advance (MCA) providers, as discussed below. See part II.D of the 2023 final rule for more detail on how the Bureau arrived at these estimates.
The Bureau estimates that the 2023 final rule would have covered about 610 nondepository institutions, consisting of: about 30 online lenders; about 140 nondepository Community Development Financial Institutions (CDFIs); about 100 merchant cash advance providers; about 240 commercial finance companies; about 70 governmental lending entities; and 60 Farm Credit System members.
One industry trade association provided additional information that there were about 100 MCA providers as of March 2024.
In part IX.E of the 2023 final rule, the Bureau explained its methodology for generating estimates of one-time and ongoing costs associated with complying with the 2023 final rule. As discussed in the previous section, many financial institutions that were covered by the 2023 final rule are no longer
The Bureau expects that compliance costs vary with the complexity of a financial institution's compliance operations. Consistent with the 2023 final rule and for the purposes of this final rule, the Bureau categorizes impacted financial institutions (FIs) into Types A, B, and C in increasing order of compliance operations complexity. Based on its prior methodology, the Bureau assumes that this complexity is correlated with the number of small business loan applications received, and therefore categorizes institutions based on application volume. The Bureau assumes that Type A FIs receive fewer than 300 applications per year, Type B FIs receive between 300 and 2,000 applications per year, and Type C FIs receive more than 2,000 applications per year. The Bureau assumes that, for Type A and B FIs, one out of two small business applications will result in an origination. Thus, the Bureau assumes that Type A FIs originate fewer than 150 covered credit transactions per year and Type B FIs originate between 150 and 999 covered credit transactions per year. The Bureau assumes that Type C FIs originate one out of three small business applications and at least 1,000 covered credit transactions per year.
The Bureau recognizes that the changes in this final rule, as discussed in subsequent sections, will remove most Types A and B financial institutions from coverage. However, the Bureau maintains both these categorizations and assumptions in order to estimate compliance at baseline and compare it to coverage under this final rule.
The Bureau understands that compliance costs vary across financial institutions due to many factors, such as size, operational structure, and product complexity, and that this variance exists on a continuum that is very difficult or impossible to fully represent. Due to data limitations, the Bureau is unable to capture many of the ways in which compliance costs vary by institution, and therefore uses these representative financial institution types with the above assumptions for its analysis. In order to aggregate costs to a market level, the Bureau must map financial institutions onto its types using discrete volume categories.
For the hiring costs discussion in part VI.F.1.i and ongoing costs discussion in part VI.F.1.ii below, the Bureau discusses costs in the context of
The one-time compliance cost estimation methodology for this final rule described in this section is the same methodology that the Bureau used in the 2023 final rule, unless otherwise noted.
The Bureau has identified the following nine categories of one-time costs that will likely be incurred by financial institutions to develop the infrastructure to collect and report data under the baseline and this final rule:
The Bureau also conducted a survey in 2020 regarding one-time implementation costs for section 1071 compliance targeted at financial institutions who extend small business credit.
Estimates from the 2020 survey respondents continue to form the basis of the Bureau's estimates for one-time compliance costs in assessing the impact of this final rule. The survey was broadly designed to ask about the one-time costs of reporting data under a regime that only included mandatory data points, used a reporting structure similar to HMDA, used the Regulation B definition of an “application,” and used the respondent's own internal small business definition.
The Bureau assumes that the number of employee hours required to implement each task has not changed but that the wages have changed to reflect labor market developments. The Bureau assumes that each task may require junior, mid-level, and senior staff hours to implement. For junior staff, the Bureau uses $18.51, the 10th percentile hourly wage estimate for “loan officers” according to the 2024 Occupational Employment Statistics compiled by the Bureau of Labor
Finally, the Bureau assumes that the non-salary expenses necessary to implement each one-time task have only changed according to inflation, as measured by the Consumer Price Index.
For hiring costs, the Bureau also assumes that a covered financial institution will need to hire enough full-time equivalent workers (FTEs) to cover the estimated number of staff hours necessary to comply with either the 2023 final rule or this final rule on an annual, ongoing basis. In part VI.E.2 below, the Bureau describes how it estimates the ongoing costs to comply with the 2023 final rule and this final rule, including the number of hours of staff time an institution needs per application. The Bureau assumes for the baseline and this final rule that an FTE will work about 2,080 hours each year (40 hours per week × 52 weeks = 2,080). The Bureau calculates that the total number of FTEs that a covered financial institution will need to hire as the number of hours per application multiplied by the estimated number of applications received per year divided by 2,080, rounded up to the next full FTE. For example, if an institution receives 500 applications per year and an employee spends one hour on each application, it will need to hire one FTE ((1 * 500)/2080 = 0.24, which is rounded up to the next full FTE,
The Bureau calculates the hiring costs using the estimated cost-per-hire of $4,683, estimated by the Society for Human Resource Management.
The Bureau assumes that some financial institutions covered by the 2023 final rule have already incurred some one-time costs in order to comply with the rule. For institutions that will no longer be covered under this final rule, those costs are sunk and cannot be recouped. The Bureau believes that, while some one-time cost activities already underway could be used for complying with this final rule, some of those activities will need to be redone in order to comply. The Bureau makes this rough assumption to capture this possibility and potential sunk cost. As discussed above, the Bureau believes, to the extent this has occurred, this reduces the institution's potential benefits under this final rule. The Bureau does not have sufficient information upon which to base its estimate of how much these institutions may have already spent upgrading their systems and, instead, makes an assumption that institutions that will no longer be covered under this final rule, on average, will have incurred 25 percent of their baseline non-hiring one-time costs. That is, institutions no longer covered by this final rule will save 75 percent of the estimated non-hiring one-time costs under the baseline, because they have not yet spent those resources. The Bureau assumes that these institutions have not yet hired new employees under the baseline. The Bureau believes these are reasonable assumptions as to the extent of one-time costs already incurred by these institutions. Under these assumptions, the total cost savings for institutions that will no longer be covered is estimated to be 75 percent of the one-time costs of implementing tasks 1-8 listed above, plus the expected hiring costs associated with the baseline.
Institutions that were covered under the baseline may have implemented changes to their processes and systems to comply with the 2023 final rule. If an institution will no longer be covered under this final rule, some of these costs may be sunk. For example, the institution may have developed a manual of policies and procedures that are no longer required if the institution is no longer covered. To the extent these institutions have already incurred some of these expenses, the Bureau believes this reduces their one-time cost savings from this final rule.
If an institution remains covered under this final rule, some of their implementation may continue to be applicable under this final rule. Other parts of their implementation may need to be changed to comply with this final rule, and thus the institution may incur the same one-time cost again. For example, an institution that already started designing data collection forms may have to change the design. The Bureau includes incurring these expenses again as part of its calculation for institutions that remain covered.
The Bureau does not have the requisite information to empirically estimate how much of the one-time costs, under the baseline, any institution is likely to have incurred. Therefore, the Bureau has decided to make a simple assumption. The Bureau assumes that all institutions will have incurred 25 percent of their non-hiring, one-time costs, at baseline, in preparation to comply with the 2023 final rule. For financial institutions that were covered under the 2023 final rule but will not be covered under this final rule, the Bureau assumes that this final rule will save the remaining 75 percent of the non-hiring, one-time costs, at baseline, plus their hiring costs.
For institutions that are covered under the baseline and will be covered under this final rule, the Bureau assumes that 25 percent of one-time, non-hiring costs under the baseline have already been incurred and are, likewise, sunk. Therefore, the one-time cost savings for these institutions are the one-time hiring and non-hiring costs under this final rule minus the one-time hiring costs and 75 percent of the non-hiring costs under the baseline.
In the 2023 final rule, the Bureau identified 15 specific data collection and reporting activities that would impose ongoing compliance costs for covered institutions and continues to use those activities as an organization principle for its analysis of the impacts of this final rule. Table 3 presents the full list of the 15 activities. The Bureau assumes that substantially the same activities will be needed to comply with this final rule. Activities 1 through 3 can broadly be described as data collection activities: these tasks are required to intake data and transfer it to the financial institution's small business data entry system. Activities 4 through 10 are related to reporting and resubmission: these tasks are necessary to collect required data, conduct internal checks, and report data consistent with the 2023 final rule or this final rule. Activities 11 through 13 are related to compliance and internal audits: employee training, and internal and external auditing procedures required to ensure data consistency and reporting in compliance with the 2023 final rule or this final rule. Finally, activities 14 and 15 are related to small business lending examinations by regulators: these tasks will be undertaken to prepare for and assist during regulatory compliance examinations. For the purpose of this analysis and for consistency with the 2023 final rule, the Bureau assumes that all financial institutions covered under this final rule or the baseline will be subject to regulatory compliance examinations and thus incur costs related to activities 14 and 15.
Table 3 also provides an example of how the Bureau calculates ongoing compliance costs associated with each compliance task. The table shows the calculation for each activity and notes whether the task is a “variable cost,” which depends on the number of applications the institution receives, or a “fixed cost” that does not depend on the number of applications. Table 3 shows these calculations for a Type A FI, or the institution with the least amount of complexity. Table 4 below summarizes the activities whose calculation differs by institution complexity and shows the calculations for Type B FIs and Type C FIs (where they differ from those for a Type A FI).
Many
In the 2023 final rule, the Bureau explained how it arrived at its assumed number of hours required per task and makes the same assumptions in this final rule.
Some activity costs in Table 3 depend on the number of applications. It is important to differentiate between these variable costs and fixed costs that do not depend on number of applications because the type of cost impacts whether and to what extent covered institutions might be expected to pass on their costs to small business loan applicants in the form of higher interest rates or fees (discussed in more detail in part VI.F.2 below). Data collection, reporting, and submission activities such as geocoding data, standard annual edits and internal checks, researching questions, and resolving question responses are variable costs. All other activities are fixed costs because they do not depend on the overall number of applications being processed. An example of a fixed cost calculation is exam preparation, where the hourly compensation is multiplied by the number of total hours required by loan officers to prepare for 1071-related compliance examinations.
Table 4 shows where and how the Bureau assumes Type B FIs and Type C FIs differ from Type A FIs for the purposes of evaluating ongoing cost. Table 4 shows the activities where the assumptions differ from those in Table 3. Type B FIs and Type C FIs use more automated procedures, which result in different cost calculations. For example, for Type B FIs and Type C FIs, transferring data to the data entry system and geocoding applications are done automatically by business application data management software licensed annually by the financial institution. The relevant address is submitted for geocoding via batch processing, rather than done manually for each application. The additional ongoing geocoding costs reflect the time spent by loan officers on “problem” applications—that is, a percentage of overall applications that the geocoding software misses—rather than time spent on all applications. However, Type B FIs and Type C FIs have the additional ongoing cost of a subscription to a geocoding software or service as well as a data management software that represents an annual fixed cost of reporting 1071 data. This is an additional ongoing cost that the less complex Type A FIs will not incur. The Bureau expects that Type A FIs will use free geocoding software available from the FFIEC or the Bureau, which may include a new batch function that could be developed by either the FFIEC or the Bureau.
Additionally, audit procedures differ between the three representative institution types. The Bureau expects a Type A FI would not conduct an internal audit but would pay for an annual external audit. A Type B FI would be expected to conduct a simple internal audit for data checks and also pay for an external audit on an annual basis. Type C FIs would have a sophisticated internal audit process in lieu of an external audit.
Table 5 below shows major assumptions that the Bureau makes for each activity for each type of financial institution. Based on this final rule and inflation, the Bureau has made changes to corresponding assumptions from the 2023 final rule where appropriate. In particular, the changes eliminating several data points are the biggest source of changes to the assumptions relative to the 2023 final rule. Because fewer data points will be collected under this final rule than under the 2023 final rule, the Bureau assumes that tasks which depend on the number of data points will see a reduction in required employee hours. The Bureau has also updated the assumed fixed cost of software and audits to account for inflation. Table 5 also shows the number of hours assumed in the baseline scenario, for comparison.
Table 5 provides the total number of staff hours the Bureau assumes are required for each task under this final rule and baseline for representative financial institutions of different types. For example, the Bureau assumes that transcribing data for a Type A financial institution with 100 applications will require 14 hours of labor under this final rule. In comparison, transcribing data would have taken 19 hours for the same representative institution under the baseline. The table also shows the assumed fixed cost of software and audits, as well as areas where the Bureau assumes there would be cost savings due to use of technology. In several cases, the activity described in a row does not apply to financial institutions of a certain type and is therefore entered in the table as not applicable (N/A).
To generate small business lending market-level impacts estimates, the Bureau relies on the same estimates of small business lending originations described in part VI.D. above, which is the same as the methodology used in the 2023 final rule, unless otherwise noted. As with institutional coverage, the Bureau separates market-level impact estimates into estimates for depository institutions and for nondepository institutions. The Bureau also separates market-level impact estimates for institutions that will be covered under this final rule and those that are covered under the 2023 final rule but are no longer to be covered under this final rule.
Under this final rule, an institution would be required to report data on applications received in 2023 if it originated at least 1,000 covered originations in both 2022 and 2023.
If two depository institutions merged between the end of 2022 and the end of 2023, the Bureau assumes that those institutions would report as one entity. Under the baseline, the Bureau categorizes each institution as a Type A DI, Type B DI, or Type C DI, as defined at the beginning of this part VI.E, based on its small business and small farm loan originations in 2023. Under this final rule, the Bureau categorizes each institution by type according to only its small business loan originations in 2023.
For each depository institution, the Bureau assigns the appropriate estimated one-time compliance costs (including hiring cost as a function of estimated applications), ongoing fixed compliance cost, ongoing variable compliance cost per application, and applications per origination associated with its institution type for both the baseline and this final rule. The estimated number of annual applications for each institution is the estimated number of originations multiplied by the assumed number of applications per origination for that institution type (see part VI.E above). The annual ongoing compliance cost for each institution (under either the baseline or this final rule) is the ongoing fixed compliance cost plus the ongoing variable compliance cost per application multiplied by the estimated number of applications. The one-time hiring cost for each institution is the estimated number of applications multiplied by the annual staff hours per application divided by 2,080, rounded up to the next full FTE, multiplied by the cost-per-hire. For each institution, the Bureau calculates the changes in one-time costs and ongoing costs for this final rule relative to the baseline.
As shown in part VI.F.1.ii, the Bureau estimates that under this final rule every impacted financial institution will experience a decrease in ongoing costs relative to the baseline, thus resulting in
The Bureau estimates that all institutions that were previously covered at baseline but that are no longer covered under this final rule will incur the benefit of cost savings on one-time costs. As discussed in part VI.E.1, the Bureau believes that, under this final rule, these institutions will receive a benefit that is 75 percent of their non-hiring one-time costs plus their estimated hiring costs at baseline. For institutions that will continue to be covered under this final rule, they will experience a benefit in the form of reduced one-time hiring costs.
To generate market-level estimates, the Bureau sums the changes over institutions. The Bureau reports market-level impacts separately for covered and no longer covered institutions and for whether or not the one-time costs will yield a cost or a benefit. As with coverage estimates, the Bureau presents a range for market-level estimates. The range reflects the uncertainty associated with the estimate of costs for banks and savings associations below the CRA reporting threshold. The Bureau has documented how it calculates these ranges as part of the 2023 final rule rulemaking process in its
The Bureau is unaware of institution-level data on originations by nondepository institutions that are comprehensive enough to estimate costs using the same method as that for depository institutions. Therefore, to generate market-level estimates for nondepository institutions, the Bureau relies on the estimates of the number of nondepository institutions discussed in part VI.D and several key assumptions, which it also relied on for estimating the impacts of the 2023 final rule. The Bureau assumes that fintech lenders and merchant cash advance providers are Type C FIs because they generally have more automated systems and originate more loans.
Many industry commenters confirmed the Bureau's analysis that the removal of certain discretionary data points would reduce the burden of collecting those data for covered institutions. Several other industry commenters argued that the Bureau should remove the remaining discretionary data points because they are still burdensome. The Bureau acknowledges that financial institutions will incur costs to collect any data point but continues to believe that the remaining discretionary data points are necessary to facilitate the collection of the statutory data points.
Many industry commenters and an independent office of a Federal agency also confirmed the Bureau's analysis that the higher coverage threshold would relieve the burden of the rule on the smaller lenders. Some industry commenters suggested that some institutions that would remain covered by the proposed rule still face high compliance costs. These commenters proposed that the Bureau adopt either a higher origination threshold or an asset threshold to reduce burden for more institutions. An industry trade association argued that a low origination threshold would discourage smaller financial institutions from entering the small business lending market. The Bureau acknowledges that covered financial institutions will incur costs associated complying with this final rule but continues to believe that the threshold appropriately considers both the costs incurred by financial institutions and the statutory data collection requirements.
Many industry commenters agreed with the Bureau's analysis that the proposal to remove the pricing data points and reduce the number of covered institutions would benefit financial institutions by reducing reputational risks. Another commenter argued that the pricing data points should not be removed because data are not operationally difficult to collect and, thus, removing those data points does not confer much of a benefit. The Bureau expects that no longer collecting pricing data from covered institutions will benefit these institutions beyond just the operational cost savings associated with not reporting the data. For example, as other industry commenters confirmed, impacted institutions will benefit from fewer resources expended addressing possibly incorrect inferences about pricing discrimination based on data collected under this rule.
Some commenters argued that the Bureau did not provide sufficient evidence for the assertion that exempted institutions lack experience with other reporting regimes. In particular, one commenter argued that many depository institutions that were exempted are likely to be HMDA reporters. The Bureau agrees that many depository institutions exempted under this rule are familiar with regulatory reporting and clarifies that primarily nondepository institutions that do not report HMDA data would benefit from
Finally, one bank confirmed that the proposal to change the small business definition to $1 million would reduce burden for financial institutions by reducing the number of reportable transactions. The Bureau agrees with this observation but does not have sufficient information to quantify it.
One consumer group argued that the Bureau's own analysis showed that compliance costs savings would be “modest.” The commenter noted that the $100 million and $44 million saved for depository and nondepository institutions exempted from coverage would be spread over 2,000 exempted lenders. When comparing on a per lender, or per application basis, the commenter characterized the cost savings as “minimal.” Another individual commenter argued that the cost savings were nearly negligible, but nonetheless the Bureau proposed changes.
An advocacy group asserted that the proposed rule, combined with the proposed rescission of the 2023 Community Reinvestment Act rule (2023 CRA rule), will require several banks and thrifts to report two similar databases, one for CRA purposes and one for section 1071. They also argue that savings for banks and thrifts not covered by the final rule will be smaller than the Bureau's estimates because they will still have to report similar data for CRA purposes.
The Bureau does not agree with the commenter that it is appropriate to attribute preexisting CRA compliance costs to the proposed 1071 rule. The CRA compliance costs that exist under the 2023 CRA rule are separate from the compliance costs of this 1071 final rule. Furthermore, it notes that the proposed recission of the 2023 CRA rule has not been finalized, so the appropriate baseline for the analysis of this final rule is under the existing 2023 CRA rule. The Bureau concludes that the 2023 CRA rule does not yet require the FDIC, OCC, and Federal Reserve System (the agencies) to use section 1071 data to assess compliance with the 2023 CRA rule.
The 2023 CRA rule does not affect the baseline for this analysis because the 2023 CRA rule, as it currently stands, still requires a separate reporting system and does not provide a benefit to lenders of reduced reporting requirements by relying on 1071 data. Furthermore, the Bureau has already appropriately accounted for how potentially duplicative reporting affects the impacts of the rule by estimating the costs and benefits of the rule in the context of complying with the relevant existing regulations, including CRA.
The Bureau continues to believe that the cost savings of this rule are significant and this analysis is supported by consumer groups' own comments and industry commenters reporting the tens of thousands of dollars in costs that they expect the rule to save them in compliance costs. Even spread over 2,000 exempted lenders, $144 million in savings would amount to $72,000 per affected entity. Various bank commenters gave estimates of $40,000, $72,000, $100,000, and $120,000 in estimated annual cost savings. Combined with the Bureau's own analysis the Bureau continues to believe this represents meaningful savings from this final rule's provisions.
Using the methodology described in part VI.E.1 above, Table 6 shows the estimated total per institution expected one-time costs of this final rule for the first eight cost categories for financial institutions covered by this final rule or under the baseline, as well as a breakdown by the eight component categories that comprise the one-time costs for Type A DIs, Type B DIs, Type C DIs, and Non-DIs.
In addition to these one-time costs, the Bureau estimates the one-time hiring costs for the additional FTEs a financial institution expects to hire based on the number of applications the institution expects to receive each year. For financial institutions that will no longer be covered under this final rule, the Bureau calculates the benefit resulting from the cost savings of no longer needing to hire more employees. The Bureau anticipates that financial institutions that continue to be covered may also experience moderate cost savings because they may report fewer loans under this final rule relative to the baseline and, as a result, may have to hire fewer employees.
The Bureau estimates that there are financial institutions covered under the baseline that will no longer be covered under this final rule. These institutions will see a benefit in the form of savings on one-time compliance costs, since the Bureau assumes they would not incur additional one-time costs as a result of this final rule. Also, as discussed in part VI.E.1, the Bureau expects that these financial institutions will have already incurred 25 percent of the baseline non-hiring costs preparing to comply with the 2023 final rule. The full amount of savings by institutions that will no longer be covered are 75 percent of the non-hiring costs and the full amount of the hiring costs. The Bureau assumes that financial institutions that are covered under both the baseline and this final rule would still incur one-time costs to implement changes to comply with this final rule but may see a reduction in one-time hiring costs due to, potentially, needing fewer new employees to comply with this final rule relative to the baseline.
In the discussion about ongoing cost in part VI.F.3.ii below, the Bureau explains how it estimates the number of staff hours per application required to comply with this final rule or under the baseline. Under this final rule, the Bureau estimates a Type C FI, the only type that will be covered, requires 0.78 hours per application. Under the baseline, the Bureau estimates that a Type A FI requires 1.1 hours per application, a Type B FI requires 1.66 hours per application, and a Type C FI requires 0.84 hours per application.
For the purposes of exposition, the Bureau presents the estimated number of FTEs for representative financial institutions. For the market-level estimates, the Bureau estimates the number of staff hours required based on the estimated number of applications each depository institution receives.
As assumed in part VI.E, the representative Type A DI receives 100 applications annually, requiring 110 hours to comply with the 2023 final rule. Under the assumptions described in part VI.E.1, the representative Type A DI would have needed to hire one additional FTE at a one-time cost of $4,683 to cover the expected annual staff hours required to comply with the 2023 final rule on an ongoing basis. This additional staff would also have to be able to cover the staff hours required to implement one-time changes because, on average, a Type A DI would require 716 staff hours for one-time changes (see Table 12 in the 2023 final rule). Under the baseline, a Type A DI would have incurred about $67,300 in non-hiring one-time costs. As discussed above, the Bureau assumes that a Type A DI, on average, already will have spent 25 percent of its non-hiring one-time costs, or about $16,825, to implement the 2023 final rule, costs which cannot be recouped. Therefore, the Bureau estimates that the representative Type A DI will save $4,683 in one-time hiring costs and about $50,475 in non-hiring one-time costs by no longer being covered under this final rule, for a total of about $55,175 in cost savings.
The Bureau assumes that a representative Type B DI receives 400 applications annually, requiring 654 hours to comply with the 2023 final rule. This DI would have needed to hire one additional FTE at a one-time cost of $4,683. This additional staff would also be able to cover the 461 staff hours, on average, required to implement one-time changes for a Type B DI. Under the baseline, a Type B DI would have incurred about $51,700 in non-hiring one-time costs. The Bureau assumes that a Type B DI, on average, will have already spent 25 percent of its non-hiring one-time costs, about $12,925, to implement the 2023 final rule, costs which cannot be recouped. Therefore, the Bureau estimates that the representative Type B DI will save $4,683 in one-time hiring costs and about $38,775 in non-hiring one-time costs by no longer being covered under this final rule, for a total of about $43,475 in cost savings.
A representative Type C DI, which the Bureau assumes receives 6,000 applications and thus remains covered under this final rule, would see no one-time cost savings as a result of this final rule. In part VI.F.3 below, the Bureau describes how these institutions may experience a one-time adjustment cost under this final rule. The representative Type C DI does not incur any one-time hiring cost savings as a result of this final rule because it receives the same number of applications as under the baseline.
The Bureau assumes that most nondepository institutions are primarily Type B and Type C FIs, so the estimated staff hours to cover ongoing tasks discussed above apply here. For one-time tasks, the Bureau estimates that a covered nondepository institution would require about 664 staff hours, on average, to implement one-time changes necessary to comply with either the baseline or this final rule. One additional FTE would be sufficient to cover these hours if the institution reallocates some tasks across staff. The Bureau estimates that all nondepositories would require about $114,000 to comply with this final rule or the baseline. Type B nondepositories and Type C merchant cash advance providers are no longer covered under this final rule. Therefore, following similar logic as above, a Type B nondepository will receive cost savings of $90,200 and a Type C merchant cash advance provider will receive cost savings of $99,600.
As mentioned above, the Bureau realizes that one-time costs vary by institution due to many factors, and that this variance exists on a continuum that is very difficult or impossible to fully represent. The Bureau focuses on representative types of financial institutions in order to generate practical and meaningful estimates of costs. As a result, the Bureau expects that individual financial institutions could have slightly different one-time costs or cost savings than the average estimates presented here.
Summing across institutions as described in part VI.E.3, the Bureau estimates that the total one-time hiring and non-hiring cost savings for depository institutions that will no longer be covered under this final rule will be between $68,900,000 and $76,700,000. Using a 7 percent discount rate and a 10-year amortization window, the annualized one-time cost savings for depository institutions that are no longer covered under this final rule will be between $9,800,000 and $10,900,000.
In addition to comments from individual financial institutions, a bank trade association argued that the Bureau underestimated the one-time costs of complying with the 2023 final rule and, thus, underestimated the one-time cost savings of the proposed rule. The trade association cited their own internal survey of compliance costs to provide evidence that the Bureau's estimates are too low.
The Bureau has reviewed these estimates and considered the information reported by the commenters, together with the existing evidence provided in the one-time cost survey. The Bureau reiterates that the costs of implementing the 2023 final rule or this final rule are all institution-specific. As discussed above, the one-time cost savings estimates should be considered the average expected cost savings for an institution based on the complexity of the institution's operations. In addition, the Bureau expects that financial institutions would have used a variety of methods to prepare for the 2023 final rule or this final rule. Some institutions would have updated systems using staff, while other institutions would have purchased updates from third-party vendors. Overall, the trade association presented estimates only moderately higher than the Bureau's, after accounting for DIs that do not need to update computer systems. The Bureau considers most estimates provided by commenters as broadly consistent with the Bureau's one-time cost savings estimates.
The Bureau requested comment on the appropriate time horizon over which to amortize one-time implementation costs but did not receive any such comments.
To estimate ongoing costs at baseline, the Bureau first reproduces Table 16 of the 2023 final rule as Table 7 below, with minor modifications reflecting inflation and changes in wage rates, as discussed in part VI.E. This table shows what the Bureau would expect the annual ongoing costs to be for representative final institutions of different types at baseline. It shows the total estimated annual ongoing costs at baseline as well as a breakdown by the 15 activities that give rise to ongoing costs for representative Type A, Type B, and Type C FIs. The bottom of the table shows the total estimated annual section 1071 ongoing compliance cost, at baseline, for each type of representative institution, along with the total cost per application processed by the financial institution. To produce the estimates in this table, the Bureau used the calculations described in Tables 3 and 4 above and the assumptions relating to each activity in Table 5.
The Bureau estimates that, at baseline, a representative low complexity Type A FI would incur around $9,580 in total annual ongoing costs, or about $96 in total cost per application processed (assuming 100 applications per year). The Bureau estimates that a representative middle complexity Type B FI, which is somewhat automated, would incur approximately $45,253 in total annual ongoing costs, or around $113 per application (assuming a representative 400 applications per year). The Bureau estimates a representative high complexity Type C FI, would incur $299,700 of total annual ongoing costs, or $50 per application (assuming a representative 6,000 applications per year).
To estimate the expected ongoing costs for an institution that remains covered under this final rule, the Bureau used the assumptions in Table 5 above, which characterize the decrease in the number of employee hours necessary for compliance occurring as a result of the changes. Table 8 below reproduces Table 16 from the 2023 final rule
The Bureau believes that removing the collection of aggregate data will reduce the resources required to complete some of the tasks described above. Therefore, to account for this, the Bureau is reducing the ongoing compliance costs in certain categories by a little less than five percent. This includes several of the tasks, like “transcribing data” or “standard annual edit and internal checks,” that depend on labor.
For institutions that remain covered under this final rule, the Bureau estimates that a representative low complexity Type A FI will incur around $8,700 in total annual ongoing costs, or about $87 in total cost per application processed (assuming 100 applications per year). The Bureau estimates that a representative middle complexity Type B FI, which is somewhat automated, will incur approximately $42,858 in ongoing costs per year, or around $107 per application (assuming a 400 applications per year). The Bureau estimates a representative high complexity Type C FI will incur $284,210 of annual ongoing costs, or a little over $47 per application (assuming 6,000 applications per year).
Under the changes in this final rule, some FIs will no longer be required to collect and report small business application data because they have more than 100 but fewer than 1,000 covered credit transactions. These FIs will no longer incur annual ongoing compliance costs from the small business data collection rule. Therefore, they will experience a benefit in the form of relief from the ongoing costs they incurred under the baseline. This annual total will be $9,580, $45,253, and $299,700 for representative Type A, B and C FIs, respectively.
Also under the changes in this final rule, FIs that continue to be covered and therefore required to collect and report small business application data will experience a benefit in the form of reduced annual ongoing compliance costs. The amount of the reduction is the difference between the costs expected to be incurred under the changes (those found in Table 8) and those expected at baseline (those found in Table 7). The annual total of this expected benefit will be $880, $2,395, and $15,490 for representative Type A, B, and C FIs, respectively.
Summing across institutions as described in part VI.E.3, the Bureau estimates that the total annual ongoing cost savings for depository institutions that remain covered under this final rule will be between about $24,000,000 and $26,000,000 per year. The Bureau estimates that the total annual ongoing cost savings for nondepository institutions that remain covered under
Summing across institutions as described in part VI.E.3, the Bureau estimates that the total annual ongoing cost savings for depository institutions that were covered under the baseline but are no longer covered under this final rule is between about $88,000,000 and $101,000,000 per year. The Bureau estimates that the total annual ongoing cost savings per year for nondepository institutions that are no longer covered by this final rule is about $53,000,000 per year.
Therefore, the estimated total annual ongoing cost savings for all impacted institutions attributable to this final rule is between $166,000,000 and $181,000,000 per year, including both depository and nondepository institutions.
Financial institutions may also experience benefits under this final rule in the form of fewer reputational risks and fewer resources spent on responding to analyses of their small business credit application data alleging credit access disparities. The public nature of any dataset will allow the general public to analyze the data, which can result in accusations of fair lending violations or potential misrepresentations, which, the Bureau has acknowledged, could result in a cost to financial institutions. In the 2023 final rule, the Bureau discussed how small entity representatives during the SBREFA process and commenters on the 2021 proposed rule raised this as an expected form of cost. The Bureau is unable to quantify this cost but does expect that this final rule will benefit FIs by reducing such costs. FIs that are no longer covered under this final rule are no longer expected to incur any reputational risks or costs of responding to analyses based on the data collected under this rule as their data will no longer be submitted or published. For entities that remain covered, the reduction in the number of data points, particularly pricing data, reduces expected reputational risks.
The Bureau believes the commenters reporting their reduced compliance costs provide support for the Bureau's analysis, which estimates significant compliance costs savings.
One industry group commented that the Bureau's analysis underestimates the ongoing cost savings of the rule. The commenter believes that the Bureau is incorrect to rely on adapted HMDA compliance costs as a basis for compliance costs for the small business lending rule. The commenter also noted that the Bureau's estimated ongoing cost of compliance is lower than the cost estimate the commenter obtained from surveying its members, and thus argued the Bureau is underestimating ongoing compliance cost savings of the rule. An additional industry commenter noted that it remained covered by the rule, and expected to incur $110 per loan in costs, which is higher than the Bureau's estimates for an institution of a similar size.
The Bureau has reviewed these estimates and considered the information reported by the commenters, together with the Bureau's own analysis. The Bureau reiterates that the costs of implementing the 2023 final rule or this final rule are all institution-specific. As discussed above, the ongoing cost savings estimates should be considered the average expected cost savings for an institution based on the complexity of the institution's operations. The Bureau continues to believe that its costs of compliance are comparable to the commenters' estimates, when appropriately converted to a per application basis using the Bureau's estimates of loan volume and assumptions about applications per loan. It also continues to believe that HMDA serves as a reasonable starting point for adapting a cost estimate for data collection and reporting.
The Bureau believes that any direct costs to small businesses from completing additional fields on small business credit applications as a result of the 2023 final rule would have been minimal and therefore small businesses will not benefit from this final rule's removal of those fields in this way.
In the 2023 final rule, the Bureau discussed how, based on economic theory and evidence from the Bureau's own survey, financial institutions would most likely react to compliance costs by raising prices and fees. In particular, the Bureau expected that ongoing variable costs would be passed through in their entirety. This final rule will eliminate ongoing variable costs for institutions that are no longer be covered and will reduce ongoing variable costs for institutions that remain covered.
The Bureau estimates that the per application ongoing variable cost, at baseline, is $34 for Type A FIs, $28 for Type B FIs, and $8 for Type C FIs. According to the analysis above, this is the expected benefit that will accrue to applicants at institutions that were covered at baseline but are no longer covered under this final rule. For institutions that continue to be covered under this final rule, the difference between the ongoing variable cost at baseline and under this final rule is $8 for Type A FIs, $4 for Type B FIs, and around $1 for Type C FIs. This difference is what the Bureau expects to be passed on to applicants at financial institutions that continue to be covered under this final rule.
Several industry commenters noted that the Bureau's proposal would also benefit small businesses by making applying for credit less costly for small businesses. For example, one commenter argued that the proposal would reduce the burdens on small businesses during the application process, including less time filling out forms and fewer procedural delays. A few financial institutions stated that they would have passed on the costs of the 2023 final rule to their small business customers in the form of higher rates and fees and would no longer do so under the proposed rule because they are exempted from coverage.
One individual commenter argued that the Bureau overestimated the pass-through benefits of the proposed rule for small businesses relative to the baseline. The commenter cited multiple research studies that provide evidence that the
At baseline, the Bureau expects that data collected under the 2023 final rule would benefit covered financial institutions in two ways. The first is that the Bureau expects that the collected data would reduce some compliance burden by reducing the number of “false positives” during fair lending review prioritization by regulators. As discussed above, this final rule would reduce the number of covered entities and the types of covered transactions, thereby reducing the total amount of information collected in accordance with the rule. To the extent that institutions would experience this benefit at baseline, the Bureau expects that this final rule could reduce those benefits, and thus financial institutions may incur a cost.
At baseline, the Bureau also expects that financial institutions could benefit from transparency resulting from the collection of small business application information under the 2023 final rule. Financial institutions might use the public data (such as number of applications, pricing data, denial rates, and information on the types of credit) to better understand the demand for small business credit products and the conditions under which they are being supplied by other financial institutions. Collecting data on fewer applications, from fewer financial institutions, and for fewer types of loans under this final rule could impose costs on financial institutions by reducing this benefit. A bank, for example, may lose the opportunity to learn more detailed information about the merchant cash advance market, which they might view as a competitor. Financial institutions of all sizes may lose insight into the lending activities of smaller competitors who fall below the reporting threshold under this final rule.
Finally, the Bureau estimates that some covered institutions will incur adjustment costs to implement changes to comply with this final rule. The Bureau describes these costs for the representative Type C DIs because only Type C institutions, those with 1,000 or more loan originations per year, are covered under this final rule. The Bureau assumes that the representative Type C DI would receive the same number of applications reportable under the baseline and this final rule. As discussed in part VI.F.1, a Type C DI would need to spend about $85,400 to implement the non-hiring one-time costs to implement changes necessary to comply with either the baseline or this final rule. As discussed above, the Bureau assumes that an institution that remains covered under this final rule has already spent, on average, about 25 percent of non-hiring one-time costs to implement changes that will not be compliant with this final rule. Thus, a Type C DI would incur the full cost of implementing this final rule but, effectively, would only receive 75 percent of the cost savings from no longer needing to comply with the baseline. The Bureau estimates that the representative Type C DI will incur total one-time costs of $21,250 to implement changes to comply with this final rule. Based on a similar calculation for Type C nondepository institutions, the Bureau also estimates that the representative Type C nondepository that remains covered under this final rule will incur total one-time costs of $28,500 to implement changes to comply with this final rule.
Summing across institutions as described in part VI.E.3, the Bureau estimates that the total one-time adjustment costs for covered depository and nondepository institutions will be between $4,600,000 and $4,700,000. Using a 7 percent discount rate and a 10-year amortization window, the annualized one-time costs for covered institutions will be about $600,000 to $700,000.
The Bureau requested comments on these and other potential costs to impacted financial institutions arising as a result of the proposed rule but did not receive any such comments.
In the 2023 final rule, the Bureau described several benefits that would accrue to small businesses from the small business lending data collection and publication. These benefits relate to the rule's two purposes: fair lending enforcement and community development. Several provisions of this final rule change the amount and types of information that will be collected and disclosed. Therefore, to the extent the Bureau expected small businesses to benefit from the collection as described in the 2023 final rule, changes that reduce or alter the amount or types of information provided will impose a cost on small businesses by reducing these expected benefits.
Several changes reduce the number of financial institutions that will report data or change the composition of institutions reporting. This final rule provides that the threshold number of originations of covered transactions for two consecutive years is raised to 1,000, which, as shown above, will substantially lower the number of depository and nondepository institutions collecting and reporting small business credit application data. This final rule also provides that several types of transactions are exempt from coverage, relative to the baseline, including transactions from FCS lenders, merchant cash advances and agricultural loans. These types of transactions and lenders are thus removed from the data collection and reporting. This final rule also provides a minimum transaction size of $1,000 for covered transactions, which will remove smaller transactions from the data relative to the baseline. Finally, this final rule reduces the gross annual revenue threshold in the definition of small business to $1 million or less in the preceding fiscal year, which will
Reducing the data collection in these ways is likely to reduce the fair lending benefits of the data collection. In the 2023 final rule, the Bureau explained that data collected under the rule would lead to more efficient use of government resources in enforcing fair lending laws. Since the above provisions will substantially reduce the number of covered entities and covered transactions, the Bureau expects small businesses will experience a reduction in this efficiency as a cost of this final rule. The Bureau also expects that having fewer covered institutions and transactions will reduce the ability of the public to use the data for transparency purposes and to conduct their own analyses of lending by financial institutions.
The Bureau also expects that having fewer covered institutions and transactions will result in a reduction in the community development benefits that the Bureau would expect to accrue to small businesses under the baseline. In the 2023 final rule, the Bureau detailed how governmental entities would likely use these data to develop solutions that achieve policy objectives in their administration of loan guarantee programs or disaster relief. The Bureau also expected that creditors would use the data to more effectively understand small business credit market conditions and that communities would use the data to identify gaps in credit access for small business owners. In each of these cases, the Bureau expects that creditors, communities, and governmental entities will experience costs in the form of a reduction in these benefits relative to the baseline.
The Bureau expects that removing certain transactions from coverage will reduce some of the expected benefit derived from covering certain markets, relative to the baseline. In section II.A of the 2023 final rule, the Bureau explained that nondepositories, some of whom provide merchant cash advances or sales-based financing, were an increasing share of the small business financing market, but that nondepositories typically do not report small business financing activity to regulators, which limits the baseline understanding of the activities of these entities. Thus, the Bureau expects that by removing these types of transactions from coverage, small businesses will experience a cost in the form of a reduction in fair lending and community development benefits related to these types of transactions, compared to the baseline.
However, the Bureau believes such costs might be limited if data on applications from FCS lenders, for agricultural loans, for sales-based financing, or for loans under $1,000 would have been of poor quality or otherwise difficult to interpret correctly. For example, the Bureau now believes that the types of collateral required in agricultural lending results in underwriting processes that would make application data difficult to interpret under the baseline collection. The Bureau also believes that application data from merchant cash advance providers would not produce data comparable to other transactions, which would limit their value as part of the dataset. Likewise, the Bureau believes that data on transactions under $1,000 likely would be of poor quality as they would come from credit providers ill-suited to comply with a data reporting rule. To the extent this is the case, it would reduce the value of including these data in the small business application dataset and would have limited their contribution to the fair lending and community development benefits described above.
This final rule also eliminates several data points from the small business data collection, including the application method, the application recipient, denial reasons, pricing information, and number of workers. It also eliminates LGBTQI+-owned business status from the business status data point. For similar reasons as above, the Bureau expects that small businesses will experience a cost from fewer collected data points in the form of less information and the benefits that they would have derived from such information in the baseline scenario.
In the 2023 final rule, the Bureau explained that it expected the pricing information to provide both fair lending and community development benefits to small businesses. Pricing is one dimension by which a lender could potentially discriminate against a credit applicant. Removing this information could reduce the efficiency of fair lending examinations or transparency that would have resulted from its inclusion, relative to the baseline. The Bureau also expected, at baseline, that pricing information would benefit community development through communities using pricing information to identify gaps in credit access or creditors better understanding small business lending conditions. The Bureau expects that eliminating the pricing data will reduce these benefits relative to the baseline.
The removal of two datapoints in particular will likely reduce, to some degree, the community development benefits relative to the baseline. The application method data point would provide additional information about how small businesses apply for credit, while the number of workers data point is one indicator of the business's size and employment. In the 2023 final rule, the Bureau expected that creditors, communities, and governmental entities may have used such information to learn more about the small business credit market and the types of businesses it serves. To the extent this would have resulted in a community development benefit at baseline, the removal of these two data points represents a cost to small businesses.
At baseline, the Bureau also expected that the inclusion of LGBTQI+-owned business status would have resulted in potential fair lending and community development benefits. The Bureau expected that the data could be used to learn about discrimination risks (to the extent that courts apply discrimination in the context of fair lending laws) against LGBTQI+-owned businesses, help creditors understand the credit needs of such businesses, and help facilitate the development of policies related to LGBTQI+ credit applicants. To the extent small businesses would have experienced such benefits at baseline, the exclusion of LGBTQI+-owned business status represents a cost.
The Bureau acknowledges, as it did in its proposal, that small businesses may incur a cost from the removed discretionary data points because of their potential fair lending value. However, the Bureau agrees with industry commenters that the fair lending value of these discretionary data points is limited, and thus the reduction of the dataset's fair lending value to small businesses is likewise limited. Loan pricing, for example, is based on
Multiple consumer group and industry group commenters noted that excluding additional types of lenders and transactions would further undermine the fair lending value of the dataset. Several commenters noted that excluding MCAs from coverage would potentially advantage MCA providers while limiting visibility into potential fair lending issues within this industry. Other industry group commenters argued that data from MCAs would be of little informational value. One commenter expressed concern that removing agricultural lending from coverage would impact the ability to address fair lending in an industry with previous fair lending concerns.
The Bureau continues to acknowledge that these exclusions may reduce the fair lending value of the dataset and thus incur a cost to small businesses. However, the Bureau continues to believe that the low value of data from these lenders and types of loans suggest that the cost of their exclusion is limited.
Multiple consumer group commenters also voiced concerns about the higher loan origination threshold and lower small business definition threshold and argued that fewer covered institutions and transactions would significantly reduce visibility into possible fair lending risk. One consumer group noted that the Bureau's own analysis showed there would be a significant decrease in the number of depository institutions covered by the rule and their own geographical analysis also suggested that the decrease in coverage would be spread unevenly by geography. One consumer group also argued that the change in small business definition to $1 million in gross annual revenue provided a perverse incentive to originate loans to businesses with over $1 million in annual revenue.
The Bureau acknowledges, as it did in its proposal, that these changes will reduce the number of covered lenders. However, the Bureau's analysis suggests that the effect on the overall fraction of covered loans is much smaller, and thus the impact of the changes to the transaction threshold and small business definition will have a limited effect on the fair lending value of the dataset.
Multiple commenters suggested that the Bureau's changes, particularly those that remove data points from collection or reduce the number of covered entities and transactions, will reduce the community development value of the collection. One consumer group, for example, argued that removing the pricing data point will make it difficult to view and compare trends and adjust small business lending policies. Another argued that removing discretionary data points restricts the ability of lenders, policymakers, and community groups from creating community development opportunities for small businesses.
In its proposal, the Bureau acknowledged the potential costs to small businesses in the form of reduced community development benefits of the data collection. The Bureau continues to acknowledge that the Bureau's changes to the Small Business Rule may impact the ability of creditors, communities, and governmental entities to use the data to learn information about the small business credit market, relative to baseline. However, as stated above, the Bureau believes the community development purposes are better served overall by a more streamlined data collection.
This section discusses two categories of alternatives considered: other methods for defining a covered financial institution and limiting the data points to those mandated by section 1071. The Bureau uses the methodologies discussed in parts VI.D and VI.E to estimate the impacts of these alternatives.
First, the Bureau considered multiple reporting thresholds for purposes of defining a covered financial institution. In particular, the Bureau considered whether to exempt financial institutions with fewer than 200, 500, or 2,000 originations in each of the two preceding calendar years instead of fewer than 1,000 originations, as provided in this final rule. The Bureau presents estimates for depository institutions because it does not have sufficient information to estimate how these differences in thresholds would impact nondepository institutions. Annualized values are calculated using a 7 percent discount rate and a 10-year amortization window.
Under a 200-origination threshold, the Bureau estimates that about 700 to 800 depository institutions would be covered and between 900 to 1,000 would no longer be covered. That is, the Bureau expects that between 500 to 600 additional depository institutions would be covered under a 200-origination threshold compared to the 1,000-origination threshold in this final rule. The Bureau estimates that an additional 3.2 to 3.7 percentage points of small business loans originated by depository institutions would be covered under a 200-origination threshold and that an additional 15 to 17 percentage points of the dollar value of such loans would be covered.
Under a 200-origination threshold, the Bureau estimates that the total one-time cost savings across all impacted depository institutions would decrease by between $25,000,000 to $29,000,000 relative to this final rule, with an annualized decrease in savings of between $3,600,000 and $4,100,000. The Bureau estimates that total one-time costs incurred by covered depository institutions would increase by between $6,000,000 to $7,000,000, with an annualized increase in costs of between $800,000 to $900,000. The Bureau estimates that the total ongoing costs savings across all impacted depository institutions would decrease by between $34,000,000 to $40,000,000 under this alternative.
Under a 500-origination threshold, the Bureau estimates that between 300 to 400 depository institutions would be covered and between 1,300 to 1,400 would no longer be covered. That is, the Bureau expects that around 200 additional depository institutions would be covered under a 500-origination threshold compared to the 1,000-origination threshold in this final rule. The Bureau estimates that an additional 1.3 to 1.7 percentage points of small business loans originated by depository institutions would be covered under a 500-origination threshold and that an additional 6.4 to 7.3 percentage points of the dollar value of such loans would be covered.
Under a 500-origination threshold, the Bureau estimates that the total one-time cost savings across all impacted depository institutions would decrease by between $8,000,000 to $10,000,000 under a 500-origination threshold relative to this final rule, with an annualized decrease in savings of between $1,200,000 and $1,400,000. The Bureau estimates that total one-time costs incurred by covered depository institutions would increase by between $1,000,000 to $1,400,000, with an annualized increase in costs of about $100,000 to $200,000. The Bureau estimates that the total ongoing costs savings across all impacted depository institutions would decrease by between $12,000,000 to $16,000,000 under this alternative.
Under a 2,000-origination threshold, the Bureau estimates that about 100 depository institutions would be
Under a 2,000-origination threshold, the Bureau estimates that the total one-time cost savings across all impacted depository institutions would increase by between $6,000,000 to $7,000,000 under a 2,000-origination threshold relative to this final rule, with an annualized increase in savings of between $900,000 and $1,000,000. The Bureau estimates that total one-time costs incurred by covered depository institutions would decrease by about $1,500,000 to $2,000,000, with an annualized decrease in costs of between $200,000 and $300,000. The Bureau estimates that the total ongoing costs savings across all impacted depository institutions would increase by between $22,000,000 to $25,000,000 under this alternative.
Second, the Bureau considered the costs and benefits for limiting its data collection to the data points specifically enumerated in 15 U.S.C. 1691c-2(e)(2)(A) through (G). In addition to those data points, the statute also requires financial institutions to collect and report any additional data that the Bureau determines would aid in fulfilling the purposes of section 1071. In addition to the data points specifically enumerated in 15 U.S.C. 1691c-2(e)(2)(A) through (G), this final rule keeps three data points from the 2023 final rule that relied on the authority in 1691c-2(e)(2)(H). These are the number of principal owners, three-digit NAICS industry code of the business, and the time in business. The Bureau has considered the impact of instead requiring only the collection of those data points enumerated in 1691c-2(e)(2)(A) through (G).
Requiring the collection and reporting of only the data points enumerated in 15 U.S.C. 1691c-2(e)(2)(A) through (G) would result in a reduction in the fair lending benefit of the data compared to the 2023 final rule. For example, not collecting time in business or industry information would obscure possible fair lending risk by covered financial institutions. As mentioned in part VI.F.3 above, the data points the Bureau continues to require in this final rule under the 15 U.S.C. 1691c-2(e)(2)(H) authority are critical to conducting more accurate and complete fair lending analyses. A reduction in the rule's ability to facilitate the enforcement of fair lending laws would negatively impact small businesses and small business owners and thus run counter to that statutory purpose of section 1071.
Limiting the rule's data collection to only the data points required under the statute would also reduce the ability of the rule to support the business and community development needs and opportunities of small businesses, which is the other statutory purpose of section 1071. For example, not including NAICS code or time in business would also reduce the ability of governmental entities to tailor programs that can specifically benefit new businesses or businesses in certain industries.
The Bureau also believes that removing the number of principal owners data point, in addition to the reduced benefits described above, would make collecting and reporting data on principal owners' ethnicity, race, and sex more difficult. Without collecting the number of principal owners, it would be harder to identify and correct erroneous submissions. For example, if an institution submitted no demographic information on for any principal owners, it would be unclear if that was an error or because the small business had no individuals that met the principal owners criteria. The operational confusion could counteract the cost reduction that stems from the fewer resources require to collect and report this field.
Only requiring the collection and reporting of the data points enumerated in 15 U.S.C. 1691c-2(e)(2)(A) through (G) would have reduced the annual ongoing cost of complying with this final rule. Under this alternative, the estimated total annual ongoing costs for representative Type A, Type B, and Type C FIs would be reduced by $149, $523, and $2,838, respectively. Per application, the estimated reduction in ongoing cost would be $1, just over $1, and less than $1 for representative Type A, Type B, and Type C FIs, respectively. The estimated total annual market-level ongoing cost savings of impacted depository institutions would increase by about $3,500,000. The Bureau does not expect that one-time costs or cost savings would be meaningfully different as a result of this alternative.
The Bureau estimates that the total quantified cost savings of the final rule relative to baseline will be between $176,000,000 and $192,000,000 per year, annualized using a 3% discount rate and a 10-year amortization schedule, or between $178,000,000 and $195,000,000 per year, annualized using a 7% discount rate and a 10-year amortization schedule.
As discussed above, this final rule excludes financial institutions with fewer than 1,000 originated covered credit transactions in both of the two preceding calendar years. The Bureau believes that the decrease in benefits of this final rule to banks, savings associations, and credit unions with $10 billion or less in total assets will be similar to the decrease in benefits to covered financial institutions as a whole, discussed above. Regarding cost savings, other than as noted here, the Bureau also believes that the impact of this final rule on banks, savings associations, and credit unions with $10 billion or less in total assets will be similar to the impact for other financial institutions covered by this final rule. The primary difference in the impact on these institutions will likely come from differences in the level of complexity of operations, compliance systems, and software, as well as number of product offerings and volume of originations of these institutions, all of which the Bureau has incorporated into the cost estimates using the three representative financial institution types.
Based on FFIEC and NCUA Call Report data for December 2023, 9,109 of 9,288 banks, savings associations, and credit unions had $10 billion or less in total assets. The Bureau estimates that between 75 and 85 of such institutions will be subject to this final rule and about 1,375 to 1,525 more were covered under the baseline but will not be
The Bureau expects that small businesses in rural areas will directly experience many of the costs of this final rule described above in part VI.F.4. This includes a reduction in benefits derived from more efficient fair lending enforcement and community development generated by data collection compared to the baseline. This final rule increases the threshold number of loan originations above which institutions have to report data, which will lead to fewer lenders in rural areas reporting data on small business credit application in rural areas. The Bureau presents estimates of this change in coverage below. This final rule also exempts agricultural credit from the types of covered transactions. Many banks and credit unions in rural areas provide credit for farming and livestock production since they are primary industries and are responsible for much employment in these areas. Small businesses, communities, governmental entities will lose insight into these areas of credit provision as a consequence of this final rule. However, as explained in part VI.F.4 above, the Bureau believes that data collected for certain loan types, including agricultural loans, would have been of poor quality and, therefore, the costs from eliminating them will be limited.
The source data from CRA submissions that the Bureau uses to estimate institutional coverage and market estimates provide information on the county in which small business borrowers are located. However, approximately 86 percent of banks did not report CRA data in 2023, and as a result the Bureau does not believe the reported data are robust enough to estimate the locations of the small business borrowers for the banks that do not report CRA data.
The Bureau used the FDIC's Summary of Deposits to identify the location of all brick and mortar bank and savings association branches and the NCUA Credit Union Branch Information to identify the location of all credit union branch and corporate offices.
As described in part VI.F.2 above, the Bureau expects that covered financial institutions will pass the cost savings from ongoing variable costs on to small businesses in the form of lower interest rates or fees but will not do so with one-time or fixed costs. The Bureau expects that this pass through from covered financial institutions will also apply to small businesses in rural areas. As described above, the variable cost savings per application is $7 for Type A FIs, $2 for Type B FIs, and $1 for Type C FIs. This is the savings that the Bureau expects would pass on to small business applicants regardless of where they are located.
The Regulatory Flexibility Act (RFA)
The Bureau convened and chaired a Small Business Review Panel under SBREFA to consider the impact of the 2020 proposals under consideration on small entities that would be subject to those proposals under consideration and to obtain feedback from representatives of such small entities. The Small Business Review Panel requirement for the present rulemaking
Having received from the Bureau information on the potential impacts of this final rules on small entities and the types of small entities that might be affected, the SBA's Chief Counsel for Advocacy noted that the Bureau had, in 2020, convened a review panel in accordance with 5 U.S.C. 609(b). The Chief Counsel for Advocacy concluded that reconvening a review panel for the present rulemaking would not advance the effective participation of small entities in the rulemaking process pursuant to 5 U.S.C. 609(e).
As part of the initial proposed regulation implementing section 1071 of the ECOA, the Bureau along with the Small Business Administration, Office of Advocacy and the Office of Information and Regulatory Affairs convened a SBREFA Panel in 2020,
The SERs had several suggestions on how to minimize the impact of data collection on small entities. The first of these was to exclude small lenders from the requirement to collect data. Several different methods of exemptions were proposed including using a number of small business loans, value of small business loans, and basing the exemption on the size of the lender rather than their small business loan portfolio specifically. The second was to use a single definition for a small business loan applicant based on revenue, rather than the SBA size standards, which vary based on industry. The SERs disagreed on what the revenue cutoff for a small business loan applicant should be with some arguing for a low value of less than $1 million while others preferred a higher value of $8 million. Finally, SERs recommended limiting the number of discretionary data points, noting that some of the required collections would be difficult to produce at the application stage.
Besides its involvement in the SBREFA panel, the Office of Advocacy has provided further feedback on the implementation of Section 1071 of the Dodd-Frank Act. In January 2022, Advocacy documented concerns that were raised by small entities, including community banks, credit unions, nondepository lenders, and automobile dealerships. They saw the 2021 proposed rule as potentially increasing the cost of credit for small businesses and discouraging lending to small, minority-, and women-owned businesses. The Office of Advocacy believed that the Bureau had underestimated compliance costs in the 2021 proposed rule, particularly the costs related to new systems, training, and reporting requirements. Advocacy believed that $5 million or less in gross annual revenue was too expansive a definition of small business loan applicant. It recommended minimizing adverse effects by considering alternative thresholds and definitions. SERs also expressed concerns about the burden of collecting extra data, potential privacy breaches (especially in smaller communities), and the risk of misinterpretation or reputational harm if unique loan pricing is disclosed without proper context. In response to Advocacy's comment letter, the Bureau made a substantial change to the filing threshold for data collection in the 2023 final rule, raising it from 25 small business loans to 100.
Under RFA section 604(a), when promulgating a final rule under 5 U.S.C. 553, after publishing a notice of proposed rulemaking, the Bureau must prepare a FRFA. Section 603(a) of the RFA also sets forth the required elements of the FRFA. Section 604(a)(1) requires the FRFA to contain a statement of the need for, and objectives of, the rule. Section 604(a)(2) requires the FRFA to contain a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments. Section 604(a)(3) requires the Bureau to respond to any comments filed by the Chief Counsel for Advocacy of the SBA in response to the proposed rule and provide a detailed statement of any change made to the proposed rule in the final rule as a result of the comments.
The FRFA further must contain a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available.
Section 1071 of the Dodd-Frank Act amended ECOA to require that financial institutions collect and report to the Bureau certain data regarding applications for credit for women-owned, minority-owned, and small businesses. Section 1071's statutory purposes are (1) to facilitate enforcement of fair lending laws, and (2) to enable communities, governmental entities, and creditors to identify business and community development needs and opportunities of women-owned, minority-owned, and small businesses. On May 31, 2023, the Bureau published a final rule in the
In this final rule, the Bureau has reconsidered certain provisions of the 2023 final rule to focus on core lending products, lenders, small businesses, and data points. Based on reactions to the 2023 final rule, including continued feedback from stakeholders and the ongoing litigation, the Bureau now believes that a better, longer-term approach to advance the statutory purposes of section 1071 will be to commence the collection of data with a narrower scope to ensure its quality, and to limit, as much as possible, any disturbance of the provision of credit to small businesses. Only as the Bureau and financial institutions learn from early iterations of data collections will the Bureau consider amending the rule as appropriate while taking care not to disturb the provision of credit to small businesses. The Bureau believes that such an incremental approach would comply with section 1071 and minimize any negative initial impact on small business lending markets and on data quality.
For a further description of the reasons why agency action is being taken, see the background discussion for this final rule in part I above.
Section 1071, in 15 U.S.C. 1691c-2(g)(2), permits the Bureau to adopt exceptions to any requirement of section 1071 and to conditionally or unconditionally exempt any financial institution or class of financial institutions from the requirements of section 1071, as the Bureau deems necessary or appropriate to carry out the purposes of section 1071. The Bureau relies on its general rulemaking authority under 15 U.S.C. 1691c-2(g)(1) in this final rule and relies on 15 U.S.C. 1691c-2(g)(2) when proposing specific exceptions or exemptions to section 1071's requirements.
To accomplish the incremental approach described above, this final rule limits the scope of the 2023 final rule's required data collection in several ways. This final rule will exclude certain categories of lending products from the definition of covered credit transaction, such as MCAs, agricultural lending, and small dollar loans. The Bureau is also excluding FCS lenders from coverage and raise the origination threshold from 100 to 1,000 covered credit transactions for each of two consecutive years. The Bureau is also changing the definition of small business to $1 million in gross annual revenue from the $5 million definition in the 2023 final rule. Lastly, the Bureau is removing certain data points from the required collection, including application method, application recipient, denial reasons, pricing information, the number of workers, and the LGBTQI+ ownership status of the small business.
For a further description of these provisions, see the discussion of this final rule in part III above.
With regards to the IRFA published in the proposal, multiple commenters noted that the Bureau had not convened a new SBREFA panel nor published a panel report for the proposal. The commenters argued that reliance on information from the 2020 SBREFA panel and panel report was insufficient, and that the Bureau should have convened one for the proposed rule.
The Bureau discussed its reliance on the 2020 SBREFA panel and report above and notes that the SBA waived the requirement to convene a new panel for this rule.
One commenter also argued that the Bureau's proposed changes could materially change burdens for small entities and noted that referring to the 2023 FRFA was insufficient. This commenter also noted that market conditions for small lenders, including the interest rate and liquidity conditions, have materially changed and were not properly accounted for by the Bureau in the IRFA.
The Bureau disagrees with the commenter's characterization of the IRFA included in the proposal. The Bureau estimated the impacts of proposed changes on small entities in the IRFA included in the proposal. This FRFA includes discussions of the number of small entities affected, how the Bureau expects the entities to be affected, and steps taken to minimize the burden on small entities.
In its letter commenting on the proposed rule, SBA's Office of Advocacy noted its support for several of the Bureau's proposed changes to the small business lending rule. SBA's Office of Advocacy supported the Bureau's decisions to increase the loan origination threshold to 1,000 transactions, change the small business definition revenue threshold to $1 million, remove certain discretionary data points from collection, and change the implementation timeline. The Bureau considered the SBA's Office of Advocacy's support in its decision-making regarding finalizing these provisions.
The SBA's Office of Advocacy noted that, while there are justifications for excluding merchant cash advance providers, agricultural lenders, and Farm Credit System lenders from coverage, there were stakeholder concerns about the potential differential treatment of these lenders compared to those that remain covered under the rule. SBA's Office of Advocacy suggested that the Bureau monitor the excluded markets to ensure that other small institutions did not experience a competitive disadvantage from the exclusions. As described above, the Bureau believes that this initial narrower scope of coverage is prudent to limit disturbances to the provision of credit to small businesses but may consider future amendments as appropriate to fulfill the statutory purposes of the rule.
For the purposes of assessing the impacts of this final rule on small entities, “small entities” is defined in the RFA to include small businesses, small nonprofit organizations, and small government jurisdictions.
Table 9 provides the Bureau's estimate of the number and types of entities that will be affected by this final rule. The first column provides the
The following paragraphs describe the categories of entities that the Bureau expects will be affected by this final rule.
The Bureau is also removing several data points from the reporting requirements. This includes the data points for application method, application recipient, denial reasons, pricing information, the number of workers, and the LBGTQI+-owned business status.
Part III above discusses these changes in greater detail.
The Bureau expects that financial institutions that were covered under the 2023 final rule and remain covered under this final rule may experience costs that stem from adjusting to complying with the requirements of this final rule instead of the 2023 final rule.
As described in part VI above, the Bureau assumes that, on average, financial institutions will have already incurred 25 percent of their non-hiring one-time costs in preparation to comply with the 2023 final rule. For financial institutions that continue to be covered under this final rule, the Bureau assumes that this percentage of non-hiring costs will have to be incurred again in order to meet the requirements of this final rule. The Bureau estimates that covered small depository institutions will spend about $21,000 each in one-time adjustment costs, annualized to about $3,000 per year, and that the covered small nondepository institutions will spend about $114,000 in one-time adjustment costs, annualized to about $4,000 per year.
Financial institutions that remain covered under this final rule will continue to require compliance personnel in order to report data under the rule. For some financial institutions, the data intake and transcribing stage could involve loan officers or processors whose primary function is to evaluate or process loan applications. For example, at some financial institutions the loan officers will take in information from the applicant to complete the application and input that information into the reporting system. However, the Bureau believes that such roles generally do not require any additional professional skills related to recordkeeping or other compliance requirements of this final rule that are not otherwise required during the ordinary course of business for small financial institutions.
The type of professional skills required for compliance varies depending on the particular task involved.
The Standard Occupational Classification (SOC) code has compliance officers listed under code 13-1041. The Bureau believes that most of the skills required for preparation of the reports or records related to this proposal are the skills required for job functions performed in this occupation. However, the Bureau recognizes that under this general occupational code there is a high level of heterogeneity in the type of skills required as well as the corresponding labor costs incurred by the financial institutions performing these functions.
Small financial institutions that were covered under the 2023 final rule and that will remain covered under this final rule will save on compliance costs in two ways. First, the Bureau expects that they will be required to report fewer loans and therefore see a reduction in associated hiring costs. This is a one-time costs savings. Second, the reduction in the number of data points to be reported under this final rule (relative to the 2023 final rule) will likely result in annual ongoing cost savings.
Using the same coverage estimation described in the 2023 final rule and in part VI above, the Bureau estimates that about 800 small depository institutions and 469 small nondepository institutions would have been covered under the 2023 final rule but not under this final rule.
For all estimates discussed below, the Bureau relies on the methodology described in part VI.E, above, but focuses on estimating the impacts of the rule on small entities.
The Bureau estimates that depository institutions with the lowest level of complexity in compliance operations (
The Bureau estimates that the overall market impact of one-time cost savings for small depository institutions will be between $34,000,000 and $41,000,000.
Small financial institutions will also experience annual ongoing cost savings under the revisions in this final rule. Small institutions that were covered under the 2023 final rule but will no longer be required to report under this final rule will save on compliance costs that they would have otherwise incurred from having to collect and report application data to the Bureau annually. Small financial institutions that will remain covered under this final rule will see an ongoing cost savings from the reduction in required data points, which reduces the cost of collecting, checking, and reporting data to the Bureau annually.
The Bureau estimates that the overall annual market impact of ongoing cost savings for small depository institutions will be between $35,000,000 and $45,000,000 per year. The Bureau estimates that the overall annual market impact of ongoing cost savings for small nondepository institutions will be about $42,000,000 per year.
The Bureau estimates that about five small depository institutions and 25 small nondepository institutions (online lenders) will be covered under this final rule. The Bureau assumes online lenders will originate the same number of reportable loans under the 2023 final rule as they will under this final rule and, thus, will not experience any cost savings. The Bureau expects that some small depository institutions may originate fewer reportable loans under this final rule relative to the baseline, primarily because loans for agricultural purposes will not be reported under this final rule. These institutions may need to hire fewer additional employees to process reportable loans. The overall market level estimate of one-time hiring cost savings for covered small depositories is between $0 and $47,000.
Throughout this rulemaking, the Bureau considered multiple reporting thresholds for purposes of defining a covered financial institution. In
The Bureau also considered limiting its data collection to the data points specifically enumerated in 15 U.S.C. 1691c-2(e)(2)(A) through (G). In this final rule, the Bureau will continue to require the collection of the number of principal owners, three-digit NAICS industry code of the business, and the time in business, in addition to the data points required by statute. The Bureau has considered the impact on small entities of proposing only the collection of those data points enumerated in 15 U.S.C. 1691c-2(e)(2)(A) through (G), excluding the additional data points that the Bureau believes help further the purposes of section 1071. Only requiring the collection and reporting of the data points enumerated in 15 U.S.C. 1691c-2(e)(2)(A) through (G) would have reduced the annual ongoing cost of complying with this final rule for small financial institutions. Under this alternative, the estimated total annual ongoing costs for representative Type A, Type B, and Type C FIs would be reduced by $149, $523 and $2,838, respectively. Per application, the estimated reduction in ongoing cost would be $1, just over $1, and less than $1 for representative Type A, Type B, and Type C, respectively. The estimated total annual market-level ongoing cost savings of impacted small depository institutions would increase by about $20,000. The Bureau does not expect that one-time cost savings would be meaningfully different as a result of this alternative.
This final rule will eliminate ongoing variable costs for institutions that will no longer be covered and will reduce ongoing variable costs for institutions that remain covered. In part VI.F.2 above, the Bureau describes how, based on economic theory and evidence from the Bureau's own surveys, financial institutions will most likely pass on these savings to small business borrowers from eliminated or lower ongoing variable costs in the form of lower prices and fees. Therefore, the Bureau expects that this final rule will decrease the cost of credit for small entities who are small business applicants for credit under the rule.
In part VI.F.2 above, the Bureau estimates that the per application ongoing variable cost, at baseline, is $34 for Type A FIs, $28 for Type B FIs, and $8 for Type C FIs. According to the analysis above, this is the expected benefit that will accrue to applicants at institutions that were covered at baseline but will no longer be covered under this final rule. For institutions that will continue to report under this final rule, the difference between the ongoing variable cost at baseline and under this final is $8 for Type A FIs, $4 for Type B FIs, and around $1 for Type C FIs. This difference is what the Bureau expects to be passed on to applicants at financial institutions that will continue to be covered under this final rule.
Furthermore, the Bureau expects that small financial institutions covered under this final rule (insofar as they are considered “small entities” for the purposes of the RFA) are unlikely to experience a meaningful change in the costs of credit. Generally, financial institutions borrow in a manner that is different from other types of small businesses, including from other financial institutions in a separate Federal Funds market or from the Federal Reserve. The changes in compliance costs due to this final rule are unlikely to significantly change the cost of borrowing for these small financial institutions.
Under the Paperwork Reduction Act of 1995 (PRA),
As part of its continuing effort to reduce paperwork and respondent
This final rule amends 12 CFR part 1002 (Regulation B), which implements ECOA. The Bureau's OMB control number for Regulation B is 3170-0013. This final rule revises the information collection requirements contained in Regulation B that OMB has approved under that OMB control number.
Under the rule, the Bureau amends one information collection requirement in Regulation B: Compilation of reportable data (revised § 1002.107), including a notice requirement (in revised § 1002.107(a)(18) and (19)).
The information collection requirements in Regulation B, as amended by this final rule, are mandatory. Certain data fields will be modified or deleted by the Bureau, in its discretion, to advance a privacy interest before the data are made available to the public (as permitted by section 1071 and the Bureau's rule). The data that are not modified or deleted will be made available to the public and are not considered confidential. Unmodified data will be considered confidential if the information:
• Identifies any natural persons who might not be applicants (
• Implicates the privacy interests of financial institutions.
The collections of information contained in this final rule, and identified as such, have been submitted to OMB for review under section 3507(d) of the PRA. A complete description of the information collection requirements (including the burden estimate methods) is provided in the information collection request (ICR) that the Bureau has submitted to OMB under the requirements of the PRA. The ICR submitted to OMB requesting approval under the PRA for the information collection requirements contained herein is available at
In the NPRM the Bureau invited comments on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) the accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
One commenter noted that the Bureau should have published a 60-day PRA notice. This commenter also stated that the Bureau did not adequately update the collection burden analysis after having altered key parameters that affect respondent burden. The Bureau believes that its notice was sufficient. The Bureau also updated burden estimates of the collection requirements in accordance with the burden estimation presented in part VI above.
Pursuant to the Congressional Review Act (5 U.S.C. 801
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select those regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; and distributive impacts). Section 3(f) of E.O. 12866 defines a “significant regulatory action” as any regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, or the President's priorities. The Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), has determined that this action is a “significant regulatory action” under Section 3(f)(1) of Executive Order 12866. Accordingly, OMB has reviewed this action.
This rule is considered an Executive Order 14192 deregulatory action with estimated quantified annualized cost savings of $156.6 million at a 7% discount rate, discounted relative to year 2024, over a perpetual time horizon.
Banks, banking, Civil rights, Consumer protection, Credit, Credit unions, Marital status discrimination, National banks, Reporting and recordkeeping requirements, Penalties.
For the reasons set forth in the preamble, the Bureau is amending Regulation B, 12 CFR part 1002, as set forth below:
12 U.S.C. 5512, 5581; 15 U.S.C. 1691b. Subpart B is also issued under 15 U.S.C. 1691c-2.
(a) * * *
(4) * * *
(vii) A creditor that was required to report small business lending data pursuant to § 1002.109 for any of the preceding five calendar years but is not currently a covered financial institution
(viii) A creditor that exceeded the loan-volume threshold in the first year of the two-year threshold period provided in § 1002.105(b) may, in the second year, collect information pursuant to subpart B of this part for covered applications from small businesses as defined in §§ 1002.103 and 1002.106(b) regarding whether an applicant is a minority-owned business or a women-owned business, and the ethnicity, race, and sex of the applicant's principal owners if it complies with the requirements for covered financial institutions pursuant to §§ 1002.107(a)(18) and (19), 1002.108, 1002.111, and 1002.112 for that application. Such a creditor is permitted, but not required, to report data to the Bureau collected pursuant to subpart B of this part if it complies with the requirements of subpart B as otherwise required for covered financial institutions pursuant to §§ 1002.109 and 1002.110.
(ix) A creditor that is not currently a covered financial institution under § 1002.105(b), and is not otherwise a creditor to which paragraph (a)(4)(vii) or (viii) of this section applies, may collect information pursuant to subpart B of this part for covered applications from small businesses as defined in §§ 1002.103 and 1002.106(b) regarding whether an applicant for a covered credit transaction is a minority-owned business or a women-owned business, and the ethnicity, race, and sex of the applicant's principal owners for a transaction if it complies with the requirements for covered financial institutions pursuant to §§ 1002.107 through 1002.112 for that application.
(x) A creditor that is collecting information pursuant to subpart B of this part or as described in paragraphs (a)(4)(vii) through (ix) of this section for covered applications from small businesses as defined in §§ 1002.103 and 1002.106(b) regarding whether an applicant for a covered credit transaction is a minority-owned business or a women-owned business, and the ethnicity, race, and sex of the applicant's principal owners may also collect that same information for any co-applicants provided that it also complies with the relevant requirements of subpart B of this part or as described in paragraphs (a)(4)(vii) through (ix) of this section with respect to those co-applicants.
(b) * * *
(7)
(8)
(9)
(ii) Every 5 years after January 1, 2030, the transaction amount set forth in this paragraph (b)(9) shall adjust based on changes to the Consumer Price Index for All Urban Consumers (U.S. city average series for all items, not seasonally adjusted), as published by the United States Bureau of Labor Statistics. Any adjustment that takes effect under this paragraph (b)(9)(ii) shall be rounded to the nearest multiple of $100. If an adjustment is to take effect, it will do so on January 1 of the following calendar year.
(b)
(b)(1)
(2) Every 5 years after January 1, 2030, the gross annual revenue threshold set forth in paragraph (b)(1) of this section shall adjust based on changes to the Consumer Price Index for All Urban Consumers (U.S. city average series for all items, not seasonally adjusted), as published by the United States Bureau of Labor Statistics. Any adjustment that takes effect under this paragraph (b)(2) shall be rounded to the nearest multiple of $100,000. If an adjustment is to take effect, it will do so on January 1 of the following calendar year.
The revisions read as follows:
(a) * * *
(18)
(19)
(c) * * *
(1)
(2) * * *
(i) The initial request for applicant-provided data occurs prior to notifying an applicant of final action taken on a covered application, or at another time reasonably designed to obtain a response;
(d)
(1) To satisfy paragraphs (a)(13), (15), and (17) through (20) of this section, the data were collected within the 36 months preceding the current covered application, or to satisfy paragraph (a)(14) of this section, the data were collected within the same calendar year as the current covered application; and
(b)
(d)
(b)
(c) * * *
(4)
The revisions read as follows:
(b) * * *
(1) A covered financial institution that originated at least 1,000 covered credit transactions for small businesses in each of calendar years 2026 and 2027 shall comply with the requirements of this subpart beginning January 1, 2028.
(4) A financial institution that did not originate at least 1,000 covered credit transactions for small businesses in each of calendar years 2026 and 2027 but subsequently originates at least 1,000 such transactions in two consecutive calendar years shall comply with the requirements of this subpart in accordance with § 1002.105(b), but in any case no earlier than January 1, 2029.
(c)
(2)
(3)
As set out in § 1002.112(b) and in comment 112(b)-1 of supplement I to this part, a financial institution is presumed to maintain procedures reasonably adapted to avoid errors with respect to a given data field if the number of errors found in a random sample of a financial institution's data submission for a given data field do not equal or exceed the threshold in column C of the following table:
The size of the random sample, under column B, shall depend on the size of the financial institution's small business lending application register, as shown in column A of table 1 to this appendix.
The thresholds in column C of table 1 to this appendix reflect the number of unintentional errors a financial institution may make within a particular data field (
For instance, a financial institution that submitted a small business lending application register containing 11,000 applications would be subject to a threshold of four errors per data field. If the financial institution had made two errors in reporting loan amount and two errors reporting gross annual income, all of these errors would be covered by the bona fide error provision of § 1002.112(b) and would not constitute a violation of the Act or this part. If the same financial institution had made five errors in reporting loan amount and two errors reporting gross annual revenue, the bona fide error provision of § 1002.112(b) would not apply to the five loan amount errors but would still apply to the two gross annual revenue errors.
Even when the number of errors in a particular data field do not equal or exceed the threshold in column C, if either there is a reasonable basis to believe that errors in that field were intentional or there is evidence that the financial institution did not maintain procedures reasonably adapted to
For purposes of determining bona fide errors under § 1002.112(b), the term “data field” generally refers to individual fields. Some data fields may allow for more than one response. For example, with respect to information on the ethnicity or race of an applicant's principal owners, a data field may identify more than one race or more than one ethnicity for a given person. If one or more of the ethnicities or races identified in a data field are erroneous, they count as one (and only one) error for that data field.
The revisions and additions read as follows:
1.
2.
3.
4.
1.
2.
3.
4.
5.
6.
7.
8.
1.
2.
3.
1.
1.
2.
3.
4.
1.
2.
3.
1.
2.
1.
2.
3.
4.
5.
6.
7.
8.
i. Two institutions that are not covered financial institutions merge. The surviving or newly formed institution meets all of the requirements necessary to be a covered financial institution. No data are required to be compiled, maintained, or reported for the calendar year of the merger (even though the merger creates an institution that meets all of the requirements necessary to be a covered financial institution).
ii. A covered financial institution and an institution that is not covered merge. The covered financial institution is the surviving institution, or a new covered financial institution is formed. For the calendar year of the merger, data are required to be compiled, maintained, and reported for covered applications from the covered financial institution and is optional for covered applications from the financial institution that was previously not covered.
iii. A covered financial institution and an institution that is not covered merge. The institution that is not covered is the surviving institution and remains not covered after the merger, or a new institution that is not covered is formed. For the calendar year of the merger, data are required to be compiled and maintained (and subsequently reported) for covered applications from the previously covered financial institution that took place prior to the merger. After
iv. Two covered financial institutions merge. The surviving or newly formed financial institution is a covered financial institution. Data are required to be compiled and maintained (and subsequently reported) for the entire calendar year of the merger. The surviving or newly formed financial institution files either a consolidated submission or separate submissions for that calendar year.
9.
10.
1.
2.
3.
4.
1.
2.
1.
2.
3.
4.
1.
i. Term loan—unsecured.
ii. Term loan—secured.
iii. Line of credit—unsecured.
iv. Line of credit—secured.
v. Credit card account, not private-label.
vi. Private-label credit card account.
vii. [Reserved]
viii. [Reserved]
ix. Other.
x. Not provided by applicant and otherwise undetermined.
2.
3.
4.
5.
6. [Reserved]
7.
i. Personal guarantee—owner(s).
ii. Personal guarantee—non-owner(s).
iii. SBA guarantee—7(a) program.
iv. SBA guarantee—504 program.
v. SBA guarantee—other.
vi. USDA guarantee.
vii. FHA insurance.
viii. Bureau of Indian Affairs guarantee.
ix. Other Federal guarantee.
x. State government guarantee.
xi. Local government guarantee.
xii. Other.
xiii. No guarantee.
8.
1.
2.
3.
4.
5.
6.
7.
8.
9.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
A. Hispanic or Latino.
B. Not Hispanic or Latino.
14.
A. American Indian or Alaska Native.
B. Asian.
C. Black or African American.
D. Native Hawaiian or Other Pacific Islander.
E. White.
ii. [Reserved]
iii.
15.
16.
i. [Reserved]
ii.
1.
1.
2.
3.
4.
5.
1.
2.
ii.
iii. [Reserved]
iv.
v.
1.
2.
3.
4.
5.
6.
7.
8.
i. If a financial institution previously collected data on a prior covered application that the applicant has been in business for four years, and then seeks to reuse that data for a subsequent covered application submitted one year later, it must update the data to reflect that the applicant has been in business for five years.
ii. If a financial institution previously collected data on a prior covered application that the applicant had been in business less than two years (and was not aware of the business's actual length of time in business at the time), and then seeks to reuse that data for a subsequent covered application submitted 18 months later, the financial institution reports time in business on the subsequent covered application as over two years in business.
9.
1.
2.
ii.
1.
2.
3.
109(a)(3) Reporting Obligations Where Multiple Financial Institutions Are Involved in a Covered Credit Transaction
1.
i. A financial institution shall report the action that it takes on a covered application, whether or not the covered credit transaction closed in the financial institution's name and even if the financial institution used underwriting criteria supplied by another financial institution. However, where it is necessary for more than one financial institution to make a credit decision in order to approve a single covered credit transaction, only the last financial institution with authority to set the material terms of the covered credit transaction is required to report. Setting the material terms of the covered credit transaction include, for example, selecting among competing offers, or modifying pricing information, amount approved or originated, or repayment duration. In this situation, the determinative factor is not which financial institution actually made the last credit decision prior to closing, but rather which financial institution last had the authority for setting the material terms of the covered credit transaction prior to closing. Whether a financial institution has taken action for purposes of § 1002.109(a)(3) and comment 109(a)(3)-1 is not relevant to, and is not intended to repeal, abrogate, annul, impair, or interfere with, section 701(d) (15 U.S.C. 1691(d)) of the Act, § 1002.9, or any other provision within subpart A of this part.
ii. A financial institution takes action on a covered application for purposes of § 1002.109(a)(3) if it denies the application, originates the application, approves the application but the applicant did not accept the transaction, or closes the file or denies for incompleteness. The financial institution must also report the application if it was withdrawn. For reporting purposes, it is not relevant whether the financial institution receives the application directly from the applicant or indirectly through another party, such as a broker, or (except as otherwise provided in comment 109(a)(3)-1.i) whether another financial institution also reviews and reports an action taken on a covered application involving the same credit transaction.
iii. Where it is necessary for more than one financial institution to make a credit decision in order to approve a single covered credit transaction and where more than one financial institution denies the application or otherwise does not approve the application, the reporting financial institution (the last financial institution with authority to set the material terms of the covered credit transaction) shall have a consistent procedure for determining how it reports inconsistent or differing data points for purposes of subpart B of this part. For example, Financial Institution A is the reporting entity because it has the last authority to set the material credit terms. Financial Institution A sends the application to Financial Institution B and Financial Institution C for review, but both Financial Institution B and Financial Institution C deny the application. Based on these denials, Financial Institution A follows suit and denies the application.
2.
i. Financial Institution A received a covered application from an applicant and approved the application before closing the covered credit transaction in its name. Financial Institution A was not acting as Financial Institution B's agent. Financial Institution B later purchased the covered credit transaction from Financial Institution A. Financial Institution A was not acting as Financial Institution B's agent. Financial Institution A reports the application. Financial Institution B has no reporting obligation for this transaction.
ii. Financial Institution A received a covered application from an applicant. If approved, the covered credit transaction would have closed in Financial Institution B's name. Financial Institution A denied the application without sending it to Financial Institution B for approval. Financial Institution A was not acting as Financial Institution B's agent. Since Financial Institution A took action on the application, Financial Institution A reports the application as denied. Financial Institution B does not report the application.
iii. Financial Institution A reviewed a covered application and made a credit decision to approve it using the underwriting criteria provided by a Financial Institution B. Financial Institution B did not review the application and did not make a credit decision prior to closing. Financial Institution A was not acting as Financial Institution B's agent. Financial Institution A reports the application. Financial Institution B has no reporting obligation for this application.
iv. Financial Institution A reviewed and made the credit decision on a covered application based on the criteria of a third-party insurer or guarantor (for example, a government or private insurer or guarantor). Financial Institution A reports the action taken on the application.
v. Financial Institution A received a covered application from an applicant and forwarded that application to Financial Institution B. Financial Institution B reviewed the application and made a credit decision approving the application prior to closing. The covered credit transaction closed in Financial Institution A's name. Financial Institution B purchased the covered credit transaction from Financial Institution A after closing. Financial Institution B was not acting as Financial Institution A's agent. Since Financial Institution B made the credit decision prior to closing, and Financial Institution A's approval was not necessary for the credit transaction, Financial Institution B reports the origination. Financial Institution A does not report the application. Assume the same facts, except that Financial Institution B reviewed the application before the covered credit transaction would have closed, but Financial Institution B denied the application. Financial Institution B reports the application as denied. Financial Institution A does not report the application because it did not take an action on the application. If, under the same facts, the application was withdrawn before Financial Institution B made a credit decision, Financial Institution B would report the application as withdrawn and Financial Institution A would not report the application for the same reason.
vi. Financial Institution A received a covered application and forwarded it to Financial Institutions B and C. Financial Institution A made a credit decision, acting as Financial Institution D's agent, and approved the application. Financial Institutions B and C are not working together with Financial Institutions A or D, or with each other, and are solely responsible for setting the terms of their own credit transactions. Financial Institution B made a credit decision approving the application, and Financial Institution C made a credit decision denying the application. The applicant did not accept the covered credit transaction from Financial Institution D. Financial Institution D reports the application as approved but not accepted. Financial Institution A does not report the application, because it was acting as Financial Institution D's agent. The applicant accepted the offer of credit from Financial Institution B, and credit was extended. Financial Institution B reports the application as originated. Financial Institution C reports the application as denied.
vii. Financial Institution A received a covered application and made a credit decision to approve it using the underwriting criteria provided by Financial Institution B. Financial Institution A was not acting as Financial Institution B's agent. Financial Institution A forwarded the application to Financial Institution B. Financial Institution B reviewed the application and made a credit decision approving the application prior to closing. Financial Institution A makes a credit decision on the application and modifies the credit terms (the interest rate and repayment term) offered by Financial Institution B. The covered credit transaction reflecting the modified terms closes in Financial Institution A's name. Financial Institution B purchases the covered credit transaction from Financial Institution A after closing. As the last financial institution with the authority for setting the material terms of the covered credit transaction, Financial Institution A reports the application as originated. Financial Institution B does not report the origination because it was not the last financial institution with the authority to set the material terms on the application. If, under the same facts, Financial Institution A did not modify the credit terms offered by Financial Institution B, Financial Institution A still reports the application as originated because it was still the last financial institution with the authority for setting the material terms, even if it chose not to so do in a particular instance. Financial Institution B does not report the origination.
viii. Financial Institution A received a covered application and forwarded it to Financial Institutions B, C, and D. Financial Institution A was not acting as anyone's agent. Financial Institution B and C reviewed the application and made a credit decision approving the application and Financial Institution D reviewed the application and made a credit decision denying the application. Prior to closing, Financial Institution A makes a credit decision on the application by deciding to offer to the applicant the credit terms offered by Financial Institution B and does not convey to the applicant the credit terms offered by Financial Institution C. The applicant does not accept the covered credit transaction. As the last financial institution with the authority for setting the material terms of the covered credit transaction, Financial Institution A reports the application as approved but not accepted. Financial Institutions B, C, and D do not report the application because they were not the last financial institution with the authority for setting the material terms of the covered credit transaction. Assume the same facts, except the applicant accepts the terms of the covered credit transaction from Financial Institution B as offered by Financial Institution A. The covered credit transaction closes in Financial Institution A's name. Financial Institution B purchases the transaction after closing. Here, Financial Institution A reports the application as originated. Financial Institutions B, C, and D do not report the application because they were not the last financial institution
ix. Financial Institution A receives a covered application and approves it, and then Financial Institution A elects to organize a loan participation agreement where Financial Institutions B and C agree to purchase a partial interest in the covered credit transaction. Financial Institution A reports the application. Financial Institutions B and C have no reporting obligation for this application.
x. Financial Institution A purchases an interest in a pool of covered credit transactions, such as credit-backed securities or real estate investment conduits. Financial Institution A does not report this purchase.
3.
1.
1.
i. Bank or savings association.
ii. Minority depository institution.
iii. Credit union.
iv. Nondepository institution.
v. Community development financial institution (CDFI).
vi. Other nonprofit financial institution.
vii. [Reserved].
viii. Government lender.
ix. Commercial finance company.
x. Equipment finance company.
xi. Industrial loan company.
xii. Online lender.
xiii. Other.
2.
3.
1.
2.
3.
1.
2.
3.
1.
2. [Reserved]
3. [Reserved]
4.
i. Financial Institution A originated 3,000 covered credit transactions for small businesses in calendar year 2026, and 3,000 in calendar year 2027. Financial Institution A has a compliance date of January 1, 2028.
ii. [Reserved]
iii. [Reserved]
iv. Financial Institution D originated 990 covered credit transactions to small businesses in calendar year 2026, 1,020 in calendar year 2027, and 990 in calendar years 2028 and 2029. Because Financial Institution D did not originate at least 1,000 covered credit transactions for small businesses in each of 2026 and 2027, it is not subject to the initial compliance date set forth in § 1002.114(b)(1). Because Financial Institution D did not originate at least 1,000 covered credit transactions for small businesses in subsequent consecutive calendar years, it is not a covered financial institution under § 1002.105(b) and is not required to comply with the rule in 2029 or 2030.
v. [Reserved]
vi. Financial Institution F originated 990 covered credit transactions for small businesses in calendar year 2026, and 1,020 in 2027, 2028, and 2029. Because Financial Institution F did not originate at least 1,000 covered credit transactions for small businesses in each of 2026 and 2027, it is not subject to the initial compliance date set forth in § 1002.114(b)(1). Because Financial Institution F originated at least 1,000 covered credit transactions for small businesses in subsequent calendar years, § 1002.114(b)(4), which cross-references § 1002.105(b), applies to Financial Institution F. Because Financial Institution F originated at least 1,000 covered credit transactions for small businesses in each of 2027 and 2028, it is a covered financial institution under § 1002.105(b) and is required to comply with the rule beginning January 1, 2029.
1.
2.
3.
4.
5.
i. A financial institution may comply with § 1002.114(c)(2) by determining the small business status of covered credit transactions by asking every applicant, prior to the closing of approved transactions, to self-report whether it had gross annual revenue for its preceding fiscal year of $1 million or less, during the period October 1 through December 31, 2026. The financial institution may annualize the number of covered credit transactions it originates to small businesses from October 1 through December 31, 2026, by quadrupling the originations for this period, and apply the annualized number of originations to both calendar years 2026 and 2027.
ii. A financial institution may comply with § 1002.114(c)(2) by asking a representative sample of applicants for covered credit transactions whether they are small businesses.
iii. A financial institution may comply with § 1002.114(c)(2) by using another methodology provided that such methodology is reasonable and documented in writing.
6.
i. Prior to July 1, 2026, Financial Institution A did not collect gross annual revenue or other information that would allow it to determine the small business status of the businesses for whom it originated covered credit transactions in calendar year 2026. Financial Institution A chose to use the methodology set out in comment 114(c)-5.i and as of July 1, 2026, began to collect information on gross annual revenue as defined in § 1002.107(a)(14) for its covered credit transactions originated for businesses. Using this information, Financial Institution A determined that it had originated 750 covered credit transactions for businesses that were small as defined in § 1002.106. On an annualized basis, Financial Institution A originated 3,000 covered credit transactions for small businesses (750 originations * 4 = 3,000 originations per year). Applying this annualized figure of 3,000 originations to both calendar years 2026 and 2027, Financial Institution A is subject to the initial compliance date set forth in § 1002.114(b)(1).
ii. Prior to July 1, 2026, Financial Institution B collected gross annual revenue information for some applicants for business credit, but such information was only noted in its paper loan files. Financial Institution B thus does not have reasonable access to information that would allow it to determine the small business status of the businesses for whom it originated covered credit transactions for the first half of calendar year 2026. Financial Institution B chose to use the methodology set out in comment 114(c)-5.i, and as of October 1, 2026, Financial Institution B began to ask all businesses for whom it was closing covered credit transactions if they had gross annual revenues in the preceding fiscal year of $1 million or less. Using this information, Financial Institution B determined that it had originated 850 covered credit transactions for businesses that were small as defined in § 1002.106. On an annualized basis, Financial Institution B originated 3,400 covered credit transactions for small businesses (850 originations * 4 = 3,400 originations per year). Applying this estimated figure of 3,400 originations to both calendar years 2026 and 2027, Financial Institution B is subject to the initial compliance date set forth in § 1002.114(b)(1).
iii. [Reserved]
iv. Financial Institution D did not collect gross annual revenue or other information that would allow it to determine the small business status of the businesses for whom it originated covered credit transactions in calendar years 2026 and 2027. Financial Institution D determined that it had originated 3,000 total covered credit transactions for businesses in each of 2026 and 2027. Applying the methodology specified in comment 114(c)-5.ii, Financial Institution D assumed that all 3,000 covered credit transactions originated in each of 2026 and 2027 were to small businesses. On that basis, Financial Institution D is subject to the initial compliance date set forth in § 1002.114(b)(1).
v. [Reserved]
vi. Financial Institution F does not have readily accessible gross annual revenue or other information that would allow it to determine the small business status of the businesses for whom it originated covered credit transactions in calendar years 2026 and 2027. Financial Institution F determined that it had originated 480 total covered credit transactions for businesses in 2026 and 550 total covered credit transactions for businesses in 2027. Applying the methodology set out in comment 114(c)-5.ii, Financial Institution F assumed that all such transactions originated in 2026 and 2027 were originated for small businesses. On that basis, Financial Institution F is not subject to the initial compliance date set forth in § 1002.114(b)(1).
vii. Financial Institution G chose to estimate its originations for 2025 and 2026 (rather than 2026 and 2027), as permitted by § 1002.114(c)(3), and does not have readily accessible gross annual revenue or other information that would allow it to determine the small business status of the businesses for whom it originated covered credit transactions in either of those calendar years. Financial Institution G chose to use the methodology set out in comment 114(c)-5.i, and as of October 1, 2025, Financial Institution G began to ask all businesses for whom it was closing covered credit transactions if they had gross annual revenue in the preceding fiscal year of $1 million or less. Using this information, Financial Institution G
Nuclear Regulatory Commission.
Proposed rule; guidance; and request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to establish a risk-informed and performance-based regulatory framework for rapid licensing of new microreactors and other reactors with comparable risk profiles and for high-volume deployment of these reactors. The proposed rule would provide a flexible set of licensing pathways, reduce regulatory burden, and ensure that safety and security requirements remain commensurate with the potential hazards posed by these facilities.
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George Tartal, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-0016, email:
The purpose of this rulemaking is to safely expedite the licensing process for microreactors and other reactors with comparable risk profiles. This effort is consistent with, and implements direction in, the Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy Act of 2024 (Pub. L. 118-67, 138 Stat. 1448) (ADVANCE Act), and Executive Order (E.O.) 14300, “Ordering the Reform of the Nuclear Regulatory Commission” (90 FR 22587; May 29, 2025).
Section 208 of the ADVANCE Act requires the NRC to develop “risk-informed and performance-based strategies and guidance to license and regulate microreactors.” The ADVANCE Act mandates that these strategies be incorporated into the existing regulatory framework, the technology-inclusive regulatory framework to be established through the rulemaking required by section 103(a)(4) of the Nuclear Energy Innovation and Modernization Act (Pub. L. 115-439, 132 Stat. 5572) (NEIMA), or a pending or new rulemaking by July 2027.
On January 20, 2025, the President declared a National Energy Emergency in E.O. 14156, “Declaring a National Energy Emergency” (90 FR 8433; January 29, 2025), and stressed the need for a reliable, diversified, and affordable supply of energy. The President also issued E.O. 14154 (90 FR 8353; January 29, 2025), titled, “Unleashing American Energy,” with an objective of unleashing “America's affordable and reliable energy and natural resources.”
On May 23, 2025, the President issued E.O. 14300. Section 5(e) of that E.O. directs the NRC to revise its regulations to “[e]stablish a process for high-volume licensing of microreactors and modular reactors, including by allowing for standardized applications and approvals and by considering to what extent such reactors or components thereof should be regulated through general licenses.” That E.O. set February 23, 2026, as the deadline for issuing this proposed rule, and the final rule must be issued by November 23, 2026.
In developing this proposed rule, the NRC considered whether to establish the rule's scope within the amended non-power production or utilization facility (NPUF) licensing framework set out in the NRC's final rule, “Non-Power Production or Utilization Facility License Renewal,” issued on December 30, 2024 (89 FR 106234). That NPUF rulemaking was primarily intended to revise and streamline the license renewal process for facilities such as research and test reactors and medical isotope production facilities and was not designed to serve as a comprehensive licensing pathway for the high-volume deployment of microreactors. However, many of the design features and siting characteristics of NPUFs are expected to closely align with those reactors within the scope of this rulemaking. NPUFs are commonly located at national laboratories, private ventures, and universities, situated in both sparsely and densely populated areas. They operate over a broad range of thermal powers—up to tens of megawatts—with large thermal capacities and fuel designed with inherent safety features that enhance their stability and safety.
The NRC considered amending part 50, “Domestic Licensing of Production and Utilization Facilities,” or part 52, “Licenses, Certifications, and Approvals For Nuclear Power Plants,” of title 10 of the
The NRC also considered developing this proposed rule's scope within the framework of 10 CFR part 53, “Risk-Informed, Technology-Inclusive Regulatory Framework for Commercial Nuclear Plants.” Although part 53 provides a pathway to support licensing of microreactors, part 53 is designed to also cover large, complex reactors. The
Collectively, the NRC's regulatory frameworks offer optionality and enable applicants to select licensing pathways that align with applicant-specific circumstances and deployment strategies.
The primary provisions of this proposed rule would establish a risk-informed and performance-based regulatory framework for rapid and high-volume licensing of microreactors and reactors with comparable risk profiles. The proposed rule would provide flexible licensing pathways with streamlined requirements, as compared to the analogous requirements in part 50 and part 52, that would ensure safety and security requirements remain commensurate with the potential hazards posed by these facilities. Licensing and approval pathways would include a construction permit (CP) and an operating license (OL), a manufacturing license, a standard design approval, and provisions for affording regulatory finality to nuclear plant designs and essentially complete standardized operational programs. Applicants could combine in a single application requests for these licenses and approvals with requests for other licenses, approvals, and certifications for special nuclear material, byproduct material, transportation, and irradiated fuel storage to enable a broad spectrum of deployment models.
The proposed rule is intended to expedite licensing reviews based on the statutory requirements of the AEA. E.O. 14300 directs the NRC to reach a final decision on an application to construct and operate a new reactor of any type within 18 months. This proposed licensing process should enable the NRC to issue an OL within 6-12 months after accepting an application, assuming that several factors beyond the NRC's control are met (
This proposed licensing framework would contain performance-based and risk-informed entry criteria consistent with design attributes that are necessary and essential for rapid, high-volume licensing of microreactors and other reactors with comparable risk profiles. Flexibilities in the proposed rule would include allowing a graded site characterization approach using existing site characterization data from Federal, State, or other organizations, provided that the data meets applicable NRC quality standards. Also, applicants would be able to define certain regulatory terms (
The proposed rule would provide applicants with other flexibilities. Applicants could propose and justify an appropriate use of codes and standards as well as quality assurance programs tailored to the safety significance of the facility's SSCs. For environmental reviews, the proposed rule would permit the use of categorical exclusions under the National Environmental Policy Act, provided that specific conditions are met. The proposed rule would provide a general license for certain construction activities before issuance of a CP for an “nth-of-a-kind” facility (
The NRC prepared a draft regulatory analysis to determine the expected quantitative costs and benefits of this proposed rule and associated guidance as well as qualitative factors to be considered in the NRC's rulemaking decision. The conclusion from the analysis is that this proposed rule and associated guidance would result in net averted costs to the industry and the NRC of approximately $3.76 billion using a 7-percent discount rate and $11.84 billion using a 3-percent discount rate. As the number of applicants increases, so do the estimated averted costs.
The draft regulatory analysis also considers qualitative factors, such as greater regulatory stability, predictability, and clarity to the licensing process. Another qualitative factor is promoting a performance-based regulatory framework that specifies requirements to be met and provides flexibility to an applicant or licensee regarding the information or approach needed to satisfy those requirements.
For more information, please see the draft regulatory analysis (available in the NRC's Agencywide Documents Access and Management System (ADAMS) Accession No. ML26111A076).
Please refer to Docket ID NRC-2025-0379 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:
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Comments must be submitted electronically using
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
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.
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,” requires 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 addresses section 5(e), which requires the NRC to “[e]stablish a process for high-volume licensing of microreactors and modular reactors, including by allowing for standardized applications and approvals and by considering to what extent such reactors or components thereof should be regulated through general licenses.”
The microreactors and other reactors with comparable risk profiles that would be licensed under this proposed rule would be commercial nuclear reactors under section 103, “Commercial Licenses,” of the Atomic Energy Act of 1954, as amended (AEA). Due to their expected small sizes, low power levels, potential mobility, and simplicity of operation compared to the current fleet of operating power reactors, microreactors and other reactors with comparable risk profiles may be useful, for example, for remote communities, non-electric industrial processes, military bases, maritime applications, disaster relief, and other applications where a grid connection is unreliable or nonexistent.
Microreactors and other reactor concepts with comparable risk profiles encompass a wide variety of reactor designs, including fuel forms, coolant types, and power levels. These concepts often incorporate inherent and passive safety design features that distinguish them from the large light water reactors
Based on input from stakeholders (see section III.B, “Public Interest in Microreactors and Other Reactors with Comparable Risk Profiles,” of this document), the NRC anticipates that microreactors and other reactors with comparable risk profiles would rely heavily on standardization of design features and mass production to simplify licensing and deployment. Some reactors may be “self-contained” in that they would incorporate the reactor, shielding, and balance of plant in one or several transportable containers and require minimal site preparation or construction activities at the deployment site. Other designs may consist of a nuclear reactor that would be fabricated in a manufacturing facility and then incorporated into or connected to the permanent structures and systems of a nuclear plant constructed at the deployment site, such as a reactor building and power conversion equipment.
The NRC understands that deployment models for microreactors and other reactors with comparable risk profiles would include various activities involving NRC licensing, certification, or approval. These activities may include designing reactors, manufacturing at a manufacturing facility, loading fuel at a manufacturing facility, operating the reactors for testing at a manufacturing facility, transporting fueled reactors to deployment sites (loaded with unirradiated or irradiated fuel), operating the reactors for the production of electrical or heat energy at the deployment sites, replacing reactors at the deployment sites, transporting reactors away from the deployment sites at the end of their useful lives, decommissioning or refurbishing and refueling reactors at locations away from the deployment sites, and re-deploying refurbished reactors to deployment sites. Some microreactors and other reactors with comparable risk profiles may also use more “traditional” approaches, including constructing the reactor in its entirety, loading fuel, or performing operational testing at the deployment site. This proposed rule would provide processes and requirements that would enable all these potential deployment models.
The NRC recognizes the public interest in the development and deployment of microreactors and other reactors with comparable risk profiles. For several years, the NRC has conducted advanced reactor stakeholder meetings to facilitate open communication between the agency, industry, and the public regarding regulatory policy, licensing pathways, and technical issues related to advanced reactors. These meetings covered a wide range of topics, including safety and security considerations, fuel qualification and transportation, siting and environmental review, emergency preparedness, quality assurance approaches, risk-informed and performance-based regulatory methods, and lessons learned from the licensing of non-power production or utilization facilities (NPUFs). Stakeholders have also discussed and presented strategies for streamlining licensing processes to accommodate the anticipated high licensing volumes associated with modular and transportable reactor concepts.
In addition to these public meetings, the NRC has received letters and formal reports from a broad spectrum of interested parties, including non-governmental organizations, policy organizations representing both the nuclear industry and public interest groups, national laboratories, and Federal, State, and local governmental entities. These submissions have provided perspectives on technical design features, operational considerations, safety analysis methodologies, environmental impacts, workforce development, and policy objectives for advanced reactor deployment. Many communications have highlighted the potential for microreactors to support energy resilience, remote power applications, industrial process heat, and national security missions.
A recurring theme in both the stakeholder discussions and the written correspondence has been the need for the NRC to develop a clear, predictable, and efficient regulatory framework that supports rapid licensing of new microreactors and other reactors with comparable risk profiles and high-volume deployment of these reactors. Several stakeholders emphasized that when a microreactor applicant demonstrates low radiological consequences at the site boundary in the unlikely event of an accident, the NRC should allow the use of a licensing approach similar to that established for NPUFs. Stakeholders have noted that such an approach—appropriately adapted for microreactors—would leverage proven regulatory structures, align safety requirements with actual risk, and reduce unnecessary regulatory burden while maintaining the NRC's safety and security standards.
Rapid and high-volume deployment of microreactors and modular reactors is needed to support national policy and market demand. The Nuclear Energy Innovation and Modernization Act seeks to streamline licensing and reduce regulatory uncertainty for advanced reactor designs. The Accelerating Deployment of Versatile, Advanced Nuclear of Clean Energy Act requires the NRC to develop “risk-informed and performance-based strategies and guidance to license and regulate microreactors.” Executive Orders promote the development of domestic energy supplies to meet the increasing demand for electricity and direct the NRC to conduct this rulemaking. Market demand for baseload power has resulted in business cases for high-volume deployment of microreactors and modular reactors in markets where traditional large-scale nuclear power plants are impractical or uneconomical.
This proposed rule is needed to establish a regulatory framework specifically tailored to rapid licensing of first-of-a-kind microreactors and other reactors with comparable risk profiles and high-volume deployment of these reactors. The use cases for such reactors support energy resilience, remote power applications, and industrial process heat. The proposed framework would be based on simplified safety requirements and would maximize the benefits of standardization. The proposed processes and requirements in this rule would enable shorter licensing timeframes that require fewer resources than those supported by existing regulations for nuclear power reactors in part 50 and part 52, which were designed for stationary, large light water reactors (LWRs). This proposed alternative regulatory framework is also needed to address Presidential and Congressional direction and stakeholder feedback.
This proposed rule is complementary to and shares several features with part 53, “Risk-Informed, Technology-Inclusive Regulatory Framework for Commercial Nuclear Plants.” The part 53 rule features a risk analysis approach that accommodates licensing all reactor technologies, including microreactors and large, complex reactors. To complement this broad scope approach, proposed part 57 would rely on streamlined safety requirements to focus on simpler license applications and rapid licensing reviews of new reactors with less complex designs and operational characteristics and low potential radiological consequences. The major provisions and features of this proposed part 57 rule include the following:
This proposed rule would provide a pathway to enable rapid licensing through streamlined and focused safety requirements, for microreactors and other reactors with comparable risk profiles. The proposed rule would leverage the simplified designs, limited nuclear inventory, and overall low risk profiles of these facilities to establish the necessary and sufficient regulatory requirements to provide for reasonable assurance of adequate protection. This approach would enable shorter licensing timeframes by streamlining the information needed to be prepared by applicants and reviewed by the NRC. The applicant would be required to submit final design information and complete operational programs in a joint application for a construction permit (CP) and associated operating licenses (OLs). The NRC would conduct a single, comprehensive safety review and potentially hold one adjudicatory hearing on the joint application. Time and resource savings would be achieved for qualifying “first-of-a-kind” and “nth-of-a-kind” designs without any adverse impact on safety and security.
This proposed rule would enable high volume licensing based on standardization of reactor designs and operational programs. An applicant would have the option to request a single CP and any number of OLs for any number of nuclear reactors of essentially the same design to be built at one or more specific sites or within designated large geographical areas. Multiple applicants for essentially the same design would have the option to reference common non-site-specific information, and the NRC could consolidate some aspects of the licensing proceedings.
This proposed rule would provide options for issuance of a CP to include approval of the final reactor design and operational programs, address siting and environmental requirements for large geographical areas or multiple specific sites, and satisfy requirements for mandatory and adjudicatory hearings if an applicant provided all necessary information in a joint application for a CP and associated OL(s). This could support licensing reactor operation within days of site selection for time-critical deployment, depending on the simplicity of onsite construction activities.
The proposed rule would provide several licensing options for applicants to choose from to meet their deployment model or business case needs, including a joint application for a CP and associated OL(s), which would allow for deployment of reactors and approval of standard designs; a manufacturing license (ML), which would allow for approval and manufacture of standardized designs and approval of operational programs; and a standard design approval (SDA), which would allow for approval of entire reactor designs or major portions thereof. Applicants would be able to combine requests for these types of licenses and approvals with requests for license(s), approvals, and certifications under other regulations in a single application to holistically address their deployment strategies.
An applicant may include in its joint application for a CP and associated OL(s) a request for generic finality. Matters resolved in a proceeding on the application for issuance of the CP and associated OL(s) for which the applicant has requested and the Commission has granted generic finality would be considered resolved in proceedings on other joint applications under proposed part 57 that reference the approved CP or associated OL(s). For joint applications for “nth-of-a-kind” nuclear reactors and nuclear plants that reference CPs and associated OL(s) afforded generic finality, the scope of licensing proceedings would be reduced to site- and applicant-specific information.
The proposed rule would include the use of features to prevent criticality to allow reactors to be fabricated, fueled, and tested at a manufacturing facility before being transported to an operating site. This proposed rule would also allow ML applicants to request and the NRC to afford finality to the entire nuclear plant design and operational programs, thereby reducing the scope of proceedings on joint application for a CP and associated OL(s) that reference the ML to site- and applicant-specific information.
The proposed rule would permit the use of categorical exclusions from the requirement for the NRC to prepare an environmental assessment or environmental impact statement under the National Environmental Policy Act (NEPA), provided that specific conditions are met.
This proposed rule would establish a general license under which an applicant that files a joint application for a CP and associated OL(s) for a “nth-of-a-kind facility” could begin construction activities before the issuance of a CP, provided that certain conditions are met.
The proposed rule would allow a graded site characterization approach with use of existing site characterization data from Federal, State, or other organizations, provided that the data meets applicable NRC quality standards.
The definitions of many terms in this proposed rule would be equivalent to the corresponding terms defined in §§ 21.3, 50.2, and 52.1, all entitled “Definitions,” and other NRC regulations. However, given the variety of microreactor and other reactor designs with comparable risk profiles, flexibility is proposed to allow applicants to redefine applicable definitions to support their specific design and licensing basis needs, provided that such redefinitions are justified and supported by the applicant's safety analysis.
The proposed rule would allow applicants to propose, with adequate justification, the use of codes and standards appropriate for their reactor design and not incorporate by reference
The proposed rule would not impose quality assurance requirements under the existing regulations in appendix B, “Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,” to 10 CFR part 50. Instead, the proposed rule would allow the applicant to choose an industry-approved quality assurance program, similar to the approach taken in American National Standards Institute/American National Standard ANSI/ANS-15.8-1995 (R2018), “Quality Assurance Program Requirements for Research Reactors.”
Information related to operational programs concerning facility operation could be standardized to facilitate fleet-wide deployment of a microreactor or other reactor with comparable risk profile. These standardized operational programs could be designed to be administered onsite or at a corporate or institutional level. Standard operational programs such as emergency preparedness and security plans would receive finality, to the extent practicable, for future applicants that reference those approvals.
This proposed rule would include provisions for applicants to specify design features for monitoring and operating a nuclear reactor from outside the site boundary and for autonomous performance of operations and safety functions. The NRC has posed a question in this proposed rule to obtain stakeholder feedback on remote operations and autonomous operations.
This proposed rule would adjust staffing, training, personnel qualifications, and human factors engineering requirements, and would include provisions for general licenses for reactor operators, to reflect the expectation that the role of operators would be reduced for microreactors and other facilities with comparable risk profiles as compared to the current fleet of large LWRs.
This proposed rule includes provisions for ML holders and holders of OLs that reference reactors manufactured under MLs to combine applications for license amendments or to make changes to the facility as described in the final safety analysis report (FSAR) without an amendment. Under certain conditions, holders of OLs for manufactured reactors would be able to implement the same changes approved by amendment to an ML without requesting amendments to their OLs that reference the ML. This would eliminate duplication of applications for NRC review of changes to manufactured reactors, including changes that might be made for improving safety or operational reliability.
This proposed rule would provide for the NRC to authorize reactor operation upon finding that reactor construction conforms to the approved design and license requirements instead of using inspections, tests, analyses, and acceptance criteria under 10 CFR part 52, which could delay this authorization.
This proposed rule would allow an applicant to propose an FFD program of its own specification if operator action would not be required to maintain the reactor within the criterion of proposed § 57.25(a) or a credible operator or maintenance error could not result in exceeding that criterion.
The NRC does not anticipate stationing a full-time resident inspector at facilities licensed under this framework. Instead, this proposed rule would rely on targeted inspections and performance oversight.
The proposed rule would add a provision that allows for a risk methodology to be used for evaluating normal and/or accident conditions in the event that an applicant cannot meet the testing and performance requirements of 10 CFR part 71, “Packaging and Transportation of Radioactive Material.”
The NRC is proposing the flexibility for applicants to develop decommissioning plans as part of the initial licensing process. This approach would offer greater flexibility, given the variety of design and operational strategies being considered. The proposed decommissioning framework primarily builds on the NPUF model while incorporating elements from the power reactor framework.
This proposed rule consists of several major components, including a new part 57, revisions to 10 CFR parts 26, “Fitness for Duty Programs,” and 73, “Physical Protection of Plants and Materials,” and conforming changes throughout 10 CFR chapter I to refer to part 57 where appropriate.
E.O. 14300 directed the NRC to consider regulating microreactors or their components through general licenses. Stakeholders also have expressed interest in the possibility of the NRC using general licenses for these reactors or redefining “utilization facility” to exclude some nuclear reactors from the licensing requirements in section 103 of the AEA. The NRC considered these potential alternative approaches for high-volume licensing and regulation of nuclear reactors or fleets of reactors in developing this proposed rule. The NRC proposes that using a general license for regulation of construction activities for certain structures, systems, and components of nuclear reactors or nuclear plants would be the most practicable approach under this proposed rule.
The NRC considered whether it would be practicable to exclude certain reactors that would otherwise be licensed under proposed part 57 from the definition of “utilization facility” and regulate them under a different regulatory framework. The pertinent portions of the definition of “utilization facility” in section 11(cc) of the AEA are the following: “(1) any equipment or device, except an atomic weapon, determined by rule of the Commission to be capable of making use of special nuclear material in such quantity as to be of significance to the common defense and security, or in such manner as to affect the health and safety of the public . . .; or (2) any important component part especially designed for such equipment or device as determined by the Commission.” The AEA definition of a utilization facility allowed the Atomic Energy Commission (AEC), the NRC's predecessor, to determine by rulemaking which equipment or devices met the criteria for a utilization facility. By connecting the definition of a utilization facility to the quantity of special nuclear material involved and the manner the material is used, and that material's potential impact on the common defense and security and public health and safety, Congress ensured that the AEC's regulatory authority would encompass facilities whose operation involves radiological safety and security.
The AEC promulgated a definition of “utilization facility” in 1956, now set forth at 10 CFR 50.2 and proposed for part 57, that was limited to “any nuclear reactor other than one designed or used primarily for the formation of plutonium or [uranium-233].” The AEC also defined “nuclear reactor” as an apparatus, other than an atomic weapon, designed or used to sustain nuclear fission in a self-supporting chain reaction. This definition, also part of this proposed rule, implements both criteria of the AEA's “utilization facility” definition. An apparatus designed or used to sustain nuclear fission in a self-supporting chain reaction meets the first criterion—capable of making use of special nuclear material (SNM) in such quantity as to be of significance to the common defense and security. Several current examples show that even a quantity of SNM less than what is required to support a self-sustaining fission reaction in a nuclear reactor is significant to the common defense and security. The U.S. Department of Energy Order 474.2A, “Nuclear Material Control and Accountability,” requires that quantities of uranium-235 or plutonium of 1 gram or larger are subject to that order and require material control and accounting and security programs. Additionally, the NRC defines a quantity of uranium-235 (contained in enriched uranium) in excess of 1 kilogram as being at least Category III material requiring material control and accounting and security requirements. Finally, the International Atomic Energy Agency's Nuclear Security Recommendation on Physical Protection of Nuclear Material and Nuclear Facilities states that a mass as small as 1 kilogram of uranium-235 (contained in enriched uranium) needs to be subject to physical security requirements. These examples are relevant to this proposed rule because all reactors that would be licensed under this proposed rule—each one an apparatus designed or used to sustain nuclear fission in a self-supporting chain reaction—would require more than these minimum amounts of SNM to operate.
An apparatus designed or used to sustain nuclear fission in a self-supporting chain reaction also meets the second criterion in the AEA definition of utilization facility—capable of making use of SNM in such manner as to affect the health and safety of the public. Decades of reactor licensing, including research reactors with power levels ranging from a few watts to several tens of megawatts, have shown that the use of SNM for self-sustaining fission reactions is capable of affecting public health and safety. Direct radiation from fission reactions, the creation and potential release of radioactive byproducts, and improperly-controlled (or uncontrolled) self-sustaining fission reactions can all affect public health and safety. Improper control of a self-sustaining fission reaction can cause significant and potentially very rapid increases in radiation levels, temperatures, and pressures, which is why the NRC requires appropriate regulatory controls that are different than those for devices that use SNM in other manners, such as a subcritical assembly for physics experiments or a neutron source for providing the initial neutrons needed to safely start up a nuclear reactor. These other devices have not typically been considered utilization facilities. The NRC anticipates that any nuclear reactor that would be licensed under proposed part 57 to use SNM for self-sustaining fission reactions for commercial purposes would clearly require controls to provide reasonable assurance of adequate protection of public health and safety.
The AEA definition of “utilization facility” requires that only the safety prong or security prong of the definition be met. The discussion of the safety and security prongs in this document suggests that any nuclear reactor would meet both prongs and constitute a utilization facility under the definition in the AEA, thereby warranting regulation by the NRC as such, consistent with the responsibilities and authorities conferred to the NRC by the AEA. The Commission has used its regulatory authority under sections 103 and 182(a) of the AEA to require technical specifications for utilization facilities to provide reasonable assurance of adequate protection of public health and safety. The NRC would continue to do so under this proposed rule.
The NRC considered whether it would be practicable to use the authority provided to the Commission by section 109(a) of the AEA to “issue general licenses for domestic activities required to be licensed under section [101 of the AEA] if the Commission determines in writing that such general licensing will not constitute an unreasonable risk to the common defense and security.” The AEA limits this authority “to those utilization and production facilities which are so determined by the Commission pursuant to section [11(cc)(2)] of [the AEA].” Section 11(cc) of the AEA is the definition of utilization facility, and section 11(cc)(2) of the AEA is “any important component part especially designed for [a utilization facility as defined in section 11(cc)(1) of the AEA] as determined by the Commission.” Thus, the NRC can issue a general license for any important component part especially designed for a utilization facility. The Commission proposes to use this authority to issue a general license in proposed § 57.45(d) for construction activities, subject to conditions in proposed § 57.45(d)(1) through (6) that would ensure that the general license would only be for any important component part especially designed for a utilization facility, not constitute an unreasonable risk to the common defense and security, and provide for adequate protection of the health and safety of the public. The proposed general license would potentially enable shorter deployment timeframes and is described in detail in section V.D of this document.
The NRC also considered whether it could include in proposed part 57 a general license for regulation of an entire utilization facility, meaning a utilization facility as defined in section 11(cc)(1) of the AEA. However, the AEA provides the NRC with the authority to issue general licenses only for utilization facilities as defined in section 11(cc)(2) of the AEA, meaning any important component part especially designed for an entire utilization facility. Therefore, in developing proposed part 57, the NRC did not consider general licensing of an entire utilization facility as viable under the current statutory structure. Instead, the proposed rule would include a licensing framework under section 103 of the AEA that would reduce the number of licensing actions, resources for their completion, and required NRC oversight associated with deployment of individual reactors or nuclear plants or fleets of such facilities, as described in section IV.B of this document.
Proposed part 57 is comprised of subparts A through Q. These subparts would provide performance criteria and would be organized to specify requirements to demonstrate compliance with those performance criteria throughout the major stages of the life cycle of microreactors and reactors with comparable risk profiles. The performance-based approach proposed in part 57 also would include regulatory requirements that would allow applicants to use a flexible and graded approach to the performance of
Proposed subpart P of part 26 would be new and would be largely consistent with the fitness-for-duty (FFD) requirements in current subpart K, “FFD Programs for Construction,” of part 26 supplemented by select requirements from subparts A through I, N, and O of part 26. These requirements are designed to ensure program effectiveness, maintain protections afforded to individuals subject to the FFD program, and align with FFD program implementation by parts 50 and 52 licensees. The proposed requirements would not be entirely equivalent with requirements in current subpart K of part 26 because the latter only applies during construction of the nuclear plant, whereas proposed subpart P of part 26 would apply during construction and operation. Furthermore, proposed subpart P of part 26 would allow the use of a variety of biological specimens for drug testing as well as innovative technologies for drug and alcohol screening and testing that are not described or allowed by the requirements in subparts A through K, N, and O of part 26, except under limited conditions.
Proposed part 57 would also include a technology-inclusive consequence-based approach for physical security and emergency preparedness for nuclear plants. The NRC used operating experience to propose additional regulatory flexibility for a part 57 licensee's implementation of security requirements. This proposed rule would also propose changes to part 73 for a technology-inclusive approach to cybersecurity. The proposed provisions for these operational programs are based on meeting the proposed entry criteria for part 57.
In addition, this proposed rule would make conforming changes throughout 10 CFR chapter I, by adding “and part 57” or similar language where appropriate to account for the addition of the proposed part 57.
Subpart A would provide the general provisions applicable to all applicants and licensees under proposed part 57. Subpart A would include provisions on purpose, scope, definitions, written communications, deliberate misconduct, employee protections, completeness and accuracy of information, information collection requirements, exemptions, standards for review, jurisdictional limits, attacks and destructive acts, rights related to SNM, license suspension and rights of recapture, backfitting and issue finality, the Advisory Committee on Reactors Safeguards, combining licenses, and filing of applications.
This proposed rule would provide its own definitions section in proposed § 57.3, “Definitions.” The definitions of many terms in proposed § 57.3 would be equivalent to the corresponding terms defined in §§ 21.3, 50.2, 52.1, and other NRC regulations. However, given the variety of microreactor and other reactor designs with comparable risk profiles, proposed § 57.3 would provide flexibility by allowing applicants to redefine applicable definitions to support their specific design and licensing basis needs, provided that such redefinitions are justified and supported by the applicant's safety analysis. Definitions established by the application would not require an exemption from proposed part 57. The flexibility to provide new definitions would extend only to definitions defined in proposed part 57 and not to those terms defined by statute, such as “special nuclear material.” Specific proposed definitions are further explained in the following paragraphs.
The NRC proposes to include a definition of “Autonomous operation” in part 57 that would provide the means for applicants to present information regarding the performance of operational and safety functions without reliance on human intervention, external command, or active control system input under normal operations and accident conditions. The design of the microreactor with inherent safety features and active structures, systems, and components (SSCs) would govern what design functions need to be executed and/or monitored during normal, off-normal and accident conditions.
The proposed definition of “Certified fuel handler” would mean a non-licensed operator who is responsible for decisions on the safe conduct of decommissioning activities, safe handling and storage of spent fuel as defined in 10 CFR 72.3, “Definitions,” and appropriate response to plant emergencies. The certified fuel handler would need to be qualified in accordance with a fuel handler training program that meets the same requirements as training programs for non-licensed operators required by proposed § 57.420, “Training and qualification for non-licensed personnel.”
The proposed definition of “Consensus code or standard” would be based on the use of these terms in the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113) and the Office of Management and Budget (OMB) Circular No. A-119, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.” As required by NTTAA, the NRC undertakes the following activities: (i) consults with voluntary consensus standards bodies; (ii) participates with voluntary consensus bodies in the development of consensus standards; and (iii) uses consensus standards to carry out the NRC's policy objectives.
The proposed definition of “Construction” is slightly different than the current definition in existing § 50.10, “License required; limited work authorization.” The proposed definition would differ from the current § 50.10 definition in that it would apply to only safety-related SSCs (as defined in proposed part 57) and SSCs relied upon to implement the proposed security requirements.
The proposed definition of “Control room” would provide a means for remote monitoring and/or remote operation outside the site boundary where actions can be taken to operate the nuclear power unit safely under normal conditions and to maintain it in a safe condition under accident conditions.
The proposed definition of “Decommission” would be slightly different than the definition in § 50.2. The proposed definition would also include permanent removal of an individually licensed nuclear reactor.
The proposed definition of “Defense in depth” would provide a philosophy of designing a nuclear facility that includes two or more independent and redundant layers of defense in the design of a facility and its operating procedures to compensate for uncertainties such that no single layer of defense, no matter how robust, is exclusively relied upon. Defense in depth includes, but is not limited to, the use of access controls, physical barriers, redundant and diverse safety functions, and emergency response measures.
The proposed definition of “Design bases” would be the information that identifies the specific functions to be performed by an SSC of a facility, and the specific values or ranges of values chosen for controlling parameters as reference bounds for design. These values may be (1) restraints derived from generally accepted “state-of-the-art” practices for achieving functional
The proposed definition of “Design features” would be the active and passive SSCs and inherent characteristics of those SSCs that contribute to limiting the total effective dose equivalent (TEDE) to individual members of the public during normal operations and prevent or mitigate the consequences of design basis accidents.
The proposed definition of “Fission product release” would be the amount and composition of radioactive material released to the environment, after accounting for any retention of radionuclides provided by reactor design features.
The proposed definition of “Fuel” would be SNM or source material, discrete elements that physically contain SNM or source material, and homogeneous mixtures that contain SNM or source material, intended to or used to create power in a nuclear reactor.
The proposed definition of “Licensing basis information” would be the information contained in regulations, orders, licenses, certifications, or approvals issued by the NRC for a nuclear plant licensed under proposed part 57 and that information submitted to the NRC by an applicant or licensee in a safety analysis report, program description, or other licensing-related document required under proposed part 57.
The proposed definition of “Manufactured reactor” would be the essential portions of a nuclear reactor that are manufactured under an ML and subsequently incorporated into a nuclear plant under a construction permit issued under subpart C of proposed part 57.
The proposed definition of “Manufacturing license” would be a license issued under subpart D of proposed part 57 that authorizes the production of manufactured reactors but not their construction, installation, or operation.
The proposed definition of “Programmatic controls and operational programs” would be administrative procedures that govern human action in implementing programs and operating, monitoring, and maintaining SSCs and equipment of a nuclear plant. Programmatic controls could be standardized to facilitate fleet-wide deployment of a microreactor. These standardized operational programs could be designed to be administered on site or at a corporate or institutional level. Implementation milestones for each operational program would need to be described depending on whether the program will be implemented all at once or on a phased basis.
The proposed definition of “Quality assurance” (QA) would be planned and systematic actions during design, construction, and modification necessary to provide adequate confidence that the SSC will perform satisfactorily in service.
The proposed definition of “Remote monitoring” would mean observing plant data from a location outside of the site boundary. Remote monitoring does not include the performance of any operator actions necessary to manipulate the reactor to protect the public health and safety (
The proposed definition of “Remote operation” would be to command and control the reactor from a location outside of the site boundary. Industry has indicated that the design of a microreactor with inherent safety features and active SSCs would govern what design functions need to be executed and/or monitored during normal, off-normal, and accident conditions.
The proposed definition of “Safe shutdown” would be bringing the nuclear reactor to safe, stable conditions specified in plant technical specifications when the reactor is under design basis accident conditions with loss of emergency power and offsite power.
The proposed definition of “Safety function” would be the purpose served by a design feature, human action, or programmatic control to prevent or mitigate unplanned events and thereby demonstrate compliance with requirements in proposed part 57 for limiting risks to public health and safety. Safety functions could be performed by any combination of the elements supported by the safety analysis and could be specified at the plant level or at the level of a particular barrier or system. Multiple plant-level safety functions would be assumed to apply to all reactor designs based on established requirements and historical practices. These fundamental safety functions would include the control of reactivity, removal of heat, and limiting the release of radioactive materials. The protection of a specific barrier or system that contributes to meeting plant-level safety criteria could also be referred to as a safety function.
The proposed definition of “Safety-related structures, systems and components” is slightly different than the definition in § 50.2. Whereas the § 50.2 definition refers to “events,” the proposed definition would refer to “accidents.” Design basis accidents bound events. Also, where the § 50.2 definition refers to a reactor coolant pressure boundary, the proposed definition would be technology neutral because some reactor designs under proposed part 57 may not operate at pressure.
The proposed definition of “Source term” would be the magnitude and mix of the radionuclides released from the fuel, expressed as fractions of the fission product inventory in the fuel, as well as their physical and chemical form, and the timing of their release. The source term would be developed by the applicant when performing the maximum hypothetical accident (MHA) or maximum credible accident (MCA) methodology. This source term would then be analyzed with site parameter information to demonstrate compliance with the accident dose-based entry criterion in proposed § 57.25(a).
The proposed definition of “Special nuclear material” would be (1) plutonium, uranium-233, uranium enriched in the isotope-233 or in the isotope-235, and any other material that the Commission, pursuant to the provisions of section 51 of the AEA, determines to be SNM, but does not include source material; or (2) any material artificially enriched by any of the foregoing, but does not include source material.
Proposed § 57.4, “Written communications,” would govern written communications and how applications and other required information must be submitted to the NRC. These requirements would be equivalent to those in § 50.4, “Written communications.”
Proposed § 57.5, “Deliberate misconduct,” would establish requirements for enforcement action to which a licensee, an applicant, or a licensee's or applicant's contractor or subcontractor, or an employee of any of them, may be subject for engaging in deliberate misconduct. These requirements would be equivalent to those in § 50.5, “Deliberate misconduct.”
Proposed § 57.6, “Employee protection,” would prohibit discrimination against an employee of a holder or applicant for an NRC license, permit, or SDA, or a contractor or subcontractor of a holder or applicant for an NRC license, permit, or SDA for engaging in certain protected activities. Proposed § 57.6 also would prescribe a procedure for seeking a remedy for employees who believe they have been discriminated against for engaging in such protected activities. These requirements would be equivalent to those in §§ 50.7 and 52.5, both entitled “Employee protection.”
Proposed § 57.7, “Completeness and accuracy of information,” would govern the completeness and accuracy of information provided to the NRC. These requirements would be equivalent to those in §§ 50.9 and 52.6, both entitled “Completeness and accuracy of information.”
Proposed § 57.8, “Information collection requirements: OMB approval,” would establish requirements for information collection requirements and OMB approval. These requirements would be equivalent to those in § 50.8, “Information collection requirements: OMB approval.”
Proposed § 57.9, “Specific exemptions,” would govern exemptions from the requirements of the regulations in proposed part 57. These requirements would be equivalent to those in §§ 50.12 and 52.7, both entitled “Specific exemptions.”
Proposed § 57.11, “Jurisdictional limits,” would require that no license or SDA issued under proposed part 57 would cover activities that are not under or within the jurisdiction of the United States. These requirements would be equivalent to those in § 50.53, “Jurisdictional limitations.”
Proposed § 57.12, “Attacks and destructive acts,” would state that licensees, holders of standard design approvals, and applicants for licenses and standard design approvals would not be required to provide design features or other measures for the specific purpose of protection against the effects of attacks and destructive acts by enemies of the United States directed against the facility or deployment of weapons incident to U.S. defense activities. These requirements would be equivalent to those in § 50.13, “Attacks and destructive acts by enemies of the United States; and defense activities.”
Proposed § 57.13, “Rights related to special nuclear material,” would establish requirements for rights related to SNM. These requirements would be equivalent to those in § 50.54(b) and (c).
Proposed § 57.14, “License suspension and rights of recapture,” would establish requirements for license suspension and rights of recapture of the material or control of the facility in a state of war or national emergency declared by Congress. These requirements would be equivalent to those in § 50.54(d).
Proposed § 57.15, “Agreement limiting access to Classified Information,” would address requirements for agreements limiting access to classified information and would be equivalent to § 50.37, “Agreement limiting access to Classified Information.”
Proposed § 57.16, “Backfitting and issue finality,” would address backfitting requirements by providing requirements that would be equivalent to those in § 50.109, “Backfitting,” and issue finality requirements by providing requirements that would be equivalent to those in §§ 52.83(a), 52.145, “Finality of standard design approvals; information requests,” and 52.171, “Finality of manufacturing licenses; information requests.” An exception is that proposed § 57.16(c) would not include an equivalent requirement to § 52.171(b)(2), which requires the Commission to determine that departures will comply with the requirements in § 52.7 and that the special circumstances for the departure would outweigh any decrease in safety that may result from the reduction in standardization caused by the departure. Proposed § 57.16(c) would instead require the joint application for the referencing CP and OL(s) to include analysis of departures from the design characteristics, site parameters, terms and conditions, or approved design of the nuclear reactor, nuclear plant, or manufactured reactor. Proposed § 57.16(c) would also specify that analysis would not be required for departures from any operational programs or requirements approved with the referenced CP, OL, or ML that are not material to the adequacy of the design, if the joint application includes proposed alternative operational programs or requirements. Under proposed § 57.16(c), all departures would be subject to litigation in the same manner as other issues in the CP or OL, which would be equivalent to § 52.171(b)(2).
Proposed § 57.17, “Referral to the Advisory Committee on Reactor Safeguards (ACRS),” would address referral to the Advisory Committee on Reactor Safeguards (ACRS) and would be equivalent to §§ 50.58, “Hearings and report of the Advisory Committee on Reactor Safeguards,” 52.141, “Referral to the Advisory Committee on Reactor Safeguards (ACRS),” and 52.165, “Referral to the Advisory Committee on Reactor Safeguards (ACRS).”
Proposed § 57.18, “Combining licenses; elimination of repetition; relationships between subparts,” would address combining applications and would be equivalent to §§ 50.31, “Combining applications,” 50.52, “Combining licenses,” and 52.8, “Combining licenses; elimination of repetition.” Proposed § 57.18 would also provide clarity about various combinations of licenses and contents of related applications that would enable various high-volume deployment strategies. While proposed part 57 clearly outlines the licensing framework for combining licenses for multiple reactors, multiple sites, manufacturing, possession of special nuclear material, and other deployment activities, this licensing framework largely exists under other parts of 10 CFR chapter I, such as parts 50, 52, and 53.
Proposed § 57.18(a)(1) would include a provision for applications that would be filed under proposed part 57 by one or more applicants for licenses to construct and operate nuclear reactors or nuclear plants of essentially the same design to be located at different sites, to refer to a single FSAR. This proposed provision would be similar to the provisions in appendix N to part 50, “Standardization of Nuclear Power Plant Designs: Permits To Construct and Licenses To Operate Nuclear Power Reactors of Identical Design at Multiple Sites.”
Proposed § 57.18(a)(2) would include a provision that an applicant may include in one application for a CP and associated OL(s) for a nuclear reactor or nuclear plant under proposed part 57 information for multiple sites at which the applicant proposes to construct and operate the reactor or plant. This proposed provision would allow for licensing construction and operation of a single nuclear reactor or nuclear plant at multiple locations over its lifetime, such as for operational testing at a manufacturing facility and power operation at a deployment site.
Proposed § 57.18(a)(3) would require an application under proposed part 57 for multiple types of permits, licenses, or certifications to clearly indicate to which permit, license, or certification information in the application pertains. This proposed requirement would facilitate the NRC's review of the application by ensuring that the NRC would apply the appropriate proposed requirements (
Proposed § 57.18(a)(4) would include provisions for holders of OLs that reference the same ML to combine among themselves, or with the holder of the ML, applications for license amendments under proposed § 57.310, “Amendment of license.” This proposed provision would potentially decrease the overall resources that would be required for applicants and the NRC for identical requests for amendments to multiple licenses as opposed to separate filings and reviews of each application for amendment.
Proposed § 57.18(a)(5) would specify that an applicant may include in a single joint application a request for a CP for any number of nuclear reactors of essentially the same design that would be built at a specific site and requests for OLs for those reactors, provided that the application would state the earliest and latest dates for completion of the construction of each nuclear reactor as would be required by proposed § 57.55(g) and would include the information that would be specified in proposed § 57.60(a)(4). This proposed provision would potentially reduce applicant and NRC resources related to licensing a nuclear plant at which multiple nuclear reactors of essentially the same design would be operated over its lifetime, including replacement reactors.
Proposed § 57.18(b), (d), and (e) would include provisions for incorporating by reference information contained in previous applications, statements, or reports filed with the Commission and applicable Commission approvals issued under part 50 or 52; referencing a standard design approval, CP, OL, ML, or combination thereof, that would be issued under proposed part 57; and referencing a relevant U.S. Department of War or U.S. Department of Energy authorization for a utilization facility that has been tested and that has demonstrated the ability to function safely, respectively. These provisions would allow applicants and the NRC to minimize duplication of previous efforts in filing and reviewing applications under proposed part 57.
Proposed § 57.18(c) would continue the Commission's practice of combining multiple authorizations for a licensee under various parts of 10 CFR chapter I into one license based on the Commission's authority under section 161(h) of the AEA to combine NRC licenses.
Proposed § 57.19, “Filing of application,” would address filing of applications and would be equivalent to §§ 50.30, “Filing of application; oath or affirmation,” 52.135, “Filing of applications,” and 52.155(a). Proposed § 57.19(f) would require an applicant for licenses to construct and operate one or more nuclear reactors under subpart C of proposed part 57 to file a joint application for a CP and associated OL(s). Proposed § 57.19(f) would also require that the joint application include the information specified in proposed §§ 57.55, “Content of applications; general information,” and 57.60, “Content of applications; technical information,” and be complete enough to permit all evaluations necessary for the issuance of the requested CP and the associated OL(s) upon the NRC making the finding required by proposed § 57.100(b)(1) (
The NRC based the development of the proposed part 57 framework on existing licensing practices for non-power and other utilization facilities that, by design and operational characteristics, present low risks of radiological consequences. These characteristics have designers approach safety by emphasizing accident prevention with inherent self-limiting reactivity feedback mechanisms and passive safety systems for heat and decay heat removal without reliance on complex active safety systems. The NRC used these characteristics to create a set of requirements to determine which applicants would be eligible to use proposed part 57. Located in proposed §§ 57.25, “Applicability,” and 57.30, “Design criteria attributes,” these proposed requirements are termed “entry criteria” and “design criteria attributes,” respectively.
Given the wide range of reactor types and their functional characteristics, this proposed rule would emphasize the “attributes” of microreactors and other reactors with comparable risk profiles. Rather than defining these reactors in terms of thermal power level, this attribute-based approach would describe microreactors and other reactors with comparable risk profiles in terms of their functional characteristics, such as the capability to prevent or mitigate accidents without active systems or operator intervention. By doing so, the NRC recognizes that reactors with inherently safe design features and more favorable safety profiles may appropriately be designed with higher power levels than other reactor designs.
The first eligibility criterion would be a dose-based acceptance value. The second eligibility criterion would be an upper limit on the amount of fuel. These eligibility criteria are intended to screen in reactor designs that are smaller, simpler, and more conducive to rapid, high-volume licensing. These eligibility criteria would be supported by six design criteria attributes. These design criteria attributes emphasize the features of inherently and passively safe reactors that make them secure and protective against radiological harm. These attributes include (1) reactivity control, (2) heat removal, (3) fission product retention, (4) shielding, (5) radioactive effluents control, (6) security by design. If an applicant for a reactor design does not meet these criteria, they can apply for a license under a different regulatory framework.
A dose-based entry criterion under accident conditions would be used to inform the analysis of postulated accidents and the development of safety measures so that, in the unlikely event of an accident, there is assurance that no acute radiation-related harm will result to any member of the public. The Commission has found the use of a dose-based entry criterion to be adequate for facility siting and design purposes based on decades of extensive experience in the criterion's application and in recognition of the assumptions and considerations applied within the radiological consequence analyses. While the dose-based entry criterion would be computed in terms of dose, it is a figure of merit used to characterize the minimum requirements for design, fabrication, construction, testing, operational limits, and performance for safety-related SSCs. The numerical value of the criterion does not represent acceptable or actual public exposures received during normal and emergency conditions, which are primarily controlled by 10 CFR part 20, “Standards for Protection Against Radiation,” and through emergency planning.
An applicant would be required to demonstrate their reactor design meets the 1 rem (10 millisieverts (mSv)) TEDE dose-based entry criterion in proposed § 57.25(a), and the NRC has found that the maximum hypothetical and
Historically, NRC licensing processes have relied on deterministic bounding analyses that, while conservative, may impose unnecessary siting, design, and operational constraints on advanced reactor designs with inherent and highly reliable passively safe reactor technologies. The Commission recognizes the need for flexibility in how applicants define their licensing basis to reflect the diversity of microreactors and other reactor designs with comparable risk profiles. Proposed part 57's inclusion of both the MHA and MCA methodologies provides risk-informed and performance-based regulatory pathways that align the applicant's safety analysis scope with the complexity and safety characteristics of their design. Proposed part 57 distinguishes between the MHA and the MCA with respect to the amount of analytical rigor necessary to justify the derived source term. By distinguishing between the MHA and MCA approaches, the Commission would allow applicants to tailor the scope and depth of their accident analyses to their design and business model needs while continuing to ensure safety.
The source term defines the magnitude and mix of the radionuclides released from the fuel, expressed as fractions of the fission product inventory in the fuel, as well as their physical and chemical form, and the timing of their release. The applicant would utilize their MHA or MCA source term to establish the site boundary and determine the level of design, qualification, testing, and maintenance of SSCs necessary to show with reasonable assurance that the radiological consequences at the site boundary are below the 1 rem TEDE entry criterion of proposed § 57.25(a).
Depending on the desired level of analysis, applicants may select either the MHA or MCA approach. The MHA approach can demonstrate safety through a postulated accident scenario, often highly conservative, which assumes a severe release of radioactive material consistent with physical laws, regardless of probability. This MHA analysis does not rely on detailed risk-informed assessment methodologies, thereby reducing analytical complexity for reactors with few to no active systems or self-limiting physical phenomena. The MHA approach may be desirable for applicants that are willing to accept additional conservatism by leveraging simplified analyses that are less time and resource intensive. Although the MHA may not necessarily reflect a realistic or credible sequence of events, it represents a bounding case to support subsequent safety decisions.
If an applicant does not wish to accept the conservatisms associated with the MHA approach, further analyses would need to be performed to support an MCA approach. The MCA approach excludes certain physically unrealistic or excessively conservative assumptions, focusing instead on events that are credible given the technology, safety systems, and plant operating conditions. The MCA analysis can leverage a variety of modern risk-informed methodologies to credibly quantify events and consequences, providing a rational basis for a smaller site boundary and focused SSC categorization and potentially reducing the number of components subject to the more stringent safety requirements.
Two identical reactor designs could, in principle, yield different site boundary distances and safety classifications depending on whether their analyses employ the MHA or MCA methodology. Under the MHA approach, conservative bounding assumptions, such as postulated worst-case system failures and maximum radionuclide release, would produce a larger source term necessitating a greater site boundary and broader safety classification of SSCs. In contrast, an MCA analysis that quantifies system performance and reliability could justify a smaller, more realistic source term and a correspondingly smaller site boundary and narrower safety classification. Both outcomes would be acceptable under proposed part 57's consequence-based framework because each would provide reasonable assurance that offsite radiological consequences remain below the 1 rem TEDE entry criterion. The preferred approach would likely depend on the scope and depth of analysis the applicant wishes to undertake. Applicants would need to be clear on which approach is being applied, and analyses would have to be supported by appropriate and sufficient technical justifications.
The NRC is providing flexibility on how the TEDE dose-based entry criterion would be met in recognition of the need for expedited licensing and deployment of the types of facilities on which proposed part 57 is focused. Including both the MHA and MCA methodologies supports the Commission's regulatory modernization goals by encouraging innovation in reactor design while maintaining a consistent safety objective. Furthermore, this graded approach would enable efficient licensing reviews by aligning analytical rigor with risk significance without diminishing safety assurance. Under this proposed framework, applicants should discuss their plans for use of an MHA or MCA with the NRC staff prior to submittal of an application. This would ensure there is common understanding of the applicant's approach and would allow for resolution of any issues before development of a complete application.
The premise of this proposed rule is to establish regulatory requirements commensurate with the low hazards posed by facilities that would be licensed under proposed part 57. These requirements would be justified by the use of a dose-based entry criterion applied to the results of a maximum hypothetical or maximum credible accident that assesses siting and the performance of safety-related SSCs. This would also be true for large LWRs with a very large site boundary. However, many of the traditional requirements that the NRC considered when creating this proposed rule have historically provided defense in depth to address unlikely events that may exceed analyzed releases. Traditional requirements include the Commission's historical treatment of severe accidents based on lessons learned from operating large LWRs. Examples of these regulations include: 10 CFR 50.46, “Acceptance criteria for emergency core cooling systems for light-water nuclear power reactors,” for assessing large-break loss of coolant accidents; 10 CFR 50.155, “Mitigation of beyond-design-basis events,” for flexible mitigation strategies for beyond-design-basis events; and several part 52 requirements for severe accident design features.
The fuel mass limit entry criteria would deterministically screen reactor designs without additional performance-based acceptance criterion or severe accident analysis to assess events beyond which SSCs could be challenged. The fuel mass limit entry criteria would be established to provide additional defense in depth for these very unlikely events by limiting the amount of decay heat that may necessitate the need for active cooling systems and overall material available for release, further limiting the potential for causing acute health effects to the public. However, the NRC has proposed a question in this proposed rule, asking whether, in lieu of applying a deterministic material limit on the quantity of SNM, the NRC should apply an alternative performance-based acceptance criterion such as an adiabatic heat rate threshold, beyond which SSCs could be challenged.
To assist in developing a quantitative basis for such a limit, the NRC reviewed and evaluated the quantities of SNM in the cores of several reactor types. In evaluating the quantities of SNM, the NRC determined the quantities of uranium (U) and plutonium (Pu). This includes the following isotopes:
In conducting this evaluation, the NRC considered a spectrum of reactor technologies, including several non-LWR designs, two small modular pressurized water reactors (PWRs) and one small modular boiling water reactor (BWR), and several representative large LWRs. The purpose of this evaluation was to understand the similarities and differences between these reactor technologies and inform an entry criterion that facilitates high-volume licensing of microreactors. The assessment compared these reactor technologies, the SNM masses, type and kinds of engineered safety features, and accident response characteristics. To perform this evaluation, the NRC considered several sources of publicly available information covering a range of reactor types and power levels.
The evaluation included several non-LWRs of various reactor types and fuel forms (
The quantities of SNM vary by reactor technology. For each reactor technology, the NRC calculated SNM quantities at the beginning and end of an operating cycle based on published core and fuel parameters and operational characteristics. To perform the calculation, the NRC utilized the Oak Ridge National Laboratory SCALE code system. The SCALE code system is a widely used modeling and simulation suite for nuclear safety analysis and design. Results of these calculations found that the large LWR SNM quantities at the beginning of an operating cycle ranged from approximately 71 metric tons heavy metal (MTHM)
Table 1 compares various reactor types by the amount of SNM, in terms of MTHM, each contains by cycle period. Table 1 provides the reactor name, fuel type, percent fuel enrichment, and cycle period for which each of the SNM quantities were estimated as beginning of life (BOL), continuous refueling (cont.), equilibrium (equil.), beginning of equilibrium cycle (BOEC), and end of equilibrium cycle (EOEC). The BOL are conditions of the reactor core at initial startup after fresh fuel loading. The end of life (EOL) describes the conditions of the reactor core at the end of its useful fuel cycle, when fuel burnup or reactivity limits have been reached. Some reactor designs operate continuously. For continually refueled systems, SNM inventories are given as equilibrium conditions. For these designs, the BOEC is a state of the reactor core at the start of a cycle once equilibrium operating conditions have been established. Likewise, the EOEC is a state of the reactor core operating on a continuous refueling cycle at the end of a typical equilibrium operating cycle, after equilibrium burnup has occurred. Uranium dioxide (UO
Reactor safety profiles vary significantly between technologies due to differences in fuel type, coolant, operating characteristics, and reliance
To understand the various reactor technology safety profiles, the NRC reviewed several published scientific studies, NRC's preliminary safety evaluation reports, and environmental review documents. The review focused on identifying common design attributes among these reactors—such as strong negativity reactivity feedback, robust fuel forms, higher thermal margins, and passive heat removal—that inherently limit transient and accident progression. The NRC found non-LWR designs and microreactors are often designed with large thermal capacities that allow them to dissipate operational and decay heat passively for relatively long periods of time without the need for active systems or operator action. These designs also feature large shutdown reactivity margins and other intrinsic safety characteristics that provide strong inherent barriers to accident progression. As a result, their overall safety behavior can be well understood without relying on sophisticated probabilistic or risk assessment methodologies, since the fundamental design attributes themselves demonstrate a robust ability to prevent and mitigate accidents that previous large LWR designs have traditionally been designed to accommodate. Accordingly, these designs do not necessarily have the need for traditional containments as there is a reduced likelihood of events occurring requiring such mitigation features. Furthermore, these designs would not warrant precautionary protective measures to respond to emergencies. Instead, as a final layer of defense in depth, licensees could rely on a risk-informed approach to emergency planning.
Based on its evaluation of SNM inventories and safety characteristics of non-LWRs, small LWRs, and representative large LWRs, the NRC concluded that the establishment of a defined SNM material limit would be technically justified as an entry criterion to proposed part 57. This material limit would be defined as a total inventory of thorium, uranium, and plutonium contained in the nuclear reactor not to exceed 10 metric tons. The evaluation showed that designs within the material limit would likely have inherent and passive safety features and exhibit favorable safety profiles despite variations in core design and thermal power levels. Together, these insights support the NRC's determination that a numerical material limit that is risk-informed due to inherent and passive design features could be part of an appropriate regulatory threshold to using a licensing approach to enable rapid and efficient licensing of microreactors and other reactor designs with comparable risk profiles.
The design criteria attributes in proposed § 57.30—reactivity control, heat removal, fission product retention, shielding, radioactive effluent control, and security by design—are rooted in the fundamental principles of nuclear safety and radiation protection.
• Reactivity Control—The reactor would need to be able to safely control the power level in normal operation, shut down quickly if needed, and stay safely shut down. The reactor would be required to have a natural “braking” effect: when temperatures rise, the power level automatically falls (net negative reactivity feedback). Also, if the fuel would be loaded into the reactor at a manufacturing facility, then the reactor design would need to have built-in protections to prevent the reactor from unplanned criticality.
• Heat Removal—Even after the reactor is shut down, heat keeps being produced. The design would be required to have highly reliable, passive systems to keep the reactor cool and within safe temperature limits, even if the main cooling system fails during events like power loss or earthquakes.
• Fission Product Retention—Barriers like the fuel itself and the reactor vessel can retain radioactive materials during both normal operations and accident conditions. The design would need to keep temperatures and pressures well below the limits these barriers can handle.
• Shielding—The reactor would need strong, durable shielding to protect workers and the public from radiation, including during transportation. The design also would have to account for heat that builds up in shielding and the removal of the heat if needed.
• Radioactive Effluents Control—The reactor would be required to meet limits for any radioactive gases, liquids, or solid wastes it would release, and have monitoring and handling systems that protect people and the environment.
• Security by Design—Where possible, the design itself should address security risks, using built-in engineering and physical protection features instead of relying only on procedural measures.
Proposed subpart C would provide requirements related to applications for NRC licenses to construct and operate utilization facilities for commercial or industrial purposes under part 57. The AEA calls these licenses “construction permits” and “operating licenses,” and the NRC proposes to use that nomenclature in proposed part 57 as it has done in part 50. Proposed part 57 would include licensing options based on the CP and OL approaches in part 50, and proposed subpart C would contain several sections that would be similar to existing regulations in part 50.
Proposed § 57.45, “License required; exceptions from licensing,” would address required licenses and identify certain exceptions from licensing. Proposed § 57.45(a) would describe activities requiring an NRC license and would be equivalent to § 50.10(b). Proposed § 57.45(b) would govern an exemption from the licensing requirements under proposed part 57.
Proposed § 57.45(d) would issue a general license for construction activities on a site that is specified in a joint application for a CP and associated OL(s) under proposed part 57 for a nuclear reactor or nuclear plant subject to certain conditions in proposed § 57.45(d)(1)-(7). The proposed general license would allow the general licensee to perform construction, as would be defined in proposed § 57.3, before NRC issuance of a construction permit for the nuclear reactor or nuclear plant.
Proposed § 57.45(d)(1) would require that the general licensee has submitted, and the Commission docketed, a joint application for a CP and associated OL(s) under proposed part 57. This proposed requirement would include several additional conditions on the joint application. First, the joint application would be required to reference an ML issued by the Commission under 10 CFR chapter I. This condition would provide assurance that the general licensee would not complete construction of the nuclear reactor or nuclear plant before issuance of the CP because the manufactured reactor would be an essential part of the reactor or plant and proposed § 57.45(d)(5) would prohibit bringing it to the site under the general license. Second, the joint application would be required to reference a CP and OL issued pursuant to proposed part 57 that the Commission afforded generic finality under proposed § 57.142(e) and that referenced the same ML as the general licensee's joint application. This condition would ensure that the complete design had been reviewed and approved by the NRC and that a nuclear reactor or nuclear plant of the same design had been successfully constructed under NRC oversight and placed into operation. This would also ensure that the public had been afforded an opportunity for hearing on the design, including the postulated site parameters for the design, in accordance with §§ 57.142(e) and 57.60(c). Third, the joint application would be required to reference a design that met the criteria for a categorical exclusion under proposed subpart K of part 57. Taken together, the requirements proposed in § 57.45(d)(1)(i) and (ii) would provide assurance that the SSCs of the nuclear reactor or nuclear plant, which could be difficult to change after their construction, would not pose obstacles to eventual issuance of an OL under proposed part 57. Fourth, proposed § 57.45(d)(1)(iii) would require the joint application to include a plan for redress of any adverse environmental impact from conduct of activities under the general license should such redress be necessary. This proposed requirement would be similar to the requirements in § 50.10(d)(3)(iii), which requires a redress plan as part of an application for a limited work authorization, and § 50.11(b)(2), which requires the Commission to consider redress of adverse environmental impacts in determining whether to grant an exemption permitting the conduct of construction activities prior to the issuance of a construction permit.
Proposed § 57.45(d)(2) would require that the general licensee has notified the NRC under proposed § 57.4 that all applicable permits, licenses, approvals, and other entitlements in connection with the proposed action that the general licensee was responsible for obtaining have been obtained. Proposed § 57.45(d)(3) would require that applicable Federal environmental consultations have been completed. This would ensure that construction activities would not begin unless the NRC has the information it would need to fulfill its obligations for environmental review under the AEA, NEPA, and other relevant laws.
Proposed § 57.45(d)(4) would require that the general licensee not allow SNM or radioactive material that would be associated with the operation of the nuclear reactor or nuclear plant under an operating license issued pursuant to proposed part 57 to be brought to the site. This would ensure that activities under the general license would not create radiological hazards or irreversible radiological impacts at the site that would otherwise be controlled by a CP or OL under proposed part 57. This would also ensure that activities under the proposed general license would not involve radiological security concerns. In addition, proposed subpart P of part 26 would require implementation of an appropriate FFD program during construction.
Proposed § 57.45(d)(6) would require that the general licensee allow for any NRC inspections that the Commission would deem necessary related to activities that would be performed under the general license. This would ensure that the NRC could apply experience gained from inspection of the construction of the same nuclear reactor or nuclear plant design if needed during construction activities that would be conducted under the proposed general license.
Proposed § 57.45(d)(7) would clarify that any activities undertaken by the general licensee or on its behalf under the general license would be entirely at the risk of the general licensee and would have no bearing on the issuance of a construction permit under proposed part 57 with respect to the requirements of the AEA, and rules, regulations, or orders issued under the AEA. However, the general licensee would be able to mitigate this additional regulatory risk through careful site selection to ensure that site characteristics are within the bounds of the postulated site parameters and by performing construction activities following appropriate QA and FFD programs.
Based on the proposed requirements in § 57.45(d)(1)-(7), the Commission has determined that such general licensing would be for only parts of utilization facilities, not constitute an unreasonable risk to the common defense and security, and, therefore, be consistent with the authority provided to the Commission by section 109(a) of the AEA.
Proposed § 57.55, “Content of applications; general information,” would provide general information requirements for the content of joint applications under proposed part 57 and would be equivalent to § 50.33, “Content of applications; general information,” with the exception that no emergency planning zones would be defined for facilities licensed under proposed part 57.
Proposed § 57.60, “Contents of applications; technical information,” would provide technical information for the content of joint applications and would be equivalent to § 50.34, “Contents of applications; technical information,” but would not include a preliminary safety analysis report. Proposed § 57.60(a) would provide the technical requirements for an FSAR submitted as part of a joint application under proposed part 57. Proposed § 57.60(a)(1)(i) would address the intended use of the reactor to include maximum power and inventory of radioactive material. Proposed § 57.60(a)(1)(ii) would provide requirements for an FSAR to describe and assess safety features and barriers designed into the facility to prevent or mitigate the consequences of an accident similar to § 50.34(a)(ii)(D) without the requirement to comply with part 100 or the radiation dose criterion for an individual in § 50.34(a)(1)(ii)(D).
Proposed § 57.60(a)(1)(iii) would require the applicant to demonstrate, through an evaluation, that the dose-
Proposed § 57.60(a)(1)(iv) through (vi) would require the applicant to describe the design features associated with any remote or autonomous operation or remote monitoring capabilities. Proposed § 57.60(a)(1)(vii) would require the applicant to provide the analysis, appropriate test programs, prototype testing, operating experience, or a combination thereof that would demonstrate that each of the design criteria attributes described by proposed § 57.30 would be met.
Proposed § 57.60(a)(2) would require the applicant to include design basis and principal design criteria information in the application including the relation of the design bases to the design criteria, and the relation of the principal design criteria to the design criteria attributes described in proposed § 57.30. The principal design criteria establish the necessary design, fabrication, construction, testing, and performance requirements for safety-related SSCs that provide reasonable assurance that the facility can be operated without undue risk to the health and safety of the public. The reference to principal design criteria in proposed § 57.60(a)(2) would not require the applicant to meet the General Design Criteria in appendix A of part 50. However, the General Design Criteria in appendix A could be generally applicable to other types of nuclear plants and used as guidance in establishing the principal design criteria for a facility using part 57.
This proposed rule would not impose QA requirements under existing appendix B to part 50. Proposed § 57.60(a)(3) would require the applicant to describe its QA program to be applied to the design, fabrication, manufacturing, construction, and testing of safety-related SSCs and would be equivalent to § 50.34(a)(7). Qualified suppliers of nuclear-grade SSCs have decreased over the last several decades. This shrinking base of suppliers, increasing demand for advanced reactors, existing SSC upgrades and maintenance needs for the operating fleet, restart of shutdown plants, and policies to buy U.S. products, are creating a need for new suppliers to enter the market. At the same time, the evolution of quality system requirements has led to the development of several QA standards with shared elements. The NRC's proposal to enable applicants to select QA programs could broaden the supplier base and increase flexibility in procurement. This approach may encourage participation from qualified commercial suppliers, thereby expanding the pool of vendors available to support nuclear projects. This could mitigate risks of shortages, backlogs, and higher costs of deployment of microreactors and reactors with comparable risk profiles.
Proposed § 57.60(a)(4) would specify requirements related to sites at which multiple nuclear reactors may be built or installed. Proposed § 57.60(a)(4)(i) and (ii) would require the applicant to analyze and specify limits on the number and configuration of reactors at the site and evaluate potential hazards to safety-related SSCs of any operating reactors that could arise from activities associated with construction, operation, and decommissioning of other reactors at the site. These requirements would be similar to existing requirements in § 50.34(a)(11). Proposed § 57.60(a)(4)(iii) would require the joint application to include a description of the portions of the nuclear plant that a nuclear reactor would share with one or more other reactors over the lifetime of the plant and to specify the functional requirements and measures to meet the requirements for any shared safety-related SSCs. Proposed § 57.60(a)(4)(iv) would require the joint application to include technical specifications, as appropriate, for shared portions of the nuclear plant.
Proposed § 57.60(a)(5) would require the applicant to include current and projected population distributions and site evaluation factors for seismic, meteorological, hydrologic, and geologic characteristics with appropriate consideration of natural phenomena. The reason for establishing siting requirements would remain the same as it has been historically, which is to ensure that licensees and applicants assess what impact the site environs may have on a nuclear plant (
Proposed § 57.60(a)(6) would require the applicant to provide an analysis and evaluation of safety-related SSCs related to performance requirements and information that show that safety functions will be accomplished and would be equivalent to § 50.34(b)(2).
Proposed § 57.60(a)(7) would require the applicant to provide information on the kinds and quantities of radioactive materials expected to be produced by operation and the means for controlling and limiting radioactive effluents and radiation exposures within the limits set forth in 10 CFR part 20 and would be equivalent to § 50.34(b)(3). The application would have to include an estimate of the quantity of each of the principal radionuclides expected to be released annually to unrestricted areas in liquid effluents produced during normal reactor operations, an estimate of the quantity of each of the principal radionuclides of the gases, halides, and particulates expected to be released annually to unrestricted areas in gaseous effluents produced during normal reactor operations, and a description of the equipment and procedures for the control of gaseous and liquid effluents and for the maintenance and use of equipment installed in radioactive waste systems.
Proposed § 57.60(a)(8) would require the applicant to provide information related to operational programs concerning facility operations. These programs could be developed specifically for an individual reactor or generically for a particular design to be administered at a corporate or institutional level to support fleet operations. Proposed § 57.60(a)(8)(i)-(iii) would require the applicant to include information related to the organizational structure, training and qualification, conduct of operations, plans for preoperational testing and initial operations, and plans for normal operations, and would be equivalent to § 50.34(b)(6)(i)-(iv). Proposed § 57.60(a)(8)(iv) would require emergency plans for responding to an accidental release or loss of control of radioactive material. Proposed § 57.60(a)(8)(iv) would also require the applicant to coordinate response needs with local emergency planning and offsite response organizations. This proposed provision would ensure adequate communication, coordination, and cooperation among applicants, licensees, and offsite response organizations to establish agreements and arrangements for offsite support and to ensure protective measures can and will be taken as conditions warrant.
An emergency planning zone (EPZ) would not be defined for facilities licensed under proposed part 57. An EPZ is most useful as a planning tool for implementing precautionary actions through predetermined, prompt protective measures to respond to
Proposed § 57.60(a)(8)(v) would require the applicant to describe its physical security program, cybersecurity program, information security program, and access authorization program and is equivalent to § 50.34(c). The physical security program would need to meet the security requirements in part 70. For radiological sabotage, because these events could disrupt the performance of the design of reactors licensed under proposed part 57, the applicant would need to perform an assessment against the threat of radiological sabotage. The purpose of this assessment would be to evaluate the design against security events derived from the design basis threat (DBT) of radiological sabotage defined in § 73.1, “Purpose and scope,” to determine if an operational program for physical security is needed. The criterion for the assessment in proposed § 57.60(a)(8)(v)(A)(
Proposed § 57.60(a)(8)(v)(B) would require licensees to establish, implement, and maintain a cybersecurity program in accordance with either § 73.54, “Protection of digital computer and communication systems and networks,” or proposed § 73.110, “Cybersecurity program.” Proposed § 57.60(a)(8)(v)(C) would require licensees to establish, implement, and maintain an information protection system that complies with the requirements of §§ 73.21, “Protection of Safeguards Information: Performance requirements,” 73.22, “Protection of Safeguards Information: Specific requirements,” and 73.23, “Protection of Safeguards Information—Modified Handling: Specific requirements,” as applicable. Proposed 57.60(a)(8)(v)(D) would require licensees to establish, implement, and maintain an access authorization program in accordance with § 73.56, “Personnel access authorization requirements for nuclear power plants.”
Proposed § 57.60(a)(8)(vi) would require the applicant to provide proposed technical specifications prepared in accordance with the requirements of § 50.36, “Technical specifications,” and would be equivalent to § 50.34(b)(6)(vi).
Proposed § 57.60(a)(8)(vii) would require the applicant to submit procedures to be used to provide assurance that limiting conditions for any operating reactors will not be exceeded as a result of activities associated with the construction of any additional reactors at the same site and would be equivalent to § 50.34(b)(6)(vii).
Proposed § 57.60(a)(8)(viii) would require the applicant to provide a radiation protection program as part of its application and would be similar to § 20.1101, “Radiation protection programs.”
Proposed § 57.60(a)(8)(ix) would require the applicant to provide a fire protection program and would be similar to § 50.48(a). Proposed § 57.60(a)(8)(ix)(A)-(C) would require the applicant to describe the fire protection program for the facility, any specific features necessary to implement the program, and an analysis to demonstrate that a fire or explosion in any area of the plant would not prevent a safety-related SSC from performing its safety function. Proposed § 57.60(a)(8)(ix)(D)-(H) would establish specific requirements for the fire protection program.
Proposed § 57.60(a)(8)(x) would require the applicant to describe how the human factors engineering requirements of proposed § 57.395 would be addressed. Proposed § 57.60(a)(8)(x) would also require the applicant to describe the training, examination, and proficiency programs necessary to meet the requirements of proposed subpart P.
Proposed § 57.60(a)(8)(xi) would require the applicant to submit its description and plan for implementation of a remote operation or monitoring program, if applicable. Remote operation and remote monitoring are defined in proposed § 57.3 as control of the reactor and observation of plant data, respectively, from a location outside of the site boundary. Stakeholders have expressed interest in the incorporation of remote operation and monitoring into their plant designs.
Proposed § 57.60(a)(8)(xii) would require the applicant to submit its program to ensure that systems and components meet the requirements in the codes and standards identified in the application in accordance with proposed § 57.60(a)(9).
Proposed § 57.60(a)(8)(xiii) would require the applicant to submit its environmental qualification of safety-related electric equipment and would be similar to § 50.49(a), which requires an applicant to establish a program for qualifying the electrical equipment. “Environmental qualification” means the applicant would assess possible degradation of safety-related SSCs by the effects of various environmental conditions.
Proposed § 57.60(a)(8)(xiv) would require the applicant to describe its FFD program under part 26 and would be equivalent to § 52.79(a)(44).
Proposed § 57.60(a)(8)(xv) would require the applicant to submit a staffing plan that details operations staffing and what staffing will be available to provide other needed support functions as proposed in § 57.395(c).
Proposed § 57.60(a)(8)(xvi) would allow the applicant to seek approval of a plan for the storage of irradiated fuel after termination of an OL and would be similar to § 50.54(bb). The plan would need to demonstrate compliance with all applicable irradiated fuel possession, safety, and environmental requirements; include a plan for funding the management of the fuel; and address, as applicable, transportation of the irradiated fuel.
Proposed § 57.60(a)(8)(xvii) would allow the applicant to seek approval of a decommissioning plan by submitting its plan with its joint application and would be similar to § 50.82(b)(1), which requires the submittal of a decommissioning plan to the Commission.
Proposed § 57.60(a)(8)(xviii) would require the applicant to describe the managerial and administrative controls to assure safe operation. The managerial and administrative controls would promote safe, reliable, and efficient plant operation, including related maintenance activities. These controls would be in effect at all times during the operational phase. These controls would be in the form of procedures to effectively implement a QA program.
Proposed § 57.60(a)(9) would require the applicant to provide information on the use of codes and standards used to design the facility. In proposed part 57, the NRC would not incorporate by reference specific codes and standards
Proposed § 57.60(a)(10) would require the applicant to provide analyses and descriptions of the equipment and systems for combustible gas control required by paragraph (d) of § 50.44, “Combustible gas control for nuclear power reactors,” and would be similar to § 50.34(g), “Combustible gas control.”
Proposed § 57.60(a)(11) would require applicants to demonstrate their technical qualifications to carry out the proposed activities in compliance with the regulations in 10 CFR chapter I. This requirement would be similar to § 50.34(a)(9).
Proposed § 57.60(a)(12) would require applicants to provide a description of the design-specific risk analysis methods used to demonstrate adequate defense in depth and safety margins, along with the results of that analysis. This approach would offer appropriate flexibility for risk analysis methods to be developed and assessed based on the application they are used to support. This would also include consideration of how risk analysis results and insights are relied upon, together with factors such as defense in depth, safety margin, simplicity of design, and treatment of uncertainty.
Proposed § 57.60(a)(13) would require an applicant to provide information demonstrating how it will comply with requirements for criticality accidents in § 50.68, “Criticality accident requirements,” with the exception that proposed § 57.60(a)(13) would limit the maximum nominal U-235 enrichment of fresh fuel assemblies specified in § 50.68(b)(7) to less than twenty (20.0) weight percent to allow for the fuel enrichments anticipated for reactors that would be licensed under proposed part 57.
Proposed § 57.60(b) would require applicants to either justify the use of a categorical exclusion or, if a categorical exclusion would not apply, submit an environmental report, or an applicant-prepared environmental assessment or environmental impact statement, in accordance with 10 CFR part 51. Proposed § 57.350(b) would establish criteria under which certain NRC actions would be categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.
Proposed § 57.60(c) would provide the option for an applicant to include in its joint application a request for generic finality. Under proposed § 57.142(e) and § 57.130(b)(7), affording the licensee “generic finality” would mean that matters resolved in the proceedings on the application for issuance of the CP and associated OL(s) for which the applicant has requested and the Commission has granted generic finality would be considered resolved in proceedings on other joint applications that reference the approved CP or associated OL(s). Proposed § 57.60(c) would require the joint application to include, in addition to the information that would be required by proposed § 57.60(a) and (b), site parameters postulated for the design, including the design basis external hazard levels for the relevant external hazards, and an analysis and evaluation of the design in terms of those site parameters, and may include generic aspects of operational programs and requirements of the types specified in proposed § 57.60(a)(8), to the extent practicable. This would provide an alternate licensing pathway to an ML under proposed subpart D for obtaining finality on a complete final design for a nuclear reactor or nuclear plant. This would support high volume licensing of designs of reactors that would be wholly constructed at the site of operation and would also serve as a means for obtaining finality on the design of the portions of a nuclear plant other than the manufactured reactor, if one or more manufactured reactors were to be used.
Proposed § 57.60(d) would provide the option for an applicant to designate in its joint application for a CP and associated OL(s) a large geographical area or areas, as opposed to a specific site or sites, within which it proposes to construct and operate one or more nuclear reactors. This proposed regulation would provide a licensing pathway that could support rapid deployment of a reactor for disaster relief or other time-critical application, or fleet deployment within a large area. Proposed § 57.60(d)(1)-(3) and (8) would require the applicant to supplement the information under proposed § 57.60(a) and (b) to cover the entire designated area or areas, include maps, and provide any restrictions on specific locations within the designated area or areas.
Proposed § 57.60(d)(4) would require a plan for storage of irradiated fuel after termination of an operating license and proposed § 57.60(d)(5) would require the application to include a decommissioning plan. Proposed § 57.60(d)(6) would require the application to include a procedure covering activities that will be conducted in connection with constructing each reactor and placing it into operation at a specific location. Together, these requirements would ensure that the entire lifecycle of any nuclear reactor deployed in this manner would be analyzed and subject to public hearing at the construction permit review stage, thereby facilitating potential rapid issuance of an operating license once a specific location is chosen and the reactor constructed.
Proposed § 57.60(d)(7) would require the application to include a procedure that describes how the applicant would determine that a specific location within a designated area is suitable for construction and operation, including notification to the NRC, in the manner specified under proposed § 57.4, before beginning construction. This procedure would provide assurance that any change in site characteristics at a specific location within the designated area or areas would be identified and verified to be within the bounds of the site characteristics approved in the construction permit. The notification that would be required by this procedure would allow the NRC to conduct any inspections deemed necessary during construction and prepare for activities needed to make the finding required by proposed § 57.100(b)(1) and issue an OL.
Proposed § 57.80, “Standards for review of applications,” would require a joint application for a CP and associated OL(s) to be reviewed under the standards in parts 20, 50, 51, 54, 55, 70, 71, 72, 73, 74, and 140, as applicable, and that the Commission must perform an environmental review of the application in accordance with
Paragraphs (a) through (i) of proposed § 57.90, “Common standards for licenses,” would establish requirements for standards that the NRC would consider in determining whether a CP or OL under part 57 would be issued to an applicant. These requirements would be equivalent to those in §§ 50.23, “Construction permits,” 50.40, Common standards,” 50.42, “Additional standard for class 103 licenses,” 50.43(a)-(d), 50.45, “Standards for construction permits, operating licenses, and combined licenses,” and 50.50, “Issuance of licenses and construction permits,” except proposed § 57.90(h) would specify that a CP would be converted into one or more OLs.
Proposed § 57.95, “Issuance of construction permit,” would address issuance of construction permits, such as the findings the Commission must make, the authorization provided by the construction permit, and limits on that authorization. Proposed § 57.95(a) is based on § 52.97, “Issuance of combined licenses,” which covers issuance of combined licenses because under proposed part 57, the Commission would review the final design and any operational programs and requirements that are material to the adequacy of the design as part of the construction permit review. Unlike § 52.97(a)(1)(iii), proposed § 57.95(a)(3) would not include a finding about whether the facility would operate in conformity with the license as this would be left for the issuance of the OL under proposed § 57.100, “Issuance of operating license.” Proposed § 57.95(b) would be equivalent to § 50.35(b), except that it would specify that the construction permit would not constitute Commission approval of the operational programs and requirements provided in the application unless the applicant specifically requests such approval and such approval is incorporated in the construction permit. Proposed § 57.95(c) would be equivalent to § 50.35(c).
Proposed § 57.100, “Issuance of operating license,” would address issuance of OLs, such as the findings the Commission must make, requests for low power testing, and conditions on the OL. Proposed § 57.100(a) would be equivalent to § 50.56, “Conversion of construction permit to license; or amendment of license.” Proposed § 57.100(b)(1) through (6) would be equivalent to § 50.57(a)(1) through (6). Proposed § 57.100(c) would be equivalent to 50.57(b). Proposed § 57.100(d) would be equivalent to 50.57(c).
Proposed § 57.100(e) would require an operating license that references an ML to include a condition, as appropriate, that would specify that the authorization to operate the reactor would be suspended while features to prevent criticality are in place. The condition would also specify that initiation of removal of features to prevent criticality would not be allowed unless either all conditions of an OL issued under proposed part 57 authorizing operating of the reactor were satisfied, or the reactor had been defueled in accordance with an appropriate license issued by the Commission.
Proposed § 57.100(f) would specify that an OL for a nuclear reactor that would be part of a nuclear plant at which portions of the nuclear plant would be shared with one or more other reactors over the lifetime of the plant as described in proposed § 57.60(a)(4)(iii), must include a condition specifying that the shared portions of the plant would be part of the facility as described in the operating license's FSAR and any related technical specifications under proposed § 57.60(a)(4)(iv) would be incorporated in the license. This proposed requirement would ensure that shared portions of a nuclear plant and any shared safety-related SSCs would be appropriately considered in each OL for a nuclear reactor that would be part of the nuclear plant and support the requirements in proposed § 57.305, “Decommissioning and license termination,” for decommissioning a nuclear plant at which more than one reactor would be operated over the lifetime of the plant.
Proposed § 57.105(a) would address the duration of a CP and OL and would be equivalent to § 50.51(a). Proposed § 57.105(b) would address cessation of operations and the continued possession and ownership of the nuclear reactor or nuclear plant and would be equivalent to § 50.51(b).
Proposed § 57.110, “Transfer of licenses,” would establish requirements for the transfer of a CP or OL by providing the equivalent requirements of § 50.80, “Transfer of licenses.”
Proposed § 57.115, “Application for renewal,” would address applications for renewal of OLs. Proposed § 57.110(a) would require the filing of an application for a renewed license to be in accordance with proposed §§ 57.4 and 57.7. Proposed § 57.115(b)-(e) would specify the information required to be included in an application for renewal to include the technical specifications and information related to general, technical, environmental, and aging management requirements and would be equivalent to §§ 54.19, “Contents of application—general information,” 54.21, “Contents of application—technical information,” and 54.22, “Contents of application—technical specifications,” albeit modified to reflect the requirements for the FSAR, environmental report, and technical specifications for reactors licensed under proposed part 57. Proposed § 57.115(f) would address hearing opportunities and would be equivalent to § 54.27, “Hearings.”
Proposed § 57.120, “Criteria for renewal,” would address the Commission's criteria for issuing a renewed operating license and would be equivalent to § 54.29, “Standards for issuance of a renewed license.”
Proposed § 57.130, “Hearings,” would address requirements for hearings for CPs and OLs and would be equivalent to the requirements in § 50.58(b) and § 54.27. If an applicant were to request generic finality under proposed § 57.60(c), then the Commission's ruling on a request for hearing or petition for leave to intervene under 10 CFR 2.309(d)(2) would consider that a petitioner may have an interest that may be affected by the proceeding on the application if matters resolved in the licensing proceeding were to be afforded generic finality under proposed § 57.142, “Finality for construction permits and operating licenses.” This would enable petitioners whose property, financial, or other interests would not be directly affected by the issuance of the CP and OL for a particular reactor to have an opportunity to intervene on generic aspects of the design that would be afforded finality and would therefore not be subject to hearing if referenced in a joint application for a CP and associated OL(s) that would affect the petitioner's property, financial, or other interest. Proposed § 57.130(b)(7) would require the Commission to include an applicant's request for generic finality as a proposed action in the joint notice of hearing and proposed action that would be required by §§ 2.104, “Notice of hearing,” and 2.105, “Notice of proposed action.”
Proposed § 57.135, “Duration of renewal,” would require that a renewed OL be issued for a fixed period of time beyond the expiration of the current OL. The period would be the sum of the amount of time beyond the expiration of the OL requested in a renewal application plus any remaining years on the operating license currently active. This proposed rule would provide that no renewed license would exceed more than 40 years in duration, which is limited by the AEA.
Proposed § 57.142 would include requirements to address finality for construction permits and operating licenses and would be similar to the finality provisions for MLs in proposed § 57.175, “Finality of manufacturing licenses; information requests.” Proposed § 57.142(e) would specify that the Commission may afford generic finality to generic aspects of the design of a nuclear reactor or nuclear plant, including postulated site parameters, and generic operational programs and requirements submitted pursuant to proposed § 57.60(c), if it finds that the proposed generic design can be constructed and operated at sites having characteristics that fall within the site parameters postulated for the design, and in accordance with the generic operational programs and requirements, without undue risk to the health and safety of the public. This proposed requirement would provide an alternative to an ML for standardization of nuclear reactor or nuclear plant designs and operational programs and requirements for the purpose of referencing in a subsequent joint application for a CP and associated OL(s) under proposed part 57.
Provisions related to MLs were first adopted by the NRC in 1973 through the addition of appendix M to part 50. The regulation supported the manufacture of a nuclear power reactor to be incorporated into a commercial nuclear plant under a CP and operated under an OL at a different location from the place of manufacture. The regulations and processes for MLs were changed substantially in the part 52 rulemaking in 2007 (72 FR 49352). The most important shift in the ML concept in that rulemaking was that a final reactor design, which would be equivalent to that required for a standard design certification under part 52 or an OL under part 50, must be submitted and approved before issuance of an ML. The rationale for that change was that approval of a final design ensures early consideration and resolution of technical matters before there is any substantial commitment of resources associated with the actual manufacture of the reactor, which greatly enhances regulatory stability and predictability.
Proposed subpart D would address applications for, issuance of, and other provisions related to MLs covering manufacturing activities at one or more licensee facilities under proposed part 57. These proposed requirements would be largely equivalent to those in part 52 for MLs.
Proposed § 57.145, “Scope,” would address the scope of the proposed subpart D sections and would be equivalent to § 52.151, “Scope of subpart,” except that it also would state that the scope of proposed subpart D includes requirements for manufacturing manufactured reactors at a manufacturing facility, loading fuel into manufactured reactors at the manufacturing facility, and transportation of manufactured reactors.
Proposed § 57.150, “Contents of applications for manufacturing licenses; general information,” would address general information requirements for the content of ML applications and would be equivalent to § 52.156, “Contents of applications; general information,” with one exception. Proposed § 57.150 would require each application for an ML to also include the information required by proposed § 57.55(e). This information would include the type of license applied for, the use to which the facility will be put, the period of time for which the license is sought, and a list of other licenses, except operator's licenses, issued or applied for in connection with the proposed facility to address the potential variations in how MLs might be formulated under proposed part 57.
Proposed §§ 57.155, “Contents of applications; technical information in final safety analysis report,” and 57.160, “Contents of applications; additional information,” would address requirements for the technical content of applications for MLs to be included in the FSAR and additional information to be included in the application and would be equivalent to §§ 52.157, “Contents of applications; technical information in final safety analysis report,” and 52.158, “Contents of applications; additional technical information,” with three significant exceptions. First, proposed § 57.155(c) would include the option for the application to include final, non-site-specific design information for a nuclear plant that would use a reactor manufactured under the ML. This would allow the NRC to review the design of the entire nuclear plant and afford finality in accordance with proposed § 57.175, which would increase the efficiency of reviewing a joint application for a CP and associated OL(s) under proposed subpart C that references the ML. Second, proposed § 57.155 would not include a requirement for proposed inspections, tests, analyses, and acceptance criteria to be included in the application because they would not be required for the issuance of OLs under proposed subpart C. Third, proposed § 57.160(a) would provide the option for an applicant to include in its application descriptions of generic operational programs and requirements, which the NRC could afford finality to in accordance with proposed § 57.175.
In addition, the requirements in proposed §§ 57.155 and 57.160 would be modified from the analogous requirements in §§ 52.157 and 52.158 to align with the technical requirements in proposed part 57. Proposed § 57.155(a) would outline the required content of the application addressing design information and state that the application must include design information equivalent to that required for a joint application for a CP and associated OL(s) under proposed subpart C, other than site-specific information, relevant to the manufactured reactor.
Proposed § 57.160(b) would require an ML application to include either the information justifying application of a categorical exclusion as described in proposed subpart K of part 57, or an environmental report or applicant-prepared environmental assessment, in accordance with 10 CFR part 51.
Proposed § 57.160(c) would require an ML application to include a description of the safeguards information program, in accordance with §§ 73.21 and 73.22 of this chapter, as applicable, to prevent any unauthorized disclosure.
Proposed § 57.160(d)(1) would require an ML application to include a description of the relevant codes and standards used in the procurement, fabrication, and assembly of components comprising the manufactured reactor. Proposed § 57.160(d)(2) would require an ML application to include a description of the organizational and management structure responsible for the design and manufacturing of the manufactured reactor. Proposed § 57.160(d)(3) would require an ML application to include a description of the tests and inspections to be performed during the manufacturing and fabrication process, including components, as well as an assembled manufactured reactor. Proposed § 57.160(d)(4) would require an ML application to include a description of the fitness-for-duty program required by part 26.
Proposed § 57.160(e) would provide application requirements related to the deployment of the completed manufactured reactor. Proposed § 57.160(e)(1) would require inclusion of information related to the procedures governing the preparation of the manufactured reactor for shipping to the site where it is to be operated, the conduct of shipping, and the verification of the condition of the
Proposed § 57.160(f) would include additional requirements for application content for applicants seeking an ML for manufactured reactors that will be fueled at the manufacturing facility under a license issued in accordance with 10 CFR part 70, “Domestic Licensing of Special Nuclear Material,” consistent with the requirements in proposed § 57.197(d). These provisions would require the application to include information related to loading fuel and the required features to prevent criticality and to otherwise provide assurance that the fueled manufactured reactor could be successfully transported, installed, and operated at a site for which the Commission has issued a CP under proposed subpart C that authorizes construction of a nuclear plant using the manufactured reactor.
Proposed §§ 57.165, “Standards for review of applications,” and 57.170, “Administrative review of applications; hearings,” would provide standards for review of applications and administrative review of applications for MLs, including hearings, and would be equivalent to §§ 52.159, “Standards for review of applications,” and 52.163, “Administrative review of applications; hearings.”
Proposed § 57.172, “Issuance of manufacturing license,” would address issuance of an ML and would be equivalent to § 52.167, “Issuance of manufacturing license,” with two exceptions. First, proposed § 57.172(a)(6) would include a requirement that the Commission make a finding that generic operational programs submitted as part of the ML application under proposed § 57.160(a) provide reasonable assurance that the manufactured reactor can be operated under an operating license that references the manufacturing license in conformity with the provisions of the AEA and the Commission's regulations. Second, proposed § 57.172(b)(4) would require each ML issued under proposed part 57 to specify that the portions of the nuclear plant other than the manufactured reactor must be as described in the information included in the ML application if the applicant chose to include this information in accordance with proposed § 57.155(c)(8) instead of interface requirements. These provisions of proposed § 57.172 could greatly reduce the scope of and timeframe for review of a joint application for a CP and associated OL(s) that references the ML because the NRC would have afforded finality to the entire nuclear plant design and potentially nearly all the operational programs through the ML proceeding, allowing the review of the joint application to focus on site-specific information.
Proposed § 57.175 would address finality of MLs and would be equivalent to § 52.171, with the exception that proposed § 57.175(d) would allow the holder of an ML to use the regulations in § 50.59, “Changes, tests, and experiments,” to determine whether changes to the facility or procedures as described in the FSAR would require an amendment to the ML. This would be different than the provisions in § 52.171 that do not allow any changes to the design of a manufactured reactor without requesting a license amendment.
Proposed § 57.180, “Duration of manufacturing license,” would address the duration of MLs. However, compared to the current analogous requirements in § 52.173, “Duration of manufacturing license,” proposed § 57.180 would not include a minimum duration for an ML and would provide for a 40-year maximum for the duration of an ML. These differences would be consistent with the requirement in proposed § 57.55(e) that each application must state the period of time for which the license is sought and the limitation on the duration of design certifications in § 52.55, “Duration of certification.” Proposed § 57.185, “Transfer of manufacturing license,” would address the transfer of MLs and would be equivalent to § 52.175, “Transfer of manufacturing license.”
Proposed § 57.190, “Renewal of manufacturing licenses,” would address the renewal of MLs and would be equivalent to §§ 52.177, “Application for renewal,” 52.179, “Criteria for renewal,” and 52.181, “Duration of renewal,” with a minor exception. Proposed § 57.190(b) would state that an ML for which a timely application for renewal has been filed would remain in effect until the Commission has made a final determination on the renewal application. However, this provision would omit a limitation from the equivalent provision in § 52.177, which prohibits the holder of an ML from beginning the manufacture of a manufacture reactor less than 3 years before the expiration of the license. This limitation would be omitted because applicants under proposed part 57 may present smaller, simpler designs in ML applications than those that were envisioned when the existing requirements were written. Eliminating the 3-year constraint in this provision would provide greater flexibility for ML holders related to manufactured reactors being produced close to the time when the ML expires. Finally, proposed § 57.190(e) would provide for a 40-year term for a renewed ML, consistent with the term for an initial ML under proposed § 57.180.
Proposed § 57.197, “Manufacturing,” would include requirements covering the activities performed under an ML issued under proposed part 57. Proposed § 57.197 would also include requirements that apply to portions of a manufactured reactor in recognition that some activities covered by an ML may occur at different fabrication facilities. Proposed § 57.197(a) would establish the requirements to have in place programs, procedures, and a well-defined command and control structure to manage manufacturing-related activities.
Proposed § 57.197(b) would include requirements for executing the manufacturing activities following receipt of an ML under proposed part 57. These requirements would include conducting manufacturing processes within facilities for which the license holder can control access and activities that might affect manufacturing, performing manufacturing in accordance with the ML and appropriate codes and standards, and establishing and implementing post-manufacturing inspections.
Proposed § 57.197(c) would provide requirements for the control of radioactive materials if the holder of an ML plans to possess and use source, byproduct, or special nuclear material as part of the manufacturing process. By and large, the proposed § 57.197 would refer to NRC regulations in 10 CFR part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material,” 10 CFR part 40, “Domestic
The most significant change proposed for MLs in part 57 (which would be similar to changes for MLs under part 53) as compared to MLs under part 52 relates to proposed § 57.197(d), which would allow and establish requirements for the loading of fuel into a manufactured reactor at the manufacturing site for subsequent transport to a nuclear plant that would be constructed pursuant to a CP that would be issued under proposed part 57. The first requirement in proposed § 57.197(d) would establish limitations on when a holder of an ML under proposed part 57 and a license under part 70 could load fuel into a reactor manufactured under the ML. The proposed regulation would require that features to prevent criticality specified in the ML be in place before loading fuel into the manufactured reactor and during the reactor's storage and transport. The proposed requirement would provide flexibility because of the potential variety of reactor designs, the variety of possible measures to prevent criticality, and the range of possible conditions associated with the loading of fuel into, storage of, and transport of manufactured reactors. For example, the features to prevent criticality that could be considered individually and collectively to address possible adverse conditions include the reactivity control systems in place to support operations, inherent features of the fuel and materials within a manufactured reactor, and temporary measures or physical mechanisms (
The proposed requirements to have in place features to prevent criticality could likewise support meeting other provisions in part 70, such as those related to equipment and procedures that protect health and minimize danger to life or property. The features to prevent criticality in the proposed part 57 requirements would reasonably ensure that a manufactured reactor does not become critical over a range of possible conditions. With the requirements for features to prevent criticality under proposed part 57 and all criticality safety controls required by part 70 in place, the presence of fuel in the manufactured reactor would not create a nuclear hazard different than the hazard from the presence of the same fuel in a storage location or container licensed under part 70. Collectively, these measures would reasonably ensure that the manufactured reactor is not capable of operations, thereby obviating the need for an OL under proposed subpart C of part 57 to authorize fuel loading. Additionally, this approach would focus the ML application and its review on the design, manufacture, and deployment of the manufactured reactor.
The activities involving SNM within the manufacturing facility, including the loading of fuel, would be regulated primarily under the part 70 license. The provisions of subpart H to part 70 would not be applicable to a part 70 license that only authorizes possession of special nuclear material for the purpose of loading fresh fuel into a manufactured reactor. The reference to the requirements in part 70 in proposed § 57.197(d) would reasonably assure that the applicant will utilize the appropriate equipment and procedures to protect health and minimize danger to life or property. The regulations in part 51 provide a flexible approach for environmental review to address the range of regulated activities under part 70. The flexibility in part 51 would enable the NRC to determine the appropriate type of environmental review based on the circumstances associated with the loading of fuel into a specific manufactured reactor.
Proposed § 57.197(d) would cite the requirements in 10 CFR parts 70 and 73 to ensure important features and programs are in place prior to the receipt of SNM. The features and programs that would be required by 10 CFR parts 70 and 73 to be in place prior to receipt of SNM would include (1) radiation monitoring instrumentation and alarms; (2) measures to detect potential criticality accidents; (3) appropriate procedures, equipment, and personnel qualified for the fuel loading; (4) programs for physical security and cybersecurity; and (5) material control and accounting (MC&A) programs.
Proposed § 57.197(d)(2) would cover the activities related to the storage, movement, and loading of fresh fuel into a manufactured reactor in the manufacturing facility and would likewise refer to the applicable regulations in part 70.
Proposed § 57.197(d)(3) would include requirements to address security programs for any ML authorizing possession of a manufactured reactor into which fuel has been loaded at the manufacturing facility. Currently, for category II SNM, security measures may be required in addition to requirements included in § 73.67, “Licensee fixed site and in-transit requirements for the physical protection of special nuclear material of moderate and low strategic significance,” on a case-by-case basis. Including appropriate security measures in the proposed part 57 regulations would provide additional openness and transparency for applicants applying for an ML who seek to load fuel into manufactured reactors at a manufacturing site.
Currently, § 73.67 only requires a security plan for licensees who possess, use, transport, or deliver to a carrier for transport SNM of moderate strategic significance, or 10 kg or more of SNM of low strategic significance. However, the physical security program for fueled manufactured reactors would require a security plan for any ML authorizing possession of a manufactured reactor into which fuel has been loaded at the manufacturing facility, regardless of fuel type, enrichment, and quantity. This would be consistent with other controls proposed for MLs, including reactivity and criticality controls.
The proposed § 57.197(d)(3) would also require a holder of an ML that would load fuel into a manufactured reactor under a part 70 license to address cybersecurity to ensure a cyberattack would not adversely impact the functions performed by digital assets necessary for physical security, radiation monitoring, or criticality prevention.
Proposed § 57.197(d)(4) would require the loading or unloading of fuel into or from a manufactured reactor and any changes to the configuration of reactivity-related systems to be performed by a certified fuel handler.
Proposed § 57.197(e) would only allow the transport or removal of a manufactured reactor or portions of a manufactured reactor for either (1) delivery to a domestic site for which the
Proposed § 57.197(f) would include requirements for the acceptance of a manufactured reactor at the site of a nuclear plant specified in a CP issued under proposed subpart C of part 57 and would require that the manufactured reactor be installed in accordance with that CP. Other requirements in proposed § 57.197(f) would address required receipt inspections and verification that any interface requirements between the manufactured reactor and the balance of the nuclear plant have been met.
Proposed subpart E would address applications for, issuance of, and other requirements related to SDAs under proposed part 57. Proposed § 57.200, “Scope,” would describe how the contents of proposed subpart E would address SDAs and would be equivalent to § 52.131, “Scope of subpart.” Proposed § 57.205, “Contents of applications; general information,” would address general information requirements for the content of applications and would be equivalent to § 52.136, “Contents of applications; general information.”
Proposed § 57.210, “Contents of applications; technical information,” would address requirements for the technical content of applications and would be largely equivalent to § 52.137, “Contents of applications; technical information.” Proposed § 57.210 would include additional requirements for applications for approval of a “major portion” of a standard design. Additional discussion regarding standard design approvals for a major portion of a standard design can be found in the NRC's “A Regulatory Review Roadmap for Non-Light Water Reactors,” which considers the Nuclear Innovation Alliance report, “Clarifying `Major Portions' of a Reactor Design in Support of a Standard Design Approval.” Proposed § 57.210(a) would outline the required content of the FSAR. This content would be modified from the analogous requirements in § 52.137 to align with the technical requirements in proposed part 57. Proposed § 57.210(b)(1) for portions of the application addressing design information would state that the application must include design information equivalent to that required for a joint application for a CP and associated OL(s) under proposed subpart C, other than site-specific information, relevant to the scope of the SDA.
Proposed § 57.213, “Standards for review of applications,” would address standards for review of applications and would be equivalent to § 52.139, “Standards for review of applications.” Proposed §§ 57.215, “Staff approval of design,” would address staff approval of designs and would be equivalent to §§ 52.143, “Staff approval of design.”
Proposed § 57.220, “Finality of standard design approvals; information requests,” would address finality of standard design approvals and information requests and would be equivalent to § 52.145, “Finality of standard design approvals; information requests.” There would be no equivalent to proposed § 57.220(d) in part 52 for standard design approvals. This provision would state that the Commission will require, before granting a CP, OL, or ML that references a standard design approval, that information normally contained in engineering documents be completed and available for audit. A similar provision is included in § 52.47, “Contents of applications; technical information,” in relation to a standard design certification. Proposed § 57.220(d) would require that design and analysis information that would be needed for the Commission to make its safety determination be complete and available for any application the NRC would be reviewing. Making this explicit would provide increased clarity to future standard design approval applicants under proposed part 57.
Proposed § 57.225, “Duration of design approval,” would specify that an SDA under the part 57 framework does not expire, which is different than the current regulation in § 52.147, “Duration of design approval,” that limits the validity of an SDA under the part 52 framework to 15 years and prohibits renewal. Proposed § 57.220(a) would specify that the NRC staff and the ACRS do not have to use or rely on the earlier determination on an SDA under the proposed § 57.215 in their review of any application under proposed part 57 that incorporates by reference the SDA if there exists significant new information or for other good cause that substantially affects the earlier determination. This would allow the NRC staff and ACRS to address potential issues, including but not limited to design obsolescence or advances in the state of the art, that might arise because of the indefinite duration of the SDA. This change would also reduce the administrative burden on applicants and the NRC associated with a request for re-approval of a standard design and would align with the indefinite validity (as supported by renewals) of OLs and MLs that could reference an SDA.
Proposed subpart F of part 57 would establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. That section requires any individual director or responsible officer of a firm constructing, owning, operating, or supplying the components of any facility or activity that is licensed or otherwise regulated pursuant to the AEA or the Energy Reorganization Act of 1974, to immediately notify the Commission if they obtain information reasonably indicating certain failures to comply or defects, unless the individual has actual knowledge that the Commission has been adequately informed of the failure to comply or defect. These failures to comply or defects are the following: the facility, activity, or basic component supplied to such facility or activity fails to comply with the AEA or any applicable rule, regulation, order, or license of the Commission relating to substantial safety hazards; or the facility, activity, or basic component supplied to such facility or activity contains defects that could create a substantial safety hazard.
The proposed § 57.240, “Definitions,” would provide definitions that are consistent with those applicable to non-power reactors in 10 CFR part 21, “Reporting of Defects and Noncompliance,” with some slight differences to be technology neutral and reflect the types of facilities that would be eligible for licensing under proposed
Proposed § 57.270, “Notification of failure to comply or existence of a defect and its evaluation,” would require the holders of construction permits and manufacturing licenses under proposed part 57 to report any significant breakdown in quality assurance and would be equivalent to requirements in § 50.55(e). Proposed § 57.285, “Maintenance and inspection of records,” would provide record retention requirements for the holders of construction permits and manufacturing licenses under proposed part 57 that would be equivalent to record retention requirements in § 50.55(e). All other sections of proposed subpart F would be equivalent to corresponding part 21 provisions.
The NRC proposes to regulate irradiated fuel storage by entities licensed under proposed part 57 by requiring a combination of a license under 10 CFR part 70, a general or site-specific license under 10 CFR part 72, and the use of a certified irradiated nuclear fuel dry storage system under part 72.
The NRC proposes to issue to the holder of an OL under proposed part 57 a part 72 general license for the disposition of irradiated fuel, similar to the general license issued to the holder of a part 50 OL under § 72.210, “General license issued.” Proposed § 57.300(a) would permit the proposed part 57 OL holder to store the irradiated fuel from its reactor at the operating site within the reactor or in an irradiated fuel storage system certified under part 72. The NRC proposes to allow in-reactor storage of irradiated fuel because the conditions of the reactor are essentially unchanged whether the reactor is in operation or has ceased operations (
Proposed § 57.300(b) would permit the holder of a manufacturing license under proposed part 57 to store at the manufacturing site the irradiated fuel from a reactor manufactured under the ML, operated under the OL, and returned to the manufacturing site. Under this scenario, the ML holder would need a part 70 license for possession of the SNM contained in the fuel and a part 72 site-specific license to allow storage of the irradiated fuel. The ML holder could store the reactor's irradiated fuel within the reactor if the reactor has been certified as a part 72 irradiated fuel storage system or move the reactor's irradiated fuel to another NRC-certified irradiated fuel storage system. In the cases where the ML holder may temporarily allow fuel to remain within a reactor, either after operational testing and before shipment, or when a reactor containing irradiated fuel is returned to the manufacturing facility site, the ML holder must demonstrate that the fuel in the reactor is maintained in a safe condition and that dose to the workers and the public is limited, consistent with the provisions provided in part 72. Proposed § 57.300(b) would not require the reactor to be a certified storage system under part 72 because the duration of the storage condition is expected to be limited as determined by the ML holder's safety evaluation.
Alternatively, under proposed § 57.300(c), the OL or ML holder may move the irradiated fuel to another part 72 licensed storage facility either by transporting the reactor still containing the irradiated fuel as an NRC-certified transportation package or by repackaging the irradiated fuel in an NRC-certified transportation package.
Proposed § 57.300(d), “Irradiated fuel storage plan,” would apply to a holder of a proposed part 57 OL, or a holder of a proposed part 57 ML that plans to store the irradiated fuel from a reactor manufactured under the ML, that did not request NRC approval of an irradiated fuel management and funding plan with its license application. Such a licensee would be required to submit, for NRC review and approval under proposed § 57.310, a plan describing how the licensee intends to manage and provide funding for the management of all irradiated fuel at a designated storage site following permanent cessation of operations of the reactor. This submission would need to occur within 1 year following permanent cessation of reactor operations, more than 2 years before expiration of the OL if storage would occur at the operating site, or more than 2 years before the expiration of the ML if the storage would occur at the manufacturing site.
Proposed § 57.305, “Decommissioning and license termination,” would contain the decommissioning requirements and is generally consistent with the framework provided in § 50.82(b). The proposed rule would accommodate the decommissioning of individual microreactors separate from the overall site, allowing licensees to use the structure of § 50.82(b)(4), tailored to the design characteristics of the licensee's facility.
In proposed § 57.60(a)(8)(xvii), applicants would be able to request NRC approval of a decommissioning plan as part of the joint application. Early approval of the decommissioning plan would provide flexibility to support a range of decommissioning strategies, including decommissioning individual reactors, transporting reactors to a designated facility, or full-site decommissioning. This approach would enable licensees to align decommissioning planning with the specific designs and operational models of their facilities.
Under proposed § 57.305(b), in the absence of an NRC-approved decommissioning plan, a licensee would be subject to the requirements of § 50.82(b). Whether at initial licensing or thereafter, the decommissioning plan
While licensees under proposed part 57 would not be required to submit post-shutdown decommissioning activities reports (required for large LWRs under § 50.82(a)(4)) or license termination plans, they would be required to provide decommissioning plans under § 50.82(b). The proposed framework is designed to be sufficiently flexible to address plausible scenarios involving remediation of radiological contamination and demolition and dismantlement of radiologically contaminated structures after reactor shutdown and final demonstration of compliance with the unrestricted release criteria for residual radioactive material in § 20.1402, “Radiological criteria for unrestricted use,” that may arise during decommissioning. For example, deployment models may involve one or several nuclear reactors at a single site, or operational activities could result in significant radiological contamination that would need to be remediated in order to meet the unrestricted release criteria. A licensee may request approval of a decommissioning plan and actions necessary for license termination prior to permanent cessation of operations, facilitating a streamlined transition from operations to decommissioning. The decommissioning plans covering individually licensed reactors are anticipated to have relatively short decommissioning timelines. Larger or more complex sites may have extended periods for decommissioning because any residual radioactivity in the onsite licensed area or environmental media and from shared systems may be addressed with the last operating unit at a nuclear plant. Licensees under proposed part 57 would not be subject to the 60-year decommissioning requirement in § 50.82(a)(3) but would be required to complete decommissioning without significant delay. The decommissioning schedules would be approved by the NRC. The proposed framework supports a graded approach to decommissioning, tailored to the specific site, design, operational characteristics, and radiological conditions.
Proposed § 57.305(c)(1) would describe the decommissioning trust fund requirements and would be equivalent to § 50.82(a)(8)(i). Proposed § 57.305(c)(2)-(3) would describe the decommissioning cost estimate annual update requirements and would be equivalent to § 50.82(a)(8)(v)-(vi), respectively.
Proposed § 57.305(d) would prohibit certain decommissioning activities and would be equivalent to § 50.82(a)(6).
Proposed § 57.305(e) would specify that the entire nuclear plant must be decommissioned before the final operating license for a reactor at the site could be terminated.
Proposed § 57.305(f) would identify the license termination requirements as those in § 50.82(b). A licensee would be required to submit an application for license termination within 2 years following permanent cessation of operation. Each application for termination of a license would need to be accompanied or preceded by the proposed decommissioning plan. The NRC would terminate the license under the criteria in § 50.82(b)(6). Proposed § 57.305 would allow for site-specific flexibility in the decommissioning plan to accommodate various decommissioning strategies for individual reactors and nuclear plants at which more than one nuclear reactor operated during the lifetime of the plant, including shared operational areas and plant systems This approach would ensure that license termination could be achieved in a manner that would maintain safety and regulatory compliance while addressing the operational and design-specific needs of the facility.
The NRC proposes to establish requirements for the maintenance of licensing basis information in proposed subpart H to part 57.
Proposed § 57.310 would be equivalent to § 50.90, “Application for amendment of license, construction permit, or early site permit,” and would require that a licensee submit an application to request an amendment to a license. Under proposed part 57, licensees would be required to include in their applications an analysis of whether the amendment would involve no significant hazards consideration, which would be equivalent to the standards in § 50.92, “Issuance of amendment.” Proposed § 57.310(e) would reference § 50.91, “Notice for public comment; State consultation,” for procedures for the Commission to use for notifying the public and State of the application requesting an amendment for an OL.
Proposed § 57.312(a) would require a licensee to use § 50.59 for evaluating changes to an FSAR and determining if an amendment to an OL is required to implement a change to a facility or procedures. Proposed § 57.312(b) would allow a holder of a part 57 OL that authorizes operation of a part 57 manufactured reactor to make changes in the facility or procedures as described in the FSAR (as updated) without requesting a license amendment if the changes would be the same as changes approved by amendment to the ML for the manufactured reactor and other conditions specified in proposed § 57.312(b) were met. This proposed requirement would prevent license holders and the NRC from having to duplicate the amendment process for each manufactured reactor.
Proposed § 57.315, “Maintenance and submittal of the final safety analysis, as updated,” would provide requirements that would be equivalent to § 50.71(e) for submitting periodic FSAR updates. Licensees would be required to submit their updated safety analysis report every 5 years, equivalent to the timeframe for an NPUF as required by § 50.71(e)(3)(iv).
Proposed § 57.317, “Updated decommissioning report,” would be similar to current § 50.75(f)(1) and would require a construction permit holder to submit an update to the information required by proposed § 57.55(i) (
Under this rulemaking, the NRC proposes to govern transportation of fissile material or irradiated fuel and associated components through the provisions of 10 CFR part 71. Part 71 would apply whether the fueled microreactor or other transportable reactor with a comparable risk profile would be transported as the packaging plus the approved contents or only as
A fueled reactor could be designated as the transportation package with the loaded fuel (unirradiated, irradiated, or both) and associated components as approved contents. To receive a Certificate of Compliance (CoC) for a transportation package containing fissile or other radioactive material, an applicant must submit an application to the NRC and demonstrate that the transportation package design meets the requirements of 10 CFR part 71. The requirements of § 71.41(a) stipulate that a transportation package be subjected to tests prescribed in §§ 71.71 and 71.73 in addition to specific Type B packages being subject to the provisions of § 71.61. The regulations in § 71.41(a) and (c) allow the NRC to approve alternatives to the testing requirements provided that those alternatives are appropriate for the features being considered and provide an equivalent level of safety, respectively.
The NRC is proposing in § 57.320(a)(1) to provide an option to allow the use of a previously endorsed or approved risk methodology or other risk-informed approach in lieu of meeting specific prescriptive requirements in 10 CFR part 71 if a fueled reactor would be used as the transportation package. The NRC endorsed a limited use of a risk-informed methodology for accident conditions specifically for a transportable microreactor (SECY-24-0062, “Risk-Informed Methodology for a Future Transportable TRISO-Based Micro-Reactor Package Application”). This endorsed risk methodology is an example of one approach developed only for accident conditions that could be modified for use as a framework to craft a design certification pathway under proposed § 57.320(a)(1). This design certification pathway could be used for both normal and accident conditions with appropriate justifications, which would allow a package designer to demonstrate the transportation package meets or exceeds the current level of safety provided by the part 71 framework.
The NRC proposes two optional considerations for a licensee with respect to transporting a fueled reactor designated only as approved contents: (1) design a new transportation package identifying the fueled reactor as approved contents and submit an application for review to the NRC for a new part 71 CoC or (2) use an existing transportation package design with an amended CoC to allow for the fueled reactor be designated as approved contents. The licensee (ML or OL) would be designated as the CoC user if they are not responsible for design authority of the transportation package and thus are not the CoC holder, or they would be designated as the CoC holder if they are the responsible design authority and have been issued a CoC by the NRC.
Proposed subpart J would establish the physical protection program requirements for licensees under proposed part 57 and present a graded approach to physical protection requirements. If a licensee could meet the criterion in proposed § 57.60(a)(8)(v)(A)(
Proposed subpart J would require that an applicant or licensee establish a physical security program to protect the reactor against the DBT for radiological sabotage to provide reasonable assurance that a DBT-initiated event would result in offsite doses below the values in § 50.34(a)(1)(ii)(D). The elements of this program would include required intrusion detection and assessment, security communications, and security response capabilities but would not establish prescriptive requirements designed to demonstrate that these elements are met. Proposed subpart J would establish a requirement to coordinate with local law enforcement and provide sufficient information and training to personnel who would be relied upon to interdict and neutralize threats up to and including the design basis threat of radiological sabotage. Proposed subpart J also would include requirements to identify target sets, establish and maintain cybersecurity, insider mitigation, and individual and vehicle search programs and develop processes to track the performance of the physical protection program.
Section 170D(a) of the AEA permits the Commission to determine which licensed facilities are part of a class of licensed facilities for which NRC-conducted force-on-force exercises are appropriate to assess the ability of a private security force of a licensed facility to defend against any applicable DBT. Due to the characteristics of reactors to be licensed under proposed part 57 and the associated physical security requirements to protect against radiological sabotage, it would not be appropriate to require force-on-force exercises to evaluate the performance of these facilities. Therefore, reactors licensed under proposed part 57 would not be subject to force-on-force exercises, but these facilities would still have tailored security requirements and oversight consistent with their relatively low risk.
As directed by the Commission in the July 28, 2025, Staff Requirements Memorandum for SECY-24-0046, “Implementation of the Fiscal Responsibility Act of 2023 National Environmental Policy Act Amendments,” and in accordance with E.O. 14300 section 5(e), the NRC is proposing for inclusion in subpart K of proposed part 57 a categorical exclusion from the requirement to prepare an environmental assessment or environmental impact statement if an application for an NRC action under proposed part 57 demonstrates that the licensed action meets the criteria for the categorical exclusion under proposed § 57.350(b). The licensed action could include the siting of multiple reactors across a region or at one site, and not just a single microreactor or other reactor with comparable risk profile. For the reasons described below, the proposed rule includes a determination in § 57.350(a) that the criteria in § 57.350(b) describe a category of actions that do not individually or cumulatively have a significant effect on the human environment as required by 10 CFR 51.22. If the licensed action does not meet the criteria for the categorical exclusion under proposed § 57.350(b), then the application would need to include an environmental report in accordance with part 51.
The criteria to be met for determining the categorical exclusion applies to a proposed action would include proposed reactor environmental plant parameter and site parameter envelope values being compared to values in Table C-1 of appendix C of part 51.
For instance, all radiological issues within NUREG-2249 are SMALL (see Table C-1 in appendix C of 10 CFR part 51). This conclusion is based on the Commission's determination, in the 1996 final rule amending its license renewal environmental review regulations (61 FR 66537), that impacts are of small significance if radiological doses to individuals and radiological effluent releases do not exceed the permissible levels in the Commission's regulations. The AEA requires the NRC to promulgate, inspect, and enforce standards that provide an adequate level of protection of the public health and safety. Health impacts on individual humans are the focus of NRC regulations limiting radiological doses. Numerous environmental assessments developed by the NRC have concluded no significant impact with respect to human health if radiological doses to individuals and radiological effluent releases do not exceed the permissible levels in the Commission's regulations. Therefore, if radiological doses to individuals and radiological effluent releases do not exceed the permissible levels in the Commission's regulations, which is the basis of the findings within NUREG-2249, the impacts are not significant.
For those environmental impacts outside of human health, when a SMALL impact is concluded in NUREG-2249, the NRC has determined that the environmental effects are not detectable or are so minor that they will neither destabilize nor noticeably alter any important attribute of the resource, and this determination is comparable to a no significant impact determination. The practical effect of this determination is that actions that fall within the bounds of those generic analyses in NUREG-2249 would meet the criteria for a categorical exclusion, or the basis for a finding of no significant impact if the NRC prepares an environmental assessment.
This categorical exclusion for this proposed rule does not rely upon Category 2 issues in NUREG-2249 because that conclusion is not generic across all sites. Instead, this proposed rule includes criteria in § 57.350(b) that, if met, ensure the environmental impacts of the action would not be significant. The NRC provides guidance in Chapter 16 of draft NUREG-2271, “Guidelines for Preparing and Reviewing Applications Under 10 CFR part 57,” on addressing these criteria.
As such, if an application for a proposed microreactor meets the values and assumptions of the plant parameter envelope and site parameter envelope for Category 1 issues as defined in NUREG-2249 and the specific criteria for all other issues that are described in Chapter 16 of draft NUREG-2271, and there is no new and significant information that would change these conclusions, then these actions related to construction permits and operating licenses for microreactors and other reactors with comparable risk profiles do not individually or cumulatively have a significant effect on the human environment under 10 CFR 51.22.
The proposed criteria for the categorical exclusion would revolve around site-specific considerations that the NRC and other Federal agencies have established based on environmentally sensitive resources. An environmentally sensitive resource is typically a resource that has been identified as needing protection through Executive Order, statute, or regulation by Federal, State, or local government, or a Federally-recognized Indian tribe. The NRC is proposing four such criteria based on past NEPA reviews and being informed on how other Federal agencies, such as the U.S. Department of Energy (DOE) and the U.S. Department of War (DOW), have defined environmentally sensitive resources. The four criteria being proposed and the rational for each are as follows:
The NRC would define “previously disturbed areas” in proposed § 57.3 as areas that have been changed by development of a prior facility and remain altered by human activity such that they do not provide habitat for ecologically important species, such as those protected under the Endangered Species Act, and no longer have the potential to yield historic and cultural resources. This definition would include the lateral and vertical extent of alteration from natural cover to a managed state. This proposed definition is based on the definition of “previously disturbed or developed” in DOE's NEPA implementing regulations under paragraph (g)(1) of § 1021.102, “Application of categorical exclusions (categories of actions that normally do not require EAs or EISs).”
In NUREG-2249, the NRC identified three water-related issues as Category 2 issues, which cannot be evaluated generically and must be evaluated on a case-by-case basis using project-specific information. Water-based cooling systems discharge waste heat and have the potential to affect the water bodies from which water is taken and into which it is discharged. If the cooling system of the facility does not result in the direct withdraw or discharge of water from surface water or groundwater resources degradation of surface water quality and impacts to aquatic biota from chemical and thermal discharges are not anticipated. The three issues involve (1) surface water quality degradation due to chemical and thermal discharges, (2) thermal discharge plume impacts on aquatic biota, and (3) other effects of cooling-water discharges on aquatic biota. Of specific note regarding surface water quality degradation due to chemical and thermal discharges, Clean Water Act section 401 on water quality certification states that a Federal agency may not issue a license or permit to conduct any activity, including
The Clean Air Act, as implemented in EPA's enabling regulations, set de minimis threshold levels for air quality in areas defined as non-attainment and maintenance areas under 40 CFR 93.153(b)(1) for non-attainment areas and 40 CFR 93.153(b)(2) for maintenance areas. This criterion on air emissions would be consistent with categorical exclusion criteria in other Federal agencies such as the DOW and DOE where all airborne emissions must be in compliance with existing applicable Federal, State, and local laws and regulations (
Any commercial construction activity may have to satisfy local land use planning and zoning requirements as enacted in ordnances outside of the NRC's licensing actions. Government ordnances could include radiological liquid effluent discharge restrictions, and land use planning and zoning requirements. Some States may also have their own environmental regulations similar to the Federal government's NEPA (
Separately, in response to E.O. 14300, section 5(c), the NRC is reexamining the NRC's NEPA implementing regulations in 10 CFR part 51.
Proposed § 57.355, “Unfettered access for inspections,” would establish requirements for the provision of facilities and unfettered access for inspections. These requirements would be equivalent to § 50.70, “Inspections,” with only minor changes proposed to provide additional flexibilities and address possible differences related to reactors licensed under proposed part 57. Proposed § 57.355 also would address inspections for transportation of radioactive material, storage of nuclear fuel and radioactive waste and would be equivalent to §§ 71.93, “Inspection and tests,” 72.82, “Inspections and tests,” and 70.55, “Inspections,” respectively.
The NRC would include regulations for material control and accounting specific to microreactors and other reactors with comparable risk profiles because the provisions in 10 CFR part 74, “Material Control and Accounting of Special Nuclear Material,” do not explicitly provide these requirements. The proposed material control and accounting requirements in proposed § 57.360, “Material control and accounting,” would be equivalent to the requirements of part 74, subpart B, “General Reporting and Recordkeeping Requirements,” which is applicable to all holders of SNM. Microreactors and other reactors with comparable risk profiles would not be required to meet the other requirements in part 74 (except enforcement), the general performance objectives and system capabilities, because those requirements were written principally for fabrication and enrichment facilities.
The NRC proposes to employ a risk-informed approach, so the material control and accounting for a microreactor or reactor with comparable risk profile would be equivalent to the measures at a large LWR, recognizing that the total amounts of material would differ. For the use of high assay low enriched uranium (HALEU) at microreactors or other reactors with comparable risk profiles, the frequency of physical inventory would not be greater than 6 months for licensees of facilities without personnel on site.
The Nuclear Material Management and Safeguards System provisions, as described in part 74, subpart B, would be applicable to proposed part 57 licensees, especially for reporting operation location as the nuclear reactors move across geographic locations. These licensees would follow the reporting requirements for nuclear material transaction reports and material balance reports, as required in part 74, subpart B and submit reports consistent with electronic reporting instructions provided in NUREG/BR-0006 and NUREG/BR-0007.
Subpart N is reserved for future rulemakings in part 57.
Subpart O would contain two provisions, proposed § 57.380, “Violations,” and § 57.385, “Criminal penalties,” which would be analogous to provisions contained in other parts of 10 CFR chapter I that impose requirements on regulated entities. Proposed § 57.380 would provide notice of the Commission's authority under the AEA to obtain injunctions or other court orders for the enumerated violations. Proposed § 57.385(a) would provide notice to all persons and entities subject to proposed part 57 that they would be subject to criminal sanctions for willful violations, attempted violations, or conspiracy to violate certain regulations under proposed part 57. Criminal sanctions would not apply to the regulations listed in proposed § 57.385(b). The regulations for which criminal penalties would apply are limited to those that establish either a regulatory obligation or prohibition.
Proposed subpart P of part 57 would include provisions to address staffing, training, personnel qualifications, and human factors engineering (HFE) requirements that would be applicable to the operation of microreactors or other facilities with comparable risk profiles. These requirements would be adapted from portions of §§ 50.34(f) and 50.54, “Conditions of licenses,” and 10 CFR part 55, “Operators' Licenses,” with considerable modification to reflect the expected reduced role of personnel in preventing and mitigating events and to be consistent with the licensing framework of other facilities with comparable risk profiles, like NPUFs. These requirements also would serve as a component of the required content of joint applications for CPs and associated OLs under proposed part 57. The requirements associated with this approach would be in proposed §§ 57.390, “Definitions,” through 57.429, “Training and qualification for non-licensed personnel.” These sections would be divided into four main portions that cover HFE and human interface system (HSI) design requirements, generally licensed reactor operator (GLRO) requirements, operator and senior operator requirements, and training requirements for other nuclear plant personnel.
Proposed § 57.390 would define specific terms. Some definitions would draw from those in § 55.4, “Definitions.” The NRC would introduce five new definitions for use within the context of proposed subpart P. These new definitions would be the following: “Auxiliary operator,” “Generally licensed reactor operator,” “Load following,” “Operator-dependent facility,” and “Operator-independent facility.”
To establish uniform conditions for the licensing operators, the NRC proposes two classes of nuclear power plants in § 57.391(a). An “operator-dependent facility” is the classification for a nuclear plant whose design demonstrates that operator actions are required to maintain the nuclear plant within the dose criterion of proposed § 57.25(a); the NRC would require the specific licensing of operators and senior operators to manipulate the controls and direct the licensed activities of operators at this class of nuclear plant under proposed § 57.420. This concept would be like provisions for operators and senior operators at “interaction-dependent-mitigation facilities” introduced in part 53.
An “operator-independent facility” is the classification for a nuclear plant whose design demonstrates that no operator actions are required to maintain the nuclear plant within the criterion of proposed § 57.25(a). A GLRO would be an individual licensed under the provisions of proposed § 57.405, “Generally licensed reactor operators,” to manipulate controls of an operator-independent facility licensed under proposed part 57 and to direct the licensed activities of GLROs. The concept of general licensing of operators under proposed part 57 would be similar to provisions for GLROs introduced in part 53.
The term “auxiliary operator” would mean any individual who would operate components of a nuclear plant licensed under proposed part 57 but would not manipulate controls or direct the manipulation of controls of the plant and would not be required to be licensed under proposed part 57. This term would distinguish between plant personnel that operate the controls of the facility and are therefore required to be licensed and those that are not required to be licensed because they do not manipulate or direct the manipulation of plant controls. The term “load following” would describe a nuclear plant automatically changing its output to match expected demand in response to externally originated instructions or signals.
Certain routine communications are necessary to facilitate the operator licensing process. The NRC would adapt the requirements of §§ 55.5, “Communications,” and 50.74, “Notification of change in operator or senior operator status,” in proposed § 57.392, “Communications,” to accomplish this.
Specific information must be collected to facilitate the initial issuance of operator licenses, as well as to allow for license renewals and required updates thereafter. Such information collection activities must also be approved by the OMB. The NRC would adapt the requirements of § 55.8, “Information collection requirements; OMB approval,” to include any needed updates in OMB approval information in proposed § 57.8 to accomplish this.
The information used within the regulatory processes of the NRC must be free from omissions and inaccuracies to facilitate effective regulation. Consistent with this, the NRC would adapt the requirements of § 55.9, “Completeness and accuracy of information,” in proposed § 57.393, “Completeness and accuracy of information,” to require the completeness and accuracy of material information provided by individual applicants and license holders.
Proposed § 57.395, “Human factors engineering requirements,” would contain the HFE requirements for applicants for or holders of an OL under proposed part 57. Proposed § 57.395(a) would contain the human-system interface design requirements. Human-system interfaces provide vital information to plant operations staff
• § 50.34(f)(2)(iv) would become proposed § 57.395(a)(1).
• § 50.34(f)(2)(v) would become proposed § 57.395(a)(2).
• § 50.34(f)(2)(xi), 50.34(f)(2)(xii), and 50.34(f)(2)(xxi) would become proposed § 57.395(a)(3).
• § 50.34(f)(2)(xvii), 50.34(f)(2)(xviii), 50.34(f)(2)(xix), and 50.34(f)(2)(xxiv) would become proposed § 57.395(a)(4).
• § 50.34(f)(2)(xxvi) would become proposed § 57.395(a)(5).
• § 50.34(f)(2)(xxvii) would become proposed § 57.395(a)(6).
• § 50.34(f)(2)(iii) would become the proposed § 57.395(d) and would only be applicable to locations where operator actions are required to maintain the reactor within the criterion of proposed § 57.25(a) or locations where a credible operator or maintenance error could result in exceeding that criterion.
In addition to the requirements of proposed § 57.395(a)(1) through (6), the human-system interfaces and operator capabilities listed in proposed § 57.395(a)(7)(i)-(iv) would be required to allow GLROs, operators, and senior operators to evaluate plant conditions and respond appropriately in the event of an emergency. This would also include the ability to immediately initiate a manual reactor shutdown. Operating experience provides an important source of information by which to inform various aspects of facility design and operations. Accordingly, the NRC would adopt in proposed § 57.395(b) the requirements of § 50.34(f)(3)(i) for requiring an operating experience program.
The NRC recognizes that the licensed operator staffing requirements of § 50.54(k) and (m) are prescriptive and in most cases would not be appropriate for the staffing needs of microreactors and other reactors with comparable risk profiles. Therefore, proposed § 57.395(c) would allow a performance-based means to determine staffing levels for proposed part 57 facilities. The staffing plan would need to be supported by HFE analyses and assessments and approved by the NRC. Once the appropriate facility staffing plan has been determined and approved by the NRC, the staffing level would need to be maintained to ensure that appropriately qualified individuals would be available when needed to support the safe operation of the facility. Therefore, the NRC would require under proposed § 57.399(a) that the staffing described within the approved facility staffing plan be maintained as a condition of the facility license. Under proposed § 57.395(c), the staffing plan would be part of the OL and, thus, a license amendment would be required for any subsequent changes to the plan.
Due to the unique authorities and responsibilities of nuclear power plant operators, it would be essential that any individual fulfilling such a role demonstrate compliance with the regulatory requirements for operator licensing. Section 107 of the AEA authorizes the Commission to prescribe conditions for the licensing of operators and to issue licenses consistent with those conditions. The NRC would adapt the requirements of § 55.3, “License requirements,” in proposed § 57.398, “Operator license requirements,” to require that any person performing the function of a GLRO, operator, or senior operator be authorized by a license issued by the Commission.
The NRC proposes to license individuals to operate proposed part 57 facilities under a general licensing framework or a specific licensing framework depending on the licensed operators' role in reactor safety. The GLRO framework would only be applicable to proposed part 57 facilities that do not require operator actions to maintain the reactor within the criterion of proposed § 57.25(a), or operator-independent facilities, as required by proposed § 57.405(a), “Applicability.” If one or more operator actions are required to maintain the reactor within the criterion of proposed § 57.25(a), then the specific licensing framework for operators at operator-dependent facilities and the requirements in proposed §§ 57.420 through 57.427, “Expiration of operator and senior operator licenses,” would apply.
GLROs would perform duties under the provisions of a general license that would be effective without the filing of an application with the Commission or the issuance of licensing documents to a particular person. The NRC proposes requirements for the general licensing process for GLROs under proposed § 57.400 through § 57.415. The requirements for GLROs would parallel those for senior operators under part 55 regarding their comparable administrative responsibilities. However, operator licensing for GLROs would have fewer requirements compared to the requirements for specifically licensed operators under part 55 due to the GLROs not having to execute operator actions to maintain the reactor within the criterion of proposed § 57.25(a) and unique safety attributes of microreactors and other reactors with comparable risk profiles.
In order to use GLROs to operate the controls of a proposed part 57 facility, an OL applicant would need to demonstrate that it would comply with the following requirements on an ongoing basis: maintain GLRO qualifications for the performance of important functions and tasks; incorporate relevant programmatic controls into technical specifications; administer the related programs for training, examination, and proficiency; and ensure that the relevant provisions of part 26 would be met. Additionally, to provide for an accurate accounting of what individuals would be licensed under the general license, facility licensees would be required to report the identities of all generally licensed reactor operators to the NRC on an annual basis. Proposed § 57.400(a) through (f) would establish requirements for facility licensees that address these topics and others.
Under the AEA, the NRC is required to license any individuals who manipulate the controls of a utilization or production facility. Because the operation of facility controls would directly affect reactivity or power level of the reactor, only those individuals who possess appropriate levels of qualification and authorization would be permitted to operate those controls. The NRC would adapt the requirements of § 50.54(i) in proposed § 57.399(b) to require that only GLROs, operators, and senior operators may operate facility controls, with allowance for specified exceptions for the purposes of operator training or proficiency.
Proposed § 57.399(c) would require that a GLRO, operator, or senior operator monitor plant conditions during the manipulation of apparatus and mechanisms, other than controls, that could affect the reactivity or power level of the reactor.
Load following occurs when plant output automatically changes in response to externally originated instructions or signals and is not permitted under the existing regulations of § 50.54. However, new technological considerations and concepts of
Core alterations such as refueling are associated with specific considerations that warrant limiting the oversight of such operations to appropriately qualified and authorized individuals. Unlike other types of fuel handling operations, core alterations occur within the confines of a reactor vessel that is specifically designed to support and sustain nuclear criticality, thereby justifying the imposition of higher qualification levels within such contexts. The NRC would adapt the requirements of § 50.54(m)(2)(iv) in proposed § 57.399(e) to require the supervision of core alterations by a GLRO, senior operator, or a senior operator limited to fuel handling, as applicable to the facility. Because certain reactor designs may be capable of refueling while at power and, in any event, overall facility oversight would already be required by a GLRO or senior operator, proposed § 57.399(f) would omit this requirement as redundant during periods where core alterations occur while the plant is operating.
The NRC cannot predict every possible scenario that a nuclear plant might potentially encounter. Therefore, it is prudent to grant the authority for appropriately qualified individuals to depart from facility license conditions when emergency circumstances dictate that doing so is in the interest of public health and safety. The NRC would adapt the requirements of § 50.54(x) and (y) in proposed § 57.399(g) and (h) to permit GLROs or senior operators to authorize departures from facility license conditions or technical specifications when emergency conditions warrant doing so for the protection of the public health and safety. While the NRC does not anticipate that GLROs will have a role in the fulfillment of safety functions at operator-independent facilities licensed under part 57 or that operators at such facilities would be in a position to significantly influence radiological safety outcomes, the very nature of § 50.54(x) and (y) and proposed § 57.399(g) and (h) concerns situations that are unanticipated and, therefore, unforeseeable. Thus, it is appropriate to propose to grant GLROs a comparable authority to that of senior licensed operators and certified fuel handlers as it relates to invoking this provision under emergency conditions as a means of accounting for such possibilities.
GLROs would be licensed as a class of individuals under the provision of proposed § 57.405(a) and would be subject to the conditions specified in proposed § 57.405(b)(1) through (8). Portions of these conditions are adapted from § 55.53, “Conditions of licenses.” The NRC would retain the ability to suspend or prohibit individuals from operating under the general license should such action be warranted.
The NRC proposes overall programmatic requirements for GLRO training, examination, and proficiency in proposed § 57.410, “Generally licensed reactor operator training, examination, and proficiency programs.” In general, these proposed requirements would be adapted from those of part 55. These requirements would include flexibility commensurate with the expected reduced level of operator actions at microreactor and other reactors with comparable risk profiles. The requirements in proposed § 57.410 would cover, in part, the initial training, initial examination, continuing training, requalification examination, and proficiency of GLROs. Proposed § 57.400(b) would require the facility licensee to develop, implement, and maintain these programs. Proposed § 57.405(b)(1)-(8), in turn, would prescribe that the requirements of proposed § 57.400 would need to be met as a requirement of the general license. The implication of this structure is that the facility licensee would need to implement these programs for training, examination, and proficiency, and GLROs would need to participate in these programs to demonstrate compliance with the requirements of the general license. The initial training process would provide GLROs with the knowledge and abilities needed to fulfill assigned duties as GLROs. The use of a systems approach to training (SAT)-based training program would serve to ensure that the training program is based upon job requirements in a manner that can be adapted to account for differences in plant technology and concepts of operations. Proposed § 57.410(b) would require facility licensees to implement an SAT-based training program for the initial training of GLROs that would be adequate to ensure that they have the necessary knowledge, skills, and abilities to perform their duties. For microreactor and other reactors with comparable risk profiles, such programs would not be subject to NRC approval, however the NRC would maintain oversight of these licensing programs through inspection.
Examinations would provide a means of assessing that individuals have achieved a degree of knowledge and ability that would be sufficient to enable them to carry out assigned duties as GLROs in a manner that is both safe and reliable. The NRC would adapt the requirements of §§ 55.40, “Implementation,” 55.41, “Written examination: Operators,” 55.43, “Written examination: Senior operators,” and 55.45, “Operating tests,” in proposed § 57.410(b), “Requirements,” to require that facility licensees establish and implement an initial examination program for GLROs. A key difference from the current comparable requirements of part 55 would be that facility licensees under proposed part 57 would have the flexibility to determine, subject to NRC approval, the examination methods and criteria to be used in assessing satisfactory individual performance. Such examination programs (including those used within the scope of continuing training) would need to provide for acceptable levels of both test validity and test reliability in order to be considered acceptable. In contrast with requirements for licensing examinations in part 55, the NRC would not administer or evaluate these initial examinations of GLROs. However, the examination processes would continue to be subject to ongoing NRC oversight including subsequent review and approval of any substantial changes to approved examination programs. The NRC plans to develop guidance to facilitate the review of initial examination programs that are proposed by facility licensees.
Continuing training programs would provide the ongoing training and examination of GLROs to ensure that they maintain the knowledge and abilities needed to support the safe and reliable performance of job duties following the completion of an initial training and examination program. The NRC would adapt the requirements of § 55.59, “Requalification,” in proposed § 57.410(b) to require that facility licensees implement both an SAT-based continuing training program and a requalification examination program.
For examinations to provide for valid assessments of the knowledge and abilities of individuals, the examinations must remain free from compromises that could affect their underlying integrity. The NRC would adapt the requirements of § 55.49, “Integrity of examinations and tests,” in proposed § 57.410(d) to require that examinations and related activities remain free from any compromise that might affect the integrity of the examination process.
Simulators provide a valuable means of training and evaluating plant operators, and the NRC is specifically authorized under section 306 of the Nuclear Waste Policy Act of 1982 (42 U.S.C. 10226) to establish regulations for the use of simulators within such context. The NRC would adapt the requirements of § 55.46, “Simulation facilities,” in proposed § 57.410(e) to address the use of simulation facilities for training and examinations, and experience requirements, as well as to address the maintenance of simulator fidelity. The use of full scope, plant-referenced simulators would not be mandatory. The potential use of alternative simulation facilities consisting of, for example, partial scope simulators or the plant itself, would be allowed provided that all associated proposed requirements were demonstrated to be met using alternative approaches and methods.
There may be situations in which GLROs have previous training and experience that justify waiving some or all of the initial examination. Therefore, under proposed § 57.410(f), the NRC would allow facility licensees to waive some or all portions of initial examinations provided that such waivers would be consistent with an examination program that has been approved by the NRC.
For GLROs to safely and reliably perform their assigned duties, they would need to perform those duties frequently enough to maintain a sufficient degree of proficiency. However, the NRC recognizes that facilities that would utilize GLROs may have concepts of operation that warrant unique proficiency considerations. Therefore, the NRC would require in proposed § 57.410(g) that facility licensees develop, implement, and maintain programs to maintain and re-establish, if needed, the proficiency of GLROs. This could occur, for example, if an individual's extended absence from watch standing rendered proficiency requirements unmet.
The NRC would require under proposed § 57.415, “Cessation of individual applicability,” that the general license would cease to be applicable on an individual basis when the individual would no longer be employed in a position that might call for the individual to manipulate the reactivity controls of the facility. However, the NRC recognizes that for some types of proposed part 57 facilities, very long periods may elapse between circumstances that necessitate manual manipulation of reactivity controls. Therefore, the general license would remain in effect for an individual as long as the individual's current position could potentially require that individual to manipulate reactivity controls at some point within the course of the individual's assigned job duties.
Specifically licensed operators would differ from GLROs because the former would be directly and independently evaluated by the NRC as part of their licensing process. This direct and independent evaluation would remain appropriate at operator-dependent facilities where operators may reasonably be expected to have a role in public health and safety outcomes. The NRC would set forth requirements for the use of a specific licensing process for licensed operators and senior operators under proposed §§ 57.420 through 57.427, with § 57.420 addressing applicability.
Medical fitness is an important component of the overall process of specifically licensing operators because it provides assurance that operators will be able to carry out important duties without being precluded from doing so by health-related issues. Medical fitness also provides assurance that such issues will not adversely affect the performance of assigned job duties or cause operational errors that endanger public health and safety. In addition to a requirement for medical fitness, a medical examination by a physician to confirm compliance with this requirement would be necessary. The NRC would adapt the requirements of §§ 55.21, “Medical examination,” 55.23, “Certification,” and 55.27, “Documentation,” under proposed § 57.421, “Medical requirements,” to require medical fitness, examinations by physicians, and medical certification for specifically licensed operators and senior operators. In recognition of the fact that GLROs are not expected to have a role in the fulfillment of safety functions at the facilities at which they are licensed, the NRC would not extend a comparable medical requirement to GLROs.
The NRC also would adapt the requirements of §§ 55.25, “Incapacitation because of disability or illness,” and 50.74(c) in proposed § 57.422, “Incapacitation because of disability or illness,” to require that timely notifications be made to the NRC if a specifically licensed operator or senior operator develops a permanent physical or mental condition that adversely affects the performance of assigned operator job duties or could cause operational errors endangering public health and safety.
The process of specifically licensing individuals as operators or senior operators requires the submittal of applications to the NRC for review. These applications must detail certain elements associated with licensing, including the demonstration of compliance with examination, experience, and medical requirements. The NRC would adapt the requirements of current subpart D, “Applications,” of part 55 in proposed § 57.423, “Applications for operators and senior operators,” to include requirements for the applications associated with the specific licensing of operators and senior operators at commercial nuclear plants licensed under proposed part 57.
The NRC proposes programmatic requirements for specifically licensed operator and senior operator training, examination, and proficiency in § 57.424, “Training, examination, and proficiency programs.” In general, the requirements are adapted from those in part 55, but with flexibility to support diverse reactor technologies and concepts of operations. Specifically, the requirements in proposed § 57.424 would concern the initial training, initial examination, requalification training, requalification examination, and proficiency of specifically licensed operators and senior operators.
The initial training process provides individuals with the knowledge and abilities needed to subsequently fulfill assigned duties as licensed operators or senior operators in a safe and reliable manner. The use of an SAT-based training program would ensure that the training program is based upon job requirements in a manner that can be adapted to account for differences in plant technology, concepts of operations, and operator roles in the
Examinations provide a means of assessing that individuals have achieved a level of knowledge and ability that is sufficient to carry out assigned duties as specifically licensed operators or senior operators in a manner that is safe and reliable. The NRC would adapt the requirements of §§ 55.40, 55.41, 55.43, and 55.45 in proposed § 57.424(b) to require that facilities establish and implement an initial examination program. However, a key difference from the comparable requirements of part 55 is that facilities would have the flexibility to propose, subject to NRC approval, the examination methods and the criteria for use in assessing applicant performance. Such examination programs (including those used within the scope of requalification training) would need to provide for acceptable levels of both test validity and test reliability in order to be considered acceptable. The NRC intends that guidance would be available to facilitate the review of licensing examination programs that are proposed by facility licensees and that, following NRC approval, initial examination programs will be subject to an appropriate change control process. Furthermore, the NRC would allow facility licensees the option to administer their own NRC-approved licensing examinations. The NRC would continue to exercise appropriate oversight of the program, make operator licensing decisions based upon the examination results, and reserve the right to administer the examinations in lieu of permitting the facility to do so.
Requalification training programs provide for the continuing training and examination of specifically licensed operators and senior operators to ensure that they maintain the knowledge and abilities needed to support the safe and reliable performance of job duties following the completion of an initial training and examination program. The NRC would adapt the requirements of § 55.59 in proposed § 57.424(c) to require that facilities implement both an SAT-based requalification training program and a biennial requalification examination program. However, a notable difference from the biennial requalification examinations required under part 55 is that facility licenses would be able to propose examination methods and criteria to be used in assessing satisfactory performance as part of their replated programs. The NRC intends that guidance would be available to facilitate the review of the requalification examination programs that are proposed by facility licensees and that, following NRC approval, requalification examination programs would be subject to an appropriate change control process.
For examinations to provide valid assessments of the knowledge and abilities of individuals, the examinations must remain free from compromises that could affect their underlying integrity. The NRC would adapt the requirements of § 55.49 in proposed § 57.424(d) to require that examinations and related activities remain free from any compromise that might affect the integrity of the examination process.
Simulators provide a valuable means of training and evaluating plant operators, and the NRC is specifically authorized under the section 306 of the Nuclear Waste Policy Act of 1982, as amended to establish regulations for the use of simulators within such context. The NRC would adapt the requirements of § 55.46 in proposed § 57.424(e) to address the use of simulation facilities for training, examinations, and applicant experience requirements, as well as to address the maintenance of simulator fidelity. However, the requirements of proposed part 57 would not mandate that full scope, plant-referenced simulators be used and would allow the use of alternative simulation facilities consisting of, for example, partial scope simulators or the plant itself, provided that all associated requirements can be demonstrated to be met using alternative approaches and methods.
There may be situations in which applicants for operator or senior operator licenses have previous training and experience that justify reducing some, or all, of the initial examination requirements. The NRC would adapt the high-level requirements of § 55.47, “Waiver of examination and test requirements,” in proposed § 57.424(f), to support the evaluation of requests for waivers of examination requirements.
For licensed operators and senior operators to perform their assigned duties safely and reliably, it is essential that they perform those duties frequently enough to maintain proficiency. The NRC would adapt the requirements of § 55.53(e) and (f) in proposed § 57.424(g) to require that specifically licensed operators and senior operators maintain proficiency and, if proficiency is not maintained, regain proficiency prior to resuming licensed duties. However, a major difference from the part 55 requirements is that the facility licenses would propose their own program for operator proficiency, subject to NRC approval. Similar to training and examination program changes, following NRC approval, proficiency programs would also be subject to an appropriate change control process.
As the holders of specific licenses, licensed operators and senior operators would be subject to license conditions on an individual basis to ensure that the basis upon which the licenses were issued remains valid. The NRC would adapt the requirements of § 55.53 in proposed § 57.425, “Conditions of operator and senior operator licenses,” to require appropriate conditions of licenses for specifically licensed operators and senior operators. However, in contrast with the requirements of § 55.53(e) and (f), the NRC would allow certain aspects of operator proficiency to be addressed by an NRC-approved facility proficiency program.
Licenses for specifically licensed operators and senior operators under part 55 are currently issued by the NRC and must remain subject to modification or revocation. The NRC would adapt the requirements of §§ 55.51, “Issuance of licenses,” and 55.61, “Modification and revocation of licenses,” in proposed § 57.426, “Issuance, modification, and revocation of operator and senior operator licenses,” to address the issuance, modification, and revocation of licenses issued to specifically licensed operators and senior operators.
Finally, proposed § 57.427 would address conditions that would cause licenses issued to specifically licensed operators and senior operators to expire.
Section 306 of the Nuclear Waste Policy Act of 1982 authorizes and directs the NRC to, in part, issue regulations and guidance that address the training and qualifications of civilian nuclear power plant operators, supervisors, technicians, and other appropriate operating personnel. The NRC implements this in part 50 through the requirements of § 50.120, “Training and qualification of nuclear power plant personnel.” The NRC would adapt under proposed § 57.429 the requirements of § 50.120 for specific categories of nuclear plant personnel.
Proposed part 57 would address various reporting and administrative requirements in subpart Q.
Proposed § 57.430, “Maintenance of records, making of reports,” would require the maintenance of records and the making of various reports by the licensee to the NRC. These requirements would be largely equivalent to § 50.71(a), (c), and (d).
Proposed § 57.430(f) would require licensees to notify the NRC of successful completion of any startup testing of a nuclear reactor to support the assessment of annual fees under 10 CFR part 171, “Annual Fees for Reactor Licenses and Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by the NRC.” The assessment of annual fees normally commences upon completion of those testing activities. With respect to annual fees, the NRC recently modified its annual fee regulations to address differences between the current fleet of large operating reactors and potential future smaller reactors. In the Fiscal Year 2023 final fee rule, the NRC amended its annual fee regulations to (1) be technology-inclusive by expanding the applicability of the small modular reactor variable fee structure to include non-LWR small modular reactors (previously it was limited to LWR small modular reactors); and (2) establish an additional minimum fee and variable rate applicable to smaller reactors.
Proposed § 57.435, “Reporting requirements,” would establish requirements for immediate notifications by licensees under proposed part 57. These requirements would be equivalent to § 50.72, “Immediate notification requirements for operating nuclear power reactors,” with minor changes proposed to make the reporting criteria technology-inclusive and remove the notification of the NRC Operations Center using the Emergency Notification System.
Proposed § 57.440, “Licensee event report system,” would require each holder of an OL under proposed part 57 to have a licensee event report system. These requirements would be equivalent to § 50.73, “Licensee event report system,” with minor changes to remove requirements of specific reactor technologies.
Proposed § 57.445(a) and (b) would require periodic reporting of the quantity of radionuclides released to unrestricted areas in liquid and gaseous effluents, and doses to members of the public. Proposed § 57.445, “Reports of radiation exposure to members of the public,” would be similar to § 50.36a(a)(2).
This proposed rule would make conforming changes throughout 10 CFR chapter I by adding “and part 57” where appropriate to account for the addition of the proposed part 57. In addition, this proposed rule would revise § 2.340(d) in three places to correct the manufacturing license reference from subpart C to subpart F.
The NRC proposes to include fitness-for-duty (FFD) requirements for microreactors and other reactors with comparable risk profiles. This proposed rule would establish a technology-inclusive, risk-informed, and performance-based approach for the application of drug and alcohol testing and fatigue management requirements for facilities licensed under proposed part 57. The proposed rule would add a new subpart P, “Fitness-for-Duty Programs for Facilities Licensed Under 10 CFR part 57,” in 10 CFR part 26, “Fitness for Duty Programs,” and make conforming changes to existing part 26 provisions. The proposed rule would also provide the option for certain reactors with comparable risk profiles to implement an FFD program of their specification (
The NRC would use operating experience to provide regulatory flexibility to proposed part 57 licensees and other entities in the part 26 framework to help support a licensee's or other entity's response to changes in societal drug use, drug testing technologies and processes, and FFD program performance. The flexibility would also help in FFD program implementation because of the wide variety of staff sizes anticipated at nuclear plants licensed under proposed part 57 and the geographically remote locations in which these nuclear plants may be sited.
Licensees and other entities would have the option to implement one of three types of FFD programs at their facilities: one that meets all the requirements of part 26 except subpart K, “FFD Program for Construction,” of part 26 and proposed subpart P; one that meets the requirements in proposed subpart P; or an FFD program of their specification. These requirements would be commensurate with the potential radiological consequences of reactors licensed under proposed part 57, and the options available to a licensee would be dependent on the human reliability considerations associated with the operation of their facilities. This risk-informed regulatory strategy would be consistent with the current part 26, which provides a comprehensive set of deterministic requirements for licensees and other entities at facilities that are operating plus a more flexible framework under subpart K for nuclear power reactors under construction.
Proposed subpart P to part 26 would be essentially equivalent to the requirements in subpart K as supplemented by select requirements from subparts E, “Collecting Specimens for Testing,” of part 26, and the requirements in subparts A, “Administrative Provisions,” I, “Managing Fatigue,” and O, “Inspection, Violations, and Penalties,” of part 26. These requirements would help deter individuals subject to proposed subpart P from drug and/or alcohol use and from being impaired from any cause including fatigue. These requirements also would help licensees and other entities identify individuals as users of impairing substances and demonstrate compliance with § 26.23, “Performance objectives.”
Proposed subpart P of part 26 would enable a part 57 licensee or other entity
A proposed part 57 nuclear plant that is sited in a geographically remote location and has a small staff size may present implementation challenges and the potential for small group dynamics that could have the potential to impact FFD program effectiveness. For example, behavioral observation may be less effective at a plant that has a small staff size, which can be subject to greater impacts from groupthink and other biasing factors.
Additionally, random testing may be less effective when applied to small staff sizes, because it may be easier for staff to communicate and predict when individuals will be subject to drug and alcohol testing. Furthermore, if a facility is sited in a remote location, program implementation could be challenged by the following factors: limited mail services to laboratories certified by the U.S. Department of Health and Human Services (HHS), availability of local clinical or medical options for treatment and determinations of fitness by an MRO or Substance Abuse Expert, and use of offsite drug and alcohol collection facilities.
The increased potential for small staff sizes to impact FFD policy compliance would necessitate additional flexibilities be provided to implement various FFD program elements. The NRC would require that facilities with small staff sizes that cannot implement random drug and alcohol testing without predictability, use a consortium/third-party administrator (C/TPA) to include the workers from multiple licensees or other entities into a combined random testing pool under § 26.907(b)(2)(vi). Use of a C/TPA would significantly improve the effectiveness of the random testing programs of sites with small worker populations and ensure that individuals would not be able to predict whether random testing would be conducted in a given period of time. Use of C/TPAs is not new in Federally-regulated testing, as the U.S. Department of Transportation has employed the use of C/TPAs in specific modal administrations, such as the Federal Motor Carrier Safety Administration under 49 CFR part 382, “Controlled Substances and Alcohol Use and Testing,” which, in part, covers independent owner-operator truck drivers that must be drug and alcohol tested. The U.S. Department of Transportation requirements in 49 CFR part 40, “Procedures for Transportation Workplace Drug and Alcohol Testing Programs” also enables the use of C/TPAs to perform a variety of functions for employers, such operating random testing programs, and contracting with specimen collection sites and HHS-certified laboratories for services.
Another flexibility would be proposed § 26.907(g)(2), where the NRC would enable the virtual collection of oral fluid specimens for drug and alcohol testing at facilities that must use a C/TPA to implement random testing under § 26.907(b)(2)(vi). These sites would have small staff sizes and could be in remote locations where accessing an in-person specimen collector might be difficult, untimely, and/or costly. Because all aspects of an oral fluid collection would be directly observed by the specimen collector, a video teleconference could accomplish many key elements of the collection process. The use of video teleconference technology would not be new to the NRC, as some clinicians complete other required evaluations, such as performing a psychological assessment under the personnel access authorization requirements in § 73.56(e)(4) or a determination of fitness performed under § 26.189(b) by a Substance Abuse Expert when potentially disqualifying FFD information is discovered about an individual that is subject to 10 CFR part 26. In addition, existing § 26.31(b)(1)(iii) enables the use of a monitor to assist a specimen collector in completing aspects of a urine collection when a trained collector is not able to complete the activity, and existing § 26.109(b)(1) permits a hydration monitor to observe a donor during the shy bladder process in lieu of the collector conducting the activity. In both cases, the monitor must receive information from the collector on his or her responsibilities.
Also, the NRC would establish a change control requirement to allow a licensee or other entity to change its subpart P FFD program while ensuring that FFD program effectiveness is maintained.
Proposed § 26.3(d) is the applicability paragraph for contractor/vendors (C/Vs) that implement FFD programs or program elements, to the extent that the licensees and other entities specified in § 26.3(a) through (c) rely on those C/V FFD programs or program elements to satisfy the requirements of part 26. Section 26.3(d) would be amended to address proposed part 57 licensees and other entities in proposed § 26.3(f).
Proposed § 26.3(f) would place part 57 licensees or other entities within the scope of part 26. For applicants for or holders of a CP or OL under proposed part 57, except a holder of an ML, proposed § 26.3(f)(1) would require the FFD program to be implemented no later than the start of construction activities. Proposed § 26.3(f)(2) would require the holder of an ML under proposed part 57 to implement its FFD program before commencing activities that assemble a reactor. All three licensees would have three FFD program options: implement all the requirements of part 26 except subparts K and P, the requirements in proposed subpart P, or an FFD program of their specification. Proposed § 26.3(f)(3) would provide the criteria by which licensees and other entities under proposed part 57 could implement an FFD program of their specification. That criterion would be if the licensee's or other entity's reactor manufactured, constructed, or operated under a part 57 license would not require operator action to maintain the reactor within the criterion of § 57.25(a) or a credible operator or maintenance error could not result in exceeding that criterion.
Current § 26.4, “FFD program applicability to categories of individuals,” describes FFD program applicability to categories of individuals. These categories are based on the duties, responsibilities, and the types of access an individual may possess. The NRC proposes to amend § 26.4 to include licensees and other entities described in proposed § 26.3(f). The NRC expects that not all categories of individuals described in current § 26.4 would be applicable to all proposed part 57 facilities.
Section 26.4(a) requires individuals who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c) and perform the duties listed in 26.4 to be subject to an FFD program that meets all of the requirements of part 26, except subpart K. The NRC would amend § 26.4(a) to except proposed subpart P as well as subpart K.
Section 26.4(a)(1) and (a)(4) would be amended to account for the possibility that certain individuals may perform or direct the performance of operational and maintenance activities from a remote facility (for example, a remote control station) for licensees or other entities licensed under proposed part 57. The framework of the current part 26 does not account for individuals who perform operating and maintenance duties at remote facilities. Although current § 26.4(a)(1) does not limit the operating of applicable SSCs to onsite operating, § 26.5, “Definitions,” limits the definition of “Maintenance,
Under the proposed amendments to part 26, the limitation of “onsite” activities to those performed within the owner-controlled area would still apply to facilities licensed under part 50 or 52. However, for licensees and other entities described in proposed § 26.3(f), the NRC would remove the “onsite” limitation to include activities performed both within the owner-controlled area as well as operations and maintenance duties performed at remote facilities where safety-significant systems and components are expected to be operated within the design basis of the nuclear plant.
In the 2008 part 26 final rule, the purpose of limiting “directing” activities to those “directing” activities that are conducted onsite was to avoid requiring work hour controls for individuals performing incidental duties, consistent with § 26.205(b)(5), from an offsite location in instances where those duties might be considered to be “directive” in nature. Under the proposed amendments to part 26, the exclusion of incidental duties while calculating work hours would still be applicable for licensees and other entities licensed under proposed part 57. However, for these licensees and other entities, beyond instances of incidental duties, the direction of operations and maintenance activities associated with safety-significant SSCs, when performed at remote facilities, would be considered in an equivalent fashion as direction performed at non-remote facilities, for the purposes of administering work hour controls.
Section 26.4(b) requires individuals who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c) and who do not perform the duties described in § 26.4(a), to be subject to an FFD program that meets all of the requirements of part 26, except §§ 26.205, “Work hours,” through 26.209, “Self-declarations,” and subpart K. The NRC would amend § 26.4(b) to except proposed subpart P as well as subpart K. Proposed § 26.4(b) also would include in an FFD program individuals who are granted unescorted access to the protected area of a facility licensed under proposed part 57 and do not perform or direct the performance of the duties described in § 26.4(a). This requirement would contribute to the defense in depth regulatory framework that helps provide that individuals who have unescorted access are fit for duty, trustworthy, and reliable.
Section 26.4(c) requires individuals who are required by a licensee in § 26.3(a) and, as applicable, (c) to physically report to the licensee's Technical Support Center or Emergency Operations Facility by licensee emergency plans and procedures to be subject to an FFD program that meets all of the requirements of part 26, except §§ 26.205 through 26.209 and subpart K. The NRC would amend § 26.4(c) to except proposed subpart P as well as subpart K.
The NRC also would amend § 26.4(c) to include in an FFD program individuals who are assigned to physically report to the proposed part 57 licensee's emergency response facility (or facilities) or participate remotely in emergency response activities, and individuals without unescorted access to the part 57 facility who, remotely or otherwise, make decisions and/or direct actions regarding plant safety or security. Proposed part 57 nuclear plants may rely upon offsite facilities to fulfill the role of a Technical Support Center or Emergency Operations Facility. Therefore, the proposed rule would account for such offsite facilities or remotely performed activities. Further, the use of personnel to operate systems and components, maintain and surveil SSCs, and respond to plant conditions and security events may be different than those included in the Technical Support Center or Emergency Operations Facility team for power reactors currently licensed under part 50 or part 52.
For the individuals whose duties for the licensees and other entities in § 26.3(c) require the individuals to have the types of access or perform the activities listed in § 26.4(e)(1) through (6) at the location where the nuclear plant will be constructed and operated, current § 26.4(e) requires them to be subject to an FFD program that satisfies all the requirements of part 26 except subparts I and K. The NRC would amend § 26.4(e) to except proposed subpart P as well as subparts I and K. The NRC would also amend § 26.4(e) to include in an FFD program the individuals whose duties for the
The proposed rule would amend § 26.4(f) to require individuals who construct or direct the construction of safety- or security-related SSCs at facilities licensed under proposed part 57 to be subject to an FFD program under proposed subpart P of part 26 or an FFD program that demonstrates compliance with all the requirements of part 26 except for subparts I, K, and P of part 26, unless the licensee or other entity meets the criteria in proposed § 26.3(f)(3) and subjects these individuals to an FFD program of its own specification.
Section 26.4(g) is the applicability paragraph for FFD program personnel (
Section 26.4(h) would be amended to include proposed subpart P of part 26 unless the licensee or other entity meets the criteria in proposed § 26.3(f)(3) and subjects these individuals to an FFD program of its own specification.
The NRC proposes to include several new definitions in § 26.5 and amend some existing definitions. The NRC is proposing to add a definition for “Biological marker.” The proposed definition would be consistent with “Biomarker” defined by the HHS in its Mandatory Guidelines for Federal Workplace Drug Testing (HHS Guidelines) using oral fluid as the biological specimen to be tested (84 FR 57554; October 25, 2019). However, the proposed definition for § 26.5 would add that the endogenous substance used to validate that the biological specimen “was produced by the donor” because subpart P of part 26 proposes to have the MRO evaluate any discrepant biological marker identified in a biological specimen collected from a donor.
The NRC is proposing a definition for the word “Change” as used in proposed § 26.903(c), “FFD program change control,” process. The proposed definition would be consistent with the definition of “Change” for a part 50 or 52 licensee's emergency plans in § 50.54(q)(1)(i).
The NRC is proposing a definition for “Consortium/third-party administrator,” which would be used in § 26.907(b)(2)(vi), with respect to administering the random testing pool and random testing selections for licensees and other entities with facilities with small staff sizes. A C/TPA also could provide access to, for example, services of medical review officers, substance abuse experts, employee assistance programs, and HHS-certified laboratories under contract to perform drug testing.
The NRC proposes to revise the definition of “Constructing or construction activities” to clarify that for licensees or other entities in proposed § 26.3(f), the definition of “Construction” would be that in proposed § 57.3.
The definitions of “Contractor/vendor” (C/V) and “Other entity” would be revised to make them applicable to proposed part 57 licensees. A holder of an ML under part 57 could be a C/V under the proposed C/V definition.
The NRC is proposing a definition for “Illicit substance” because this phrase would be used in proposed subpart P of part 26 and would address substances that cause impairment and possible addiction but would not be an “illegal drug” as defined in § 26.5. This proposal is based on operating experience where individuals have admitted to using common household, non-drug substances to achieve a high or satisfy an addiction. These common household items include, but are not limited to nitrous oxide, butane, propane, glue, paint vapors, lighter fluid, nail polish remover, degreasers, permanent markers, and methyl alcohol (which is found in hand sanitizer and mouthwash).
The NRC is proposing a definition for “Reduction in FFD program effectiveness” because this phrase, similar to the proposed definition for “Change,” would be used in proposed § 26.903(c). The proposed definition is generally consistent with the definition of “Reduction in effectiveness” provided for emergency plans in § 50.54(q)(1)(iv).
The proposed rule would make the current definition of “Reviewing official” applicable to those licenses and other entities in proposed § 26.3(f).
The current part 26 definition of “Safety-related structures, systems, and components” would be amended to use the NRC's proposed definition in § 57.3 for the part 57 licensees and other entities described in proposed § 26.3(d) and (f).
The NRC would amend the definition of “Security-related SSCs” in § 26.5 to make it applicable to a licensee or other entity described in proposed § 26.3(d) and (f).
The NRC proposes a definition for “Special nuclear material” that would refer to the definition in § 70.4, “Definitions,” to ensure consistency.
The NRC is proposing a revision of the definition of “Unit outage” to account for the potential use of nuclear plants for purposes other than electricity generation.
The proposed rule would amend § 26.8, “Information collection requirements: OMB approval,” to reflect the addition of proposed subpart P to part 26.
Section 26.21, “Fitness-for-duty program,” an applicability statement for part 26 FFD programs, would be amended to include licensees and other entities described in proposed § 26.3(f) that choose to implement an FFD program that implements all part 26 requirements, except those in subparts K and P of part 26, and do not implement an FFD program of their own specification if they meet the criteria in proposed § 26.3(f)(3).
The proposed rule would amend § 26.35(c)(3) to include a reference to proposed § 26.906(b)(2)(vii), which would ensure that licensees and other entities take immediate action upon receiving notice from the EAP that an individual's condition or actions pose or have posed an immediate hazard to themself or others.
Section 26.51, “Applicability,” would be amended to apply to licensees and other entities described in proposed § 26.3(f) that elect not to implement the requirements in proposed subpart P of part 26 for the categories of individuals in § 26.4, and do not implement an FFD program of their own specification if they meet the criteria in proposed § 26.3(f)(3).
Section 26.53(e) and (g) through (i), which are general provisions for granting and maintaining authorization, would be amended to apply to licensees and other entities described in proposed § 26.3(f).
Section 26.63(d), a suitable inquiry requirement, would be amended to apply to licensees and other entities described in proposed § 26.3(f).
Section 26.73, “Applicability,” the applicability statement for subpart D of part 26, would be amended to apply to licensees and other entities described in proposed § 26.3(f) that elect not to implement the requirements in proposed subpart P of part 26 for the categories of individuals in § 26.4 and do not implement an FFD program of their own specification if they meet the criteria in proposed § 26.3(f)(3).
Section 26.81, “Purpose and applicability,” the purpose and applicability statement for subpart E of part 26, would be amended to apply to licensees and other entities described in proposed § 26.3(f) that elect not to implement the requirements in proposed subpart P of part 26 for the categories of individuals in § 26.4 and do not implement an FFD program of their own specification if they meet the criteria in proposed § 26.3(f)(3). The subpart E requirements to be implemented are listed in proposed § 26.907(c)(2)(i) and (c)(2)(ii) and (c)(3).
The NRC proposes to revise § 26.97(a) and (b) to enable the virtual collection of oral fluid specimens for drug and alcohol testing, as would be permitted under proposed § 26.907(g)(2). The NRC also would amend § 26.97(a) and (b) to update the oral fluid specimens collection process requirements.
Section 26.201, “Applicability,” the applicability statement for subpart I of part 26, would be amended to apply to licensees and other entities described in proposed § 26.3(f). Also, the applicability statement would be divided into two paragraphs for clarity.
The NRC proposes to add § 26.202, “General provisions for facilities licensed under part 57,” for licensees or other entities described in proposed § 26.3(f) that elect to implement the requirements in subpart I of part 26 in accordance with proposed § 26.904, “FFD program requirements.” Proposed § 26.202 would establish requirements equivalent to those in current § 26.203, “General provisions,” which is applicable to part 50 and 52 licensees. The NRC would add the separate § 26.202 because § 26.203 would refer to various requirements under subpart B of part 26, which would not be applicable to facilities licensed under proposed part 57 that implement proposed subpart P of part 26.
Additionally, proposed § 26.202(c), “Training and assessments,” unlike current § 26.203(c), “Training and examinations,” would not include a comprehensive examination requirement because trainee assessment is conducted as part of an SAT that would be required as proposed under the FFD program training requirements in proposed § 26.908, “FFD program training.”
Proposed changes in §§ 26.205, 26.207, “Waivers and exceptions,” and 26.211, “Fatigue assessment,” would add references to new requirements in subparts I and P of part 26 that would be applicable specifically to licensees and other entities in proposed § 26.3(f). The NRC would not change the specific provisions for work hour requirements in current § 26.205(d).
Proposed changes to §§ 26.207(a)(1)(ii) and 26.211(b) would allow licensees and other entities in proposed § 26.3(f) to perform face-to-face assessments to support the approval of work hour control waivers and the conduct of fatigue assessments, respectively, using electronic communications. These proposals would allow supervisors to conduct such assessments from a remote location under appropriate circumstances. Such remotely conducted assessments would need to be supported by someone who is present in-person with the individual being assessed and who is trained in accordance with the requirements of either § 26.29, “Training,” and § 26.203(c) or proposed § 26.908 and § 26.202(c). The reasoning for these proposals and the associated need for in-person support to augment electronic communications is addressed further in the preamble discussion of proposed § 26.919, “Suitability and fitness determinations.”
Proposed § 26.709, “Applicability,” would make the recordkeeping and reporting requirements in subpart N, “Recordkeeping and Reporting Requirements,” of part 26 applicable to licensees and other entities of facilities licensed under proposed part 57 that elect not to implement the requirements in proposed subpart P of part 26 and do not implement an FFD program of their own specification if they meet the criteria in proposed § 26.3(f)(3).
Proposed § 26.711(c) and (d) would be amended to make these requirements applicable to licensees or other entities described in proposed § 26.3(f). Section 26.711(c) provides protection to individuals subject to part 26 by enabling an individual's right to review FFD-related information and correct any inaccurate or incomplete information. Section 26.711(d) requires, in part, that any FFD-related information shared with other licensees or other entities is correct and complete.
The proposed rule would add a new subpart P to part 26 that would provide alternative FFD requirements for licensees and other entities licensed under proposed part 57.
Proposed § 26.901, “Applicability,” would make subpart P of part 26 applicable to part 57 licensees and other entities, at their discretion. As provided for in proposed § 26.3(f), a part 57 licensee or other entity that does not elect to implement an FFD program that demonstrates compliance with the requirements of proposed subpart P must implement an FFD program that demonstrates compliance with all part 26 requirements, except for those requirements in subparts K and P, or an FFD program of their specification if they meet the criteria in proposed § 26.3(f)(3).
Proposed § 26.903(a), “FFD program description,” would require a proposed part 57 applicant to include a description of its FFD program in its FSAR, required by proposed subparts C and D of part 57. Unlike an application for a license, a description of an FFD program would not receive NRC review for possible approval. The applicant would provide the NRC with information about the applicant's proposed FFD program to inform the NRC's inspection program and to demonstrate that the FFD program would be effectively implemented before a licensee or other entity commences any activity making individuals at the NRC-licensed facility subject to the FFD program.
Proposed § 26.903(a)(1) would require a discussion that informs the NRC of the applicability of the applicant's FFD program to individuals as specified in § 26.4. This description should summarize any key differences between the staff at the site and any remote facility and the categories of individuals in § 26.4. The principal purpose of providing this description would be to inform the NRC of any substantial differences in the applicability of the FFD program to the categories of individuals in § 26.4. Proposed § 26.903(a)(1) would also require the FFD program description to describe how the program would be implemented at a facility authorized to assemble or perform non-operational testing of a manufactured reactor under an ML issued under proposed part 57, if applicable.
Proposed § 26.903(a)(2) would require a description of the drug and alcohol testing and fitness determination process to be implemented through the licensee's or other entity's procedures, including the collection and testing facilities to be used, biological specimens to be collected and tested, and sanctions to be imposed for FFD policy violations. This process would
Proposed § 26.903(b), “FFD program implementation and availability,” would establish the longevity of the FFD program. Unlike the current part 26 regulations, § 26.903(b) would state that an FFD program is not applicable during decommissioning under proposed part 57. Proposed § 26.903(b) would require the holder of a manufacturing license under proposed part 57 to maintain its FFD program until expiration of the manufacturing license.
In proposed § 26.903(c), “FFD program change control,” the NRC proposes a change control requirement for subpart P of part 26 FFD programs. Licensees and other entities would be required to demonstrate compliance with certain requirements before implementing changes to their FFD programs. Change control would rely on the licensee or other entity maintaining its procedures in a manner that details how its FFD program is to be implemented while incorporating changes, with documentation that justifies the changes to support audits and NRC inspection.
Proposed § 26.903(c)(1) would permit the licensee or other entity to implement changes to its FFD program if the licensee or other entity performs and retains an analysis demonstrating that the changes do not reduce the effectiveness of the FFD program or the changes were necessitated or justified by a change to part 26, laboratory processes, or guidance issued by the HHS or NRC. The change control requirement would enable flexibility in program implementation should the NRC or HHS change its drug testing procedures (as implemented by the licensee or other entity through its procedures) in response to changes in societal substance abuse or drug testing technologies.
Proposed § 26.903(c)(2) would require that if a change reduces FFD program effectiveness, then the licensee or other entity must implement a mitigating strategy so the FFD program, as revised, would continue to demonstrate compliance with the performance objectives in § 26.23 and not result in a reduction in program effectiveness.
Proposed § 26.903(c)(3) would prohibit the use of the change control process to reduce the minimum panel of drugs to be tested and would reference the drugs listed in proposed § 26.907(c)(1). Proposed § 26.907(c)(1) would reference current § 26.31(d)(1), which states that, at a minimum, licensees and other entities shall test for marijuana metabolite, cocaine metabolite, opioids (codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, and oxymorphone), amphetamines (amphetamine, methamphetamine, methylenedioxymethamphetamine, and methylenedioxyamphetamine), phencyclidine, and alcohol. The testing of these drugs and drug metabolites and alcohol is necessary for the FFD program to remain effective.
Also, there is no proposed subpart P requirement stating that this panel of drugs and drug metabolites needs to consist of only scheduled drugs. This flexibility would account for the situation where an impairing substance becomes prevalent in society and a licensee or other entity elects to add the substance to their panel of substances to be tested prior to it being scheduled by the Drug Enforcement Administration. Alternatively, if HHS proposes to remove a class of drugs from the panel of drugs to be tested that is listed in § 26.31(d)(1), then a licensee or other entity may not make a similar change to its panel of drugs to be tested, because this change would be a reduction in FFD program effectiveness even with a mitigative strategy implemented.
Changes in the HHS panel of drugs and drug metabolites to be tested could potentially shift from one metabolite to a different metabolite for the same drug. Should HHS issue such a change to its panel, this would not be expected to result in a reduction in FFD program effectiveness because HHS would be targeting a more effective metabolite for identifying an existing drug already being tested in its panel. This situation could occur as HHS gathers more operating experience from Federal government implementation of its HHS Guidelines, or data generated by drug testing laboratories and Federally mandated drug testing programs required by Federal agencies such as the NRC and U.S. Department of Transportation.
Proposed § 26.903(c)(4) would require that change control records be maintained for a 5-year record retention period based on the current NRC practice to conduct triennial inspections of licensees' and other entities' FFD programs. This would afford the NRC an opportunity to review the licensee's or other entity's determination that FFD program changes have not reduced the effectiveness of their FFD program. Licensees and other entities would also be required to summarize each change made under proposed § 26.903(c) in their annual FFD performance reports required by proposed § 26.917(b)(2) or § 26.717, “Fitness-for-duty program performance data,” as applicable.
Proposed § 26.904(a) would provide the timing for when a licensee or other entity under proposed part 57 would be required to have its subpart P FFD program in place and in effect. The timing of proposed § 26.904(a) would be equivalent to that for an LWR licensee or other entity that is performing those same activities at a facility licensed under part 50 or 52 and would help provide assurance that those individuals who assemble, conduct non-operational testing, or perform construction activities as defined in § 26.5 or direct these activities are fit for duty and trustworthy and reliable. This is important because assembly and non-operational testing of a manufactured reactor and the construction and testing of SSCs required for facility operation require, in part, adherence to procedures, possible implementation of unique and precise assembly techniques, and QA and controls. Additionally, SSCs within a manufactured reactor may not be accessible, testable, or available for quality assurance and verification after the reactor is assembled. This requirement also would address solo-assembly activities that may cause latent failures and passive SSCs located internal to a reactor (for example, a fusible link designed to melt at a particular temperature to trigger an actuation mechanism) that would be relied upon for safe operation but could not be inspected or tested for proper installation, configuration, or operation after installation. A proposed subpart P FFD program for these types of activities would be equivalent to the FFD program applicable to the assembly of the reactor vessel internals and testing of the SSCs internal to the reactor at an LWR licensed under part 50 or 52.
The holder of the ML should establish in its procedures when reactor assembly commences and what constitutes assembly. For example, the FFD program would not need to be implemented for the receipt, storage, inspection, and staging of components and systems used to assemble (
Proposed § 26.904(b) would set out the requirements that each subpart P FFD program would be required to implement. These requirements include FFD program elements similar to those in subpart B of part 26, but the proposed new requirements would be less prescriptive, enabling more flexibility in program implementation like that offered in subpart K of part 26. For example, the requirements in subpart B of part 26 are explicit requirements for, in part, the collection and testing of urine specimens. Subpart B of part 26 does not enable the use of oral fluid for drug testing, except under very limited situations as described in subpart E of part 26, or the use of hair specimens, unlike proposed subpart P. Proposed subpart P would require drug and alcohol testing based on either the requirements in part 26 or the HHS Guidelines. The principal benefits of the proposed subpart P FFD program would be that it would provide a regulatory framework that is consistent with the radiological consequences for microreactors and other reactors with comparable risk profiles, and would afford flexibilities in the conduct of drug and alcohol testing.
Proposed § 26.906, “Written policy and procedures,” would require licensees and other entities to implement and maintain an FFD policy and procedures for their FFD programs. Proposed § 26.906(a)(1) would require each licensee and other entity to provide a written FFD policy statement to individuals subject to the FFD program before the individuals are subjected to any FFD program drug and alcohol test. This would be a protection measure afforded to individuals subject to the FFD program to help ensure that they know what is expected of them before being subject to the FFD program and potential consequences should they violate the FFD policy or procedures. This requirement would also contribute to safety and security because understanding FFD program responsibilities may enhance an individual's safety culture or the individual may self-select out of the licensee's or other entity's hiring process.
Proposed § 26.906(a)(2) would require that the FFD policy statement describe the performance objectives in § 26.23, which are the same FFD program performance objectives required for facilities licensed under part 50, 52, or 70. Having a standard performance outcome based on a licensee or other entity satisfying the § 26.23 performance objectives would enhance consistency in FFD program implementation across all entities subject to part 26. It would also generate confidence that individuals subject to part 26 will safely and competently perform their duties and responsibilities and use NRC-licensed materials in a manner that will protect the public health and safety and common defense and security.
Proposed § 26.906(a)(3) would require that the FFD policy statement describe the licensee's or other entity's implementation of the minimum days off requirements in § 26.205(d)(3) or maximum average work hours requirements in § 26.205(d)(7).
Proposed § 26.906(a)(4) would require the FFD policy statement be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy, including those elements described in proposed § 26.903(b), part 26-required sanctions, and required medical/clinical treatment and follow-up testing for FFD policy violations. This requirement would be equivalent to § 26.403(a) of subpart K but would include an additional description of what the policy statement must include. For example, the policy would describe the NRC-required sanctions to help deter substance abuse and required medical/clinical treatment and follow-up testing for FFD policy violations. This provision would provide a protection measure by helping the individual get the assistance they need and help ensure that the individual refrains from substance abuse.
Proposed § 26.906(a)(5) would require that the FFD policy statement describes the individual's responsibilities to report for work in a physiological and psychological condition that enables the safe and competent performance of assigned duties and responsibilities and to inform a licensee- or other entity-designated representative when the individual determines that this cannot be accomplished.
Proposed § 26.906(a)(6) would require the FFD policy statement to prohibit alcohol consumption within at least 5 hours prior to the individual's arrival at the licensee's or other entity's facility.
Proposed § 26.906(a)(7) would require the FFD policy statement to convey that abstaining from alcohol for at least 5 hours before any scheduled tour of duty is a minimum necessary measure, though it may not be sufficient to ensure fitness for duty.
Proposed § 26.906(b) would require licensees and other entities implementing a proposed subpart P FFD program to establish, implement, and maintain written procedures for their FFD programs. This requirement would be equivalent to that in § 26.403(b) of subpart K.
Proposed § 26.906(b)(1) would establish requirements for a proposed subpart P FFD program to have written procedures for the drug and alcohol testing program. This provision would be equivalent to the requirements in current § 26.403(b)(1) of subpart K, but proposed § 26.906(b)(1)(i) through (iv) proposes additional clarity and specificity that licensees and other entities would be required to detail in their procedures to address new testing methods in proposed subpart P that are not permitted under the current part 26 framework. Clarity and specificity in procedural instructions would support consistent program implementation, which protects all individuals subject to the program.
Proposed § 26.906(b)(1)(iv) would require that if the licensee or other entity elects to use the HHS Guidelines for the conduct of drug testing, the FFD program procedures must include the name of the specific HHS Guideline and revision being implemented by the licensee or other entity and a description of the specific sections in the guideline that are being implemented, including specimen collections, drug testing, laboratory procedures, and evaluation of test results. This requirement would help ensure the following: the validity and accuracy of drug testing because the specimens would be subject to laboratory testing that has been certified by the HHS; protection of worker rights equivalent to the privacy, information, and due process protections afforded to Federal workers under the HHS Guidelines because the HHS Guidelines are used in the Federally mandated drug testing programs; consistency in program implementation because all individuals subject to the FFD program would be subject to the same collection, testing, and evaluation processes; and FFD program effectiveness because the effectiveness of the HHS Guidelines have been verified by HHS's National Laboratory Certification Program (NLCP). Detailed procedures would enhance MRO and FFD program personnel reviews of individual test results because instructions would be provided for, in part, the evaluation of specific test results (
Proposed § 26.906(b)(2) would require licensees and other entities to include in their written procedures the immediate and follow-up actions that would be taken, and the procedures that would be used, in certain situations specified in proposed § 26.906(b)(2)(i) through (vi). Proposed § 26.906(b)(2) would be equivalent to the requirements in current § 26.403(b)(2), which provides the same requirement under an FFD program for construction for part 50 or 52 licensees and other entities. This would help ensure the effectiveness of the FFD program and its consistent implementation, because part 57 licensees and other entities would be implementing procedures to address the same requirements and with individuals who would understand what is expected of them no matter what part 57 facility they were assigned.
The situation specified in proposed § 26.906(b)(2)(i) would arise when individuals subject to the FFD program have been involved in the use, sale, or possession of illegal substances, illegal drugs, or illicit substances. This provision would be equivalent to current § 26.403(b)(2)(i), except that the phrase “illegal drugs” would be replaced with “illegal substances, illegal drugs, or illicit substances.” Illegal substances would include legal substances used in a manner inconsistent with Federal or State law.
The situation specified in proposed § 26.906(b)(2)(ii) would arise when individuals are impaired by any substance or the consumption of alcohol as determined by behavioral observation or a test that measures blood alcohol concentration, as defined in § 26.5. Except for a few differences, this provision would be equivalent to current § 26.403(b)(2)(ii) of subpart K. The NRC would not include the phrases “to excess” and “accurately” in proposed § 26.906(b)(2)(ii). Proposed subpart P of part 26 would be a performance-based framework that focuses on impaired human performance, and for alcohol, impairment is determined by blood alcohol concentrations exceeding the limits in § 26.103, “Determining a confirmed positive test result for alcohol,” using an evidentiary breath testing device (EBT) for alcohol (not whether an individual drank “to excess”).
The NRC would include the phrase “illegal substances, illegal drugs, and illicit substances” in proposed § 26.906(b)(2)(ii) based on operating experience and the terminology in current § 26.23(b). There are far more substances that may cause impairment than those designated by U.S. Drug Enforcement Administration as controlled substances (
The situation specified in proposed § 26.906(b)(2)(iii) would arise when individuals attempt to subvert the testing process by adulterating or diluting specimens (
The situation specified in proposed § 26.906(b)(2)(iv) would arise when individuals refuse to provide a specimen for analysis or refuse to follow instructions provided by FFD program personnel. Except for one difference, this provision would be equivalent to current § 26.403(b)(2)(iv). The NRC would include the phrase “or follow the instructions provided by FFD program personnel” based on an existing requirement in § 26.89(c) that the collector must inform the donor that if the donor refuses to cooperate in the specimen collection process, then such refusal will be considered a refusal to test and sanctions for subverting the testing process will be imposed.
The situation specified in proposed § 26.906(b)(2)(v) would arise when individuals had legal action taken relating to drug or alcohol use. This requirement would be equivalent to current § 26.403(b)(2)(v).
The situation specified in proposed § 26.906(b)(2)(vi) would be when individuals subject to an FFD program demonstrated character or actions indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, SNM, or sensitive information. This includes character traits beyond those attributed to drug or alcohol use. This proposal would help ensure that the licensee or other entity will implement an FFD program designed to demonstrate compliance with the § 26.23(c) performance objective that FFD programs must provide “reasonable measures for the early detection of individuals who are not fit to perform the duties that require them to be subject to the FFD program.” An individual who is not trustworthy and reliable is not fit to perform or direct the performance of those duties and responsibilities or be afforded those types of access that make the individual subject to an FFD program.
The phrase “character or actions” would be used in proposed § 26.906(b)(2)(vi) to focus on observed examples that indicate an individual subject to proposed subpart P may not be fit for duty or trustworthy and reliable. Character traits would include but not be limited to personality, temperament, honesty, carelessness, apathy, psychosis, and commitment to safety culture. Assessment of an individual's character should consider the potential for changes in these traits when compared to a previous baseline. Actions would include a physical or verbal demonstration of a character trait that could call into question an individual's fitness, trustworthiness, or reliability. For example, the individual does something physically, verbally, or in writing (
Unlike the background investigation and reviews of “character and reputation” in § 73.56(d)(6) and (k)(1)(v), which are principally retrospective reviews of an individual and may be based on third-party information (
The situation specified in proposed § 26.906(b)(2)(vii) would be when an individual's condition or actions pose or have posed an immediate hazard to themself or others, as notified by EAP personnel under § 26.35(c)(2).
Proposed § 26.906(b)(3) would require licensees and other entities to address in their procedures the process, including the duties and responsibilities of FFD program personnel, to be followed if an individual's behavior or condition raises an FFD concern. This provision would also require a process to be conducted when credible information is received by the licensee or other entity that the individual is not fit for duty, trustworthy, and reliable.
With a few exceptions, proposed § 26.906(b)(3) would be equivalent to current § 26.403(b)(3). Instead of the phrase “while constructing or directing the construction of safety- or security-related SSCs” in current § 26.403(b)(3), the NRC would use “on the NRC-licensed facility” in proposed § 26.906(b)(3) because this provision would apply during nuclear plant construction and operation in addition to holders of an ML as described in proposed § 26.3(f). The requirement that the roles and responsibilities of FFD program personnel be described was developed from current §§ 26.4(g) and 26.31(b) and operating experience, which has demonstrated that clear job descriptions help ensure that individuals know who is designated by the licensee or other entity to make decisions regarding FFD program implementation and who can be approached when physiological or psychological help is needed. This is principally a protection consideration afforded to individuals subject to the FFD program.
Proposed § 26.906(b)(3) would also include two conditions not found in current § 26.403(b) that would clarify the initiation of the fitness determination process should an individual's behavior or condition raise an FFD concern. The phrase, “impairment from any cause that in any way could adversely affect the individual's ability to safely and competently perform the individual's duties,” would reflect the § 26.23(b) performance objective. The condition, “the receipt of credible information indicating that the individual cannot be trusted or relied on to perform those duties and responsibilities making the individual subject to this part,” would reflect the § 26.23(a) performance objective. In either case, as required by § 26.23(c), the FFD program would have to provide reasonable measures for the early detection of individuals who are not fit to perform the duties that require them to be subject to the FFD program.
Proposed § 26.906(b)(4) would require licensees and other entities to have written procedures that address the operation and oversight of onsite and offsite collection facilities. This requirement would be equivalent to current §§ 26.403(b) and 26.405(e) and is developed from § 26.41(b), which states that each licensee and other entity who is subject to subpart B of part 26, shall ensure that the entire FFD program is audited, which is part of a licensee's or other entity's oversight of the facility, and § 26.87(a), which states that each FFD program must have one or more designated collection sites that have all necessary personnel, materials, equipment, facilities, and supervision to collect specimens for drug testing and to perform alcohol testing. Having procedures for the operation and oversight of onsite and offsite collection facilities would enhance consistency in program implementation, protect individuals subject to testing, and account for the flexibilities afforded in the types of biological specimens than may be collected under an FFD program subject to proposed subpart P of part 26. Proposed § 26.906(b)(4), when used with the audit requirement in proposed § 26.915, “Audits,” would help maintain FFD program effectiveness and prevent subversion attempts at facilities that may not be under the direct day-to-day oversight of FFD program personnel.
Proposed § 26.906(b)(5) would require licensees and other entities to have written procedures that address the fatigue management requirements in proposed § 26.202(b), “Procedures,” and either § 26.205(d)(3) or (d)(7).
Proposed § 26.906(b)(6) would require licensees and other entities to have written procedures that provide measures to prevent subversion of drug and alcohol tests conducted onsite and offsite. This proposal was developed from § 26.27(c)(1).
Proposed § 26.907, “Drug and alcohol testing,” would establish drug and alcohol testing requirements for licensees and other entities. Except for a few differences, proposed § 26.907 would be equivalent to current § 26.405, “Drug and alcohol testing,” which requires licensees and other entities implementing an FFD program under subpart K of part 26 to have a drug and alcohol testing program that demonstrates compliance with the requirements in § 26.405(b) through (g). The differences are commensurate with the risk consequences presented by a part 57-licensed facility as compared to a part 50 or 52 nuclear power plant. These proposed requirements would improve flexibility in the conduct of drug and alcohol testing while maintaining protections afforded to individuals subject to the FFD program.
Proposed § 26.907(a), “Split specimens,” would require licensees and other entities to obtain a split specimen for all drug tests using oral fluid or urine for all test conditions in proposed § 26.907(b), “Test conditions,” and (j), “Blood testing.” Neither current subpart K nor current subparts B or E of part 26 require a split specimen. However, many of the LWR fleet uses split specimens for drug testing, and commercially available drug screening products use a split specimen technique. Since publication of the 2008 part 26 final rule, the HHS has issued guidelines for urine and oral fluid specimen testing that require split specimen collections. The U.S. Department of Transportation regulations under 49 CFR part 40 also require split specimen collections for urine and oral fluid. The proposed HHS Guidelines for hair testing also require split specimen collections.
The required use of a split specimen process would protect the individual because, upon a donor-alleged discrepant or questionable test result, the donor may provide permission to test the split specimen (specimen B) in an effort to refute the laboratory test results for specimen A. The requirement also would enable the MRO to direct laboratory testing of specimen B if specimen A were invalid; though the NRC expects specimens becoming invalid at the laboratory to be a rare occurrence as testing would be conducted by HHS-certified laboratories. If a specimen is determined to be invalid, then the occurrence would likely warrant further investigation by the MRO and laboratory to identify the cause. This protocol would be equivalent to the special analysis testing in current § 26.163(a)(2) for dilute specimens and specimens collected under most directly observed collection conditions in that additional laboratory analysis is performed because of a questionable test result.
If a split specimen is tested by an HHS-certified laboratory, then the test result from specimen B must be used as part of the determination for an FFD policy violation as required by § 26.185(n), “Evaluating results from a second laboratory.” However, this is not to say that the test results from specimen A should be discarded. Since the HHS-certified laboratory should report all test results from all specimens tested to the MRO, like the information described in § 26.169, “Reporting
Proposed § 26.907(a) would state that split specimen collections of oral fluid or urine must be used for the test conditions described in proposed § 26.907(b). In addition, testing of the split specimen (specimen B) would require the donor's permission unless ordered by the MRO to resolve an invalid test result obtained for specimen A.
Proposed § 26.907(b) would require the licensee or other entity to subject individuals identified in § 26.4 to drug and alcohol testing under the five conditions listed in proposed § 26.907(b)(1) through (5). Proposed § 26.907(b) would be equivalent to current § 26.405(c).
Proposed § 26.907(b)(1), “Pre-access,” would require pre-access testing similar to current § 26.405(c)(1), which requires testing before assignment to construct or direct the construction of safety- or security-related SSCs. Unlike current § 26.405(c)(1), the proposed requirement would not include the phrase, “construct or direct the construction of safety- or security-related SSCs,” because, for licensees or other entities under proposed part 57, the pre-access test condition would apply to construction and operation to help inform a licensee's or other entity's authorization determination. The proposed requirement also would use “pre-access” instead of “pre-assignment,” which is used in current § 26.405(c)(1).
A pre-access test would require the collection of an oral fluid or a urine specimen no more than 14 days before the individual is granted unescorted access. Although this change has roots in the 2008 part 26 final rule, which reduced the period within which pre-access testing must be performed from 60 days to 30 days or less, the 14-day proposal is based on two lessons learned from operating experience.
First, the 14-day period would be a large enough window of time to collect the specimen and evaluate test results because licensees or other entities typically receive laboratory test results within 5 business days of laboratory receipt of the biological specimen. At the same time, the 14-day period would be small enough to help ensure that the test results are representative of the individual's recent drug use before being granted authorization.
Second, the NRC does not expect licensees and other entities licensed under proposed part 57 to have the large and periodic influxes of individuals (either licensee employees or C/Vs) that large LWRs have to support facility operation, maintenance, engineering design changes, or nuclear refueling. Therefore, these licensees or other entities would not be periodically challenged to in-take a large workforce within the proposed 14-day pre-access testing window.
Proposed § 26.907(b)(2), “Random,” would require the licensee or other entity to conduct random drug and alcohol testing of all individuals subject to the FFD program. With some exceptions, this proposed requirement would be equivalent to current § 26.405(b). Section 26.405(b) gives licensees and other entities that implement an FFD program subject to subpart K of part 26 the option to impose random drug and alcohol testing. Proposed § 26.907(b)(2) would not offer that option because proposed subpart P of part 26, unlike subpart K, would not allow a licensee or other entity to implement a fitness monitoring program under current § 26.406, “Fitness monitoring,” instead of a random testing program. The principal reasons for not allowing this flexibility would be that no licensee or other entity has ever implemented a fitness monitoring program (
Proposed § 26.907(b)(2)(i) through (v) would provide specific requirements for the conduct of a random testing program. These paragraphs would be equivalent to § 26.405(b)(1) through (4), although with a few differences. The similar provisions would be proposed § 26.907(b)(2)(i), (b)(2)(iii), and (b)(2)(iv).
The differing provisions would include proposed § 26.907(b)(2)(ii), which would refer to an “FFD program procedure” instead of the reference to an “FFD program policy” in § 26.405(b)(2) because procedures contain the instructions that implement FFD program requirements, but the FFD policy need not contain specific instructions. Proposed § 26.907(b)(2)(ii) also would require individuals who are selected for random testing to report to the onsite collection site, as opposed to the collection site in § 26.405(b)(2), because alcohol metabolism necessitates a timely alcohol test. This change is also proposed because the NRC expects that part 57 licensees and other entities may use a combination of onsite (for random, for-cause, and post-event testing) and offsite (for pre-access, post-event, and follow-up testing) collection facilities for drug and alcohol testing and may have to afford reasonable accommodation to certain individuals, which would add complexity in the licensee's or other entity's procedurally determined time period in which an individual must report to the collection facility.
Another difference from § 26.405(b) is proposed § 26.907(b)(2)(v), which would establish the random testing rate for the population of individuals subject to testing. Subpart K of part 26 does not establish a random testing rate. The proposed requirement would be equivalent to current § 26.31(d)(2)(vii), which requires that the sampling process used to select individuals for random testing provides that the number of random tests performed annually is equal to at least 50 percent of the population that is subject to the FFD program at the NRC-licensed site.
Proposed § 26.907(b)(3), “For cause,” would require for-cause testing equivalent to that used in current FFD programs implementing § 26.405(c)(2). The NRC is proposing for-cause testing, like random testing, to be conducted onsite to ensure that the test is conducted as soon as reasonably practicable. This is an important consideration when for-cause testing for alcohol or using oral fluid for drug screening or testing because human metabolism continually lowers the concentrations of the drugs, drug metabolites, and alcohol perhaps to concentrations lower than the initial or confirmatory testing cutoffs. Additionally, for facilities that are sited in geographically remote locations, an offsite collection facility might be too far away or not readily accessible.
Proposed § 26.907(b)(4), “Post-event,” would require post-event testing in a manner equivalent to current § 26.405(c)(3), with a few adjustments. For proposed part 57 licensees or other entities, the NRC is proposing post-event testing under two conditions: events involving human errors that may have caused or contributed to the events (proposed § 26.907(b)(4)(i)), and events
Proposed § 26.907(b)(4)(i) would require the licensee or other entity to define in its procedures the term “human error.” This term may take on various meanings and it is not defined in the current or proposed rule, so the licensee or other entity would be required to describe or define this term to help ensure consistent implementation of proposed subpart P and that the post-event test condition would be consistently applied to all individuals subject to the FFD program. The § 26.405(c)(3)(i) requirement that “the event is recordable under the Department of Labor standards contained in 29 CFR 1904.7, and subsequent amendments thereto,” would not be carried over to proposed § 26.907(b)(4). Instead, the NRC proposes to prescribe the post-event test conditions in proposed § 26.907(b)(4), in part so they would not change unless the NRC amends the requirement.
Proposed § 26.907(b)(5), “Follow-up,” would require follow-up testing. This requirement would be equivalent to current § 26.405(c)(4), although proposed § 26.907(b)(5) would further describe follow-up testing. The NRC proposes to describe follow-up testing as part of a series of tests for drugs, alcohol, or both, which are performed after an individual subject to part 26 has violated the FFD policy on substance use or abuse, or the sale, use, or possession of illegal drugs. Follow-up testing would be used to verify an individual's continued abstinence from substance abuse. The NRC would not include a reference to a follow-up plan as in § 26.405(c)(4) because the intent of a follow-up plan is to conduct a series of drug tests, alcohol tests, or both, to verify continuing abstinence from substance abuse. Nevertheless, individuals who violate an FFD policy on substance use or abuse, or the sale, use, or possession of illegal drugs, should have a follow-up plan that includes a definition of “abstinence” from the medical professional prescribing the plan.
Proposed § 26.907(c), “Urine and oral fluid specimens,” would provide additional testing requirements. The proposed requirement would be equivalent to § 26.405(d) and would require implementation of select requirements from current subpart E of part 26. The proposed requirements would govern directly observed collections, shy bladder situations, special analysis testing, and alcohol testing. These requirements would be necessary to maintain FFD program effectiveness equivalent to that currently implemented by the LWR fleet.
Proposed § 26.907(c)(1) would establish the minimum panel of drugs and drug metabolites to be tested. This panel would be the same as those in §§ 26.31(d)(1) and 26.405(d) because, based on operating experience from LWR FFD program implementation, this panel has been determined to contribute to a licensee or other entity satisfying the FFD performance objectives in § 26.23(a) through (d).
Section 26.405(d) requires that urine specimens collected for drug testing be subject to validity testing. Like § 26.405(d), proposed § 26.907(c)(1) would require testing of urine specimens for validity. Oral fluid specimens could also be subject to validity testing, including a biological marker, as specified in either part 26 or the HHS Guidelines.
Proposed § 26.907(c)(2) would include requirements that already exist in the part 26 framework that provide protections for individuals subject to the FFD program and contribute to testing effectiveness when collecting and assessing a urine specimen. Specifically, current § 26.115, “Collecting a urine specimen under direct observation,” describes the exclusive grounds for performing a directly observed collection and the process to be followed to protect the privacy of the individual. Section 26.119, “Determining `shy' bladder,” establishes the process to be followed when a donor is not able to produce a sufficient amount of urine for testing, and § 26.163(a)(2) requires special analysis testing when a specimen is dilute to help prevent a subversion attempt.
Proposed § 26.907(c)(3) would require implementation of all the current alcohol testing requirements in § 26.91, “Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use,” through § 26.103. Using the same alcohol testing framework for parts 50, 52, 57, and 70 licensees and other entities would provide for regulatory consistency, protections for individuals subject to the FFD program (
Proposed § 26.907(c)(4) would establish additional testing requirements. This proposal would be equivalent to current § 26.405(f) for facilities licensed under proposed part 57 for the conduct of drug testing. Unlike § 26.405(f), proposed § 26.907(c)(4) would not reference validity screening and initial drug and validity tests at licensee testing facilities. Another minor difference between § 26.405(f) and proposed § 26.907(c)(4) would reflect the requirement in proposed subpart P to use an HHS-certified laboratory for all biological specimens collected and not just for urine specimens.
Consistent with § 26.405(f), proposed § 26.907(c)(4) would require the use of an HHS-certified laboratory for all test conditions listed in proposed § 26.907(b), MRO-directed tests, and the testing of a split specimen. Further, HHS-certified laboratory test results using urine or oral fluid would be required for the issuance of an FFD policy violation and part 26-required sanction.
All drug testing would need to be performed at an HHS-certified laboratory to help ensure FFD program effectiveness and to protect the donor from a false positive test result and an unwarranted FFD policy violation. The donor would be protected because laboratory procedures for specimen accessioning, testing, custody and control, and evaluation of test results and the training and qualification of laboratory personnel are evaluated by HHS as part of the NLCP. This would
There are three phrases or requirements in § 26.405(f) that the NRC does not propose to use in proposed § 26.907(c)(4). The first is the phrase, “consistent with its standards and procedures for certification,” regarding the operation of an HHS-certified laboratory, because the laboratory would not be HHS-certified if it were not following “its standards and procedures for certification.” The second is the requirement that urine specimens that yield positive, adulterated, substituted, or invalid initial validity or drug test results must be subject to confirmatory testing by the HHS-certified laboratory, except for invalid specimens that cannot be tested. This requirement would not be used because, under proposed subpart P of part 26, licensees or other entities would not be required to use an HHS-certified laboratory. For a laboratory to be HHS-certified, it must follow the HHS Guidelines and include procedures that describe when a specimen cannot be tested. Lastly, the § 26.405(f) requirement that other specimens that yield positive initial drug test results must be subject to confirmatory testing by a laboratory that demonstrates compliance with stringent quality control requirements that are comparable to those required for certification by the HHS, would not be used because proposed subpart P of part 26 would require the use of an HHS-certified laboratory.
Proposed § 26.907(c)(5) would require the licensee or other entity to contract with an HHS-certified laboratory and would specify the same requirements that current § 26.153(f) requires for contracts between licensees or other entities who are subject to part 26 and HHS-certified laboratories. Proposed § 26.907(c)(5)(ii) would state that records and documents must be provided and/or able to be photocopied and removed from the premises to support the inspection or audit. This requirement would be equivalent to current § 26.41(d), except that laboratories would not be able to limit the use and dissemination of documents copied or taken from the laboratory by a licensee or other entity. This would be necessary to ensure the continuing effectiveness of FFD programs, because NLCP findings and audit results could adversely impact FFD program effectiveness. Pertinent information includes and should not be limited to NLCP-identified weaknesses (
Proposed § 26.907(d), “Privacy and integrity,” would help protect the donor from mistakes made during the drug and alcohol testing processes and help ensure FFD program effectiveness. The NRC would require the licensee or other entity to protect the individual's privacy and the integrity of the specimen and to implement quality controls to ensure that test results are valid and attributable to the correct individual. This proposed requirement would be equivalent to the first sentence of current § 26.405(e), except that the word “stringent” would be removed from the phrase “stringent quality controls,” because the word “stringent” is not defined.
Proposed § 26.907(e), “Offsite collection facilities,” would describe the requirements for licensees and other entities that use offsite collection facilities. Consistent with current § 26.405(e), a licensee or other entity would be able to conduct specimen collections and alcohol testing at a local hospital or other facility, except for those specimens that must be collected onsite under proposed § 26.907(b)(3) and (4). Unlike § 26.405(e), proposed § 26.907(e) would not restrict licensees and other entities to use hospitals and other facilities that meet the U.S. Department of Transportation requirements in 49 CFR part 40 because proposed subpart P of part 26 is intended to provide flexibilities beyond those in the current part 26 framework. Licensees and other entities may use these Department of Transportation requirements to inform their procedures under proposed § 26.906(b)(1) as long as the procedures do not conflict with the requirements in part 26 or the HHS Guidelines.
Proposed § 26.907(e) would also require licensees and other entities to audit offsite collection facilities before their use and biennially to confirm that the facility procedures are comparable to those described in subpart E of part 26 or the HHS Guidelines for urine and oral fluid. This prosed requirement is based on current § 26.41(a) and (b). The proposed § 26.907(e) audit requirement is a program effectiveness consideration because offsite collection facilities may not require vigilance of their collectors (
The offsite facility used by a licensee or other entity under proposed § 26.907(e) would have to be licensed to conduct specimen collections and perform alcohol testing, and be audited, by the State or a State-designated entity. This requirement would help provide assurance of adequate collection facility performance and may help reduce the burden on the licensee or other entity and the collection facility. Crediting a State audit (or State licensure, oversight, or regulation) is established in §§ 26.4(i)(4) and (j), 26.91(e)(5), 26.153(f)(1), and 26.183(a).
Proposed § 26.907(f), “Initial testing,” would provide the requirements for initial drug testing. This provision would be equivalent to § 26.405(f) except to account for the testing of urine and oral fluid specimens under proposed subpart P of part 26. The initial test would have to use an immunoassay or an alternative technology, as specified in the HHS Guidelines for the specific biological specimen that is to be tested. Examples of alternative technologies include liquid or gas chromatography and mass spectrometry. Another difference from § 26.405(f) would be changing the word “urine” in § 26.405(f) to “biological specimens” in proposed § 26.907(f). Lastly, proposed § 26.907(f) would include the phrase “discrepant biological marker” as a drug screening result that would have to be analyzed by an HHS-certified laboratory and evaluated by the MRO to help inform the MRO's determination of a subversion attempt.
Proposed § 26.907(g), “Oral fluid testing,” would enable a part 57 licensee to use oral fluid as a biological specimen for testing. This requirement would be equivalent to § 26.31(d)(5), which enables the MRO to conduct drug and alcohol testing using alternative methods, and § 26.405, which does not preclude the use of oral fluid specimens for FFD programs that implement subpart K of part 26 requirements. In order to provide assurance that drug testing is effective and protects the worker, proposed § 26.907(g) would require that the licensee's or other
Proposed § 26.907(g) would require that the oral fluid device must not expire before the date of the collection of the specimen. Also, the drugs, drug metabolites, initial and confirmatory testing cutoffs, and biological markers, if applicable, would need to be those established by the HHS Guidelines for oral fluid drug testing and the alcohol cutoffs in part 26. If they were not established by the HHS Guidelines or part 26 for the paneled drugs and drug metabolites, then they would be determined and documented by a forensic toxicologist review under § 26.31(d)(1)(i)(D).
Proposed § 26.907(g)(2) would permit the virtual collection of oral fluid specimens for drug and alcohol testing but only at facilities that must use a C/TPA to implement random testing under proposed § 26.907(b)(2)(vi). A virtual collection monitor would be permitted in the location where the specimen collection is to be performed to assist the virtual collector, such as by completing Federal CCF paperwork; observing activities outside the viewable area of the video teleconference equipment to ensure that the donor does not attempt to subvert the testing process; providing information to the virtual collector if/when requested; and ensuring that the oral fluid specimen(s) once packaged for shipping are secured until picked up for transportation to the HHS-certified laboratory.
Proposed § 26.907(h) would enable the collection of hair specimens for drug testing to supplement pre-access testing of urine or oral fluid specimens. Hair testing would be a new feature in the part 26 framework. The NRC proposes to permit the use of hair testing for only Schedule I or II drugs or their metabolites to inform a licensee's or other entity's determination whether the individual is trustworthy and reliable. For example, if an individual stated no prior use of illegal drugs, a pre-access hair test could be performed to ascertain the validity of the individual's statement. However, if the HHS-certified laboratory were to report a positive test result, an FFD policy violation could not be administered. This laboratory information would need to be treated as potentially disqualifying FFD information, unless the individual were determined to have attempted to subvert the testing process, in which case a permanent denial of authorization would be required under proposed § 26.910(b)(4). To provide assurance of testing effectiveness and protections afforded to individuals subject to the FFD program, proposed § 26.907(h) would require that an HHS-certified laboratory must be used to test the hair specimen. The forensic toxicologist review would be necessary if the panel of drug or drug metabolites to be tested and their cutoffs were not established by HHS or part 26 for hair.
Proposed § 26.907(i), “Portal area screening,” would enable the use of portal area screening instruments to test for drugs, alcohol, or both, should these types of screening tests become available for use. This technology could substantially contribute to a licensee or other entity satisfying the § 26.23 performance objectives by helping ensure that all individuals who arrive at the NRC-licensed facility to perform or direct those duties and responsibilities or maintain those types of access making them subject to the FFD program are fit for duty and deterred from arriving onsite in a physiological condition that may be adverse to safety and security. Additionally, screening could be conducted when individuals exit the NRC-licensed facility to provide assurance that substance abuse had not occurred onsite (see § 26.23(d)). The screening instrument could be electronically linked to temporarily prevent ingress or egress and could automatically inform licensee- or other entity-designated officials of the portal area alarm. The use of portal area screening technologies could also represent cost savings because, for NRC-licensed facilities that have small staff sizes or are geographically remote, passive drug and alcohol screening technologies could be an innovative alternative to a random testing program, although the license or other entity would need to request and receive an exemption.
Proposed § 26.907(i) would also provide that if the portal area screening instrument detects a substance that exceeds the instrument's established setpoint, the individual then would need to be for-cause tested under proposed § 26.907(b)(3) for drugs, alcohol, or both, depending on the screening test result received. A portal area screening test result is to be considered credible use information, which would strengthen the effectiveness of a licensee's or other entity's BOP. The requirements would not allow an individual to be rescreened by the portal area screening instrument following an initial screening detection that exceeded an established setpoint in order to prevent a subversion attempt. To ensure the accuracy of any portal area screening testing performed by a licensee or other entity, a performance-based approach would need to be used to verify the continuing accuracy of the testing for each substance tested by the instrument. A portal area screening test could be used so long as the accuracy of the test result for a specific substance were confirmed by the resultant for-cause testing performed on an oral fluid or urine specimen for drugs, oral fluid or breath specimen for alcohol, or both. If a portal area screening result for a specific drug or drug metabolite were confirmed by drug testing performed at an HHS-certified laboratory, or oral fluid or breath alcohol testing for at least 85 percent of the specimens testing positive on portal area screening in the past 12-month data reporting period for a specific substance, the portal area screening test for that substance could continue to be used. This performance-based measure would balance the use of the technology with the protection afforded to individuals from unnecessary testing. If these instruments and alcohol screening devices have the capability, they could also be used to determine the true identity of individuals to facilitate the implementation of the FFD BOP, which could be very practicable at facilities that operate with small staff sizes.
Proposed § 26.907(j) would enable the use of a blood specimen for drug, alcohol, or other testing for certain medical conditions as determined by the licensee- or other entity-designated MRO. This requirement would be equivalent to current § 26.31(d)(5). The use of a licensee- or other entity-designated MRO and not one designated by a third party, such as an MRO employed by an offsite specimen collection facility, would be important because the MRO must be familiar with the proposed subpart P requirements. To help ensure testing effectiveness and protect the worker, the blood test would need to be conducted by a laboratory that demonstrates compliance with quality control requirements that are comparable to those required for certification by the HHS, such as a hospital or clinic certified by the State, Commonwealth, or territory.
Proposed § 26.907(k), “Federal custody and control form,” would require licensee and other entities to use a Federal custody and control form (Federal CCF) as defined in § 26.5 for the collection and packaging of hair, oral fluid, and urine specimens for drug testing. This proposed requirement is based on the Federal CCF documentation requirements in current subpart E of part 26 because subpart K of part 26 does not require the use of a Federal CCF under § 26.117(e).
Proposed § 26.907(l), “Medical Review Officer,” would establish requirements for the licensee- or other entity-designated MRO. Proposed § 26.907(l)(1) would be equivalent to § 26.405(g), however, the word “designated” would be added to the first sentence to clarify that the MRO would be designated by the licensee or other entity, and not by a third party. As stated with regard to proposed § 26.907(j), this change would clarify that it is the licensee's or other entity's responsibility, through their designated MRO, to determine whether an individual is fit for duty and trustworthy and reliable. This would be consistent with the description of FFD program personnel in current § 26.31(b) and help provide FFD program effectiveness and protections to individuals subject to the FFD program. The paragraph was also modified from § 26.405(g) to address the determinations of FFD policy violations and fitness required by subpart H of part 26.
Proposed § 26.907(l)(2) would help ensure that MRO reviews are consistent with those MRO reviews conducted at other NRC-licensed facilities subject to part 26 and that the MRO maintains knowledge of drug collection, testing processes and procedures, and evaluation of testing results.
The NRC also proposes that if an MRO performed the duties and responsibilities in §§ 26.185, “Determining a fitness-for-duty policy violation,” and 26.187, “Substance abuse expert,” for at least three continuous years in the last 10 years prior to being hired or contracted by the licensee or other entity, then the MRO would not need to repeat the initial training and examination requirements. The basis for 3 years is that the MRO would have experienced three annual cycles of evaluating drug and alcohol test results, contributed to the annual FFD program performance data reported to the NRC, experienced a refueling or maintenance outage, understood the duties and responsibilities of individuals subject to the FFD program to make informed determinations of fitness, demonstrated a safety culture that helps ensure FFD program effectiveness, and been subject to NRC inspection. The basis for 10 years is the relatively long periods between significant changes to part 26 and the HHS Guidelines.
Proposed § 26.907(l)(3) would require that the MRO attend a medical- or clinical-based training session every 5 years. This proposal was developed, in part, from section 13.1 of the HHS Guidelines for the testing of urine and oral fluid specimens and 49 CFR 40.121 of the U.S. Department of Transportation's requirements. The NRC would not include an examination requirement as part of this refresher training requirement because it could limit the types of trainings that MROs may attend. The proposed requirements are justified to maintain currency on changes in societal drug use, forensic toxicology, determinations of fitness, and other part 26 technical areas necessary to perform required responsibilities as an MRO performing services under proposed subpart P.
Proposed § 26.907(l)(4) would require the MRO to evaluate drug testing results by implementing the requirements in § 26.185 or the HHS Guidelines through the licensee's or other entity's procedures. This requirement would help ensure FFD program effectiveness and enhance consistency across the commercial nuclear industry for the evaluation of drug testing results. This also would help protect individuals because they would be subject to the same evaluation criteria. If § 26.185 provides insufficient information for an MRO to make a determination on a drug testing result (including adulterant and discrepant biological markers), the guidance issued by a State agency in the state in which the NRC-licensed facility is located, Federal agency, or nationally recognized MRO training and certification organization may be used to inform an MRO determination. This provision would ensure that the MRO has the flexibility to inform their evaluation of the drug testing results and fitness determination, if necessary, considering the drug- and alcohol-related flexibilities afforded in subpart P of part 26.
The proposed requirement would also state that an MRO need not review alcohol test results, including positive confirmatory alcohol test results determined by an EBT under proposed § 26.907(c)(3)(vi) and (vii), which are the current requirements in §§ 26.101, “Conducting a confirmatory test for alcohol,” and 26.103, respectively. Proposed § 26.907(c)(3)(i) would require the use of an EBT under § 26.91, which would ensure that confirmatory alcohol test results are precise and accurate to issue FFD policy violations.
Proposed § 26.907(l)(5) would require the licensee- or other entity-designated MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a requested specimen for testing. This proposed requirement would be equivalent to § 26.31(d)(5), which enables the use of an alternative specimen collection if a medical condition makes the collection of the biological specimen difficult. This determination and the retest must be completed as soon as reasonably practicable and documented to support recordkeeping, auditing, and NRC inspection.
Proposed § 26.907(l)(6) would require that the MRO review all specimen test results associated with a drug-related FFD policy violation. This would include split specimens and all specimens taken to resolve a discrepant condition, such as a possible subversion attempt, impairment without a known cause, or a donor-requested or MRO-directed retest. To resolve a discrepant condition, the MRO would be authorized to test a specimen for a biological marker, adulterants, or additional drugs. The broad scope of this MRO evaluation would be necessary because of the variety of different screening and testing methods that may have been associated with the FFD policy violation. All information learned from the conduct of part 26 drug and alcohol screening and testing should be used in the evaluation of an individual's trustworthiness and reliability, issuance of a sanction, and development of a follow-up treatment and testing plan, if administered.
Proposed § 26.907(m), “Limitations of screening and testing,” would be equivalent to current § 26.31(d)(6) and would establish limits on the screening and testing of biological specimens. This would be a protection consideration afforded to individuals subject to the FFD program and was not provided in subpart K of part 26. This proposed requirement would state that specimens collected under NRC regulations may only be designated or approved for screening and testing as described in part 26 and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses and tests that would not be permissible would include, but would not be limited to, deoxyribonucleic acid (
The NRC proposes to require that no biological specimens may be passively sampled and analyzed in a manner different than described in proposed subpart P of part 26 to ensure workers are protected from non-consensual passive screening. The proposed subpart P framework would enable passive detection of drugs and alcohol, whereas passive detection is not afforded in subparts A through I, N, and O of part 26.
Proposed § 26.907(n), “Specimen collectors,” would be equivalent to current §§ 26.31(b)(1)(iii)(A) and 26.89 and would require that all specimen collections be conducted by a licensee- or other entity-designated and -trained individual. For proposed subpart P of part 26, this would include onsite specimen collections, except a collection by a portal area screening instrument in proposed § 26.907(i).
Proposed § 26.908 would require licensees and other entities to provide FFD program training to individuals subject to the FFD program. The performance-based proposed § 26.908 requirement was developed from the prescriptive training requirements in current § 26.29 and modeled on current § 50.120 because there is no training requirement in subpart K of part 26.
Proposed § 26.908(a)(1) would require an FFD training program that includes the licensee's or other entity's FFD policies and procedures, including fatigue management, and the individuals' FFD program responsibilities. Individuals who collect specimens for testing would also need to be trained in specimen collector duties and responsibilities, including, at a minimum, specimen collection, custody and control, identification and response to subversion attempts, and privacy. For individuals specified in § 26.4, a licensee or other entity of a nuclear plant would be required to use a systems approach to training as defined in proposed in § 57.390. These requirements are based on requirements in § 26.29(a)(2), (3), (9), and (10).
Proposed § 26.908(a)(2) would require training on the BOP. This requirement would be based on §§ 26.29(a)(8), (9), and (10) and 26.33, “Behavioral observation.” The proposal would require individuals to be trained in the detection of behaviors or conditions that may indicate the use of illegal drugs, as in the current § 26.33 BOP requirements, and the use of illicit drugs and substance abuse onsite and offsite. Also, in reference to impairment from fatigue or any cause if left unattended, the phrase in § 26.33, “may constitute a risk to public health and safety or the common defense and security,” would be replaced in proposed § 26.908(a)(2)(iii) with “could result in inattentiveness or human errors,” because proposed subpart P of part 26 would be focused, in part, on ensuring individuals are fit for duty to perform or direct the performance of assigned duties and responsibilities safely and competently.
Proposed § 26.908(a)(2)(iv) would focus on training to inform individuals that they are responsible for their own conduct, as well as observing others. Specifically, individuals would be trained to recognize when they feel unable to safely and competently perform assigned duties and responsibilities, as well as to recognize when others appear unable to safety and competently perform assigned duties and responsibilities or act in an untrustworthy and unreliable manner. The training requirement and the self-reporting requirement in proposed § 26.906(a)(5) would be in the interest of safety and security because the individual is proactively announcing that assistance may be necessary. This would be consistent with the performance objectives in § 26.23(b) and (c), where certain behavior or stress conditions may be indicative of an individual not being fit for duty, trustworthy, and reliable.
Proposed § 26.908(a)(3) would help ensure that individuals subject to the FFD program understand that FFD policy violations would result in an FFD program sanction and that program information learned or generated by FFD program implementation would be used to aid licensee or other entity authorization determinations and be shared, as requested, with other licensees or other entities subject to parts 26 and 73. This proposed requirement would be equivalent to § 26.29(a)(1). Proposed § 26.908(a)(3) would be a protection measure afforded to individuals subject to the FFD program because they would understand that licensees and other entities subject to parts 26 and 73 would be informed of, in part, an individual's character, reputation, and ability to follow policies, procedures, and instructions to safely and competently perform assigned duties and responsibilities in a trustworthy and reliable manner. Fitness for duty-related information would include drug and alcohol testing results (not quantitative testing values), issuance of any sanctions, FFD-determinations regarding trustworthiness and reliability, testing programs, treatment, and other remedial or corrective action.
Proposed § 26.908(b), “Training and assessments,” would require individuals to be trained on the FFD program and to receive a trainee assessment before pre-access testing. Proposed § 26.908(b) also would require that FFD program refresher training and trainee assessments be conducted on a nominal 24-month frequency or more frequently if the need is indicated. These requirements would be equivalent to § 26.29(c)(1). However, proposed § 26.908(b) was developed from the systems approach to training-based training requirements in § 50.120 and training elements from the annual FFD program refresher training requirements in § 26.29(c)(2). A trainee assessment would be the same as in currently required systems approach to training-based training programs.
Proposed § 26.908(c), “Training program review,” would require licensees and other entities to periodically evaluate their FFD training programs and revise them as appropriate. This training focus is not required by subpart K of part 26 or § 26.29 but is proposed to address the flexibilities afforded in proposed subpart P of part 26. This section would be equivalent to § 50.120(b)(3).
Proposed § 26.909 would require the implementation of a BOP. The requirement would be equivalent to that in §§ 26.33 and 26.407, “Behavioral observation,” and would apply during construction and operation. Under the FFD program, the purpose of the BOP would be to help ensure that individuals subject to the FFD program are fit for duty and trustworthy and reliable to perform or direct those duties and responsibilities and maintain those types of access that make the individual subject to the FFD program. This assurance would be accomplished by requiring each individual subject to proposed subpart P to be subject to behavioral observation, and by requiring all individuals to perform behavioral observation of others and report FFD concerns to the licensee- or other entity-designated representative(s). The intent of the BOP requirement would not be to require that all individuals be observed at all times by others; NRC-licensed operators, maintenance professionals, security officers, and others routinely perform solo operations periodically throughout the day. However, individuals would need to be subject to observation while they are performing or directing the performance of duties and responsibilities or maintaining the types of access making them subject to the FFD program. Observing behavior only at the beginning of a work shift would not be sufficient to ascertain whether an individual is fit for duty, trustworthy, and reliable. Impairing substances may have a delayed effect between use (
Proposed § 26.909(a) would differ from §§ 26.33 and 26.407 in that it would place the responsibility for performing behavioral observation on “all individuals subject to this subpart,” rather than only those “individuals specified in § 26.4(f) [who] are constructing or directing the construction of safety- or security-related SSCs” in § 26.407 or “individuals who are trained under § 26.29 to detect behaviors” in § 26.33 to improve clarity.
Proposed § 26.909(b) would require all individuals subject to the FFD program to report to the licensee- or other entity-designated representative any onsite or offsite behaviors or activities by individuals subject to part 26 that could constitute an unreasonable risk to the safety or security of the NRC-licensed facility or SNM or may cause harm to others. The NRC would require this description of reportable conduct because an individual's activities (
Proposed § 26.909(c) would require that licensees and other entities perform behavioral observation visually, in-person, and, when necessary, remotely by live video and audible streaming and capture. This requirement was developed from the security observation requirements in § 73.55(e)(7)(i)(B) and (C), (h)(2)(v), and (i)(2) and (i)(5)(ii). Conducting an in-person observation of another individual would be the preferred method to ascertain whether the observed individual can safely and competently perform assigned duties and responsibilities. When in-person observations would not be feasible (
In situations involving small staff sizes, facilities sited in geographically remote locations, or both, additional observers would enhance the effectiveness of a BOP. Technological developments in automated safety and security systems may enable licensees or other entities to reduce staff sizes to 10 to 40 percent of the staff size of an LWR facility licensed under part 50 or 52. Smaller staff sizes may translate into more solo operations, less teamwork, fewer peer checks, or infrequent management oversight of field activities, leading to fewer behavioral observations. Therefore, a licensee or other entity may have fewer opportunities to observe whether individuals are fit for duty.
Proposed § 26.909(d) would require that licensees or other entities perform behavioral observation of NRC-licensed operators who manipulate the controls of any nuclear plant licensed under proposed part 57, remotely by live video and audible streaming capture for those part 57 facilities where individual task loading does not allow for the effective conduct of behavior observation in addition to assigned operational tasks. The purpose of this paragraph would be similar to that of proposed § 26.909(c), where the possibility of in-person observation is significantly diminished because of solo operations or because the facility may only require a minimum staff size onsite.
Proposed § 26.910(a) would be similar to § 26.409, “Sanctions,” and would require the licensee or other entity to establish sanctions for FFD policy violations that, at a minimum, would prohibit the individuals specified in § 26.4 from being assigned to perform or direct those duties and responsibilities or maintaining authorization making them subject to proposed subpart P of part 26. To be consistent with § 26.75, “Sanctions,” the severity of the sanction as described in proposed § 26.910(b) would escalate with the number of occurrences and severity of the FFD policy violation. The sanction would be long enough to help deter future FFD policy violations and facilitate counseling and treatment before the licensee reinstates the individual's access to the facility.
Proposed § 26.910(b)(1) would require a minimum 14-day denial of access for an individual's first violation of the FFD policy involving a confirmed positive drug or alcohol test result. Proposed § 26.910(b)(2) would require a minimum 3-year denial of access for an individual's second violation of the FFD policy involving a confirmed positive drug or alcohol test result.
Equivalent to § 26.75(c), proposed § 26.910(b)(3) would require a minimum 5-year denial of access for who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any facility licensed under proposed part 57 or within a transporter's facility or vehicle used in the conveyance of formula quantities of strategic SNM. Equivalent to § 26.75(b), proposed § 26.910(b)(4) would require a permanent denial of authorization be issued for a third violation of the FFD policy involving a confirmed positive drug or alcohol test result or a subversion attempt of any drug or alcohol test or screening process.
Proposed § 26.911, “Protection of information,” would protect information collected from FFD program implementation and would be equivalent to current § 26.411, “Protection of information.” The protected information would include, but not be limited to, privacy and medical information. Proposed § 26.911 would not include the § 26.411 requirement that FFD programs must maintain and use the personal information with the highest regard for individual privacy because such a requirement would be unnecessary considering the proposed § 26.911(a) requirement that licensees and other entities would have to establish and maintain a system of files and procedures to prevent unauthorized disclosure.
Proposed § 26.911(b), although equivalent to § 26.411(b), would require licensees and other entities to have all individuals sign a consent to be subject to the FFD program before subjecting the individual to the FFD program (
Proposed § 26.913 would be equivalent to § 26.413, “Review process.” The proposed title would be changed to an appeal process to clarify that proposed § 26.913 would be the process implemented when an individual elects to appeal a licensee or other entity determination that the individual had violated the FFD policy. The proposal would also require that the process include a schedule for the completion of the review of the determination that the individual had violated the FFD policy. The NRC proposes this requirement because operating experience demonstrates that workers may not be protected from a continuous review process that does not result in an outcome.
Proposed § 26.915, “Audits,” would require licensees and other entities to perform audits of the FFD program. The proposed section would be similar to § 26.415, “Audits.” Under proposed § 26.915(a), audits would be performed at a frequency that ensures the FFD program's continuing effectiveness. Corrective actions would be taken as soon as reasonably practicable to resolve any problems identified and preclude recurrence. Proposed § 26.915(b) would require the subject matter, scope, and frequency of audits to be revised as necessary to improve or maintain FFD program performance based on annual FFD program performance data reviews performed under proposed § 26.917(d) and unsatisfactory performance or programmatic weaknesses identified under proposed § 26.917(b)(3) and (e).
Proposed § 26.915(c) would be equivalent to § 26.415(b) and would enable licensees and other entities to conduct joint audits or accept audits of C/Vs so long as the audit addresses the relevant services of the C/Vs.
Proposed § 26.915(d) would be equivalent to § 26.415(c) by establishing requirements for the auditing of HHS-certified laboratories. Unlike § 26.415(c), the proposal would not contain a reference to the U.S. Department of Transportation drug and alcohol testing requirements. This would broaden the regulatory flexibility afforded to a licensee or other entity in that they may use an offsite collection or testing facility that does not meet the Department of Transportation requirements.
Proposed § 26.915(d) would state that licensees and other entities need not audit an HHS-certified laboratory if the licensee's or other entity's panel of drugs and drug metabolites to be tested is equivalent to the panel by which the laboratory is certified by HHS or is subject to the standards and procedures for drug testing and evaluation used by the laboratory under the HHS Guidelines. The NRC would afford this flexibility because the NRC is aware that HHS desires to streamline changes in its guidelines to its panel of drugs and drug metabolites to be tested. Therefore, if a licensee or other entity elects to implement the HHS Guidelines in its procedures and maintains the minimum panel of drugs and drug metabolites to be tested as required by proposed subpart P, a licensee or other entity may still use (and not audit) the HHS-certified laboratory because the proposed § 26.903(e) change control process would maintain FFD program effectiveness.
To help ensure FFD program effectiveness, § 26.915(d) would also require that collection facility procedures are comparable to those required in subpart E of part 26, including a proposed requirement that the offsite facility's specimen collection and testing procedures are audited on a biennial basis, which is also a protection consideration afforded to individuals subject to the FFD program. Conducting this audit on a biennial basis would be equivalent to that required in § 26.41(b) and would help ensure that the specimen collection process at the facility remains effective.
Proposed § 26.917, “Recordkeeping, reporting and FFD program performance,” would establish recordkeeping, reporting, and FFD program performance requirements similar to those in current § 26.417, “Recordkeeping and reporting.” However, proposed § 26.917 would require retention of records pertaining to administration of the FFD program and FFD performance data required by § 26.717 until license termination, which is based on current § 26.711(a) because § 26.417 does not provide for a retention period.
Proposed § 26.917(b)(1) would be identical to the reporting requirements in § 26.417(b)(1) regarding the licensee's or other entity's FFD program.
Proposed § 26.917(b)(2) would require the reporting of annual (
Proposed § 26.917(b)(3) would require the reporting of drug and alcohol testing errors to the NRC within 30 days of completing an investigation of any testing errors or unsatisfactory performance, discovered at an HHS-certified laboratory or through the processing of appeals under proposed § 26.913, or matters that could adversely reflect on the integrity of the random selection or random testing process. Licensees and other entities would be required to describe in the reports the incident and any corrective actions taken or planned.
Proposed § 26.917(c) would require that FFD-related information be shared within the nuclear industry when requested to support authorization determinations. This requirement would help individuals seeking employment by another NRC-licensed facility subject to subpart C of part 26, complete their NRC-required sanctions and licensee-administered or -directed drug and/or alcohol abuse treatment plans before the restoration of authorization by a licensee or other entity. Information sharing may also enhance FFD program effectiveness because FFD-related lessons learned from, for example, substance testing, subversion attempts, and laboratory and MRO performance would have to be shared when requested.
Proposed § 26.917(d) would require that licensees and other entities must analyze FFD program performance data at least annually and take appropriate actions to correct any identified program weakness.
Proposed § 26.917(e) would require that licensees and other entities must document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee's or other entity's corrective action program. However, to protect individual privacy, drug and alcohol test results could not be tracked in a manner that would permit the identification of any individuals.
Proposed § 26.919, “Suitability and fitness determinations,” would require
In considering the current restriction on the use of electronic means of communication for determinations of fitness conducted for cause, the NRC finds that since publication of the 2008 part 26 final rule, there have been developments in using electronic means of communication (
The NRC proposes several conforming changes to its regulations in 10 CFR part 73. Changes to §§ 73.1, 73.2, “Definitions,” 73.8, “Information collection requirements: OMB approval,” 73.50, “Requirements for physical protection of licensed activities,” 73.56, “Personnel access authorization requirements for nuclear power plants,” 73.57, “Requirements for criminal history records checks of individuals granted unescorted access to a nuclear power facility, a non-power reactor, or access to Safeguards Information,” and 73.58, “Safety/security interface requirements for nuclear power reactors,” would be needed to incorporate proposed part 57 into these requirements. Changes to § 73.54, “Protection of digital computer and communication systems and networks,” would require a licensee that elects to implement the requirements of § 73.54 to establish and implement cybersecurity reviews to assess the effectiveness of the implementation of the cybersecurity program. Changes to § 73.77, “Cyber security event notifications,” would incorporate proposed § 73.110 into the cyberattack notification requirement and simplify the regulation by eliminating specific event notifications and redirecting licensees to existing notification processes.
Proposed § 73.110 would establish requirements for the development and maintenance of a cybersecurity program for nuclear plants licensed under proposed part 57. This section would implement a graded approach to determine the level of cybersecurity protection required for digital computers, communication systems, and networks. The proposed new section is informed by: (1) the operating experience from power reactors and insights from cyber-related assessments of fuel cycle facilities; and (2) the existing § 73.54 framework, which addresses some of the basic issues for cybersecurity regardless of the type of reactor. Differences between the § 73.54 requirements and those proposed in § 73.110 are primarily based on the implementation of a consequence-based approach to cybersecurity that provides flexibility to accommodate the wide range of reactor technologies the NRC expects to assess under proposed part 57. A graded approach based on consequences would account for the differing risk levels among reactor technologies. Specifically, the proposed new section would require licensees to demonstrate protection against cyberattacks in a manner that is commensurate with the potential consequences from those attacks.
In this proposed rule, the NRC proposes several conforming changes to its regulations in part 140 of this chapter. These conforming changes would be needed to include licenses issued under the proposed part 57 into the NRC's financial protection requirements and in accordance with the requirements set forth in the Price-Anderson Act (42 U.S.C. 2210). During the development of this proposed rule, the NRC also considered a reduction in the amount of financial protection required for facilities licensed under proposed part 57. Facilities that would be licensed under proposed part 57 could pose reduced risks in comparison to existing facilities, for which the current financial protection requirements were established, thereby warranting a reduced amount of required financial protection. Upon receipt of a joint application under proposed part 57, the NRC would perform the necessary review(s) in which to make a technical finding of this presumption. If a lesser amount of financial protection were determined to be commensurate with the reduced risk profile of the reactor, the NRC would exercise its regulatory discretion to establish a reduced amount of financial protection for facilities licensed under part 57, based on factors such as those specified in the Price-Anderson Act: (A) the cost and terms of private insurance; (B) the type, size, and location of the licensed activity and other factors pertaining to the hazard; and (C) the nature and purpose of the licensed activity.
Similarly, the NRC could also consider reducing indemnification fees for certain licensees. The Price-Anderson Act establishes indemnification fees but gives discretion to the NRC to establish lower indemnification fees for some licensees. During its review of part 57 joint applications, the NRC could consider establishing reduced indemnification fees for those applicants based on factors such as those specified in the Price-Anderson Act: (1) the type, size, and location of facility involved, and other factors pertaining to the hazard, and (2) the nature and purpose of the facility.
The NRC is seeking advice and recommendations from the public on this proposed rule. We are particularly interested in comments and supporting rationale from the public on the following:
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As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule, if adopted, will not have a significant economic impact on a substantial number of small entities. This proposed rule affects only the licensing and operation of nuclear power plants. The companies that own these plants do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).
The NRC has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the NRC. The conclusion from the analysis is that this proposed rule and associated guidance would result in net averted costs (cost savings) to the industry and the NRC of approximately $3.76 billion using a 7-percent discount rate and $11.84 billion using a 3-percent discount rate due to reductions in exemption requests. The analysis also assumes 2,235 applicants under part 57 over the 40 years of the analysis. As the number of applicants increases, so do the estimated averted costs. The NRC requests public comment on the draft regulatory analysis, which is available as indicated in the “Availability of Documents” section of this document. Comments on the draft analysis may be submitted to the NRC as indicated under the
This section describes the backfitting and issue finality implications of this proposed rule and the draft guidance document described in section XVIII, “Availability of Guidance,” of this document, as applied to pertinent NRC approvals and certain applicants that reference NRC approvals in their applications. The NRC's current backfitting provisions relevant to this proposed rule appear in § 50.109, § 70.76, and § 72.62, all entitled “Backfitting,” and apply to holders of construction permits and operating licenses for commercial and industrial purposes under part 50, holders of licenses under part 70, and holders of general or specific licenses under part 72, respectively. Issue finality provisions (analogous to the backfitting provisions in § 50.109) for approvals under part 52 are in various provisions of part 52. The NRC Management Directive 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests,” describes the Commission's policies on backfitting and issue finality.
This proposed rule would provide a regulatory scheme for entities to apply for approvals under parts 30, 40, 57, 70, 71, and 72. The parts 50, 70, and 72 backfitting provisions and part 52 issue finality provisions apply to actions taken by the NRC under parts 50, 70, 72, and 52, respectively, or actions taken by the NRC under other parts of 10 CFR chapter I that, for holders of certain approvals under part 50, 70, 72, or 52, inextricably affect their activities regulated under part 50, 70, 72, or 52, respectively. Issuance and implementation of proposed part 57 would not constitute actions taken under part 50, 70, 72, or 52. Therefore, the issuance and implementation of proposed part 57 would not affect part 50, 70, 72, or 52 entities' activities regulated under those parts. The addition of part 57 through this proposed rule would not be within the scope of the part 50, 70, or 72 backfitting or part 52 issue finality provisions.
The NRC also proposes conforming changes to parts 1, 2, 10, 11, 19, 20, 21, 25, 26, 30, 40, 50, 51, 70, 72, 73, 74, 75, 95, 140, and 150 to reflect the addition of part 57 (see section VI.A of this document). These changes would not meet the definition of “backfitting” in § 50.109 or § 70.76 because the proposed changes would not modify or add to the systems, structures, components, or design of a facility or to the procedures or organization required to operate a facility under part 50 or 70. These changes would not meet the definition of “backfitting” in § 72.62 because the proposed changes would not add, eliminate, or modify the SSCs of an independent spent fuel storage installation or the procedures or organization required to operate an independent spent fuel storage installation. These proposed changes would not inextricably affect activities regulated under parts 50, 52, 70, or 72. Therefore, the proposed changes to parts 1, 2, 10, 11, 19, 20, 21, 25, 26, 30, 40, 50, 51, 70, 72, 73, 74, 75, 95, 140, and 150 would not constitute backfitting under parts 50, 70, or 72 or affect the issue finality of an approval under part 52.
The NRC is issuing one draft guidance document that, if issued as a final guidance document, would provide guidance on the methods acceptable to the NRC for complying with aspects of this proposed rule. This guidance would not apply to holders of approvals issued under part 50 or part 52. Although the guidance could apply to holders of part 70 or part 72 licenses, the guidance would apply to them only in relation to a part 57 license, and there would be no
The NRC seeks to minimize potential negative consequences resulting from the cumulative effects of regulation (CER). The NRC believes that the de-regulatory impacts of this rulemaking activity are unlikely to cause implementation challenges for stakeholders. In addition, during the pendency of this rulemaking, the NRC is deprioritizing issuance of regulatory actions that might influence the implementation date for the new rule requirements (
To fully understand any potential CER implications that could result from this rulemaking, the NRC is asking the following questions. Response to these questions is voluntary and any input will be considered during development of the final rule.
1. The NRC is proposing an effective date that will be 30 days after the date of publication of a final rule. Does this provide sufficient time to implement the proposed requirements? Please provide a rationale for your response.
2. Are there unintended consequences related to this rulemaking and how should they be addressed? Please provide a rationale for your response.
3. Please comment on the NRC's cost and benefit estimates in the regulatory analysis that supports this proposed rule.
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885). The NRC requests comment on this document with respect to the clarity and effectiveness of the language used.
The NRC has prepared this environmental assessment (EA) in compliance with the agency's environmental review requirements in 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” which implement the National Environmental Policy Act of 1969, as amended. This EA evaluates and documents the potential environmental impacts resulting from the proposed rulemaking related to amending the regulations by creating an alternative regulatory framework for licensing microreactors and other reactors with comparable risk profiles.
Sections III and IV of this document provide the background regarding E.O. 14300, the proposed action, along with the purpose of and need for the proposed action. Section V of this document describes the structure of the proposed part 57. Further discussion of these topics does not need to be repeated in this EA. The organization of this EA addresses the conforming changes under this proposed part 57 rule, environmental impacts of the proposed action, the environmental impacts of the alternative to the proposed action, agencies and persons consulted, proposed finding of no significant environmental impacts, stakeholder interactions, and the references noted in this EA.
This rulemaking would make conforming changes throughout 10 CFR chapter I. Table B.1-1 lists the chapter I parts with conforming changes for this proposed rule. Most of these changes would only insert the appropriate part 57 cross-reference and are considered administrative changes.
Most of the subparts to the proposed part 57 are related to establishing programs and related procedures rather than actions requiring technical analysis with approved methodologies or guidance. Additionally, many of these subparts establish technical requirements that would be equivalent to companion regulations under 10 CFR part 21, part 50, part 52, part 70, part 71, part 72, part 73, and part 74. Thus, these subparts are procedural provisions or incorporate similar requirements as existing regulations and are not substantive environmentally different regulations. Therefore, since this group of subparts would generally address administrative, procedural processes, and technical requirements equivalent to ones under various parts under 10 CFR, their implementation would result in no significantly different environmental impacts under this rule. The proposed part 57 subpart regulations with their equivalent regulations are listed in Table C-1.
As noted in Table C-1, proposed subpart C would contain several sections that would be similar to existing regulations in part 50. Proposed part 57 also relies upon regulatory radiological limits under 10 CFR part 20 and an entry criterion of 1 rem (10 mSv) dose threshold to any individual located in the unrestricted area. Similarly, for other facilities with comparable risk profiles, such as research reactors licensed under 10 CFR part 50, the NRC applies the radiological limit requirements in 10 CFR part 20 and a comparable accident dose criterion of 1 rem (10 mSv), as specified in § 50.34(a)(1)(i). Other regulations under proposed subpart C would be new regulations that would also provide assurance that the complete design had been reviewed and approved by the NRC or are related to required processes and procedures necessary to further support such reasonable assurance.
Proposed § 57.45(d) would establish a general license for construction activities on a site that is specified in a joint application for a construction permit and associated operating license(s) under proposed part 57, subject to certain conditions. These conditions would include requirements that the application references a reactor of the same design that had been constructed and placed into operation under Commission oversight and that had met the criteria for a categorical exclusion under the regulations in proposed subpart K of part 57. In addition, the proposed § 57.45(d)(4) would require that the general licensee must not allow special nuclear material or radioactive material that would be associated with operation under an operating license issued pursuant to proposed part 57 to be brought to the site under the general license. Therefore, the activities that would be conducted under the general license would not give rise to nuclear or radiological hazards. Also, proposed § 57.45(d)(1)(iii) would require that the application submitted by the general licensee would include a plan for redress of any adverse environmental impact from conduct of activities under the general license should such redress be necessary.
Therefore, the regulations under proposed subpart C would provide the
As previously noted, the proposed subpart D would address applications for, issuance of, and other provisions related to MLs covering manufacturing activities at one or more licensee facilities. These proposed requirements would be largely equivalent to those in part 52 for MLs. The most significant change proposed for MLs in part 57 as compared to MLs under part 52 relates to proposed § 57.197(d), which would allow and establish requirements for the loading of fuel into a manufactured reactor at the manufacturing site for subsequent transport to a nuclear plant that would be constructed pursuant to a CP that would be issued under proposed part 57. Because the proposed § 57.197(d) would cite the requirements in 10 CFR parts 70 and 73 to ensure important features and programs are in place prior to the receipt of SNM, the same level of reasonable assurance of adequate protection of public health and safety would be maintained as for currently licensed operating plants for their receipt of SNM. Thus, implementation of subpart D would provide an equivalent level of reporting, administrative, and safety requirements as the current ML and fuel possession and loading regulatory framework with no significant environmental impacts.
Categorical exclusions provide a mechanism to identify types of Federal actions that normally do not have significant environmental effects to the human environment and for which neither an environmental assessment nor environmental impact statement is normally required. This ensures that resources are not expended conducting environmental analysis of proposals that do not present potential for significant environmental impacts. The proposed § 57.350 establishes the criteria for determining whether a categorial exclusion applies in support of a license under this part. Additionally, determining whether a categorical exclusion applies is a NEPA process to inform the decision-maker of the environmental impacts for issuing a license and, thus, an administrative step. Therefore, there would be no significant environmental effects with implementing this proposed new categorical exclusion regulation.
The conforming changes to part 25 for activities in connection with the proposed part 57 are a revision to a definition, the addition of a reference regarding access authorizations for individuals who need access to classified information, and an update to apply the requirements for classified visits to licensees and applicants under proposed part 57. Therefore, these changes to part 25 would be at a level equivalent to the current 10 CFR part 25 regulatory framework and its implementation would have no significantly different environmental impacts.
As stated in section VI.B. of this document, proposed part 57 would add a new subpart P in 10 CFR part 26, “Fitness for Duty Programs,” and make other conforming changes to existing part 26 provisions. The NRC proposes a flexible, technology-inclusive, risk-informed, and performance-based approach with options to the application of drug and alcohol testing and fatigue management requirements for facilities licensed under proposed part 57. Proposed part 57 licensees and other entities could implement requirements in proposed subpart P of part 26, all the requirements of part 26 except subparts K and P, or an FFD program of their specification. Notwithstanding the type of FFD program a licensee or other entity would implement, the licensees and other entity that would apply for or have been issued an OL or CP under proposed part 57 would be required, no later than the start of construction activities, to implement the FFD program. Holders of an ML under proposed part 57 would be required to implement their FFD program before commencing activities that assemble a manufactured reactor.
Concerning an FFD program of their specification, licensees and other entities that would apply for or would have been issued an OL or CP under proposed part 57, and holders of an ML under proposed part 57, could elect to implement an FFD program of their specification only if the licensee's or other entity's reactor manufactured under an ML issued under proposed part 57, constructed under a construction permit issued under proposed part 57, or operated under an OL issued under proposed part 57, as applicable, would not require operator action to maintain the reactor within the criterion of proposed § 57.25(a) or a credible operator or maintenance error could not result in exceeding that criterion.
The FFD requirements would be commensurate with the radiological risks presented by the facilities in question (
Additional text under 10 CFR 51.4, “Definitions,” for “construction” would point to the definition of “construction” under § 57.3 to account for differences among that definition and the definitions of “construction” under 10 CFR parts 50 and 52. This proposed change to the definition of “construction” in 10 CFR part 51 would be administrative in application and, as such, would not have a significant environmental impact.
Changes to part 73 in support of proposed part 57 address cybersecurity programs by implementing a graded approach to determine the level of cybersecurity protection required for digital computers, communication systems, and networks. The changes are based on (1) the operating experience from power reactors and insights from cyber-related assessments of fuel cycle facilities; and (2) the existing § 73.54 framework. Differences between the § 73.54 requirements and those proposed by part 57 changes to part 73 are primarily based on the implementation of a consequence-based approach to cybersecurity. This consequence-based approach would provide flexibility to accommodate the wide range of reactor technologies and would account for the differing risk
With regard to potential environmental effects, implementation of the proposed part 57 rule would not have a significant environmental impact. Proposed requirements would be administrative in application, a matter of procedure, or would provide an equivalent level of safety and security for protection of public health and safety as existing regulations with no significant environmental effects to the human environment with implementing this new regulation.
In addition, requirements under proposed part 57 would not affect any threatened or endangered species or historic properties since this proposed rule would result in no physical changes to the environment.
Accordingly, the NRC finds that this proposed rulemaking action would not have a significant effect on the quality of the human environment.
Under the no-action alternative (
The NRC developed the proposed rule and is requesting public comment on this draft EA. The NRC intends to hold a public meeting during the proposed rule comment period to allow stakeholders to ask questions about the proposed rule and this EA. The agency will consider comments received on the docket as it develops the final rule and the final EA. The NRC will issue the final EA when it publishes the final rule.
The proposed rule is one step in the rulemaking process. During the development of this proposed rule, the NRC conducted public meetings and other interactions with stakeholders related to the development of the part 57 regulations. Table G-1 in Section G of this EA provides details about stakeholder interactions.
The proposed rule would provide an equivalent level of safety as the current regulations in 10 CFR part 50 and 10 CFR part 52 and would result in no significant impact on the environment. As such, the rulemaking would not impact threatened or endangered species or critical habitat; the NRC has determined that a section 7 consultation under the Endangered Species Act is not necessary. Likewise, the NRC has determined that the proposed rulemaking would not cause any adverse effects to historic properties. Therefore, the NRC has determined that no consultation is required under section 106 of the National Historic Preservation Act.
The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in 10 CFR part 51, that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, and an environmental impact statement is not required. The basis of this determination is that NRC's proposed action (rulemaking) would provide adequate protection of the public health and safety and common defense and security for microreactors and reactors with comparable risk profiles without the need to grant specific exemptions or license amendments in certain regulatory areas. Rulemaking would reduce the need for exemptions from existing regulations and license amendment requests and would support the principles of good regulation, including openness, clarity, and reliability. Therefore, the proposed rulemaking meets the need for the proposed agency action.
The determination of this EA is that this proposed agency action would not have a significant effect on the quality of the human environment. Public stakeholders should note, however, that comments on any aspect of this EA may be submitted to the NRC as indicated under the
The NRC has sent a copy of the EA and this proposed rule to every State Liaison Officer and has requested comments.
The stakeholder interactions for part 57 thus far are listed in Table G-1 for interactions between the NRC and stakeholders during public meetings and communications on issues related to the part 57 rulemaking. The NRC received feedback from various stakeholders on part 57 during or as a result of these interactions.
This proposed rule contains new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This proposed rule has been submitted to the Office of Management and Budget (OMB) for review and approval of the information collections.
The proposed rule covers diverse topics, which result in recordkeeping and reporting requirements related to construction and manufacturing, contents of applications, plant design and analysis, facility operations, decommissioning, FFD, physical security, cybersecurity, siting, programs, staffing, and quality assurance.
In addition to the new information collections in the proposed regulations, proposed part 57 would result in new collections via NRC Forms 361T, 366, 366A, 366B, 396, 398, 893, and 894. A new version of NRC Form 361 (NRC Form 361T) would be created for use by proposed part 57 licensees, covering an equivalent scope as the requirements in § 50.72, but without LWR-specific terminology to ensure technology inclusiveness. NRC Forms 366, 366A, and 366B would be modified to include reportable events in proposed part 57, subpart Q, covering an equivalent scope as the requirements in § 50.73, but without LWR-specific terminology to ensure technology inclusiveness. NRC Forms 396 and 398 would be modified to satisfy requirements in proposed part 57, subpart P, to certify the medical fitness of an applicant for an operator or senior operator license. Finally, the proposed rule would require part 57 licensees to use NRC Forms 893 and 894 to report on positive drug and alcohol test results (NRC Form 893) and annual fitness-for-duty program performance
The NRC is seeking public comment on the potential impact of the information collections contained in this proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility? Please explain your response.
2. Is the estimate of the burden of the proposed information collection accurate? Please explain your response.
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? Please explain your response.
4. How can the burden of the proposed information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology? Please explain your response.
A copy of the OMB clearance package and proposed rule are available in the “Availability of Documents” section of this document or may be viewed free of charge by contacting the NRC's Public Document Room reference staff at 1-800-397-4209, at 301-415-4737, or by email to
You may submit comments on any aspect of these proposed information collection(s), including suggestions for reducing the burden and on these issues, by the following method:
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Submit comments by June 1, 2026.
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.
The following are Executive orders that are related to this proposed rule:
The Office of Information and Regulatory Affairs (OIRA) has determined that this proposed rule is an economically significant regulatory action. Accordingly, the NRC submitted this proposed 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 information can be found in section IX, “Regulatory Analysis,” of this document.
The NRC has examined this proposed rule and has determined that it is consistent with the policies and directives outlined in E.O. 14154.
This action is tentatively determined to be a deregulatory action as defined by E.O. 14192. Details on the estimated costs of this proposed rule can be found in Section IX, of this document, “Regulatory Analysis.”
E.O. 14270, “Zero-Based Regulatory Budgeting to Unleash American Energy,” requires the NRC to insert a conditional sunset date into all new or amended NRC regulations provided the regulations are (1) promulgated under the Atomic Energy Act of 1954, as amended (AEA), the Energy Reorganization Act of 1974, as amended (ERA), or the Nuclear Waste Policy Act of 1982, as amended (NWPA); (2) not statutorily required; and (3) not part of the NRC's permitting regime. The NRC determined that the regulatory changes proposed in this rule are required because they would be necessary for providing reasonable assurance of adequate protection of public health and safety and provide for the common defense and security, and would be part of the NRC's permitting regime authorized by the AEA. Therefore, the NRC views this rulemaking to be outside the scope of E.O. 14270 and does not propose to insert conditional sunset dates for the regulatory changes in this proposed rule.
This proposed rule includes Federal regulations that, if adopted, would be enforceable by criminal penalty, as authorized by section 223 of the AEA. Therefore, per E. O. 14294, those regulations constitute “criminal regulatory offenses.”
For the purposes of section 223 of the AEA, the NRC is issuing this proposed rule that would add a new part 57 and amend 10 CFR parts 19, 20, 21, 25, 26, 30, 40, 50, 70, 72, 73, 74, 95, and 140 under one or more of sections 161(b), 161(i), or 161(o) of the AEA, except as noted in §§ 19.40(b), 20.2402(b), 21.62(b), 25.39(b), 26.825(b), 30.64(b), 40.82(b), 50.111(b), 57.385(b), 70.92(b), 72.86(b), 73.81(b), 74.84(b), 95.63(b), and 140.89(b). The applicability of criminal penalties to regulations in parts 19, 20, 21, 25, 26, 30, 40, 50, 57, 70, 72, 73, 74, 95, and 140 is set forth in §§ 19.40, 20.2402, 21.62, 25.39, 26.825, 30.64, 40.82, 50.111, 57.385, 70.92, 72.86, 73.81, 74.84, 95.63, and 140.89, respectively. Willful violations of the 10 CFR parts 19, 20, 21, 25, 26, 30, 40, 50, 57, 70, 72, 73, 74, 95, and 140 regulations, other than those listed in §§ 19.40(b), 20.2402(b), 21.62(b), 25.39(b), 26.825(b), 30.64(b), 40.82(b), 50.111(b), 57.385(b), 70.92(b), 72.86(b), 73.81(b), 74.84(b), 95.63(b), and 140.89(b) (including as updated by this proposed rule), would be subject to criminal enforcement.
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 proposed rule, the NRC will revise regulations by adding a regulatory framework for microreactors and other reactors with comparable risk profiles. This action does not constitute the establishment of a standard that contains generally applicable requirements.
The NRC is issuing draft guidance in NUREG-2271, “Guidelines for Preparing and Reviewing Applications Under 10 CFR part 57,” for implementation of the proposed requirements in this rulemaking. The draft guidance is available in ADAMS under Accession No. ML25259A304. When finalized, NUREG-2271 would provide stakeholders with guidance for implementing the final requirements contemplated by this proposed rule. You may submit comments on the draft regulatory guidance by the methods outlined in the
The NRC will conduct a public meeting on the proposed rule for the purpose of describing the proposed rule to the public and answering questions
The NRC will publish a notice of the location, time, and agenda of the meeting in the
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at
Flags, Organization and functions (Government Agencies), Seals and insignia.
Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Confidential business information, Freedom of information, Environmental protection, Hazardous waste, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal.
Administrative practice and procedure, Classified information, Government employees, Security measures.
Hazardous materials transportation, Investigations, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Security measures, Special nuclear material.
Criminal penalties, Environmental protection, Nuclear Energy, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Sex discrimination.
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.
Nuclear power plants and reactors, Penalties, Radiation protection, Reporting and recordkeeping requirements.
Classified information, Criminal penalties, Investigations, Penalties, Reporting and recordkeeping requirements, Security measures.
Administrative practice and procedure, Alcohol abuse, Alcohol testing, Appeals, Drug abuse, Drug testing, Employee assistance programs, Fitness for duty, Management actions, Nuclear power plants and reactors, Privacy, Protection of information, Radiation protection, Reporting and recordkeeping requirements.
Byproduct material, Criminal penalties, Fusion, Government contracts, Intergovernmental relations, Isotopes, Nuclear energy, Nuclear materials, Penalties, Radiation protection, Reporting and recordkeeping requirements, Whistleblowing.
Criminal penalties, Exports, Government contracts, Hazardous materials transportation, Hazardous waste, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Source material, Uranium, Whistleblowing.
Administrative practice and procedure, Antitrust, Backfitting, Classified information, Criminal penalties, Education, Emergency planning, Fire prevention, Fire protection, Intergovernmental relations, Nuclear power plants and reactors, Penalties, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements, Whistleblowing.
Administrative practice and procedure, Environmental impact statements, Hazardous waste, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Reporting and recordkeeping requirements.
Administrative practice and procedure, Antitrust, Backfitting, Atomic energy, Construction permit, Combined license, Classified information, Criminal Penalties, Early site permit, Emergency planning, Fees, Fire prevention, Fire protection, Inspection, Intergovernmental relations, Limited work authorization, Manufacturing license, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Nuclear safety, Operating license, Penalties, Prototype, Radiation Protection, Radioactive materials, Reactor siting criteria, Reporting and recordkeeping requirements, Standard design, Standard design certification, Training programs.
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.
Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.
Criminal penalties, Exports, Hazardous materials transportation, Imports, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Security measures.
Accounting, Criminal penalties, Hazardous materials transportation, Material control and accounting, Nuclear energy, Nuclear materials, Packaging and containers, Penalties, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment, Special nuclear material.
Criminal penalties, Intergovernmental relations, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Security measures, Treaties.
Classified information, Criminal penalties, Penalties, Reporting and recordkeeping requirements, Security measures.
Insurance, Intergovernmental relations, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements.
Criminal penalties, Hazardous materials transportation, Intergovernmental relations, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Security measures, Source material, Special nuclear material.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing to amend 10 CFR parts 1, 2, 10, 11, 19, 20, 21, 25, 26, 30, 40, 50, 51, 70, 72, 73, 74, 75, 95, 140, and 150 and add 10 CFR part 57:
Atomic Energy Act of 1954, secs. 23, 25, 29, 161, 191 (42 U.S.C. 2033, 2035, 2039, 2201, 2241); Energy Reorganization Act of 1974, secs. 201, 203, 204, 205, 209 (42 U.S.C. 5841, 5843, 5844, 5845, 5849); Administrative Procedure Act (5 U.S.C. 552, 553); Reorganization Plan No. 1 of 1980, 5 U.S.C. Appendix (Reorganization Plans).
Atomic Energy Act of 1954, secs. 29, 53, 62, 63, 81, 102, 103, 104, 105, 161, 181, 182, 183, 184, 186, 189, 191, 234 (42 U.S.C. 2039, 2073, 2092, 2093, 2111, 2132, 2133, 2134, 2135, 2201, 2231, 2232, 2233, 2234, 2236, 2239, 2241, 2282); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); Nuclear Waste Policy Act of 1982, secs. 114(f), 134, 135, 141 (42 U.S.C. 10134(f), 10154, 10155, 10161); Administrative Procedure Act (5 U.S.C. 552, 553, 554, 557, 558); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note. Section 2.205(j) also issued under 28 U.S.C. 2461 note.
(e) Standard design approvals under part 52 or part 57 of this chapter.
(a) * * *
(3) * * *
(i) Submit to the Director, Office of Nuclear Reactor Regulation, or Director, Office of Nuclear Material Safety and Safeguards, as appropriate, such additional copies as the regulations in part 50, part 51, and part 57 of this chapter require;
(a) * * *
(4) An amendment to an operating license, combined license, or manufacturing license for a facility of the type described in § 50.21(b) or § 50.22 of this chapter, as applicable, or for a testing facility, as follows:
(i) If the Commission determines under § 50.58 or § 57.130 of this chapter that the amendment involves no significant hazards consideration, though it will provide notice of opportunity for a hearing pursuant to this section, it may make the amendment immediately effective and grant a hearing thereafter; or
(ii) If the Commission determines under §§ 50.58 and 50.91 or § 57.130 of this chapter, as applicable, that an emergency situation exists or that exigent circumstances exist and that the amendment involves no significant hazards consideration, it will provide notice of opportunity for a hearing pursuant to § 2.106 (if a hearing is requested, it will be held after issuance of the amendment);
(13) A manufacturing license under subpart F of part 52 or subpart D of part 57 of this chapter.
(b) If the licensee of a nuclear power plant of the type described in § 50.21(b) or § 50.22 of this chapter files a sufficient application for renewal of either an operating license or a combined license at least 5 years before the expiration of the existing license, the existing license will not be deemed to have expired until the application has been finally determined.
(d) If the licensee of a manufacturing license under subpart F of part 52, or under subpart D of part 57 of this chapter files a sufficient application for renewal under § 52.177 or § 57.190 of this chapter at least 12 months before the expiration of the existing license, the existing license will not be deemed to have expired until the application has been finally determined.
(a)(1) A submittal for a standard design approval under subpart E of part 52 or under subpart E of part 57 of this chapter shall be subject to §§ 2.101(a) and 2.390 to the same extent as if it were an application for a permit or license.
(b) Upon initiation of review by the NRC staff of a submittal for an early review of site suitability issues under appendix Q to part 50 of this chapter, or for a standard design approval under subpart E of part 52 or under subpart E of part 57 of this chapter, the Director, Office of Nuclear Reactor Regulation, shall publish in the
(e)(1) If the order involves the modification of a part 50 or a part 57 license and is a backfit, the requirements of § 50.109 or § 57.16 of this chapter, as applicable, shall be followed, unless the licensee has consented to the action required.
(5) If the order involves a change to a standard design approval referenced by that plant's application, the requirements of § 52.145 or § 57.220 of this chapter, as applicable, must be followed unless the applicant or licensee has consented to follow the action required.
(6) If the order involves a modification of a manufacturing license under subpart F of part 52 or under subpart D of part 57 of this chapter, the requirements of § 52.171 or § 57.175 of this chapter, as applicable, must be followed, unless the applicant or licensee has consented to the action required.
(h) * * *
(2) If the proceeding pertains to a production or utilization facility (as defined in § 50.2 or § 57.3 of this chapter) located within the boundaries of the State, local governmental body, or Federally-recognized Indian Tribe seeking to participate as a party, no further demonstration of standing is required. If the production or utilization facility is not located within the boundaries of the State, local governmental body, or Federally-recognized Indian Tribe seeking to participate as a party, the State, local governmental body, or Federally-recognized Indian Tribe also must demonstrate standing.
(d) The provisions of this section do not apply to an initial decision directing the issuance of a limited work authorization under 10 CFR 50.10; an early site permit under subpart A of part 52 of this chapter; a construction permit or construction authorization under part 50 or part 57 of this chapter; a combined license under subpart C of part 52 of this chapter; or a manufacturing license under subpart F of part 52 or under subpart D of part 57.
(d)
(1) Matters in controversy; presiding officer consideration of matters not put in controversy by parties. In any initial decision in a contested proceeding on an application for a manufacturing license under subpart F of part 52 or subpart D of part 57 of this chapter (including an amendment to or renewal of a manufacturing license), the presiding officer shall make findings of fact and conclusions of law on the matters put into controversy by the parties and any matter designated by the Commission to be decided by the presiding officer. The presiding officer also shall make findings of fact and conclusions of law on any matter not put into controversy by the parties, but only to the extent that the presiding officer determines that a serious safety, environmental, or common defense and security matter exists, and the Commission approves of an examination of and decision on the matter upon its referral by the presiding officer under, inter alia, the provisions of §§ 2.323 and 2.341.
(2)
(i) In a contested proceeding for the initial issuance or renewal of a manufacturing license under subpart F of part 52 or subpart D of part 57 of this chapter, or the amendment of a manufacturing license, the Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate, after making the requisite findings, shall issue, deny, or appropriately condition the permit or license in accordance with the presiding officer's initial decision once that decision becomes effective.
(ii) In a contested proceeding for the initial issuance or renewal of a manufacturing license under subpart F of part 52 or subpart D of part 57 of this chapter, or the amendment of a manufacturing license, the Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate (appropriate official), may issue the license, permit, or license amendment in accordance with § 2.1202(a) or § 2.1403(a) before the presiding officer's initial decision becomes effective. If, however, the presiding officer's initial decision becomes effective before the license, permit, or license amendment is issued under § 2.1202 or § 2.1403, then the Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate, shall issue, deny, or appropriately condition the license, permit, or license amendment in accordance with the presiding officer's initial decision.
(f)
(i)
(a) In the case of applications under appendix N of part 50 of this chapter for construction permits for nuclear power reactors of the type described in § 50.22 of this chapter, or applications under appendix N of part 52 of this chapter for combined licenses, or applications under part 57 of this chapter for construction permits, the Secretary will issue notices of hearing pursuant to § 2.104.
(a) In the case of applications under appendix N of part 50 of this chapter for construction permits for nuclear power reactors of a type described in 10 CFR 50.22, or applications pursuant to appendix N of part 52 of this chapter for combined licenses, or applications under part 57 of this chapter for construction permits and operating licenses, the Commission or the presiding officer may order separate hearings on particular phases of the proceeding, such as matters related to the acceptability of the design of the reactor in the context of the site parameters postulated for the design or environmental matters.
In the case of applications pursuant to appendix N of part 50 or part 57 of this chapter for operating licenses for nuclear power reactors, if the
If a request for a hearing and/or petition for leave to intervene is filed within the time prescribed in the notice of proposed action on an application for an operating license pursuant to appendix N of part 50 or part 57 of this chapter with respect to a specific reactor(s) at a specific site, and the Commission, the Chief Administrative Judge, or a presiding officer has issued a notice of hearing or other appropriate order, then the Commission, the Chief Administrative Judge, or the presiding officer may order separate hearings on particular phases of the proceeding and/or consolidate for hearing two or more proceedings in the manner described in § 2.402.
Notwithstanding any other provision of this chapter, in a proceeding conducted pursuant to this subpart and appendix N to part 50 or 52 or part 57 of this chapter, no matter which has been reserved for consideration in one phase of the hearing shall be considered at another phase of the hearing except on the basis of significant new information that substantially affects the conclusion(s) reached at the other phase or other good cause.
This subpart prescribes procedures applicable to licensing proceedings that involve the consideration in separate hearings of an application for a license to manufacture nuclear power reactors under subpart F of part 52 or subpart D of part 57 of this chapter.
(a) In the case of an application under subpart F of part 52 or subpart D of part 57 of this chapter for a license to manufacture nuclear power reactors of the type described in § 50.22 or part 57 of this chapter to be operated at sites not identified in the license application, the Secretary will issue a notice of hearing to be published in the
(a) * * *
(3) An application for a manufacturing license under subpart F of 10 CFR part 52 or under subpart D of 10 CFR part 57;
(6) Production or utilization facility licensing actions that involve significant hazards considerations as defined in § 50.92 or subpart H of part 57 of this chapter.
Atomic Energy Act of 1954, secs. 145, 161 (42 U.S.C. 2165, 2201); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); E.O. 10450, 18 FR 2489, 3 CFR, 1949-1953 Comp., p. 936, as amended; E.O. 10865, 25 FR 1583, 3 CFR, 1959-1963 Comp., p. 398, as amended; E.O. 12968, 60 FR 40245, 3 CFR, 1995 Comp., p. 391.
Atomic Energy Act of 1954, secs. 161, 223 (42 U.S.C. 2201, 2273); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note. Section 11.15(e) also issued under 31 U.S.C. 9701; 42 U.S.C. 2214.
Atomic Energy Act of 1954, secs. 53, 63, 81, 103, 104, 161, 223, 234, 1701 (42 U.S.C. 2073, 2093, 2111, 2133, 2134, 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 211, 401 (42 U.S.C. 5841, 5851, 5891); 44 U.S.C. 3504 note.
(a) * * *
(1) All persons who receive, possess, use, or transfer material licensed by the NRC under the regulations in parts 30 through 36, 39, 40, 60, 61, 63, 70, or 72 of this chapter, including persons licensed to operate a production or utilization facility under part 50, part 52, or part 57 of this chapter, persons licensed to possess power reactor spent fuel in an independent spent fuel storage installation (ISFSI) under part 72 of this chapter, and in accordance with 10 CFR 76.60 to persons required to obtain a certificate of compliance or an approved compliance plan under part 76 of this chapter;
(2) All applicants for and holders of licenses (including construction permits
(3) All applicants for and holders of a standard design approval under subpart E of part 52 or under subpart E of part 57 of this chapter; and
(a) Each licensee (except for a holder of an early site permit under subpart A of part 52 of this chapter, or a holder of a manufacturing license under subpart F of part 52 or subpart D of part 57 of this chapter) shall post current copies of the following documents:
(b) Each applicant for and holder of a standard design approval under subpart E of part 52 or subpart E of part 57 of this chapter, each applicant for an early site permit under subpart A of part 52 of this chapter, each applicant for a standard design certification under subpart B of part 52 of this chapter, and each applicant for and holder of a manufacturing license under subpart F of part 52 or subpart D of part 57 of this chapter shall post:
(e)(1) Each licensee, each applicant for a specific license, each applicant for or holder of a standard design approval under subpart E of part 52 or subpart E of part 57 of this chapter, each applicant for an early site permit under subpart A of part 52 of this chapter, and each applicant for a standard design certification under subpart B of part 52 of this chapter shall prominently post NRC Form 3, “Notice to Employees,” dated August 1997. Later versions of NRC Form 3 that supersede the August 1997 version shall replace the previously posted version within 30 days of receiving the revised NRC Form 3 from the Commission.
(a) Each licensee, applicant for a license, applicant for or holder of a standard design approval under subpart E of part 52 or subpart E of part 57 of this chapter, applicant for an early site permit under subpart A of part 52 of this chapter, and applicant for a standard design certification under subpart B of part 52 of this chapter shall afford to the Commission at all reasonable times opportunity to inspect materials, activities, facilities, premises, and records under the regulations in this chapter.
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.
(b)(1) Waste oils (petroleum derived or synthetic oils used principally as lubricants, coolants, hydraulic or insulating fluids, or metalworking oils) that have been radioactively contaminated in the course of the operation or maintenance of a nuclear power reactor licensed under part 50 or part 57 of this chapter may be incinerated on the site where generated provided that the total radioactive effluents from the facility, including the effluents from such incineration, conform to the requirements of appendix I to part 50 of this chapter and the effluent release limits contained in applicable license conditions other than effluent limits specifically related to incineration of waste oil. The licensee shall report any changes or additions to the information supplied under § 50.34, § 50.34a, or subpart C of part 57 of this chapter associated with this incineration pursuant to § 50.71 or 57.315 of this chapter, as appropriate. The licensee shall also follow the procedures of § 50.59 of this chapter with respect to such changes to the facility or procedures.
(b) * * *
(2) * * *
(i) For holders of an operating license for a nuclear power plant, the events included in paragraph (b) of this section must be reported under the procedures described in § 50.73(b), (c), (d), (e), and (g) or § 57.440(b), (c), (d), and (e) of this chapter and must include the information required in paragraph (b)(1) of this section, and
(c) A duplicate report is not required under paragraph (b) of this section if the licensee is also required to submit a report pursuant to § 30.55(c), § 37.57, § 37.81, § 40.64(c), § 50.72, § 50.73, subpart Q of part 57, § 70.52, § 73.27(b), § 73.67(e)(3)(vii), § 73.67(g)(3)(iii), § 73.1205, or § 150.19(c) of this chapter.
(c) For holders of an operating license or a combined license for a nuclear power plant, the occurrences included in paragraph (a) of this section must be reported under the procedures described in § 50.73(b), (c), (d), (e), and (g) or § 57.440(b), (c), (d), and (e) of this chapter, and must include the information required by paragraph (b) of this section. Occurrences reported under § 50.73 or § 57.440(b), (c), (d), and (e) of this chapter need not be reported by a duplicate report under paragraph (a) of this section.
(a) * * *
(1) Operate a nuclear reactor that is both designed to produce electrical or heat energy and of the type described in § 50.21(b) or § 50.22 of this chapter, or is a testing facility as defined in § 50.2 of this chapter; or
Atomic Energy Act of 1954, secs. 53, 63, 81, 103, 104, 161, 223, 234, 1701 (42 U.S.C. 2073, 2093, 2111, 2133, 2134, 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.
(a) * * *
(1) * * *
(2) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, that constructs a production or utilization facility licensed for manufacture, construction, or operation under part 50, part 52, or part 57 of this chapter, an ISFSI for the storage of spent fuel licensed under part 72 of this chapter, an MRS for the storage of spent fuel or high-level radioactive waste under part 72 of this chapter, or a geologic repository for the disposal of high-level radioactive waste under part 60 or part 63 of this chapter; or supplies basic components for a facility or activity licensed, other than for export, under parts 30, 40, 50, 52, 57, 60, 61, 63, 70, 71, or 72 of this chapter;
(4) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, applying for or holding a standard design approval under part 52 or part 57 of this chapter; or supplying basic components with respect to a standard design approval under part 52 or part 57 of this chapter.
(b) For persons licensed to construct a facility under either a construction permit issued under § 50.23 or § 57.95 of this chapter or a combined license under part 52 of this chapter (for the period of construction until the date that the Commission makes the finding under § 52.103(g) of this chapter), or to manufacture a facility under part 52 or part 57 of this chapter, evaluation of potential defects and failures to comply and reporting of defects and failures to comply under § 50.55(e) or § 57.270 of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects and failures to comply under this part and the responsibility of individual directors and responsible officers of these licensees to report defects under Section 206 of the Energy Reorganization Act of 1974.
(c) For persons licensed to operate a nuclear power plant under part 50, part 52, or part 57 of this chapter, evaluation of potential defects and appropriate reporting of defects under § 50.72, § 50.73, § 57.270, or §§ 73.1200 and 73.1205 of this chapter, satisfies each person's evaluation, notification, and reporting obligation to report defects under this part, and the responsibility of individual directors and responsible officers of these licensees to report defects under Section 206 of the Energy Reorganization Act of 1974.
(1) When applied to nuclear power plants licensed under 10 CFR part 50, commercial grade item means a structure, system, or component, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (
(2) When applied to facilities and activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 57, 60, 61, 63, 70, 71, or 72, commercial grade item means an item that is:
(i) Not subject to design or specification requirements that are unique to those facilities or activities;
(ii) Used in applications other than those facilities or activities; and
(iii) To be ordered from the manufacturer/supplier on the basis of specifications set forth in the manufacturer's published product description (for example, a catalog)
(1) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to the regulations in this part if, on the basis of an evaluation, the deviation could create a substantial safety hazard;
(2) The installation, use, or operation of a basic component containing a defect as defined in this section;
(3) A deviation in a portion of a facility subject to the early site permit, standard design certification, standard
(4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued under part 50, part 52, or part 57 of this chapter; or
(5) An error, omission or other circumstance in a design certification, or standard design approval that, on the basis of an evaluation, could create a substantial safety hazard.
(a) * * *
(3) Ensure that a director or responsible officer subject to the regulations of this part is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in paragraphs (a)(1) or (a)(2) of this section if the manufacture, construction, or operation of a facility or activity, a basic component supplied for such facility or activity, the design certification or design approval under part 52 of this chapter, or the design approval under part 57 of this chapter—
(d)(1) * * *
(i) The manufacture, construction or operation of a facility or an activity within the United States that is subject to the licensing requirements under parts 30, 40, 50, 52, 57, 60, 61, 63, 70, 71, or 72 of this chapter and that is within his or her organization's responsibility; or
(ii) A basic component that is within his or her organization's responsibility and is supplied for a facility or an activity within the United States that is subject to the licensing, design certification, or approval requirements under parts 30, 40, 50, 52, 57, 60, 61, 63, 70, 71, or 72 of this chapter.
(b) Any NRC licensee or applicant for a license (including an applicant for, or holder of, a permit), applicant for a design certification under part 52 of this chapter during the pendency of its application, applicant for a design certification after Commission adoption of a final design certification rule for that design, or applicant for or holder of a standard design approval under part 52 or part 57 of this chapter subject to the regulations in this part who fails to provide the notice required by § 21.21, or otherwise fails to comply with the applicable requirements of this part shall be subject to a civil penalty as provided by Section 234 of the Atomic Energy Act of 1954, as amended.
Atomic Energy Act of 1954, secs. 145, 161, 223, 234 (42 U.S.C. 2165, 2201, 2273, 2282); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note; E.O. 10865, 25 FR 1583, as amended, 3 CFR, 1959-1963 Comp., p. 398; E.O. 12829, 58 FR 3479, 3 CFR, 1993 Comp., p. 570; E.O. 13526, 75 FR 707, 3 CFR, 2009 Comp., p. 298; E.O. 12968, 60 FR 40245, 3 CFR, 1995 Comp., p. 391. Section 25.17(f) and Appendix A also issued under 31 U.S.C. 9701; 42 U.S.C. 2214.
(a) The number of classified visits must be held to a minimum. The licensee, certificate holder, applicant for a standard design certification under part 52 of this chapter (including an applicant after the Commission has adopted a final standard design certification rule under part 52 of this chapter), or other facility, or an applicant for or holder of a standard design approval under part 52 or part 57 of this chapter shall determine that the visit is necessary and that the purpose of the visit cannot be achieved without access to, or disclosure of, classified information. All classified visits require advance notification to, and approval of, the organization to be visited. In urgent cases, visit information may be furnished by telephone and confirmed in writing.
Atomic Energy Act of 1954, secs. 53, 103, 104, 107, 161, 223, 234, 1701 (42 U.S.C. 2073, 2133, 2134, 2137, 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); 44 U.S.C. 3504 note.
(a) Licensees who are authorized to operate a nuclear power reactor under 10 CFR 50.57, and holders of a combined license under 10 CFR part 52 after the Commission has made the finding under 10 CFR 52.103(g) shall comply with the requirements of this part, except for subparts K and P of this part. Licensees who receive their authorization to operate a nuclear power reactor under 10 CFR 50.57 after the date of publication of this final rule in the
(b) Licensees who are authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM) under part 70 of this chapter, and any corporation, firm, partnership, limited liability company, association, or other organization who obtains a certificate of compliance or an approved compliance plan under part 76 of this chapter, only if the entity elects to engage in activities involving formula quantities of SSNM shall comply with the requirements of this
(c) Before the receipt of special nuclear material in the form of fuel assemblies, the following licensees and other entities shall comply with the requirements of this part, except for subparts I and P of this part; and, no later than the receipt of special nuclear material in the form of fuel assemblies, the following licensees and other entities shall comply with the requirements of this part, except for subpart P of this part:
(d) Contractor/vendors (C/Vs) who implement FFD programs or program elements, to the extent that the licensees and other entities specified in paragraphs (a) through (c) and (f) of this section rely on those C/V FFD programs or program elements to meet the requirements of this part, shall comply with the requirements of this part.
(f) Applicants for and holders of licenses, permits, and approvals under part 57 of this chapter, as applicable, must implement their FFD programs as follows:
(1) No later than the start of construction activities, licensees and other entities that have applied for or have been issued an operating license or construction permit under part 57 of this chapter must implement the requirements in subpart P of this part, all the requirements of this part except subparts K and P, or an FFD program of their specification.
(2) Holders of a manufacturing license under part 57 of this chapter must implement the requirements in subpart P, all the requirements of this part except subparts K and P, or an FFD program of their specification, before commencing activities that assemble a manufactured reactor.
(3) Licensees and other entities that have applied for or have been issued an operating license or construction permit under part 57 of this chapter, and holders of a manufacturing license under part 57 of this chapter, may elect to implement an FFD program of their specification only if the licensee's or other entity's reactor manufactured under a manufacturing license issued under part 57 of this chapter, constructed under a construction permit issued under part 57 of this chapter, or operated under an operating license issued under part 57 of this chapter, as applicable, would not require operator action to maintain the reactor within the criterion of § 57.25(a) of this chapter or a credible operator or maintenance error could not result in exceeding that criterion.
(a) All persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3 (a) and, as applicable, (c) and perform the following duties shall be subject to an FFD program that meets all of the requirements of this part, except subparts K and P of this part, and those persons who are granted unescorted access to either nuclear power reactor protected areas or remote facilities where safety-significant systems or components may be operated within the design basis of a nuclear plant, by the licensees and other entities in § 26.3(f) and perform the following duties must be subject to an FFD program that satisfies either the requirements in subpart P of this part or all of the requirements of this part except subparts K and P, unless the licensee or other entity meets the criteria in § 26.3(f)(3) and subjects these individuals to an FFD program of its own specification:
(1) For persons who are granted unescorted access by the licensees in § 26.3(a) and, as applicable, (c), operating or onsite directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety; for those persons who are granted unescorted access by the licensees and other entities in § 26.3(f), operating or directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety;
(4) For persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c), performing maintenance or onsite directing of the maintenance of SSCs that a risk-informed evaluation process has shown to be significant to public health and safety; for those persons who are granted unescorted access to nuclear power reactor protected areas by the licensees and other entities in § 26.3(f), performing maintenance or directing of the maintenance of SSCs that a risk-informed evaluation process has shown to be significant to public health and safety; and
(b) All persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c) and who do not perform the duties described in paragraph (a) of this section shall be subject to an FFD program that meets all of the requirements of this part, except §§ 26.205 through 26.209 and subparts K and P of this part. All persons who are granted unescorted access to a facility licensed under part 57 of this chapter, and who do not perform or direct the performance of the duties described in § 26.4(a), must be subject to either the requirements in subpart P of this part or all the requirements of this part, except §§ 26.205 through 26.209 and subparts K and P, unless the licensee or other entity meets the criteria in § 26.3(f)(3) and subjects these individuals to an FFD program of its own specification.
(c) All persons who are required by a licensee in § 26.3(a) and, as applicable, (c) to physically report to the licensee's Technical Support Center or Emergency Operations Facility by licensee emergency plans and procedures shall be subject to an FFD program that meets all of the requirements of this part, except §§ 26.205 through 26.209 and subparts K and P of this part. For licensees or other entities in § 26.3(f), all persons without unescorted access to the facility who make decisions and/or direct actions regarding plant safety and security, and all persons who participate remotely in emergency response activities or physically report to the Technical Support Center or Emergency Operations Facility (or an equivalent facility), must be subject to an FFD program that satisfies either all of the requirements described in subpart P of this part or all the requirements of this part, except §§ 26.205 through 26.209 and subparts K and P, unless the licensee or other entity meets the criteria in § 26.3(f)(3) and subjects these individuals to an FFD program of its own specification.
(e) When construction activities, as defined in § 26.5, begin, any individual whose duties for the licensees and other entities in § 26.3(c) require him or her to have the following types of access or perform the following activities at the location where the nuclear power plant will be constructed and operated shall be subject to an FFD program that meets all of the requirements of this part, except subparts I, K, and P of this part, and for any individual whose duties for the licensees and other entities in § 26.3(f) require him or her to have the
(f) Any individual who is constructing or directing the construction of safety- or security-related SSCs shall be subject to an FFD program that meets the requirements of subpart K, or, if applicable, subpart P of this part or all the requirements of this part, except for subparts I, K, and P of this part, unless the licensee or other entity meets the criteria in § 26.3(f)(3) and subjects these individuals to an FFD program of its own specification.
(g) All FFD program personnel who are involved in the day-to-day operations of the program, as defined by the procedures of the licensees and other entities in § 26.3(a) through (c), and, as applicable, (d) and whose duties require them to have the following types of access or perform the following activities shall be subject to an FFD program that meets all of the requirements of this part, except subparts I, K, and P of this part, and, at the licensee's or other entity's discretion, subpart C of this part. All personnel whose duties require them to have the following types of access or perform the following activities at facilities licensed under part 57 of this chapter must be subject to the requirements in either subpart P or all the requirements of this part, except subparts I, K, and P, and, at the licensee's or other entity's discretion, subpart C of this part, unless the licensee or other entity meets the criteria in § 26.3(f)(3) and subjects these individuals to an FFD program of its own specification:
(h) Individuals who have applied for authorization to have the types of access or perform the activities described in paragraphs (a) through (d) of this section shall be subject to §§ 26.31(c)(1), 26.35(b), 26.37, 26.39, and the applicable requirements of subparts C, E through H, and P of this part, unless the licensee or other entity meets the criteria in § 26.3(f)(3) and subjects these individuals to an FFD program of its own specification.
(b) The approved information collection requirements contained in this part appear in §§ 26.9, 26.27, 26.29, 26.31, 26.33, 26.35, 26.37, 26.39, 26.41, 26.53, 26.55, 26.57, 26.59, 26.61, 26.63, 26.65, 26.67, 26.69, 26.75, 26.77, 26.85, 26.87, 26.89, 26.91, 26.93, 26.95, 26.97, 26.99, 26.101, 26.103, 26.107, 26.109, 26.111, 26.113, 26.115, 26.117, 26.119, 26.125, 26.127, 26.129, 26.135, 26.137, 26.139, 26.153, 26.157, 26.159, 26.163, 26.165, 26.167, 26.168, 26.169, 26.183, 26.185, 26.187, 26.189, 26.202, 26.203, 26.205, 26.207, 26.211, 26.401, 26.403, 26.405, 26.406, 26.407, 26.411, 26.413, 26.415, 26.417, 26.711, 26.713, 26.715, 26.717, 26.719, 26.821, 26.903, 26.904, 26.906, 26.907, 26.908, 26.909, 26.911, 26.913, 26.917, and 26.919.
The licensees and other entities specified in § 26.3(a) through (c) and (f) (for those licensees and other entities that do not implement the requirements in subparts P and K of this part, and do not implement an FFD program of their own specification if they meet the criteria in § 26.3(f)(3) shall establish, implement, and maintain FFD programs that, at a minimum, comprise the program elements contained in this subpart. The individuals specified in § 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, § 26.4(f), and, if necessary, § 26.4(j) shall be subject to these FFD programs. Licensees and other entities may rely on the FFD program or program elements of a C/V, as defined in § 26.5, if the C/V's FFD program or program elements satisfy the applicable requirements of this part.
(c) * * *
(3) If a licensee or other entity receives a report from EAP personnel under paragraph (c)(2) of this section, the licensee or other entity must ensure that the requirements of §§ 26.69(d) and 26.77(b), or the procedures and actions required by § 26.906(b)(2)(vii) are implemented, as applicable.
The requirements in this subpart apply to the licensees and other entities identified in § 26.3(a), (b), and, as applicable, (c) for the categories of individuals in § 26.4(a) through (d), and, at the licensee's or other entity's discretion, in § 26.4(g) and, if necessary, § 26.4(j). The requirements in this subpart also apply to the licensees and other entities specified in § 26.3(c), as applicable, for the categories of individuals in § 26.4(e). At the discretion of a licensee or other entity in § 26.3(c), the requirements of this subpart also may be applied to the categories of individuals identified in § 26.4(f). In addition, the requirements in this subpart apply to the entities in § 26.3(d) to the extent that a licensee or other entity relies on the C/V to satisfy the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h). The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart P for the categories of individuals in § 26.4 and do not implement an FFD program of their own specification if they meet the criteria in § 26.3(f)(3).
(e) Licensees and other entities in § 26.3(a) through (c) and (f) may also rely on a C/V's FFD program or program elements when granting or maintaining the authorization of an individual who is or has been subject to the C/V's FFD program, if the C/V's program or program elements meet the applicable requirements of this part.
(g) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), shall identify any violation of any requirement of this part to any licensee who has relied on or intends to rely on the FFD program element that is determined to be in violation of this part.
(h) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), may not initiate any actions under this subpart without the knowledge and written consent of the subject individual. The individual may withdraw his or her consent at any time. If an individual withdraws his or her consent, the licensee or other entity may not initiate any elements of the authorization process specified in this subpart that were not in progress at the time the individual withdrew his or her consent, but shall complete and document any elements that are in progress at the time consent is withdrawn. The licensee or other entity shall record the individual's application for authorization; his or her withdrawal of consent; the reason given by the individual for the withdrawal, if any; and any pertinent information gathered from the elements that were completed (
(i) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), shall inform, in writing, any individual who is applying for authorization that the following actions related to providing and sharing the personal information required under this subpart are sufficient cause for denial or unfavorable termination of authorization:
(d) When any licensee or other entity in § 26.3(a) through (d) and (f) is legitimately seeking the information required for an authorization decision under this subpart and has obtained a signed release from the subject individual authorizing the disclosure of information, any licensee or other entity subject to this part shall disclose whether the subject individual's authorization was denied or terminated
The requirements in this subpart apply to the licensees and other entities identified in § 26.3(a), (b), and, as applicable, (c) for the categories of individuals specified in § 26.4(a) through (d) and (g). The requirements in this subpart also apply to the licensees and other entities specified in § 26.3(c), as applicable, for the categories of individuals in § 26.4(e). At the discretion of a licensee or other entity in § 26.3(c), the requirements of this subpart also may be applied to the categories of individuals identified in § 26.4(f). In addition, the requirements in this subpart apply to the entities in § 26.3(d) to the extent that a licensee or other entity relies on the C/V to satisfy the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart P for the categories of individuals in § 26.4 and do not implement an FFD program of their own specification if they meet the criteria in § 26.3(f)(3).
This subpart contains requirements for collecting specimens for drug testing and conducting alcohol tests by or on behalf of the licensees and other entities in § 26.3(a) through (d) for the categories of individuals specified in § 26.4(a) through (d) and (g). At the discretion of a licensee or other entity in § 26.3(c), specimen collections and alcohol tests must be conducted either under this subpart for the individuals specified in § 26.4(e) and (f) or the licensee or other entity may rely on specimen collections and alcohol tests conducted under the requirements of 49 CFR part 40 for the individuals specified in § 26.4(e) and (f). The requirements of this subpart do not apply to specimen collections and alcohol tests that are conducted under the requirements of 49 CFR part 40, as permitted in this paragraph and under §§ 26.4(j) and 26.31(b)(2) and subpart K. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart P for the categories of individuals in § 26.4 and do not implement an FFD program of their own specification if they meet the criteria in § 26.3(f)(3).
(a) The collector, with the assistance of a virtual collection monitor as permitted under § 26.907(g)(2) of this chapter, if applicable, shall perform the oral fluid specimen collection consistent with the device manufacturer's instructions. At a minimum, the collector shall—
(1) Check the expiration date on the device and show it to the donor (the device cannot be used after its expiration date).
(2) Explain the collection process to the donor, including any actions the donor must perform during the collection process, and that a failure to cooperate with the specimen collection process will be considered a refusal to test and sanctions for subverting the testing process will be imposed.
(3) Instruct the donor to wash and dry their hands before providing a specimen. If a sink is not available in the area where the collection is to be conducted, another equivalent method to clean the donor's hands must be provided (
(4) Ensure that the donor's mouth is free of any items that could impede or interfere with the collection of an oral fluid specimen, such as food or tobacco.
(5) Open in the presence of the donor, or direct the donor to open an individually wrapped or sealed package containing the device.
(6) Instruct the donor to insert the device into their mouth to gather oral fluids in the manner described in the device manufacturer's instructions.
(7) When the device is ready to be removed from the donor's mouth, follow the device manufacturer's instructions to complete the collection process.
(b) If all steps in paragraph (a) of this section could not be completed successfully (
(1) Discard the oral fluid specimen device;
(2) Document the reason(s) that a new specimen collection is required, or the reasons that a donor has been determined to have refused the test; and
(3) If a new specimen collection is required, collect a new specimen under paragraph (a) of this section.
(a) The requirements in this subpart, with the exception of § 26.202, apply to the licensees and other entities identified in § 26.3(a); if applicable, (c), (d), and (f), for licensees and other entities not implementing the requirements in subparts K and P and that do not implement an FFD program of their own specification if they meet the criteria in § 26.3(f)(3). For the licensees and other entities to whom the requirements in this subpart, with the exception of § 26.202, apply, the requirements in §§ 26.203 and 26.211 apply to the individuals identified in § 26.4(a) through (c). In addition, the requirements in § 26.205 through § 26.209 apply to the individuals identified in § 26.4(a).
(b) The requirements in this subpart, with the exception of § 26.203, apply to the licensees or other entities identified in § 26.3(f) implementing this subpart under § 26.904. For these licensees and other entities, the requirements in §§ 26.202 and 26.211 apply to the individuals identified in § 26.4(a) through (c) and any person licensed to operate under 10 CFR part 57; and the requirements in §§ 26.205 through 26.209 apply to the individuals identified in § 26.4(a).
(a)
(b)
(1) Describe the process to be followed when any individual identified in § 26.4(a) through (c) makes a self-declaration that the individual is not fit to safely and competently perform his or her duties for any part of a working tour as a result of fatigue. The procedure must—
(i) Describe the individual's and licensee's rights and responsibilities related to self-declaration;
(ii) Describe requirements for establishing controls and conditions under which an individual may be permitted or required to perform work after that individual declares that he or she is not fit due to fatigue; and
(iii) Describe the process to be followed if the individual disagrees with the results of a fatigue assessment that is required under § 26.211(a)(2);
(2) Describe the process for implementing the controls required under § 26.205 for the individuals who are performing the duties listed in § 26.4(a);
(3) Describe the process to be followed in conducting fatigue assessments under § 26.211; and
(4) Describe the disciplinary actions that the licensee may impose on an individual following a fatigue assessment, and the conditions and considerations for taking those disciplinary actions.
(c)
(1) Knowledge of the contributors to worker fatigue, circadian variations in alertness and performance, indications and risk factors for common sleep disorders, shiftwork strategies for obtaining adequate rest, and the effective use of fatigue countermeasures; and
(2) Ability to identify symptoms of worker fatigue and contributors to decreased alertness in the workplace.
(d)
(1) Records of work hours for individuals who are subject to the work hour controls in § 26.205;
(2) For licensees implementing the requirements of § 26.205(d)(3), records of shift schedules and shift cycles, or, for licensees implementing the requirements of § 26.205(d)(7), records of shift schedules and records showing the beginning and end times and dates of all averaging periods, of individuals who are subject to the work hour controls in § 26.205;
(3) The documentation of waivers that is required in § 26.207(a)(4), including the bases for granting the waivers;
(4) The documentation of work hour reviews that is required in § 26.205(e)(3) and (e)(4); and
(5) The documentation of fatigue assessments that is required in § 26.211(g).
(e)
(1) A summary for each nuclear power plant site of all instances during the previous calendar year when the licensee waived one or more of the work hour controls specified in § 26.205(d)(1) through (d)(5)(i) and (d)(7) for individuals described in § 26.4(a). The summary must include only those waivers under which work was performed. If it was necessary to waive more than one work hour control during any single extended work period, the summary of instances must include each of the work hour controls that were waived during the period. For each category of individuals specified in § 26.4(a), the licensee must report—
(i) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (iii), (d)(2)(i) and (ii), (d)(3)(i) through (v), and (d)(7) was waived for individuals not working on outage activities;
(ii) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (iii), (d)(2)(i) and (ii), (d)(3)(i) through (v), (d)(4) and (d)(5)(i), and (d)(7) was waived for individuals working on outage activities; and
(iii) A summary that shows the distribution of waiver use among the individuals applicable within each category of individuals identified in § 26.4(a) (
(2) A summary of corrective actions, if any, resulting from the analyses of these data, including fatigue assessments.
(f)
(d) * * *
(7) * * *
(iii) Each licensee shall state, in its FFD policy and procedures required by either § 26.27 and § 26.203(a) and (b) or § 26.202(a) and (b) and § 26.906, the work hour counting system in § 26.205(d)(7)(ii) the licensee is using.
(8) Each licensee shall state, in its FFD policy and procedures required by either § 26.27 and § 26.203(a) and (b) or § 26.202(a) and (b) and § 26.906, the requirements with which the licensee is complying: the minimum days off requirements in § 26.205(d)(3) or maximum average work hours requirements in § 26.205(d)(7).
(a) * * *
(1) * * *
(ii) A supervisor assesses the individual face to face and determines that there is reasonable assurance that the individual will be able to safely and competently perform his or her duties during the additional work period for which the waiver will be granted. The supervisor performing the assessment shall be trained as required by either § 26.29 and § 26.203(c) or § 26.202(c) and § 26.908 and shall be qualified to direct the work to be performed by the individual. If there is no supervisor on site who is qualified to direct the work, the assessment may be performed by a supervisor who is qualified to provide oversight of the work to be performed by the individual. At a minimum, the assessment must address the potential for acute and cumulative fatigue considering the individual's work history for at least the past 14 days, the potential for circadian degradations in alertness and performance considering the time of day for which the waiver will be granted, the potential for fatigue-related degradations in alertness and performance to affect risk-significant functions, and whether any controls and conditions must be established under which the individual will be permitted to perform work. For licensees and other entities in § 26.3(f), the assessment may be performed remotely using electronic communications. In such instances, the assessment must be supported by someone who is present in-person with the individual whose alertness may be impaired, and that supporting person must be trained under the requirements of either § 26.29 and § 26.203(c) or § 26.202(c) and § 26.908.
(a) * * *
(1) For-cause. In addition to any other test or determination of fitness that may be required under §§ 26.31(c), 26.77, 26.907(b), and 26.919, a fatigue
(3) Post-event. A fatigue assessment must be conducted in response to events requiring post-event drug and alcohol testing as specified in § 26.31(c) or post-event tests in § 26.907(b)(4). Licensees may not delay necessary medical treatment in order to conduct a fatigue assessment; and
(b) Only supervisors and FFD program personnel who are trained under either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.908 may conduct a fatigue assessment. The fatigue assessment must be conducted face to face with the individual whose alertness may be impaired. For licensees and other entities in § 26.3(f), a fatigue assessment may be performed remotely using electronic communications. In such instances, the fatigue assessment must be supported by someone who is present in-person with the individual whose alertness may be impaired, and that supporting person must be trained in accordance with the requirements of either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.908.
(a) The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(a) through (d), except for FFD programs that are implemented under subpart K of this part.
(b) The requirements in this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(f) that elect not to implement the requirements in subpart P and do not implement an FFD program of their own specification if they meet the criteria in § 26.3(f)(3).
(c) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), shall inform each individual of his or her right to review information about the individual that is collected and maintained under this part to assure its accuracy. Licensees and other entities shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is documented by licensees and other entities about the individual.
(d) Licensees and other entities shall ensure that only correct and complete information about individuals is retained and shared with other licensees and entities. If, for any reason, the shared information used for determining an individual's eligibility for authorization under this part changes or new information is developed about the individual, licensees and other entities shall correct or augment the shared information contained in the records. If the changed or developed information has implications for adversely affecting an individual's eligibility for authorization, a licensee and other entity specified in § 26.3(a) and, as applicable, (c), (d), and (f), who has discovered the incorrect information, or develops new information, shall inform the reviewing official of any FFD program under which the individual is maintaining authorization of the updated information on the day of discovery. The reviewing official shall evaluate the information and take appropriate actions, which may include denial or unfavorable termination of the individual's authorization.
A licensee or other entity in § 26.3(f) that elects to implement the requirements of this subpart must establish, implement, and maintain a fitness-for-duty (FFD) program that satisfies the requirements of this subpart for those categories of individuals in § 26.4, as applicable, and any person licensed to operate under 10 CFR part 57.
(a)
(1) A discussion of the applicability of the FFD program to those individuals described in § 26.4 and how the program will be implemented at a facility authorized to assemble or perform non-operational testing of a manufactured reactor under a manufacturing license issued under part 57 of this chapter, if applicable; and
(2) A description of the drug and alcohol testing and fitness determination process to be implemented through the licensee's or other entity's procedures, including the collection and testing facilities to be used, biological specimens to be collected and tested, and sanctions to be imposed for FFD policy violations.
(b)
(c)
(1) The licensee or other entity may make changes to its FFD program under this subpart if—
(i) The licensee or other entity performs and retains an analysis demonstrating that the changes do not reduce the effectiveness of the FFD program; or
(ii) The change was necessitated or justified by a change to part 26, laboratory processes or procedures, or guidance issued by the HHS or NRC, as implemented by the licensee or other entity though its procedures.
(2) A licensee or other entity desiring to make a change that decreases FFD program effectiveness must implement a mitigating strategy so the FFD program, as revised, will continue to satisfy the performance objectives in § 26.23 and
(3) Notwithstanding § 26.903(c)(1)(ii), the change control process may not be used to reduce the minimum panel of drugs to be tested in § 26.907(c)(1).
(4) The licensee must retain a record of each change made under this section for a period of at least 5 years from the date the change was implemented and summarize this change in its annual FFD performance report required by § 26.917(b)(2) or § 26.717, as applicable.
(a) The licensee or other entity must establish, implement, and maintain an FFD program under this subpart before the start of—
(1) for a holder of a manufacturing license, activities authorized by the manufacturing license;
(2) for a holder of a construction permit, construction activities as defined in § 26.5;
(3) for the holder of an operating license—
(i) operational testing of a manufactured reactor at a manufacturing facility; and
(ii) the earliest occurrence of the following at the operating site, as applicable:
(A) the loading of fuel into a reactor vessel;
(B) the receipt of a fueled manufactured reactor; and
(C) individuals subject to part 26 operate, test, perform maintenance of, or direct the maintenance or surveillance of security-related equipment or equipment that a risk-informed evaluation process has shown to be significant to public health and safety; and
(4) for a general licensee under § 57.45(d), construction activities as defined in § 26.5.
(b) The FFD program required by this subpart must:
(1) Apply to those individuals described in § 26.4, as applicable; and
(2) Implement the following requirements and subparts:
(i) Section 26.23, Performance objectives;
(ii) Section 26.35, Employee assistance programs;
(iii) Section 26.903, General provisions;
(iv) Section 26.906, Written policies and procedures;
(v) Section 26.907, Drug and alcohol testing;
(vi) Section 26.908, FFD program training;
(vii) Section 26.909, Behavioral observation;
(viii) Section 26.910, Sanctions;
(ix) Section 26.911, Protection of information;
(x) Section 26.913, Appeals process;
(xi) Section 26.915, Audits;
(xii) Section 26.917, Recordkeeping, reporting, and FFD program performance;
(xiii) Section 26.919, Suitability and fitness determinations;
(xiv) Subpart A—Administrative Provisions;
(xv) Subpart I—Managing Fatigue; and
(xvi) Subpart O—Inspections, Violations, and Penalties.
(a) Licensees and other entities that implement an FFD program under this subpart must ensure that—
(1) A written FFD policy statement is provided to each individual who is subject to the program before the individual is subject to drug and alcohol testing.
(2) The FFD policy statement describes the performance objectives in § 26.23.
(3) The FFD policy statement describes the minimum days off requirements in § 26.205(d)(3) or maximum average work hours requirements in § 26.205(d)(7).
(4) The FFD policy statement must be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy, including those elements described in § 26.906(b), part 26-required sanctions, and required medical/clinical treatment and follow-up testing for FFD policy violations.
(5) The FFD policy statement describes the individual's responsibilities to report for work in a physiological and psychological condition that enables the safe and competent performance of assigned duties and responsibilities and inform a licensee- or other entity-designated representative when the individual determines that this cannot be accomplished.
(6) The FFD policy statement must prohibit the consumption of alcohol, at a minimum, within an abstinence period of 5 hours preceding the individual's arrival at the licensee's or other entity's facility.
(7) The FFD policy statement must convey that abstinence from alcohol for the 5 hours preceding any scheduled tour of duty is considered to be a minimum that is necessary, but may not be sufficient, to ensure that the individual is fit for duty.
(b) Licensees and other entities must establish, implement, and maintain written procedures that address the following topics:
(1) For the drug and alcohol testing program under this subpart,
(i) The methods and techniques to collect and test for drugs and alcohol and for the shipping and temporary storage of biological specimens used for drug testing at HHS-certified laboratories,
(ii) The urine specimen volumes, techniques for split specimen collections, and the acceptability of a urine specimen as described in § 26.111 or as described in the HHS Guidelines,
(iii) Protecting the privacy of an individual who provides a specimen, protecting the integrity of the specimen, and ensuring that the test results are valid and attributable to the correct individual, and
(iv) If the licensee or other entity elects to use the HHS Guidelines, the name of the specific HHS Guideline and revision being implemented by the licensee or other entity and a description of the specific sections in the guideline that are being implemented in the procedure, including specimen collections, drug testing, and evaluation of test results.
(2) The immediate and follow-up actions that will be taken, and the procedures to be used, in those cases in which individuals who are subject to the FFD program:
(i) Have been involved in the use, sale, or possession of illegal substances, illegal drugs, or illicit substances;
(ii) Are impaired by any illegal substances, illegal drugs, or illicit substances or the consumption of alcohol as determined by behavioral observation or a test that measures blood alcohol concentration;
(iii) Attempted to subvert the testing process by adulterating or diluting specimens (
(iv) Refused to provide a specimen for analysis or follow instructions provided by FFD program personnel;
(v) Had legal action taken relating to drug or alcohol use;
(vi) Demonstrated character or actions indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, special nuclear material (SNM), or sensitive information; or
(vii) Have a condition or have taken actions that pose or have posed an immediate hazard to themselves or others, as notified by EAP personnel under § 26.35(c)(2).
(3) The process, including the duties and responsibilities of FFD program
(4) Operation and oversight of any onsite or offsite collection facility.
(5) The fatigue management requirements in §§ 26.202(b) and either 26.205(d)(3) or (d)(7).
(6) Measures to prevent subversion of drug and alcohol tests conducted onsite and offsite.
Licensees and other entities must perform drug and alcohol testing that complies with the following requirements—
(a)
(b)
(1)
(2)
(i) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected;
(ii) Require individuals who are selected for random testing to report to the onsite collection site as soon as reasonably practicable after notification, within the time period specified in the FFD program procedure;
(iii) Ensure that all individuals in the population that is subject to random testing on a given day have an equal probability of being selected and tested;
(iv) Ensure that an individual completing a test is immediately eligible for another random test; and
(v) Ensure that the sampling process used to select individuals for random testing provides that the number of random tests performed annually is equal to at least 50 percent of the population that is subject to the FFD program at the NRC-licensed site.
(vi) If the number of individuals subject to random testing at an NRC-licensed site is such that paragraph (b)(2)(v) of this section cannot be implemented without predictable outcomes, the licensee must use a consortium/third-party administrator to manage the random testing pool and make selections for testing throughout the year. In such instances, the consortium/third-party administrator must ensure that the testing rate for the random testing pool from which they sample meets the requirement in paragraph (b)(2)(v).
(3)
(4)
(i) As soon as practical after an event involving a human error that was committed by an individual specified in § 26.4, where the human error may have caused or contributed to the event. This test must be conducted onsite unless the individual requires offsite medical care. The licensee or other entity must test the individual(s) who committed or directed the error and need not test individuals who were affected by the event and whose actions likely did not cause or contribute to the event. The licensee or other entity must describe in its procedures what constitutes a human error.
(ii) Within 4 hours of an event unless immediate medical intervention precludes the conduct of the test on the individual(s) who caused or contributed to the accident(s), if the event results in—
(A) An illness or personal injury to any individual which results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury, as diagnosed by a licensee- or other entity-designated physician or other licensed health care professional, even if the illness or injury does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness; or
(B) Damage to any safety- or security-related structures, systems, and components; and
(5)
(c)
(1) All urine or oral fluid specimens must be tested for the substances listed in § 26.31(d)(1), except as allowed by § 26.903(c)(3). All urine specimens must be subject to validity testing as specified in either this part or the HHS Guidelines. All oral fluid specimens may be subject to validity testing, including a biological marker, as specified in either this part or the HHS Guidelines.
(2) For the use of urine as the biological specimen to be tested, the following requirements must be implemented—
(i) Section 26.115, Collecting a urine specimen under direct observation;
(ii) Section 26.119, Determining “shy” bladder; and
(iii) Section 26.163, Cutoff levels for drugs and drug metabolites.
(3) For alcohol testing onsite, the following requirements must be implemented—
(i) Section 26.91, Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use;
(ii) Section 26.93, Preparing for alcohol testing;
(iii) Section 26.95, Conducting an initial test for alcohol using a breath specimen;
(iv) Section 26.97, Collecting oral fluid specimens for alcohol and drug testing;
(v) Section 26.99, Determining the need for a confirmatory test for alcohol;
(vi) Section 26.101, Conducting a confirmatory test for alcohol; and,
(vii) Section 26.103, Determining a confirmed positive test result for alcohol.
(4) For all test conditions in § 26.907(b), MRO-directed tests under § 26.185, and the testing of a split specimen, drug testing must be performed at an HHS-certified laboratory for the specific biological
(5) The licensee or other entity must establish and maintain a contract with an HHS-certified laboratory for each specimen to be tested. Each contract must stipulate the following:
(i) The laboratory must comply with the applicable provisions of any State licensor requirements;
(ii) Laboratory records and documents must be provided and/or able to be photocopied and removed from the premises to support an inspection or audit;
(iii) The laboratory must make available qualified personnel to testify in an administrative or disciplinary proceeding against an individual when that proceeding is based on test results reported by the HHS-certified laboratory;
(iv) The laboratory must maintain test records in confidence, consistent with the requirements of § 26.37, and use them with the highest regard for individual privacy;
(v) Consistent with the principles established in section 503 of Public Law 100-71, any employee of a licensee or other entity who is the subject of a drug test (or his or her representative designated under § 26.37(d)) must, on written request, have access to the laboratory's records related to his or her validity and drug test and any records related to the results of any relevant certification, review, or revocation-of-certification proceedings;
(vi) The laboratory may not enter into any relationship with the licensee's or other entity's MRO(s) that may be construed as a potential conflict of interest, including, but not limited to, the relationships described in § 26.183(b), and may not derive any financial benefit by having a licensee or other entity use a specific MRO; and
(vii) The laboratory must permit representatives of the NRC and any licensee or other entity using the laboratory's services to inspect the laboratory at any time, including unannounced inspections.
(d)
(e)
(f)
(g)
(1) If the licensee or other entity elects to use oral fluid for drug or alcohol testing, the collection, packaging, temporary storage and shipment of an oral fluid specimen to an HHS-certified laboratory for drug testing, or the collection of an oral fluid specimen for alcohol testing must be performed in accordance with licensee- or other entity-established procedures based either on the requirements in this part or the procedures in HHS Guidelines identified by the licensee or other entity in § 26.906(b)(1)(iv). The oral fluid device must not expire before the date of the collection of the specimen for testing. The drugs, drug metabolites, initial and confirmatory testing cutoffs, and biological markers, if applicable, must be those established by the HHS Guidelines for oral fluid testing and the alcohol cutoffs in this part or, if not established by the HHS Guidelines or this part for the panel of drugs and drug metabolites to be tested, as determined and documented by a forensic toxicologist review conducted pursuant to § 26.31(d)(1)(i)(D).
(2) The virtual collection of oral fluid specimens for drug and alcohol testing is only permitted for sites that must use a consortium/third-party administrator to implement random testing under § 26.907(b)(2)(vi). For a licensee or other entity to utilize a virtual oral fluid specimen collection process, the following must apply or should be considered, as applicable:
(i) The specimen collector completing the virtual collection must meet the requirements in 10 CFR 26.85, “Collector qualifications and responsibilities.”
(ii) The oral fluid specimen collection process must be completed as described in § 26.97, “Collecting oral fluid specimens for alcohol and drug testing,” and § 26.99, “Determining the need for a confirmatory test for alcohol.”
(iii) An individual other than the donor (
(iv) If a virtual collection monitor is used to assist the specimen collector in completing an oral fluid specimen collection, then the virtual specimen collector must explain the collection process to the monitor and provide instruction to the monitor on required activities to be performed during the collection process. The monitor's name must be recorded on the Federal CCF for drug testing specimens, or an analogous document for alcohol testing.
(v) Video teleconference communication method(s) must provide sufficient visual and aural clarity to complete the process and ensure that a donor is not able to subvert the testing process.
(vi) Collection kit materials must be maintained in a secure fashion until the virtual collector initiates the virtual collection process with the donor.
(vii) The licensee or other entity's written FFD procedures must describe in detail the virtual collection process and when and how it is to be implemented.
(viii) The virtual collection procedure must address problem collections, such as the video teleconference becomes inoperable during the collection process or the donor is unable to provide an oral fluid specimen of sufficient quantity to complete the specimen collection process for drug or alcohol testing.
(ix) The virtual collection procedure must include steps to collect a breath specimen using an EBT if the oral fluid specimen test result under § 26.99(b) requires a confirmatory testing for alcohol under § 26.101. At a minimum, a donor with an oral fluid specimen test result requiring confirmatory testing for alcohol must be removed from duty pending additional testing.
(h)
(1) If used, this process must be described in the licensee's or other entity's FFD policy and described in detail in its procedure. The panel of drugs and drug metabolites to be evaluated must only include those listed as Schedule I or II of section 202 of the Controlled Substances Act [21 U.S.C. 812]. The collection, packaging, and temporary storage of a hair specimen and shipment of the specimen to an HHS-certified laboratory must be conducted in accordance with the HHS Guidelines. The licensee- or other entity-designated FFD program personnel must conduct the collection, packaging, temporary storage, shipping, and custody and control of the specimen.
(2) Before the licensee or other entity begins to conduct hair testing, the initial and confirmatory testing cutoffs must be the cutoffs established by the HHS Guidelines for hair testing or, if not established by the HHS Guidelines or this part, as determined by a forensic toxicologist review conducted pursuant to § 26.31(d)(1)(i)(D).
(3) Confirmed positive test results must be considered potentially disqualifying FFD information until proven otherwise by a review under § 26.913. Sanctions under this subpart must not be issued for any FFD policy violation involving a drug test using a hair specimen unless the licensee or other entity determines that the individual has attempted to subvert the testing process, as defined in § 26.5, for the hair test.
(i)
(1) The instrument must be operated in accordance with the manufacturer's specifications. If screening detects the presence of any drug, drug metabolite, or alcohol at or above the instrument set point(s), the individual screened by the instrument must be subject to for-cause testing under § 26.907(b)(3).
(2) Annually, the licensee or other entity must verify the accuracy of the portal area screening test for each substance with any positive results. If at least 85 percent of the positive portal area screening test results for a substance in the past 12 months do not subsequently confirm positive on for-cause testing performed under paragraph (i)(1) of this section, the licensee or other entity cannot continue to use the screening test for the particular substance until such time as corrective actions have been implemented to improve the testing accuracy.
(3) A part 26 sanction may not be issued to an individual based solely on a portal area screening instrument detection that drugs or alcohol exceed the instrument's established setpoint.
(j)
(k)
(l)
(1) Require their designated MRO to review positive, positive and dilute, adulterated, substituted, and invalid confirmatory drug and validity test results to determine whether the donor has violated the FFD policy. The review must be completed before reporting the results to the individual designated by the licensee or other entity to assess authorization or perform the suitability and fitness determinations required under § 26.919, or, if required, that are described in subpart H of this part.
(2) Require their MRO to satisfy the requirements in § 26.183 and, prior to conducting any activities under this part, attend and pass a medical- or clinical-based training session to improve his/her knowledge of MRO duties and responsibilities, drug and alcohol testing processes and procedures, and evaluation of drug testing results. This training session must be conducted by a nationally recognized MRO training and certification organization that has been assessed by the licensee's or other entity's FFD program personnel to include the technical elements an MRO must implement under § 26.185. An MRO who performed the duties and responsibilities in §§ 26.185 and 26.187 for at least 3 continuous years in the last 10 years prior to being hired or contracted by the licensee or other entity satisfies the requirements in this paragraph (l)(2).
(3) Require their MRO to attend a medical- or clinical-based training session at least every 5 years to improve his/her knowledge of changes in drug and alcohol testing processes and procedures and evaluation of drug testing results.
(4) Require their MRO to determine whether a biological specimen is positive, positive and dilute, adulterated, substituted, or invalid by implementing the requirements in § 26.185 or the HHS Guidelines through the licensee's or other entity's procedures.
(i) If § 26.185 or the HHS Guidelines, as used by the licensee or other entity in its procedures, are insufficient to make this determination, then guidance issued by a State agency in the State in which the NRC-licensed facility is located, Federal agencies, or nationally recognized MRO training and certification organizations may be used to inform an MRO determination.
(ii) An MRO need not review alcohol test results, including positive confirmatory alcohol test results determined by an EBT under § 26.907(c)(3)(vi) and (vii).
(5) Require their MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a specimen for testing. This determination and the retest must be documented and completed as soon as reasonably practicable.
(6) Require the MRO to review all specimen test results associated with drug-related FFD policy violations. This review includes split specimens and all specimens taken to resolve a discrepant condition, such as a possible subversion attempt, impairment without a known cause, or a donor-requested or MRO-directed retest. To resolve a discrepant condition, the MRO is authorized to test a specimen for a biological marker, adulterants, or additional drugs.
(m)
(n)
(a)
(1) Individuals must be trained in the FFD policy and procedure, including fatigue management, and their FFD program responsibilities. Individuals who collect specimens for testing must also be trained in specimen collector duties and responsibilities, including, at a minimum, specimen collection, custody and control, identification and response to subversion attempts, and privacy. For licensees and other entities of nuclear plants, the FFD program training program must use a systems approach to training as described in § 57.390 of this chapter for those individuals in § 26.4.
(2) FFD program training must include training on the behavioral observation program. The behavioral observation program training must include the detection of physiological behaviors or conditions that may indicate—
(i) Possible use, sale, or possession of illegal drugs or illicit drugs, or substance abuse on- or offsite;
(ii) Use or possession of alcohol onsite or use while on duty offsite;
(iii) Impairment from fatigue or any cause that, if left unattended, could result in inattentiveness or human errors; and
(iv) Any individual's inability to safely and competently perform assigned duties and responsibilities or act in a trustworthy and reliable manner while having access to protected areas, SNM, or sensitive information.
(3) Training must explain that an individual's FFD policy violation will—
(i) Subject the individual to an FFD program-required sanction designed to preclude recurrence of an FFD policy violation;
(ii) Contribute to the licensee's or other entity's assessment of whether the individual can be trusted and relied upon to safely and competently perform the assigned duties and responsibilities making the individual subject to this subpart;
(iii) Be used to inform the licensee's or other entity's insider mitigation program under § 57.325 of this chapter and access authorization program under § 73.56 of this chapter; and
(iv) Be used to inform other NRC licensees and other entities subject to part 26 when FFD program information is requested to support authorization determinations under subpart C of part 26 or § 73.56 of this chapter.
(b)
(c)
(a) Licensees and other entities must ensure that the individuals who are subject to this subpart are subject to behavioral observation and that behavioral observation is performed by all individuals subject to this subpart.
(b) Licensees and other entities must require all individuals subject to the FFD program to report to the licensee- or other entity-designated representative any onsite or offsite behaviors or activities by individuals subject to this part that may constitute an unreasonable risk to the safety or security of the NRC-licensed facility or SNM or may cause harm to others. This reporting must include any information relating to character or reputation of the individual indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, SNM, or sensitive information that makes them subject to part 26.
(c) Behavioral observation must be performed visually, in-person, and, when necessary, remotely by live video and audible streaming and capture, to observe the behavior of individuals in the workforce subject to the requirements in this subpart.
(d) Not withstanding § 26.909(c), for a reactor facility where individual task loading does not allow for the effective conduct of behavior observation in addition to assigned operational tasks, the licensee or other entity must implement a live video and audible streaming and capture system to conduct behavioral observation of persons licensed to operate under 10 CFR part 57 who manipulate the controls of any nuclear plant licensed under 10 CFR part 57.
(a) Licensees and other entities that implement an FFD program under this subpart must establish sanctions for FFD policy violations that, at a minimum, prohibit the individuals specified in § 26.4 from being assigned to perform or direct those duties and responsibilities or maintaining authorization making them subject to this subpart.
(b) The severity of the sanction must escalate with the number of occurrences and severity of the FFD policy violation. The sanction must be long enough to act as a deterrent and, if the individual is retained as a licensee employee or contractor/vendor, facilitate the individual to complete counseling or treatment. The sanctions must include an immediate unfavorable termination of the individual's authorization as follows:
(1) A minimum 14-day denial of access for a first violation of the FFD policy involving a confirmed positive drug or alcohol test result;
(2) A minimum 3-year denial of access for a second violation of the FFD policy involving a confirmed positive drug or alcohol test result;
(3) A minimum 5-year denial of access for any individual who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any facility licensed under part 57 of this chapter or within a transporter's facility or vehicle used in the conveyance of formula quantities of strategic SNM while the individual is subject to this subpart; and
(4) A permanent denial of access for a third violation of the FFD policy involving a confirmed positive drug or alcohol test result or a subversion attempt of any drug or alcohol test or screening process.
(a) Licensees and other entities that collect personal information about an individual for the purpose of complying with this subpart must establish and maintain a system of files and procedures to prevent unauthorized disclosure.
(b) Licensees and other entities must obtain a signed consent that documents the individual's acceptance of being subject to the FFD program and authorizes the disclosure of the personal information collected and maintained under this subpart, except for disclosures to the individuals and entities specified in § 26.37(b)(1)
Licensees and other entities that implement an FFD program under this subpart must establish and implement procedures for the review of a determination that an individual in § 26.4 has violated the FFD policy. The procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy and a schedule for the completion of the review.
(a) Licensees and other entities that implement an FFD program under this subpart must audit their programs at a frequency that ensures the continuing effectiveness of their FFD program, FFD program elements that are provided by C/Vs, and the FFD programs of C/Vs that are accepted by the licensee or other entity. Corrective actions must be taken as soon as reasonably practicable to resolve any problems identified in an audit and preclude recurrence.
(b) The subject matter, scope, and frequency of audits must be revised as necessary to improve or maintain program performance based on annual FFD program performance data reviews performed under § 26.917(d) and unsatisfactory performance or programmatic weaknesses identified under § 26.917(b)(3) and (e).
(c) Licensees and other entities may conduct joint audits or accept audits of C/Vs so long as the audit addresses the relevant services of the C/Vs.
(d) Licensees and other entities must audit HHS-certified laboratories unless the licensee's or other entity's panel of drugs and drug metabolites to be tested is equivalent to the panel by which the laboratory is certified by HHS or is subject to the standards and procedures for drug testing and evaluation used by the laboratory under the HHS Guidelines. Licensees and other entities must audit any hospital or other facility licensed by the State (or State-designated entity) if used to conduct specimen collections and perform alcohol testing under this part on a biennial basis to confirm that the facility procedures are comparable to those described in subpart E of this part, for urine and oral fluid.
(a) Licensees and other entities that implement FFD programs under this subpart must ensure that records pertaining to the administration of their program, which may be stored and archived electronically, are maintained so that they are available for NRC inspection purposes and for any legal proceedings resulting from the administration of the program. Records pertaining to the administration of the FFD program and FFD performance data required by § 26.717 must be retained until license termination.
(b) Licensees and other entities must make the following reports:
(1) Reports to the NRC Headquarters Operations Center by telephone within 24 hours after the licensee or other entity discovers any intentional act that casts doubt on the integrity of the FFD program and any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse by individuals who are subject to this subpart. These events must be reported under this subpart, rather than under the provisions of § 73.1200 of this chapter;
(2) Annual FFD program performance data under § 26.717(b) for each FFD program subject to this subpart. Licensees and other entities must submit FFD program performance data (for January through December) to the NRC annually, before March 1 of the following year and must use unexpired NRC-provided forms for the electronic submission of FFD information to the NRC; and
(3) Reports on drug and alcohol testing errors within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered at an HHS-certified laboratory or through the processing of appeals under § 26.913, or errors or matters that could adversely reflect on the integrity of the random selection or random testing process. The reports must describe the incident and any corrective actions taken or planned.
(c) Licensees and other entities subject to this subpart must describe in sufficient detail to support an authorization determination, an individual's FFD policy violation (while protecting privacy information under § 26.911) and FFD program weakness to the NRC, licensees, and other entities subject to part 26 when requested to support authorization determinations under subpart C of this part or to support licensee or other entity performance monitoring.
(d) Licensees and other entities must analyze FFD program performance data at least annually and take appropriate actions to correct any identified program weakness.
(e) Licensees and other entities must document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee's or other entity's corrective action program, but may not track or trend drug and alcohol test results in a manner that would permit the identification of any individuals.
Licensees and other entities that implement FFD programs under this subpart must develop, implement, and maintain procedures for evaluating whether to assign individuals to perform or direct those duties and responsibilities making them subject to this subpart. A suitability or fitness determination conducted for cause must be performed face to face. A suitability or fitness determination conducted for cause may be performed remotely using electronic communications that provide sufficient visual and aural clarity to complete the assessment. A fitness determination may be supported by someone who is present in-person with the individual being assessed only during for-cause drug and alcohol testing determinations under § 26.907(b)(3) and fatigue assessments performed under § 26.211(a)(1). The supporting person must be trained in accordance with the requirements of either § 26.29 or § 26.908.
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.
83. In § 30.50, revise paragraph (c)(3) to read as follows:
(c) * * *
(3) The provisions of § 30.50 do not apply to licensees subject to the notification requirements in § 50.72 or
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.
(c) * * *
(3) The provisions of § 40.60 do not apply to licensees subject to the notification requirements in § 50.72 or § 57.435, of this chapter. They do apply to those part 50 or part 57 licensees possessing material licensed under part 40 of this chapter who are not subject to the notification requirements in § 50.72 or § 57.435 of this chapter, respectively.
Atomic Energy Act of 1954, secs. 11, 101, 102, 103, 104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186, 187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135, 2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note.
(c) Requirements for future water-cooled reactor applicants and licensees.
(d)
(b) This section applies to each holder of an operating license issued under this part, or a combined license issued under part 52 of this chapter, or a manufacturing license, construction permit, or operating license issued under part 57 of this chapter, including the holder of a license authorizing the operation of a nuclear power reactor that has submitted the certification of permanent cessation of operations required under § 50.82(a)(1) or § 52.110 or 57.305 of this chapter, a reactor licensee whose license has been amended to allow possession of nuclear fuel but not operation of the facility, or a non-power production or utilization facility that has permanently ceased operations.
(c) * * *
(3) In implementing this paragraph, the FSAR (as updated) is considered to include FSAR changes resulting from evaluations performed pursuant to this section and analyses performed pursuant to § 50.90 or § 57.312 of this chapter since submittal of the last update of the final safety analysis report pursuant to § 50.71 or § 57.315 of this chapter.
(d) * * *
(2) The licensee shall submit, as specified in § 50.4 or § 52.3 or § 57.4 of this chapter, as applicable, a report containing a brief description of any changes, tests, and experiments, including a summary of the evaluation of each. A report must be submitted at intervals not to exceed 24 months. For combined licenses, the report must be submitted at intervals not to exceed 6 months during the period from the date of application for a combined license to the date the Commission makes its findings under 10 CFR 52.103(g).
(a) Each holder of a construction permit or operating license for a nuclear power reactor issued under this part or part 57 of this chapter, or a combined license for a nuclear power reactor issued under part 52 of this chapter, shall comply with either 10 CFR 70.24 of this chapter or the requirements in paragraph (b) of this section.
(1) For production and utilization facilities licensed under 10 CFR part 50 or 10 CFR part 52, the activities in paragraph (1)(i) of this definition, and does not mean the activities in paragraph (1)(ii) of this definition.
(3) For utilization facilities licensed under 10 CFR part 57, the activities in the definition of
Atomic Energy Act of 1954, secs. 11, 101, 103, 108, 122, 147, 161, 181, 182, 183, 184, 185, 186, 187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135, 2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note; Pub. L. 118-67, div. B, July 9, 2024, 138 Stat. 1448.
Subpart A provides general provisions applicable to all applicants and licensees subject to the requirements of this part.
For the purposes of this part, the following definitions apply, although an applicant may provide its own definitions of these terms in an application submitted under this part if the definitions are supported by the applicant's safety analysis, except for those terms defined in the Atomic Energy Act of 1954 (68 Stat. 919), as amended (AEA).
(1) Has qualified in accordance with a fuel handler training program that demonstrates compliance with the same requirements as training programs for non-licensed operators required by § 57.420, and
(2) Is responsible for decisions on—
(i) Safe conduct of decommissioning activities,
(ii) Safe handling and storage of spent fuel, and
(iii) Appropriate response to plant emergencies.
(1) Release of the property for unrestricted use and termination of the license; or
(2) Release of the property under restricted conditions and termination of the license.
(1) Restraints derived from generally accepted “state-of-the-art” practices for achieving functional goals; or
(2) Requirements derived from analysis (based on calculation and/or experiments) of the effects of a postulated accident for which an SSC must meet its functional goals.
(1) Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, government agency other than the Commission or the Department,
(2) Any legal successor, representative, agent, or agency of the foregoing.
(1) Design, manufacture, or utilization of atomic weapons;
(2) The production of special nuclear material; or
(3) The use of special nuclear material in the production of energy but must not include data declassified or removed from the Restricted Data category pursuant to section 142 of the AEA.
(1) The capability to adequately control thermodynamic conditions and reactivity, and to retain radioactive material;
(2) The capability to shut down the reactor and maintain it in a safe shutdown condition; or
(3) The capability to prevent or mitigate the consequences of accidents analyzed to meet the entry criteria in subpart B of this part.
(1) Plutonium, uranium-233, uranium enriched in the isotope-233 or in the isotope-235, and any other material that the Commission, pursuant to the provisions of section 51 of the AEA, determines to be special nuclear material, but does not include source material; or
(2) Any material artificially enriched by any of the foregoing, but does not include source material.
(a)
(b)
(1)
(2)
(3)
(4)
(i) Physical security plan;
(ii) Safeguards contingency plan;
(iii) Cybersecurity plan;
(iv) Application for amendment of the physical security plan, safeguards contingency plan, or cybersecurity plan as part of an application for amendment of the license; and
(v) Changes to the physical security plan, safeguards contingency plan, or cybersecurity plan made without prior Commission approval if the changes do not decrease the safeguards effectiveness of these plans.
(5)
(i) The licensee must maintain records of changes to the submissions in paragraphs (b)(4)(i) through (iii) of this section made without prior approval for a period of three years from the date of the change, and must, within two months after the change is made, submit a report addressed to Director, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, in accordance with this section, containing a description of each change.
(ii) A copy of the report must be sent to the Regional Administrator of the appropriate NRC Regional Office specified in appendix A to part 73 of this chapter.
(6)
(i) Emergency plan; and
(ii) Change to an emergency plan.
(7)
(8)
(9)
(10)
(c)
(d)
(a) Any licensee or applicant for a license, or holder of or applicant for a standard design approval, under this part; employee of a licensee or holder of a standard design approval, or applicant for a license or standard design approval under this part; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or applicant for a license, or holder of or applicant for a standard design approval under this part, who knowingly provides to any licensee, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's or applicant's activities in this part, may not—
(1) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or
(2) Deliberately submit to the NRC, a licensee, an applicant, or a licensee's or applicant's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the NRC.
(b) A person who violates paragraph (a)(1) or (2) of this section may be subject to enforcement action in accordance with the procedures in subpart B of 10 CFR part 2.
(c) For the purposes of paragraph (a)(1) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows—
(1) Would cause a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commission; or
(2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, applicant, contractor, or subcontractor.
(a) Discrimination by a Commission licensee, a holder of a standard design approval, an applicant for a license or standard design approval, or a contractor or subcontractor of a Commission licensee, holder of a standard design approval, or an applicant for a license or standard design approval, against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reorganization Act of 1974, as amended, and in general are related to the administration or enforcement of a requirement imposed under the AEA or the Energy Reorganization Act of 1974, as amended.
(1) The protected activities include but are not limited to—
(i) Providing the Commission or his or her employer information about alleged violations of either of the statutes named in paragraph (a) of this section or possible violations of requirements imposed under either of those statutes;
(ii) Refusing to engage in any practice made unlawful under either of the statutes named in paragraph (a) of this section or under these requirements if the employee has identified the alleged illegality to the employer;
(iii) Requesting the NRC to institute action against his or her employer for the administration or enforcement of these requirements;
(iv) Testifying in any Commission proceeding, or before Congress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) of this section; and
(v) Assisting or participating in, or being about to assist or participate in, these activities.
(2) These activities are protected even if no formal proceeding is actually initiated as a result of the employee assistance or participation.
(3) This section does not apply to any employee alleging discrimination prohibited by this section who, acting without direction from his or her employer (or the employer's agent), deliberately causes a violation of any requirement of the Energy Reorganization Act of 1974, as amended, or the AEA.
(b) Any employee who believes that they have been discharged or otherwise discriminated against by any person for engaging in protected activities specified in paragraph (a)(1) of this section may seek a remedy for the discharge or discrimination through an administrative proceeding in the Department of Labor. The administrative proceeding must be initiated within 180 days after an alleged violation occurs. The employee may do this by filing a complaint alleging the violation with the Department of Labor, Wage and Hour Division. The Department of Labor may order reinstatement, back pay, and compensatory damages.
(c) A violation of paragraph (a), (e), or (f) of this section by a Commission licensee, a holder of a standard design approval, an applicant for a Commission license or standard design approval, or a contractor or subcontractor of a Commission licensee or holder of a standard design approval, or any applicant may be grounds for—
(1) Denial, revocation, or suspension of the license or standard design approval;
(2) Imposition of a civil penalty on the licensee, holder of a standard design approval, or applicant, or a contractor or subcontractor of the licensee, holder of a standard design approval or applicant; or
(3) Other enforcement action.
(d) Actions taken by an employer, or others, which adversely affect an employee may be predicated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An employee's engagement in protected activities does not automatically render him or her immune from discharge or discipline for legitimate reasons or from adverse action dictated by nonprohibited considerations.
(e) To ensure employees are informed of their rights, each license holder or applicant must follow the guidelines for posting NRC Form 3, “Notice to Employees,” as follows:
(1) Each holder or applicant for a license or design approval must prominently post the revision of NRC Form 3, “Notice to Employees,” referenced in § 19.11(e)(1) of this chapter. This form must be posted at locations sufficient to permit employees protected by this section to observe a copy on the way to or from their place of work. Premises must be posted no later than 30 days after an application is docketed and remain posted while the application is pending before the Commission, during the term of the license, and for 30 days following license termination.
(2) Copies of NRC Form 3 may be obtained by writing to the Regional Administrator of the appropriate NRC Regional Office listed in appendix D to 10 CFR part 20, via email to
(f) No agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Department of Labor pursuant to section 211 of the Energy Reorganization Act of 1974, as amended, may contain any provision which would prohibit, restrict, or otherwise discourage an employee from participating in protected activity as defined in paragraph (a)(1) of this section including, but not limited to, providing information to the NRC or to his or her employer on potential violations or other matters within NRC's regulatory responsibilities.
(g) Part 19 of 10 CFR sets forth requirements and regulatory provisions applicable to licensees, holders of a standard design approval, applicants for a license or standard design approval, and contractors or subcontractors of a Commission licensee or holder of a standard design approval, and are in addition to the requirements in this section.
(a) Information provided to the Commission by a holder of a license, construction permit, or standard design approval under this part or an applicant for a license, construction permit, or standard design approval under this part, and information required by statute or by the Commission's regulations, orders, license conditions, or terms and conditions of a standard design approval to be maintained by the applicant or the licensee must be complete and accurate in all material respects.
(b) Each applicant or licensee and each holder of a standard design approval under this part must notify the Commission of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant, licensee, or holder violates this paragraph only if the applicant, licensee, or holder fails to notify the Commission of information that the applicant, licensee, or holder has identified as having a significant implication for public health and safety or common defense and security. Notification must be provided to the Administrator of the appropriate Regional Office within 2 working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the Commission by other reporting or updating requirements.
(a) The NRC has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501
(b) The approved information collection requirements contained in this part appear in §§ 57.7, 57.9, 57.15, 57.45, 57.55, 57.60, 57.95, 57.110, 57.115, 57.145, 57.150, 57.155, 57.160, 57.190, 57.197, 57.205, 57.210, 57.220, 57.255, 57.270, 57.285, 57.300, 57.305, 57.310, 57.315, 57.317, 57.325, 57.395, 57.399, 57.400, 57.405, 57.410, 57.424, 57.425, 57.429, 57.430, 57.435, 57.445.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. The information collection requirement and the control numbers under which it is approved are as follows:
(1) In §§ 57.421, 57.422, and 57.423, NRC Form 396 is approved under control number 3150-0024.
(2) In §§ 57.423 and 57.424, NRC Form 398 is approved under control number 3150-0090.
(3) In § 57.435, NRC Form 361 is approved under control number 3150-0238.
(4) In § 57.440, NRC Form 366 is approved under control number 3150-0104.
(a) The Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of the regulations of this part, which are authorized by law, will not present an undue risk to the public health and safety, and are consistent with the common defense and security.
(b) The Commission will not consider granting an exemption unless special circumstances are present. Special circumstances are present whenever—
(1) Application of the regulation in the particular circumstances conflicts with other rules or requirements of the Commission;
(2) Application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule;
(3) Compliance would result in undue hardship or other costs that are significantly in excess of those contemplated when the regulation was adopted, or that are significantly in excess of those incurred by others similarly situated;
(4) The exemption would result in benefit to the public health and safety that compensates for any decrease in safety that may result from the grant of the exemption;
(5) The exemption would provide only temporary relief from the applicable regulation and the licensee or applicant has made good faith efforts to comply with the regulation; or
(6) There is present any other material circumstance not considered when the regulation was adopted for which it would be in the public interest to grant an exemption. If such condition is relied on exclusively for demonstrating compliance with paragraph (b) of this subsection, the exemption may not be granted until the Executive Director for Operations has consulted with the Commission.
(c) Any person may request an exemption permitting the conduct of construction before the issuance of a construction permit. The Commission may grant such an exemption upon considering and balancing the following factors:
(1) Whether conduct of the proposed activities will give rise to a significant adverse impact on the environment and the nature and extent of such impact, if any;
(2) Whether redress of any adverse environment impact from conduct of the proposed activities can reasonably be effective should such redress be necessary;
(3) Whether conduct of the proposed activities would foreclose subsequent adoption of alternatives; and
(4) The effect of delay in conducting such activities on the public interest, including whether the power needs to be used by the proposed facility, the availability of alternative sources, if any, to meet those needs on a timely basis and delay costs to the applicant and to consumers.
(d) Issuance of such an exemption will not be deemed to constitute a
(e) The Commission's consideration of requests for exemptions from requirements of the regulations of other parts in this chapter that are applicable by virtue of this part will be governed by the exemption requirements of those parts.
No license or standard design approval under this part may be deemed to have been issued for activities that are not under or within the jurisdiction of the United States.
Licensees, holders of a standard design approval, applicants for licenses and design approvals, and applicants for an amendment to any license or design approval under this part are not required to provide for design features or other measures for the specific purpose of protection against the effects of—
(a) Attacks and destructive acts, including sabotage, directed against the facility by an enemy of the United States, whether a foreign government or other person; or
(b) Use or deployment of weapons incident to U.S. defense activities.
(a) No right to the SNM will be conferred by a license issued under this part except as may be defined by the license.
(b) Neither a license issued under this part, nor any right thereunder, nor any right to utilize or produce SNM may be transferred, assigned, or disposed of in any manner, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission, after securing full information, finds that the transfer is in accordance with the provisions of the AEA and gives its consent in writing.
Any license issued under this part will be subject to suspension and to the rights of recapture of the material or control of the facility reserved to the Commission under section 108 of the AEA in a state of war or national emergency declared by Congress.
As part of its application under this part and in any event before the receipt of Restricted Data or classified National Security Information or the issuance of a license or standard design approval, the applicant must agree in writing that it will not permit any individual to have access to, or any facility to possess, Restricted Data or classified National Security Information until the individual and/or facility has been approved for access under the provisions of 10 CFR parts 25 and/or 95. The agreement of the applicant becomes part of the license or standard design approval.
(a)
(1)
(i)
(A) The date of issuance of a construction permit under subpart C of this part;
(B) The date of issuance of an operating license under subpart C of this part;
(C) The date of issuance of a manufacturing license under subpart D of this part; or
(D) The date of issuance of a standard design approval under subpart E of this part.
(ii)
(iii)
(iv)
(A) That a modification is necessary to bring a facility into compliance with a license or the rules or orders of the Commission, or into conformance with written commitments by the licensee; or
(B) That regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security; or
(C) That the regulatory action involves defining or redefining what level of protection to the public health and safety or common defense and security should be regarded as adequate.
(v)
(vi)
(vii)
(2)
(i) Statement of the specific objectives that the proposed backfit is designed to achieve;
(ii) General description of the activity that would be required by the licensee or applicant in order to complete the backfit;
(iii) Potential change in the risk to the public from the accidental off site release of radioactive material;
(iv) Potential impact on radiological exposure of facility employees;
(v) Installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay;
(vi) The potential safety impact of changes in plant or operational complexity, including the relationship to proposed and existing regulatory requirements;
(vii) The estimated resource burden on the NRC associated with the proposed backfit and the availability of such resources;
(viii) The potential impact of differences in facility type, design or age on the relevancy and practicality of the proposed backfit;
(b)
(1) For which a construction permit or operating license issued under part 50 of this chapter, or a standard design approval or combined license issued under part 52 of this chapter, is referenced, the NRC staff and the Advisory Committee on Reactor Safeguards will use and rely on the reactor design and any operational programs or requirements with generic applicability that were approved in the proceeding on the application for issuance or renewal of the construction permit or operating license under part 50 of this chapter or the standard design approval or combined license under part 52 of this chapter, unless there exists significant new information that substantially affects the earlier determination or other good cause.
(2) For which an early site permit, standard design certification, or manufacturing license issued under part 52 of this chapter is referenced, the Commission will treat as resolved those matters resolved in the proceeding on the application for issuance or renewal of the early site permit, standard design certification, or manufacturing license under part 52 of this chapter.
(c)
The Commission will refer a copy of each initial joint application submitted under this part for a construction permit and associated operating license(s) and each application for a manufacturing license or standard design approval to the ACRS. The ACRS must apply the standards in §§ 57.80, 57.165, and 57.213 in accordance with the finality provisions for any construction permit, operating license, manufacturing license, or standard design approval referenced in the application. The ACRS review will focus on aspects of the design that are principally unique, novel, and noteworthy. Any report will be made part of the record of the application and available to the public, except to the extent that security classification prevents disclosure.
(a) Applicants under this part may combine applications for multiple and different kinds of licenses, certifications, and approvals under the regulations of this part and parts 30, 40, 70, 71, and 72 of this chapter.
(1) In situations in which applications are filed under this part by one or more applicants for licenses to construct and operate nuclear reactors or nuclear plants of essentially the same design to be located at different sites, reference may be made to a single final safety analysis report other than for applicant- or site-specific information.
(2) An applicant may include in its joint application for a construction permit and operating licenses for a nuclear reactor or nuclear plant under this part the information required by § 57.60(a)(5) and 10 CFR part 51 for multiple sites at which the applicant proposes to construct and operate the reactor or plant.
(3) An application under this part for multiple types of permits, licenses, or certifications must clearly indicate to which permit, license, or certification information in the application pertains.
(4) Holders of operating licenses under this part that reference the same manufacturing license may combine applications for a license amendment under § 57.310 that would affect the facility or the procedures described in the final safety analysis report for the manufacturing license, and may combine, with the holder of the manufacturing license that is referenced in the operating licenses, applications for a license amendment submitted by the holder of the manufacturing license under § 57.310.
(5) An applicant may include in a joint application a request for a construction permit for any number of nuclear reactors of essentially the same design to be built at a specific site and requests for operating licenses for those reactors, provided that the application states the earliest and latest dates for completion of the construction of each nuclear reactor as required by § 57.55(g) and includes the information specified in § 57.60(a)(4).
(b) An applicant may incorporate by reference in its application information contained in previous applications, statements, or reports filed with the Commission and applicable Commission approvals issued under part 50 or 52 of this chapter, provided that such references are clear and specific. For an application under this part that references an approval issued under part 50 or 52 of this chapter, the scope and nature of matters resolved for that application are governed by § 57.16(b).
(c) The Commission may combine in a single license the activities of an applicant that would otherwise be licensed separately.
(d) A joint application for a construction permit and associated operating license(s) filed under this part may reference a standard design approval, construction permit, operating license, manufacturing license, or combination thereof, issued under this part. An application for a manufacturing license under this part may reference a
(e) An application for a standard design approval or manufacturing license or a joint application for a construction permit and associated operating license(s) filed under this part may reference a relevant U.S. Department of War or U.S. Department of Energy authorization for a utilization facility that has been tested and that has demonstrated the ability to function safely. Any reference must identify how aspects of the authorization address applicable NRC regulations in this part.
(f) Subparts in this part may be used independently.
(a) Any person, except one excluded by 10 CFR 50.38, may file a joint application for a construction permit and associated operating license(s), or an application for a manufacturing license under this part with the Director, Office of Nuclear Reactor Regulation.
(b) Any person may submit a proposed standard design for a nuclear reactor of the type described in this part to the NRC staff for its review. The submittal may consist of either the final design for the entire nuclear reactor or the final design of major portions thereof.
(c) The application must comply with the applicable filing requirements of 10 CFR 50.30 and subpart A of 10 CFR part 2.
(d) The submittal for review of a proposed standard design must be made in the same manner as provided in 10 CFR 50.30 for license applications.
(e) The fees associated with the filing and review of applications under this part are set forth in 10 CFR part 170.
(f) An applicant for licenses to construct and operate one or more nuclear reactors under subpart C of this part must file a joint application for a construction permit and associated operating license(s). The joint application must include the information specified in § 57.55 and § 57.60 and be complete enough to permit all evaluations necessary for the issuance of the requested construction permit and the associated operating license(s) upon the NRC making the finding required by § 57.100(b)(1).
This subpart specifies the applicability criteria for construction permit, operating license, and manufacturing license applicants and the design criteria attributes for these applicants and standard design approval applicants, under which these entities may be considered eligible to use the provisions of this part.
To be eligible for a construction permit and operating license or a manufacturing license under this part, an applicant must demonstrate that its nuclear reactor or nuclear plant design and operation meets the following entry criteria:
(a) An evaluation of the applicable radiological consequences shows with reasonable assurance that any individual located in the unrestricted area following the onset of a postulated accident that bounds a broad range of design basis accidents would not exceed 1 rem (0.01 Sv) TEDE for the duration of the accident; and
(b) The total inventory of thorium, uranium, and plutonium contained in the nuclear reactor or any individual nuclear reactor that is part of the nuclear plant must not exceed 10 metric tons.
The applicant for a license or design approval under this part must provide information that demonstrates that the nuclear reactor or nuclear plant design has design criteria attributes that satisfy the following:
(a)
(1) Control of the power level during normal operations;
(2) Rapid insertion of reactivity control devices to immediately shut down the reactor and maintain it in a safe shutdown state under accident conditions; and
(3) Net negative reactivity feedback as a result of increased reactor power.
(b)
(c)
(d)
(1) Adequate permanent and temporary shielding to comply with 10 CFR part 20 for the protection of workers and the public from direct radiation exposure from the reactor and radioactive sources during operation, shutdown, and transport, including during abnormal conditions; and
(2) Sufficient robustness and heat removal to prevent loss of shielding integrity during normal and accident conditions
(e)
(f)
(a) If an applicant for a construction permit, license, or standard design approval under this part can demonstrate that its reactor design meets the applicable eligibility requirements of §§ 57.25 and 57.30, then the applicant must comply with the applicable application and procedural requirements set forth in this part.
(b) Notwithstanding the requirements of part 50 or 52 of this chapter, if an applicant is issued a construction permit, license, or design approval under this part, then that entity is subject to the requirements of this part and not part 50 or 52 of this chapter unless specifically required by this part.
This subpart sets forth the requirements and procedures applicable to Commission issuance of construction permits and operating licenses for utilization facilities of the type described in § 50.22 of this chapter.
(a) Except as provided for in paragraph (b) of this section, no person within the United States may transfer or receive in interstate commerce, manufacture, produce, transfer, acquire, possess, or use any utilization facility under this part except as authorized by a license issued under this part by the Commission.
(b) Nothing in this part may be deemed to require a license for the transportation or possession of a utilization facility by a common or contract carrier or warehousemen in the regular course of carriage for another or storage incident thereto.
(c) Except as provided for in paragraph (d) of this section, no person may begin the construction of a utilization facility on a site on which
(d) A general license is hereby issued for construction activities on a site that is specified in a joint application for a construction permit and associated operating license(s) under this part, subject to the following conditions:
(1) The general licensee has submitted and the Commission docketed a joint application for a construction permit and associated operating license(s) under this part that meets the following criteria:
(i) The joint application references a manufacturing license issued by the Commission under this chapter;
(ii) The joint application references a construction permit and operating license issued pursuant to this part that the Commission afforded generic finality under § 57.142(e), that referenced the same manufacturing license as the general licensee in its joint application, and that met the criteria for a categorical exclusion under subpart K of this part.
(iii) The joint application includes a plan for redress of any adverse environmental impact from conduct of activities under the general license should such redress be necessary.
(2) The general licensee has notified the NRC under § 57.4 that all applicable permits, licenses, approvals, and other entitlements in connection with the proposed action have been obtained.
(3) All applicable Federal environmental consultations have been completed.
(4) The general licensee must not allow special nuclear material or radioactive material that would be associated with operation under an operating license issued pursuant to this part to be brought to the site under the general license;
(5) The general licensee must not allow a manufactured reactor to be brought to the site under the general license.
(6) The general licensee must allow for NRC inspections that the Commission deems necessary related to activities performed under the general license.
(7) Any activities undertaken by the general licensee or on its behalf under the general license are entirely at the risk of the general licensee and have no bearing on the issuance of a construction permit with respect to the requirements of the AEA, and rules, regulations, or orders issued under the AEA.
Each application must state:
(a) Name of applicant;
(b) Address of applicant;
(c) Description of business or occupation of applicant;
(d) Organization information of applicant, including the following information:
(1) If applicant is an individual, the citizenship of applicant.
(2) If applicant is a partnership, the name, citizenship and address of each partner and the principal location where the partnership does business.
(3) If applicant is a corporation or an unincorporated association, the following information:
(i) The state where it is incorporated or organized and the principal location where it does business;
(ii) The names, addresses and citizenship of its directors and of its principal officers;
(iii) Whether it is owned, controlled, or dominated by an alien, a foreign corporation, or foreign government, and if so, give details.
(4) If the applicant is acting as agent or representative of another person in filing the application, identify the principal and furnish information required under this paragraph with respect to such principal.
(e) The type of license(s) applied for, the use to which the facility will be put, the period of time for which the license(s) are sought, and a list of other licenses, issued or applied for in connection with the proposed facility.
(f) Except for an electric utility applicant for a license to operate a utilization facility, information sufficient to demonstrate to the Commission the financial qualification of the applicant to carry out, in accordance with regulations in this chapter, the activities for which the construction permit and operating license is sought. As applicable, the following must be provided:
(1) For a construction permit under this section, the applicant must submit information that demonstrates that the applicant appears to be financially qualified to cover estimated construction costs and related fuel cycle costs. The applicant must submit estimates of the total construction costs of the facility and related fuel cycle costs, a financial capacity plan, and any source(s) of funds available at the time of application to cover these costs. If available funding at the time of application is 50 percent or less, the applicant should include proposed license conditions to facilitate verification that funding is available prior to the start of construction.
(2) For an operating license under this section, the applicant must submit information that demonstrates the applicant appears to be financially qualified to cover estimated operation costs for the period of the license. The applicant must submit estimates for total annual operating costs for each of the first 5 years of operation of the facility and a financial capacity plan and indicate any source(s) of funds available at the time of application to cover these costs. If available funding at the time of application is 50 percent or less, the applicant should include proposed license conditions to facilitate verification that funding is available prior to the start of operations. An applicant seeking to renew or extend the term of an operating license need not submit the financial information that is required in an application for an initial license.
(g) If the applicant proposes to construct or materially alter a utilization facility, the application must state the earliest and latest dates for completion of the construction or material alteration.
(h) If the proposed activity is the generation and distribution of electric energy under a license under this part, a list of the names and addresses of such regulatory agencies as may have jurisdiction over the rates and services incident to the proposed activity, and a list of trade and news publications that circulate in the area where the proposed activity will be conducted and that are considered appropriate to give reasonable notice of the application to those municipalities, private utilities, public bodies, and cooperatives, which might have a potential interest in the facility.
(i) Information in the form of a report, as described in 10 CFR 50.75, indicating how reasonable assurance will be provided that funds will be available to decommission the facility.
(j) If the application contains Restricted Data or classified National Security Information, confirmation that all Restricted Data and classified National Security Information are separated from the unclassified information.
(a)
(1) A description and safety assessment of the site and a safety assessment of the facility, including the following:
(i) Intended use of the reactor including the maximum power level
(ii) The safety features that are to be engineered into the facility and those barriers that must be breached as a result of an accident before a release of radioactive material to the environment can occur. Special attention must be directed to design features intended to prevent and mitigate the radiological consequences of accidents.
(iii) An evaluation that meets the dose-based entry criterion of § 57.25(a). In performing this evaluation, an applicant must assume a fission product release utilizing a postulated accident source term that represents the most limiting fission product inventory during the lifetime of the nuclear reactor while assuming that the reactor is operated at the ultimate power level contemplated.
(iv) As applicable, a description and assessment of SSCs for remote operation of the reactor from outside the site boundary that demonstrates that the reactor can be safely operated and can reach and maintain a safe shutdown state, including under abnormal conditions.
(v) As applicable, a description and assessment of design features for remote monitoring of the nuclear reactor or nuclear plant from outside the site boundary and protecting the integrity of important safety parameters and safety function data needed to perform human actions that protect public health and safety, and to protect sensitive plant data that could be used to aid in an attack (physical or cyber) against the reactor.
(vi) As applicable, a description and assessment of design features for autonomous performance of operations and safety functions without reliance on human intervention, external command, or active control system input under normal, abnormal, and accident conditions.
(vii) Analysis, appropriate test programs, prototype testing, operating experience, or a combination thereof that demonstrates that each of the design criteria attributes described in § 57.30 are met. This demonstration must consider interdependent effects throughout the nuclear plant for the duration of the nuclear plant's lifetime.
(2) The design basis of the facility, including:
(i) The principal design criteria.
(ii) Relation of the design bases to the principal design criteria.
(iii) Relation of the principal design criteria to the design criteria attributes described in § 57.30.
(3) A description of the quality assurance program to be applied to the design, fabrication, manufacture (as applicable), construction, and testing of the safety-related SSCs of the facility.
(4) For sites at which multiple nuclear reactors may be built or installed under a construction permit under this part, the application must—
(i) specify limitations on and provide an analysis of the number and configuration of nuclear reactors that may be in various stages of construction, operation, shutdown, and decommissioning at any time from the commencement of construction of the first reactor to the termination of the last operating license;
(ii) include an assessment of potential hazards to safety-related SSCs of the operating reactors at the site posed by activities related to the construction, operation, and decommissioning of other reactors at the site;
(iii) include a description of the portions of the nuclear plant that will be shared by multiple reactors over the lifetime of the plant and specify functional requirements and measures to meet the requirements for any safety-related SSCs of the nuclear plant that will be shared by multiple reactors over the lifetime of the plant; and
(iv) include technical specifications in accordance with § 57.60(a)(8)(vi), as appropriate, for the portions of the nuclear plant that will be shared with one or more other reactors over the lifetime of the plant.
(5) Information relating to current and projected population distributions in the surrounding area and applicable site evaluation factors for seismic, meteorological, hydrologic, and geologic characteristics with appropriate consideration of natural phenomena, including, as applicable, information demonstrating that the site characteristics are bounded by the site parameters postulated for the design.
(6) An evaluation of the safety-related SSCs of the facility, with emphasis upon performance requirements; the bases, with their technical justifications, upon which such requirements have been established; and the evaluations required to show that safety functions will be accomplished. The evaluation must be sufficient to permit understanding of the system designs and their relationship to safety analyses.
(7) The kinds and quantities of radioactive materials expected to be produced by operation of the nuclear reactor or nuclear plant and the means for controlling and limiting radioactive effluents and radiation exposures within the limits set forth in part 20 of this chapter, including:
(i) An estimate of the quantity of each of the principal radionuclides expected to be released annually to unrestricted areas in liquid effluents produced during normal operations;
(ii) An estimate of the quantity of each of the principal radionuclides of the gases, halides, and particulates expected to be released annually to unrestricted areas in gaseous effluents produced during normal operations; and
(iii) A description of the equipment and procedures for the control of gaseous and liquid effluents and for the maintenance and use of equipment installed in radioactive waste systems.
(8) Information related to operational programs concerning facility operation. Implementation milestones for each operational program must be described depending on whether the program will be implemented all at once or on a phased basis. Programs concerning facility operations include:
(i) The applicant's organizational structure, allocations of responsibilities and authorities, personnel qualifications and training requirements, and conduct of operations.
(ii) Plans for preoperational testing and initial operations.
(iii) Plans for conduct of normal operations, including maintenance, surveillance, and periodic testing of safety-related SSCs.
(iv) An emergency plan for responding to events that could lead to an accidental release or loss of control of radioactive material, and to any associated hazards directly incident thereto. Each applicant and licensee under this part must coordinate response needs with local emergency planning and offsite response organizations. The applicant must provide the offsite response organizations that are expected to respond in an emergency with the opportunity to provide input on the emergency plan before submitting it to the NRC. The application must contain any input on the emergency plan received from offsite organizations.
(v) Security programs.
(A) Physical Security.
(
(
(
(B) Cybersecurity. Each applicant and licensee under this part must develop, implement, and maintain a cybersecurity program under § 73.54 or § 73.110 of this chapter.
(C) Information Security. Each applicant and licensee under this part must develop, implement, and maintain an information protection system under §§ 73.21, 73.22, and 73.23 of this chapter, as applicable.
(D) Access Authorization. Each applicant and licensee under this part must establish, implement, and maintain an access authorization program under § 73.56 of this chapter and must describe the program in the physical security plan.
(vi) Proposed technical specifications prepared in accordance with the requirements of § 50.36 of this chapter.
(vii) As applicable, procedures to be used to provide assurance that the limiting conditions for operation of any operating reactor will not be exceeded as a result of activities associated with construction of additional reactors at the same site.
(viii) The radiation protection program.
(ix) The fire protection program.
(A) Each application must include a fire protection plan that describes the overall fire protection program for the facility; identifies the various positions within the licensee's organization that are responsible for the program; states the authorities that are delegated to each of these positions to implement those responsibilities; and outlines the plans for fire protection, fire detection and suppression capability, and limitation of fire damage.
(B) The fire protection plan must also describe specific features necessary to implement the program described in paragraph (a)(8)(ix)(A) of this section such as the following: administrative controls and personnel requirements for fire prevention and manual fire suppression activities; training requirements for any fire brigade members; automatic and manually operated fire detection and suppression systems, as appropriate; and the means to limit fire damage to safety-related SSCs.
(C) The fire protection plan must include an analysis to demonstrate that a fire or explosion in any plant area would not prevent safety-related SSCs from fulfilling safety functions.
(D) Safety-related SSCs must be designed, located, and maintained to minimize, consistent with other safety requirements, the likelihood and effect of fires and explosions.
(E) Noncombustible and fire-resistant materials must be used wherever practical in locations with safety-related SSCs.
(F) Fire detection and fire suppression systems of appropriate capacity and capability must be provided and designed and maintained to minimize the adverse effects of fires on safety-related SSCs.
(G) Fire suppression systems must be designed and maintained to ensure that their rupture or inadvertent operation does not significantly impair the ability of safety-related SSCs to perform their safety functions.
(H) Fire detection and fire suppression systems must also consider and address, as appropriate, any impact from collocated facilities within the site boundary.
(x) A description of how the human factors engineering requirements of § 57.395 are addressed and the training, examination, and proficiency programs necessary to meet the requirements of subpart P of this part.
(xi) As applicable, a description and plans for implementation of a remote operation or monitoring program.
(xii) Program(s), and their implementation, necessary to ensure that the systems and components meet the requirements in the codes or standards identified in the application in accordance with § 57.60(a)(9).
(xiii) The program, and its implementation, for the environmental qualification of safety-related electric equipment.
(xiv) A fitness-for-duty program under part 26 of this chapter.
(xv) A staffing plan and supporting analysis in accordance with § 57.395(c).
(xvi) If the applicant seeks, with its application, approval of a plan for storage of irradiated fuel after termination of an operating license, then a plan that demonstrates compliance with all applicable irradiated fuel possession, safety, and environmental requirements; includes a plan for funding the management of the fuel; and addresses, as applicable, transport of the fuel to a designated storage site.
(xvii) If the applicant seeks, with its application, approval of a decommissioning plan, then a decommissioning plan prepared using the framework of § 50.82(b)(4) of this chapter, limited to those provisions applicable to the design characteristics of the nuclear reactor or nuclear plant, that addresses, as applicable, transport of a nuclear reactor to a designated facility for final decommissioning, final decommissioning of individual nuclear reactors, and final decommissioning of the entire nuclear plant, and ensures compliance with all applicable safety and environmental requirements.
(xviii) Managerial and administrative controls to be used to assure safe operation.
(9) Information related to the use of codes and standards. In the case that generally recognized consensus codes or standards are used and applied to the design of the facility, they must be named and evaluated for applicability, adequacy, and sufficiency. Justification must be provided if they are to be supplemented or modified in keeping with the safety importance of the function to be performed. Criteria from these consensus codes or standards must be clearly stated and must be shown to provide the appropriate level of reliability, safety, and performance capability. The applicability of these criteria must be determined from the safety assessment.
(10) The analyses and descriptions of the equipment and systems for combustible gas control required by § 50.44(d) of this chapter.
(11) The technical qualifications of the applicant to engage in the proposed activities in accordance with the regulations of this chapter.
(12) A description of the design-specific risk analysis methods applied to demonstrate adequate defense in depth and safety margin and the results of the analysis; and
(13) Information demonstrating how the applicant will comply with requirements for criticality accidents in § 50.68 of this chapter, except that the maximum nominal U-235 enrichment of the fresh fuel assemblies is limited to less than twenty (20.0) weight percent for the purposes of § 50.68(b)(7).
(b)
(c)
(d)
(1) Under § 57.60(a)(1), descriptions and safety assessments of the designated areas, including maps showing the boundaries of the areas;
(2) Under § 57.60(a)(4), any restrictions on the relative specific locations of the nuclear reactors proposed in the application within a designated area;
(3) Under § 57.60(a)(5), information covering the entirety of the designated areas, including information demonstrating that the site parameters postulated for the design bound the maximum values for site evaluation factors within the designated areas;
(4) A plan for storage of irradiated fuel after termination of an operating license as described in § 57.60(a)(8)(xvi);
(5) A decommissioning plan as described in § 57.60(a)(8)(xvii);
(6) A procedure covering activities that will be conducted in connection with constructing each utilization facility and placing it into operation at a specific location, including considerations related to § 57.60(a)(8)(vii) and NRC inspections required by § 57.100(b)(1);
(7) A procedure that describes how the applicant will determine that a specific location within a designated area is suitable for construction and operation, including notification to the NRC, in the manner specified under § 57.4, prior to beginning construction; and
(8) Under § 57.60(b), information in the environmental report or applicant-prepared environmental assessment or environmental impact statement, required by part 51 of this chapter pertaining to the entirety of the designated areas, as appropriate.
(a) Applications filed under this part will be reviewed according to the standards set out in this part and 10 CFR parts 20, 50, 51, 54, 70, 71, 72, 73, 74, and 140, as applicable.
(b) The Commission must perform an environmental review during review of the application in accordance with the applicable provisions of subpart K of this part and 10 CFR part 51.
In determining that a construction permit or operating license in this part will be issued to an applicant, the Commission will be guided by the following considerations:
(a) The processes to be performed, the operating procedures, the facility and equipment, the use of the facility, and other technical specifications, or the proposals, in regard to any of the foregoing collectively provide reasonable assurance that the applicant will comply with the regulations in this chapter, including the regulations in part 20 of this chapter, and that the health and safety of the public will not be endangered.
(b) The applicant for a construction permit and operating license is technically and financially qualified to engage in the proposed activities in accordance with the regulations in this chapter. However, no consideration of financial qualification is necessary for an electric utility applicant for an operating license under this part.
(c) The issuance of a construction permit or operating license to the applicant will not, in the opinion of the Commission, be inimical to the common defense and security or to the health and safety of the public.
(d) Any applicable requirements of 10 CFR part 51 have been satisfied.
(e) In determining whether a construction permit or operating license will be issued to an applicant, the Commission will consider whether the proposed activities will serve a useful purpose proportionate to the quantities of special nuclear material or source material to be utilized.
(f) Upon determination that an application for a license meets the standards and requirements of the AEA and regulations, and that notifications, if any, to other agencies or bodies have been duly made, the Commission will issue a construction permit or operating license in such form and containing such conditions and limitations including technical specifications, as it deems appropriate and necessary.
(g) An applicant for an operating license or an amendment of an operating license who proposes to construct or materially alter a utilization facility will be initially granted a construction permit if the application is in conformity with and acceptable under the criteria of §§ 57.55 through 57.80, and the standards of this section as applicable.
(h) A construction permit under this part for the construction of one or more utilization facilities will be issued before the issuance of any license to operate a utilization facility if the application is otherwise acceptable. The construction permit will be converted into one or more operating licenses upon the completion of construction and Commission action. A construction permit for a material alteration of a utilization facility will be issued before the issuance of an amendment of a license, if the application for amendment is otherwise acceptable, as provided in § 57.310.
(i) In the case of a construction permit or operating license under this part for a facility for the generation of commercial power:
(1) The NRC will—
(i) Give notice in writing of each application to the regulatory agency or State as may have jurisdiction over the rates and services incident to the proposed activity;
(ii) Publish notice of the application in trade or news publications as it deems appropriate to give reasonable notice to municipalities, private utilities, public bodies, and cooperatives which might have a potential interest in the utilization facility; and
(iii) Publish notice of the application once each week for four consecutive weeks in the
(2) If there are conflicting applications for a limited opportunity for such license, the Commission will give preferred consideration in the following order: first, to applications submitted by public or cooperative bodies for facilities to be located in high cost power areas in the United States; second, to applications submitted by others for facilities to be located in such areas; third, to applications submitted by public or cooperative bodies for facilities to be located in areas other than high cost power areas; and, fourth, to all other applicants.
(3) The licensee who transmits electric energy in interstate commerce, or sells it at wholesale in interstate commerce, will be subject to the regulatory provisions of the Federal Power Act.
(4) Nothing must preclude any government agency, now or hereafter authorized by law to engage in the production, marketing, or distribution of electric energy, if otherwise qualified, from obtaining a construction permit or operating license under this part for a utilization facility for the primary purpose of producing electric energy for disposition for ultimate public consumption.
(a) After conducting a hearing in accordance with § 57.130 and receiving the report submitted by the ACRS, the Commission may issue a construction permit if the Commission finds that:
(1) The applicable standards and requirements of the AEA and the Commission's regulations have been met;
(2) Any required notifications to other agencies or bodies have been duly made;
(3) There is reasonable assurance that the facility will be constructed in conformity with the construction permit, the provisions of the AEA, and the Commission's regulations.
(4) The applicant is technically and financially qualified to engage in the activities authorized;
(5) Issuance of the construction permit will not be inimical to the common defense and security or to the health and safety of the public; and
(6) The findings required by part 51 of this chapter have been made.
(b) A construction permit will constitute an authorization to the applicant to proceed with construction but will not constitute Commission approval of the operational programs or requirements, other than those material to the adequacy of the design, unless the applicant specifically requests such approval and such approval is incorporated in the construction permit. The applicant, at its option, may request such approvals in the construction permit or, from time to time, by amendment of its construction permit. The Commission may, in its discretion, incorporate in any construction permit provisions requiring the applicant to furnish periodic reports of the progress.
(c) Any construction permit must state the earliest and latest dates for the completion of the construction of each nuclear reactor or modification authorized by the permit.
(a) Upon completion of the construction or material alteration of a facility, in compliance with the terms and conditions of the construction permit and subject to any necessary testing of the facility for health or safety purposes, the Commission will, in the absence of good cause shown to the contrary, issue an operating license or an appropriate amendment of the license, as the case may be.
(b) An operating license may be issued by the Commission, up to the full term authorized by § 57.105(a), upon finding that:
(1) Construction of the facility has been substantially completed, in conformity with the construction permit and the application as amended, the provisions of the AEA, and the rules and regulations of the Commission;
(2) The facility will operate in conformity with the application as amended, the provisions of the AEA, and the rules and regulations of the Commission;
(3) There is reasonable assurance that the activities authorized by the operating license can be conducted without endangering the health and safety of the public and will be conducted in compliance with the regulations in this chapter;
(4) The applicant is technically and financially qualified to engage in the activities authorized by the operating license in accordance with the regulations in this chapter. However, no finding of financial qualification is necessary for an electric utility applicant for an operating license for a utilization facility;
(5) The applicable provisions of part 140 of this chapter have been satisfied; and
(6) The issuance of the operating license will not be inimical to the common defense and security or to the health and safety of the public.
(c) Each operating license will include appropriate provisions with respect to any uncompleted items of construction and such limitations or conditions as are required to ensure that operation during the period of the completion of such items will not endanger public health and safety.
(d) An applicant may, in a case where a hearing is held in connection with a pending proceeding under this section make a motion in writing, under this paragraph, for an operating license authorizing low power testing, and further operations less than full power operation. Action on such a motion by the presiding officer will be taken with due regard to the rights of the parties to the proceedings, including the right of any party to be heard to the extent that his contentions are relevant to the activity to be authorized. Before taking any action on such a motion that any party opposes, the presiding officer must make findings on the matters specified in paragraph (b) of this section as to which there is a controversy, in the form of an initial decision with respect to the contested activity sought to be authorized. The Director of Nuclear Reactor Regulation will make findings on all other matters specified in paragraph (b) of this section. If no party opposes the motion, the presiding officer will issue an order in accordance with § 2.319(p) of this chapter authorizing the Director of Nuclear Reactor Regulation to make appropriate findings on the matters specified in paragraph (b) of this section and to issue a license for the requested operation.
(e) Each operating license for a nuclear reactor issued under this part that references a manufacturing license issued under subpart D of this part must include, as applicable, a condition that—
(1) The authorization to operate the reactor is suspended while the features to prevent criticality described in the manufacturing license are in place; and
(2) Removal of the features to prevent criticality may not be initiated unless—
(i) All conditions of an operating license under this part are met, or
(ii) The reactor has been defueled in accordance with an appropriate license issued by the Commission.
(f) The operating license for a nuclear reactor that is part of a nuclear plant at which portions of the nuclear plant will be shared by multiple reactors over the lifetime of the plant as described in § 57.60(a)(4)(iii), must include a condition specifying that the shared portions of the plant are part of the facility as described in the operating license's final safety analysis report and any related technical specifications under § 57.60(a)(4)(iv) are incorporated in the license.
(a) Each construction permit and operating license will be issued for a fixed period of time to be specified in the license but in no case to exceed 40 years from date of issuance. Where the operation of a facility is involved, the Commission will issue the operating license for the term requested by the applicant or for the estimated useful life of the nuclear reactor or nuclear plant if the Commission determines that the estimated useful life is less than the term requested. Licenses may be renewed by the Commission upon the expiration of the period. Renewal of operating licenses requirements are provided in § 57.115 and § 57.120. Application for termination of license is to be made pursuant to § 57.305.
(b) Each operating license for a facility that has permanently ceased operations,
(1) Take actions necessary to decommission and decontaminate the facility and continue to maintain the facility, including, where applicable, the storage, control and maintenance of irradiated fuel, in a safe condition, and
(2) Conduct activities in accordance with all other restrictions applicable to the facility in accordance with the NRC regulations and the provisions of the specific license for the facility.
(a) No construction permit or license under this part, or any right thereunder, may be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license or construction permit to any person, unless the Commission gives its consent in writing.
(b) Contents of license transfer applications.
(1) An application for transfer of a license or construction permit must include:
(i) For a construction permit or operating license under this part, as much of the information described in §§ 57.55 and 57.60 with respect to the identity and technical and financial qualifications of the proposed transferee as would be required by those sections if the application were for an initial construction permit or license.
(ii) For a manufacturing license under this part, as much of the information described in §§ 57.150 and 57.155 with respect to the identity and technical qualifications of the proposed transferee as would be required by those sections if the application were for an initial license.
(2) For a construction permit or operating license under this part, the Commission may require additional information such as data respecting proposed safeguards against hazards from radioactive materials and the applicant's qualifications to protect against such hazards.
(3) The application must include a statement of the purposes for which the transfer of the construction permit or license is requested, the nature of the transaction necessitating or making desirable the transfer, and an agreement to limit access to Restricted Data and classified National Security Information pursuant to § 57.15. The Commission may require any person who submits an application for a construction permit or license pursuant to the provisions of this section to file a written consent from the existing licensee or a certified copy of an order or judgment of a court of competent jurisdiction attesting to the person's right (subject to the licensing requirements of the AEA and these regulations) to possession of the facility or site involved.
(c) After appropriate notice to interested persons, including the existing licensee, and observance of such procedures as may be required by the AEA or regulations or orders of the Commission, the Commission will approve an application for the transfer of a construction permit or license, if the Commission determines:
(1) That the proposed transferee is qualified to be the holder of the license; and
(2) That transfer of the construction permit or license is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto.
(a) The filing of an application for renewal must be in accordance with subpart A of part 2 of this chapter, § 57.4, and § 57.7.
(b) Each application for renewal must include the information described in § 57.55(a) through (e), (g), and (h).
(c) Each application must include any information required by 10 CFR part 51.
(d) Each application must include any technical specification changes or additions necessary to manage the effects of aging during the period of extended operation as part of the renewal application. The justification for changes or additions to the technical specifications must be contained in the operating license renewal application.
(e) Each application for renewal must include technical information as follows:
(1) Identify safety-related SSCs subject to an aging management review, excluding those that are not subject to replacement based on a qualified life or specified time period.
(2) For each safety-related SSC identified in paragraph (e)(1) of this section, demonstrate that the effects of aging will be adequately managed so that the intended safety function(s) will be maintained consistent with the licensing basis for the period of extended operation.
(3) At least 3 months before scheduled completion of the NRC review, an amendment to the renewal application must be submitted that identifies any change to the licensing basis of the facility that materially affects the contents of the license renewal application, including the FSAR supplement.
(4) A list of time-limited aging analyses to demonstrate the following:
(i) The analyses remain valid for the period of extended operation;
(ii) The analyses have been projected to the end of the period of extended operation; or
(iii) The effects of aging on the safety function(s) will be adequately managed for the period of extended operation.
(5) An FSAR supplement for the facility that contains a summary description of the programs and activities for managing the effects of aging and the evaluation of time-limited aging analyses for the period of extended operation.
(f) A notice of an opportunity for a hearing will be published in the
A renewed license may be issued by the Commission up to the full term authorized by § 57.135 if the Commission finds that:
(a) Actions have been identified and have been or will be taken with respect to the matters identified in paragraphs (a)(1) and (a)(2) of this section, such that there is reasonable assurance that the activities authorized by the renewed license will continue to be conducted in accordance with the current licensing basis, and that any changes made to the plant's current licensing basis in order to comply with this paragraph are in accord with the AEA and the Commission's regulations. These matters are:
(1) Managing the effects of aging during the period of extended operation on the functionality of structures and components that have been identified to require review under § 57.115(e)(1); and
(2) Time-limited aging analyses that have been identified to require review under § 57.115(e)(4).
(b) Any applicable requirements of 10 CFR part 51 have been satisfied.
(c) Any matters raised under 10 CFR 2.335 have been addressed.
(a) A notice of an opportunity for a hearing will be published in the
(b) Hearings procedure.
(1) The Commission will hold a hearing after at least 30 days' notice and publication once in the
(2) When an application is made for an amendment to a construction permit or operating license, the Commission may hold a hearing after at least 30 days' notice and publication once in the
(3) If the Commission finds, in an emergency situation, as defined in § 50.91 of this chapter, that no significant hazards consideration is presented by an application for an amendment to an operating license, it may dispense with public notice and comment and may issue the amendment. If the Commission finds that exigent circumstances exist, as described in § 50.91, it may reduce the period provided for public notice and comment.
(4) Both in an emergency situation and in the case of exigent circumstances, the Commission will provide 30 days' notice of opportunity for a hearing, though this notice may be published after issuance of the amendment if the Commission determines that no significant hazards consideration is involved.
(5) The Commission will use the standards in subpart H of this part to determine whether a significant hazards consideration is presented by an amendment to an operating license and may make the amendment immediately effective, notwithstanding the pendency before it of a request for a hearing from any person, in advance of the holding and completion of any required hearing, where it has determined that no significant hazards consideration is involved.
(6) No petition or other request for review of or hearing on the staff's significant hazards consideration determination will be entertained by the Commission. The staff's determination is final, subject only to the Commission's discretion, on its own initiative, to review the determination.
(7) If an applicant requests generic finality under § 57.60(c), then the Commission will include a request for generic finality as a proposed action in the joint notice of hearing and proposed action under §§ 2.104 and 2.105 of this chapter.
A renewed license will be issued for a fixed period of time, which is the sum of the additional amount of time beyond the expiration of the operating license that is requested in a renewal application plus the remaining number of years on the operating license currently in effect. The term of any renewed license may not exceed 40 years.
(a) Notwithstanding any provision in § 57.16, during the term of a construction permit or operating license issued under this part, the Commission may not modify, rescind, or impose new requirements on the terms and conditions of the construction permit or operating license afforded generic finality pursuant to paragraph (e) of this section, unless the Commission determines that a modification is necessary to bring the construction permit or operating license into compliance with the Commission's requirements applicable and in effect at the time the construction permit or operating license was issued, or to provide reasonable assurance of adequate protection to public health and safety or common defense and security.
(b) In the proceedings for issuance of a construction permit or operating license, or in any enforcement hearing other than one initiated by the Commission under paragraph (a) of this section, in which a construction permit or operating license issued under this subpart is referenced, the Commission must treat as resolved those matters resolved in the proceeding on the application for issuance or renewal of the referenced construction permit or operating license, including, if applicable, the adequacy of a reactor design and any generic aspects of operational programs or requirements, where the referenced construction permit or operating license was afforded finality pursuant to paragraph (e) of this section.
(c) The holder of a construction permit or operating license afforded generic finality pursuant to paragraph (e) of this section may make changes to the facility or procedures as described in the FSAR associated with the construction permit or operating license without obtaining a license amendment pursuant to § 57.310 if the change meets the criteria in § 50.59(c) of this chapter. If the change does not meet the criteria in § 50.59(c) of this chapter, then the request for a change must be in the form of an application for a license amendment under § 57.310.
(d) Except for information requests seeking to verify compliance with the current licensing basis of the construction permit or operating license, the NRC must prepare the reason or reasons for each information request to the holder of a construction permit or operating license under this part before issuance to ensure that the burden to be imposed on respondents is justified in view of the potential safety significance of the issue to be addressed in the requested information. Each such justification provided for an evaluation performed by the NRC staff must be approved by the Executive Director for Operations or designee before issuance of the request.
(e) The Commission may afford generic finality to generic aspects of the design of a nuclear reactor or nuclear plant, including postulated site parameters, and generic aspects of operational programs and requirements submitted pursuant to § 57.60(c), if it finds that the proposed generic design can be constructed and operated at sites having characteristics that fall within the site parameters postulated for the design, and in accordance with the generic aspects of operational programs and requirements, without undue risk to the health and safety of the public.
This subpart sets out the requirements and procedures applicable to Commission issuance of a license under this part authorizing the manufacture of manufactured reactors. This subpart also sets out requirements for manufacturing, loading fuel into, and transportation of manufactured reactors.
Each application for a manufacturing license under this part must include the information required by § 57.55(a) through (e) and (j).
The application must include a final safety analysis report containing the
(a) Other than site-specific information, the information required by § 57.60(a)(1) through (3), (6), (7), and (9) through (12) relevant to the manufactured reactor;
(b) The site parameters postulated for the design of the reactor to be manufactured under this subpart, including the design basis external hazard levels for the relevant external hazards, and an analysis and evaluation of the design in terms of those site parameters; and
(c) Information necessary to establish that the design of the reactor to be manufactured under this subpart complies with the technical requirements in 10 CFR chapter I, including:
(1) A description and analysis of the fire protection design features for the manufactured reactor necessary to comply with § 57.60(a)(8)(ix)(B);
(2) Information demonstrating how the applicant will comply with requirements for criticality accidents in § 50.68(b)(2) through (4) of this chapter;
(3) The information required by § 20.1406 of this chapter;
(4) The technical qualifications of the applicant to engage in the proposed activities in accordance with the regulations in this chapter;
(5) Proposed technical specifications applicable to the manufactured reactor, prepared in accordance with the requirements of § 57.60(a)(8)(vi);
(6) The interface requirements between the manufactured reactor and the remaining portions of the nuclear plant or connections to other facilities outside of the nuclear plant. These requirements must be sufficiently detailed to allow for applicants for construction permits and operating licenses under this part that reference the manufactured reactor to complete the final safety analysis;
(7) A representative conceptual design for a nuclear plant using the manufactured reactor, to aid the NRC in its review of the final safety analysis report required by this section and to permit assessment of the adequacy of the interface requirements;
(8) As an alternative to the information required by paragraphs (c)(6) and (7) of this section, the application may include all non-site-specific information on the remaining portions of the nuclear plant that would be included in a joint application for a construction permit and associated operating license(s) under subpart C of this part;
(9) Justification that compliance with the interface requirements of paragraph (c)(6) of this section or the information provided under paragraph (c)(8) is verifiable through inspections, testing, or analysis; and
(10) Unless the application includes essentially complete plans for preoperational testing and initial operation under § 57.160(a), necessary parameters to be used in developing such plans.
(a) An applicant may include in its application descriptions of generic operational programs and requirements of the types described in § 57.60(a)(8). The NRC may afford finality to such programs in accordance with §§ 57.16 and 57.175.
(b) The application must include information justifying application of a categorical exclusion or, if a categorical exclusion is not applicable, an environmental report or applicant-prepared environmental assessment, in accordance with part 51 of this chapter.
(c) The application must contain a description of the program to protect safeguards information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.
(d) The application must include the following information related to the manufacturing processes, organization, controls, and inspections:
(1) A description, including references to relevant codes and standards, of the processes that will be used to procure, fabricate, and assemble components that make up the manufactured reactor. The description must clearly define which activities are proposed to be within the scope of the manufacturing license and those, such as the making of a component to be procured from a separate company for installation in the manufactured reactor, that are not considered to be within the scope of the manufacturing license;
(2) A description of the organizational and management structure singularly responsible for direction of the design and manufacture of the manufactured reactor. The information should include a description of the management plans, technical qualifications, and controls in place to demonstrate compliance with the requirements of § 57.197.
(3) A description of the inspections and tests to be performed as part of the manufacturing process, including the inspection of procured components, inspection and testing of fabrication processes, and inspections and testing of the assembled manufactured reactor;
(4) A description of the fitness-for-duty program required by part 26 of this chapter and its implementation.
(e) The application must include a description of the following information related to the deployment of a manufactured reactor:
(1) Procedures governing the preparation of the manufactured reactor or portions of the manufactured reactor for shipping to the site where it is to be operated; the conduct of shipping; and verifying the condition of the shipped items upon receipt at the site;
(2) Details of the interaction of the design, manufacture, and installation of a manufactured reactor within the applicant's organization and how the applicant will ensure integration between the designer, contractors, and any facility in which the manufactured reactor is to be installed; and
(3) Measures to be used for the control of interfaces, including the consideration of significant site parameters, between the holder of the manufacturing license and the holder of the construction permit for the nuclear plant at which the manufactured reactor is to be installed.
(f) An application for a manufacturing license for a manufactured reactor that will be fueled at the manufacturing facility under a 10 CFR part 70 license must include the following information related to loading fuel and the required features to prevent criticality and to otherwise provide reasonable assurance that the fueled manufactured reactor can be transported to and installed at a site for which the Commission has issued a construction permit that authorizes construction of a nuclear plant using the manufactured reactor and operated in accordance with an operating license issued under this part:
(1) A description of the procedures used during the fueling of the manufactured reactor that ensure that the configuration of fuel within the fueled manufactured reactor is consistent with the design and analyses supporting operation of the manufactured reactor under the operating license at the place of operation. The description may reference the applicable 10 CFR part 70
(i) The application must describe the measures taken for inspections and non-nuclear testing performed to ensure that the configuration of fuel within the fueled manufactured reactor is consistent with the design and analyses supporting operation of the manufactured reactor under the operating license at the place of operation.
(ii) The application must describe the design features included in the manufactured reactor to prevent criticality, the associated functional design criteria applied to those design features, and the physical and programmatic controls implemented during manufacturing, storage, and transport that are credited to ensure the features function as designed when subject to potential hazards and human errors. The descriptions must include how those measures will be controlled during installation under the manufacturing license and removal under the operating license at the place of operation.
(2) A description of the procedures governing the transfer of responsibilities for the fueled manufactured reactor from the holder of the manufacturing license to the holder of the construction permit for the installation site.
(3) If available at the time of filing the manufacturing license application or, if not available at the time of filing the manufacturing license application, submitted as an amendment to the manufacturing license or manufacturing license application at the time of filing the 10 CFR part 70 application, a description of the programs needed to demonstrate compliance with the requirements of § 57.197(d) and 10 CFR parts 70, 71, and 73 for the receipt, storage, and loading of SNM into a manufactured reactor and the transport of the fueled manufactured reactor to a site for which the Commission has issued a construction permit that authorizes construction of a nuclear plant using the manufactured reactor, including the following:
(i) A physical security program in accordance with § 57.197(d)(3)(i).
(ii) A cybersecurity program in accordance with § 57.197(d)(3)(i).
Applications for manufacturing licenses under this part will be reviewed according to the applicable standards set out in this subpart as well as applicable standards in 10 CFR parts 20, 25, 26, 50, 51, 57, 70, 71, 73, and 75.
A proceeding on a manufacturing license under this part is subject to all applicable procedural requirements contained in 10 CFR part 2, including the requirements for docketing in § 2.101(a)(1) through (4) of this chapter, and the requirements for issuance of a notice of proposed action in § 2.105 of this chapter, provided, however, that the designated sections may not be construed to require that the environmental report or applicable environmental review by the NRC include an assessment of the benefits of constructing and/or operating the manufactured reactor or an evaluation of alternative energy sources. All hearings on manufacturing licenses are governed by the hearing procedures contained in 10 CFR part 2, subparts C, E, G, L, and N.
(a) After completing any hearing under § 57.170, and receiving the report submitted by the ACRS under § 57.17, the Commission may issue a manufacturing license if the Commission finds that:
(1) Applicable standards and requirements of the AEA and the Commission's regulations have been met;
(2) There is reasonable assurance that the manufactured reactor will be manufactured, and can be transported, incorporated into a nuclear plant, and operated in conformity with the manufacturing license, the provision of the AEA, and the Commission's regulations;
(3) The proposed manufactured reactor can be incorporated into a nuclear plant, including, as applicable, the nuclear plant described in the manufacturing license application, and operated at sites having characteristics that fall within the site parameters postulated for the design of the manufactured reactors in conformity with the requirements in subpart B of this part and without undue risk to the health and safety of the public;
(4) The applicant is technically qualified to design and manufacture the proposed manufactured reactor;
(5) The proposed parameters to be used in developing plans for preoperational testing and initial operation, or the essentially complete plans provided in the application, are necessary and sufficient, within the scope of the manufacturing license, to provide reasonable assurance that the manufactured reactor will be manufactured and operated in conformity with the license, the provisions of the AEA, and the Commission's regulations;
(6) The generic operational programs and requirements proposed for the manufactured reactor provide reasonable assurance that the manufactured reactor can be operated under an operating license that references the manufacturing license in conformity with the provisions of the AEA and the Commission's regulations.
(7) The issuance of a manufacturing license to the applicant will not be inimical to the common defense and security or to the health and safety of the public; and
(8) The findings required by 10 CFR part 51 have been made.
(b) Each manufacturing license issued under this subpart must specify:
(1) Terms and conditions as the Commission deems necessary and appropriate;
(2) Technical specifications for operation of the manufactured reactor, as the Commission deems necessary and appropriate;
(3) Significant site parameters and significant design characteristics for the manufactured reactor; and
(4) The interface requirements to be met by the site-specific elements of the facility not within the scope of the manufactured reactor, or that the portions of the nuclear plant other than the manufactured reactor must be as described in the application.
(a) Notwithstanding any provision in § 57.16, during the term of a manufacturing license issued under this part the Commission may not modify, rescind, or impose new requirements on the design of the nuclear reactor being manufactured under the manufacturing license, or the requirements for the manufacture of the nuclear reactor, unless the Commission determines that a modification is necessary to bring the design of the reactor or its manufacture into compliance with the Commission's requirements applicable and in effect at the time the manufacturing license was issued, or to provide reasonable assurance of adequate protection to public health and safety or common defense and security.
(b) Any modification to the design of a manufactured reactor that is imposed by the Commission under paragraph (a) of this section will be applied to all reactors manufactured under the license, including those that have already been transported and sited, except those reactors to which the modification has been rendered
(c) In the proceedings for issuance of a construction permit or operating license, or in any enforcement hearing other than one initiated by the Commission under paragraph (a) of this section, in which a manufacturing license under this part is referenced, the Commission must treat as resolved those matters resolved in the proceeding on the application for issuance or renewal of the manufacturing license, including the adequacy of design of the manufactured reactor, the adequacy of the design of the remaining portions of a nuclear plant described in the manufacturing license application, and any essentially complete operational programs or requirements.
(d) The holder of a manufacturing license under this part may make changes to the facility or procedures as described in the FSAR associated with the manufacturing license without obtaining a license amendment pursuant to § 57.310 if the change meets the criteria in § 50.59(c) of this chapter. If the change does not meet the criteria in § 50.59(c) of this chapter, then the request for a change must be in the form of an application for a license amendment under § 57.310.
(e) Except for information requests seeking to verify compliance with the current licensing basis of either the manufacturing license or the manufactured reactor, the NRC must prepare the reason or reasons for each information request to the holder of a manufacturing license under this part or an applicant or licensee using a manufactured reactor before issuance to ensure that the burden to be imposed on respondents is justified in view of the potential safety significance of the issue to be addressed in the requested information. Each such justification provided for an evaluation performed by the NRC staff must be approved by the Executive Director for Operations or designee before issuance of the request.
A manufacturing license issued under this subpart may be valid for up to 40 years from the date of issuance. Upon expiration of the manufacturing license, the manufacture of any uncompleted reactors must cease unless a timely application for renewal has been docketed with the NRC.
A manufacturing license may be transferred in accordance with § 57.110.
(a) Not less than 12 months, nor more than 5 years before the expiration of the manufacturing license, or any later renewal period, the holder of the manufacturing license issued under this part may apply for a renewal of the license. An application for renewal must contain all information necessary to bring up to date the information and data contained in the previous application. The filing of an application for a renewed license must be in accordance with subpart A of 10 CFR part 2 of this chapter and § 57.19.
(b) A manufacturing license issued under this part, either original or renewed, for which a timely application for renewal has been filed, remains in effect until the Commission has made a final determination on the renewal application.
(c) Any person whose interest may be affected by renewal of the license may request a hearing on the application for renewal. The request for a hearing must comply with § 2.309 of this chapter. If a hearing is granted, notice of the hearing will be published in accordance with § 2.104 of this chapter.
(d) The Commission may grant the renewal if the Commission determines—
(1) The manufacturing license complies with the AEA and the Commission's regulations and orders applicable and in effect at the time the manufacturing license was originally issued; and
(2) Any new requirements the Commission may wish to impose are—
(i) Necessary for adequate protection to public health and safety or common defense and security;
(ii) Necessary for compliance with the Commission's regulations and orders applicable and in effect at the time the manufacturing license was originally issued; or
(iii) A substantial increase in overall protection of the public health and safety or the common defense and security to be derived from the new requirements, and the direct and indirect costs of implementation of those requirements are justified in view of this increased protection.
(e) A renewed manufacturing license may be issued for a term up to 40 years, plus any remaining years on the manufacturing license then in effect before renewal. The renewed license will be subject to the requirements of § 57.175.
(a) Holders of manufacturing licenses must ensure that the following plans, programs, and organizational units are developed and implemented to manage and control the manufacturing activities within the scope of the manufacturing license:
(1) Programs to ensure that the manufacturing of a reactor complies with the design and analysis requirements in this part. The entity with design authority for the manufactured reactor covered by the manufacturing license must be identified in the license.
(2) An organizational and management structure responsible for managing, controlling, and evaluating the adequacy of the reactor design and manufacturing activities.
(3) Procedures describing the qualifications for personnel in key positions in the licensee's management and control organization and the organizational responsibilities, authority, and interfaces with other parts of the licensee's organization.
(4) A fitness-for-duty program, in accordance with part 26 of this chapter.
(5) A quality assurance program to be applied to the design, fabrication, construction, and testing of the safety-related SSCs of the manufactured reactor.
(6) A radiation protection program, in accordance with 10 CFR part 20, that includes measures for monitoring the dose to individuals if the manufacturing activities include working with radioactive materials.
(7) An information security program in accordance with §§ 73.21, 73.22 and 73.23 of this chapter, as applicable.
(b) Holders of manufacturing licenses must satisfy the following requirements:
(1) The manufacturing process must be conducted within facilities for which the manufacturing license holder has the authority to establish controls on any activity that might affect manufacturing. The licensee must establish access controls to the portions of each facility involved in the manufacturing processes governed by the manufacturing license.
(2) Manufacturing processes must be performed in accordance with the manufacturing license, including the codes or standards described in the manufacturing license application under § 57.160(d) and found acceptable by the NRC.
(3) A post-manufacturing inspection and acceptance process to verify that manufacturing activities have been completed in accordance with the manufacturing license must be established and implemented before transporting a manufactured reactor or portions of a manufactured reactor for installation at a nuclear plant.
(c) As appropriate considering the types and quantities of radioactive materials being brought into the manufacturing facility—
(1) Procedures must be in place to receive, transfer, possess, and use source, byproduct, and special nuclear material in accordance with the applicable portions of 10 CFR parts 30, 40 and 70.
(2) A fire protection program must be established and implemented before the initial receipt of byproduct, source, or non-fuel special nuclear material (excluding exempt quantities as described in § 30.18 of this chapter).
(3) An emergency plan appropriate for responding to the facility-specific hazards of an accidental release of radioactive material and to limit the health effects of the associated chemical hazards of licensed material must be approved and implemented prior to the receipt of byproduct, source, or special nuclear material (excluding exempt quantities as described in § 30.18 of this chapter).
(4) A plant staff training program associated with the receipt of radioactive material must be approved and implemented before initial receipt of byproduct, source, or special nuclear material (excluding exempt quantities as described in § 30.18 of this chapter).
(5) Security requirements must be implemented for the protection of SNM based on the type, enrichment, and quantity in accordance with 10 CFR part 73, as applicable, and for the protection of Category 1 and Category 2 quantities of radioactive material in accordance with 10 CFR part 37, as applicable.
(d) Fuel loading.
(1) The Commission has determined that a fueled manufactured reactor in which features to prevent criticality are in place is not in operation.
(i) A holder of a manufacturing license may load fuel into a manufactured reactor pursuant to a license issued under part 70 of this chapter only if the manufactured reactor is configured before its fuel loading and during storage and transport with features to prevent criticality that are specified in the manufacturing license.
(ii) Upon issuance of an operating license for a nuclear plant that incorporates the manufactured reactor, the features to prevent criticality may be removed. Upon initiating the removal of the features to prevent criticality, the fueled manufactured reactor has commenced operation.
(2) Holders of 10 CFR part 70 licenses authorizing the possession and loading of fuel into reactors manufactured under a manufacturing license issued under this part must comply with the requirements of 10 CFR part 70 for the facilities and activities related to the storage, movement, and loading of fuel in the manufactured reactors. Procedures, equipment, and personnel required by the 10 CFR part 70 license must be in place before the receipt of SNM at the manufacturing facility.
(3) Before the receipt of SNM, the licensee must have security programs in place that meet the performance objectives of 10 CFR 73.67, with the following additions and exceptions:
(i) A physical security plan describing the physical security program must be maintained and a cybersecurity program must be established for the possession and loading of fresh fuel into a manufactured reactor authorized by a 10 CFR part 70 license, regardless of fuel type, enrichment, and quantity.
(ii) The physical security program must be designed to prevent unintended and uncontrolled criticality events.
(iii) The cybersecurity program must provide reasonable assurance that a cyberattack would not adversely impact the functions performed by digital assets necessary for implementing the physical security requirements of this section, or the radiation monitoring and criticality requirements in this section or in 10 CFR part 70.
(iv) All holders of a 10 CFR part 70 license that authorizes loading of fresh fuel into a manufactured reactor must perform the screening required in § 73.67(d)(4) of this chapter to confirm the identity, trustworthiness, and reliability of individuals prior to granting unescorted access to special nuclear material, and these determinations must be documented.
(4) The loading or unloading of fresh fuel into or from a manufactured reactor and any changes to the configuration of reactivity control and prevention systems for the fueled manufactured reactor must be performed by a certified fuel handler.
(e) Transportation.
(1) A holder of a manufacturing license under this part may not transport or allow to be removed from the places of manufacture the reactor manufactured under the manufacturing license except for either transport to a site for which the Commission has issued a construction permit that references the subject manufacturing license or for export in accordance with 10 CFR part 110.
(2) A holder of a manufacturing license must include in any contract governing the transport of a manufactured reactor or portions thereof as defined in the manufacturing license from the places of manufacture to any other location, a provision requiring that the person transporting the manufactured reactor comply with all shipping requirements in applicable NRC regulations, certificates of compliance, and NRC-issued licenses.
(3) Procedures governing the preparation of the manufactured reactor or portions thereof as defined in the manufacturing license for transport and the conduct of the transport must be issued prior to transport. The procedures must implement the protective measures and restrictions described in NRC regulations and NRC-issued licenses to protect the reactor from potential conditions that would adversely affect the safe operation of a nuclear plant.
(4) For a manufactured reactor that is to be loaded with fresh fuel before transport to the place of operation, the manufacturing license must specify that transportation will be in accordance with parts 71 and 73 of this chapter.
(f) Acceptance and installation at the site for which the Commission has issued a construction permit that references the subject manufacturing license.
(1) Installation must be in accordance with the construction permit that references the subject manufacturing license.
(2) Upon arrival at the site, the manufactured reactor may not be installed in its place of operation unless the construction permit holder performs inspections sufficient to verify the reactor is in compliance with the manufacturing license and has not been damaged in transit. The construction permit holder must perform these inspections in accordance with documented procedures subject to quality assurance measures commensurate with their importance to safety. In addition, inspections must confirm that the interface requirements between the manufactured reactor or portions of a manufactured reactor and the remaining portions of the nuclear plant are met.
This subpart sets out procedures for the filing and NRC staff review of standard designs, or major portions thereof, for a nuclear reactor of the type to which this part is applicable.
The application must contain all of the information required by 10 CFR 57.55(a) through (c) and (j).
(a) If the applicant seeks review of a major portion of a standard design, the application need only contain the information required by this section to the extent the requirements are applicable to the major portion of the standard design for which NRC staff approval is sought. If an applicant seeks approval of a major portion of the design, the application must demonstrate compliance with the design criteria attributes in § 57.30, as applicable, for the major portion of the standard design for which NRC staff approval is sought. Such applicants must identify conditions related to interfaces with systems outside the scope of the major portion of the standard design for which NRC staff approval is sought, and functional or physical boundary conditions between the major portion of the standard design for which NRC staff approval is sought and the remainder of the standard design. These conditions must be demonstrated when the standard design approval is incorporated into a subsequent joint application for a construction permit and associated operating license(s) or a manufacturing license application under this part.
(b) The application must contain a final safety analysis report that describes the facility, presents the design bases and the limits on its operation, and presents a safety analysis of the safety-related SSCs and of the facility, or major portion thereof, and must include the following information:
(1) Other than site-specific information, the information required by § 57.60(a)(1) through (3), (a)(6) and (7), and (a)(9) through (13) relevant to the standard design;
(2) A description and analysis of the fire protection design features for the standard plant necessary to limit fire damage to safety-related SSCs as required by § 57.60(a)(8)(ix)(B);
(3) The information necessary to demonstrate that the standard plant complies with the environmental information relating to applicable site evaluation factors for seismic, meteorological, hydrologic, and geologic characteristics with appropriate consideration of natural phenomena;
(4) A description, analysis, and evaluation of the interfaces between the standard design and the balance of the nuclear plant; and
(5) The information required by § 20.1406 of this chapter.
Applications filed under this part will be reviewed under the standards set out in 10 CFR parts 20, 57, and 73.
Upon completion of its review of a submittal under this subpart and receiving any report submitted by the ACRS under § 57.17, the NRC staff must publish a determination in the
(a) An approved design must be used by and relied upon by the NRC staff and the ACRS in their review of any joint application for a construction permit and associated operating license(s) or a manufacturing license application under this part that incorporates by reference a standard design approved in accordance with this paragraph unless there exists significant new information that substantially affects the earlier determination or other good cause.
(b) The determination and report by the NRC staff do not constitute a commitment to issue a construction permit, operating license, or manufacturing license in any way affect the authority of the Commission, Atomic Safety and Licensing Board Panel, or presiding officers in any proceeding under part 2 of this chapter.
(c) Except for information requests seeking to verify compliance with the current licensing basis of the standard design approval, the NRC must prepare the reason or reasons for each information request to the holder of a standard design approval under this part before issuance to ensure that the burden to be imposed on respondents is justified in view of the potential safety significance of the issue to be addressed in the requested information. Each such justification provided for an evaluation performed by the NRC staff must be approved by the Executive Director for Operations or designee before issuance of the request.
(d) The Commission will require, before granting a construction permit, operating license, or manufacturing license that references a standard design approval, that engineering documents, such as analyses, drawings, procurement specifications, or construction and installation specifications, be completed and available for audit if the more detailed information is necessary for the Commission to verify the information in the application and make its safety determination, including the determination that the application is consistent with the design approval information. This information may be acquired by appropriate arrangements with the design approval applicant.
A standard design approval issued under this subpart has no expiration date.
The regulations in this subpart establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. That section requires any individual director or responsible officer of a firm constructing, owning, operating, or supplying the components of any facility or activity that is licensed or otherwise regulated pursuant to the AEA or the Energy Reorganization Act of 1974, who obtains information reasonably indicating:
(a) that the facility, activity or basic component supplied to such facility or activity fails to comply with the AEA or any applicable rule, regulation, order, or license of the Commission relating to substantial safety hazards; or
(b) that the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard, to immediately notify the Commission of such failure to comply or such defect, unless the individual has actual knowledge that the Commission has been adequately informed of such defect or failure to comply.
(a) The regulations in this subpart apply to:
(1) Each individual, partnership, corporation, or other entity applying for or holding a license or construction permit under this part to construct, manufacture, possess, own, operate, or transfer within the United States, a utilization facility; and each director and responsible officer of such a licensee;
(2) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, that constructs a utilization facility licensed for manufacture, construction, or operation under this part; or supplies basic
(3) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, applying for or holding a standard design approval under this part; or supplying basic components with respect to a standard design approval under this part.
(b) For persons licensed to construct a facility under subpart C of this part, or to manufacture a facility under subpart D of this part, evaluation of potential defects and failures to comply and reporting of defects and failures to comply satisfies each person's evaluation, notification, and reporting obligation to report defects and failures to comply under this part and the responsibility of individual directors and responsible officers of these licensees to report defects under Section 206 of the Energy Reorganization Act of 1974.
(c) For persons licensed to operate a nuclear plant under subpart C of this part, evaluation of potential defects and appropriate reporting of defects under this subpart satisfies each person's evaluation, notification, and reporting obligation to report defects under this part, and the responsibility of individual directors and responsible officers of these licensees to report defects under Section 206 of the Energy Reorganization Act of 1974.
(d) Nothing in these regulations should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item (as defined in § 57.240) not subject to the regulations in this part from reporting to the Commission, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. NRC regional offices and headquarters will accept collect telephone calls from individuals who wish to speak to NRC representatives concerning nuclear safety-related problems. The location and telephone numbers of the four regions (answered during regular working hours) are listed in appendix D to part 20 of this chapter. The telephone numbers of the NRC Headquarters Operations Center (answered 24 hours a day—including holidays) are listed in appendix A to part 73 of this chapter.
For purposes of this subpart, the definitions in § 57.3 of this part apply, except the term “construction.” The following definitions also apply for the purposes of this subpart.
(1) a structure, system, or component, or part thereof necessary to ensure:
(i) The capability to adequately control thermodynamic conditions and reactivity, and to retain radioactive material;
(ii) The capability to shut down the reactor and maintain it in a safe shutdown condition; or
(iii) The capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposures comparable to those referred to in § 57.25(a).
(2) Basic components are items designed and manufactured under a quality assurance program complying with § 57.60(a)(3) of this part, or commercial grade items which have successfully completed the dedication process.
(3) In all cases,
(1) Not subject to design or specification requirements that are unique to facilities or activities licensed pursuant to this part;
(2) Used in applications other than facilities or activities licensed pursuant to this part; and
(3) To be ordered from the manufacturer/supplier on the basis of specifications set forth in the manufacturer's published product description (for example, a catalog).
(1) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to the regulations in this part if, on the basis of an evaluation, the deviation could create a substantial safety hazard;
(2) The installation, use, or operation of a basic component containing a defect as defined in this part;
(3) A deviation in a portion of a facility subject to the construction permit or manufacturing licensing requirements of this part, provided the deviation could, on the basis of an evaluation, create a substantial safety hazard and the portion of the facility containing the deviation has been offered to the purchaser for acceptance;
(4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued under this part; or
(5) An error, omission or other circumstance in a standard design approval that, on the basis of an evaluation, could create a substantial safety hazard.
(a) Posting of documents.
(1) Each individual, partnership, corporation, dedicating entity, or other entity subject to the regulations in this part must post current copies of —
(i) The regulations in this part;
(ii) Section 206 of the Energy Reorganization Act of 1974; and
(iii) Procedures adopted pursuant to the regulations in this part.
(2) These documents must be posted in a conspicuous position on any premises within the United States where the activities subject to this part are conducted.
(b) If posting of the regulations in this part or the procedures adopted pursuant to the regulations in this part is not practicable, the licensee or firm subject to the regulations in this part may, in addition to posting Section 206 of the Energy Reorganization Act of 1974, post a notice that describes the regulations or procedures, including the name of the individual to whom reports may be made, and states where they may be examined.
Suppliers of commercial grade items are exempt from the provisions of this part to the extent that they supply commercial grade items.
(a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part must adopt appropriate procedures to—
(1) Evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable, and, except as provided in paragraph (a)(2) of this subsection, in all cases within 60 days of discovery, in order to identify a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected.
(2) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the Commission through a director or responsible officer or designated person as discussed in § 57.270(d)(5). The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within 60 days of discovery of the deviation or failure to comply.
(3) Ensure that a director or responsible officer subject to the regulations of this part is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in paragraphs (a)(1) or (a)(2) of this section if the manufacture, construction, or operation of a facility or activity, a basic component supplied for such facility or activity, or standard design approval of this part—
(i) Fails to comply with the AEA or any applicable rule, regulation, order, or license of the Commission, relating to a substantial safety hazard, or
(ii) Contains a defect.
(iii) For construction permit and manufacturing license holders, undergoes any significant breakdown in any portion of the quality assurance program conducted under the requirements of § 57.60(a)(3), which could have produced a defect in a basic component. These breakdowns in the quality assurance program are reportable whether the breakdown actually resulted in a defect in a design approved and released for construction, installation, or manufacture.
(b) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply, pursuant to § 57.270(a).
(c) A dedicating entity is responsible for—
(1) Identifying and evaluating deviations and reporting defects and failures to comply associated with substantial safety hazards for dedicated items; and
(2) Maintaining auditable records for the dedication process.
(d) Notifications to the NRC.
(1) A director or responsible officer subject to the regulations of this part or a person designated under § 57.270(d)(5) must notify the Commission when he or she obtains information reasonably indicating a failure to comply or a defect affecting—
(i) The manufacture, construction, or operation of a facility or an activity within the United States that is subject to the licensing requirements under this part and that is within his or her organization's responsibility; or
(ii) A basic component that is within his or her organization's responsibility and is supplied for a facility or an activity within the United States that is subject to the licensing or approval requirements under this part;
(iii) For construction permit and manufacturing license holders, a quality assurance program that undergoes any significant breakdown that could have produced a defect in a basic component.
(2) The notification to the NRC of a failure to comply or of a defect under paragraph (d)(1) of this section and the evaluation of a failure to comply or a defect under paragraphs (a)(1) and (a)(2) of this section, are not required if the director or responsible officer has actual knowledge that the Commission has been notified in writing of the defect or the failure to comply.
(3) Notification required by paragraph (d)(1) of this section must be made as follows—
(i) Initial notification to the NRC Headquarters Operations Officer email address:
(ii) Written notification to the NRC at the address specified in § 57.4 within 30 days following receipt of information by the director or responsible corporate officer under paragraph (a)(3) of this subsection, on the identification of a defect or a failure to comply.
(4) The written report required by paragraph (d)(1) must include, but need not be limited to, the following information, to the extent known:
(i) Name and address of the individual or individuals informing the Commission.
(ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States that fails to comply or contains a defect.
(iii) Identification of the firm constructing the facility or supplying the basic component that fails to comply or contains a defect.
(iv) Nature of the defect or failure to comply and the safety hazard that is created or could be created by such defect or failure to comply.
(v) The date on which the information of such defect or failure to comply was obtained.
(vi) In the case of a basic component that contains a defect or fails to comply, the number and location of these components in use at, supplied for, being supplied for, or may be supplied for, manufactured, or being manufactured for one or more facilities or activities subject to the regulations in this part.
(vii) The corrective action that has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.
(viii) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.
(5) The director or responsible officer may authorize an individual to provide the notification required by this paragraph, provided that, this must not relieve the director or responsible officer of his or her responsibility under this paragraph (d).
(e) Individuals subject to this part may be required by the Commission to supply additional information related to a defect or failure to comply. Commission action to obtain additional information may be based on reports of defects from other reporting entities.
Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part must ensure that each procurement document for a facility, or a basic component issued by him, her or it specifies, when applicable, that the provisions of 10 CFR part 57, subpart F apply.
Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part must permit the Commission to inspect records, premises, activities, and basic components as necessary to accomplish the purposes of this part.
(a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part must prepare and maintain records necessary to accomplish the purposes of this part, specifically —
(1) Retain evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation;
(2) Suppliers of basic components must retain any notifications sent to purchasers and affected licensees for a minimum of five years after the date of the notification.
(3) Suppliers of basic components must retain a record of the purchasers of basic components for 10 years after delivery of the basic component or service associated with a basic component.
(4) Applicants for or holders of a standard design approval under subpart E of this part and others providing a design that is the subject of a design approval must retain any notifications sent to purchasers and affected licensees for a minimum of 5 years after the date of the notification, and retain a record of the purchasers for 15 years after delivery of the design which is the subject of the design approval or service associated with the design.
(b) The holder of a construction permit or manufacturing license must prepare and maintain records necessary to accomplish the purposes of this part, specifically—
(1) Retain procurement documents, which define the requirements that facilities or basic components must meet in order to be considered acceptable, for the lifetime of the facility or basic component.
(2) Retain records of evaluations of all deviations and failures to comply for the longer of:
(i) Ten (10) years from the date of the evaluation; or
(ii) Five (5) years from the date of the delivery of a manufactured reactor.
(3) Suppliers of basic components must retain records of:
(i) All notifications sent to affected licensees or purchasers for a minimum of 10 years following the date of the notification;
(ii) The facilities or other purchasers to whom basic components or associated services were supplied for a minimum of 15 years from the delivery of the basic component or associated service.
(c) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part must permit the Commission the opportunity to inspect records pertaining to basic components that relate to the identification and evaluation of deviations, and the reporting of defects and failures to comply, including (but not limited to) any advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component.
(a) Any director or responsible officer of an entity (including dedicating entity) that is not otherwise subject to the deliberate misconduct provisions of this chapter but is subject to the regulations in this part who knowingly and consciously fails to provide the notice required by § 57.270 will be subject to a civil penalty equal to the amount provided by section 234 of the AEA.
(b) Any NRC licensee or applicant for a license (including an applicant for, or holder of, a construction permit), or applicant for or holder of a standard design approval under subpart E, subject to the regulations in this part who fails to provide the notice required by § 57.270, or otherwise fails to comply with the applicable requirements of this part will be subject to a civil penalty as provided by section 234 of the AEA.
(c) The dedicating entity, pursuant to § 57.270(c) of this part, is responsible for identifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintaining auditable records of the dedication process. NRC enforcement action can be taken for failure to identify and evaluate deviations, failure to report defects and failures to comply, or failure to maintain auditable records.
While an irradiated fuel transportation package certified under 10 CFR part 71 of this chapter or irradiated fuel storage system certified under 10 CFR part 72 is in the SNM handling or storage area, the requirements in 10 CFR part 71 or 72, as applicable, and the requirements of the certificate of compliance for that package or storage system, are the applicable requirements for the fuel within that package or storage system.
(a)
(b)
(c)
(d)
(1) Submission of this plan must occur (1) within 1 year following permanent cessation of operations of the reactor, (2) more than 2 years before expiration of the reactor operating license if storage occurs at the reactors site, or (3) more than 2 years before expiration of the manufacturing license if storage occurs at the manufacturing site, whichever occurs first.
(2) The licensee must demonstrate to the NRC that the storage management and funding plan is in compliance with all applicable possession, safety, and environmental requirements for storage of irradiated fuel, and must address, as applicable, transport to a designated storage site.
(a)(1) When a licensee has determined to permanently cease operations, the licensee must, within 30 days, submit a written certification to the NRC, consistent with the requirements of § 57.4(b)(8);
(2) If the fuel has been permanently removed from the reactor on site or transferred to a licensed remediation or storage facility, the licensee must submit a written certification to the NRC that meets the requirements of § 57.4(b)(9);
(3) A licensee that permanently ceases site operations must make notification of the permanent cessation of operations no later than 1 year prior to the expiration of the operating license.
(b) Licensees that do not have an approved decommissioning plan at the time of permanent cessation of operations are subject to the requirements of § 50.82(b) of this chapter. These licensees' decommissioning plans may be limited to those provisions applicable to the design characteristics of the nuclear reactors or nuclear plants and must address, as applicable, transport of nuclear reactors to designated facilities for final decommissioning, final decommissioning of individual nuclear reactors, or final decommissioning of entire nuclear plants, and ensure compliance with all applicable safety and environmental requirements.
(c)(1) Decommissioning trust funds may be used by licensees that meet the following requirements:
(i) The withdrawals are for expenses for legitimate decommissioning activities consistent with the definition of decommissioning in § 57.3;
(ii) The expenditure would not reduce the value of the decommissioning trust below an amount necessary to place and maintain the reactor in a safe storage condition if unforeseen conditions or expenses arise; and
(iii) The withdrawals would not inhibit the ability of the licensee to complete funding of any shortfalls in the decommissioning trust needed to ensure the availability of funds to ultimately release the site and terminate the license.
(2) Unless otherwise noted in a licensee's NRC-approved decommissioning plan, and until the licensee has completed its final radiation survey and demonstrated that residual radioactivity has been reduced to a level that permits termination of its license, the licensee must annually submit to the NRC, by March 31, a financial assurance status report. The report must include the following information, current through the end of the previous calendar year:
(i) The amount spent on decommissioning, both cumulative and over the previous calendar year, the remaining balance of any decommissioning funds, and the amount provided by other financial assurance methods being relied upon;
(ii) An estimate of the costs to complete decommissioning, reflecting any difference between actual and estimated costs for work performed during the year, and the decommissioning criteria upon which the estimate is based;
(iii) Any modifications occurring to a licensee's current method of providing financial assurance since the last submitted report; and
(iv) Any material changes to trust agreements or financial assurance contracts.
(3) If the sum of the balance of any remaining decommissioning funds, plus earnings on such funds calculated at not greater than a 2 percent real rate of return, together with the amount provided by other financial assurance methods being relied upon, does not cover the estimated cost to complete the decommissioning, the financial assurance status report must include additional financial assurance to cover the estimated cost of completion.
(d) Licensees may not perform any decommissioning activities that—‐
(1) Foreclose release of the site for possible unrestricted use;
(2) Result in significant environmental impacts not previously reviewed; or
(3) Result in there no longer being reasonable assurance that adequate funds will be available for decommissioning.
(e) If the operating license is the only operating license for a nuclear reactor using the shared portions of the plant described in § 57.60(a)(4)(iii), then the entire nuclear plant must be decommissioned before termination of the operating license.
(f) All holders of operating licenses are subject to the license termination provisions of § 50.82(b) of this chapter.
(a) Whenever a holder of a construction permit, operating license, or manufacturing license desires to amend the license, application for an amendment must be filed with the Commission, as specified in § 57.4, as applicable. The application must fully describe the changes desired and follow, as far as applicable, the form prescribed for original applications.
(b) In determining whether an amendment to a license issued under this part will be issued to the applicant, the Commission will be guided by the considerations that govern the issuance of initial licenses to the extent applicable and appropriate. If the application involves the material alteration of a licensed facility, a construction permit will be issued before the issuance of the amendment to the license. However, no application for a construction permit is required if the application involves a material alteration to a nuclear reactor manufactured under a manufacturing license issued under this part before the reactor is installed at a site. If the amendment involves a significant hazards consideration, the Commission will give notice of its proposed action according to the following:
(1) Under § 2.105 of this chapter before acting thereon; and
(2) As soon as practicable after the application has been docketed.
(c) The Commission will be particularly sensitive to a license amendment request that involves irreversible consequences (such as one that permits a significant increase in the amount of effluents or radiation emitted by a nuclear plant).
(d) The Commission may make a final determination, under the procedures in § 50.91 of this chapter, that a proposed amendment to an operating license under this part involves no significant hazards consideration, if operation of the facility in accordance with the proposed amendment would not:
(1) Involve a significant increase in the likelihood or consequences of an accident previously evaluated; or
(2) Create the possibility of a new or different kind of accident from any accident previously evaluated; or
(3) Involve a significant reduction in a margin of safety.
(e) For an application requesting an amendment to an operating license under this part, the Commission will use the procedures in § 50.91 of this chapter for notifying the public and consulting the State.
(a) A licensee under this part may make changes in the facility as described in the final safety analysis report, make changes in the procedures as described in the final safety analysis report, and conduct tests or experiments not described in the final safety analysis report without obtaining a license amendment pursuant to § 57.310 in accordance with the requirements in § 50.59 of this chapter.
(b) The holder of an operating license issued under this part that authorizes operation of a manufactured reactor may make changes in the facility as described in the final safety analysis report (as updated) and make changes in the procedures as described in the final safety analysis report (as updated) if the changes are identical to changes approved by the Commission by amendment to the manufacturing license for the manufactured reactor and upon determining that implementation of the changes will be consistent with the basis for the Commission's approval of the amendment to the manufacturing license and not involve any additional changes that would require an amendment to its operating license.
(a) Each holder of an operating license issued under this part and each holder of a manufacturing license issued under this part must update periodically the FSAR originally submitted as part of the application for the license, to ensure that the information included in the report contains the latest information developed. This submittal must contain all the changes necessary to reflect information and analyses submitted to the Commission by the applicant or licensee or prepared by the applicant or licensee pursuant to Commission requirement since the submittal of the original FSAR, or as appropriate, the last update to the FSAR under this section. The submittal must include the effects of all changes made in the facility or procedures as described in the FSAR; all safety analyses and evaluations performed by the applicant or licensee either in support of approved license amendments or in support of conclusions that changes did not require a license amendment in accordance with § 50.59(c)(2) or (e) of this chapter and all analyses of new safety issues performed by or on behalf of the applicant or licensee at Commission request. Effects of changes include appropriate revisions of descriptions in the FSAR such that the FSAR (as updated) is complete and accurate. The updated information must be appropriately located within the update to the FSAR.
(b) The licensee must submit revisions containing updated information to the Commission, as specified in § 57.4, on a replacement-page basis that is accompanied by a list which identifies the current pages of the FSAR following page replacement. Each submittal must reflect all changes made to the FSAR up to a maximum of 6 months prior to the date of filing the submittal.
(c) The submittal must include:
(1) a certification by a duly authorized officer of the licensee that either the information accurately presents changes made since the previous submittal, necessary to reflect information and analyses submitted to the Commission or prepared pursuant to Commission requirement, or that no such changes were made; and
(2) an identification of changes made under the provisions of § 50.59 of this chapter but not previously submitted to the Commission.
(d) Each replacement page must include both a change indicator for the area changed,
(e) The updated FSAR must be retained by the licensee until the Commission terminates their license.
The report required by § 57.55(i) must be updated and submitted to the NRC as specified in § 57.4 before issuance of any operating license associated with an approved construction permit, within 3 years following issuance of an operating license, and no more than every 3 years thereafter for that operating license. The updated information must include the amount of decommissioning funds estimated to be required; the amount of decommissioning funds accumulated to the end of the calendar year preceding the date of the report; a schedule of the annual amounts remaining to be collected; and the assumptions used regarding rates of escalation in decommissioning costs, rates of earnings on decommissioning funds, and rates of other factors used in funding projections.
This subpart sets forth the requirements and procedures applicable
While an irradiated fuel transportation package approved under 10 CFR part 71 of this chapter is in the SNM handing or storage area at the licensee's site, the requirements in 10 CFR part 71, as applicable, and the requirements of the certificate of compliance for that package, are the applicable requirements for the fuel within that package.
(a)
(1) The requirements of 10 CFR part 71 considering the reactor as the transportation package have been met. In lieu of an evaluation of the effects of the tests required by 10 CFR 71.41(a) and specified in 10 CFR 71.71, 71.73 and 71.61 on a package, a risk methodology or other risk-informed approach for evaluating normal and/or accident conditions that has been endorsed or otherwise approved by the Commission may be used to evaluate a package for certification, and
(2) Features to prevent criticality that meet the requirements of § 57.160(f)(1)(ii) are in place.
(b)
(1) A general licensee must meet the requirements of 10 CFR 71.17, and
(2) Features to prevent criticality that meet the requirements of § 57.160(f)(1)(ii) must be in place before the first use of the package.
(a)
(1) Each licensee that is licensed to operate a nuclear reactor under this part and did not meet the requirement in § 57.60(a)(8)(v)(A)(
(2) The security plans must identify, describe, and account for site-specific conditions that affect the licensee's capability to satisfy the requirements of this section.
(b)
(1) The licensee must establish, implement, and maintain a physical protection program and a security organization, which will have as their objective to provide reasonable assurance that activities involving special nuclear material are not inimical to the common defense and security and do not constitute an unreasonable risk to the public health and safety.
(2) The physical protection program must be designed to prevent a release of radionuclides from any source from exceeding the dose reference values defined in § 50.34(a)(1)(ii)(D)(
(3) To satisfy the general performance objective of paragraph (b)(1) of this section, the physical protection program must protect against the design basis threat of radiological sabotage as stated in § 73.1 of this chapter.
(4) The physical protection program must be designed and implemented to achieve and maintain the reliability and availability of SSCs required for demonstrating compliance with the following performance requirements at all times:
(i)
(ii)
(iii)
(iv)
(5) The licensee must provide necessary information about the facility and make available periodic training to law enforcement or other offsite armed responders who will fulfill the interdiction and neutralization functions for threats up to and including the design basis threat of radiological sabotage.
(6) The licensee must be capable of detecting and denying unauthorized access to persons and pass-through of contraband materials to protected areas.
(7) The licensee must document and maintain the process used to develop and identify target sets, to include the site-specific analyses and methodologies used to determine and group the target set equipment or elements.
(8) The licensee must implement a process for the oversight of target set equipment and systems to ensure that changes to the configuration of the identified equipment and systems are considered in the licensee's protective strategy. Where appropriate, changes must be made to documented target sets.
(9) The licensee must establish, implement, and maintain a performance evaluation program to assess the effectiveness of the licensee's implementation of the physical protection program to protect against the design basis threat of radiological sabotage.
(10) The licensee must establish, implement, and maintain a cybersecurity program under § 73.54 or § 73.110 of this chapter and must describe the program in the cybersecurity plan.
(11) The licensee must establish, implement, and maintain an insider mitigation program and must describe the program in the physical security plan.
(12) The licensee must have the capability to track, trend, correct, and prevent recurrence of failures and deficiencies in the implementation of the requirements of this section.
(13) Implementation of security plans and associated procedures must be coordinated with other onsite plans and procedures to preclude conflict during both normal and emergency conditions and ensure the adequate management of the safety and security interface.
(14) The licensee must ensure that the firearms background check requirements of § 73.17 of this chapter are met for all members of the security organization whose official duties
(c)
(d)
(e)
(f)
(g)
(1) The licensee may suspend implementation of affected requirements of this section in accordance with § 57.399(g)-(h) of this chapter under the following conditions:
(i) In an emergency, when action is immediately needed to protect the public health and safety; and
(ii) During severe weather, when the suspension of affected security measures is immediately needed to protect the personal health and safety of personnel.
(2) Suspended security measures must be reinstated as soon as conditions permit.
(3) The suspension of security measures must be reported and documented in accordance with the provisions of §§ 73.1200 and 73.1205 of this chapter.
(h)
(1) The Commission may inspect, copy, retain, and remove all reports, records, and documents required to be kept by Commission regulations, orders, or license conditions, whether the reports, records, and documents are kept by the licensee or a contractor.
(2) The licensee must maintain all records required to be kept by Commission regulations, orders, or license conditions, until the Commission terminates the license for which the records were developed and must maintain superseded portions of these records for at least 3 years after the record is superseded, unless otherwise specified by the Commission.
(3) If a contracted security force is used to implement the onsite physical protection program, the licensee's written agreement with the contractor must be retained by the licensee as a record for the duration of the contract.
(4) Review and audit reports must be available for inspection, for a period of 3 years.
(a) The NRC has determined that the categories of actions identified in paragraph (b) of this section meet the criteria for categorical exclusion pursuant to 10 CFR 51.22.
(b) The issuance of an initial or renewed license for a microreactor or other reactor with a comparable risk profile, and all forms of related NRC actions, including amendments, exemptions and orders, under this part, are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement, provided that the following criteria are met:
(1) The application for the initial or renewed license, amendment, or exemption, or the order, demonstrates that the licensed action is within the environmental plant parameter and site parameter envelope for Table C-1 of Appendix C of 10 CFR part 51, which may include the siting of multiple reactors across a region or at one site.
(2) The application for the initial or renewed license, amendment, or exemption, or the order, demonstrates the following:
(i) The site will be within a previously disturbed area as defined in § 57.3;
(ii) The cooling system(s) will not require the use or consumption of water withdrawn directly from surface water or groundwater sources or discharges to surface water or groundwater sources;
(iii) Air emissions will be below de minimis threshold levels in 40 CFR 93.153(b)(1) or (b)(2), as applicable; and
(iv) The licensed activity will be in accordance with applicable State and local requirements (such as land use planning, zoning requirements, and coastal zone management program requirements under the Coastal Zone Management Act) in the proposed site or region.
(a) Each applicant for or holder of a construction permit, operating license, or manufacturing license, and each general licensee under § 57.45(d), must permit inspection, by duly authorized representatives of the Commission, of its records, premises, and activities, and of licensed materials in possession or use, related to the license or construction permit as may be necessary to effectuate the purposes of the AEA and the Energy Reorganization Act of 1974, as amended.
(b) Each holder of a construction permit, operating license, or manufacturing license must provide adequate facilities and access for Commission inspection personnel as follows:
(1) Each holder of a construction permit, operating license, or manufacturing license must provide temporary office space for the exclusive use of the Commission inspection personnel. Heat, air conditioning, light, and electrical outlets must be furnished by each licensee and each holder of a construction permit. The office space must be convenient to and have full access to the facility and must provide the inspectors with both visual and acoustic privacy. The office space must be generally commensurate with other office accommodations at the site.
(2) The licensee or permit holder must afford any NRC inspectors identified by the Regional Administrator as likely to inspect the facility, immediate unfettered access, equivalent to access provided regular plant employees, following proper identification and compliance with applicable access control measures for security, radiological protection, and personal safety.
(3) The licensee or permit holder must ensure that the arrival and presence of an NRC inspector, who has been properly authorized facility access as described in paragraph (b)(2) of this section, is not announced or otherwise
(c) For fuel cycle facilities licensed under part 70, NRC inspections are conducted in accordance with 10 CFR 70.55.
(d) For a licensee, certificate holder, and applicant for a certificate of compliance, NRC transportation inspections are conducted in accordance with 10 CFR 71.93.
(e) For a holder of a license to receive, possess, package, or transfer irradiated fuel, high-level radioactive waste, or reactor-related greater than Class C waste, NRC inspections are conducted in accordance with 10 CFR 72.82.
(a) Licensees of facilities licensed under this part and containing special nuclear material (SNM) are subject to the material control and accounting requirements found in 10 CFR 74.11, 74.13, 74.15, and 74.19.
(b) Licensees of facilities under this part with initial unirradiated fuel load that averages greater than 10% uranium-235 (U-235) enrichment but less than 20% U-235 enrichment and that do not have personnel on site must perform the physical inventory with not greater than 6 months periodicity.
(c) Each licensee under this part that possesses more than 1 gm of SNM must report location changes in accordance with 10 CFR 74.15.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The AEA;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued under those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the AEA:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the AEA;
(ii) Section 206 of the Energy Reorganization Act of 1974, as amended;
(iii) Any rule, regulation, or order issued under the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the AEA.
(a) Section 223 of the AEA provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161(b), 161(i), or 161(o) of the AEA. For purposes of section 223, all the regulations in part 57 are issued under one or more of sections 161(b), 161(i), or 161(o), except for the sections listed in paragraph (b) of this section.
(b) The regulations in 10 CFR part 57 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 57.1, 57.2, 57.3, 57.4, 57.8, 57.9, 57.11, 57.12, 57.15, 57.16, 57.17, 57.18, 57.19, 57.20, 57.25, 57.30, 57.35, 57.40, 57.55, 57.60, 57.80, 57.90, 57.95, 57.100, 57.105, 57.115, 57.120, 57.130, 57.135, 57.142, 57.145, 57.150, 57.155, 57.160, 57.165, 57.170, 57.172, 57.175, 57.180, 57.185, 57.190, 57.200, 57.205, 57.210, 57.213, 57.215, 57.220, 57.225, 57.230, 57.235, 57.240, 57.260, 57.290, 57.310, 57.319, 57.350, 57.380, 57.385, 57.390, 57.415.
For the purposes of this subpart, the following definitions apply:
(1) Systematic analysis of the jobs to be performed.
(2) Learning objectives derived from the analysis which describe desired performance after training.
(3) Training design and implementation based on the learning objectives.
(4) Evaluation of trainee mastery of the objectives during training.
(5) Evaluation and revision of the training based on the performance of trained personnel in the job setting
(a)
(b)
(1) Sections 57.391 through 57.399 address staffing, training, personnel qualifications, and human factors engineering requirements. The regulations within these sections are applicable to all applicants for or holders of operating licenses under this part, except where specifically stated otherwise.
(2) Sections 57.400 through 57.415 address generally licensed reactor operator requirements. The regulations within these sections are applicable to those applicants for or holders of operating licenses under this part for operator-independent facilities that have not yet certified the permanent cessation of operations and permanent removal of fuel from the reactor vessel as described under § 57.305(a).
(3) Sections 57.420 through 57.427 address operator and senior operator requirements. The regulations within these sections are in lieu of §§ 57.400 through 57.415 for those applicants for or holders of operating licenses under this part for operator-dependent facilities that have not yet certified the permanent cessation of operations and permanent removal of fuel from the reactor vessel as described under § 57.305(a).
(4) Section 57.429 provides general personnel training and qualification requirements. The regulations within this section are applicable to all applicants for or holders of operating licenses under this part.
(a) Except as provided under a regional licensing program identified in paragraph (b) of this section, an applicant or licensee or facility licensee must submit any communication or report required by the regulations contained within §§ 57.391 through 57.429 and any application filed under these regulations to the Commission using any of the methods specified in § 57.4(a).
(b) (1) The Director, Office of Nuclear Reactor Regulation, has delegated to the Regional Administrators of Regions I, II, III, and IV authority and responsibility under the regulations in this part for the issuance of licenses for operators and senior operators of nuclear power reactors licensed under this part and located in these regions.
(2) Any application for an operator or senior operator license filed under the regulations in § 57.420 and any related inquiry, communication, information, or report must be submitted to the appropriate Regional Administrator listed in appendix D to 10 CFR part 20 by a method specified in § 57.4(a). The Regional Administrator or their designee will transmit to the Director, Office of Nuclear Reactor Regulation, any matter that is not within the scope of the Regional Administrator's delegated authority.
(c) Each facility licensee that is required to comply with the requirements of §§ 57.420 through 57.427 must notify the appropriate Regional Administrator regarding an operator or senior operator within 30 days of the following events:
(1) Permanent reassignment from the position for which the facility licensee has certified the need for an operator or senior operator under § 57.423(a)(1);
(2) Termination of any operator or senior operator; or
(3) Permanent disability or illness as required under § 57.422.
Information provided to the Commission by an applicant for an operator or senior operator license or by a licensee or information required by statute or the Commission's regulations, orders, or license conditions to be maintained by the applicant or the licensee must be complete and accurate in all material respects.
Applicants for or holders of an operating license for a nuclear plant licensed under this part must comply with the following:
(a)
(1) Features for displaying to operating personnel a minimum set of parameters that define the safety status of the plant and are capable of displaying both the full range of important plant parameters and data trends on demand, as well as indicating when process limits are being approached or exceeded;
(2) Automatic indication of the bypassed and operable status of safety systems;
(3) Direct indication of SSC status that relates to the ability of the SSC to perform its safety function, such as relief and safety valve position (
(4) Instrumentation to measure, record, and display key plant parameters related to the performance of SSCs and the integrity of barriers important to fulfilling safety functions to support operators in monitoring plant conditions and responding to plant events.
(5) Leakage control and detection in the design of systems that pass through barriers important to fulfilling safety functions for the release of radionuclides.
(6) Monitoring of in-plant radiation and airborne radioactivity as appropriate for a broad range of normal operating and accident conditions; and
(7) The capability for GLRO, operator, or senior operator to do the following:
(i) Receive plant operating data, including reactor parameters and information needed for the evaluation of emergency conditions.
(ii) Promptly dispatch operations and maintenance personnel.
(iii) Immediately implement responsibilities under the facility emergency plan, as applicable.
(iv) Immediately initiate a reactor shutdown from their location.
(b)
(c)
(1) The staffing plan must include a description of how the proposed numbers, positions, and qualifications of GLROs, operators, or senior operators will be sufficient to ensure that plant safety functions will be maintained across all modes of plant operations. The staffing plan must be supported by human factors engineering analyses and assessments.
(2) The staffing plan must include a description of how the positions and responsibilities of personnel contained within those plans will adequately satisfy necessary support functions within areas such as plant operations, equipment surveillance and maintenance, radiological protection, chemistry control, fire brigades, engineering, security, and emergency response.
(3) The staffing plan must be approved by the NRC as part of its approval of the operating license for the plant. The approved staffing plan is subject to the requirements of § 57.312.
(d)
A person must be authorized by a license issued by the Commission to perform the function of a GLRO, operator, or senior operator, as defined in this part.
(a) The facility licensee must maintain the staffing complement described under its approved staffing plan until such time as the permanent cessation of operations and permanent removal of fuel from the reactor vessel has been certified as described under § 57.305(a). The facility licensee must develop, implement, and maintain facility technical specifications that provide the necessary administrative controls to ensure the implementation of the approved staffing complement.
(b) The facility licensee may not permit the manipulation of the controls of any facility by anyone who is not a GLRO, operator, or senior operator, as appropriate, except in cases where a non-licensed operator manipulates the controls under the direction and in the presence of a GLRO, operator, or senior operator as part of the individual's training as part of the operator training program or to load or unload fuel into, out of, or within the reactor vessel while the reactor is not operating.
(c) Apparatus and mechanisms other than controls, the operation of which may affect the reactivity or power level of a reactor, must be manipulated only while plant conditions are being monitored by an individual who is a GLRO, operator, or senior operator, as appropriate.
(d)
(1) Load following is permitted if at least one of the following is immediately capable of refusing demands when they could challenge the safe operation of the plant or when precluded by the plant equipment conditions:
(i) The actuation of an automatic protection system that utilizes setpoints more conservative than those otherwise credited for the purposes of reactor protection;
(ii) An automated control system; or
(iii) GLRO, operator, or senior operator, as appropriate,
(2) The provisions of paragraph (c) of this section do not apply during load following operations.
(e) Facility licensees must have present during alteration of the core (including fuel loading or transfer) an individual holding a GLRO license, a senior operator license, or a senior operator license limited to fuel handling to directly supervise the activity and, during this time, the facility licensee must not assign other duties to this person.
(f) The provisions of paragraph (e) of this section do not apply to core alterations performed as part of refueling operations while a facility that is capable of online refueling is operating at power.
(g) A facility licensee may take reasonable action that departs from a license condition or a technical specification (contained in a license issued under this part) in an emergency when this action is immediately needed to protect the public health and safety and no action consistent with license conditions and technical specifications that can provide adequate or equivalent protection is immediately apparent.
(h) Facility licensee action permitted by subparagraph (g) of this section must be approved, as a minimum, by a GLRO or senior operator, or, at a nuclear plant for which the certifications required under § 57.305(a) have been submitted, by either a GLRO or a certified fuel handler, prior to taking the action.
Licensees of operator-independent facilities that have not yet certified the permanent cessation of operations and permanent removal of fuel from the reactor vessel as described under § 57.305(a) must demonstrate compliance with the following requirements:
(a) Ensure that, in addition to being qualified to perform those items identified by the facility-specific systems approach to training conducted under § 57.410, GLROs are qualified to safely and competently—
(i) Perform administrative tasks, including compliance with technical specifications, and perform operability determinations;
(ii) Implement maintenance and configuration controls;
(iii) Comply with radioactive release limitations;
(iv) Understand plant operating data, including reactor parameters, and evaluate emergency conditions;
(v) Initiate a reactor shutdown from necessary locations;
(vi) Dispatch and direct operations and maintenance personnel;
(vii) Implement any applicable responsibilities under the facility emergency plan; and
(viii) Make required notifications to local, State, participating Tribal, and Federal authorities.
(b) Develop, implement, and maintain the GLRO training, examination, and proficiency programs required under § 57.410.
(c) Ensure that GLROs are subject to the facility's GLRO training, examination, and proficiency programs required under § 57.410. Ensure that GLROs are subject to and comply with the applicable programmatic requirements for plant personnel required under 10 CFR parts 26 and 73 of this chapter. An individual that is not in compliance with any of these programs is not qualified to be in a position that may involve the manipulation of the controls of the nuclear plant.
(d) Report annually to the NRC the identity of all GLROs at the nuclear plant, including all additions and deletions since the previous report.
(e) Develop, implement, and maintain facility technical specifications that provide the necessary administrative controls to ensure the implementation of the requirements of § 57.399(a) and paragraphs (a) through (d) of this section.
(f) Ensure that the facility design and operation continue to not rely on
(a)
(b)
(1) A general license to manipulate the controls of a facility licensed under this part and to direct the licensed activities of generally licensed reactor operators is hereby issued to any individual employed in a position that may involve the manipulation of the controls of that facility and who observes the restrictions of this section.
(2) A GLRO must comply with the operating procedures and other conditions specified in the license authorizing operation of the facility.
(3) The general license is limited to the facility or facilities at which the operator is employed.
(4) The Commission will suspend the general license on an individual basis for violations of any provision of the AEA or any rule or regulation issued thereunder whenever the Commission deems such suspension desirable, including—
(i) For willful violation of, or failure to observe, any of the terms and conditions of the AEA or the general license, or of any rule, regulation, or order of the Commission;
(ii) For any conduct determined by the Commission to be a hazard to safe operation of the facility; or
(iii) For the sale, use, or possession of illegal drugs, or refusal to participate in the facility drug and alcohol testing program, or a confirmed positive test for drugs, drug metabolites, or alcohol in violation of the conditions and cutoff levels established by § 57.405(b)(6) or the consumption of alcoholic beverages where the individual perform activities requiring a general license, or a determination of unfitness for scheduled work as a result of the consumption of alcoholic beverages.
(5) The Commission may require information from a GLRO to determine whether a general license should be revoked or suspended with respect to that operator.
(6) The GLRO must not consume or ingest alcoholic beverages in any location where they perform activities requiring a general license. The GLRO must not use, possess, or sell any illegal drugs. The GLRO must not perform activities requiring a general license while under the influence of alcohol or any prescription, over-the-counter, or illegal substance that could adversely affect his or her ability to safely and competently perform these activities. For the purpose of this paragraph, with respect to alcoholic beverages and drugs, the term “under the influence” means the GLRO exceeded, as evidenced by a confirmed test result, the lower of the cutoff levels for drugs or alcohol contained in 10 CFR part 26, or as established by the facility licensee. The term “under the influence” also means the GLRO could be mentally or physically impaired as a result of substance use including prescription and over-the-counter drugs, as determined under the provisions, policies, and procedures established by the facility licensee for its fitness-for-duty program, in such a manner as to adversely affect his or her ability to safely and competently perform GLRO duties.
(7) The GLRO must notify the Commission within 30 days about a conviction for a felony.
(8) The GLRO must complete a training and examination program as described in § 57.410.
(a)
(b)
(1) The facility licensee must develop, implement, and maintain training and examination programs that demonstrate compliance with the requirements of paragraphs (b)(2) and (3) of this section.
(2) The training program must provide for both the initial and continuing training of GLROs and be derived from a systems approach to training as defined in § 57.390.
(3) Training and examination program requirements.
(i) The training program must incorporate the instructional requirements necessary to provide qualified GLROs to operate and maintain the facility in a safe manner in all modes of operation. The training program must comply with the facility license, including all technical specifications and applicable regulations. The facility licensee must periodically evaluate and revise the training program as appropriate to reflect industry experience and relevant changes, including changes to the facility, procedures, regulations, and quality assurance requirements. Facility licensee management must periodically review the training program for effectiveness.
(ii) The training program must ensure that GLROs have and maintain the knowledge, skills, and abilities necessary to operate and maintain the facility in a safe manner.
(iii) The training program must include the GLROs manipulating the controls of either the facility or a simulation facility that demonstrates compliance with the requirements of § 57.410(e).
(iv) The training program must include an initial examination program for testing a representative sample of the knowledge, skills, and abilities needed to safely perform GLRO duties, to include both the examination methods and criteria to be used to assess passing performance. The facility licensee must provide the opportunity for a representative of the Commission to be present during initial examination administration.
(v) The training program must include a requalification examination program for testing a sample of the topics included under the systems approach to training and include the examination methods and criteria to assess passing performance. The requalification examination program must specify an appropriate periodicity for administering a complete requalification examination to each GLRO, and the facility licensee must provide the opportunity for a representative of the Commission to be present during requalification examination administration.
(A) The facility licensee must ensure that any GLRO who either demonstrates unsatisfactory performance on, or fails to complete, the requalification examination is removed from the performance of GLRO duties until any necessary remedial training has been completed and a retake examination has been passed.
(B) [Reserved]
(vi) The initial and requalification examination programs must provide valid and reliable examinations and must be approved by the Commission prior to their first use.
(c)
(1) Sufficient records must be maintained by the facility licensee to maintain the integrity of the programs and kept available for NRC inspection to verify the adequacy of the programs.
(2) The facility licensee must maintain records documenting the participation of each GLRO in the
(3) Each record required by this part must be legible throughout the retention period. The record may be the original, a reproduced copy, or an electronic copy provided that the copy is authenticated by authorized personnel.
(d)
(e)
(1) Simulation facilities used for training purposes, for maintaining proficiency, or for the conduct of examinations must demonstrate compliance with the following criteria as they relate to the facility licensee's reference plant:
(i) The simulation facility must be of sufficient scope and fidelity for individuals to acquire and demonstrate the necessary knowledge, skills, and abilities to safely perform GLRO duties.
(ii) The simulation facility must utilize models relating to nuclear, thermal-hydraulic, and other applicable design-specific characteristics that either replicate the most recent fuel load in the reference nuclear plant or, prior to initial fuel load (or, for a fueled manufactured reactor, prior to initiating the removal of the features to prevent criticality), replicate the intended initial fuel load for the reference nuclear plant, with the exception of those portions of the simulation facility that utilize the reference plant itself.
(iii) Simulator fidelity must be demonstrated so that significant control manipulations are completed without procedural exceptions, simulator performance exceptions, or deviation from the approved training scenario sequence.
(2) Facility licensees that maintain a simulation facility for training purposes, for maintaining proficiency, or for the conduct of examinations must—
(i) Conduct performance testing throughout the life of the simulation facility in a manner sufficient to ensure that paragraph (e)(1) of this section is met;
(ii) Retain the results of performance testing for 4 years after the completion of each performance test or until superseded by updated test results;
(iii) Promptly correct modeling and hardware discrepancies and discrepancies identified from scenario validation and from performance testing or provide justification for why the presence of such discrepancies will not adversely affect the criteria of paragraph (e)(1) of this section;
(iv) Make the results of any uncorrected performance test failures that may exist at the time of an inspection available for NRC review; and
(v) Maintain the provisions for examination integrity consistent with § 57.410(d).
(f)
(g)
The general license ceases to be applicable on an individual basis once a GLRO is no longer being employed in a position that may involve the manipulation of the controls of the operator-independent facility.
(a)
(b) [Reserved]
(a) An applicant for an operator or senior operator license must have a medical examination by a physician or other licensed medical examiner. An operator or senior operator must have a medical examination by a physician or other licensed medical examiner every 2 years. The physician or other licensed medical examiner shall determine that the applicant or licensee meets the requirements of § 57.423(b)(1)(i).
(b) To certify the medical fitness of an applicant for an operator or senior operator license, an authorized representative of the facility licensee must complete and sign NRC Form 396, “Certification of Medical Examination by Facility Licensee,” which can be obtained by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by calling 301-415-7232, or by visiting the NRC's website at
(1) NRC Form 396 must certify that a physician or other licensed medical examiner has conducted the medical examination of the applicant as required in paragraph (a) of this section.
(2) When the medical certification requests a conditional license based on medical evidence, the medical evidence must be submitted on NRC Form 396 to the Commission to enable the Commission to make a determination in accordance with § 57.425(b).
(c) The facility licensee must document and maintain the results of medical qualifications data, test results, and each operator's or senior operator's medical history for the current license period and provide the documentation to the Commission upon request. The facility licensee must retain this documentation while an individual performs the functions of an operator or senior operator.
If, during the term of the operator or senior operator license, the licensee develops a permanent physical or mental condition that causes the licensee to fail to demonstrate compliance with the requirements of § 57.423(b)(1)(i), the facility licensee must notify the Commission within 30 days of learning of the diagnosis. For conditions for which a conditional license (as described in § 57.423(b)) is requested, the facility licensee must provide medical certification on NRC Form 396 to the Commission (as described in § 57.421(b)).
(a)
(1) The applicant for an operator or senior operator license must—
(i) Complete NRC Form 398, “Personal Qualification Statement— Licensee,” which can be obtained by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by calling 301-415-5877, or by visiting the NRC's website at
(ii) File an original of NRC Form 398, or an equivalent electronic submittal, together with the information required in paragraphs (a)(1)(iii) and (a)(1)(iv) of this section, with the appropriate Regional Administrator.
(iii) Provide evidence that the applicant, as a trainee, has successfully demonstrated competence in manipulating the controls of either the facility for which a license is sought or a simulation facility that demonstrates compliance with the requirements of § 57.424(e). For operators applying for a senior operator license, certification that the operator has successfully operated the controls of the facility as an operator will be accepted; and
(iv) Provide certification by the facility licensee of medical condition and general health on NRC Form 396, to comply with § 57.421.
(2) The Commission may at any time after the application has been filed, and before the license has expired, require further information under oath or affirmation to enable it to determine whether to grant or deny the application or whether to revoke, modify, or suspend the license.
(3) An applicant whose application has been denied because of a medical condition or their general health may submit a further medical report at any time as a supplement to the application.
(4) Each application and statement must contain complete and accurate disclosure as to all matters required to be disclosed. The applicant must sign statements required by paragraphs (a)(1)(i) and (a)(1)(ii) of this section.
(b)
(1)
(i)
(ii)
(2)
(c)
(1) An applicant whose application for a license has been denied because of failure to pass the examination may file a new application. The application must be submitted on NRC Form 398 and include a statement signed by an authorized representative of the facility licensee by whom the applicant will be employed that states in detail the extent of the applicant's additional training and remediation since the denial and certifies that the applicant is ready for re-examination.
(2) An applicant who has passed a portion of the examination and failed another may request in a new application on NRC Form 398 to be excused from re-examination on the portions of the examination that the applicant has passed. The Commission may in its discretion grant the request if it determines that sufficient justification is presented.
(a)
(1) A program that is based upon a systems approach to training, as defined by § 57.390, must be utilized for the training of applicants for operator and senior operator licenses. The program must ensure that applicants at the facility will possess the knowledge, skills, and abilities necessary to protect public health and safety and maintain plant safety functions specific to the facility design. The program must be approved by the Commission prior to its use for training applicants.
(2) The facility licensee must maintain operator licensing initial training program records documenting the initial operator licensing training administered and completed by each applicant. The facility licensee must retain these records during the period in which any trainees subsequently remain licensed as operators or senior operators at the facility.
(b)
(1) The facility licensee must establish and implement an examination program for testing a representative sample of the knowledge, skills, and abilities needed to safely perform operator and senior operator duties, to include both the examination methods and criteria to be used to assess passing performance. The program must provide for valid and reliable examinations and be approved by the Commission prior to its use for examining applicants.
(2) The facility licensee must submit prepared examinations to the Commission for review and approval in advance of their administration.
(3) The Commission will either administer an approved examination or allow the facility licensee to administer the examination. The facility licensee must ensure that sufficient advance notification is provided to the Commission to either administer the examination or allow for a representative of the Commission to be afforded the opportunity to be present when the facility licensee administers the examination.
(4) Graded examination documentation for each applicant must be provided to the Commission for review in making operator licensing decisions.
(5) The facility licensee must maintain operator licensing initial examination program records documenting the participation of each operator and senior operator applicant in the initial examination. The records must contain copies of examinations administered, the answers given by the applicant, documentation of the grading of examinations, and documentation of any additional training administered in areas in which an applicant exhibited deficiencies. The facility licensee must retain these records during the period in which the associated operators or senior operators remain licensed at the facility.
(c)
(1) A program based upon a systems approach to training must be utilized for the continuing training of operators and senior operators.
(i) The program must ensure that operators and senior operators at the facility maintain the knowledge, skills, and abilities necessary to protect the public health and safety and maintain plant safety functions specific to the facility design. The program must be conducted for a continuous period not to exceed 24 months in duration.
(ii) The program must be approved by the Commission prior to its use for continuing training and implemented upon commencing the administration of initial examinations under the operator licensing examination program required under § 57.424(b).
(2) The following requirements apply to operator licensing requalification programs:
(i) The facility licensee must propose a requalification examination program for testing, for each requalification period, a sample of the topics included under the systems approach to training, to include both the examination methods and criteria to be used to assess passing performance. The program must provide for valid and reliable examinations and be approved by the Commission prior to its use for examining operators and senior operators.
(ii) The following requirements apply to the requalification examination program:
(A) The facility licensee must make prepared requalification examinations available to the Commission for review.
(B) The facility licensee must ensure that a representative of the Commission is afforded the opportunity to be present during requalification examination administration.
(C) The facility licensee must ensure that each operator and senior operator is administered a complete requalification examination on a periodicity not to exceed 24 months. Additionally, the facility licensee must ensure that any operator or senior operator who either demonstrates unsatisfactory performance on, or fails to complete, this biennial requalification examination is removed from the performance of operator and senior operator duties until any necessary remedial training has been completed and a retake examination has been passed.
(D) The facility licensee must promptly provide a summary of examination results to the NRC for each operator and senior operator following the completion of the requalification examination.
(3) The facility licensee must maintain operator licensing requalification program records documenting the participation of each operator and senior operator in the requalification program. The records must contain copies of examinations administered, the answers given by the operator or senior operator, documentation of the grading of examinations, and documentation of any additional training administered in areas in which an operator or senior operator exhibited deficiencies. The facility licensee must retain these records until the operator's or senior operator's license is renewed.
(d)
(e)
(1) This section addresses the use of a simulation facility for the administration of examinations, for training, or to demonstrate compliance with experience requirements for applicants for operator and senior operator licenses.
(2) Simulation facilities used for training purposes, for demonstrating compliance with experience requirements, or for the conduct of examinations under § 57.424(b) and (c) must demonstrate compliance with the following criteria as they relate to the facility licensee's reference plant:
(i) The simulation facility must be of sufficient scope and fidelity for individuals to acquire and demonstrate the necessary knowledge, skills, and abilities to safely perform operator and senior operator duties.
(ii) The simulation facility must utilize models relating to nuclear, thermal-hydraulic, and other applicable design-specific characteristics that either replicate the most recent fuel load in the reference nuclear plant or, prior to initial fuel load (or, for a fueled manufactured reactor, prior to initiating the removal of the features to prevent criticality), replicate the intended initial fuel load for the reference nuclear plant, with the exception of those portions of the simulation facility that utilize the reference plant itself.
(iii) Simulation facility fidelity must be demonstrated so that significant control manipulations are completed without procedural exceptions, simulator performance exceptions, or deviation from the approved training scenario sequence.
(3) Facility licensees that maintain a simulation facility that has been approved by the Commission for training purposes, demonstrating compliance with experience requirements, or the conduct of examinations under § 57.424(b) and (c) for the facility licensee's reference plant must:
(i) Conduct performance testing throughout the life of the simulation facility in a manner sufficient to ensure that paragraph (e)(2) of this section is met;
(ii) Retain the results of performance testing for 4 years after the completion of each performance test or until superseded by updated test results;
(iii) Promptly correct modeling and hardware discrepancies and discrepancies identified from scenario validation and performance testing or provide justification as to why the presence of such discrepancies will not adversely affect simulator performance with respect to the criteria of paragraph (e)(2) of this section;
(iv) Make the results of any uncorrected performance test failures that may exist at the time of the initial license examination or requalification examination available for NRC review, prior to or concurrent with preparations for each initial license examination or requalification examination; and
(v) Maintain the provisions for license application and examination integrity consistent with § 57.424(d).
(4) A simulation facility must demonstrate compliance with the requirements of paragraphs (e)(2) and (e)(3) of this section for the Commission to accept the simulation facility for conducting initial examinations as described in § 57.424(b), requalification training as described in § 57.424(c), or performing control manipulations that affect reactivity to establish eligibility for an operator or senior operator license as described in § 57.423(a).
(f)
(1) Recent operating experience at a comparable facility;
(2) Proof of the applicant's past competent and safe performance; and
(3) Proof of the applicant's current qualifications.
(g)
(h)
Each operator and senior operator license contains and is subject to the following conditions whether stated in the license or not:
(a) Neither the license nor any right under the license may be assigned or otherwise transferred.
(b) The license is limited to the facility or facilities for which it is issued.
(c) The license is limited to those controls of the facility or facilities specified in the license.
(d) The license is subject to, and the licensee must observe, all applicable rules, regulations, and orders of the Commission.
(e) The licensee must maintain or re-establish proficiency in accordance with the facility licensee's Commission-approved proficiency program required under § 57.424(g).
(f) The licensee must be subject to the facility's Commission-approved operator licensing requalification and requalification examination programs required under § 57.424(c).
(g) The licensee must have a biennial medical examination as described by § 57.421.
(h) The licensee must notify the Commission within 30 days about a conviction for a felony.
(i) The licensee must not consume or ingest alcoholic beverages within the protected area of nuclear plants. The licensee must not use, possess, or sell any illegal drugs. The licensee must not perform activities authorized by a license issued under this part while under the influence of alcohol or any prescription, over-the-counter, or illegal substance that could adversely affect his or her ability to safely and competently perform his or her licensed duties. For the purpose of this paragraph (i), with respect to alcoholic beverages and drugs, the term “under the influence” means the licensee exceeded, as evidenced by a confirmed test result, the lower of the cutoff levels for drugs or alcohol contained in 10 CFR part 26, or as established by the facility licensee. The term “under the influence” also means the licensee could be mentally or physically impaired as a result of substance use including prescription and over-the-counter drugs, as determined under the provisions, policies, and procedures established by the facility licensee for its fitness-for-duty program, in such a manner as to adversely affect his or her ability to safely and competently perform licensed duties.
(j) Each licensee must participate in the drug and alcohol testing programs as required under 10 CFR part 26.
(k) The licensee must comply with any other conditions that the Commission may impose to protect health or to minimize danger to life or property.
(a)
(b)
(1) The terms and conditions of all operator and senior operator licenses are subject to amendment, revision, or modification by reason of rules, regulations, or orders issued in accordance with the AEA or any amendments thereto.
(2) Any license may be revoked, suspended, or modified, in whole or in part—
(i) For any material false statement in the application or in any statement of fact required under section 182 of the AEA;
(ii) Because of conditions revealed by the application or statement of fact or any report, record, inspection, or other means that would warrant the Commission to refuse to grant a license on an original application;
(iii) For willful violation of, or failure to observe, any of the terms and conditions of the AEA or the license, or of any rule, regulation, or order of the Commission;
(iv) For any conduct determined by the Commission to be a hazard to safe operation of the facility; or
(v) For the sale, use, or possession of illegal drugs, or refusal to participate in the facility drug and alcohol testing program, or a confirmed positive test for drugs, drug metabolites, or alcohol in violation of the conditions and cutoff levels established by § 57.425(i) or the consumption of alcoholic beverages within the protected area of nuclear plants, or a determination of unfitness for scheduled work as a result of the consumption of alcoholic beverages.
Each operator license and senior operator license expires upon termination of employment with the facility licensee, or upon determination by the facility licensee that the licensed individual no longer needs to maintain a license. The facility licensee shall notify the Commission, as described in § 57.392, within 30 days of either occurrence. An operator license or senior operator license also expires upon the Commission's determination that a licensed individual's general medical condition does not meet the minimum standards under § 57.423(b)(1)(i) and that the medical condition cannot be accommodated.
(a) The regulations within this section address personnel training requirements and are applicable to all applicants for or holders of an operating license under this part.
(b) Prior to initial fuel load (or, for a fueled manufactured reactor, prior to initiating the removal of the features to prevent criticality), each holder of an operating license under this part must, with sufficient time to provide trained and qualified personnel to operate the facility, establish, implement, and maintain a training program that demonstrates compliance with the requirements of paragraphs (c) and (d) of this section.
(c) The training program must be derived from a systems approach to training as defined in § 57.390 and must provide, at a minimum, for the training and qualification of the following categories of nuclear plant personnel:
(1) Supervisors (
(2) Technicians (
(3) Other appropriate operating personnel (
(d) The training program must incorporate the instructional requirements necessary to provide qualified personnel to operate components of a nuclear plant and maintain the facility in a safe manner in all modes of operation. The training program must be developed to be in compliance with the facility license, including all technical specifications and applicable regulations.
(1) The training program must be periodically evaluated and revised as appropriate to reflect industry experience and relevant changes, including changes to the facility, procedures, regulations, and quality assurance requirements. The training program must be periodically reviewed by facility licensee management for effectiveness.
(2) Sufficient records must be maintained by the facility licensee to maintain program integrity and kept available for NRC inspection to verify the adequacy of the training program.
(a) Each holder of a manufacturing license, operating license, or construction permit must maintain all records and make all reports, in connection with the activity, as may be required by the conditions of the license or permit or by the regulations and orders of the Commission in effectuating the purposes of the AEA and the Energy Reorganization Act of 1974, as amended. Reports must be submitted in accordance with § 57.4.
(b) Records that are required by this part, by license condition, or by technical specifications must be retained for the period specified by the appropriate regulation, license condition, or technical specification. If a retention period is not otherwise specified, these records must be retained until the Commission terminates the facility license.
(c) Records that must be retained under this part may be the original or a reproduced copy or a microform if the reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability of producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee must maintain adequate safeguards against tampering with and loss of records.
(d) Each licensee must keep records of information important to the decommissioning of the facility in accordance with the requirements of 10 CFR 50.75(g).
(e) If there is a conflict between the Commission's regulations in this part, license condition, or technical specification, or other written Commission approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations of this part for such records must apply unless the Commission, pursuant to § 57.9 of this part, has granted a specific exemption from the record retention requirements in the regulations of this part.
(f) Each licensee must notify the Commission as specified in § 57.4, of successfully completing startup testing, as applicable, within 30 calendar days of completing the testing.
(a)
(b)
(1)
(i) Any event resulting in activation of the emergency plan.
(ii) Any deviation from the plant's Technical Specifications authorized pursuant to § 57.399(g) of this part.
(2)
(i) The initiation of any nuclear plant shutdown required by the plant's Technical Specifications.
(ii) Any event or condition that results in actuation of the reactor protection system when the reactor is critical except when the actuation results from and is part of a pre-planned sequence during testing or reactor operation.
(iii) Any event or condition that results in an unplanned actuation of a safety-related cooling system.
(iv) Any event or condition that results in an unplanned movement of, change of state in, or chemical interaction involving a significant amount of radioactive material within the nuclear plant.
(v) Any event or situation, related to the health and safety of the public or onsite personnel, or protection of the environment, for which a news release is planned or notification to other government agencies has been or will be made. Such an event may include an onsite fatality or inadvertent release of radioactively contaminated materials.
(3)
(i) Any event or condition that results in—
(A) The condition of the nuclear plant, including its principal safety barriers, being seriously degraded; or
(B) The nuclear plant being in an unanalyzed condition that significantly degrades plant safety.
(ii) Any event or condition that results in valid actuation of a safety-related system, except when the actuation results from and is part of a pre-planned sequence during testing or reactor operation.
(iii) Any event or condition that at the time of discovery could have prevented the fulfillment of the safety function of structures or systems that are needed to—
(A) Shut down the reactor and maintain it in a safe shutdown condition;
(B) Remove residual heat;
(C) Control the release of radioactive material; or
(D) Mitigate the consequences of an accident.
(iv) Events covered in paragraph (b)(3)(iii) of this section may include one or more procedural errors, equipment failures, and/or discovery of design, analysis, fabrication, construction, and/or procedural inadequacies. However, individual component failures need not be reported pursuant to paragraph (b)(3)(iii) of this section if redundant equipment in the same system was operable and available to perform the required safety function.
(v) Any event requiring the transport of a radioactively contaminated person to an offsite medical facility for treatment.
(c)
(1) Immediately report:
(i) Any further degradation in the level of safety of the plant or other worsening plant conditions, including those that require activation of the emergency plan, if such a declaration has not been previously made,
(ii) Any escalation in emergency response measures has been necessitated, and
(iii) Termination of an emergency event.
(2) Immediately Report:
(i) The results of ensuing evaluations or assessments of plant conditions,
(ii) The effectiveness of response or protective measures taken, and
(iii) Important information related to plant behavior that is not understood.
(3) Maintain an open, continuous communication channel with the NRC Operation Center upon request by the NRC. *Other requirements for immediate notification of the NRC by licensed operating nuclear plants are contained elsewhere in this chapter, in particular, §§ 20.1906, 20.2202, 72.216, 73.71, and 73.77 of this chapter.
(a)
(1) Each licensee holding an operating license under this part must submit a licensee event report for any event of the type described in this section within 60 days after discovery of the event. In the case of an invalid actuation reported under § 57.440(a)(2)(iv)(B), other than automatic reactor shutdown when the reactor is critical, the licensee may, at its option, provide a telephone notification to the NRC Operations Center within 60 days after discovery of the event instead of submitting a written licensee event report. Unless otherwise specified in this section, the licensee must report an event if it occurred within 3 years of the date of discovery regardless of the plant mode or power level, and regardless of the significance of the structure, system, or component that initiated the event.
(2) The licensee must report—
(i) The completion of any nuclear plant shutdown required by the plant's Technical Specifications.
(ii) Any operation or condition that was prohibited by the plant's Technical Specifications except when—
(A) The Technical Specification is administrative in nature;
(B) The event consisted solely of a case of a late surveillance test where the oversight was corrected, the test was performed, and the equipment was found to be capable of performing its specified safety functions; or
(C) The Technical Specification was revised prior to discovery of the event such that the operation or condition was no longer prohibited at the time of the event.
(iii) Any deviation from the plant's Technical Specifications authorized pursuant to § 57.399(g) of this part.
(iv) Any event or condition that resulted in—
(A) The condition of the nuclear plant, including its principal safety barriers, being seriously degraded; or
(B) The nuclear plant being in an unanalyzed condition that significantly degraded plant safety.
(v) Any natural phenomena or other external condition that posed an actual threat to the safety of the nuclear plant or significantly hampered site personnel in the performance of duties necessary for the safe operation of the nuclear plant.
(vi) Any event or condition that resulted in manual or automatic actuation of a safety-related system, except when—
(A) The actuation resulted from and was part of a pre-planned sequence during testing; or
(B) The actuation was invalid and—
(
(
(vii) Any event or condition that could have prevented the fulfillment of the safety function of structures or systems that are needed to—
(A) Shut down the reactor and maintain it in a safe shutdown condition;
(B) Remove residual heat;
(C) Control the release of radioactive material; or
(D) Mitigate the consequences of an accident.
(viii) Events covered in paragraph (a)(2)(v) of this section may include one or more procedural errors, equipment failures, and/or discovery of design, fabrication, construction, and/or procedural inadequacies. However, individual component failures need not be reported pursuant to paragraph (a)(2)(v) of this section if any other equipment was operable and available to perform the required safety function.
(ix) Any event where a single cause or condition caused at least one independent train or channel to become inoperable in multiple systems or two independent trains or channels to become inoperable in a single system designed to—
(A) Shut down the reactor and maintain it in a safe shutdown condition;
(B) Remove residual heat;
(C) Control the release of radioactive material; or
(D) Mitigate the consequences of an accident.
(x) Any of the following types of releases—
(A) Airborne radioactive release that, when averaged over a time period of 1 hour, resulted in airborne radionuclide concentrations in an unrestricted area that exceeds 20 times the applicable concentration limits specified in appendix B to part 20 of this chapter, table 2, column 1.
(B) Liquid effluent release that, when averaged over a time period of 1 hour, exceeds 20 times the applicable concentrations specified in appendix B to part 20 of this chapter, table 2, column 2, at the point of entry into the receiving waters (
(xi) Any event or condition that as a result of a single cause could have prevented the fulfillment of a safety function for two or more trains or channels in different systems that are needed to—
(A) Shut down the reactor and maintain it in a safe shutdown condition;
(B) Remove residual heat;
(C) Control the release of radioactive material; or
(D) Mitigate the consequences of an accident.
(xii) Events covered in paragraph (a)(2)(ix)(A) of this section may include cases of procedural error, equipment failure, and/or discovery of a design, analysis, fabrication, construction, and/or procedural inadequacy. However, licensees are not required to report an event pursuant to paragraph (a)(2)(ix)(A) of this section if the event results from—
(A) A shared dependency among trains or channels that is a natural or expected consequence of the approved plant design; or
(B) Normal and expected wear or degradation.
(xiii) Any event that posed an actual threat to the safety of the nuclear plant or significantly hampered site personnel in the performance of duties necessary for the safe operation of the plant, including fires, toxic gas releases, or radioactive releases.
(b)
(1) A brief abstract describing the major occurrences during the event, including all component or system failures that contributed to the event
(2) A specific description of the event as follows:
(i) A clear, specific narrative description of what occurred so that knowledgeable readers conversant with the design of nuclear plants, but not familiar with the details of a particular plant, can understand the complete event.
(ii) The narrative description must include the following specific information as appropriate for the particular event:
(A) Plant operating conditions before the event.
(B) Status of structures, components, or systems that were inoperable at the start of the event and that contributed to the event.
(C) Dates and approximate time of the occurrences.
(D) The cause of each component or system failure or personnel error, if known.
(E) The failure mode, mechanism, and effect of each failed component, if known.
(F) For failures of components with multiple functions, include a list of systems or secondary functions that were also affected.
(G) For failure that rendered a train of a safety system inoperable, an estimate of the elapsed time from the discovery of the failure until the train was returned to service.
(H) The method of discovery of each component or system failure or procedural error.
(I) For each human performance related root cause, the licensee must discuss the cause(s) and circumstances.
(J) Automatically and manually initiated safety system responses.
(K) The manufacturer and model number (or other identification) of each component that failed during the event.
(3) An assessment of the safety consequences and implications of the event. This assessment must include—
(i) The availability of systems or components that could have performed the same function as the components and systems that failed during the event, and
(ii) For events that occurred when the reactor was shut down, the availability of systems or components that are needed to shut down the reactor and maintain safe shutdown conditions, remove residual heat, control the release of radioactive material, or mitigate the consequences of an accident.
(4) A description of any corrective actions planned as a result of the event, including those to reduce the likelihood of similar events occurring in the future.
(5) Reference to any previous similar events at the same plant that are known to the licensee.
(6) The name and contact information of a person within the licensee's organization who is knowledgeable about the event and can provide additional information concerning the event and the plant's characteristics.
(c)
(d)
(e)
(a) Each holder of an operating license must submit a report to the Commission annually that specifies the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in gaseous effluents during the previous 12 months. In addition, the report must include an estimate of the dose received by the maximally exposed member of the public in an unrestricted area from effluents and direct radiation from contained sources during the previous 12 months and include any other information as may be required by the Commission to estimate maximum potential annual radiation doses to the public. If the TEDE to members of the public in unrestricted areas during the reporting period is greater than 10 mrem/year TEDE, the report must specify the causes for exceedance and describe any corrective actions.
(b) The reports required by this section must be submitted as specified in § 57.4, and the time between submission of the reports must be no longer than 12 months.
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.
(b) Each application for a license to possess special nuclear material, to possess equipment capable of enriching uranium, to operate an uranium enrichment facility, to possess and use at any one time and location special nuclear material in a quantity exceeding one effective kilogram, except for applications for use as sealed sources and for those uses involved in the operation of a nuclear reactor licensed pursuant to part 50 or part 57 of this chapter and those involved in a waste disposal operation, must contain a full description of the applicant's program for control and accounting of such special nuclear material or enrichment equipment that will be in the applicant's possession under license to show how compliance with the requirements of § 74.31, 74.33, 74.41, or 74.51 of this chapter, as applicable, will be accomplished.
(h)(1) Each application for a license to possess or use, at any site or contiguous sites subject to licensee control, a formula quantity of strategic special nuclear material, as defined in § 70.4, other than a license for possession or use of this material in the operation of a nuclear reactor licensed pursuant to part 50 or part 57 of this chapter, must include a physical security plan. The plan must describe how the applicant will meet the applicable requirements of part 73 of this chapter in the conduct of the activity to be licensed, including the identification and description of jobs as required by 10 CFR 11.11(a). The plan must list tests, inspections, audits, and other means to be used to demonstrate compliance with the requirements of 10 CFR parts 11 and 73, if applicable.
(j)(1) Each application for a license to possess or use at any site or contiguous sites subject to control by the licensee uranium-235 (contained in uranium enriched to 20 percent or more in the uranium-235 isotope), uranium-233, or
(k) Each application for a license to possess or use at any site or contiguous sites subject to licensee control, special nuclear material of moderate strategic significance or 10 kg or more of special nuclear material of low strategic significance as defined under § 70.4, other than a license for possession or use of this material in the operation of a nuclear power reactor licensed pursuant to part 50 or part 57 of this chapter, must include a physical security plan that demonstrates how the applicant plans to meet the requirements of paragraphs (d), (e), (f), and (g) of § 73.67 of this chapter, as appropriate. The licensee shall retain a copy of this physical security plan as a record for the period during which the licensee possesses the appropriate type and quantity of special nuclear material under each license, and if any portion of the plan is superseded, retain that superseded portion of the plan for 3 years after the effective date of the change.
(c)(1) Each license authorizing the possession and use at any one time and location of uranium source material at an uranium enrichment facility or special nuclear material in a quantity exceeding one effective kilogram, except for use as sealed sources and those uses involved in the operation of a nuclear reactor licensed pursuant to part 50 or part 57 of this chapter and those involved in a waste disposal operation, shall contain and be subject to a condition requiring the licensee to maintain and follow:
(d) The licensee shall make no change which would decrease the effectiveness of the plan for physical protection of special nuclear material in transit prepared pursuant to § 70.22(g) or § 73.20(c) of this chapter without the prior approval of the Commission. A licensee desiring to make such changes shall submit an application for a change in the technical specifications incorporated in his or her license, if any, or for an amendment to the license pursuant to § 50.90, § 57.310, or § 70.34 of this chapter, as appropriate. The licensee may make changes to the plan for physical protection of special nuclear material without prior Commission approval if these changes do not decrease the effectiveness of the plan. The licensee shall retain a copy of the plan as a record for the period during which the licensee possesses a formula quantity of special nuclear material requiring this record under each license and each change to the plan for three years from the effective date of the change. Within two months after each change, a report containing a description of the change must be furnished to the Director of the NRC's Office of Nuclear Material Safety and Safeguards, using an appropriate method listed in § 70.5(a); and a copy must be sent to the appropriate NRC Regional Office shown in appendix A to part 73 of this chapter.
(d) The provisions of § 70.50 do not apply to licensees subject to § 50.72 or § 57.435 of this chapter. They do apply to those 10 CFR part 50 or part 57 licensees possessing material licensed under 10 CFR part 70 that are not subject to the notification requirements in § 50.72 or § 57.435 of this chapter, respectively.
Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.
(e) * * *
(5) In the case of licensees who are issued a power reactor license under part 50 or part 57 of this chapter or ISFSI licensees who are an electric utility, as defined in part 50 or part 57 of this chapter, with a specific license issued under this part, the methods of § 50.75(b), (e), and (h) or § 57.55(i) of this chapter, as applicable. In the event that funds remaining to be placed into the licensee's ISFSI decommissioning external sinking fund are no longer approved for recovery in rates by a competent rate making authority, the licensee must make changes to provide financial assurance using one or more of the methods stated in paragraphs (1) through (4) of this section.
(i) * * *
(1) * * *
(ii) Licensees issued a general license under § 72.210, after the licensee has
A general license is hereby issued for the storage of spent fuel in an independent spent fuel storage installation at power reactor sites to persons authorized to possess or operate nuclear power reactors under 10 CFR part 50, 52, or 57.
(b) * * *
(8) Before use of the general license, determine whether activities related to storage of spent fuel under this general license involve a change in the facility Technical Specifications or require a license amendment for the facility pursuant to § 50.59(c) or § 57.312 of this chapter. Results of this determination must be documented in the evaluations made in paragraph (b)(5) of this section.
(a) The notification regarding the program for the management of spent fuel at the reactor required by § 50.54(bb) or § 57.300 of this chapter must include a plan for removal of the spent fuel stored under this general license from the reactor site. The plan must show how the spent fuel will be managed before starting to decommission systems and components needed for moving, unloading, and shipping this spent fuel.
(b) An application for termination of a reactor operating license issued under 10 CFR part 50 and submitted under § 50.82 of this chapter, or a combined license issued under 10 CFR part 52 and submitted under § 52.110 of this chapter, or an operating license issued under 10 CFR part 57 and submitted under § 57.305 of this chapter must contain a description of how the spent fuel stored under this general license will be removed from the reactor site.
Atomic Energy Act of 1954, secs. 53, 147, 149, 161, 161A, 170D, 170E, 170H, 170I, 223, 229, 234, 1701 (42 U.S.C. 2073, 2167, 2169, 2201, 2201a, 2210d, 2210e, 2210h, 2210i, 2273, 2278a, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.
Section 73.37(b)(2) also issued under sec. 301, Pub. L. 96-295, 94 Stat. 789 (42 U.S.C. 5841 note).
(b) * * *
(1) * * *
(i) The physical protection of production and utilization facilities licensed under part 50, 52, or 57 of this chapter,
(a) Terms defined in parts 50, 52, 57, 70, and 95 of this chapter have the same meaning when used in this part.
(b) The approved information collection requirements contained in this part appear in §§ 73.5, 73.15, 73.17, 73.20, 73.21, 73.24, 73.25, 73.26, 73.27, 73.37, 73.40, 73.45, 73.46, 73.50, 73.54, 73.55, 73.56, 73.57, 73.58, 73.60, 73.67, 73.70, 73.72, 73.73, 73.74, 73.77, 73.110, 73.1200, 73.1205, 73.1210, 73.1215, and appendices B and C to this part.
Each licensee who is not subject to § 73.51, but who possesses, uses, or stores formula quantities of strategic special nuclear material that are not readily separable from other radioactive material and which have a total external radiation level in excess of 1 gray (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surfaces without intervening shielding other than at a nuclear reactor facility licensed under part 50, 52, or 57 of this chapter, shall comply with the following:
(g) Each licensee that is licensed to operate a nuclear plant under 10 CFR part 50 or 52 after [INSERT THE EFFECTIVE DATE OF THE FINAL RULE] and elects to implement the requirements of this section, and each licensee that is licensed to operate a nuclear plant under 10 CFR part 57 and elects to implement the requirements of this section, must establish and implement cybersecurity reviews to assess the effectiveness of the implementation of the cybersecurity program.
(1) The licensee must review each element of the cybersecurity program at a frequency commensurate with the importance or significance to safety of plant operations to ensure timely identification and documentation of vulnerabilities, improvements, and corrective actions.
(2) Cybersecurity reviews must be performed by individuals independent of those personnel responsible for program management and any individual who has direct responsibility for implementing the cybersecurity program.
(3) The licensee must establish and perform self-assessments to ensure the effective implementation of the cybersecurity program.
(4) The results and recommendations of the cybersecurity program reviews, management's findings regarding program effectiveness, and any actions taken as a result of recommendations from prior program reviews, must be documented in a report and must be maintained in an auditable form and available for inspection.
(a) * * *
(3) Each applicant for an operating license under the provisions of part 50
(a) * * *
(3) Before receiving its operating license under part 50 or part 57 of this chapter or before the Commission makes its finding under § 52.103(g) of this chapter, each applicant for a license to operate a nuclear power reactor (including an applicant for a combined license) or a non-power reactor may submit fingerprints for those individuals who will require unescorted access to the nuclear power facility or non-power reactor facility.
(a) Each operating nuclear power reactor licensee with a license issued under part 50, 52, or 57 of this chapter shall comply with the requirements of this section.
(a) Each licensee subject to the provisions of § 73.54 or § 73.110 must notify the NRC Headquarters Operations Center of a cyberattack that adversely impacted a safety or security function using the procedures of § 50.72 or § 57.435 of this chapter or § 73.1200 based on the function adversely impacted (safety or security).
(b) If it is later determined that the cause of a previously reported event was from a cyberattack, the licensee must inform the NRC using one of the following applicable methods:
(1) Follow-up notification process as specified in § 50.72 or § 57.435 of this chapter;
(2) Significant supplemental information process as specified in § 73.1200; or
(3) Submission of a Licensee Event Report as specified in § 50.73 or § 57.440 of this chapter.
(a) Each licensee that is licensed to operate a nuclear plant under 10 CFR part 57 and elects to implement the requirements of this section, and each licensee that is licensed to operate a nuclear plant under 10 CFR part 50 or 52 after [INSERT THE EFFECTIVE DATE OF THE FINAL RULE] and elects to implement the requirements of this section, must establish, implement, and maintain a cybersecurity program that is commensurate with the potential consequences resulting from cyberattacks, up to and including the design basis threat as described in § 73.1. The cybersecurity program must provide reasonable assurance that digital computer and communication systems and networks are adequately protected against cyberattacks that are capable of causing the following consequences:
(1) Adversely impacting the safety, security, and emergency preparedness functions performed by digital assets that prevent a postulated fission product release resulting in offsite doses exceeding the values in § 50.34(a)(1)(ii)(D) or 52.47(a)(2)(iv) of this chapter, as applicable.
(2) Adversely impacting the security functions performed by digital assets necessary for implementing the physical security requirements in § 57.60(a)(8)(v)(A) of this chapter or § 73.55, as applicable.
(b) To protect digital computer and communication systems and networks associated with the functions described in paragraphs (a)(1) and (2) of this section (including support systems and equipment that, if compromised, adversely impact these functions), the licensee must—
(1) Analyze the potential consequences resulting from cyberattacks on digital computer and communication systems and networks and identify those assets that must be protected to demonstrate compliance with paragraph (a) of this section; and
(2) Implement the cybersecurity program in accordance with paragraph (d) of this section.
(c) The licensee must protect the systems and networks identified in paragraph (b)(1) of this section in a manner that is commensurate with the potential consequences resulting from cyberattacks that:
(1) Adversely impact the integrity or confidentiality of data and/or software;
(2) Deny access to systems, services, and/or data; and
(3) Adversely impact the operation of systems, networks, and associated equipment.
(d) The cybersecurity program must be designed in a manner that is commensurate with the potential consequences resulting from cyberattacks through the following steps:
(1) Implement security controls to protect the assets identified under paragraph (b)(1) of this section from cyberattacks, commensurate with the assets' safety and security significance;
(2) Apply and maintain defense in depth protective strategies to ensure the capability to detect, delay, respond to, and recover from cyberattacks capable of causing the consequences identified in paragraph (a) of this section;
(3) Mitigate the adverse effects of cyberattacks capable of causing the consequences identified in paragraph (a) of this section; and
(4) Ensure that the functions of protected assets identified under paragraph (b)(1) of this section are not adversely impacted due to cyberattacks.
(e) The licensee must implement the following requirements in a manner that is commensurate with the potential consequences resulting from cyberattacks:
(1) As part of the cybersecurity program, the licensee must comply with the requirements in § 73.54(d)(1), (2), and (4), and must ensure that modifications to assets, identified under paragraph (b)(1) of this section are evaluated before implementation to ensure that the cybersecurity performance objectives identified in paragraph (a) of this section are maintained.
(2) The licensee must establish, implement, and maintain a cybersecurity plan that implements the cybersecurity program requirements of this section.
(i) The cybersecurity plan must describe how the requirements of this section will be implemented and must account for the site-specific conditions that affect implementation.
(ii) The cybersecurity plan must include measures for incident response and recovery for cyberattacks. The cybersecurity plan must include the analysis identified under paragraph (b)(1) of this section and describe how the licensee will—
(A) Apply and maintain defense in depth protective strategies as required in paragraph (d)(2) of this section;
(B) Maintain the capability for timely detection and response to cyberattacks;
(C) Mitigate the consequences of cyberattacks;
(D) Correct exploited vulnerabilities; and
(E) Restore affected systems, networks, and/or equipment affected by cyberattacks.
(3) The licensee must develop and maintain written policies and implementing procedures to implement the cybersecurity plan. Policies, implementing procedures, and other supporting technical information used by the licensee need not be submitted for Commission review and approval as part of the cybersecurity plan but are subject to inspection by NRC staff on a periodic basis.
(4) The licensee must establish and implement cybersecurity reviews to assess the effectiveness of the implementation of the cybersecurity program.
(i) The licensee must review each element of the cybersecurity program at a frequency commensurate with the importance or significance to safety of plant operations to ensure timely identification and documentation of vulnerabilities, improvements, and corrective actions.
(ii) Cybersecurity reviews must be performed by individuals independent of those personnel responsible for program management and any individual who has direct responsibility for implementing the cybersecurity program.
(iii) The licensee must establish and perform self-assessments to ensure the effective implementation of the cybersecurity program.
(iv) The results and recommendations of the cybersecurity program reviews, management's findings regarding program effectiveness, and any actions taken as a result of recommendations from prior program reviews, must be documented in a report and must be maintained in an auditable form and available for inspection.
(5) The licensee must retain all records and supporting technical documentation required to demonstrate compliance with the requirements of this section as a record until the Commission terminates the license for which the records were developed and must maintain superseded portions of these records for at least three (3) years after the record is superseded, unless otherwise specified by the Commission.
(a)
(c) * * *
(1) Each licensee subject to the provisions of § 73.20, § 73.45, § 73.46, § 73.50, § 73.51, § 73.55, § 73.60, § 73.67, or subpart J of part 57 of this chapter, must notify the NRC Headquarters Operations Center as soon as possible but no later than 1 hour after the time of discovery of the following significant facility security events involving—
(e) * * *
(1) Each licensee subject to the provisions of § 73.20, § 73.45, § 73.46, § 73.50, § 73.51, § 73.55, § 73.60, § 73.67, or subpart J of part 57 of this chapter, must notify the NRC Headquarters Operations Center within 4 hours after time of discovery of the following facility security events involving—
(4) For licensees subject to the provisions of § 73.55 or subpart J of part 57 of this chapter, an event involving the licensee's suspension of security measures.
(g) * * *
(1) Each licensee subject to the provisions of § 73.20, § 73.45, § 73.46, § 73.50, § 73.51, § 73.55, § 73.60, § 73.67, or subpart J of part 57 of this chapter, must notify the NRC Headquarters Operations Center within 8 hours after time of discovery of the following facility security program failures involving—
(iv) For licensees subject to the provisions of § 73.77, a cybersecurity event that impacted the ability of the facility's SSCs to perform their intended security functions.
(b) * * *
(2)(i) Licensees subject to § 50.73 or subpart J of part 57 of this chapter must prepare the written follow-up report on NRC Form 366.
(ii) Licensees not subject to § 50.73 or subpart J of part 57 of this chapter must prepare the written follow-up report in a letter format.
(a) * * *
(1) Licensees with facilities or shipment activities subject to the provisions of § 73.20, § 73.25, § 73.26, § 73.27, § 73.37, § 73.45, § 73.46, § 73.50, § 73.51, § 73.55, § 73.60, § 73.67, or subpart J of part 57 of this chapter, must record the physical security events and conditions adverse to security that are specified in paragraphs (c) through (f) of this section.
(b) * * *
(3)(i) Licensees must record these physical security events and conditions adverse to security in either a stand-alone safeguards event log or as part of the licensee's corrective action program, as specified under the applicable quality assurance program provisions of parts 50, 52, 57, 60, 63, 70, and 72 of this chapter, or both.
(d) * * *
(1) For licensees subject to the provisions of § 73.20, § 73.45, § 73.46, § 73.50, § 73.51, § 73.55, § 73.60, § 73.67, or subpart J of part 57 of this chapter, the licensees must report activities they assess are suspicious. Examples include, but are not limited to, the following:
Definitions
Terms defined in parts 50, 57, 70, and 73 of this chapter have the same meaning when used in this appendix.
Atomic Energy Act of 1954, secs. 53, 57, 161, 182, 223, 234, 1701 (42 U.S.C. 2073, 2077, 2201, 2232, 2273, 2282,
(a)
(a)
(a)
Atomic Energy Act of 1954, secs. 53, 63, 103, 104, 122, 161, 223, 234, 1701 (42 U.S.C. 2073, 2093, 2133, 2134, 2152, 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.
As used in this part:
Unless otherwise defined in this section, the terms defined in §§ 40.4, 50.2, 57.3, and 70.4 of this chapter have the same meaning when used in this part.
(1) * * *
(6) Any plant or location where the possession of more than 1 effective kilogram of nuclear material is licensed pursuant to 10 CFR part 40, 50, 57, 60, 61, 63, 70, 72, 76, or 150 of this chapter or an Agreement State license.
Atomic Energy Act of 1954, secs. 145, 161, 223, 234 (42 U.S.C. 2165, 2201, 2273, 2282); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note; E.O. 10865, as amended, 25 FR 1583, 3 CFR, 1959-1963 Comp., p. 398; E.O. 12829, 58 FR 3479, 3 CFR, 1993 Comp., p. 570; E.O. 12968, 60 FR 40245, 3 CFR, 1995 Comp., p. 391; E.O. 13526, 75 FR 707, 3 CFR, 2009 Comp., p. 298.
(a)
Atomic Energy Act of 1954, secs. 161, 170, 223, 234 (42 U.S.C. 2201, 2210, 2273, 2282); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); 44 U.S.C. 3504 note.
(a) * * *
(1) To each person who is an applicant for or holder of a license issued under 10 CFR part 50, 52, 54, or 57 to operate a nuclear reactor, and
(2) With respect to an extraordinary nuclear occurrence, to each person who is an applicant for or holder of a license to operate a production facility or a utilization facility (including an operating license issued under part 50 or part 57 of this chapter and a combined license under part 52 of this chapter), and to other persons indemnified with respect to the involved facilities.
This subpart applies to each person who is an applicant for or holder of a license issued under 10 CFR part 50, 54, or 57 to operate a nuclear reactor, or is the applicant for or holder of a combined license issued under 10 CFR part 52 or 54, except licenses held by persons found by the Commission to be Federal agencies or nonprofit educational institutions licensed to
(b) In any case where a person is authorized under 10 CFR part 50, 52, 54, or 57 to operate two or more nuclear reactors at the same location, the total primary financial protection required of the licensee for all such reactors is the highest amount which would otherwise be required for any one of those reactors; provided, that such primary financial protection covers all reactors at the location.
(c) In any case where a person is authorized under 10 CFR part 50, 52, 54, or 57 to operate two or more nuclear reactors at the same location, the total financial protection required of the licensee for all such reactors is the highest amount which would otherwise be required for any one of those reactors; provided, that such financial protection covers all reactors at the location.
Each holder of a 10 CFR part 50 or part 57 construction permit, or a holder of a combined license under part 52 of this chapter before the date that the Commission had made the finding under § 52.103(g) of this chapter, who also holds a license under part 70 of this chapter authorizing ownership, possession and storage only of special nuclear material at the site of the nuclear reactor for use as fuel in operation of the nuclear reactor after issuance of either an operating license under 10 CFR part 50 or part 57, or a combined license under 10 CFR part 52, shall, during the period before issuance of a license authorizing operation under 10 CFR part 50 or part 57, or the period before the Commission makes the finding under § 52.103(g) of this chapter, as applicable, have and maintain financial protection in the amount of $1,000,000. Proof of financial protection shall be filed with the Commission in the manner specified in § 140.15 before issuance of the license under part 70 of this chapter.
(a) * * *
(1)(i) The effective date of the license (issued under part 50 or part 57 of this chapter) authorizing the licensee to operate the nuclear reactor involved; or
Atomic Energy Act of 1954, secs. 11, 53, 81, 83, 84, 122, 161, 181, 223, 234, 274 (42 U.S.C. 2014, 2201, 2231, 2273, 2282, 2021); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.
(a) * * *
(7) * * *
(iii) Greater than Class C waste, as defined in part 72 of this chapter, in an ISFSI or an MRS licensed under part 72 of this chapter; the Greater than Class C waste must originate in, or be used by, a facility licensed under part 50, part 52, or part 57 of this chapter.
(8) Greater than Class C waste, as defined in part 72 of this chapter, that originates in, or is used by, a facility licensed under part 50, part 52, or part 57 of this chapter and is licensed under part 30 and/or part 70 of this chapter.
Office of Postsecondary Education, Department of Education.
Final rule.
The Secretary amends the regulations for the Federal student loan programs authorized under title IV of the Higher Education Act (HEA) of 1965, as amended (the title IV, HEA programs) to implement the statutory changes to the title IV, HEA programs included in Public Law 119-21, the Working Families Tax Cuts Act signed into law by President Trump on July 4, 2025. The Department previously referred to the Working Families Tax Cuts Act as the “One Big Beautiful Bill Act,” including in the Notice of Proposed Rulemaking published on January 30, 2026. These changes include establishing new loan limits for graduate students, professional students, and parents, and phasing out the Graduate PLUS (Grad PLUS) Program. The Working Families Tax Cuts Act also simplifies the current broken and confusing myriad of Federal student loan repayment plans by phasing out the existing Income-Contingent Repayment (ICR) plans, creating a new Tiered Standard repayment plan option, and establishing a new income-driven repayment plan known as the Repayment Assistance Plan. The Working Families Tax Cuts Act also enables borrowers in default who have previously rehabilitated a defaulted loan a second chance to rehabilitate their loan(s) and resume repayment.
This final rule is effective on July 1, 2026.
Tamy Abernathy, Office of Postsecondary Education, 400 Maryland Ave. SW, 5th Floor, Washington, DC 20202. Telephone: (202) 245-4595. Email:
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.
A brief summary of these final regulations is available at
The Secretary implements the amendments made to the HEA relating to the Federal student loan programs made by Public Law 119-21, the Working Families Tax Cuts Act, through these final regulations.
These regulations revise the Direct Loan Program under 34 CFR part 685 by amending the annual and aggregate loan limits for graduate, professional, and parent loan borrowers. The regulations also implement two new streamlined student loan repayment plans, the Repayment Assistance Plan and the Tiered Standard repayment plan. The regulations also make conforming amendments to current regulations on consolidation, deferment, forbearance, and Public Service Loan Forgiveness (PSLF). The regulations also provide borrowers in default a second opportunity to rehabilitate their loans and resume repayment, even if they previously rehabilitated a defaulted loan.
These final regulations:
• Amend §§ 674.39, 682.215, and 682.405 to allow loan rehabilitation up to twice per each loan borrowed under the Federal Perkins Program, Federal Family Education Loan Program, and the Direct Loan Program, up from only one.
• Amend § 685.102 to include new definitions for the following terms: expected time to credential, graduate student, professional student, and program length.
• Amend § 685.200 to include Direct PLUS Loan eligibility for graduate and professional students.
• Amend § 685.201 to establish the limited Direct PLUS Loan eligibility for a graduate or professional student.
• Amend § 685.203 to include new Direct Loan annual and aggregate limits, create a new lifetime maximum aggregate limit, establish less than full-time reduction of annual loan limits, and permit institutions to limit borrowing for specific programs.
• Amend § 685.204 to clarify conditions and borrower eligibility for the unemployment deferment and the economic hardship deferment.
• Amend § 685.205 to establish the modified eligibility criteria for borrowers to receive a forbearance.
• Amend § 685.208 to establish the terms for the Tiered Standard repayment plan, set the minimum payment for the Tiered Standard repayment plan, and restructure each Fixed repayment plan's terms under their respective plan.
• Amend § 685.209 to establish terms for the Repayment Assistance Plan and sunset ICR plans and conditions.
• Amend § 685.210 to provide information to borrowers about choosing a repayment plan.
• Amend § 685.211 to establish miscellaneous repayment provisions including the minimum payment increase for the Income-Based Repayment (IBR) plan.
• Amend § 685.219 to clarify that repaying under the Repayment Assistance Plan will qualify for PSLF if all other eligibility criteria are met.
• Amend § 685.220 to provide terms and repayment plan eligibility for consolidation loans.
• Amend § 685.221 to clarify when a borrower may be eligible for an alternative repayment plan.
• Amend § 685.303 to waive the substantially equal disbursement requirement for an institution when a borrower has less than full-time enrollment for the academic year and is subject to the schedule of reductions.
The regulations in this final rule consider each change to be a discrete change and independent from the other changes. Consistent with 34 CFR 685.109, “[i]f any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice will not be affected thereby.”
As further detailed in the
As also further detailed in the RIA, these final regulations provide benefits to students, borrowers, and taxpayers. These benefits include potentially lower tuition costs for students, simplified repayment terms for student loan borrowers, and lower costs for taxpayers.
This regulatory action seeks to effectuate regulations that address the statutory changes made by the Working Families Tax Cuts Act.
Public Law 119-21, which the Department refers to as the “Working Families Tax Cuts Act,” was signed into law by President Trump on July 4, 2025. This landmark legislation makes extensive statutory changes to fix broken and unnecessarily complex aspects of the Federal student loan programs, specifically, in the areas of loan limits, repayment plans, and related provisions in title IV of the HEA. Among other changes, the Working Families Tax Cuts Act sets a new lifetime borrowing cap ($257,500 for most borrowers), eliminates the authority to disburse new Graduate PLUS Loans, limits borrowing under the PLUS program for parents, maintains current annual limits under the Federal Direct Stafford Loan Program for undergraduate and graduate students, increases annual Federal Direct Stafford loan limits for professional degree students, establishes aggregate limits for graduate students, professional degree students, and parents of undergraduates, and reduces annual loan amounts for students enrolled less than full-time. For repayment, the Working Families Tax Cuts Act simplifies and streamlines the current confusing patchwork of repayment plan options for future borrowers to two flexible options: a new Tiered Standard repayment plan for fixed monthly payments over a 10 to 25-year term, and a new income-driven plan called the Repayment Assistance Plan that allows borrowers the opportunity to actually pay down their student loan debt by preventing negative amortization over the life of the loan. Confusing, outdated (and in some cases, unlawful) repayment plans are phased out, including the Income-Contingent Repayment plan (ICR), Pay As You Earn plan (PAYE), and Saving on a Valuable Education plan (SAVE), which has been held as unlawful in Federal court.
This final rule complies with Section 492 of the HEA, which requires the Secretary to obtain public input and conduct negotiated rulemaking before issuing proposed regulations for the title IV, HEA programs. To meet those requirements and implement the new statutory directives provided for in the Working Families Tax Cuts Act, the Department convened the Reimagining and Improving Student Education (RISE) negotiated rulemaking committee (Committee). The Committee was composed of representatives from institutions, students and borrowers, State officials, financial aid administrators, loan servicers, and consumer and civil rights organizations. The Committee met over multiple sessions with the first session being from September 29 through October 3, 2025, and the second session being held November 3-6, 2025. The Committee reached consensus on the entirety of the regulatory text. In accordance with the protocols established by the Committee, the Department incorporated the regulatory amendatory text that was mutually agreed upon into a Notice of Proposed Rulemaking (NPRM) published on January 30, 2026. Building on the statutory and regulatory history, the Committee's consensus language, and the public comments received, this final rule amends Direct Loan regulations to the changes enacted in the Working Families Tax Cuts Act by revising loan limit provisions, restructuring repayment options (including IBR and adding the new Repayment Assistance Plan), updating PSLF eligibility and qualifying payment rules, and aligning consolidation, deferment, forbearance, and borrower relief provisions with the revised statutory framework.
Congress passed legislation that amended statutory provisions governing programs administered by the Department, and this final rule implements those changes in the Department's regulations. The Working Families Tax Cuts Act amended portions of the HEA related to the Federal student loan programs administered by the Department. The Secretary has been granted the broad authority by Congress to implement Federal student aid programs under title IV of the HEA, including amendments made by the Working Families Tax Cuts Act.
Congress may waive, modify, or rescind requirements in the HEA and Administrative Procedure Act (APA) that require the Department to follow certain processes and procedures when engaging in informal notice-and-comment rulemaking.
At the same time, the court in
Absent an explicit rule of construction in the HEA, we rely on the ordinary tools of statutory interpretation to glean the meaning of the statute. The Harmonious-Reading Canon provides that statutes should, when possible, be interpreted in a way that renders them compatible, not contradictory, but such an approach is not always possible if context and other considerations (including the application of other canons) make it impossible to do so, another approach to statutory interpretation, such as the General/Specific Canon must be applied.
Here, the Working Families Tax Cuts Act was enacted on July 4, 2025. The Working Families Tax Cuts Act directs the Department to implement roughly a dozen provisions by July 1, 2026. Many of these provisions are not self-executing and could not be implemented absent the Department promulgating regulations to provide details for institutions on how to comply with the Working Families Tax Cuts Act. Congress gave the Secretary discretion within the Working Families Tax Cuts Act to implement the provisions impacting the title IV, HEA programs and knew that its commands were not self-executing when directing the Secretary to take action. Congress expected the Secretary to act via rulemaking before July 1, 2026, to enable these provisions to actually go into effect.
The master calendar in the HEA provides that regulatory changes initiated by the Secretary affecting the title IV, HEA programs must be published in final form by November 1st in order for them to go into effect by July 1st of the following year. 20 U.S.C § 1089(c)(1). Section 492 of the HEA requires the Department to undertake negotiated rulemaking as part of any regulation under title IV of the HEA. In order to conduct negotiated rulemaking and meet APA requirements, the Department must have a public hearing (providing notice to the public), solicit nominations from the public to serve on a negotiated rulemaking Committee, select non-Federal negotiators, hold negotiations, develop an NPRM, publish an NPRM (with at least a 30-day comment period), and then publish a final rule that responds to any substantive comments received. The fastest possible timeframe in which the negotiated rulemaking process for the rulemaking packages assigned to the RISE Committee could have occurred is 149 days, which is irreconcilable with the timeline allowed by the enactment of the Working Families Tax Cuts Act, due to the fact that there were 120 days from July 4, 2025, (the day the Working Families Tax Cuts Act was enacted), through and including November 1, 2025, (the publication date of the final rule required by the master calendar).
It would not have been possible for the Department to undertake every step of the negotiated rulemaking process by November 1, 2025, in order to implement the provisions that become effective in the Working Families Tax Cuts Act by July 1, 2026, which is the statutory effective date. Congress was aware of this temporal impossibility when they passed the Working Families Tax Cuts Act, yet Congress decided that these provisions would still go into effect on July 1, 2026. Because these provisions are not self-implementing and cannot go into effect unless the Department promulgates a final rule, the Working Families Tax Cuts Act implicitly waives the master calendar.
With important details unanswered by the plain text of the Working Families Tax Cuts Act, it is clear that the policy scheme set forth in the HEA made by the Working Families Tax Cuts Act cannot be implemented absent regulatory action by the Department. At the same time, even though the requirements of negotiated rulemaking are onerous, it is possible to undergo negotiated rulemaking and publish a final rule at least 30 days prior to the effective date of these Working Families Tax Cuts Act provisions on July 1, 2026. Therefore, the Working Families Tax Cuts Act does not waive negotiated rulemaking nor any provision in the APA. For provisions in the Working Families Tax Cuts Act that become effective July 1, 2027, and beyond, Congress did not implicitly repeal the master calendar because it is possible for the Department to publish a final rule that complies with the master calendar to implement those provisions.
“It is axiomatic” that a regulation may be invalid in part but not in whole or as applied to one set of facts but not another.
On January 30, 2026, the Secretary published an NPRM for these regulations in the
The Department does not typically address comments that are out of scope. For purposes of this final rule, out-of-scope comments are those that are not addressed in the NPRM (91 FR 4254) altogether. Generally, comments that are outside of the scope of the NPRM (91 FR 4254) are comments that do not discuss the content or impact of the proposed regulations or the Department's evidence or reasons for the proposed regulations.
Following the public hearing, the Department convened a negotiated rulemaking Committee in fall 2025, consistent with the requirements of the HEA. The Department selected non-Federal negotiators representing affected constituencies and stakeholders. This negotiated rulemaking process provided additional opportunities for stakeholders to offer feedback prior to publication of the NPRM (91 FR 4254).
After publication of the NPRM (91 FR 4254), the Department provided a 30-day public comment period, which is consistent with the Department's obligations under the APA. During that period, the Department received 80,793 public comments, many of which included detailed and substantive feedback. The Department carefully reviewed these comments to determine whether clarification or revisions to the final regulations were appropriate.
Although some commenters requested that the Department extend the comment period or hold additional hearings, the Department believes that the opportunities for stakeholder engagement, including the public hearing, negotiated rulemaking sessions, and the NPRM (91 FR 4254) comment period provided the public with sufficient opportunity to comment on the proposed regulations.
With respect to system and operational changes, as we state in the
Throughout the public comment period, over 81,000 other commenters were able to successfully submit comments. If the commenter believed they were unable to submit a comment, we provided clear instructions in the NPRM (91 FR 4254) that if a commenter cannot otherwise submit their comments via
This is not a new concept as Congress has changed the terms and conditions of title IV loan programs numerous times, including for borrowers who had already taken out loans. As we also explain in the PSLF final rule (90 FR 48978), the MPN disclaims the notion that terms and conditions of Federal student loans are fixed and can only be changed through the legal process. The legal process here is through the legislative changes enacted by Congress and signed by the President. Here, the statutory changes to the HEA mandate that we provide these revised terms and conditions.
We also reject the commenter's recommendation that we grandfather a borrower who was on track to PSLF so that they may retain the right to remain in an income-contingent repayment plan until forgiveness or paid in full as the statute is clear that these income-contingent repayment plans must be sunset. Borrowers on track toward receiving PSLF will have other PSLF-qualifying repayment plans available to them. Congress was clear that income-contingent repayment plans sunset and will be no longer available after July 1, 2028. The Department has no authority to alter this sunset date.
The commenter also requested that the Department include in regulatory text the clarification provided in the preamble to the NPRM that participation in the Fresh Start Initiative does not count as a rehabilitation for purposes of the statutory limit on the number of rehabilitations permitted. The commenter recommended that the Department codify this clarification in the regulations and establish outreach procedures to notify borrowers of their eligibility for a second rehabilitation opportunity.
Participation in the Fresh Start Initiative does not constitute a loan rehabilitation for purposes of the statutory limit, as this program purported to rely on a different legal authority. The Department does not believe additional regulatory text changes are necessary to implement this clarification and declines to make the proposed changes.
The Department declines to reduce the number of payments required for full rehabilitation or to create a regulatory “hold” for enrollment. Section 428F(a)(1) of the HEA specifically requires a borrower to make nine payments within ten consecutive months to successfully rehabilitate a defaulted loan. The Department does not have the statutory authority to change this requirement through regulation.
We agree with commenters that operational improvements to make it easier to enroll in income-driven repayment plans following rehabilitation is important to make a seamless transition to repayment for borrowers exiting default. Many borrowers who rehabilitate their loans ultimately redefault if they do not enroll in an affordable income-driven repayment plan. To that end, the final rule will enable the Secretary to create a single application for rehabilitation agreements for Direct Loans that also includes the option to sign up for an eligible IDR plan. This single application will not be available to Perkins Loan or FFEL borrowers. Borrowers who only wish to enroll in loan rehabilitation will not be forced to also sign up for IDR; however, the Department believes that giving borrowers the option to do so will make it easier for borrowers to sign up. This all-in-one application will allow borrowers to replace multiple applications with one single transaction that would allow them to become enrolled in an affordable payment plan after they successfully rehabilitate their loan. Borrowers will also have the option to sign up for auto-debit for both the rehabilitation agreement and the IDR plan, making it easy for borrowers to make payments without the need for additional actions.
Under this single, all-in-one application, the Secretary would be able to calculate the borrower's payment under the IDR plan using the Federal tax information (FTI) (with the borrower's approval under HEA, as amended by the FUTURE Act)
If the borrower elects to see the monthly payment under and IDR plan through this single application process, the Secretary now has the borrower's monthly payment.
34 CFR 685.211 requires borrowers to make 9 monthly payments that are reasonable and affordable to rehabilitate a loan. The regulations include a provision that states that “The Secretary initially considers the borrower's reasonable and affordable payment amount to be an amount equal to the payment required under the IBR plan.”
When a borrower elects to have their FTI pulled for the purposes of determining an IDR monthly payment rate, the Secretary may use that derivative monthly payment rate (with the borrower's approval) as the monthly payment rate for the purposes of the rehabilitation agreement. 34 CFR 685.211(f)(1)(ii) currently calls on the borrower to submit documentation to verify income, but in this limited circumstance, the Department believes that additional documentation is generally unnecessary. As such, the Department proposes to give the Secretary the option not to require additional verification.
In some circumstances even when FTI is used to calculate the IDR rate (which becomes the reasonable and affordable rate under a rehabilitation), it may be appropriate for the Secretary to require additional documentation. This may include when the borrower represents that his or her income is higher or lower than what was reported on his or her taxes, and when their family size has changed. In these circumstances, the Secretary may have an interest in requesting additional documentation from the borrower.
If the income information is unavailable or the Secretary does not believe it is accurate, the borrower will be required to provide alternative documentation of income. This approach is consistent with and complements the regulations implementing the rehabilitation improvements enacted in the Working Families Tax Cuts Act.
In addition, Parent PLUS borrowers are no longer eligible to enroll in IDR
The Department's changes in these final regulations enable, but do not require, the Secretary to provide a single application. The Department intends to provide a single application to borrowers as soon as practical but notes that several operational and technical changes must be made to Department systems to make this possible. As such, the Department will not have the single application available on July 1, 2026. However, as explained in the Paperwork Reduction Act section of this preamble, the Department will make the draft application publicly available and open a 60-day and 30-day public comment period before being made available for use.
Lastly, the Department notes that borrowers who have a defaulted student loan are ineligible for any IDR plan. As such, if a defaulted borrower were to apply for an IDR plan under our current regulations, the Secretary would be required to deny the application. However, we propose changes to the regulations that allow the Secretary to hold the IDR application, when it is submitted in combination with a rehabilitation agreement application on the single application, until the borrower has either: (1) completed the rehabilitation, or (2) failed to complete the rehabilitation by not making the required nine payments in a ten month period.
When a borrower successfully completes the rehabilitation, the Secretary then approves the IDR plan and automatically enrolls the borrower into the IDR plan. The single application will also enable the borrower to sign up for auto-debit such that the Secretary may continue the auto-debit after automatically enrolling the borrower into an IDR plan. If the borrower fails to complete the rehabilitation, then the Secretary denies the IDR application because the borrower is ineligible for the plan.
As a result of these improvements to loan rehabilitation, we also make two technical corrections to paragraphs (f)(2) and (3). In (f)(2), we replace “account” with “loans” and in (f)(3), we replace “objects to” to “rejects”.
We also make two technical corrections to §§ 685.211(f)(2) and (3).
When the Secretary determines the amount of a borrower's reasonable and affordable payment for loan rehabilitation, we initially proposed that the loan rehabilitation payment amount to be an amount equal to the minimum payment required under the IBR plan, except if this amount was less than $5 (or $10 beginning on or after July 1, 2027), the monthly payment was $5 (or $10 beginning on or after July 1, 2027). After further review, if the borrower avails themself of the rehabilitation agreement under § 685.211(f)(1)(ii), the loan rehabilitation payment amount will be the minimum amount under the IDR plan proactively selected by the borrower in their application. We note, however, that if a borrower's IDR monthly payment is $0, the borrower's loan rehabilitation payment amount will be $10 in accordance with the aforementioned.
Section 494(b) of the HEA and 26 U.S.C. 6103(l)(13) limits the Secretary's authority to obtain FTI from the IRS only for purposes of administering the FAFSA®, enrollment in an IDR plan, and total and permanent disability discharge determinations. However, in response to the commenters' desire to streamline the rehabilitation process as well as an on-ramp to affordable repayment, we believe we can proactively obtain the borrower's FTI for enrollment in an IDR plan with their approval. As such, we are using the IDR rate, derived from the borrower's FTI, to determine the reasonable and affordable rate for loan rehabilitation.
The borrower is not required to actually enroll in the IDR plan for the Department to be able to use its authority (with borrower approval) to access FTI and calculate eligible IDR payment amounts. 20 U.S.C. 1098h. This enables the borrower to compare different IDR plans before selecting a plan or deciding not to enroll.
If the borrower elects to see the repayment rates through this single application process, the Secretary now has the borrower's monthly repayment rate.
The Department may not require borrowers to check their IDR payment rates using FTI, and even if a borrower elects to do so, the Department cannot require the borrower to use the derivative monthly payment rate as the reasonable and affordable rate. However, the Department believes that we may provide this option to borrowers to reduce the need for additional documentation of income and family size, potentially reducing the process that currently takes a few weeks down to a matter of minutes.
Section 494(b) of the HEA limits the Secretary's authority to obtain FTI from the IRS only for purposes of administering the FAFSA®, enrollment in an IDR plan, and total and permanent disability discharge determinations. However, in response to the commenters' desire to streamline the rehabilitation process as well as into better facilitate on-ramp to repayment, we believe we can proactively obtain the borrower's FTI for enrollment in an IDR plan. Since we would have the borrower's income at that point, with the borrower's approval, we could use that income information for purposes of calculating a reasonable and affordable payment for loan rehabilitation which will facilitate support a more seamless process for struggling distressed borrowers. This reasonable and affordable payment will align with the minimums in § 685.211(f)(1)(i).
We believe that regulatory text is needed to clarify the borrower's enrollment in an IDR plan after rehabilitation. Because we share commenters' concern to make post-rehabilitation enrollment in an IDR plan as seamless as possible, we will add a new paragraph (f)(14) that states a borrower who has a defaulted Direct Loan that is rehabilitated on or after July 1, 2026, may be transferred to the income-driven repayment plan by the Secretary if that borrower applied for such plan on a single application.
With respect to involuntary collections during rehabilitation, the Department's regulations reflect the statutory framework governing loan rehabilitation and the suspension of AWG under § 685.211, and therefore, we decline to make the commenter's proposed changes.
As stated earlier, we are compelled that facilitating enrollment in income-driven repayment plans following rehabilitation is important to make a seamless transition to repayment after exiting default. We explained that we will create a single application for purposes of enrollment in an IDR plan as well as a rehabilitation agreement. To implement this approach, we will amend § 685.211(f)(1)(ii). We explained that we will create a single, all-in-one application for purposes of enrollment in an IDR plan as well as a rehabilitation agreement and that, under this single application, the Secretary would be able to calculate the borrower's payment under the IDR plan using the FTI (with the borrower's approval under the FUTURE Act) to inform the borrower what their IDR payment would be after rehabilitation. Because the borrower would have already disclosed their FTI to the Secretary, we then can use the income information (with the borrower's approval) to calculate a reasonable and affordable payment for rehabilitation and additional documentation would not be necessary. To codify this approach that is consistent with and complements the regulations implementing the rehabilitation improvements enacted in the Working Families Tax Cuts Act, we will amend § 685.211(f)(1)(ii).
However, under the HEA, the Secretary does not have the unilateral authority to select a specific repayment plan for a borrower who is no longer in default without the borrower's affirmative selection and authorization. While the Repayment Assistance Plan will be the primary income-driven option for new borrowers under the Working Families Tax Cuts Act, the administrative transition into that plan is an operational matter. These improvements, including the use of online self-service tools to facilitate enrollment, will be addressed through implementation guidance and system updates, and, as such, we decline to make commenters' proposed changes to paragraph (f)(13).
However, we believe that regulatory text is needed to clarify the borrower's enrollment in an IDR plan after rehabilitation. Because we share commenters' concern to make post-rehabilitation enrollment in an IDR plan as seamless as possible, we will add a new paragraph (f)(14) that states a borrower who has a defaulted Direct Loan that is rehabilitated on or after July 1, 2026, may be transferred to the income-driven repayment plan by the Secretary if that borrower applied for such plan on a single application.
Commenters also raised implementation and classification concerns regarding how programs will be identified for purposes of placing borrowers into the correct category, including concerns about inconsistent institutional labeling and program coding. Some commenters asked whether doctoral programs could be swept into the professional category unintentionally, while others urged the Department to treat certain graduate programs as professional even if they were not originally included in the definition.
The Department further clarifies that, unless a borrower is enrolled in a program that satisfies the incorporated professional-degree framework, a borrower in graduate-level enrollment is treated as a graduate student for purposes of the Direct Loan regulations. This approach provides a clearer and more uniform boundary than commenter-suggested approaches that hinge on program title, generalized licensure concepts, or case-by-case characterizations of professional status.
Commenters also raised process questions about uniformity across institutions, particularly where similarly titled programs have different pacing models, and asked whether program length is intended to reflect the minimum published time for full-time enrollment or the typical time a student actually takes to complete their degree, including for part-time attendance or stop-outs.
The Department further notes that, where a borrower enrolls part-time, pauses enrollment, or otherwise deviates from the standard full-time progression, the borrower's
The Department believes that an objective, published measure is necessary because the transition provisions use program length as an input for related definitions, including
The NPRM (91 FR 4261) explains that the Department included the July 1, 2026, date and the cross-reference to
The Department received a substantial number of comments concerning both
Second, the Department addresses comments concerning specific professions and degree pathways, applying the same governing framework of the definition of professional student to the particular fields and programs discussed by commenters in order of the enumerated list of professional degrees as explained in the NPRM (91 FR 4260-4266), and then by other degrees not specifically mentioned in the NPRM. This organization promotes clarity, reduces unnecessary repetition, and explains the basis for the Department's responses in a consistent and uniform manner.
At the onset, the Department notes that our classification of particular professions and degree pathways into either “graduate” or “professional” does not represent a normative judgment regarding whether we think the underlying career is worthy. The term “professional student” is used in the new amendments to the Higher Education Act to classify degrees based upon particular characteristics
Conversely, the word “professional” is used in common parlance to describe how individuals approach their work or the nature of their employment. Throughout our economy, there are many workers who are appropriately described as “professional” in that they have significant skills and carry out their duties in a competent manner. This rule does not pass judgment regarding the relative worth of those careers, nor does it claim that the work that many Americans are engaged in is not professional.
The Higher Education Act uses the term “professional student” in an entirely different context and defines that term in a manner that is quite different than the common usage of the word “professional.” In this rule, we interpret the law as written and do not claim that degrees that do not meet the definition of “professional student” are of lesser worth.
Some commenters also supported the Department's use of a bounded and objective framework for implementing the statutory distinction between graduate students and professional students. These commenters generally agreed that a clear rule would be easier for institutions and borrowers to administer, would reduce
Some commenters supported the inclusion of doctoral-level clinical psychology within the professional student framework. These commenters agreed that doctoral-level clinical psychology fits within the incorporated professional degree definition because it signifies completion of the academic requirements for beginning practice in a distinct profession, requires a level of professional skill beyond that normally required for a bachelor's degree, and generally requires licensure. Commenters also supported the Department's conclusion that inclusion of doctoral-level clinical psychology is consistent with the structure of the incorporated definition and the context supplied by the illustrative examples in the NPRM (91 FR 4262-63).
The Department also agrees with commenters who supported inclusion of doctoral-level clinical psychology. As explained in the NPRM (91 FR 4263-64), doctoral-level clinical psychology satisfies each element of the incorporated framework. First, obtaining a doctorate in clinical psychology because it signifies completion of the academic requirements for beginning practice in a distinct profession, as a doctorate in clinical psychology is explicitly required for licensure (and therefore to practice) as a psychologist in every State.
In addition to satisfying the operative requirements, a doctorate in clinical psychology also shares common characteristics with the other degrees included in the illustrative list of professional degrees in the definition. Like nearly all of the other degrees in the illustrative list, a Doctor of Psychology (Psy. D.) requires a minimum of three full-time academic years of graduate study (or the equivalent thereof) plus an internship to graduate from any APA-accredited program.
Similarly, at least one commenter stated that the Doctor of Public Health (DrPH) functions as the terminal professional practice doctorate in public health and therefore, should be treated as a professional degree. These comments also urged the Department to move away from a bounded cross-reference and toward a broader, more contemporary standard linked to licensure, professional responsibility, and practice expectations.
Some commenters also stated that the Department's definition of
The Department also does not agree with commenters who argued that physician assistant, physical therapy, occupational therapy, social work, graduate-level nursing programs, Doctor of Public Health programs, and similar graduate programs should qualify because they allegedly satisfy the operative elements of the incorporated definition. The Department is not interpreting the cross-referenced definition as a free-standing test under which any graduate program involving advanced study, clinical preparation, licensure-related requirements, accreditation, or occupational responsibility must be treated as a professional degree program. Nor is the Department treating the enumerated professional degree examples in 34 CFR 668.2 as indicative of an open-ended category to be added to at the Department's discretion. Rather, the Department is applying the incorporated definition as a bounded and uniform classification informed by the listed examples and the same general class of programs reflected in the enumerated examples. Applying that interpretation, the Department's conclusion is that the additional programs identified by the commenters do not qualify.
As discussed in the NPRM (91 FR 4261-65) and in the program-specific discussions below, the Department reviewed these proposals and concluded that the cited additional programs do not fall within the incorporated professional degree framework for title IV loan limit purposes.
The statute creates an operative definition with elements that must be applied to all degree programs. In addition, the illustrative list of degrees in the statute provides context and limiting principles that are common across all, or substantially all, of the illustrative programs listed in the definition. Degree programs that meet the operative elements and satisfy the contextual principles are professional degrees; all other programs at the graduate level do not. The statute is not fixed in the sense that new degree programs could, at some point in the future, be professional degrees even if the program-type was not in existence when Congress passed the Act. As the economy evolves and new degrees and careers are created, it is possible that those degree pathways could meet the definition of professional student. Therefore, our definition of
Although the commenters point out that one of the elements of
In paragraph (1)(iv) of our definition of
Relatedly, in paragraph (1)(ii) of the definition of
In the same way, the taxonomy used here for only loan eligibility purposes does not rank academic fields, confer professional recognition, or determine whether a program, occupation, or degree carries greater status, worth, legitimacy, or public value than another. Nor does the Department interpret or apply this terminology to govern State licensure, scope of practice, payer credentialing, insurer recognition, reimbursement, contracting, employer treatment, or malpractice coverage. Those matters arise under separate statutory, regulatory, and private frameworks and are not controlled by the title IV loan classifications adopted in this rule. The Department therefore does not revise the rule based on commenters' concern that third parties might misread title IV terminology for purposes beyond Federal student aid administration. To the extent commenters urged the Department to broaden the professional student category in order to avoid perceived downstream signaling effects, the Department declines to do so, because that is not a factor Congress directed the Department to consider when classifying programs for the purpose of
By stating that the law does not contemplate a narrow or exhaustive definition of professional degree, we believe that commenters mischaracterize our approach in defining
Here, we rely on the illustrative list of degrees provided by Congress, as well as the historical context in which that list was originally developed by the Department, to identify common characteristics of those degrees. We further explain each of those commonalities and attributes of these professional degrees.
With respect to adding the doctorate in clinical psychology to an illustrative list of professional degrees, we explain in the NPRM (91 FR 4263-4264) how, during negotiated rulemaking, the Committee was able to determine that the doctorate in clinical psychology met all of the criteria in the definition of
Some commenters also asserted that the Department's reliance on supervision in some States overlooks the dynamic and evolving nature of State licensure frameworks and wrongly treats supervision as equivalent to subordinate status, even though many jurisdictions recognize broader Advanced Practice Registered Nurses (APRN) authority, for example. Other commenters argued that the proposed rule's supervision rationale is internally inconsistent because clinical residency in medicine and postgraduate training in clinical psychology are also forms of supervised practice. Still others maintained that State-by-State variation in supervision or collaborative-practice requirements should not determine a nationwide, Federal classification, particularly where commenters believed nurse practitioner programs otherwise meet the incorporated elements of 34 CFR 668.2.
The Department likewise does not agree that variation in State supervision and practice-authority is relevant to determining whether a program may be considered a professional degree. To implement Section 455(a)(4)(C)(ii) of the HEA, the Department used the tools of statutory construction to determine what programs were substantially similar to the list outlined in § 668.2. Supervision, collaboration, and practice authority is consistent among the list of professional degrees in § 685.102(b)(ii)(A) in that people who practice these professions may obtain a license and practice without supervision of another licensed professional, and, to the extent they are supervised at the beginning of their careers, it is by someone who holds the same degree and practices the same profession; it is not for the degrees mentioned with varying State supervision and practice authority. We decline to amend the regulations to create a dynamic classification keyed to a certain numerical court of State laws, as this would undermine clarity, predictability, and nationally uniform administration.
Several commenters believed that various graduate-level nursing programs, such as the Master of Science in Nursing (MSN), Doctor of Nursing Practice (DNP), Doctor of Nurse Anesthesia Practice (DNAP) lead to employment in distinct professions (nurse practitioners, clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists), sometimes collectively referred to APRNs). These commenters stated that these programs were fundamentally distinct from that of Registered Nurse and met the operative definition's three-part test and argued that completion of these programs signifies completion of academic requirements for beginning practice; requires skill beyond the baccalaureate level; and leads to licensure. Another commenter provided a detailed analysis and believed that our definition of professional student departed from the statutory framework Congress enacted in the Working Families Tax Cuts Act. Finally, one commenter from a professional association representing naturopathic medicine claimed that we made an
With respect to the commenters who argued that APRNs should be considered to hold a distinct professions, the Department agrees that nurse practitioners, clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists, hold unique roles that are specialized in nature and all require training at the graduate level—a MSN or Doctor of Nursing Practice DNP in the case of nurse practitioners, clinical nurse specialists, and certified nurse midwives; a DNP or a DNAP in the case of certified registered nurse anesthetists. Therefore, as a result, the Department acknowledges that nurse practitioners, clinical nurse specialists, and certified nurse midwives, and certified registered nurse anesthetists can all be considered to hold a fundamentally distinct profession, both in respect to other APRNS, as well as to Registered Nurses.
In response to commentors' assertions that the MSN, DNP, and DNAP meet the operative definition's three-part test, we explain in the NPRM (91 FR 4262) that, in addition to the operative test, the definition of
We also disagree with the second commenter who asserted our definition of
Finally, with respect to the third commenter, we disagree with the assertions made. Contrary to the commenter's argument, the proposal would not have unlawfully narrowed the definition of professional degree. The Department did not claim that the proposed definition was fixed and unalterable. To the contrary, the degree programs that are developed in the future have the opportunity to satisfy the definition of a professional degree if they meet the operative test and the program is consistent with the contextual elements. We address the commenter's concern in the NPRM (91 FR 4263), and we specify that the list of degrees in the
To the degree the commenter is suggesting that the Department lacks the authority to regulate on defining
Commenters are confused about this fundamental point in that they seem to assert that Congress enshrined the text of the regulation in 34 CFR 668.2 and made it unalterable by the Department. Congress did nothing of the sort: they created a new statute but chose not to, for whatever reason, paste the words of the regulation into the Act and used a cross reference instead. Had Congress wished to halt the Department from making regulatory changes in the CFR, they would have been explicit like they did in Section 85001 and Section 85002, where they enshrined previous versions of other Department regulations for a period of time. Instead, Congress incorporated the words of the regulation into the statute through a reference to a text to the regulation. Congress's decision to create binding statutory text through this reference has no bearing on the Department's authority to regulate. Commenter's attempt to glean interpretive meaning from this typographical drafting choice is misplaced.
The regulation itself is vague and begs to be expounded upon. Millions of students who are enrolled in tens of thousands of programs participate in the Direct Loan program every year. All those students must have clear information regarding how much they are eligible to borrow from the Department. Because professional students can borrow up to $50,000 annually, while graduate students may borrow up to $20,500 annually, it is important that students know which
In regard to the commenter's assertion that naturopathic medical programs have been classified as first-professional degrees in NCES for the purposes of IPEDs, that is not relevant here. Instead, we are interpreting the statute provided under the Working Families Tax Cuts Act, which does not reference IPEDS reporting classification. Rather, the statute has an operative test and there is contextual information in the illustrative list of degrees that helps to further interpret the definition.
Naturopathic medicine is illegal in several States.
Another commenter claimed that our definition of
The Department notes that the paths to becoming a licensed architect differ from State-to-State and, while some require an individual to hold a bachelors or master's degree in architecture, this is not universally the case, as some States allow applicants for licensure to substitute work experience in place of a degree (in some cases, allowing even individuals with no higher education at all to obtain licensure as architects).
We also disagree with the second commenter's supposition that the use of
Commenters stated that, similar to chiropractic, optometry, podiatry, veterinary medicine, and clinical psychology, other fields were also licensed or practice-oriented fields. These commenters stated we were being underinclusive and internally inconsistent. Some commenters more specifically emphasized that medicine and osteopathic medicine require doctoral level education, extensive supervised clinical training, national licensing examinations, State licensure for independent practice, and ongoing professional competency requirements, and they urged the Department to preserve those programs as professional degree programs.
Other commenters likewise highlighted podiatry and veterinary medicine as already included
A smaller number of commenters pointed to chiropractic specifically as an example of what they viewed as internal inconsistency, arguing that retaining chiropractic while excluding other contemporary licensure leading programs was arbitrary and unsupported.
To the extent commenters referenced psychiatry, the Department understands those programs relating to medicine or osteopathic medicine, not a separate degree category. Students pursuing an M.D. or D.O. are considered professional students for the purposes of the definition regardless of the specialty they enter, including psychiatry.
The Department likewise declines to adopt commenters' argument that excluded programs should be treated similarly to chiropractic, optometry, podiatry, veterinary medicine, clinical psychology, or other already included fields merely because commenters view those programs as analogous in rigor, licensure structure, clinical responsibility, or public importance. As explained in the NPRM (91 FR 4262-65) and elsewhere in this final rule, among other requirements, the Department considers a three-part operative test to determine if a degree is a professional degree.
The Department therefore retains the NPRM's (91 FR 4261) treatment of the enumerated included fields while declining, for the reasons discussed elsewhere in this section, either to remove legacy included fields or to broaden the category beyond the incorporated framework.
As explained above, the statute explicitly includes such degrees in the definition and therefore the Department is foreclosed, by statute, from removing them. No further interpretive work is required for these degree programs to be classified as professional degrees.
In promulgating the definition of professional degree in 34 CFR 668.2, the Department did not consider the lack of State licensure for individuals with theology degrees to be dispositive. The First Amendment would not permit a State or the Federal government to require professional clergy to be licensed to act as religious leaders. The Free Exercise Clause of the First Amendment prevents excessive government entanglement in the exercise of religion. Indeed, even broadly applicable and facially neutral labor laws do not apply to the employment of clergy under what is known as the ministerial exception.
A subset of commenters urged the Department to treat accounting pathways, particularly those intended to prepare students for CPA licensure, like other included professional programs. These commenters emphasized public protection responsibilities, ethical obligations, State licensure requirements, and the central role of CPAs in attestation, auditing, tax, and financial reporting. Several State CPA societies argued that graduate accounting programs remain a critical and widely used route to CPA licensure, even where States now provide more than one educational pathway. For example, commenters emphasized that their State allows either a bachelor's degree plus two years of experience, or a master's degree plus one year of experience, both coupled with the passage of the Uniform CPA Examination and satisfaction of ethics and competency standards as pathways to licensure.
Other commenters argued that even where a master's degree is not universally required, accounting should still qualify, as graduate study is often the practical route to meet the 150-credit hour expectation, the profession is heavily regulated, and the work implicates public trust and economic stability. Some commenters also urged the Department to either include accounting expressly or to retain non-exclusive phrasing that would preserve flexibility for inclusion of accounting and similarly situated programs.
Some also requested clarification regarding accounting concentrations housed within business schools and how program identification would be administered for business-related degrees.
The Department does not adopt commenters' requests because, as the NPRM (91 FR 4265) specifically explained, an MBA does not satisfy the incorporated professional degree definition where it is not required for entrance into a specific profession and does not itself carry accompanying licensure. The NPRM (91 FR 4265) further explained that even if MBA coursework may satisfy certain prerequisite requirements relevant to another licensed field, that does not make the MBA itself a licensure qualifying professional degree. Put plainly, there is no single recognized profession that an MBA prepares students to enter. For the same reason, the Department declines to consider other business programs, such as an executive MBA, D.B.A., or related business doctoral study as professional degrees. The Department does not contest that these programs may have career value or otherwise assist students in satisfying certain prerequisite licensure requirements. But, for example, to obtain licensure as a certified public accountant, an applicant must have completed 150 credit hours of coursework but is not required to have earned a specific post-baccalaureate degree, which is relevant when the Department determines whether a specific degree is a professional degree.
The Department also disagrees with commenters that advanced accounting degrees beyond the baccalaureate level should be considered professional degrees. As the commenters themselves concede, these master's degrees are not required, in general, to become a Certified Public Accountant (CPA). Even though students must have completed 150-credit hours or 225 quarter hours to sit for the Uniform CPA Examination, there is no specific requirement to earn a master's degree. In other words, the master's degree does not signify the beginning of practice in a given profession, because earning 150 credit hours is the primary determinate. In general, undergraduate accounting students can take all of the requisite coursework required to sit for the exam as part of their baccalaureate coursework, although the Department acknowledges that most institutions require less than 150 credit hours to graduate.
Many commenters argued that the Department's approach understates the role of graduate and post-baccalaureate education in modern educator preparation, particularly for school leadership, specialized instructional support, endorsements, and career change pathways. Commenters also argued that limiting graduate borrowing for educators will disproportionately burden lower income, first generation, and part time students and weaken the teacher pipeline, including in specialized teaching fields and underserved communities. In discussing education related pathways, commenters repeatedly referenced the Master of Arts in Teaching (MAT), Master of Education (M.Ed.), Education Specialist (Ed.S.), Master of Library Sciences (MLS), and Doctor of Education (Ed.D.) programs associated with certification, licensure advancement, specialization, or leadership roles in education.
Another commenter asserted that many graduate education programs provide initial certification for school administrators or other specialized roles and that those positions often require 30 to 60 graduate credit hours, supervised clinical practice, and licensure assessments beyond a bachelor's degree. Individual educator commenters similarly argued that the Department's focus on entry into classroom teaching is too narrow, because school leadership and certain specialized roles require a completed master's degree as a gatekeeping credential.
Other commenters argued that many individuals who change careers pursue master's level programs for initial certification, particularly in high need fields, and that degree titles vary across institutions and States even where the programs lead to regulated professional roles. Still, others urged the Department to include post-baccalaureate certificates and other educator preparation programs, including programs leading to initial certification or additional educator endorsements, arguing that the proposed framework does not fit how educator preparation operates for working adults, part time students, and mid-career professionals.
The NPRM (91 FR 4260-63) then specifically concluded that the M.Ed. and Ed.D. do not satisfy the incorporated professional degree definition because they are not required for entrance into a specific profession or for licensure. It further explained that, although several States ultimately require teachers to obtain a master's degree to maintain a license, no State requires an M.Ed. or similar master's degree to begin work as a teacher, and an Ed.D. may offer career advancement but is not required for entrance into a specific profession or as a prerequisite for licensure in a field. Many schools may require these upper-level degrees for career progression through school administration. However, these jobs do not require licensure nor is there a specific pathway that must be followed in order to become a school administrator.
The Department does not agree with commenters' arguments that the NPRM (91 FR 4265) focuses too narrowly on entry into classroom teaching and does not adequately account for school leadership, specialized instructional support, certain administrative roles, or master's level initial certification pathways for career changers. Because these advanced roles are not required to enter into the profession, as required by the first part of the operative test (91 FR 4262), these programs are not professional degree programs for the purposes of Direct Loan eligibility.
Some commenters who discussed physical-therapy emphasized that the Doctor of Physical Therapy (DPT) is now the current entry-to-practice credential for physical therapists nationwide and argued that the Department should not rely on older, historical treatment from periods when physical therapy was not a doctoral-entry field.
Other commenters who discussed occupational-therapy similarly argued that, for U.S.-educated students, graduation from an accredited MSOT or OTD program by the Accreditation Council for Occupational Therapy Education (ACOTE) is the route to certification from the National Board for Certification in Occupational Therapy (NBCOT) and State licensure as an occupational therapist, and they further argued that the NPRM misread the occupational-therapy entry pathway by treating the Occupational Therapist Eligibility Determination (OTED) process as though it created an alternative domestic route into the profession.
Commenters across both fields also argued that these programs are clinically intensive, cohort-based, and difficult to complete while working, and that lower Federal loan limits would increase reliance on private loans, create front-loaded funding gaps, reduce access for lower-income and first-generation students, and worsen workforce shortages and access-to-care problems in rural, school-based, disability, home-health, hospital, and other underserved settings. A subset of commenters further argued that the Department's approach is inconsistent with the statute because DPT, MSOT, and OTD programs satisfy what commenters described as the operative functional criteria in 34 CFR 668.2 and are comparable to other modern health-professions pathways that commenters view as paradigmatic professional education.
Commenters emphasized that the DPT is now the current entry-to-practice credential for physical therapists nationwide and argued that the Department therefore should not rely on earlier historical treatment from periods when physical therapy was not a doctoral-entry field.
The Department does not agree with that argument. The fact that the PT profession has evolved to a doctoral-entry model establishes that the profession's educational requirements have changed over time; it does not establish that PT must therefore be treated as falling within the incorporated professional-degree framework. The Department does not treat PT as falling within the incorporated profession degree framework solely because the profession later moved to a doctoral-entry model tied to licensure and clinical training. That later shift in credential level shows that entry requirements changed over time; it does not itself alter the incorporated definition in § 668.2.
In addition, many States provide for licensure for individuals who have obtained a master's degree in physical therapy. Where there are multiple pathways to licensure, like here, the Department finds that the degree is not professional because that feature makes the profession dissimilar to the features of the program in the illustrative list of degrees in the definition of
The Department is specifically concerned that recognizing this shift from the master's level credential to the doctoral level credential as a professional degree could create a moral hazard to incentivize unnecessary degree inflation, which has been a documented problem for many years.
This conclusion is likewise dispositive for OT. Commenters argued that, for U.S.-educated students, graduation from an ACOTE-accredited MSOT or OTD program is the route to NBCOT certification and State licensure as an occupational therapist, and they
The Department does not treat accreditation, national board eligibility, front-loaded tuition, or the existence of strong workforce demand as independently sufficient to establish professional degree status. The statute instead directs the Department to implement the incorporated professional degree framework Congress chose to reference for title IV loan limit purposes.
With respect to the licensure requirement in the three-part test, some commenters further argued that the Department is improperly reading “generally required” to mean licensure in a majority of States, or some other threshold not found in the regulation, and asserted instead that licensure in 26 jurisdictions representing more than half the U.S. population is sufficient to satisfy that concept. They claimed that the Department should not weigh the prohibitions in three jurisdictions over the 26 States and territories with licensure frameworks and that the prohibitions in these three jurisdictions are irrelevant to the three-part operative test. Furthermore, since licensure remains the legal gateway to professional practice, these commenters argued that the Department's interpretation to exclude ND programs from the definition of
As we explain in the NPRM (91 FR 4265), the Department determined that an ND would not satisfy the first and third part of the
As explained above, the definition for professional student requires, among other things, that the degree signifies the beginning of practice in a profession where “[p]rofessional licensure is also generally required.” Here, obtaining a Doctor of Naturopathic Medicine does prepare students to begin practice in naturopathic medicine; however, professional licensure is not possible in certain States because the practice is altogether prohibited. In contrast, every degree listed in the illustrative list leads to professions that are legal in every State. Naturopathic Medicine cannot legally operate in any capacity in certain States and therefore they do not meet the definition of
Other commenters argued that the Department's nursing analysis is inconsistent because we state that graduate education is not required to enter nursing generally, rather than whether graduate education is required to enter an advanced role in the nursing field, such as a nurse practitioner, clinical nurse specialist, a certified registered nurse anesthetist, and a certified nurse midwife. These commenters argued that advanced roles in the nursing field requiring completion of a graduate-level nursing program are a distinct profession, not merely a specialization within registered nursing, and that the Department's reasoning gives insufficient weight to the regulatory term “generally.”
Finally, other commenters took issue with the Department's position that the fact that many States require APRNs to practice under the supervision by a physician as a basis for not designating graduate-level nursing programs to be professional. Some commentors arguing that this factor was irrelevant, dismissed the fact that APRNs have full, independent practice authority in some States, and ignored the fact that other professions, such as physicians, are required to be supervised by other professionals during their required residencies.
The Department has further considered commenters' arguments that reduced Federal borrowing capacity may increase reliance on private loans, deter qualified applicants, and constrain the pipeline of advanced practice nurses and certified registered nurse anesthetists, including in rural and underserved communities. Those concerns are not relevant for these purposes because the law does not permit us to use those bases as considerations in determining whether a program is a professional degree.
With respect to commenters' points that graduate nursing programs are academically rigorous, licensure linked, and in some cases doctoral entry programs that lead directly to high responsibility clinical practice, we note that these factors cannot be used as considerations whether a program is a professional degree as the statute does not support that. While, as discussed previously, these factors do support the conclusion that nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, and certified nurse midwife are all distinct professions, these factors do not fully support treating the MSN, DNP, or DNAP as being eligible for the higher professional loan limits, due to the contextual requirements imposed by the illustrative list of credentials included in the definition of
The MSN appears to satisfy the three parts of the operative test but fails to satisfy the contextual requirements imposed by the illustrative list of credentials included in the definition of
In regard to the operative test factors, first, the MSN signifies completion of the academic requirements for beginning practice in a given profession, as it is the minimum requirement for licensure as a nurse practitioner, or to obtain certification and/or licensure as a certified nurse midwife or clinical nurse specialist. Second, the professions that graduates of MSN programs enter require a level of professional skill beyond what is normally required for a bachelor's degree, as nurse practitioners, clinical nurse specialists, and certified nurse midwives all perform specialized roles that require unique training that exceeds the type of training provided to holders of a BSN. Third, the professions that a holder of an MSN may enter after graduating generally require professional licensure, or they must obtain additional authorization to begin practicing in all States.
However, while the MSN appears to satisfy the three parts of the operative test, it fails to satisfy the contextual test provided by the illustrative list of degrees included in the definition of
First, the MSN is a master's-level degree, while the illustrative list suggests that a
Secondly, an MSN does not require the same amount of post-graduate training as other degrees included in the illustrative list of degrees. The degrees included within that list generally require at least six academic years of postsecondary education coursework for completion, including at least two years of post-baccalaureate level coursework. By comparison, a traditional MSN (where the student already has a BSN) may be completed in 18 months, with programs requiring as few as 36 credit hours to complete (though this can vary substantially, based on the institution), meaning that a traditional MSN student may be able to earn the degree while only having completed five and one-half academic years of postsecondary education coursework for completion, with only 18 months of post-baccalaureate level coursework.
Third, the MSN leads to employment in professions which may require career-long supervision by persons in a different profession, as a condition of licensure and practice, in some States, physician oversight is often required for APRNs to be allowed to practice. This is true for all APRN professions, with State-level requirements differing based on each individual profession:
The Department notes that, due to the unsettled practice authority landscape discussed above, the MSN differs substantially from the other degrees which are included within the illustrative list of degrees, as none of those degrees lead to employment in a profession that requires career-long supervision, much less by individuals with a different profession.
By contrast, the professions that an MSN leads to employment in lack a nationwide, uniform standard for practice and prescriptive authority. In a significant proportion of States, nurse practitioners, certified nurse midwives, and clinical nursing specialists, are subject to career-long supervision or are otherwise required to enter into formal relationships with physicians as a condition of their authority to practice their profession. As noted previously, no State imposes a comparable requirement in regard to the professions requiring the degrees included within the illustrative list of
Therefore, because no State imposes restrictions on professions requiring the degrees included within the illustrative list of
Like the MSN, the DNP appears to satisfy the three parts of the operative test but fails to satisfy the contextual requirements imposed by the illustrative list of credentials included in the definition of
The DNP appears to satisfy the three parts of the operative test. First, the DNP signifies completion of the academic requirements for beginning practice in a given profession, the degree enables the holder to obtain licensure as a nurse practitioner, as well as to obtain certification as a clinical nurse specialist and certified nurse midwife. Second, the professions that graduates of DNP programs enter require a level of professional skill beyond what is normally required for a bachelor's degree, as nurse practitioners, clinical nurse specialists, and certified nurse midwives all perform specialized roles that require unique training that exceeds the type of training provided to holders of a BSN. Third, the professions that a holder of a DNP may enter after graduating require professional licensure and/or additional authorization to begin practicing in all States.
However, while the DNP appears to satisfy the three parts of the operative test, it fails to satisfy the contextual test provided by the illustrative list of degrees included in the definition of
First, as discussed more fully in the “
Therefore, because no State imposes restrictions on professions requiring the
Secondly, the DNP (except in the case of DNPs in nurse anesthesia) exceeds the minimum credential level required for an individual to begin practice as a nurse practitioner, certified nurse midwife, and clinical nurse specialists, as an MSN is the minimum degree required to obtain the licensure/certifications necessary to begin practice in those fields. With a sole exception, for each profession with multiple degrees included in the illustrative list of
With the exception of certified registered nurse anesthetist, the MSN leads to employment in same professions as the DNP. Likewise, with the exception of certified registered nurse anesthetist, the DNP does not enable its holders to obtain any additional professional licensure or certification necessary to practice in a given field beyond that which an individual holding an MSN is able to obtain. Therefore, the Department believes DNP degrees (outside of those awarded in nurse anesthesia DNP programs) fail to satisfy a contextual requirement which can be inferred from the degrees included in the illustrative list of
Furthermore, the Department believes that it would be illogical to treat a DNP leading to employment as a nurse practitioner, certified nurse midwife, or clinical nurse specialist as satisfying the requirements of the illustrative list of
The DNP in Nurse Anesthesia and DNAP appear to satisfy the three parts of the operative test but fail to satisfy the contextual requirements imposed by the illustrative list of credentials included in the definition of
First, both degrees signify completion of the academic requirements for beginning practice in the certified registered nurse anesthetist profession. Second, the professions that graduates of the DNP in Nurse Anesthesia and DNAP programs enter require a level of professional skill beyond what is normally required for a bachelor's degree, as certified registered nurse anesthetists perform specialized roles that require unique training that exceeds the type of training provided to holders of a BSN. Third, the professions that the holder of a DNP in Nurse Anesthesia or DNAP may enter after graduating require professional licensure in all States.
However, while the DNP in Nurse Anesthesia and DNAP appear to satisfy the three parts of the operative test, both fail to satisfy the contextual test provided by the illustrative list of degrees included in the definition of
Seventeen States (as well as the District of Columbia, Guam, and the Northern Mariana Islands) grant certified registered nurse anesthetists independent practice authority, allowing them to practice independent of a physician's supervision (though, in some States, nurse practitioners may only transition to such full independent practice authority after undergoing a period of physician supervision). By contrast, thirty-three States (as well as Guam, Puerto Rico, and the U.S. Virgin Islands) require a certified registered nurse anesthetist to have a relationship with a physician that outlines procedures the certified registered nurse anesthetist may perform and procedures for consulting with the physician, including outlining the certified registered nurse anesthetist's prescribing authority.
Note that, while the prescriptive authority of certified registered nurse anesthetist's varies by State, certified registered nurse anesthetists are not required to have prescriptive authority to provide anesthesia care and may order and directly administer controlled substances and other drugs perioperatively within their scope of practice. Therefore, because the prescriptive authority does not impact a certified registered nurse anesthetist's ability to carry out their core profession of providing anesthesia care, the Department did not take prescriptive authority into consideration in this situation.
The Department notes that, due to the unsettled practice authority landscape discussed above, a DNP in Nurse Anesthesia and DNAP differ substantially from the other degrees which are included within the illustrative list of degrees, as none of those degrees lead to employment in a profession that requires career-long supervision, much less by individuals with a different profession.
Therefore, because no State imposes restrictions on professions requiring the degrees included within the illustrative list of
Finally, the Department likewise declines to adopt commenters' position that doctoral entry, national certification, extensive clinical training, or comparisons to physician anesthesia education are sufficient by themselves to consider DNP nurse anesthesia programs or DNAP programs as professional degrees, as these are also not bases under which we may consider a program is a professional degree program.
Some commenters further argued that the NPRM's (91 FR 4266) reliance on variation in collaboration or supervision is overstated because post-degree supervision structures exist in other medical professions included in the Department's definition of
Some commenters described this rule as misaligned with Congressional and Trump Administration priorities for primary care and rural health workforce, which they say views PAs as a solution for rural health workforce shortages via the Rural Health Transformation program.
The Department disagrees with the commenters' argument that we unlawfully added extra statutory criteria by discussing variation in credential level, licensure, scope of practice, prescribing authority, collaboration requirements, or supervision structures. In context, those observations do not create a new regulatory test. Rather, they help explain why the Department does not view PA pathways as fitting within the incorporated professional degree framework Congress chose to reference. The Department likewise is not persuaded by commenters' comparisons to other licensed professions. An MSPA, which is a master's level credential that enables the graduate to sit for licensure. But after the graduate becomes licensed, their practice must generally be supervised by medical doctors. With just a few exceptions, States do not provide for independent practice authority for licensed physician assistants. As explained in more detail in the section on “Loan Limits,” Congress did not ask the Department to align the definition of
Several commenters advanced more specific examples. Other commenters argued that accredited MPH and DrPH programs include structured practica, capstones, and applied training designed to prepare graduates for direct public health practice, rather than research alone. APHA and related commenters argued that professional public health degrees prepare graduates for emergency preparedness, disease prevention, health promotion, and leadership in public health systems and that public health credentialing structures, including the Certified in Public Health (CPH) credential, show that the field has recognized practice standards even without a single universal license. Several individual commenters also argued that the DrPH, in particular, functions as the terminal professional practice doctorate in public health and should be treated differently from research doctorates as it is oriented toward applied leadership, policy implementation, emergency response, and public health governance.
Congress did not authorize the Department to adopt a broader standard under which graduate pathways become qualifying professional degree programs
Additionally, the term
Many commenters argued that the Department improperly conflated the possibility of some social work employment with a bachelor's degree with whether graduate education is required for independent clinical social work practice, including psychotherapy, diagnosis, and autonomous practice under Licensed Clinical Social Worker (LCSW) or similar clinical licensure frameworks. These commenters further claimed that the existence of BSW licensure does not change the fact that the licensure entry point requirement for independent practice is the graduate degree. They also explained that students who earn the Licensed Bachelor of Social Work (LBSW) are limited to specific roles, such as case manager and patient navigator, and are unable to perform the independent work of a licensed professional without at least a master's degree.
Some commenters also argued that clinical social work should be treated as a distinct professional pathway, rather than as a mere specialization within broader social work, and pointed to State licensure structures, supervised postgraduate practice, examination requirements, and Federal recognition of clinical social workers as independent providers. They stated that CMS (Medicare/Medicaid), State laws, the Association of Social Work Boards (ASWB), and the Social Work Licensure Compact all treat clinical social work as a separate professional category with its own licenses, exams, and scope, like clinical psychology, which the Department recognizes as a professional degree. A few commenters pointed out that the Bureau of Labor Statistics (BLS) affirms that clinical social work requires a master's degree and State licensure, directly contradicting the Department's claim that a bachelor's degree is sufficient to practice. One commenter highlighted clinical social workers' independence by citing Section 1861(hh)(1)(A) of the Social Security Act, which defines a “clinical social worker” as an individual who possesses a master's or doctors' degree in social work, has completed at least two years of supervised clinical social work, and is licensed or certified as a clinical social worker.
Some commenters also made a legal argument that the Department's reasoning focuses too heavily on beginning practice in a given profession and not enough on qualification for independent professional practice, which they argued more accurately reflects the operative concept of a professional degree.
The Department rejects the commenters' position that the MSW and DSW should be treated like clinical psychology based on asserted functional similarity. As we explained in the NPRM (91 FR 4263, 4265), the Department treated clinical psychology as within the incorporated professional degree framework based on the definition of
These commenters stated that FAA certified Part 141 programs function like graduate education in substance, even when they remain structured as undergraduate or non-graduate programs. Commenters argued that students in these programs complete extensive postsecondary, profession specific training; obtain licenses, certificates, and ratings while enrolled; and enter a Federally regulated profession in which licensure is required for employment. Commenters also argued that these programs intentionally remain undergraduate or non-graduate in structure to avoid credential inflation, unnecessary coursework, additional time to completion, and higher student cost. On that basis, commenters urged the Department to treat FAA Part 141 programs as graduate degree programs. Some commenters proposed specific amendments to the definition of
Commenters also argued that excluding these programs from higher borrowing limits would undermine the pilot pipeline, worsen regional and rural air service constraints, and impose particularly acute burdens on low- and middle-income students, because training costs are front loaded while students are still enrolled in undergraduate or non-graduate programs. Other commenters framed their request as a narrow clarification, rather than a request for special treatment, and argued that pilot training represents a high return workforce investment associated with strong earnings and repayment capacity. These commenters requested that we clarify the treatment of accredited flight training programs under our definition of
Many commenters argued that the post-degree experience and exam requirements in architecture and landscape architecture are analogous to medical residency, rather than additional academic coursework; therefore, completing the M.Arch. or M.L.A. meets the academic requirements for beginning practice. Some argued that the Department's use of law and theology as comparable fields reveals inconsistency because, in their view, the J.D. is not universally required for initial licensure in every jurisdiction and professional licensure is not generally required in theology, while architecture and landscape architecture satisfy the operative test more cleanly. Other commenters emphasized that many States have no in-State B.Arch. option and that graduate architecture pathways now constitute a substantial share of accredited architecture graduates, and they urged the Department to, at minimum, recognize NAAB accredited architecture programs, among other post-baccalaureate State licensed professions, as professional degrees. Commenters also stressed that the high costs associated with the structure of studio-based design education, including dedicated studio space, fabrication, software, computing, and extended building access, and argued that lower borrowing limits would delay degree completion, defer licensure, and weaken the architecture and design workforce supporting housing, infrastructure, and economic development.
As reflected in the NPRM (91 FR 4260-65), the Department does not conclude that architecture fits that framework where a graduate architecture degree is not generally required across jurisdictions for entry into the profession and where a five-year Bachelor of Architecture commonly serves as the academic predicate for licensure. In that circumstance, the M.Arch. does not function as the single graduate level academic threshold to begin practice in the profession the way commenters propose; therefore it cannot be considered a professional degree. The same basic structural concern applies to commenters' arguments regarding landscape architecture, where multiple undergraduate and graduate pathways exist.
The Department likewise declines to adopt commenters' requests for a broader criteria-based rule that would include architecture, landscape architecture, or other post-baccalaureate licensed professions that do not satisfy the operative test or contextual requirements for what constitutes a
Commenters also urged the Department to adopt more explicit criteria for professional degree classification, such as accreditation standards, terminal degree status, supervised clinical training requirements, licensure mandates, and scope of independent practice. Some argued that the proposed rule fails to apply such criteria consistently across similarly situated programs and instead draws distinctions that undervalue modern behavioral health professions. Some also raised a separate concern that classifying counseling and related mental health clinicians as non-professional could be misread by third-party payers, credentialing entities, or employers as signaling that these pathways are less rigorous or less legitimately clinical than included professions.
Several commenters offered more specific examples. Program directors and faculty commenters emphasized that ACEND accredited master's, plus supervised practice programs, are now the required educational route to RDN credentialing, and argued that the financial structure of those programs is comparable to other graduate health pathways already treated as professional. The Academy of Nutrition and Dietetics argued that RDNs are licensed healthcare professionals who complete a master's degree, supervised practice, and extensive clinical training before entering the workforce and that lower borrowing limits will worsen shortages in hospitals, long term care, community health, and rural settings. Individual commenters similarly stressed that their internships required full-time clinical or hospital rotations of 40 or more hours per week, that outside employment was impracticable during their time to credential, and that they relied on Federal loans to complete their training. Other commenters argued that RDNs reduce health care costs through disease prevention, nutrition counseling, and medical nutrition therapy and that Federal student aid policy should reflect the structure of modern dietetics training, rather than older assumptions about the field.
In applying that incorporated definition, the Department considers the structure of the existing regulation, the context supplied by the enumerated examples, the characteristics of the program, and the requirements of the profession, rather than broader workforce need, public health value, or the general importance of the work. Under that framework, the Department does not adopt commenters' request to treat nutrition and dietetics pathways as professional degree programs because the RDN pathway now requires a master's degree, accredited supervised practice, and credentialing.
That is the core reason the Department is not revising the rule here. The incorporated framework does not ask whether a graduate credential has become the preferred or current route to a valued healthcare credential, or whether a profession now uses a master's degree plus supervised practice as part of one important pathway into regulated work. It asks, in substance, whether the degree itself functions as the graduate level academic threshold for beginning practice in the profession within the framework Congress chose to incorporate. The Department concludes that the RDN pathway does not satisfy that framework where the graduate credential at issue is not the basis for entry into the broader nutrition or dietetics field as a whole, and where commenters' arguments depend heavily on the structure of one credentialing pathway within a broader field of nutrition related practice. The Department therefore does not revise the rule merely because the RDN pathway is now graduate entry, supervised practice based, and professionally significant.
The Department has considered commenters' argument that required supervised practice is not optional advancement, but a mandatory component of qualifying for RDN credentialing, and that RDNs therefore should be treated more like other clinically oriented, graduate entry health professions. The Department does not dispute that supervised practice and credentialing are mandatory features of the RDN pathway. However, the various degrees that enable the holder to become credentialed as an RDN do not meet the necessary criteria to be for eligibility for the higher
To obtain credentialing as an RDN, an individual is required to pass the Registered Dietitian examination administered by the Commission on Dietetic Registration (CDR). To be eligible to take the examination (among other requirements), an individual must hold a graduate degree from an Accreditation Council for Education in Nutrition and Dietetics(ACEND)—accredited didactic program in dietetics, an ACEND-accredited coordinated program, an ACEND-accredited graduate program, or, alternatively, a doctorate from an institution that is accredited by an institutional accreditor recognized by the Department.
In addition, masters degrees leading to RDN certification fail the operative test for two reasons: (1) it is possible to complete some degrees that confer eligibility to take the Registered Dietitian examination in as few as five years of postsecondary education and (2) to the extent that they take six years or longer, such degrees are at the master's level, not the doctorate level. We note that it is possible to obtain a master's degree from an ACEND-accredited program in as little as one year.
Many pointed out that Medicare covers acupuncture for chronic low back pain, and the U.S. Department of Veterans Affairs integrates acupuncture in its Whole Health model—evidence; therefore, commenters argue that Federal health systems view it as legitimate, regulated care. Several also noted major insurers reimburse acupuncture services. Commenters added that the CIP code 51.3301 (“Acupuncture”) explicitly describes preparation for independent professional practice, which they believed aligns with the Department's own professional degree definition.
Some commenters argued that MPP and MPA programs, in particular, should receive treatment more comparable to professional degree pathways because they prepare students for specialized public-sector, institutional, or policy-facing roles involving substantial responsibility even without a traditional licensure model. More generally, commenters suggested that advanced graduate study, specialized expertise, and the institutional, scholarly, civic, or public value of research-oriented, knowledge-intensive, or policy-facing disciplines should be enough to warrant treatment more comparable to professional degree pathways for borrowing purposes.
Some commenters further argued that lower Federal borrowing limits could constrain the pipeline for engineering and infrastructure-related professions and that the Department's approach gives insufficient weight to the public-safety and licensure-adjacent features of these fields.
Architecture and landscape architecture commenters made a related point, arguing that the existence of professional undergraduate degrees such as the B.Arch. should not disqualify post baccalaureate pathways such as the M.Arch. or M.L.A. where graduate study is, in their view, the principal or most realistic route to licensed practice for many students. These commenters generally urged the Department to adopt a more flexible reading of the incorporated framework that would better accommodate mixed entry or layered professional pathways.
That is the core reason the Department is not revising the rule here. The Department continues to consider whether the graduate degree itself functions within the incorporated framework as the academic threshold for beginning practice in the relevant profession. Where commenters rely on undergraduate pathways as comparator evidence, whether to show that a field includes multiple tiers of practice or to argue that a graduate pathway should still qualify despite the existence of an undergraduate professional route, the Department has considered those arguments but does not view them as a basis to depart from the incorporated framework.
The Department therefore does not revise the rule based on commenters' references to bachelor's level social work, dental hygiene, or mixed undergraduate/graduate design structures. Those comments underscore that some professions have layered educational and licensure models. They do not alter the Department's conclusion that this rule implements a title IV classification tied to the incorporated definition of
To the extent commenters relied on bachelor's-level or otherwise undergraduate pathways, those programs remain governed by the undergraduate Direct Loan limit framework and are not eligible for the graduate or professional annual loan limits addressed by this rule. For these reasons, the Department retains the NPRM's (91 FR 4260-65) approach to the extent commenters invoked undergraduate pathways as part of broader arguments about beginning practice, mixed entry professions, or graduate level professional recognition.
These commenters claimed that these loan limits will reduce the overall diversity of degree seekers in these careers and increase existing racial and gender wealth gaps, making higher education less accessible to students from historically marginalized communities. One commenter opposed the proposed rule because they believe limiting access to graduate education for low-income and minority students violates the spirit of civil rights laws aimed at ensuring equal access to educational opportunities. A few commenters claimed that this will reverse years of progress toward building a workforce that reflects the population it serves. Several commenters requested that the Department preserve Grad PLUS for students who serve communities with high needs. Many of these commenters urge the Department to reconsider implementing these loan limits and eliminating Grad PLUS to uphold the values of equity and access in education.
Further, one commenter requested that the Department consider transitional provisions for current and near-term students who planned to go to graduate school with the expectation that the Grad PLUS program and the ability to borrow up to the cost of attendance would be available. Another recommended that the interim exceptions apply to all students for three years, regardless of whether they remain continuously enrolled throughout that period.
Students in programs that lead only to a graduate or professional degree and do not meet the regulatory requirements to be considered graduate or professional degree students, are not considered to be enrolled in an undergraduate program of study and are ineligible to receive any type of title IV aid. Accordingly, they would not have received a Direct loan prior to July 1, 2026, and would not be eligible for any interim exceptions in this rule.
Some commenters asked the Department to annually adjust the limits with inflation, rising institutional costs, and cost-of-living variability. Several commenters requested the Department permit higher loan limits for graduate-level healthcare programs with documented clinical and patient-safety obligations. One commenter recommended the Department tie graduate loan access to a debt-to-earnings ratio or other outcomes-based accountability measure, rather than a prescribed cap.
Other commenters claim that the $50,000 professional loan cap is too low for programs in medicine, veterinary, dental, and law, where tuition is higher than the cap. These commenters argue that lowering tuition is nearly impossible since programs need to compete with the private sector for professors. Several commenters recommended increasing the annual loan limit to at least $100,000.
We disagree with the commenter's claim that this change will make the country less educated or cost the U.S. more money in the long term, as their claim is pure speculation and was submitted without substantiating evidence.
The statutory construct of the HEA supports our position that these transfer programs are not considered the same program at the new institution. Section 101(a)(3),
Consistent with how the Department treats aggregate loan limits, the consolidation loan is not included in a student's maximum aggregate loan limit because the underlying title IV loans were paid off through a consolidation loan and are already included in the lifetime maximum aggregate limit. HEAL and Health professional loans authorized under the Public Health Service Act are excluded.
Furthermore, a borrower who is eligible for the interim exception, is not subject to the new annual, aggregate and lifetime aggregate loan limits that are effective July 1, 2026, during the interim exception period.
However, if a borrower begins a new program because they are no longer borrowing under the interim exception, they are subject to the new loan limits. Once a borrower borrows up to the lifetime aggregate loan limit, they are ineligible for additional loan funds.
We disagree with the commenters' conclusion that there is inconsistent application of lifetime maximum aggregate loan limits. We note that Section 455(a)(6) excludes only Parent PLUS loans from consideration (“. . . other than other than a Federal Direct PLUS loan, or loan under Section 428B, made to the student as a parent borrower on behalf of a dependent student.”) The statute clearly states that any loan made, guaranteed, or insured under the Act that a student may borrower is included in the lifetime maximum aggregate limit.
Our regulatory language in § 685.203(j)(2) resolves the confusion expressed by the commenters as to inclusion of Grad PLUS loans in aggregate lifetime loan limits when borrowers are not borrowing under the interim exception.
Some commenters also maintained that reducing a later disbursement based on an earlier enrollment change could create midyear billing surprises for families, increase the risk that students stop out if they cannot cover an unexpected balance, and create pressure on students to remain enrolled in courses they otherwise would appropriately withdraw from for academic or personal reasons. Some commenters further stated that these effects could be particularly difficult for smaller institutions with more limited administrative capacity.
Some commenters also asserted that mandatory reductions based on less than full-time enrollment could disproportionately affect students whose enrollment intensity is reduced because of disability-related accommodations or other documented circumstances and urged the Department to provide additional flexibility in such cases.
The Department understands commenters' concern that later adjustments to annual loan eligibility may create administrative and financial challenges for students and institutions. Those concerns do not alter the statutory requirement that annual Direct Loan eligibility for a student who enrolls less than full-time during an academic year or its equivalent be reduced in proportion to the student's enrollment status. The Department has, however, clarified the implementation framework to provide institutions greater operational clarity and flexibility regarding packaging assumptions, the treatment of undisbursed amounts, and the administration of adjusted annual eligibility across payment periods.
The Department also understands commenters' concern regarding students whose enrollment status may be reduced because of disability-related accommodations or other documented circumstances. The statute did not make an exception or waive the requirement of reducing a direct loan when a borrower enrolls less than full-time in an academic year or its equivalent. The Department notes, however, that institutions may continue to administer other applicable title IV aid rules (
The Department has also considered comments asserting that, where one period of enrollment is less than half-time, the order in which a student enrolls over the academic year may affect when a disbursement may be made. That effect, however, follows from the interaction between the annual limit reduction required by § 685.203(m)(1) and otherwise applicable disbursement rules. That interaction does not provide a basis to replace the academic year framework required by the statute with a separate term-based methodology.
Some commenters requested clarification regarding whether institutions may adopt a policy to make an adjustment during the same period of enrollment if the student drops classes after a disbursement has already been made, rather than waiting to adjust a later undisbursed amount or subsequent disbursement. These commenters stated that, in some cases, institutions may believe it is better for students to address the effect of an enrollment reduction in the term in which it occurred rather than in a later term.
Moreover, some commenters argued that coursework from which a student later withdraws should not be treated the same as coursework dropped early in the payment period. These commenters stated that withdrawn coursework remains attempted coursework, may appear on the transcript with a W, and may be treated differently for other title IV purposes. They therefore urged the Department to distinguish more clearly between dropped and withdrawn coursework for § 685.203(m)(1) purposes or to avoid phrasing that suggests every post-disbursement course status change should be treated identically.
The Department concludes that additional clarity is warranted but does not believe the rule should be revised to create a separate recalculation regime for each post-disbursement enrollment-change scenario. The better course is to align the reduction to existing eligibility and disbursement processes rather than to create multiple institution-specific adjustment frameworks. Accordingly, institutions may determine a student's reduced annual eligibility using the best information available about the student's expected enrollment for the academic year or its equivalent and may revise undisbursed amounts, including subsequent disbursements, once the student's actual or expected enrollment pattern becomes known. The Department intends to provide additional operational guidance addressing common post-disbursement enrollment change scenarios.
The Department further clarifies that nothing in § 685.203(m)(1) prohibits an institution from adopting a consistently applied policy under which it reduces an undisbursed amount during the same period of enrollment after a post-disbursement reduction in enrollment, provided the institution administers that policy consistent with otherwise applicable disbursement rules. The Department further understands commenters' concern that later changes in coursework, including withdrawals, may not track the same way they do in other title IV contexts. But those other frameworks do not control the separate annual Direct Loan limit determination required by § 685.203 (m)(1). The better
Some commenters also requested additional examples illustrating how the schedule of reductions applies across a full academic year and in common enrollment-change scenarios, including dropped classes, withdrawn classes, incomplete grades, failed coursework, full withdrawal from a term, and later disbursements following an earlier enrollment change. These commenters stated that, although the concept of reducing annual loan eligibility for less than full-time enrollment is straightforward at a high level, its application across varying enrollment patterns and academic structures is more complex in practice.
Some commenters requested written clarification regarding how the less than full-time annual limit reduction interacts with existing loan limitations and disbursement rules, including proration for less than an academic year, cost of attendance (COA) constraints, and late disbursement requirements. Some commenters characterized the combined application of these provisions as “double proration” and requested a written explanation of the order in which institutions should apply these overlapping requirements.
Some commenters also requested clarification on how the schedule of reductions applies in nonstandard-term programs, programs with required summer enrollment, programs that use borrower-based academic years (BBAYs), and programs in which course sequencing, clinical components, or fluctuating enrollment patterns may affect how credit load is measured across the academic year.
For non-standard terms, the Department believes existing title IV disbursement rules are already tightly linked to academic progress; therefore the schedule of reduction is not required. Students in these programs generally may not receive subsequent disbursements until they complete the required number of clock or credit hours, and institutions calculate payment periods and disbursements based on hours completed rather than fixed terms of time. The Department further concludes that additional clarity is warranted because the schedule of reductions is built on the institution defining what full-time enrollment is for the academic year or its equivalent and what is considered full-time enrollment by the student for that enrollment period. The Department does not agree that these academic structures require a separate legal framework under § 685.203(m)(1). The general applicability of § 685.203(m)(1) while provides a formula that is applicable to borrower-based academic years, required summer terms, modular enrollment patterns, and fluctuations in similar enrollment changing-status scenarios.
The Department believes that the existing framework and schedule of reductions provision is already applicable and adaptable to modular, accelerated, and clinical programs because the institution defines what is considered full-time for the academic year and what constitutes full-time enrollment for students.
The Department recognizes commenters' concern that determining annual Direct Loan eligibility based on enrollment across the academic year or its equivalent differs from the more term-based administration with which institutions are familiar and may require operational and systems changes for the institution. For that reason, the Department is clarifying how institutions may determine a student's reduced annual eligibility using the best information available about expected enrollment and may administer that amount through equal or proportional disbursements across payment periods and determining eligibility for the loan at the time of disbursement. As this is an annual loan limit, in so much that an institution may adjust a subsequent disbursement to resolve the less than half-time status or to increase a loan based on adjustments to enrollment. The Department believes these clarifications provide a workable means of implementing the statutory requirement.
Accordingly, an institution is not required to use a single packaging assumption in all cases. If the institution reasonably expects at the outset that the student will enroll less than full-time for the academic year or its equivalent, it may initially package the borrower at the reduced annual
The Department is also clarifying that institutions have flexibility in how they administer the reduced annual amount once determined. Because the regulations do not require substantially equal disbursements, an institution may divide the adjusted annual eligibility evenly across payment periods, or it may allocate that amount proportionally based on each payment period's enrollment relative to the total enrollment on which the annual eligibility determination is based. This flexibility allows institutions to implement the statutory requirement across a range of academic calendars, program structures, and enrollment patterns without establishing a separate uniform Federal enrollment-status framework for this provision.
The Department does not agree that the waiver should be removed. The proposed amendment does not newly impose a substantially equal disbursement requirement; rather, it creates a limited exception to an existing rule so that institutions can disburse in accordance with the schedule of reductions when a borrower is subject to the award-year loan limit for less than full-time enrollment. The Department believes this is the more administrable approach because it reduces, rather than increases, conflict within the disbursement framework. The Department also emphasizes that the waiver is narrow. It is not a blanket authorization for unequal Direct Loan disbursements. Instead, it applies only in the specific circumstances in which a borrower is subject to the less than full-time annual-limit framework and the institution would disburse in accordance with the schedule of reductions. The Department therefore concludes that retaining the waiver is necessary to align § 685.303 with the revised loan-limitation structure and to avoid operational inconsistency in administering the rule.
Some commenters clarified that, although they have historically supported institutional authority to limit borrowing, they did not support an approach under which mandatory less than full-time reductions would also be applied to institutionally determined limits without any ability to account for individual circumstances through professional judgment.
The Department recognizes commenters' clarification regarding prior support for institutional loan-limit authority. However, where an institution establishes a lower loan limit under the regulation, the required reduction for less than full-time enrollment applies to the limit that governs the student's borrowing under that provision. The Department does not interpret the statute to permit case-by-case restoration of the full statutory annual amount through professional judgment where the law requires a reduction based on less than full-time enrollment.
The Department also explained in the NPRM (91 FR 4276) that it expects an institution's decision to reduce borrowing for a specific program of study to occur before the start of the
The Department further believes that the possibility of differing program-level caps across institutions is not, in itself, a reason to eliminate the provision. Institutions already vary in program price, structure, and borrowing patterns. As we stated in the NPRM (91 FR 4268), this authority gives institutions a tool to set more appropriate loan caps tied to program cost and borrowing risk, thereby helping to prevent overborrowing. In the Department's view, that objective is consistent with the broader statutory changes enacted in the Working Families Tax Cuts Act, which were intended to constrain excessive borrowing and reduce the risk that students will incur debt they may struggle to repay.
The Department also notes that the NPRM (91 FR 4276) distinguishes this new program-level authority from the institution's existing case-by-case authority in § 685.301(a)(8). The Department believes that retaining both authorities is appropriate: existing § 685.301(a)(8) continues to govern individualized reductions or refusals to originate loans, while proposed § 685.203(m)(2) governs prospective program-level caps that apply uniformly to all students in the affected eligible program. The Department is therefore not adopting additional regulatory text on this point.
It is important to note that borrowers with loans made before July 1, 2027, will retain the economic hardship and unemployment deferment benefit for loans made before July 1, 2027.
We do not believe that the terms and conditions of the Tiered Standard plan would be unknown by the borrower. Throughout a loan's lifecycle, we seek to continuously inform borrowers about their repayment plans, including periodic updates to
We note that we made technical corrections in § 685.209 and replaced “Federal Offset” with “Treasury Offset Program”.
We also believe that institutions will have adequate time and information to communicate with their student borrowers appropriately. Institutions will be made aware of the various repayment plans, including the Repayment Assistance Plan, and borrowers' eligibility for the repayment plans based on the borrower's circumstances. Institutions will have this information by the time to comply with the counseling requirements (entrance and exit counseling).
Conversely, some commenters expressed appreciation for our treatment of married borrowers and the proration of monthly payments for married borrowers.
We appreciate the commenters who supported our approach to prorate monthly payments for married borrowers.
In the course of our review, we note that our final regulations did not reflect this statutory requirement for payments under the Repayment Assistance Plan. While we explain in the NPRM (91 FR 4281) that we initially proposed to add § 685.209(g)(3) for spousal proration that we would adjust a monthly payment under Repayment Assistance Plan to a minimum payment of $10, the statute requires us to establish a minimum payment of $10 for all monthly payment calculations for the Repayment Assistance Plan, not just in the case of spousal proration. Accordingly, our regulations at § 685.209(g)(3) now reflect the minimum payment for spousal proration as well as any payment calculated for the Repayment Assistance Plan. Because of our amendments to § 685.209(g)(3), we also make conforming changes to cross-references to paragraph (g)(3) including those in § 685.209(o).
Sunsetting these ICR plans does not violate the terms of the loans, nor is it arbitrary and capricious. For more information regarding changes to the terms of an MPN, see “Legal Authority.”
A few comments argue that they should keep the terms of their original loan if they must transition to a new repayment plan and should not have additional years of repayment added to their timeline toward forgiveness.
However, borrowers who have existing Parent PLUS loans in
Finally, we note that we have provided periodic updates to
We note that in light of the
Conversely, consistent with Section 455(q)(1)(F)(iv) and (v) of the HEA, in § 685.209(k)(8)(i)(C)(
Additionally, the Department notes a technical correction in § 685.209(o)(3)(i). Section 685.209(o)(3) defines on-time payments and § 685.209(o)(3)(i) discusses the circumstances where a borrower may opt out of advancing a due date. However, we never explained why these terms are necessary or what they pertain to. To clarify that the terms pertain to the interest and principal subsidy for purposes of the Repayment Assistance Plan, the Department adds clarifying language to § 685.209(o)(3)(i), which states that unless a borrower opts out of advancing a due date, they will not receive the matching principal or interest subsidy in § 685.209(o).
With respect to “old IBR” that the commenters mention, Congress authorized the IBR plan in 2007. Under the original IBR plan, borrowers' monthly payments were generally equal to one-twelfth of 15 percent of their discretionary income with a maximum repayment period of 25 years. In 2010, Congress amended the HEA to authorize another IBR plan available only to new borrowers. These borrowers' monthly payments were generally equal to one-twelfth of 10 percent of their discretionary income, with a maximum repayment period of 20 years. Section 493C(e) of the HEA restricts eligibility for the IBR plan to new borrowers on or after July 1, 2014, and before July 1, 2026, with 10 percent of the borrower's discretionary income and a repayment period of 20 years. Therefore, despite the commenters' dissatisfaction, the terms of “new IBR” are a statutory restriction.
With respect to the commenter who asked how a borrower could repay a loan under IBR with both pre- and post-2026 loans, we intended to convey several scenarios in the NPRM (91 FR 4286), but we believe we could have stated that clearer. In the NPRM, we stated that Committee members provided scenarios that involved borrowers with loans made before, and after, July 1, 2026, and requested confirmation that those borrowers could continue to change plans (91 FR 4286). We intended that sentence to represent multiple, distinct scenarios with different implications. One scenario could explain the repayment plans available for a borrower with pre-2026 loans and another scenario could explain the limited plans available to a borrower with post-2026 loans and the limited plans available to such borrowers. The first scenario includes the instance where a pre-2026 borrower and who does not obtain any other Direct Loan after July 1, 2026. Such borrower would be permitted to move between IBR and the Repayment Assistance Plan, where permitted. However, the commenter is generally correct that upon receipt of a Direct Loan on or after July 1, 2026, that borrower is no longer eligible for the IBR plan.
Under Executive Orders (E.O.) 12866, the Office of Management and Budget (OMB) must determine whether a regulatory action is “significant” and, therefore, subject to the requirements of the E.O. and subject to review by OMB. Section 3(f) of E.O. 12866 defines a “significant regulatory action” as an action likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the E.O.
The Department estimates the downward net budgetary impacts to be −$409.3 billion from changes in transfers between the Federal Government and student loan borrowers resulting from changes in annual and lifetime loan limits; the introduction of Repayment Assistance Plan and Tiered Standard repayment plans, and additional repayment plan changes; proration for less than full-time enrollment; the elimination of economic hardship and unemployment deferments; and limitations on the length of discretionary forbearance compared to the President's Budget for FY 2026 baseline. The definition of
Quantified economic impacts include annualized transfers of −$42.3 billion at 3 percent discounting and −$44.3 billion at 7 percent discounting, paperwork burden ($25.0/$37.2 million), administrative updates to Government systems ($10.4/$12.1 million), staffing ($5.5/$6.0 million), and ongoing costs to operate and maintain systems to administer the provisions ($7.43/$7.76 million) at 3 percent and 7 percent discounting, respectively. Therefore, based on our estimates, the Office of Information and Regulatory Affairs (OIRA) has determined that this proposed rule is “economically significant” under section 3(f)(1) of E.O. 12866 and subject to OMB review 3(f)(1).
We have also reviewed these regulations under E.O. 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in E.O. 12866. To the extent permitted by law, E.O. 13563 requires that an agency:
(1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and considering, among other things, and to the extent practicable, the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives, such as user fees or marketable permits, to encourage the desired behavior, or provide information that enables the public to make choices.
The E.O. 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” OIRA has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
This final rule is considered an E.O. 14192 deregulatory action. We estimate that this rule generates $11.1 million in annualized cost savings at a 7% discount rate, discounted relative to year 2024, over a perpetual time horizon. E.O. 14192 directs agencies of the executive branch to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and to alleviate unnecessary regulatory burdens placed on the American people.
These final regulations are needed to implement certain provisions of the Working Families Tax Cuts Act that affect students, borrowers, and the title IV, HEA program participants. The Working Families Tax Cuts Act amended numerous provisions of the HEA affecting the terms and eligibility criteria for students and institutions of higher education that participate in the Federal student loan program. The Department has limited discretion in implementing many provisions in the Working Families Tax Cuts Act. Many of the changes included in these final regulations simply modify the Department's regulations to reflect statutory changes made by the Working Families Tax Cuts Act.
In some cases, the Secretary has exercised her limited discretion to implement certain provisions of the Working Families Tax Cuts Act. Areas of limited discretion include the treatment of married borrowers repaying under the Repayment Assistance Plan and the definition of
While the Department finds that some subgroups of small entities would experience greater than a 3 percent loss in revenue on average due to the proposed rule, extremely small entities (which tend to be institutions that offer a single program or credential, such as a college of naturopathic medicine) will experience a smaller loss in revenue (1.2%) than institutions broadly (1.9%). The next smallest category of institutions of higher education (very small entities) is estimated to lose 2.6% of revenue, which is below the 3-percent threshold for economic significance under the rule. Separately, the Department does not believe it has discretion to differentiate its definition of
With respect to the use of data regarding programs that meet licensure requirements or prepare students for licensure exams in a given occupation, the Department has started collecting data under the Financial Value and Transparency and Gainful Employment regulations
The final regulations change many provisions related to the terms and benefits available to borrowers in the Federal student loan program, resulting in both costs and benefits for students, borrowers, institutions, private companies, and taxpayers. Note that costs to one party which are completely offset by benefits to another party are classified as transfers, as required by OMB Circular A-4.
The provisions in the final regulations that produce significant costs or benefits include new annual and aggregate loan limits for graduate and professional students, as well as parents who borrow under the Parent PLUS Program. Under the policy preceding the final regulations, loans to these borrowers were available up to the full cost of attendance with no aggregate limit. The final regulations also reduce the amount of loans students may receive when they enroll less than full-time. Prior policy made no distinction between full-time and less than full-time attendance with respect to loan eligibility; students attending on at least a half-time basis could receive the same loan disbursement as if they were attending full-time.
The final regulations also replace all prior IDR plans in the Federal student loan program for new borrowers and loans with a new plan, the Repayment Assistance Plan. Features of the Repayment Assistance Plan will result in costs for some borrowers but benefits for others. The final regulations reduce forbearance and deferment benefits for borrowers in the Federal student loan program but allow borrowers to receive additional loan rehabilitation benefits.
The reduction in loan volume is due to several policy changes imposed by the Working Families Tax Cuts Act. First, prior to the Working Families Tax Cuts Act, graduate students and parents of dependent undergraduates were able to borrow up to an institution's full cost of attendance annually and with no aggregate limit. Beginning July 1, 2026, the Working Families Tax Cuts Act imposes annual and aggregate limits on these loans. Annual limits for graduate students, professional students, and parents are $20,500, $50,000, and $20,000, respectively. The aggregate limits are $100,000, $200,000, and $65,000 (per dependent student of the parent), respectively. The new loan limits do not apply to borrowers who are currently enrolled in higher education programs who had received Federal loans made prior to July 1, 2026. In other words, the new limits apply only to new borrowers on or after July 1, 2026.
Second, a reduction in loan volume will occur due to the proration of loans for students enrolled less than full-time. Beginning July 1, 2026, the Working Families Tax Cuts Act imposes new loan limits for students enrolled less than full-time. Specifically, a student will only be able to borrow up to a prorated annual limit based on the individual borrower's enrollment status. Prior to the Working Families Tax Cuts Act, undergraduate and graduate students could borrow up to the full annual loan limit, as long as they were enrolled at least half-time.
Table 3.2 describes the number of borrowers and loan volume that could be affected by the proration provision using Department data from FY 2025. Of the $92.7 billion in non-consolidated Federal student loans disbursed in FY 2025, $84 billion was disbursed to full-time students. The remaining disbursements ($8.7 billion) were to students enrolled less than full-time and would therefore be subject to the prorated annual loan limit beginning July 1, 2026.
These loan limits will create several new costs for borrowers relative to pre-Working Families Tax Cuts Act policy. First, borrowers may have to reduce their enrollment due to the inability to afford the cost of their program. This could delay the time it takes students to finish their program. Second, students may need to seek other forms of financing to maintain their enrollment, such as by pursuing employment while enrolled or taking out private loans. Private loans may have less favorable terms than Federal student loans, meaning some students and parents who utilize these financing options could face higher interest rates and fees. Third, some students and parents may not be able to secure non-Federal loans to replace the borrowing capacity lost under the Working Families Tax Cuts Act, whether that be because non-Federal lenders deem the programs and institutions the students attend to be financially risky, or because the borrowers do not have adequate credit histories or cannot obtain a co-signer. Some of these borrowers may have to drop out of their program due to their inability to afford their program through alternative means. These effects will require some affected borrowers to reconsider their enrollment and financing decisions. These, in turn, may have further effects, such as on timing of on when individuals enter the labor force and their career choices. The changes to Federal student loan limits create indirect costs for institutions. Institutions of higher education will receive less loan revenue from the Federal government if those loans are used to cover education expenses paid directly to the institution, such as tuition and fees. While that revenue may be replaced by students securing other sources of financing or using more of their own funds to pay for postsecondary education, some of it may not be replaced. This will cause a loss of revenue for institutions. These institutions are likely to incur costs determining their best response to these changes, which may include reducing tuition prices or restructuring their programs. Table 3.3 shows that loan disbursements to institutions will differ across sectors and may be largest for institutions that enroll large shares of graduate students.
Beyond the costs associated with changes to Federal student loan limits, another source of costs to borrowers are through changes to student loan repayment plans. The Working Families Tax Cuts Act creates a new student loan repayment plan, the Repayment Assistance Plan, which replaces all prior IDR plans beginning on July 1, 2026. The Repayment Assistance Plan will create new costs for borrowers relative to a pre-Working Families Tax Cuts Act baseline. Borrowers' payments in the Repayment Assistance Plan are calculated on a sliding scale relative to their incomes, ranging from 1 percent for borrowers with $10,000 of annual income, to 10 percent for borrowers earning $100,000 or more. Although those terms will result in similar monthly payments for many borrowers compared with some prior IDR plans, monthly payments will be higher for all borrowers compared to repayment terms
Some low-income borrowers will also face higher costs under the Repayment Assistance Plan compared to any prior IDR plan due to higher monthly payments. Unlike prior IDR plans, there is no exempted income under the Repayment Assistance Plan. This means monthly payments are calculated using the borrower's entire income. The Repayment Assistance Plan also includes a minimum payment amount, which requires borrowers earning less than $10,000 annually to pay $10 per month. Prior IDR plans allowed borrowers to make $0 payments if their incomes were below the level of exemption.
The Repayment Assistance Plan also reduces loan forgiveness benefits relative to prior IDR plans. Some of that loss in benefits is, however, offset by the Repayment Assistance Plan's interest subsidies and new principal payment matching discussed later in the RIA. The Repayment Assistance Plan provides loan forgiveness to borrowers who make a total of 360 on-time payments in the plan. Prior IDR plans generally provided loan forgiveness after 20 or 25 years of payments, although the SAVE plan would have provided loan forgiveness in as early as 10 years for undergraduate borrowers with lower balances.
A final repayment-related cost for borrowers results from changes to forbearance options. The Working Families Tax Cuts Act reduces the time that a borrower may use a forbearance to 9 months in any 24-month period. Prior policy allowed borrowers 12-month forbearances for up to three years. The Working Families Tax Cuts Act also eliminates the economic hardship deferment and unemployment deferment as options for borrowers with new loans made on or after July 1, 2027. As with changes to loan limits, changes to repayment may affect enrollment, financing, and labor market decisions for affected borrowers.
The final regulations will also impose administrative costs on the Department to implement the changes to the Federal student loan program (Table 4.5). We estimate that, based on comparable changes made in the past, those administrative costs would average approximately $23.86 million (using a 3 percent discount rate, Table 4.5) in systems modifications, contract change requests, and staffing costs on an annual basis over the 2026-2035 period. The majority of these estimated costs, 62 percent, will be incurred during the first three years of implementation. The Department will incur administrative costs as it works with the private companies that administer the Federal student loan program (loan servicers) to update their systems, training, and communications to implement and operate the two new repayment plans in the Working Families Tax Cuts Act: the Repayment Assistance Plan and the Tiered Standard plan by July 1, 2026. The Department is also updating its systems for loan origination and repayment tracking to align them with the changes to loan limits and repayment plans. One of these systems, the Common Origination and Disbursement (COD) system, is designed to support origination, disbursement, and reporting for Direct Loan, Federal Pell Grant, and the Teacher Education Assistance for College and Higher Education (TEACH) Grant programs. The system uses a single “Common Record” (XML format) for efficiency and eliminating duplicate student and borrower data, providing a centralized system for title IV program administration used by the Department and all institutions across the country that participate in the delivery of Federal student aid. The other system that will be updated, the National Student Loan Data System (NSLDS), is the central database for all Federal student aid, tracking title IV loans and grants (like Pell Grants) through their entire lifecycle, from approval to repayment or closure. The system provides an integrated view for students, schools, and servicers to manage aid, loan status, balances, and enrollment. It consolidates data from schools, lenders, and programs, enabling users to access loan history, disbursement details, and servicer information via the FSA Partner Connect portal.
The COD system and NSLDS must be modified to reflect the terms of the new repayment plans (which include new features, such as matching principal payments), new annual and lifetime loan limits for graduate and professional students and Parent PLUS Loans, and elimination of Graduate PLUS Loans. For the COD system, these changes include updates to current fields and the collection of additional fields, such as modifications to grade level definitions. In addition, new system edits will be added to account for loan limit exceptions and other changes. For NSLDS, these changes reflect new reporting requirements for servicers and system changes to account for new aggregate loan limits and exceptions that must now be tracked to determine borrower eligibility. In addition, NSLDS will be updated to account for new pre-and-post screening processes related to aggregate loan limits and new academic levels that account for the different loan limits for graduate and professional students.
While most of the administrative costs the Department will incur implementing the Working Families Tax Cuts Act occur in the first few years, the Department will incur long-term administrative costs maintaining the Department's COD, NSLDS, and other system changes in future years to account for ongoing development, operations, and maintenance. The Department does not estimate that it will incur a large increase in long-term administrative costs with respect to payments to loan servicers. The Department pays loan servicers based on monthly borrower counts and the Department does not expect the number of student loan borrowers to change significantly in the future due to changes in the Working Families Tax Cuts Act. The Department will, however, incur additional costs to monitor data reported by loan servicers. The Department expects to incur additional administrative costs to train and support institutions of higher education that now must align their procedures and systems with the new loan disbursement policies in the Working Families Tax Cuts Act.
The final regulations provide benefits to students, borrowers, and taxpayers. These benefits include potentially lower tuition costs for students, simplified repayment terms for student loan borrowers, and lower costs for taxpayers. Benefits to students and borrowers are discussed first, followed by the benefits to taxpayers. The first benefit to students and borrowers stems from the new limits on Federal student loans for graduate and professional programs. Research finds that these loan limits could provide an incentive to institutions to limit tuition increases, benefiting current and future students.
Similarly, the Working Families Tax Cuts Act's limits on graduate loans will help reduce the number of degree programs that result in low earnings relative to the prices institutions charge. Prior research has found that approximately 43 percent of master's degrees and 23 percent of doctoral and professional degrees do not increase students' earnings enough to justify the costs of those programs.
Borrowers will also benefit through changes to repayment provisions. The first repayment-related benefit for borrowers is the new provision that allows borrowers who default on Federal student loans to rehabilitate a second time. Prior to the Working Families Tax Cuts Act, borrowers were allowed to rehabilitate a defaulted loan only once. Under rehabilitation, a borrower makes a series of nine on-time payments that fulfill the rehabilitation agreement and return their loans to good standing, and the Department then requests that the credit reporting bureau remove the default from the borrower's record. A second rehabilitation will benefit borrowers by providing borrowers who re-default a pathway to return their loans to good standing and, in turn, increase their ability to purchase a home, automobile, or other items financed through consumer credit markets as result of the removal of the default from their record. This provision will also allow defaulted borrowers to avoid administrative wage garnishments, the Treasury Offset Program, and collection fees associated with defaulted loans.
The second repayment-related benefit for borrowers is through the new loan repayment terms provided under the Repayment Assistance Plan. These benefits stem from several provisions. First, relative to most existing IDR plans (such as IBR but not SAVE), some borrowers using the Repayment Assistance Plan will see a reduction in their calculated monthly payment. Table 3.4 shows that relative to IBR (for new borrowers as of 2014), monthly payments are lower under the Repayment Assistance Plan for borrowers with adjusted gross incomes between $30,000 and $70,000. For borrowers with an adjusted gross income lower than $30,000, monthly payments only differ marginally, by approximately $10 to $22 per month.
Second, some borrowers will receive new benefits under the Repayment Assistance Plan that have historically not been available on prior IDR plans. The Repayment Assistance Plan waives unpaid interest for borrowers with on-time payments that do not fully cover accruing interest. That benefit applies to all loan types at any point in repayment. Prior IDR plans generally did not waive all unpaid interest on all types of loans at any point in repayment (with the exception of the SAVE plan).
Third, the Repayment Assistance Plan includes a new principal subsidy for borrowers who are not reducing their principal balance. Under this plan, the Department matches borrowers' payments dollar-for-dollar, up to $50 in loan principal reduction each month. No prior IDR plan included a principal subsidy such as the one included in the Repayment Assistance Plan.
Together, these provisions prevent borrowers' loan balances from increasing while they repay under the Repayment Assistance Plan, and some of these policies would disproportionately benefit low-income borrowers. Unlike prior IDR plans, the loan balances of borrowers using the Repayment Assistance Plan will decline each month if they make an on-time payment, because their unpaid interest is first fully waived, and the Department then reduces their principal balance equal to the payments the borrower makes, up to $50.
To better understand these benefits, the Department simulated how future cohorts of borrowers would benefit under the Repayment Assistance Plan relative to existing repayment plans. The Department used data from the College Scorecard and Integrated Postsecondary Education Data System (IPEDS) to create a synthetic cohort of borrowers. Using Census Bureau data, the Department projected earnings and employment, marriage, spousal debt, spousal earnings, and family size for each borrower up to age 60. Using these projections, payments under different loan repayment plans can be calculated
Using these simulations, Table 3.5 illustrates borrower repayment outcomes across different repayment plans. Under the Repayment Assistance Plan, borrowers spend fewer years both in repayment and where they are not reducing their loan balance, on average, relative to other types of income-driven repayment plans. Further, for borrowers with initial loan balances of less than $50,000, borrowers will fully repay their loans faster under the Repayment Assistance Plan while paying a similar amount (in present value terms) than they would under IBR, as shown by the repayment ratio in Table 3.5.
The changes in the Working Families Tax Cuts Act also produce significant savings to taxpayers. These savings are summarized in Table 3.6 (note that interactive budget effects are not included in these estimates). The largest benefits to taxpayers—which are the focus of the following discussion—come from changes to student loan repayment plans. These changes are estimated to save taxpayers $121.8 billion in modifications to cohorts from 1994-2025, and another $246.5 billion in outlays between 2026-2035.
These changes to repayment plans benefit taxpayers for several reasons. First, the Working Families Tax Cuts Act eliminates the SAVE plan, producing significant savings.
Second, under the Repayment Assistance Plan, larger proportions of loans will be repaid, saving taxpayers money. This is seen in the average repayment ratio (defined as the share of a borrower's initial balance that is ultimately repaid in present value terms) shown in Table 3.5. Under the Repayment Assistance Plan, the repayment ratio is consistently higher than other IDR plans. This is because the Repayment Assistance Plan requires borrowers to repay their loans for longer (30 years instead of 10 to 25 years under prior plans) before qualifying for loan forgiveness, because monthly payments are calculated using a borrower's full income, and because there is a minimum monthly payment requirement.
Third, the Repayment Assistance Plan also requires borrowers with higher incomes to make higher monthly payments than prior IDR plans, and the income brackets used to determine the monthly payment amount under the Repayment Assistance Plan are not indexed to inflation. Together, these changes will increase the amount borrowers are expected to repay in future years, reducing costs to taxpayers. Lastly, these features will discourage over-borrowing, as the terms of the Repayment Assistance Plan reduce the moral hazard associated with IDR relative to previous plans with shorter repayment periods and lower total payments.
To better understand these benefits, the Department modeled the share of loan volume repaid through different repayment plans using the cohort of loans entering repayment in 2030. These estimates are shown in Table 3.7. Prior to the Working Families Tax Cuts Act, the Department estimated that, for loans entering repayment in 2030, 59 percent of Unsubsidized graduate loans and 67 percent of Graduate PLUS Loans were expected to be repaid through an IDR plan. After the Working Families Tax Cuts Act, the Department now estimates that, for the same cohort, 47 percent of Unsubsidized graduate loans and 55 percent of Graduate PLUS Loans will be repaid through an IDR plan. The Department estimates that graduate borrowers will enroll in the standard repayment plan at higher rates (relative to pre-Working Families Tax Cuts Act policy), reducing the amount of loan volume that could be forgiven.
As anticipated in the NPRM published January 30, 2026, the Department has released an updated budget since that publication. The Working Families Tax Cuts Act changes implemented in these final regulations are considered current law and included in the President's Budget for FY 2027 (PB2027) baseline, and as no significant additional changes have been made to these final regulations, there is no significant net budget impact compared to the PB2027 baseline. Table 4.1A provides an updated estimate of the net Federal budget impact of expanding the professional student definition from the 6-digit CIP level to the 4-digit CIP level and the inclusion of Clinical Psychology, an area in which the Department exercised its discretion during negotiated rulemaking. This is estimated compared to a modified PB2027 baseline that defines
For informational purposes, we have included Table 4.1B that restates the net Federal budget impact of the modification executed in September 2025 to reflect the provisions of the Working Families Tax Cuts Act as understood at that time and scored against the President's Budget for FY2026. This includes both the effects of a modification to existing loan cohorts and costs for loan cohorts from 2026 to 2035. A cohort reflects all loans originated in a given fiscal year. Consistent with the requirements of the Credit Reform Act of 1990, budget cost estimates for the Federal student loan programs reflect the estimated net present value of all future non-administrative Federal costs associated with a cohort of loans.
The final regulations implement several provisions of the Working Families Tax Cuts Act including the introduction of the Repayment Assistance Program, the Tiered Standard repayment plan, and associated eligibility provisions for borrowers with all loans disbursed before July 1, 2026, and those with loans disbursed on or after July 1, 2026; elimination of the availability of economic hardship and unemployment deferments for loans disbursed on or after July 1, 2027; discretionary forbearances limited to a period that does not exceed nine months within a 24-month period; annual and aggregate loan limits; the ability to undergo a second loan rehabilitation; definition of qualifying payments for the purposes of the PSLF program to include ICR plans only up to July 1, 2028 and the Repayment Assistance Plan, and certain deferments not counting towards PSLF fulfillment under the Repayment Assistance Plan; elimination of Graduate PLUS Loans with some grandfathering for existing borrowers; and other provisions as detailed and described in this NPRM.
Overall, these provisions have a net budget impact of -$312 billion for loan cohorts 2026 to 2035, and of an additional -$122 billion in modifications for loan cohorts from 1994 to 2025 (Table 4.1B). Several provisions reduce transfers from the Federal government to borrowers, such as the modifications to repayment plans, the new loan limits for graduate and professional students, and the proration for less than full-time students. Other provisions increase transfers from the Federal government to borrowers, such as the new loan limits for parent borrowers on behalf of dependent undergraduate students and the modifications to forbearance options.
As noted in the
The Department estimated the net budget impact of the final regulations through changes to several assumptions involved in its student loan modeling, including predicted volumes, the percentage of volumes assigned to different repayment plans, deferments and forbearance, the IDR sub model which includes changes to PSLF, and updated calculations within the Student Loan Model (SLM) for the Tiered Standard repayment plan. The possibility of a second rehabilitation was evaluated by adding second rehabilitation activities into the collection assumption. The assumed population for the second rehabilitation included borrowers who have previously rehabilitated their loans and subsequently consolidated them. We used the payment data from the first rehabilitation to model potential second rehabilitation activity, which resulted in a 0.035 percent increase in all payments. This did not affect the subsidy rates for loans at the 2-digit decimal place for scoring a budget impact and is therefore not specified in Table 4.1B. Specific changes related to key provisions are described in this section.
The Department did not have specific data to estimate whether loan volume in
For borrowers in the IDR sub model with loan originations on or after July 1, 2026, payments are calculated based on the terms of the Repayment Assistance Plan. Key provisions that affect the change in payments include the 1 percent of income per $10,000 in AGI payment calculation, non-accrual of interest when monthly payments are made, thirty years of payments timeline to forgiveness, principal reduction up to $50 monthly, $50 reductions in payments per dependent, and changes in the treatment of deferments and forbearances. Loan limit provisions also affect these borrowers and reduce the balances for some borrowers, which potentially reduced their flow of payments compared to the baseline for Table 4.1B. The combination of the changes results in a much higher percentage of borrowers paying off their balances than receiving forgiveness compared to the baseline. In the President's Budget for FY 2026, we estimated that approximately 44.5 percent of borrowers entering repayment in FY 2030 and enrolling in an IDR plan, who are much more likely to have the Repayment Assistance Plan as their only income-driven repayment option, would pay their loans in full.
As noted previously, one change made during the RISE negotiated rulemaking that affected the definition of
A commenter requested additional information about the assumptions the Department used in estimating the effect of the definition of
Using data in Federal Student Aid's (FSA) Enterprise Data Warehouse, the Department evaluated borrowers who had entered repayment in 2021 to 2024 in the designated CIP codes by credential level and total loan amount upon entering repayment to generate a percentage in those categories considered professional. The IDR sub model does not have program level information, so the percentage across all the CIP codes is applied by the debt ranges (up to $100k, $101-$150k, $151-$175k, $176-$200k, more than $200k) to randomly assign graduate borrowers in the IDR sub model to professional or graduate status for the application of loan limits. The percentages applied by debt range shown in Table 4.2 were for the IDR sub-model only. The IDR sub-model is not loan-level, it is based on synthetic borrowers and amounts aggregated to the loan type level for cohorts entering repayment. Therefore, the cash flow effects related to the 6-digit CIP professional student definition and loan limits within IDR included in the repayment plans change score ($368.3 billion in Table 4.1B) capture the impact of the overall loan limits. The annual loan limits have no effect in the IDR sub-model results but do affect the loan volumes assigned to IDR plans in the aggregated Student Loan Model (SLM) assumptions.
A similar analysis of borrowers was performed for overall graduate level borrowers entering repayment in 2021-2024. The $537 million estimate for the budget impact of the professional/graduate definition in Table 4.1A reflects the change from the 6-digit CIP to 4-digit CIP with Clinical Psychology. The approximately −$51.8 billion non-IDR budget effect of loan limits in the § 685.203 row of Table 4.1B represents the cost of applying the full loan limit policy, both annual and overall, to loan volume of non-IDR borrowers. The marginal cost of changing the definition
Along with the new provisions related to the Repayment Assistance Plan, the Working Families Tax Cuts Act affected existing income-driven repayment plan availability. Borrowers who did not meet the statutory requirements for 10-percent IBR by being a new borrower as of July 1, 2014, will have the option of 15-percent IBR and 25 years to repayment. These changes also increase payments and the percentage of borrowers who fully pay off their loans in the model compared to the baseline.
The IDR sub model has the features of the existing plans built in, so the major updates for these estimates were to include the Repayment Assistance Plan as an option and to assign borrowers to the plans available to them. Incorporating the features of the Repayment Assistance Plan was straightforward and involved bringing the Repayment Assistance Plan features coded in the part of the model handling those required to be in the Repayment Assistance Plan into the program for those with a choice.
For the choice of IBR or the Repayment Assistance Plan, we adapted the process we have used in recent cycles to make the choice of plan. While under the baseline, the choice of plan is determined by the net present value of payments over the life of the loan under the different plans, for the choice of the Repayment Assistance Plan versus IBR we compared payments for FY 2027 and beyond for the first three years of the Repayment Assistance Plan availability and the total payments made during the life of the loans. If both conditions were lower for the Repayment Assistance Plan, the borrower would choose to switch into that plan. We also assumed that borrowers eligible for 10 percent IBR would stay in that plan. With this approach, approximately 3 percent of borrowers with a choice selected the Repayment Assistance Plan. For the estimate of the Working Families Tax Cuts Act statute that is reflected in Table 4.1B, this choice was made up-front and did not change. We believe the PB2026 approach that limits switching is appropriate with the clarification that RAP payments will not count towards forgiveness under IBR. The plan choice process and the changes to the availability of existing plans were significant contributors to the modification score in the Repayment Assistance Plan row of Table 4.1B.
Tiered Standard repayment plan: Estimates for the Tiered Standard repayment plan was scored through applying changes to the SLM calculations. The percent volume assumption was changed to include a new plan and to distribute loan volume entering repayment from FY 2027 on to the Tiered Standard repayment plan and the IBR plans, which would be assigned to the Repayment Assistance Plan in the IDR sub model. The lower and upper bounds for the maturity term table were adjusted. As the tiers are based on the amount of debt, we created a new distribution of volume to the breakouts shown in Table 4.3.
This changed the maturity term in the SLM and generated a different cashflow than that associated with the percentage of volume that was assigned to the standard, extended, or graduated repayment plans under the baseline, resulting in the downward cost estimate in Table 4.1.
To estimate the effect of the changes implemented by the final regulations, the Department removed the unemployment deferment factor from the regression models predicting outyear deferments. The effect of the removal of economic hardship deferments was calculated by calibrating the results from the adjusted regressions without unemployment deferments. This was done by multiplying those outyear deferment rates by 91.13 percent to reflect the removal of the estimated 8.87 percent of deferments categorized as an economic hardship.
The limitation on discretionary forbearances to no more than 9 months during any 24-month period was estimated by calibrating the forbearance rate. Discretionary forbearances represent about 19 percent of forbearances in the Department's data. The calibration factor was calculated as shown in the following expression:
The effects of these changes that reduce the deferment and forbearance outyear rates without any other Working Families Tax Cuts Act changes are −2.1 billion and 1.2 billion, respectively.
As noted in the
Consistent with OMB Circular A-4, we have prepared an accounting statement showing the classification of the expenditures associated with the provisions of these final regulations. Table 4.5 provides our best estimate of the changes in annualized effects that may result from these final regulations. Expenditures are classified as transfers from the Federal government to affected student loan borrowers.
As part of the development of these final regulations, the Department engaged in the negotiated rulemaking process in which we received comments and proposals from non-Federal negotiators representing numerous impacted constituencies. These included higher education institutions, State officials, legal assistance organizations, student loan servicers, student loan borrowers, and organizations representing taxpayer and public interests. Non-Federal negotiators submitted a variety of proposals relating to the issues under discussion. Information about these proposals is available on our negotiated rulemaking website at:
Most of these final regulations implement statutory provisions of the Working Families Tax Cuts Act where the Department does not have discretion. There are two areas under the Working Families Tax Cuts Act where the Department exercised discretion and the alternatives the Department considered have significant impact:
(1) Whether payments in the Repayment Assistance Plan for married borrowers who each have student debt are calculated on each spouse's respective income or calculated on their combined income; and
(2) Defining a professional student, which allows certain degree programs to access higher annual and aggregate loan limits than a graduate program.
While there are other provisions of the Working Families Tax Cuts Act where the Department also exercised more limited discretion in implementing the law, the alternatives considered in those cases do not result in significant impact. Therefore, our discussion of alternatives considered by the Department is limited to the two areas listed above.
Like prior IDR plans, the Repayment Assistance Plan requires the Department to calculate monthly payments for borrowers using their “adjusted gross income” for the most recent tax year as defined in Section 62 of the Internal Revenue Code of 1986, except that, in the case of a married borrower who files a separate Federal income tax return,
The Department considered two options for how payments under the Repayment Assistance Plan should be calculated for married individuals who each have Federal student loans. In one, the monthly payments would be calculated for each borrower based on the married filers' joint income. Under this approach, borrowers effectively owe double payments on their loans; each borrower has a payment calculated on the couple's combined income. The Repayment Assistance Plan's progressive payment calculation, that charges higher rates as income increases, creates an additional penalty because married borrowers would pay a higher share of their incomes when their incomes are combined. For example, consider a married couple where each individual has an adjusted gross income of $27,500 (or $55,000 combined) and each individual has $20,000 in student debt (or $40,000 combined). Under the terms of the Repayment Assistance Plan, each individual would have a $229 monthly payment (a combined monthly payment of $458). While these borrowers could file separate Federal income tax returns to address this issue, and each pay $46 per month ($92 combined), they could then face higher taxes as a result.
In the other approach, a total combined loan payment for the couple would be calculated based on the filers' joint income and then that payment would be divided between each filer based on the share of the total Federal student loan balance each held. Put another way, a single payment is calculated off the combined income, and then it is prorated among the two borrowers based on the share of the combined Federal student loan balance. The couple in the example above with a $55,000 income would instead owe $229 per month on their combined Federal student loans, not $458. The Department adopted this proration approach in 2009 when implementing the Income-Based repayment plan and that policy has been in place since for all IDR plans.
The Department proposes to maintain the proration approach for married borrowers who use the Repayment Assistance Plan. The Department believes that the alternative creates two penalties for borrowers: it first “double counts” married borrowers' income and then assesses them a higher payment threshold due to their higher incomes. This excessive marriage penalty undermines the intent of the Repayment Assistance Plan, which is to provide borrowers with an income-based repayment option to help make certain loans affordable. Although the Repayment Assistance Plan allows these borrowers to file separate income tax returns to reduce their payments, the Department believes that option can be burdensome and costly for tax filers and should be reserved for borrowers in extenuating circumstances, not the normal course of action for borrowers using the Repayment Assistance Plan. Given the large penalty in the monthly payments married borrowers would face if they filed a joint tax return while using Repayment Assistance Plan, the Department is concerned that many borrowers would be forced to file separate tax returns for the Repayment Assistance Plan to work as Congress intended. The Department's data on past IDR plan use shows that only 8 percent of married borrowers repaying in IDR file separate tax returns, suggesting that separate filing is uncommon.
The Department's baseline budget estimates of the Working Families Tax Cuts Act and the Repayment Assistance Plan assumed that the Department's longstanding policy to allow prorated payments would continue in the Repayment Assistance Plan. Therefore, the proration policy in the final regulations would not increase budgetary costs relative to either the pre-statutory baseline or the current-law baseline.
The Working Families Tax Cuts Act terminated the Graduate PLUS Loan program that allowed graduate and professional students to borrow up to the full cost of attendance, with no aggregate limit. In place of that policy, the Working Families Tax Cuts Act establishes new annual and aggregate loan limits for Direct loans for students enrolled in graduate or professional degree programs. Graduate students may borrow $20,500 annually with an aggregate limit of $100,000. Professional students may borrow $50,000 annually with an aggregate limit of $200,000.
The Working Families Tax Cuts Act defines a
The Department considered several options that would expand the list of professional degree programs beyond those listed in Section 668.2, including one proposed by non-Federal negotiators. These options, including the Department's definition, are discussed in the following sections and summarized in Table 5.1. We compare the impact of these options to a baseline option, which the Department also considered, where professional degree programs are defined as only the 10 examples listed in Section 668.2.
Under the baseline option, only programs from 10 unique 6-digit CIP codes would qualify for the $50,0000 annual and $200,000 aggregate loan limit: Pharmacy (Pharm.D.), Dentistry (D.D.S. or D.M.D.), Veterinary Medicine (D.V.M.), Chiropractic (D.C. or DCM.), Law (L.L.B. or J.D.), Medicine (M.D.), Optometry (O.D.), Osteopathic Medicine (D.O.), Podiatry (D.P.M., D.P.), and Theology (M.Div., or M.H.L.).
Students enrolled in these programs represent 12.1 percent of Federal student loan borrowers in all graduate and professional programs, and 27.1 percent of all loan dollars disbursed to borrowers in these programs (Table 5.1).
The Department initially considered expanding the baseline list of 10 programs to include one additional program at the 6-digit CIP level: Clinical Psychology.
The Department ultimately opted to propose a broader definition to include all programs that are adjacent to the 10 programs listed in 668.2 at the 4-digit CIP code level and Clinical Psychology that also meet program length and licensure requirements for a professional degree. In total, programs within 38 unique 6-digit CIP codes meet this definition. The Department's definition encompasses 12.9 percent of the Federal student loan borrowers in graduate programs, 0.8 percentage points more than the baseline 10 programs listed in Section 668.2.
The characteristics of these programs that meet the Department's definition are listed in the top panel of Table 5.3. In total, graduate students in these programs received $11.2 billion in Federal student loan disbursements during the 2023-24 award year. Across these programs, fewer than 15 percent of annual loan disbursements were in excess of $50,000, suggesting that the loan limit will have a binding effect on relatively few borrowers.
The Department considered a proposal from RISE Committee non-Federal negotiators that would define a professional student more broadly than the Department's definition.
The bottom panel of Table 5.3 provides summary information about the programs included in the negotiators' proposal. The non-Federal negotiators' proposal includes programs in 219 unique 6-digit CIP codes (compared with 38 under the Department's definition) that cover 17.5 percent of graduate student borrowers. Unlike the Department's definition, the non-Federal negotiators' definition includes all professional programs in health care and health care-related fields and therefore encompasses several large fields with high levels of borrowing, such as physical therapy and nursing. Over 24,000 professional and doctoral students in physical therapy borrowed nearly $1 billion in Federal student loans in the 2023-24 award year.
In addition to examining the numbers and types of programs included in the alternative definitions of a
The Department's definition would increase outlays by $112 million over the 10-year budget window relative to restricting professional degrees to only the 10 programs listed in Section 668.2 (Table 5.4). Loan disbursements would increase by $961 million between 2026-2035 under the Department's definition, mostly due to the addition of programs in Clinical Psychology (Table 5.5). Conversely, the non-Federal negotiators' proposal would increase outlays by $1.12 billion in the 2026-2035 budget window, relative to the cost of limiting professional programs to only the 10 programs in Section 668.2 (Table 5.4). Additionally, the non-Federal negotiators' proposal would increase loan disbursements by an estimated $9.79 billion, relative to the same baseline (Table 5.5). Programs in physical therapy and nursing account for a large share of the projected increase in loan disbursements and budget costs relative to the Department's definition and the baseline 10 programs.
This section considers the effects that the proposed regulations may have on small entities in the Educational Sector as required by the Regulatory Flexibility Act (RFA, 5 U.S.C.
The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA) or any other statute unless the agency certifies that the rule will not have a “significant impact on a substantial number of small entities.”
This final rule amends the regulations for the Federal student loan programs authorized under the title IV, HEA programs to implement the statutory changes to the title IV, HEA programs
As we describe below, the Department anticipates that this regulatory action will have a significant economic impact on a substantial number of small entities. We therefore present this Final Regulatory Flexibility Analysis. Our analysis focuses on the loan limit components of the Working Families Tax Cuts Act and the final regulation, as those would have the most economically significant implications for small entities.
The Small Business Administration (SBA) defines “small institution” using data on revenue, market dominance, tax filing status, governing body, and population. The majority of entities to which the Office of Postsecondary Education's (OPE) regulations apply are postsecondary institutions, which do not report such data to the Department. As a result, for purposes of this final rule, the Department proposes to continue defining “small entities” by reference to enrollment, to allow meaningful comparison of regulatory impact across all types of higher education institutions. We construct four different categories of small entities for the purposes of classifying higher education institutions:
As seen in Table 5.7, small entities (all four categories combined) in the public sector generate $3.5 billion in institutional revenues annually, small entities (all four categories combined) in the private non-profit sector generate $12.3 billion in institutional revenues annually, and small entities (all four categories combined) in the for-profit sector generate $4.2 billion in institutional revenues annually. An outsized share of these revenues come from institutions in the largest category of small entities (institutions with 750-999 FTE). These institutions make up just 9 percent of all institutions classified as a small entity (having fewer than 1,000 FTE) but comprise 38 percent of the annual revenues generated by these institutions.
Table 5.8 shows the estimated change in annual loan disbursements from the Department to small entities as a result of the new loan limits established in the Working Families Tax Cuts Act. As noted in the previous section, the Working Families Tax Cuts Act includes new annual and aggregate loan limits for graduate and professional students as well as parents of dependent undergraduate students who use the Parent PLUS Program. The annual limits, as described in the previous section, are $20,500 for graduate students, $50,000 for professional students as defined in the proposed regulation, and $20,000 for parents borrowing on behalf of their dependent undergraduate student.
Among all small entities (institutions with 1-999 FTE), the percentage of annual loan volume that exceeds the new annual loan limits is approximately 13.9 percent on average, though there is variation across institutional sectors. Among private non-profit small entities, the average share of annual loan volume above the limit is 21 percent, whereas the share of annual volume above the limit at public and for-profit small entities is between 4 percent-6 percent. These values represent an estimate of the share of annual Federal student loan disbursements to small entities that will no longer be issued due to the Working Families Tax Cuts Act's loan limits for graduate students and parent borrowers.
Federal student loans can comprise a significant portion of institutions' revenue, including small institutions, if such funds are used to pay tuition and other costs billed directly by the institution. However, it is important to note that not all Federal loan disbursements contribute to institutional revenues. Sometimes, Federal loan dollars are used to pay for other items, like housing, transportation, and food, which do not always go to the institution the student attends. Therefore, the new loan limits could result in a reduction in institutional revenue unless those direct costs are funded by other sources, such as grants, non-Federal loans, or personal savings. Due to data limitations, we are unable to estimate reliably the share of Federal loan disbursements to small entities that the institution receives and therefore are unable to reliably estimate the share of small entities' revenue affected by the loan limit reduction. Table 5.8 presents the maximum amount of revenue that could be affected, but the actual amount will be lower and may vary by institution.
The regulations are unlikely to result in additional reporting, recordkeeping, or additional compliance requirements for small entities beyond the paperwork burden as described in the
The regulations are unlikely to conflict with or duplicate existing Federal regulations.
The Department examined whether the final rule could incorporate other options or changes to the rule intended to make compliance less burdensome for small institutions of higher education. Specifically, the Department considered whether small institutions of higher education could be exempted from the changes to the statue in the final rule, or whether they could be granted a delayed start date to the changes, particularly those changes related to the reductions in student loan limits in the Working Families Tax Cuts Act. The Department does not have discretion in the Working Families Tax Cuts Act to exempt certain institutions of higher education from the Working Families Tax Cuts Act requirements. The statute also establishes the effective date for the changes to the Federal student loan program and does not leave flexibility to the Department to consider granting a delay in compliance for small entities that may benefit from such a delay. Therefore, the Department determined that none of these options would be permissible under the statute.
As part of its continuing effort to reduce paperwork and respondent burden, the Department provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps make certain that: the public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.
This Final Rule contains information collection requirements that include reporting or recordkeeping burden. Under the PRA, the Department has or will at the required time submit a copy of these sections and Information Collection requests to OMB for its review.
A Federal agency may not conduct or sponsor a collection of information unless OMB approves the collection under the PRA and the corresponding information collection instrument displays a currently valid OMB control number. Notwithstanding any other provision of law, no person is required to comply with or is subject to penalty for failure to comply with, a collection of information if the collection instrument does not display a currently valid OMB control number. In these final regulations, we display the control numbers assigned by OMB to any information collection requirements proposed in the NPRM and adopted in the final regulations. This final rule amends the following information collections:
The regulations will also modify other existing information collections. However, at this time it is unclear what changes will be made to these existing collections. In the below table, we identify information collections that we anticipate will also be modified by these regulations. The Department will separately seek public comment on the proposed revisions to these collections before changes go into effect.
Below we identify the provisions of the regulation that have an impact on information collections.
Section 685.102 adds the following new definitions: expected time to credential; graduate student; professional student; and program length. To comply, institutions will be required to update their internal systems and policies to bifurcate and update the definition of graduate or professional student in order to determine a student's annual and aggregate loan limits. We expect the associated burden on institutions will be minimal. Institutions already differentiate graduate students from baccalaureate students while packaging aid. The regulation would not create a new burden for schools as they already have a process to differentiate students in their systems. We believe separating graduate and professional student would only slightly alter the burden already assigned to this type of activity within this regulation.
Section 685.102 will require institutions to update their internal system definitions of expected time to credential and program length. We believe the burden to conform with these new definitions will be minimal as the definitions serve to provide consistency and clarity of these terms rather than change them.
In sum, to conform to all definitions in § 685.102, institutions would be required to review the new definitions, update internal policies and procedures, modify systems, perform basic testing, and train staff. We believe there will be a small increase in burden of approximately 300 hours per institution in order to implement these regulations. This additional burden is assigned to this regulatory collection, 1845-0021.
Section 682.215(b) amends the terms and conditions of the IBR plan to remove any references to partial financial hardship to conform with changes from the Working Families Tax Cuts Act Section 82001(f)(1)(B). This will decrease burden on borrowers as they will no longer be required to demonstrate a partial financial hardship to apply for an IDR plan, including the IBR plan. Updates to the IDR form and burden estimates on individual borrowers will be completed and made available for comment in a separate public comment notice issued under OMB Control # 1845-0102 Income-Driven Repayment Plan Request for the William D. Ford Federal Direct Loans and Federal Family Education Loan Programs before being made available for use by the effective date of the regulations.
Likewise, loan servicers will no longer have to determine that the borrower meets the partial financial hardship requirement before placing a borrower in the income-based repayment plan, nor will they be required to make annual redeterminations of partial financial hardship status.
The elimination of the partial financial hardship requirement will reduce burden on loan servicers. When partial financial hardship was first implemented, the Department estimated there would be an increase of 90,286 burden hours on loan servicers. Because these partial financial hardship determinations will no longer be required under this regulation, the Department removes all 90,286 hours of burden from this regulatory collection, 1845-0021.
Before July 1, 2026, for a graduate or professional student to apply for a Direct PLUS Loan, the borrower would complete a FAFSA and submit it in accordance with instructions in the application. The borrower would also complete the Direct PLUS Loan Request and the Direct PLUS Loan MPN.
Section 685.201 would align the regulations with the changes to Section 81001(1)(C) of the Working Families Tax Cuts Act, which amends Section 455(a)(3)(C) of the HEA by terminating graduate and professional students' access to the Direct PLUS Loan Program for any period of instruction beginning on or after July 1, 2026 (except for those current students who qualify for the interim exception).
By discontinuing the Graduate PLUS Loan Program for new students and those who do not qualify for the interim exception for certain students, the Department proposes removing an entire category of loan processing requirements for servicers and institutions. This will reduce burden in any collection related to PLUS loans, including the 1845-0021 collection.
In the 2024-25 award year, there were 2,020 title IV eligible schools who originated and disbursed at least one Graduate PLUS Loan. Of those, 124 proprietary schools made an average of 465 Graduate PLUS Loans; 1,341 private schools made an average of 279 Graduate PLUS Loans; and 555 public schools made an average of 413 Graduate PLUS Loans.
Title IV eligible schools may still participate in the Direct PLUS Loan Program. Proposed § 685.201 would disqualify graduate and professional students from eligibility, but parents of dependent undergraduate students remain eligible to borrow Parent PLUS Loans. Therefore, this specific loan program will not be eliminated in its entirety. Because of this, we estimate there would be a 620-hour reduction in burden per title IV institution participating in the Direct PLUS Loan Program. This would remove approximately 1,252,400 hours of burden from the 1845-0021 William D. Ford Federal Direct Loan Program collection.
Additional reductions in burden on individual borrowers stemming from § 685.201 will be assessed to OMB Control # 1845-0103 William D. Ford Federal Direct Loan Program, Federal Direct PLUS Loan Request for Supplemental Information and OMB Control # 1845-0129 PLUS Adverse Credit Reconsideration Loan Counseling. As previously mentioned, these updates will be completed and made available for comment through a separate public comment notice before these requirements are in effect.
Section 82001(c)(2)(B) of the Working Families Tax Cuts Act made statutory changes to permit defaulted borrowers to consolidate their loans for the purposes of obtaining access to the IBR or Repayment Assistance Plan plans to fix the default. The Department amends § 685.220 to conform with these statutory changes. Before July 1, 2028, defaulted borrowers may consolidate to gain access to the IBR and/or ICR plans. On or after July 1, 2028, defaulted borrowers may consolidate to gain access to the IBR plan or the Repayment Assistance Plan. Notwithstanding the foregoing, Section 455(g)(3) of the HEA provides that a Direct Consolidation Loan made on or after July 1, 2026, may only be repaid under Repayment Assistance Plan or the Tiered Standard repayment plan.
Section 685.220 would allow defaulted borrowers to consolidate into the Direct Loan Program and defines which repayment plans they have access to, including the Repayment Assistance Plan. Increases in burden to individual borrowers will be assessed under OMB Control # 1845-0007 William D. Ford Federal Direct Loan Program (Direct Loan Program) Promissory Notes and related form, which the Department will seek comment on in a separate public comment notice.
Servicers are already in the practice of limiting repayment plans available to defaulted borrowers. We do not believe that the particular change in § 685.220 will have an impact on the burden hours or number of respondents currently assessed to OMB Control # 1845-0021.
Three of the proposed regulations would allow a borrower to rehabilitate and/or receive the benefit of a suspension of AWG for a second time: Sections 674.39, 682.405, and 685.211. This widens eligibility for loan rehabilitation and therefore adds burden to servicers who process rehabilitations.
The Department estimates that approximately 91,700 additional borrowers would successfully rehabilitate their loan for a second time. If a servicer spends 8 hours on each borrower's loan rehabilitation, this adds 733,600 burden hours for loan servicers under this regulatory collection, 1845-0021 William D. Ford Federal Direct Loan Program regulations.
Updates to burden on individuals due to the increased number of respondents for loans eligible for rehabilitation and/or administrative wage garnishment will be assessed under form changes to OMB Control # 1845-0120 Loan Rehabilitation: Reasonable and Affordable Payments. The Department will seek comment on this in a separate public comment notice.
The Department restructures § 685.208 to provide fixed repayment plans based on when a Direct Loan was made. Loans made before July 1, 2026, will contain the following fixed repayment plans: standard, graduated, and extended. Loans made on or after July 1, 2026, would only have the Tiered Standard repayment plan as a fixed repayment plan option. Updates would be made to the form and the burden assessed under OMB Control # 1845-0014 William D. Ford Federal Direct Loan Program Repayment Plan Selection Form. These updates will be completed and made available for comment through a separate public comment notice before the requirements are in effect.
This will also require loan servicers to update their systems, including eligibility logic for the updated repayment plans, train staff, and make edits to communications materials.
Based upon experience with prior repayment plan changes, the
Section 685.210 changes the eligible repayment plans available for loans made on or after July 1, 2026. Updates will be made to the form and the burden assessed under OMB Control #1845-0014 William D. Ford Federal Direct Loan Program Repayment Plan Selection Form. These updates will be completed and made available for comment through a separate public comment notice before requirements go into effect.
Additional burden on loan servicers due to changes to repayment plans in their systems was accounted for in § 685.208.
Section 81001 of the Working Families Tax Cuts Act amended Section 455(a)(3)(C) of the HEA by eliminating the graduate and professional Direct PLUS Loan Program for new loans made on or after July 1, 2026. This regulation decreases burden on institutions and individuals.
Section 685.200 requires Direct PLUS Loan applicants who have been denied a Direct PLUS Loan due to an adverse credit history determination to complete enhanced Direct PLUS Loan counseling and submit documentation of extenuating circumstances to the Secretary to request a review of their loan application.
Section 685.200 results in a change in burden for institutions. Because graduate and professional students would no longer be eligible for PLUS loans there will be a reduction in the number of PLUS loans originated by institutions and therefore a reduction of respondents to form OMB Control #1845-0129 PLUS Adverse Credit Reconsideration Loan Counseling. The Department will seek approval for this modification through a separate public comment notice before the requirements are in effect.
Section 685.204 updates the eligibility criteria for an economic hardship deferment based on loan disbursement date. Section 82002 of the Working Families Tax Cuts Act amends Section 455(f) of the HEA to remove the authority for unemployment and economic hardship deferments for Direct Loans made on or after July 1, 2027.
The changes will decrease burden related to the deferment processes. Updates will need to be made to the current deferment forms under OMB Control #1845-0011 Federal Student Loan Program Deferment Request Forms and its associated burden. This form update will be completed and made available for comment through a separate public comment notice before requirements go into effect.
Section 82002 of the Working Families Tax Cuts Act amends Section 455(f) of the HEA to limit the use of forbearance for future borrowers with loans made on or after July 1, 2027.
Section 685.205 decreases burden related to the forbearance process due to new limitations on the use of forbearance. Updates will need to be made to OMB Control #1845-0018 Federal Student Loan Program: Internship/Residency and Loan Debt Burden Forbearance Forms and its associated burden. The Department will seek comment on this form update in a separate public comment notice before requirements go into effect.
Section 82001(b) of the Working Families Tax Cuts Act amended Section 455(d)of the HEA to define which repayment plans are available to borrowers with loans made on or after July 1, 2026, thereby limiting which loans may use the alternative repayment plan to borrowers with Direct Loans made before July 1, 2026. We do not believe this regulation would require a change to burden estimates for loan servicers. The alternative repayment plan was promulgated into regulation for borrowers with extreme circumstances.
There is no OMB control number currently assigned to this repayment plan because the annual number of respondents does not meet the minimum required by OMB. As a result, the Department does not anticipate there will be enough borrowers who meet the alternative repayment plan requirements each year to have an impact on burden for loan servicers.
To conform with changes from the Working Families Tax Cuts Act, § 685.203 requires updates to loan limits. Additionally, due to the changes in § 685.203, the Department will waive the requirement in § 685.303(d)(5) that prevents Direct Loans from being disbursed in any amount other than substantially equal installments when a borrower is enrolled for less than full-time enrollment.
These changes create burden on institutions. A school may need to make significant changes to implement revised disbursement requirements including the ability to accommodate uneven disbursements between periods of enrollment.
Section 685.203(m) addresses when a student is enrolled in an eligible program on a less than full-time basis that would require a school to calculate and reduce a borrower's loan disbursement amount based upon less than full-time enrollment status. Schools are already required to package title IV aid evaluating for half-time or greater enrollment and less than half-time enrollment and adjusting, as needed.
The Department estimates that changes in § 685.203 will take 950 hours per institution or servicer to complete creating a total of 5,350,400 additional burden hours assigned to the 1845-0021 William D. Ford Federal Direct Loan Program collection.
Section 685.209 makes several modifications to the administration of IDR plans. First, we add a new repayment plan, the Repayment Assistance Plan, to § 685.209 of the Direct Loan regulations. This repayment plan would be available to all Direct Loan borrowers regardless of when the borrower received their loan except for excepted Direct Loans. The legacy plans of PAYE, IBR, and ICR would only be
This regulation will alter the current IDR form. Any adjustments to burden calculation and number of respondents due to revisions to income-driven repayment regulations will be captured under OMB Control #1845-0102 Income-Driven Repayment and the Department will seek public comment on this in a separate notice before requirements go into effect. § 685.209 also requires loan servicers to update their systems and policies and procedures to comply with the modified regulations. This includes changes related to repayment plan eligibility and monthly payment calculations.
We estimate it will take loan servicers 700 hours to complete systems programming and integration; 190 hours for testing; 50 hours for edits to letters or communication material; and 600 hours for project management for a total of 1,540 burden hours. Currently there are six loan servicers, which would create 9,240 additional burden hours assessed to this regulatory collection, 1845-0021 William D. Ford Federal Direct Loan Program regulations.
Requirements:
The Department amends § 685.219 Public Service Loan Forgiveness in accordance with amendments made by 82004(b)(1) through (3) of the Working Families Tax Cuts Act to specify the qualifying repayment plans for the purposes of PSLF. § 685.219 expands the definition of a qualifying repayment plan for PSLF by adding two new categories: (1) income-contingent repayment plans, but only for payments made on or before June 30, 2028, and (2) the new Repayment Assistance Plan in § 685.209.
This will require updates to burden assessed to OMB Control #1845-0110 Application and Employment Certification for Public Service Loan Forgiveness. The Department will update this form through a separate public comment notice before requirements go into effect.
We provide below our estimates for burden changes and potential costs associated with changes to information collections impacted by these regulations. For institutions, we used the median hourly wage for Education Administrators, Postsecondary (11-9033) from the U.S. Bureau of Labor Statistics. In 2024 this was $49.98.
Certain regulations in this notice add approximately 7,816,800 hours of burden; other adjustments in regulation reduce the burden by approximately 1,342,686 hours. This results in a net increase of 6,474,114 burden hours assessed to 1845-0021 William D. Ford Federal Direct Loan Program Regulations.
A Federal agency may not conduct or sponsor a collection of information unless OMB approves the collection under the PRA and the corresponding information collection instrument displays a currently valid OMB control number. Notwithstanding any other provision of law, no person is required to comply with or is subject to penalty for failure to comply with, a collection of information if the collection instrument does not display a currently valid OMB control number.
Pursuant to the Congressional Review Act (5 U.S.C. 801
This program is subject to E.O. 12372 and the regulations in 34 CFR part 79. One of the objectives of the E.O. is to foster an intergovernmental partnership and strengthen Federalism. The E.O. relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.
This document provides early notification of our specific plans and actions for this program.
In accordance with section 411 of the General Education Provisions Act, 20 U.S.C. 1221e-4, the Secretary requests comments on whether these final regulations would require transmission of information that any other agency or authority of the United States gathers or makes available.
E.O. 13132 requires us to provide meaningful and timely input by State and local elected officials in the development of regulatory policies that have Federalism implications. “Federalism implications” means substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. The proposed regulations do not have Federalism implications.
You may also access documents of the Department published in the
Administrative practice and procedure, Annual and aggregate loan limits, Colleges and universities, Education, Federal Family Education Loan (FFEL) Program, Federal Perkins Loan Program, Less than full-time enrollment, Loan consolidation, Reporting and recordkeeping
For the reasons discussed in the preamble, the Secretary of Education amends parts 674, 682, and 685 of title 34 of the Code of Federal Regulations as follows:
20 U.S.C. 1071—1087ii; 1087dd(h)(1)(D).
(e)(1) On or before June 30, 2027, the borrower may rehabilitate a defaulted loan only one time.
(2) On or after July 1, 2027, the borrower may rehabilitate a defaulted loan a maximum of two times.
20 U.S.C. 1071—1087-2, 1078-6(a)(5).
(a) * *
(4)
(b) * * *
(1) For the Income-Based Repayment plan, a borrower may elect to have their aggregate monthly payment recalculated to not exceed the applicable amount. The borrower's aggregate monthly loan payments are limited to no more than 15 percent of the amount by which the borrower's AGI exceeds 150 percent of the poverty line income applicable to the borrower's family size, divided by 12. The loan holder adjusts the calculated monthly payment if—
(i) Except for borrowers provided for in paragraph (b)(1)(ii) of this section, the total amount of the borrower's eligible loans includes loans not held by the loan holder, in which case the loan holder determines the borrower's adjusted monthly payment by multiplying the calculated payment by the percentage of the total outstanding principal amount of the borrower's eligible loans that are held by the loan holder;
(ii) Both the borrower and the borrower's spouse have eligible loans and filed a joint Federal tax return, in which case the loan holder determines—
(A) Each borrower's percentage of the couple's total eligible loan debt;
(B) The adjusted monthly payment for each borrower by multiplying the calculated payment by the percentage determined in paragraph (b)(1)(ii)(A) of this section; and
(C) If the borrower's loans are held by multiple holders, the borrower's adjusted monthly payment by multiplying the payment determined in paragraph (b)(1)(ii)(B) of this section by the percentage of the total outstanding principal amount of the borrower's eligible loans that are held by the loan holder;
(iii) The calculated amount under paragraph (b)(1), (b)(1)(i), or (b)(1)(ii) of this section is less than $5.00, in which case the borrower's monthly payment is $0.00; or
(iv) The calculated amount under paragraph (b)(1), (b)(1)(i), or (b)(1)(ii) of this section is equal to or greater than $5.00 but less than $10.00, in which case the borrower's monthly payment is $10.00.
(5) Except as provided in paragraph (b)(4) of this section, accrued interest is capitalized at the time the borrower chooses to leave the income-based repayment plan or when the applicable amount exceeds the maximum amount calculated under paragraph (d)(1)(i) of this section.
(6) If the borrower's monthly payment amount is not sufficient to pay any principal due, the payment of that principal is postponed until the borrower chooses to leave the income-based repayment plan or when the applicable amount exceeds the maximum amount calculated under paragraph (d)(1)(i) of this section.
(7) The special allowance payment to a lender during the period in which the borrower has their aggregate monthly payment recalculated to not exceed the applicable amount, under the income-based repayment plan, is calculated on the principal balance of the loan and any accrued interest unpaid by the borrower.
(d) * * *
(1) If a borrower's applicable amount exceeds the maximum amount calculated under paragraph (d)(1)(i) of this section, the borrower may continue to make payments under the income-based repayment plan, but the loan holder must recalculate the borrower's monthly payment. The loan holder also recalculates the monthly payment for a borrower who chooses to stop making income-based payments. In either case, as a result of the recalculation—
(i) The maximum monthly amount that the loan holder requires the borrower to repay is the amount the borrower would have paid under the FFEL standard repayment plan based on a 10-year repayment period using the amount of the borrower's eligible loans that was outstanding at the time the borrower began repayment on the loans with that holder under the income-based repayment plan; and
(ii) The borrower's repayment period based on the recalculated payment amount may exceed 10 years.
(e) * * *
(1) The loan holder recalculates the borrower's aggregate monthly payment to not exceed the applicable amount for the year the borrower elects the Income-Based Repayment plan and for each subsequent year that the borrower remains on the plan. To make this determination, the loan holder requires the borrower to—
(i) Provide documentation, acceptable to the loan holder, of the borrower's AGI;
(ii) If the borrower's AGI is not available, or the loan holder believes that the borrower's reported AGI does not reasonably reflect the borrower's current income, provide other documentation to verify income;
(iii) If the spouse of a married borrower who files a joint Federal tax return has eligible loans and the loan holder does not hold at least one of the spouse's eligible loans—
(A) Confirm that the borrower's spouse has provided consent for the loan holder to obtain information about the spouse's eligible loans from the National Student Loan Data System; or
(B) Provide other documentation, acceptable to the loan holder, of the spouse's eligible loan information; and
(iv) Annually certify the borrower's family size. If the borrower fails to certify family size, the loan holder must assume a family size of one for that year.
(2) After determining the borrower's aggregate monthly payment for the year the borrower initially elects the plan and for any subsequent year that the
(i) The borrower's scheduled monthly payment amount, as calculated under paragraph (b)(1) of this section, and the time period during which this scheduled monthly payment amount will apply (annual payment period);
(ii) Information about the requirement for the borrower to annually provide the information described in paragraph (e)(1) of this section, if the borrower chooses to remain on the income-based repayment plan after the initial year on the plan, and an explanation that the borrower will be notified in advance of the date by which the loan holder must receive this information;
(iii) An explanation of the consequences, as described in paragraph (e)(1)(iv) and (e)(7) of this section, if the borrower does not provide the required information;
(iv) An explanation of the consequences if the borrower no longer wishes to repay under the income-based repayment plan; and
(v) Information about the borrower's option to request, at any time during the borrower's current annual payment period, that the loan holder recalculate the borrower's monthly payment amount if the borrower's financial circumstances have changed and the income amount that was used to calculate the borrower's current monthly payment no longer reflects the borrower's current income. If the loan holder recalculates the borrower's monthly payment amount based on the borrower's request, the loan holder must send the borrower a written notification that includes the information described in paragraphs (e)(2)(i) of this section through this paragraph (e)(2)(v).
(3) For each subsequent year that a borrower remains on the income-based repayment plan, the loan holder must notify the borrower in writing of the requirements in paragraph (e)(1) of this section no later than 60 days and no earlier than 90 days prior to the date specified in paragraph (e)(3)(i) of this section. The notification must provide the borrower with—
(i) The date, no earlier than 35 days before the end of the borrower's annual payment period, by which the loan holder must receive all of the information described in paragraph (e)(1) of this section (annual deadline); and
(ii) The consequences if the loan holder does not receive the information within 10 days following the annual deadline specified in the notice, including the borrower's new monthly payment amount as determined under paragraph (d)(1) of this section, the effective date for the recalculated monthly payment amount, and the fact that unpaid accrued interest will be capitalized at the end of the borrower's current annual payment period in accordance with paragraph (b)(5) of this section.
(4) Each time a loan holder recalculates the borrower's monthly payment amount for a subsequent year that the borrower wishes to remain on the plan, the loan holder must send the borrower a written notification that provides the borrower with—
(i) The borrower's recalculated monthly payment amount, as determined in accordance with paragraph (d)(1) of this section;
(ii) An explanation that unpaid accrued interest will be capitalized in accordance with paragraph (b)(5) of this section; and
(iii) Information about the borrower's option to request, at any time, that the loan holder recalculate the monthly payment amount, if the borrower's financial circumstances have changed and the income amount used does not reflect the borrower's current income, and an explanation that the borrower will be notified annually of this option. If the loan holder recalculates the borrower's monthly payment amount based on the borrower's request, the loan holder must send the borrower a written notification that includes the information described in paragraphs (e)(2)(i) through (e)(2)(v) of this section.
(5) For each subsequent year that a borrower remains on the income-based repayment plan, the loan holder must send the borrower a written notification that includes the information described in paragraph (e)(4)(iii) of this section.
(6) If a borrower who is currently repaying under another repayment plan selects the income-based repayment plan but does not provide the documentation described in paragraphs (e)(1)(i) through (e)(1)(iii) of this section, the borrower remains on his or her current repayment plan.
(f) * * *
(1) To qualify for loan forgiveness after 25 years, the borrower must have participated in the income-based repayment plan and satisfied at least one of the following conditions during that period—
(i) Made reduced monthly payments as provided in paragraph (b)(1) of this section, including a monthly payment amount of $0.00, as provided in paragraph (b)(1)(iii) of this section;
(ii) Made reduced monthly payments or stopped making income-based payments as provided in paragraph (d)(1) of this section;
(iii) Made monthly payments under any repayment plan, that were not less than the amount required under the FFEL standard repayment plan described in § 682.209(a)(6)(vi) with a 10-year repayment period for the amount of the borrower's loans that were outstanding at the time the loans initially entered repayment;
(iv) Made monthly payments under the FFEL standard repayment plan described in § 682.209(a)(6)(vi) based on a 10-year repayment period; or
(v) Received an economic hardship deferment on eligible FFEL loans.
(a) * * *
(3) * * *
(iii)(A) Through July 1, 2027, a borrower may only obtain the benefit of suspension of administrative wage garnishment while also attempting to rehabilitate a defaulted loan once.
(B) On or after July 1, 2027, a borrower may only obtain the benefit of suspension of administrative wage garnishment one time per each attempt to rehabilitate a defaulted loan.
(4)(i) After the loan has been rehabilitated, the borrower regains all benefits of the program, including any remaining deferment eligibility under section 428(b)(1)(M) of the Act, from the date of the rehabilitation.
(ii) A loan may only be rehabilitated once between August 14, 2008, through June 30, 2027. On or after July 1, 2027, a loan may only be rehabilitated a maximum of two times over the loan's lifetime, regardless of when the loan was made.
20 U.S.C. 1087a—1087j.
Subpart A also issued under U.S.C. 1087e(a)
Subpart B also issued under U.S.C 1078, 1078-3, 1087(e), 1087e(a)(2), 1087e(a), 1087e(a)(3), 1087e(b), 1087e(d), 1087e(d)(1), 1087e(f), 1087e(g), 1087(m)(1)(A), 1091(a), 1092(d)(1), 1098e(a)(2), 1098e(a)(3), 1098h(a)(2)
Subpart C also issued under U.S.C 1087a
(b) * * *
(i) Three academic years, as defined in 34 CFR 668.3; or
(ii) The period determined by calculating the difference between—
(A) The program length for the program of study in which the individual is enrolled; and
(B) The period of such program of study that such individual has completed as of the date of the determination under paragraph (ii) of this definition.
(A) Except as provided in paragraph (ii)(C) of this definition, national service education awards or post-service benefits under title I of the National and Community Service Act of 1990 (AmeriCorps).
(B) Except as provided in paragraph (ii)(G) of this definition, veterans' education benefits;
(C) Any educational benefits paid because of enrollment in a postsecondary education institution, or to cover postsecondary education expenses;
(D) Fellowships or assistantships, except non-need-based employment portions of such awards;
(E) Insurance programs for the student's education; and
(F) The estimated amount of other Federal student financial aid, including but not limited to a Federal Pell Grant, campus-based aid, and the gross amount (including fees) of subsidized and unsubsidized Federal Stafford Loans, Direct Subsidized and Unsubsidized Loans, and Federal PLUS or Direct PLUS Loans.
(ii) Other financial assistance does not include—
(A) Those amounts used to replace the expected family contribution (EFC), including the amounts of any TEACH Grants, unsubsidized Federal Stafford Loans or Direct Unsubsidized Loans, Federal PLUS or Direct PLUS Loans, and non-Federal non-need-based loans, including private, State-sponsored, and institutional loans. However, if the sum of the amounts received that are being used to replace the students' EFC exceed the EFC, the excess amount must be treated as other financial assistance;
(B) Federal Perkins loan and Federal Work-Study funds that the student has declined;
(C) For the purpose of determining eligibility for a Direct Subsidized Loan, national service education awards or post-service benefits under title I of the National and Community Service Act of 1990 (AmeriCorps);
(D) Any portion of the other financial assistance described in paragraph (i) of this definition that is included in the calculation of the student's EFC;
(E) Non-need-based employment earnings;
(F) Assistance not received under a title IV, HEA program, if that assistance is designated to offset all or a portion of a specific amount of the cost of attendance and that component is excluded from the cost of attendance as well. If that assistance is excluded from either other financial assistance or cost of attendance, it must be excluded from both;
(G) Federal veterans' education benefits paid under—
(
(
(
(
(
(
(
(
(
(
(
(
(
(H) Iraq and Afghanistan Service Grants made under section 420R of the HEA.
(i) A professional degree is a degree that:
(A) Signifies both completion of the academic requirements for beginning practice in a given profession, and a level of professional skill beyond that normally required for a bachelor's degree;
(B) Is generally at the doctoral level, and that requires at least six academic years of postsecondary education coursework for completion, including at least two years of post-baccalaureate level coursework;
(C) Generally requires professional licensure to begin practice; and
(D) Includes a four-digit program CIP code, as assigned by the institution or determined by the Secretary, in the same intermediate group as the fields listed in paragraph (ii)(A) of this definition.
(ii) A professional degree may be awarded in the following fields:
(A) Pharmacy (Pharm.D.), Dentistry (D.D.S. or D.M.D.), Veterinary Medicine (D.V.M.), Chiropractic (DC or DCM.), Law (L.L.B. or J.D.), Medicine (M.D.), Optometry (O.D.), Osteopathic Medicine (D.O.), Podiatry (D.P.M., D.P., or Pod.D.), Theology (M.Div., or M.H.L.), and Clinical Psychology (Psy.D. or Ph.D.).
(B) [Reserved]
(iii) A professional student under this definition:
(A) May not receive title IV aid as an undergraduate student for the same period of enrollment; and
(B) Must be enrolled in a program leading to a professional degree under paragraph (ii) of this definition.
(b)
(i) The student is enrolled, or accepted for enrollment, on at least a half-time basis in a school that participates in the Direct Loan Program.
(ii) The student meets the requirements for an eligible student under 34 CFR part 668.
(iii) The student meets the requirements of paragraphs (a)(1)(iv) and (a)(1)(v) of this section, if applicable.
(iv) The student has received a determination of his or her annual loan maximum eligibility under the Direct Unsubsidized Loan Program and, for periods of enrollment beginning before July 1, 2012, the Direct Subsidized Loan Program; and
(v) The student meets the requirements that apply to a parent under paragraphs (c)(2)(viii)(A) through (G) of this section.
(2)(i) Beginning on July 1, 2026, a graduate student or professional student may not borrow a Direct PLUS Loan.
(ii) The limitation for making new Federal Direct PLUS Loan awards described in paragraph (b)(2)(i) of this section shall not be applicable to student borrowers during the period of the student's expected time to credential, if—
(A) the student is enrolled in a program of study at an institution as of June 30, 2026; and
(B) a Direct Loan was made for such program of study prior to July 1, 2026.
(3) If the student withdraws in accordance with § 668.22 or otherwise ceases to be enrolled in the program of study at any point after receiving the exception under paragraph (b)(2)(ii) of this section, the limitations under paragraph (b)(2)(i) shall apply.
The revisions read as follows:
(b) * * *
(2) * * *
(i) Before July 1, 2026, for a graduate or professional student to apply for a Direct PLUS Loan, the student must complete a Free Application for Federal Student Aid and submit it in accordance with instructions in the application. The graduate or professional student must also complete the Direct PLUS Loan MPN.
(ii) On or after July 1, 2026, a graduate student or professional student may only apply for a Direct PLUS Loan if the student satisfies the conditions set forth in § 685.200(b)(2)(ii).
The revisions and additions read as follows:
(b) * * *
(2) * * *
(iii) In the case of a graduate or professional student for a period of enrollment beginning on or after July 1, 2012, and ending on or before June 30, 2026, the total amount the student may borrow for any academic year of study under the Direct Unsubsidized Loan Program may not exceed $8,500.
(iv)
(A)(
(
(B) The limitations in effect on July 1, 2026, for annual loan limits as described in paragraph (b)(2)(iv)(A) of this section shall not be applicable to student borrowers during the period of the student's expected time to credential if—
(
(
(C) If the student withdraws in accordance with § 668.22 or otherwise ceases to be enrolled in the program of study at any point after receiving the exception under paragraph (b)(2)(iv)(B) of this section, the limitations under paragraph (b)(2)(iv)(A) shall apply.
(c) * * *
(2) * * *
(v) In the case of a graduate or professional student for a period of enrollment through June 30, 2026, $12,000.
(e) * * *
(3) For a graduate or professional student for periods of enrollment beginning before July 1, 2026, $138,500, including any loans for undergraduate study, minus any Direct Subsidized Loan, Subsidized Federal Stafford Loan, and Federal SLS Program loan amounts.
(4) For a graduate student for a period of enrollment beginning on or after July 1, 2026—
(i) Who is not and has never been a professional student at an institution, $100,000, which includes any Direct Subsidized Loan, Subsidized Federal Stafford Loan, and Federal SLS Program loan, if applicable.
(ii) Who is or has been a professional student at an institution, $200,000, minus any amounts such student borrowed as a professional student, which includes any Direct Subsidized Loan, Subsidized Federal Stafford Loan, Federal SLS Program loan, if applicable.
(5) For a professional student for a period of enrollment beginning on or after July 1, 2026, $200,000, minus any amounts such student borrowed as a graduate student, which includes any Direct Subsidized Loan, Subsidized Federal Stafford Loan, and Federal SLS Program loan amounts, if applicable.
(6) The limitations for aggregate loan limits described in paragraphs (e)(4) and (e)(5) of this section shall not be applicable to student borrowers during the period of the student's expected time to credential, if—
(i) The student is enrolled in a program of study at an institution as of June 30, 2026; and
(ii) A Direct Loan was made for such program of study prior to July 1, 2026.
(7) If the student withdraws in accordance with § 668.22 or otherwise ceases to be enrolled in the program of study at any point after receiving the
(f)
(2)
(ii) The limitation for annual loan limits described in paragraph (f)(2)(i) of this section shall not be applicable to parent borrowers, who borrow a loan on behalf of a dependent student, during the period of the student's expected time to credential, if—
(A) the student is enrolled in a program of study at an institution as of June 30, 2026; and
(B) a Direct Loan was made to the parent borrower for such program of study on behalf of the dependent student, or a Direct Loan was made to the dependent student for such program of study.
(iii) If the student withdraws in accordance with § 668.22 or otherwise ceases to be enrolled in the program of study at any point after receiving the exception under paragraph (f)(2)(ii) of this section, the limitations under paragraph (f)(2)(i) of this section shall apply to the parent borrower of that dependent student.
(iv) For the purposes of this subparagraph (f), a student who changes majors within the same degree or certificate shall be considered to be enrolled in the same program of study.
(3)
(g)
(2)
(3) The limitation for aggregate loan limits described in paragraph (g)(2) of this section shall not be applicable to parent borrowers during the period of the student's expected time to credential, if—
(i) The student is enrolled in a program of study at an institution as of June 30, 2026; and
(ii) A Direct Loan was made to the parent for such program of study on behalf of the dependent student, or a Direct Loan was made to the dependent student for such program of study prior to July 1, 2026.
(4) If the student withdraws in accordance with § 668.22 or otherwise ceases to be enrolled in the program of study at any point after receiving the exception under paragraph (g)(3) of this section, the limitations under paragraph (g)(2) of this section shall apply.
(5) For the purposes of this paragraph (g), a student who changes majors within the same degree or certificate shall be considered to be enrolled in the same program of study.
(6)
(j)
(i) The student's other financial assistance for that period; and
(ii) In the case of a Direct Subsidized Loan, the borrower's expected family contribution for that period.
(2) Effective July 1, 2026, the lifetime maximum aggregate amount of loans made, insured, or guaranteed under the Act that a student may borrow, shall be $257,500, excluding Federal Direct PLUS or Federal PLUS loans made to that student as a parent on behalf of another dependent undergraduate student. Such maximum, aggregate loan amount shall be determined without regard to any amounts repaid, forgiven, canceled, or otherwise discharged on such loans. Any amount of loan funds that have been returned by the institution, or the borrower, will not count against the lifetime maximum aggregate loan limit in this paragraph (j)(2).
(3) The limitation for lifetime maximum aggregate loan limits described in paragraph (j)(2) of this section shall not be applicable to student borrowers during the period of the student's expected time to credential, if—
(i) The student is enrolled in a program of study at an institution as of June 30, 2026; and
(ii) A Direct Loan was made for such program of study prior to July 1, 2026.
(4) If the student withdraws in accordance with § 668.22 or otherwise ceases to be enrolled in the program of study at any point after receiving the exception under paragraph (j)(3) of this section, the limitations under paragraph (j)(2) of this section shall apply.
(l) For the purposes of this section, if a student is enrolled in a program that awards both a graduate degree and professional degree, the student shall be considered a professional student if more than 50 percent of the credit hours in that program count toward the professional degree.
(m)
Equation 11 to paragraph (m)(1) introductory text
(i)
(A) The institution shall first determine the amount of the academic year loan limit under this section that the term represents.
(B) The institution shall then determine the borrower's eligibility for a disbursement of a Direct Loan for the term, in accordance with 34 CFR 668.164(b)(3).
(C) The institution shall then reduce the borrower's Direct Loan amount based on less than full-time enrollment for that term at that institution, as follows:
Equation 12 to paragraph (m)(1)(i)(C)
(ii)
(A) For the first and second subscription periods, in any case in which the institution has determined that a student is enrolled in an eligible program on a less than a full-time basis, the amount of any Direct Loan that student may borrow for an academic year or its equivalent shall be reduced in direct proportion under (m)(1)based on the student's enrollment status determined by the institution for the subscription-based program and the number of credit hours calculated by the institution for the student to complete before receiving subsequent disbursements for that program; and
(B) For the third subscription period and for each subsequent subscription period, the institution would treat the student as enrolled full-time in a non-term program.
(2)
(ii) An institution that limits the total amount of Direct Loans for an eligible program under paragraph (m)(2)(i) of this section must document its decision and follow the record retention and examination requirements in 34 CFR 668.24.
(iii) An institution must provide clear and conspicuous information describing any program of study that is subject to the loan limitation and explain the need for such limitation to current and prospective students, including, but not limited to: publication in the institution's course catalog, publication on institution's website(s), and award notifications.
(iv) Prior to taking such action under paragraph (m)(2)(i) of this section, an institution must notify the student who plans to enroll or is enrolled in the program subject to this limitation.
(v) For purposes of this paragraph (m)(2), program of study means eligible program.
(f)
(ii) For loans disbursed on or after July 1, 2027, a borrower may not receive an unemployment deferment.
(3) For the purposes of obtaining an unemployment deferment under paragraph (f)(2)(ii) of this section, the following rules apply:
(g)
(ii) For loans disbursed on or after July 1, 2027, a borrower may not receive an economic hardship deferment under paragraph (g) of this section.
(iii) An economic hardship deferment is granted for periods of up to one year at a time, except that a borrower who receives a deferment under paragraph (g)(2)(iv) of this section may receive an economic hardship deferment for the lesser of the borrower's full term of service in the Peace Corps or the borrower's remaining period of economic hardship deferment eligibility under the 3-year maximum.
(c)
(ii) For loans disbursed on or after July 1, 2027, and notwithstanding paragraph (c)(1)(i) of this section, the Secretary grants forbearance for a period that does not exceed nine months within a 24-month period for forbearances under paragraph (a)(1) of this section. The forbearance under this paragraph (c)(1)(ii) begins on the first month for which the forbearance is granted.
(a)
(b)
(i) Under this repayment plan, a borrower must repay a loan in full within ten years from the date the loan entered repayment by making fixed monthly payments.
(ii) A borrower's payments under this repayment plan are at least $50 per month, except that a borrower's final payment may be less than $50.
(iii) The number of payments or the fixed monthly repayment amount may be adjusted to reflect changes in the variable interest rate identified in § 685.202(a).
(iv) The repayment period for the repayment plan described in this paragraph (b)(1) does not include periods of authorized deferment or forbearance.
(2) Standard repayment plan for Direct Consolidation Loan borrowers entering repayment on or after July 1, 2006, and who have not received a Direct Loan on or after July 1, 2026.
(i) Under this repayment plan, a borrower must repay a loan in full by making fixed monthly payments over a repayment period that varies with the total amount of the borrower's student loans, as described in paragraph (b)(2)(iii) of this section.
(ii) A borrower's payments under this repayment plan are at least $50 per month, except that a borrower's final payment may be less than $50.
(iii) Under this repayment plan, if the total amount of the Direct Consolidation Loan and the borrower's other student loans, as defined in § 685.220(i), is—
(A) Less than $7,500, the borrower must repay the Consolidation Loan within 10 years of entering repayment;
(B) Equal to or greater than $7,500 but less than $10,000, the borrower must repay the Consolidation Loan within 12 years of entering repayment;
(C) Equal to or greater than $10,000 but less than $20,000, the borrower must repay the Consolidation Loan within 15 years of entering repayment;
(D) Equal to or greater than $20,000 but less than $40,000, the borrower must repay the Consolidation Loan within 20 years of entering repayment;
(E) Equal to or greater than $40,000 but less than $60,000, the borrower must repay the Consolidation Loan within 25 years of entering repayment; and
(F) Equal to or greater than $60,000, the borrower must repay the Consolidation Loan within 30 years of entering repayment.
(iv) The repayment period for the repayment plan described in this paragraph (b)(2) does not include periods of authorized deferment or forbearance.
(3) Extended repayment plan for all Direct Loan borrowers who entered repayment before July 1, 2006, and who have not received a Direct Loan on or after July 1, 2026.
(i) Under this repayment plan, a borrower must repay a loan in full by making fixed monthly payments within an extended period of time that varies with the total amount of the borrower's loans, as described in paragraph (b)(4)(iv) of this section.
(ii) A borrower makes fixed monthly payments of at least $50, except that a borrower's final payment may be less than $50.
(iii) The number of payments or the fixed monthly repayment amount may be adjusted to reflect changes in the variable interest rate identified in § 685.202(a).
(iv) Under the repayment plan, if the total amount of the borrower's Direct Loans is—
(A) Less than $10,000, the borrower must repay the loans within 12 years of entering repayment;
(B) Greater than or equal to $10,000 but less than $20,000, the borrower must repay the loans within 15 years of entering repayment;
(C) Greater than or equal to $20,000 but less than $40,000, the borrower must repay the loans within 20 years of entering repayment;
(D) Greater than or equal to $40,000 but less than $60,000, the borrower must repay the loans within 25 years of entering repayment; and
(E) Greater than or equal to $60,000, the borrower must repay the loans within 30 years of entering repayment.
(v) The repayment period for the repayment plan described in this paragraph (b)(3) does not include periods of authorized deferment or forbearance.
(4) Extended repayment plan for all Direct Loan borrowers entering repayment on or after July 1, 2006, and who have not received a Direct Loan on or after July 1, 2026.
(i) Under this repayment plan, a new borrower with more than $30,000 in outstanding Direct Loans accumulated on or after October 7, 1998, must repay either a fixed annual or graduated repayment amount over a period not to exceed 25 years from the date the loan entered repayment. For this repayment plan, a new borrower is defined as an individual who has no outstanding principal or interest balance on a Direct Loan as of October 7, 1998, or on the date the borrower obtains a Direct Loan on or after October 7, 1998.
(ii) A borrower's payments under this plan are at least $50 per month and will be more if necessary to repay the loan within the required time period.
(iii) The number of payments or the monthly repayment amount may be adjusted to reflect changes in the variable interest rate identified in § 685.202(a).
(iv) The repayment period for the repayment plan described in this paragraph (b)(4) does not include periods of authorized deferment or forbearance.
(5) Graduated repayment plan for all Direct Loan borrowers who entered repayment before July 1, 2006, and who have not received a Direct Loan on or after July 1, 2026.
(i) Under this repayment plan, a borrower must repay a loan in full by making payments at two or more levels within a period of time that varies with the total amount of the borrower's loans, as described in paragraph (b)(5)(iv) of this section.
(ii) The number of payments or the monthly repayment amount may be adjusted to reflect changes in the variable interest rate identified in § 685.202(a).
(iii) No scheduled payment under this repayment plan may be less than the amount of interest accrued on the loan between monthly payments, less than 50 percent of the payment amount that
(iv) Under this repayment plan, if the total amount of the borrower's Direct Loans is—
(A) Less than $10,000, the borrower must repay the loans within 12 years of entering repayment;
(B) Greater than or equal to $10,000 but less than $20,000, the borrower must repay the loans within 15 years of entering repayment;
(C) Greater than or equal to $20,000 but less than $40,000, the borrower must repay the loans within 20 years of entering repayment;
(D) Greater than or equal to $40,000 but less than $60,000, the borrower must repay the loans within 25 years of entering repayment; and
(E) Greater than or equal to $60,000, the borrower must repay the loans within 30 years of entering repayment.
(v) The repayment period for the repayment plan described in this paragraph (b)(5) does not include periods of authorized deferment or forbearance.
(6) Graduated repayment plan for Direct Subsidized Loan, Direct Unsubsidized Loan, and Direct PLUS Loan borrowers entering repayment on or after July 1, 2006, and who have not received a Direct Loan on or after July 1, 2026.
(i) Under this repayment plan, a borrower must repay a loan in full by making payments at two or more levels over a period of time not to exceed ten years from the date the loan entered repayment.
(ii) The number of payments or the monthly repayment amount may be adjusted to reflect changes in the variable interest rate identified in § 685.202(a).
(iii) A borrower's payments under this repayment plan may be less than $50 per month. No single payment under this plan will be more than three times greater than any other payment.
(iv) The repayment period for the repayment plan described in this paragraph (b)(6) does not include periods of authorized deferment or forbearance.
(7) Graduated repayment plan for Direct Consolidation Loan borrowers entering repayment on or after July 1, 2006, and who have not received a Direct Loan on or after July 1, 2026.
(i) Under this repayment plan, a borrower must repay a loan in full by making monthly payments that gradually increase in stages over the course of a repayment period that varies with the total amount of the borrower's student loans, as described in paragraph (b)(7)(iii) of this section.
(ii) A borrower's payments under this repayment plan may be less than $50 per month. No single payment under this plan will be more than three times greater than any other payment.
(iii) Under this repayment plan, if the total amount of the Direct Consolidation Loan and the borrower's other student loans, as defined in § 685.220(i), is—
(A) Less than $7,500, the borrower must repay the Consolidation Loan within 10 years of entering repayment;
(B) Equal to or greater than $7,500 but less than $10,000, the borrower must repay the Consolidation Loan within 12 years of entering repayment;
(C) Equal to or greater than $10,000 but less than $20,000, the borrower must repay the Consolidation Loan within 15 years of entering repayment;
(D) Equal to or greater than $20,000 but less than $40,000, the borrower must repay the Consolidation Loan within 20 years of entering repayment;
(E) Equal to or greater than $40,000 but less than $60,000, the borrower must repay the Consolidation Loan within 25 years of entering repayment; and
(F) Equal to or greater than $60,000, the borrower must repay the Consolidation Loan within 30 years of entering repayment.
(iv) The repayment period for the repayment plan described in this paragraph (b)(7) does not include periods of authorized deferment or forbearance.
(8) Tiered Standard repayment plan for Direct Loan borrowers who received a Direct Loan before July 1, 2026, and also received a Direct Loan that was made on or after July 1, 2026.
(i) Under this repayment plan, a borrower must repay a loan in full by making fixed monthly payments over a repayment period that varies with the total amount of the borrower's Direct Loans, as described in paragraph (b)(8)(ii) of this section.
(ii) A borrower's payments under this repayment plan are at least $50 per month, except that when a borrower's balance is less than $50, the minimum payment will be equal to the outstanding amount due.
(iii) Under this repayment plan, if the total amount of Direct Loans at the time the borrower is entering repayment, is—
(A) Less than $25,000, the borrower must repay the Direct Loan within 10 years of entering repayment;
(B) Equal to or greater than $25,000 but less than $50,000, the borrower must repay the Direct Loan within 15 years of entering repayment;
(C) Equal to or greater than $50,000 but less than $100,000, the borrower must repay the Direct Loan within 20 years of entering repayment; and
(D) Equal to or greater than $100,000, the borrower must repay the Direct Loan within 25 years of entering repayment.
(c)
(1) Tiered Standard repayment plan for Direct Loan borrowers who received a Direct Loan on or after July 1, 2026.
(i) Under this repayment plan, a borrower must repay a loan in full by making fixed monthly payments over a repayment period that varies with the total amount of the borrower's Direct Loans, as described in paragraph (c)(1)(ii) of this section.
(ii) A borrower's payments under this repayment plan are at least $50 per month, except that when a borrower's balance is less than $50, the minimum payment will be equal to the outstanding amount due.
(iii) Under this repayment plan, if the total amount of Direct Loans at the time the borrower is entering repayment, is—
(A) Less than $25,000, the borrower must repay the Direct Loan within 10 years of entering repayment;
(B) Equal to or greater than $25,000 but less than $50,000, the borrower must repay the Direct Loan within 15 years of entering repayment;
(C) Equal to or greater than $50,000 but less than $100,000, the borrower must repay the Direct Loan within 20 years of entering repayment; and
(D) Equal to or greater than $100,000, the borrower must repay the Direct Loan within 25 years of entering repayment.
(a)
(1) The Revised Pay As You Earn (REPAYE) plan, which may also be referred to as the Saving on a Valuable Education (SAVE) plan;
(2) The Income-Based Repayment (IBR) plan;
(3) The Pay As You Earn (PAYE) Repayment plan; and
(4) The Income-Contingent Repayment (ICR) plan; and
(5) The Repayment Assistance Plan.
(b) For the purposes of this section, the following terms apply:
(1)
(i) For a borrower who is not a new borrower under the IBR plan, 15 percent of the result obtained by calculating on at least an annual basis, the amount of the borrower's adjusted gross income, and the borrower's spouse's adjusted gross income if married filing jointly, that exceeds 150 percent of the poverty guideline;
(ii) For a new borrower under the IBR plan, 10 percent of the result obtained by calculating on at least an annual basis, the amount of the borrower's adjusted gross income, and the borrower's spouse's adjusted gross income if married filing jointly, that exceeds 150 percent of the poverty guideline; or
(iii) For any borrower under the PAYE plan, 10 percent of the result obtained by calculating on at least an annual basis, the amount of the borrower's adjusted gross income, and the borrower's spouse's adjusted gross income if married filing jointly, that exceeds 150 percent of the poverty guideline.
(2)
(i) Not more than $10,000, is $120;
(ii) More than $10,000 and not more than $20,000, is 1 percent of such adjusted gross income;
(iii) More than $20,000 and not more than $30,000, is 2 percent of such adjusted gross income;
(iv) More than $30,000 and not more than $40,000, is 3 percent of such adjusted gross income;
(v) More than $40,000 and not more than $50,000, is 4 percent of such adjusted gross income;
(vi) More than $50,000 and not more than $60,000, is 5 percent of such adjusted gross income;
(vii) More than $60,000 and not more than $70,000, is 6 percent of such adjusted gross income;
(viii) More than $70,000 and not more than $80,000, is 7 percent of such adjusted gross income;
(ix) More than $80,000 and not more than $90,000, is 8 percent of such adjusted gross income;
(x) More than $90,000 and not more than $100,000, is 9 percent of such adjusted gross income; and
(xi) More than $100,000, is 10 percent of such adjusted gross income.
(3)
(4)
(i) For the REPAYE plan, 225 percent of the applicable Federal poverty guideline;
(ii) For the IBR and PAYE plans, 150 percent of the applicable Federal poverty guideline; and
(iii) For the ICR plan, 100 percent of the applicable Federal poverty guideline.
(5)
(i) Any outstanding loan made to a borrower under the Direct Loan Program, except for a Direct PLUS Loan made to a parent borrower, or an excepted consolidation loan; and
(ii) Any outstanding loan made to a borrower under the FFEL Program, except for a Federal PLUS Loan made to a parent borrower, or an excepted consolidation loan.
(6)
(i)(A) A FFEL or Direct Consolidation Loan if such consolidation loan repaid a FFEL or Direct PLUS Loan made to a parent borrower on behalf of a dependent student; or
(B) A FFEL or Direct Consolidation Loan that repaid a FFEL or Direct Consolidation loan described under paragraph (b)(6)(i)(A) of this definition that repaid a FFEL or Direct PLUS Loan made to a parent borrower on behalf of a dependent student; and
(ii) Excludes a loan described under paragraphs (b)(6)(i)(A) or (B) of this definition that was being repaid under the ICR, PAYE, or IBR plans on any date on or after July 4, 2025, through anCd including June 30, 2028. For purposes of paragraph (b)(6)(ii) of this definition, being repaid means at least one payment was made under the ICR, PAYE, or IBR repayment plans.
(7)
(i) a Federal Direct PLUS Loan made to a parent borrower on behalf of a dependent student; or
(ii) a Federal Direct Consolidation Loan, if it repaid an excepted PLUS loan (as defined in this section) or an excepted consolidation loan (as defined in this section).
(8)
(9)
(i)(A) The borrower;
(B) The borrower's spouse, for a married borrower filing a joint Federal income tax return;
(C) The borrower's children, including unborn children who will be born during the year the borrower certifies family size, if the children receive more than half their support from the borrower and are not included in the family size for any other borrower except the borrower's spouse who filed jointly with the borrower; and
(D) Other individuals if, at the time the borrower certifies family size, the other individuals live with the borrower and receive more than half their support from the borrower and will continue to receive this support from the borrower for the year for which the borrower certifies family size.
(ii) The Department may calculate family size based on FTI reported to the Internal Revenue Service.
(10)
(i) The borrower's and, if applicable, the spouse's Adjusted Gross Income (AGI) as reported to the Internal Revenue Service; or
(ii) The amount calculated based on alternative documentation of all forms of taxable income received by the borrower and provided to the Secretary.
(11)
(12)
(i) A required monthly payment as determined in accordance with paragraphs (k)(4)(i) through (iii) of this section;
(ii) A month in which a borrower receives a deferment or forbearance of repayment under one of the deferment or forbearance conditions listed in paragraph (k)(4)(iv) of this section; or
(iii) A month in which a borrower makes a payment in accordance with procedures in paragraph (k)(6) of this section.
(13)
(i) For the purpose of the PAYE plan, an individual who—
(A) Has no outstanding balance on a Direct Loan Program loan or a FFEL program loan as of October 1, 2007, or who has no outstanding balance on such a loan on the date the borrower receives a new loan after October 1, 2007; and
(B) Receives a disbursement of a Direct Subsidized Loan, a Direct Unsubsidized Loan, a Direct PLUS Loan made to a graduate or professional student, or a Direct Consolidation Loan on or after October 1, 2011, except that a borrower is not considered a new borrower if the Direct Consolidation Loan repaid a loan that would otherwise make the borrower ineligible under paragraph (13)(i)(A) of this definition.
(ii) For the purposes of the IBR plan, an individual who has no outstanding balance on a Direct Loan or FFEL program loan before July 1, 2014, and obtains no new loan on or after July 1, 2026, or who has no outstanding balance on such a loan on the date the borrower obtains a loan after July 1, 2014, but before July 1, 2026.
(14)
(15)
(c)
(2) Through June 30, 2028, a Direct Loan borrower who has not received a Direct Loan on or after July 1, 2026, may repay under the REPAYE plan if the borrower has loans eligible for repayment under the plan;
(3)(i) Except as provided in paragraph (c)(3)(ii) of this section, any Direct Loan borrower may repay under the IBR plan if the borrower has loans eligible for repayment under the plan and elects to have their aggregate monthly payment amount recalculated to not exceed the applicable amount when the borrower initially enters the plan.
(ii) A borrower who has made 60 or more qualifying repayments under the REPAYE plan on or after July 1, 2024, may not enroll in the IBR plan.
(4) Through June 30, 2028, a borrower may repay under the PAYE plan only if the borrower—
(i) Has loans eligible for repayment under the plan;
(ii) Is a new borrower;
(iii) Elects to have their aggregate monthly payment amount recalculated to not exceed the applicable amount when the borrower initially enters the plan;
(iv) Was repaying a loan under the PAYE plan on July 1, 2024. A borrower who was repaying under the PAYE plan on or after July 1, 2024, and changes to a different repayment plan in accordance with § 685.210(b) may not re-enroll in the PAYE plan; and
(v) Has not received a Direct Loan on or after July 1, 2026.
(5)(i) Except as provided in (c)(5)(ii) or (c)(5)(iii) of this section, and through June 30, 2028, a borrower may enroll under the ICR plan only if the borrower—
(A) Has loans eligible for repayment under the plan;
(B) Was repaying a loan under the ICR plan on July 1, 2024. A borrower who was repaying under the ICR plan on or after July 1, 2024, and changes to a different repayment plan in accordance with § 685.210(b) may not re-enroll in the ICR plan unless they meet the criteria in paragraphs (c)(5)(ii) or (c)(5)(iii); and
(C) Has not received a Direct Loan on or after July 1, 2026.
(ii)(A) Through June 30, 2028, a borrower may choose the ICR plan to repay a Direct Consolidation Loan disbursed on or after July 1, 2006, and that repaid a parent Direct PLUS Loan or a parent Federal PLUS Loan.
(B) Paragraph (c)(5)(ii)(A) of this section shall not apply if that borrower received a Direct Loan on or after July 1, 2026.
(iii)(A) Through June 30, 2028, a borrower who has a Direct Consolidation Loan disbursed on or after July 1, 2025, which repaid a Direct Parent PLUS Loan, a FFEL Parent PLUS Loan, or a Direct Consolidation Loan that repaid a consolidation loan that included a Direct Parent PLUS or FFEL Parent PLUS Loan may not choose any IDR plan except the ICR plan.
(B) Paragraph (c)(5)(iii)(A) of this section shall not apply if that borrower received a Direct Loan on or after July 1, 2026.
(6) Any Direct Loan borrower may repay under the Repayment Assistance Plan if the borrower has loans eligible for repayment under the plan.
(7) Transition from Income-Contingent Repayment Plans
(i) Before July 1, 2028, a borrower repaying Direct Loans under the PAYE, and ICR plan, respectively, under paragraphs (a)(1), (a)(3), or (a)(4) of this section, or who is in an administrative forbearance (as defined under § 685.205(b)) associated with PAYE, or ICR, must elect to repay those Direct Loans under one of the following repayment plans for which they are otherwise eligible before July 1, 2028:
(A) the Repayment Assistance Plan under paragraph (a)(5) of this section;
(B) the IBR plan under paragraph (a)(2) of this section;
(C) the standard repayment plans under § 685.208(b)(1) or (b)(2);
(D) the graduated repayment plans under § 685.208(b)(5), (b)(6), or (g)(7);
(E) the extended repayment plans under § 685.208(b)(3) or (b)(4); or
(F) through June 30, 2028, the PAYE and ICR plans, respectively, under paragraphs (a)(3) and (4) of this section.
(ii) A borrower who elects to repay their loans under paragraph (c)(7)(i) of this section shall begin repaying under the terms of their elected repayment plan on July 1, 2028. Notwithstanding the foregoing, the borrower may elect to repay their loans earlier than July 1, 2028.
(iii) (A) In the case of a borrower who does not select a repayment plan under paragraph (c)(7)(i) of this section by July 1, 2028, the Secretary shall require the loans to be repaid under the following repayment plans:
(
(
(B) The Secretary will require the borrower to repay their Direct Loans that are in a repayment status in PAYE, or ICR or an administrative forbearance associated with PAYE, or ICR repayment plan under the terms of the applicable plan under paragraphs (c)(7)(iii)(A)(
(d)
(2) The following loans, including defaulted loans, are eligible to be repaid under the IBR plan: Direct Subsidized Loans, Direct Unsubsidized Loans, Direct PLUS Loans made to graduate or professional students, and Direct Consolidation Loans that are not excepted consolidation loans.
(3) Through June 30, 2028, the following loans are eligible to be repaid under the ICR plan: Direct Subsidized Loans, Direct Unsubsidized Loans, Direct PLUS Loans made to graduate or
(4) The following loans, including defaulted loans, are eligible to be repaid under the Repayment Assistance Plan: Direct Subsidized Loans, Direct Unsubsidized Loans, Direct PLUS Loans made to graduate or professional students, and Direct Consolidation Loans that are not excepted consolidation loans.
(5) Notwithstanding the conditions under paragraphs (d)(1) through (3) of this section, only Direct Loans made before July 1, 2026, may be repaid under the PAYE, IBR, and ICR plans.
(e)
(A) For an unmarried borrower, a married borrower filing a separate Federal income tax return, or a married borrower filing a joint Federal tax return who certifies that the borrower is currently separated from the borrower's spouse or is currently unable to reasonably access the spouse's income, only the borrower's income is used in the calculation.
(B) For a married borrower filing a joint Federal income tax return, except as provided in paragraph (e)(1)(i)(A) of this section, the combined income of the borrower and spouse is used in the calculation.
(ii) For purposes of calculating the monthly payment amount under the ICR plan—
(A) For an unmarried borrower, a married borrower filing a separate Federal income tax return, or a married borrower filing a joint Federal tax return who certifies that the borrower is currently separated from the borrower's spouse or is currently unable to reasonably access the spouse's income, only the borrower's income is used in the calculation.
(B) For married borrowers (regardless of tax filing status) who elect to repay their Direct Loans jointly under the ICR Plan or (except as provided in paragraph (e)(1)(ii)(A) of this section) for a married borrower filing a joint Federal income tax return, the combined income of the borrower and spouse is used in the calculation.
(2)
(ii) For the ICR plan, the spouse's loans that are eligible for repayment under the ICR plan in accordance with paragraph (d)(3) of this section are included in the calculation of the borrower's monthly payment amount only if the borrower and the borrower's spouse elect to repay their eligible Direct Loans jointly under the ICR plan.
(f)
(i) $0 for the portion of the borrower's income, as determined under paragraph (e)(1) of this section, that is less than or equal to 225 percent of the applicable Federal poverty guideline; plus
(ii) 5 percent of the portion of income as determined under paragraph (e)(1) of this section that is greater than 225 percent of the applicable poverty guideline, prorated by the percentage that is the result of dividing the borrower's original total loan balance attributable to eligible loans received for the borrower's undergraduate study by the original total loan balance attributable to all eligible loans, divided by 12; plus
(iii) For loans not subject to paragraph (f)(1)(ii) of this section, 10 percent of the portion of income as determined under paragraph (e)(1) of this section that is greater than 225 percent of the applicable Federal poverty guidelines, prorated by the percentage that is the result of dividing the borrower's original total loan balance minus the original total loan balance of loans subject to paragraph (f)(1)(ii) of this section by the borrower's original total loan balance attributable to all eligible loans, divided by 12.
(2) For new borrowers under the IBR plan and for all borrowers on the PAYE plan, the borrower's monthly payments are the lesser of—
(i) 10 percent of the borrower's discretionary income, divided by 12; or
(ii) What the borrower would have paid on a 10-year standard repayment plan based on the eligible loan balances and interest rates on the loans at the time the borrower began paying under the IBR or PAYE plans, except that the borrower may repay such loans in excess of 10 years.
(3) For those who are not new borrowers under the IBR plan, the borrower's monthly payments are the lesser of—
(i) 15 percent of the borrower's discretionary income, divided by 12; or
(ii) What the borrower would have paid on a 10-year standard repayment plan based on the eligible loan balances and interest rates on the loans at the time the borrower began paying under the IBR plan, except that the borrower may repay such loans in excess of 10 years.
(4)(i) For the ICR plan, the borrower's monthly payments are the lesser of—
(A) What the borrower would have paid under a repayment plan with fixed monthly payments over a 12-year repayment period, based on the amount that the borrower owed when the borrower began repaying under the ICR plan, multiplied by a percentage based on the borrower's income as established by the Secretary in a
(B) 20 percent of the borrower's discretionary income, divided by 12.
(ii)(A) Married borrowers may repay their loans jointly under the ICR plan. The outstanding balances on the loans of each borrower are added together to determine the borrowers' combined monthly payment amount under paragraph (f)(4)(i) of this section;
(B) The amount of the payment applied to each borrower's debt is the proportion of the payments that equals the same proportion as that borrower's debt to the total outstanding balance, except that the payment is credited toward outstanding interest on any loan before any payment is credited toward principal.
(5) For the Repayment Assistance Plan, the borrower's applicable monthly payment is an amount equal to—
(i) the borrower's applicable base payment, divided by 12; minus
(ii) $50 for each dependent of the borrower.
(g)
(i) In cases where the spouse's loan debt is included in accordance with paragraph (e)(2)(i) of this section, the borrower's payment is adjusted by—
(A) Dividing the outstanding principal and interest balance of the borrower's eligible loans by the couple's combined outstanding principal and interest balance on eligible loans; and
(B) Multiplying the borrower's payment amount as calculated in accordance with paragraphs (f)(1) through (3) of this section by the percentage determined under paragraph (g)(1)(i) of this section.
(ii) In cases where the borrower has outstanding eligible loans made under the FFEL Program, the borrower's
(A) Dividing the outstanding principal and interest balance of the borrower's eligible loans that are Direct Loans by the borrower's total outstanding principal and interest balance on eligible loans; and
(B) Multiplying the borrower's payment amount as calculated in accordance with paragraphs (f)(1) through (3) of this section or the borrower's adjusted payment amount as determined in accordance with paragraph (g)(1) of this section by the percentage determined under paragraph (g)(2)(i) of this section.
(iii) In cases where the borrower's monthly payment amount calculated under paragraphs (f)(1) through (3) of this section or the borrower's adjusted monthly payment as calculated under paragraph (g)(1)(i) or(g)(1)(ii) of this section is—
(A) Less than $5, the monthly payment is $0; or
(B) Equal to or greater than $5 but less than $10, the monthly payment is $10.
(2) Monthly payment amounts calculated under paragraph (f)(4) of this section will be adjusted to $5 in circumstances where the borrower's calculated payment amount is greater than $0 but less than or equal to $5.
(3)(i) Monthly payment amounts calculated under paragraph (f)(5) of this section will be adjusted in cases when the borrower's spouse's loan debt is included in accordance with paragraph (e)(2)(i) of this section:
(A) The borrower's payment is adjusted by—
(
(
(B) If a borrower's adjusted monthly payment, as calculated under paragraph (g)(3)(i), is less than $10, the monthly payment is $10. (ii) In cases where the borrower's monthly payment amount calculated under paragraph (f)(5) of this section is less than $10, the monthly payment is $10 except that the final payment may be less than $10.
(h)
(1) Under the REPAYE plan, during all periods of repayment on all loans being repaid under the REPAYE plan, the Secretary does not charge the borrower's account any accrued interest that is not covered by the borrower's payment;
(2)(i) Under the IBR and PAYE plans, the Secretary does not charge the borrower's account with an amount equal to the amount of accrued interest on the borrower's Direct Subsidized Loans and Direct Subsidized Consolidation Loans that is not covered by the borrower's payment for the first three consecutive years of repayment under the plan, except as provided for the IBR and PAYE plans in paragraph (h)(2)(ii) of this section;
(ii) Under the IBR and PAYE plans, the 3-year period described in paragraph (h)(2)(i) of this section excludes any period during which the borrower receives an economic hardship deferment under § 685.204(g); and
(3) Under the ICR plan, the Secretary charges all accrued interest to the borrower.
(4) (i) Under the Repayment Assistance Plan, during all periods of repayment on all loans being repaid under the Repayment Assistance Plan, the Secretary does not charge the borrower's account for any accrued interest that is not covered by the borrower's on-time payment of the amount due for that month.
(ii) If a borrower's payment is credited to a future monthly payment, and the payment equals or exceeds the on-time monthly payment amount made under the Repayment Assistance Plan under (f)(5)(i) of this section, the Secretary charges the borrower's account any accrued interest that is not covered by the borrower's on-time payment of the amount due for that month, in accordance with paragraph (h)(4)(i) of this section.
(i)
(j)
(2) Under the IBR plan, the Secretary capitalizes unpaid accrued interest—
(i) In accordance with § 685.202(b);
(ii) When a borrower's payment is the amount described in paragraphs (f)(2)(ii) and (f)(3)(ii) of this section; and
(iii) When a borrower leaves the IBR plan.
(k)
(2) In the case of a borrower repaying under the REPAYE plan who is repaying only loans received for undergraduate study, or a Direct Consolidation Loan that repaid only loans received for undergraduate study, a borrower repaying under the IBR plan who is a new borrower, or a borrower repaying under the PAYE plan, the borrower receives forgiveness of the remaining balance of the borrower's loans after the borrower has satisfied 240 monthly payments or the equivalent in accordance with paragraph (k)(4) of this section over a period of at least 20 years;
(3) Notwithstanding paragraphs (k)(1) and (2) of this section, a borrower receives forgiveness if the borrower's total original principal balance on all loans that are being paid under the REPAYE plan was less than or equal to $12,000, after the borrower has satisfied 120 monthly payments or the equivalent, plus an additional 12 monthly payments or the equivalent over a period of at least 1 year for every $1,000 if the total original principal balance is above $12,000.
(4) For the PAYE, ICR, and IBR plans, a borrower receives a month of credit toward forgiveness by—
(i)(A) Notwithstanding paragraph (k)(4)(i)(B) of this section, making a payment under an IDR plan except the Repayment Assistance Plan or having a monthly payment obligation of $0;
(B) For the IBR plan only, making a payment on or before June 30, 2028, under the PAYE, or ICR plan or having a monthly payment obligation of $0;
(ii) Making a payment under the 10-year standard repayment plan under § 685.208(b)(1);
(iii) Making a payment under a repayment plan with payments that are as least as much as they would have been under the 10-year standard
(iv) Deferring or forbearing monthly payments under the following provisions:
(A) A cancer treatment deferment under section 455(f)(3) of the Act;
(B) A rehabilitation training program deferment under § 685.204(e);
(C) An unemployment deferment under § 685.204(f);
(D) An economic hardship deferment under § 685.204(g), which includes volunteer service in the Peace Corps as an economic hardship condition;
(E) A military service deferment under § 685.204(h);
(F) A post active-duty student deferment under § 685.204(i);
(G) A national service forbearance under § 685.205(a)(4) on or after July 1, 2024;
(H) A national guard duty forbearance under § 685.205(a)(7) on or after July 1, 2024;
(I) A Department of Defense Student Loan Repayment forbearance under § 685.205(a)(9) on or after July 1, 2024;
(J) An administrative forbearance under § 685.205(b)(8) or (9) on or after July 1, 2024; or
(K) A bankruptcy forbearance under § 685.205(b)(6)(viii) on or after July 1, 2024, if the borrower made the required payments on a confirmed bankruptcy plan;
(v) Making a qualifying payment as described under § 685.219(c)(2);
(vi)(A) Counting payments a borrower of a Direct Consolidation Loan made on the Direct Loans or FFEL program loans repaid by the Direct Consolidation Loan if the payments met the criteria in paragraph (k)(4) of this section, the criteria in § 682.209(a)(6)(vi) that were based on a 10-year repayment period, or the criteria in § 682.215;
(B) For a borrower whose Direct Consolidation Loan repaid loans with more than one period of qualifying payments, the borrower receives credit for the number of months equal to the weighted average of qualifying payments made rounded up to the nearest whole month;
(C) For borrowers whose Joint Direct Consolidation Loan is separated into individual Direct Consolidation loans, each borrower receives credit for the number of months equal to the number of months that was credited prior to the separation; or
(vii) Making payments under paragraph (k)(6) of this section.
(5) For the IBR plan only, a monthly repayment obligation for the purposes of forgiveness includes—
(i) A payment made pursuant to paragraph (k)(4)(i) or (k)(4)(ii) of this section on a loan in default;
(ii) An amount collected through administrative wage garnishment or Treasury Offset Program that is equivalent to the amount a borrower would owe under paragraph (k)(4)(i) of this section, except that the number of monthly payment obligations satisfied by the borrower cannot exceed the number of months from the Secretary's receipt of the collected amount until the borrower's next annual repayment plan recertification date under IBR; or
(iii) An amount collected through administrative wage garnishment or Treasury Offset Program that is equivalent to the amount a borrower would owe on the 10-year standard plan.
(6)(i) A borrower may obtain credit toward forgiveness as defined in paragraph (k) of this section for any months in which a borrower was in a deferment or forbearance not listed in paragraph (k)(4)(iv) of this section, other than periods in an in-school deferment, by making an additional payment equal to or greater than their current IDR payment, including a payment of $0, for a deferment or forbearance that ended within 3 years of the additional repayment date and occurred after July 1, 2024.
(ii) Upon request, the Secretary informs the borrower of the months for which the borrower can make payments under paragraph (k)(6)(i) of this section.
(7) In the case of a borrower repaying under the Repayment Assistance Plan, the borrower receives forgiveness of the remaining balance of the borrower's loans after the borrower has satisfied 360 monthly payments or the equivalent in accordance with paragraph (k)(8) of this section over a period of at least 30 years.
(8) For a borrower repaying at least one loan under the Repayment Assistance Plan—
(i) To qualify for loan forgiveness, a borrower must have—
(A) participated in the Repayment Assistance Plan during any period;
(B) made their final payment under such Repayment Assistance Plan prior to loan cancellation; and
(C) Made 360 qualifying monthly payments, which includes any of the following:
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(l)
(2) If a borrower (and their spouse, if applicable) does not provide approval for the disclosure of applicable tax information under sections 493C(c)(2) and 494(a)(2) of the Act when completing the promissory note or on the application form for an IDR plan, the borrower must provide documentation to the Secretary—
(i) For the Income-Based Repayment plan, of the borrower's income and family size; or
(ii) For the Repayment Assistance Plan, the borrower's income and the number of dependents of the borrower.
(3) If the Secretary has received approval for disclosure of applicable tax information, but cannot obtain the borrower's tax information from the Internal Revenue Service, the borrower (and their spouse, if applicable) must provide documentation to the Secretary—
(i) For the Income-Based Repayment plan, the borrower's income and family size; or
(ii) For the Repayment Assistance Plan, the borrower's income and the number of dependents.
(4) After the Secretary obtains sufficient information to calculate the borrower's monthly payment amount, the Secretary calculates the borrower's payment and establishes the 12-month period during which the borrower will be obligated to make a payment in that amount.
(5) The Secretary sends to the borrower a repayment disclosure that—
(i) Specifies the borrower's calculated monthly payment amount;
(ii) Explains how the payment was calculated;
(iii) Informs the borrower of the terms and conditions of the borrower's selected repayment plan;
(iv) Informs the borrower of how to contact the Secretary if the calculated payment amount is not reflective of the borrower's current income and family size, or income and the number of dependents for the Repayment Assistance Plan;
(v) Informs the borrower of the right of the Secretary to follow the procedures in paragraph (l)(3) of this section and in accordance with section 493C(c)(2) of the Act on an annual basis to automatically recertify their eligibility for an IDR plan; and
(vi) Informs the borrower of their right to opt out, at any time, of the disclosure of applicable tax information under section 493C(c)(2) of the Act and describes the process for affirmatively opting out.
(6) If the borrower believes that the payment amount is not reflective of the borrower's current income and family size, or income and the number of dependents for the Repayment Assistance Plan, the borrower may request that the Secretary recalculate the payment amount. To support the request, the borrower must also submit alternative documentation of income and family size, or income and the number of dependents for the Repayment Assistance Plan to account for circumstances such as a decrease in income since the borrower last filed a tax return, the borrower's separation from a spouse with whom the borrower had previously filed a joint tax return, the birth or impending birth of a child, or other comparable circumstances.
(7) If the borrower provides alternative documentation under paragraph (l)(6) of this section or if the Secretary obtains documentation from the borrower or spouse under paragraph (l)(3) of this section, the Secretary grants forbearance under § 685.205(b)(9) to provide time for the Secretary to recalculate the borrower's monthly payment amount based on the documentation obtained from the borrower or spouse.
(8) Once the borrower has 3 monthly payments remaining under the 12-month period specified in paragraph (l)(4) of this section, the Secretary follows the procedures in paragraphs (l)(3) through (l)(7) of this section.
(9) If the Secretary requires information from the borrower under paragraph (l)(3) of this section to recalculate the borrower's monthly repayment amount under paragraph (l)(8) of this section, and the borrower does not provide the necessary documentation to the Secretary by the time the last payment is due under the 12-month period specified under paragraph (l)(4) of this section—
(i) For the IBR and PAYE plans, the borrower's monthly payment amount is the amount determined under paragraphs (f)(2)(ii) or (f)(3)(ii) of this section;
(ii) For the ICR plan, the borrower's monthly payment amount is the amount the borrower would have paid under a 10-year standard repayment plan based on the total balance of the loans being repaid under the ICR Plan when the borrower initially entered the ICR Plan;
(iii) For the REPAYE plan, the Secretary removes the borrower from the REPAYE plan and places the borrower on an alternative repayment plan under which the borrower's required monthly payment is the amount the borrower would have paid on a 10-year standard repayment plan based on the current loan balances and interest rates on the loans at the time the borrower is removed from the REPAYE plan; and
(iv) For the Repayment Assistance Plan, the borrower's required monthly payment is the amount the borrower would have paid on a 10-year standard repayment plan based on the total balance of the loans when such loans entered repayment.
(10) At any point during the 12-month period specified under paragraph (l)(4) of this section, the borrower may request that the Secretary recalculate the borrower's payment earlier than would have otherwise been the case to account for a change in the borrower's circumstances, such as a loss of income or employment or divorce. In such cases, the 12-month period specified under paragraph (l)(4) of this section is reset based on the borrower's new information.
(11) The Secretary tracks a borrower's progress toward eligibility for forgiveness under paragraph (k) of this section and forgives loans that meet the criteria under paragraph (k) of this section without the need for an application or documentation from the borrower.
(m)
(1) The borrower is otherwise eligible for the plan;
(2) The borrower has approved the disclosure of tax information under paragraph (l)(1) of this section;
(3) The borrower has not made a scheduled payment on the loan for at least 75 days or is in default on the loan and is not subject to an offset under the Treasury Offset Program, administrative wage garnishment under section 488A of the Act, or to a judgment secured through litigation; and
(4) The Secretary determines that the borrower's payment under the IDR plan would be lower than or equal to the payment on the plan in which the borrower is enrolled.
(n)
(1) The borrower provides information necessary to calculate a payment under paragraph (f) of this section;
(2) The payment calculated pursuant to paragraph (f) of this section is $0; and
(3) The income information used to calculate the payment under paragraph (f) of this section includes the point at which the loan defaulted.
(o)
(2)(i)
(A) the lesser of—
(
(
(B) the amount of the monthly payment that is applied to such total outstanding principal balance.
(ii) If a borrower's payment is credited to a future monthly payment, and the payment equals or exceeds the monthly repayment amount made under (f)(5)(i) of this section, the Secretary does not provide the borrower a matching principal payment in accordance with paragraph (o)(2)(i) of this section.
(3) For purposes of the Repayment Assistance Plan under this section, a borrower's monthly payment under (f)(5) of this section is considered on-time if the payment is received on or before the due date for the current month, but after the due date for the previous month.
(i) When the borrower elects to make a payment in excess of the amount due, the next payment due date is automatically advanced. A borrower is not eligible to receive matching principal and interest payment for the periods without a due date. To receive a matching principal and interest payment a borrower must opt out of advancing payment due date. The Secretary allows the borrower to opt-out of advancing the due date which is provided for in 34 CFR 685.211. In the case where the borrower makes an electronic payment, the Secretary allows the borrower to select when submitting the payment whether the excess payment will advance the due date (and eliminate the possibility of a Repayment Assistance Plan subsidy until the next month in which a payment becomes due), or to not advance the due date. No matter the method of payment, the borrower may contact their servicer to elect not to advance the due date. The Secretary shall disclose to the borrower the potential consequences of electing to advance the due date or not.
(ii) If a borrower elects to make a payment in excess of the amount due and does not opt-out of advancing the due date through the process described in subparagraph (o)(3)(i), for the month the payment was made, as well as for each month the borrower would have been required to make a payment if the due date had not been advanced, the borrower will be considered to have made:
(A) a qualifying monthly payment under subparagraph (k)(8)(C) of this section;
(B) a monthly payment for the purposes of the Public Service Loan Forgiveness Program under section § 685.219(c)(2).
(a)
(ii) Borrowers with Direct Loans made on or after July 1, 2026, may select—
(A) The Tiered Standard repayment plan in accordance with § 685.208 if those Direct Loans are otherwise eligible to be repaid under the plan; or
(B) The Repayment Assistance Plan in accordance with § 685.209 if those Direct Loans are otherwise eligible to be repaid under the plan.
(2)(i) For Direct Loans made before July 1, 2026, if a borrower does not select a repayment plan, the Secretary designates the standard repayment plan described in § 685.208(b)(1) or (b)(2) for the borrower, as applicable.
(ii) For Direct Loans made on or after July 1, 2026, if a borrower does not select a repayment plan, the Secretary designates the Tiered Standard repayment plan described in § 685.208(c)(1) for the borrower.
(3) All Direct Loans obtained by one borrower must be repaid together under the same repayment plan, except that—
(i) A borrower of a Direct PLUS Loan or a Direct Consolidation Loan that is not eligible for repayment under an IDR plan may repay the Direct PLUS Loan or Direct Consolidation Loan separately from other Direct Loans obtained by the borrower;
(ii) A borrower of a Direct PLUS Consolidation Loan that entered repayment before July 1, 2006, may repay the Direct PLUS Consolidation Loan separately from other Direct Loans obtained by that borrower; and
(iii)(A) A borrower of a Direct PLUS Loan or an excepted consolidation loan defined under § 685.209 that is not eligible for repayment under the Repayment Assistance Plan must repay the Direct PLUS Loan or excepted consolidation loan separately from other Direct Loans obtained by the borrower that are being repaid under the Repayment Assistance Plan.
(B) A borrower who has received an excepted loan as defined under § 685.209 made on or after July 1, 2026, must repay the excepted loan under the Tiered Standard repayment plan under § 685.208(c)(1) and may repay the other Direct Loans separately from such excepted loan.
(b)
(i) The borrower was required to and did make a payment under the IBR plan or other IDR plan in each of the prior three months; or
(ii) The borrower was not required to make payments but made three reasonable and affordable payments in each of the prior 3 months; and
(iii) The borrower makes, and the Secretary approves, a request to change plans.
(2)(i) For Direct Loans made before July 1, 2026, a borrower may not change to a repayment plan that would cause the borrower to have a remaining repayment period that is less than zero months, except that an eligible borrower may change to an IDR plan under § 685.209 at any time.
(ii) For the purposes of paragraph (b)(2)(i) of this section, the remaining repayment period is—
(A) For a fixed repayment plan under § 685.208 or an alternative repayment plan under § 685.221, the maximum repayment period for the repayment plan, the borrower is seeking to enter, less the period of time since the loan has entered repayment, plus any periods of deferment and forbearance; and
(B) For an IDR plan under § 685.209, as determined under § 685.209(k).
(3) For Direct Loans made before July 1, 2026, a borrower who made payments under the IBR plan and successfully completed rehabilitation of a defaulted loan may choose the REPAYE plan when the loan is returned to current repayment if the borrower is otherwise eligible for the REPAYE plan and if the monthly payment under the REPAYE plan is equal to or less than their payment on IBR.
(4)(i) For Direct Loans made before July 1, 2026, if a borrower no longer wishes to pay under the IBR plan, the borrower must pay under the standard repayment plan or the Repayment Assistance Plan. For the standard repayment plan, the Secretary recalculates the borrower's monthly payment based on—
(A) For a Direct Subsidized Loan, a Direct Unsubsidized Loan, or a Direct PLUS Loan, the time remaining under the maximum ten-year repayment period for the amount of the borrower's loans that were outstanding at the time the borrower discontinued paying under the IBR plan; or
(B) For a Direct Consolidation Loan, the time remaining under the applicable repayment period as initially determined under § 685.208(b)(7)(iii) and the amount of that loan that was outstanding at the time the borrower discontinued paying under the IBR plan.
(ii) For Direct Loans made before July 1, 2026, a borrower who no longer wishes to repay under the IBR plan and who is required to repay under the Direct Loan standard repayment plan in accordance with paragraph (b)(4)(i) of this section may request a change to a different repayment plan after making one monthly payment under the Direct Loan standard repayment plan. For this purpose, a monthly payment may include one payment made under a forbearance that provides for accepting smaller payments than previously scheduled, in accordance with § 685.205(a).
(5) For Direct Loans made on or after July 1, 2026, a borrower may change repayment plans in accordance with this paragraph (b)(5) at any time after the loan has entered repayment by notifying the Secretary.
(i) A borrower who is enrolled in the Tiered Standard repayment plan under § 685.208(c)(1) or is placed in the Tiered Standard repayment plan in accordance with the provisions under paragraph (a)(2)(ii) of this section may change to the Repayment Assistance Plan under § 685.209.
(ii) A borrower who is enrolled in the Repayment Assistance Plan under § 685.209 may change to the Tiered Standard repayment plan under § 685.208(c)(1).
(a) * * *
(1) * * *
(i) Except as provided for the Income-Based Repayment plan or Repayment Assistance Plan in paragraph (a)(1)(ii) of this section, the Secretary applies any payment in the following order:
(A) Accrued charges and collection costs.
(B) Outstanding interest.
(C) Outstanding principal.
(ii) The Secretary applies any payment made under the Income-Based Repayment plan or the Repayment Assistance Plan in the following order:
(A) Accrued interest.
(B) Collection costs and late charges.
(C) Loan principal.
(d) * * *
(3) * * *
(ii) If a borrower defaults on a Direct Subsidized Loan, a Direct Unsubsidized Loan, a Direct Consolidation Loan that is not an excepted consolidation loan as defined in § 685.209, or a student Direct PLUS Loan, the Secretary may designate the Repayment Assistance Plan or the income-based repayment plan for the borrower.
(f)
(i)(A) Before July 1, 2027, the Secretary initially considers the borrower's reasonable and affordable payment amount to be an amount equal to the payment required under any eligible income-driven repayment plan, except if this amount is less than $5, the borrower's monthly payment is $5.
(B) Beginning on and after July 1, 2027, the Secretary initially considers the borrower's reasonable and affordable payment amount to be an amount equal to the payment required under any eligible income-driven repayment plan, except that if this amount is less than $10, the borrower's monthly payment is $10.
(ii)(A) The Secretary may calculate the payment amount based on information provided orally (or through other means) by the borrower or the borrower's representative and provide the borrower with a rehabilitation agreement using that amount.
(B) The Secretary may provide a single application for the purpose of enabling a borrower to apply for loan rehabilitation and income driven repayment simultaneously, and may, with the borrower's approval, calculate the payment amount for any income driven repayment plan that the borrower would otherwise be eligible for (after successful rehabilitation of the defaulted loan) to inform the borrower of the projected monthly repayment amount under such plan after the loans are rehabilitated. The Secretary may use the calculated payment required under any eligible income driven repayment plan for the purpose of determining the reasonable and affordable payment amount under this paragraph (f)(1), with the borrower's approval. Nothing in this section prohibits the Secretary from accepting an application from a borrower for an IDR plan who is currently enrolled in a rehabilitation agreement but has not yet completed such agreement by making the requisite payments.
(C) The Secretary requires the borrower to provide documentation to confirm the borrower's AGI and family size, except that the Secretary may, in his or her discretion, consider such additional documentation unnecessary if the borrower approves having the payment amount calculated by the Secretary for an eligible income driven repayment plan as the borrower's reasonable and affordable payment. If the borrower's AGI or family size is not available, or if the Secretary believes that the borrower's reported AGI or family size may be inaccurate, the borrower must provide other documentation to verify income or family size. If the borrower fails to provide acceptable documentation to verify family size, the Secretary assumes a family size of one. If the borrower does not provide the Secretary with any income documentation requested by the Secretary to calculate or confirm the
(iii) A reasonable and affordable payment amount is not—
(A) A required minimum loan payment amount (
(B) A percentage of the borrower's total loan balance; or
(C) Based on other criteria unrelated to the borrower's total financial circumstances.
(iv) Within 15 business days of the Secretary's determination of the borrower's loan rehabilitation payment amount, the Secretary provides the borrower with a written rehabilitation agreement which includes the borrower's reasonable and affordable payment amount, a prominent statement that the borrower may object orally or in writing to the reasonable and affordable payment amount with the method and timeframe for raising such an objection, a statement that the rehabilitation is null and void if the borrower does not provide the documentation required to calculate the reasonable and affordable payment amount, and an explanation of any other terms and conditions applicable to the required series of payments that must be made. To accept the agreement, the borrower must sign and return the agreement or accept the agreement electronically under a process provided by the Secretary. The Secretary does not impose any other conditions unrelated to the amount or timing of the rehabilitation payments in the rehabilitation agreement. The written rehabilitation agreement informs the borrower of the effects of having the loans rehabilitated (
(2) The Secretary provides the borrower with a written statement confirming the borrower's reasonable and affordable payment amount, as determined by the Secretary, and explaining any other terms and conditions applicable to the required series of payments that must be made before the borrower's loans can be rehabilitated. The statement informs the borrower that the borrower may object to the terms and conditions of the rehabilitation agreement and explains the method and timeframe for objecting to the terms and conditions of the rehabilitation agreement.
(3) If the borrower rejects the monthly payment amount determined under paragraph (f)(1) of this section, the Secretary recalculates the payment based solely on information provided on a form approved by the Secretary and, if requested, supporting documentation from the borrower and other sources, and considerations
(i) The borrower's, and if applicable, the spouse's current disposable income, including public assistance payments, and other income received by the borrower and the spouse, such as welfare benefits, Social Security benefits, Supplemental Security Income, and workers' compensation. Spousal income is not considered if the spouse does not contribute to the borrower's household income;
(ii) Family size as defined in § 685.209; and
(iii) Reasonable and necessary expenses, which include—
(A) Food;
(B) Housing;
(C) Utilities;
(D) Basic communication expenses;
(E) Necessary medical and dental costs;
(F) Necessary insurance costs;
(G) Transportation costs;
(H) Dependent care and other work-related expenses;
(I) Legally required child and spousal support;
(J) Other title IV and non-title IV student loan payments; and
(K) Other expenses approved by the Secretary.
(4) The Secretary provides the borrower with a new written rehabilitation agreement confirming the borrower's recalculated reasonable and affordable payment amount. To accept the agreement, the borrower must sign and return the agreement or accept the agreement electronically under a process provided by the Secretary.
(5) The Secretary includes any payment made under paragraph (1) of the definition of “satisfactory repayment arrangement” in § 685.102(b) in determining whether the 9 out of 10 payments required under paragraph (f)(1) of this section have been made.
(6) A borrower may request that the monthly payment amount be adjusted due to a change in the borrower's total financial circumstances only upon providing the documentation specified in paragraph (f)(3) of this section.
(7) During the rehabilitation period, the Secretary limits contact with the borrower on the loan being rehabilitated to collection activities that are required by law or regulation and to communications that support the rehabilitation.
(8) If a defaulted loan is rehabilitated, the Secretary instructs any consumer reporting agency to which the default was reported to remove the default from the borrower's credit history.
(9) A defaulted Direct Loan on which a judgment has been obtained may not be rehabilitated.
(10) A Direct Loan obtained by fraud for which the borrower has been convicted of, or has pled nolo contendere or guilty to, a crime involving fraud in obtaining title IV, HEA program assistance may not be rehabilitated.
(11)(i) If a borrower's loan is being collected by administrative wage garnishment while the borrower is also making monthly payments on the same loan under a loan rehabilitation agreement, the Secretary continues collecting the loan by administrative wage garnishment until the borrower makes five qualifying monthly payments under the rehabilitation agreement, unless the Secretary is otherwise precluded from doing so.
(ii) After the borrower makes the fifth qualifying monthly payment, the Secretary, unless otherwise directed by the borrower, rescinds the garnishment order issued to the borrower's employer.
(iii)(A) Before July 1, 2027, a borrower may only obtain the benefit of a suspension of administrative wage garnishment while also attempting to rehabilitate a defaulted loan once.
(B) On or after July 1, 2027, a borrower may only obtain the benefit of a suspension of administrative wage garnishment while also attempting to rehabilitate a defaulted loan a maximum of twice per loan.
(12)(i) Effective for any defaulted Direct Loan that is rehabilitated on or after August 14, 2008, and before July 1, 2027, the borrower cannot rehabilitate the loan again if the loan returns to default status following the rehabilitation.
(ii) Effective for any defaulted Direct Loan on or after July 1, 2027, the borrower may not rehabilitate the loan again if the loan returns to default status following the second rehabilitation.
(13) A borrower who has a Direct Loan that is rehabilitated and which has been returned to repayment status on or after July 1, 2024, may be transferred to REPAYE by the Secretary if the borrower's minimum payment amount on REPAYE would be equal to or less than the minimum payment amount on the Income-Based Repayment Plan.
(14) A borrower who has a defaulted Direct Loan that is rehabilitated on or after July 1, 2026, may be automatically transferred to the income-driven repayment plan by the Secretary if that borrower applied for such plan on a single application.
(a) Purpose. The Public Service Loan Forgiveness Program is intended to encourage individuals to enter and continue in full-time public service employment by forgiving the remaining balance of their Direct loans after they satisfy the public service and loan payment requirements of this section.
(b) Definitions. The following definitions apply to this section:
(1)
(2) AmeriCorps service means service in a position approved by the Corporation for National and Community Service under section 123 of the National and Community Service Act of 1990 (42 U.S.C. 12573).
(3)
(i) The use of puberty blockers, including GnRH agonists and other interventions, to delay the onset or progression of normally timed puberty in an individual who does not identify as his or her sex; and
(ii) The use of sex hormones, such as androgen blockers, estrogen, progesterone, or testosterone, to align an individual's physical appearance with an identity that differs from his or her sex.
(4)
(5)
(6)
(7)
(8)
(9)
(i) To whom an organization issues an IRS Form W-2;
(ii) Who receives an IRS Form W-2 from an organization that has contracted with a qualifying employer to provide payroll or similar services for the qualifying employer, and which provides the Form W-2 under that contract;
(iii) who works as a contracted employee for a qualifying employer in a position or providing services which, under applicable State law, cannot be filled or provided by a direct employee of the qualifying employer.
(10)
(11)
(i) Working in qualifying employment in one or more jobs—
(A) A minimum average of 30 hours per week during the period being certified,
(B) A minimum of 30 hours per week throughout a contractual or employment period of at least 8 months in a 12-month period, such as elementary and secondary school teachers and professors and instructors, in higher education, in which case the borrower is deemed to have worked full time; or
(C) The equivalent of 30 hours per week as determined by multiplying each credit or contact hour taught per week by at least 3.35 in non-tenure track employment at an institution of higher education.
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25)
(26)
(27)
(i)(A) A United States-based Federal, State, local, or Tribal government organization, agency, or entity, including the U.S. Armed Forces or the National Guard;
(B) A public child or family service agency;
(C) An organization under Section 501(c)(3) of the Internal Revenue Code of 1986 that is exempt from taxation under Section 501(a) of the Internal Revenue Code;
(D) A Tribal college or university; or
(E) A nonprofit organization that—
(1) Provides a non-governmental public service as defined in this section, attested to by the employer on a form approved by the Secretary; and
(2) Is not a business organized for profit, a labor union, or a partisan political organization; and
(ii) Does not include organizations that engage in activities such that they have a substantial illegal purpose, as defined in this section.
(28)
(i) An income-driven repayment plan under § 685.209;
(ii) The 10-year standard repayment plan under § 685.208(b) or the consolidation loan standard repayment plan with a 10-year repayment term under § 685.208(c);
(iii) Except for the alternative repayment plan, any other repayment plan if the monthly payment amount is not less than what will have been paid under the 10-year standard repayment plan under § 685.208(b);
(iv) An income-contingent repayment plan under § 685.209 for which a payment was received on or before June 30, 2028; or
(v) The Repayment Assistance Plan as defined as defined under § 685.209.
(29)
(30)
(i) aiding or abetting violations of 8 U.S.C. 1325 or other Federal immigration laws;
(ii) Supporting terrorism, including by facilitating funding to, or the operations of, cartels designated as Foreign Terrorist Organizations consistent with 8 U.S.C. 1189, or by engaging in violence for the purpose of obstructing or influencing Federal Government policy;
(iii) Engaging in the chemical and surgical castration or mutilation of children in violation of Federal or State law;
(iv) Engaging in the trafficking of children to another State for purposes of emancipation from their lawful parents in violation of Federal or State law;
(v) Engaging in a pattern of aiding and abetting illegal discrimination; or
(vi) Engaging in a pattern of violating State laws as defined in paragraph (b)(34) of this section.
(31)
(32)
(33)
(34)
(i) Trespassing;
(ii) Disorderly conduct;
(iii) Public nuisance;
(iv) Vandalism; or
(v) Obstruction of highways.
(35)
(c)
(1) A borrower may obtain loan forgiveness under this program if the borrower—
(i) Is not in default on the loan at the time forgiveness is requested;
(ii) Is employed full-time by a qualifying employer or serving in a full-time AmeriCorps or Peace Corps position—
(A) When the borrower satisfied the 120 monthly payments described under paragraph (c)(1)(iii) of this section; and
(B) At the time the borrower applies for forgiveness under paragraph (e) of this section; and
(iii) Satisfies the equivalent of 120 monthly payments after October 1, 2007, as described in paragraph (c)(2) of this section, on eligible Direct loans.
(2) Except as provided in paragraph (c)(4) of this section, a borrower will be considered to have made monthly payments under paragraph (c)(1)(iii) of this section by—
(i) Paying at least the full scheduled amount due for a monthly payment under the qualifying repayment plan;
(ii) Paying in multiple installments that equal the full scheduled amount due for a monthly payment under the qualifying repayment plan;
(iii) For a borrower on an income-driven repayment plan under § 685.209, paying a lump sum or monthly payment amount that is equal to or greater than the full scheduled amount in advance of the borrower's scheduled payment due date for a period of months not to exceed the period from the Secretary's receipt of the payment until the borrower's next annual repayment plan recertification date under the qualifying repayment plan in which the borrower is enrolled;
(iv) For a borrower on the 10-year standard repayment plan under § 685.208(b)(1) or the consolidation loan standard repayment plan with a 10-year repayment term under § 685.208(b)(2), paying a lump sum or monthly payment amount that is equal to or greater than the full scheduled amount in advance of the borrower's scheduled payment due date for a period of months not to exceed the period from the Secretary's receipt of the payment until the lesser of 12 months from that date or the date upon which the Secretary receives the borrower's next submission under subsection (e).
(v) Except during periods when a borrower is enrolled in the Repayment Assistance Plan under § 685.209, receiving one of the following deferments or forbearances for the month:
(A) Cancer treatment deferment under section 455(f)(3) of the Act;
(B) Economic hardship deferment under § 685.204(g);
(C) Military service deferment under § 685.204(h);
(D) Post-active-duty student deferment under § 685.204(i);
(E) AmeriCorps forbearance under § 685.205(a)(4);
(F) National Guard Duty forbearance under § 685.205(a)(7);
(G) U.S. Department of Defense Student Loan Repayment Program forbearance under § 685.205(a)(9);
(H) Administrative forbearance or mandatory administrative forbearance under § 685.205(b)(8) or (9); and
(vi) Being employed full-time with a qualifying employer, as defined in this section, at any point during the month for which the payment is credited.
(3) If a borrower consolidates one or more Direct Loans into a Direct Consolidation Loan, including a Direct PLUS Loan made to a parent borrower, the weighted average of the payments the borrower made on the Direct Loans prior to consolidating and that met the criteria in paragraphs (c)(2)(i) through (vi) of this section will count as qualifying payments on the Direct Consolidation Loan.
(4) Effective on or after July 1, 2026, through a standard as described in paragraph (h) of this section, no payment shall be credited as a qualifying payment for any month subsequent to a determination that a qualifying employer engaged in activities enumerated in paragraph (b)(30) such that it has a substantial illegal purpose, as described in this section.
(d)
(e)
(1) Notwithstanding paragraph (f) of this section, after making the 120 monthly qualifying payments on the eligible loans for which loan forgiveness is requested while working the 120 months of qualifying service, a borrower may request loan forgiveness by filing an application approved by the Secretary.
(2) If the Secretary has sufficient information to determine the borrower's qualifying employer and length of employment, the Secretary informs the borrower if the borrower is eligible for forgiveness.
(3) If the Secretary does not have sufficient information to make a determination of the borrower's eligibility for forgiveness, the borrower must provide additional information about the borrower's employment and employer on a form approved by the Secretary.
(4) If the borrower is unable to secure a certification of employment from a qualifying employer, the Secretary may determine the borrower's qualifying employment or payments based on other documentation provided by the borrower at the Secretary's request.
(5) The Secretary may request reasonable additional documentation pertaining to the borrower's employer or employment before providing a determination.
(6) The Secretary may substantiate an employer's attestation of information provided on the form in paragraph (e)(3) of this section based on a review of information about the employer.
(7) If the Secretary determines that the borrower meets the eligibility requirements for loan forgiveness under this section, the Secretary—
(i) Notifies the borrower of this determination; and
(ii) Forgives the outstanding balance of the eligible loans.
(8) If the Secretary determines that the borrower does not meet the eligibility requirements for loan forgiveness under this section, grants forbearance of payment on both principal and interest for the period in which collection activity was suspended. The Secretary notifies the borrower that the application has been denied, provides the basis for the denial, and informs the borrower that the Secretary will resume collection of the loan. The Secretary does not capitalize any interest accrued and not paid during this period.
(9) If the Secretary has notified the borrower's employer that the employer may no longer satisfy the definition of qualifying employer set forth in paragraph (b)(28) of this section, pending a determination made under paragraph (h) of this section, the Secretary notifies the borrower of the potential change in the employer's status.
(10) If the Secretary has determined the borrower's employer has ceased to be a qualifying employer as a result of a determination made under paragraph (h) of this section, the Secretary notifies the borrower of the change in the employer's status.
(f)
(g)
(1) Within 90 days of the date the Secretary sent the notice of denial of forgiveness under paragraph (e)(8) of this section to the borrower, the borrower may request that the Secretary reconsider whether the borrower's employer or any payment meets the requirements for credit toward forgiveness by requesting reconsideration on a form approved by the Secretary. Borrowers who were denied loan forgiveness under this section after October 1, 2017, and prior to July 1, 2023, have 180 days from the effective date of this Final Rule to request reconsideration.
(2) To evaluate a reconsideration request, the Secretary considers—
(i) Any relevant evidence that is obtained by the Secretary; and
(ii) Additional supporting documentation not previously provided by the borrower or employer.
(3) The Secretary notifies the borrower of the reconsideration decision and the reason for the Secretary's determination.
(4) If the Secretary determines that the borrower qualifies for forgiveness, the Secretary adjusts the borrower's number of qualifying payments or forgives the loan, as appropriate.
(5) After the Secretary makes a decision on the borrower's reconsideration request, the Secretary's decision is final, and the borrower will not receive additional reconsideration unless the borrower presents additional evidence.
(6) Except for repayment periods when a borrower is repaying under the Repayment Assistance Plan under § 685.209, for any months in which a borrower postponed monthly payments under a deferment or forbearance and was employed full-time at a qualifying employer as defined in this section but was in a deferment or forbearance status besides those listed in paragraph (c)(2)(v) of this section, the borrower may obtain credit toward forgiveness for those months, as defined in paragraph (d) of this section, for any months in which the borrower—
(i) Makes an additional payment equal to or greater than the amount they would have paid at that time on a qualifying repayment plan or
(ii) Otherwise qualified for a $0 payment on an income-driven repayment plan under § 685.209.
(7) Notwithstanding paragraph (g)(1) of this section, a borrower may not request reconsideration under this paragraph (g) based on the Secretary's determination that the organization lost its status as a qualifying employer due to engaging in activities that have a substantial illegal purpose under the standard described in paragraph (h) of this section.
(h)
(1) The Secretary determines by a preponderance of the evidence, and after notice and opportunity to respond (which is referred to as the “employer reconsideration process”), that a qualifying employer has engaged on or after July 1, 2026, in illegal activities such that it has a substantial illegal purpose by considering the materiality of any illegal activities or actions as described in paragraph (b)(30) of this section. In making such a determination, the Secretary shall presume that any of the following is conclusive evidence that the employer engaged in activities enumerated in paragraph (b)(30):
(i) A final judgment by a State or Federal court, whereby the employer is found to have engaged in illegal activities that have a substantial illegal purpose;
(ii) A plea of guilty or
(iii) A settlement that includes admission by the employer that it engaged in illegal activities that have a substantial illegal purpose described in paragraph (h) of this section.
(2) Nothing in this paragraph (h)(2)shall be construed to authorize the Secretary to determine an employer has a substantial illegal purpose based upon the employer or its employees exercising their First Amendment protected rights, or any other rights protected under the Constitution.
(i)
(1) The Secretary will determine that a qualifying employer violated the standard under paragraph (h) of this section when the Secretary:
(i) Receives an application as referenced under paragraph (e) of this section in which the employer fails to certify that it did not participate in activities that have a substantial illegal purpose; or
(ii) Determines that the qualifying employer engaged in activities such that it has a substantial illegal purpose under paragraph (h) of this section, unless, prior to the issuance of the Secretary's determination, the Secretary includes the factors set forth in paragraph (j)(2) of this section.
(2) Notwithstanding paragraph (i)(1) of this section, the Secretary shall, in the event an employer is operating under a shared identification number or other unique identifier, consider the organization to be separate if the employer is operating separately and distinctly, for the purposes of determining whether an employer is eligible.
(j)
(1) 10 years from the date the Secretary determines the organization engaged in activities such that it has a substantial illegal purpose in accordance with paragraph (h) of this section, if, at or after that time, the organization certifies on a borrower's subsequent application that the organization is no longer engaged in activities that have a substantial illegal purpose as defined in paragraph (b)(30) of this section; or
(2) The Secretary approves a corrective action plan signed by the employer that includes—
(i) a certification by the employer that it is no longer engaging in activities that have a substantial illegal purpose as defined in paragraph (b)(30) of this section;
(ii) a report describing the employer's compliance controls that are designed to ensure that the employer does not continue to engage in activities that have a substantial illegal purpose as defined in paragraph (b)(30) of this section in the future; and
(iii) any other terms or conditions imposed by the Secretary designed to ensure that employers do not engage in actions or activities that have a substantial illegal purpose.
(k)
(d) * * *
(2) * * *
(i)(A) Before July 1, 2028, the borrower has a Federal Consolidation Loan that is in default or has been submitted to the guaranty agency by the lender for default aversion, and the borrower wants to consolidate the Federal Consolidation Loan into the Direct Loan Program for the purpose of obtaining an income-contingent repayment plan or an income-based repayment plan; or
(B) On or after July 1, 2028, the borrower has a Federal Consolidation Loan that is in default or has been submitted to the guaranty agency by the lender for default aversion, and the borrower wants to consolidate the Federal Consolidation Loan into the Direct Loan Program for the purpose of obtaining the Repayment Assistance Plan; or
(h)(1) For a Direct Consolidation Loan made before July 1, 2026, a borrower may choose a repayment plan, in accordance with §§ 685.208, 685.209, and 685.221, and may change repayment plans in accordance with § 685.210(b).
(2) For a Direct Consolidation Loan made on or after July 1, 2026, a borrower may choose the Tiered Standard repayment plan, or the Repayment Assistance Plan, in accordance with §§ 685.208, 685.209 and may change repayment plans in accordance with § 685.210(b).
(i) * * *
(2)(i) Borrowers who entered repayment before July 1, 2006. The Secretary determines the repayment period under § 685.208 (b)(3)(iv) or (5)(iv) on the basis of the outstanding balances on all of the borrower's loans that are eligible for consolidation and the balances on other education loans except as provided in paragraphs (i)(3)(i), (ii), and (iii) of this section.
(ii) Borrowers entering repayment on or after July 1, 2006. The Secretary determines the repayment period under § 685.208 (b)(2)(iii) or (7)(iii) on the basis of the outstanding balances on all of the borrower's loans that are eligible for consolidation and the balances on other education loans except as provided in paragraphs (i)(3)(i) through (iii) of this section.
(3)(i) The total amount of outstanding balances on the other education loans used to determine the repayment period under § 685.208(b)(2)(iii), (3)(iv), (5)(iv), and (7)(iii) may not exceed the amount of the Direct Consolidation Loan.
(ii) The borrower may not be in default on the other education loan unless the borrower has made satisfactory repayment arrangements with the holder of the loan.
(iii) The lender of the other educational loan may not be an individual.
(a) The Secretary may provide an alternative repayment plan to a borrower who has not received a Direct Loan on or after July 1, 2026, and who demonstrates to the Secretary's satisfaction that the terms and conditions of the repayment plans specified in §§ 685.208 and 685.209 are not adequate to accommodate the borrower's exceptional circumstances.
(e) The repayment plan under this section shall only apply to Direct Loans made before July 1, 2026.
(d) * * *
(5) The school must disburse loan proceeds in substantially equal